Quality assurance Guidelines for Breast PatholoGy services · Quality Assurance Guidelines for...

Quality assurance Guidelines for Breast PatholoGy services

Second edition

NHSBSP Publication No 2July 2011

EditorProfessor Ian EllisProfessor of Cancer Pathology, University of Nottingham, School of Molecular Medical Sciences; Department of Histopathology, Nottingham City Hospital, Hucknall Road, Nottingham NG7 2UH

Tel: 0115 969 1169 ext 56875

Fax: 0115 962 7768

Email: [email protected]

Editorial committee members

national Quality assurance coordinating Group for Breast screening Pathology

Dr Ruth Adamson Dr Fiona Knox Dr Cecily Quinn

Dr Neil Anderson Ms Sandhya Kodikara Dr David Rowlands

Dr Yoon Chia Dr Andrew Lee Dr Salam al-Sam

Dr Derek Coleman Dr Tong Fang Lioe Dr Jyotsna Shrimankar

Dr Charles Connolly Dr Elizabeth Mallon Mr Mark Sibbering

Dr Nick Dallimore Dr Sue Moss Dr Tim Stephenson

Professor Ian Ellis Dr Ruth Nash Professor Rosemary Walker

Dr Anne Girling Dr David Parham Dr Clive Wells

Dr Sally Ann Hales Dr Neera Patel Dr Robin Wilson

Professor Andrew Hanby Professor Julietta Patnick Mr Richard Winder

Mr Kieran Horgan Professor Sarah Pinder

Writing Group of the national Quality assurance coordinating Group for Breast screening Pathology

Published byNHS Cancer Screening ProgrammesFulwood HouseOld Fulwood RoadSheffieldS10 3TH

Tel: 0114 271 1060Fax: 0114 271 1089

Email: [email protected]: www.cancerscreening.nhs.uk

© NHS Cancer Screening Programmes 2011

ISBN 978-1-84463-072-1

The contents of this document may be copied for use by staff working in the public sector but may not be copied for any other purpose without prior permission from NHS Cancer Screening Programmes.The document is available in PDF format on the NHS Cancer Screening Programmes website.

Typeset by Prepress Projects Ltd, Perth (www.prepress-projects.co.uk)Printed by Duffield Printers

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Quality Assurance Guidelines for Breast Pathology Services | iii

CONTENTS

ACKNOWLEDGEMENTS iv

1. INTRODUCTION 1

2. PATHOLOGICAL REPORTING OF BREAST SPECIMENS 2

2.1 Standardisation of terminology and diagnostic criteria 22.2 Key issues relating to the quality of service provision 2

3. QUALITy ASSURANCE OBJECTIVES FOR BREAST SCREENING PATHOLOGy 5

3.1 Outcome objectives 5

4. ACHIEVING THE PATHOLOGy QUALITy ASSURANCE OBJECTIVES 8

4.1 National delivery of breast pathology quality 84.2 External quality assessment 94.3 Education and training 94.4 Information technology 114.5 Research and development 124.6 Regional delivery of breast pathology quality 124.7 Local delivery of breast pathology quality 134.8 Resource implications 15

REFERENCES 17

APPENDIX 1: FORMS 18

APPENDIX 2: BREAST HISTOPATHOLOGy – EXAMPLE SyNOPTIC REPORT 25

APPENDIX 3: EXTERNAL QUALITy ASSESSMENT SCHEME IN BREAST SCREENING PATHOLOGy 28

APPENDIX 4: SPECIFICATION FOR A REGIONAL COORDINATOR IN BREAST SCREENING PATHOLOGy 31

APPENDIX 5: TEMPLATE PATHOLOGy QUALITy ASSURANCE VISIT QUESTIONNAIRE 33

APPENDIX 6: ROyAL COLLEGE OF PATHOLOGISTS: WORKLOAD COMPLEXITy FOR BREAST PATHOLOGy 40

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iv | Quality Assurance Guidelines for Breast Pathology Services

ACKNOWLEDGEMENTSThe editorial committee is grateful to the following for their contributions to the Guidelines

• the Information Group of the National Quality Assurance Coordinating Group for Breast Screening Pathology, for the data forms at Appendix 1

• the East Midlands Quality Assurance Reference centre, for the Pathology Quality Assurance Visit Questionnaire at Appendix 5.

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Quality Assurance Guidelines for Breast Pathology Services | 1

1. INTRODUCTIONThe quality of pathology services is central to the delivery of high-quality breast screening services, because the definitive diagnosis of cancer and its subsequent classification are in most cases determined by pathologists. They are required not only to distinguish cancer from benign condi-tions but also to report histological features of prognostic significance, thus helping to ensure that patients are treated appropriately. The prognostic features of screen-detected cancers should be more favourable than those of symptomatic cancers. However the full significance of these patho-logical characteristics can be recognised only if they are reported consistently by all pathologists.

Consistency would be optimised if these guidelines were adopted not only by pathologists working in breast screening programmes but also by those in symptomatic breast services, as pathology data are a key element in the effective monitoring of both areas. Although the success of a breast screening programme is ultimately measured by a reduction in mortality in the invited population, statistically significant mortality data do not become available for many years. Other methods are therefore used to monitor the effectiveness of programmes over the medium term: they include the number of tumours detected, their size and their prognostic features.

In addition to their role in monitoring the breast screening programme and supporting patients and their treatment, pathology data contribute to surgical, radiological and pathological audit, future pathology review, cancer standards audit, and clinical research. The quality of these data depends on the expertise of pathologists and the techniques and reporting methods they employ. Within the NHS Breast Screening Programme (NHSBSP), specimens from screened women may make more demands on this expertise than those from symptomatic women, on both macroscopic and histological examination. In particular, impalpable lesions often require specimen radiography, making the process of examining and reporting a biopsy specimen more than usually complex.

To generate high-quality pathological data and achieve the standards required by the NHSBSP, pathologists need to be able to draw on appropriate managerial and administrative support and rely on robust quality assurance (QA) processes. The pathology QA process is led and coordinated by the UK National Coordinating Committee for Breast Pathology (NCCBP) on behalf of the NHSBSP and the Royal College of Pathologists. It is part of the larger QA programme involving all professional groups working in the NHSBSP. The QA process for breast pathology operates and is managed on a regional basis, and is coordinated by the NCCBP.

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2 | Quality Assurance Guidelines for Breast Pathology Services

2. PATHOLOGICAL REPORTING OF BREAST SPECIMENS

2.1 Standardisation of terminology and diagnostic criteria

A key objective of the QA programme is to unify the terminology and diagnostic criteria employed in reporting breast lesions. Central to this are the revised reporting forms for histopathology, needle core biopsy and cytopathology that are used to enter pathological data on the national breast screening system (NBSS). (See Appendix 1.) By ensuring consistent reporting of features and consistent terminology these forms enable a standard set of data to be collected from each woman. The forms are not designed to replace existing reporting procedures in individual laboratories but could do so if desired. It is recommended that they are completed at the time the specimen is reported; in cases where a second opinion is sought their completion should be delayed until the definitive diagnosis is reached. To minimise variation in diagnostic criteria, definitions of terms and more detailed guidance on using the forms are set out in the NHSBSP/Royal College of Pathologists publication Pathology Reporting of Breast Disease (NHSBSP Publication No 58)1 and Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening (NHSBSP Publication No 50).2

Use of synoptic reports that include the RCPath minimum dataset and NHSBSP pathology datasets is strongly encouraged. This ensures comprehensive and consistent provision of pathology data and eases their transfer to NHSBSP, cancer registry and audit datasets. A sample synoptic report is provided at Appendix 2.

2.2 Key issues relating to the quality of service provision

2.2.1 Macroscopic examination of specimens

Macroscopic examination is a vital part of the screening process. It should be undertaken only by experienced pathologists, trained biomedical scientists (BMSs) or trainee pathologists under consultant supervision. Detailed guidance on the macroscopic examination of diagnostic and therapeutic biopsies, including wide local excision samples, mastectomy samples and lymph node specimens, can be found in Pathology Reporting of Breast Disease (NHSBSP Publication No 58).1

2.2.2 Access to specimen radiography facilities

It is mandatory for the surgeon to arrange immediate specimen radiography of biopsies containing impalpable lesions, to confirm that they include the radiological abnormality. Additional specimen radiography of the sliced sample may help to ensure that the correct blocks of tissue are selected for examination. Histological reporting of impalpable lesions can be undertaken only if facilities for specimen radiography are available.

Specimen radiography may take place in the radiology department, the operating theatre complex or the pathology laboratory. Histopathologists reporting these samples should have ready access to specimen x-ray facilities or services. If these are located in the pathology laboratory, a radiation

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protection officer or medical physics QA scheme should be in place to monitor safety and perfor-mance. In addition, high-intensity viewing boxes are needed for examining mammographic films; and where films have been replaced by digital x-ray, facilities should be available to permit timely examination of the digital images. Written laboratory protocols should be in place for examining breast specimens and for using and monitoring the associated equipment.

2.2.3 Histological examination

Audits of national external quality assessment (EQA) performance and non-operative diagnosis performance statistics have identified variations in practice relating to diagnosis and classification of some breast lesions. Pathologists are required to be familiar, and practise in accordance, with the NHSBSP and RCPath guidelines on reporting breast specimens.1,2

2.2.4 Identifying atypical proliferative lesions

Some non-cancerous atypical proliferative lesions are associated with an increased risk of develop-ing carcinoma3 and it is important to identify them accurately and reproducibly. Appropriate patient management can then be instituted and more learned about their biological potential. Pathologists must be familiar with current classification methods for these lesions1,2 and seek a second opinion in cases where doubt remains.

2.2.5 Recording features of prognostic and predictive significance

Recording histological features of invasive carcinomas that are of prognostic and predictive sig-nificance (ie tumour size, grade, vascular invasion, tumour type) will affect the patient’s immediate management. It will also allow comparison of cancers detected by screening and those presenting symptomatically – either as interval cancers or in unscreened women. The number of positive and negative lymph nodes and the total number of lymph nodes received should also be recorded. Effective clinical follow-up will enable clinicians and pathologists to correlate the pathological features of tumours with clinical outcomes.

2.2.6 Frozen section examination of impalpable lesions

Frozen section examination has now largely been displaced by more effective non-operative diagnosis techniques. However frozen section examination of palpable lesions may be justified in those rare cases where a definitive diagnosis cannot be made preoperatively. Only in exceptional circumstances should frozen sections be undertaken on impalpable lesions, and then only after consultation between the pathologist and surgeon.

2.2.7 Non-operative diagnosis

Guidance on the principles and practical aspects of needle core biopsy and fine needle aspiration cytology (FNAC) is provided in Guidelines for Non-operative Procedures and Reporting in Breast Cancer Screening (NHSBSP Publication No 50).2

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If needle biopsy or cytology investigations are negative in the face of clinical and radiological evi-dence of malignancy then they should be repeated; if they are still negative, an open biopsy should be performed. It is possible to achieve definitive diagnosis of benign lesions. Current evidence indicates that the use of non-operative diagnosis substantially reduces the number of unnecessary operations performed both for benign disease and for malignancy, with reduced discomfort and inconvenience to the patient.2 Definitive surgery for carcinoma can be planned preoperatively using the triple approach of radiological imaging, clinical examination and needle biopsy (or FNAC). This permits treatment for many malignant lesions in a one-stage operation.

2.2.8 Non-operative specimens

All needle core biopsy and FNAC specimens should be reported by a named NHSBSP breast screening consultant pathologist or a trainee pathologist under consultant supervision.

2.2.9 Operator skills

The detection of carcinoma by cytology or needle biopsy depends on the ability of the pathologist to identify malignancy; but it depends also on the operator’s skill in localising the lesion with the needle, obtaining an adequate sample and, in the case of cytology, making a satisfactory prepara-tion. Failure to detect carcinoma by needle techniques often reflects inadequate sampling of the target lesion or poor preparation of FNAC samples. Guidance on the practical aspects of biopsy or aspiration, including image-guided specimens, can be found in the Guidelines for Non-operative Procedures and Reporting in Breast Cancer Screening.2

2.2.10 Training for clinical staff performing fine needle aspiration

Where non-operative diagnostic sampling is performed by staff with limited experience and poor training, this can lead to a higher proportion of unsatisfactory and false negative specimens.2 All clinical staff using these techniques should therefore receive adequate training in localising and sampling lesions and making satisfactory preparations.

2.2.11 Technical quality of specimen preparation

Accurate histological and cytological diagnosis relies on high-quality samples. At present, conven-tional methods for preparing slides are adequate for diagnosing most breast diseases, although immunohistology is required in a small number of cases. Although there are minor differences in processing and staining methods from laboratory to laboratory, these do not significantly alter pathological interpretation. Whatever their methods and slide quality, all laboratories involved in breast cancer screening should participate in the national immunocytochemistry EQA scheme and also in general histology technical schemes. For laboratories providing therapeutic predictive testing of patient samples, such as hormone receptor and human epidermal growth factor receptor 2 (HER-2) assays, participation in a recognised EQA scheme is essential.

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3. QUALITY ASSURANCE OBJECTIVES FOR BREAST SCREENING PATHOLOGY

3.1 Outcome objectives

The four QA objectives for breast screening pathology in the NHSBSP are listed below. (Similar objectives can be applied to symptomatic breast pathology.)

1. to improve the identification and pathological characterisation of lesions producing mam-mographic abnormalities

2. to improve the consistency of diagnoses made by pathologists3. to improve the quality of prognostic and predictive information in pathological reports4. to minimise the number of unnecessary surgical operations.

The outcome measurements, performance standards and means of achieving these objectives are presented in more detail in Table 1. These align with the outcome measures for other professional disciplines.4

Table 1 Outcome measurements, performance standards and outline methods of achieving objectives

Qa objectivesoutcome measurements standards

outline methods of achieving objectives

1. To improve the identification and pathological characterisation of lesions producing mammographic abnormalities

Proportion of specimens containing the mammographic abnormality in which it is not identified histopathologically

< 1% (i) High-quality specimen radiography for impalpable lesions

(ii) Adequate macroscopic examination and sampling of biopsy specimens

(iii) High-quality tissue fixation and section preparation

(iv) Participation in technical EQA schemes

(v) Prospective multidisciplinary meetings to correlate radiological and pathological findings

2. To improve the consistency of diagnoses made by pathologists

Diagnostic consistency measured in the UK National Breast Pathology EQA scheme:

(i) Use of the standardised terminology and diagnostic criteria

(a) For invasive carcinoma

(a) Minimal k = 0.8Achievable k = 0.9

(ii) High-quality tissue fixation and section preparation

(b) For ductal carcinoma in situ (including microinvasive carcinoma)

(b) Minimal k = 0.7Achievable k = 0.8

(iii) Participation in technical EQA schemes

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(c) For benign lesions (excluding atypical ductal hyperplasia)

(c) Minimal k = 0.8Achievable k = 0.9

(iv) Continuing medical education in breast pathology

(v) Participation in the UK National Breast Pathology EQA scheme

(vi) Referral of difficult cases for second opinion

(vii) Research and development work on borderline lesions

(viii) Procedures in place for timely transport and receipt of specimens

3. To improve the quality of prognostic information in pathological reports

(i) Procedures in place for timely transport and receipt of specimens and for tissue fixation

(ii) Participation in technical EQA schemes

(a) Ensure high-quality tissue fixation and section preparation

(a) Minimal > 95%Achievable > 99% (except in inappropriate specimens)a

(a-i) Application of grading and size measurement criteriab

(b) Proportion of invasive carcinomas graded and measured

(b) Minimal k = 0.5Achievable k = 0.7

(b-i) Following grading criteriab

(b-ii) Research and development on grading methods which provide improved consistency

(c) Consistency of grading in national EQA scheme

(c) Minimal > 88% of measurements within 3 mm of the median valueAchievable > 90% of measurements within 3 mm of the median value

(c-i) Following guidance on measuring tumour sizeb

(d) Consistency of tumour measurement in national EQA scheme

(d) Minimal > 95%Achievable > 99% (except in inappropriate specimens)a

(d-i) Appropriate preservation and preparation of tissue(d-ii) Following receptor assessment methodologyb

(e) Proportion of invasive cancer cases assessed for hormone HER-2 receptor status

(e) Availability of EQA scheme results and prompt remedial action following identification of substandard performance

(f) Consistency of satisfactory performance in receptor EQA schemes

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4. To minimise the number of unnecessary surgical operationsc

(a) Benign biopsy rate (a) See radiology standards4

(a) Monitoring performance using the biopsy QA and cytology QA systems and addressing deficiencies

(b) Unsatisfactory samples from cancer-bearing breasts and core biopsy miss rate (B1 + B2) from cancer-bearing breasts

(b) For needle core biopsyMinimal < 15%Achievable < 10%

For cytologyMinimal < 10%Achievable < 5%

(b) Ensuring that clinical staff are able to obtain satisfactory samples and check the quality of the preparations

(c) False positive rated (c) For needle core biopsyMinimal < 0.5%Achievable < 0.1%

For cytologyMinimal < 1%Achievable < 0.5%

(c-i) Produce guidelines on reporting non-operative diagnosis specimens(c-ii) Run national educational courses on non-operative diagnosis specimen interpretation(c-iii) Development of EQA scheme for needle core biopsy using telepathology

(d) False negative rated (d) For needle core biopsy, use miss rate (b) above

For cytologyMinimal < 5%Achievable < 4%

(d) Provide guidance in breast needle core biopsy and FNAC technique

aInappropriate specimens include needle biopsies, carcinomas less than 10 high-power fields in size, post neoadjuvant treatment specimens and cases where section quality or tissue preservation is too poor to assess the relevant histological characteristics.

bFor these, see Pathology Reporting of Breast Disease.1

cAchieving the standards depends not only on the performance of the pathologist but also upon the clinicians undertaking the aspirations or needle biopsy sampling procedures.

dFor definitions see Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening.2

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4. ACHIEVING THE PATHOLOGY QUALITY ASSURANCE OBJECTIVES

4.1 National delivery of breast pathology quality

The NCCBP is responsible for coordinating QA procedures and guidance.

The group meets twice yearly to consider developments which impact on the practice of breast pathology. It comprises all the pathology regional coordinators of the NHSBSP; the Director of NHS Cancer Screening Programmes; the Royal College of Pathologists’ Specialty Advisor in Breast Pathology (a role usually taken by the chair of the committee); and co-opted pathologists with specialist expertise in breast pathology. Information on current membership and contact details can be found on the NCCBP website (http://www.nccbp.com/).

The NCCBP’s terms of reference are to

• recommend minimum acceptable standards and provide guidelines and advice on pathological examination of breast tissues, in order to maximise detection of malignancy and achieve a high level of accuracy and consistency in reporting breast lesions

• consider ways of achieving these objectives and to identify resource implications• advise the NHSBSP, the Royal College of Pathologists and other medical organisations on

breast pathology-related issues• provide support and information for regional pathology coordinators• identify the educational needs of pathologists and organise training, including national courses• monitor the adequacy of data provided by pathologists• ensure that issues relating to quality and standards receive timely attention• keep the pathology information system under continual review• act as the steering committee for the UK National Breast Pathology EQA scheme• monitor the performance of non-operative diagnostic services• enable the exchange of information and discussion of quality issues with other professional

groups• facilitate the exchange of information between pathologists and cancer registries, particularly

to improve the recording of information on interval cancers• facilitate the exchange of information and pathological material between pathologists and the

wider research community.

In addition to acting as the steering committee for the UK National Breast Pathology EQA scheme, the group has four small subgroups covering the following quality assurance responsibilities

• education and training• information and technology• non-operative diagnosis• research and development.

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4.2 External quality assessment

4.2.1 National EQA scheme

Participation in the UK National Breast Pathology EQA scheme is mandatory for consultant pathologists who provide a breast screening pathology service, and recommended for all consult-ant pathologists who report breast specimens. The EQA scheme has achieved clinical pathology accreditation (CPA) and includes personal performance appraisal. Outline details of the scheme are provided in Appendix 3; fuller details, including the scheme’s standard operating procedures (SOPs), can be accessed via the NCCBP website (http://www.nccbp.com/) or the Royal College of Pathologists’ EQA pages (http://www.rcpath.org/).

New members of the scheme can register and obtain their unique EQA identification number through their regional QA reference centre (QARC). They should also register separately on the NCCBP website, to which EQA scheme returns may be submitted electronically.

4.2.2 Quality assessment for non-operative diagnosis

The NBSS is able to generate QA statistical reports automatically from screening and histology data. The non-operative diagnosis subgroup of the NCCBP recommends that, for the present, non-operative EQA in breast screening be performed using the NBSS cytology quality assurance (CQA) routine and biopsy quality assurance (BQA) routine. [For details see Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening (NHSBSP Publication No 50)2].These reports give measures of sensitivity and specificity for the tests and permit detailed examination of the results, allowing the performance of a unit to be assessed.

It is recommended that, wherever possible, the software supporting the CQA and BQA routines on NBSS be loaded also on to computer systems dealing with symptomatic breast disease, as this will contribute to the standardisation of pathological reporting.

In future, telepathology systems are expected to be able to overcome the difficulties associated with cytology and needle core EQA, such as limited availability of the sample, allowing this area to be explored further.

4.3 Education and training

4.3.1 Training requirements

Consultants taking on breast screening responsibilities for the first time should attend a recognised NHSBSP multidisciplinary training course. One of the main functions of the basic NHSBSP course is to describe the multidisciplinary approach to breast screening.

Pathologists who have already attended the multidisciplinary course are advised to keep up to date and participate in the Royal College of Pathologists’ continuing professional development (CPD) scheme. CPD activity should include regular, relevant, breast pathology-associated content. Update and refresher courses are provided by the national breast screening training centres and

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other professional organisations to support ongoing breast pathology education. Courses offered by the national training centres cover pathology practice in more detail, including methods for examining specimens from screened women and specific diagnostic problems. A national breast pathology update course takes place every two years in the spring, alternately concentrating on non-operative diagnosis and breast histology. It is currently held at the Nottingham Breast Institute on behalf of the national breast screening training centres. All of these courses form part of the continuing medical education (CME) recommended by the Royal College of Pathologists. Where more individual tuition is needed, secondments to training centres can be arranged through regional pathology coordinators.

4.3.2 Participation in EQA

Participation in the UK National Breast Pathology EQA scheme is mandatory for pathologists working in the NHSBSP. Three educational cases are included in the EQA scheme, with a view to encouraging the development of further expertise. (See 4.3.5 below.)

4.3.3 Participation in regional QA meetings

It is an NHSBSP requirement that at least one pathologist representative from each screening unit or pathology department attends the regional pathology QA meetings. All pathologists participating in the provision of breast screening services should attend at least one meeting every 18 months, and preferably one each year.

4.3.4 Second opinions

Seeking second opinions on difficult cases is a useful educational exercise and recognised as good practice.

4.3.5 Educational role of regional pathology coordinators

Regional pathology coordinators should play a key role in facilitating education and training within regions for all pathologists dealing with breast specimens. They should hold regular regional breast screening pathology meetings, which may contain a slide seminar component. The discussion of slides circulated in the national EQA scheme together with the analyses of consistency (produced by the Cancer Screening Evaluation Unit) are regarded as an indispensable educational activity.

4.3.6 Service level agreements

Attendance at basic training courses and CME in aspects of breast pathology is mandatory in NHSBSP contractual agreements.

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4.4 Information technology

4.4.1 Information subgroup

The function of the information technology (IT) subgroup is to address the problems in gathering reliable and internally consistent histological and cytological data in the NHSBSP. The subgroup also has a function in determining the structure of the NBSS and is involved with major updates to this. It also processes change requests to the system. There is cross-representation with the NBSS Programme Board and the group meets as necessary to discuss changes of importance to the computer system as these impinge upon pathology data collection.

4.4.2 NBSS computer system

The NBSS computer system is in use in all breast screening offices in England, Wales and Northern Ireland.

4.4.3 Histology and cytology proformas

In order to gather relevant pathological information, proformas have been approved by the NCCBP to cover both needle core biopsy and cytological data (see Appendix 1). These have been con-tinually modified during the course of the NHSBSP in an attempt to improve both the quality of the information and its ease of entry. Quality assurance evaluation of these data from individual screening centres can be achieved as well as allowing regional and national evaluation. Such information is capable of many substratifications, but requires careful appraisal before statistically valid conclusions can be drawn.

4.4.4 Other functions of the information subgroup

Ancillary functions undertaken by the information subgroup have been the preparation of a guide for the use and benefits of different specimen radiographic machines and ancillary apparatus, input to the non-operative diagnosis group in devising a QA system, and general advice to the NCCBP. Software modifications recommended by the NCCBP are also processed through the information group.

4.4.5 Interactions with other subgroups

There are overlaps with other pathology subgroups, notably research and development. In addi-tion, the functions of the information group potentially affect activities in the training and education quarter. Cross-representation and membership of these other subgroups harmonises these different activities.

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4.5 Research and development

4.5.1 Importance of research

Research is a vital component of pathology in breast cancer screening, which provides excellent opportunities to study the early stages of human breast cancer. Applied research that aims to refine diagnostic criteria is fundamental to improving the consistency of reporting. Better ways of evaluating the significance of borderline lesions and the features of established neoplasms will help to ensure that patients are managed appropriately. More research is also needed to improve understanding of the basic biology of the lesions found in clinical practice and breast screening and to support clinical pathologists in the more effective evaluation of breast biopsies.

4.5.2 Contributing to the research effort

All pathologists can make a contribution to research, whether or not they have specific research programmes. Vital to this contribution is effective cooperation between research groups and those delivering the clinical service. Local and national trials depend on access to reliable and adequate pathological data, and regional pathology coordinators should play a major role in facilitating research within their regions. Established researchers need ready access to ethically acquired pathological material derived from breast lesions in screened women. Use of tissue and associated data for research purposes should conform to national standards and regulatory requirements laid down by the Human Tissue Authority. These requirements, which cover consent, research ethics approval, storage and data protection, can be found on the Authority’s website (http://www.hta.gov.uk/).

4.6 Regional delivery of breast pathology quality

4.6.1 Regional QA network

The QA process is operated and managed on a regional network basis. It is coordinated by regional QARCs with regionally appointed coordinators in each professional discipline.

4.6.2 Role of the regional pathology coordinators

Regional pathology coordinators play a key role in facilitating the QA process and are integral members of the regional QA teams. They also support education and training initiatives, for example by holding regular regional breast screening pathology meetings with managerial and educational components. A specimen service level agreement for a regional coordinator in breast screening pathology appears at Appendix 4.

4.6.3 Regional QA visits

Pathology departments involved in the screening programme are visited regularly by regional QA teams who inspect local facilities and ensure that performance meets agreed standards. This process is detailed in Guidelines on Quality Assurance Visits (NHSBSP Publication No 40).5 Visits normally occur at least once in the agreement period (usually once every three years). Their

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outcomes are currently reported to the regional breast screening QA committee, the host trust, the national coordinating team and (pending restructuring) the commissioning primary care trust (PCT). Appropriate action is taken where performance is assessed as inadequate. A template for a pathology QA visit questionnaire is provided at Appendix 5.

4.7 Local delivery of breast pathology quality

4.7.1 Breast pathology lead

Laboratories involved in diagnosing screen-detected breast disease (and also those diagnosing symptomatic disease) should be accredited by CPA UK Ltd. Each laboratory is required to have a nominated lead pathologist with responsibility for breast pathology. This pathologist and other pathologists supporting provision of the service are regarded as members of the multidisciplinary breast screening team. They have a responsibility to comply with QA guidance and take part in regular case management meetings. They should also participate in the UK National Breast Pathology EQA scheme and ensure the timely provision of all data required by the NHSBSP.

4.7.2 Requirements for breast screening pathologists

There is currently no consensus regarding the definition of a specialist breast pathologist. However the recommended minimum standards for all pathologists providing a service to the NHSBSP are that the pathologist should

• attend an appropriate multidisciplinary training course prior to taking up post• participate in relevant CPD for each CPD round (the recommendation is at least 8 hours)• participate in the UK National Breast Pathology EQA scheme• participate in relevant and regular audit• regularly attend regional QA and specialist meetings• be a member of a specialist breast service multidisciplinary team and participate regularly in

clinical multidisciplinary team meetings• ensure multidisciplinary case discussion meetings are attended by at least one pathologist of

consultant level• be registered as a provider of breast pathology services for the purposes of National Cancer

Peer Review (NCPR)• participate in NHSBSP QA visits.

(To optimise consistency, the NCCBP recommend that these standards are also adopted by pathologists in the specialist breast symptomatic service and that similar standards be used for specialist breast pathology services in the private sector.)

4.7.3 Provision of breast pathology services

Pathologists should have ready access to specimen radiography facilities and adequate technical and secretarial support.

Laboratory procedures (SOPs) for handling and reporting breast specimens should be well documented.

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Pathologists should provide a non-operative diagnosis service that meets the quality standards laid down in Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening.2 All histological and cytological specimens should be reported by a consultant pathologist or a trainee under consultant supervision. Meeting pathology turnaround times is critical if current cancer service standards are to be achieved.

Effective liaison between pathology laboratories and cancer registries benefits all parties. Data on interval cancers and cancers in unscreened women are essential for monitoring the screening programme. The use of synoptic reporting can facilitate the transfer of data to registries.

4.7.4 Audit and multidisciplinary discussion

Audit and multidisciplinary discussion are mandatory. Where effective, they can enable problems in preoperative tissue diagnosis and overall performance to be identified and addressed.

4.7.5 Attendance at multidisciplinary meetings

Attendance at routine multidisciplinary case management meetings by one or more of the patholo-gists providing a service to the breast unit is mandatory.

4.7.6 Service agreements for breast pathology

Pending restructuring, PCTs retain their role in promoting the quality of pathology services by embedding quality standards in agreements with hospitals. Achieving these standards has been eased by the formation of breast cancer units dealing with a minimum number of cases per annum and the development of related cancer services.

4.7.7 Workload

A recommendation has been made by the NCCBP that a minimum workload be set for breast pathologists. The minimum workload for a breast surgeon in the UK is 50 breast cancer cases per year. EU guidance on a pathologist’s minimum workload is also 50 cancer cases per year. It is recommended that the minimum workload for a breast pathologist in the UK be set at 50 primary breast cancer resection specimens per year with their related specimens. Such a workload would involve handling additional specimens, including non-cancer and cancer-related diagnostic speci-mens and those relating to follow-up and subsequent treatment episodes.

4.7.8 Specialist breast units

The publication in 1996 of Improving Outcomes in Breast Cancer: Guidance for Purchasers6 recog-nised the importance of multidisciplinary working in breast units and the importance of high-quality pathology services as part of that process. It led to the formation of specialist breast units, which are helping to raise the standards of diagnosis and management of patients with breast disease and making more efficient use of resources.7

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4.8 Resource implications

4.8.1 Provision of local services

The provision of high-quality pathology services depends on appropriate resourcing. This includes adequate staffing levels and funding to meet capital equipment and running costs. Breast histopa-thology and cytopathology service providers should comply with the Royal College of Pathologists’ workload guidance; updated guidance for breast pathology is provided at Appendix 5. Wherever possible, pathologists should be given access to additional PA support for CPD, audit and multi-disciplinary team meetings as set out in the Royal College of Pathologists’ guidelines.

4.8.2 Technical and secretarial support

High-quality histology and cytology services rely on adequate secretarial support. Breast screening pathology also makes particular demands on technical time: it may require a large number of blocks, for example specimen radiography and film development. Additional technical and secretarial sup-port is needed by regional coordinators when preparing material for QA purposes.

4.8.3 Specimen radiography equipment

High-quality specimen radiography equipment is vital for all laboratories handling breast specimens. Resources should be allocated for its maintenance and timely replacement, and it should be subject to a physics quality control programme.

4.8.4 Teaching facilities

Access to suitable teaching facilities (including closed circuit colour television, where available) is needed when local and national EQA cases are discussed at regional meetings.

4.8.5 IT support

All breast pathologists require adequate IT support, including personal computers and monitors capable of viewing digital x-ray images and web-based EQA and educational material.

i. The minimum specification for a computer and monitor for viewing digital web-based histological virtual slide preparations is

• Processor Minimum 3 GHz Intel processor, or equivalent• Memory Minimum 1 GB, ideal 4 GB• Graphics card Minimum 128 MB, ideal 512 MB; able to handle the appropriate

display• Display Able to handle minimum 1280 × 1024 in 32-bit colour• Hard disk Needed only if images are to be stored locally• Ethernet Minimum 5 Gb bandwidth, ideal 20 Mb bandwidth. (This figure is

for real working, not potential, bandwidth.)• Operating system Minimum Windows XP or equivalent

NHSBSP July 2011


ii. The recommended standard for IT equipment suitable for viewing digital x-ray material in pathology laboratories is the professional standard detailed in Table 2 below and described in Guidance on Image Display Equipment for Use in Breast Screening (NHSBSP Publication No 71).8

Table 2 Technical guidance on display equipment used in breast screening for digital images (liquid crystal display, LCD, only)

Parameter diagnostic Professional General

Display technology LCD LCD LCDColour/monochrome Monochrome Colour/monochrome Colour/monochromeConfiguration Pair of monitors Single monitor/pair Single monitorMonitor orientation Portrait Portrait LandscapeDisplay size (H × V) 32 cm × 42 cm approx 32 cm × 42 cm approx 33 cm × 27 cm approxImage size (diagonal) 50 cm approx 50 cm approx 43 cm approxNative resolution 5 MP

Typically 2048 × 2560 2–3 MPTypically 1200 × 1600

1 MPTypically 1280 × 1024

Pixel pitch 0.16 mm approx 0.27 mm approx 0.26 mm approxViewing angle 170° approx 170° approx 160° approxMaximum luminance available

700 cd/m2 700 cd/m2 400 cd/m2

Typical operating maximum luminance

500 cd/m2 500 cd/m2 300 cd/m2

Contrast ratio 600:1 1000:1 600:1Display calibration DICOMa DICOMa SMPTEb or DICOMa

Backlight stabiliser yes yes NoViewing environment Controlled diffuse

lightingControlled diffuse lighting

Subdued lighting

Certification and standards

ISO 13406-2 class 2, CE (Medical Device Directive), FDA 510(k)

ISO 13406-2 class 2, CE (Medical Device Directive), FDA 510(k)

ISO 13406-2 class 2, CE marking

aSoftware and hardware are required to calibrate the monitor and graphics card to the DICOM 3.14 grey-level display function. This must include suitable luminance test patterns pre-loaded on the workstation.

bSuitable test patterns such as AAPM or SMPTE are required pre-loaded on the workstation to check the luminance response.

NHSBSP July 2011


REFERENCES1. Pathology Reporting of Breast Disease. NHS Cancer Screening Programmes, 2005 (NHSBSP Publication No 58).2. Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening. NHS Cancer

Screening Programmes, 2001 (NHSBSP Publication No 50).3. Tavassoli FA, Hoefler H, Rai J et al. Intraductal proliferative lesions. In: Tavassoli FA, Devilee P (eds) WHO

Classification of Tumours. Tumours of the Breast and Female Genital Organs. Lyon, IARC Press, 2003: 63–73.4. Consolidated Guidance on Standards for the NHS Breast Screening Programme. NHS Cancer Screening

Programmes, 2005 (NHSBSP Publication No 60).5. Guidelines on Quality Assurance Visits. NHS Cancer Screening Programmes, 2000 (NHSBSP Publication No 40).

Revision pending.6. Cancer Guidance Sub-Group of the Clinical Outcomes Group. Improving Outcomes in Breast Cancer: Guidance

for Purchasers: The Manual. London, Department of Health, 1996.7. Kingsmore D, Hole D, Gillis C. Why does specialist treatment of breast cancer improve survival? The role of surgical

management. Br J Cancer, 2004, 90: 1920–1925.8. Guidance on Image Display Equipment for Use in Breast Screening. NHS Cancer Screening Programmes, 2010

(NHSBSP Publication No 71). In preparation.9. Ellis IO, Coleman D, Wells C et al. Impact of a national external quality assurance scheme for breast pathology in

the UK. J Clin Pathol, 2006, 59: 138–145.10. Parham DM, Coleman D, Kodikara S, et al. The NHS breast screening programme (pathology) EQA: experience in

recent years relating to issues involved in individual performance appraisal. J Clin Pathol, 2006, 59: 130–137.

NHSBSP July 2011


APPENDIX 1: FORMS

SURGERY FORM

Surname:

Forenames: Date of Birth:

SX Number: NHS Number:

Page 1 of 3

Date Performed: Location: Consultant:

Side Assessed: Right Left¨¨

Lesions and Abnormalities:

SURGERY PROCEDURE

Surgeon:

Hospital Code: Hospital Number: What for:

Local Trial Code: In National Trial: Which Trial:

Diagnosis Treatment¡ ¡

Applies To All Lesions: ¨

LESION OR ABNORMALITY

Surgical Procedures

Diagnostic:

Treatment:

Breast Reconstruction:

Staging and Therapeutic:

Non-Surgical Treatments:

Procedure Comment:

Additional:

Additional:

Date Radiotherapy Started:

Pathology Report

No Yes

Date Reported:

Pathologist:

Specimen Radiograph?:

Mammo Abnormality?:

Histological Calcification:

Specimen Type:

Axillary Procedures:

Report Number:

Laboratory:

Specimen Weight (gm):

No YesUnsure

Absent MalignantBenign Both

¡ ¡

¡ ¡ ¡

¡ ¡ ¡ ¡

Benign Lesions

Benign Lesions?:

Benign Lesions:

Epithelial Proliferation:

Other Benign Lesion:

No Yes¡ ¡

KETTERING SO TITLE (KKE, NBSS_DEV) Surgery Form v1.2

NHSBSP July 2011


SURGERY FORM

Surname:



Page 2 of 3

Malignant Lesions

Malignant Lesions?:

In Situ Carcinoma Not Present:

In Situ Components:

DCIS Grade:

DCIS Growth Pattern(s):

Size (mm) if Ductal:

Microinvasion:

Other Growth Pattern:

No Yes

Ductal Paget'sLobular

High LowIntermediate Not assessable

Not present PossiblePresent

¡ ¡

¨ ¨ ¨

¡ ¡ ¡ ¡

¡ ¡ ¡

¨

Malignant Invasive Lesions

Invasive Carcinoma Not Present:

Invasive Tumour Size (mm):

Whole Tumour Size (mm):

Invasive Tumour Type:

Other Invasive Type:

Invasive Components:

Other Component(s):

Invasive Grade:

Disease Extent:

Vascular Invasion:

Ductal/NST MixedPure Special Type Other

I IIIII Not assessable

Localised Not assessableMultiple

Not present PresentPossible

Tubular/cribriform MucinousLobular Medullary like

OtherDuctal/NST

¡ ¡ ¡ ¡

¨ ¨ ¨ ¨¨¨

¡ ¡ ¡ ¡

¡ ¡ ¡

¡ ¡¡

¨

Axillary etc,

Axillary Nodes Present?:

Other Nodes Present?:

Excision Margins:

Oestrogen Receptor:

Progesterone Receptor:

HER 2 Status:

No Yes

No Yes

Not to margin UncertainReaches margin

Positive Not PerformedNegative


Positive Not PerformedNegative Borderline

Total +ve Single Node Type:

Total +ve Site:

Quick (Allred) Score:


Score:

Excision Distance:

¡ ¡

¡ ¡

¡ ¡ ¡

¡ ¡ ¡

¡ ¡ ¡

¡ ¡ ¡ ¡

Opinion

Comments/additional information:


NHSBSP July 2011


SURGERY FORM

Surname:



Page 3 of 3

Cancer on KC62:

Histological Diagnosis: H1 Normal H5 MalignantH2 Benign H0 Cannot report¡ ¡ ¡ ¡

Type of Site:

Needs Localising: Localisation:

Lesion Notes:

Single Multiple

X-Ray Guidance Uss Guidance Skin Marker

¡¡

¨ ¡ ¡ ¡

Lesion Header

¡ MRI

Lesion Description: Asymmetry Calcification only

Clinical abnormality

Cyst Distortion Lymph node

Mass Mass with calc.

Other:

¡ ¡

¡

¡ ¡ ¡

¡ ¡

¡

No significant abnormality¡

¨

Date Episode Closed: Responsible Person: Clinical Team:

Final Action:

Recall Due Date:

RR - Routine Recall EC - Short Term Recall

Recall Reason: Other:Woman's Choice Clinical Uncertainty

CLOSE EPISODE

¡ ¡ ¡

¡ ¡


NHSBSP July 2011


CYTOLOGY FORM

Surname:



Page 1 of 2

Date Performed: Location: Clinician:



FNA PROCEDURE

Hospital Code: Number:

Time:


Specimen Acquisition

Localisation Type:

Specimen Type:

Clinical Details:

Palpation Prone stereoStereotactic X-ray

FNA Cyst Node aspirateFNA solid Nipple discharge

Ultrasound

Nipple/skin scrape

¡ ¡ ¡ ¡ ¡

¡¡ ¡ ¡¡

Cytology Result

Date Reported:

Pathologist:

Pathologist's Comments:

Report Number:

Laboratory:

Cytological Opinion:

C1 Unsatisfactory C3 UncertainC2 Benign C4 Suspicious¡ ¡ ¡ ¡ C5 Malignant¡

Type of Site:


Lesion Notes:

Single Multiple

X-Ray Guidance Ultrasound Guidance Skin Marker

¡¡

¨ ¡ ¡ ¡

Lesion Header





Other:

¡ ¡

¡

¡ ¡ ¡

¡ ¡

¡


BREAST SCREENING SERVICE (FEP, Epping LIVE) Cytology Form v1.1

NHSBSP July 2011


CYTOLOGY FORM

Surname:



Page 2 of 2


Final Action:

Recall Due Date:



CLOSE EPISODE

¡ ¡ ¡

¡ ¡

BREAST SCREENING SERVICE (FEP, Epping LIVE) Cytology Form v1.1

NHSBSP July 2011


HISTOLOGY FORM

Surname:



Page 1 of 2

Date Performed: Location: Clinician:



WBN PROCEDURE

Hospital Code: Number:

Time:


Specimen Acquisition

Localisation Type:

Localisation Marker Used?:

Number of Cores:

Specimen Type:

Lymph Node?:

Clinical Details:

Calc on Specimen X-ray?:

No Yes

NoYes Radiograph Not Seen

Palpation Prone stereoStereotactic X-ray

Core biopsy Vac excisionVac diagnostic Vac unsp

Ultrasound

Nipple/skin biopsy

¡ ¡

¡ ¡ ¡ ¡ ¡

¡ ¡ ¡ ¡ ¡

¡ ¡ ¡¨

Histology ResultDate Reported:

Pathologist:

Histological Opinion:

Malignancy Type:

Histological Calcification:

Pathologist's Comments:

Report Number:

Laboratory:

Absent MalignantBenign Both¡ ¡ ¡ ¡

B1 Unsatisfactory B3 UncertainB2 Benign B4 Suspicious¡ ¡ ¡ ¡ B5 Malignant

(b) Invasive (c) Not assessable(a) In-situ¡ ¡ ¡

¡

Benign Lesions

Benign Lesions:

Epithelial Proliferation:

Other Benign Lesion:

BREAST SCREENING SERVICE (FEP, Epping LIVE) Histology Form v1.1

NHSBSP July 2011


HISTOLOGY FORM

Surname:



Page 2 of 2

Malignant In Situ Lesions

In Situ Carcinoma Not Present:

In Situ Components:

DCIS Grade:

Ductal Paget'sLobular

High LowIntermediate Not assessable

¨ ¨ ¨

¡ ¡ ¡ ¡

¨

Malignant Invasive Lesions

Invasive Carcinoma Not Present:

Invasive Tumour Size (mm):

Invasive Tumour Type:

Other Invasive Type:

Invasive Components:

Other Component(s):

Invasive Grade:

Ductal/NST MixedPure Special Type Other

I IIIII Not assessable

Tubular/cribriform MucinousLobular Medullary like

OtherDuctal/NST

¡ ¡ ¡ ¡

¨ ¨ ¨ ¨¨¨

¡ ¡ ¡ ¡

¨

Lesion Receptors

Oestrogen Receptor:

Progesterone Receptor:

HER 2 Status:



Positive Not PerformedNegative Borderline



Score:

¡ ¡ ¡

¡ ¡ ¡

¡ ¡ ¡ ¡

Type of Site:


Lesion Notes:

Single Multiple

X-Ray Guidance Ultrasound Guidance Skin Marker

¡¡

¨ ¡ ¡ ¡

Lesion Header





Other:

¡ ¡

¡

¡ ¡ ¡

¡ ¡

¡



Final Action:

Recall Due Date:



CLOSE EPISODE

¡ ¡ ¡

¡ ¡

BREAST SCREENING SERVICE (FEP, Epping LIVE) Histology Form v1.1

NHSBSP July 2011


APPENDIX 2: BREAST HISTOPATHOLOGY – EXAMPLE SYNOPTIC REPORTSPECIMEN TYPE • DIAGNOSTIC MARKER

• THERAPEUTIC MARKER• WIDE LOCAL EXCISION• RE-EXCISION• OTHER

• SIMPLE MASTECTOMy• SUBCUTANEOUS/SKIN-

SPARING• MASTECTOMy• PATEy/MODIFIED RADICAL

MASTECTOMy• ONCOPLASTIC MAMMOPLASTy

SIDE RIGHT LEFT

Specimen radiograph provided

yES NO

Radiological abnormality seen

yES NO UNCERTAIN

Radiological lesion • STELLATE LESION• CIRCUMSCRIBED MASS

• CALCIFICATION• PARENCHyMAL DEFORMITy

Lesion position in specimen x-ray

CENTRAL CLOSE TO MARGIN

Radiological abnormality corresponds to macroscopic lesion

yES NO NOT APPLICABLE

Histological calcification present

BENIGN MALIGNANT BENIGN AND MALIGNANT

ABSENT

Specimen weight gm

Ellipse of skin X mm

Nipple NORMAL INDRAWN NOT ASSESSABLE

Fibrous fatty tissue X X mm

Lesion location OUQ OLQ IUQ ILQ RETROAREOLAR NOT KNOWN

A well defined/moderately defined/poorly defined lesion is seenmeasuring mm superior to inferior x mm medial to lateral x mm anterior to posterior

Distance from nipple mm

Macroscopic distance to margins

mm to lateralmm to medialmm to superiormm to inferior

FINAL PATHOLOGY MALIGNANT INVASIVE

Main category Components

DUCTAL/NST NST BASAL

PURE SPECIAL TyPE (SPECIFy COMPONENTS)

TUBULAR MEDULLARy-LIKE

MIXED (SPECIFy COMPONENTS)

LOBULAR

OTHER PRIMARy CARCINOMA

MUCINOUS

NHSBSP July 2011


OTHER MALIGNANT TUMOUR

OTHER

Invasive carcinoma size mm

Whole tumour (DCIS + invasive carcinoma) size

mm

Extent LOCALISED MULTIPLE FOCI

Grade 1 2 3 T 1 2 3 P 1 2 3 M 1 2 3 N/A

TUMOUR TYPE NST TUBULAR MIXED INVASIVE PAPILLARy

MEDULLARy-LIKE/NST with lymphocyte-rich stroma

MIXED DUCTAL AND SPECIAL TyPE INVASIVE MICRO-PAPILLARy

BASAL MIXED DUCTAL AND LOBULAR METAPLASTIC

NST/APOCRINE LOBULAR – CLASSICAL OTHER RARE/NEW TyPE

TUBULAR LOBULAR – SOLID NOT ASSESSABLE

INVASIVE CRIBRIFORM

LOBULAR – ALVEOLAR OTHER (describe)

MUCINOUS LOBULAR – MIXED

TUBULO-LOBULAR

Vascular invasion NONE PROBABLE DEFINITE

Associated DCIS NONE MINIMAL EXTENSIVE (>1mm beyond invasive)

DCIS grade LOW INTERMEDIATE HIGH

DCIS architecture SOLID CRIBRIFORM MICRO-PAPILLARy

PAPILLARy CARCINOMA IN SITU

DCIS necrosis yES NO

Lobular neoplasia present

yES NO (ALH LCIS)

Paget’s disease present yES NO NOT APPLICABLE

EXCISION

Excision statusmastectomy specimen

COMPLETE INCOMPLETE UNCERTAIN

Wide local excision specimen

Invasive tumour reaches margins

yES NO

Closest relevant margin(s) to invasive tumour

at mm distant at mm distant

NHSBSP July 2011


DCIS reaches margins yES NO

Closest relevant margin(s) to DCIS

at mm distant at mm distant

Re-excision specimen yES NO

Re-excision specimen details

Final excision statuswide local excision specimen

COMPLETE INCOMPLETE UNCERTAIN

Stage 1 2 3 N/A

Lymph nodes sampled yES NO

Number of axillary nodes sampled (including apical nodes)

Number of axillary nodes containing tumour (including apical nodes)

Size of largest metastasis Isolated tumour cells (< 0.2mm)

Micrometastasis (> 0.2 mm to < 2 mm)

Macrometastasis (>2mm)

Apical nodes sampled yES NO

Number of apical nodes sampled

Number of apical nodes containing tumour

STAGE COMMENTS

Nottingham Prognostic Index

Oestrogen receptor status

POSITIVE NEGATIVE TO FOLLOW

% Positive cells – (0–100) Quick score – H score – (0–300)

Internal control satisfactory

yES NO

Progesterone receptor status

POSTIVE NEGATIVE TO FOLLOW

% Positive cells – (0–100) Quick score – H score – (0–300)

Internal control satisfactory

yES NO

HER-2 status immunohistochemistry

POSITIVE NEGATIVE TO FOLLOW

0 SIGNIFICANCE – NEGATIVE1+ SIGNIFICANCE – NEGATIVE2+ SIGNIFICANCE – BORDERLINE3+ SIGNIFICANCE – POSITIVE

FISH NON-AMPLIFIEDEQUIVOCALAMPLIFIEDREQUESTED

ADDITIONAL COMMENTS

SNOMED

NHSBSP July 2011


APPENDIX 3: EXTERNAL QUALITY ASSESSMENT SCHEME IN BREAST SCREENING PATHOLOGYThis outline description of the UK National Breast Pathology EQA scheme is accurate at the time of writing. However the scheme is under continual review and may change in the light of experience and future developments. Full, current details can be found on the NCCBP website (http://www.nccbp.com/).

Summary of the scheme

The EQA scheme in breast screening pathology is based on consensus: unless there is clear evi-dence to the contrary, the correct diagnosis is generally accepted to be that made by the majority of participants.* In addition to identifying substandard performance the scheme has significant educational value, giving participants regular opportunities to compare and discuss their diagnoses. For this reason, some rare and difficult lesions may be included. Cases deemed unsuitable are those that generate insufficient agreement among the participants. Another advantage of this approach is that it allows valid studies of diagnostic consistency to be made, as cases are selected in a random manner within diagnostic categories.

Operation of the scheme

Three sets of 15 slides are sent to each regional QARC every six months; three slides in each set are considered purely educational and, since agreement on them is not required, are excluded from the statistics. Each QARC arranges for the slides to be circulated over a period of around four months to consultant pathologists registered with the scheme in their regions. Participants report the sections using the printed EQA reporting form or an electronic form completed and submitted via the NCCBP website. Completed forms are forwarded to the Cancer Screening Evaluation Unit (CSEU) at the Institute of Cancer Research, where the responses are analysed.

Apart from investigating the consistency with which major diagnoses are made, the scheme is also used to determine the level of agreement when reporting prognostic features such as tumour size, grade and type.

Assessing performance

The assessment of performance is based on four major diagnostic categories: benign, atypical hyperplasia, in situ carcinoma (including microinvasive carcinoma) and invasive carcinoma. In each group, cases are included in the assessment only if there is a majority diagnosis of at least 80%.

If a participant’s diagnosis accords with the majority opinion, a score of 3 is given. A score of 2 is awarded if the diagnosis deviates by one group, 1 if it deviates by two groups, and 0 if it deviates

*Compare ‘proficiency testing’ schemes, in which correct diagnoses are determined in advance by the organisers.

NHSBSP July 2011


by three groups. Thus, for a majority diagnosis of invasive carcinoma, scores of 3, 2, 1 and 0 would be awarded for diagnoses of invasive carcinoma, in situ carcinoma, atypical hyperplasia and benign respectively. Each participant’s scores are then added together. A participant is deemed to be a ‘persistent substandard performer’ if her total score for a circulation falls below the fifth percentile of the whole group and remains below this level in one of the next two circulations. Participants are informed of their score in each round and whether it is above or below the fifth percentile.

Release of results

The consistency of diagnoses and of the reporting of prognostic features in each case is analysed, and these general analyses are sent to all participants in anonymised form.† They are thus able to see the spread of opinions and how their own relate to those of the majority. There is evidence that this process promotes diagnostic consistency.9,10

Substandard performance

Any individual with a mark of 0 or 1 should review the slide in the light of comments made at the review session, reflect on the case, and decide if further educational activity is needed. Further action to be taken on identifying consistently substandard performance follows the guidance of the Royal College of Pathologists and the National Quality Assurance Advisory Panel (NQAAP). Like that guidance it will change over time; current arrangements are set out on the Royal College of Pathologists’ website.‡

Participants appreciate the value of a specialist EQA scheme. Even the best directed and managed schemes are not infallible, however, and may not fully reflect the performance of a histopathologist in daily diagnostic practice. The EQA scheme is, in this sense, primarily a screening procedure designed to identify a small number of pathologists who may be performing inadequately in their clinical practice. The first response is therefore to determine if that is indeed the case: if so, the second is to determine the cause of the problem so that appropriate educational or other remedial action may be taken.

Participation

It is mandatory that consultant pathologists who are routinely involved in reporting on breast pathol-ogy within the NHSBSP participate in the EQA scheme. They are awarded two CME points for completing a circulation and one for attending a regional meeting. Given that all those taking part in the scheme will regularly be reporting breast specimens, and that cases are included for scoring only where a majority of 80% are in agreement, participants are not permitted to omit any cases.

Participation is monitored and pathologists are normally expected to participate in at least two out of every three circulations. At the end of each circulation, CSEU provides regional coordina-tors with the names of participants for that circulation. Unlike the results for individual readers (which are identified by a code number rather than a name), participation in the scheme is thus not

†A secretary in the CSEU links participants’ codes to their names and addresses so that the scheme organiser and other CSEU members are unaware of individual participants’ opinions.‡For details see the relevant page of the Royal College of Pathologists’ website (http://www.rcpath.org/index.asp?PageID=1052).

NHSBSP July 2011


anonymous. A certificate of participation for each circulation is issued by the QARC through the regional pathology coordinator to those who fulfil the criteria outlined here.

Trainees may participate in the EQA scheme. Their scores are not included in this assessment process, however; only consultants who take ultimate responsibility for their diagnoses in their normal working practice are assessed.

NHSBSP July 2011


APPENDIX 4: SPECIFICATION FOR A REGIONAL COORDINATOR IN BREAST SCREENING PATHOLOGY

Agreement objective

To provide a regional coordinator in the QA aspects of breast screening pathology for the regional QA programme for breast screening. Agreements should normally be for a minimum period of three years.

Definition of the service to be provided

The postholder will develop and manage QA initiatives in pathology in the NHSBSP. They will be a member of the multidisciplinary QA team and will be involved in assessing performance of all the breast screening centres in the region, which includes monitoring and evaluating results and reporting findings and their implications to the regional QA manager. They will also be involved in making formal QA visits with other members of the regional team.

In addition they will

• ensure that the NHSBSP guidelines for pathologists and updates are communicated and understood by pathologists involved in breast pathology service provision, and will monitor their implementation

• represent the region on the National Coordinating Group for Breast Screening Pathology• coordinate the national EQA scheme within the region but will have no role in identifying sub-

standard performance. They will hold meetings (at least twice yearly) to discuss the circulated slides and accompanying analyses and ideally circulate additional cases for discussion

• assist screening units and the regional cancer registry in maintaining a complete, accurate and timely record of all pathologically confirmed breast cancers detected by the screening programme

• provide advice for health authorities on matters of breast care QA• manage, initiate, lead and develop all other regional QA initiatives of the screening programme

relevant to pathology for the whole region• facilitate research within their region as appropriate. They should also ensure that the neces-

sary specialised diagnostic techniques (eg hormone receptor determinations) are available to regional pathologists where required.

Outcome measures

Accurate and standardised pathology data from the whole of the region from the breast screening programme.

NHSBSP July 2011


Standards

The postholder will follow the guidelines for breast pathology services agreed by the Royal College of Pathologists and the NHSBSP National Coordinating Group for Breast Screening Pathology.

Administrative and technical support

The administrative and technical support necessary for the post will be provided by the breast screening programme and should include secretarial and laboratory technical support if required.

Location of post

It is expected that the postholder will undertake the histological and/or cytological reporting of biopsies and aspirates from screened and symptomatic women from a breast unit assessment centre in the region and be based in a department undertaking such work.

Term of agreement

This agreement would be subject to annual review.

Financial allocation

The regional QA programme will contribute to the costs of an NHS consultant post to the employer.§

§Figure to be agreed between commissioner and host hospital but should be at least one programmed activity depending on the size of the region and responsibilities.

NHSBSP July 2011


APPENDIX 5: TEMPLATE PATHOLOGY QUALITY ASSURANCE VISIT QUESTIONNAIRE

NHSBSP July 2011


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......

......

......

......

......

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......

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......

......

......

......

......

......

......

......

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......

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......

......

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......

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......

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......

......

......

......

......

......

......

NHSBSP July 2011


QU

ES

TIO

NS

PAT

HO

LOG

Y T

EA

M C

OM

ME

NT

S

WO

RK

LOA

D (C

ON

TIN

UE

D)

His

topa

thol

ogy

serv

ice

Num

ber

of s

peci

men

s pe

r an

num

Num

ber

of W

TE

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

Aut

opsy

ser

vice

Num

ber

of a

utop

sy s

peci

men

s pe

r an

num

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

Bre

ast

How

man

y br

east

spe

cim

ens

are

repo

rted

per

ann

um?

Bre

ast F

NA

C

App

roxi

mat

e sc

reen

ing/

sym

ptom

atic

spl

it

Wid

e-bo

re n

eedl

e co

re b

iops

ies

App

roxi

mat

e sc

reen

ing/

sym

ptom

atic

spl

it

Sur

gica

l spe

cim

ens

App

roxi

mat

e sc

reen

ing/

sym

ptom

atic

spl

it

Froz

en s

ectio

ns

App

roxi

mat

e sc

reen

ing/

sym

ptom

atic

spl

it

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

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......

......

......

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......

......

......

......

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......

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......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

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......

......

......

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......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

STA

FFIN

G/A

CC

RE

DIT

AT

ION

Who

dep

utis

es in

the

abse

nce

of th

e le

ad b

reas

t pat

holo

gist

?

Do

all c

onsu

ltant

s pa

rtic

ipat

e in

bre

ast s

cree

ning

ser

vice

s w

ork?

Are

all

path

olog

y sa

mpl

es fr

om th

e lo

cal b

reas

t scr

eeni

ng s

ervi

ce

repo

rted

in th

e la

bora

tory

?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

NHSBSP July 2011


STA

FFIN

G/A

CC

RE

DIT

AT

ION

(CO

NT

INU

ED

)

How

man

y pa

thol

ogis

ts re

port

cyt

opat

holo

gy a

nd h

isto

path

olog

y sp

ecim

ens

gene

rate

d by

the

loca

l bre

ast s

cree

ning

ser

vice

in y

our

labo

rato

ry?

Doe

s th

e cu

rren

t num

ber

of m

edic

al s

taff

sess

ions

in th

e la

bora

tory

co

mpl

y w

ith R

CP

ath/

CPA

gui

delin

es?

Wha

t cro

ss-c

over

arr

ange

men

ts a

re in

pla

ce b

etw

een

the

brea

st

path

olog

ists

?

Is th

e la

bora

tory

sta

ffing

ade

quat

e?

Is th

e se

cret

aria

l sup

port

ade

quat

e?

Wha

t is

the

curr

ent s

tatu

s of

CPA

acc

redi

tatio

n?

•fu

ll

•co

nditi

onal

(ple

ase

give

reas

ons)

•re

ferr

ed (p

leas

e gi

ve re

ason

s)

Whe

n is

the

next

CPA

revi

ew d

ate?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

LAB

OR

AT

OR

Y P

RO

CE

SS

Who

repo

rts

•br

east

cyt

opat

holo

gy s

ampl

es?

•br

east

his

topa

thol

ogy

sam

ples

?

Is im

med

iate

cyt

olog

y re

port

ing

unde

rtak

en?

Who

per

form

s th

e as

pira

tions

?

Are

ade

quat

e sp

ecim

en tr

ansp

ort f

acili

ties

avai

labl

e?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

NHSBSP July 2011


LAB

OR

AT

OR

Y P

RO

CE

SS

(CO

NT

INU

ED

)

Do

spec

imen

s ar

rive

in a

sat

isfa

ctor

y st

ate

for

exam

inat

ion?

Are

ded

icat

ed s

peci

men

x-r

ay fa

cilit

ies

avai

labl

e?

Is a

cces

s to

spe

cim

en r

adio

grap

hy a

dequ

ate?

Is th

e qu

ality

of s

peci

men

rad

iogr

aphs

ade

quat

e?

Are

cop

ies

of s

peci

men

rad

iogr

aphs

sup

plie

d w

ith s

peci

men

s?

Are

the

natio

nal g

uide

lines

for

mac

rosc

opic

exa

min

atio

n an

d

sam

plin

g of

spe

cim

ens

follo

wed

?

Is s

peci

men

wei

ght r

outin

ely

reco

rded

?

Wha

t are

the

aver

age

turn

arou

nd ti

mes

for

scre

enin

g ca

ses?

•cy

tolo

gy s

ampl

es

•ne

edle

bio

psy

sam

ples

•op

en b

iops

ies

(incl

udin

g lo

calis

atio

n bi

opsi

es)

Are

you

sat

isfie

d w

ith th

e cu

rren

t lab

orat

ory

equi

pmen

t and

m

aint

enan

ce?

Is th

e eq

uipm

ent r

epla

cem

ent p

roce

ss s

atis

fact

ory?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

NHSBSP July 2011


CO

MM

UN

ICA

TIO

N

Is c

omm

unic

atio

n w

ith th

e fo

llow

ing

staf

f sat

isfa

ctor

y:

•ra

diol

ogis

ts?

•su

rgeo

ns?

•sc

reen

ing

staf

f?•

onco

logi

sts?

Are

mul

tidis

cipl

inar

y m

eetin

gs d

ealin

g w

ith p

atie

nt m

anag

emen

t hel

d

•pr

ospe

ctiv

ely?

•re

tros

pect

ivel

y?

How

oft

en a

re m

ultid

isci

plin

ary

team

mee

tings

hel

d?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

DA

TA C

OLL

EC

TIO

N

Do

path

olog

ists

pro

vide

the

brea

st s

cree

ning

his

topa

thol

ogy

natio

nal

min

imum

dat

a se

t?

Do

path

olog

ists

use

the

reco

mm

ende

d di

agno

stic

cat

egor

ies

for

cyto

logy

and

nee

dle

biop

sy s

peci

men

s?

If no

, why

not

?

Is a

syn

optic

repo

rtin

g sy

stem

use

d?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

QU

ALI

TY

AS

SU

RA

NC

E

Do

path

olog

ists

par

ticip

ate

in th

e na

tiona

l bre

ast s

cree

ning

hi

stop

atho

logy

EQ

A s

chem

e?

(The

QA

Ref

eren

ce C

entr

e w

ill p

rovi

de c

onfir

mat

ion

for

the

visi

t)

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

.....

NHSBSP July 2011


QU

ALI

TY

AS

SU

RA

NC

E (C

ON

TIN

UE

D)

Is th

e la

bora

tory

invo

lved

in in

tern

al a

udit

rega

rdin

g:

•br

east

cyt

opat

holo

gy?

•br

east

his

topa

thol

ogy?

•ot

her

path

olog

y?

Wha

t res

ults

wer

e ob

tain

ed a

nd w

hat c

hang

es h

ave

been

mad

e as

a

cons

eque

nce

of in

tern

al a

udit?

Doe

s th

e la

bora

tory

par

ticip

ate

in a

ny te

chni

cal E

QA

sch

emes

? If

so,

whi

ch o

nes?

Doe

s th

e de

part

men

t sup

port

any

clin

ical

tria

ls?

If so

, whi

ch o

nes?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

TR

AIN

ING

/CM

E

Is th

ere

adeq

uate

sup

port

and

cov

er a

rran

gem

ents

to e

nabl

e pa

thol

ogis

ts to

att

end

rele

vant

edu

catio

nal c

ours

es?

Hav

e al

l bre

ast p

atho

logi

sts

atte

nded

any

bre

ast s

cree

ning

upd

ate

cour

ses

sinc

e th

e la

st v

isit?

Ple

ase

deta

il

Are

pat

holo

gist

s’ C

PD

por

tfol

ios

mai

ntai

ned

to R

CP

ath

stan

dard

s?

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

......

PE

RFO

RM

AN

CE

AS

SE

SS

ME

NT

/PE

ER

RE

VIE

W

To b

e ca

rrie

d ou

t by

the

visi

ting

path

olog

ist

OT

HE

R IS

SU

ES

Are

ther

e an

y ot

her

issu

es y

ou w

ould

like

to r

aise

with

the

visi

ting

team

?

NHSBSP July 2011


APPENDIX 6: ROYAL COLLEGE OF PATHOLOGISTS: WORKLOAD COMPLEXITY FOR BREAST PATHOLOGY

NHSBSP July 2011


Type

of s

peci

men

Num

ber

of b

lock

s ta

ken

– m

edia

n (ra

nge)

Spe

cial

feat

ures

(le

vels

, sta

ins)

Inte

rpre

tativ

e w

orkl

oad

(in

mul

tiple

s of

six

m

inut

es)

Pro

visi

onal

co

mpl

exity

gr

oup

(1–6

)

Com

men

ts

FNA

CN

A

Bre

ast c

ore

biop

sy1

Leve

ls a

nd IH

C

som

e ca

ses

12

Bre

ast c

ore

biop

sy w

ith fo

ur o

r m

ore

leve

ls

and/

or im

mun

ohis

toch

emis

try

1Le

vels

and

IHC

23

Dia

gnos

tic m

amm

otom

e bi

opsy

spe

cim

en3

Leve

ls a

nd IH

C

som

e ca

ses

23

Mam

mot

ome

exci

sion

spe

cim

en4

Leve

ls a

nd IH

C

som

e ca

ses

23

Exc

isio

n (u

norie

ntat

ed) b

enig

n br

east

lesi

on2

IHC

som

e ca

ses

12

Exc

isio

n be

nign

bre

ast l

esio

n re

quiri

ng 3

-D

orie

ntat

ion

6IH

C s

ome

case

s2

3

Red

uctio

n m

amm

opla

sty

(uni

late

ral o

r bi

late

ral)

41

2

Exc

isio

n m

aste

ctom

y sc

ar (r

econ

stru

ctio

n)2

12

Pro

phyl

actic

mas

tect

omy

91

2

Nip

ple

biop

sy1

IHC

som

e ca

ses

13

Mic

rodo

chec

tom

y4

IHC

som

e ca

ses

13

Tota

l duc

t cle

aran

ce4

12

Impl

ant c

apsu

le e

xam

inat

ion

21

1

Dia

gnos

tic s

urgi

cal e

xcis

ion

biop

sy n

on-

palp

able

mic

roca

lcifi

c le

sion

s8

Spe

cim

en x

-ray

, IH

C s

ome

case

s2

3M

ay u

se la

rge

bloc

ks

Dia

gnos

tic s

urgi

cal e

xcis

ion

biop

sy o

f mas

s 4

23

Wid

e lo

cal e

xcis

ion

for

mal

igna

nt

calc

ifica

tion/

DC

IS re

quiri

ng 3

-D o

rient

atio

n15

Spe

cim

en x

-ray

35

May

use

larg

e bl

ocks

Wid

e lo

cal e

xcis

ion

mal

igna

nt m

ass

lesi

on

103

5

NHSBSP July 2011


Type

of s

peci

men

Num

ber

of b

lock

s ta

ken

– m

edia

n (ra

nge)

Spe

cial

feat

ures

(le

vels

, sta

ins)

Inte

rpre

tativ

e w

orkl

oad

(in

mul

tiple

s of

six

m

inut

es)

Pro

visi

onal

co

mpl

exity

gr

oup

(1–6

)

Com

men

ts

Mas

tect

omy

spec

imen

for

mal

igna

nt m

ass

102

4

Mas

tect

omy

spec

imen

for

mal

igna

nt

calc

ifica

tion/

DC

IS12

Spe

cim

en x

-ray

so

me

case

s3

4M

ay u

se la

rge

bloc

ks

Re-

exci

sion

of b

reas

t tum

our

61

3Ve

ry d

epen

dent

on

size

Axi

llary

nod

e di

ssec

tion

5–15

(see

co

mm

ents

)2

3B

lock

num

ber

varie

s w

ith lo

cal p

ract

ice:

on

e no

de p

er b

lock

or

mul

tiple

nod

es p

er

bloc

k

Sen

tinel

lym

ph n

ode

(SLN

) bio

psy

5Le

vels

and

IHC

so

me

case

s2

2A

vera

ge n

umbe

r of

S

LNs

is 2

.2

Axi

llary

nod

e sa

mpl

e6

Leve

ls a

nd IH

C

som

e ca

ses

22

Froz

en s

ectio

n of

SLN

11

2

Touc

h im

prin

t cyt

olog

y of

SLN

NA

2

Mor

e co

mpl

ex c

ases

, eg

requ

iring

x-r

ay

of b

lock

s/sl

ices

, rep

eate

d bl

ock

sele

ctio

n se

ssio

ns, o

r m

ultip

art m

amm

ogra

phic

ally

lo

calis

ed m

alig

nanc

y w

ith s

peci

men

x-r

ays

and

sepa

rate

mar

gina

l sam

ples

15 –

see

com

men

tsS

peci

men

x-r

ay a

nd

IHC

som

e ca

ses

56

Hor

mon

e re

cept

or s

tatu

s (E

R a

nd P

R)

IHC

13

HE

R-2

sta

tus

IHC

onl

yIH

C1

3

HE

R-2

sta

tus

IHC

and

FIS

HIH

C a

nd F

ISH

33

HE

R-2

sta

tus

FIS

H o

nly

FIS

H2

3

HE

R-2

sta

tus

CIS

H o

nly

CIS

H1

3

NHSBSP July 2011


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