Good Professional

Practice for

Biomedical Scientists

Second Edition

Good Professional Practice

for

Biomedical Scientists

Second Edition 2005

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FOREWORD This second edition of the ‘Code of Professional Conduct and Code of Practice for Biomedical Science Laboratories’ represents a major revision, occasioned by the changing ethos in the provision of healthcare and the need to reflect the consequential changes in the way biomedical scientists practise. The political and social culture has shifted significantly, placing greater reliance for self-regulation on professional groups within the health service. The adoption of Evidence Based Practice and Clinical Governance also entails a heavy responsibility for professional bodies.

These evolutionary changes are reflected in the emphasis of this document. Best Practice is identified where it is recognised as such and the guidance for Good Practice is strongly recommended. Attention has been given also to subjects which have caused tension since the first edition was published, some of which have almost reached crisis proportions.

In addition, the replacement of the Council for Professions Supplementary to Medicine by the Health Professions Council (HPC) has led to some major changes in statutory regulation of biomedical scientists and other health professionals. There is a change towards light-touch, profession-led regulation. The emphasis is now that self-regulation is the responsibility of each individual professional person. With this in mind, the HPC has moved to generic codes for all its registrants. It will supplement these where necessary, with the codes of conduct and codes of practice produced by the professions themselves. In other words, the HPC itself will not seek to determine what any particular profession should do or not do. That is what gives this second edition so much significance.

This edition also provides the necessary guidance and professional support in enabling members to execute their professional duties in compliance with legal requirements. Those who reach the highest levels of excellence in their scientific practice are now eligible to be chartered through the Institute.

It is in the best interests of biomedical scientists to adhere to this guidance and thus help to ensure professional body support should it become necessary.

A R Potter Chief Executive

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CONTENTS

FOREWORD .................................................................................................................2 INTRODUCTION .........................................................................................................4 1 CODE OF PROFESSIONAL CONDUCT ........................................................7 2 GUIDE TO GOOD PROFESSIONAL PRACTICE..........................................8

2.1 PROFESSIONAL STANDARDS AND GUIDELINES...............................8 2.2 Professional Ethics.........................................................................................8 2.3 PROFESSIONAL PRACTICE......................................................................9 2.4 Relationships................................................................................................10 2.5 Management and Administration.................................................................12 2.6 Staffing and Skill Mix..................................................................................15 2.7 Staffing and Workload.................................................................................17 2.8 Laboratory Records......................................................................................18 2.9 Training........................................................................................................19 2.10 Professional Development ...........................................................................21 2.11 Promotion of the Profession and its Ideals ..................................................23 2.12 Quality Assurance........................................................................................24 2.13 Poor Performance.........................................................................................26 2.14 Health and Safety.........................................................................................28 2.15 Information Technology ..............................................................................33

REFERENCES ............................................................................................................36 USEFUL CONTACTS ................................................................................................39

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INTRODUCTION

One of the prime responsibilities of a professional body is to set the standards to which its members conform. Where a profession is also regulated by statute it will be necessary for members to abide by legal requirements first and foremost, but to look also to the professional body to guide them at the boundary between the regulatory framework and best practice.

The purpose of this guidance document is to cover two types of situation: those where the regulator sets generic requirements that need profession-specific interpretation, and those in which the professional body alone has responsibility to guide its members.

No less than its members, the Institute of Biomedical Science (IBMS) as a body has to work in a manner commensurate with the public interest. The ways in which some of these objectives are met are outlined below.

It is unfortunate that in the wider field of healthcare there have been incidents in which professionals in pathology and laboratory medicine have performed below the level of public expectation, with the result of damage to the image of all. It thus behoves all biomedical scientists to conform to the highest standards of public expectation. It is with this in mind that this guidance document has been prepared.

External standards

One of the major advantages for biomedical scientists and their colleagues in related professions is the range of external bodies and systems that exist to ensure that the highest standards are maintained. These include, amongst others, Clinical Pathology Accreditation UK Ltd (CPA), National External Quality Assessment Schemes (NEQAS), the Health Professions Council (HPC), other regulatory bodies (eg Medicines and Healthcare products Regulatory Agency (MHRA) and the Health and Safety Executive (HSE), National Pathology Benchmarking service and government departments. In addition, some specific organisations eg The Science Council of which the Institute is a member body, the National Health Service Cervical Screening Programme (NHSCSP), British Blood Transfusion Society (BBTS) and counterparts in Wales and Scotland) also strongly influence maintenance of standards.

Statutory regulation

Where the work of biomedical scientists includes the provision of services to patients or the public, the statutory provision is the Health Professions Order (2001). This gives authority to the Health Professions Council (HPC) to register practitioners and to regulate their activities. This includes the protecting of the professional title ‘Biomedical Scientist’. Thus members of the public who need the services of biomedical scientists can be assured that they are receiving attention from professionals who have met, and are continuing to meet, minimum standards including those relating to education and training and CPD.

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The IBMS and the regulator

The Institute of Biomedical Science (IBMS) works in close cooperation with the HPC to ensure that regulatory standards and professional standards exist in harmony. The IBMS endorses the HPC’s standards and expects no less of its members than scrupulously to maintain conformance to them. Where members work outside of the statutory remit of HPC the IBMS expects its members to work to equivalent professional standards.

The IBMS may, at its discretion, expel from membership those found guilty of gross professional misconduct; this action has though no statutory standing.

The IBMS and the Science Community

The IBMS as a licensed member of The Science Council holds the authority to charter those of its members who hold a Masters degree and demonstrate high standards of scientific practice and excellence so that their names may be held on Science Council’s central register of Chartered Scientists.

It is a requirement of The Science Council that all Chartered Scientists demonstrate their role in the wider scientific community by maintaining continuing professional development to reflect the benchmark of best practice and scientific status. The IBMS through its continuing professional development (CPD) scheme monitors the professional practice of biomedical scientists who carry the charter mark of excellence by annually assessing their understanding and critical awareness of new and current developments in the field of science.

The IBMS and trades unions

The IBMS as a professional body perceives that on occasion the interests of a member and the interests of the profession may be at variance. It is for this and other reasons, such as expertise, that it chooses not to seek trade union status. The IBMS does maintain close links with the unions in areas of mutual interest, notably where the Institute’s stated objectives of promoting biomedical science and its practitioners accord with the bettering of terms and conditions of service.

The IBMS and employers

The main employer of biomedical scientists in the UK is of course the National Health Service (NHS). Within this, however, are the individual trusts and affiliated employers, eg Health Protection Agency (HPA) and the National Blood Service (NBS), and others, such as universities, veterinary institutions, and industrial and commercial sector employers. Exercising influence over these by way of national policy are the separate home country health departments. All these bodies have policies and procedures of their own with varying fields of applicability. Biomedical scientists, whether employed primarily in clinical practice, teaching research or management of their profession, must conform to their employer’s policies as a matter of paramount importance.

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The IBMS and other professional bodies and networks

The IBMS since its inception has been a body that incorporates the diverse specialties within its sphere of influence. Naturally there are special interest groups for all the major subject areas, some with a great deal of influence in the setting of standards. The Institute is pleased to work in close collaboration with all the important organisations so that its guidance is concordant with the best subject specific standards currently available.

Guidance

This document gives guidance that is necessarily generic on good professional practice with a recommendation that the principles contained herein be adopted by biomedical scientists. Where this is done, the IBMS will feel able and competent to support its members. Where these recommendations are ignored (or flouted) it would be very difficult to do so, and indeed this could be reflected in the attitude of the providers of the Institute’s professional indemnity insurance.

This guide to Good Professional Practice for Biomedical Scientists briefly summarises current regulations and guidance relating to laboratory medicine, primarily in the field of pathology. Both the IBMS and the HPC have an interest in the professional standards and competence of biomedical scientists.

Codes of conduct and of professional practice are supplemented by subject specific guidance and, where appropriate, members’ attention is drawn to guidance issued by other organisations, for example, The Royal College of Pathologists, which is referenced in the text.

The IBMS publishes its own Guide to Good Professional Practice herewith, to which members are expected to conform.

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1 CODE OF PROFESSIONAL CONDUCT

All members of the Institute of Biomedical Science shall always:

1 Exercise their professional judgement, skill and care to the best of their ability.

2 Fulfil their professional role with integrity, refraining from its misuse to the detriment of patients, employers or professional colleagues.

3 Seek to safeguard patients and others, particularly in relation to health and safety.

4 Treat with discretion all confidential and other information requiring protection and avoid disclosing to any unauthorised person the result of any investigation or other information of a personal or confidential nature gained in the practice of their profession.

5 Act in good faith towards those with whom they stand in professional relationship and conduct themselves so as to uphold the reputation of their profession.

6 Strive to maintain, improve and update their professional knowledge and skill.

7 Promote the study and development of biomedical science and the education and training of biomedical scientists.

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2 GUIDE TO GOOD PROFESSIONAL PRACTICE

2.1 PROFESSIONAL STANDARDS AND GUIDELINES

There are several standards to which biomedical scientists in healthcare, collectively and individually, should conform. These include:

• Health Professions Council standards o Standards of Conduct, Performance and Ethics1

o Standards of Proficiency2

o Standards of Education and Training3

o Standards for Continuing Professional Development4

• This guide to Good Professional Practice issued by the IBMS • Standards for the Medical Laboratory issued by Clinical Pathology

Accreditation (UK) Ltd5,6,7,8

• Good Laboratory Practice• External Quality Assessment • Continuing Professional Development • Chartered Scientist status –a benchmark of excellence

Each of these has among its principal objectives the provision of a high-class professional service, and they are designed to safeguard and reassure the public. From time to time the IBMS publishes guidance on specific topics and much of this guidance is available in leaflets available from the IBMS office or on the IBMS website.

To disregard the principles and/or details of these standards might endanger patients.

One area, which still has scope for wider implementation, is the identification and implementation of best practice. Opportunities for this are increasing and should be grasped.

2.2 PROFESSIONAL ETHICS

Registration with the HPC permits the use of the protected title ‘Biomedical Scientist’. Accordingly the HPC document Standards of Conduct, Performance and Ethics1 establishes the framework within which biomedical scientists work in relation to patient expectation, professional limitations and confidentiality. However, ethics are more than just documented enforceable requirements. The ethical framework within which biomedical scientists should practise is concerned with:

• professional competence • professional relationships with colleagues, doctors and patients • public duties - confidentiality, honesty, diligence • integrity.

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2.3 PROFESSIONAL PRACTICE

2.3.1 Functions of a biomedical scientist and scope of practice

Biomedical scientists demonstrate the threshold level of knowledge and skills at the time of attaining registration, even though they may have undergone training in a variety of environments. Publications such as the QAA Benchmarking Statement for Biomedical Science10 and the HPC’s guidancethat accompanies the Standards of Education and Training3 describe the educational core of pre-registration education, while the HPC Standards of Proficiency2 describe the outcomes to be demonstrated at the point of registration.

Subsequent to registration many careers take an individual turn, such that specialisation becomes an increasingly dominant part of professional life. The Functionality Map for Biomedical Scientists gives a broad outline of the total role of a biomedical scientist. No matter how one’s professional practice develops, the basic standards of proficiency must still be met for one’s current scope of practice. Biomedical scientists must always ensure that, when moving to practise in a new area, or returning to practise in an old area, they undertake suitable refresher training or education before engaging in autonomous practice.

2.3.2 Expert practice, extended practice and advanced practice

Biomedical scientists progress their careers in a wide variety of ways including moving into research, teaching or management of their profession. Recent initiatives have opened greater possibilities for career progression in scientific or clinical job roles. To this end the IBMS provides a suite of relevant qualifications to recognise these skills and to enable certification to be used as evidence in support of its members. All of these forms of career development fit within the Functionality Map.

Expert practice is seen as the consolidation of high levels of skill and scientific or technical expertise in areas traditionally the province of biomedical scientists.

Extended practice may be defined as a move laterally from the historical core areas of biomedical science and into roles and responsibilities in completely new areas, or those more often associated with another profession. These may be at differing levels of skill, from basic to higher and beyond.

Advanced practice is seen as taking on roles and responsibilities in traditional areas of pathology and laboratory medicine but at the highest levels of clinical practice and/or consultation.

Whatever roles and responsibilities eventually become as a career progresses, biomedical scientists must never abandon the core values that are taught to new entrants to the profession. In fact it is a responsibility to use life-long learning models to maintain those values as they evolve in response to professional and healthcare pressures.

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2.3.3 Competence

All laboratory staff should be appraised annually as a minimum, so that further education and/or training needs can be identified and discussed and incorporated into a Personal Development Plan. The IBMS sees competence as different but inseparable from Continuing Professional Development (CPD): a measured and tested statement commensurate with the work in which the individual is involved. CPD has a wider connotation related to the professional ethos of evolving practice, which the public expects of experts and specialists4.

2.3.4 Quality assurance

Internal quality control and external quality assessment systems are additional weapons in the armoury to inspire and confirm patient confidence, as is compliance with all other CPA standards.

2.4 RELATIONSHIPS

2.4.1 Organisational

Biomedical scientists must be aware of their employer’s mission statement and corporate objectives. It is essential that all professionals are clear about the personal contribution expected of them in support of these aims and about their responsibilities as department or section managers.

All professionals, within their duty of care, have a responsibility to bring to the attention of their manager any difficulties that may be encountered in the performance of their professional duties.

Biomedical scientists will find it necessary to provide professional input informally or formally through committee structures. Such activity forms part of the wider responsibilities that accompany a professional. Contributions must be made with integrity and without compromise to professional standards.

2.4.2 Inter-professional

Biomedical scientists must be aware of and respect the integrity of other professional groups and collaborate and work jointly with others in the interests of patients and users of the service.

Decision-making concerning the role and activity of biomedical scientists should be sensitive to the objectives of other professions and, where possible, avoid conflicting activity.

2.4.3 Team working

Biomedical scientists work as members of a team, usually within a hospital department, providing a service primarily to clinicians. Although the team leader is for many purposes a doctor, there are areas of activity where a biomedical scientist is effectively the team leader. This role implies a

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particular responsibility, for the standard and ethos of the laboratory is a corporate one. Every effort must be made to ensure continuous improvement in that standard because it determines the quality of service provided.

Adapted from Irvine (BMJ 1997: 314: 1613-5)

2.4.4 Professional relationships

In all ways, biomedical scientists should exhibit a courteous and respectful attitude towards patients, doctors, managers and other hospital staff. The perception of the profession and its practice is determined by the service provided and the attitude and behaviour of its members.

When dealing with patients there should be a conscious awareness of their anxieties and those of their relatives. Concern and compassion are important elements of the proper handling and analysing of patients’ samples.

Biomedical scientists in senior and managerial positions have a duty to ensure that the performance of the laboratory reaches the highest possible standards and that relationships with other managers are developed to enhance that performance.

Public expectations are that the professions will identify poor performance in healthcare provision, whether by teams or by individuals. This is a most difficult and delicate area but the weight of public expectation is reinforced by government policy11 that poor performers be identified and given every opportunity to bring their performance within the expected range, for example, by quality assurance (QA) processes and/or personal appraisal systems. Where QA tools identify failures there is a duty for all healthcare workers to act to ensure there is no risk of harm to patients.

The present culture of the health service and the concept of Clinical Governance encourage the reporting of colleagues who are performing poorly. (They need not necessarily belong to the same profession.) Where there are suspicions of a colleague’s performance, these should be raised via the relevant organisational procedure to the appropriate laboratory management level and, if appropriate, to the relevant healthcare regulator. Where a colleague from a different profession is involved, in most cases the appropriate reporting route will be via the clinical director of pathology. Before taking any different or additional course of action, members are advised to discuss the matter with the IBMS. It is expected that individual professionals will exhaust local and statutory procedures and consider the issues very seriously before considering making public any concerns.

Individual biomedical scientists Pathology laboratories Institute � � �

personal standards laboratory standards national standards � � �

self-assessment local audit external review

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2.4.5 Constraints

The demands on the public purse for healthcare are limitless. It is therefore incumbent on all practising biomedical scientists to ensure that none of that precious resource is wasted. This may be achieved on a large scale by, for example, contract negotiations, but is equally appropriate at individual level, for example in the careful use of reagents.

Constant monitoring and analysis to identify high quality, cost effective practice is recommended.

2.5 MANAGEMENT AND ADMINISTRATION

Members of the profession who have achieved the basic qualification to practise and been assigned any level of responsibility, be it for analysis, staff or working practice, have a managerial role. Progression through a career is synonymous with increasing managerial responsibilities. There will be a formal written management structure within laboratories and those appointed will apply themselves to these tasks no less diligently than to their scientific and analytical duties.

2.5.1 Management awareness

In pursuit of management competence, no less than scientific and technical competence, individual biomedical scientists must make themselves familiar with the laws and regulations relevant to their workplace and working practices.

These will include:

• human resources (HR) issues, including o equal opportunities (diversity awareness) o recruitment and selection

• safety issues • education issues, including

o pre- and post-registration qualifications o training programmes o continuing professional development o appraisals

• European law related to o staff and recruitment issues o purchasing standards o working time.

It is not anticipated that an in depth knowledge of all the above will be acquired simultaneously, but rather that it will be developed as needed during career progression. Nor is the above list prescriptive; the individual must keep abreast of new and revised laws, regulations and standards as they are introduced.

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2.5.2 Awareness of organisational policies

It is necessary to be familiar with the policies of the organisation including business plans. The objectives of an organisation are set out to facilitate clearly the achievements to which all members of the organisation can contribute and aspire. Professionals have a responsibility to their organisation and to their profession to direct their efforts to that end.

2.5.3 Development of management awareness and ability

Management does not happen only at the top of a career ladder; rather it is a gradual enlargement of experience, knowledge and needs, which begins early and continues throughout a career.

By a process of continuing interest, education and development, there is an onus on the individual to enlarge his/her knowledge and abilities in the field of laboratory management. Those with responsibilities for other staff must exhibit appropriate management skills by fostering and developing management awareness and opportunities in their staff.

2.5.4 Head of Department

Within the National Health Service, the Clinical Head of Department has ultimate responsibility for all clinical matters. The Head of Department will normally be responsible to the Clinical Director of Pathology and delegate such management functions as he/she may see fit to the Laboratory Manager. These will include the deployment of resources.

2.5.5 Laboratory Manager

The Laboratory Manager will deploy resources equitably in the best interests of the department and service needs. The Laboratory Manager’s role also includes responsibility for the scientific and technical work within the laboratory, for overall staff management and training and for the smooth administration of the department.

Much of the day to day running of the department will be delegated.

Laboratory Managers will be involved with other managers in budget management and control and in the overall organisation of supplies and maintenance contracts for their own departments.

Staff recruitment will be the responsibility of the manager, in liaison with the personnel or HR department, to ensure that organisational policies are maintained12.

Managers have overall responsibility for the teaching, training and education of all groups of staff in the laboratory. Statutory requirements are to be regarded as an absolute minimum, with best professional practice being the target. Staff communication will also be a crucial part of their role.

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Business management is a wider role with responsibilities, which include liaison with users of the service and meeting their needs and demands.

2.5.6 Relationship between management and professional issues

As managerial responsibilities of the individual grow, so the real and/or perceived areas of conflict between professional standards and organisational demands may become manifest. Good management must be able to blend apparent differences by judicious defence of realistic professional standards. High professional standards are the safeguard which the nation has demanded for improved healthcare.

2.5.7 Staff management

Good working relationships are essential to a high quality laboratory service.

Strengths of individual members of staff will be identified and utilised to the benefit of others and of the service provided. Equally, weaknesses will require pastoral aid, training and continuing education. The needs of individual staff members must be addressed so that they may contribute fully to the effectiveness of the unit as the service develops.

Job plans, personal professional development and appraisal will all form part of optimising the contributions each individual may make, including helping to realise ambitions and recognising limitations.

2.5.8 Training

Each laboratory will ensure that training officers and others will have sufficient time within their job roles to perform the duties associated with the necessary initial and continuing training of laboratory staff. The training officer must hold a promoted post with supervisory responsibility and a higher degree or equivalent.

2.5.9 Budgets

Either the Head of Department or the Laboratory Manager is commonly the budget holder. Management of the budget may be a responsibility devolved to the Head Biomedical Scientist or to the Business Manager. These two functions may be combined.

The budget manager will ensure that it is used appropriately for service provision and, by forecasting, help ensure it is sufficient to meet the demands on the service.

2.5.10 Communications

Good understanding of aims and objectives are central to the operation of the laboratory. Misunderstandings are a common cause of grievance and may easily undermine the morale and enthusiasm of the workforce. Active involvement of all staff in departmental meetings with carefully agreed minutes could help prevent misconceptions. At these meetings, staff must

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never be made to feel threatened or intimidated. All staff should be aware of formal (and informal) relationships within the department and with structures outside it.

2.5.11 Delegation

Over-control can lead to resentment and may be avoided by appropriate delegation. Systems do not operate well in a straitjacket and staff should be encouraged to manage workloads appropriate to their ability, experience and seniority. This will enhance job satisfaction.

2.6 STAFFING AND SKILL MIX

The scientific, technical and support staff of the clinical laboratory or department include:

• Laboratory and/or Business Manager or equivalent • Biomedical Scientists • Advanced Practitioners • Clinical Scientists (whose role is not included in this guide) • Trainee Biomedical Scientists • Cervical Cytology Screeners • Trainee Cervical Cytology Screeners • Biomedical support workers (Medical Laboratory Assistants) • Phlebotomists/Venesectors • Healthcare Assistants/Assistant practitioners • Anatomical Pathology Technologists • Secretarial and administrative staff • Ancillary staff.

Staffing of each laboratory is dependent on workload12, the complexity of the work performed within the department and the automation and computerisation in operation.

There must be a balanced grade structure in place which properly recognises the responsibilities of staff at a variety of levels.

2.6.1 Head biomedical scientist

The lead biomedical scientist who supports a Consultant Head of each and any of the recognised disciplines of pathology should be employed on a professional manager (or Advanced Practitioner) grade.

The grading and qualifications of the staff may be influenced by the amount of research undertaken. Thus the staffing in a teaching hospital will differ from that in a smaller district general hospital.

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2.6.2 Support grade supervision

Biomedical support workers must be supervised by biomedical scientists, in a ratio that should not exceed three biomedical support staff to one registered practitioner.

There must be sufficient biomedical scientist staff to ensure that biomedical support workers work only within the published guidelines approved by the Department of Health (DH)13. Within this guidance is particular reference to the work and competencies required of this group of support staff. To exceed the expected competencies is to risk compromising patient care.

2.6.3 Biomedical support workers

With an appropriate staffing structure, biomedical support workers may contribute at most some 25% of the total scientific and technical staff of a department, excluding venesectors and healthcare assistants. It has been shown12 that there is no financial saving in increasing this percentage, and to do so seriously compromises the future availability of qualified biomedical scientists.

Biomedical support workers must be supervised by qualified biomedical scientists, at all times. The numerous tasks which biomedical support workers may undertake are essentially dependent on the degree of supervision necessary and the ability of the individual. Reference should be made to the Institute’s policy leaflet on Medical Laboratory Assistants14.

The training of biomedical support workers must ensure a thorough understanding of the function of the laboratory and how it relates to other departments in the hospital and to general practitioners. In addition, the core generic values of HPC’s Standards of Proficiency2 should be incorporated into biomedical support worker training programmes. There must be a named individual biomedical scientist responsible for biomedical support worker training, including induction training. Training must follow the Manual for training and competence assessment of medical laboratory assistants, written by the DH and endorsed by other relevant bodies, including the IBMS13.

The ability of biomedical support workers must be assessed on a regular basis to monitor their progress and preparedness for other duties.

2.6.4 Phlebotomists/Venesectors

Staff of this grade may take blood from both inpatients and outpatients and are appointed to a variety of grades. Ideally they should be under the direction of the laboratory. Where they are not under such direct control, the laboratory must have an appropriate input into their training and education to ensure they meet laboratory requirements. All staff must complete a recognised venupuncture training course in accordance with the National Occupational Standards as recommended by the National Association of Phlebotomists.

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2.7 STAFFING AND WORKLOAD

Quantifying laboratory workload to draw comparisons between organisations and as a measure to predict appropriate staff and grading structures is difficult because of variations in work profiles, methodology and variable baselines12.In cellular pathology, work has been reported which relates the number of biomedical scientists required to support Consultant Histopathologists in the South West of England15.

Appropriate measures and comparison points are exacerbated by cross-discipline working and variable approaches to service delivery. Conversely, such variation also needs a framework for comparison to ensure the maintenance of proper and appropriate professional standards. The numbers of biomedical scientist posts are, as much as medical posts, directly linked with service quality and must not be reduced to provide finance to support posts in another profession.

An imbalance between numbers of staff in post and workload causes professional standards to become eroded. Numerical formulae, which show insufficient staff, require justification in terms of patient disbenefit, loss of service or unacceptable professional standards. Large and diverse workloads make it difficult to be prescriptive in numerical terms about the number and grades of staff appropriate. However, key indicators of service delivery must be identified and justified to determine whether staffing is insufficient or inappropriate.

The National Pathology Benchmarking Service16 is gradually allowing justifiable comparisons to be made in working practices, including staff numbers and skill mix ratios. The IBMS commends the scheme.

Other significant indicators of appropriate/inappropriate staffing include:

• specimen turnaround time • completion of acute work during normal

laboratory ‘opening times’ • urgent specimen arrangements • staff sickness records • unexplained absences • staff morale • error rates.

It is recommended that each of these factors should be recorded and, when reaching levels that are believed to be straining realistic professional standards, they should be used to secure measures to relieve these strains.

It may be particularly relevant to study error rates to help forestall serious diminution of standards.

The Institute has published guidance on error logging9.

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2.7.1 Management and organisation

Exact requirements will depend on the type and size of the laboratory, but at least three sessions a week (approximately 30% of total working time) should be allocated to the most senior grade biomedical scientist for involvement in management and organisation. It is recognised that local management arrangements will cause significant differences in systems of working, particularly those involving:

• extended working day • on call arrangements • flexitime working • 24-hour service.

Irrespective of the system operated, biomedical support workers must not work other than under direct supervision, with sufficient biomedical scientist staff present to ensure that this is possible at all times within the guidelines referred to in section 2.6 above.

2.7.2 Safety provision

Well-established legal requirements exist for safety provision. A safety auditor should be identified in each specialty. This appointment should be at a senior grade and supported by appropriate training and time allocation. Each laboratory should have an overall safety co-ordinator, and overall staffing complements should recognise this by providing staff time for the activity. See also section 2.14.

2.7.3 Research and development

Requirements in R & D vary greatly between laboratories and are ultimately driven by the requirements of the employer. Activity of this type should be quantified, funded and supported by sufficient staff at the appropriate grade and of appropriate experience.

2.8 LABORATORY RECORDS AND ARCHIVES

Security of data is an essential requirement of medical practice (see also section 2.15). Confidentiality of information on individual patients must be preserved in accordance with the law; failure in this also contravenes one of the central tenets of the HPC Standards and can result in the ultimate sanction of erasure from the Register.

The ethical use of tissue for non-diagnostic purposes is an area of great public concern and biomedical scientists must be aware of and follow published guidance based on the requirements of the Human Tissue Act17.

The joint guidance of The Royal College of Pathologists and the IBMS on specimen retention and storage18,19 includes recommendations to satisfy the requirements of the Act and must be observed.

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Separate guidance has been published on the legitimate transfer of pathological specimens that may be requested for legal and forensic reasons20.

2.9 TRAINING

2.9.1 Training and education

Biomedical scientists have a professional obligation and a duty of care to ensure they have sufficient identified time both to be trained and to provide training to more junior grades of staff. This is essential to:

• maintain the quality of service • maintain the quality of the professional pool • maintain professional standards • incorporate new technologies • provide a system for staff progression • conform to Health and Safety legislation21-32.

Sufficient numbers of staff with appropriate gradings and experience are required to address these issues formally, see section 2.5.8. The IBMS recommends the following as evidence of commitment to professional training:

• statement of training philosophy • logging system for maintaining evidence of training and

documentation to support this standard; the IBMS CPD Members Portfolio is useful for qualified staff in this respect, as are personal development plans

• named departmental training officers of senior grade • a minimum of 5% of the biomedical scientist staff complement to be

allocated to training • specifically scheduled training • novel methods of recruitment and training are encouraged and these

may include, for example: extra-numerary posts; co-operation between disciplines and even between neighbouring hospitals and/or trusts, to ensure an adequate pool of fully trained biomedical scientists

• employers’ requirement that all staff keep up to date and that a policy requiring staff to participate in continuing professional development (that can conform to HPC requirements) be in operation with active employer participation4

• a quantified training budget expressed as pounds sterling per annum per biomedical scientist.

2.9.2 Training and co-ordination

Every biomedical scientist must assume, as an integral part of his/her responsibilities, the training of junior members of the profession and others and the proper recording of that training.

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This will not simply include the bench level demonstration of skills and technique but will incorporate the passing on of knowledge and experience to ensure continuity. It is essential that each laboratory should have a training scheme flexible enough to accommodate the needs of all grades of staff at the appropriate level. It is proper professional practice to appoint individuals to arrange and to deliver the correct training and to establish quality control procedures to monitor progress and success rates. This should include appropriate and defensible documentation.

Training may take place wholly or partly in a clinical laboratory, or within a higher education institution. It may be undertaken whilst in employment or as part of a student placement. The IBMS has a key role in monitoring placements for students preparing to submit their portfolios for the Certificate of Competence, which supports application to the HPC for registration.

2.9.3 Role of the trainee biomedical scientist

The trainee biomedical scientist’s period of training should equip him/her not only to qualify for registration33 (where relevant) but also to become a ‘fit and proper’ person to stand alongside his/her peers as a member of the profession.

Both trainee and trainer have duties and responsibilities in the development of the trainee’s abilities. The period of training must be sufficient to include the acquisition of the skills and experience necessary for the performance of the job and the broader approach of attitude and curiosity of mind which characterises the professional scientific worker.

2.9.4 Pre- and post-qualifying training

It must not be assumed that training ends at any given level of qualification34.The duty to continue to enhance and improve skills and knowledge of an individual never ceases to be a professional responsibility. The role of the training co-ordinator will vary according to the continuing training and development needs of the individual.

2.9.5 Induction training for higher grades

It must not be forgotten that on appointment all staff must receive induction training. This must include not only introduction to a new workplace, but also training into newly promoted roles and responsibilities, according to the specific needs of the individual. See also section 2.14.7.

2.9.6 Training of support grades

It is the responsibility of the professional biomedical scientist to ensure that the correct and appropriate training is given to all staff employed in support grades for which he/she has responsibility. In many cases, the relevant training will be in-house, will be specifically directed to the immediate needs of the laboratory and will be updated as necessary. Where training needs exceed this minimum requirement, the training mechanism should be integrated into the system already established for staff in trainee grades. Appropriate and

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thorough training is an integral part of the responsibility for supervision of support grades. See also section 2.6.3.

2.10 PROFESSIONAL DEVELOPMENT

2.10.1 Continuing professional development

The Institute defines CPD as:

“The continuous process by which individual biomedical scientists maintain, improve and extend their knowledge and skill for the performance of their professional and scientific duties”35.

For HPC purposes CPD has additional specific meanings in terms of life long learning, keeping up to date and enhancement of patient and/or service outcomes4.

CPD has been a feature of normal professional life for many practitioners, but there is now an increasing public demand that all professionals offering a public service, and particularly those in healthcare, should be committed to ensuring that their knowledge is up to date and relevant. This has had the obvious consequence of greater regulation, including direction, control and monitoring.

Individual professional development

As members of a professional team, biomedical scientists share with their colleagues a personal responsibility to remain motivated and keep abreast of developments within their subject area in the broadest sense. Opportunities to broaden horizons should be seized and a determined attempt made in preparedness for promotion and changed responsibilities and/or working practices.

Maintaining and improving competence to practise will be seen as a programme of:

• continuous updating in scientific theory and practice • acquiring new skills and knowledge • demonstrating competence • developing individually in personal and professional terms • taking necessary steps to adapt to new job roles • contributing to the knowledge base of the profession • upholding and developing the reputation and image of the profession.

A record or portfolio of achievement should be maintained.

Means by which these objectives may be secured are addressed by the IBMS’s Continuing Professional Development scheme. This includes recommendations on recording the outcomes of CPD activity.

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2.10.2 Funding CPD

Implicit in CPA (UK) Ltd laboratory accreditation is that opportunities and facilities for CPD should be available for all grades of biomedical scientist. The requirements of Agenda for Change36 also mean that employers must make provision for CPD.

Pressure should be applied by local management and by professional bodies to ensure that biomedical scientists, in common with other staff, are supported in CPD. Scientific knowledge is considered to have a ‘half-life’ of only some five years. The requirement for all scientists to engage in continual updating is paramount.

There is also clear guidance in A first class service – quality in the new NHS11

that staff must take some responsibility for their own updating. This White Paper emphasises the need and individual responsibility for keeping up to date. It is one of the foundations of professional practice and one of the reasons why the IBMS makes a big investment in CPD for its members.

2.10.3 Time for CPD

While it is reasonable for practitioners to use some of their own time to keep themselves up to date, it is incumbent on employers to recognise that many significant CPD activities can only take place during working hours. All the necessary facilities, including time, must be adequately resourced. The example set by some of the royal colleges (see, for example, The Royal College of Anaesthetists) is that normal work should be scheduled to include quality issues such as CPD, audit, training, QA etc. They should be features of, and given equal priority within, normal working practice.

2.10.4 Monitoring and directing CPD

The IBMS as a professional body plays an important role in providing CPD, through courses and other activities, local support and monitoring.

Directing individuals towards identified CPD targets, perhaps to meet the needs of the organisation, is the responsibility of the laboratory or training managers, notwithstanding the individual’s own responsibility for his/her personal needs.

2.10.5 Responsibility for staff development

Senior staff have a duty to set an example and to encourage and facilitate participation by their junior colleagues in CPD activities. Goals and objectives for such development should be set and reviewed regularly. Achievement should be measured against targets set and discussed with all staff involved.

An awareness of the importance of personal development should be encouraged in other grades of staff.

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2.10.6 Need for individual professional appraisal

All staff with managerial responsibility should make themselves familiar with the progress, shortcomings and aspirations of the staff for whom they are responsible and should seek to guide their progress. The best means of achieving this is by a process of individual staff appraisal, which includes mutual participation in reviewing progress, discussing real and perceived problems and developing targets over regular periods.

It is by the above means that a significant contribution can be made to morale and to the maximisation of contributions by individuals to the effort that characterises the best professional teams. Performance is dependent on motivation and is affected adversely by barriers perceived by an individual. It is good practice to create effective teamwork, increase motivation, optimise performance and minimise difficulties.

2.10.7 Limitations of CPD

It is unreasonable to expect that CPD alone can provide the individual with all the skills and knowledge necessary within a given specialty. It is important that these skills are held collectively. Acknowledgement of this situation means that no biomedical scientist should be reluctant to seek help or advice from colleagues.

CPD should form an exciting and challenging part of a career, from initial registration for practice to retirement. No practising biomedical scientist should ever stop learning.

2.11 PROMOTION OF THE PROFESSION AND ITS IDEALS

Professional standards cannot be set, maintained or improved by individuals acting alone. It is only collectively that these can be achieved. It is by their professional standards that biomedical scientists will be judged. The individual therefore has a personal responsibility to meet and maintain standards set jointly by peers in the profession.

As part of this measure of collective responsibility, the individual also has an obligation to promote the profession, its ideals and the standards by which these are met.

2.11.1 Assessment and introduction of new technology

Outdated, outmoded and discredited methodology represents a hazard to patients, clinicians and all others whom the profession serves. It is therefore incumbent on the profession, individually and collectively, to embrace changes in technology and scientific practice to the benefit of those served. The need for careful assessment and evaluation on scientific, technological and financial grounds is implicit in this duty. Experienced professionals are best suited to make these assessments and must take a professional lead.

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2.11.2 Publication of developments

Every effort must be made to share experience in the evaluation and assessment of new developments. As shared objectives and experience make for a good team, so dissemination of information facilitates the advance of the profession for the good of those requiring its services.

Opportunities should be taken to facilitate this collective experience through formal and informal arenas, including discussion groups, workshops, seminars and publications.

2.11.3 Promoting confidentiality

Biomedical scientists share, with many other professionals, information confidential to individuals, to other professionals and, in the case of clinical laboratories, to patients. They have a duty of confidentiality no less than that of the medical profession for the last. This duty of confidentiality is set out in the Institute’s Code of Professional Conduct (see Part 1), which is binding on all members. This duty must be a common value of the team. A further duty of care is implicit in the Health Professions Order (2001), as expressed in the HPC’s Standards of Conduct, Performance and Ethics1, breach of which can lead to formal sanctions being imposed. See also section 2.15.2.

2.11.4 Practice within budgetary controls

The responsible use of principles of evidence-based medicine will lead to implementation of testing algorithms and protocols that best serve local patient needs, while maintaining proper financial controls. Adherence to these will ensure best use of resources and maintenance of agreed levels of professional practice.

2.12 QUALITY ASSURANCE

The following comments are directed at clinical laboratories, but nevertheless should be taken to represent good practice in similar laboratories.

Quality control is a programme for ensuring that all laboratory results produced are reliable. It should cover all aspects of the service, both analytical and non-analytical.

The quality manager and quality officer(s) should ensure that written procedures are carried out, reviewed when necessary and audited.

2.12.1 Quality control of the test procedure

Components of quality control of test procedures include the following:

• Proficiency surveillance. To ensure strict adherence to written procedures. Laboratory staff are responsible for auditing the process and results.

• Internal quality control (IQC). The main objective is to maintain day-to-day consistency of results and thereby ensure a swift response to problems.

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This entails checking results on control material for drift and imprecision. The assigned value of purchased quality control material must never be used as a calibrant. IQC results from every assay performed must be kept, even if an assay fails. This is particularly important for methods in which the result is subjective, eg staining techniques.

• External quality assessment (EQA) schemes in the UK. It is essential that laboratories register with schemes approved by CPA (EQA) Ltd, where available, for the appropriate range of test or analyses. Examples include UK National External Quality Assessment Service (NEQAS). Regional, national or international EQA schemes are acceptable. EQA results must be made available for examination by all laboratory staff and external assessors. The Laboratory Director and Head Biomedical Scientist must review EQA results on a regular basis.

• Internal quality assessment. This is normally done by re-submitting anonymised specimens through the whole analytical process. As for EQA, results of IQA must be used for education of laboratory staff and inspection by assessors. The laboratory management must ensure review of IQA results on a regular basis.

• Equipment monitoring. This arm of the quality monitoring system monitors and records essential equipment performance parameters. Biomedical scientists must review equipment control charts and ensure their archiving for the recommended periods of time18.

2.12.2 Standard operating procedures

Standard operating procedures (SOPs) must be in place for all test and most other procedures. The primary purpose of an SOP is to guide and standardise working procedure and thus ensure the reliability of the results produced.

It is essential that SOPs are written in a standard format that is clear and easy to understand.

They should include:

• a descriptive title with reference number • date when the SOP became operative • all aspects of the procedure • edition number and statement when the SOP replaces an earlier edition • the site where the procedure is carried out • identity of the individual responsible for writing the SOP • identity of the person or committee authorising the SOP • identity of the individual issuing the SOP (normally the quality

manager) • other minimum current requirements of CPA5.

SOPs must be reviewed on a regular basis, with the date of the revision recorded and the obsolete SOP withdrawn (and filed). The number and location of copies of each SOP in existence must be known to ensure all can be withdrawn. SOPs have the status of controlled documents, as have other significant documents, such as policy statements and risk assessments.

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2.12.3 Audit

In order to comply with accreditation standards, laboratories must be able to demonstrate that they audit their activities, record the findings and act on the findings by completing the audit loop. Audit should be done using both vertical and horizontal approaches. Vertical audit activities will include safety and internal quality control and assurance.

Error logging is recommended as an effective means of identifying problem areas both within and external to the department9. It must be developed within a ‘no blame’ culture. ‘Customer’ focus, protocol based requesting, review of service needs and clinical relevance of analytes performed all contribute to effective audit.

2.12.4 Audit trails

Data audit, an effective part of quality assurance, is the examination and review of raw data produced during or in support of any laboratory procedure.

Manual audit trail

Manual examination of data must include study of specimen reception, reagent preparation, worksheets, analyser or other mechanical printouts, QC libraries, graphs and other notes relating to the work carried out. SOPs, for which there should also be an audit procedure, should be inspected when carrying out an audit exercise.

Electronic data

Formal computer audit trail procedures should be in place. It is essential to ensure that software supplied with computers is capable of examination at each stage of the data entry and validation process.

Data correction

Computerised clinical records must have the facility to identify any data corrected, by whom, the time and the date. Data verification must be performed and recorded at each stage of completion and validation. Security against unwarranted access is essential.

2.13 POOR PERFORMANCE

The identification of poor performers is of increasing importance to the public mind and is a necessity for maintaining high standards of service provision within the laboratory. Managing poor performers is an even more sensitive task, but where poor performance impinges on patient care, action, which may be of serious consequence to individuals, must be taken. Careful and considered actions, however, will usually improve practice to safe and acceptable levels. Managers must be trained and competent to deal with such issues.

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2.13.1 Preventing poor performance

The culture within a department can play a large part in ensuring high standards of performance. A department that is poorly led, inappropriately managed and sloppily run is unlikely to enhance a culture of high quality performance.

Attention to detail in matters of leadership, communication, good working practices and pastoral concern is more likely to lead to high morale and high personal standards.

Low morale will lead to poor performance. If low morale is engendered by too heavy or too a light professional leadership of the laboratory, CPA standards may be breached and the balance needs redressing.

2.13.2 Measuring performance

Most laboratory tests and all laboratories will be subject to sophisticated systems of quality control, quality assessment and total quality assurance.

Individual poor performance may be identified through study of the outcomes of the various stages of quality assurance.

It is almost as likely that poor performance may be identified through the diligent observations of colleagues. These should not be ignored but require more considerate handling.

2.13.3 Managing the individual poor performer

Identifying and managing the poor performer can be difficult and is invariably sensitive. The person concerned will most probably be a work colleague, perhaps a friend, and often of long standing. In dealing with such cases, it is helpful to have clear objectives, which may be summarised as follows:

• to protect patients from harm – a primary objective which must always be uppermost in everyone’s mind

• to ensure that the person is treated justly according to fair and open procedures

• to provide opportunities for that individual to improve their performance according to properly managed processes.

2.13.4 Terminology

A poorly performing biomedical scientist is one whose performance falls outside the relevant local or national standards set by the laboratory as demonstrated by quality measures and the achievements of the laboratory staff as a whole.

Fitness to practise as a registered healthcare professional may be impaired by deficiencies of:

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• personal conduct: behaviour of practitioners unrelated to the exercise of their professional skills (at any time)

• professional competence: inadequacy of performance of practitioners related to the exercise of their scientific and technical skills and professional judgement.

In addition, one’s status as an HPC registered health professional may be at risk of sanction:

• in cases of criminal conviction or caution, • in event of fraudulent entry to the register,• when a sanction has been imposed by another healthcare regulator, or• where personal health problems adversely affect fitness to practise.

2.13.5 Procedures to be followed

Locally agreed policy procedures should always be followed. In addition reporting to the relevant healthcare regulator should be done at an early stage of suspicion or investigation, because failure to do so could put patients at continued risk.

2.13.6 Performance deficiencies in equipment or other medical devices

If defects or deficiencies are identified in medical devices or equipment, especially if CE marked, then the Medicines and Healthcare products Regulatory Agency must be informed in addition to any local reporting or error logging procedures. This may be done via http://www.medical-devices.gov.uk.

2.14 HEALTH AND SAFETY

All practitioners have a responsibility to consider the possible hazardous effect(s) of their working practices on others. There is also an ascending responsibility for safe working practice. The duty of care lies heavily on many laboratory workers, particularly those working in clinical laboratories. It is a serious professional responsibility to ensure safe working practices.

2.14.1 Compliance with legislation

Transport of infectious substances

It should be noted that a considerable amount of mail moved within the UK now travels by air, so that these regulations apply to both national and international transportation. Conditions for receiving and sending infectious material through the post or by courier must comply with requirements which conform to the packing instructions contained in the International Civil Aviation Organisation (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air (PI602).

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All human tissues and specimens (including clinical waste) are regarded as infectious materials for transport purposes. The HSE document BiologicalAgents: Managing the risks in laboratories and healthcare premises28 containsa useful summary of the regulations in force at the time of writing. These divide infectious substances into two categories, A and B, of which A contains the organisms capable of causing the most severe diseases. Category A materials must be sent by dedicated courier services under stringent conditions. Attention must also be paid to Schedule 5 of the Anti-terrorism, Crime and Security Act 200129.

Receipt of specimens from outside the organisation should be monitored for compliance with these standards and senders notified of any inadequacy in their practice and of where to obtain suitable advice and/or packing materials.

All carriers of specimens including the Royal Mail conform to the same national and international standards.

Dedicated means of transport must also comply with guidance published in the transport regulations.

Transport of other dangerous goods

Other legislation that applies to transport includes the Chemicals (Hazard Information and Packaging for Supply) (Amendment) [Nos 1(SI 1999, No 197) and 2(SI 1999, No 3165)] Regulations and The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) Regulations 200530,37 and where appropriate the Chemicals, Hazard, Information & Packaging (CHIP) Regulations30.

Department of Health directives

In laboratories ultimately governed by the DH, eg NHS laboratories, copies of all relevant DH directives, bulletins and notices and records of action taken in response must be retained. Those not governed by the DH should take this advice as an example of good practice and use it accordingly.

Health & safety regulations

Senior laboratory staff must ensure access to the latest editions of major legislation, Approved Codes of Practice and Guidance Notes applying to their operations. These are produced by, for example, the Health & Safety Executive, the DH and professional and other bodies such as the Health Protection Agency21-32,38,39,40.

Arrangements must be made to ensure compliance with statutory and applicable DH requirements.

Laboratories outside the UK should use local regulations; those of the UK may be used as examples of good practice where there are no local equivalents.

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2.14.2 Compliance with standards

British and EU standards

Laboratory staff must ensure they are aware of advice given in appropriate published standards and have a system of compliance with relevant requirements. These are seen as good or best practice.

Standards are also published as Codes of Practice21-24.

Professional and accreditation standards

There should be access within laboratories to relevant standards laid down by professional bodies and accreditation organisations such as CPA (UK) Ltd, the British Standards Institution and the King’s Fund. These represent essential or desirable standards for accredited laboratories and for those applying for accreditation, and good practice for others.

Best practice

Other authoritative sources of good or best practice are available from textbooks and published articles and they should be used or action taken to introduce them. In laboratories not covered by UK standards, those described should be used as a guide to good practice.

2.14.3 Hazardous substances

Infection risks

Senior staff must ensure arrangements for compliance with the Control of Substances Hazardous to Health Regulations (COSHH)21, consider the infection risk of clinical and other specimens25 and ensure that written assessments of risks to health are carried out. The HSE document BiologicalAgents: Managing the risks in laboratories and healthcare premises28 bringstogether the most up to date guidance on aspects of conforming to all current regulations that involve infectious materials.

Waste

Arrangements must be made for compliance with COSHH, special waste32 and local regulations, which also take account of the generation, handling and disposal of all wastes. Written assessments must be made of the risk to health. If clinical waste is to be transported by road or rail, then the appropriate transport regulations must also be followed.

Other substances

Arrangements for compliance with the COSHH regulations must be in place and take account of other substances such as chemicals, reagents and hazardous substances to which staff and others may be exposed.

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2.14.4 Infection control

Equipment decontamination

Procedures must be written to ensure equipment to be serviced, adjusted, maintained or sent from the laboratory for examination or for scrap is disinfected and/or rendered safe according to the manufacturer’s instructions or currently accepted good practice.

Immunisation

A policy and procedures must be in place for immunising staff against any relevant infections and for ensuring that any immunisations necessary according to risk assessment or medical advice are kept up to date.

Other aspects

Hygiene and infection control must be a part of the induction and basic training of all laboratory workers, including domestic, secretarial, clerical and portering staff.

2.14.5 Equipment maintenance

All equipment should have appropriate and regular inspection and maintenance, records of which must be logged. Maintenance of electrical equipment should cover electrical and functional safety aspects. Electrical safety checks should be of a type described in the HSE Guidance Note Maintaining portable and transportable electrical equipment41. Safety equipment, such as mechanical ventilation, that has been introduced as engineering controls under COSHH must be serviced and maintained in accordance with COSHH regulations.

2.14.6 Safety of premises

Building

Arrangements must be in place (in co-operation with building or works departments where relevant) to ensure that the building structure is sound and poses no risk to the health and safety of those who work within or visit the premises. This includes fire safety, including the prevention of fire hazards as well as the provision of means for detecting fire, fire fighting, raising the alarm and means of escape. Buildings must conform to either the Firecode38

(DH) or the standard specified in the Fire Precautions in the Workplace Regulations39 and hold a current certificate from the local fire.

Work environment

The work environment must as far as reasonably practicable protect the health and safety of anyone working in or visiting the premises, whether employees or not. Minimum standards to be met are found in the HSE Approved Code of Practice to the Workplace Regulations24.

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2.14.7 Training

Induction training

A programme must be written for induction training, including basic hygiene, fire safety, first aid arrangements, manual handling, display screen equipment and accident and incident reporting.

Strict supervision of new staff is necessary when they come into contact with clinical specimens or potentially contaminated articles, or use equipment or machinery, until they have been trained and approved as competent.

Other health and safety training

Fire safety training must be provided for every member of staff at least once a year. All training must be documented.

2.14.8 Safety management

A formal system of safety management must be in place as outlined in HSE Guidance Note HS (G) 65: Successful health and safety in the health service: information for directors and managers40. This will include:

• Safety policy: an up-to-date safety policy with a plan of action, set of rules and goals for health and safety must be in place

• Inspections and audit: there must be regular safety inspections or audits, and action must be taken on deficiencies found

• Risk assessments: there must be written assessments of the risk to health from all activities with a significant risk

• Safety advice: access to a competent authority able to advise on the requirements of legislation, good practice and any health and safety issues found within the laboratory must be available

• Consultation: staff must be consulted on health and safety issues, this is often best done through a safety committee or by trade union appointed safety representatives, although any effective means of achieving this is acceptable

• Emergency arrangements: written arrangements must be in place for dealing with all foreseeable emergencies that could arise, such as fire or spillage of chemicals; staff should be trained in these, and any appropriate equipment needed must be available.

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2.15 INFORMATION TECHNOLOGY

2.15.1 General

It is desirable to have a specific person acting as a local data security officer responsible for maintaining an up-to-date register of installed software, hardware and communications changes and for keeping the data protection officer informed of any relevant changes.

2.15.2 Legislation

Data Protection Act 1984

The Act aims to ensure that all computers holding personal data are registered with the data protection registrar and those specific principles of security are adhered to (ref Data Protection Act 1984 Schedule 1, Part142). The principles laid down in the Act are explained in Part 2 of the schedule; any lack of understanding should be clarified with the local data protection officer or the office of the Data Protection Registrar. The Caldicott principles should be followed43.

Computer Misuse Act 1990

Under the Computer Misuse Act 199044 it is an offence punishable by law to gain unauthorised access into a computer system, and if the person gaining access alters either programs or data the fine is unlimited and imprisonment is possible. It is good practice therefore, to assume that without an official password into a system you do not have official access.

Confidentiality

Although this is implicit in the Data Protection Act, the importance of data confidentiality cannot be stressed too highly. Patient information is provided specifically in relation to the investigations requested and to the collation of statistics and cannot be used in an identifiable way for any other purposes. Failure to comply with this is a serious breach of trust and would almost certainly lead to disciplinary procedure, dismissal and possible prosecution, plus the prospect of sanction by HPC.

Freedom of Information Act

The Freedom of Information Act 200045 covers all public bodies, including those in the health service. It gives the public the right to access any information that is held particularly but not exclusively relating to how public bodies make decisions and run services. Information is defined legally as something that has already been recorded, including e-mails, and thus does not cover new explanation, opinion or further analysis. Advice and analysis are in any case not included. The Act specifies how requests for information must be handled, and it sets a time limit of twenty days for a full reply. The Act does not conflict with the duty to maintain patient confidentiality, and there are certain other exemptions, both absolute and qualified. Any member of the

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public can request information without having to explain why it has been requested. Information that is known to be part of an information request must not be deliberately altered or destroyed. The penalty is a personal fine of up to £5000.

Most public bodies will have appointed and trained a freedom of information (FOI) officer, or equivalent. A biomedical scientist receiving a request for information that is or appears to be made under the FOI Act must act immediately to refer the request to the FOI officer who is able to respond in accordance with the Act. A written request must be forwarded. In the event of a verbal request the enquirer must be given the contact details of the FOI officer. In the event that the FOI officer refers a request for information to an employee because of his/her expertise in the subject, then he/she is responsible for responding within the time limits indicated by the FOI officer. If this is not possible the expert must contact the FOI officer to discuss the situation and how to proceed.

Routine requests for information relating to normal services are not affected and should be handled in the normal way.

2.15.3 Other considerations

Licensed software

All commercial computer software is protected by licence, and failure to comply with the terms of the licence may well lead to prosecution. The use of ‘pirated’ software, which includes copying to additional machines without additional licences, is illegal, and individuals and/or the employing authority are liable under copyright law.

Faxes

The security of data transmitted by fax must be as tight as possible. Transmission to an unknown destination could have serious consequences. All faxes should be preceded by an official header sheet containing the following: • Sender’s name, fax number and telephone number • Number of sheets, including the header • A request that the sender be informed immediately should the stated

number of pages not be received • Name of the individual for whom the fax is intended • It is expected that the receiving fax machine is in a secure location (safe

haven); steps should be taken to ensure this • ‘Catch all statement’ states confidential/legal nature. Advises contact and

destruction.

Software viruses

Computer viruses of program codes and documents, via ‘macros’, are mischievously or sometimes unwittingly introduced into computers with the aim of damaging and corrupting data. A common means of entry is by loading

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programs from colleagues. Where possible, only new unopened licensed copies of software should be installed. In instances where this is not possible, for example with macro-viruses which infect documents, a suitable virus checker, regularly updated, should be used frequently to detect damaging code on hard and/or floppy disks or CDs.

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REFERENCES

1. HPC Standards of conduct, performance and ethics – your duties as a registrant. London: HPC, 2003.

2. HPC Standards of Proficiency. July 2003.

1a: Professional autonomy and accountability

1b: Professional relationships

2a: Identification and assessment of health and social care needs

2b: Formulation and delivery of plans and strategies for meeting health and social care needs

2c: Critical evaluation of the impact of, or response to, the registrant's actions

3a: Knowledge, understanding and skills

3. HPC Standards of Education and Training. London: HPC, July 2004.

4. HPC. Standards for Continuing Professional Development. (Consultation Document.) London: HPC, September 2004.

5. CPA Standards for the Medical Laboratory, version 1.02, May 2003.

6. Conduct of CPA (UK) Ltd Medical Laboratory Assessments. Version 1.0, July 2003.

7. CPA Standards for EQA Schemes in Laboratory Medicine, version 4.01, September 2003.

8. Conduct of CPA (UK) Ltd EQA Scheme Assessments. Version 1.0, January 2004.

9. IBMS. Error logging in clinical laboratories. London: IBMS, 2002/3.

10. QAA. Benchmark statement: health care programmes, phase 2. Mansfield: QAA, 2004.

11. Department of Health. A first class service – quality in the new NHS. London: DH, 1998.

12. IBMS. Staffing and workload in UK clinical diagnostic laboratories. London: IBMS, 1996.

13. IBMS. Manual for training and competence assessment of medical laboratory assistants, 3rd Edn (Approved by the Department of Health). London: IBMS, 1994.

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14. IBMS. Medical laboratory assistants – their status in the laboratory. London: IBMS, 1999.

15. Hall PJ, Bullock P. Non-medical staffing and workload in histopathology and cytology. Biomedical Scientist 1996. September: 461-3.

16. Dyson R. Benchmarking pathology services. The Biomedical Scientist 1999; 7: 549 – 552.

17. HMSO. Human Tissue Act 2004. London: HMSO, 2004.

18. The Royal College of Pathologists/IBMS. The retention and storage of pathological records and archives. 3rdEdn. London: RCPath, 2005.

19. The Royal College of Pathologists/IBMS. Consensus statement of recommended policies for uses of human tissue in research education and quality control with notes reflecting UK law land practices, prepared by a working party of the RCPath and the IBMS. London: RCPath 1999.

20. The Royal College of Pathologists/IBMS. Guidelines on the release of specimens and data to the police and other law enforcement agencies, RCPath and the IBMS. London: RCPath 2005.

21. Health and Safety Executive. Approved Code of Practice (ACOP) to the Control of Substances Hazardous to Health Regulations, 2002. London: HSE Books, 2002.

22. Approved Code of Practice (ACOP) to the Management of Health & Safety at Work Regulations, 1999.

23. Approved Code of Practice (ACOP) to the Personal Protective Equipment at Work Regulations, 1992.

24. Approved Code of Practice (ACOP) to the Workplace (Health, Safety & Welfare) Regulations, 1998.

25. Health Services Advisory Committee. Safe working and the prevention of infection in clinical laboratories and similar facilities. 2nd Edn. HSE Books, 2003.

26. Advisory Committee on Dangerous Pathogens. Categorisation of biological agents according to hazard and categories of containment. 4th Edn. 1995. Second Supplement 2000.

27. Advisory Committee on Dangerous Pathogens. The management, design and operation of microbiological containment laboratories. HSE Books, 2001.

28. Advisory Committee on Dangerous Pathogens. Biological agents: Managingthe risks in laboratories and healthcare premises HSE, 2005 http://www.hse.gov.uk.

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29. The Stationery Office. Anti-terrorism, Crime and Security Act 2001. Ch24. 2002 (ISBN 0 10 542401 3).

30. Health and Safety Executive. Chemicals (Hazard Information and Packaging for Supply) (Amendment) (Nos 1(SI 1999, No 197) and 2 (SI 1999, No 3165)) Regulations 1999 - CHIP 99. 1999. London: The Stationery Office, 1999.

31. HSE. COSHH and Control of Carcinogenic Substances and Control of Biological Agents L5 (rev) Approved Codes of Practice. (ISBN 0 7176 0819 0).

32. Health and Safety Commission. HSAC. Safe disposal of clinical waste. Sudbury: HSE Books, 1999.

33. IBMS Certificate of Competence Registration Portfolio. London: IBMS, 2004.

34. IBMS. Professional education and training for biomedical scientists. London: IBMS, 2004.

35. IBMS. CPD Information and Registration. London: IBMS, 2004.

36. Department of Health. Agenda for Change: NHS Terms and Conditions of Service Handbook. London: DH, 2005.

37. Department for Transport. The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) Regulations 2005. London: DfT, 2004

38. Department of Health. Firecode: fire precautions in existing hospitals 1994; Firecode: fire precautions in new hospitals 1996.

39. Fire Precautions in the Workplace: Information for Employers about the Fire Precautions (Workplace) Regulations 1997.

40. HSE. Guidance Note HS (G) 65: Successful health and safety in the health service: information for directors and managers.

41. HSE. Maintaining portable and transportable electrical equipment, 2nd Edn (HSG 107). London; HMSO, 2004 (ISBN 0717628051).

42. The Data Protection Registrar. Data Protection Act 1984 Schedule 1.Wilmslow: Office of the Data Protection Registrar, 1985.

43. The Caldicott Committee. Report on the review of patient–identifiable information. Oxford: Oxford Radcliffe Hospital, Dec 1997.

44. Computer Misuse Act 1990. London: HMSO, 1990. (ISBN 0 10 541890 0).

45. Freedom of Information Act 2000 London: HMSO.

46. HSE 1999/154 Continuing professional development: quality in the new NHS.

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USEFUL CONTACTS

BritishStandardsInstitution (BSI)

389 Chiswick High RoadLondonW4 4AL

Tel:020 8996 9000

Fax:020 8996 7001

email: cservices@bsi-global.com

web:http://www.bsi-global.com/

ClinicalPathologyAccreditation (UK) Ltd (CPA)

45 Rutland Park Botanical Gardens Sheffield S10 2PB

Tel:0114 251 5800

Fax:0114 251 5801

email: office@cpa-uk.co.uk

web:http://www.cpa-uk.co.uk/

HealthProfessionsCouncil (HPC)

Park House 184 Kennington Park Road LondonSE11 4BU

Tel:020 7582 0866

Fax:020 7820 9684

email: info@hpc-uk.org

web:http://www.hpc-uk.org/

Health and Safety Executive

HSE Information

Services

CaerphillyBusiness Park CaerphillySouth Wales CF83 3GG

Tel:0845 345 0055

email:hse.infoline@natbrit.com

web:http://www.hse.gov.uk/

Kings Fund 11-13 Cavendish SquareLondon.W1G 0AN

Tel:020 7307 2400

Fax:020 7307 2801

web:http://www.kingsfund.org.uk/

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HealthProtectionAgency (HPA)

61 Colindale AvenueLondonNW9 5HT

Tel:020 8200 4400

Fax:020 8327 6009

web:http://www.hpa.org.uk/

The Royal College of Pathologists(RCPath)

2 Carlton House Terrace LondonSW1Y 5AF

Tel:020 7451 6700

Fax:020 7451 6701 020 7451 6702

email: info@rcpath.org

web:http://www.rcpath.org/

The Science Council

210 Euston Road LondonNW1 2BE

Tel:020 7611 8754

Fax:020 7611 8743

email: inquiries@sciencecouncil.org

web:http://www.sciencecouncil.org/

UK National External Quality AssessmentScheme(NEQAS) Office

PO Box 401 Sheffield S5 7YZ

Tel:0114 261 1689

Fax:0114 261 1049

email: office@uknequas.org.uk

web:http://www.uknequas.org.uk/

Institute of BiomedicalScience(IBMS)

12 Coldbath Square LondonEC1R 5HL

Tel:020 7713 0214

Fax:020 7436 4946

email: mail@ibms.org

web:http://www.ibms.org/

Institute of Biomedical Science12 Coldbath SquareLondon EC1R 5HLtel 020 7713 0214fax 020 7436 4946email mail@ibms.orgweb www.ibms.org

The Institute of Biomedical Science is a company limited by guarantee registered in England, No 377268 and a registered charity, No 261926hds 300/9/05