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References for use with CPA StandardsMarch 2008
The references presented here may be used as a resource to assist applicants and assessors in preparation for accreditation. The references posted here are the most up to date version that is known to CPA at the time of posting. CPA does not accept responsibility for any omissions or changes made to documents by other bodies. The material included within this list comes from a wide variety of sources, some of which are mandatory and others advisory. Scope The references given below are grouped to correspond to the most appropriate sections of the standards However, a reference may sometimes be applicable to more than one section of the standards. Where possible an ISBN number is given or a web site address provided 1. General 2. Organisation and the Quality Management System A 3. Personnel B 4. Premises and Environment C 5. Equipment, Information systems and Reagents D 6. Pre Examination Processes E 7. Examination Processes F 8. Post Examination Processes G 9. Evaluation and Quality Assurance H
1 General
§ ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence. § ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. § A Practical Guide to Accreditation in Laboratory Medicine. Burnett D, ACB Venture Publications, London 2002 (ISBN 0 90 2429396). § Clinical Pathology Accreditation (UK) Ltd, Standards for the Medical Laboratory 2007 www.cpa-uk.co.uk § . Clinical Pathology Accreditation: Standards for the Medical Laboratory. D Burnett, C Blair, M R Haeney, S L Jeffcoate, K W M Scott, D L Williams J Clin Path 2002, 55, 729-733 § Department of Health and Social Services (Northern Ireland). Health Estates Agency, Stoney Road, Dundonald, Belfast, BT16 § Standards for Pathology Laboratories, National Pathology Accreditation Advisory Council, Canberra Australia www.health.gov.au/npaac § European Communities Confederation of Clinical Chemistry. Additional essential criteria for quality systems of medical laboratories. Jansen, R.T.P., Blaton, V, Burnett, D, Huisman, W, Queralto, J.M., Zérah, S, Allman, B, Clinical Chemistry and Laboratory Medicine; 36, 249-252, 1998. § European Communities Confederation of Clinical Chemistry. Essential criteria for quality systems of medical laboratories. Jansen, R.T.P., Blaton, V, Burnett, D, Huisman, W, Queralto, J.M., Zérah, S, Allman, B, European Journal of Clinical Chemistry and Clinical Biochemistry. 35, 121-132, 1997. § Modernising Pathology Services, Department of Health Feb 2004 www.dh.gov.uk § NHS Health of Wales Information Service Website (HOWIS) www.wales.nhs.uk § The Scottish Office, St Andrews House, Regent Road, EH1 3DG www.scotland.gov.uk § The Audit Steering Committee, Royal College of Pathologists' United Kingdom pilot study of laboratory accreditation J Clin Pathol 1990 43: 89-91. § The Audit Steering Committee. Royal College of Pathologists' accreditation pilot study, a year later. J Clin Pathol, 1991, 44, 172-173. § The Medicine and Healthcare Products Regulatory Agency – Medical Device Section, Hannibal House, Elephant and Castle, London SE1 6TQ. Department of Health, PO Box 777, London SE1 6XH www.mhra.gov.uk § Your guide to the NHS. Department of Health 2001. www.nhs.uk
2 Organisation and quality management system
§ ISO 9000:2005 Quality management systems - Fundamentals and vocabulary. § ISO 9001:2000 Quality management systems – Requirements. § ISO 9004: 2000 Quality management systems - Guidelines for performance improvement. § ISO 15189:2007 Medical laboratories – Particular requirements for quality and competence. (Informative) Ethics in Laboratory Medicine § ISO 22870:2006 Point-of-care testing (POCT) – Requirements for quality and competence. § Accreditation and point-of care testing Burnett D. Ann Clin Biochem 2003;37:241-243 § Accreditation for microbiological laboratories EA-4/10 European Co-operation for Accreditation 2002 www.european-accreditation.org § Additional essential criteria for quality systems of medical laboratories, Jansen, R T P. Blaton. V. Burnett, D. Huisman W. Queraltó J M. Zérah S. Allman B Clin Chem Lab Med 1998; 36: 249-252 § Genetics White Paper (Our inheritance, Our Future: Realising the Potential of Genetics in the NHS) www.dh.gov.uk § Getting Ahead of the Curve. A strategy for combating infectious diseases. Department of Health 2003. www.dh.gov.uk § Guidance on the role of the Pathology Quality Manager 2003 Institute of Biomedical Science www.ibms.org § Guidelines for quality systems in medical laboratories, National Pathology Accreditation Advisory Council (NPAAC) Canberra, Australia, 2001 www.health.gov.au/npaac § Interim guidance on the use of clinical samples retained in the pathology laboratory, The Royal College of Pathologists, January 2005. § IWA 1 : 2001 Quality Management Systems – Guidelines for Process Improvements in Health Service Organisation § Recommendations for the Provision and Management of Antenatal Screening in Wales, 2002. www.velindre-tr.wales.nhs.uk/antenatal § Records management: NHS code of practice. Department of Health April 2006. www.dh.gov.uk § Retention of Laboratory Records and Diagnostic Material. Commonwealth Department of Health NPAAC, Canberra, Australia, Draft 2nd edition 2001. www.health.gov.au/npaac § Sickle Cell and Thalassaemia Screening Programme www.kcl-phs.org.uk/haemscreening § The Retention and Storage of Pathological Records and Archives, The Royal College of Pathologists 3rd Edition 2005. www.rcpath.org § Usefulness of EC4 Essential criteria for Quality Systems of medical Laboratories as Guideline to the ISO 15189 and ISO 17025 Documents Jansen R T P. Kenny D. Blaton V. Burnett D. Huisman W. Plebani M. Queraltó J M. Zérah S. van Lieshout J. Clin Chem Med Lab 2003; 38: 1057-1064
3 Personnel
§ IBMS: Professional Pathways for Biomedical Scientists: General Guidance for Professional Education and Training, Appendix 4: Guidelines for Training for Multidisciplinary Working Practices. www.ibms.org § IBMS: Staffing and Workload in UK Clinical Diagnostic Laboratories. www.ibms.org § Code of Practice on Disciplinary and Grievances Procedures, ACAS 2000 www.acas.org.uk § Code of Professional Conduct and Code of Practice for Biomedical Science Laboratories – Institute of Biomedical Science www.ibms.org § Employment Handbook, The A-Z of work, ACAS 2001 www.acas.org.uk § Good Medical Practice in Pathology, RCPath, 2001 www.rcpath.org § Knowledge and Skills Framework – Department of Health Paper 2003 § Making the Change: A Strategy for the Professions in Health Care Science – Department of Health 2001 § Medical Laboratory Assistants-Their Status in the Laboratory Institute of Biomedical Science 2002 www.ibms.org § National Occupational Standards for Healthcare Scientists www.noshcs.co.uk/html/about.htm § Standards of Proficiency: Biomedical Scientists, Health Professions Council 2003 www.hpc-uk.org § Substandard professional performance: guidance for Trusts and pathologists, The Royal College of Pathologists (RCPath), 2002 www.rcpath.org
4 Premises and environment
§ ISO 15190 (Sept 2003) Medical Laboratories – Requirements for safety § ACDP Infection at work - Controlling the risks ACDP 2003 www.hse.gov.uk/aboutus/meetings/acdp § ACPD The Approved List of Biological Agents, 3rd Edition, Categorisation 1998. www.hse.gov.uk/ § ACDP Guidance ‘Biological Agents – Managing the Risks’, Appendix 1.2 Transport of infectious substances pages 50-60. Available only by internet from the HSE website www.hse.gov.uk/biosafety/biologagents.pdf § Advisory Committee on the Microbiological Safety of Blood and Tissues for Transplantation, MSBT, Books, (ISBN 0 7176 1248 1) 1998 § A guide to risk assessment requirements – Common provision in health and safety law, 1999 HSE, UK www.hse.gov.uk § A short guide to Personal protective Equipment at Work Regulations, 1996 HSE, UK www.hse.gov.uk § Changes to Infectious substances transport procedures in 2005, http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsLegislation/PublicationsLegislationArticle/fs/en?CONTENT_ID=4114809&chk=8ziaOg § Biological agents: Managing the risks in laboratories and healthcare premises, Advisory Committee on Dangerous Pathogens, HSE, May 2005. § COSHH in Laboratories, Second edition, The Royal Society of Chemistry 1996 www.rsc.org § Everyone’s guide to RIDDOR, 1995; Reporting of injuries, diseases and dangerous occurrences regulations, HSE, UK. www.hse.gov.uk § Facilities for mortuary and post-mortem room services, HBN 20, NHS Estates, Department of Health, 2001 www.nhsestates.gov.uk § Firecode - Laboratories on hospital premises. Fire Practice Note 10 HSE Estates 1996 ISBN 0 11 322038 3 § Guidance on the microbiological safety of human organs, tissues and cells used in transplantation, Department of Health www.dh.gov.uk § Health and Safety Commission, The protection of persons against ionising radiation arising from any work activity. The Ionising Radiations Regulations 1999 London: HMSO (ISBN 0-11-085614-7) § Health Services Advisory Committee, Guidance on Manual Handling of Loads in the Health Services. HSE books 1998 www.nhs.uk/backinwork/contact.htm § Health Services Advisory Committee - Safe Disposal of Clinical Waste (HSAC 1999) ISBN 0 7176 2492 7 § Health Services Advisory Committee - Safe working and the prevention of infection in clinical laboratories and similar facilities 2003 HSE Books ISBN 0 7176 2513 3 § Health Services Advisory Committee - Safe working and the prevention of infection in the mortuary and post mortem room 2003 HSE Books ISBN 0 776 2293 2 § In Control of Horizontal Infection Ayliffe GAJ, Fraise AP, Geddes AM, Mitchell K 4th Edition 2000 ISBN 0 340 75911 9 § Manual handling: Manual Handling Operations Regulations 1992, Guidance on Regulations HSE Books, Sudbury, UK www.hse.gov.uk § NCCLS Clinical Laboratory Safety; Approved Guideline - Second Edition (2004). NCCLS Document GP17-A2 (ISBN 1-56238-530-5). NCCLS, Wayne, PA. § NCCLS Clinical Laboratory Waste Management; Approved Guideline - Second Addition (2002). NCCLS Document GP05-A2 (ISBN 1-56238-457-0) NCCLS, Wayne, PA. § NCCLS Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Second Edition (2001). NCCLS Document M29-A2 (ISBN 1-56238-453-8). NCCLS, Wayne, PA. § NCCLS Implementing a Needlestick and Sharps Injury Prevention Program in a Clinical Laboratory; Report - First Edition (2002). NCCLS Document X03-R (ISBN 1-56238-460-0). NCCLS, Wayne, PA. § Protection against Blood-borne infections in the workplace: HIV and Hepatitis.1995 HSE Books (ISBN 011 321953-9) § Statutory Instruments 1997 No. 1840, The Fire Precautions (Workplace) Regulations 1997 (ISBN 0110647386)1993 § The Health Act 2006: Code of Practice for the Prevention and Control of Health Care Associated Infections, Department of Health, October 2006. www.dh.gov.uk § The management design and operation of microbiological containment laboratories, 2001; Health and Safety Commission, Advisory Committee on Dangerous Pathogens, HSE Books, Sudbury, UK. www.hse.gov.uk § The Reporting of Injuries, Diseases and Dangerous Occurrence Regulations 1995: Guidance for employers in the healthcare sector, Health Services Sheet 1, 1998 HSE, UK. www.hse.gov.uk § Tuberculosis prevention and treatment: a toolkit for planning, commissioning and delivering high-quality services in England, Department Health, June 2007, www.dh.gov.uk § Working with VDU’s, 1998 HSE, UK. www.hse.gov.uk § Workplace, Health, Safety and Welfare, a short guide for managers, HSE, UK, 1997 www.hse.gov.uk
5 Equipment, information systems and reagents
§ ISO 15189:2003 Medical laboratories – Particular requirements for quality and competence. Annex B (Informative) Laboratory Information Systems § Consumer Protection Act, 1987, Chapter 43; London: HMSO, 1987 (ISBN 0 10 544387-5) § Data Protection Act 1998. London: The Stationery Office Ltd, 1998 § Electrically operated blood storage refrigerators. British Standard BS 4376, Part 1 BSI 1991, (ISBN 0 580 19313-6) Part 2 BSI 1996 Specification for cabinets for the storage of frozen plasma § European Committee for Standardization (CEN). Medical informatics - Structure for nomenclature, classification, and coding of properties in clinical laboratory sciences. (ENV 1614). CEN: Brussels, 1995 § European Committee for Standardization. Medical informatics - Expression of the results of measurement in health sciences. (ENV 12435). CEN: Brussels, 1996 § Freedom of Information Act 2000 ISBN 0 105 43600 3 § Management and Use of IVD Point of Care Test devices, MDA Device Bulletin 2002(03) 2002 www.medical-devices.gov.uk
§ Management of In Vitro Diagnostic Medical Devices, MDA Device Bulletin 2002(02) 2002 § Management of Medical Devices Prior to Repair, Service or Investigation. Device Bulletin DB 2003 (05) § Medical Device and Equipment Management for Hospital and Community-based Organisations, MDA DB 9801; January 1998 § Medical Devices Agency: The In Vitro Diagnostic (IVD) Medical Devices Regulations 2000, (ISBN 0 110 99260 1) § MHRA Reporting Adverse Incidents and Disseminating Medical Device Alerts MDA 2004/001 § Official Journal of the European Communities (7.12.98) L331/1-37, Directive 98/79EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices § Report, audit and improvement on the use of patient identifiable data, Caldicott - HSC 1999/12 § Safety requirements for electrical equipment for measurement, control, and laboratory use. BS EN 61010- 1; 2001 AMD 8961 § The Medical Devices Regulations 1994, S.I. No 3017 § Use and Disclosure of Health Data Guidance on the Application of the Data Protection Act 1998, 2002 www.informationcommissioner.gov.uk
6 Pre examination processes
§ Accreditation and point-of care testing Burnett D. Ann Clin Biochem 2003;37:241-243 § British Society for Clinical Cytology, Cytopathology: Recommended Code of Practice for Laboratories Providing a Cytopathology Service 1997 § Clinical Laboratory Technical Procedure Manuals - Fourth Edition, Approved Guideline 2002 NCCLS Document GP2-A4 § Collection, Transport and Processing of Blood Specimens for Coagulation Testing and Performance of Coagulation Assays; Approved Guideline - Third Edition 1998 NCCLS Document H21-A3 § Delivering For Health; Guidance On Implementation, HDL(2006) 12, Scottish Executive Health Department (SEHD), www.sehd.scot.nhs.uk/hdl.asp?offset=40 § EU Tissues and Cells. Directive 2004/23/EC of the European Parliament and of the Council 31 March 2004, Official Journal of the European Union, 7 April 2004, www.hfea.gov.uk § Families and Post Mortems – A Code of Practice, Department of Health 2003 § Human Tissue Act 2004 (HT Act), www.hta.gov.uk § IBMS: Patient Sample and Request Form Identification Criteria www.ibms.org § NCCLS GP16-A: Routine Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline. NCCLS: Wayne, PA.,1995 § NCCLS GP9-A: Selecting and Evaluating a Referral Laboratory; Approved Guideline. NCCLS: Wayne, PA.,1998 § NCCLS H3-A4: Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Fourth Edition. NCCLS: Wayne, PA.,1998 § Patient Sample and Request Form Identification Criteria – Institute of Biomedical Science § Setting Standards of Quality and Safety for the Collection, Testing, Processing, Storage and Distribution of Human Blood and Blood Components. Directive 2002/98/EC of the European Parliament and of the Council 2003 § Transport of Infectious Substances – Best Practice Guidance for Microbiology Laboratories, Department of Health, June 2007. www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_075439 § United Kingdom Hospital Policy for Organ and Tissue Donation: UK Transplant 2003 www.uktransplant.org.uk
7 Examination processes
§ BMA: Interim BMA guidelines on retention of human tissue at post-mortem examination for the purposes of medical education and research, November 2000 § British Committee for Standards in Haematology, Guidelines, § EN 12322:1999 In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media § EN 12376:1999 In Vitro diagnostic medical devices – Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology § EN 13641:2002 Elimination of risk of infection related to in vitro diagnostic reagents § Guidelines for the performance of the pathology surgical cutup, NPAAC, Canberra, Australia, 2001 www.health.gov.au/npaac § Guidelines in Autopsy Practice. Report of Working Group of the Royal College of Pathology 2002 § Guidance Notes on the Processing, Storage and Issue of Bone Marrow and Blood Stem Cells, Department of Health, 1997 § Guide to the expression of uncertainty in measurement issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML, revised 1995 § Guidelines for the Blood Transfusion Service in the United Kingdom, Fourth Edition 2000 (ISBN 0113223137) § OECD Guidelines for Quality Assurance in Molecular Genetic Testing, Organisation For Economic Co-Operation and Development, 2007. www.oecd.org/sti/biotechnology/qualityassurance § Standards for Blood and Marrow progenitor cell processing, collection and transplantation, Joint Accreditation Committee of ISHAGE-Europe and EBMT 4th Edition, February 1998 § The Royal College of Pathologists: Guidelines for the retention of tissues and organs at post-mortem examination, March 2000 § The Retention and Storage of Pathological Records and Archives. The Royal College of Pathologists and the Institute of Biomedical Science, 3rd Edition 2005. www.rcpath.org
8 Post examination processes
§ Confidentiality: Protecting and Providing Information, General Medical Council, London 2000 § Delivering For Health; Guidance On Implementation, HDL(2006) 12, Scottish Executive Health Department (SEHD), www.sehd.scot.nhs.uk/hdl.asp?offset=40 § IBMS: Giving Results over the Telephone www.ibms.org § Guidelines for the reporting of ophthalmic pathology specimens, The Royal College of Pathologists, October 2007 (revised March 2008) http://www.rcpath.org/resources/pdf/g053v2_guidelinesreportingophthalmicspecs_mar08.pdf § The Royal College of Pathologists’ advice relating to the ownership, storage and release of pathology results. Royal College of Pathologists UK 2001 www.rcpath.org § The systemized Nomenclature of Medicine: Cote, R.A., Rothwell, D.J., Palotay J.L., Becket, R.S., Brochu, L. (eds), SNOMEDŇ International. College of American Pathologists, Northfield, IL, 1993 § Use and Disclosure of Health Data, Guidance on the Application of the Data Protection Act 1998, 2002 www.informationcommissioner.gov.uk
9 Evaluation and quality assurance
§ ISO 9004:2000 Quality management systems-Guidelines for performance improvement § Clinical Audit in Pathology, The Royal College of Pathologists, The Institute of Biomedical Science, The Association of Clinical Biochemists, June 1997 § Accreditation of external quality assessment schemes in the United Kingdom Goldie D J. Clin Chim Acta 2001;309:179-181 § Building a Safer NHS for Patients 2001 www.dh.gov.uk § Guideline for the requirements for the competence of providers of proficiency testing Schemes ILAC-G13-2000: www.ilac.org § Laboratory-Related Measures of Patient Outcomes: An Introduction, ed. Bissell M G. AACC 2000 www.aaccdirect.org § Learning from patients: Pietroni, P., Winkler, F., Graham, L., Cultural revolution. BMJ, June 2003, 326, 1304-1306 § NCCLS Selecting and Evaluating a Referral Laboratory; Approved Guideline - First Edition (1998). NCCLS Document GP09-A (ISBN 1-56238-357-4). NCCLS, Wayne, PA. § NPAAC, Canberra, Australia, www.health.gov.au/npaac § The Serious Hazard of Blood Transfusion (SHOT) Scheme www.shotuk.org § What patients want from their doctors: Stone, M., BMJ June 2003, 326, 1294 |
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