BreastScreen Aotearoa National Policy and Quality …...Mammography Screening and the BreastScreen...

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BreastScreenA O T E A R O A

National Policy & Quality StandardsNational Policy & Quality Standards

for BreastScreen Aotearoa


Published in February 2004 by the National Screening Unit

PO Box 5013, Wellington, New Zealand

ISBN 0-478-25872-0 (Book)

IBSN 0-478-25873-9 (Internet)

HP 3746

This document is available on the healthywomen website:http://www.healthywomen.org.nz

The National Screening Unit is a separate unit of the Ministry of Health

National Policy & Quality Standards

February 2004 – BreastScreen Aotearoa National Policy and Quality Standards VERSION 1A 1

FOREWORD

FOREWORD

The National Policy and Quality Standards determine the minimum requirements for any ServiceProvider of BreastScreen Aotearoa services, be they Independent Service Providers, LeadProviders or Subcontracted Providers working within New Zealand’s National Breast ScreeningProgramme, BreastScreen Aotearoa.

Breast screening has the potential to prevent premature death and disability and to improve thequality of life. However, it also has additional costs and the potential to harm.

Breast screening is a complex process, and for those women participating in the screeningpathway the requirement exists for the National Screening Unit and its service providers toreassure women that services are based on quality evidence, and operate within the context of aneffective quality assurance programme.

The Interim Standards have been in existence for some time, and following extensive revision,consultation with Providers, Professional Groups, Consumers and Key Stakeholders theseNational Policy and Quality Standards have been developed. While for some the process toachieve this was initially perceived as straightforward, the task to ensure robust evidence-basedStandards was more complex than anticipated and the timeframes were extended toaccommodate these requirements.

Our present stage is one of implementing the National Policy and Quality Standards and ongoingwork to ensure these Standards remain a dynamic document. The development of additionalStandards and/or protocols will be undertaken as required, to ensure they are both appropriateand current.

We would like to thank all those who have worked extremely hard in developing these NationalPolicy and Quality Standards, and we look forward to working with everyone concerned, toensure New Zealand’s National Breast Cancer Screening Programme, BreastScreen Aotearoa,maintains (or surpasses) a level of quality which is comparable to the best programmesinternationally.

Barbara Phillips Dr Madeleine Wall

Manager Clinical Leader BreastScreen Aotearoa BreastScreen Aotearoa National Screening Unit National Screening Unit


BreastScreenA O T E A R O A

National Policy & Quality Standards

INTRODUCTION (RED)

SECTION 1 UNIVERSAL REQUIREMENTS (LIGHT BLUE)

SECTION 2 THE SCREENING PATHWAY (DARK BLUE)

SECTION 3 MANDATORY LEADERSHIP POSITIONS (GREEN)

SECTION 4 PROFESSIONAL REQUIREMENTS (YELLOW)

APPENDICES A-Z (RED)


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RO

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INTRODUCTION

INTRODUCTION

Acknowledgments ................................................................................................................................................2

Document Version Control Form ..................................................................................................................3

Background to the standards ..........................................................................................................................4

A guide to the standards..................................................................................................................................4

The Quality Framework ..................................................................................................................................4

Explanation of terminology..............................................................................................................................5

Background to Breast Screening............................................................................................................................6

Breast cancer in New Zealand ........................................................................................................................6

Early detection of breast cancer......................................................................................................................6

Organised approach to screening....................................................................................................................7

Expected benefits from population-based screening ......................................................................................7

History of BreastScreen Aotearoa ..................................................................................................................7

National Policy ......................................................................................................................................................9

Eligibility ..........................................................................................................................................................9

Eligibility for treatment ..................................................................................................................................10

Scope ............................................................................................................................................................10

Configuration ................................................................................................................................................10

Incorporating the Treaty of Waitangi ............................................................................................................11

Reducing inequalities for all New Zealanders, including Maori and Pacific peoples......................................11

BreastScreen Aotearoa Priority Groups for Screening..................................................................................11

Health and Disability Commissioner’s Code of Consumers’ Rights..............................................................12

Ethical Issues ..................................................................................................................................................12

Document Maintenance of National Policy and Quality Standards ....................................................................12

Monitoring and Audit of National Policy and Quality Standards ........................................................................13


INTRODUCTION

ACKNOWLEDGMENTS

The Ministry of Health would like to acknowledge theindividuals and groups who have contributed to thedevelopment and subsequent completion of theBreastScreen Aotearoa National Policy and QualityStandards.

We are grateful to the BreastScreen Aotearoa LeadProviders and Independent Services Providers, who gavewillingly of their time, and the support from theprofessional groups involved.

In addition, we acknowledge the importance of theEuropean Guidelines for Quality Assurance inMammography Screening and the BreastScreen AustraliaNational Accreditation Standards as reference documentswhich contributed to the completion of the BreastScreenAotearoa National Policy and Quality Standards.

2 VERSION 1A BreastScreen Aotearoa National Policy and Quality Standards – February 2004

INTRODUCTION

DOCUMENT VERSION CONTROL FORM

Document Owner – BSA Manager (B Phillips) and Clinical Leader (Dr M Wall)

DATE PAGES CHANGED/ VERSION ACTIONED ISSUED COMMENT NUMBER BY PROVIDER #

February 2004 First Issue NP&QS 1A

# Signature of person in provider organisation who received changes and ensured document control


INTRODUCTION

BACKGROUND TO THE STANDARDSStandards New Zealand (SNZ), on behalf of the Ministry ofHealth, facilitated the initial development of the NationalPolicy and Quality Standards (NP&QS) for BreastScreenAotearoa in line with internationally recognised processes,while working with representatives from the health sectorand key stakeholders.

Subsequently, a decision was made to move this process in-house with the inception of the National Screening Unitand the establishment of a dedicated BreastScreenAotearoa team.

The resulting NP&QS are a collaborative effort betweenthe National Screening Unit, BreastScreen Aotearoa LeadProviders, Independent Service Providers (ISPs), keystakeholders and consumers. They align with those ofinternational breast screening programmes.

A GUIDE TO THE STANDARDSThe NP&QS apply to all Providers (Lead Providers, theirsubcontractors and Independent Service Providers) whoprovide services to BreastScreen Aotearoa. It is theresponsibility of Lead Providers and Independent ServiceProviders to ensure that all providers for which they haveresponsibility meet the NP&QS.

Providers are contractually obliged to meet the NP&QSwhich also provide the basis for the National ScreeningUnit’s ongoing programme monitoring and Providercompliance audit.

The NP&QS replace the BreastScreen Aotearoa InterimNational Quality Standards (1996) and the InterimBreastScreen Aotearoa National Operations Manual (1998),which had previously determined the operational andquality standards, and level of service required for thenational programme.

As well as meeting the NP&QS, it is expected that eachProvider will meet its legal obligations, including recognitionand adherence to health legislation and any legislationrelated to the privacy of health information; in particular:

• Health Act 1956

• Medicines Act 1981

• Cancer Registry Act 1992

• Privacy Act 1993

• Health and Disability Services Act 1993

• Health Information Privacy Code 1994

• Health and Disability Commissioner’s Act 1994

• New Zealand Health and Disabilities Act 2000.

THE QUALITY FRAMEWORKProviders are also expected to align quality processes withthe Quality Framework for Screening Programmes in NewZealand. The Quality Framework stems from the NationalScreening Unit’s Strategic Plan. It is derived from theVision, Strategic Outcomes (Health Improvement andReducing Inequalities), Strategic Objectives (Sustainability,Maximising Benefits, Building Understanding) and a key areafor action: Quality Improvement.

The National Screening Unit’s vision for the future is:

Saving Lives, Reducing Inequalities, and Building

the Nation’s Health by Leading the Delivery of

Screening Programmes, Uncompromising in Their

Quality, and Trusted by the Communities we Serve.

The Quality Framework is the National Screening Unit’sresponse to the New Zealand Health and Disability SystemQuality Improvement Strategy for Screening Programmes inNew Zealand. The Quality Framework articulates high levelquality expectations for screening programmes and sets thestrategic foundation for New Zealand’s screeningprogrammes. The purpose statement of the QualityFramework is:

Implementing the Quality Framework for Screening

Programmes in New Zealand will assist in

achieving the National Screening Unit’s vision and

ensure the best possible outcomes for the eligible

populations served by the screening programmes

in New Zealand.

The Quality Framework applies to the National CervicalScreening Programme (NCSP), the national breastscreening programme – BreastScreen Aotearoa (BSA) andany future national screening programmes managed fromthe offices of the National Screening Unit. It is alsogenerally applicable to both organised and opportunisticscreening programmes in New Zealand.

The Quality Framework will shape the culture of the NewZealand Screening Programmes. The Programmes include:the National Screening Unit, Providers of services to thenational screening programmes, and the eligible populationsthe programmes intend to serve*.


INTRODUCTION

The National Screening Unit, in its leadership role, wishesto share its quality purpose, vision and language and fostera culture within the screening programmes of:

• working together as ‘one programme’

• striving for excellence in a collaborative, learningenvironment

• encouraging clarity of accountability for quality

• managing quality through a ‘systems approach’

• enhancing co-ordination of quality improvementactivities.

In line with the New Zealand Health and Disability SystemQuality Improvement Strategy1 the Quality Frameworkindicates a shift in environment from quality assurance toquality improvement. This does not imply that qualityassurance activities are of lesser importance, rather thatthey become part of a wider quality system which focuseson continual improvement where incremental steps aretaken to incorporate new knowledge, changes intechnology and changing expectations.

The Quality Framework can be summarised as comprisingthree key elements:

• principles

• quality requirements

• factors enabling implementation.

EXPLANATION OF TERMINOLOGY

Standard

The Standard is the overall goal, and wherever possible isoutcome-focused and relates directly to the woman. Thestandard will always specify the objective that is expected.

The Standard is achieved when all indicators associatedwith it are met,

e.g.The entire screening pathway and all other activitiesprovided within BreastScreen Aotearoa have a keyfocus on women and their needs (as they relate tobreast screening) to ensure each woman has confidencein the Programme.

Quality Indicators

The quality indicators in this document should bemeasurable elements of service provision. Qualityindicators will usually relate to the desired outcome orperformance of staff or services,

e.g.BreastScreen Aotearoa Providers have a commitmentto work collaboratively with women; women’s groupsor community organisations; or with women and theirrepresentatives to ensure the Programme is wellwomen-centred and reflects the particular issuesrelevant to the screening of asymptomatic women.

Criteria

The criteria are components of service provision (inputs)that are required to be in place in order to achieve theindicator,

e.g.BreastScreen Aotearoa Providers ensure that all womenparticipating in the Programme receive services whichare:

a. delivered in a professional manner consistent witheach woman’s physical, emotional, spiritual andcultural needs

b. provided in line with all relevant standards andlegislation and in accordance with:

i. the Code of Practice and ethics of eachprofession

ii. the philosophy of minimising potential harm andoptimising the quality of life for that individual.

Evaluation Process

The evaluation process is the means through which thecriteria are assessed,

e.g.1. Satisfaction surveys.

2. The internal audit process ensures that the criteriaare complied with, and identified issues areaddressed through the Continuous QualityImprovement (CQI) process.

Evaluation Target

Targets are only specified where quantitative measures areavailable. If no target has been set, the expectation is thatthere will be full compliance with all criteria.

The evaluation target should clearly identify the level ofcompliance required to meet the specific standard,indicator or criteria,

e.g.1. 95% of women respondents report that the overallservice they received is women-centred and meetstheir needs.

2. All other criteria are met.

* The eligible populations the programmes intend to serve includes those people who participate in screening services and any follow-up diagnostic or therapeutic treatments they may access, as well as those persons eligible to participate in the programme who arenot currently participating, other than those who have made an active choice (informed decision) not to participate in the screeningprogramme. 1 Ministry of Health. 2003. New Zealand Health and Disability System Quality Improvement Strategy.


INTRODUCTION

Appendices

The referenced appendices included in this document areconsidered part of the NP&QS.

Interpretation

The broad diversity and uniqueness of the health anddisability sector have necessitated the use of a number ofgeneric phrases and terminology throughout this document.It is not the intention of this document to standardiseterminology throughout the sector; rather that eachProvider interprets the intent of the statement into theireveryday language.

Deviations from the National Policy and Quality Standards

The National Policy and Quality Standards (NP&QS)determine the level and standard of service provided by theLead Providers, subcontracted Providers and theIndependent Service Providers (ISPs). In specificcircumstances, where Lead Providers and ISPs are unableto meet the NP&QS, a Quality Deviation would need to besought from the National Screening Unit.

The application for a Quality Deviation will document therequest on the Quality Deviation template, including thereason(s)/ rationale for a Deviation, the relevant Standard,additional information pertaining to the location, monitoringor supervisory mechanisms etc. Furthermore, strategiesand procedures should be included which could beimplemented to ensure the Standards are upheld while theDeviation remained in force. Refer: Appendix T: QualityDeviation Application Template and Process.

BACKGROUND TO BREASTSCREENING

BREAST CANCER IN NEW ZEALANDBreast cancer is an important health concern in NewZealand. It is the leading cause of cancer registrations anddeaths for non-Maori women in New Zealand, and theleading cause of cancer registrations and second leadingcause of cancer deaths (after lung cancer) for Maori women.In 1998 (the most recently published data)2, 628 NewZealand women died from the disease, and 2061 wereregistered as having been diagnosed with breast cancer.

The total breast cancer registration rate has increased by16 percent from 1993 to 1996 with most of the increaseoccurring prior to 1994. Rationale for the increase since1993 may be due to more complete reporting since theintroduction of the Cancer Registry Act on 1 July 1994,which made registration a legislative requirement.

Internationally, New Zealand’s annual age-standardisedbreast cancer incidence rate is among the highest in theworld3 and the projections of the cancer burden in NewZealand suggest that breast cancer mortality andincidence can be expected to increase steadily throughto the year 20214. Any reduction in breast cancermortality related to BreastScreen Aotearoa would notbe expected to be detected for a minimum of ten yearsfrom the start of the programme.

EARLY DETECTION OF BREAST CANCERAlthough risk factors for breast cancer have been identified5,primary prevention of breast cancer is not yet possible.

However, mammographic screening is able to identify cancersat an early stage, thereby improving the probability of apositive outcome, as survival after diagnosis and treatment isdirectly related to the stage at which the cancer is diagnosed.In addition, early stage small tumours are more amenable totreatment with breast-conserving surgery (that is, completelocal excision) which is known to have some importantpsychological and practical advantages over mastectomy.

Mammographic screening as a cancer control strategy hasbeen introduced in a number of nations, including NewZealand. International evidence has shown that breastscreening delivered through a properly organisedprogramme is efficacious in reducing mortality from breastcancer for women aged 50-69 by 30 percent.6


INTRODUCTION

ORGANISED APPROACH TO SCREENINGOrganised breast screening programmes aim to reducebreast cancer mortality by routinely screening an entire,defined population at regular intervals (in thesecircumstances, women asymptomatic of breast cancer). Areduction in mortality at a population level depends uponhigh levels of coverage of the population, quality screeningand follow-up services.

For screening to be effective in meeting its aim of reducingmortality it is important that a programme is well organisedand focused. For this reason, an organised approach toscreening on a national basis is more successful at reducingthe incidence and mortality from breast cancer than ad hocscreening. Furthermore, the initiative is that of the healthservice and not the women.

The key difference between an ad hoc screening approachand an organised population-based screening approach isthat ad hoc screening does not necessarily include thefollowing essential components of an effective screeningprogramme:

1. co-ordination of all elements of the service

2. a population-based register (currently no such registeris available to BreastScreen Aotearoa)

3. an invitation and recall system

4. a multidisciplinary team approach to screening,assessment and diagnosis

5. close linkages with treatment services

6. specific operational policies, quality standards and on-going monitoring and quality assurance processes.

EXPECTED BENEFITS FROM POPULATION-BASED SCREENINGIt has been estimated that an organised breast screeningprogramme in New Zealand could save approximately 100lives per year in the first five years, and up to 175 lives peryear after twenty years of screening. It should also benoted that the number of deaths from breast cancer peryear is influenced by other factors, including the trueincidence of breast cancer and treatment advances.Therefore, while there is confidence that an organisedbreast screening programme will result in a reduction in thenumber of deaths, the actual number will also be influencedby factors other than screening.

HISTORY OF BREASTSCREEN AOTEAROADuring the 1980s a number of nations implemented local,regional and national population-based breast screeningprogrammes.

In 1987, on the basis of early international evidence, theCancer Society of New Zealand and the then Departmentof Health invited a working group to makerecommendations on breast screening by mammography.The resulting report, now known as the Skegg Report,7

concluded that New Zealand had a shortage of professionalsskilled in the specialised techniques required for thescreening of asymptomatic* women. It recommended thatdecisions about routine screening be delayed until pilotprogrammes were established, with an assessment of theireffectiveness, economic efficiency and social acceptability.

As a result of the Skegg Report, the Government agreed tofund two pilot mammography screening programmes (inWaikato and Otago/Southland). These were established andbegan screening in 1991. Initially, the pilots were set up tocomplete one and a half rounds of screening by June 1994.In December 1993, the Minister of Health approved theextension of the pilots to December 1996 to allow for thecompletion of two full rounds of screening.

During 1995, the Government was faced with two optionsfor the future direction of breast screening services:

1. to develop and implement an organised population-based breast screening programme

2. to co-ordinate an organised approach to the existing adhoc opportunistic screening approach.

The two pilot programmes were based on an organisedpopulation-based screening model. They actively identified,invited, and recalled eligible women in the community,provided a screening service at both mobile and fixed units,ensured follow-up assessment services and informed thecommunity about breast screening. Dedicated informationsystems enabled organised monitoring and auditing of thepilots and the entire process provided an opportunity toestablish close links with treatment services.

Outside the two pilot programme areas, there existed anad hoc approach to breast screening. Women who wereaware of the importance of mammography screening, andthose who could afford it, sought out those services if theywere available in their region. While some private providersactively promoted their services, there was generally nosystematic identification and invitation of women forscreening outside of the pilot programmes.

2 NZHIS. 2002. Cancer, new registrations and deaths 1996. Wellington: Ministry of Health.3 Parkin DM, Whelan SL, Ferlay J, et. al. 1997. Cancer Incidence in Five Continents (Vol 11).4 Cox B. 1995. Projections of the cancer burden in New Zealand. Wellington: Public Health Commission.5 Love RR. 1995. Approaches to the prevention of breast cancer. Journal of Clinical Endocrinological Metabolism 80:1757-60.6 International Agency for Research on Cancer. 2002. IARC handbooks of cancer prevention: volume 7 – breast cancer screening.

Lyon: IARC Press.

7 Skegg D, Paul C, Benson-Cooper D, Chetwynd J, et al. 1988. Mammographic screening for breast cancer: prospects for New Zealand.New Zealand Medical Journal 101: 531-533.

* Asymptomatic women are women who do not have a symptom that may be due to breast cancer. (Refer Appendix A: Glossary)


INTRODUCTION

In June 1995, the Minister of Health announced that theGovernment would be introducing a nationwide breastcancer screening programme (note ‘nationwide’ rather thannational) for women aged 50 to 64 years of age. The basisfor that decision was:

• breast cancer was a significant health issue in NewZealand

• there was clear evidence of the efficacy ofmammographic screening in reducing mortality frombreast cancer

• studies confirmed that breast cancer screening wasbetter value for money relative to other available healthinterventions

• the early results from the pilot programmesdemonstrated that mammographic screening (asdelivered in those pilot programmes) could be doneeffectively and efficiently in New Zealand

• mammographic screening was effective in reducingmortality from breast cancer among women aged 50-64years

• the health sector had the capacity to accommodate ascreening programme for women aged 50-64 years.

Following this announcement, the Minister of Healthappointed a Breast Cancer Screening Policy AdvisoryGroup (BCSPAG) in July 1995 to provide policy advice onthe establishment of a population-based screeningprogramme in New Zealand.

Key recommendations of the Group were that:

1. the programme should be an organised, population-based screening programme as part of a strategicapproach to breast cancer detection and management

2. there should be central planning, co-ordination,monitoring and evaluation of the programme

3. the service specifications should be based on those ofthe pilot programmes, but modified according tolessons learned

4. national quality standards should be developed

5. all women aged 50 to 70 without symptoms should beeligible

6. there should be no charge to women for access to theprogramme.

Further planning and policy development was requiredbefore any implementation of a national breast screening

programme could occur. Between 1996 and 1998, workwas undertaken on the development of national targets andindicators, a national monitoring and evaluation system andan information system to support the programme.

There were major changes in policy that originated in 1991for the delivery of health services in New Zealand. Theseaffected the development of breast screening services fromthe pilot programmes into the national breast screeningprogramme when it was extended nationwide. Delivery ofthe BSA services across New Zealand through six LeadProvider organisations was chosen as the method ofadministering the programme. This resulted in a partiallycentralised programme, with national policy but regionaladministration through contracts with the six Lead Providerorganisations.

While the BCSPAG had originally recommended two-yearly, and two-view mammography for asymptomaticwomen aged 50-69 years,8 the Government of the daydecided to limit the programme to women aged 50-64 andto review the age range at a later date.

This decision was in response to concerns that the thenhealth service may not have had sufficient trained staff (i.e.MRTs, Radiologists) to operate a breast screeningprogramme. There were also concerns that theprogramme may have had major flow-on effects for breastsurgery and radiation oncology departments.

Furthermore, the Minister reiterated that the Governmentwould seek further advice from a Ministry of HealthAdvisory Group on whether the programme should beextended to older and/or younger women.9

In June 1996, the Ministry of Health published the InterimNational Quality Standards. This document outlined theStandards that would be required to be met by breastscreening Providers in order to maximise the quality of theprogramme to women.

In 1997, the Regional Health Authorities (RHAs) enteredinto a tendering process with interested parties in order toidentify and select appropriate providers from which topurchase breast screening services. A decision was madewhereby the RHAs would enter into an agreement with adefined provider to cover the bulk of breast screeningservices within a geographic region. Providers wererequired to meet the Interim National Quality Standards indetermining configuration and delivery of their serviceswithin that region. Subsequently contracts were enteredinto with six main Lead Providers in 1998.


INTRODUCTION

Following the restructuring within the New Zealand healthservices, the former Health Funding Authority (HFA)established Independent Service Providers (ISPs) who werecontracted during 1997 and 1998 to provide health promotionand support services for Maori and Pacific Island women.

The Interim National Operations Manual was completed in1998 and implemented to complement the Interim NationalQuality Standards in delivering breast screening services.

BreastScreen Aotearoa was launched nationally inDecember 1998 with services being offered in each of theregions from that time. Since then, large numbers of eligiblewomen have participated in BreastScreen Aotearoa.

NATIONAL POLICY

The aim of screening is to reduce morbidity or mortalityfrom a specific health condition. It reduces the risk ofdevelopment of, or dying from a disease, but is not aguarantee of prevention, or diagnosis and cure. Asscreening has its benefits, cost and potential harm, there isan ethical obligation to minimise harm and maximisebenefits at a reasonable cost.

The National Screening Unit has adopted a definition of‘screening’ based upon that of the National ScreeningCommittee of the United Kingdom, and adapted by theNew Zealand National Health Committee.

‘Screening is a health service in which members of

a defined population, who either do not

necessarily perceive they are at risk of, or are

already affected by a disease or its complications,

are asked a question or offered a test, to identify

those individuals who are more likely to be helped

than harmed by further tests or treatment to

reduce the risk of a disease or its complications.’

(National Health Committee 2003)10

In order for a screening programme to be successful, a co-ordinated approach is required. The essentials of suchan approach include clear lines of accountability, high-quality service provision, effective monitoring of definedpolicy and quality standards, the timely availability andappropriate integration of screening services with diagnosticand treatment services, and high levels of programmeenrolment and participation. In addition, it is important toidentify priority groups who are most likely to benefit fromscreening and to ensure that the programme is accessibleto these groups.

Three principal factors in influencing how much benefit canbe obtained in any population are the proportion of theeligible women who are screened, the sensitivity of thescreening test (mammography) in detecting invasive cancersat an early stage, and the adequacy of treatment providedfor the screen-detected cancers.

ELIGIBILITYCurrently, BreastScreen Aotearoa offers freemammography every two years to:

• women aged 50-64 years of age

• women who have not had mammography within theprevious 12 months

10 NHC. 2003. Screening to improve health in New Zealand Criteria to Assess Screening Programmes in New Zealand. Wellington: NationalHealth Committee.

8 BCSPAG. A summary of interim recommendations to the Director-General of Health from the Breast Cancer Screening Policy Advisory Group.Recommendation 6. Nov 1995.

9 Minister of Health. Media Release, 15 June 1995.


INTRODUCTION

• women who are free from breast cancer. If previouslydiagnosed with breast cancer women who are at leastfive years since diagnosis

• asymptomatic women

• women who are New Zealand citizens including thosewhose usual place of abode is in the Cook Islands, Niueor Tokelau

• women who hold an immigration permit that allows astay in New Zealand of two or more years.

(Refer Appendix G: 2003 Direction of the Minister ofHealth relating to Eligibility for Publicly Funded Personaland Disability Health Services In New Zealand.)

ELIGIBILITY FOR TREATMENTRegardless of an individual’s participation in thisProgramme, free treatment services for individualsdiagnosed with cancer are only available to those who areeligible for publicly funded health services in New Zealand.(Refer Appendix G: 2003 Direction of the Minister ofHealth relating to Eligibility for Publicly Funded Personaland Disability Health Services In New Zealand.)

A number of private services also provide treatment, butthere is a cost to the woman, or her insurance company.

SCOPEBreastScreen Aotearoa provides a national screeningprogramme, which includes:

1. promotion of screening

2. education about breast cancer, screening and treatment

3. identification and invitation of women eligible forscreening

4. invitation and recall of women eligible for screening attwo-yearly intervals

5. screening mammography for eligible women

6. multidisciplinary assessment for screened womenincluding clinical examination, ultrasound, fine needleaspiration biopsy, core needle biopsy, stereotactic-directed biopsy, open biopsy and pathology services

7. communication of the screening results to women andtheir primary health care provider

8. support and counselling for women undergoingassessment procedures

9. referral to treatment for those women identified withbreast cancer

10. an information system to support the screeningprogramme

11. quality assurance, audit, monitoring and evaluation.

CONFIGURATIONThe National Screening Unit is a separate unit of the PublicHealth Directorate of the Ministry of Health and isresponsible for:

• national management and oversight of BreastScreenAotearoa

• funding of BreastScreen Aotearoa Providers

• national co-ordination of Providers

• national health promotion activities (includingdevelopment of standardised resources and nationalpromotions)

• national strategy and policy development

• national monitoring, evaluation and audit.

BREASTSCREEN AOTEAROA PROVIDERSBreastScreen Aotearoa is delivered to women on both anational and regional basis. For the purposes of thisdocument, a BreastScreen Aotearoa Provider is defined asbeing any Lead, subcontracted Provider or IndependentServices Provider (ISP) who deliver services on behalf ofBreastScreen Aotearoa.

Each Lead Provider is responsible for providing, eitherdirectly or by subcontracting another provider, all services(except those provided by Independent Service Providers)throughout their region. This includes:

• health promotion

• invitation

• screening

• assessment

• referral to treatment

• quality assurance.

Screening is provided at both fixed and mobile sitesthroughout each Lead Provider region while assessment isprovided at a reduced number of locations.

The Lead Provider and Independent Service Providerremain responsible for ensuring that all services within theirarea, either provided directly or through a subcontract withanother Provider, are delivered according to the NP&QScontractually required of them.

Independent Service Providers (ISPs) are contracted by theNational Screening Unit to provide health promotion,invitation and support services directly to specific groups ofwomen who might otherwise not be reached by LeadProviders, that is, Maori/Iwi and Pacific women. Each ISP isresponsible for providing services throughout their region.

Independent Service Providers and Lead Providers work inpartnership with each other while being accountable to theNational Screening Unit.


INTRODUCTION

INCORPORATING THE TREATY OFWAITANGI

The BreastScreen Aotearoa National Policy and QualityStandards acknowledge the Treaty of Waitangi as thefounding document of New Zealand and both recogniseand respect the Principles of the Treaty.

BreastScreen Aotearoa is committed to working with Maoriin good faith, with mutual respect, co-operation and trust.

This commitment is reflected in the Government’s strategicobjectives for Maori health and focuses on:

1. building the capacity for Maori participation at all levelsof the health and disability sector

2. enabling Maori communities to identify and provide fortheir own health needs

3. recognising the importance of relationships betweenMaori and the Crown in health services, bothmainstream and those provided by Maori

4. ensuring accessible and appropriate services for Maori

5. fostering Maori health workforce development.

REDUCING INEQUALITIES FOR ALL NEWZEALANDERS, INCLUDING MAORI ANDPACIFIC PEOPLESThe Ministry of Health paper Reducing Inequalities inHealth11 articulates the Crown’s broader responsibilities toall New Zealanders under the Treaty of Waitangi.Furthermore Durie12 has said that the Treaty speaks aboutcitizenship for non-Maori as well as Maori, which infersensuing Crown obligations towards the non-Maoripopulation.

The main non-Maori ethnic groups in New Zealand are:

• NZ European peoples

• Pacific peoples

• Asian peoples.

The NSU is committed to reducing inequalities andeffecting improvements across all population groups thatparticipate in screening programmes, particularly Maori andPacific.

BREASTSCREEN AOTEAROA PRIORITYGROUPS FOR SCREENING The National Screening Unit will ensure that strategies aredeveloped which ensure priority is given to groups ofwomen known to be at increased risk of developing breastcancer and/or are likely to be underscreened. Groupsidentified as priority for invitation, screening, re-screeningand treatment within BreastScreen Aotearoa include:

• Maori women

• Pacific women

• unscreened women (women who have either neverbeen screened or have not been screened for fiveyears)

• underscreened women (groups of women whosecoverage and participation rates are well below thoseof the total eligible population).

HEALTH AND DISABILITY COMMISSIONER’SCODE OF CONSUMERS’ RIGHTSCompliance with this Standard will assist services inmeeting their obligations under the Code of Health andDisability Services Consumers’ Rights 1996 (the Code), aregulation under the Health and Disability CommissionerAct 1994.

Therefore, the NP&QS should be interpreted in a mannerthat is consistent with Consumers’ Rights and Providers’Obligations under the Code. Every individual ororganisation subject to the NP&QS should beknowledgeable about the Code and comply with itsobligations.

11 Ministry of Health. 2002. Reducing Inequalities in Health. Wellington: Ministry of Health.12 Durie M. 1998. Whaiora: Maori health development. Auckland: Oxford University Press.


INTRODUCTION

MONITORING AND AUDIT OF NATIONAL POLICY AND QUALITYSTANDARDS

BreastScreen Aotearoa Providers will be monitoredcomparatively against a number of key national evaluationtargets on a regular basis.

It is expected that each BreastScreen Aotearoa Providerwill have systems in place, including internal auditprocesses, which ensure their adherence to the NP&QS onan on-going basis. Ultimate responsibility for this processoccurring rests with the contracted Lead Provider orIndependent Service Provider.

The evaluation processes outlined in the NP&QS providespecific protocols to follow, where appropriate, in order toassist in this process. There is an expectation that, whereshortcomings are identified as a result of internal auditing,steps will be taken (and documented) to meet the requiredStandard and relevant targets. Where the evaluationprocess includes surveys, it is expected that these will beundertaken annually.

In addition, an audit framework will provide the basis forexternal Provider audits. The external audit process enablesa verification of adherence to each of these Standards.

ETHICAL ISSUESScreening can be an effective way of identifying early signsof disease so progression can be halted and treatmentprovided. However, screening does have limitations anduncertainties and no screening test offered can be 100%accurate. Furthermore, healthy and asymptomatic peoplecould be subjected to unnecessary interventions anddistress as a result of the screening process.

It is also important to note that personnel involved with ascreening programme understand the difference from anethical perspective, between providing services to anindividual seeking medical help or treatment and activelyinviting and encouraging people to participate in screeningprocedures.

Some consequences of screening can have a major impacton people’s lives. The failure to clearly explain thelimitations of screening can result in a lack of confidence inthe entire programme. It is also important to provide anaccurate assessment of the risks of the disease beingscreened for, so that individuals do not overestimate theirpersonal risk of the disease.

It is therefore very important to ensure that womenconsidering participation in the breast screeningprogramme are provided with sufficient information tomake an informed choice. Refer Standard 5: Consent.

DOCUMENT MAINTENANCEOF NATIONAL POLICY AND QUALITYSTANDARDS

The NP&QS are distributed to Lead Providers,subcontracted Providers, Independent Service Providers,professional groups and key stakeholders. It is also availablefrom the National Screening Unit’s website(www.healthywomen.co.nz) and Ministry of Health website(www.moh.govt.nz).

It is intended that the NP&QS remain a dynamic documentreflecting the challenges and changes within the screeningsector. In order to achieve this, reviews of the NP&QS arerequired to ensure they remain both appropriate andapplicable. The process for maintaining this document isone where particular areas or sections will be reviewedbased on evidence informed findings and in accordancewith international practice. Any amendments to theNP&QS issued between now and the next review will besent to those parties listed on the database held by theNational Screening Unit as having received the document.The updates will also be posted on the website.


INTRODUCTION


UN

IVER

SAL R

EQU

IREM

ENT

S


Universal Requirements – SECTION 1

SECTION 1 UNIVERSAL REQUIREMENTS

1. Well Women-Centred Services ......................................................................................................................3

1.1 Well Women-Centred Services ..............................................................................................................3

1.2 Well Women-Centred Services – BreastScreen Aotearoa Priority Groups............................................3

2. Cultural Appropriateness ................................................................................................................................4

2.1 Cultural Appropriateness – Treaty of Waitangi ......................................................................................4

2.2 Cultural Appropriateness – Te Whare Tapa Wha....................................................................................5

2.3 Cultural Appropriateness – Individual Cultural Needs............................................................................5

2.4 Cultural Appropriateness – Pacific Women ............................................................................................6

3. Communication ..............................................................................................................................................6

3.1 Communication – Effective Communication ..........................................................................................6

3.2 Communication – Written Information ..................................................................................................7

3.3 Communication – Telephone and Personal Contact ..............................................................................7

3.4 Communication about BreastScreen Aotearoa – Media Strategies and Communication ......................8

3.5 Communication about BreastScreen Aotearoa – Visual Identity Guide ................................................8

4. Access to the Programme ..............................................................................................................................9

4.1 Access to the Programme ......................................................................................................................9

5. Consent..........................................................................................................................................................10

5.1 Consent ................................................................................................................................................10

6. Support/Advocacy..........................................................................................................................................11

6.1 Rights ....................................................................................................................................................11

7. Personal Privacy ............................................................................................................................................12

7.1 Personal Privacy ....................................................................................................................................12

8. Complaint Management ................................................................................................................................12

8.1 Complaint Management ........................................................................................................................12

9. Information Privacy........................................................................................................................................13

9.1 Information Privacy................................................................................................................................13

10. Clinical Record ..............................................................................................................................................14

10.1 Clinical Record Keeping ........................................................................................................................14

10.2 Clinical Record Management ................................................................................................................15

11. Data Management..........................................................................................................................................16

11.1 Data Management – Electronic Clinical Information System ................................................................16

11.2 Data Management – Data Collection and Monitoring ..........................................................................17

11.3 Data Management – Data Integrity ......................................................................................................17

11.4 Data Management – Release of Data ....................................................................................................18

12. Quality and Risk Management ......................................................................................................................19

12.1 Quality Management Systems ..............................................................................................................19

12.2 Continuous Quality Improvement (CQI) – Risk Management Systems................................................20

13. Adverse/Sentinel Events Reporting................................................................................................................20

13.1 Adverse/Sentinel Events Reporting........................................................................................................20

14. General Practice/Primary Care Provider Liaison ..........................................................................................22

14.1 General Practice (GP)/Primary Care Provider (PCP) Involvement ......................................................22

14.2 General Practice (GP)/Primary Care Provider (PCP) Liaison – Communicating Results......................23

14.3 Working Relationship Between Lead Providers and Independent Service Providers ..........................23

15. Programme Management and Official requirements ....................................................................................24

15.1 Programme Management ......................................................................................................................24

15.2 Legislative Requirements ......................................................................................................................25

15.3 Standards ..............................................................................................................................................26

16. Human Resource Management......................................................................................................................26

16.1 Human Resource Management ............................................................................................................26

17. Women Transferring Between Lead Providers..............................................................................................27

17.1 Women Transferring Between Lead Providers......................................................................................27

18. New Technologies ........................................................................................................................................28

18.1 New Technologies ................................................................................................................................28

19. Research ........................................................................................................................................................28

19.1 Research ................................................................................................................................................28


SECTION 1 – Universal Requirements



1. WELL WOMEN-CENTRED SERVICES

Standard – The entire screening pathway and all

other activities provided within BreastScreen

Aotearoa have a key focus on women and their

needs (as they relate to breast screening) to ensure

each woman has confidence in the Programme.

1.1 WELL WOMEN-CENTRED SERVICES

Quality Indicator

BreastScreen Aotearoa Providers have a commitment towork collaboratively with women; women’s groups orcommunity organisations or with women and theirrepresentatives to ensure the Programme is well women-centred and reflects the particular issues relevant to thescreening of asymptomatic women.

Criteria

1. BreastScreen Aotearoa Providers ensure that all womenparticipating in the Programme receive services whichare:

a. delivered in a professional manner consistent witheach woman’s physical, emotional, spiritual andcultural needs

b. provided in line with all relevant standards andlegislation and in accordance with:

i. the Code of Practice and ethics of eachprofession

ii. the philosophy of minimising potential harm andoptimising the quality of life of that individual.

2. BreastScreen Aotearoa Providers shall encourage eachwoman to be actively involved in discussions anddecisions about procedures to be undertaken.

3. BreastScreen Aotearoa Providers shall ensure that allstaff working in the Programme:

a. undergo culturally consumer-focused training

b. work as members of a multidisciplinary team inpartnership with each woman, with her consent,and her family-whanau

c. enable each woman to make informed choicesabout breast screening

d. demonstrate excellent communication skills and theability to establish rapport with women

e. work in a manner that respects consumer rights,and in particular the Code of Health and DisabilityServices Consumer Rights1 and the HealthInformation Privacy Code 1994

f. are sensitive to both the needs of the age group anda woman’s cultural needs

g. recognise and respond to the requirements ofwomen with disabilities.

4. BreastScreen Aotearoa Providers shall include wellwomen consumer representatives on any advisorycommittees it establishes, or those which operatewithin the region.

Evaluation Process

1. Satisfaction surveys.

2. The internal audit process ensures that the criteria arecomplied with, and identified issues are addressedthrough the Continuous Quality Improvement (CQI)process.

Evaluation Target

1. 95% of women surveyed report that the overall servicethey received is women-centred and meets their needs.


1.2 WELL WOMEN-CENTRED SERVICES –BREASTSCREEN AOTEAROA PRIORITYGROUPS

Quality Indicator

BreastScreen Aotearoa Providers have a commitment tomaximise coverage and participation of the women fromthe BreastScreen Aotearoa Priority Groups from invitationto screening and re-screening through to possibleassessment and/or treatment.

Criteria

1. Evidence informed invitation strategies are developedby BreastScreen Aotearoa Providers to ensure thatpriority is given to the following groups:

• Maori women

• Pacific women

• unscreened women (women who have either neverbeen screened or have not been screened for fiveyears)

• underscreened women (groups of women whosecoverage and participation rates are well belowthose of the total eligible population).

2. Invitation strategies for these priority groups are basedon a regional needs assessment and subsequentlydeveloped in collaboration with other relevant providers.

1 Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996.



3. Screening, re-screening and assessment services areprovided in a manner that ensures the priority groupsare encouraged to participate and feel safe in doing so.

4. Known barriers to screening for the priority groups areconsidered by Providers in the planning and provision ofservices.

These barriers include:

• lack of appropriate information

• cost

• shyness/whakama

• embarrassment

• previously painful or unpleasant experiences

• fear of having cancer

• transport and/or childcare difficulties

• distance to Service Providers and other locationissues

• generational and cultural factors.

Evaluation Process

The internal audit process ensures that the criteria arecomplied with, and identified issues are addressed throughthe Continuous Quality Improvement (CQI) process.

Evaluation Target

All criteria are met.

2. CULTURAL APPROPRIATENESS

Standard – Staff practise in a manner that meets

individual cultural needs for each woman and her

family and whanau and they are culturally

appropriate.

2.1 CULTURAL APPROPRIATENESS – TREATY OF WAITANGI

Quality Indicator

Staff practice reflects knowledge of the principles andarticles of the Treaty of Waitangi and applicability to theservices provided.

NOTE: The principles of the Treaty of Waitangi are:

Partnership: Maori and the Crown will have a relationshipof good faith, mutual respect andunderstanding and shared decision-making

Participation: the Crown and Maori will work together toensure Maori (including whanau, hapu, iwiand communities) participate at all levels ofdecision-making around health and disabilityissues. Participation includes the right to self-determination and self-management

Protection: the Crown actively contributes to improvingthe wellbeing of Maori, including support forindependent living and the protection ofMaori property and identity, in accordancewith Maori values. Maori have the samerights and privileges as other citizens.

Criteria

BreastScreen Aotearoa Providers will ensure that all staff:

1. recognise and understand the principles and articles ofthe Treaty of Waitangi, and that this is reflected in theirpractice

2. recognise and respect the unique identity of Maori asTangata Whenua in the planning and provision of services

3. assist each Maori woman to access relevant services,support and resources such as ‘for Maori, by Maori’services where these exist

4. consult iwi and Maori in order to meet the needs ofMaori women during service provision.

Evaluation Process


2. Formal cultural evaluation of the service, for example,an external cultural audit.

3. Specific iwi and Maori feedback.

4. Partnership with iwi and Maori to establish appropriatemonitoring and evaluation processes.




Evaluation Targets

1. 95% of Maori women surveyed report that theircultural needs were addressed in a manner that wasculturally appropriate.


2.2 CULTURAL APPROPRIATENESS – TE WHARE TAPA WHA

Quality Indicator

Staff recognise the philosophy of Te Whare Tapa Wha intheir practice.

NOTE: The four dimensions of Te Whare Tapa Wha are:

• Te taha hinengaro – mental wellbeing

• Te taha tinana – physical wellbeing

• Te taha wairua – spiritual wellbeing

• Te taha whanau – family wellbeing.

Criteria

BreastScreen Aotearoa Providers ensure that all staffunderstand the holistic framework of Te Whare Tapa Wha2

as being central to the wellbeing of Maori.

Evaluation Process


2. Specific iwi and Maori feedback.


4. Partnerships made with iwi and Maori to establishappropriate monitoring and evaluation processes.


Evaluation Targets

1. 95% of Maori women surveyed report that theircultural needs were addressed in a manner that wasculturally appropriate.


2.3 CULTURAL APPROPRIATENESS –INDIVIDUAL CULTURAL NEEDS

Quality Indicator

The individual cultural needs of each woman and her familyand whanau during each stage of the Programme arerecognised and relevant cultural advice and/or guidance issought to ensure both the practice and maintenance ofcultural appropriateness.

Criteria


1. recognise the impact that diversity of cultural practicesand beliefs may have on the breast screening process

2. practise in a manner that respects the identity of eachwoman and her family and whanau who accompany herand which upholds their right to personal beliefs andvalues

3. identify cultural barriers within their control whichreduce access for women

4. assist each woman to gain appropriate support andrepresentation from those who understand her culture,needs and preferences

5. recognise their own beliefs, values and prejudice thatmay arise in relation to each woman’s ethnicity, culture,beliefs, sexual orientation, health status and/or disability

6. provide alternative arrangements when culturalappropriateness is undermined

7. validate that their own practice is culturally appropriate,particularly when providing direction or supervision toother staff.

Evaluation Process




Evaluation Targets

1. 95% of women surveyed report that their culturalneeds were addressed in a manner that was culturallyappropriate.


2 Te Whare Tapa Wha is a well-recognised and endorsed health concept for Maori. It is an holistic approach in which health andwellbeing is described in relation to four walls of a strong house. A person is considered unwell if any one of these foundations isweak, and healthy if all four walls are strong. If the strength of the whanau, for example, is disrupted by insensitive practices, thisaffects all of the foundations. For further information refer to Durie M. 1998.



2.4 CULTURAL APPROPRIATENESS – PACIFIC WOMEN

Quality Indicator

The individual cultural needs of each Pacific woman and herfamily during each stage of the Programme are recognisedand relevant cultural advice and/or guidance are sought toensure both the practice and maintenance of culturalappropriateness.

Criteria


1. recognise the impact that diversity of cultural practicesand beliefs may have on the breast screening process

2. practise in a manner that respects the identity of eachwoman and her family who accompany her and whichupholds their right to personal beliefs and values

3. identify cultural barriers within their control whichreduce access for women

4. assist each woman to gain appropriate support andrepresentation from those who understand her culture,needs and preferences

5. recognise their own beliefs, values and prejudice thatmay arise in relation to each woman’s ethnicity, culture,beliefs, sexual orientation, health status and/or disability

6. provide alternative arrangements when culturalappropriateness is undermined

7. validate that their own practice is culturally appropriate,particularly when providing direction or supervision toother staff.

Evaluation Process




Evaluation Targets

1. 95% of Pacific women surveyed report that theircultural needs were addressed in a manner that wasculturally appropriate.


3. COMMUNICATION

Standard – Effective staff communication ensures

each woman receives relevant and timely

information in a manner which is easily

understood.

3.1 COMMUNICATION – EFFECTIVECOMMUNICATION

Quality Indicator

Each woman participating in the Programme receivesrelevant information that maximises the opportunity forunderstanding and that demonstrates respect and culturalappropriateness.

Criteria

1. BreastScreen Aotearoa Providers ensure that the keymessages about the overall aims of breast screening arecommunicated to women (Refer to Appendix P: KeyMessages for BreastScreen Aotearoa).

The intent of these messages is to raise the awarenessand understanding of participation in the breast screeningservice provided by BreastScreen Aotearoa and aims to:

a. provide accurate and appropriate information aboutthe Programme in order to inform and encourageparticipation

b. undertake the above in the context of improving,promoting and protecting the health of women inNew Zealand.

2. The information provided by BreastScreen Aotearoa towomen needs to include the:

a. purpose of screening

b. potential benefits and limitations of screening

c. role of a mammogram and other procedures whenthese are indicated

d. likelihood of false negative or false positive resultsand what this means

e. possibility and implications of finding abnormalitiesthat could include cancer

f. availability of counselling and support services

g. importance of seeking medical advice if there areany subsequent breast symptoms or concerns, evenif a recent screening mammogram was normal

h. uncertainties and risks associated with the screeningpathway.

3. BreastScreen Aotearoa Providers will ensure that:

a. information is provided in a format best suited tothe needs of the woman and her family and whanau



b. all information provided is consistent with thenational information and key messages developed byBreastScreen Aotearoa

c. all staff are well informed about and fully conversantwith current methods of early detection and thebenefits and possible adverse effects of breastscreening. This will enable staff to respond to eachwoman’s questions and concerns with confidence, sohelping to allay any fears, guilt or anxieties. If theinformation that is required is outside the jurisdictionor knowledge of the particular team member thenreferral on to the relevant individual(s) shall occur.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed report that they receivedrelevant and easily understood information.


3.2 COMMUNICATION – WRITTENINFORMATION

Quality Indicator

Appropriate written information, approved or developedby the National Screening Unit, is made available to allwomen explaining breast screening, proposed procedures,interventions and options.

Criteria

BreastScreen Aotearoa Providers shall ensure thatappropriate written information is made available forwomen.

Evaluation Process



Evaluation Target

95% of women surveyed report that written informationwas made available that was appropriate and accessible tothem.

3.3 COMMUNICATION – TELEPHONE ANDPERSONAL CONTACT

Quality Indicator

Communication in person, or by telephone, is conducted ina respectful and culturally appropriate manner.

Criteria

1. BreastScreen Aotearoa Providers shall have protocolsfor telephone and/or personal contact with women,which take into consideration the principles of respect,sensitivity and cultural appropriateness.

2. When making telephone contact, information is givenonly to the woman concerned and the Providerrepresentative must:

a. identify the woman by name

b. identify themselves by name, and not by workplace

c. confirm the woman’s full name and date of birth

d. if asked by a third party advise them that the call is‘personal’

e. not leave messages on answering machines or withfriends or relatives of the woman, unless thewoman has given instructions to do so (suchinstructions must be documented)

f. if leaving personal written messages for womenwith family, they should be left in an envelopemarked ‘Confidential’.

3. Staff are educated as to why this process is undertaken,including privacy issues and relevant legislative clausesand appropriate levels of management involvement ifrequired.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed report that privacy wasmaintained and telephone and/or personal contact wasrespectful and culturally appropriate.




3.4 COMMUNICATION ABOUTBREASTSCREEN AOTEAROA – MEDIASTRATEGIES AND COMMUNICATION

Quality Indicator

All BreastScreen Aotearoa media communication ispresented in a nationally consistent and accurate manner.

Criteria

1. BreastScreen Aotearoa Providers ensure that:

a. regional/local radio and print media strategiescomplement any national media activities

b. while there may be some paid advertising, regionallythe emphasis will be on unpaid coverage includinginterviews and media releases

c. priority should be given to effective media coveragefor women from BreastScreen Aotearoa prioritygroups. This will involve participation of Maori andPacific Providers and other key stakeholders, forexample, organisations involving older women

d. BreastScreen Aotearoa media issues are discussedwith the National Screening Unit to ensure effectivemanagement (refer to Standard 1.2 Well Women-Centred Services – Priority Groups)

e. any communication with the media initiated byProviders about the Programme (for example,media releases) requires prior written approval bythe National Screening Unit

f. where agreed, routine or repeated operationalnotices may be placed without additional approval,for example, the Mobile schedule.

2. National Screening Unit will review media material andreturn it to the Provider within 48 hours wherepossible.

Evaluation Process


Evaluation Target


3.5 COMMUNICATION ABOUTBREASTSCREEN AOTEAROA – VISUALIDENTITY GUIDE

Quality Indicator

All material identifying BreastScreen Aotearoa must complywith the BreastScreen Aotearoa Visual Identity Guideavailable from Lead Providers or ISP Managers.

Criteria

1. BreastScreen Aotearoa Providers are required to ensure:

a. all communications issued by Providers as a result ofactivities of BreastScreen Aotearoa (includingeducational materials, advertising mediacommunications and signage) comply with the VisualIdentity Guide and include the BreastScreen Aotearoalogo. These items should not have other logos placedon them, except where specific approval has beengiven by the National Screening Unit

b. use of the standard design ‘shell’ when developingprint advertisements relating to BreastScreenAotearoa

NOTE: A range of standard design ‘shells’ has beendeveloped for communication about BreastScreenAotearoa (included in the BreastScreen AotearoaVisual Identity Guide). Providers may insert theirown content within these shells

c. the National Screening Unit is notified of anymaterial that is developed and final copy must beapproved by the National Screening Unit

NOTE: This includes material about relatedprogrammes and how they interface withBreastScreen Aotearoa and marketing material. Thematerial will be reviewed and returned to theProviders within 10 working days where possible.

d. appropriate signage incorporating the BreastScreenAotearoa logo is displayed at all BreastScreenAotearoa screening and assessment sites.

2. The National Screening Unit approves all Providers’service advertisements (which must include the BSAlogo).

3. The BreastScreen Aotearoa logo is used only inassociation with documents and resources associatedwith BreastScreen Aotearoa.

a. any material developed by Providers on which thelogo appears must be approved by the NationalScreening Unit

b. letters on BreastScreen Aotearoa letterhead do notrequire prior approval.

Evaluation Process

1. The internal audit process confirms compliance with theVisual Identity Guide.


Evaluation Target




4. ACCESS TO THE PROGRAMME

Standard – There is acceptable access to

BreastScreen Aotearoa services for all eligible

women.

4.1 ACCESS TO THE PROGRAMME

Quality Indicator

Each woman in the eligible age group has access toBreastScreen Aotearoa services.

Criteria

BreastScreen Aotearoa Providers will ensure that:

1. every endeavour is made to encourage eligible womento access the Programme

2. each woman is supported in accessing the Programme;to an extent that can be reasonably expected whateverher particular needs

3. Maori and Pacific women have an option to accessMaori and Pacific Independent Service Provision wherethese Providers exist

4. consideration is given to the following in order tomaximise access:

a. location of fixed units

b. location and scheduling of the mobile units

c. timing of regional promotions to coincide withmobile unit schedules

d. clear instructions regarding the location of units

e. access to public transport

f. culturally appropriate locations for units, forexample, marae

g. accessibility for women with disabilities

h. flexibility of opening hours

i. acceptable waiting times for appointments

j. availability of interpreters.

5. barriers experienced or reported by women are actedon and subsequently taken into consideration for futureplanning

6. mammograms will be provided at fixed or mobile sitesand the distribution of services:

a. enables all women to have access to a screeningunit

b. takes into consideration the ProfessionalRequirements (Refer: Section 4), which ensures staffcompetency

c. allows mobile screening units to be made availablefor women who have difficulty accessing fixed units

d. allows evening/weekend clinics for women whowork, where a need is demonstrated and wherepractical.

Evaluation Process

1. Information is collected through the National Minimumdata set for monitoring and evaluation purposes (ReferCurrent DMM).

2. Review of the provision of access to the Programmeand related information, prior to a decision being madeto change the configuration, mobile routes or locationof fixed sites.


Evaluation Targets

1. >=70% of eligible women receive a screen within theProgramme in the most recent 24 months.

2. 90% of eligible women should be within 60 minutestravelling time of a screening unit (mobile or fixed).






5. CONSENT

Standard – Each woman is able to make informed

choices about having a screening mammogram and

further assessment, if necessary, based on full and

accurate information, and informed consent

practices comply with the requirements of The Code

of Health and Disability Services Consumers’ Rights.

5.1 CONSENT

Quality Indicator

Each woman is appropriately informed about screening,mammography and further assessment if necessary throughthe use of effective information and communication,enabling her to make an informed choice and give informedconsent.

Criteria


a. the requirements of the Health and Disability Codeof Rights 5 and 6 are fully met, ensuring women areable to give informed consent to all aspects of thescreening pathway

b. the service clearly identifies and documents whenwritten consent is required and how this is to berecorded

c. written consent is obtained and a record kept forthe following:

i. a screening mammogram

ii. ensuring a woman’s GP/PCP is informed of herparticipation in BreastScreen Aotearoa

iii. obtaining previous mammograms.

d. written consent is obtained where a service,treatment or investigation is to be provided underanaesthetic and/or where there is a significant risk ofadverse effects e.g. assessment procedures. For allinvasive procedures involving an anaesthetic, astandard surgical and anaesthetic consent formshould be used.

REFER: Appendix I: Pro Forma Letters and Forms.

2. BreastScreen Aotearoa Providers shall ensure that eachwoman:

a. is provided with sufficient and relevant informationin an appropriate manner that she understands, andthat enables her to give informed consent inaccordance with Standard 3.1. This includes form,language and manner

b. is able to have any questions she has answered byan appropriate person

c. is aware that she can decline a procedure at anytime and is aware of the consequences of thatdecision

d. with an implant must be given information regardingthe additional risks of mammography for them andadditional special consent. (Refer: Protocol forScreening Women with Breast Implants, Appendix J:National Screening Protocols)

Evaluation Process


2. Monthly auditing of clinical records for womenscreened in the previous month at each screening unit.


Evaluation Targets

1. 95% of women report that they were appropriatelyinformed about the processes involved prior to givingconsent.

2. 100% of records have appropriate consentdocumented where informed consent is required to beprovided by the woman.




6. SUPPORT/ADVOCACY

Standard – Each woman’s right to have support

persons and/or advocates present is recognised

and upheld.

6.1 RIGHTS

Quality Indicator

Providers respect the woman’s right to a support person oradvocate being present.

Criteria

1. The Code of Health and Disability Services Consumers’Rights gives each woman participating in BreastScreenAotearoa the right to have one or more supportpersons present except where safety may becompromised.


a. each woman is informed of her right to supportand/or advocacy throughout the screening pathway

b. staff will help any woman who requires assistance toobtain support or advocacy

c. Maori and Pacific women have access to Maori orPacific Independent Service Providers where theseProviders exist

d. each woman’s right to have one or more supportperson(s) of her choice present is met, exceptwhere safety may be compromised or anotherwoman’s rights may be unreasonably infringed

e. where the above occurs, the woman and hersupport persons are provided with a detailedexplanation; and/or alternative arrangements aremade

f. policies/procedures are in place that specifyadvocacy and support processes.

This may be achieved by, but is not limited to:

g. involving family and whanau or otherrepresentatives when requested by the woman oras appropriate

h. the use of independent advocate/advocacy serviceswhere required

i. the use of cultural support persons where required

j. the provision of access to consumer support groupsor agencies where requested and/or appropriate

k. the facilitation of access to advocacyinformation/material/ leaflets/brochures etc

l. the encouragement of women attending assessmentclinics to bring a support person with them

m. the provision of a safe area for support personspresent during mammography.

NOTE: Appropriate radiation protection shall beprovided for support persons if they are in the roomwhile the mammogram is performed. This will require aprotective screen with a thickness equivalent to 2mm ofaluminium or 0.1mm of lead.3 However, wherepossible, it is preferable for support people to leave theroom while exposures are made.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed, who chose to have a supportperson or advocate with them, report that they wereencouraged to bring a support person, and that theywere made to feel welcome.


3 NRL 1994



7. PERSONAL PRIVACY

Standard – The physical environment and

practices at all BreastScreen Aotearoa facilities

provide personal privacy for all women

participating in the Programme.

7.1 PERSONAL PRIVACY

Quality Indicator

The personal privacy of each woman receiving services isrespected at all times.

Criteria

BreastScreen Aotearoa Providers ensure that:

1. there are documented policies and procedures in placethat ensure the protection of personal privacy for eachwoman participating in the Programme

2. consultations and the provision of services occur in anenvironment that provides for optimum visual andauditory privacy

This may include but is not limited to:

a. no personal information, other than a woman’sname, being elicited verbally in waiting rooms

b. discussions with, and counselling of women areundertaken in a private environment.

3. attention is paid to issues such as a woman’s privacywhile changing and while in a gown during screeningand assessment. Women, if they wish, should be able tobe dressed in their own clothes when participating indiscussions with health professionals

4. women participating in the Programme have theopportunity to communicate with others in privacy

This may include but is not limited to access to:

a. a visitors’ room

b. private waiting space

c. private counselling rooms.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed report that their privacy wasrespected.


8. COMPLAINT MANAGEMENT

Standard – The right of each woman to complain,

if dissatisfied with the service, is upheld by

BreastScreen Aotearoa staff.

8.1 COMPLAINT MANAGEMENT

Quality Indicator

A clearly documented and accessible process for theidentification, management and resolution of complaints.

NOTE: A complaint may be defined as a consumer-basedresponse to an event they have experienced. It is anexpression of dissatisfaction that requires a response fromthe Provider. Complaints may be voiced in person or overthe phone, received in writing, emerge from a survey, by aconsumer, their family or whanau or alternatively, a thirdparty.

Criteria


1. consumers of BreastScreen Aotearoa services areaware of the right to, and the procedure for,complaining to the Provider of the service and/or theHealth and Disability Commissioner and/or independentadvocacy services

2. there is a clearly defined process for identifying,managing and resolving complaints and that this isunderstood and implemented by all Provider staff withthe underlying principle being resolution at the lowestpossible level

3. the complaint management process complies withlegislative and contractual requirements

4. all complaints and any relevant comments andsuggestions are recorded in a specific servicelogbook/file/database

5. in the event of a woman expressing dissatisfaction withany aspect of the service, the complaint is dealt with inaccordance with the requirements of the Health andDisability Services Consumers’ Rights [SR 1996/78]

6. the requirements of the Privacy Act 1993 will becomplied with and supported by written protocols todeal with requests for access to clinical records, wherethis information is requested by the woman as part ofthe complaint investigation

7. specific personnel are identified and are responsible forensuring that the complaint management process iseffective and efficient

8. each woman who accesses the complaint process willbe assured of anonymity and confidentiality



9. the complaints management process links to theservice’s quality and risk management systems in orderto facilitate feedback and improvements.

Evaluation Process



Evaluation Targets

1. 95% of women participating in the Programmesurveyed have received detailed information of thecomplaint process.

2. 100% of complaints are managed in accordance withthe service’s specified policy and timeframes.


9. INFORMATION PRIVACY

Standard – Individual clinical records are unique

to each woman, protected from unauthorised

access and treated confidentially.

9.1 INFORMATION PRIVACY

Quality Indicator

All staff ensure that the confidentiality and privacy ofinformation is maintained.

Criteria


a. women’s personal information and data aboutwomen is collected, stored, accessed and destroyedto a standard that complies with the HealthInformation Privacy Code 1994

The Code requires that women will be fullyinformed in writing (called ‘use of informationnotification’) of the purpose, use and recipients ofinformation that is collected about them and anyconsequences of not supplying such information.This notification needs to be provided to women atany point when information is collected about them.Refer to Appendix I: 5 – Information Notification

NOTE: Women are not required to sign theInformation Notification as a written signature is notrequired by the Health Information Privacy Codeand may be interpreted as coercion if obtainedunder duress.

b. there are written protocols for the maintenance andprivacy of each woman’s clinical information

c. access to clinical records (both in use or in storage)is limited to those with authorisation

d. identifiable names, lists and files are not on display inpublic areas

e. copies of a woman’s information are only forwardedto the GP/PCP with the woman’s prior consent.

2. BreastScreen Aotearoa Providers will ensure the staffinvolved in the Programme:

a. sign a confidentiality declaration at thecommencement of their employment

b. know of, understand and adhere to writtenprotocols for the maintenance of the privacy andconfidentiality of each woman’s clinical information

c. are aware that access to an individual woman’s datais restricted to the minimum number of persons andon a ‘need to know’ basis.



Evaluation Process


Evaluation Target


10. CLINICAL RECORD

Standard – Each woman’s clinical record provides

an accurate record of services received and is

readily accessible to the relevant clinicians.

10.1 CLINICAL RECORD KEEPING

Quality Indicator

Each woman’s clinical records (including films, slides andreports) are accurate, accessible, authorised and complete.

Criteria


1. clinical records meet the requirements of appropriatelegislation and relevant professional and sectorstandards where these exist

2. there are documented and implemented policies,procedures and protocols for each step of the screeningpathway, that clearly identify the recordingrequirements of staff (for example, role, responsibility,level of detail, frequency, etc.)

3. clinical records are reviewed regularly to ensure:

a. identified standards are met

b. variances/trends in record keeping are responded to

c. records are objective and factual.

4. the woman’s access to her personal records isappropriately managed

5. clinical records are up to date and reflect the currentstatus of the woman

This may be achieved by, but is not limited to policiesand procedures that ensure all:

a. records indicate which Lead Provider provided thereferral

b. records are current and reflect current status

c. ethnicity and ethnic groups are recorded

d. historical records are accessible and an effectiverecord tracking system exists

e. recent test/investigation/assessment information isaccessible or indicated as pending

f. records contain appropriate information anddocument any/all actions taken.

6. women self-identify their ethnicity and their ethnicgroup(s) at any time

NOTE: Ethnicity categories will be determined by theNational Screening Unit and will be updated inaccordance with New Zealand Census categories.(Refer Appendix H: Collecting Ethnicity Data)



7. all records are legible and all entries are identifiable

This may be achieved by, but is not limited to ensuring:

a. all entries are written clearly

b. abbreviations are listed and approved

c. signature, designation and date (authorisation) arerecorded in a legible manner by staff members

d. entries are made in ink, electronic or othermediums acceptable under statute

e. entries are readable and not defaced or obliteratedby correction fluid.

8. all clinical records shall be signed by the relevant healthprofessional, directly responsible for each part of thescreening pathway and/or assessment episode

9. all BreastScreen Aotearoa and other relevantdocumentation pertaining to an individual woman’sbreast health record(s) are integrated

This may be achieved by, but is not limited to ensuring:

a. systems or processes facilitate a comprehensive andaccessible record of support or care and/or supportfor each woman

b. interventions are documented in a continuousrecord for each woman

c. records associated with other service providers (forexample, treatment) are cross-referenced and/ortraceable.

Evaluation Process

1. Monthly auditing of clinical records for womenscreened during the previous month at each screeningand assessment site (this may occur in conjunction withthe Data Quality Plan requirements).


Evaluation Targets

1. 100% of records audited are complete and accurate.


10.2 CLINICAL RECORD MANAGEMENT

Quality Indicator

Each woman’s clinical records (including films, slides andreports) are appropriately referenced, kept secure, trackedand readily accessible.

Criteria


1. a documented process is implemented to ensure thatclinical records are complete and all appropriate actionshave been taken prior to filing/archiving

2. systems are in place to electronically and/or manuallytrack and retrieve clinical records and films when theyare removed from the main record management area

This may be achieved by, but is not limited to, a systemwhere:

a. filing processes facilitate timely retrieval

b. filing is centrally referenced

c. filing is cross-referenced

d. the destination of removed files is logged.

3. retained/archived clinical records and films are securelymaintained in a suitable order and condition so thatthey may be retrieved when required

This may be achieved by, but is not limited to ensuringrecords are:

a. protected from destructive forces

b. secure.

4. timeframes for retention of information are known andmet, and subsequently meet the relevant guidelines(Refer to Health Records Standard NZS 8153:2002)

5. electronic back-up of information is secure, protectedfrom loss, corruption, inappropriate alteration ormiscalculation

6. easily retrievable

7. each woman’s record is stored in an individual file.

Evaluation Process

1. Monthly auditing of clinical records for womenscreened during the previous month at each screeningunit/assessment site. (This may occur in conjunctionwith the Data Quality Plan requirements).


Evaluation Targets

1. 100% of hard copy clinical records audited arereferenced, secured, tracked and readily accessible.




11. DATA MANAGEMENT

Standard – All data collected is accurate, reliable

and reported in a consistent and timely manner

ensuring each woman has confidence in the data

management of the Programme.

11.1 DATA MANAGEMENT – ELECTRONICCLINICAL INFORMATION SYSTEM

Quality Indicator

The clinical information system complies with legislativerequirements, Government policy on health information,and new policy principles where appropriate.

Criteria

BreastScreen Aotearoa Providers will ensure:

1. the clinical information system is developed withconsideration for the following principles:

a. the use of, and direct access to, national informationsystems, particularly the unique identifier from theNational Health Index (NHI)

b. sensitivity to the views and expectations of Maoriand Pacific women in relation to the collection anduse of breast screening information

c. mandatory collection of accurate ethnicity data

d. the definition of ethnicity should be updatedcontinually to reflect the current New ZealandCensus categories, determined by the NationalScreening Unit (Refer Appendix C: Ethnicity)

e. adherence to, and compliance with the current BSAData Management Manual (DMM), nationalstandards, definitions and guidelines maintaining theintegrity and security of the databases andtransmission or exchange of data betweenorganisations.

2. the information system will support BreastScreenAotearoa by:

a. storing and maintaining information on screening,assessment, and treatment in accordance with thecurrent Data Management Manual (DMM)

b. ensuring recall of each woman screened and follow-up through assessment as appropriate

c. providing information required to support qualityassurance activities

d. providing information required for routinemonitoring and evaluation of programme outcomesand screening processes

e. providing screening and assessment results forwomen and their GP/PCP

f. providing a fail-safe process to ensure all screeningprocesses and episodes are completed and havebeen managed appropriately

g. providing appropriate security access controlswithin the information system to limit access toidentified users and/or organisations.

3. information systems used for making decisions aboutwomen participating in BreastScreen Aotearoa aredesigned and maintained to be fail-safe, thereby,ensuring women do not ‘fall through gaps’ in referralprocesses or health care services provided

4. women’s personal information and data are managed insuch a way that it meets the standards set out in theCode of Practice for Information Security Management(AS/NZS ISO/IEC 17799:2001) and The HealthNetwork Code of Practice (SNZ HB 8169:2002)

5. data and software are to be safeguarded againsttampering, secured against illegitimate use andunintentional destruction. These access protocolsdemand both system and data security measures:

a. when updating records it must not be possible toalter or erase previous entries without an audit trailbeing maintained

b. all information updates in the database shall have anaudit trail which identifies the change, author and date

c. where the record is to be used by a large numberof health professionals for different purposes, itmust be possible to withhold certain informationfrom general viewing.

6. transfer of data must be as secure as possible, andreferences to external data must be maintained ontransmission

7. data must never be assimilated into a clinical recordwithout the involvement of a clinician who is willing totake legal responsibility for that inclusion. ‘Automatic’amendments by computer systems are not acceptableto clinical users

8. the author of the record (electronic signature) is to beidentifiable

9. the individual responsible for the updating ofinformation should be unambiguously identified. If, forexample, a secretary were to enter a clinician’s notesinto the record, the transactions would be entered bythe secretary and confirmed and authorised for entry bythe clinician.

Evaluation Process




Evaluation Target


11.2 DATA MANAGEMENT – DATACOLLECTION AND MONITORING

Quality Indicator

Sufficient data is collected to enable BreastScreen AotearoaProviders to operate at the highest standard and toundertake/participate in evaluation at both a regional andnational level.

Criteria


1. sufficient data is collected and analysed to:

a. regionally and nationally monitor the Programme

b. evaluate the Programme’s effectiveness andefficiency

c. support effective business processes

d. efficiently invite, manage and track womenthroughout the Programme

e. enable ongoing improvement of the Programme’sperformance

f. inform future policy and Programme developmentdecisions.

2. data management conforms to relevant legislation andto the guiding principles of data collection andmanagement as described in NZHIS Guide to DataRequirements4

3. collecting and reporting on the data requirements, dataquality checks and periodic audits as detailed in thecurrent Data Management Manual and Data QualityPlan are maintained

4. procedures are implemented to ensure:

a. data is captured in a complete, timely and accuratemanner

b. checks are implemented for identifying any errorsthat may arise during data entry

c. data is validated against the business rulesdocumented in the current Data ManagementManual

d. definitions and edit rules are understood and arefollowed

e. inconsistencies are investigated and rectified.

5. quality control procedures for data management aredocumented and undertaken at all levels of thescreening and assessment pathway, and all relevant staffare instructed in how to follow these procedures in linewith the current Data Management Manual and DataQuality Plan or subsequent versions

6. a designated individual is responsible for the overallinformation system management, security, data integrityand availability in line with the current DataManagement Manual and Data Quality Plan.

NOTE: BreastScreen Aotearoa Providers may collectadditional data to assist them in the provision of acomprehensive service to participating women. Newcore data elements must be advised to the NationalScreening Unit for inclusion in the Data ManagementManual and the manual updated accordingly.

Evaluation Process


Evaluation Target


11.3 DATA MANAGEMENT – DATA INTEGRITY

Quality Indicator

The BreastScreen Aotearoa Provider will ensure thatcaptured data is accurate and complete before use.

Criteria


1. protocols are developed that clearly describe staffresponsibilities for accurate, timely and complete dataentry

Protocols include the accurate recording of a woman’sethnicity according to categories determined by theNational Screening Unit and updated in accordancewith New Zealand Census categories. Refer: AppendixH: Collecting Ethnicity Data

NOTE: women must be allowed to self-identify theirethnicity and ethnic group(s) at any time.

2. staff involved in data entry have adequate time, thatallows them to correctly use the system, interruptionsare minimised and the environment is conducive todetailed data entry

4 NZHIS Guide to Data Requirements.



3. staff involved in data entry (including the interpretationand recording of clinical screening, analysis/treatmentnotes) are adequately trained and supported in theprocess

Non-clinical staff members involved in data entry arenot permitted to interpret data but are to be givenadequate training in the reading of data provided by theclinicians and to subsequently enter it into the IS system

4. clinicians are responsible for recording their ownscreening and assessment data (either directly into thecomputer system or as a paper record) and for itsaccuracy and completeness. If the computer recordingsystem does not allow sufficient detail to be recorded,then a paper record must supplement this

5. the NSU is notified if the computer recording systemdoes not meet data management requirements.

Evaluation Process

1. Monthly auditing of clinical records for womenscreened during the previous month at each screeningand assessment site. (This may occur in conjunctionwith the Data Quality Plan requirements).


Evaluation Target

1. 100% of records audited were entered correctly intothe system.

2. All criteria are met

11.4 DATA MANAGEMENT – RELEASE OFDATA

Quality Indicator

The BreastScreen Aotearoa Provider will ensure thatwomen’s personal information and data about women areused in a way that is consistent with BSA overall purposeand goals, protects the interests and privacy of womeninvolved in the Programme, whilst complying with healthinformation and privacy legislation.

Criteria


1. procedures for women seeking access to their personalinformation are consistent with the requirements of theOfficial Information Act 1987 and the Privacy Act 1993

2. all requests for aggregate data are forwarded to theManager and Clinical Leader, BreastScreen Aotearoa,the National Screening Unit, Ministry of Health.

Evaluation Process


Evaluation Target




12. QUALITY AND RISK MANAGEMENT

Standard – The safety of the women, staff and

others is protected through comprehensive quality

and risk management systems.

12.1 QUALITY MANAGEMENT SYSTEMS

Quality Indicator

The BreastScreen Aotearoa Provider has an established,quality and risk management system that reflectscontinuous quality improvement principles.

Criteria

1. BreastScreen Aotearoa Providers will maintain writtenpolicies, procedures, guidelines, systems or plans thatensure compliance with the National Policy and QualityStandards (NP&QS) and all relevant standards theService must comply with, such as the NationalRadiation Laboratory (NRL), IANZ, Infection Control,and others including:

a. updating or formulating procedures and processeswhenever it is found that there is an absence ofdocumentation that could potentially affect thesafety and/or quality of service delivery

b. ensuring that staff are adequately informed andregularly updated of the content of thesedocuments.

2. BreastScreen Aotearoa Providers have a currentdocumented quality management system that:

a. clearly identifies the personnel that are responsiblefor ensuring the quality management processes aredocumented and implemented

b. clearly identifies in detail all quality improvementprocesses that will be undertaken in the LeadProvider region and includes an internal audit plan

c. references the quality model or philosophy selectedby the organisation, for example, PDCA Cycle (Plan,Do, Check, Act), Accreditation, ISO Certification,etc

d. is reviewed by the management at regular intervalsto ensure compliance

e. has the commitment and participation ofmanagement and staff, and enables consumerparticipation wherever appropriate.

3. BreastScreen Aotearoa Providers:

a. implement a system to regularly assess all practicesincluding management systems, policies, proceduresand guidelines, to ensure the NP&QS aremaintained and carried out by staff

b. ensure that changes/advances in practice adopted bythe Provider are documented, are communicatedto, and implemented by all staff involved in servicedelivery

c. ensure that quality improvement information iscollected, analysed and evaluated and the resultscommunicated to Providers and, where appropriate,consumers as part of the quality improvementprocess

d. ensure that quality improvement information isrelevant to the organisation’s needs and its analysisis both accurate and unbiased

e. ensure that there are appropriate linkages betweenthe Continuous Quality Improvement (CQI) processand the Risk Management process

f. ensure that there is a process informing Programmemanagement and the National Screening Unit aboutCQI activities and findings

g. ensure a corrective action plan, addressing areasrequiring improvement in order to meet thespecified standard or requirement, is developed andimplemented

h. ensure that satisfaction surveys and questionnairesare in the standardised format or have beenapproved by the National Screening Unit prior touse

i. ensure that the use of questionnaires and surveysfollows a process approved by the NationalScreening Unit, that includes pre-testing

j. ensure written evidence of routine quality assuranceis available for audits and site visits

k. ensure information and experience gained from theCQI processes are shared within the Providerorganisation and where appropriate, through theBreastScreen Aotearoa Manager and Clinical Leaderto Unidisciplinary Groups and to other Providers.

Evaluation Process

The internal audit process shall:

1. evaluate documentation and implementation of thequality management plan

2. evaluate compliance of staff in meeting therequirements of the quality management system

3. ensure identified non-compliances are addressed at theearliest opportunity.

Evaluation Target




12.2 CONTINUOUS QUALITY IMPROVEMENT(CQI) – RISK MANAGEMENT SYSTEMS

Quality Indicator

Policies and procedures have a risk management focus tomaximise the safety of women, staff and others through theidentification and minimisation of preventable and/oravoidable risks throughout the Programme.

Criteria

BreastScreen Aotearoa Providers are to ensure that:

1. significant risks within their control are identified andmanaged

2. the National Screening Unit is notified of any mattersrelating to a significant risk within a specified timeframe

3. assessment of risk is based on factual information andinformed opinion. Information accuracy is essential andthe determinants of this include sufficiency, relevance,competency and timeliness

4. individual staff are aware of their responsibility forimplementing the requirements of the organisation’squality and risk management system in order tominimise potential harm to women, colleagues andothers

5. identified risks are monitored and reassessed at afrequency determined by the severity of the risk, andthe probability of change in the status of that risk, in linewith the organisation’s policies and procedures.

Evaluation Process

The internal audit process shall:

1. ensure the risk management system reflects continuousquality improvement principles

2. evaluate staff compliance in meeting the requirementsof the risk management system

3. ensure identified non-compliance issues are addressedat the earliest opportunity.

Evaluation Target


13. ADVERSE/SENTINEL EVENTSREPORTING

Standard – There is a robust process for

adverse/sentinel event management, which is

linked to the Continuous Quality Improvement

(CQI) process to ensure the safety of women, staff

and others.

13.1 ADVERSE/SENTINEL EVENTS REPORTING

Quality Indicator

The Provider systematically records all adverse/sentinel,unplanned or untoward events.

NOTE: A serious adverse event is one that may significantlycompromise screening and/or assessment activities and/oroutcomes, and/or an event for which a facility fails to takeappropriate corrective action in a timely manner.

A sentinel event is ‘an event that signals something serioushas occurred and warrants in-depth investigation.’5

Criteria


1. a process to identify and appropriately respond toadverse events exists

2. adverse, unplanned, untoward or sentinel events arereported, recorded, managed and evaluated in order toidentify opportunities to improve service delivery

Adverse/sentinel events include but are not limited to:

a. poor mammographic image quality

b. failure to send mammography reports in a timelymanner

c. employment of personnel who do not meet thenecessary requirements

d. accidents, incidents, near misses and clinical events

e. complaints and suggestions

f. infections/notifiable diseases

g. other reportable serious events and/or sentinelevents as indicated by legislation, regulation,professional practice standards and contracts.

3. the adverse/sentinel event reporting system is a plannedand co-ordinated process that links to the quality andrisk management system where appropriate6




a. investigation

b. analysis

c. identification of trends

d. planned corrective action

e. ensuring implementation is timely, complete andsigned off

f. processes are reviewed to ascertain theeffectiveness of corrective action.

4. the clinical care of an individual(s) who has/have beenplaced at unnecessary risk is made a priority. TheClinical Director is fully informed, and has the authorityand resources to provide the appropriate care at theearliest opportunity. During the review it may bedeemed appropriate and/or necessary to shareinformation with outside agencies, for example, theAccident Compensation Commission (ACC), the Healthand Disability Commission (HDC) and professionalorganisations in view of public health and safety

5. the Clinical Director shall undertake an internal reviewof all such cases and outcomes. Those which couldcontribute to improving BreastScreen Aotearoa will beshared with the National Screening Unit and otherProviders. The results of such reviews shall be madeavailable to auditors and may be referred to outsideagencies such as ACC, HDC and professional bodies inview of public health and safety

6. adverse/sentinel events are reported to the NationalScreening Unit at the earliest opportunity and inwriting, these include but are not limited to:

a. events compromising the quality of the service

b. failure to meet the needs of women

c. failure to meet the overall aims of the Programme

d. events that may attract negative media attention.

7. where the screening quality at a facility has beencompromised, Providers shall provide clinical imagesand other relevant information, as specified by theNational Screening Unit, for review by another entitydesignated by the National Screening Unit

8. where the National Screening Unit, or entity designatedby the National Screening Unit, determines that thequality of screening performed by a facility, is inconsistentwith the NP&QS and presents a significant risk toindividual or public health, the Provider may be requiredto notify each woman who has received mammograms atthat facility, and her GP/PCP, of the deficienciespresenting such risk, the resulting potential harm,appropriate remedial measures, and other relevantinformation as the National Screening Unit may require

9. where a review of the Provider is stipulated:

a. the National Screening Unit, or an entity approvedby the National Screening Unit is responsible forperforming the review undertaken in conjunctionwith the Provider concerned

b. the review may be conducted as an on-site audit atthe facility or may be performed through the reviewof films and/or other materials off-site

c. the reports of any reviews shall be made available tothe National Screening Unit.

Evaluation Process

The internal audit process confirms that the adverse/sentinelevents reporting system is available and complied with.

Evaluation Target


5 Ministry of Health. Sept 2001. Reportable Events Guidelines. Wellington: Ministry of Health.6 Injury Prevention, Rehabilitation and Compensation Act 2001.

14. GENERAL PRACTICE/PRIMARY CAREPROVIDER LIAISON

Standard – Effective links with General

Practitioners and other Primary Care Providers

including Maori, or Pacific Providers are

established and maintained.

14.1 GENERAL PRACTICE (GP)/PRIMARY CAREPROVIDER (PCP) INVOLVEMENT

Quality Indicator

The importance of strong relations with GeneralPractitioners (GPs) and Primary Care Providers (PCPs),which include Maori and Pacific Providers, is recognised byLead Providers and ISPs.

NOTE: While many women will self-refer to BreastScreenAotearoa, GPs and other PCPs are a point of informationand access to the Programme. It is essential to establish andmaintain good working relationships with all providers ofhealth services.

Criteria

1. BreastScreen Aotearoa Providers recognise theimportant role that GPs/PCPs fulfil in the Programme,particularly in:

a. outlining the benefits and limitations of screeningmammography to eligible women

b. co-ordinating ongoing care

c. encouraging women to attend further rounds ofscreening

d. providing information, support and counselling forwomen.

2. GPs and other PCPs should be actively involved inBreastScreen Aotearoa Provider services to ensure thesuccess of the Programme and maintain the confidenceof women including:

a. identification of eligible women (review of age/sexregisters, consultation with women, completion ofthe BSA GP Enrolment Form)

b. invitation to eligible women (with GPs/PCPs supportof invitation)

c. result reporting (where the GP/PCP is nominatedby the woman, the GP/PCP should be directlyinformed of the woman’s results)

d. confirming information prior to woman’s recall(GPs/PCPs confirm a woman’s eligibility and contactdetails before the woman is recalled).

3. BreastScreen Aotearoa Providers ensure:

a. GPs and other PCPs are informed about theProgramme and their active support is encouragedand maintained

b. GPs and other PCPs are provided with theopportunity for up-skilling in relation toBreastScreen Aotearoa so they may activelypromote the Programme

c. relevant Providers are informed that referrals are onlymade following the woman’s informed consent andthat the principles of confidentiality are adhered to

d. the distribution of appropriate promotional andeducational resources to relevant providers andpractitioners

e. effective working relationships and support forIwi/Maori and Pacific Primary Care Providers existsto achieve equitable coverage

f. information seminars for GPs and other PCPsinclude information on how best and mostappropriately to inform, support and recruit Maoriwomen, Pacific women and other ethnic groups

g. sufficient information is available including seminarsfor GPs and other PCPs featuring information onhow best and most appropriately to inform, supportand recruit women with disabilities

h. Programme education includes information aboutinappropriate referrals and the differences betweenscreening and diagnostic mammography

i. information provided by a woman’s GP/PCP isaccepted on the understanding that the GP/PCP hassatisfied the requirements of the Health InformationPrivacy Code 1994 regarding the initial collectionand disclosure of this information

j. a comprehensive strategy is maintained to ensureGPs and other PCPs are involved in the Programme.


• researching GP/PCP information requirementsin relation to BreastScreen Aotearoa

• developing resources for GPs, other PCPs andpractice nurses in line with key messages.

4. an identified BreastScreen Aotearoa Provider staffmember has designated responsibility for maintainingregular contact (at least six-monthly) and liaison withGPs, PCPs and Provider groups in their region (this maybe through face to face contact, newsletters, etc.)

5. women presenting to BreastScreen Aotearoa without acurrent GP/PCP (or wishing to nominate a GP/PCP)should be encouraged to nominate one, and if required,be offered a list of local GPs/PCPs.





Evaluation Process

1. Satisfaction surveys of GPs/PCPs.


Evaluation Targets

1. 95% of GPs/PCPs surveyed report that they areadequately involved and informed by BreastScreenAotearoa Lead Providers and ISPs.


14.2 GENERAL PRACTICE (GP)/PRIMARY CARE PROVIDER (PCP) LIAISON –COMMUNICATING RESULTS

Quality Indicator

The GP/PCP shall be kept informed of the resultspertaining to women from within their practice.

Criteria

1. Where a woman has given prior consent, the GP/PCPshall be informed as follows:

Screening result Directly informed of the reporting: woman’s screening results

Assessment recall: Directly informed of thewoman’s assessment recall

Cancer diagnosis and Directly informed of the treatment referral: woman’s cancer diagnosis and

referrals for treatment and thisshould ideally occur inconsultation with the woman’sGP/PCP.

NOTE: Women do not have to consult with theirGP/PCP if they do not want or need to but areencouraged to do so by the Programme

2. With the woman’s consent BreastScreen AotearoaProviders shall ensure that the timeframes specified inAppendix C: Communication Matrix, forcommunication with GPs/PCPs, are met.

3. Communication with the GPs/PCPs should includefeedback about the number of women from theirpractice participating in the Programme, for example,regular reports of women screened, outcomes, etc.

Evaluation Process

1. Satisfaction surveys of GPs/PCPs.


Evaluation Target

1. 95% of GPs/PCPs surveyed report that feedback fromBreastScreen Aotearoa Lead Providers is prompt andaccurate.


14.3 WORKING RELATIONSHIP BETWEENLEAD PROVIDERS AND INDEPENDENTSERVICE PROVIDERS

Quality Indicator

Lead Providers and Independent Service Providers worktogether in partnership to deliver BreastScreen Aotearoaservices and have a good understanding of each other’sroles.

Breast Screen Aotearoa Lead Providers understand the rolethat ISPs fulfil in the Programme such as outlining thebenefits and limitations of screening mammography topriority women, co-ordinating ongoing care, encouragingwomen to attend further rounds of screening and providinginformation and support for the women.

Criteria

1. ISPs and Lead Providers demonstrate commitment toworking collaboratively to identify any issues that ariseand resolve them in a collaborative manner.

2. BSA Lead Provider Managers, Health Promoters andISPs shall:

a. meet at least quarterly to discuss relevant issues

b. undertake joint planning sessions annually with aparticular focus on Mobile scheduling, healthpromotion and recruitment issues and programmeperformance data.

3. ISPs should be actively involved with Lead Providerservices to contribute to the success of the Programmeand maintain the confidence of women including:

a. identification of eligible women (review of age/sexregisters, consultation with women, completion ofthe BSA Enrolment Form)

b. invitation to eligible women

c. reviewing information prior to women beingrecalled (for example, GPs/PCPs check a woman’seligibility and contact details before the woman isrecalled).

Evaluation Process

1. Satisfaction surveys of ISPs.


Evaluation Target


15. PROGRAMME MANAGEMENT ANDOFFICIAL REQUIREMENTS

Standard – The BreastScreen Aotearoa programme

is effectively and efficiently managed by each

Provider ensuring a high level of public confidence

and is provided in a manner that is consistent

with relevant legislation, standards and Ministry

of Health policy.

15.1 PROGRAMME MANAGEMENT

Quality Indicator

The day-to-day operation of the service is managed in anefficient and effective manner which ensures the provisionof timely, appropriate and safe services to all women.

Criteria


1. each Provider has a clearly documented managementstructure which includes:

a. identification of the person who has designatedresponsibility for the management of all aspects ofthe service, and clarification of roles, where there isjoint accountability

b. responsibilities and accountabilities of specificindividuals, groups and/or committees and therelationship between them

c. clear delineation of the relationships andresponsibilities of medical and non-medical staff

d. representation of relevant consumer andprofessional groups on any advisory and/ormanagement groups.

2. legislation, regulatory and contractual requirements,that determine the provision of services, are clearly met

3. all copies of the National Policy and Quality Standardsand other BreastScreen Aotearoa documentation iskept up-to-date using a version control process

4. during the temporary absence of the Manager, a suitablyqualified and experienced person will undertake theManager’s role


a. ensuring the availability of appropriately trained anddesignated replacements, for example, nominateddelegates [temporary absence includes but is notlimited to illness, leave and position vacancy]

b. the level of resources, expertise or equipmentprovided by the service to meet normalvolumes/activities is appropriate.





5. Lead Provider Managers meet with representatives ofthe multidisciplinary team regularly to discuss bothclinical and operational issues. Such meetings will occurin partnership.

a. A regular (at least three-monthly) managementmultidisciplinary meeting shall be held. This mayconstitute an extension of the existing regularClinical multidisciplinary team meetings.

b. Management multidisciplinary team meetings arerequired at both Lead Providers and subcontractedProvider levels.

c. A minutes register is maintained for all meetingsheld, including attendees.

6. the management multidisciplinary team meeting at theLead Provider site shall be attended by:

a. Lead Provider Manager

b. Clinical Director

c. Data Manager

d. Lead Clinicians as agreed (for example, LeadRadiologist, Lead Pathologist, Lead Surgeon, LeadMRT)

e. Health Promotion representative

f. Quality Co-ordinator

g. at least one representative from each subcontractassessment site (six-monthly)

h. others working in the Programme as appropriate.

7. the management multidisciplinary team meeting at thesubcontracted Provider sites may be attended by:

a. Lead Provider Manager or Clinical Director fromthe Lead Provider site

b. others working at the subcontract site.

8. the purpose of the management multidisciplinary teammeetings include:

a. Lead Provider/subcontractor co-ordination

b. co-ordination of mobile scheduling and healthpromotion activities

c. peer review and exchange of information

d. process and systems reviews

e. complaints review

f. review of feedback from internal and externalmonitoring, quality assurance and audit activities

g. communicating changes in policy, protocols orprocedures

h. review of consumer questionnaires

i. ensuring fail-safe mechanisms are in place andoperating routinely.

9. all mandated team members shall attend at least 60percent of management multidisciplinary meetings.Team members must nominate a delegate to attend ontheir behalf, when they are unable to attend.Attendance may be by teleconference if appropriate

10. attendance by relevant team members at nationalUnidisciplinary Groups meetings as per schedule (Refer:Appendix X: Schedule of Uni- and MultidisciplinaryMeetings).

Evaluation Process


Evaluation Target


15.2 LEGISLATIVE REQUIREMENTS

Quality Indicator

The day-to-day operation of the Programme complies withthe principles and detail of relevant legislation.

Criteria

BreastScreen Aotearoa Providers ensure that therequirements of the following legislation (and any other thatis deemed relevant) are met:

• Building Act 1991

• Building Regulations 1992

• Cancer Registry Act 1993

• Cancer Registry Regulations 1994

• Health Act 1956

• Health and Disability Commissioner (Code of Healthand Disability Services Consumers’ Rights) Regulations1996

• Health (Retention of Health Information) Regulations1996

• Health Information Privacy Code 1994

• Health and Safety in Employment Act 1992

• Human Rights Act 1993

• Medical Practitioners Act 1995

• Medical Radiation Technologists Regulations 1995

• Medicines Act 1981

• Medicines Regulations 1984

• New Zealand Public Health and Disability Act 2000

• Radiation Protection Act 1965

• Radiation Protection Regulations 1982



4. orientation/induction programmes for new and/ortransferred staff that cover the essential components ofservices provided

This may be achieved by, but is not limited to ensuringstaff are familiar with:

a. the philosophy of breast screening

b. the roles and responsibilities of the Lead Provider,Subcontracted Provider and ISPs

c. the nature, authority and responsibilities of theposition

d. quality improvement responsibilities

e. BreastScreen Aotearoa and Provider policies andprocedures

f. Consumer Code of Rights

g. cultural appropriateness

h. confidentiality and privacy requirements

i. health, safety and emergency procedures.

5. a system to identify, plan, facilitate and record trainingand education for staff is implemented

This may be achieved by, but not limited toimplementing:

a. a documented plan (organisational and/orindividual) to meet identified training needs andassociated timeframes to achieve these

b. training plans with evidence ofprogress/achievement

c. appraisal/performance/feedback/developmentsystems to identify and review effectiveness/appropriateness of the training provided

d. a system to meet supervision requirements.

6. the analysis of staff turnover and exit interviewfeedback.

Evaluation Process


Evaluation Target


17. WOMEN TRANSFERRING BETWEENLEAD PROVIDERS

Standard – Women who move between regions at

any stage during their involvement with

BreastScreen Aotearoa will be managed efficiently

to ensure continuity of care.

17.1 WOMEN TRANSFERRING BETWEENLEAD PROVIDERS

Quality Indicator

Each woman is transferred between Lead Providersaccording to the current Data Management Manual (DMM)requirements.

Criteria

BreastScreen Aotearoa Providers ensure that the policy fortransferring women between Lead Providers during ascreening episode is complied with (Refer Appendix T:Women Transferring Between Providers Protocol).

Evaluation Process


Evaluation Target


• Official Information Act 1982

• Privacy Act 1993.

Evaluation Process


Evaluation Target


15.3 STANDARDS

Quality Indicator

The BreastScreen Aotearoa Provider utilises relevantStandards as guidelines for evidence informed practice.

Criteria

BreastScreen Aotearoa Providers ensure that the followingStandards (and any others that are relevant) are referred toas part of delivering a screening programme:

• NZS 8134:2001 Health and Disability SectorStandards

• NZS 8142:2000 Infection control

• NZS 8153:2002 Health records

• AS/NZS 4360:1999 Risk management

• AS/NZS 3816:1998 Management of clinical and relatedwastes.

Evaluation Process


Evaluation Target


16. HUMAN RESOURCE MANAGEMENT

Standard – Processes and systems ensure that

human resource management complies with good

employment practice and legislation.

16.1 HUMAN RESOURCE MANAGEMENT

Quality Indicator

Human resource management processes are conducted inaccordance with good employment practice and meet thelegislative requirements.

Criteria


1. the accountability, responsibilities, authority, functionsand outcomes to be achieved in each position aredocumented

These may be included in, but are not limited to:

a. employment contracts

b. position descriptions

c. delegations of authority

d. human resource/personnel policies

e. organisation chart/reporting lines

f. performance appraisal/review process.

2. professional qualifications are validated, includingevidence of registration where applicable prior toemployment


a. sighting and recording of practicequalifications/registration/certificate renewalinformation

b. internal processes for evaluating competence.

3. appropriately qualified and experienced staff areappointed who can safely meet the needs of eachwoman

These processes may include, but are not limited to:

a. recruitment, selection, appointment and re-appointment processes

b. recruitment of staff that reflect the eligiblepopulation where appropriate

c. education/qualification checking

d. reference checking

e. written declaration in relation to physical health andcriminal history.



18. NEW TECHNOLOGIES

Standard – New technologies are utilised in

accordance with the National Screening Unit’s

Framework For New Technology Assessment.*

18.1 NEW TECHNOLOGIES

Quality Indicator

The approval and inclusion of new technologies is managedin accordance with evidence-informed principles and theNational Screening Unit’s Framework for New TechnologyAssessment, relevant policies and procedures and ethicalreview where required.

Criteria


1. all new technologies considered for use within theProgramme are identified using a Pro Forma andsubmitted to the National Screening Unit forconsideration

2. the service establishes a robust process in conjunctionwith the National Screening Unit to review andsubsequently approve the use of new technologies

3. the introduction of interventional procedures should bestrictly controlled and undertaken after an appropriateperiod of training, and the development andimplementation of appropriate policies and protocols

4. monitoring and evaluation of new technologies isundertaken and reported to the National ScreeningUnit.

Evaluation Process


Evaluation Target


19. RESEARCH

Standard – The Service has established protocols

for conducting and/or participating in research

activities.

19.1 RESEARCH

Quality Indicator

Research applications and approved research projects(including clinical trials and studies) are managed inaccordance with the evidence-informed principles, currentlegislation, the National Screening Unit and BreastScreenAotearoa Providers policies and procedures for research,the Code of Rights 19967 and ethical review requirements.

Criteria


1. all research proposals comply with legal, professional,ethical and other relevant standards or criteria, and areapproved by the appropriate ethics committee

2. prior to commencement of any research activity, theNational Screening Unit is notified of:

a. research activities incorporating breast screeningparticipants and/or their data

b. publishing of research incorporating breastscreening participants and/or their data.

3. all research activities meet the legislative requirementsfor informed consent, adequate information andconfidentiality and the ability of potential participants tosay ‘no’ or participants to ‘opt out’

4. the National Screening Unit, or a Provider, has aprocess to resolve ethical issues in relation to researchactivities.

Evaluation Process


Evaluation Target


* In production7 Code of Health and Disability Services Consumers’ Rights [SR 1996/78].




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The Breast Screening Pathway – SECTION 2

SECTION 2 THE BREAST SCREENING PATHWAY

The Breast Screening Pathway ..............................................................................................................................3

20. Health Promotion ............................................................................................................................................4

20.1 Health Promotion – Objectives ............................................................................................................4

20.2 Health Promotion – Management ........................................................................................................4

20.3 Health Promotion – General Requirements ........................................................................................5

20.4 Health Promotion – Eligibility of Women ............................................................................................5

20.5 Health Promotion – Regional Health Promotion Plan ..........................................................................6

20.6 Health Promotion – Regional Strategies ..............................................................................................6

20.7 Health Promotion – Health Education..................................................................................................7

20.8 Health Promotion – Resources ............................................................................................................7

20.9 Health Promotion – Advocacy ..............................................................................................................8

20.10 Health Promotion – Workforce Development ....................................................................................8

21. Entering the Programme ................................................................................................................................9

21.1 Entering the Programme – Appointment-making ................................................................................9

21.2 Entering the Programme – Special Needs ............................................................................................9

21.3 Entering the Programme – Significant Symptoms Prior to Attendance................................................9

22. First Impressions............................................................................................................................................10

22.1 First Impressions – First Point of Entry ..............................................................................................10

23. Screening........................................................................................................................................................11

23.1 Screening – Waiting Times..................................................................................................................11

23.2 Screening – Breast History..................................................................................................................11

23.3 Screening – Explanation of Procedure ................................................................................................11

23.4 Screening – MRT Communication Skills and Rapport ........................................................................12

23.5 Screening – Signs and Symptoms at Screening ..................................................................................12

23.6 Screening – Routine Views Performed ..............................................................................................12

23.7 Screening – Special Imaging Protocols ................................................................................................13

23.8 Screening – Film Identification Labelling ............................................................................................13

23.9 Screening – Film Processing................................................................................................................14

23.10 Screening – Mammographic Film Optical Density..............................................................................14

23.11 Screening – High Quality Radiographic Technique..............................................................................15

23.12 Screening – Mammographic Quality Assurance (MQA) ....................................................................15

23.13 Screening – Reading the Screening Mammogram ..............................................................................16

23.14 Screening – Film Accessibility..............................................................................................................19

24. Outcome of Screening ..................................................................................................................................20

24.1 Outcome of Screening – Notification of Results or Recall..................................................................20

24.2 Outcome of Screening – Routine Re-Screening..................................................................................20

24.3 Outcome of Screening – Recall to Assessment ..................................................................................21

24.4 Outcome of Screening – Failure or Refusal to Attend Assessment....................................................21



THE BREAST SCREENING PATHWAY 25. Assessment ....................................................................................................................................................22

25.1 Assessment – Waiting Times ..............................................................................................................22

25.2 Assessment – Education, Information and Consent ..........................................................................22

25.3 Assessment – Support ........................................................................................................................23

25.4 Assessment – Quality Assurance Protocols for Equipment ................................................................24

26. Multidisciplinary Management........................................................................................................................25

26.1 Multidisciplinary Team – Clinical ........................................................................................................25

27. Level 1 Assessment........................................................................................................................................26

27.1 Level 1 Assessment – Imaging the Breast at Assessment ..................................................................26

27.2 Level 1 Assessment – Grading of Lesions ..........................................................................................26

27.3 Level 1 Assessment – Extended Assessment......................................................................................26

27.4 Level 1 Assessment – Clinical Examination ........................................................................................27

27.5 Level 1 Assessment – Staged Assessment ..........................................................................................28

28. Level 2 Assessment – Non-operative Diagnosis............................................................................................28

28.1 Level 2 Assessment – Minimising Delay to Needle Biopsy ................................................................28

28.2 Level 2 Assessment – Work up, Information and Consent ................................................................28

28.3 Level 2 Assessment – Needle Biopsy Tissue Sampling of Screen-detected Lesions – (FNAC), Core Biopsy, including vacuum-assisted biopsy specimens ..............................................29

28.4 Level 2 Assessment – Labelling of Specimens ....................................................................................30

28.5 Level 2 Assessment – Pathologic Examination of Core Needle Biopsy Specimen (CNBS) ..............30

28.6 Level 2 Assessment – Pathologic Examination of Fine Needle Aspiration Cytology (FNAC) Specimens ..........................................................................................................................................31

28.7 Level 2 Assessment – Laboratory Facilities and Processes for Reporting on Screen-detected Material ..............................................................................................................................................31

29. Level 3 Assessment – Surgical Biopsy............................................................................................................32

29.1 Level 3 Assessment – Surgical Biopsy General Principles ..................................................................32

29.2 Level 3 Assessment – Pre-operative Localisation of Impalpable Lesions ..........................................33

29.3 Level 3 Assessment – Orientation of Specimen ................................................................................33

29.4 Level 3 Assessment – Size of Specimen..............................................................................................33

29.5 Level 3 Assessment – Specimen Radiography ....................................................................................34

29.6 Level 3 Assessment – Pathology Reporting of Surgical Biopsy Specimens ........................................35

30. Outcome of Assessment................................................................................................................................36

30.1 Outcome of Assessment – Notification of Results ............................................................................36

30.2 Outcome of Assessment – Referral to Treatment ..............................................................................36

31. No further active recall..................................................................................................................................38

31.1 No further active recall ......................................................................................................................38


SECTION 2 – The Breast Screening Pathway

Level 1 and/or 2 Assessment outcome

and notification of results

Open biopsy recommended

Open biopsy

TREATMENT

LEVEL 3ASSESSMENT

LEVEL 2ASSESSMENT

LEVEL 1ASSESSMENT

• Health promotion• Identification, invitation of,

and participation by eligible women

Mammographic screeningFilm reading and reporting

SCREENING

HEALTHPROMOTION

No mammographicallysuspicious abnormality detected

Mammographically suspiciousabnormality detected

Notified of results andrecalled for assessment

Notified that nobreast cancer detected

One or more assessment procedures:

• further mammography

• ultrasound

• clinical examination

∑• FNAC

• core biopsy

No breast cancerdetected

Routine re-screeningin 2 years

Open biopsy outcome andnotification of result

No breast cancer detectedBreast cancer detected

• Surgery• Radiotherapy• Chemotherapy• Counselling

Ongoing Management

20. HEALTH PROMOTION

Standard – Health promotion activities are

planned and delivered within recognised public

health, population based, health promotion

frameworks. This will ensure maximum

participation based on evidence-based strategies

to increase awareness and informed choice.

20.1 HEALTH PROMOTION – OBJECTIVES

Quality Indicator

Health promotion plans and strategies support the overallobjectives of BreastScreen Aotearoa in the reduction ofillness, disability and death from breast cancer and meet thekey health promotion objectives.

Criteria

Key BreastScreen Aotearoa health promotion objectivesinclude, but are not limited to:

1. improving, promoting and protecting the health ofeligible woman in New Zealand

2. ensuring participation by eligible women as a result ofinformed decision-making and ensuring informedconsent underpins all health promotion activities

3. providing accurate, understandable and relevantinformation in a culturally appropriate manner

4. providing comprehensive information about thepurpose of screening, in addition to the potentialbenefits and limitations

5. increasing the awareness of breast health, breastscreening and breast cancer

6. encouraging participation in BreastScreen Aotearoa

7. ensuring health promotion messages do not imply anegative reaction among women who choose not toattend for screening

8. ensuring that strategies are evidence-based, and followbest practice standards and ethical requirements.

Evaluation Process


Evaluation Target


20.2 HEALTH PROMOTION – MANAGEMENT

Quality Indicator

Effective health promotion management ensures theimplementation of appropriate health promotion principlesand practices through the development and support ofthose involved in health promotion.

Criteria

BreastScreen Aotearoa Providers ensure that thoseinvolved in health promotion:

1. understand and work within principles based on theTreaty of Waitangi

2. understand and work within health promotionframeworks based on the Ottawa Charter, JakartaDeclaration, Te Pae Mahutonga and other models ofhealth relating to Maori and Pacific health

3. have sufficient orientation and training to clearlyunderstand the ethics and principles of population-based screening programmes

4. have a sound understanding of breast cancer, breastscreening and the breast cancer screening pathway

5. demonstrate the knowledge and skills required forcompetent practice

6. demonstrate a detailed knowledge of the Code ofRights1

7. participate in quality assurance and quality improvementactivities

8. provide feedback on issues that constrain or preventparticipation in BreastScreen Aotearoa

9. participate in decisions that may constrain or preventevidence based health promotion

10. develop a close working relationship with the screeningand assessment teams

11. have access to accurate and current informationenabling them to fulfil their health promotion role.

Evaluation Process


Evaluation Target






20.3 HEALTH PROMOTION – GENERALREQUIREMENTS

Quality Indicator

Health promotion strategies are aligned with the PublicHealth Services Handbook2 and the National HealthPromotion Framework for the National Screening Unit.*

Criteria

1. BreastScreen Aotearoa Providers will:

a. develop and implement health promotion strategiesthat include family and whanau, from a communitydevelopment approach

b. work collaboratively with other providers,practitioners and community organisations involvedwith the programme to implement the healthpromotion strategies in an appropriate manner

c. ensure BreastScreen Aotearoa promotionalmaterials and resources are used appropriately:

i. that the full range of BreastScreen Aotearoaresources are available to women at all sites

ii. resources are distributed to identified groups,agencies and community-based facilities (eglibraries, CABs, churches, women’s centres etc)

iii. follow the provisions laid out in the VisualIdentity Guide when producing/distributing anyresources/material.

2. BreastScreen Aotearoa Providers will not endorse orpromote products nor will they offer inducements orgifts to encourage participation in BreastScreenAotearoa, without the prior approval of the NationalScreening Unit.

Evaluation Process


Evaluation Target


20.4 HEALTH PROMOTION – ELIGIBILITY OFWOMEN

Quality Indicator

Only eligible women are invited to participate inBreastScreen Aotearoa.

Criteria

1. All asymptomatic women in the eligible age range, whoare entitled to free health and disability services in NewZealand as defined in section 25 of the Health andDisability Services Act 1993 and Amendments, areeligible for inclusion in BreastScreen Aotearoa andshould be encouraged to participate. (Refer: AppendixG: 2000 Direction of the Minister of Health relating tothe eligibility for publicly funded Personal and DisabilityHealth Services in New Zealand)

BreastScreen Aotearoa eligibility criteria:

• women aged 50-64 years

• asymptomatic women

• women who are New Zealand citizens or ordinarilyresident in New Zealand

• women who hold an immigration permit that allowsa stay in New Zealand of two or more years.3

The following are exceptions to the eligibility criteria:

• pregnant women

• women with a history of previous breast cancer,who are less than five years since diagnosis

• women with significant signs and symptomssuspicious of breast cancer (including GP/PCPreferrals due to symptoms). Symptomatic womenmust be referred to diagnostic services

• women who have had mammography within the lasttwelve months.

2. BreastScreen Aotearoa Providers shall accept andencourage into the programme all eligible womenincluding:

• women who self-refer

• women who are referred by their GP/PCP as aresult of a direct request to their GP/PCP

• women whose GP/PCP has sent them an invitationpack as prearranged with the Lead Provider.

3. In those localities serviced by mobile units, theprocesses used may differ from those used in the maincentres.

1 The Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996.

2 HFA/MOH Public Health Services Handbook 2001.* In production3 Health and Disability Services Act 1993, section 25.

4. Women with a previous breast cancer who are well, i.e.no recurrence of breast cancer since their initialdiagnosis, are five years post-operative and are notreceiving surveillance and follow-up are eligible to rejointhe Programme.

5. Women with a previous biopsy of atypical ductalhyperplasia are eligible to participate in the Programmefor a screening mammogram every two years.

NOTE: If at any stage after joining the Programme aProvider becomes aware of a woman’s history of recentbreast cancer(s) the woman will be unable to continuein the programme and an appropriate arrangement ismade for referral back to the woman’s GP/PCP.

6. A Provider may construct a separate list of ineligible orinactive women who have approached BreastScreenAotearoa in order to be able to invite and enrol them ata later date when they are eligible.

Evaluation Process


Evaluation Target


20.5 HEALTH PROMOTION – REGIONALHEALTH PROMOTION PLAN

Quality Indicator

A regional health promotion plan is developed, monitoredand evaluated annually and is consistent with the principlesof a population-based screening programme, and healthpromotion principles, and is aligned to the National HealthPromotion Framework for the National Screening Unit.*

Criteria

BreastScreen Aotearoa Providers ensure that the regionalhealth promotion plan includes the following elements:

1. needs assessment analysis based on relevantdemographic data, catchment area and coverage data

2. definition of the role and responsibilities of the variouspersonnel involved in informing and inviting women toBreastScreen Aotearoa

3. collaboration between BreastScreen AotearoaProviders, health providers and community networks toencourage enrolment of women

4. other groupings of women specifically identified in theplan, for example, remote/rural women and otherethnic groups

5. appropriate utilisation of health education resources

6. advocacy

7. workforce development

8. evaluation of the effectiveness of the regional healthpromotion plan.

Evaluation Process

1. The internal audit process confirms that the regionalhealth promotion plan is available and implemented.


Evaluation Target


20.6 HEALTH PROMOTION – REGIONALSTRATEGIES

Quality Indicator

Health promoters are responsible for including in their planappropriate regional strategies that raise awareness,encourage participation and inform about BreastScreenAotearoa.

Criteria


1. all strategies used reflect the service specifications inthe Provider contract

2. strategies are delivered in the wider context ofwomen’s health

3. strategies include the screening pathway

4. evidence-based/best practice strategies are used

5. strategies are consistent with an informed consentapproach to screening

6. there is collaboration between BreastScreen AotearoaProviders, practitioners and community organisations

7. strategies are developed that include family/whanau andcommunity based approaches

8. strategies are developed that recognise the diversity ofcultural practices.





Evaluation Process


Evaluation Target


20.7 HEALTH PROMOTION – HEALTHEDUCATION

Quality Indicator

Women-focused health education strategies and resourcesencourage women to make fully informed decisions aboutparticipating in BreastScreen Aotearoa.

Criteria


1. educational resources used in education sessions shallbe either the national education resources (consumer,educator and promotional) or other approvedresources (Refer: Appendix D: Breast ScreeningResources) and are used in accordance with theRegional Health Promotion Plan

2. educational sessions are developed and delivered bythose with BreastScreen Aotearoa health promotiontraining with input from others as appropriate

3. education sessions includes key messages (Refer:Appendix E: Key Messages for BreastScreen Aotearoa)

4. education sessions are needs-based and women-focused

5. education sessions are participatory and appropriate tothe audience

6. education sessions are evaluated and peer-reviewed asappropriate.

Evaluation Process


Evaluation Target


20.8 HEALTH PROMOTION – RESOURCES

Quality Indicator

BreastScreen Aotearoa health promotion resources aredeveloped to provide information about the Programmeand encourage eligible women to participate.

Criteria

The BreastScreen Aotearoa Health Promoters shall ensurethat:

1. national BreastScreen Aotearoa resources andpromotional items are used in accordance with theRegional Plans and National Health PromotionFramework

2. the development of additional resources or promotionalitems shall follow the National Guidelines for HealthEducation Resource Development in New Zealand,June 20024

3. any additional resources and promotional items are tobe approved by the National Screening Unit before use

4. BreastScreen Aotearoa resources are readily available atall BreastScreen Aotearoa sites and in particular, thegeneral BreastScreen Aotearoa pamphlet* is available incommunity facilities, (for example, GP/PCP practiceslibraries, citizen advice bureaux, churches, marae,women’s centres, etc.) (Refer: Appendix R: BreastScreening Resources)

5. written resources are:

a. provided in the language of the participant whereavailable (Refer: Appendix D: Breast ScreeningResources)

b. appropriate and acceptable to the group for whomthey are intended.

6. only material approved by the National Screening Unitis to be offered to women through BreastScreenAotearoa sites and displayed with BreastScreenAotearoa material.

Evaluation Process


Evaluation Target


* In production4 Available from the Ministry of Health website – Booklet ISBN No 0-478-27058-5.* Code 10102.

20.9 HEALTH PROMOTION – ADVOCACY

Quality Indicator

The use of appropriate strategies to raise the profile ofBreastScreen Aotearoa in the context of women’s health.

Criteria

BreastScreen Aotearoa Providers ensure:

1. the use of appropriate public forums to provideaccurate information about screening

2. liaison and collaboration with key organisations,stakeholders, community representatives and others tosupport them in encouraging eligible women andfamilies and whanau to facilitate the communityownership of BreastScreen Aotearoa

3. that the identification of appropriate key organisations,groups and communities to assist in promoting keymessages to women is undertaken using a communitydevelopment approach

4. they encourage the distribution of BreastScreenAotearoa health education resources to women.

Evaluation Process


Evaluation Target


20.10 HEALTH PROMOTION – WORKFORCEDEVELOPMENT

Quality Indicator

Appropriately trained personnel deliver health promotionwithin BreastScreen Aotearoa.

Criteria


1. the health promotion team has an appropriate skill mix,range of experience, cultural competencies andexpertise required to effectively deliver the service

2. adequate supervision and support is available for new orinexperienced health promotion practitioners

3. opportunities for health promotion practitioners toprogress through the competency levels outlined in:

a. Nga Kaiakatanga Hauora mo Aotearoa HealthPromotion Competencies for Aotearoa-NewZealand

b. National Screening Unit Competencies, includingCultural Competencies.

4. all health promotion practitioners are provided withtraining specific to BreastScreen Aotearoa enablingthem to provide accurate, culturally appropriate andnationally consistent messages

5. regional training reflects the requirements of theNational Health Promotion Strategy and Framework.

Evaluation Process


Evaluation Target






21. ENTERING THE PROGRAMME

Standard – Each woman’s interest in participating

in BreastScreen Aotearoa is appropriately recorded

and an initial appointment is made efficiently.

21.1 ENTERING THE PROGRAMME –APPOINTMENT-MAKING

Quality Indicator

All eligible women will receive an appropriate invitation toattend an appointment with BreastScreen Aotearoa.

Criteria

1. the appointment-making process will be initiated afterthe woman has been identified through the mechanismsoutlined in the recruitment plan and the BreastScreenAotearoa Provider has recorded the woman’s interestin the Programme

2. BreastScreen Aotearoa Providers will ensure that theappointment-making process includes the following:

a. obtaining information to register the women withinthe Programme, including any special needs

b. the name of the Provider, where the service isprovided and any relevant information the womanrequires before attending for a screeningmammogram

c. an appointment (or confirmation of an appointment)and information about how to change herappointment time, if required

d. a comprehensive consent and notification form

e. the national information brochure about theProgramme.

Evaluation Process


Evaluation Target


21.2 ENTERING THE PROGRAMME – SPECIAL NEEDS

Quality Indicator

Information relating to special needs is obtained prior tofinalising a woman’s appointment.

Criteria


1. the woman is asked, during the appointment-makingprocess, if she has an impairment, disability or specialneed that will need to be accommodated at the time ofher screen. For example, interpreters, attendant carers,additional time, wheelchair access

2. the woman is asked whether there have been anyconcerns with previous mammograms she may have had

3. interpreters and any other additional services requiredto assist a woman are organised prior to her attending

4. disabled women are encouraged to attend a fixed siteas they are better equipped to provide access,additional time and accommodate carers

5. women who have implants must attend a fixed site,where their films are processed immediately forchecking by the MRT for technical quality.

Evaluation Process


Evaluation Target


21.3 ENTERING THE PROGRAMME –SIGNIFICANT SYMPTOMS PRIOR TOATTENDANCE

Quality Indicator

Women who indicate current symptoms that have notpreviously been investigated prior to attendance atscreening shall be advised to see their GP/PCP for aconsultation.

NOTE: If a woman attends screening with symptoms,without the BreastScreen Aotearoa Providers priorknowledge, refer to Standard 23.5 Signs and Symptoms atScreening.

Criteria


1. if the woman indicates the presence of significant signsand symptoms that have not been previouslyinvestigated prior to attendance for screening, it is thenappropriate for the booking staff to recommend that thewoman makes an appointment to see her GP/PCP tohave this assessed prior to enrolment

Significant signs and symptoms are:

• a new lump or thickening

• puckering or dimpling of the skin

• any change in one nipple such as:

– a turned in nipple

– a watery or bloodstained discharge whichpersists without squeezing.

2. a protocol exists to ensure staff are aware of theprocess, criteria and appropriate responses when awoman reports symptoms prior to attendance. Refer:Appendix F: Guidelines for Booking Staff.

Evaluation Process


Evaluation Target


22. FIRST IMPRESSIONS

Standard – Each woman experiences a welcoming

and helpful response when first making contact

with the Programme.

22.1 FIRST IMPRESSIONS – FIRST POINT OF ENTRY

Quality Indicator

Telephone and reception staff demonstrate effectivecommunication and listening skills, and respond in aprofessional and timely manner.

Criteria

1. Protocols that outline communication and presentationexpectations of staff who have personal contact witheach woman, her family/whanau and other members ofthe public are followed.

2. Staff are friendly, welcoming and helpful and take intoconsideration that each woman may have differingexpectations of the Programme.

3. Opportunities are provided for all staff with front-linecontact with women, for example, telephone andreception staff, to be trained to:

a. provide a well women-centred approach

b. provide accurate information

c. understand the eligibility criteria for the Programme

d. meet privacy and confidentiality requirements

e. know when and where to refer each woman

f. provide and maintain appropriate communicationand listening skills

g. respond effectively to difficult situations

h. address, at the earliest opportunity, unsatisfactoryexperiences reported by women

i. recognise their own knowledge limitations.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed find the reception andbooking staff professional, caring and helpful.






23. SCREENING

Standard – The screening service is well women-

centred and produces timely, reliable and high-

quality results.

23.1 SCREENING – WAITING TIMES

Quality Indicator

The screening unit processes ensure that women are notkept waiting unnecessarily.

Criteria


1. screening schedules shall be well planned anddocumented, and take into account the needs ofwomen requiring additional time (for example, implants,disabilities.)

2. staff resources and training facilitate screening schedulesto be kept on target/time.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed report that they did not waitunnecessarily.


23.2 SCREENING – BREAST HISTORY

Quality Indicator

Each woman shall have a specified breast history recorded,and this information will be made available to the readingradiologist.

Criteria

BreastScreen Aotearoa Providers ensure that the breasthistory includes but is not limited to:

1. date and place of previous mammogram(s)

2. any family history of breast cancer

3. previous breast surgery or treatment

4. scars, moles and other ‘signs’ (position recorded)

5. current symptoms, for example, nipple discharge, lump,etc, outlined in Standard 21.3 Entering the Programme– Significant Symptoms Prior to Attendance

6. relevant medication including the use of hormonereplacement therapy (HRT)

7. the breast history information is readily available to theradiologist during mammogram reading.

Evaluation Process

Monthly auditing of clinical records for women screenedduring the previous month at each screening unit. (Thismay be undertaken in conjunction with the DataManagement Manual requirements.)

Evaluation Targets

1. 100% of women who comply shall have the specifiedbreast history recorded so that it is readily available tothe reading radiologist.


23.3 SCREENING – EXPLANATION OFPROCEDURE

Quality Indicator

Each woman receives a full explanation of the procedurebefore commencement of her screen.

Criteria


1. the woman has an understanding of the screeningprocess, including benefits and limitations, in order tomake an informed decision to participate inmammography. Refer: Standard 5 – Consent

2. women using HRT should be informed that theaccuracy of mammography screening tests may belower for women using HRT

3. the need for adequate compression and advantages inenhancing image quality and reducing radiation dose isexplained before commencement of the screen.

Evaluation Process

Satisfaction surveys.

Evaluation Target

95% of women surveyed report that they receivedsufficient information in order to make an informed choice,and understand the process.

23.4 SCREENING – MRT COMMUNICATIONSKILLS AND RAPPORT

Quality Indicator

Each woman finds the mammogram process acceptable,which encourages her return for subsequent re-screening.

Criteria

BreastScreen Aotearoa Medical Radiation Technologists(MRTs) ensure that:

1. rapport with the woman is established

2. the woman’s potential fears and anxieties regarding theprocedure are acknowledged

3. every effort is made to make the woman comfortable,for example, maintaining her personal privacy anddignity

4. the woman is offered a gown or a korowai duringscreening

5. the woman is given a sense of control within theprocedure, to help allay anxiety and discomfort/pain

6. pain is acknowledged if it occurs, and the procedureterminated if the woman requests

7. mechanisms are in place to deal with issues that haveoccurred during the mammogram

This shall include, but are not limited to:

a. further discussion

b. advice on pain relief prior to or subsequent to amammogram

c. advice on future mammograms.

Evaluation Process


Evaluation Target

95% of women surveyed report finding the MRTreassuring, caring and helpful.

23.5 SIGNS AND SYMPTOMS AT SCREENING

Quality Indicator

Women who present to a screening appointment with signsand symptoms shall have their mammogram performed,but will be appropriately referred for symptommanagement irrespective of screening outcome.

NOTE: If a woman identifies current signs and symptomsPRIOR to screening. Refer: Standard 21.3 Entering theProgramme – Significant Symptoms Prior to Attendance.

Criteria


1. a protocol exists to ensure the appropriate referral ofeach woman in whom signs and symptoms areidentified during the screening visit

Signs and symptoms are:

• a new lump or thickening (lump that the woman canfeel that has arisen in the last 12 months)

• pain or tenderness

• puckering or dimpling of the skin

• any change in one nipple such as:

– a turned-in nipple

– a watery or bloodstained discharge whichpersists without squeezing.

2. the woman and her nominated GP/PCP (providedconsent has been obtained) are notified in writing ofany signs and/or symptoms that may require furtherinvestigation

3. where the result of the screening mammogram isnegative the BreastScreen Aotearoa Provider, with thewoman’s consent, will refer her (in order of priority) to:

a. her GP/PCP

b. a specialist diagnostic clinic through the publichospital service, or

c. a private provider.

NOTE: the National Screening Unit recommends thefirst referral option is the most appropriate option forthese women and all Lead Providers are to refer thesewomen back to their GP/PCP unless there are specificreasons for not doing so. The reasons for not doing soshould be documented in the woman’s file.

Evaluation Process


Evaluation Target


23.6 SCREENING – ROUTINE VIEWSPERFORMED

Quality Indicator

All screening examinations shall be comprehensive andcomplete with unnecessary exposure to radiation kept to aminimum.





Criteria


1. all screening mammograms will have a cranio-caudaland medio-lateral oblique view of each breast. Anydeviation from this will be recorded by the MRTperforming the screen

2. MRTs are permitted to use their professional discretionto decide any additional views required to image theentire breast with unnecessary exposure to radiationkept to a minimum. The number of these films shall berecorded

3. the name of the MRT performing the screen is recorded

4. for each screening examination the total number offilms taken are recorded

5. for each screening examination the total number offilms rejected are recorded

6. the MRT performing the examination should check itfor completeness and document the MIQ Grading(Refer: Appendix N: Mammographic Image Quality(MIQ) Classification)

7. another MRT, other than the one performing theexamination, may review the films prior to them beingread, and this will usually occur with mammogramsperformed on the mobile units.

Evaluation Process

1. The MRT monthly peer review process will reviewfilms for completeness. (Refer: Section 4, ProfessionalRequirements: Medical Radiation Technologist andAppendix N: Mammographic Image Quality (MIQ)Classification.)

2. Monthly auditing of clinical records for womenscreened during the previous month at each screeningunit (This may occur in conjunction with the DataManagement Manual requirements).

3. Information is collected through the National MinimumData Set for monitoring and evaluation purposes (Refer:Current DMM).

Evaluation Targets

1. 100% of all screening examinations are comprehensiveand complete according to MIQ Classification. (Refer:Appendix N: Mammographic Image Quality (MIQ)Classification.)

2. >80% of women screened have four films or fewer.

23.7 SCREENING – SPECIAL IMAGINGPROTOCOLS

Quality Indicator

Specific imaging protocols are used within screening unitsfor women who have large breasts, breast implants, had amastectomy, breast conservation surgery or are at high risk.

Criteria

BreastScreen Aotearoa Providers ensure that the followingnationally consistent protocols are used within theProgramme (Refer: Appendix J: National ScreeningProtocols):

1. large breasts

2. breast implants

3. mastectomy

4. women treated by breast conservation surgery (widelocal excision)

5. high risk women.

Evaluation Process


Evaluation Target


23.8 SCREENING – FILM IDENTIFICATIONLABELLING

Quality Indicator

Each mammographic image shall have the followinginformation on it in a permanent, legible, and unambiguousmanner and placed so as not to obscure anatomicstructures.

Criteria

1. there are fail-safe processes in place to ensure that thewoman’s details, clinical record and labels are matched.

2. BreastScreen Aotearoa Providers ensure that thefollowing information is recorded:

a. full name of the woman

b. date of birth

c. NHI number

d. date of examination

e. view and laterality (This information should beplaced on the image near the axilla)

f. facility name and location

g. MRT identification

h. cassette/screen identification

i. mammography unit identification, if there is morethan one unit at a facility.

Evaluation Process

1. Monthly auditing of clinical records for women screenedduring the previous month at each screening unit.


Evaluation Targets

1. 100% of films are correctly labelled.


23.9 SCREENING – FILM PROCESSING

Quality Indicator

Film quality is not compromised as a result of delays in filmprocessing.

Criteria


1. films are processed promptly, according to themanufacturer’s guidelines and the requirements of theQuality Control Process, Refer Appendix K:Mammographic Quality Assurance (MQA) Programme.These must be in place and the staff will bothunderstand and follow these protocols to addressparameters approaching, or exceeding, limits

2. films will normally be processed while the woman ispresent at the screening site

3. all films (including mobile films) are processed within 24hours, and ideally within 12 hours of exposure, unless afilm type is used that does not show significant loss ofimage quality due to latent image fading. If the latterfilm type is being used then appropriate tests must havebeen performed and documented to substantiate thevalidity of this delayed processing and the maximumtime delay documented

4. there is a written protocol outlining actions when adelay in processing of screening films is anticipated (forexample, processor breakdown):

a. the exposure of a sensitometric strip before the firstwoman is screened ‘blind’ is conducted. This willrepresent the longest delay between exposure andprocessing of films

b. the unit should have established the maximum timefor which films may remain unprocessed withoutfilm degradation of image quality as assessed by a20% reduction in phantom objects seen.

5. if it appears that processing will be delayed beyond themaximum time that the site can assure the maintenanceof image quality, screening of women should not beperformed

NOTE: These protocols must be accepted by the LeadProvider MQA Committee consisting of the Leadradiologist, Lead MRT, Clinical Director and MedicalPhysicist.

6. there must be ongoing physical evidence that imagequality is not degraded, by the procedures being used

7. each batch of films must be accompanied by asensitometric strip, which is exposed before the firstclient in that batch.

Evaluation Process


Evaluation Target


23.10 SCREENING – MAMMOGRAPHIC FILMOPTICAL DENSITY

Quality Indicator

Mean film optical density is maintained between 1.6 and 1.8in order to optimise the detection of small cancers andminimise the radiation dose.

Criteria

1. BreastScreen Aotearoa Providers ensure that a 4 cmPerspex block (representing a 4.5 cm compressedbreast) is imaged as per daily AEC tests.

2. The QC MRT at each screening site ensures that dailyAEC tests occur and are documented.

Evaluation Process


Evaluation Targets

1. Mean optical density 4cm from the chest wall andcentred laterally, between 1.6 and 1.8 is maintained.






23.11 SCREENING – HIGH QUALITYRADIOGRAPHIC TECHNIQUE

Quality Indicator

All screen detectable breast cancers are shown on themammogram which should include as much breast tissueon the plate as possible.

Criteria

1. While the Clinical Director in the screening programmehas ultimate responsibility for image quality it is the roleand function of all MRTs to produce images of thehighest quality for reading.

2. BreastScreen Aotearoa Providers ensure that there isaccurate recording of any factors including techniquewhich assist in the production of quality images forfuture screens.

3. For the reading radiologist to evaluate minutestructures within the breast the MRT must image thebreast by paying attention to the following areas:

• quality control

• positioning

• exposure factors.

4. It is the responsibility of the MRT to check all images for:

• positioning

• sharpness

• contrast

• correct exposure

• compression

• processor faults

• correct annotation

• women’s identification label

• absence of artefacts

• completeness of examination according to the MIQclassification. (Refer: Appendix N: MammographicImage Quality (MIQ)

This should occur before images are hung for reading.

5. It is the reading radiologist’s responsibility tocontinuously monitor the technical quality ofmammograms and provide constructive feedback toMRTs. This is particularly important in situations whereMRTs cannot view their own films (mobile units withouton-site processing) or do not have direct contact withthe radiologist who reports the films (satellite centres).The aim of feedback is to improve overall film qualitywhile reducing the number of reject films.

6. All MRTS will attend regular sessions (at least monthly)reviewing films for technical quality. This shall beattended by the designated radiologist or ClinicalDirector quarterly and it is their responsibility to informthe other radiologists of the outcomes of this meetingwhere it impacts on radiologist technical recalls.

Evaluation Process



Evaluation Targets

1. Technical reject rate: The number of films rejected as apercentage of the number of films taken, calculatedseparately for women who are screened in a fixed unitand a mobile unit.

Screened on a fixed unit or a mobile unit< 3%

2. Technical recall rate: The number of women who haveto return to a screening unit (either fixed or mobile) forfurther films to complete their screening episode,expressed as a percentage of the number screened.

Screened on a fixed unit < 0.5%

Screened on a mobile unit < 3%


23.12 SCREENING – MAMMOGRAPHICQUALITY ASSURANCE (MQA)

Quality Indicator

A Mammographic Quality Assurance (MQA) programmeshall be complied with to ensure high qualitymammographic imaging.

Criteria

1. BreastScreen Aotearoa Providers ensure that theRANZCR Mammographic Quality AssuranceProgramme 2002 or subsequent versions are compliedwith.


a. the MQA committee, which, in association with adesignated individual from each screening site, willensure there is a comprehensive CQI process.(Refer Appendix K: Mammographic QualityAssurance (MQA) Programme)

b. they own or access appropriate and adequate testequipment. (Refer: Appendix P: Test Equipment)

3. Individual screening units recognise that these areminimum standards and that often increased frequency(especially for items such as screen cleaning) oradditional tests may be necessary to ensure quality.Frequency beyond the minimum requirements is at thediscretion of the screening/assessment site:

a. all tests shall be fully documented

b. for some tests a standardised report shall berequired

c. test results shall be made available for inter-comparison and the collation of national statistics

d. to promote high quality imaging for all women andcompliance with NRL-C55, a programme of dosemeasurements on women shall be included.

4. Current quality test records are held for each X-ray setand processor used within the programme, these shallbe kept until after the following NRL audit whichauthorised disposal

5. Equipment test records show that the equipmentparameters are maintained within operating limits, andcorrective action has been taken where required

6. Medical Physics tests are conducted within 20 workingdays of the due date

7. Where the equipment fails the image quality or meanglandular dose tests it is withdrawn from use

8. Other defects detected by the Medical Physicists testsshall be rectified within 30 working days.

Evaluation Process


Evaluation Targets

1. 100% compliance with all Medical Physics tests.


23.13 SCREENING – READING THESCREENING MAMMOGRAM

Quality Indicator

The reading of the screening mammogram shall occur insuch a manner as to maximise detection of anymammographic abnormality that could be cancer.

Criteria


1. there is uninterrupted time scheduled for readingscreening mammograms:

a. the room should be quiet and lights dimmed

b. an automated viewer is highly desirable and apractical necessity for a screening unit. (Refer:Appendix O: Film View Box)

c. a bright spotlight is available

d. magnification glasses are available

2. previous mammograms are obtained, wheneverpossible, for comparison. Failure to obtain the previousmammograms will be documented in the clinical record

3. radiologists assess all films for:

a. positioning

b. sharpness

c. contrast

d. density

e. processor faults

f. correct labelling

g. completeness of examination.

4. the mammogram is reported as technically adequate ornot

Technically inadequate usually means that the woman isrecalled for further views to complete the examination.There are instances where the mammogram isincomplete or technically inadequate but unable to beimproved upon, for example, when a woman has afrozen shoulder. In these situations both the woman andher GP/PCP should be informed of the limitations ofthe examination and be given a recommendationregarding further participation in the Programme. Forsuggested text to insert in the response letter refer:Appendix I: Pro Forma Letters and Forms





Where a woman refuses for whatever reason to allowcompletion of her screening mammograms, the filmsshould be read in the usual manner. A report indicatingwhether or not there is an abnormality shall be sent tothe woman (and her GP/PCP if consented). This reportshould indicate that the examination was incomplete,that the woman has refused further views and arecommendation has been made which includes eitherreturn to screening or recall to assessment

5. feedback to the MRTs by the Clinical Director shouldinclude comments regarding technically adequatemammograms that could be improved upon (forexample. skin fold, lack of sharpness in only one view)and when the examination is technically perfect

6. the radiologist should have access to availableinformation when interpreting mammograms, whichincludes any symptoms, previous breast surgery andhormone replacement therapy. This information shouldbe readily available to the reading radiologist

7. reader fatigue may adversely influence visualperception. It is therefore recommended that thesecond reader review the films in the reverse order tothe first

8. films are read independently by two radiologists, bothof whom meet the radiology training requirements asspecified in this document

NOTE: The IT system should ensure that the secondradiologist is reading in a true independent manner andcannot view or alter the results entered by the firstreader

9. lesions for categorisation include:

a. calcifications

b. spiculated mass

c. multiple masses

d. discrete mass with/without calcification

e. architectural distortion

f. non-specific density

g. other.

10. suggested categorisation of these lesions by readingradiologists are:

Category 1. Normal/Benign – return to routine re-screening

Category 2. Probably benign – may need assessment toconfirm

Category 3. Indeterminate – needs assessment toelucidate

Category 4. Probably malignant – requires assessmentand probably a tissue diagnosis

Category 5. Malignant – probably requires a tissuediagnosis

NOTE: Categorisation should allow triage of women toan appropriate assessment centre (where stagedassessment is an option) or appropriate appointmentscheduling.

11. films are reported as either:

a. ‘Normal’ (continue two-yearly screening)

b. ‘For assessment’ (refer for further mammographicor clinical work-up at an assessment clinic)

12. the subsequent report is sent to the woman and hernominated GP/PCP

13. there is a written protocol for resolving cases in whichconsensus between the blind reads is not reached. Thismay include interpretation by a third reader or aconsensus process. The result of this process will be asingle recommendation either ‘normal’ or ‘forassessment’ (as above).

Evaluation Process

1. Individual radiologists shall receive performancefeedback, as specified in the Section 4: ProfessionalStandards – radiologist. These records are madeavailable for external audit as de-identified data.



5 NRL 1994 Code of Safe Practice for the use of X-rays in Medical Diagnosis Report NRL C5 Christchurch National Radiation Laboratory.

Evaluation Targets

Radiologist Specific Targets

Individual radiologists’ reading statistics shall lie within 95%confidence intervals for rates of cancer detection anddetection of small cancers. Where an individual fails tomeet these criteria, the Clinical Director will ensurestrategies for improving performance are implemented.This will be monitored by visiting audit teams.

1. Positive Predictive Value of screening mammogram:>9%

2. False positive rate:

Initial (Prevalent) Screening Examination < 9% minimum

Initial (Prevalent) Screening Examination < 6% desired

Subsequent (Incident) Screening Examination < 4% minimum

Subsequent (Incident) Screening Examination< 3% desired

3. Referral to assessment:

Initial (Prevalent) Screening Examination< 10% minimum

Initial (Prevalent) Screening Examination < 7% desired

Subsequent (Incident) Screening Examination < 5% minimum

Subsequent (Incident) Screening Examination< 4% desired

4. Cancer detection rate (including DCIS) per 10,000women screened:

Initial (Prevalent) Screening Examination≥ 3 x the background incidence = 69.0

Subsequent (Incident) Screening Examination≥ 1.5 x the background incidence = 34.5

5. Small invasive screen-detected cancers (≤ 10 mm) per 10,000 women screened: Initial (Prevalent) Screening Examination ≥ 25% (of invasive cancers) = 17.3

Subsequent (Incident) Screening Examination ≥ 30% (of invasive cancers) = 10.45

6. Small invasive screen-detected cancers (<15 mm) per 10,000 women screened:

Initial (Prevalent) Screening Examination> 50% (of invasive cancers) = 34.5

Subsequent (Incident) Screening Examination > 50% (of invasive cancers) = 17.3

7. Node-negative invasive screen-detected cancers:

Initial (Prevalent) Screening Examination > 70% (of invasive cancers)

Subsequent (Incident) Screening Examination > 75% (of invasive cancers)

8. Ductal carcinoma in situ (DCIS): (of all cancers detected by the programme)10-25%

9. Interval cancers (including DCIS):

Per 10,000 women screened within one calendar yearof previous screen< 6.9

Programme Evaluation Targets

In addition to the above evaluation of the Programme willinclude:

10. Specificity of screening mammogram (actual):6

> 93%

11. Specificity of Programme (approximate): > 93%

12. Standardised Detection Ratio: > 0.75 minimum> 1% desired

13. Sensitivity of screening mammogram7

no target8 (EU guidelines)

NOTE: (Refer: Appendix A: Glossary)





23.14 SCREENING – FILM ACCESSIBILITY

Quality Indicator

BreastScreen Aotearoa retains ownership of all originalmammogram films taken within the Programme.

Criteria


a. screening films are stored separately from generalradiology films

b. screening films are to be retained by the LeadProvider for ten years beginning on the day after thedate shown in the health information/record as themost recent date on which a provider provided(services) to that individual9

c. original films are to be retained by the Lead Providerto ensure interval cancer peer review may occur

d. all films are adequately stored and accessible formonitoring and subsequent audit.

2. BreastScreen Aotearoa Providers will ensure that in theevent of a woman changing Lead Providers or movingoverseas:

a. films will be released to the new Provider on thereceipt of the designated request form from thenew Provider or the woman concerned

b. during transfer of original films to a new Provider, atrack and trace system and record of receipt of filmsmust be implemented

c. a note is made in the client electronic file and therequest form retained

d. a copy of the most recent screen is retained forquality assurance purposes in the event that aninterval cancer is detected

e. the films are then the responsibility of the newProvider.


a. under most circumstances, film copies, rather thanthe originals should be sent to other Providers. Ifthese are considered inadequate for comparativepurposes, original films may be released on receiptof a written request (letter or fax) from other healthprofessionals (for example, surgeons, radiologists)

b. a copy of the films and a note is made in the clientfile and the request is also retained on file

c. the films are dispatched following the completion ofthe tracking requirements

d. a record/log of films that have been released, is keptby each Lead Provider and the Lead Provider will berequired to track the:

i. date of the request

ii. requesting health professional/hospital

iii. expected return date

iv. return date.

e. the log is monitored on a monthly basis to ensurethat all outstanding films are followed up andreturned to the Lead Provider

f. all original films released (100%) are to be returnedto their original site within three months of release.

4. Women may:

a. request their films in writing

b. be informed not to expect originals to be provided

c. expect copies to be provided and that the cost willbe paid by them or by the Lead Provider

d. expect that the Lead Provider will inform them that,if undergoing a mammogram with a private provider(radiologist), the radiologist may access the originals,and copies are not required in this situation

e. expect to be informed if the quality of the copies issuch that they cannot be used clinically

f. expect a note will be placed in their client fileindicating that copies have been made anddispatched to them.

Evaluation Process

The internal audit process ensures the criteria are compliedwith and identified shortfalls are addressed through theContinuous Quality Improvement (CQI) Process.

Evaluation Target


6 Number with true negative screening results (Y) as a percentage of Y plus number with false positive screening results.7 Number with cancer detected during a screening episode (X) as a percentage of X plus the number with cancer detected within one

year from a clear screen.8 European Guidelines for Quality Assurance in Mammography Screening. 3rd Ed. 9 Health (Retention of Health Information) Regulations 1996, sections 5 & 6 (1).

24. OUTCOME OF SCREENING

Standard – Women are followed up appropriately

to ensure they either return to routine re-screening

or are recalled to assessment.

24.1 OUTCOME OF SCREENING –NOTIFICATION OF RESULTS OR RECALL

Quality Indicator

Each woman receives timely and accurate notification ofher results.

Criteria


1. each woman will have the method and timeframe ofresult notification discussed with her at the completionof the screen

2. the woman’s nominated GP/PCP is also to be advised ofthe results simultaneously, if the woman has givenconsent, so that she can contact her GP/PCP forsupport and advice if required

3. each woman will receive an explanation if she is recalledfor technical repeat films. The woman should beoffered the opportunity to view her films when recalledfor repeats, if appropriate. This may help allay some ofthe anxiety associated with recall.

Evaluation Process

1. Regular reports, which identify women who are outsidethe target parameters, shall be generated and reviewedby the Clinical Director and Lead Provider Manager ora designated individual.

2. Information is collected through the National MinimumData Set for monitoring and evaluation purposes.(Refer: Current DMM)

Evaluation Targets

1. Films must be read promptly enough so that > 90-95%of women can be notified within 10 working days of thescreening mammogram.


24.2 OUTCOME OF SCREENING – ROUTINE RE-SCREENING

Quality Indicator

Each woman eligible for routine re-screening is invited backto the programme in an appropriate timeframe.

NOTE: Routine re-screening is for eligible women with a‘normal’ screening mammogram or women who have beenassessed as having ‘no evidence of cancer’ after assessment,and who are re-invited for a repeat screening mammogramevery two years until no longer eligible.

Criteria


1. a process is implemented to offer eligible women anappointment for re-screening between 20 and 24months from the date of previous screen

2. at the time of screening, eligible women will be advisedthat they will be re-invited

3. GPs/PCPs are encouraged to assist providers to confirmongoing eligibility of women, for example, if they havemoved, are unwell, or have had an interval cancer

4. women contacting the programme with intervalsymptoms (that is, between routine screeningmammograms), are to be advised to see their GP/PCPfor a consultation.

Evaluation Process

1. Regular reports shall be generated and reviewed by theLead Provider Manager to ensure scheduling enableswomen to be screened within the targets and timeframes.



Evaluation Targets

1. > 75% of women who return for a screen are re-screened between 20 and 24 months from theirprevious screen.10

2. > 85% of women screened in a Programme round aresubsequently (if eligible) re-screened in the nextProgramme round.






24.3 OUTCOME OF SCREENING – RECALL TO ASSESSMENT

Quality Indicator

All women with mammographic abnormalities that may bemalignant are recalled to assessment.

Criteria


1. each woman is notified of the need to attend theassessment clinic, by the breastcare nurse, as soon aspossible after screening. The breastcare nurse clearlyidentifies herself, her role and availability at this time

2. where the woman has consented, the GP/PCP isnotified of the recall to assessment at the same time asthe woman

3. every effort is made to reduce anxiety or uncertaintyexperienced by the woman

4. where possible, reasonable notice is given to women.Consideration is to be given to reducing the duration ofany anxiety by contacting the woman close to theproposed assessment day, for example, not just beforea weekend or public holiday.

Evaluation Process

1. Reports that identify women who are to be recalled forassessment shall be generated regularly and arereviewed by the Lead Provider Manager, ClinicalDirector or a designated individual and retained forfuture audit activities.



Evaluation Targets

1. 90% of women are offered an assessment appointmentwithin 15 working days of their final screeningmammogram.11


24.4 OUTCOME OF SCREENING – FAILUREOR REFUSAL TO ATTEND ASSESSMENT

Quality Indicator

The BreastScreen Aotearoa Provider ensures timely andappropriate follow-up when a woman fails or refuses toattend for assessment.

Criteria

The BreastScreen Aotearoa Provider should undertake aminimum of three attempts to contact the woman (viatelephone, mail and GP/PCP, if consent for this has beengiven):

1. if the woman attends, no further action is required

2. if the woman does not attend:

a. the woman is sent a letter as a final sign-off ofresponsibility, that is, this should be done inaccordance with the Code of Health and DisabilityConsumers’ Rights. The letter should be sent bycourier where a residential address is supplied

b. the woman’s GP/PCP is advised that the womanfailed to attend, (if the woman had previously givenconsented for her GP/PCP being informed)

3. if the woman refuses to attend assessment or declinesto complete assessment (with BreastScreen Aotearoaor elsewhere), further re-screening within theProgramme becomes irrelevant:

a. this implies that the woman is requesting dischargefrom BreastScreen Aotearoa

b. the woman is then allocated ‘stopped status’ inBreastScreen Aotearoa and is advised to see herGP/PCP with any concerns

c. the woman’s GP/PCP is advised:

i. of the screening findings

ii. of the woman’s refusal to attend for assessment

iii. that the woman has been discharged fromProgramme at her request.

10 BreastScreen Australia National Accreditation Standards. 2001. 11 European Guidelines for Quality Assurance in Mammography Screening 3rd Ed.

DMM Field Codes

0=Not Specified;

1=Stopped – Woman Transferred to Other LeadProvider

2=Stopped – Unable to Contact Woman

3=Stopped – Woman Refused Assessment

4=Stopped – Woman Declined to CompleteAssessment

5=Stopped – Woman unable to CompleteAssessment due to ill health

9=Stopped – Other

4. if the woman chooses to ‘exit’ the Programme andundergoes further assessment with a private provider,the results of that private assessment will be recorded,where available. If the woman’s results are benign, sheshould be invited for re-screening when that is next due.

Evaluation Process


Evaluation Target


25. ASSESSMENT

Standard – The assessment process provides

accurate diagnosis for women with screen-

detected lesions and returns those who do not

have breast cancer to routine re-screening. This is

carried out in an effective and efficient manner

that is women-centred and minimises morbidity.

25.1 ASSESSMENT – WAITING TIMES

Quality Indicator

The multidisciplinary assessment team functions effectivelyand efficiently in the assessment clinic to ensure thatwomen are not kept waiting unnecessarily.

Criteria


1. a simple, well co-ordinated system through which thewoman progresses, with the least chance of confusionor delay, is implemented

2. assessment schedules are planned and documented

3. during assessment the woman is kept informed of anylikely waiting times

4. at each stage of the process the woman shall be fullyinformed of what is happening

5. staff resources and training ensure assessmentschedules are kept on time.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed report not waitingunnecessarily during the assessment clinic, or they wereinformed of why they were waiting.


25.2 ASSESSMENT – EDUCATION,INFORMATION AND CONSENT

Quality Indicator

The members of the multidisciplinary team ensure thateach woman attending assessment receives relevantinformation in a manner that enables her to make informedchoices regarding assessment and any further interventions.





NOTE: Information and understanding enables the womanto make informed choices and contributes to the reductionof anxiety.

Criteria


1. women invited to assessment are provided withapproved information prior to attending the assessmentclinic

2. sufficient uninterrupted time is available to allow forrelevant information to be shared with each woman andwith her consent, her family or whanau

3. the woman is greeted and the assessment process isfully explained so that she is able to make an informeddecision about proceeding. Ideally this should beundertaken by the breastcare nurse or relevantClinician

4. there is an appropriate private area for discussion ofoptions

5. the woman’s concerns regarding the assessmentprocedure, or any other related issues, are discussedand addressed in a manner that ensures the privacy ofthe individual and any relevant parties

6. with the woman’s consent, follow-up contact is madeby the breastcare nurse to assess information retentionand further individual needs, in a manner whichminimises stress to the woman concerned

7. a wide range of information about breast cancer andtreatment, such as the resources produced by theNational Screening Unit are available for womenattending assessment and their families (Refer:Appendix D: Breast Screening Resources)

8. a woman is eligible for travel and accommodationassistance for herself and a support person if she holdsa Community Services Card (CSC) and has 80 km ormore to travel from the nearest screening centre(including mobile site) to the relevant assessment centre

a. transport assistance is at 20 cents per kilometre forprivate transport, or an amount that equates to thatof public transport available from the nearestscreening centre (including mobile site) to therelevant assessment centre

b. accommodation assistance is $75 per night ifrequired

c. meals will be at the expense of the individual

d. payment will be made by full reimbursement uponreceipts being presented to the Provider.

Evaluation Process



Evaluation Targets

1. 95% of women surveyed who attended assessmentclinics report receiving sufficient information about theassessment process to make informed decisions andprovide their consent.


25.3 ASSESSMENT – SUPPORT

Quality Indicator

The wellbeing of each woman undertaking assessmentprocedures is monitored by the breastcare nurse inassociation with other members of the multidisciplinaryteam.

NOTE: Wellbeing can be protected by timely recognitionof emotional issues, and appropriate intervention and/orreferral to other support services in consultation with thewoman.

Criteria


1. the breastcare nurse liaises with each woman beingrecalled for assessment. This includes:

a. providing on-site support and assistance with anypractical arrangements required, for all womenrecalled for assessment

b. being available to provide follow-up for women whorequire support. Where follow-up availability islimited to telephone links, then the breastcare nursemust be able to demonstrate knowledge andlinkages with local support networks.

2. the wellbeing of each woman undertaking assessmentprocedures is monitored

3. sufficient time is provided to address each woman’ssupport needs

4. a private area is available for discussion and this shallinclude access to a telephone

5. appropriate support and/or referral options arerecommended to each woman who is distressed to anextent where additional help is required

6. the woman is informed (verbally and in writing) how tocontact the breastcare nurse, or a designated staffmember

7. the breastcare nurse documents all nursing supportprovided in the woman’s records

8. where required, and with a woman’s consent, thewoman may be referred to other specialist agencies andthis is facilitated by the breastcare nurse in consultationwith the woman’s GP/PCP

9. access to counselling support from a suitably trainedbreastcare nurse or counsellor is available, either on siteor via referral to a specialist agency.

Evaluation Process


Evaluation Target

95% of women surveyed who attended assessment reportthat they received adequate support and/or appropriatereferral where indicated.

25.4 ASSESSMENT – QUALITY ASSURANCEPROTOCOLS FOR EQUIPMENT

Quality Indicator

All equipment used for assessment meets the Standardreferred to and/or specified in this document.

Criteria

BreastScreen Aotearoa Providers ensure that the followingprotocols are complied with:

1. ultrasound scanner (Refer: Appendix M: UltrasoundSystem Performance and Quality Control)

2. stereotactic localisation device (Refer: Appendix L 2, 3:Stereotactic Breast Biopsy Quality Assurance (QA)Programme)

3. appendix K: Mammographic Quality Assurance MQAProgramme

4. current quality test records are held for each item ofequipment used within the programme

5. equipment test records show that the equipmentparameters are maintained within operating limits, andcorrective action has been taken as where and whenrequired

6. Medical Physics tests are conducted within 20 workingdays of being due

7. where any X-ray equipment fails the image quality ormean glandular dose tests it is withdrawn from useimmediately and the National Screening Unit is notifiedconcurrently

8. Medical Physicists will forward copies of reports to therelevant Charge MRT and the the National Co-ordinator of Mammography Physics, within 20 workingdays of the Medical Physics audit

9. other defects detected by the Medical Physicists’ testsshall be rectified within 30 working days.

Evaluation Process


Evaluation Targets

1. 100% of reports are forwarded to the National Co-ordinator of Mammography Physics within 20 workingdays of the Medical Physics audit.

2. 95% of defects are rectified within the timeframespecified by the Medical Physicist.






26. MULTIDISCIPLINARYMANAGEMENT

Standard – Each stage of the programme

is co-ordinated in a manner that promotes

a multidisciplinary team approach where

appropriate.

26.1 MULTIDISCIPLINARY TEAM – CLINICAL

Quality Indicator

A close, co-operative working relationship between all staffinvolved in the Programme ensures an effectivemultidisciplinary approach to care.

NOTE: The number of assessment teams are to be limitedto ensure the team sees enough cases to maintain their skillsand experience, in order to provide a high quality serviceand a consistent approach to assessment and treatment.

Criteria


1. co-ordinated specialist intervention from all membersof the team results in the optimum care of each womanparticipating in the screening pathway

2. staff demonstrate good interpersonal skills and workclosely with all disciplines to ensure a quality service isdelivered

3. each assessment centre must have a clinicalmultidisciplinary team that includes:

a. radiologists (reading and assessing)

b. surgeons

c. pathologists (reporting both FNAC and core biopsy)

d. MRTs

e. breastcare nurses

f. other professionals as appropriate.

4. clinical multidisciplinary team meetings are required atall assessment sites

5. the clinical multidisciplinary team shall meet preferablyweekly but at least fortnightly

6. clinical multidisciplinary team members are required toattend meetings with a frequency as outlined in therelevant Professional Requirements section of thisdocument

7. the purpose of the clinical multidisciplinary teammeetings is to ensure that women have completedassessment undertaken by the Lead Providerassessment team, and shall include the following:

a. ongoing management and review of results ofassessment cases

b. concordance of the radiological, surgical andpathological lesion findings for women undergoinglevel 2 and 3 assessment at that site

c. special consideration to ensure appropriatemanagement where needle-biopsy results of ADH,radial scar, papillary lesions and mucocoeles areobtained, or where microcalcifications are notidentified in samples as expected

d. a lesion seen only on one view should not proceedto surgery until its position on an orthogonal plane isdetermined by further work-up views, ultrasound,CT or MRI

e. radiological and pathological review of all Level 2(needle biopsy) and Level 3 (open biopsy)assessments originating from that site

f. review of all staged assessment results at the initialassessment site

g. peer review and exchange of information

h. review of post-assessment interval cancers

i. correlation of treatment pathology slides withneedle biopsy diagnosis

j. analysis of screening and treatment results

k. process and systems reviews

l. review of feedback from internal and externalmonitoring, quality assurance and audit activities

m. ongoing management and review of results of allcases of extended assessment

n. discussion of treatment options for women withcancer.

8. co-ordination and consistency between assessmentcentres within a Lead Provider region should bepromoted by regular visits of personnel for attendanceat Lead Provider clinical MDT meetings or vice versa.

Evaluation Process

1. A register of minutes for all these meetings is held,including attendees.


Evaluation Target


27. LEVEL 1 ASSESSMENT

Standard – Women with abnormal screening

mammograms who do not have a screen-detected

lesion requiring biopsy diagnosis are returned to

routine re-screening.

27.1 LEVEL 1 ASSESSMENT – IMAGING THEBREAST AT ASSESSMENT

Quality Indicator

The radiologist must be able to prove a lesion is benign orconfirm a malignancy while keeping invasive procedures forbenign abnormalities to a minimum. The aim therefore is toincrease specificity without compromising sensitivity.

Criteria

1. BreastScreen Aotearoa Providers ensure thatradiologists performing Level 1 assessment arecompetent in all radiological specialised diagnostictechniques available at their assessment clinic.

2. BreastScreen Aotearoa Providers ensure theradiological specialised diagnostic techniques include:

a. additional mammographic views

b. magnification.

3. Breast ultrasound examination:

a. shall be undertaken by or under the directsupervision of the radiologist

b. which includes hard copy or digital storage ofultrasound images shall be of a quality that permitspeer review

c. of any significant lesion(s) must have the size, side,clock face position and an indication of distancefrom the nipple recorded on the image.

4. BreastScreen Aotearoa Providers will ensure a secondradiologist reviews all specialised diagnostic images foreach woman recalled to assessment. This shall occurbefore the final result is issued.

Evaluation Process


Evaluation Targets

1. 100% of radiological specialised diagnostic techniquesare performed by staff competent in the procedure andare reviewed by another radiologist.


27.2 LEVEL 1 ASSESSMENT – GRADING OFLESIONS

Quality Indicator

At the completion of Level 1 Assessment a radiologicalcategory will be assigned to all lesions assessed.

Criteria

The BreastScreen Aotearoa Provider ensures that allradiological lesions are categorised as follows:

Category 1. Normal/benign – return to routine re-screening

Category 2. Probably benign – may require biopsy diagnosisfor confirmation

Category 3. Indeterminate – biopsy diagnosis required

Category 4. Probably malignant – biopsy diagnosis required

Category 5. Malignant – biopsy diagnosis required.

Evaluation Process

Monthly auditing of clinical records for women screenedduring the previous month at each screening unit.

Evaluation Target

100% of lesions assessed have their category recorded.

27.3 LEVEL 1 ASSESSMENT – EXTENDEDASSESSMENT

Quality Indicator

Individual women may be referred to ‘extendedassessment’ as an alternative to biopsy when they have aCategory 2 lesion identified at assessment.

NOTE: It is desirable that a woman be given a definitivediagnosis at her first assessment and every effort should bemade to obtain such a diagnosis. However, in a very smallnumber of cases, extended assessment may be offered as asuitable option when the lesion has a low probability of beingcancer, is (or had proven) difficult to biopsy, and when re-biopsy would cause unnecessary morbidity to the woman.

The term ‘extended assessment’ has been used in theliterature to include a range of practices. These include:

Early Re-screen: a woman asked to return earlier than theusual screening interval for furtherscreening mammography.

Early Recall: a woman asked to return earlier than the usualscreening interval for a range of furtherinvestigations at an assessment centre.

Within BSA, only Early Recall is permitted. Consequentlywithin the NP&QS, ‘extended assessment’ will only mean‘early recall’.





Criteria

1. Following consultation with a woman, an informeddecision is subsequently made by the woman andCategory 2 lesions shall be managed by either:

a. cytological or biopsy diagnosis

b. extended assessment.

NOTE: Category 2 lesions managed by extendedassessment have a risk of malignancy of ≤ 2%.

2. Where assessment results in a lesion classification of ≤ 3and percutaneous biopsy is not possible. Investigationswith dynamic contrast enhanced MRI, Sestamibi or CTScan should be considered, in order to locate the lesionfor hookwire.

NOTE: BreastScreen Aotearoa does not provide theseservices, and women would need to be referredaccordingly.

3. BreastScreen Aotearoa Providers ensure that there is auniform process to ensure informed consent forextended assessment that complies with the consentprocess outlined in Standard 5. In addition the processshould include:

a. an assessment of breast cancer risk

b. informing the woman that any change in theappearance of the lesion may necessitate a biopsy.

Refer: Standard 5 Consent and Standard 25.2Assessment – Education, Information and Consent(Refer: Appendix I: Proforma letters and forms)

4. All women referred to assessment are recalled to a fullassessment clinic at six months and/or twelve months(for example, not simply further mammographic views),at which time a decision is made either to proceed totissue diagnosis or return to routine screening.

5. Either an increase in the lesion size or a change toCategory 3 or above shall be an indication for biopsy.

6. Extended assessment is complete when the lesion isunchanged at twelve months and the woman can returnto routine re-screen for a full bilateral mammogramtwo years from the previous screening mammogram.Where a woman will be outside the age range, she maybe kept on extended assessment to allow a twenty-fourmonth mammogram to be performed.

7. A record of the total number of women currently onextended assessment, the rationale for their placementand outcomes is maintained.

8. All cancers diagnosed during extended assessment areconsidered to be interval cancers.

Evaluation Process


Evaluation Targets

1. Extended assessment cases shall be ≤ 2% of totalwomen assessed.


27.4 LEVEL 1 ASSESSMENT – CLINICALEXAMINATION

Quality Indicator

All women requiring further invasive intervention (Level 2Assessment) shall be examined first by a clinicianexperienced in breast examination. Clinical examinationmay be offered but is not required for women considerednot to have breast cancer on Level 1 Assessment.

Criteria


1. a surgeon shall be present at all assessment clinics for atleast part of the time and will examine, or beresponsible for ensuring that an experienced clinicianexamines, each woman with a confirmed abnormalityprior to any invasive procedure

NOTE: This does not necessarily include women whoare recalled for technical reasons or for lesions that areclear on mammographic work-up.

2. each woman requiring clinical examination shall beassigned to the rostered surgeon who is responsible forthe clinical examination

3. the surgeon responsible and the person performing theexamination should be recorded in the woman’srecords.

Evaluation Process


Evaluation Target


27.5 LEVEL 1 ASSESSMENT – STAGEDASSESSMENT

Quality Indicator

Staged assessment is where a woman’s assessment occurson separate occasions over a number of sites.

NOTE: Staged assessment may be used in peripheral areaswhere a woman would be required to travel a considerabledistance in order to access complete assessment services,or when a local clinic does not have specialised staff and/orequipment for second level assessment, for example, digitalstereotactic equipment.

Criteria

1. BreastScreen Aotearoa Providers may only providestaged assessment with prior written approval of theNational Screening Unit.

2. At centres which have staged assessment, all womenrecalled for assessment must be:

a. advised that they may be required to travelelsewhere or return on another day for part of theirassessment

b. provided with a choice of travelling to an alternativecentre from the outset thereby, ensuring allassessment procedures may be completed in theone visit.

3. Centres involved in staged assessment must clearlydocument the protocols for managing this processeffectively.

4. The radiologist initially assessing the woman mustobtain feedback (including pathology and subsequentradiology) on all cases that have been referred forfurther assessment.

Evaluation Process


2. The internal audit process ensures that the criteria arecomplied with and identified issues are addressedthrough the Continuous Quality Improvement (CQI)process.

Evaluation Targets

1. 95% of surveyed women affected by staged assessmentreport receiving sufficient information about theassessment process to make an informed choice aboutwhich centre to attend.


28. LEVEL 2 ASSESSMENT – NON-OPERATIVE DIAGNOSIS

Standard – The non-operative diagnosis of screen-

detected abnormalities is maximised by obtaining

accurate needle biopsy specimens of palpable and

impalpable lesions.

28.1 LEVEL 2 ASSESSMENT – MINIMISINGDELAY TO NEEDLE BIOPSY

Quality Indicator

The delay between the decision to perform a needle biopsyand it being undertaken should be minimised.

NOTE: Accurate and appropriate needle biopsy utilisationhas been identified as the most effective and least morbidpathway to definitive cancer surgery and minimises theneed for open surgical biopsy (and attendant morbidity) forbenign abnormalities.

Criteria


1. processes are in place to ensure that the assessmentclinic is appropriately resourced to allow for timelyneedle biopsy

2. Fine Needle Aspiration Cytology (FNAC) and/or corebiopsy are offered at the same assessment appointmentwhere possible.

Evaluation Process

1. Regular reports which identify women who are to berecalled for needle biopsies are reviewed by the LeadProvider Manager or a designated individual.


Evaluation Target

90% of needle biopsies are performed within five workingdays of the first assessment visit.

28.2 LEVEL 2 ASSESSMENT – WORK UP,INFORMATION AND CONSENT

Quality Indicator

Women shall be given both appropriate information andwork-up prior to invasive breast procedures (Level 2 andLevel 3 assessment) being performed.





Criteria

BreastScreen Aotearoa Providers ensure:

1. written consent is obtained from the woman before anyLevel 2 assessment is undertaken, including all biopsies.Refer: Standard 5 Consent and Standard 25.2Assessment – Education, Information and Consent(Refer: Appendix I: Pro Forma letters and forms)

2. invasive procedures are only carried out after thoseperforming the radiological work-up and clinicalexamination have completed their assessment and thewoman has been fully informed and has provided consent.

Evaluation Process

Monthly auditing of clinical records for women screenedduring the previous month at each screening unit.

Evaluation Targets

1. 100% of records audited show women providedwritten consent before a Level 2 assessment wascarried out.

2. All other criteria are met

28.3 LEVEL 2 ASSESSMENT – NEEDLE BIOPSYTISSUE SAMPLING OF SCREEN-DETECTEDLESIONS – FINE NEEDLE ASPIRATIONCYTOLOGY, CORE BIOPSY, INCLUDINGVACUUM-ASSISTED BIOPSY SPECIMENS

Quality Indicator

Needle biopsies are used to maximise preoperativediagnosis of cancer and non-operative diagnosis of benignabnormalities requiring further work-up.

NOTE: In this section, core biopsy includes vacuumassisted biopsy.

Criteria


1. all women requiring needle biopsy for diagnosis areassessed and biopsied by Clinicians who are competentin needle biopsy techniques as follows:

a. all image guided needle biopsies of impalpable orpalpable lesions shall be performed by a radiologist

b. needle biopsy of palpable lesions shall be performedby either a radiologist, pathologist or surgeon

c. all Clinicians performing needle biopsies must berecognised members of the multidisciplinary team.

2. appropriate equipment is available at assessment tocarry out any of the necessary needle biopsy techniques

3. radiologists performing assessment must be competentin all image-guided tissue sampling techniques availableat their assessment site and be able to advise which isthe most appropriate for each woman

4. the appropriate image guided tissue sampling techniquefor each woman should be agreed upon by members ofthe multidisciplinary team. Intervention should becarried out in a manner that causes the least discomfortto the woman (for example, ultrasound), and maximisesaccurate preoperative diagnosis

5. where there is a possibility of removing the entiremammographic lesion a marker should be left to allowaccurate localisation, should further excision berequired

6. where a marker is to be left for this or other reasons,these must be explained to the woman and informedconsent must be obtained.

Evaluation Process

1. The Clinical Director shall ensure that the sensitivityand specificity according to the operator, biopsytechnique, mode and reporting pathologist aremeasured and monitored.



Evaluation Targets

1. Screen detected cancers are diagnosed preoperatively:> 70% minimum > 90% desired.

2. Image-guided FNAC procedures with aninadequate/insufficient result should be: < 25% minimum < 15% desired.

3. Other suggested thresholds for cytology and corebiopsy performance (Refer: Appendix W: FNAC QualityAssurance12).


12 NHSBSP June 2001 Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening, Chapter 6. QualityAssurance, NHS Cancer Screening Programmes: Sheffield, Publication No 50.

28.4 LEVEL 2 ASSESSMENT – LABELLING OFSPECIMENS

Quality Indicator

A written protocol for the labelling of pathology specimensexists.

Criteria


1. there is a written protocol for the labelling of pathologyspecimens. This will ensure that the same screeninglesion number on the request form is maintained in thepathology laboratory, pathology and radiology reportsand woman’s notes

2. the clinician performing the test is responsible forchecking correct labelling of specimens

3. all specimens or request forms are clearly identifiedwith a BreastScreen Aotearoa label to indicate that theyoriginated from within the Programme

4. where multiple lesions are sampled, each sample isclearly differentiated and consistently labelled and tracked

5. all specimens require double identifiers, that is, nameand date of birth, or name and NHI number.

Evaluation Process


Evaluation Target


28.5 LEVEL 2 ASSESSMENT – PATHOLOGICEXAMINATION OF CORE NEEDLE BIOPSYSPECIMEN (CNBS)

Quality Indicator

Successful pathologic readings of specimens.

Criteria


1. the radiologist or surgeon provides full clinicalinformation to the reporting pathologist. The latter shallinclude the exact location of the lesion(s), the

mammographic/sonographic findings, the radiologicalgrade of the abnormalities and the findings of clinicalexamination. A standardised and dedicated requestform may facilitate adequate communication

2. specimens taken from areas of microcalcification shall beX-rayed before they are transported to the pathologist

3. a copy of this radiograph should accompany thespecimen

4. the radiologist shall indicate to the reporting pathologistwhether they consider calcifications are present in thecore biopsy specimen X-ray

5. it is recommended that core biopsies containingmicrocalcification are submitted in separately labelledspecimen containers from the other cores

6. core specimens are processed as for a routine surgicalbiopsy, with sections from at least six levels in the tissueblock examined

7. separately labelled specimens should be processed asseparate specimens

8. reporting terminology and diagnostic categories usedfor screen-detected breast specimens should follow thecurrent National Health Service Breast ScreeningProgramme guidelines13

9. in an attempt to improve diagnostic concordance onclassification of DCIS, reporting pathologists shouldadopt the criteria as set out in The Pathology Reportingof Breast Cancer.14 (Refer Appendix R: MicroscopicReporting of Ductal Carcinoma In Situ)

10. in addition to any specific diagnostic categories used, thereporting pathologist should also categorise the corebiopsy (Refer: Appendix W: FNAC Quality Assurance15):

B1: Inadequate sample or normal breast tissue

B2: Benign breast lesion

B3: Uncertain malignant potential

B4: Suspicious of malignancy

B5: Malignant breast lesion.

11. core needle biopsy and FNAC specimens from thesame woman should be read in the samedepartment/laboratory and the findings correlated.Where this is not possible, mechanisms for co-operation and combined review of the two modalitiesmust be put in place, with the findings correlated priorto the multidisciplinary meeting





12. all BreastScreen Aotearoa pathologists are encouragedto forward difficult-to-diagnose, issues/uncertain casesin consultation, either to Lead pathologists orrecognised overseas pathologists for second opinions. Itneeds to be acknowledged that this will delay the finaldiagnosis in such cases by a period of one to threeweeks. Any potential delay in diagnosis shall becommunicated to the Lead Provider ClinicalDirector/Manager and the woman at the earliestopportunity.

Evaluation Process


Evaluation Targets

1. > 80% of core biopsy results are reported to theassessment centre within 3 working days of a core orvacuum assisted biopsy being performed.


28.6 LEVEL 2 ASSESSMENT – PATHOLOGICEXAMINATION OF FINE NEEDLE ASPIRATIONCYTOLOGY (FNAC) SPECIMENS

Quality Indicator

All Fine Needle Aspiration Cytology (FNAC) specimensshall be appropriately reported.

Criteria


1. handling and reporting of screen-detected breastspecimens should follow the National Health ServiceBreast Screening Programme (NHSBSP) guidelines16

2. it is desirable but not mandatory for a cytopathologistor cytotechnologist to attend the assessment clinic toreport on FNAC material. However, if adequacy ofspecimens does not achieve the specified targets then acytopathologist or a cytotechnologist shall be present atthe assessment clinics:

a. the period of time which the cytopathologist orcytotechnologist shall attend assessment clinics aftera drop in adequacy is at the discretion of the ClinicalDirector

b. a record of this and the rationale for reducing thecytopathologists or cytotechnicians visits shall bemaintained.

3. if a cytotechnologist attends the assessment clinic theymay render an opinion as to the adequacy of thematerial obtained but they are not to give either averbal or written cytological diagnosis

4. if a cytopathologist or cytotechnologist is to accesscytological material in the assessment clinic setting,adequate space and equipment must be provided forpreparation and staining, together with a good qualitymicroscope

5. in addition to any specific diagnostic categories used,the reporting cytopathologist should also categorise theFNAC findings in one of the following groups:

C1: Inadequate sample

C2: Benign breast lesion

C3: Atypical or indeterminate changes

C4: Suspicious of malignancy

C5: Malignant breast lesion.

6. FNAC specimens and core biopsy specimens should beread in the same department/laboratory and thefindings correlated. Where this is not possiblemechanisms for co-operation and combined review ofthe two modalities must be put in place, with theirfindings correlated prior to the multidisciplinarymeeting. A written report of FNAC results is receivedby the screening unit within 2 working days.

Evaluation Process


Evaluation Targets

1. 100% of written reports containing FNAC results arereceived by the screening assessment unit within 2working days.


28.7 LEVEL 2 ASSESSMENT – LABORATORYFACILITIES AND PROCESSES FOR REPORTINGON SCREEN DETECTED MATERIAL

Quality Indicator

Pathologists and laboratories participating in theprogramme must demonstrate that there are adequatefacilities and processes for reporting on screen-detectedmaterial.13 NHSBSP June 2001 Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening, Chapter 6. Quality

Assurance, NHS Cancer Screening Programmes: Sheffield, Publication No 50.14 Australian Cancer Network 2001 (2nd Ed) The Pathology Reporting of Breast Cancer: A guide for pathologists, surgeons, radiologists

and oncologists. pp 38 – 40.15 NHSBSP June 2001 Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening, Chapter 6. Quality

Assurance, NHS Cancer Screening Programmes: Sheffield, Publication No 50, pp46-53.16 NHSBSP. 1993. Guidelines for Cytology Procedures and Reporting in Breast Cancer Screening – Cytology Subgroup of the National Co-

ordinating Group for Breast Screening Pathology NHSBSP Publication 22.

Criteria


1. all laboratories involved in the programme are IANZaccredited for histopathology, and where fine needleaspiration cytology is undertaken, cytology IANZaccreditation is also required

2. the reporting laboratory must have suitable X-rayviewing boxes available near the specimen cut-up areaand must have access to facilities for specimenradiography should additional radiography be requiredof the sliced specimen

3. where the pathology laboratory is handling specimensfrom diagnostic procedures not detailed in the abovesection (for example, handling specimens that arederived from screening, vacuum assisted biopsy probes(‘Mammotome’) or excisional needle biopsy (‘ABBI’)then full documentation should be available onprotocols for the pathologic examination of thesespecimens within that laboratory.

Evaluation Process


Evaluation Target


29. LEVEL 3 ASSESSMENT – SURGICAL BIOPSY

Standard – Open surgical biopsy should be carried

out in a timely and accurate manner that

minimises morbidity for women.

29.1 LEVEL 3 ASSESSMENT – SURGICALBIOPSY GENERAL PRINCIPLES

Quality Indicator

The aim of the open surgical biopsy is to successfullyidentify and remove mammographically detected lesion(s)for pathological assessment with the minimum of morbidityfor the woman.

Criteria


1. the number of women requiring an open surgical biopsyfor the diagnosis of cancer is minimised

2. the number of women undergoing open surgical biopsyfor benign lesions is minimised

NOTE: On occasion a woman may need to undergo anopen surgical biopsy to make a diagnosis. This may bedue to a number of reasons – the nature of the lesion,failure of previous interventional biopsy (FNAC orcore), a mammographic lesion may be difficult to image,too small, or the woman may request an open biopsy.

3. open surgical biopsy should be carried out by thesurgeon who will be responsible for ongoing surgicalmanagement, should cancer be diagnosed

4. women are given information to enable their decisionabout whether to have their surgery undertaken in thepublic sector and the implications of these options forfuture management

5. the delay between the surgical decision to operate andthe operation being performed is minimised

6. written informed consent is obtained in an appropriatemanner. Refer: Standard 5 Consent and Standard 25.2Assessment – Education, Information and Consent

7. appropriate support is offered before, during and aftersurgical intervention.

Evaluation Process







Evaluation Targets

1. Open biopsies performed for benign disease per 1,000women screened

Prevalent ≤ 3.517

Incident ≤ 1.6

2. 90% of women requiring open surgical biopsy shouldhave their operation performed within 15 working daysof being notified of the need for this operation.


29.2 LEVEL 3 ASSESSMENT – PREOPERATIVELOCALISATION OF IMPALPABLE LESIONS

Quality Indicator

Lesions are successfully localised preoperatively.

Criteria


1. radiologists performing preoperative localisations arecompetent in these techniques, which must all beavailable on-site at the assessment clinic

2. localisation of impalpable lesions is performed beforesurgery. The approach and method of localisation foreach woman should be decided in discussion betweenthe surgeon and radiologist. If several methods oflocalisation are possible, the one chosen should be themost comfortable for the woman (for example, if thelesion is visible under ultrasound, this would probablybe the quickest and most comfortable means ofguidance for localisation)

Other methods that use X-ray guidance include:

• stereotactic localisation

• manual localisation using co-ordinates

3. the marker used will generally be a hookwire or carbon

4. whichever localisation method is used, sufficient viewsof the marker placement (with skin markers ifnecessary) should be obtained at the end of theprocedure, to aid surgical planning. It is helpful if thesefilms are reviewed with the surgeon prior to surgery,particularly if the marker placement is not ideal

5. the radiologist will document in writing the method oflocalisation and position of the marker in relation to themammographic lesion. An accompanying diagram isimportant, and should be included with the woman’snotes.

Evaluation Process


Evaluation Targets

1. > 95% of impalpable lesions should be successfullylocalised preoperatively.18

2. > 90% of markers should be within 10mm of thelesion.18


29.3 LEVEL 3 ASSESSMENT – ORIENTATIONOF SPECIMEN

Quality Indicator

To enable the radiologist and the pathologist to orientatethe specimen in order to assist any potential wider localexcision, where appropriate marking is essential.

Criteria

1. The surgeon taking the specimen(s) ensures that allspecimen(s) are oriented using radiopaque makersattached by sutures or other appropriate means asagreed between the radiologists, pathologist andsurgeon.

2. Feedback from the pathologist(s) confirms thespecimen(s) is (are) correctly orientated.

Evaluation Process


Evaluation Target


29.4 LEVEL 3 ASSESSMENT – SIZE OFSPECIMEN

Quality Indicator

The adverse impact of diagnostic surgical biopsy on breastappearance, contour or shape shall be minimised.

17 National Accreditation Standards. 2001. Australia.18 European Guidelines for Quality Assurance in Mammography Screening 3rd Ed.



Evaluation Targets

1. 100% of tissue specimens from impalpable lesions areappropriately imaged perioperatively and reported by aradiologist.

2. > 95% of specimen images and/or verbal reportsshould be received in less than 15 minutes of thespecimen being sent from the operating theatre.

3. > 95% of impalpable lesions are excised at the firstbiopsy operation.


29.6 LEVEL 3 ASSESSMENT – PATHOLOGYREPORTING OF SURGICAL BIOPSY SPECIMENS

Quality Indicator

Accurate pathological assessment of surgical excised tissueshall be provided.

Criteria


1. the surgeon provides the reporting pathologist with fullclinical information, which includes:

a. the mammographic/sonographic nature of thelesion(s)

b. the exact location within the breast (ideally indiagrammatic form)

c. a guide to the location of any orientationsutures/clips attached

d. the nature of the biopsy procedure (for example,full thickness biopsy – subcutaneous tissue topectoral fascia)

e. the results of any pre-operative FNAC and/or coreneedle biopsy procedures

f. any special or additional information pertinent tothe pathological examination of the tissue.

2. a copy of the specimen mammogram accompanies thesurgical specimen from impalpable lesions to thepathology suite. It is desirable for the reportingpathologist to include the radiologist’s description of theabnormality in the specimen radiograph as part of thegross description of the case

3. unless there is a very definite correlation between theradiographic abnormality in the specimen radiographand the macroscopic findings, additional radiography ofthe sliced specimen should be performed (Refer: Level3 Assessment – Specimen Radiography). This secondstage radiography can be undertaken either in thescreening suite, an alternative radiology facility or withspecially designed equipment located in the pathologysuite. The radiologist should be consulted if there is anydoubt by the pathologist as to the presence of thelesion in the sliced specimen radiographs

4. frozen section examination shall not be undertaken onimpalpable breast lesions

5. reporting terminology, diagnostic categories used andthe recording of routine prognostic variables for screen-detected breast specimens shall follow the NationalHealth Service Breast Screening Programme guidelines21

6. reporting pathologists should adopt the criteria as setout in The Pathology Reporting of Breast Cancer,22 in anattempt to improve diagnostic concordance onclassification of DCIS

7. this report and the slides of the specimen must bemade available to the treatment service in a timelymanner to avoid delay in surgery.

Evaluation Process


Evaluation Targets

1. In 90% of cases a written histology report is receivedby the screening unit within 5 working days of thepathology laboratory receiving the specimen.


Criteria

1. The clinician ensures that excess amounts of breasttissue are not removed when performing open surgicalbiopsy.

2. All specimens are weighed and the weight recorded.

Evaluation Process



Evaluation Target

1. > 90% of biopsies, which prove to be benign, shouldweigh < 30 grams.19


29.5 LEVEL 3 ASSESSMENT – SPECIMENRADIOGRAPHY

Quality Indicator

Specimen imaging is used to confirm excision of the lesionand to indicate the specific area of interest to thepathologist, while minimising the time between surgicalexcision and receipt of the X-ray or report in theatre.

Criteria


1. initial specimen radiography or ultrasound is performedto ensure that an impalpable lesion has been removedand because this occurs while the patient remainsanaesthetised in theatre, speed is essential. Handling ofthe specimen should be in accordance with adocumented protocol agreed to by the multidisciplinaryteam, thereby minimising delays

2. the radiologist who performs the localisation (or aradiologist who has the preoperative films for review) isavailable to make an immediate report (usually bytelephone) to the surgeon and a written report for thepathologist, and to document the result in the woman’sscreening record. Ideally, the surgeon should be able tosee the specimen X-ray, in particular when there is anyquestion over completeness of removal or adequacy ofmargins

3. before the open biopsy is completed, if the lesion hasnot been fully excised, the radiologist may be able toindicate to the surgeon in which direction further tissueshould be removed, by reviewing the specimenradiograph in conjunction with post-localisation checkfilms. This is facilitated if the surgeon has usedradiopaque markers and sutures to indicate theorientation of the specimen within the breast, and if thespecimen has been orientated in an anatomical positionprior to radiography

4. occasionally, an impalpable lesion may not be visible onmammography or specimen radiography. If ultrasoundwas used for preoperative localisation, ultrasound of thespecimen may be necessary to confirm removal of thelesion

5. specimen radiography should be performed usingmagnification, without a grid, and with the specimencentred over the automatic exposure control (AEC)chamber. Compression may be useful to aid detectionof ill-defined, low density lesions20 but may also distortmargins of the specimen, making pathological evaluationdifficult. Use of compression should therefore beaccording to a documented protocol agreed to by themultidisciplinary team

6. at least two radiographs should be obtained of thespecimen, one shall accompany the specimen to thePathology Department and the other be retained in thewoman’s screening record

7. further radiology of the sliced specimen may beperformed to improve efficiency of pathologicaldiagnosis and should be performed for lesionscontaining calcifications. The radiologist should markthe mammographic abnormality on this film, so that theappropriate slices can be examined by the pathologist

8. all tissue specimens from impalpable lesions should beappropriately imaged perioperatively.

Evaluation Process




19 European Guidelines for Quality Assurance in Mammography Screening 3rd Ed.20 RANZCR 2002.

21 NHSBSP June 2001 Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening, Chapter 6. QualityAssurance, NHS Cancer Screening Programmes: Sheffield, Publication No 50.

22 Australian Cancer Network 2001 (2nd Ed) The Pathology Reporting of Breast Cancer: A guide for pathologists, surgeons, radiologists andoncologists, Chapter 6.



Criteria


1. the surgeon or other relevant clinician shall discusstreatment and provider options with the woman inconjunction with the breastcare nurse

2. the breastcare nurse shall also be available to thewoman during or immediately after she has beeninformed of her treatment and provider options

3. the information regarding the treatment and provideroptions shall not be given solely by any person, as itmay be interpreted as biased

4. information about appropriate treatment options areprovided to the woman. This includes but is not limitedto:

a. the Treatment and Support Services for Women withBreast Cancer brochure (Refer: Appendix D: BreastScreening Resources)

b. all available options for treatment provision, theiradvantages and disadvantages (including benefits,costs where relevant and actual waiting times)

c. the full consequences of all treatment options(including adjuvant therapy)

d. a list of names of surgeons who are eligible for fullmembership of the Breast Section of the RoyalCollege of Surgeons is available to women

e. the possibility of requiring radiotherapy and theimplications of this regardless of whether surgery isprovided in the private or public sector (for example,travel to a main centre, attending a public hospital).

5. the woman is advised of the option to discuss herchoices of treatment provider with her GP/PCP, butmust be advised that the cost of the GP/PCP visit is notcovered by the Programme

6. each woman is actively involved in the decision makingprocess and should be provided with options foraccessing information regarding treatment andtreatment providers such as her GP/PCP, the CancerSociety and any other appropriate local supportagencies

7. where a woman has decided to attend the publicsystem for free treatment she may choose:

a. the nearest public hospital to her residence, or

b. the nearest high-volume public provider.

8. if a woman chooses a private provider she needs to beinformed that she will be required to pay for anysurgical treatment

9. referrals for treatment are made in accordance with thewoman’s wishes unless she specifically requests that areferral not be made

10. the Provider is required to refer the woman to thetreatment provider of her choice, unless she hasrequested that her GP/PCP undertake this

11. the GP or PCP is informed by letter of the options oftreatment provider given to the woman and the choicesshe has made at the time

12. all appropriate information, including the size of thelesion on imaging, and records pertaining to the womanreferred for treatment are forwarded directly to thetreatment provider

13. every effort is made to obtain treatment informationrequired by BreastScreen Aotearoa from the treatmentprovider. This will be collected on national standardisedforms (Refer: Appendix S: Breast Cancer SynopticReports).

Evaluation Process




Evaluation Targets

1. 95% of women surveyed report that they are satisfiedwith the information that was provided in choosing atreatment provider.

2. 90% of women should normally receive their firstsurgical treatment within 20 working days of receivingtheir final diagnostic results.

3. Data entry of treatment outcomes (in particularhistopathology details) is completed for 90% of womenwithin nine months of their last screening exam.


30. OUTCOME OF ASSESSMENT

Standard – Each woman is notified of her

assessment results, and if required, is referred to

treatment in a manner that is unbiased and

cognisant of her informed decision.

30.1 OUTCOME OF ASSESSMENT –NOTIFICATION OF RESULTS

Quality Indicator

Each woman receives timely and accurate assessmentresult notification.

Criteria


1. final results are only communicated to women after allclinical review processes are completed (that is, afterthe multidisciplinary meeting). The method andtimeframe of result notification is discussed with thewoman at the completion of her assessment visit

2. wherever possible, provisional results are to be givenon the day of assessment

3. if the woman can be returned to two yearly recall afterthe radiological assessment (that is, after further viewswith or without ultrasound), the results are to be givenby the radiologist at assessment

4. where it is not possible to give results on the day ofassessment, the woman is to be informed of when toexpect the results (allowing for a second read by aradiologist, pathology results and clinicalmultidisciplinary team meetings), and an arrangementmade for her to return to the centre for this

5. if the woman has to travel a long distance,consideration will be given to other arrangement forresults (for example, if consent has been given, awoman’s GP/PCP will provide her with her resultsfollowing discussions with the surgeon.) The breastcarenurse will follow up in a timely manner

6. if the diagnosis is cancer, the breastcare nurse shall bepresent when the diagnosis is explained (Refer:Standard 25.3: Assessment – Support)

7. if consent has been obtained, the results will also begiven to the woman’s GP/PCP or practice nurse:

• where this is a diagnosis of cancer, the GP/PCP, (orif not available, the practice nurse), is to be advisedimmediately by telephone, and followed up with aletter

• where the diagnosis is not cancer the GP/PCP is tobe advised by letter

8. where the result of the assessment is ‘no evidence ofcancer’ eligible women are placed on the routine re-screen list (Refer: Standard 24.2: Outcome of Screening– Routine Re-screening)

9. assessments are reported according to therecommendations in Breast Imaging – a Guide toPractice23 – EXCEPT for lesion classification where theNP&QS grading of lesions will be used. (Refer section27.2)

Evaluation Process

1. Regular reports, which identify women who have notbeen notified of their results, are reviewed by the LeadProvider Manager or a designated person and thereason for the delay is documented.



Evaluation Target

1. Time taken from final diagnostic needle biopsy toreporting results to the woman – 90% of womenreceive results within 5 working days of final diagnosticneedle biopsy.


30.2 OUTCOME OF ASSESSMENT – REFERRALTO TREATMENT

Quality Indicator

Comprehensive information relevant to her situation,provided within a supportive environment, allows thewoman to make an informed decision regarding hertreatment options and the process of a woman’s referral totreatment.24



23 Breast Imaging – A Guide for Practice 2002 National Breast Cancer Care Centre Australia. 24 Ministry of Health. 2002. Outcomes of the treatment provider data indicators review (TPDIR). Wellington: Ministry of Health.

31. NO FURTHER ACTIVE RECALL

Standard – Women have a clear understanding of

the reasons for no longer being eligible for the

programme, the process of no further active recall

to BreastScreen Aotearoa or choosing not to

participate in BreastScreen Aotearoa.

31.1 NO FURTHER ACTIVE RECALL

Quality Indicator

Each woman is informed that she will no longer be activelyrecalled for routine re-screening when the eligibility criteriaare no longer met, or she chooses to leave BreastScreenAotearoa.

Criteria

1. BreastScreen Aotearoa Providers will ensure that thewoman is no longer recalled for routine re-screeningwith BreastScreen Aotearoa when she:

a. has a positive diagnosis of breast cancer, and isreferred for treatment

b. actively requests not to be recalled by BreastScreenAotearoa

c. falls outside the eligible age range

d. has died

e. fails or refuses to attend assessment (Refer:Standard 24.4: Outcome of Screening – Failure orRefusal to Attend Assessment).

DMM Field Codes

0=Not Specified

1=Stopped – Woman Transferred to Other LeadProvider

2=Stopped – Unable to Contact Woman

3=Stopped – Woman Refused Assessment

4=Stopped – Woman Declined to CompleteAssessment

5=Stopped – Woman unable to CompleteAssessment due to ill health

9=Stopped – Other

2. with the woman’s permission, the GP/PCP is alsoinformed that she is not to be recalled, and the reasonsfor this.

Evaluation Process


Evaluation Target





LEAD

ERSH

IP POSIT

ION

S


Mandatory Leadership Positions – SECTION 3

SECTION 3 MANDATORY LEADERSHIP POSITIONS

32. Mandatory Leadership Positions in Breast Screening ......................................................................................2

33. Clinical Director ..............................................................................................................................................2

33.1 The role of the Clinical Director ............................................................................................................2

33.2 Professional standards ............................................................................................................................3

34. Lead Radiologist ..............................................................................................................................................3

34.1 The role of the Lead Radiologist ............................................................................................................3

34.2 Designated Medical Quality Assurance (MQA) Radiologist ....................................................................4

35. Lead Pathologist ..............................................................................................................................................4

35.1 The role of the Lead Pathologist ............................................................................................................4

36. Lead Surgeon ..................................................................................................................................................5

36.1 The role of the Lead Surgeon ................................................................................................................5

37. Lead Medical Radiation Technologist ..............................................................................................................5

37.1 The role of the Lead Medical Radiation Technologist (MRT) ................................................................5


37.3 The role of the Charge MRT ..................................................................................................................6


37.5 The role of the Designated Quality Control (QC) MRT........................................................................6


38. Lead Provider Manager....................................................................................................................................6

38.1 The role of the Lead Provider Manager ................................................................................................6

38.2 Minimum qualifications required ............................................................................................................7

38.3 Lead Provider Manager expertise ..........................................................................................................7

38.4 Training....................................................................................................................................................7

39. Data Manager ..................................................................................................................................................7

39.1 The role of the Data Manager ................................................................................................................7


39.3 Data Manager’s expertise ......................................................................................................................8

39.4 Staff in training (New and Trainee Staff) ................................................................................................8

32. MANDATORY LEADERSHIPPOSITIONS IN BREAST SCREENING

Breast screening is a team activity and success depends onleadership and teamwork from all participants. At any givenstage in the pathway, only part of the team is involved, butfew of the boundaries are rigid and co-operation andunderstanding is vital. This team approach cannot beachieved passively; rather it requires an ongoing effort.

Identified individuals must fill the leadership positionsoutlined in this section. The positions identified here willrequire a clear allocation of time to fulfil their roles. Theremay be circumstances where some of the roles can beundertaken by one individual, eg Lead MRT and designatedQC MRT.

All individuals must fulfil the qualifications and continuingprofessional development requirements of the relevantprofession and/or position within the Programme.

33. CLINICAL DIRECTOR

33.1 THE ROLE OF THE CLINICAL DIRECTORMammographic screening for breast cancer is a radiologicalprocedure and it is appropriate that the Clinical Director ofa BreastScreen Aotearoa Lead Provider is a radiologist and,in these circumstances, the Clinical Director may alsoundertake the tasks of the Lead Radiologist as described inthis document.

The Clinical Director is ultimately responsible for theoverall clinical performance of the Programme in thedetection and diagnosis of breast cancer in the geographicalarea defined by the Lead Provider contract, including anyand all subcontractors. In undertaking their respectiveroles, the Clinical Director and Lead Provider Manager areresponsible for implementing the operation of BreastScreenAotearoa within their Lead Provider region.

Responsibilities of the Clinical Director include:

1. the implementation of a high-quality mammography andassessment service subject to adequate resources

2. direct leadership of the clinical team throughout theLead Provider region, (including associatedsubcontractors)

3. ensuring all screening staff receive adequate clinicaltraining and regular updates subject to adequatefunding/resources

4. oversight of clinical performance monitoring, with theLead Clinicians

5. ensuring that fail-safe mechanisms are in place so thatwomen with radiological abnormalities are recalled toassessment

6. ensuring that the National Policy and Quality Standardsare implemented monitored and evaluated through acontinuous quality improvement (CQI) process inrespect to technical, radiological and clinical servicesand subject to the availability of adequate resources

7. overall responsibility for the accuracy of internal dataaudits

8. ongoing review of Programme performance data, withparticular attention to cancer detection and the reviewof interval cancers

9. ensuring advertising and publicity material is clinicallycorrect via feedback to the National Screening Unit

10. active involvement in the assessment clinics

11. regular attendance at Clinical Directors unidisciplinarymeetings


SECTION 3 – Mandatory Leadership Positions



Responsibility

1. The Clinical Director has responsibility for the clinicalperformance of positions with a clinical aspect withinthe Lead Provider region, including:

a. Lead Radiologist, pathologist and surgeon (andthrough them all BreastScreen Aotearoaradiologists, pathologists and surgeons)

b. the Lead MRT (and through them all BreastScreenAotearoa MRTs)

c. other positions with a clinical component to theirwork (for example, medical physicist, BreastcareNurse, Data Manager – if inputting or coding clinicaldata).

2. The Clinical Director shall visit each screening andassessment site in their region at least annually and liaisewith those at the clinical multidisciplinary meeting.

3. Internal Quality Control of Radiology

The Clinical Director shall submit an annual return tothe National Screening Unit showing the number of filmreview meetings attended in the year by eachradiologist, regardless of whether they work in the mainsite or a subcontracted site.

33.2 PROFESSIONAL STANDARDSThe Clinical Director will be medically qualified, registeredto practice in New Zealand, hold vocational registration,and be active professionally within the Programme. Theymust also meet all the professional requirements of theirrelevant profession within the Programme (refer Section 4– Professional Requirements). They should demonstrateparticipation in breast radiology components for a total ofat least fifteen educational hours during the preceding threeyears, in keeping with the RANZCR MammographyContinuing Professional Development (CPD) programme.

Continuing professional development

Every three years, participating Clinical Directors mustsubmit to the Clinical Directors’ Unidisciplinary Groupevidence that they have attended national and/orinternational meetings with a component on breastscreening. They should demonstrate that they haveparticipated in breast screening components for a total of atleast ten educational hours during the preceding threeyears.

CPD shall include all the requirements of the appropriatespeciality within the Programme. It is expected that theClinical Director will also actively participate in regional andnational quality assurance activities (for example, intervalcancer review).

34. LEAD RADIOLOGIST

34.1 THE ROLE OF THE LEAD RADIOLOGISTThe Lead Radiologist is ultimately responsible for thequality of films, subsequent reports produced under his/herdirection and the overall imaging performance of theProgramme within their Lead Provider area.

The Lead Radiologist is responsible for the operation of themammographic and associated MQA programmes at allsites within the Lead Provider contract, and hence mustliaise well with designated MQA radiologists atsubcontractor sites.

Responsibilities of the Lead Radiologist are:

1. to select a medical physicist(s) who will administer theMQA programme, perform the physicist(s) QC testsand oversee the work of the QC MRTs

2. to ensure that the NP&QS Standards relevant toimaging are implemented, monitored and evaluated[Reference: Standards 23.7-14, 27.1-27.5]

3. to ensure that all imaging equipment is performingsatisfactorily

4. to ensure that GP/PCPs are kept fully informed of thescreening outcomes for women registered with theirpractices

5. to review radiologist performance data by site andindividual radiologist, as per the NP&QS. Individual datais confidential to the radiologist concerned, the LeadRadiologist and the Clinical Director

6. actively involved as a screening and assessmentradiologist within the Programme

7. to ensure BreastScreen Aotearoa radiologists receiveadequate training and regular updates.

Responsibility

The Lead Radiologist is responsible for the clinicalperformance of BreastScreen Aotearoa radiologists in theirregion.

Co-ordination

The Lead Radiologist, Lead MRT and medical physicist areresponsible for co-ordinating regular (for example,quarterly) MQA meetings within their Lead Providerregion. These are to ensure that site-specific MQAprogrammes are in place and reviewed and that fail-safemechanisms are in place and operating routinely. Thesemeetings must involve the medical physicist, either with apresence at the meeting, by teleconference, or during theplanning stage.



36. LEAD SURGEON

36.1 THE ROLE OF THE LEAD SURGEONThe Lead Surgeon has ultimate responsibility for thesurgical aspects of the Programme in their Lead Providerregion.

The specific responsibilities of the Lead Surgeon include butare not limited to:

1. ensuring that an effective quality assurance programmeexists for all surgery performed within the Programme

2. ensuring that the relevant NP&QS standards areimplemented and evaluated

3. facilitating the return of surgical treatment data viasynoptic forms/reporting

4. ensuring BreastScreen Aotearoa surgeons receiveadequate opportunities for clinical training and regularupdates

5. being actively involved, as well as having an operationalrole within the assessment process in their region

6. regular attendance at surgeons unidisciplinary meetings.

Responsibility

The Lead Surgeon is responsible for monitoring the clinicalperformance of BreastScreen Aotearoa surgeons.

Co-ordination

The Lead Surgeon is responsible for the co-ordination ofregular (at least annual) surgical meetings with all surgeonsin the Lead Provider region. These are to ensure thatmonitoring of activities and data occurs and that qualityassurance processes are in place and operating routinely.

37. LEAD MEDICAL RADIATIONTECHNOLOGIST

37.1 THE ROLE OF THE LEAD MEDICALRADIATION TECHNOLOGIST (MRT)The Lead MRT provides professional leadership to MRTswithin their region. The Lead MRT is responsible for:

1. ensuring site visits occur at least every six months

2. ensuring a high standard of mammographic film qualityis achieved by all MRTs in the Lead Provider region

3. ensuring individual MRT performance is monitored andfeedback is provided to each MRT in the team

4. ensuring all MRTs participate in the monthly peerreview process using MIQ criteria

5. identifying any training needs of MRTs and ensuring anyappropriate training occurs

6. overseeing the overall performance of the MQAprogramme within the Lead Provider region.

7. regular attendance at MRTs unidisciplinary meetings

Responsibility

The Lead MRT is responsible for the clinical performanceof the following within their region:

1. all BreastScreen Aotearoa MRTs

2. the designated QC MRT (if other than a BreastScreenAotearoa MRT).

37.2 PROFESSIONAL STANDARDSThe Lead MRT will:

1. be actively involved in performing a minimum of 700screening mammograms within the Programme and isrequired to comply with Standard 44.2

2. demonstrate a high standard of mammography andmaintain a strong clinical focus

3. retain responsibilities as below but be able to delegate

4. the Lead, Charge and Charge QC MRT will otherwisemeet all the professional and continuing professionaldevelopment requirements of an MRT detailed in 44.2.In addition continuing professional developmentrelevant to the managerial aspects of the charge rolewill be undertaken.

The Lead Radiologist is responsible for the co-ordination ofregular, (at least six-monthly) radiologist meetings with allBreastScreen Aotearoa radiologists in their Lead Providerregion. These are to ensure that monitoring of activitiesand data occurs, that regional interval cancer review isperformed and that fail-safe mechanisms are in place andoperating routinely. The Lead Radiologist will be requiredto visit each assessment site to co-ordinate a clinicalmultidisciplinary meeting at least annually.

34.2 DESIGNATED MEDICAL QUALITYASSURANCE (MQA) RADIOLOGISTEach screening and/or assessment site shall have aDesignated MQA radiologist who is also the PrincipalLicensee, as described by the NRL1 for mammography atthe site, where they work. This ensures that theresponsibilities of the MQA programme and the regulatoryrequirements are focused on one individual, wherepossible.

1. The specific responsibilities of the Designated MQAradiologist include but are not limited to2:

a. ensure that an effective MQA programme exists forall mammography performed at the site

b. select, in consultation with the Charge MRT, a singleMRT to be the QC MRT, performing the prescribedquality control (QC) tests at the site.

2. The Designated MQA radiologist will review the MQAprogramme annually with the medical physicist for thatsite and ensure compliance with NRL-C53.

35. LEAD PATHOLOGIST

35.1 THE ROLE OF THE LEAD PATHOLOGISTThe Lead Pathologist is ultimately responsible for providingprofessional leadership and ensuring compliance with theNational Policy and Quality Standards (NP&QS) for allpathologists in the Lead Provider region.

The specific responsibilities of the Lead Pathologist includebut are not limited to:

1. ensuring that the agreed BreastScreen Aotearoa CQIprogramme is implemented for all sites

2. ensuring all pathology staff receive adequate clinicaltraining and regular updates

3. ensuring that processes are in place to implement,monitor and evaluate the relevant NP&QS

4. ensuring that processes are in place to monitor theaccuracy of pathology data (for example, the correctuse of the pathology synoptic forms. Refer: Appendix S:Synoptic Forms)

5. ensuring there is a designated pathologist from eachcontributing laboratory responsible for the quality ofwork at that site

6. active involvement with pathology assessment processof BreastScreen Aotearoa women within their region

7. monitoring and assuring provision of reports and slidesto the assessment centre and treatment providers whilemeeting the specified timeliness requirements.

8. regular attendance at pathologist unidisciplinarymeetings

Responsibility

The Lead Pathologist is responsible for overseeing theclinical performance of the following within their region:

1. BreastScreen Aotearoa pathologists

2. Cytotechnologists

3. Laboratory staff.

Co-ordination

The Lead Pathologist is responsible for the co-ordination ofregular (at least annual) pathology meetings with allBreastScreen Aotearoa pathologists in their Lead Providerregion. These are to ensure that monitoring of activitiesand data occurs and that failsafe mechanisms are in placeand operated routinely.



1 NRL. 1993.2 RANZCR 1994a.3 NRL 1994.



d. Health Promotion staff

e. Quality Co-ordinator.

2. The Lead Provider Manager will visit each screening andassessment site in their region a minimum of every sixmonths. This could be timed to coincide with themanagement multidisciplinary meeting.

38.2 MINIMUM QUALIFICATIONS REQUIRED1. Management skills and experience appropriate to the

position.

2. Relevant tertiary qualifications or working towards,preferably in a health related area.


Continuing professional development shall include servicespecific training, for example, the Diploma of Public Health,breast screening courses/conferences in addition tomanagement training and multidisciplinary courses.

38.3 LEAD PROVIDER MANAGER EXPERTISEThe Lead Provider Manager’s expertise includes but is notlimited to:

1. an understanding of the philosophy and operations of abreast screening programme

2. strong leadership skills

3. planning for service provision

4. working within budgets and financial allocations

5. an understanding of working with the community

6. managing people, bringing together a team, liaising withother professions.

38.4 TRAINING

New Lead Provider Managers in training

There will be appropriate training and orientation for newManagers. The orientation is designed to ensure that a newLead Provider Manager has exposure to the relevant facetsof the Programme to ensure an appropriate level ofunderstanding.


1. visiting other sites within the Programme

2. visiting subcontractor sites

3. liaison with other Lead Provider Managers within theProgramme

4. attendance at regular national programme managementmeetings.

39. DATA MANAGER

39.1 THE ROLE OF THE DATA MANAGERThe Data Manager works as a member of amultidisciplinary team providing timely, accurate andreliable data to support all phases of the screening,assessment and treatment processes. The Data Manager isresponsible for the overall data quality and consistency ofinformation recorded in the Lead Provider database andthat the data is forwarded to the national monitoringdatabase as per the agreed timetable.

The Data Manager needs to understand each phase of theBreastScreen Aotearoa Programme from the identification,screening, assessment, treatment and follow-up of womendiagnosed as having breast cancer. The Data Managershould support the different professional groups involvedwith breast screening in meeting the NP&QS by providingaccurate and timely information.

The Data Manager has the responsibility to ensure that theinformation system complies with all the National ScreeningUnit Standards documented in the BreastScreen Aotearoadocuments, for example:

1. Data Management Manual (DMM), the current version

2. Breast Screening Compliance Scripts (NZHIS), thecurrent Version

3. Breast Screening National Database File Layouts, thecurrent version

4. Breast Screen Aotearoa Data Quality Plan, the currentversion

5. official clarification documents issued by the NationalScreening Unit (as required).

This will be facilitated by regular attendance at the DataManager’s Unidisciplinary Group.

Liaison requirements

To ensure that activity and results are accurately monitoredand on a regular basis, the Data Manager liaises with:

1. members of the Multidisciplinary Team

2. the Health Promotion team (if not represented withinthe multidisciplinary team)

3. software vendors

4. other BreastScreen Aotearoa Data Managers

5. the National Screening Unit

6. key stakeholders.

37.3 THE ROLE OF THE CHARGE MRTA MRT in charge of screening, Charge MRT, is to beappointed at each screening site. They are responsible for:

1. ensuring MQA at that site occurs and is reported backto the Lead MRT/Lead QC MRT

2. technical/support staff who support MRTs

3. reviewing the MQA programme annually with the LeadMRT and Lead QC MRT, designated MQA radiologistand the medical physicist to ensure compliance withNRL-C54. Ensuring that all MRTs at the Lead Providerand subcontractor sites meet the minimum entry andongoing requirements for screening MRTs within theProgramme.

37.4 PROFESSIONAL STANDARDSThe designated Charge MRT will:

1. be actively involved in the Programme


3. retain responsibilities as below, but be able to delegate

4. will meet all the professional and continuing professionaldevelopment relevant to the managerial aspects of therole

37.5 THE ROLE OF THE DESIGNATEDQUALITY CONTROL (QC) MRTEach screening and/or assessment site shall have adesignated QC MRT. This may be the Charge MRT oranother designated MRT at each screening site.

The designated QC MRT is responsible for:

1. ensuring that the mammographic quality assurance(MQA) programme occurs at that site

2. ensuring all QC tests are performed, data collection isadequate, current and that any corrective action isinitiated as required

3. ensuring the accuracy of the QC data.

37.6 PROFESSIONAL STANDARDSThe designated QC MRT will:

1. be actively involved in the Programme


3. retain responsibilities as below, but be able to delegate

4. will meet all the professional and continuing professionaldevelopment relevant to the managerial aspects of therole.

38. LEAD PROVIDER MANAGER

38.1 THE ROLE OF THE LEAD PROVIDERMANAGERThe Lead Provider Manager ensures the provision ofeffective operational management, leadership, planning andco-ordination for the service. In undertaking theirrespective roles, they have joint responsibility with theClinical Director for the operation of the BreastScreenAotearoa Programme within their Lead Provider region.

The Lead Provider Manager’s areas of responsibility includebut are not limited to:

1. advocating for adequate resources being available withinfunding allocations to meet the requirements of theNP&QS

2. ensuring effective use of available resources

3. ensuring all non-clinical aspects of the NP&QS areimplemented, monitored and evaluated

4. ensuring the organisational Quality Plan is developed,implemented, monitored and evaluated includingoverseeing the internal quality improvement activitiesand ensuring corrective actions where Standards arenot met

5. overseeing the recruitment, education, training,professional development and ongoing quality of non-clinical staff involved in the Programme

6. ensuring recommendations from the BreastScreenAotearoa Independent Monitoring Group (BSA IMG)Report recommendations are acted upon

7. facilitating a close working relationship betweenmembers of a multidisciplinary group (including healthpromotion, screening and assessment personnel)

8. ensuring adequate policies and procedures are in placeto meet the requirements of the NP&QS and thecurrent Data Management Manual (DMM)

9. distributing any amendments to national documents

10. communicating and liaising regularly with the ClinicalDirector to ensure the success of the service

11. regular attendance of the Lead Provider Manager’sUnidisciplinary Group.

Responsibility

1. The Lead Provider Manager is responsible for theperformance of all non-clinical staff including the following:

a. Data Manager

b. reception staff

c. clerical staff



4 NRL 1994.

39.2 PROFESSIONAL STANDARDS

Qualifications

It is essential that the Data Manager demonstrates:

1. experience in data management, including reportgeneration

2. a minimum of two years experience managing a‘business critical’ information system

3. interpretation of report data

4. experience in managing data quality.


Continuing professional development requirements include:

1. database management skills

2. quality assurance

3. data analysis

4. breast screening issues, for example, site visits

5. attendance at a data management/audit course everytwo years.

39.3 DATA MANAGER’S EXPERTISEExpertise should include:

1. an understanding of BreastScreen Aotearoa and thebreast screening pathway

2. a meticulous and methodical approach to data accuracyand completeness

3. an understanding of audit, monitoring and evaluationrequirements

4. an understanding of the data managementresponsibilities for example, audit and quality issues formanual and computer records

5. the ability to monitor and facilitate the maintenance ofappropriate information systems and databasehousekeeping activities

6. appropriate knowledge and adequate training in theinformation system/database which captures and storesthe information

7. a thorough knowledge of the relationships with otherinformation systems and interfaces

8. the ability to provide ad hoc reports to the ClinicalDirector and other staff when required

9. the ability to recognise restrictions and exceptions inorder to ensure accuracy of these reports

10. the ability to demonstrate well developed written andoral communication skills

11. the ability to identify problem areas and possible areasof improvement and implement solutions asappropriate, following authorisation by the LeadProvider Manager

12. the ability to develop good working relationships withthe other staff and stakeholders to ensure that targetsare met and the data is accurate.

39.4 STAFF IN TRAINING (NEW AND TRAINEESTAFF)

Supervision requirements

New Data Managers and staff in training shall receiveadequate supervision until they reach a level of competencethat satisfies their immediate Manager. Due to the pivotalnature of this position, it is essential that contingencies beestablished to manage episodes of extended leave, sicknessor the resignation of the Data Manager to ensure thecontinuity of data management and reporting.

Practice limitations

New staff and staff in training shall limit their datamanagement activities to the areas they have been deemedcompetent in by their immediate Manager.




PRO

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Professional Requirements – SECTION 4

SECTION 4 PROFESSIONAL REQUIREMENTS

40. Other Mandatory Roles within BreastScreen Aotearoa ..................................................................................3

41. Breastcare nurse ..............................................................................................................................................3

41.1 The role of the breastcare nurse............................................................................................................3


41.3 Nursing expertise....................................................................................................................................4

41.4 Staff in training (new and trainee staff) ..................................................................................................4

42. Health promoter..............................................................................................................................................5

42.1 The role of the health promoter ............................................................................................................5


42.3 Health Promotion expertise ..................................................................................................................6


43. Medical physicist ..............................................................................................................................................7

43.1 The role of the medical physicist ............................................................................................................7


43.3 Medical Physics expertise ......................................................................................................................8


43.5 Quality assurance ....................................................................................................................................8

44. Medical radiation technologist (MRT)............................................................................................................10

44.1 The role of the medical radiation technologist ....................................................................................10

44.2 Professional standards ..........................................................................................................................10

44.3 Staff in training (new and trainee staff) ................................................................................................10

44.4 MRT expertise ......................................................................................................................................10

45. Pathologist......................................................................................................................................................11

45.1 The role of the pathologist ..................................................................................................................11


45.3 Pathologist expertise ............................................................................................................................12


45.5 Quality assurance ..................................................................................................................................12

46. Quality Co-ordinator ....................................................................................................................................13

46.1 The role of the Quality Coordinator ....................................................................................................13



47. Radiologist......................................................................................................................................................14

47.1 The role of the radiologist ....................................................................................................................14


46.3 Radiologist expertise ............................................................................................................................14


47.5 Quality assurance ..................................................................................................................................15

48. Surgeon ..........................................................................................................................................................16

48.1 The role of the surgeon........................................................................................................................16


48.3 Surgeon expertise ................................................................................................................................17

48.4 Training..................................................................................................................................................17


48.6 Quality Assurance ................................................................................................................................17


SECTION 4 – Professional Requirements



40. OTHER MANDATORY ROLESWITHIN BREASTSCREEN AOTEAROA

The provision of an expert multidisciplinary team and theprovision of a quality breast screening service requiresspecific key roles which are considered mandatory.

All mandatory roles are detailed in the following section.The requirements of each role in relation to the specificresponsibilities, professional standards, continuingprofessional development (CPD) and quality are specified.All professional requirements should be included in jobdescriptions and be subject to performance appraisals.

Mandatory roles include:

41 breastcare nurses

42 health promoters

43 medical physicists

44 medical radiation technologists

45 pathologists

46 quality co-ordinator

47 radiologists

48 surgeons.

The BreastScreen Aotearoa Lead Provider, subcontractorsand ISPs must maintain an up to date list of all personnelfilling mandated BreastScreen Aotearoa roles within theirregion.

The BreastScreen Aotearoa provider may choose toprovide additional expertise in addition to the mandatoryroles listed above in order to meet specific needs ofwomen receiving their services.

Additional complementary roles (non-mandatory) mayinclude:

1. counsellors

2. cytotechnicians

3. GP/PCP liaison

4. interpreters

5. medical officers

6. reception, administration and clerical

7. sonographers.

It is a requirement that all staff undergo culturally consumerfocused training, for example, Well Women CustomerService.

41. BREASTCARE NURSE

41.1 THE ROLE OF THE BREASTCARE NURSEThe breastcare nurse primarily provides information,education, support and counselling services for womenundergoing assessment, but is available to assist women atany stage of the screening process, if required.

1. All women participating in BreastScreen Aotearoa areentitled to services from the breastcare nurse which:

a. comply with legal, professional, ethical and otherstandards relevant to the profession of nursing

b. are delivered in a professional manner consistentwith the physical, psychological, spiritual and culturalneeds of the individual

c. are delivered according to the ethics of the nursingprofession; minimising any potential harm to andoptimising the quality of life of that individual.

2. The breastcare nurse works as a member of amultidisciplinary team in partnership with women, theirfamilies and whanau, to empower each woman to makeinformed choices and optimise her health andwellbeing.

The role of the breastcare nurse includes, but is notlimited to:

a. empathetically providing support to women andtheir family/whanau

b. acting as advocate for the woman and hersupporters

c. providing education and information with aparticular emphasis on facilitating informed decisionmaking for women prior to attending assessmentand after a diagnosis of cancer

d. promoting awareness of psychosocial issues ofconcern to well women participating in screening

e. referring women (where appropriate) to othersupport services

f. facilitating communication between other healthprofessionals and services (particularly GPs/PCPs)regarding the care of individual women

g. nursing support for women and clinicians during allstages of assessment

h. ensuring there are appropriate infection controlprotocols in place

i. facilitating appropriate handling and pathways forpathology specimens

j. facilitating access to clinical supplies for assessmentdays

k. regular attendance at the breastcare nurse’sunidisciplinary group.



f. treatment options/trial protocols

g. self-help groups/support services and communitynetworks

h. issues relating to population screening of wellwomen

i. principles and processes of research and qualityassurance

j. professional ethics

k. Health Information Privacy Code (1994)

l. Health and Disabilities Service Consumers’ Rights [SR 1996/78]

m. The Treaty of Waitangi and its subsequent impact onMaori health.

2. The breastcare nurse demonstrates excellent skills in:

a. written and verbal communication

b. nursing and health assessment

c. support and advocacy

d. client information and educational needs assessment

e. participation as a member of a multidisciplinaryteam

f. quality improvement activities.

42. HEALTH PROMOTER

42.1 THE ROLE OF THE HEALTH PROMOTER Health promotion is the process of enabling people toincrease control over, and to improve their health. To reacha state of complete physical, mental and social wellbeing, anindividual or group must be able to identify and realiseaspirations, to satisfy needs, and to change or cope with theenvironment. Health is, therefore, seen as a resource foreveryday life, not the objective of living. Health is a positiveconcept emphasising social and personal resources, as wellas physical capacities. Therefore, health promotion is notjust the responsibility of the health sector, but goes beyondhealthy lifestyles to wellbeing.1


Qualifications

To maximise effective health promotion and nationalconsistency of messages, all health promotion staffemployed in the Programme shall be able to demonstrate agood understanding of the theory and practice of publichealth and health promotion approaches.

Minimum competency requirements

BreastScreen Aotearoa providers will use:

• Nga Kaiakatanga Hauora mo Aotearoa HealthPromotion Competencies for Aotearoa-New Zealand2

• National Screening Unit Competencies, includingCultural Competencies


Professional development and continuing educationrequires that health promotion staff employed orsubcontracted by BreastScreen Aotearoa Providers shall:

1. promote and demonstrate sound health promotionprinciples and practice

2. maintain professional knowledge and skills relating tobreast cancer and screening in addition to healthpromotion

3. develop and maintain cultural knowledge and skills

4. identify, develop and maintain community andprofessional networks

5. critically reflect on and evaluate own work

6. participate in peer review processes.


Qualifications

The role of a BreastScreen Aotearoa breastcare nurse isundertaken by a Registered Nurse (RCON or RCPN) witha current practising certificate and a minimum of two yearspostgraduate work experience as a Registered Nurse and astrong commitment to the provision of a high standard ofcare.

The registered nurse will have demonstrated anunderstanding of and a commitment to meeting theNP&QS.

Within the first year of employment, the BreastScreenAotearoa Nurse must have attended/or be attending abreastcare nurse course accredited by the New ZealandNursing Council.

Enrolled Nurses currently working in the Programme maycontinue in their role but they will participate in ongoingeducation/training as specified and have their practiceoverseen by a registered nurse.


In order to provide a specialist service for women, thebreastcare nurse shall have access to ongoing professionaldevelopment.

The breastcare nurse, in consultation with the Manager,shall develop both short and long-term strategies relating topersonal career development within the Programme.

The breastcare nurse shall actively update her nursingknowledge and practice while maintaining currentknowledge in breast screening through participation ingraduate nursing study, planned educational programmes,and self-directed study.

In addition to this, the breastcare nurse shall maintain up todate knowledge and skills by participation in:

1. clinical multidisciplinary in-house sessions for case review,60% or 15 meetings annually, whichever is the greater

2. programme study sessions

3. nationally recognised education programmes, or

4. regional, national or international seminars, conferencesor courses, attending three in any five-year period

5. regular clinical supervision if available and requested bythe breastcare nurse.

41.3 NURSING EXPERTISEThe breastcare nurse demonstrates advanced knowledge ofnursing theory and practice with an emphasis on:

1. anatomy and physiology of the breast

2. signs and symptoms of breast disorders

3. pathology of breast cancer

4. diagnostic procedures/interventions and potentialcomplications

5. therapeutic interventions and potential complications

6. treatment options/trial protocols

7. self-help groups/support services and communitynetworks

8. issues relating to population screening of well women

9. principles and processes of research and qualityassurance

10. professional ethics

11. Health Information Privacy Code (1994)

12. Health and Disability Service Consumers’ Rights [SR 1996/78]

13. the Treaty of Waitangi and the subsequent impact onMaori health.

The breastcare nurse demonstrates excellent skills in:

1. breast awareness

2. nursing and health assessment

3. client information and educational needs assessment

4. assessment and support

5. determining when the woman requires referral torelevant health professionals for additional specialisedpsychological care

6. written and verbal communication

7. communication/listening

8. evaluation and feedback

9. support and advocacy

10. participation as a member of a multidisciplinary team

11. quality improvement activities.

41.4 STAFF IN TRAINING (NEW AND TRAINEESTAFF) 1. The breastcare nurse must have attended or be

attending a recognised Breast Care course.

2. The Nurse shall receive an orientation programme tothe role and the BreastScreen Aotearoa Programme.

3. The Nurse demonstrates a sound knowledge of nursingtheory and practice with a particular emphasis on:

a. anatomy and physiology of the breast

b. signs and symptoms of breast disorders

c. pathology of breast cancer

d. diagnostic procedures/interventions and potentialcomplications

e. therapeutic interventions and potentialcomplications



1 WHO, 1986, Ottawa charter for health promotion: First International Conference on Health Promotion. 21 November.2 HPFNZ. 2000. Nga Kaiakatanga Hauora mo Aotearoa Health Promotion Competencies for Aotearoa-New Zealand. Health Promotion

Forum of New Zealand – Runanga Whakapiki ake i te Hauora o Aotearoa.



43. MEDICAL PHYSICIST

43.1 THE ROLE OF THE MEDICAL PHYSICISTThe medical physicist’s areas of responsibility include, butare not limited to:

1. ensure that the quality assurance (MQA) programme isof the required standard and is operating effectively4

2. ensure that all imaging and ancillary equipment iscovered by the QA programme, for example, X-rayequipment, film processors, film illuminators,localisation devices, ultrasound imagers and hard copydevices4

3. be a member of the breast screening site MQAcommittee which will meet quarterly to review resultsand annually to review the QA programme (Refer:Appendix K: Mammographic Quality Assurance (MQA)Programme)

4. perform the physics quality control (QC) tests4

5. ensure the performance and calibration of QC testequipment (Refer: Appendix P: Test Equipment)

6. perform acceptance testing on new imaging andassociated equipment prior to its use on women4

7. assist the QC MRT in the review of MRT QC test data4

8. advise the QC MRT on all matters concerning imagequality and the MQA programme (Refer: Appendix K:Mammographic Quality Assurance (MQA) Programme)

9. advise the Designated MQA radiologist, specifically inthe areas of image quality, all aspects of the MQAprogramme, safety and equipment purchase4

10. advise the Lead Provider Manager and/or ClinicalDirector specifically in the areas of safety, QC analysisand equipment purchase, including the preparation ofequipment specifications4

11. co-operate with all others involved in the Programme4

12. co-operate with and support other medical physicistsworking in BreastScreen Aotearoa5

13. provide radiation protection advice to the screeningunit, particularly the licensee, ensuring the radiationsafety of the women, staff and members of the public6

14. ensure regulatory compliance7.

All medical physicists working in the Programme aremembers of the medical physicists Unidisciplinary Group(UDG) and are required to take part in these meetings andother activities.

Acceptance testing is required by New Zealand regulations(NRL 1994) and the RANZCR (1994) but not described bythem. A list of necessary tests is provided in Appendix K:Mammographic Quality Assurance (MQA) Programme.Additional tests are included within the NHSBSP Standard(IPSM 1994) and in ASNZS (4184.3.2: 1998).

QC tests are required for ultrasound scanners used inassessment. Refer: Appendix M: Ultrasound SystemPerformance and Quality Control.

Testing is also required for stereotactic localisation devicesand specimen X-ray cabinets. Refer: Appendix L:Stereotactic Breast Biopsy Quality Assurance (QA)Programme.

NOTE: The documents quoted above will be supersededby subsequent versions as advised by the medical physicists,radiologists and MRT Unidisciplinary Groups and agreed bythe National Screening Unit.


Qualifications

Medical physicists providing services to BreastScreenAotearoa must:

1. be explicitly trained in the physics of mammography andin the philosophy of breast screening. Approved coursesagreed by the RANZCR and ACPSEM and practices areprovided by the ACPSEM. Other internationallyrecognised courses (for example those provided in theUSA by the AAPM/ACRT and in the UK by the IPEM)are acceptable.

To be acceptable, a course must contain a minimum of20 contact hours of documented, specialised training inconducting surveys of mammography facilities. Timemust also be spent visiting established screening units inorder to gain practical experience working withphysicists in the field.8

2. be licensed under the Radiation Protection Act (1965)to use X-rays to perform tests and measurements aspart of the quality assurance programmes in radiationprotection

42.3 HEALTH PROMOTION EXPERTISEIn addition to generic health promotion knowledge andskills a health promoter will be able to:

1. advocate for health promotion at all levels

2. promote an understanding of the need for, and theadoption of health promotion practices based on theTreaty of Waitangi, and health promotion modelsoutlined in the National Screening Unit HealthPromotion Strategy

3. demonstrate the full range of knowledge and skillsrequired for competent practice

4. demonstrate accountability and effectiveness to a rangeof stakeholders

5. model and support consultative ways of working withother key health promotion principles

6. have a recognised, or be working towards, a healthpromotion or related qualification.

In addition to generic health promotion knowledge andskills a health promoter in a leadership role will be able to:

1. successfully negotiate or support negotiations ofcontracts and funding for sustainable services

2. actively develop the health promotion workforce

3. demonstrate strategic health promotion leadership

4. facilitate strategic health promotion planning includingwriting, implementing and evaluating health promotionplans

5. challenge organisational decisions that constrain orprevent good health promotion practice

6. facilitate robust critical debate and reflection on healthpromotion practice

7. access and provide opportunities for quality healthpromotion training for staff

8. develop and implement quality assurance and qualityimprovement strategies.


Scope of involvement within the Programme

Staff in training shall:

1. become familiar with the BreastScreen Aotearoa healthpromotion resources, develop a comprehensiveunderstanding of the screening pathway and the rangeof health professional roles in the Programme

2. undertake an individualised orientation programme withthe guidance of an experienced health promoter toobserve and participate as skills develop

3. be working towards achieving relevant competencies

• Nga Kaiakatanga Hauora mo Aotearoa HealthPromotion Competencies for Aotearoa-NewZealand3

• National Screening Unit Competencies, includingCultural Competencies

4. attend a BreastScreen Aotearoa nationally organisedtraining event within 12 months of joining theProgramme.


The trainee will present health education sessions underguidance and supervision until deemed competent by anexperienced health promoter.



3 HPFNZ. 2000. Nga Kaiakatanga Hauora mo Aotearoa Health Promotion Competencies for Aotearoa-New Zealand. Health PromotionForum of New Zealand – Runanga Whakapiki ake i te Hauora o Aotearoa.

4 RANZCR 2002 or subsequent versions; NHSBSP 1995 a; ACR 1999; IPSM 1994.5 NHSBSP 1995 a, adapted.6 RANZCR 2002 or subsequent versions; NHSBSP 1995 a; ACR 1999: IPSM 1994; NRL 1994.7 NHSBSP 1995 a; IPSM 1994; NRL 1994.8 RANZCR 2002 or subsequent versions; NHSBSP 1995 a; ACR 1999; IPSM 1994.



The service shall be specified in a written agreementbetween a breast screening unit and the designated medicalphysics services.

The physics QA tests must be performed in a standardisedmanner and to the national protocols, in order to facilitatethe exchange of data. A national protocol of tests, based onthose recommended by the Royal Australian and NewZealand College of Radiologists (RANZCR) have beenagreed, and will be continually reviewed by the medicalphysicists UDG. Additions to the RANZCR tests arenecessary for regulatory compliance.11

In accordance with the United Kingdom (UK) NHS BreastScreening Programme guidelines12, and to promotecompliance with NRL-C5,13 a programme of dosemeasurements on women is included. The medicalphysicists UDG will develop the testing protocol andfrequency.

Specific quality targets/requirements

The internal quality system ensures that:

1. all critical test failures must be identified to the facilityon the day testing is complete

2. 95% of preliminary reports are provided to the unit onthe day testing is completed

3. 95% of final reports are provided to the unit within 20working days of the day testing is completed

4. defects must be reviewed when identified and themedical physicist shall specify the timeframe in whichthey shall be resolved in consultation with the ClinicalDirector.

National co-ordination and sharing

To promote the highest standards of breast screening it isimportant that the medical physicists involved are able touse their collective experience and knowledge, whichrequires a mechanism for the collation and exchange ofdata. The designated medical physicist shall send MedicalPhysics QA survey results to the National Physics Co-ordinator, who shall collate the results.

The medical physicists UDG shall ensure the efficientexchange of information and furthermore to maintain andrevise national protocols to ensure they remain evidenceinformed.

Reference materials

The medical physicist will require the following documentswhile performing the tests:

1. RANZCR Mammography Quality Control Manual: 2002including revisions or

2. American College of Radiology – Mammography QualityControl Manual: 1999 ACR SEM Position Paper

3. National Radiation Laboratory Code of Safe Practice forthe use of X-rays in Medical Diagnosis, NRL-C5 1994 orsubsequent versions.

Additional supportive documents

1. Institute of Physical Sciences in Medicine. 1994.Commissioning and Routine Testing of Mammographic X-ray Systems. IPSM Report 59 (2nd Edition).

2. Goodsitt M M, Witt S, Hykes D L and Kofler J M Jr.1998. Real-time B-mode ultrasound quality control testprocedures: Report of AAPM Ultrasound Task GroupNo. 1. Med. Phys. 25: 1385 - 1406.

3. ACR Standards14.

3. be recognised by the National Radiation Laboratory(NRL) as a qualified health physicist within the contextof NRL-C59 and mammography

4. hold a Masters Degree or a higher qualification in aphysical science

5. have recognised, documented, specialised training inconducting surveys of mammography facilities as perACR or RANZCR Standards

6. have experience of conducting surveys of at least onemammography facility within BreastScreen Aotearoaand a total of at least ten units. Experience conductingsurveys must be acquired under the direct supervisionof a medical physicist who meets all the requirementsof the NP&QS.


Medical physicists providing such services will participate incontinuing professional development (CPD) in the area ofmammography physics.

Continuing Professional Development (CPD) includes:

1. attendance at, at least one scientific meeting orrefresher course, with content specific tomammography physics, every two years. Only timespent on ‘Mammography Physics’ may count towardsthe 15 hours CPD

2. attendance at relevant multidisciplinary or peer reviewand audit meetings

3. review of current journals and authoritative materialrelevant to mammography physics.

The medical physicist must meet the RANZCR/ACRStandard of 15 hours CPD in mammography physics duringthe 36 months immediately proceeding any facility survey. Arecord of medical physicists practising in New Zealand whomeet this Standard will be kept by the National Physics Co-ordinator. The National Physics Co-ordinator, in conjunctionwith the medical physicists Unidisciplinary Group, will giveadvice on the attainment of CPD requirements.

43.3 MEDICAL PHYSICS EXPERTISETo achieve and maintain an adequate awareness of currenttechnology and techniques the medical physicist shall:10

1. during the 24 months immediately preceding anysurvey, conduct two full facility surveys including reviewof the facility MQA programme and either:

• perform MQA surveys on six mammography units inthe previous 12 months to RANZCR Standards, or

• perform MQA surveys on four mammography unitsplus

• have extensive experience and

• work in general diagnostic radiology.

2. participate in the review of MQA data from surveys onat least six mammography units at least once a year, andhave access to such data when necessary

3. liaise with other mammography Physicists and attendnational meetings on mammography physics organisedby the medical physicists Unidisciplinary Group (UDG)and support practical inter-comparison sessionsassociated with the UDG meetings

4. undertake visits to other centres active inmammography physics to compare techniques, at leastevery two years (‘Buddy Visits’).

43.4 STAFF IN TRAINING (NEW AND TRAINEESTAFF) Staff in training can perform medical physics duties underthe direct supervision of a qualified medical physicistcurrently practising with BreastScreen Aotearoa, whomeets the requirements of Section 43.2.


Staff in training shall undertake the full range of tasks underthe direct supervision of the medical physicist. Trainees shallundertake duplicate surveys and be directly supervised forany procedure conducted within the Programme.


Until a medical physicist meets the requirements of Section43.2 the survey remains the responsibility of the supervisingmedical physicist, and must be signed by them.

43.5 QUALITY ASSURANCE

Performance evaluation

The designated Medical Physics service must participate ina planned, co-ordinated MQA programme covering allimaging equipment that will be used in achieving adiagnosis, as well as, ancillary equipment such as filmprocessors and viewing boxes. The MQA programme mustalso include the test and calibration of the MQA testequipment itself and the provision of the medical physicsservice.



11 NRL 1994.12 NHSBSP 1995a.13 NRL 1994.14 ACR. 1998a. Ultrasound Accreditation Programme. Reston, Virginia: American College of Radiology.

ACR. 1998b. Ultrasound-guide Breast Biopsy Accreditation Programme. Reston, Virginia: American College of Radiology. 9 NRL 1994.10 NHSBSP 1995 a.



NOTE: Recalling women to screening units for technicallyrejected films contributes to increased anxiety levels in thescreened population and this should be minimised toenhance service acceptability.

Monthly MRT peer review

Monthly peer review of all MRTs’ work usingmammographic image quality (MIQ) criteria will occur(refer Appendix M: Mammographic Image Quality (MIQ)Classification). Appropriate and regular feedback will beprovided to each MRT to maintain the focus of excellencerequired for screening mammography. Any training needswill be identified and promptly addressed. It is theresponsibility of the Lead MRT to ensure that this is carriedout at all screening sites within the Lead Provider region.

Mammography workload

All MRTs involved in BreastScreen Aotearoa must beperforming no less than 1,000 mammograms per year or80 per month or 0.4 FTE within BreastScreen Aotearoa.

Mobile units

MRTs will initially work at a fixed unit with processingfacilities and have their skill level assessed before working‘blind’ on the mobile.

The skill level of MRTs working on mobile units must besuch that their technical reject rate is < 3% beforecommencing work on the mobile.

Any additional training needs will be identified andaddressed before commencing work on the mobile unit.

NOTE: The skill level of the MRT working on mobile unitsrequires special consideration, as they do not receive‘instant feedback’ by seeing their films as they work. Theymust therefore have the opportunity to view their work ata later time and receive regular feedback to maintain theirskills. A further consideration is that recalling women tomobile units for repeat films generates higher levels ofanxiety and lack of acceptance of the service.

Assessment clinics and multidisciplinarymeetings

1. All MRTs working in either fixed or mobile sites are toattend a minimum of 2 assessment clinics and 4 clinicalmultidisciplinary meetings per year.

2. MRTs should participate fully in the breast care teamcontributing their expertise as appropriate.

45. PATHOLOGIST

45.1 THE ROLE OF THE PATHOLOGISTPathology specimens from screened women presentparticular challenges. At the macroscopic level is the needto adequately sample impalpable lesions, requiring theadditional modality of specimen radiography.

At the histological level the pathologist is presented with anumber of difficult to classify conditions, many of which lieon the border between benign and malignant. Thereproducibility diagnosis of atypical hyperplasia andcarcinoma in situ is the ideal.


Qualifications

A pathologist involved in BreastScreen Aotearoa will bemedically qualified and registered to practice in NewZealand. All BreastScreen Aotearoa pathologists shouldhold recognised postgraduate qualifications in pathologyand be enrolled on the New Zealand Medical Council’sVocational Register in anatomic or general pathology.

Accreditation process

1. All pathologists working in the BSA Programme requireaccreditation to do so.

2. Each pathologist will be assessed on their qualifications,training etc and a decision will be made by theAccreditation Committee based on informationsubmitted in the Accreditation Template (Refer:Appendix V: Accreditation Processes).

3. A recommendation will be made by BreastScreenAotearoa, regarding their ability to work in theProgramme and the outcome will be communicated totheir Lead Provider Manager, Clinical Director and thepathologist concerned.


Participating pathologists must be enrolled in the RCPA’sContinuing Professional Development scheme [CPD] andcomplete the appropriate requirements for participation inthe Programme.

Every three years, participating pathologists must submit tothe Unidisciplinary Pathologists Group, evidence that theyhave attended national and/or international pathologymeetings with a component on breast pathology. Theyshould demonstrate that they have participated in the breastpathology components for a total of at least six educationalhours over the proceeding three years.

44. MEDICAL RADIATIONTECHNOLOGIST (MRT)

44.1 THE ROLE OF THE MEDICAL RADIATIONTECHNOLOGISTBreast screening is a service for well women. For mostwomen attending BreastScreen Aotearoa, the MRT is theonly health professional with whom they interact. Thequality of this interaction is critical to the woman’s decisionto re-attend for subsequent screens. MRTs thereforerequire skills that will make this an acceptable experiencefor women with minimal anxiety at all stages of thescreening pathway.

The MRT has two main areas of responsibility:

1. the provision of an acceptable screening experience forwomen who participate in BreastScreen Aotearoa

2. the provision of medical images of high quality to ensurethe detection of small cancers. The detection of suchcancers will demonstrate the benefits of screeningmammography for women.


Qualifications

A MRT is a trained and qualified health professionalemployed in the field of medical radiation technology. AllMRTs performing screening mammography withinBreastScreen Aotearoa must be registered with the medicalradiation technologists Board (MRTB) and hold a currentpractising licence.

Additionally all MRTs must have completed a Certificate ofProficiency (NZIMRT, or its recognised equivalent) inMammography within two years of commencingemployment with the Programme. Those who are alreadyworking within the Programme, but have not completedthe Certificate of Proficiency (or its recognised equivalent)by January 2004, will be reassessed.


To assist in maintaining the necessary skill level andexpertise, MRTs should:

1. remain up to date with advances in clinical practice andmammography techniques

2. be conversant with current methods of early detectionand treatment of breast disease.

These should be achieved by regular attendance (three inany five-year period) at validated update courses,conferences or seminars. These may be at regional, nationalor international and it is desirable that one event contains aclinical component. Within each screening centre, ongoingeducation shall occur through regular in-house study

programmes, journal reviews and peer teaching sessions.

All continuing education should be of a quality that wouldenable it to be included in the continuing professionaldevelopment programme (CPD) endorsed by NZIMRT.



All new MRT staff requiring training will be supervised by anMRT who holds a mammography qualification recognised byNZIMRT. Mentoring of the MRT in training shall occur untilthe level of competency reached enables the MRT tofunction with a technical reject rate of less than 3%.


Staff under training shall progressively become involved inall relevant aspects of the screening programme as theircompetency levels develop.

44.4 MRT EXPERTISE

Technical reject rate

All MRTs performing screening mammograms in BSA shallassess each examination using the MIQ classificationcriteria. These MIQ classification criteria are to be used inall training situations and when ever conducting peerreview.

All images that fall into the inadequate category must berejected and recorded as such.

The Standard is for all MRTs to have a reject rate of < 3%.This measure should be considered in conjunction with theStandard 23.6: Screening – Routine Views Performed.

Definition: The number of films rejected as a percentage ofthe number of films taken calculated separately for womenscreened at a fixed unit and a mobile unit

Technical recall rate

Technical recalls will occur when the MRT is unable to viewthe films while the woman is still present (normally forwomen seen at mobile units) or because a readingradiologist finds the study to be inadequate.

The technical recall rate is defined as the number ofwomen who have to return to a screening unit (either fixedor mobile) for further films to complete their screeningepisode, expressed as a percentage of the numberscreened.

The technical recall rate for screening units of womenrequiring repeat films for technical reasons must be < 3%of the total number of women screened at a mobile unit,and < 0.5% for women screened at a fixed unit.





46. QUALITY CO-ORDINATOR

46.1 THE ROLE OF THE QUALITYCOORDINATOR The Quality Co-ordinator, on behalf of the Clinical Directorand Lead Provider Manager, co-ordinates the operation ofthe quality management systems within their Lead Providerregion. This is expected to be a part-time role and can beone that is combined another role, for example, thebreastcare nurse.

The Quality Co-ordinator will help ensure that systems andprotocols exist with Lead Providers and subcontracted sitesto meet quality requirements.

The Quality Co-ordinator will assist professional groups,the Manager and Clinical Director to:

1. ensure the National Policy and Quality Standards(NP&QS) are met

2. co-ordinate corrective actions where Standards are notmet

3. ensure the organisation’s quality plan is current,implemented, monitored and evaluated

4. ensure BreastScreen Aotearoa Independent MonitoringGroup (BSAIMG) Reports’ recommendations areresponded to

5. ensure all relevant information, policies and proceduresremain current

6. facilitate internal quality improvement activities

7. organise quality-related meetings on a regular basis,maintaining a record of these including attendance andoutcomes

8. manage internal document control of NP&QS across allsites including subcontractors.

Liaison requirements

The Quality Co-ordinator liaises with Clinical Director andLead Provider Manager to:

1. document protocols and processes and plan ortimetable for all internal audit requirements

2. provide comparisons of Provider data with externalaudit, with a focus on BSA IMG Reports

3. ensure the effective provision of clinical performanceinformation

4. develop and facilitate the monitoring of the quality planon a quarterly basis.

The Quality Co-ordinator liaises with the Lead Clinicians toensure analysis of individual staff performance measures.Such information is confidential within the respectiveprofessional group(s).

The Quality Co-ordinator liases with the Charge MRT to:

1. review MQA data to monitor effective operation of thescreening process

2. ensure analysis of individual staff performancemeasures. Such information remains confidential withinthe professional group.

The Quality Co-ordinator liases with the Data Manager to:

1. verify protocols for determining all audit andperformance data

2. review all Programme data for anomalous results

3. ensure analysis of performance data by individual sites,where appropriate

4. ensure the resolution of all missing/erroneous/suspectdata on a case by case basis.


Qualifications

The Quality Co-ordinator will have a quality and/or auditexperience and experience in a health-related field.

Quality Co-ordinator expertise

It is expected that the Quality Co-ordinator will havedemonstrated an abilitiy in implementing quality and auditsystems.


New Quality Co-ordinators in training

There will be appropriate training and orientation for staffnew to Quality Co-ordinator role. The orientation will bedesigned to ensure that the new Quality Co-ordinator hasexposure to all relevant facets of the Programme to ensurean appropriate level of understanding.


1. visiting sub-contractor sites within their region

2. visiting other sites within the Programme

3. liaison with other Quality Co-ordinators within theProgramme

4. attendance at regular Unidisciplinary National QualityManagement meetings.

Supervision Requirements

The Quality Co-ordinator will have a close workingrelationship with the Clinical Director and the LeadProvider Manager.

45.3 PATHOLOGIST EXPERTISEWhere an individual pathologist is reporting on fifty orfewer patient biopsy episodes from BreastScreen Aotearoaassessment clinics patients per annum, then the pathologymaterial from those episodes must be reviewed and signedout by the Lead pathologist. A patient biopsy episode isdefined as all the pathology material derived from anassessment clinic visit for that patient; FNAC alone, corebiopsy alone or combined FNAC and core biopsy count asone episode.

Each pathologist must attend the greater of 60% or 15clinical multidisciplinary meetings per annum.

45.4 STAFF IN TRAINING (NEW AND TRAINEE STAFF) Within 24 months of commencing reporting within theProgramme, all BreastScreen Aotearoa pathologists mustshow evidence that they have attended a multidisciplinarytraining course in breast screening. Such courses areoffered on a regular basis in Australia, USA and GreatBritain and the UDG should produce a list of approvedcourses on an annual basis to the National Screening Unit.

Pathologists in training may undertake gross and microscopicdescriptions of screen-detected lesions however the materialmust be reviewed and signed out by a BreastScreenAotearoa pathologist.


Performance evaluation

Internal

Pathologists reporting on screen-detected lesions shouldhave sufficient exposure to relevant material to develop andmaintain competence in reporting of such cases.

The Lead pathologist should endeavour to make materialfrom larger assessment centres available to pathologistsworking with smaller volumes as a teaching/learningresource.

External

All BreastScreen Aotearoa pathologists shall be enrolledand participate in the RCPA Australasian Breast ExternalQuality Assurance Scheme (ABEQAS), which consists of aslide-based circulation EQA scheme based on the UnitedKingdom model using pro forma reporting and groupedstatistical analysis of performance.

BreastScreen Aotearoa pathologists must participate on anindividual rather than a laboratory basis and complete atleast five of the six surveys per year. The results ofparticipation in EQA scheme must be recorded andprovided to the Programme by the Lead pathologist and beavailable for external audit as required.

Participation in this scheme will be recognised by the RCPABoard of Education as an activity for Fellows countingtowards continued professional development.

Quality system recognition

All laboratories involved in the Programme must be IANZaccredited for histopathology, and where FNAC isundertaken, cytology IANZ accreditation is also required.

All participating laboratories should be enrolled in the RoyalCollege of Pathologists of Australasia (RCPA) anatomicpathology external assurance programme and, whereappropriate, the cytology quality assurance programme.While these programmes cover all aspects of routine histo-and cytopathology, they also include important componentsof laboratory practice which impinge on breast pathology.





d. radiologists who perform ultrasound, biopsy andlocalisation techniques at an assessment clinic mustbe competent at these procedures

To achieve this it is recommended that theseradiologists have a regular weekly commitment tobreast imaging, which must include diagnostic,screening, assessment clinic and audit sessions

e. read screening mammograms and should participatein assessment clinics

It is recognised that this may be difficult to achievewhile still allowing assessment clinic radiologists todevelop and maintain sufficient expertise. For thisreason it is desirable for screening radiologists to beperforming assessment in diagnostic clinics outsidethe Programme.

4. radiologists shall attend regular radiology reviewsessions to allow:

a. interval cancer review and internal classification

b. review of reading or assessment procedures andprotocols

c. review of literature

d. review of interesting cases or third reads.

47.4 STAFF IN TRAINING (NEW AND TRAINEE STAFF)

Competency

It is desirable for Radiology Registrars to rotate through abreast screening unit and Trainees may participate inBreastScreen Aotearoa under supervision from anBreastScreen Aotearoa Radiologist.

Criteria

1. Trainees may be involved in the assessment andmanagement of women in the Programme under directsupervision commensurate with their degree ofexperience and as agreed by the local sitemultidisciplinary team.

2. Informed consent shall be obtained from the woman forany trainee participating in, or observing a woman’sassessment phase (the Registrar should not be presentwhilst this consent is requested).

3. The time that is spent in the screening unit shall bedivided between reading screening mammograms andassessment.

4. Trainees shall be directly supervised for any procedureconducted within the Programme.

5. Trainees may perform dummy third reads. These readsshould not influence outcomes for women.


Interval cancer review process

Retrieval and review of interval cancers will be undertakenby Lead Providers which includes a monthly interchange often sample mammograms. These films may or may notcontain any interval cancer(s) and will be blind double readwith the receiving Provider’s regular screens. This processwill allow classification of interval cancers into ‘miss’ or ‘notmiss’. Further classification (occult cancers) shall occur atthe original screening unit.

Refer: Appendix Q: Interval Cancer Review Process

Performance feedback

The screening unit’s data management system shall allowregular monitoring of an individual radiologist’s performanceand feedback of information. At a minimum this will includethe number of films read, total referral rate and smallinvasive cancer and overall cancer detection rates.

This information shall be provided every three months, willbe cumulative and shall include performance criteria forassessment (for example, no more than 15% of FNAs areinadequate). Individual performance data shall beconfidential to the individual reader and to the ClinicalDirector, but will be available for scrutiny by the visitingBreastScreen Aotearoa radiologist Auditor.

47. RADIOLOGIST

47.1 THE ROLE OF THE RADIOLOGISTRadiologists working within BreastScreen Aotearoaparticipate in the two phases of the screening process:reading the screening mammogram and participating inassessment clinics.

In the first phase the radiologist works alone, performingone of the two initial readings of the mammogram. There isalso a close association with the MRTs who performscreening mammography and their QC tests and with themedical physicist in the operation of the MQA programme.In the second phase the radiologist works as part of amultidisciplinary team which includes MRTs, surgeons,pathologists and breastcare nurses.


Qualifications

Radiologists involved in the BreastScreen Aotearoa will bemedically qualified, registered to practise in New Zealand,and hold vocational registration in diagnostic radiology.They will also have a basic qualification in radiology, such asthe Fellowship of the Royal Australian and New ZealandCollege of Radiologists (RANZCR).

Minimum Qualification Required/Entry LevelRequirements

BreastScreen Aotearoa radiologists must undertake furthertraining prior to commencing screening mammographywithin the Programme. This should include a minimum ofthe following:

1. attendance at one teaching course currently recognisedby the RANZCR within the last two years

2. completion of 300 dummy third reads within the threemonths prior to commencement. A recall rate of notmore than 12% is required

3. participation as an observer at the full clinicalmultidisciplinary team meetings and the process ofresolution, of discordant readings during the period oftraining as a third reader

4. demonstration of reader sensitivity of 80% from acancer seeded set of films such as PERFORMS.

Minimum Qualification Required forUnsupervised Assessments

Prior to commencing unsupervised assessment, radiologistsmust satisfy the Clinical Director that they are competentin the following:

1. supervising and interpreting mammographic work-up

2. performing and interpreting breast ultrasound

3. performing all invasive procedures available in theirassessment clinic

4. attendance and supervised participation within the 12months prior to commencement in ten assessmentsessions within an established national population-basedscreening programme either in New Zealand oroverseas, at a screening facility approved by theRANZCR.


1. All radiologists working in the BSA Programme requireaccreditation to do so.

2. Each radiologist will be assessed on their qualification,training etc and a decision will be made by theAccreditation Committee based on informationsubmitted in the Accreditation Template. Refer:Appendix V: Accreditation Processes.

3. A recommendation will be made by BreastScreenAotearoa, regarding their ability to work in theProgramme. The outcome will be communicated totheir Lead Provider Manager, Clinical Director and theradiologist concerned.


Continuing Professional Development (CPD) includes:

1. attendance at, at least one scientific meeting or refreshercourse specific to mammography every two years

2. attendance at multidisciplinary review and auditmeetings

3. reviewing current journals and material on relevantradiological websites.

46.3 RADIOLOGIST EXPERTISEEvery radiologist involved in the screening programme shallread a minimum of 2000 screening mammograms withinthe Programme every year.

This may be accomplished by:

1. moving films between centres, ensuring that this doesnot delay a woman’s results

2. moving the radiologist between centres.

3. the BreastScreen Aotearoa radiologist must also:

a. obtain feedback (including pathology) on at least80% of individual cases which have resulted in recallto assessment

b. attend at least 15 meetings or 60% (whichever isthe greater) of clinical multidisciplinary reviewmeetings, using video conferencing if necessary

c. participate in the Programme’s interval cancerreview and other audit sessions





Criteria

All surgeons (FRACS and non FRACS) must meet the RACSBreast Section requirements which are:

1. full participation in the Breast Section Audit withinformation on entered cases assessed against the RACSaverage for a number of clinical indicators. The clinicalindicators will be determined and reviewed by theExecutive of the Section after consideration by anaccreditation sub-committee.

2. meeting audit and CPD criteria as for full membershipof the Breast Section of the College. The CPDrequirements include:

a. an ongoing commitment to CPD activities in breastdisease. Each year Breast Screen surgeons will beasked to complete three questions which specificallyrelate to breast disease. These questions will beincluded in the annual RACS CPD form distributedby the College. This form is to be made available tosurgeons who are not Fellows of the RACS for a fee.

The questions will be:

i. attendance at significant breast-related CPDmeetings including, for example, RACS ASCBreast Section lectures, ANZ Breast CancerTrials Group Meetings, Leura, Overseas breastmeetings, etc

ii. attendance at specific breast related clinico-pathology and clinico-radiology meetings(including hospital meetings, BreastScreenAotearoa and private breast clinics)

iii. reading of journal articles related to breastdisease or computer-based and/or distancelearning

iv. attendance at the greater of 60% or 15 of theunit’s clinical multidisciplinary meetings perannum.

48.3 SURGEON EXPERTISEThe RACS Section of Breast Surgery expects full membersof the Section to enter into the Section Audit of all theircases of breast cancer but does not set minimumrequirements for the number of women treated. The auditwill enable each participating surgeon to compare theirperformance, in terms of a series of clinical indicators, withthat of the Section as a whole.

48.4 TRAININGSurgeons involved in the Programme will have extensivetraining in breast surgery as part of their training in GeneralSurgery.

Indicators

Surgeons will ensure that they have acquired the necessaryskills in the management of screen detected lesions byattending approved multidisciplinary training activities, suchas those organised by the RACS and by spending time in abreast screening unit.


Competency

It is recognised that it is important for surgical trainees andqualified surgeons to undergo training in breast screening.Trainees may participate in BreastScreen Aotearoa undersupervision from an established BreastScreen Aotearoasurgeon.

Criteria

1. Surgical trainees may be involved in the assessment andmanagement of women in the Programme under directsupervision commensurate with their degree ofexperience and as agreed by the local sitemultidisciplinary team.

2. Informed consent shall be obtained from the woman forany trainee participating in, or observing her assessmentphase (the trainee should not be present whilst thisconsent is requested).


Performance Evaluation

Internal

1. BreastScreen Aotearoa surgeons will be subject toregular peer review at the multidisciplinary meetings.

2. BreastScreen Aotearoa surgeons will receive regularreports on their compliance with programme qualitytargets and requirements.

External

1. Compliance of BreastScreen Aotearoa surgeons withthe standards will be monitored by the NSU.

2. BreastScreen Aotearoa surgeons must meet theongoing CPD requirements for the RACS BreastSection or its equivalent.

48. SURGEON

48.1 THE ROLE OF THE SURGEONFor breast cancer screening to meet its goal of reducingbreast cancer mortality, the screening process must includetimely and appropriate surgical intervention. The role of thesurgeon commences during the assessment phase andcontinues through treatment and follow-up.15 BreastScreenAotearoa surgeons must be trained and skilled in themanagement of breast diseases. In addition to clinical skillsthey must be able to communicate effectively with womenin the Programme and be able to work as part of aMultidisciplinary Team.

It is expected that surgeons in the Programme will beclosely involved with assessment and surgical aspects of thediagnosis and therapy of cancers detected. In addition, thesurgeon will contribute to setting Standards, audit andadministrative aspects of the Programme as required.

General expectations

Surgeons involved within BreastScreen Aotearoa should:

1. contribute to setting standards that a woman in thescreening programme may reasonably expect includingrapid assessment and surgical opinion, access to timelyand appropriate therapy for cancer

2. set quality standards suitable for use in clinical auditincluding the number of impalpable lesions correctlyidentified and surgically removed at the first localisationbiopsy.


Qualifications

1. Registration to practise in New Zealand with a currentAnnual Practising Certificate (APC).

2. Hold a qualification in General Surgery and beVocationally Registered in General Surgery with theMedical Council of New Zealand.

3. Participate in a re-certification programme in generalsurgery.

Competency

A surgeon in the Programme, in addition to training andexperience in general surgery, should have specialist surgicalexpertise and a major interest in breast cancermanagement.


1. All surgeons working in BSA Programme requireaccreditation to do so.

2. Each surgeon will be assessed on their qualifications,training, etc, and a decision will be made by theAccreditation Committee based on informationsubmitted in the Accreditation Template. Refer:Appendix V: Accreditation Processes

3. BreastScreen Aotearoa, regarding their ability to workin the Programme, will make a recommendation. Theoutcome will be communicated to their Lead ProviderManager, Clinical Director and the surgeon.

Indicators

BreastScreen Aotearoa surgeons should be:

1. vocationally registered in General Surgery

2. credentialled to an accredited hospital.

Criteria

The surgeon should meet these criteria:

1. Re-certification requirements:

a. participation in audit

b. credentialled by an accredited hospital

c. meets CPD requirements.

2. Meets criteria for full membership of Section of BreastSurgery of RACS:

a. enters all cases of breast cancer into RACS BreastSection Audit

b. meets CPD requirements for breast disease (thisincludes attendance at national and internationalmeetings on breast disease).

Continuing professional development and re-certification requirements

BreastScreen Aotearoa surgeons should maintain anongoing level of specialist expertise in diagnosis andmanagement of screen detected breast lesions.



15 NHSBSP QA Guidelines for Surgeons [NZSBSP 1996]. UK.

Performance feedback

BreastScreen Aotearoa surgeons should receive all qualityassurance monitoring reports on the breast screeningprogramme and should participate in regular meetings toreview these reports and Programme performance ingeneral.

Involvement in auditing and training

It is expected that BreastScreen Aotearoa surgeons will:

1. participate in a regular multidisciplinary audit of qualityassurance (QA) outcomes and morbidity data, includingreview of records for those women with intervalcancers

2. participate in the training of staff involved with thescreening programme.

New Technologies and New TreatmentProcedures

Any new technologies or treatment procedures to be usedin consultation for women in BreastScreen Aotearoa shouldmeet at least one of the following criteria:

1. the technology or treatment is being used inaccordance with RACS Breast Section policy

2. is being evaluated under the appropriate assessmentprocess for New Zealand, for example, ASERNIPS

3. has Ethics Committee approval or is part of researchprotocol

4. any new or innovative mode of treatment funded byBreastScreen Aotearoa must be approved by:

a. BreastScreen Aotearoa, or

b. any national body established with ethical approval,or

c. the local ethical committee.

Refer to Standard 18: New Technologies

Research

Participation in appropriate research protocols such asthose co-ordinated by the ANZ Breast Cancer Trials Groupor as organised locally with approval of the local EthicsCommittee and multidisciplinary team is encouraged.




APPEN

DIC

ES


APPENDICES

APPENDICES

49. Appendix A: Glossary ......................................................................................................................................2

50. Appendix B: Bibliography ..............................................................................................................................13

51. Appendix C: Communication Matrix ............................................................................................................15

52. Appendix D: Breast Screening Resources ....................................................................................................16

53. Appendix E: Key Messages for BreastScreen Aotearoa ................................................................................18

54. Appendix F: Guidelines for BreastScreen Aotearoa Booking Staff ................................................................19

55. Appendix G: 2003 Direction of the Minister of Health Relating to Eligibility for Publicly Funded Personal Health and Disability Services in New Zealand ..............................................20

56. Appendix H: Collecting Ethnicity Data ..........................................................................................................23

57. Appendix I: Pro Forma Letters and Forms....................................................................................................23

58. Appendix J: National Screening Protocols ....................................................................................................26

59. Appendix K: Mammographic Quality Assurance (MQA) Programme ..........................................................28

60. Appendix L: Stereotactic Breast Biopsy Quality Assurance (QA) Programme ............................................36

61. Appendix M: Ultrasound System Performance and Quality Control ............................................................40

62. Appendix N: Mammographic Image Quality (MIQ) Classification.................................................................43

63. Appendix O: Film View Box ..........................................................................................................................47

64. Appendix P: Test Equipment..........................................................................................................................48

65. Appendix Q: Interval Cancer Review Process ..............................................................................................49

66. Appendix R: Microscopic Reporting of Ductal Carcinoma in Situ ................................................................53

67. Appendix S: Breast Cancer Synoptic Reports................................................................................................54

68. Appendix T: Women Transferring Between Providers Protocol ..................................................................58

69. Appendix U: Quality Deviation Application Template and Process ..............................................................58

70. Appendix V: Accreditation Protocols ............................................................................................................60

71. Appendix W: FNAC Quality Assurance ........................................................................................................70

72. Appendix X: Schedule of Uni- and Multidisciplinary Group meetings ..........................................................72

73. Appendix Y: Funnel Plots ..............................................................................................................................75

74. Appendix Z: Quality indicators, Evaluation Process and Evaluation Targets ................................................83


APPENDICES

49. APPENDIX A: GLOSSARY

Term/Abbreviation Description

Age standardised rate This is a summary rate of disease, or death, in a population, that takes intoaccount differences in the age-structure of different populations. Agestandardised rates are used, since so many diseases are more common atsome ages than others (usually more common as people get older). It gives abetter indication than crude or age-specific mortality rates of the ‘true’burden of disease in a population, presented as a single figure.

Assessment Assessment is all the follow-up examination and investigations arising from awoman’s attendance for a screening mammogram, up to and includingcytological or histological diagnosis. Assessment is a multidisciplinary process.

Assessment – Level 1 Further mammographic views and/or ultrasound and/or clinical examination.

Assessment – Level 2 Needle Biopsy

Assessment – Level 3 Open Biopsy

Assessment visit An assessment visit is any visit by a woman to an assessment clinic for thepurpose of all follow-up investigative procedures arising from a woman’sattendance for screening, up to and including cytological or histologicaldiagnosis.

Asymptomatic Asymptomatic women are women who do not have a symptom that may bedue to breast cancer.

Atypical hyperplasia An abnormal increase in the number of epithelial cells in the breast. Womenwith this diagnosis are at a slightly increased risk of developing breast cancer.

Background incidence rate This is the expected incidence of a disease in the absence of screening. It isusually calculated from the incidence before screening began, combined withthe change in incidence that was occurring before screening began, adjustedfor other factors such as population changes.

Benign diagnostic open An open biopsy that was recommended for diagnostic purposes, and where biopsy the histopathology was not of invasive cancer or DCIS; examples include

atypical hyperplasia, radial scar or LCIS.

Benign A benign tumour is an abnormal growth that is neither malignant, nor acancer. A benign tumour is not capable of spreading, and usually does notrecur after being removed.

Biopsy Removal of a sample of tissue from the body, for examination under amicroscope, to assist with the diagnosis of a disease.

Breast awareness Breast awareness involves a woman knowing what her breasts are likenormally, including understanding how her breasts change at different times ofthe month and as she grows older. A woman should consult a doctor if anychanges that seem different from usual are noted.


APPENDICES


Breast cancer A pathologically-proven malignant lesion that is classified as ductal carcinomain situ or invasive breast cancer.

Breast cancer classification Breast cancers are classified in terms of tumour type, grade, size, nodalinvolvement, and stage, as specified in the current TNM Classification ofBreast Cancer.

Breast cancer incidence rate The rate at which new cases of breast cancer occur in a population. Thenumerator is the number of newly diagnosed cases of breast cancer thatoccur in a defined time period. The denominator is the population at risk ofbeing diagnosed with breast cancer during this defined period, sometimesexpressed in person-time.

Breast cancer mortality rate The rate at which deaths of breast cancer occur in a population. Thenumerator is the number of breast cancer deaths that occur in a defined timeperiod. The denominator is the population at risk of dying from breast cancerduring this defined period, sometimes expressed in person-time.

Breast compression The application of pressure to the breast during mammography so as toimmobilise the breast and to present a lower and move uniform breastthickness to the X-ray beam thereby maximising image quality and minimisingradiation dose.

Breast conserving surgery A type of surgery that involves removing a breast cancer, together with amargin of normal breast tissue. The whole breast is not removed.

Breast Implant A round or teardrop-shaped sack inserted into the chest in order to restoreor enhance the shape of the breast. A breast implant may be filled with saline,silicone or a synthetic material.

Breast Reconstruction The formation or recreation of breast shape after a total mastectomy.

BreastScreen Aotearoa BreastScreen Aotearoa is New Zealand’s free national breast screeningprogramme. The programme offers free mammograms every two years towomen in the eligible age group who have no symptoms of breast cancer.

Cancer A general term for a large number of diseases which all display uncontrolledgrowth and spread of abnormal cells. Also called a malignant tumour. Cancercells have the ability to continue to grow, invade and destroy surroundingtissue, and leave the original site and travel via the lymph or blood systems toother parts of the body where they may establish further cancerous tumours.

Cancer detection rate The cancer detection rate is the number of people who have cancer detectedwithin a screening programme, usually expressed as a rate per 1000 peoplescreened. It is influenced by the incidence of cancer in the population – allother things being equal, the higher the incidence in the backgroundpopulation, the higher the cancer detection rate will be. A low cancerdetection rate signifies that more people will have to be screened to detectthe same number of cancers.


APPENDICES


Enrolment When a woman gives her name, or allows her name to be given, toBreastScreen Aotearoa to begin the registration process.

Ethnicity The current official (Statistics New Zealand) definition of an ethnic group is asocial group whose members:

– share a common origin

– claim a common and distinctive history and destiny

– possess one or more dimensions of collective and cultural individuality suchas unique language, religion, customs, mythology or folklore

– feel a sense of unique collective solidarity.

In New Zealand, ethnicity is based on self-identification. People can belong tomore than one ethnic group. At different time in their lives, they may wish toidentify with other groups.

Ethnicity is not the same as the country people were born in, live in orancestry.

BSA requires that ethnicity is collected using the 2001 Census question.

Evidence Informed Decisions based on the best available evidence.

Extended assessment The term ‘extended assessment’ has been used in the literature to include arange of practices. These include:

Early Re-screen – occurs when a woman is asked to return earlier than theusual screening interval for further screening mammography.

Early recall – occurs when a woman is asked to return earlier than the usualscreening interval for a range of further investigations at an assessment centre.

Within BSA, only early recall is permitted.

False negative A negative screening test in a person who does have the condition beingscreened for. People with false negative tests are falsely reassured that theydo not have the disease in question, and as a result may delay seeking help ifsymptoms develop later.

False positive A positive screening test in a person who does not have the condition beingscreened for. The higher the proportion of false positives, the more peopleare referred for unnecessary further assessment. A test with a false positiverate of 0% will mean that no one is referred for further assessmentunnecessarily.

False positive rate for The proportion of women who do not have cancer, but are given an screening mammograms abnormal mammogram result (false positives) calculated as the number of (FPR) false positive results divided by the total number of women screened.

First screening episode This is a woman’s first mammogram in the screening programme. It should of the programme occur at least 12 months after a previous mammogram taken outside the

screening programme.

Fine needle aspiration (FNA) The procedure to remove cells or fluid from tissues using a fine needle.


Carcinoma A malignant tumour made up of epithelial cells that may infiltrate surroundingtissues and spread to other parts of the body via the blood or lymph system.

Code of Health and The Code is a regulation under the Health and Disability Commissioner ActDisability Consumers’ Rights 1994.

Continuous Quality Ongoing collection and evaluation of information about important aspects of Improvement Process a process to identify and rectify problems, control unintended variations and

to identify and manage opportunities for improving the process.

Core Needle Biopsy Sampling of breast tissue with a needle to obtain a tiny cylinder of tissue, forexamination by a pathologist.

Coverage rate The percentage or proportion of eligible women screened by the programme,calculated as the number of women screened, divided by the number of thosewho are eligible by age and domicile according to the census. The Maoricoverage rate is calculated as the number of self-identified Maori womenscreened divided by the number of Maori women, as identified by the census.

Cytology An examination by a pathologist of a sample of cells.

DCIS – Ductal carcinoma A form of breast cancer, which spreads along the ducts of the breast, in situ but has not invaded the duct wall.

Delay time The time between when a cancer could be detected by a screeningprogramme, and the time it actually is detected.

Detection rate See ‘Cancer detection rate’.

Diagnosis The process of identifying a disease by its characteristic signs, symptoms andfindings on investigation.

Direct Supervision The person supervising is physically present and actively involved in theprocess, takes ultimate responsibility and signs the report.

Early Recall Early recall occurs when a woman is asked to return earlier than the usualscreening interval for a range of further investigations at an assessment centre.

Early Re-screen Early Re-screen occurs when a woman is asked to return earlier than theusual screening interval for further screening mammography.

Effectiveness The effectiveness of an intervention is used to describe the impact in everydaypractice.

Eligible Age Group Currently 50 – 64 years.

Eligible population The adjusted target population. In practice, this is the target population, minusthose who are excluded according to screening policy on the basis of eligibilitycriteria other than age, sex and geography, i.e. women who have had breastcancer within the last five years are not eligible for screening in BSA.


APPENDICES


FNAC Fine needle aspiration cytology.

FTE Full-time equivalents.

Further assessment These are the extra investigations carried out to clarify the nature of anabnormality detected at screening. In BSA, this includes further mammograms,ultrasound and biopsy.

GP/PCP GP/PCP is a generic term for a woman’s General practitioner (GP) or othernominated Primary Care Provider (PCP). Includes Iwi, Maori and Pacificproviders.

Health Information This code of practice applies rules to agencies in the health sector to better Privacy Code 1994 ensure the protection of individual privacy. The rules in the Code are

enforceable by complaining to the Privacy Commissioner and, if necessary,later to the Complaints Review Tribunal. The Code is available at the PrivacyCommission’s website.

Histology The examination of the structure and composition of tissues by a pathologist.

Identification rate The percentage of eligible women who are identified for the purposes ofbeing invited to the screening programme. This measure is calculated as: thetotal invitation roll at the end of a screening round, divided by the populationof eligible women, as defined by the census. This measure should also becalculated by the source or method of identifying eligible women.

Incidence The number of new cases of a disease in a given population during a givenperiod of time. Incidence is usually expressed per 100,000 people per year.

Initial Screen The screening episode of a woman who has never had a mammogram before,or who has not had a mammogram within the past five years within the BSAProgramme.

Interval cancer This is a cancer that is diagnosed between a negative screen, and the time thenext screen would have occurred. In BSA, this is a cancer diagnosed withintwo years of a negative screen. All interval cancers should be classifiedaccording to the standard classification. Interval cancers should also becategorised as either a ‘true interval’ (one that cannot be detected inretrospect on screening mammograms), or a ‘missed cancer’ (one that waspresent at the previous screening, but was not detected). ‘Occult’ cancers area subgroup of ‘true’ interval cancers, which are not detected bymammography at the time of subsequent diagnosis.

Refer Appendix Q: Interval Cancer Review Process

Interval cancer rate The number of interval cancers diagnosed in a given population during a givenperiod of time. The interval cancer rate is usually expressed per 1000 peopleper year. The interval cancer rate should be calculated by 12-month intervalsfrom the time of the last screen, and by using the entire time interval fromthe previous screening.


APPENDICES


APPENDICES


Invasive Procedure A procedure which involves the introduction of instruments or otherobjectives into the body, or body cavities.

IPA Independent Practitioner Association.

Lead Provider One of six service providers who contracts with the National Screening Unitto provide breast screening services. The Lead Provider has the overallresponsibility for the provision of the programme in a defined geographicalarea, although it will not necessarily provide all components, and may enterinto subcontracts with other providers.

Lesion An area of tissue damaged by disease or injury. Within BSA, lesions arecategorised as follows:

Category 1 – Normal/Benign – return to routine re-screening

Category 2 – Probably benign – may need assessment to confirm

Category 3 – Indeterminate – needs assessment to elucidate

Category 4 – Probably malignant – requires assessment and probably a tissuediagnosis

Category 5 – Malignant – probably requires a tissue diagnosis.

Mammogram A soft tissue X-ray of the breast which may be used to evaluate a lump, orwhich may be used as a screening test in women with no signs or symptomsof breast cancer.

Mammography The process of taking a mammogram.

Maori The indigenous people of New Zealand.

Mastectomy Surgical removal of the breast. A mastectomy may be total (all of the breast)or partial.

MoH Ministry of Health.

Mortality rate The number of deaths from a disease in a given population during a givenperiod of time. The mortality rate is usually expressed per 100,000 peopleper year.

MRT Medical Radiography Technologist, or Radiographer.

Multidisciplinary An approach where a range of health professionals work together as a team,with the woman as the focus.

National Screening Unit A business unit of the Ministry of Health, responsible for BSA. The authoritythat funds the Programme, its agents, nominee, or successor.

Negative mammogram A mammogram that has been classified as normal during a routine screening.

Negative predictive value The negative predictive value is the proportion of those who are healthyamong those with a negative test.


APPENDICES


Participation rate This is the number of people who have a screening test, expressed as aproportion of the eligible population. The participation rate is calculated byscreening round.

PCP Primary Care Provider, (refer also GP/PCP).

Population-based screening A population-based screening programme is one in which screening is programme systematically offered by invitation to a defined, identifiable population: this

requires a means of identifying and inviting the target population, for examplethrough a population register.

Positive predictive value The positive predictive value (PPV) of a screening test is the proportion of (PPV) of screening people having the outcome in question (i.e. a cancer) if the screening test is mammogram abnormal, usually expressed as a percentage. The higher the positive

predictive value, the more likely it is that the person has the outcome inquestion (i.e. a cancer) when their test is positive. A screening test with a highpositive predictive value is beneficial, since it will reduce the proportion ofpeople having unnecessary further investigations.

It is calculated as: the number of women with cancer and an abnormalmammogram result, divided by the total number of women with an abnormalscreening mammogram result, both with and without cancer.

Preoperative diagnosis A malignant result on FNA or core biopsy (including both DCIS and invasive of cancer cancer), which is consistent with suspicious or malignant imaging findings.

Prevalent screen (changed to The screening episode of a woman who has never had a mammogram before, ‘initial screen’ as per TPDIR) or has not had a mammogram within the past five years within the programme.

Programme (the Programme) The National Breast Screening Programme, also known as BreastScreenAotearoa.

Quality Assessment Performance measurement against Standards.

Quality Assurance Detection of problems through external or internal inspection, and theircorrection through systematic activity.

Quality Improvement Prevention of problems and control of unintended variations in processthrough total quality management.

Radiotherapy The use of radiation, usually X-rays or gamma rays, to kill tumour cells.

Referral to assessment This is the referral of a woman, in order to clarify a perceived abnormalitydetected at screening, by performing an additional procedure.

Referral to assessment rate The number of individuals recalled to assessment, expressed as a proportionof all those screened.

RGON Registered General Obstetric Nurse.

RCompN Registered Comprehensive Nurse.


Negative screening result The final diagnosis of ‘no cancer’ after screening and assessment procedures.

NHI National Health Index: A unique identifier allotted to people who havecontact with health services in New Zealand. The NHI is administered by theNew Zealand Health Information Service (NZHIS) on behalf of the Crown.

Non-operative diagnosis rate The percentage of women diagnosed with cancer who have a confirmeddiagnosis prior to an open surgical biopsy. Calculated as: the total number ofwomen with a confirmed diagnosis prior to open surgery biopsy, divided bythe total number of women with cancer diagnosed. This is a measure of thequality of the assessment part of the screening programme.

NP&QS National Policy and Quality Standards (i.e. this document).

Number needed to screen The number needed to screen (NNS) is an easily-understood measure of the(NNS) absolute benefit of being screened, and is literally the number of people who

would need to be screened (for a given period of time) in order to prevent asingle event (i.e. death from breast cancer). The NNS often varies markedlywith risk factors such as age. The smaller the NNS, the fewer people thatneeds to be screened to prevent an event (i.e. death from breast cancer).

Open biopsy rate The percentage of screened women who undergo open biopsy procedures.Calculated as: the number of screened women who undergo open biopsyprocedures, divided by the total number of women screened.

Open surgical biopsy Surgery performed under a local or general anaesthetic in which a sample ofbreast tissue is removed to be examined by a pathologist.

Opportunistic screening Screening outside an organised screening programme. The key feature thatdistinguishes opportunistic screening from screening within a screeningprogramme is the lack of a quality process, including routine monitoring andevaluation. Opportunistic screening usually occurs when a person who ispresenting to the health system for another reason is asked a question oroffered a test in order to detect the presence or confirm the absence of aspecific condition. Opportunistic screening may be organised to a greater orlesser degree. However, because there are no attendant quality processes, itssafety, effectiveness and cost-effectiveness cannot be assessed and/orguaranteed.

Optical density (OD) The optical density is a measure of film density. It is one of the manymeasures of mammographic quality, and is measured with a test object. It iscalculated as; the logarithm of the ration of the intensity of perpendicularlyincident light (I0) on a film to the light intensity (I) transmitted by the film:OD=log10 (I0/l). Optical density differences should be measured in a lineperpendicular to the tube axis to avoid influences by the heel effect.

Pacific women Women of Pacific Islands ethnic origins (for example, Tongan, Niuean, Fijian,Samoan, Cook Islands Maori, and Tokelauan). Includes women of PacificIslands ethnic origin born in New Zealand as well as those born overseas.


APPENDICES


APPENDICES


Site The identified physical location at which BreastScreen Aotearoa services areprovided.

Specificity Number with true negative screening results (Y) as a percentage of Y plus thenumber of false positive screening results. The higher the specificity, thebetter the test is at excluding cancers when they aren’t present. A test with alow specificity will mean that a lot of people are referred for furtherassessment unnecessarily. A test with a specificity of 100% will mean that noone is referred for further assessment unnecessarily.

Standardised Detection Ratio A measure of cancer detection that takes into account what the age-specificincidence of breast cancer would be if no screening took place. BSA detectionrates are compared against the rates for the ‘gold standard’ Swedish TwoCounties (S2C) Trial detection rates. The SDR is BSA’s surrogate mortalityindicator that most closely approximates BSA’s potential mortality reductionrates.

Stereotactic Needle Biopsy A biopsy carried out while the breast is compressed under mammography.This technique is used when a mammographic abnormality is difficult tobiopsy by alternative methods. A series of pictures locate the lesion, and aradiologist enters information into a computer. The computer calculates thethree dimensional co-ordinates of the lesion within the breast and helpsposition a needle-holder over the lesion. A needle is inserted into the lesion,and a piece of tissue or sample of cells is removed and sent to the laboratoryfor analysis.

Subsequent Screen Any screen that is not an initial screen.

Symptomatic Women Women reporting breast symptoms at the screening examination.

Technical recall rate The number of women who have to return to a screening unit (either fixed ormobile) for further films to complete their screening episode, expressed as apercentage of the number screened.

Technical reject rate This is the number of films rejected as a percentage of the number of filmstaken, calculated separately for women who are screened in a fixed unit and amobile unit.

The Code Refer: ‘Code of Health and Disability Consumers’ Rights’.

True negative The screening test correctly identifies a person without the disease.

True positive The screening test correctly identifies a person with the disease.

Tumour An abnormal growth of tissue. A breast tumour may be: localised withoutpotential (benign), malignant and growing inside the milk ducts (DCIS),malignant and invading nearby tissues (invasive), or malignant and invadingdistant tissues (metastatic).


Routine re-screening Routine re-screening is for women with a ‘normal’ screening mammogram, orwho have been assessed as having ‘no evidence of cancer’ after assessment,who are re-invited for a repeat screening mammogram every two years untilno longer eligible.

Screen-detected cancer A screen-detected cancer is any invasive breast cancer or DCIS diagnosedduring a screening episode.

Screening Screening is the examination of asymptomatic people in order to classify themas likely or unlikely to have the disease that is the object of screening. Theaim of screening is to detect disease before it is clinically apparent, and forthis to improve the outcome for people with the disease.

Screening episode A woman’s attendances for screening and assessment relating to a particularround of screening. A screening episode is complete when a definitivediagnosis is made, or the woman is returned to routine screening. Thisincludes extended assessments.

Screening interval This is the fixed interval between routine screens, specific to the screeningprogramme, and dependent on the screening policy. In BSA, the screeninginterval is two years.

Screening pathway This is the screening process from a participant’s perspective. It includes:

• an invitation to be screened

• being given information about the purpose of the screening, the likelihoodand possibility of false positive/negative results, the uncertainties and risksattached to the screening process, any significant medical, social or financialimplications of screening for the particular condition or predisposition,follow up plans, including the availability of counseling and support services

• being questioned or offered a test

• having the test

• receiving of test results

• assessment and diagnosis if the test is positive

• possible treatment

• understanding that there are activities to monitor and evaluate all thesestages.

Screening policy The specific policy of a screening programme, which dictates the targeted ageand gender group, the geographic area to target, the screening interval, andother key features.

Sensitivity Number with cancer detected during a screening episode (X) as a percentage ofX plus the number with cancer detected within one year from a clear screen.The higher the sensitivity, the better the test is at detecting cancer. A test with alow sensitivity will miss a lot of cancers. A test with a sensitivity of 100% willdetect all cancers present. It should be calculated for the screening mammogramalone, and for the screening programme (i.e. both screening and assessment).


APPENDICES


APPENDICES

50. APPENDIX B: BIBLIOGRAPHY

ACR. 1998a. Ultrasound Accreditation Programme. Reston,Virginia: American College of Radiology. http://www.acr.org.

ACR. 1998b. Ultrasound-guide Breast Biopsy AccreditationProgramme. Reston, Virginia: American College of Radiology.http://www.acr.org.

ACR. 1999a. Mammography Quality Control Manual. Reston,Virginia: American College of Radiology. ISBN 1-55903-142-5.

ACR. 1999b. Stereotactic Breast Biopsy Quality ControlManual. Reston, Virginia: American College of Radiology.ISBN 1-55903-143-3.

Australian Cancer Network. October 2001. The PathologyReporting of Breast Cancer A Guide for Pathologists, Surgeons,Radiologists and Oncologists. 2nd ed. North Sydney:IntraMed Educational Group.

Ballard-Barbash et al. 1999. Breast Cancer SurveillanceConsortium: A national mammography screening andoutcomes data-base. Am J Roentgenol 169, 1001-1008.

Barrows GH, Anderson TJ, Lamb JL, Dixon JM. 1986. Fineneedle aspiration of breast cancer – relationship of clinicalfactors to cytology results in 689 primary malignancies.Cancer 58: 1493-98.

Blanks and Moss. 1996. Monitoring the performance ofbreast screening programmes. 2 papers. Journal of MedicalScreening 3(2): 79-84.

Bondesan L and Lindholm K. 1990. Aspiration cytology oftubular breast carcinoma. Acta Cytologica 34: 15-20.

BCSPAG. 1995. A summary of interim recommendations tothe Director-General of Health from the Breast CancerScreening Policy Advisory Group. Recommendation 6.

BCSPAG. 1998. Population-based breast cancer screening:policy advice for a New Zealand screening programme. BreastCancer Screening Policy Advisory Group. Comment in:New Zealand Medical Journal 111: 1074-370

Breast Imaging – A Guide for Practice 2002 National BreastCancer Centre Australia.

BreastScreen Australia 2001. National AccreditationStandards.

Britton PD, McCann J. 1999. Needle biopsy in the NHSBreast Screening Programme 1996/1997: How much andhow accurate? The Breast 8: 5-11.

Cox B. 1995. Projections of the cancer burden in NewZealand. Wellington: Public Health Commission.

Crotch-Harvey M A, Loughran C V. 1996. Combinedstereotactic wide core needle biopsy and fine needleaspiration cytology in the assessment of impalpablemammographic abnormalities detected in a breastscreening programme. The Breast 5: 48-49.

Durie M. 1998. Whaiora: Maori health development.Auckland: Oxford University Press.

Elston CW, Ellis IO. 1991. Pathological Prognostic Factors inBreast Cancer. Histopathology 19(5).

European Guidelines for Quality Assurance in MammographyScreening 3rd Ed.

Goodsitt M M, Witt S, Hykes D L and Kofler J M Jr. 1998.Real-time B-mode ultrasound quality control testprocedures: Report of AAPM Ultrasound Task Group No.1. Med. Phys. 25: 1385-1406.

Health and Disability Services Act 1993, section 25.

Health and Disability Commissioner (Code of Health andDisability Services Consumers’ Rights) Regulations 1996.

Health (Retention of Health Information) Regulations 1996,sections 5 & 6 (1).

HFA/MOH Public Health Services Handbook 2001.Wellington:Ministry of Health.

HPFNZ. 2000. Nga Kaiakatanga Hauora mo Aotearoa HealthPromotion Competencies for Aotearoa-New Zealand. HealthPromotion Forum of New Zealand – Runanga Whakapikiake i te Hauora o Aotearoa.

IARC. 2002. IARC handbooks of cancer prevention: volume 7 –breast cancer screening. Lyon: International Agency forResearch on Cancer, WHO.

IARC. 2002. Breast cancer screening. Lyon: InternationalAgency for Research on Cancer, WHO.

Injury Prevention, Rehabilitation and Compensation Act 2001.

Institute of Physical Sciences in Medicine. 1994.Commissioning and Routine Testing of Mammographic X-raySystems. IPSM Report 59 (2nd Edition).

IPSM Report 59 (2nd Edition) (IPSM 1994).

Kerliowske K, Smith-Bindman R and Sickles EA. 2003.Short-interval follow-up mammography: Are we doing theright thing? Journal of the National Cancer Institute 95(6): 418-19.

Kimme-Sith C, Solberg T. 1994. Acceptance testing pronestereotactic breast biopsy units. Med Phys 21(7): 1197-201.

Law J, Dance D R, Faulkner K, Fitzgerald M C, Ramsdale ML, Robinson A. 1994. The Commissioning and Routine Testingof Mammographic X-Ray Systems. 2nd ed. Report 59. York,UK: Institute of Physics and Engineering in Medicine.

Love RR. 1995. Approaches to the prevention of breastcancer. Journal of Clinical Endocrinological Metabolism80: 1757-60.

Ministry of Health. June 2001. Guide to eligibility for publicly-funded personal health and disability services in New Zealand.Wellington: Ministry of Health.


Ultrasound The use of high frequency sound waves to study an organ or tissue.Ultrasound helps to determine if a breast abnormality is likely to be benign ormalignant, and is particularly useful for distinguishing fluid-filled structuresfrom solid lesions.

Under-screened women Groups of women for whom there is evidence that they are less likely to bescreened regularly.

Unscreened women Women who have either never been screened or have not been screened forfive years.


APPENDICES


APPENDICES

51. APPENDIX C: COMMUNICATION MATRIX

TABLE C:1 COMMUNICATION MATRIX

Scenario Contact Within Method

Appointment Woman 5 working days prior to By telephone or letterconfirmation appointment

Did not attend screening Woman and/or 10 working days of appointment By telephone andappointment GP/PCP follow-up letter

Negative Screening Woman 10 working days of screen date By letterresults

Negative Screening GP/PCP 10 working days of screen date By letter by mail or results fax or electronic

delivery

Screen-detected Woman As soon as possible following the By telephone andabnormalities recall final reading of the mammogram follow-up letterfor assessment and offered appointment within

15 working days of final screening mammogram

Screen-detected GP/PCP As soon as possible following the Letter by fax orabnormalities recall final reading of the mammogram electronic deliveryfor assessment

Assessment appointment Woman 1-2 working days before By telephoneconfirmation assessment

Did not attend Woman and 1 day (next working day) By telephone andassessment appointment GP/PCP follow-up letter

Diagnosis of cancer Woman Informed at results clinic Face to faceconsultation

Diagnosis of cancer GP/PCP Immediately after speaking with Telephone and letterthe woman

Ministry of Health, 2003, New Zealand Health and DisabilitySystem Quality Improvement Strategy. Wellington: Ministry ofHealth.

Ministry of Health. 2002. Reducing Inequalities in Health.Wellington: Ministry of Health.

Ministry of Health. 2002. Outcomes of the treatment providerdata indicators review (TPDIR). Wellington: Ministry ofHealth.

Ministry of Health. Sept 2001. Reportable Events Guidelines.Wellington: Ministry of Health.

Ministry of Health. 2000. Direction of The Minister ofHealth Relating To Eligibility For Publicly Funded PersonalHealth And Disability Services In New Zealand.

Meyer JE. 1992. Value of large core biopsy of occult breastlesions. American Journal of Roentgenology 158: 991-992.

National Health Committee. 2003. Screening to improvehealth in New Zealand: Criteria to assess screeningprogrammes. Wellington: National Health Committee.

National Health Committee. 1999. Guidelines for SugicalManagement of Breast Cancer. Wellington: National HealthCommittee.

New Zealand Health Information Service. NZHIS. Guide toData Requirements. Wellington: Ministry of Health.

New Zealand Health Information Service.1999. Mortalityand Demographic Data 1996. Wellington: Ministry of Health.

New Zealand Health Information Service. 2000. Cancer:new registrations and deaths 1996. Wellington: Ministry ofHealth.

NHC. 1997. Guidelines for the Surgical Management ofBreast Cancer. Wellington: National Health Committee.

NHSBSP. 1993. Guidelines for Cytology Procedures andReporting in Breast Cancer Screening – Cytology Subgroup ofthe National Co-ordinating Group for Breast ScreeningPathology NHSBSP Publication 22.

NHSBSP. June 2001. Guidelines for non-operative diagnosticprocedures and reporting in breast cancer screening,Chapter 6. Quality Assurance. Sheffield: NHS CancerScreening Programmes. 50: 46-53.

NHSBSP. March 2000. Publication Number 30.

NHSBSP. 1995a. Quality assurance guidelines for medicalphysics sciences. UK: National Health Science BreastScreening Programme. 33.

NHSBSP. 1996. QA Guidelines for surgeons [NZSBSP 1996].UK.

NRL. 1994. Code of Safe Practice for the Use of X-rays inMedical Diagnosis. Report NRL-C5. Christchurch: NationalRadiation Laboratory.

NRL. 1995. Guidelines for Quality Assurance in RadiationProtection for Diagnostic X-Ray Facilities: Large X-RayFacilities. NRL Report. 1995/1. Christchurch: NationalRadiation Laboratory.

Parkin, DM, Whelan SL, Ferlay J, Raymond L and Young J(eds). 1997. Cancer Incidence in Five Continents. Vol. VII(IARC Scientific publications No. 143). Lyon: IARC.

Paul, S. Background Incidence of Breast Cancer in NZ: Areport for NSU. Nov 2033. Wellington: Ministry of Health.

Perry N, et al (eds). 2001. European guidelines for qualityassurance in mammography screening. 3rd ed. Luxembourg:European Communities.

RACR. 1994a. Mammography Quality Control Radiologist’sManual. Sydney: Royal Australasian College of Radiologists.

RACR .1994b. Mammography Quality Control MedicalRadiation Technologist’s Manual. Sydney: Royal AustralasianCollege of Radiologists.

RACR. 1994c. Mammography Quality Control MedicalPhysicist’s Manual. Sydney: Royal Australasian College ofRadiologists.

RANZCR. 2002. Mammography Quality Control Manual.Sydney: Royal Australian and New Zealand College ofRadiologists.

Sadler GP, McGee S, Dallimore NS, et al. 1994. Role of fineneedle aspiration cytology and needle core biopsy in thediagnosis of lobular carcinoma of the breast. British Journalof Surgery 81: 1315-1317.

Skegg DC, Paul C, Benson-Cooper D, Chetwynd J, ClarkeA, Fitzgerald N, Gray A, St George I, Simpson A. 1988.Mammographic screening for breast cancer: prospects forNew Zealand. New Zealand Medical Journal 101: 531-3.

Standards New Zealand. 2000. NZS 8142: 2000: InfectionControl. Wellington: Standards New Zealand.

Wells C A. 1995. Quality assurance in breast cancerscreening cytology: A review of the literature and a reporton the UK National Cytology Scheme. European Journal ofCancer 31A: 273-280.

Wells C A, Perera R, White F E, Domizio P. 1999. Fineneedle aspiration cytology in the UK Breast ScreeningProgramme – a national audit of results. The Breast8: 261-266.

WHO, 1986, Ottawa charter for health promotion: FirstInternational Conference on Health Promotion. 21 November.

Yaffe et al. 1995. Recommended Specifications for NewMammography Equipment: Report of the ACR-DCD FocusGroup on mammography Equipment. Radiology 197: 19-26.

Yeoman L J, Michel M J, Humphreys S, et al. 1996.Radiographically guided fine needle aspiration cytology andcore biopsy in the assessment of impalpable breast lesions.The Breast 5: 41-47.


APPENDICES


APPENDICES

Code No Title Resource

10129 BreastScreen Aotearoa – Niuean Pamphlet

10130 BreastScreen Aotearoa – Fijian Pamphlet

10131 BreastScreen Aotearoa – Samoan A2 poster

10132 BreastScreen Aotearoa – Tongan A2 poster

10133 BreastScreen Aotearoa – Cook Islands Maori A2 poster

10134 BreastScreen Aotearoa – Tokelauan A2 poster

10135 BreastScreen Aotearoa – Niuean A2 poster

10136 BreastScreen Aotearoa – Fijian A2 poster

10147 BreastScreen Aotearoa Frequently asked questions A5 card similar to 10122

1201 BreastScreen Aotearoa – Asian A3 poster

1210 Is BreastScreen Aotearoa for you? PamphletInformation for women who have breast problems

To order a Ministry of Health publication, you can

Telephone (04) 496 2277

or write to:

Ministry of Health Publications

c/- Wickliffe Press

PO Box 932, Dunedin

email: [email protected]

The brochure Treatment and Support Services for Women with Breast Cancer can be obtained directly from theNational Screening Unit.

For information on developing additional resources for BreastScreen Aotearoa, Providers must follow theMinistry of Health National Guidelines for Health Education Resource Development in New Zealand,Wellington, June 2002. The document sets out the main steps to be taken, which incorporate planning,financial, cultural and practical issues that need to be considered during the development and production of theresource. It is available on the Ministry of Health website (www.moh.govt.nz).

52. APPENDIX D: BREAST SCREENING RESOURCES

Code No Title Resource

10102 BreastScreen Aotearoa General pamphlet in English

10107 More about Breast Screening Detailed booklet

10111 CHI BreastScreen Aotearoa Chinese pamphlet

10112 HIN BreastScreen Aotearoa Hindi pamphlet

10113 JAP BreastScreen Aotearoa Japanese pamphlet

10114 KOR BreastScreen Aotearoa Korean pamphlet

10115 THAI BreastScreen Aotearoa Thai pamphlet

10116 VIE BreastScreen Aotearoa Vietnamese pamphlet

10117 Now that you’ve had your mammogram Pamphlet

10118 When you are called for an assessment Pamphlet

10119 Information for Women under 50 Pamphlet

10120 Information for Women over 65 Pamphlet

10121 It’s time to take care of ourselves A2 poster

10121A It’s time to take care of ourselves A3 poster

10122 Information for General Practice and A5 question and answer card Primary Health Care Providers

10123 BreastScreen Aotearoa – Maori Pamphlet

10124 BreastScreen Aotearoa - Maori A2 Poster

10125 BreastScreen Aotearoa – Samoan Pamphlet

10126 BreastScreen Aotearoa – Tongan Pamphlet

10127 BreastScreen Aotearoa – Cook Islands Maori Pamphlet

10128 BreastScreen Aotearoa – Tokelauan Pamphlet


APPENDICES


APPENDICES

53. APPENDIX E: KEY MESSAGES FORBREASTSCREEN AOTEAROA

• Nearly 10% of women in New Zealand develop breastcancer.

• The risk of developing breast cancer increases with age.

• Free mammograms (breast x-rays) are available forwomen aged 50 – 64 years through the National BreastScreening Programme.

• Screening mammograms detect breast cancer beforeyou can feel or notice anything unusual.

• Early detection and treatment can save lives.

• Mammograms need to be repeated every two years.

• Most women who have mammograms will be reassuredthey do not have breast cancer.

• Most women who develop breast cancer have norelatives with the disease.

• Women of any age who feel or notice anything unusualabout their breast should seek advice from their doctor.


APPENDICES

54. APPENDIX F: GUIDELINES FOR BREASTSCREEN AOTEAROA BOOKING STAFF

Women with the following are excluded from the BreastScreen Aotearoa Programme.

EXCLUDED EXCEPTIONS(cannot be booked for screening) (can be booked for screening)

Mammogram within last 12 month (may book Nonefor screening when 12 months has elapsed)

Breast cancer within the last 5 years None(may book for screening 5 years after diagnosis)

SYMPTOMS* All MUST bring any old mammograms to screening

New breast lump or thickening you can feel now Present unchanged for 12 months or more.

Or

Previously investigated by mammogram/ultrasound orbiopsy and found to be benign.

Puckering or dimpling of the skin Present unchanged for 12 months or more.

Or

Previously investigated and found to be benign.

Turned in nipple Present unchanged for 12 months or more.

Or

Previously investigated and found to be benign.

Nipple discharge Present unchanged for 12 months or more

Or

Bilateral (both sides) and NOT blood stained orpersists without squeezing.

* If women indicate they have the following symptoms, they must be informed that they need to see their GPto investigate the symptoms fully, before they can be booked at a later date for screening.


APPENDICES

person or agency other than the Crown, whether or notthe purchasing of those services results in a part charge tothe person receiving the services;

“public health acute services” has the same meaning asin section 6 of the IPRAC Act;

“services” means personal health services, mental healthor disability support services;

“Work Permit Holder” means a person who:

a. holds a work permit issued under section 26 of theImmigration Act 1987:

i. entitling that person to remain in New Zealand for aperiod that equals or exceeds two years; or

ii. entitling that person to remain in New Zealand for aspecified period of time which, together with theperiod of time that person has already been lawfullyin New Zealand immediately prior to obtaining thepermit, equals or exceeds two years; and

b. includes a dependent child aged 19 years or under, ofany such person.

3. SCOPE OF THIS DIRECTION 1. This direction covers all publicly-funded services funded

by DHBs, whether in or outside a health care facility,and without limitation includes primary health services;

2. Except as provided in clause 3(3) below, this directiondoes not operate retrospectively2;

3. An individual on a student or visitor permit who as at29 October 2003 would have been eligible underclauses 2 (e) and (f) of the 2000 Direction had it notbeen revoked, will retain eligibility under the 2000Direction if he or she is:

a. a visitor permit holder and is granted consecutivepermits to remain in or re-enter New Zealand;

b. a student permit holder and is granted consecutivepermits to remain in or re-enter New Zealand,even where the individual leaves New Zealand forshort periods (of up to four months).

4. ELIGIBILITY CRITERIAA person is eligible for publicly funded services if he or sheis in New Zealand at the time of seeking services and fallsinto any one or more of the following categories:

1. A New Zealand citizen3;

2. Ordinarily resident in New Zealand;

3. A person who has refugee status in New Zealand or isin the process of having an application for refugee statusdetermined by NZIS,or a person who is in the processof having an appeal against refusal of refugee statusdetermined by the Refugee Status Appeal Authority;

4. A student receiving funding under the New ZealandAgency for International Development OfficialDevelopment Assistance Programme, or is the partner,or dependent child under the age of 18 years, of such astudent;

5. A participant in the Ministry of Education’s ForeignLanguage Teaching Assistantship Scheme;

6. The holder of a Commonwealth Scholarship;

7. In respect only of eligibility for services required to beprovided under the agreement referred to in theSchedule to the Health Benefits (Reciprocity withAustralia) Act 1986 or any of its successors, a resident ofAustralia who is in New Zealand on a temporary basis;

8. In respect only of eligibility for services required to beprovided under the agreement set out in the Scheduleto the Health Benefits (Reciprocity with the UnitedKingdom) Act 1982 or any of its successors, a personrecognised by the Government of the United Kingdomas a national, who has his or her usual place of abode inthe United Kingdom, and is in New Zealand on atemporary basis; or

9. A child under the age of 18 years who is for the timebeing in the care and control of:

a. his or her parent or guardian, and his or her parentor guardian meets either of the eligibility criteriaspecified in clauses 4 (1) or (2) or is a personreferred to in clause 3 (3); or

b. a person who is in the process of legally adoptingthat child and that person meets either of theeligibility criteria specified in clauses 4 (1) or (2) or isa person referred to in clause 3 (3);

55. APPENDIX G: 2003 DIRECTION OFTHE MINISTER OF HEALTH RELATINGTO ELIGIBILITY FOR PUBLICLY FUNDEDPERSONAL HEALTH AND DISABILITYSERVICES IN NEW ZEALAND

Pursuant to section 32 of the New Zealand Public Healthand Disability Act 2000, the Minister of Health, afterconsulting with boards as required by that section, herebygives the following direction to District Health Boards(DHBs) established under section 32 of that Act.

1. TITLE AND COMMENCEMENT 1. This direction may be cited as the Health and Disability

Services Eligibility Direction 2003.

2. This direction comes into force on 30 October 2003.

2. INTERPRETATIONIn this direction, unless the context otherwise requires:

“Commonwealth Scholarship” means a postgraduateuniversity scholarship awarded to a member of theCommonwealth under the Commonwealth Scholarship andFellowship Plan;

“Crown Funding Agreement” means an agreementwithin the meaning of section 10 of the NZPHD Actentered into by a DHB, and for the purposes of clause 4(12) may include a service agreement entered into undersection 301 of the IPRAC Act;

“DHB” means a District Health Board established undersection 19 of the NZPHD Act, and for the purposes of thisdirection includes the Ministry of Health where the Ministryis acting as purchasing agent for a DHB pursuant to anagency agreement;

“disability support services” has the same meaning as insection 6 of the NZPHD Act;

“eligibility” means the right to be considered for receiptof publicly-funded services, but does not equate to anentitlement to receive those services, and eligibility isassessed at the time services are sought (it may not operateretrospectively);

“eligibility criteria” means the criteria set out in clause 4of this direction, any of which, as a minimum, must besatisfied before any person may receive any publicly-fundedservice;

“guardian” has the same meaning as in section 3 of theGuardianship Act 1968 or any successors to that Act;

“health care facility” means a hospital, or other facilityfor the provision of services operated by a DHB (whetheror not located in a hospital);

“IPRAC Act” means the Injury Prevention, Rehabilitationand Compensation Act 2001, and includes any successor tothat Act and any Regulations made under that Act;

“Minister” means the Minister of Health;

“New Zealand” includes all waters within the outer limitsof the territorial sea of New Zealand as defined in section 3of the Territorial Sea and Exclusive Economic Zone Act1977, but does not include the Cook Islands, Niue, Tokelauor the Ross Dependency;

“New Zealand citizen” means a person who has NewZealand citizenship under the Citizenship Act 1977 or theCitizenship (Western Samoa) Act 1982;

“NZIS” means the New Zealand Immigration Service;“NZPHD Act” means the New Zealand Public Health andDisability Act 2000;

“Ordinarily resident in New Zealand” refers to aperson who is lawfully present in New Zealand at the timeof seeking services and who–

a. holds a residence permit issued under the ImmigrationAct 1987, and

i. holds a current returning resident’s visa issuedunder the Immigration Act 1987; or

ii. immediately prior to seeking services, has remainedin New Zealand for a period that equals or exceedstwo years; or

b. is a person exempted, by virtue of being a citizen of theCommonwealth of Australia or by virtue of holding acurrent resident return visa issued by the Governmentof Australia, from holding a residence permit issuedunder the Immigration Act 1987, and can demonstratean intention, on reasonable grounds, to remain in NewZealand for a period that, together with the time thatperson has already been in New Zealand immediatelyprior to seeking the services, equals or exceeds twoyears; or

c. is a Work Permit Holder;

“partner” means–

a. where the parties are legally married, either thehusband or the wife, as the case requires; or

b. a “de facto partner” within the meaning of that term insection 2C of the Property (Relationships) Act 1976;

“prison” includes a Gazetted police jail, or correctivetraining institution;

“publicly-funded services” means personal health,mental health and disability support services funded by aDHB using funds provided by the Crown under a CrownFunding Agreement or section 88 notice and, except inrelation to public health acute services, does not includeservices funded by a DHB using funds provided by any


APPENDICES

1 The Eligibility Direction sets out who is entitled to publicly funded health services in New Zealand. If you do not meet one of thecriteria set out in this direction, you are not entitled to free or subsidised services and are liable to be charged for any health servicesaccessed.

2 Eligibility is assessed at the time of seeking services and cannot be backdated, therefore eligibility changes made by this reviseddirection apply only to persons seeking services after this direction comes into force.

3 This category includes New Zealand citizens living in the Cook Islands, Niue or Tokelau who visit New Zealand on a temporary basis.


APPENDICES

56. APPENDIX H: COLLECTINGETHNICITY DATA6

In New Zealand, ethnicity is based on self-identification. Youcan belong to more than ethnic group. At different times ofyour life you may wish to identify with other groups.

Ethnicity is not the same as the country you were born in,the country you live in, or your ancestry.

Many organisations are now using the 2001 Censusquestion to collect ethnicity information.

This is the question being asked about ethnicity in the 2001Census.

Which ethnic group do you belong to?

Mark the space or spaces which apply to you.

• NZ European

• Maori

• Samoan

• Cook Island Maori

• Tongan

• Niuean

• Chinese

• Indian

• Other (such as Dutch, Japanese, Tokelauan). Please state:

WHY DO PEOPLE NEED TO ASK THISQUESTION?This information helps in developing appropriate servicesand policies for everyone and ensuring that people’s needsare met.

The best way to collect ethnicity data is to ask you to fill inthe ethnicity question.

Deciding from appearance or guessing is not reliable, so the best way is to ask. It is your decision which ethnic group(s)you belong to.

Information that you provide to organisations such as thoselisted above is protected by privacy rules. If you wish, youcan ask to see your information and make any changes.

57. APPENDIX I: PRO FORMA LETTERS AND FORMS

I:1 Consent for Mammography

I:2 Women with Implants

I:3 Assessment

I:4 Notification of Collection of Treatment Data

I:5 Information Notification

I:6 Women with Technical Inadequate Result

I:7 Results of screening

Deviation from these standard texts should be checkedwith the BSA Clinical Director.

I:1 CONSENT FOR MAMMOGRAPHY

Scenario

Written consent is required prior to the screeningmammogram. This is to ensure each woman has been givenadequate information and has had opportunity to askquestions and feel they are fully informed about theprocedure, the risks and benefits of a screeningmammogram and possible outcomes of participation in theProgramme.

Written consent must be asked for as part of theregistration process but should be on a separate form sothat the consent process, the registration and notificationabout the use of information are not confused.

Standard Text

BreastScreen Aotearoa needs to ensure that you agree to thefollowing before you have a breast screening mammogram aspart of the free national programme. If you have any concernsregarding this please telephone us so we may discuss thesewith you or if you prefer telephone your General Practitioner(GP) or Primary Care Provider to discuss further.

I (consent/wish/agree*) to have a screening mammogram. I have been provided with information about the screeningprogramme. I understand that mammograms do not find allbreast cancers nor do they prevent breast cancer.

10. In respect only of eligibility for compulsory servicesunder the Tuberculosis Act 1948, the Health Act 1956,the Alcoholism and Drug Addiction Act 1966, theMental Health (Compulsory Assessment and Treatment)Act 1992, or any Regulations made under any of thoseenactments (together the “enactments”), a personreceiving or eligible to receive services under theenactments;

11. In respect only of eligibility for services not availablethrough the prison health services, a prison inmate(including an individual on remand in prison custody);

12. A person who:

a. in respect only of eligibility for public health acuteservices required by that person for a personalinjury for which that person has cover andentitlement4 to treatment under the IPRAC Act, isseeking services covered by a Crown FundingAgreement; or

b. in respect of eligibility for disability support services,requires those services for a personal injury forwhich the person has cover and entitlement underthe IPRAC Act, but has been disentitled to any ofthose services under any of sections 118-122 of theIPRAC Act; or

c. has cover and entitlement under the IPRAC Act, andseeks primary-referred pharmaceutical andlaboratory services5.

5. DISPUTES AND PAYMENTSIf any question or dispute arises as to whether or not aperson satisfies any of the eligibility criteria, that questionor dispute shall be determined by the Ministry of Health.

6. AMENDMENT, REVOCATION AND TERM OFDIRECTION 1. The Minister may from time to time, by notice under

section 32 of the NZPHD Act, amend or revoke thisdirection.

2. The Health and Disability Services Eligibility Direction2000 is revoked by this direction.

3. This direction (together with any amendments to itmade under clause (1) of this section) will remain inforce until it is revoked by the Minister. Dated atWellington this 19th day of September 2003.

Annette King

Minister of Health


APPENDICES

4 “Entitlement” in clause 4 (12) (a) means a person who has statutory entitlements in terms of section 69 of the IPRAC Act, and whohas not been disentitled under sections 118-122 of the IPRAC Act.

5 The services covered by subclause 4 (12) (c) are outlined in the 2000/2001 Crown-ACC funding agreement for primary-referredpharmaceutical and laboratory services between ACC and the Minister of Health. go6367.

6 This brochure was developed in 2001 by HURA [Health Utilisation Research Alliance], with funding from the HFA [Health FundingAuthority]. HURA is a joint project between Te Ropu Rangahau Hauora a Eru Pomare, Departments of General Practice and PublicHealth at the Wellington School of Medicine and Health Sciences, and the Wellington Independent Practitioners Association (WIPA).


APPENDICES

I:5 INFORMATION NOTIFICATION

Scenario

This notification should be printed on any form that is usedto collect information from women, such as the registrationform. The font should be distinct from the main text but nosmaller than 9 point. Women should be able to keep a copyof this notification to refer to later.

Standard Text

The text below contains the required components whichmust be included in any form used for the specifiedfunction:

The information you have given on this form and yourscreening results will be used by the Provider of the breastscreening programme, BreastScreen Aotearoa, to provide youwith any necessary follow-up assessment including inviting youfor your next mammogram.

This information and the X-ray film will be held securely by theProvider of the screening programme, BreastScreen Aotearoa,on their premises and only authorised personnel will haveaccess to your information.

In order to assess the effectiveness of the breast screeningprogramme and monitor the quality of the National breastscreening programme, BreastScreen Aotearoa. Someinformation collected about you is also forwarded to theMinistry Of Health or its agents, e.g. another entity designatedby the National Screening Unit of BreastScreen Aotearoa, theNew Zealand Health Information Service and the CancerRegistry, by National Health Index Number (NHI).

Information about any further assessment or treatment forbreast cancer that is necessary for you, will also be collectedfrom both public and private providers by BreastScreenAotearoa.

It is only by monitoring the care and outcome of all womenwho have mammograms, that the ongoing quality of theProgramme can be properly assessed.

You have the right to see and if necessary correct theinformation held about you.

Please tick the box if you agree to the GeneralPractitioner or Primary Care Provider you have named onthe questionnaire being informed of your screeningresults. (This is strongly recommended but not arequirement to participate in BreastScreen Aotearoa).

I:6 TECHNICALLY INADEQUATE RESULT

Scenario

Women whose mammography was technically inadequatebut cannot be improved upon (for example, physicalimmobility problems etc.) should be sent a normal resultletter including the following standard text or similarapproved wording.

Standard Text

Due to problems with positioning this examination does notshow all the breast tissue. However, there was no evidence ofbreast cancer in the areas imaged. Despite these limitations,continued screening is recommended. Accordingly we will recallyou for a further screen in two years time.

I:7 RESULTS OF SCREENING

Scenario

This notification should be printed on all normal resultletters sent to woman and GPs/PCPs.

NOTE: Any signatory to a clinical report is deemed to havereviewed the clinical information (for example, films) andagreed with the content of the report. Clearly this is notthe case for every set of mammography films for which ageneric normal result letter is sent out.

Generic letters do not require the signature of the ClinicalDirector in addition to their name. Lead Providers who arealready appending a signature to these letters may continueto do so.

Standard Text

Following your visit to the breast screening centre on (date) weare pleased to inform you that your mammogram has beenreviewed and reported by two qualified radiologists and thatthey found no evidence of breast cancer.

I authorise BreastScreen Aotearoa to obtain relevant filmsand/or clinical information regarding any mammograms orbreast procedures I have had or will have elsewhere. This willenable a more accurate assessment of my mammograms andcontribute to monitoring the quality of the Programme.

Signed: Date:

* Providers may use any such wording.

I:2 WOMEN WITH IMPLANTS

Scenario

This form may be used to record the informed consent toscreening of a woman who has a breast implant(s) in place.Women should be given appropriate information so theyunderstand the additional risks associated with screeningmammography where implants are in place.

These include a greater risk of cancer not being detectedbecause of reduced coverage of breast tissue, and aminimal risk of rupture of the implant at mammography.Women should also be informed that they will need moreviews and what will happen if damage to the implant isdiscovered. As the implant ages there is an increasedlikelihood of unsuspected rupture and mammography mayindicate this.

Standard Text

BreastScreen Aotearoa needs to ensure that you agree to thefollowing before you have a breast screening mammogram aspart of the free national programme. If you have any concernsregarding this please telephone us so we may discuss thesewith you or if you prefer telephone your General Practitioner(GP) or Primary Care Provider to discuss further.

I have a breast implant(s) in place and I understand that whilethe Medical Radiation Technologists (MRTs) have been trainedin the appropriate examination methods to obtain the bestpossible views of the breast, implants can interfere with thedetection of early cancer and may ‘hide’ suspicious lesions.

I also understand that since the breast is compressed duringmammography it is possible, although very unusual, for animplant to rupture.

Signature: Date:

I:3 ASSESSMENT

Scenario

This form may be used to record a woman’s informedconsent to an assessment procedure which does notinvolve an anaesthetic.

Standard Text

BreastScreen Aotearoa needs to ensure that you agree to thefollowing before you have a breast screening assessment aspart of the free national programme.

I understand that my mammogram findings require furtherinvestigation.

I have had adequate opportunity to ask questions about theprocedure(s) and I have been given the information I require.

I agree to the following assessment procedure(s):

Signed: Dated:

I:4 NOTIFICATION OF COLLECTION OFTREATMENT DATA

Standard Text

In order to assess its effectiveness and monitor the quality ofBreastScreen Aotearoa programme, BreastScreen Aotearoawish to notify you that relevant clinical information regardingtreatment procedures that you may receive will be collectedfrom treatment providers. Some of this information will beforwarded to the Ministry of Health or its agent, e.g. anotherentity designated by the National Screening Unit orBreastScreen Aotearoa, the New Zealand Health InformationService and the Cancer Registry, by National Health IndexNumber (NHI).

You have the right to see and correct any information heldabout you. To do so, please advise BreastScreen Aotearoa.

Date of Notification:

Signature of person providing notification:

Name/position of person providing notification:


APPENDICES


APPENDICES

Mammographic Views

Standard Four Views:

This is medio-lateral oblique and cranio-caudal of bothbreasts with the implants in place. These views enable theposterior part of the breast to be evaluated.

Modified Positioning Technique:

The implant is displaced posteriorly against the chest walland the breast tissue is pulled over and in front of theimplant. This allows compression of the breast tissue withimproved visualisation.

90º Medio-lateral View:

The true lateral view of the breast should be included aswell as the medio-lateral oblique view, especially if theimplant is rigidly encapsulated.

Spot compression views:

Compression spot views may also be necessary to image allof the breast tissue satisfactorily.

Photocell:

The photocell may need to be repositioned or a manualexposure used to obtain correct exposure. For any oneexamination five views of each breast may be necessary,thus increasing the radiation dose.

After screening, if the examination has failed to showsufficient breast tissue to be of diagnostic value, the womanshall be informed of this and advised to exit the programmeand discuss her options with her GP/PCP. The outcomemust be documented and appropriate outcome dataprovided to BreastScreen Aotearoa.

J:3 MASTECTOMY PROTOCOLWomen who have had a mastectomy with or withoutreconstruction are eligible for routine two-viewmammography of the unaffected breast, within theprogramme, after five years following the diagnosis ofbreast cancer.

The National Screening Unit, in conjunction with theClinical Director’s UDG and Medical RadiationTechnologist’s UDG will develop a National MastectomyProtocol for the Programme.

J:4 BREAST CONSERVATIONWomen who have undergone breast conservation therapyare eligible for bilateral screening mammography within theprogramme, five years following a diagnosis of breastcancer. In the absence of a new mammographicabnormality these women will not be recalled toassessment for clinical examination.

J:5 HIGH RISK WOMENWhere Atypical Ductal Hyperplasia has been detectedwithin the programme the woman and her GP/PCP (withthe appropriate consent) will be informed of her increasedrisk of developing breast cancer.

58. APPENDIX J: NATIONALSCREENING PROTOCOLS

J:1 Large Breast Protocol

J:2 Protocol for Imaging Women with Breast

Implant(s)

J:3 Mastectomy

J:4 Breast Conservation

J:5 High Risk Women

J:1 LARGE BREAST PROTOCOL

Objective

To produce high quality mammograms in women with largebreasts, in such a manner that the radiation dose and timetaken for the examination is kept to a minimum.

Rationale

There are specific technical issues that must be addressedwhen imaging women with large breasts. These include:difficulty in obtaining optimum position due to body size;long exposure time; scattered radiation within the breast:potential for injuring fragile skin areas; and physical fatigueof both the MRT and woman.

Criteria

Each screening unit shall have a specific protocol forimaging women with large breasts. This may include:

1. two standard views of each breast using large (24 cm x30 cm) film format

2. a combination of large or small film format with minimaloverlap, if sufficient coverage is not obtained using apage film format (24 cm x 30 cm).

The MRT should use their professional expertise in decidingwhich of these techniques is appropriate for an individualwoman, taking into account the woman’s previous imagingand other factors, such as body shape, which maynecessitate additional films regardless of breast size.

Each fixed and mobile screening unit shall be appropriatelyequipped to enable them to perform screeningmammography according to the protocols above. Thisincludes film/cassette combinations, film reading viewers(or viewing boxes on mobiles) and film storage facilities.

J:2 PROTOCOL FOR IMAGING WOMEN WITHBREAST IMPLANT(S)

Objective

To produce high quality mammograms and maximisecoverage of breast tissue in women with breast implants.

Rationale

Mammographic screening is more difficult in women withbreast implants and requires additional mammographicviews. Despite extra views an unknown portion of breasttissue will not be imaged.

Screening Versus Diagnosis

Mammography is the screening procedure of choice andthe normal screening interval applies as with the currenteligible age group.

When making an imaging appointment for a woman withimplants, the screening unit should be made aware of theimplants so that they may allow additional time formammography.

Clinical and ultrasound examinations of the breast arediagnostic procedures and should be reserved forsymptomatic women or for assessment of a mammographicabnormalities.

Although, Ultrasound is sometimes used to assess theintegrity of an implant prior to mammography, it has a lownegative predictive value when used for this purpose.

Timetabling

Processes should be in place to identify women with breastimplants at the initial contact to enable appropriatescheduling. These women should be examined at a fixedsite where processing and viewing are available.Mammography in these women requires additional timeand mammographic expertise.

Consent

Specific informed consent shall be obtained (ReferAppendix I:2) usually by the MRT performing theexamination. Women should be given appropriateinformation so they understand the additional risksassociated with screening mammography where implantsare in place. These include a greater risk of cancer notbeing detected because of reduced coverage of breasttissue, and a minimal risk of rupture of the implant atmammography. Women should also be informed that theywill need more views and what will happen if damage tothe implant is discovered. As the implant ages there is anincreased likelihood of unsuspected rupture andmammography may indicate this.


APPENDICES


APPENDICES

59. APPENDIX K: MAMMOGRAPHICQUALITY ASSURANCE (MQA)PROGRAMME

K:1 MQA Programme

K:2 MQA Committee

K:3 MRT QC Checks and Tests

K:4 MRT AEC Compensation Test Protocol

K:5 Medical Physicist’s Checks and Tests

K:6 Acceptance Testing of Mammographic X-ray

Units

While each screening and/or assessment site will have itsown MQA programme with the required personnel, theoversight of the MQA programme for all sites covered bythe Lead Provider contract is the ultimate responsibility ofthe Lead radiologist.

K:1 MQA PROGRAMMEThe professions involved have agreed to adopt theprotocols and standards of the RANZCR MammographyAccreditation Programme as the basis of the MQAprogramme used in the BreastScreen AotearoaProgramme. The quality control (QC) tests will be as perthe RANZCR manuals (RANZCR (2002)7 or subsequentversions) with modifications to meet regulatoryrequirements or New Zealand conditions, implyingadditional tests without loss of acceptability to the RACRaccreditation scheme. (While BreastScreen Aotearoa haveagreed on the Standard, it is by no means the intention thatall screening units must be accredited to the RANZCRscheme). Where the requirements of the regulations andthe RANZCR are different, this will be explained.

K:2 MQA COMMITTEEThere shall be a site MQA committee, where thedesignated MQA radiologist, MQC MRT and MedicalPhysicist co-ordinate the QC tests and their frequencies,review the results and the MQA programme generally. Thiscommittee will convene initially a minimum of every threemonths, or more frequently until consistency has beenachieved, thereafter twice a year.

There shall also be a lead MQA committee where the Leadradiologist, Lead MRT and Medical Physicist for the LeadProvider ensure that all MQA requirements are metthrough the Lead Provider region six monthly. The localand regional MQA Committee meetings may be combined.

K:3 MRT QC CHECKS AND TESTSThe MRT performing the role of QC MRT must hold eithergrandparenting status (Refer: Standard 44.2: ProfessionalStandards) with NZIMRT or have completed amammography course endorsed by NZIMRT.

It is desirable that the Charge MRT be the QC MRT, as themaintenance of the comprehensive MQA programme willbe one of their major management tasks. The QC MRTneed not be the individual who performs every test butthey shall ensure that tests are performed, and collate theresults and analyse them in consultation with the ChargeMRT and the Medical Physicist. The Charge MRT shall alsomonitor equipment maintenance, which shall be recordedin the QC log and advise, in consultation with the MedicalPhysicist, when these interventions require the review ofQC tests, intervention levels, repeat tests and relatedpractices.

It is particularly important that the MRTs and MedicalPhysicists act co-operatively in their QC tests to ensureappropriate coverage of all aspects of the task. TheRANZCR scheme gives an appropriate allocation of duties,the MRT contribution to which is summarised below, withthe additions necessary for regulatory compliance. This isrecognised as a minimum requirement and inevitably localadditions, either to tests or to frequencies, will be requiredto deal with particular circumstances. These shall be agreedwith the Medical Physicist8. The QC MRT shall supervisethe performance of the tests in accordance with theRANZCR Manual.

There must be an appropriate allocation of staff time toperform these tests.9

A record shall be kept of the test measurements as well asany faults, breakdowns or maintenance of equipment. Thisshould include, for example, any fault messages from on-board computers, even if they resolve themselves.


APPENDICES

Individual screening units must recognise that theseare minimum standards and that often increasedfrequency (specifically items such as screen cleaning)or additional tests may be necessary to ensure quality.This will vary from site to site and time to time:

1. All tests must be fully documented using theRANZCR 2002 protocol, but a daily check of theAEC is required by the regulatory authority anddocumented using Template under K:4.

2. All tests must be fully documented using theappropriate protocol.

3. Test results must be made available for inter-comparison and the collation of national statistics.

If any QC test fails, the problem must beidentified and corrective action taken. Insome cases, when the test result falls outsideaction limits, this corrective action must bedone before any further examinations aremade. Other test failures must be correctedwithin 30 days of the test date.

7 RANZCR. 2002. Mammography Quality Control Manual. Sydney: Royal Australian and New Zealand College of radiologists.8 NRL 1994. Code of Safe Practice for the Use of X-rays in Medical Diagnosis.Report NRL-C5. Christchurch: National Radiation Laboratory.9 RANZCR 2002 or subsequent versions

TABLE K:1 MRT QC CHECKS AND TESTS

RANZCR10 Corrective Action11

DAILY:

Darkroom cleanliness RANZCR protocol

Processor quality control RANZCR protocol Immediately

Mobile Unit QC RANZCR protocol Immediately

Automatic exposure control RANZCR protocol Immediately(AEC)

Processor cleaning Follow manufacturer’s protocols (crossover rollers) and recommendations

WEEKLY:

Clean screens (dry and wet) RANZCR protocol (may require Immediately (whenever an artefact far more frequent attention) is identified by an MRT or

radiologist)

View boxes and viewing RANZCR protocol As per RANZCR 2002conditions

Phantom images RANZCR protocol Immediately

Processor: clean racks and rollers Follow manufacturer’s recommendations and protocols

10 RANZCR (2002) or subsequent versions11 The failure of any critical test would require immediate suspension from use, for non-critical tests, at the radiologist’s

discretion, from 30 days of test date.


APPENDICES


APPENDICES

RANZCR10 Corrective Action11

MONTHLY:

Visual checklist RANZCR protocol Immediately

QUARTERLY:

Repeat analysis RANZCR protocol Within 30 days of test date.

Analysis of fixer retention RANZCR protocol Within 30 days of test date.in film

AEC Compensation RANZCR protocol *as per attached protocol(test to 6cm)

SIX-MONTHLY:

Darkroom fog RANZCR protocol Immediately

Screen film contact RANZCR protocol Immediately

Compression RANZCR protocol Immediately

Mobile Mammography

The Lead Provider shall verify that each mobilemammography unit meets the mammography QCstandards as stated above. In addition, on arrival ateach location the facility shall verify satisfactoryperformance by performing a phantom test andnoting parameters recorded on the machine. Ifparameters are within acceptable limits, screening cancommence. Once the phantom has been processed, ifit is found to be outside acceptable limits thenscreening should cease immediately.

It is expected that once a unit is established at a siteApproach B12 would be sufficient to ensure quality.

K:4 MRT AEC COMPENSATION TESTPROTOCOL The MRT AEC Compensation test protocol. Testingshould be done at perspex thicknesses of 2cm, 4cmand 6cm, using only one size film (18x24) and a largefocal spot.

AEC Tests are to be undertaken every three monthsand a record is to be kept of the KV, mAs, anode andfilter (even if tested in an automatic manner).

K4. Procedure: Automatic Exposure Control (AEC) Compensation Assessment

BreastScreen Aotearoa: This is a version of the AEC test which will give uniformity within BSA.Technique factors should be agreed with your Medical Physicist.

OBJECTIVE

To assess the ability of the automatic exposure control system to correct for changes in kVp and breastthickness.

FREQUENCY

This test must be carried out quarterly.

REQUIRED TEST

Mammographic X-ray unit

EQUIPMENT

Perspex slabs of 2, 4 and 6 cm thicknesses

Densitometer

Test cassette

Test record sheet

TEST PROCEDURE STEPS

1. Position a 2 cm perspex slab on the breast table, centred laterally, and place loaded cassette in theBucky.

2. Ensure that the automatic exposure control detector is in the chest wall position and bring thecompression paddle into gentle contact with the phantom.

3. Select a phototimed imaging mode that allows manual selection of kVp. Use the kVp that would be usedclinically for a breast with radiographic properties equivalent to the perspex thickness being used.

4. Repeat steps 1 – 4 for 4 cm and 6 cm of perspex.

5. If alternative target/filter combinations are available (eg. Mo/Rh, Rh/ Rh, W/Rh), obtain images for 6 cmof perspex using the combination used clinically at the appropriate kVp. Reach an agreement ontechnique with your medical physicist.

6. Calculate the mean optical density for the above group of films and the maximum variation in opticaldensity from this mean.

PRECAUTIONS AND CAVEATS

The cassette used should be designated for this test and be in routine clinical use. Normal clinical filmshould be used. See Appendix 1, Section 3.4.14

RECOMMENDED PERFORMANCE CRITERIA AND CORRECTIVE ACTION

The optical density of any film must be within +/- 0.15 of the mean optical density. The mean opticaldensity must be within 0.20 of the baseline and greater than 1.40.

12 RANZCR. 2002. Mammography Quality Control Manual. Sydney: Royal Australian and New Zealand College ofradiologists.


APPENDICES

AEC CALIBRATION TESTBreastScreen Aotearoa

AEC Calibration test

Room: Film: Cassette # Month: Yr

Small Cassette ID: Large Cassette ID:

Thickness Tracking

Image receptor (Small / large) Grid (yes / no) Focal Spot (small / large)

AEC sensor position: Density Control mA

Phantom thickness Image # AEC Mode kVp Anode & Filter mAs OD

2cm

4cm

6cm

6cm (optional)

6cm (optional)

8cm (optional)

Overall AEC Performance Contact Mode

Site baseline OD (1.6 to 2.0) Mean OD (2-6 cm) OD Range Allowed OD Range

Action Limit: If the OD range exceeds ±0.15 of mean OD, when thickness is varied from 2 to 6 cm andthe kVp is varied over those values clinically relevant, then contact your medical physicist for completeassessment.

Artefact present?


APPENDICES

K:5 MEDICAL PHYSICIST’S CHECKS ANDTESTSAll tests must be recorded on the approved formsand in the manner described in the RANZCR Manual.

Prompt reporting is important. A preliminary report,(Refer: RANZCR 200213 for the format), should begiven to the facility on the day that testing iscompleted. If any equipment fails a criticalexamination (MGD or Image Quality), then everyeffort must be made to advise the Licensee, thedesignated MQA radiologist, and the Charge MRTimmediately. A written preliminary report shall beretained by the facility documenting the failure. A final

report for all tests shall be sent to the designatedCharge MRT and National Physics Co-ordinatorwithin 20 working days.

The base frequency of testing recommended byRANZCR14 is annual, although many authoritiessuggest some checks be done more frequently. Theminimum testing frequency for the CriticalExaminations and the AEC tests, is six monthly. Thequalified Medical Physicist may decide to increase thefrequency of certain tests, perhaps only for a limitedperiod of time, based upon the machineperformance. These tests must be performed within30 days of their due date.

13 RANZCR. 2002. Mammography Quality Control Manual. Sydney: Royal Australian and New Zealand College of Radiologists.14 RANZCR. 2002. Mammography Quality Control Manual. Sydney: Royal Australian and New Zealand College of Radiologists.

TABLE K:2 MEDICAL PHYSICIST’S CHECKS AND TESTS

Test Frequency Corrective Action

1. Mammographic unit assembly evaluationSix-monthly Within 30 days of test date

2. Collimation assessmentWithin 30 days of test date

3. Evaluation of focal spot performanceWithin 30 days of test

4. kVp accuracy and reproducibilitySix-monthly abbreviated test Within 30 days of test dateAnnually, full test

5. Beam quality assessment (half-value layer)Within 30 days of test date

6. Automatic exposure control (AEC) system performance assessmentSix-monthly (Density control function annually) Within 30 days of test dateNote: Care must be taken to test this control over the range of breast thicknesses encountered amongstthe screened population. In particular it may be necessary to go down to 1 cm and up to 8 cm (forexample, the Waikato pilot programme has found 10% of their women to have >8 cm compressed breastthickness).

7. Uniformity of screen speedWithin 30 days of test date


APPENDICES

K:6 ACCEPTANCE TESTING OFMAMMOGRAPHIC X-RAY UNITSThese tests, performed by the Medical Physicist, providebaseline values for the Physicist’s tests, ensure compliancewith NRL-C515 and ensure that equipment performancemeets the contract specifications. The tests must beperformed prior to the use of the equipment for breastcancer screening.16 To facilitate this, ample notice of theinstallation data must be supplied to the Medical Physicist.A comprehensive description of acceptance tests is given inthe UK NHSBSP document.17

Acceptance testing should be done against the followingStandards. The first two apply to all equipment used in theProgramme, the third and fourth to new equipment, andthe remainder are valuable guidance, but allowance mustbe made for the New Zealand regulations and the purchaseconditions.

1. Tests as per Approach B of the document, i.e. modifiedRANZCR (2002)18.

2. For stereotactic breast biopsy units, the ACRMammography Quality Manual19 for stereotactic unitsshould be followed.

3. Code of Safe Practice for the use of x-rays in MedicalDiagnosis, NRL-C520.

4. The purchase contract.

5. The manufacturer’s specifications.

Resource Materials

1. A list documenting the specific tests that are required tobe met for Medical Physicists acceptance testing.

2. Commissioning and Routine Testing of MammographicX-ray Systems.21 This provides very detailed tests.Some allowance must be made for New Zealandregulations. Compliance with some of the tests herewould need to be specified at purchase

3. Acceptance testing prone stereotactic breast biopsyunits.22

4. Recommended Specifications for New MammographyEquipment: Report of the ACR-DCD Focus Group onmammography Equipment.23

Electrical Safety

Under the Electricity Regulations 1993, responsibility forelectrical safety lies principally with the owners andoperators of medical equipment. Electrical safety will bechecked initially by the suppliers at installation, but furtherchecks will normally be made by engineers employed bythe Lead Providers or the subcontracted parties. Theresponsibility for electrical safety checks (both at installationand afterwards) should be clearly laid down, e.g. in thepurchase or maintenance contract. QA Medical Physicistsnormally have no training or experience in this field.

It should be noted that stereotactic localisation equipment,where the normal electrical resistance of the skin is brokenby the penetration of the needle, will require ‘bodyprotected’ status.


8. Breast entrance exposure, average glandular dose, and AEC reproducibilitySix-monthly Immediately if >3mGy; *

Within 30 days if >2mGy

9. Image quality evaluationSix-monthly Immediately

10. Artefact evaluation**Within 30 days of test date

11. Assessment of site’s QC programmeSix-monthly Within 30 days of test date

12. Measurement of view box luminance and illuminanceWithin 30 days of test date

13. Output linearityWithin 30 days of test date


APPENDICES

* It is unusual for the MGD to the MAP to exceed 2 mGy. If this occurs then technique and equipment parameters shallbe reviewed to bring it below 2 mGy. If the MGD exceeds 3 mGy then the system shall be suspended from use untilMGD is brought under control.

** This test may have to be modified by the Medical Physicist to accommodate daylight loading film processors.

15 NRL 1994. 16 NRL 1994.17 IPSM Report 59 (2nd Edition) (IPSM 1994). 18 RANZCR. 2002. Mammography Quality Control Manual. Sydney: Royal Australian and New Zealand College of Radiologists.19 ACR 1999. Mammography Quality Control Manual. Reston, Virginia: American College of Radiology. ISBN 1- 55903-142-5.20 NRL 1994.21 IPSM Report 59 (2nd Edition) (IPSM 1994).22 Kimme-Sith C Solberg T. 1994. Acceptance testing prone stereotactic breast biopsy units. Med Phys 21(7):1197-201.23 Yaffe et al. 1995. Recommended Specifications for New Mammography Equipment: Report of the ACR-DCD Focus Group on

mammography Equipment. Radiology 197:19-26.


APPENDICES

60. APPENDIX L: STEREOTACTICBREAST BIOPSY QUALITY ASSURANCE(QA) PROGRAMME

L:1 QA Responsibilities and Relationships

L:2 MRT QC Checks and Tests for Stereotactic

Equipment

L:3 Medical Physicist’s Checks and Tests

L:1 QA RESPONSIBILITIES ANDRELATIONSHIPSResponsibilities for the Stereotactic Breast Biopsy QAProgramme are the same as for the MQA Programme,Appendix K.

Stereotactic Breast Biopsy QA Programme

This should be as per the ACR Stereotactic Breast BiopsyAccreditation Programme,24 modified as detailed:

1. when a completely dedicated Stereotactic Breast Biopsysystem is used, or where the unit does not otherwisehave documented testing to satisfy the requirements ofAppendix K then it must be tested, in full, to the ACRStandard25

2. when the Stereotactic Breast Biopsy system is anaccessory, attached to a mammography system whichhas been satisfactorily tested, as per Appendix K thenthe modified tests tabulated below may be used toavoid duplication.

Individual screening units must recognise that these areminimum standards and that often increased frequency oradditional tests may be necessary to ensure quality. Thiswill vary from site to site and time to time.

NRL-C5 requires that the MQA programme is approved bythe Medical Physicist:26

1. all tests must be fully documented

2. or a number of tests a standardised report must beused.

Test results must be made available for inter-comparisonand the collation of national statistics.

If any QC test fails, the problem must beidentified and corrective action taken. In somecases, when the test result falls outside action limits,this must be done before any further examinationsare made, or any films processed, using thecomponent of the mammography system that failedthe test. Other test failures must be correctedwithin 30 days of the test date.

L:2 MRT QC CHECKS AND TESTS FORSTEREOTACTIC EQUIPMENTThe QC MRT shall supervise the performance of the testsin accordance with the RANZCR or ACR Manual. Theremust be an appropriate allocation of staff time to performthese tests.27 All MRTs need to be able to perform thesetests and notify the QC MRT of any issues. These tests shallbe agreed with the Medical Physicist.28

There shall be a record kept of the test measurements aswell as any faults, breakdowns or maintenance ofequipment. This should include, for example, any faultmessages from on-board computers, even if they resolvethemselves.


APPENDICES

24 ACR. 1999 b.25 ACR. 1999 b.26 NRL. 1994.27 RANZCR 2002, ACR. 1999b.28 NRL. 1994.

* Each day that the stereotactic breast biopsy system is used on patients.** Each week that the stereotactic breast biopsy system is used on patients.*** If hardcopy is produced from digital data.**** The failure of any critical test would require immediate suspension from use; for non-critical tests, at the radiologist’s

discretion, 30 days of test date.

TABLE L:1 MRT QC CHECKS AND TESTS FOR STEREOTACTIC EQUIPMENT

Comments Corrective Action

DAILY*:

Localisation Accuracy (in air) ACR, or manufacturer’s protocol Immediately except where the (The needle length shall be radiologist performing the biopsyidentical to that most commonly is satisfied that they can correct for used clinically) a consistent registration error

Zero Alignment If required by manufacturer As specified by manufacturerBefore each patient

WEEKLY**

Phantom images ACR protocol. Immediately except where theNot required for screen: radiologist performing the biopsy isfilm systems tested as part of satisfied that there is sufficient image Appendix K detail to permit successful localisation

MONTHLY

Hardcopy Output Quality*** ACR, or manufacturer’s protocol Within 30 days of test date.

Visual checklist ACR protocol Immediately ****

SIX-MONTHLY

Repeat analysis ACR protocol Within 30 days of test date

Compression ACR protocol. Immediately Force limits are >150N and <200N


APPENDICES

TABLE L:2 ADDITIONAL TEST FOR SCREEN: FILM SYSTEMS

Comments Corrective Action

DAILY*

Processor quality control ACR protocol. No additional Immediately testing required if processor assessed as per Appendix K

Processor cleaning Follow manufacturer’s protocols and(crossover rollers) recommendations; not required if

covered by Appendix K

WEEKLY**

Clean screens (dry and wet) ACR protocol; not required if Immediatelycovered by Appendix K (whenever an artefact is identified

by a MRT or radiologist)

View boxes and viewing ACR protocol; not required if As per ACR 1999aconditions covered by Appendix K

QUARTERLY

Analysis of fixer retention ACR protocol; not required if Within 30 days of test datein film covered by Appendix K

SIX-MONTHLY

Darkroom fog ACR protocol; not required if Immediatelycovered by Appendix K

Screen film contact ACR protocol; not required if Immediatelycovered by Appendix K


APPENDICES

L:3 MEDICAL PHYSICIST’S CHECKS ANDTESTSAll tests must be recorded on the approved forms ora spreadsheet equivalent, in the manner described inthe ACR Manual29, with copies sent to thedesignated MQA radiologist, Charge MRT andNational Mammography Physics Co-ordinator.

Prompt reporting is important. If any equipment fails acritical examination (MGD, Image Quality or accuratelocalisation) then every effort must be made to advise

the Licensee, the Designated MQA radiologist and theCharge MRT immediately. A written preliminaryreport shall be left with the facility documenting thefailure. A final report for all tests shall be sent to thefacility within 15 working days.

Except where specified in Table L:2, tests must beperformed at least annually. The qualified MedicalPhysicist may decide to increase the frequency ofcertain tests, perhaps only for a limited period oftime, based upon the machine performance.

29 ACR 1999 b* Each day that the stereotactic breast biopsy system is used on patients.** Each week that the stereotactic breast biopsy system is used on patients.

TABLE L:3 ACR STEREOTACTIC CHECKS AND TESTS


1. Mammographic Unit assembly evaluationSix-monthly Within 30 days of test date

2. Collimation assessmentWithin 30 days of test date

3. Evaluation of focal spot performance*Within 30 days of test date

4. kVp accuracy and reproducibilitySix-monthly abbreviated Within 30 days of test dateFull test annually

5. Beam quality assessment (half-value layer)**Within 30 days of test date

6. Automatic exposure control (AEC) system performance assessmentSix-monthly Within 30 days of test dateDensity control function annuallyNote: ACR 1999b explicitly requires AEC testing to a thickness of 8 cm

7A. Uniformity of screen speedWithin 30 days

7B. Digital Receptor UniformityWithin 30 days of test date

8. Breast entrance exposure, average glandular dose, and AEC reproducibilitySix-monthly Immediately if >3mGy;

Within 30 days of test date if >2 mGy***

9. Image quality evaluationSix-monthly Immediately

10. Artefact evaluationWithin 30 days of test date

11. Localisation Accuracy (Gelatine Phantom Test****)Six-monthly

* At commissioning this shall be evaluated for the sterotactic geometry, after that monitoring as per Appendix K willsuffice.

** This test is systematically different from that in Appendix K. This test shall be performed at commissioning (to establishthe difference). Thereafter monitoring as per Appendix K will suffice

*** It is unusual for the MGD to the MAP to exceed 2 mGy. If this occurs then technique and equipment parameters shallbe reviewed to bring it below 2 mGy. If the MGD exceeds 3 mGy then the system shall be suspended from use untilMGD is brought under control.

**** This requires phantom availability.


APPENDICES

TABLE M:2 ULTRASOUND SYSTEM QUALITY CONTROL AND PERFORMANCEREQUIREMENTS

Procedure* Minimum Procedure Control Limits/Frequency Elements Requirements

Physical and Six-monthly Inspection of transducers, power Satisfactory operation and mechanical inspection cords, controls and system cleanliness. condition.

Display monitor Six-monthly Verification that contrast and bright- Number of grey scale test set-up and fidelity ness settings are in baseline positions. pattern steps visible

Evaluation of number of grey scale should not decrease by test pattern steps visible. more than 2.Evaluation of clarity of displayed text.

Image Uniformity Six-monthly Evaluation of a uniform region of No significanttissue-mimicking phantom and non-uniformities.identification of deviation from smooth tissue texture.

Depth of penetration/ Six-monthly Evaluation of maximum depth of <6 mm change in depth visualisation either ultrasound speckle or object of penetration/

perception. visualisation.

Hard copy fidelity Six-monthly Comparison of on-screen image and No significant change hard copy image. from baseline images.Verification that the weakest echoes visible on the display are visible in the hard copy image.Comparison with baseline image.

Distance Accuracy Six-monthly Measurement of known distances in Vertical measurement vertical and horizontal directions. error less than 1.5 mm

or 1.5%.Horizontal measurementerror less than 2 mm or 2%.

Anechoic object Six-monthly Evaluation of image quality. No major distortion or imaging Comparison with baseline images. change from baseline

performance.

Axial resolution Six-monthly Evaluation of full-width half-maximum Resolution ≤ 1 mm. (FWHM) from profile. OR No significant change Evaluation of filament targets in an from baseline values.axial resolution grouping.


APPENDICES

61. APPENDIX M: ULTRASOUNDSYSTEM PERFORMANCE AND QUALITYCONTROL

Quality assurance is of the greatest importance in breastscreening and this applies no less to the ultrasoundequipment used in assessment than it does to themammographic X-ray units. The requirements for qualityassurance specified below are based on the American

Association of Physicists in Medicine (AAPM)recommendations30 and the American College of RadiologyUltrasound31 and Ultrasound Guided Breast BiopsyAccreditation Programmes.32

M:1 Ultrasound User Tests

M:2 Ultrasound Acceptance Testing/Baseline

Readings

M:3 Ultrasound Performance Assessment Tests

APPENDICES

M:2 ULTRASOUND ACCEPTANCETESTING/BASELINE READINGSThese tests shall be performed by a Medical Physicist withtraining and experience in diagnostic ultrasound. The initialvisit to an ultrasound scanner is to:

1. compile the machine performance profile (baselinemeasurements) for both the user and the MedicalPhysicist’s tests

2. determine compliance with the manufacturer’s declaredperformance and the radiologists’ National QualityStandards document.

All the tests described below should be performed andrecorded in a standardised manner. Locally it may beconsidered appropriate, perhaps because of the availabilityof test objects, to extend the range of tests (e.g. to includepower output).

M:3 ULTRASOUND USER TESTSThese tests shall be performed by a Medical Physicist withtraining and experience in diagnostic ultrasound, theNational Screening Unit will make tissue equivalentphantoms available for these tests. The Medical PhysicistsUnidisciplinary Group will produce and maintain a set ofprotocols.

For all procedures it is essential that system settings arewell described and reproducible. Settings that should berecorded are:

1. transducer model/serial number

2. dynamic range

3. grey level map (where available)

4. power level

5. gain

6. Time Gain Control (TGC) settings

7. mode (where relevant)

8. set focal length (may be multiple focal zones)

9. depth of tissue (range).

30 Goodsitt MM et al. 1998.31 ACR 1998 a32 ACR 1998 b.

M:1 ULTRASOUND USER TESTSThe test to be performed are as detailed below.

TABLE M:1 ULTRASOUND USER TESTS

Procedure

Visual Inspection: Monthly Check all cables for signs of damage and/or wear and tear.Check each transducer and its cable for similar signs or cracks,chips and so on.

Hard copy device: Monthly (Can be reduced Use the ACR Stereotactic Hardcopy protocol (ACR 1999 b), to 6 monthly by the or similar manufacturer’s protocol, preferably employing a Medical Physicist) SMPTE (or similar) pattern.

* Procedure should be repeated for each transducer (excluding Display Monitor Set-up and Hardcopy fidelity).


APPENDICES

Procedure* Minimum Procedure Control Limits/Frequency Elements Requirements

Lateral resolution or Six-monthly Measurement of filament image FWHM < 0.8 mmresponse width width. OR

Evaluation of FWHM from image Image width or spacingprofile OR between targets Evaluation of filament targets in a < 1.5 mmlateral resolution grouping. No major change from

baseline values.

Ring down or Six-monthly Imaging of filament targets near Dead zone < 4 mm dead zone scanning window. OR (for > 7 MHz

Evaluation of image texture features. transducer).

Review of User QC Six-monthly


APPENDICES

62. APPENDIX N:MAMMOGRAPHIC IMAGE QUALITY(MIQ) CLASSIFICATION

USING THE MIQ CLASSIFICATIONAll mammographic images are to be assessed foracceptability prior to hanging for reading. The toolfor this assessment is the MIQ criteria as statedbelow in Table N:2. This assessment may be madeby the MRT performing the mammogram or anotherMRT with the appropriate level of competency.

NOTE: MRTs working on mobile units withoutprocessing will be dependent on another MRTperforming this assessment. Any relevant feedback

should be given promptly to the MRT concerned.

The MIQ criteria33, apply to all images, irrespectiveof the subject, from easy to extremely difficultanatomical types.

Regular monthly peer review should also occur usingthe MIQ criteria. The appropriate sample sizeprovides a balance of these representations. Arandom sample is used to represent the total unitoutput so the size of that sample must bedetermined by complex statistical arguments toensure a valid result. The sample sizes required togive an acceptable accuracy level (± 5%) have beenpublished34 and are given below.

33 NHSBSP. March 2000 Publication No 30. 34 NHSBSP. March 2000 Publication No 30.

TABLE N:1 REQUIRED SAMPLE SIZE TO GIVE ACCURACY OF + 5% FOR DIFFERENTSIZES OF SCREENING CENTRE.

Average Monthly Examinations Required Monthly sample size

250 125

500 150

750 200

1000 and above 250

Measurements must be followed by analysis and comparison with the performance targets given below as wellas with previous MIQ results.

Classification Target level (% of films appraised)

Perfect ≥ 10%

Perfect and Good > 75%

Moderate < 22%

Inadequate < 3%

Analysis must be followed by feedback. It is imperative that results, recommendations and positive feedbackare communicated promptly to the MRTs performing the imaging.


APPENDICES

TABLE N:2 MAMMOGRAPHIC IMAGE QUALITY (MIQ) CLASSIFICATION

Perfect Images Good Images

Maximum breast tissue imaged: Maximum breast tissue imaged:Cranio-caudal position Nipple profiled in one view onlyBreast & nipple positioned centrallyNipple in profile Cranio-caudal position:Medial aspect shown As for Perfect category except pectoral muscle notAs much axillary tail as possible shown but breast tissue imaged well back to chest Pectoral muscle shadow at chest wall wall.

Medio-lateral oblique position: Medio-lateral oblique position:Pectoral muscle shadow to nipple level Pectoral muscle well demonstrated (but not Pectoral muscle at appropriate angle meeting Perfect criteria)Nipple in profile Infra-mammary angle clearly demonstrated.Infra mammary angle clearly demonstrated

Correct annotation clearly shows: Correct annotation clearly shownWoman’s identification labelPositioned markersDate of examination

Appropriate exposure Appropriate exposure

Appropriate compression Appropriate compression

Absence of movement/geometric blur Absence of movement/geometric blur

Correct processing Correct processing

Absence of artefacts Artefacts – a minor degree will be acceptable

Skin fold free Skin folds (not obscuring breast tissue) to a minor degree

Symmetrical images Asymmetrical images – to a minor degree will beacceptable

FIGURE N:1 CRITERIA FOR IMAGE ASSESSMENT OF MEDIO-LATERAL OBLIQUE


APPENDICES

Pectoral muscle andaxilla not obscured byskin folds or creases

Pectoral muscle at back ofthe breast demonstrate tothe level of the nippple

Nipple in profile

Retroareolar areawell demonstrated

Breast tissue welldemonstrated and firmlyheld compression

Relaxed pectoral muscleat the appropriate angle

Anatomical marker

Radiographer I.D.

Anatomical marker

Radiographer I.D.

Nipple in profileRetroareolar areawell demonstrated

Breast tissue welldemonstrated and firmlyheld compression

Pectoral muscle

Auxillary tail

NH number

Name

Date of birth

Screening Centre

Date

Annotationsclearly shown

NH number

Name

Date of birth

Screening Centre

Date

Annotationsclearly shown

Moderate Images Inadequate images

Maximum breast tissue imaged: Any of the following criteria will determine inadequateNipple profiled in one view only imaging:

Part of breast not imagedCranio-caudal position:

As for Good category

Medio-lateral oblique position:Pectoral muscle well demonstratedInfra-mammary angle present, but minor tissue overlap

Correct annotation, clearly shown Inadequate identification/annotation

Appropriate exposure Incorrect exposure

Appropriate compression Inadequate compression

Absence of movement/geometric blur Movement/geometric blur

Correct processing Incorrect processing

Minimal artefacts, but not obscuring breast tissue Overlying artefacts

Skin folds but not obscuring breast tissue


APPENDICES


APPENDICES

63. APPENDIX O: FILM VIEW BOX

A film view box with uniform brightness of at least 3,000cd.m-2 is required for adequate viewing of mammograms;unused areas of viewing screen shall be masked and room-ambient light levels shall be 50 lux or less35 tomaximise the ability to detect low contrast lesions. A brightspotlight (at least 20,000 cd.m-2 over 8 cm diameter)preferably with iris diaphragm36 and magnifying glass withmagnification of x 2 to x 4 are also essential. Viewingconditions shall be monitored quarterly, with a full MedicalPhysicist’s quality check annually.

35 ACR 1994.36 IPSM 1994.


APPENDICES

65. APPENDIX Q: INTERVAL CANCERREVIEW PROCESS

OVERVIEWThe Interval Cancer Review Process is a two-step processaimed at ensuring quality of screen reading within theProgramme.

Step 1. Monthly External Review by screen readers fromanother Lead Provider.

Step 2. Internal Review with the original screen readers.

DEFINITION OF INTERVAL CANCERThis is a cancer that is diagnosed between a negativescreen and the time the next screen would have occurred.In BSA, this is a cancer diagnosed within two years of anegative screen. All interval cancers should be classifiedaccording to the standard classification. Interval cancersshould also be categorised as either a ‘true interval’ (onethat cannot be detected in retrospect on screeningmammograms), or a ‘missed cancer’ (one that was presentat the previous screening, but was not detected). ‘Occult’cancers are a subgroup of ‘true’ interval cancers, which arenot detected by mammography at the time of subsequentdiagnosis.

CLASSIFICATION OF INTERVAL CANCERS

Purpose

• Internal audit.

• Continual reader improvement.

• Identification of individual training requirements.

Requirements

• Screening films (originals).

• Diagnostic films and/or report.

• Histopathology report from surgery.

Classification Process

Duplicate the screen reading process as closely as practicable.

‘Overcalling’ is not encouraged (leading to higherassessment recall rates).

The process must be independent, transparent and fair toboth women and participating radiologists.

EXTERNAL REVIEW

Purpose

To classify films by independent peer review into MISS orNOT MISS categories.

Process

1. Each Lead Provider sends 10 original screening filmsmonthly to another Lead Provider.

These films may be all normal screening films, allintervals, or a mix. This ‘unknown’ mix ensures readersare less likely to be primed for a certain number ofrecalls.

2. Films are mounted on viewers duplicating the originalreading conditions (i.e., if originally read withprevious/old films, these are reviewed as well).

3. Three readers independently record a decision of Recallto Assessment or Return to Screen and document inthe usual way (i.e. site, side, lesion type, number andcategory).

4. Classify original reading as MISS or NOT MISS fromconsensus of external readers.

A consensus decision (two or more external readers) iscreated for each film reviewed. The consensus decisionclassifies the original reading as a MISS (Recall toAssessment) or NOT A MISS (Return to Screen).

5. All the films, along with the reader forms and consensusdecision for each film, are sent back to the parent LeadProvider.

INTERNAL REVIEW

Purpose

To subclassify readings following External Review andrecord subject to external audit.

Occurs with radiologists who originally read the films.

Radiologists review screening films with diagnostic films.

Where External Review was ‘Return to Screen’

Subclassify as follows:

Occult If the cancer was not visible on diagnostic films, orthe diagnostic film report said ‘normal’.

True interval If a new lesion was present on diagnosticfilm or mentioned in film report.

Minimal sign If retrospectively, subtle signs on thescreening mammogram are present at site of cancer ondiagnostic films.

64. APPENDIX P: TEST EQUIPMENT

TABLE P:1 FOR MAMMOGRAPHY X-RAY EQUIPMENT:

Instrument Features Precision Accuracy Calibration

kV meter Suitable mammo ±0.1 kV 1.0 kV Biennially

Ion chamber or ss detector/ Suitable mammo Bienniallydosemeter

Exposure timer Suitable mammo

Aluminium sheets 99.5% purity or ±0.01 mm(HVL measurement) Type1100 +correction thick

10 cm slit camera NEMA spec

High contract resolution pattern 16Ip. mm–1; 20 preferred

Focal spot measurement jig ? made in-house

Magnifier + graticule 0.2 mm div.(measuring focal spot films) x10 mag

Perspex blocks (for AEC tests). 10 or 20 mm blocks; ±1 mmtotal 80 mm thick

Spot densitometer Range ≥ 3.0 OD ±0.01 OD ±0.02 OD Annually37

(0-3 OD) (0-3 OD)

Image quality phantom/test object As per RANZCR Must be available on site

Mammography film illuminator >3000 cd.m-2 Must be available on site

Personal computer system for analysis and reporting

Light meter Range >3500 cd.m 2

Stereotactic localisation test object Provided by BSA

TABLE P:2 FOR TESTING MAMMOGRAPHY ULTRASOUND SCANNERS:

Instrument Features Calibration

Ultrasound test object Provided by BSA


APPENDICES

37 By measurement of a calibration film.


APPENDICES

FIGURE Q:1 SUBCLASSIFICATION OF INTERVAL CANCERNOTE: This is not a false negative, because to recall allsimilar lesions would risk elevating recall rates above targetswith little gain.

Unclassified Diagnostic films or report not available.

Films where External Review was ‘Recall toAssessment’

Subclassify as follows:

True interval If new cancer was visible on diagnostic filmsand not in site of lesion on screening films for whichassessment was recommended by external review

False negative If the cancer on diagnostic filmscorresponded to lesion site on screening films.

Post Assessment Intervals

(Developed interval cancer after negative assessment)

• These will be included in evaluation of ‘programmesensitivity’ and usually require review to identifyinadequate assessment or pathology misreads. Any‘process’ errors should lead to change of internalassessment protocols.

• However, where the subsequent cancer was at adifferent site to the lesion assessed, the films shouldproceed through the external review process as aboveto ensure this was not a screen-reading miss.


APPENDICES

Cancer diagnosed<2 years after normal

screening

No abnormalitydetected

Internal reviewof mammogram

at diagnosis

Confirm pathologicaldiagnosis of breast cancer

from surgical histopathology(refer next page)

External blinded review ofscreening mammograms(see page 49 for process)

Abnormalitydetected

Internal reviewof mammogram

at diagnosis

UNCLASSIFIEDFilms not available

Abnormalitydemonstrated

Lesion correspondsto carcinoma

No abnormalitydemonstrated

New lesion indifferent site toexternal review

abnormality

Cancer in differentsite to external

review abnormalityand not visible on

diagnosticmammogram

Informed reviewof screening

mammograms

Abnormalityvisible in retrospect

No abnormalitydemonstrated

MINIMAL SIGNS OCCULT FALSE NEGATIVE

TRUE INTERVAL


APPENDICES

66. APPENDIX R: MICROSCOPICREPORTING OF DUCTAL CARCINOMA IN SITU38

Ductal carcinoma in situ (DCIS) has various histologicalforms with differing growth patterns, nuclear morphologyand natural history.

There is currently no generally agreed classification ofDCIS, but there are several classifications in use, all ofwhich assess the same factors. It is important to recordthese factors both in an attempt to give prognosticinformation and to correlate with the radiological findingsof a particular case.

A system of reporting pathology findings for pure ductalcarcinoma in situ was developed by pathologists fromthroughout Australia at a consensus workshop held inMarch 1996 under the auspices of the Australian and NewZealand Breast Cancer Trials Group. This system wassubsequently ratified by a multidisciplinary workshop. Bothgroups reached the consensus that no current classificationsystem for ductal carcinoma in situ should be adopted. Inpreference, it was agreed that the following characteristicsshould be recorded for each case of pure ductal carcinomain situ:

• size

• margins

• nuclear grade

• necrosis

• architecture

• calcification.

SIZEThe pathologist should record the maximum diameter ofthe entire lesion using measurement on the slide and withreference to the gross specimen and imaging findings asnecessary. It may be useful to refer to the radiologicalreport, which will have been available to the pathologist atthe time of block selection. It is recognised that DCIS mayshow apparently uninvolved areas between involved ducts.In this case, the longest distance between involved ductsshould be recorded, including any intervening normaltissue.

MARGINSThe distance from each margin should be stated inmillimetres when <10 mm, and ‘>10 mm’ statedotherwise. If ductal carcinoma in situ is present at themargin, this should be reported, specifying the margininvolved and stating the extent of margin involvement inmillimetres.

The phrase ‘excision is complete’ is not recommended foruse in reporting, because clear margins do not necessarilymean completeness of excision.

NUCLEAR GRADENuclear grade should be reported as low, intermediate orhigh, based on the criteria advocated by Elston and Ellis39

for grading invasive carcinoma. The highest grade present inthe biopsy should be reported.

NECROSISTwo categories are recognised:

• necrosis not present or minimal (no central ductnecrosis is present but focal necrosis and isolatedapoptotic cells may be present)

• necrosis present (central necrosis is identified in ducts,i.e. comedo necrosis).

Specify the percentage of involved ducts in comedonecrosis. Some classification systems for ductal carcinomain situ have used specific cut-off points for the percentageof ducts with comedo necrosis. The inclusion of thisinformation will allow clinicians to apply these systems ifnecessary.

ARCHITECTUREMany tumours show more than one type.

These should be identified as:

• dominant pattern

• other pattern(s).

For both of these, the terms may include solid, cribriform,micropapillary and papillary.

FIGURE Q:2 PATHOLOGY COMPONENT OF INTERVAL CANCER CHART


APPENDICES

Yes

Yes

Yes

Yes

Yes

Interval CancerDiagnosed after assessment

and returned to screen

Internal reviewof diagnostic mammogram

• Surgery

• Radiotherapy

• Chemotherapy

• Counselling

Ongoing Management

Cancer same siteas assessed lesion

Cancer in different siteto area assessed

External Review ofscreening mammograms(see page 49 for process)

Internal reviewof diagnostic mammogram

Further views Error?

Ultrasound Error?

Clinical Exam Error?

Needle Biopsy Error?

External Reviewof Slides

Reading Error?

MDT Error?

Eg. Address trainingor clinical protocol issue

38 Australian Cancer Network, October 2001. Microscopic Reporting of Ductal Carcinoma in Situ in The Pathology Reporting of BreastCancer A Guide for pathologists, surgeons, radiologists and Oncologists, 2nd ed, Chapter 8, pages 38-40.

39 Elston and Ellis. 1991. Pathological Prognostic Factors in Breast Cancer. Histopathology 19(5).


APPENDICES

To ensure that synoptic reporting for pathology treatmentdata is successful, it is imperative that involved partiesprovide feedback on a regular basis. There will be regularforums for discussion in the form of UDG meetings. It isalso important that communication is held on a regionallevel between pathologists, data collectors, and otherinterested parties (such as surgeons and oncologists).

CALCIFICATION AND DUCTAL CARCINOMAIN SITUThe primary purpose of recording calcification is to fosterimproved understanding of the relationship betweenradiological and pathological findings. More detaileddescriptions of the size and extent of calcifications may beneeded in individual cases to allow histo-radiologicalcorrelation, to assist in confirmation of excision of thelesion. This may require close consultation with theradiologist and careful study of the tissues in conjunctionwith specimen radiography.

Two categories are recognised:

• calcification present (specify whether associated withnecrosis)

• calcification absent.

NOTE: The presence of ‘cancerisation of lobules’ should beincluded in any assessment of ductal carcinoma in situ,including size measurement.

67. APPENDIX S: BREAST CANCERSYNOPTIC REPORTS

S:1 PATHOLOGY SYNOPTIC FORMThe following data is for use in a synoptic form that hasbeen developed by the National Screening Unit inconsultation with pathologists and other interested parties.

The intent of the form is that it be used by pathologists forrecording treatment data on screen and non-screendetected breast cancer.

The form includes ‘mandatory data’ which is all thepathology treatment data that is required to be collectedon screen detected breast cancer for BreastScreenAotearoa.40 This information is vital for monitoring of thesuccess of breast cancer screening in New Zealand. Datafrom patients with cancer detected through BreastScreenAotearoa will be collected by data collectors and forwardedto the National Screening Unit for analysis. It is hoped thatsynoptic reporting will greatly improve the quality andquantity of pathology data collected.

Data from patients with non-screen detected cancers willnot be collected for the National screening Unit. However,recording the same information for both screen and non-screen detected cancer may encourage consistency in thesynoptic reporting of screen detected cases. Furthermore,the data from non-screen detected cases is forwarded tothe Cancer Registry and used in calculating the intervalcancer rate; hence, synoptic reporting of screen and non-screen detected cancers will improve the quality of theanalysis of interval cancer rate because the analysis wouldbe based on comparable data. Synoptic reporting for non-screen detected cancers is also the first step toward thepossibility of an in-depth analysis of data on screen versusnon-screen detected cases in the future.

Along with the ‘mandatory data’ from the BSA DataManagement Manual there are questions on the form forrecording data for purely clinical purposes. Such data isdesignated ‘non-mandatory’. It is hoped that the form willnot be altered significantly at the regional level, but it isacknowledged that different regions may wish to add more‘non mandatory’ fields.

Because pathologists enter data in a variety of ways, aselection of synoptic forms have been developed including aprompt card for dictation, a one page synoptic form forhandwritten results, and a word document for directcomputer entry.


APPENDICES

40 This manadatory data set has been recently revised and will be included in the latest version of the BreastScreen Aotearoa DataManagement manual.


APPENDICES


APPENDICES

BREAST CANCER SYNOPTIC DATA (Form will be distributed)For screen and non-screen detected breast cancer

ONE FORM PER BREAST• If there is a lesion in each breast use two forms: for screen-detected cancers, data collectors will decide which lesion

is the most significant clinical lesion (based on the Nottingham Prognostic Index formula (NPI)).• If there is more than one lesion in a breast use one form. For multiple tumours record elements marked with an *asterix

for the most clinically significant tumour as per the NPI.• NPI = (Size in cm x 0.2) + Grade (1-3) + Nodes (1-3; 1=node negative, 2 = 1–3 nodes positive, 3 = >3 nodes positive,

or the apical node positive)

Elements marked with this symbol are mandatory fields

DATA VALUE

NHI Number

Name

Date of birth

Date

Pathologist

Breast: L= Left R= Right

Source of pathology data:1 = Cytology2 = Standard core3 = Large core / suction biopsy,

i.e. Mammotome4 = Abbi

5 = Open excision includingexcision biopsy

6 = AutopsyU = not available/unknown/unsure

Re-excision: Y= Yes N= No

Histopathology of invasive lesions:00 = No invasive component01 = Invasive duct not otherwise specified02 = Invasive tubular03 = Invasive cribriform04 = Invasive mucinous (colloid)05 = Invasive medullary06 = Invasive lobular classical07 = Invasive lobular variants

08 = Mixed invasiveductal/lobular09 = Other invasive malignancy (primary)10 = Other invasive malignancy (secondary)U = Not available/unknown/unsure

If 9 or 10 specify type in writing.

Histopathology of CIS lesions:00 = No DCIS.11 = Low nuclear grade12 = Intermediate nuclear grade13 = High nuclear grade

14 = Lobular carcinoma in situ (LCIS)19 = Other DCISU = Not available/unknown/unsure

EIC: P= Positive N= Negative

Calcification: P= Present A= Absent. Give size

Central duct necrosis: P= Present A= Absent

* Size:Give size in mm to 1 decimal point (00.0)If multiple tumour– record size of largestinvasive lesion – refer to TMN 2002

U = Not available / unknown / unsure

– Invasive component

– Entire lesion (invasive and DCIS component)

DATA VALUE

NHI Number

Name

* pT Staging

pTX = Primary tumourcannot be assessedhistologically

pTO = No histologicalevidence ofprimary tumour

pTis = Carcinoma in situTmic = < 1mmPTla = >0.1 to 0.5 cmpT1b = >0.5 to 1 cmpT1c = >1 to 2 cmpT2 = >2 to 5 cm

pT3 = >5 cmpT4 = Chest wall

/skin/inflammatorycarcinoma.

DCIS with microinvasion is classified as 01 = invasive duct not otherwise specified.Microinvasion is </= 1mm.

LCIS is not recorded unless it is in association with invasive disease. Hormone receptor assay requested Y = Yes N = No P = Pending

Multiple tumours Y= Yes N= No U= Not available/unknown/unsure

– Number of nodes examined by pathologist

– Number of nodes found positive

Other findings or comments:Add any information that is not covered in the synoptic report categories (e.g. Paget’sdisease of the nipple). There may be particular features that are specific to a given caseand that need to be recorded or details that need to be expanded or further reinforced.

DATA VALUE

Histological grade as per the Bloom, Richardson and Elston system0 = No Grading1 = Grade 1

2 = Grade 23 = Grade 3

U = Not available/unknown/unsure

Regional nodesIncludes sentinel, intramammary, subscapular, supraclavicular and regional nodes.U = Not available /unknown /unsure

Sentinel node involvement

1 = Node(s) negative2 = Node(s) positive3 = Sentinel node biopsy attempted but

no sentinel node identified4 = Sentinel nodes positive on

immunohistochemistry(note micro-metastasis 0.2 –2mm)

5 = ITC < 0.2mm onimmunohistochemistry

U = Not available / unknown / unsure2 = sentinel nodes positive on histology4 = Only positive on immunohistochemistry

N Staging

pNX = Regional lymph nodes cannotbe assessed

pN0 = No regional lymph nodemetastasis

pN1 = Lymph node metastases >2mm

pN1mi = Micrometastases >0.2 mm,but none > 2.0 mm in greatestdimension

pN2 = Metastases to ipsilateral axillarylymph nodes that are fixed toone another or to otherstructures

pN3 = Metastases to one or moreipsilateral internal mammary

Isolated tumour cells (ITC) <0.2 mm arenot considered true metastases forthis classification.

Clearance from marginsMargins are to be reported in mm to 1 decimal point (00.0). An involved margin would be 00.0If value is U please record reason. If >99.9; record as 99.9

– Invasive. Radial

– Invasive Subcutaneous or pectoral fascia

Margins are to be reported in mm to 1 decimal point (00.0). An involved margin would be 00.0If value is U please record reason. If >99.9; record as 99.9

– Invasive. Radial

– Invasive Subcutaneous or pectoral fascia

– Invasive Unoriented sample

– Non-Invasive Radial

– Non-Invasive Subcutaneous or pectoral fascia

– Non-Invasive Unoriented sample

– Comments

Lymphovascular invasion1 = present 2 = absent U = Not available/unknown/unsure

– ER: P = Positive N = NegativePercentage of nuclei stainedPredominant intensity of staining

– PR: P = Positive N = NegativePercentage of nuclei stainedPredominant intensity of staining

HER2 testing requested Y = Yes N = No P = Pending

HER2 resultsP = Positive N = Negative

DIAGNOSTIC SUMMARY


APPENDICES

BREASTSCREEN AOTEAROA QUALITY DEVIATION REQUEST

Sections 1 to 6 to be completed by Lead Provider

1. Lead Provider

2. Name of Applicant

3. Date Request Sent by LP to NSU

4. Deviation Requested

5. Reference to NP&QS

6. Supporting Evidence for the Application

NSU to complete

7. Date received by the NSU

8. Action undertaken by BSA

9. Clinical Leader, BSA

Comment:

Date:

10. Manager, BSA

Comment:

Date:

11. BSA Recommendation

12. Clinical Leader, BSA Dr Madeleine Wall

Sign Off:

Date:

13. Manager, BSA Barbara Phillips

Sign Off:

Date:

68. APPENDIX T: WOMENTRANSFERRING BETWEEN PROVIDERSPROTOCOL

TRANSFERRING WOMEN BETWEEN LEADPROVIDER REGIONS DURING A SCREENINGEPISODEWomen may enrol and attend a mammographyappointment outside of their region. Every attempt must bemade to encourage the woman to continue to have anyrequired assessment, within the region that performed thescreening mammogram.

On registration, any woman having a mammogram outsideof their region must be asked for both their permanent andany temporary addresses.

The Lead Provider who provided the screening services isresponsible for sending the result letter to the woman andher GP/PCP (if consent is obtained) and to recall thewoman for assessment, if required. If the woman transfersto another region for assessment the screening LeadProvider/Data Manager is responsible for ensuring thecompletion of the ‘Transfer of Woman’ form and themanual transfer of films, written and, where relevant,electronic records to the assessment Lead Provider. A copyof the ‘Transfer of Woman’ form is also to be sent to theData Manager, National Screening Unit.

TRANSFERRING OF WOMEN OUTSIDE OFTHE SCREENING EPISODEIf a woman transfers to another Lead Provider after thecompletion of her screening round the Data Manager willensure that a completed ‘Transfer of Woman’ form, filmsand written records is to be sent to the new Lead Provider.On receipt of the transfer letter the residential LeadProvider is responsible for recalling the woman in twoyears.

69. APPENDIX U: QUALITY DEVIATIONAPPLICATION TEMPLATE ANDPROCESS

The National Policy and Quality Standards (NP&QS)determine the level and standards of service provided bythe Lead Providers. In specific circumstances, where LeadProviders are unable to meet the NP&QS, a QualityDeviation would need to be sought from BSA.

The application for a Quality Deviation would documentthe request on the attached template, including thereason(s)/rationale for a Deviation, the relevant Standard,any additional information pertaining to the location,monitoring or supervisory mechanisms etc. that could beimplemented to ensure quality standards are upheld, whilethe Deviation remained in force.

Timeliness of applications is an important requirementwhen Lead Providers apply for a Deviation. Adequate leadin time of a minimum of eight weeks is required to ensurethe process can be both initiated and completed by bothLead Providers and BSA.

Receipt of Quality Deviation request from LeadProvider

Acknowledgement of request received by BSA to LeadProviderWithin 5 working days

Review of the request by BSAWithin 5 working days

Consultation Process/Request for additional informationetc.Within 15 working days

Final consideration by Manager BSA and Clinical Leader Within 5 working days

Outcome communicated to Lead Provider Within 5 working days


APPENDICES


APPENDICES

70. APPENDIX V: ACCREDITATIONPROTOCOLS

All radiologists/surgeons/pathologists intending to practisein the national breast screening programme, BreastScreenAotearoa are required to have undergone an accreditationprocess which ensures that they been deemed as meetingthe programmes requirements.

1. The submission of a radiologist/surgeon/pathologistaccreditation template to the Clinical Leader, BSA,where both the Lead Provider Clinical Director/LeadSurgeon/Lead Radiologist and radiologist/surgeon/pathologist have completed the relevant sections.

2. The allocation by BSA of a non-identifiable pseudonym,from the central register e.g. BSAN 5.

3. A review of the template by the Clinical Leader – forconsistency, content etc., and if necessary additionalinformation being sought.

Note: The pathologists have delegated responsibility tothe Clinical Leader, BSA to make the decision whetherthe pathologist meets the criteria. Where a decisioncannot be made by the Clinical Leader, the pathologistwill be referred to the UDG for follow-up/discussion.

4. Inclusion as an agenda item at the next radiologist/surgeon/pathologist Unidisciplinary Group (UDG)meeting.

5. Where the timeframes from receipt of the template tothe date of the next UDG meeting are deemedprotracted by the Clinical Leader, and where they maysubsequently disadvantage the Leader Provider in theprovision of services. The Clinical Leader may requestemail/correspondence or a teleconference to reviewthe application, and make a decision, alternatively theapplication may be presentation of the radiologists/surgeons/pathologists UDG meeting, where it issubsequently discussed. During the teleconference orUDG each Clinical Director/Lead Surgeon/Leadpathologist will complete their panel evaluationtemplate.

6. Once agreement has been reached on the status of theapplication all documentation (e.g. template, evaluationtemplate) is returned to the Clinical Leader, BSA, ordestroyed.

7. A quorum of four radiologists/surgeons/pathologists(members of the UDG) is required to participate andthe sponsoring Clinical Director is excluded from boththe quorum and the final decision-making process.

8. Following the teleconference/UDG, a letter is sent tothe Lead Provider/Clinical Director/Lead Surgeon/Leadpathologist and copied to the Lead Provider Managerconcerned notifying them of the outcome related totheir accreditation application.

V:1 Radiologist Accreditation Template

V:2 Pathologist Accreditation Template

V:3 Surgeon Accreditation Template


APPENDICES

V:1 RADIOLOGIST ACCREDITATION TO WORK IN THE BSA PROGRAMME

Lead Provider

Code Identifier

Pre-Employment Criteria [Statutory Requirements](Clinical Director to confirm)

NZMC Registration

NRL Licence

Annual Practising Certificate

References/Performance Appraisal

Qualifications

Basic radiology qualifications e.g. FRACR.Where and when

Post-FRACR diploma When and where?

Mammography experience

• Where worked

• Amount of time spent there

• Whether involved in screening or diagnostic/ad hoc screening

• If this was an organised screening programme, approximately how many women were screened there per annum

• Role in screening unit, e.g. observing/reading, involvement in MDT meetings and assessment

• Estimations of the volume of mammograms read e.g. weekly/monthly


APPENDICES

RADIOLOGIST ACCREDITATION TO WORK IN THE BSA PROGRAMME

Panel Evaluation

Lead Provider Name/Code

Pre-Employment Requirements • NZ Qualifications• Overseas Qualifications • Requires NZ Registration • APC• NRL Licence

Pre-Entry Requirements • Dummy Reads (300)• Sensitivity• Specificity• Recall Rate

Training and Courses Attended • Sufficient • Borderline • Insufficient

Mammography Experience • Sufficient • Borderline • Insufficient

Overall Grading • Sufficient • Borderline • Insufficient

Recommendation • Suitably Qualified• Requiring a specific set of defined training activities • Not eligible to practice as a principle

For example: • May continue working in the programme• Recommend working under supervision as a

third reader for 3 to 6 months while completing courses

• Exposure to a major multidisciplinary course within 12 months

• Attendance at a Tabar course required


APPENDICES

Pre-Entry Requirements(Clinical Director to complete)

Timing and results of a minimum of 300 Dummy reads

Recall Rate

Adequate sensitivity (from cancer seeded set)

Observed/Competency

• Ultrasound

• Guided biopsy

• Sterotactic Core Biopsy

• Localisation for Open Biopsy

Training and Experience

Courses attendede.g. Tabar or RANZCR multidisciplinary meetings attended, and when

Additional meetings/courses attended relevant to mammography

BreastScreen Aotearoa

Please outline your current/planned involvemente.g. working with lead provider/subcontracted, working in one centre or more

General

Please make any other comments relating to mammography experience that are not summarised elsewhereInclude publications/presentations


APPENDICES

• Estimations time spent dealing with breast pathology, e.g. weekly/monthly


Courses attended, e.g. FRCP multidisciplinary meetings attended, and when

Additional meetings/courses attended relevant to breast pathology


Please outline your current/planned involvemente.g. working with lead provider/subcontracted, working in one centre or more

General

Please make any other comments relating to breast pathology that are not summarised elsewhereInclude Publications/Presentations

V:2 PATHOLOGIST ACCREDITATION TO WORK IN THE BSA PROGRAMME

Lead Provider

Code Identifier

Pre-Employment Criteria [Statutory Requirements](Lead Pathologist to confirm)

NZMC Registration

Annual Practising Certificate

References/Performance Appraisal

Qualifications

Basic pathology qualifications e.g. FRCP.Where and when

Post FRCP Diploma When and where?

Enrolled on the NZMC vocational register in anatomic or general Pathology.

Enrolment in the RCPA’s Continuing Professional Development Programme [CPDP]

Enrolment in the RCPA Australasian Breast External Quality Assurance Scheme (ABEQAS).

Pathology experience with breast screening

• Where worked


• Whether involved in screening or diagnostic/ad hoc screening

• If this was an organised screening programme, approximately how many women were screened there per annum

• Role in screening unit, e.g. involvement in MDT meetings

• Assessment – FNAC alone, core biopsy alone or combined FNAC and core biopsy count/volumes


APPENDICES


APPENDICES

V:3 SURGEONS ACCREDITATION TO WORK IN THE BSA PROGRAMME

Lead Provider

Code Identifier

Pre-Employment Criteria [Statutory Requirements]

NZMC Registration Yes No

Vocationally registered in General Surgery with NZMC Yes No

Annual Practising Certificate Yes No

Evidence of hospital credentialing Yes No

References/Performance Appraisal Yes No

Qualifications (Applicant to complete)

Basic surgery qualifications, e.g. FRACS.Where and when?

Post FRACS diploma When and where?

Surgical experience with breast screening

• Where worked


• Whether involved in screening or diagnostic

• Role in screening unit, e.g. MDT meetings and assessment

• Estimations of time spent dealing with breast surgery, e.g. weekly/monthly

PATHOLOGIST ACCREDITATION TO WORK IN THE BSA PROGRAMME

Panel Evaluation

Lead Provider Name/Code

Pre-Employment Requirements • NZ Registration • APC• References

Qualifications• NZ • Overseas • Vocational Enrolment• CPDP Enrolment• ABEQAS Enrolment

Pathology Experience • Sufficient • Borderline • Insufficient




For example – A specific set of activities • May continue working in the programme• Recommend working under supervision while

completing courses • Recommend exposure to a major multidisciplinary

course within 12 months


APPENDICES


APPENDICES

SURGEON ACCREDITATION TO WORK IN THE BSA PROGRAMME

Panel Evaluation

Lead Provider/Code Identifier

Pre-Employment Requirements • NZ Qualifications• Overseas Qualifications • Requires NZ Registration • APC

Pre-Entry Requirements


Breast Surgery Experience • Sufficient • Borderline • Insufficient



For example: • May continue working in the programme• Recommend working under supervision while

completing courses • Exposure to a major multidisciplinary course

within 12 months


Participation in a re-certification programme in general surgery

Courses attended, e.g. FRACS multidisciplinary meetings attended, and when

Additional meetings/courses attended relevant to breast surgery

CME requirements for re-certification – RACS Breast Section Audit

Participation in local and national breast screen audit with peer review


Please outline your current/planned involvement e.g. working with lead provider/subcontracted, working in one centre or more

General

Please make any other comments relating to breast surgery that are not summarised elsewhereInclude publications/presentations


APPENDICES


APPENDICES

TABLE W:I SUGGESTED THRESHOLDS FOR CYTOLOGY PERFORMANCE (WHERE THERAPY IS PARTIALLY BASED ON FNAC)

Minimum Preferred Current median(%) (%) (%)

Absolute sensitivity (AS) >60 >70 57.1

Complete sensitivity (CS) >80 >90 81.5

Specificity (full) (SPEC) (including non-biopsied cases) (as calculated above) >55 >65 58.4

Positive predictive value (+PV) >98 >99 99.6

False negative rate (F–) <6 <4 6.3

False positive rate (F+) <1 <0.5 0.2

Inadequate rate (INAD) <25 <15 23.4

Inadequate rate from cancers <10 5 9.8

Suspicious rate <20 <15 15.8

TABLE W:II SUGGESTED THRESHOLDS FOR CORE BIOPSY PERFORMANCE

Minimum Preferred Current median (%) (%) (%)

Absolute sensitivity (AS) >70 >80 76.4

Complete sensitivity (CS) >80 >90 84.5

Specificity (full) (SPEC) (including non-biopsied cases) (as calculated above) >75 >85 81.2

Positive predictive value (+PV) >99 >99.5 100

False positive rate (F+) <0.5 <0.1 0

Miss rate (B1 + B2) from cancer <15 <10% 15.1

Suspicious rate <10 <5 4.8

71. APPENDIX W: FNAC QUALITYASSURANCE41

CYTOLOGY AND CORE BIOPSYPERFORMANCESuggested thresholds for cytology and core biopsyperformance are shown in Tables W:I and W:II respectively.These figures will obviously depend on sampling techniquesand the experience and care of the aspirator42 and will varywidely between units.

HOW TO INTERPRET THE RESULTSThe performance measures are interrelated, and strategyto improve one aspect of performance will affect others.Thus, an attempt to reduce the inadequate rate will oftenincrease the number of suspicious reports, attempts toimprove the sensitivity are likely to increase the falsepositive rate, attempts to improve the specificity willincrease the false negative rate, and so on. Also, attemptsto reduce the benign biopsy rate by not biopsying themajority of lesions called benign on cytology will reduce thespecificity where this is based on benign histology resultsrather than on all aspirated cases.

The most common problem encountered in the NHSBSPsurveys43,44 appears to be low sensitivities combined withhigh false negative rates and high inadequate rates fromlesions that subsequently turn out to be cancer. This

combination of statistics suggests a problem with theaccurate localisation of lesions for aspiration.45 A significantproportion of these lesions will have been palpable orthought to be palpable as an area of thickening; aspirationof these areas without radiological guidance may accountfor some of the problems. It is of interest to note that, incentres where cytology has not been as useful in non-operative diagnosis, there has been a swing towards theuse of core biopsy,46 as is commonly reported inpublications from the United States.47 Audit of core biopsyin the NHSBSP shows similar variability in practice.48 Someunits are using the two techniques to complement eachother and are achieving higher non-operative diagnosisrates in difficult cases.49 This can be especially useful inlobular and tubular carcinomas where cytology is less ableto give an unequivocal diagnosis.50,51,52

High inadequate rates without a corresponding increase inthe inadequate rate from cancers can be seen in occasionalunits. In these units, a high proportion of the women whowere recalled for assessment had a needling procedure.This suggests that, in these units, the clinicians wereneedling lesions with a low predictive value for malignancyin order to reassure either the patient or themselves. Thisis not necessarily a problem, and therefore the crudeinadequate rate may not be a good measure of aspirationtechnique. A better measure appears to be the inadequaterate from lesions which turn out subsequently to be canceror, for core biopsy, the miss rate (refer Table W:II).


APPENDICES

41 NHSBSP. June 2001. Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening, Chapter 6. QualityAssurance, NHS Cancer Screening Programmes: Sheffield. Publication No 50, pp46-53.

42 Barrows GH, Anderson TJ, Lamb JL, Dixon JM. 1986. Fine needle aspiration of breast cancer – relationship of clinical factors tocytology results in 689 primary malignancies. Cancer 58: 1493–98.

43 Wells C A, Perera R, White F E, Domizio P. 1999. Fine needle aspiration cytology in the UK Breast Screening Programme – a nationalaudit of results. The Breast 8: 261–266.

44 Britton PD, McCann J. 1999. Needle biopsy in the NHS Breast Screening Programme 1996/1997: How much and how accurate? TheBreast 8: 5–11.

45 Wells C A. 1995. Quality assurance in breast cancer screening cytology: A review of the literature and a report on the UK NationalCytology Scheme. European Journal of Cancer 31A: 273–280.

46 Crotch-Harvey M A, Loughran C V. 1996. Combined stereotactic wide core needle biopsy and fine needle aspiration cytology in theassessment of impalpable mammographic abnormalities detected in a breast screening programme. The Breast 5: 48–49.

47 Meyer JE. 1992. Value of large core biopsy of occult breast lesions. American Journal of Roentgenology 158: 991–992. 48 Britton P D and McCann J. 1999. Needle biopsy in the NHS Breast Screening Programme 1996/1997: How much and how accurate?

The Breast 8: 5–11. 49 Yeoman L J, Michel M J, Humphreys S, et al. 1996. Radiographically guided fine needle aspiration cytology and core biopsy in the

assessment of impalpable breast lesions. The Breast 5: 41–47.50 Bondesan L and Lindholm K. 1990. Aspiration cytology of tubular breast carcinoma. Acta Cytologica 34: 15–20.51 Britton PD and McCann J. 1999. Needle biopsy in the NHS Breast Screening Programme 1996/1997: How much and how accurate?

The Breast 8: 5–11.52 Sadler GP, McGee S, Dallimore NS, et al. 1994. Role of fine needle aspiration cytology and needle core biopsy in the diagnosis of

lobular carcinoma of the breast. British Journal of Surgery 81: 1315–1317.


APPENDICES


APPENDICES

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APPENDICES

73. APPENDIX Y: FUNNEL PLOTS

FUNNEL PLOTSThe proportion of cancers detected in a screeningprogramme is dependent on the background incidence ofbreast cancer, the proportion of women screened in theprogramme, the screening interval (for second orsubsequent screening) and the sensitivity of the screeningprocess.

The following targets and 95% credible intervals have beencalculated from the background incidence of breast cancerin NZ women aged 50-64 in the absence of screening, andtake into account the expected increased in cancers overthe next (3-5) years. (Paul et al)

PURPOSEThe funnel plots allow comparison of programme,subcontractor and individual (de-identified) readerperformance by allowing for statistical variation due tosample size. The 95% credible interval limits indicate actionpoints at which the NSU, audit teams or Clinical Directorswill institute corrective actions to ensure an improvementin screening performance. Exceeding the 95% credibleintervals however, should not serve as the only indicationfor action and root cause analysis should be initiated iftrend data shows the lower limits are being approachedover time.

HOW TO USE THE FUNNEL PLOTSUsers of the funnel plots should insert the relevant cancerdetection rate, given the number of women screened inthat period, into the graph.

Eg. For incident (subsequent screen) cancers detected in a6 month period of 27 from 8700 screened women:

Rate 27/8700 x 10,000 = 31.0

Use the funnel plot for incident (subsequent screen)cancers

Plot 31 on the y-axis and 8700 along the x-axis. If the pointof intersection lies between the limits of the credibleinterval, it is likely that the target is being met. As notedabove however a trend of reducing rates should beinvestigated before limits are reached.


APPENDICES

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mot

ion

repr

esen

tativ

e

othe

r pr

ofes

siona

ls as

app

ropr

iate

surg

eons

Clin

ical

Co-

ordi

nato

r

brea

stca

re n

urse

sA

t le

ast

one

repr

esen

tativ

e fr

om e

ach

subc

ontr

acte

d sit

e (s

ix-m

onth

ly)

data

man

ager

sO

ther

s w

orki

ng in

the

Pro

gram

me

as a

ppro

pria

te.

Trea

tmen

t D

ata

Col

lect

ors

med

ical

phy

sicist

s

heal

th p

rom

oter

s

100

120

80

60

40

20

0500 1500 2500 3500 4500 5500 6500 7500 8500 9500 10500 11500 12500 13500 1450015500

Cas

es d

etec

ted

per 1

0000

scre

ens

Number of Screens

16500

Target Rate

95% Bounds forcredible interval

x


APPENDICES

CANCERS DETECTED ON SUBSEQUENT (INCIDENT)SCREENCANCERS DETECTED ON FIRST (PREVALENT) SCREEN


APPENDICES

120

180

100 60 40 20 0

500

1500

2500

3500

4500

5500

6500

7500

8500

9500

1050

011

500

1250

013

500

1450

015

500

Cases detected per 10000 screens

1650

0

80140

160

Num

ber o

f Scr

eens

Targ

et R

ate

95%

Bou

nds f

orcr

edib

le in

terv

al

100

120 80 60 40 20 0

500

1500

2500

3500

4500

5500

6500

7500

8500

9500

1050

011

500

1250

013

500

1450

015

500


Num

ber o

f Scr

eens

1650

0

Targ

et R

ate

95%

Bou

nds f

orcr

edib

le in

terv

al


APPENDICES

SMALL INVASIVE CANCERS DETECTED ON SUBSEQUENT (INCIDENT) SCREEN(<=10MM)

SMALL INVASIVE CANCERS DETECTED ON FIRST (PREVALENT) SCREEN (<=10MM)


APPENDICES

3045 25 15 10 5 050

015

0025

0035

0045

0055

0065

0075

0085

0095

0010

500

1150

012

500

1350

014

500

1550

0


1650

0

203540

Num

ber o

f Scr

eens

Targ

et R

ate

95%

Bou

nds f

orcr

edib

le in

terv

al

5070 40 30 20 10 050

015

0025

0035

0045

0055

0065

0075

0085

0095

0010

500

1150

012

500

1350

014

500

1550

0


Num

ber o

f Scr

eens

1650

0

60Ta

rget

Rat

e

95%

Bou

nds f

orcr

edib

le in

terv

al


APPENDICES

OTHER SMALL INVASIVE CANCERS DETECTED ON SUBSEQUENT (INCIDENT)SCREEN (< 15MM)

OTHER SMALL INVASIVE CANCERS DETECTED ON FIRST (PREVALENT) SCREEN (< 15MM)


APPENDICES

5070 40 30 20 10 050

015

0025

0035

0045

0055

0065

0075

0085

0095

0010

500

1150

012

500

1350

014

500

1550

0


Num

ber o

f Scr

eens

1650

0

60Ta

rget

Rat

e

95%

Bou

nds f

orcr

edib

le in

terv

al

100

120 80 60 40 20 0

500

1500

2500

3500

4500

5500

6500

7500

8500

9500

1050

011

500

1250

013

500

1450

015

500


Num

ber o

f Scr

eens

1650

0

100

120 80 60 40 20 0

500

1500

2500

3500

4500

5500

6500

7500

8500

9500

1050

011

500

1250

013

500

1450

015

500


Num

ber o

f Scr

eens

1650

0

100

120 80 60 40 20 0

500

1500

2500

3500

4500

5500

6500

7500

8500

9500

1050

011

500

1250

013

500

1450

015

500


Num

ber o

f Scr

eens

1650

0

Targ

et R

ate

95%

Bou

nds f

orcr

edib

le in

terv

al


APPENDICES

INTERVAL CANCERS


APPENDICES

74.

APP

END

IX Z

: Q

UA

LIT

Y I

ND

ICA

TO

RS,

EV

ALU

AT

ION

PR

OC

ESS

AN

D E

VA

LUA

TIO

N T

AR

GET

S

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

1.

Wel

l W

omen

-Cen

tred

Ser

vice

sTh

e e

nti

re s

creen

ing p

ath

wa

y a

nd

all

oth

er a

cti

vit

ies p

rovid

ed

wit

hin

Brea

stS

creen

Aote

aroa

ha

ve a

key f

ocu

s o

n w

om

en

an

d t

heir

need

s

(as t

hey r

ela

te t

o b

rea

st

screen

ing)

to e

nsu

re e

ach

wom

an

ha

s c

on

fid

en

ce i

n t

he P

rogra

mm

e.

1.1

WE

LL W

OM

EN

-CE

NT

RE

D S

ER

VIC

ES

Brea

stSc

reen

Aot

earo

a Pr

ovid

ers

have

aco

mm

itmen

t to

wor

k co

llabo

rativ

ely

with

wom

en;

wom

en’s

gro

ups

or c

omm

unity

org

anisa

tions

or

with

wom

en a

nd t

heir

repr

esen

tativ

es t

o en

sure

the

Prog

ram

me

is w

ell w

omen

-cen

tred

and

ref

lect

s th

epa

rtic

ular

issu

es r

elev

ant

to t

he s

cree

ning

of

asym

ptom

atic

wom

en.

1.Sa

tisfa

ctio

n su

rvey

s.2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.95

% o

f wom

en s

urve

yed

repo

rt t

hat

the

over

all

serv

ice

they

rec

eive

d is

wom

en c

entr

ed a

ndm

eets

the

ir ne

eds.

2.A

ll ot

her

crite

ria a

re m

et.

1.2

WE

LL W

OM

EN

-CE

NT

RE

D S

ER

VIC

ES

– B

RE

AST

SCR

EE

N A

OT

EA

RO

A P

RIO

RIT

Y G

RO

UP

SBr

east

Scre

en A

otea

roa

Prov

ider

s ha

ve a

com

mitm

ent

to m

axim

ise c

over

age

and

part

icip

atio

nof

the

wom

en fr

om t

he B

reas

tScr

een

Aot

earo

aPr

iorit

y G

roup

s fr

om in

vita

tion

to s

cree

ning

and

re-

scre

enin

g th

roug

h to

pos

sible

ass

essm

ent

and/

ortr

eatm

ent.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

3045 25 15 10 5 050

015

0025

0035

0045

0055

0065

0075

0085

0095

0010

500

1150

012

500

1350

014

500

1550

0


1650

0

203540

Num

ber o

f Scr

eens

Targ

et R

ate

95%

Bou

nds f

orcr

edib

le in

terv

al


APPENDICES


APPENDICES

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

2.

Cult

ura

l A

pp

rop

ria

ten

ess

Sta

ff p

ra

cti

se i

n a

ma

nn

er t

ha

t m

eets

in

div

idu

al

cu

ltu

ra

l n

eed

s f

or e

ach

wom

an

an

d h

er f

am

ily a

nd

wh

an

au

an

d t

hey a

re c

ult

ura

lly

ap

prop

ria

te.

2.1

CU

LTU

RA

L A

PP

RO

PR

IAT

EN

ESS

– T

RE

AT

Y O

F W

AIT

AN

GI

Staf

f pra

ctic

e re

flect

s kn

owle

dge

of t

he p

rinci

ples

and

Art

icle

s of

the

Tre

aty

of W

aita

ngi a

ndap

plic

abili

ty t

o th

e se

rvic

es p

rovi

ded.

1.

Satis

fact

ion

surv

eys

2.

Form

al c

ultu

ral e

valu

atio

n of

the

ser

vice

, for

exam

ple

an e

xter

nal c

ultu

ral a

udit

3.

Spec

ific

Iwi a

nd M

aori

feed

back

4.

Part

ners

hip

with

Iwi a

nd M

aori

to e

stab

lish

appr

opria

te m

onito

ring

and

eval

uatio

n pr

oces

ses.

5.T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

95%

of M

aori

wom

en s

urve

yed

repo

rt t

hat

thei

rcu

ltura

l nee

ds w

ere

addr

esse

d in

a m

anne

r th

atw

as c

ultu

rally

app

ropr

iate

.2.

A

ll ot

her

crite

ria a

re m

et.

2.2

CU

LTU

RA

L A

PP

RO

PR

IAT

EN

ESS

–T

E W

HA

RE

TA

PA W

HA

Staf

f rec

ogni

se t

he p

hilo

soph

y of

Te

Wha

re T

apa

Wha

in t

heir

prac

tice.

1.Sa

tisfa

ctio

n su

rvey

s2.

Sp

ecifi

c Iw

i and

Mao

ri fe

edba

ck3.

Fo

rmal

cul

tura

l eva

luat

ion

of t

he s

ervi

ce, f

orex

ampl

e, a

n ex

tern

al c

ultu

ral a

udit

4.

Part

ners

hips

mad

e w

ith Iw

i and

Mao

ri to

est

ablis

hap

prop

riate

mon

itorin

g an

d ev

alua

tion

proc

esse

s.5.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.95

% o

f Mao

ri w

omen

sur

veye

d re

port

tha

t th

eir

cultu

ral n

eeds

wer

e ad

dres

sed

in a

man

ner

that

was

cul

tura

lly a

ppro

pria

te.

2.

All

othe

r cr

iteria

are

met

.

2.3

CU

LTU

RA

L A

PP

RO

PR

IAT

EN

ESS

– I

ND

IVID

UA

L C

ULT

UR

AL

NE

ED

ST

he in

divi

dual

cul

tura

l nee

ds o

f eac

h w

oman

and

her

fam

ily a

nd w

hana

u du

ring

each

sta

ge o

f the

Prog

ram

me

are

reco

gnise

d an

d re

leva

nt c

ultu

ral

advi

ce a

nd/o

r gu

idan

ce is

sou

ght t

o en

sure

bot

h th

epr

actic

e an

d m

aint

enan

ce o

f cul

tura

l app

ropr

iate

ness

.

1.

Satis

fact

ion

surv

eys.

2.

Form

al c

ultu

ral e

valu

atio

n of

the

ser

vice

, for

exam

ple,

an

exte

rnal

cul

tura

l aud

it.3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d re

port

tha

t th

eir

cultu

ral n

eeds

wer

e ad

dres

sed

in a

man

ner

that

was

cul

tura

lly a

ppro

pria

te.

2.

All

othe

r cr

iteria

are

met

.

2.4

CU

LTU

RA

L A

PP

RO

PR

IAT

EN

ESS

– P

AC

IFIC

WO

ME

NT

he in

divi

dual

cul

tura

l nee

ds o

f eac

h Pa

cific

wom

anan

d he

r fa

mily

dur

ing

each

sta

ge o

f the

Pro

gram

me

are

reco

gnise

d an

d re

leva

nt c

ultu

ral a

dvic

e an

d/or

guid

ance

is s

ough

t to

ens

ure

both

the

pra

ctic

e an

dm

aint

enan

ce o

f cul

tura

l app

ropr

iate

ness

.

1.

Satis

fact

ion

surv

eys.

2.

Form

al c

ultu

ral e

valu

atio

n of

the

ser

vice

, for

exam

ple,

an

exte

rnal

cul

tura

l aud

it.3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of P

acifi

c w

omen

sur

veye

d re

port

tha

t th

eir

cultu

ral n

eeds

wer

e ad

dres

sed

in a

man

ner

that

was

cul

tura

lly a

ppro

pria

te.

2.

All

othe

r cr

iteria

are

met

.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

4.

Acc

ess

to t

he

Pro

gra

mm

eTh

ere i

s a

ccep

tab

le a

ccess t

o B

rea

stS

creen

Aote

aroa

servic

es f

or a

ll e

ligib

le w

om

en

.

4.1

AC

CE

SS T

O T

HE

PR

OG

RA

MM

EEa

ch w

oman

in t

he e

ligib

le a

ge g

roup

has

acc

ess

toBr

east

Scre

en A

otea

roa

serv

ices

.1.

In

form

atio

n is

colle

cted

thr

ough

the

Nat

iona

lM

inim

um D

ata

Set

for

mon

itorin

g an

d ev

alua

tion

purp

oses

(Ref

er: C

urre

nt D

MM

).2.

Re

view

of t

he p

rovi

sion

of a

cces

s to

the

Prog

ram

me

and

rela

ted

info

rmat

ion,

prio

r to

ade

cisio

n be

ing

mad

e to

cha

nge

the

conf

igur

atio

n,M

obile

rou

tes

or lo

catio

n of

fixe

d sit

es.

3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

>=

70%

of e

ligib

le w

omen

rec

eive

a s

cree

nw

ithin

the

Pro

gram

me

in t

he m

ost

rece

nt 2

4m

onth

s2.

90

% o

f elig

ible

wom

en s

houl

d be

with

in 6

0m

inut

es t

rave

lling

tim

e of

a s

cree

ning

uni

t(m

obile

or

fixed

).3.

95

% o

f elig

ible

wom

en s

houl

d be

with

in 9

0m

inut

es t

rave

lling

tim

e of

a s

cree

ning

uni

t(m

obile

or

fixed

).4.

99

% o

f elig

ible

wom

en s

houl

d be

with

in 1

20m

inut

es t

rave

lling

tim

e of

a s

cree

ning

uni

t(m

obile

or

fixed

).5.

A

ll ot

her

crite

ria a

re m

et.

Sta

nd

ard

5.

Con

sen

t E

ach

wom

an

is a

ble

to m

ake i

nfo

rm

ed

ch

oic

es a

bou

t h

avin

g a

screen

ing m

am

mogra

m a

nd

fu

rth

er a

ssessm

en

t, i

f n

ecessa

ry,

ba

sed

on

fu

ll a

nd

accu

ra

te i

nfo

rm

ati

on

, a

nd

in

form

ed

con

sen

t p

ra

cti

ces c

om

ply

wit

h t

he r

eq

uir

em

en

ts o

f Th

e C

od

e o

f H

ea

lth

an

d D

isa

bil

ity S

ervic

es C

on

su

mers’

Rig

hts

.

5.1

CO

NSE

NT

Ea

ch w

oman

is a

ppro

pria

tely

info

rmed

thr

ough

the

use

of e

ffect

ive

info

rmat

ion

and

com

mun

icat

ion,

enab

ling

her

to m

ake

an in

form

ed c

hoic

e an

dpr

ovid

e in

form

ed c

onse

nt w

here

it is

req

uire

d.

1.

Satis

fact

ion

surv

eys.

2.

Mon

thly

aud

iting

of c

linic

al r

ecor

ds fo

r w

omen

scre

ened

in t

he p

revi

ous

mon

th a

t ea

chsc

reen

ing

unit.

3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

rep

ort

that

the

y w

ere

appr

opria

tely

info

rmed

abo

ut t

he p

roce

sses

invo

lved

prio

r to

giv

ing

cons

ent.

2.

100%

of r

ecor

ds h

ave

appr

opria

te c

onse

ntdo

cum

ente

d w

here

info

rmed

con

sent

is r

equi

red

to b

e pr

ovid

ed b

y th

e w

oman

.3.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

3.

Com

mu

nic

ati

on

Eff

ecti

ve s

taff

com

mu

nic

ati

on

en

su

res e

ach

wom

an

receiv

es r

ele

va

nt

an

d t

imely

in

form

ati

on

in

a m

an

ner w

hic

h i

s e

asil

y u

nd

ersto

od

.

3.1

CO

MM

UN

ICA

TIO

N –

EFF

EC

TIV

E C

OM

MU

NIC

AT

ION

Each

wom

an p

artic

ipat

ing

in t

he P

rogr

amm

ere

ceiv

es r

elev

ant

info

rmat

ion

that

max

imise

s th

eop

port

unity

to

unde

rsta

nd a

nd t

hat

dem

onst

rate

sre

spec

t an

d cu

ltura

l app

ropr

iate

ness

.

1.Sa

tisfa

ctio

n su

rvey

s.2.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

95%

of w

omen

sur

veye

d re

port

tha

t th

eyre

ceiv

ed r

elev

ant

and

easil

y un

ders

tood

info

rmat

ion.

2.

All

othe

r cr

iteria

are

met

.

3.2

CO

MM

UN

ICA

TIO

N –

WR

ITT

EN

IN

FOR

MA

TIO

NA

ppro

pria

te w

ritte

n in

form

atio

n, a

ppro

ved

orde

velo

ped

by t

he N

atio

nal S

cree

ning

Uni

t, is

mad

eav

aila

ble

to a

ll w

omen

exp

lain

ing

brea

st s

cree

ning

,pr

opos

ed p

roce

dure

s, in

terv

entio

ns a

nd o

ptio

ns.

Satis

fact

ion

surv

eys.

95%

of w

omen

sur

veye

d re

port

tha

t w

ritte

nin

form

atio

n w

as m

ade

avai

labl

e th

at w

as a

ppro

pria

tean

d ac

cess

ible

to

them

.

3.3

CO

MM

UN

ICA

TIO

N –

TE

LEP

HO

NE

AN

D P

ER

SON

AL

CO

NT

AC

TC

omm

unic

atio

n in

per

son,

or

by t

elep

hone

, is

cond

ucte

d in

a r

espe

ctfu

l and

cul

tura

lly a

ppro

pria

tem

anne

r.

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d re

port

tha

t pr

ivac

yw

as m

aint

aine

d an

d te

leph

one

and/

or p

erso

nal

cont

act

was

res

pect

ful a

nd c

ultu

rally

app

ropr

iate

.2.

A

ll ot

her

crite

ria a

re m

et.

3.4

CO

MM

UN

ICAT

ION

ABO

UT

BRE

AST

SCRE

EN A

OT

EARO

A –

MED

IA S

TRA

TEG

IES

AN

D C

OM

MU

NIC

ATIO

N

All

Brea

stSc

reen

Aot

earo

a m

edia

com

mun

icat

ion

ispr

esen

ted

in a

nat

iona

lly c

onsis

tent

and

acc

urat

em

anne

r.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

3.5

CO

MM

UN

ICA

TIO

N A

BO

UT

BR

EA

STSC

RE

EN

AO

TE

AR

OA

– V

ISU

AL

IDE

NT

ITY

GU

IDE

All

mat

eria

l ide

ntify

ing

Brea

stSc

reen

Aot

earo

a m

ust

com

ply

with

the

Brea

stSc

reen

Aot

earo

a Vi

sual

Iden

tity

Gui

de a

vaila

ble

from

Lea

d Pr

ovid

ers

or IS

P M

anag

ers.

The

inte

rnal

aud

it pr

oces

s co

nfirm

s co

mpl

ianc

e w

ithth

e Vi

sual

Iden

tity

Gui

de.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

9.

Info

rma

tion

Pri

vacy

In

div

idu

al

cli

nic

al

record

s a

re u

niq

ue t

o e

ach

wom

an

, p

rote

cte

d f

rom

un

au

thoris

ed

access a

nd

trea

ted

con

fid

en

tia

lly.

9.1

IN

FOR

MA

TIO

N P

RIV

AC

Y

All

staf

f ens

ure

that

the

con

fiden

tialit

y an

d pr

ivac

y of

info

rmat

ion

is en

sure

d an

d m

aint

aine

d.T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crit

eria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

s ar

ead

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

All

crite

ria a

re m

et.

Sta

nd

ard

10

. Cl

inic

al

Rec

ord

Ea

ch

wom

an

’s c

lin

ica

l record

provid

es a

n a

ccu

ra

te r

ecord

of

servic

es r

eceiv

ed

an

d i

s r

ea

dil

y a

ccessib

le t

o t

he r

ele

va

nt

cli

nic

ian

s.

10

.1 C

LIN

ICA

L R

EC

OR

D K

EE

PIN

GEa

ch w

oman

’s c

linic

al r

ecor

ds (i

nclu

ding

film

s, s

lides

and

repo

rts)

are

acc

urat

e, a

cces

sible

, aut

horis

ed a

ndco

mpl

ete.

1.

Mon

thly

aud

iting

of c

linic

al r

ecor

ds fo

r w

omen

scre

ened

dur

ing

the

prev

ious

mon

th a

t ea

chsc

reen

ing

and

asse

ssm

ent

site

(thi

s m

ay o

ccur

inco

njun

ctio

n w

ith t

he D

ata

Qua

lity

Plan

requ

irem

ents

). 2.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

100%

of r

ecor

ds a

udite

d ar

e co

mpl

ete

and

accu

rate

.2.

A

ll ot

her

crite

ria a

re m

et.

10

.2 C

LIN

ICA

L R

EC

OR

D M

AN

AG

EM

EN

TEa

ch w

oman

’s c

linic

al r

ecor

ds (i

nclu

ding

film

s, s

lides

and

repo

rts)

are

app

ropr

iate

ly r

efer

ence

d, k

ept

secu

re, t

rack

ed a

nd r

eadi

ly a

cces

sible

.

1.

Mon

thly

aud

iting

of c

linic

al r

ecor

ds fo

r w

omen

scre

ened

dur

ing

the

prev

ious

mon

th a

t ea

chsc

reen

ing

unit/

asse

ssm

ent

site.

(Thi

s m

ay o

ccur

in c

onju

nctio

n w

ith t

he D

ata

Qua

lity

Plan

requ

irem

ents

). 2.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

100%

of h

ard

copy

clin

ical

rec

ords

aud

ited

are

refe

renc

ed, s

ecur

ed, t

rack

ed a

nd r

eadi

lyac

cess

ible

.2.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

6.

Sup

por

t/A

dvo

cacy

Ea

ch

wom

an

’s r

igh

t to

ha

ve s

up

port

person

s a

nd

/or a

dvoca

tes p

resen

t is

recogn

ised

an

d u

ph

eld

.

6.1

RIG

HT

SPr

ovid

ers

resp

ect

the

wom

an’s

rig

ht t

o a

supp

ort

pers

on o

r ad

voca

te b

eing

pre

sent

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d, w

ho c

hose

to h

ave

asu

ppor

t per

son

or a

dvoc

ate

with

them

, rep

ort t

hat

they

wer

e en

cour

aged

to b

ring

a su

ppor

t per

son,

and

that

they

wer

e m

ade

to fe

el w

elco

me.

2.

All

othe

r cr

iteria

are

met

.

Sta

nd

ard

7.

Per

son

al

Pri

vacy

Th

e p

hysic

al

en

vir

on

men

t a

nd

pra

cti

ces a

t a

ll B

rea

stS

creen

Aote

aroa

fa

cil

itie

s p

rovid

e p

erson

al

priv

acy f

or a

ll w

om

en

pa

rti

cip

ati

ng i

n t

he

Progra

mm

e.

7.1

PR

IVA

CY

IN

DIC

AT

OR

The

per

sona

l priv

acy

of e

ach

wom

an r

ecei

ving

serv

ices

is r

espe

cted

at

all t

imes

.1.

Sa

tisfa

ctio

n su

rvey

s.2.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

95%

of w

omen

sur

veye

d re

port

tha

t th

eir

priv

acy

was

res

pect

ed.

2.

All

othe

r cr

iteria

are

met

.

Sta

nd

ard

8.

Com

pla

int

Ma

na

gem

ent

Th

e r

igh

t of

ea

ch

wom

an

to c

om

pla

in,

if d

issa

tisfi

ed

wit

h t

he s

ervic

e,

is u

ph

eld

by B

rea

stS

creen

Aote

aroa

sta

ff.

8.1

CO

MP

LAIN

T M

AN

AG

EM

EN

TA

cle

arly

doc

umen

ted

and

acce

ssib

le p

roce

ss fo

r th

eid

entif

icat

ion,

man

agem

ent

and

reso

lutio

n of

com

plai

nts.

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

par

ticip

atin

g in

the

Pro

gram

me

surv

eyed

hav

e re

ceiv

ed d

etai

led

info

rmat

ion

ofth

e co

mpl

aint

pro

cess

.2.

10

0% o

f com

plai

nts

are

man

aged

in a

ccor

danc

ew

ith th

e se

rvic

e’s

spec

ified

pol

icy

and

timef

ram

es.

3.

All

othe

r cr

iteria

are

met

.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

12.

Qu

ali

ty a

nd

Ris

k M

an

age

men

t Th

e s

afe

ty o

f th

e w

om

en

, sta

ff a

nd

oth

ers i

s p

rote

cte

d t

hrou

gh

com

preh

en

siv

e q

ua

lity

an

d r

isk m

an

agem

en

t syste

ms.

12

.1 Q

UA

LIT

Y M

AN

AG

EM

EN

T S

YST

EM

ST

he B

reas

tScr

een

Aot

earo

a Pr

ovid

er h

as a

nes

tabl

ished

, qua

lity

and

risk

man

agem

ent

syst

em t

hat

refle

cts

cont

inuo

us q

ualit

y im

prov

emen

t pr

inci

ples

.

The

inte

rnal

aud

it pr

oces

s sh

all:

1.

eval

uate

doc

umen

tatio

n an

d im

plem

enta

tion

ofth

e qu

ality

man

agem

ent

plan

2.

eval

uate

com

plia

nce

of s

taff

in m

eetin

g th

ere

quire

men

ts o

f the

qua

lity

man

agem

ent

syst

em3.

en

sure

iden

tifie

d no

n-co

mpl

ianc

es a

re a

ddre

ssed

at t

he e

arlie

st o

ppor

tuni

ty.

All

crite

ria a

re m

et.

12

.2 C

ON

TIN

UO

US

QU

ALI

TY

IM

PR

OV

EM

EN

T (

CQ

I) –

RIS

K M

AN

AG

EM

EN

T S

YST

EM

SPo

licie

s an

d pr

oced

ures

hav

e a

risk

man

agem

ent

focu

s to

max

imise

the

saf

ety

of w

omen

, sta

ff an

dot

hers

thr

ough

the

iden

tific

atio

n an

d m

inim

isatio

n of

prev

enta

ble

and/

or a

void

able

risk

s th

roug

hout

the

Prog

ram

me.

The

inte

rnal

aud

it pr

oces

s sh

all:

1.

ensu

re t

he r

isk m

anag

emen

t sy

stem

ref

lect

sco

ntin

uous

qua

lity

impr

ovem

ent

prin

cipl

es2.

ev

alua

te s

taff

com

plia

nce

in m

eetin

g th

ere

quire

men

ts o

f the

risk

man

agem

ent

syst

em3.

en

sure

iden

tifie

d no

n-co

mpl

ianc

e iss

ues

are

addr

esse

d at

the

ear

liest

opp

ortu

nity

.

All

crite

ria a

re m

et.

Sta

nd

ard

13.

Ad

vers

e/Se

nti

nel

Eve

nts

Rep

orti

ng

Th

ere i

s a

rob

ust

process f

or a

dverse/sen

tin

el

even

t m

an

agem

en

t, w

hic

h i

s l

inked

to t

he C

on

tin

uou

s Q

ua

lity

Im

provem

en

t (C

QI)

pro

cess t

o e

nsu

re

the s

afe

ty o

f w

om

en

, sta

ff a

nd

oth

ers i

s p

rote

cte

d.

13

.1 A

DV

ER

SE/S

EN

TIN

EL

EV

EN

TS

RE

PO

RT

ING

The

Pro

vide

r sy

stem

atic

ally

rec

ords

all

adve

rse/

sent

inel

, unp

lann

ed o

r un

tow

ard

even

ts.

The

inte

rnal

aud

it pr

oces

s co

nfirm

s th

at t

head

vers

e/se

ntin

el e

vent

s re

port

ing

syst

em is

ava

ilabl

ean

d co

mpl

ied

with

.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

11.

Da

ta M

an

age

men

tA

ll d

ata

coll

ecte

d i

s a

ccu

ra

te,

reli

ab

le a

nd

rep

orte

d i

n a

con

sis

ten

t a

nd

tim

ely

ma

nn

er e

nsu

rin

g e

ach

wom

an

ha

s c

on

fid

en

ce i

n t

he d

ata

ma

na

gem

en

t of

the P

rogra

mm

e.

11

.1D

AT

A M

AN

AG

EM

EN

T –

ELE

CT

RO

NIC

CLI

NIC

AL

INFO

RM

AT

ION

SY

STE

MT

he c

linic

al in

form

atio

n sy

stem

com

plie

s w

ithle

gisla

tive

requ

irem

ents

, Gov

ernm

ent

polic

y on

heal

th in

form

atio

n, a

nd n

ew p

olic

y pr

inci

ples

whe

reap

prop

riate

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

11

.2 D

AT

A M

AN

AG

EM

EN

T –

DA

TA

CO

LLE

CT

ION

AN

D M

ON

ITO

RIN

GSu

ffici

ent

data

are

col

lect

ed t

o en

able

Bre

astS

cree

nA

otea

roa

Prov

ider

s to

ope

rate

at

the

high

est

stan

dard

and

to

unde

rtak

e/pa

rtic

ipat

e in

eva

luat

ion

at b

oth

a re

gion

al a

nd n

atio

nal l

evel

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

11

.3 D

AT

A M

AN

AG

EM

EN

T –

DA

TA

IN

TE

GR

ITY

11

.4 D

AT

A M

AN

AG

EM

EN

T –

RE

LEA

SE O

F D

AT

A

The

Bre

astS

cree

n A

otea

roa

Prov

ider

will

ens

ure

that

capt

ured

dat

a is

accu

rate

and

com

plet

e be

fore

use

.1.

M

onth

ly a

uditi

ng o

f clin

ical

rec

ords

for

wom

ensc

reen

ed d

urin

g th

e pr

evio

us m

onth

at

each

scre

enin

g an

d as

sess

men

t sit

e. (T

his

may

occ

urin

con

junc

tion

with

the

Dat

a Q

ualit

y Pl

anre

quire

men

ts).

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.10

0% o

f rec

ords

aud

ited

wer

e en

tere

d co

rrec

tlyin

to t

he s

yste

m.

2.

All

crite

ria a

re m

et.

The

Brea

stSc

reen

Aot

earo

a Pr

ovid

er w

ill en

sure

that

wom

en’s

pers

onal

info

rmat

ion

and

data

abo

ut w

omen

is us

ed in

a w

ay th

at is

con

siste

nt w

ith B

SA o

vera

llpu

rpos

e an

d go

als, p

rote

cts

the

inte

rest

s an

d pr

ivac

y of

wom

en in

volv

ed in

the

Prog

ram

me,

whi

lst c

ompl

ying

with

hea

th in

form

atio

n an

d pr

ivac

y le

gisla

tion.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

15.

Pro

gra

mm

e M

an

age

men

t a

nd

Off

icia

l R

equ

irem

ents

Th

e B

rea

stS

creen

Aote

aroa

progra

mm

e i

s e

ffecti

vely

an

d e

ffic

ien

tly m

an

aged

by e

ach

Provid

er a

nd

en

su

res a

hig

h l

evel

of

pu

bli

c c

on

fid

en

ce.

Sta

nd

ard

16

. H

um

an

Res

ourc

e M

an

age

men

t P

rocesses a

nd

syste

ms e

nsu

re t

ha

t h

um

an

resou

rce m

an

agem

en

t com

pli

es w

ith

good

em

plo

ym

en

t p

ra

cti

ce a

nd

legis

lati

on

.

15

.1 P

RO

GR

AM

ME

MA

NA

GE

ME

NT

16

.1 H

UM

AN

RE

SOU

RC

E M

AN

AG

EM

EN

T

The

day

-to-

day

oper

atio

n of

the

ser

vice

is m

anag

edin

an

effic

ient

and

effe

ctiv

e m

anne

r w

hich

ens

ures

the

prov

ision

of t

imel

y, a

ppro

pria

te a

nd s

afe

serv

ices

to a

ll w

omen

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Hum

an r

esou

rce

man

agem

ent

proc

esse

s ar

eco

nduc

ted

in a

ccor

danc

e w

ith g

ood

empl

oym

ent

prac

tice

and

mee

t th

e le

gisla

tive

requ

irem

ents

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

15

.2 L

EG

ISLA

TIV

E R

EQ

UIR

EM

EN

TS

The

day

-to-

day

oper

atio

n of

the

Pro

gram

me

com

plie

s w

ith t

he p

rinci

ples

and

det

ail o

f rel

evan

tle

gisla

tion.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

15

.3 S

TA

ND

AR

DS

The

Bre

astS

cree

n A

otea

roa

Prov

ider

util

ises

rele

vant

Stan

dard

s as

gui

delin

es fo

r ev

iden

ce in

form

edpr

actic

e.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

14

. G

ener

al

Pra

ctic

e/P

rim

ary

Ca

re P

rovi

der

Lia

ison

E

ffecti

ve l

inks w

ith

Gen

era

l P

ra

cti

tion

ers a

nd

oth

er P

rim

ary C

are P

rovid

ers i

nclu

din

g M

aori,

or P

acif

ic P

rovid

ers a

re e

sta

bli

sh

ed

an

d m

ain

tain

ed

.

14

.1 G

EN

ER

AL

PR

AC

TIC

E (

GP

)/P

RIM

AR

Y C

AR

E P

RO

VID

ER

(P

CP

) IN

VO

LVE

ME

NT

The

impo

rtan

ce o

f str

ong

rela

tions

with

Gen

eral

Prac

titio

ners

(GPs

) and

Prim

ary

Car

e Pr

ovid

ers

(PC

Ps),

whi

ch in

clud

e M

aori

and

Paci

fic P

rovi

ders

are

reco

gnise

d by

Lea

d Pr

ovid

ers

and

ISPs

.

1.

Satis

fact

ion

surv

eys

of G

Ps/P

CPs

.2.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

95%

of G

Ps/P

CPs

sur

veye

d re

port

tha

t th

ey a

read

equa

tely

invo

lved

and

info

rmed

by

Brea

stSc

reen

Aot

earo

a Le

ad P

rovi

ders

and

ISPs

.2.

A

ll ot

her

crite

ria a

re m

et.

14

.2G

EN

ER

AL

PR

AC

TIC

E (

GP

)/P

RIM

AR

Y C

AR

E P

RO

VID

ER

(P

CP

) L

IAIS

ON

– C

OM

MU

NIC

AT

ING

RE

SULT

ST

he G

P/PC

P sh

all b

e ke

pt in

form

ed o

f the

res

ults

pert

aini

ng t

o w

omen

from

with

in t

heir

prac

tice.

1.

Satis

fact

ion

surv

eys

of G

Ps/P

CPs

.2.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

95%

of G

Ps/P

CPs

sur

veye

d re

port

tha

t fe

edba

ckfr

om B

reas

tScr

een

Aot

earo

a Le

ad P

rovi

ders

ispr

ompt

and

acc

urat

e.2.

A

ll ot

her

crite

ria a

re m

et.

14

.3W

OR

KIN

G R

EL

AT

ION

SHIP

BE

TW

EE

N L

EA

D P

RO

VID

ER

S A

ND

IN

DE

PE

ND

EN

T S

ER

VIC

E P

RO

VID

ER

S Le

ad P

rovi

ders

and

Inde

pend

ent S

ervi

ce P

rovi

ders

wor

k to

geth

er in

par

tner

ship

to d

eliv

er B

reas

tScr

een

Aot

earo

a se

rvic

es.

Brea

stSc

reen

Aot

earo

a Pr

ovid

ers

reco

gnise

the

rol

eth

at IS

Ps fu

lfil i

n th

e Pr

ogra

mm

e, p

artic

ular

ly in

outli

ning

the

ben

efits

and

lim

itatio

ns o

f scr

eeni

ngm

amm

ogra

phy

to p

riorit

y w

omen

, co-

ordi

natin

g on

-go

ing

care

, enc

oura

ging

wom

en t

o at

tend

furt

her

roun

ds o

f scr

eeni

ng a

nd p

rovi

ding

info

rmat

ion

and

supp

ort

for

the

wom

en.

1.

Satis

fact

ion

surv

eys

of IS

Ps.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

20

. H

ealt

h P

rom

otio

nH

ea

lth

prom

oti

on

acti

vit

ies a

re p

lan

ned

an

d d

eli

vered

wit

hin

recogn

ised

pu

bli

c h

ea

lth

pop

ula

tion

ba

sed

prom

oti

on

al

fra

mew

orks.

Th

is w

ill

en

su

re m

ax

imu

m p

arti

cip

ati

on

ba

sed

on

evid

en

ce-i

nfo

rm

ed

str

ate

gie

s t

o i

ncrea

se a

wa

ren

ess a

nd

in

form

ed

ch

oic

e.

20

.1 H

EA

LTH

PR

OM

OT

ION

– O

BJE

CT

IVE

SH

ealth

pro

mot

ion

plan

s an

d st

rate

gies

sup

port

the

over

all o

bjec

tives

of B

reas

tScr

een

Aot

earo

a in

the

redu

ctio

n of

illn

ess,

disa

bilit

y an

d de

ath

from

bre

ast

canc

er a

nd m

eet t

he k

ey h

ealth

pro

mot

ion

obje

ctiv

es.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

20

.2 H

EA

LTH

PR

OM

OT

ION

MA

NA

GE

ME

NT

Effe

ctiv

e he

alth

pro

mot

ion

man

agem

ent

ensu

res

the

impl

emen

tatio

n of

app

ropr

iate

hea

lth p

rom

otio

npr

inci

ples

and

pra

ctic

es t

hrou

gh t

he d

evel

opm

ent

and

supp

ort

of t

hose

invo

lved

in h

ealth

pro

mot

ion.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

20

.3 H

EA

LTH

PR

OM

OT

ION

MA

NA

GE

ME

NT

– G

EN

ER

AL

RE

QU

IRE

ME

NT

S

20

.4 I

NV

ITA

TIO

N –

ELI

GIB

ILIT

Y O

F W

OM

EN

Hea

lth p

rom

otio

n st

rate

gies

are

alig

ned

with

the

Publ

ic H

ealth

Ser

vice

s H

andb

ook

and

the

Nat

iona

lH

ealth

Pro

mot

ion

Stra

tegy

for

Brea

stSc

reen

Aot

earo

a.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et

Onl

y el

igib

le w

omen

are

invi

ted

to p

artic

ipat

e in

Brea

stSc

reen

Aot

earo

a.T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crit

eria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

s ar

ead

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

17.

Wom

en T

ran

sfer

rin

g Bet

wee

n L

ead

Pro

vid

ers

Wom

en

wh

o m

ove b

etw

een

regio

ns a

t a

ny s

tage d

urin

g t

heir

in

volv

em

en

t w

ith

Brea

stS

creen

Aote

aroa

wil

l b

e m

an

aged

eff

icie

ntl

y t

o e

nsu

re

con

tin

uit

y o

f ca

re.

17

.1 W

OM

EN

TR

AN

SFE

RR

ING

BE

TW

EE

N L

EA

D P

RO

VID

ER

SEa

ch w

oman

is t

rans

ferr

ed b

etw

een

Lead

Pro

vide

rsac

cord

ing

to t

he c

urre

nt D

ata

Man

agem

ent

Man

ual

(DM

M) r

equi

rem

ents

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Sta

nd

ard

18.

New

Tec

hn

olog

ies

New

tech

nolo

gie

s a

re u

tili

sed

in

accord

an

ce w

ith

th

e N

ati

on

al

Screen

ing U

nit

’s F

ra

mew

ork F

or N

ew

Tech

nolo

gy A

ssessm

en

t.

18

.1 N

EW

TE

CH

NO

LOG

IES

The

app

rova

l and

incl

usio

n of

new

tec

hnol

ogie

s ar

em

anag

ed in

acc

orda

nce

with

evi

denc

e in

form

edpr

inci

ples

and

the

Nat

iona

l Scr

eeni

ng U

nit’s

Fram

ewor

k fo

r N

ew T

echn

olog

y A

sses

smen

t,re

leva

nt p

olic

ies

and

proc

edur

es a

nd e

thic

al r

evie

ww

here

req

uire

d.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Sta

nd

ard

19

. R

esea

rch

Th

e S

ervic

e h

as e

sta

bli

sh

ed

proto

cols

for c

on

du

cti

ng a

nd

/or p

arti

cip

ati

ng i

n r

esea

rch

acti

vit

ies.

19

.1R

ESE

AR

CH

Rese

arch

app

licat

ions

and

app

rove

d re

sear

chpr

ojec

ts (i

nclu

ding

clin

ical

tria

ls an

d st

udie

s) a

rem

anag

ed in

acc

orda

nce

with

the

evi

denc

e in

form

edpr

inci

ples

, cur

rent

legi

slatio

n, t

he N

atio

nal S

cree

ning

Uni

t an

d Br

east

Scre

en A

otea

roa

Prov

ider

s po

licie

san

d pr

oced

ures

for

rese

arch

, the

Cod

e of

Rig

hts

1996

and

eth

ical

rev

iew

req

uire

men

ts.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

21.

En

teri

ng

the

Pro

gra

mm

eE

ach

wom

an

’s i

nte

rest

in p

arti

cip

ati

ng i

n B

rea

stS

creen

Aote

aroa

is a

pp

rop

ria

tely

record

ed

an

d a

n i

nit

ial

ap

poin

tmen

t is

ma

de e

ffic

ien

tly.

21

.1 E

NT

ER

ING

TH

E P

RO

GR

AM

ME

– A

PP

OIN

TM

EN

T M

AK

ING

All

elig

ible

wom

en w

ill r

ecei

ve a

n ap

prop

riate

invi

tatio

n to

att

end

an a

ppoi

ntm

ent

with

Brea

stSc

reen

Aot

earo

a.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

21

.2 E

NT

ER

ING

TH

E P

RO

GR

AM

ME

– S

PE

CIA

L N

EE

DS

Info

rmat

ion

rela

ting

to s

peci

al n

eeds

is o

btai

ned

prio

r to

the

fina

lisin

g of

an

appo

intm

ent

for

aw

oman

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

21

.3 E

NT

ER

ING

TH

E P

RO

GR

AM

ME

– S

IGN

IFIC

AN

T S

YM

PT

OM

S P

RIO

R T

O A

TT

EN

DA

NC

E

Sta

nd

ard

22.

Firs

t Im

pre

ssio

ns

Ea

ch

wom

an

ex

perie

nces a

welc

om

ing a

nd

help

ful

resp

on

se w

hen

fir

st

ma

kin

g c

on

tact

wit

h t

he P

rogra

mm

e.

Wom

en w

ho in

dica

te c

urre

nt s

ympt

oms,

tha

t ha

veno

t pr

evio

usly

bee

n in

vest

igat

ed, p

rior

to a

tten

danc

eat

scr

eeni

ng, s

hall

be a

dvise

d to

see

the

ir G

P/PC

Pfo

r a

cons

ulta

tion.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

22

.1 F

IRST

IM

PR

ESS

ION

S –

FIR

ST P

OIN

T O

F E

NT

RY

Tele

phon

e an

d re

cept

ion

staf

f dem

onst

rate

effe

ctiv

eco

mm

unic

atio

n an

d lis

teni

ng s

kills

, and

res

pond

in a

prof

essio

nal m

anne

r.

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d fin

d th

e re

cept

ion

and

book

ing

staf

f pro

fess

iona

l, ca

ring

and

help

ful.

2.

All

othe

r cr

iteria

are

met

.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

20

.5 H

EA

LTH

PR

OM

OT

ION

– R

EG

ION

AL

HE

ALT

H P

RO

MO

TIO

N P

LAN

A r

egio

nal h

ealth

pro

mot

ion

plan

is d

evel

oped

,m

onito

red

and

eval

uate

d an

nual

ly a

nd is

con

siste

ntw

ith t

he p

rinci

ples

of a

pop

ulat

ion

base

d sc

reen

ing

prog

ram

me,

hea

lth p

rom

otio

n pr

inci

ples

and

isal

igne

d to

the

Nat

iona

l Hea

lth P

rom

otio

n St

rate

gyfo

r th

e N

atio

nal S

cree

ning

Uni

t.

1.

The

inte

rnal

aud

it pr

oces

s co

nfirm

s th

at t

here

gion

al h

ealth

pro

mot

ion

plan

is a

vaila

ble

and

impl

emen

ted.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

All

crite

ria a

re m

et.

20

.6 H

EA

LTH

PR

OM

OT

ION

– R

EG

ION

AL

STR

AT

EG

IES

Hea

lth p

rom

otio

n pr

actit

ione

rs a

re r

espo

nsib

le fo

rin

clud

ing

in t

heir

plan

app

ropr

iate

reg

iona

l str

ateg

ies

that

rai

se a

war

enes

s, e

ncou

rage

par

ticip

atio

n an

din

form

abo

ut B

reas

tScr

een

Aot

earo

a.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

20

.7 H

EA

LTH

PR

OM

OT

ION

– H

EA

LTH

ED

UC

AT

ION

20

.8 H

EA

LTH

PR

OM

OT

ION

– R

ESO

UR

CE

S

20

.9 H

EA

LTH

PR

OM

OT

ION

– A

DV

OC

AC

Y

Wom

en-f

ocus

ed h

ealth

edu

catio

n st

rate

gies

and

reso

urce

s en

cour

age

wom

en t

o m

ake

fully

info

rmed

deci

sions

abo

ut p

artic

ipat

ing

in B

reas

tScr

een

Aot

earo

a.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Brea

stSc

reen

Aot

earo

a he

alth

pro

mot

ion

reso

urce

sar

e de

velo

ped

to p

rovi

de in

form

atio

n ab

out

the

Prog

ram

me

and

enco

urag

e el

igib

le w

omen

to

part

icip

ate.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

The

use

of a

ppro

pria

te s

trat

egie

s to

rai

se t

he p

rofil

eof

Bre

astS

cree

n A

otea

roa

in t

he c

onte

xt o

f wom

en’s

heal

th.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

20

.10

HE

ALT

H P

RO

MO

TIO

N –

WO

RK

FOR

CE

DE

VE

LOP

ME

NT

App

ropr

iate

ly t

rain

ed p

erso

nnel

del

iver

hea

lthpr

omot

ion

with

in B

reas

tScr

een

Aot

earo

a.T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crit

eria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

s ar

ead

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

23

.6 S

CR

EE

NIN

G –

RO

UT

INE

VIE

WS

PE

RFO

RM

ED

All

scre

enin

g ex

amin

atio

ns s

hall

be c

ompr

ehen

sive

and

com

plet

e w

ith u

nnec

essa

ry e

xpos

ure

tora

diat

ion

kept

to

a m

inim

um.

1.

The

MRT

mon

thly

pee

r re

view

pro

cess

will

revi

ew fi

lms

for

com

plet

enes

s. (R

efer

: Sec

tion

4,Pr

ofes

siona

l Req

uire

men

ts: M

edic

al R

adia

tion

Tech

nolo

gist

and

App

endi

x N

: Mam

mog

raph

icIm

age

Qua

lity

(MIQ

) Cla

ssifi

catio

n.)

2.

Mon

thly

aud

iting

of c

linic

al r

ecor

ds fo

r w

omen

scre

ened

dur

ing

the

prev

ious

mon

th a

t ea

chsc

reen

ing

unit

(Thi

s m

ay o

ccur

in c

onju

nctio

nw

ith t

he D

ata

Man

agem

ent

Man

ual

requ

irem

ents

). 3.

In

form

atio

n is

colle

cted

thr

ough

the

Nat

iona

lM

inim

um D

ata

Set

for

mon

itorin

g an

d ev

alua

tion

purp

oses

(Ref

er: C

urre

nt D

MM

).

1.

100%

of a

ll sc

reen

ing

exam

inat

ions

are

com

preh

ensiv

e an

d co

mpl

ete

acco

rdin

g to

MIQ

Cla

ssifi

catio

n. (R

efer

: App

endi

x N

:M

amm

ogra

phic

Imag

e Q

ualit

y (M

IQ)

Cla

ssifi

catio

n.)

2.

>80

% o

f wom

en s

cree

ned

have

four

film

s or

less

.

23

.7 S

CR

EE

NIN

G –

SP

EC

IAL

IMA

GIN

G P

RO

TO

CO

LSSp

ecifi

c im

agin

g pr

otoc

ols

are

used

with

in s

cree

ning

units

for

wom

en w

ho h

ave

larg

e br

east

s, b

reas

tim

plan

ts, h

ad a

mas

tect

omy,

bre

ast

cons

erva

tion

surg

ery

or a

re a

t hi

gh r

isk.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

23

.8 S

CR

EE

NIN

G –

FIL

M I

DE

NT

IFIC

AT

ION

LA

BE

LLIN

GEa

ch m

amm

ogra

phic

imag

e sh

all h

ave

the

follo

win

gin

form

atio

n on

it in

a p

erm

anen

t, le

gibl

e, a

ndun

ambi

guou

s m

anne

r an

d pl

aced

so

as n

ot t

oob

scur

e an

atom

ic s

truc

ture

s.

1.M

onth

ly a

uditi

ng o

f clin

ical

rec

ords

for

wom

en s

cree

ned

duri

ng t

he p

revi

ous

mon

that

eac

h sc

reen

ing

unit.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

100%

of f

ilms

are

corr

ectly

labe

lled.

2.

All

othe

r cr

iteria

are

met

.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

23.

Scre

enin

g Th

e s

creen

ing s

ervic

e i

s w

ell

wom

en

-cen

tred

an

d p

rod

uces t

imely

, reli

ab

le a

nd

hig

h q

ua

lity

resu

lts.

23

.1 S

CR

EE

NIN

G –

WA

ITIN

G T

IME

ST

he s

cree

ning

uni

t pr

oces

ses

ensu

re t

hat

wom

enar

e no

t ke

pt w

aitin

g un

nece

ssar

ily.

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d re

port

tha

t th

ey d

idno

t w

ait

unne

cess

arily

.2.

A

ll ot

her

crite

ria a

re m

et.

23

.2 S

CR

EE

NIN

G –

BR

EA

ST H

IST

OR

YEa

ch w

oman

sha

ll ha

ve a

spe

cifie

d br

east

hist

ory

reco

rded

, and

thi

s in

form

atio

n w

ill b

e m

ade

avai

labl

eto

the

rea

ding

rad

iolo

gist

.

Mon

thly

aud

iting

of c

linic

al r

ecor

ds fo

r w

omen

scre

ened

dur

ing

the

prev

ious

mon

th a

t eac

h sc

reen

ing

unit.

(Thi

s m

ay b

e un

dert

aken

in c

onju

nctio

n w

ith th

eD

ata

Man

agem

ent M

anua

l req

uire

men

ts).

1.

100%

of w

omen

who

com

ply

shal

l hav

e th

esp

ecifi

ed b

reas

t hi

stor

y re

cord

ed s

o th

at it

isre

adily

ava

ilabl

e to

the

rea

ding

rad

iolo

gist

.2.

A

ll ot

her

crite

ria a

re m

et.

23

.3 S

CR

EE

NIN

G –

EX

PLA

NA

TIO

N O

F P

RO

CE

DU

RE

23

.4 S

CR

EE

NIN

G –

MR

T C

OM

MU

NIC

AT

ION

SK

ILLS

AN

D R

AP

PO

RT

23

.5 S

IGN

S A

ND

SY

MP

TO

MS

AT

SC

RE

EN

ING

Each

wom

an r

ecei

ves

a fu

ll ex

plan

atio

n of

the

proc

edur

e be

fore

com

men

cem

ent

of h

er s

cree

n.Sa

tisfa

ctio

n su

rvey

s.95

% o

f wom

en s

urve

yed

repo

rt t

hat

they

rec

eive

dsu

ffici

ent

info

rmat

ion

in o

rder

to

mak

e an

info

rmed

choi

ce, a

nd u

nder

stan

d th

e pr

oces

s.

Each

wom

an fi

nds

the

mam

mog

ram

pro

cess

acce

ptab

le, w

hich

enc

oura

ges

her

retu

rn fo

rsu

bseq

uent

re-

scre

enin

g.

Satis

fact

ion

surv

eys.

95%

of w

omen

sur

veye

d re

port

find

ing

the

MRT

reas

surin

g, c

arin

g an

d he

lpfu

l.

Wom

en w

ho p

rese

nt to

a s

cree

ning

app

oint

men

t with

signs

and

sym

ptom

s sh

all h

ave

thei

r m

amm

ogra

mpe

rfor

med

, but

will

be a

ppro

pria

tely

ref

erre

d fo

rsy

mpt

om m

anag

emen

t of s

cree

ning

out

com

e.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

23

.13

SC

RE

EN

ING

– R

EA

DIN

G T

HE

SC

RE

EN

ING

MA

MM

OG

RA

MT

he r

eadi

ng o

f the

scr

eeni

ng m

amm

ogra

m s

hall

occu

r in

suc

h a

man

ner

as t

o m

axim

ise d

etec

tion

ofan

y m

amm

ogra

phic

abn

orm

ality

tha

t co

uld

beca

ncer

.

1.

Indi

vidu

al r

adio

logi

sts

shal

l rec

eive

per

form

ance

feed

back

, as

spec

ified

in th

e Se

ctio

n 4:

Pro

fess

iona

lSt

anda

rds

– ra

diol

ogist

. The

se r

ecor

ds a

re m

ade

avai

labl

e fo

r ex

tern

al a

udit

as d

e-id

entif

ied

data

.2.

In

form

atio

n is

colle

cted

thr

ough

the

Nat

iona

lM

inim

um D

ata

Set

for

mon

itorin

g an

d ev

alua

tion

purp

oses

(Ref

er: C

urre

nt D

MM

).3.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

Rad

iolo

gist

Spe

cific

Tar

gets

Indi

vidu

al r

adio

logi

sts’

rea

ding

sta

tistic

s sh

all l

iew

ithin

95%

con

fiden

ce in

terv

als

for

rate

s of

can

cer

dete

ctio

n an

d de

tect

ion

of s

mal

l can

cers

. Whe

re a

nin

divi

dual

fails

to

mee

t th

ese

crite

ria, t

he C

linic

alD

irect

or w

ill e

nsur

e st

rate

gies

for

impr

ovin

gpe

rfor

man

ce a

re im

plem

ente

d. T

his

will

be

mon

itore

d by

visi

ting

audi

t te

ams.

1.

Posit

ive

Pred

ictiv

e Va

lue

of s

cree

ning

mam

mog

ram

: >9%

2.

False

pos

itive

rat

e:In

itial

(Pre

vale

nt) S

cree

ning

Exa

min

atio

n <

9%

min

imum

Initi

al (P

reva

lent

) Scr

eeni

ng E

xam

inat

ion

< 6

% d

esire

dSu

bseq

uent

(Inc

iden

t) S

cree

ning

Exa

min

atio

n <

4%

min

imum

Subs

eque

nt (I

ncid

ent)

Scr

eeni

ng E

xam

inat

ion

< 3

% d

esire

d3.

Re

ferr

al t

o as

sess

men

t:In

itial

(Pre

vale

nt) S

cree

ning

Exa

min

atio

n<

10%

min

imum

Initi

al (P

reva

lent

) Scr

eeni

ng E

xam

inat

ion

< 7

% d

esire

dSu

bseq

uent

(Inc

iden

t) S

cree

ning

Exa

min

atio

n <

5%

min

imum

Subs

eque

nt (I

ncid

ent)

Scr

eeni

ng E

xam

inat

ion

< 4

% d

esire

d

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

23

.10

SC

RE

EN

ING

– M

AM

MO

GR

AP

HIC

FIL

M O

PT

ICA

L D

EN

SIT

YM

ean

film

opt

ical

den

sity

is m

aint

aine

d be

twee

n 1.

6–

1.8

in o

rder

to

optim

ise t

he d

etec

tion

of s

mal

lca

ncer

s an

d m

inim

ise r

adia

tion

dose

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

Mea

n op

tical

den

sity

of b

etw

een

1.6

and

1.8

ism

aint

aine

d.2.

A

ll ot

her

crite

ria a

re m

et.

23

.11

SC

RE

EN

ING

– H

IGH

QU

ALI

TY

RA

DIO

GR

AP

HIC

TE

CH

NIQ

UE

All

scre

en d

etec

tabl

e br

east

can

cers

are

sho

wn

onth

e m

amm

ogra

m w

hich

sho

uld

incl

ude

as m

uch

brea

st t

issue

on

the

plat

e as

pos

sible

.

1.

Info

rmat

ion

is co

llect

ed t

hrou

gh t

he N

atio

nal

Min

imum

Dat

a Se

t fo

r m

onito

ring

and

eval

uatio

npu

rpos

es (R

efer

: Cur

rent

DM

M).

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

Tech

nica

l rej

ect

rate

: T

he n

umbe

r of

film

s re

ject

ed a

s a

perc

enta

ge o

fth

e nu

mbe

r of

film

s ta

ken,

cal

cula

ted

sepa

rate

lyfo

r w

omen

who

are

scr

eene

d in

a fi

xed

unit

and

a m

obile

uni

t. Sc

reen

ed o

n a

fixed

uni

t or

a m

obile

uni

t <

3%

2.

Tech

nica

l rec

all r

ate:

T

he n

umbe

r of

wom

en w

ho h

ave

to r

etur

n to

asc

reen

ing

unit

(eith

er fi

xed

or m

obile

) for

furt

her

film

s to

com

plet

e th

eir

scre

enin

g ep

isode

,ex

pres

sed

as a

per

cent

age

of t

he n

umbe

rsc

reen

ed.

Scre

ened

on

a fix

ed u

nit

< 0

.5%

Scre

ened

on

a m

obile

uni

t <

3%

3.

All

othe

r cr

iteria

are

met

.

23

.12

SC

RE

EN

ING

– M

AM

MO

GR

AP

HIC

QU

ALI

TY

ASS

UR

AN

CE

(M

QA

)A

Mam

mog

raph

ic Q

ualit

y A

ssur

ance

(MQ

A)

prog

ram

me

shal

l be

com

plie

d w

ith t

o en

sure

hig

hqu

ality

mam

mog

raph

ic im

agin

g.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

100%

com

plia

nce

with

all

Med

ical

Phy

sics

test

s.2.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

23

.9 S

CR

EE

NIN

G –

FIL

M P

RO

CE

SSIN

GFi

lm q

ualit

y is

not

com

prom

ised

as a

res

ult

of d

elay

sin

film

pro

cess

ing.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.


APPENDICES


APPENDICES

Pro

gram

me

Eval

uati

on T

arge

tsIn

add

ition

to

the

abov

e ev

alua

tion

of t

hePr

ogra

mm

e w

ill in

clud

e:

10.S

peci

ficity

of s

cree

ning

mam

mog

ram

(act

ual):

*>

93%

11.S

peci

ficity

of P

rogr

amm

e (a

ppro

xim

ate)

: >

93%

12.S

tand

ardi

sed

Det

ectio

n Ra

tio:

> 0

.75

min

imum

> 1

% d

esire

d13

.Sen

sitiv

ity o

f scr

eeni

ng m

amm

ogra

m*

no t

arge

t8(E

U g

uide

lines

)*N

OT

E: (R

efer

: App

endi

x A

: Glo

ssar

y)

23

.14

SC

RE

EN

ING

– F

ILM

AC

CE

SSIB

ILIT

YBr

east

Scre

en A

otea

roa

reta

ins

owne

rshi

p of

all

orig

inal

mam

mog

ram

film

s ta

ken

with

in t

hePr

ogra

mm

e.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

e cr

iteria

are

com

plie

d w

ith a

nd id

entif

ied

shor

tfalls

are

add

ress

edth

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I)pr

oces

s.

All

crite

ria a

re m

et.

Sta

nd

ard

24

. O

utc

ome

of S

cree

nin

gW

om

en

are f

oll

ow

ed

up

ap

prop

ria

tely

to e

nsu

re t

hey e

ith

er r

etu

rn

to r

ou

tin

e r

e-s

creen

ing o

r a

re r

eca

lled

to a

ssessm

en

t.

24

.1 O

UT

CO

ME

OF

SCR

EE

NIN

G –

NO

TIF

ICA

TIO

N O

F R

ESU

LTS

OR

RE

CA

LLEa

ch w

oman

rec

eive

s tim

ely

and

accu

rate

notif

icat

ion

of h

er r

esul

ts.

1.

Regu

lar

repo

rts,

whi

ch id

entif

y w

omen

who

are

outs

ide

the

targ

et p

aram

eter

s, s

hall

be g

ener

ated

and

revi

ewed

by

the

Clin

ical

Dire

ctor

and

Lea

dPr

ovid

er M

anag

er o

r a

desig

nate

d in

divi

dual

.2.

In

form

atio

n is

colle

cted

thr

ough

the

Nat

iona

lM

inim

um D

ata

Set

for

mon

itorin

g an

d ev

alua

tion

purp

oses

. (Re

fer:

Cur

rent

DM

M)

3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

e cr

iteria

are

com

plie

d w

ith a

nd id

entif

ied

shor

tfalls

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

Film

s m

ust

be r

ead

prom

ptly

eno

ugh

so t

hat

>90

- 9

5% o

f wom

en c

an b

e no

tifie

d w

ithin

10

wor

king

day

s of

the

scr

eeni

ng m

amm

ogra

m.

2.

All

othe

r cr

iteria

are

met

.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

4.

Can

cer

dete

ctio

n ra

te (i

nclu

ding

DC

IS) p

er10

,000

wom

en s

cree

ned:

Initi

al (P

reva

lent

) Scr

eeni

ng E

xam

inat

ion

≥3

x th

e ba

ckgr

ound

inci

denc

e =

69.

0Su

bseq

uent

(Inc

iden

t) S

cree

ning

Exa

min

atio

n≥

1.5

x th

e ba

ckgr

ound

inci

denc

e =

34.

55.

Sm

all i

nvas

ive

scre

en-d

etec

ted

canc

ers

(≤10

mm

) per

10,

000

wom

en s

cree

ned:

In

itial

(Pre

vale

nt) S

cree

ning

Exa

min

atio

n ≥

25%

(of i

nvas

ive

canc

ers)

= 1

7.3

Subs

eque

nt (I

ncid

ent)

Scr

eeni

ng E

xam

inat

ion

≥30

% (o

f inv

asiv

e ca

ncer

s) =

10.

456.

Sm

all i

nvas

ive

scre

en-d

etec

ted

canc

ers

(<15

mm

) per

10,

000

wom

en s

cree

ned:

Initi

al (P

reva

lent

) Scr

eeni

ng E

xam

inat

ion

> 5

0% (o

f inv

asiv

e ca

ncer

s) =

34.

5Su

bseq

uent

(Inc

iden

t) S

cree

ning

Exa

min

atio

n >

50%

(of i

nvas

ive

canc

ers)

= 1

7.3

7.

Nod

e-ne

gativ

e in

vasiv

e sc

reen

-det

ecte

d ca

ncer

s:

Initi

al (P

reva

lent

) Scr

eeni

ng E

xam

inat

ion

> 7

0% (o

f inv

asiv

e ca

ncer

s)Su

bseq

uent

(Inc

iden

t) S

cree

ning

Exa

min

atio

n >

75%

(of i

nvas

ive

canc

ers)

8.

Duc

tal c

arci

nom

a in

situ

(DC

IS):

(of a

ll ca

ncer

s de

tect

ed b

y th

e pr

ogra

mm

e)10

-25%

9.

Inte

rval

can

cers

(inc

ludi

ng D

CIS

):Pe

r 10

,000

wom

en s

cree

ned

with

in o

ne c

alen

dar

year

of p

revi

ous

scre

en<

6.9

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

25.

Ass

essm

ent

Th

e a

ssessm

en

t p

rocess p

rovid

es a

ccu

ra

te d

iagn

osis

for w

om

en

wit

h s

creen

dete

cte

d l

esio

ns a

nd

retu

rn

s t

hose w

ho d

o n

ot

ha

ve b

rea

st

ca

ncer

to r

ou

tin

e r

e-s

creen

ing.

Th

is i

s c

arrie

d o

ut

in a

n e

ffecti

ve a

nd

eff

icie

nt

ma

nn

er t

ha

t is

wom

en

-cen

tred

an

d m

inim

ises m

orb

idit

y.

25

.1 A

SSE

SSM

EN

T –

WA

ITIN

G T

IME

S T

he m

ultid

iscip

linar

y as

sess

men

t te

am fu

nctio

nsef

fect

ivel

y an

d ef

ficie

ntly

in t

he a

sses

smen

t cl

inic

to

ensu

re t

hat

wom

en a

re n

ot k

ept

wai

ting

unne

cess

arily

.

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d re

port

not

wai

ting

unne

cess

arily

dur

ing

the

asse

ssm

ent

clin

ic, o

rth

ey w

ere

info

rmed

of w

hy t

hey

wer

e w

aitin

g.2.

A

ll ot

her

crite

ria a

re m

et.

25

.2 A

SSE

SSM

EN

T –

ED

UC

AT

ION

, IN

FOR

MA

TIO

N A

ND

CO

NSE

NT

The

mem

bers

of t

he m

ultid

iscip

linar

y te

am e

nsur

eth

at e

ach

wom

an a

tten

ding

ass

essm

ent

rece

ives

rele

vant

info

rmat

ion

in a

man

ner

that

ena

bles

her

to

mak

e in

form

ed c

hoic

es r

egar

ding

ass

essm

ent

and

any

furt

her

inte

rven

tions

.

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d w

ho a

tten

ded

asse

ssm

ent c

linic

s re

port

rec

eivi

ng s

uffic

ient

info

rmat

ion

abou

t the

ass

essm

ent p

roce

ss to

mak

ein

form

ed d

ecisi

ons

and

prov

ide

thei

r co

nsen

t.2.

A

ll ot

her

crite

ria a

re m

et.

25

.3 A

SSE

SSM

EN

T –

SU

PP

OR

T

25

.4 A

SSE

SSM

EN

T –

QU

ALI

TY

ASS

UR

AN

CE

PR

OT

OC

OLS

FO

R E

QU

IPM

EN

T

The

wel

lbei

ng o

f eac

h w

oman

und

erta

king

asse

ssm

ent

proc

edur

es is

mon

itore

d by

the

Brea

stca

re N

urse

in a

ssoc

iatio

n w

ith o

ther

mem

bers

of t

he m

ultid

iscip

linar

y te

am.

Satis

fact

ion

surv

eys.

95%

of w

omen

sur

veye

d w

ho a

tten

ded

asse

ssm

ent

repo

rt t

hat

they

rec

eive

d ad

equa

te s

uppo

rt a

nd/o

rap

prop

riate

ref

erra

l whe

re in

dica

ted.

All

equi

pmen

t us

ed fo

r as

sess

men

t m

eets

the

Stan

dard

ref

erre

d to

and

/or

spec

ified

in t

his

docu

men

t.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

100%

of r

epor

ts a

re fo

rwar

ded

to t

he N

atio

nal

Co-

ordi

nato

r of

Mam

mog

raph

y Ph

ysic

s w

ithin

20

wor

king

day

s of

the

Med

ical

Phy

sics

audi

t.2.

95

% o

f def

ects

are

rec

tifie

d w

ithin

the

timef

ram

e sp

ecifi

ed b

y th

e M

edic

al P

hysic

ist.

3.

All

othe

r cr

iteria

are

met

.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Each

wom

an e

ligib

le fo

r ro

utin

e re

-scr

eeni

ng is

invi

ted

back

to

the

prog

ram

me

in a

n ap

prop

riate

timef

ram

e.

1.

Regu

lar

repo

rts

shal

l be

gene

rate

d an

d re

view

edby

the

Lea

d Pr

ovid

er M

anag

er t

o en

sure

sche

dulin

g en

able

s w

omen

to

be s

cree

ned

with

inth

e ta

rget

s an

d tim

efra

mes

.2.

In

form

atio

n is

colle

cted

thr

ough

the

Nat

iona

lM

inim

um D

ata

Set

for

mon

itorin

g an

d ev

alua

tion

purp

oses

(Ref

er: C

urre

nt D

MM

).3.

T

he in

tern

al a

udit

proc

ess

ensu

res

the

crite

riaar

e co

mpl

ied

with

and

iden

tifie

d sh

ortfa

lls a

read

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

> 7

5% o

f wom

en w

ho r

etur

n fo

r a

scre

en a

rere

-scr

eene

d be

twee

n 20

and

24

mon

ths

from

thei

r pr

evio

us s

cree

n.2.

>

85%

of w

omen

scr

eene

d in

a P

rogr

amm

ero

und

are

subs

eque

ntly

(if e

ligib

le) r

e-sc

reen

edin

the

nex

t Pr

ogra

mm

e ro

und.

3.

All

othe

r cr

iteria

are

met

.

24

.3 O

UT

CO

ME

OF

SCR

EE

NIN

G –

RE

CA

LL T

O A

SSE

SSM

EN

TA

ll w

omen

with

mam

mog

raph

ic a

bnor

mal

ities

tha

tm

ay b

e m

alig

nant

are

rec

alle

d to

ass

essm

ent.

1.

Repo

rts

that

iden

tify

wom

en w

ho a

re t

o be

reca

lled

for

asse

ssm

ent

shal

l be

gene

rate

dre

gula

rly a

nd a

re r

evie

wed

by

the

Lead

Pro

vide

rM

anag

er, C

linic

al D

irect

or o

r a

desig

nate

din

divi

dual

and

ret

aine

d fo

r fu

ture

aud

it ac

tiviti

es.

2.

Info

rmat

ion

is co

llect

ed t

hrou

gh t

he N

atio

nal

Min

imum

Dat

a Se

t fo

r m

onito

ring

and

eval

uatio

npu

rpos

es (R

efer

: Cur

rent

DM

M).

3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

e cr

iteria

are

com

plie

d w

ith a

nd id

entif

ied

shor

tfalls

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

90%

of w

omen

are

offe

red

an a

sses

smen

tap

poin

tmen

t w

ithin

15

wor

king

day

s of

the

ir fin

alsc

reen

ing

mam

mog

ram

.2.

A

ll ot

her

crite

ria a

re m

et.

24

.4 O

UT

CO

ME

OF

SCR

EE

NIN

G –

FA

ILU

RE

OR

RE

FUSA

L T

O A

TT

EN

D A

SSE

SSM

EN

TT

he B

reas

tScr

een

Aot

earo

a Pr

ovid

er e

nsur

es t

imel

yan

d ap

prop

riate

follo

w-u

p w

hen

a w

oman

fails

or

refu

ses

to a

tten

d fo

r as

sess

men

t.

1.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

24

.2 O

UT

CO

ME

OF

SCR

EE

NIN

G –

RO

UT

INE

RE

-SC

RE

EN

ING


APPENDICES


APPENDICES

27

.4 L

EV

EL

1 A

SSE

SSM

EN

T –

CLI

NIC

AL

EX

AM

INA

TIO

NA

ll w

omen

req

uirin

g fu

rthe

r in

vasiv

e in

terv

entio

n(L

evel

2 A

sses

smen

t) s

hall

be e

xam

ined

firs

t by

acl

inic

ian

expe

rienc

ed in

bre

ast

exam

inat

ion.

Clin

ical

exam

inat

ion

may

be

offe

red

but

is no

t re

quire

d fo

rw

omen

con

sider

ed n

ot t

o ha

ve b

reas

t ca

ncer

on

Leve

l 1 A

sses

smen

t.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

27

.5 L

EV

EL

1 A

SSE

SSM

EN

T –

ST

AG

ED

ASS

ESS

ME

NT

Stag

ed a

sses

smen

t is

whe

re a

wom

an’s

ass

essm

ent

occu

rs o

n se

para

te o

ccas

ions

ove

r a

num

ber

of s

ites.

1.

Satis

fact

ion

surv

eys.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

affe

cted

by

stag

ed a

sses

smen

tsu

rvey

ed r

epor

t re

ceiv

ing

suffi

cien

t in

form

atio

nab

out

the

asse

ssm

ent

proc

ess

to m

ake

anin

form

ed c

hoic

e ab

out

whi

ch c

entr

e to

att

end.

2.

All

othe

r cr

iteria

are

met

.

Sta

nd

ard

28.

Leve

l 2 A

sses

smen

t –

Non

-Op

era

tive

Dia

gnos

isTh

e n

on

-op

era

tive d

iagn

osis

of

screen

dete

cte

d a

bn

orm

ali

ties i

s m

ax

imis

ed

by o

bta

inin

g a

ccu

ra

te n

eed

le b

iop

sy s

pecim

en

s o

f p

alp

ab

le a

nd

imp

alp

ab

le l

esio

ns.

28

.1 L

EV

EL

2 A

SSE

SSM

EN

T –

MIN

IMIS

ING

DE

LAY

TO

NE

ED

LE B

IOP

SY

28

.2 L

EV

EL

2 A

SSE

SSM

EN

T –

WO

RK

UP,

IN

FOR

MA

TIO

N A

ND

CO

NSE

NT

The

del

ay b

etw

een

the

deci

sion

to p

erfo

rm a

nee

dle

biop

sy a

nd it

bei

ng u

nder

take

n sh

ould

be

min

imise

d.1.

Re

gula

r re

port

s w

hich

iden

tify

wom

en w

ho a

reto

be

reca

lled

for

need

le b

iops

ies

are

revi

ewed

by t

he L

ead

Prov

ider

Man

ager

or

a de

signa

ted

indi

vidu

al.

2.

Info

rmat

ion

is co

llect

ed t

hrou

gh t

he N

atio

nal

Min

imum

Dat

a Se

t fo

r m

onito

ring

and

eval

uatio

npu

rpos

es. (

Refe

r: C

urre

nt D

MM

)

90%

of n

eedl

e bi

opsie

s ar

e pe

rfor

med

with

in 5

wor

king

day

s of

the

firs

t as

sess

men

t vi

sit.

Wom

en s

hall

be g

iven

bot

h ap

prop

riate

info

rmat

ion

wor

k-up

prio

r to

inva

sive

brea

st p

roce

dure

s (L

evel

2an

d Le

vel 3

ass

essm

ent)

bei

ng p

erfo

rmed

.

Mon

thly

aud

iting

of c

linic

al r

ecor

ds fo

r w

omen

scre

ened

dur

ing

the

prev

ious

mon

th a

t ea

chsc

reen

ing

unit.

1.

100%

of r

ecor

ds a

udite

d sh

ow w

omen

pro

vide

dw

ritte

n co

nsen

t be

fore

a L

evel

2 a

sses

smen

t w

asca

rrie

d ou

t.2.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

Sta

nd

ard

26

. M

ult

idis

cip

lin

ary

Ma

na

gem

ent

Ea

ch

sta

ge o

f th

e p

rogra

mm

e i

s c

o-o

rd

ina

ted

in

a m

an

ner t

ha

t p

rom

ote

s a

mu

ltid

iscip

lin

ary t

ea

m a

pp

roa

ch

wh

ere a

pp

rop

ria

te.

26

.1 M

ULT

I-D

ISC

IPLI

NA

RY

TE

AM

– C

LIN

ICA

L A

clo

se, c

o-op

erat

ive

wor

king

rel

atio

nshi

p be

twee

nal

l sta

ff in

volv

ed in

the

Pro

gram

me

ensu

res

anef

fect

ive

mul

tidisc

iplin

ary

appr

oach

to

care

.

1.

A r

egist

er o

f min

utes

for

all t

hese

mee

tings

ishe

ld, i

nclu

ding

att

ende

es.

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

All

crite

ria a

re m

et.

Sta

nd

ard

27.

Lev

el 1

Ass

essm

ent

Wom

en

wit

h a

bn

orm

al

screen

ing m

am

mogra

ms w

ho d

o n

ot

ha

ve a

screen

dete

cte

d l

esio

n r

eq

uir

ing b

iop

sy d

iagn

osis

are r

etu

rn

ed

to r

ou

tin

e r

e-

screen

ing.

27

.1 L

EV

EL

1 A

SSE

SSM

EN

T –

IM

AG

ING

TH

E B

RE

AST

AT

ASS

ESS

ME

NT

27

.2 L

EV

EL

1 A

SSE

SSM

EN

T –

GR

AD

ING

OF

LESI

ON

S

27

.3 L

EV

EL

1 A

SSE

SSM

EN

T –

EX

TE

ND

ED

ASS

ESS

ME

NT

The

rad

iolo

gist

mus

t be

abl

e to

pro

ve a

lesio

n is

beni

gn o

r co

nfirm

a m

alig

nanc

y w

hile

kee

ping

inva

sive

proc

edur

es fo

r be

nign

abn

orm

aliti

es t

o a

min

imum

. The

aim

the

refo

re is

to

incr

ease

spec

ifici

ty w

ithou

t co

mpr

omisi

ng s

ensit

ivity

.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

100%

of r

adio

logi

cal s

peci

alise

d di

agno

stic

tech

niqu

es a

re p

erfo

rmed

by

staf

f com

pete

nt in

the

proc

edur

e an

d ar

e re

view

ed b

y an

othe

rra

diol

ogist

.2.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

At

the

com

plet

ion

of L

evel

1 A

sses

smen

t a

radi

olog

ical

cat

egor

y w

ill b

e as

signe

d to

all

lesio

nsas

sess

ed.

Mon

thly

aud

iting

of c

linic

al r

ecor

ds fo

r w

omen

scre

ened

dur

ing

the

prev

ious

mon

th a

t ea

chsc

reen

ing

unit.

100%

of l

esio

ns a

sses

sed

have

the

ir ca

tego

ryre

cord

ed.

Indi

vidu

al w

omen

may

be

refe

rred

to

‘ext

ende

das

sess

men

t’ as

an

alte

rnat

ive

to b

iops

y w

hen

they

have

a C

ateg

ory

2 le

sion

iden

tifie

d at

ass

essm

ent.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

Exte

nded

ass

essm

ent

case

s sh

all b

e ≤

2% o

fto

tal w

omen

ass

esse

d.2.

A

ll ot

her

crite

ria a

re m

et.


APPENDICES


APPENDICES

28

.7 L

EV

EL

2 A

SSE

SSM

EN

T –

LA

BO

RA

TO

RY

FA

CIL

ITIE

S A

ND

PR

OC

ESS

ES

FOR

RE

PO

RT

ING

ON

SC

RE

EN

DE

TE

CT

ED

MA

TE

RIA

LPa

thol

ogist

s an

d la

bora

torie

s pa

rtic

ipat

ing

in t

hepr

ogra

mm

e m

ust

dem

onst

rate

tha

t th

ere

are

adeq

uate

faci

litie

s an

d pr

oces

ses

for

repo

rtin

g on

scre

en-d

etec

ted

mat

eria

l.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Sta

nd

ard

29

. Le

vel

3 A

sses

smen

t –

Su

rgic

al

Bio

psy

Op

en

su

rgic

al

bio

psy s

hou

ld b

e c

arrie

d o

ut

in a

tim

ely

an

d a

ccu

ra

te m

an

ner t

ha

t m

inim

ises m

orb

idit

y f

or w

om

en

.

29

.1 L

EV

EL

3 A

SSE

SSM

EN

T –

SU

RG

ICA

L B

IOP

SY G

EN

ER

AL

PR

INC

IPLE

ST

he a

im o

f the

ope

n su

rgic

al b

iops

y is

to s

ucce

ssfu

llyid

entif

y an

d re

mov

e m

amm

ogra

phic

ally

det

ecte

dle

sion(

s) fo

r pa

thol

ogic

al a

sses

smen

t w

ith t

hem

inim

um o

f mor

bidi

ty fo

r th

e w

oman

.

1.

Info

rmat

ion

is co

llect

ed t

hrou

gh t

he N

atio

nal

Min

imum

Dat

a Se

t fo

r m

onito

ring

and

eval

uatio

npu

rpos

es (R

efer

: Cur

rent

DM

M).

2.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

Ope

n bi

opsie

s pe

rfor

med

for

beni

gn d

iseas

e pe

r1,

000

wom

en s

cree

ned

Prev

alen

t ≤

3.5,

Inci

dent

≤1.

62.

90

% o

f wom

en r

equi

ring

open

sur

gica

l bio

psy

shou

ld h

ave

thei

r op

erat

ion

perf

orm

ed w

ithin

15

wor

king

day

s of

bei

ng n

otifi

ed fo

r th

e ne

ed fo

rth

is op

erat

ion.

3.

All

othe

r cr

iteria

are

met

.

29

.2 L

EV

EL

3 A

SSE

SSM

EN

T –

PR

E-O

PE

RA

TIV

E L

OC

ALI

SAT

ION

OF

IMPA

LPA

BLE

LE

SIO

NS

Lesio

ns a

re s

ucce

ssfu

lly lo

calis

ed p

reop

erat

ivel

y.T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crit

eria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

s ar

ead

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

> 9

5% o

f im

palp

able

lesio

ns s

houl

d be

succ

essf

ully

loca

lised

pre

oper

ativ

ely.

2.

> 9

0% o

f mar

kers

sho

uld

be w

ithin

10m

m o

fth

e le

sion.

3.

All

othe

r cr

iteria

are

met

.

29

.3 L

EV

EL

3 A

SSE

SSM

EN

T –

OR

IEN

TA

TIO

N O

F SP

EC

IME

NTo

ena

ble

the

radi

olog

ist a

nd t

he p

atho

logi

st t

oor

ient

ate

the

spec

imen

in o

rder

to

assis

t an

ypo

tent

ial w

ider

loca

l exc

ision

, whe

re a

ppro

pria

tem

arki

ng is

ess

entia

l.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

28

.3LE

VE

L 2

ASS

ESS

ME

NT

– N

EE

DLE

BIO

PSY

TIS

SUE

SA

MP

LIN

G O

F SC

RE

EN

DE

TE

CT

ED

LE

SIO

NS

– (F

NA

C),

CO

RE

BIO

PSY

,IN

CLU

DIN

G V

AC

UU

M-A

SSIS

TE

D B

IOP

SY S

PE

CIM

EN

SN

eedl

e bi

opsie

s ar

e us

ed t

o m

axim

ise p

reop

erat

ive

diag

nosis

of c

ance

r an

d no

n-op

erat

ive

diag

nosis

of

beni

gn a

bnor

mal

ities

req

uirin

g fu

rthe

r w

ork-

up.

1.

The

Clin

ical

Dire

ctor

sha

ll en

sure

tha

t th

ese

nsiti

vity

and

spe

cific

ity a

ccor

ding

to

the

oper

ator

, bio

psy

tech

niqu

e, m

ode

and

repo

rtin

gpa

thol

ogist

is m

easu

red

and

mon

itore

d.2.

In

form

atio

n is

colle

cted

thr

ough

the

Nat

iona

lM

inim

um D

ata

Set

for

mon

itorin

g an

d ev

alua

tion

purp

oses

. (Re

fer:

Cur

rent

DM

M)

3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

Scre

en d

etec

ted

canc

ers

are

diag

nose

d pr

e-op

erat

ivel

y:>

70%

min

imum

, > 9

0% d

esire

d.2.

Im

age

guid

ed F

NA

C p

roce

dure

s w

ith a

nin

adeq

uate

/insu

ffici

ent

resu

lt sh

ould

be:

<

25%

min

imum

, < 1

5% d

esire

d.

3.

Oth

er s

ugge

sted

thr

esho

lds

for

cyto

logy

and

core

bio

psy

perf

orm

ance

(Ref

er: A

ppen

dix

W:

FNA

C Q

ualit

y A

ssur

ance

)4.

A

ll ot

her

crite

ria a

re m

et.

28

.4 L

EV

EL

2 A

SSE

SSM

EN

T –

LA

BE

LLIN

G O

F SP

EC

IME

NS

A w

ritte

n pr

otoc

ol fo

r th

e la

belli

ng o

f pat

holo

gysp

ecim

ens

exist

s.T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crit

eria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

s ar

ead

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

All

crite

ria a

re m

et.

28

.5LE

VE

L 2

ASS

ESS

ME

NT

– P

AT

HO

LOG

IC E

XA

MIN

AT

ION

OF

CO

RE

NE

ED

LE B

IOP

SY S

PE

CIM

EN

(C

NB

S)

28

.6 L

EV

EL

2 A

SSE

SSM

EN

T –

PA

TH

OLO

GIC

EX

AM

INA

TIO

N O

F FI

NE

NE

ED

LE A

SPIR

AT

ION

CY

TO

LOG

Y (

FNA

C)

SPE

CIM

EN

S

Succ

essf

ul p

atho

logi

c re

adin

gs o

f spe

cim

ens.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

> 8

0% o

f cor

e bi

opsy

res

ults

are

rep

orte

d to

the

asse

ssm

ent

cent

re w

ithin

3 w

orki

ng d

ays

of a

core

or

vacu

um a

ssist

ed b

iops

y be

ing

perf

orm

ed.

2.

All

othe

r cr

iteria

are

met

.

All

Fine

Nee

dle

Asp

iratio

n C

ytol

ogy

(FN

AC

)sp

ecim

ens

shal

l be

appr

opria

tely

rep

orte

d.T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

riaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent (

CQ

I) pr

oces

s.

1.

100%

of w

ritte

n re

port

s co

ntai

ning

FN

AC

resu

lts a

re r

ecei

ved

by t

he s

cree

ning

ass

essm

ent

unit

with

in 2

wor

king

day

s.2.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES


APPENDICES

Sta

nd

ard

30

. O

utc

ome

of A

sses

smen

tE

ach

wom

an

is n

oti

fied

of

her a

ssessm

en

t resu

lts,

an

d i

f req

uir

ed

, is

refe

rred

to t

rea

tmen

t in

a m

an

ner t

ha

t is

un

bia

sed

an

d c

ogn

iza

nt

of

her

info

rm

ed

decis

ion

.

30

.1 O

UT

CO

ME

OF

ASS

ESS

ME

NT

– N

OT

IFIC

AT

ION

OF

RE

SULT

SEa

ch w

oman

rec

eive

s tim

ely

and

accu

rate

asse

ssm

ent

resu

lt no

tific

atio

n.1.

Re

gula

r re

port

s, w

hich

iden

tify

wom

en w

ho h

ave

not b

een

notif

ied

of th

eir

resu

lts, a

re r

evie

wed

by

the

Lead

Pro

vide

r M

anag

er o

r a

desig

nate

d pe

rson

and

the

reas

on fo

r th

e de

lay

is do

cum

ente

d.2.

In

form

atio

n is

colle

cted

thr

ough

the

Nat

iona

lM

inim

um D

ata

Set

for

mon

itorin

g an

d ev

alua

tion

purp

oses

(Ref

er: C

urre

nt D

MM

).3.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

Tim

e ta

ken

from

fina

l dia

gnos

tic n

eedl

e bi

opsy

to

repo

rtin

g re

sults

to

the

wom

an –

90%

of

wom

en r

ecei

ve r

esul

ts w

ithin

5 w

orki

ng d

ays

offin

al d

iagn

ostic

nee

dle

biop

sy.

2.

All

othe

r cr

iteria

are

met

.

30

.2 O

UT

CO

ME

OF

ASS

ESS

ME

NT

– R

EFE

RR

AL

TO

TR

EA

TM

EN

TC

ompr

ehen

sive

info

rmat

ion

rele

vant

to

her

situa

tion,

prov

ided

with

in a

sup

port

ive

envi

ronm

ent,

allo

ws

the

wom

an t

o m

ake

an in

form

ed d

ecisi

on r

egar

ding

her

trea

tmen

t op

tions

and

the

pro

cess

of a

wom

an’s

refe

rral

to

trea

tmen

t.

1.

Satis

fact

ion

surv

eys.

2.

Info

rmat

ion

is co

llect

ed t

hrou

gh t

he N

atio

nal

Min

imum

Dat

a Se

t fo

r m

onito

ring

and

eval

uatio

npu

rpos

es (R

efer

: Cur

rent

DM

M).

3.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

95%

of w

omen

sur

veye

d re

port

tha

t th

ey a

resa

tisfie

d w

ith t

he in

form

atio

n th

at w

as p

rovi

ded

in c

hoos

ing

a tr

eatm

ent

prov

ider

.2.

90

% o

f wom

en s

houl

d no

rmal

ly r

ecei

ve t

heir

first

sur

gica

l tre

atm

ent

with

in 2

0 w

orki

ng d

ays

ofre

ceiv

ing

thei

r fin

al d

iagn

ostic

res

ults

.3.

D

ata

entr

y of

tre

atm

ent

outc

omes

(in

part

icul

arhi

stop

atho

logy

det

ails)

is c

ompl

eted

for

90%

of

wom

en w

ithin

nin

e m

onth

s of

the

ir la

stsc

reen

ing

exam

.4.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

29

.4 L

EV

EL

3 A

SSE

SSM

EN

T –

SIZ

E O

F SP

EC

IME

NT

he a

dver

se im

pact

of d

iagn

ostic

sur

gica

l bio

psy

onbr

east

app

eara

nce,

con

tour

or

shap

e sh

all b

em

inim

ised.

1.

Info

rmat

ion

is co

llect

ed t

hrou

gh t

he N

atio

nal

Min

imum

Dat

a Se

t fo

r m

onito

ring

and

eval

uatio

npu

rpos

es. (

Refe

r: C

urre

nt D

MM

)2.

T

he in

tern

al a

udit

proc

ess

ensu

res

that

the

crite

ria a

re c

ompl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

> 9

0% o

f bio

psie

s, w

hich

pro

ve t

o be

ben

ign,

shou

ld w

eigh

< 3

0 gr

ams.

2.

All

othe

r cr

iteria

are

met

.

29

.5 L

EV

EL

3 A

SSE

SSM

EN

T –

SP

EC

IME

N R

AD

IOG

RA

PH

YSp

ecim

en im

agin

g is

used

to

conf

irm e

xcisi

on o

f the

lesio

n an

d to

indi

cate

the

spe

cific

are

a of

inte

rest

to

the

path

olog

ist, w

hile

min

imisi

ng t

he t

ime

betw

een

surg

ical

exc

ision

and

rec

eipt

of t

he X

-ray

or

repo

rtin

the

atre

.

1.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

hecr

iteria

are

com

plie

d w

ith, a

nd id

entif

ied

issue

sar

e ad

dres

sed

thro

ugh

the

Con

tinuo

us Q

ualit

yIm

prov

emen

t (C

QI)

proc

ess.

1.

100%

of t

issue

spe

cim

ens

from

impa

lpab

lele

sions

are

app

ropr

iate

ly im

aged

per

iope

rativ

ely

and

repo

rted

by

a ra

diol

ogist

.2.

>

95%

of s

peci

men

imag

es a

nd/o

r ve

rbal

rep

orts

shou

ld b

e re

ceiv

ed in

less

than

15

min

utes

of t

hesp

ecim

en b

eing

sen

t fro

m th

e op

erat

ing

thea

tre

3.

> 9

5% o

f im

palp

able

lesio

ns a

re e

xcise

d at

the

first

bio

psy

oper

atio

n.4.

A

ll ot

her

crite

ria a

re m

et.

29

.6 L

EV

EL

3 A

SSE

SSM

EN

T –

PA

TH

OLO

GY

RE

PO

RT

ING

OF

SUR

GIC

AL

BIO

PSY

SP

EC

IME

NS

Acc

urat

e pa

thol

ogic

al a

sses

smen

t of

sur

gica

l exc

ised

tissu

e sh

all b

e pr

ovid

ed.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

1.

In 9

0% o

f cas

es a

writ

ten

hist

olog

y re

port

isre

ceiv

ed b

y th

e sc

reen

ing

unit

with

in 5

wor

king

days

of t

he p

atho

logy

labo

rato

ry r

ecei

ving

the

spec

imen

.2.

A

ll ot

her

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget


APPENDICES

Sta

nd

ard

31.

No

Furt

her

Act

ive

Rec

all

Wom

en

ha

ve a

cle

ar u

nd

ersta

nd

ing o

f th

e r

ea

son

s f

or n

o l

on

ger b

ein

g e

ligib

le f

or t

he p

rogra

mm

e,

the p

rocess o

f n

o f

urth

er a

cti

ve r

eca

ll t

o

Brea

stS

creen

Aote

aroa

or c

hoosin

g n

ot

to p

arti

cip

ate

in

Brea

stS

creen

Aote

aroa

.

31

.1 N

O F

UR

TH

ER

AC

TIV

E R

EC

ALL

Each

wom

an is

info

rmed

tha

t sh

e w

ill n

o lo

nger

be

activ

ely

reca

lled

for

rout

ine

re-s

cree

ning

whe

n th

eel

igib

ility

crit

eria

are

no

long

er m

et, o

r sh

e ch

oose

sto

leav

e Br

east

Scre

en A

otea

roa.

The

inte

rnal

aud

it pr

oces

s en

sure

s th

at t

he c

riter

iaar

e co

mpl

ied

with

, and

iden

tifie

d iss

ues

are

addr

esse

d th

roug

h th

e C

ontin

uous

Qua

lity

Impr

ovem

ent

(CQ

I) pr

oces

s.

All

crite

ria a

re m

et.

Qua

lity

Indi

cato

r Ev

alua

tion

Proc

ess

Eval

uatio

n Ta

rget

BreastScreen Aotearoa National Policy and Quality …...Mammography Screening and the BreastScreen...

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Transcript of BreastScreen Aotearoa National Policy and Quality …...Mammography Screening and the BreastScreen...