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ISO and CEN documents on quality in medical laboratories
Clinica Chimica Acta 309 Ž2001. 121–125 www.elsevier.comrlocaterclinchim
ISO and CEN documents on quality in medical laboratories Desmond Kenny ) Department of Clinical Biochemistry, Our Lady’s Hospital for Sick Children, Crumlin, Dublin 12, Ireland
Abstract The forthcoming international standard ISO 15189 AQuality management in the medical laboratoryB is a document of great importance for the development of quality systems and accreditation for medicalrclinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. The document takes into account the special requirements imposed by the medical environment and by the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form ŽISOrDIS 15190., deals with safety management for medical laboratories. ISO 15189 Žand probably 15190 also. are expected be adopted by CEN as a European Standard ŽEN.. q 2001 Elsevier Science B.V. All rights reserved. Keywords: Medical laboratories; Clinical laboratories; Quality management; Accreditation; Standards
1. Introduction It is now universally recognized by professional bodies, governments, health care administrators and other interested parties that accreditation ŽTable 1. of clinicalrmedical laboratories is essential in order to ensure the high standards of service which patients and clinicians should be able to take for granted. Until now, accreditation of medical laboratories has been based either on AlocalB standards, e.g. CAP ŽUS., CPA ŽUK., CCKLTest ŽNL., 1 or on international standards which are not particularly suited for the purpose: ISO Guide 25 w1x or its European
)
Tel.: q353-1-409-6434; fax: q353-1-455-9073. E-mail address: [email protected] ŽD. Kenny.. 1 CAPsCollege of American Pathologists; CPA sClinical Pathology Accreditation; CCKL sCoordinatie Commissie voor ¨ Kwaliteitsbewaking in Laboratoria in de gezondheidszorg.
equivalent, EN 45001 w2x, which were designed for accreditation of industrial Acalibration and testing laboratoriesB Žthese documents have recently been replaced by the new standard ISO 17025 w3x.. It should be obvious that there is a fundamental difference between - testing industrial products to see Žfor example. if they comply with the appropriate regulations and - the testing of patient samples which constitutes a large part of the role of the clinical laboratory’s service Žand of course there is more to the clinical laboratory service than merely performing tests and issuing results.; this testing is an integral part of medical treatment, especially with regard to diagnosis and monitoring. There is a need for an international standard which takes into account the special nature of medical laboratories, including such aspects as Ø advising on the use of the service, Ø interpretation of results,
0009-8981r01r$ - see front matter q 2001 Elsevier Science B.V. All rights reserved. PII: S 0 0 0 9 - 8 9 8 1 Ž 0 1 . 0 0 5 0 8 - 3
122
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
Table 1 ISO definition of accreditation
Table 2 Structure of ISOrDIS 15189
Accreditation: AProcedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasksB ŽISOrIEC Guide 2..
Contents: Introduction 1. Scope 2. Normative references 3. Terms and definitions 4.Management requirements . . . 5. Technical requirements . . . Annexes A Žinformative.: Cross reference tables B Žinformative.: Lab Information Systems C Žinformative.: Ethics in Laboratory Medicine D Žinformative.: Bibliography
Ø contributing to clinical audit, Ø organizing the service to meet medical needs, for example with respect to turnaround times and responding to medical emergencies, Ø education and training, not only of laboratory staff but also of medical, nursing and other professional staff Žthis is not an exhaustive list.. To fulfil this need, a newly established ISO Technical Committee, ISO TC 212, began work in 1995 on a draft which is now wDecember 2000x close to acceptance as an ISO standard: ISO 15189 AQuality management in the medical laboratoryB w4x. The document is also being processed by CEN ŽComite´ Europeen ´ de Normalisation. as a draft European Standard. When finalised within ISO, this document will be circulated by ISO and CEN for final vote as an international and European standard. Its adoption as a European standard ŽEN. will give it the status of a national standard in all CEN member countries. 2. ISO r DIS 2 15189 CQuality management in the medical laboratoryD 3 The purpose of this standard is to provide a basis for Quality systems and Accreditation in medicalr
2
DISs Draft International Standard. Since the presentation of this paper in October 2000, the title of this document has been changed to CMedical laboratories— Particular requirements for quality and competenceD. The Introduction and Scope clauses have been slightly modified and Annex A has been normative. In all other respects, the text and format of the document are unchanged as of the date of writing this note ŽJune 2001.. Changes proposed at the meeting of ISOrTC 212rWG 1 in Vancouver, March 2001, were withdrawn by resolution w5x at the meeting of ISOrTC 212 in Dublin, June 2001. 3
clinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. Work on this document started in 1995 in Working Group 1 of ISO technical Committee 212 ŽISOrTC 212rWG 1.. The text discussed here is that agreed at the ISOrTC 212 meeting in Philadelphia in June 2000. The uses of 15189 will probably differ in different countries Ø as a stand-alone accreditation standard in countries which currently use AlocalB standards designed specifically for the accreditation of medical laboratories and in countries which are Table 3 ISOrDIS 15189, extract from the Introduction Introduction This International Standard provides requirements relevant to the quality management of medical laboratories . . . . Medical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel . . . . These services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples with subsequent validation, interpretation, reporting, and advice, as well as safety and ethics of medical laboratory work . . . . Bodies that recognise the competence of medical laboratories may use this International Standard as the basis for their activities. If a laboratory seeks accreditation for a part or all of its activities, it should select an accreditation body that operates in a manner, which takes into account the special requirements of medical laboratories . . . .
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125 Table 4 ISOrDIS 15189, subclause headings of clause 4
Table 6 ISOrDIS 15189, subclause headings of clause 5
4 Management requirements: 4.1 Organization and management 4.2 Quality management system 4.3 Document control 4.4 Examination by referral laboratories 4.5 External services and supplies 4.6 Identification and control of nonconformities 4.7 Corrective action 4.8 Advisory services and resolution of complaints 4.9 Continuous improvement process 4.10 Quality and technical records 4.11 Internal audits 4.12 Management review
5 Technical requirements 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment 5.4 Pre-examination process 5.5 Examination procedures 5.6 Assuring the quality of examination procedures 5.7 Post-examination process 5.8 Reporting of results 5.9 Alterations and amendments of reports
establishing new medical laboratory accreditation systems; Ø as a guidance document for the application of ISOrIEC 17025 Žthe successor to Guide 25 and EN 45001. in medical laboratories in some countries which currently use the Acalibration and testing laboratoryB standards for accreditation of medical laboratories.
Table 5 ISOrDIS 15189, selected subclauses from clause 4 Management requirements 4.1.2 Medical laboratory services, including . . . interpretation and advisory services, shall be designed to meet the needs of patients and . . . clinical personnel . . . . 4.4.4 The referring laboratory and not the referral laboratory shall report . . . results and findings. The report shall include all essential elements . . . without alterations that could effect clinical interpretation. Note: This does not mandate that the laboratory report every word and the exact format of the referral lab report unless required by nationalrlocal laws . . . may provide additional interpretative remarks wauthor must be identifiedx. 4.6.1.c The medical significance of the nonconforming examinations is considered, and where appropriate, the requesting clinician informed. 4.8.2 Appropriate laboratory professional staff shall provide advice on choice of examinations and use of the service . . . where appropriate, interpretation of the results of examinations shall be provided. 4.12.1 . . . management shall review the laboratory’s quality management system and all of its medical services, including examination and advisory activities to ensure continuing suitability and effectiveness in support of patient care.
123
ISOrDIS 15189 includes cross-reference tables showing the correspondence between sub-clauses of 15189 and ISO 9001:2000 w6x and between 15189 and ISOrIEC 17025. ISO 15189 incorporates a large part of the EC4 AEssential criteria for quality systems of medical laboratoriesB w7x and AAdditional essential criteria . . . B w8x. A recent paper, also from EC4, gives details of the correspondences between the AEssential criteriaB documents and ISO 15189 and 17025 w9x. The structure of the draft standard is shown in Table 2. An Introduction followed by clauses 1–3: Scope, NormatiÕe references and Terms and definitions is the usual structure for an ISO standard. The main normative text is in sections 4 and 5 and there are four annexes, which are designated as Ainformative.B 4 Division of the normative text into Management and Technical requirements parallels the structure of ISOrIEC 17025. The Introduction ŽTable 3. clearly places the activities of the medical laboratory in the context of patient care and emphasizes that medical laboratories have special requirements which must be taken into
4
ANormativeB and AinformativeB are terms used in international standards work to distinguish two kinds of text in standards documents. NormatiÕe text is the core of the standard, and contains requirements, which must be satisfied in order to claim compliance with the standard. InformatiÕe text does not contain requirements, and is given for information only. The informative text of a standard includes the Introduction, all text in Notes, and any annexes which are stated to be Informative.
124
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
Table 7 ISOrDIS 15189, selected subclauses from clause 5 Technical requirements 5.1.3 The laboratory shall be directed by a person or persons . . . who have the competence to assume responsibility for the service provided. Note 1: Competence is here understood as the product of basic academic, postgraduate, and continuing education, as well as training and experience of several years in a medical laboratory. 5.1.4 The responsibilities of the laboratory director or designees shall include professional, scientific, consultative or advisory, organisational, administrative, and educational matters . . . . 5.1.10 There shall be a continuing education programme available for all levels of staff. 5.1.13 The personnel making professional judgements with reference to examinations shall have applicable theoretical and practical background as well as recent experience. They shall take part in regular professional development or other professional liaison. 5.4.1 The request form shall contain sufficient information to identify the patient and the authorised requester, as well as providing pertinent clinical data . . . . 5.4.2 Specific instructions for the proper collection and handling of primary samples . . . shall be contained in a primary sample collection manual. 5.5.1 The laboratory shall use examination procedures . . . which meet the needs of the users of laboratory services . . . Procedures published in peer-reviewed texts or journals or as international, national or regional recommended guidelines are preferred. In-house procedures shall be appropriately validated . . . . 5.6.4 The laboratory shall participate in . . . external quality assessment . . . . 5.6.5 wwhere EQA is not available, the laboratory shall develop alternatives such as exchange of samples with other laboratoriesx. 5.7.1 Authorized personnel shall systematically review and authorize the release of results of examinations. 5.8.1 The laboratory management shall be responsible for the formatting of reports . . . to be determined in discussion with the users of the service 5.8.6 wprocedures for notification of results falling within AalertB or AcriticalB intervalsx 5.8.7 . . . turnaround time shall reflect clinical needs.
account when they are being assessed for accreditation. The structure of clause 4, Management requirements, is shown in Table 4. The clause includes all the essential points which are also found in other accreditation standards, but emphasizes the importance and special nature of the patient care environment in which medical laboratories operate ŽTable 5..
The structure of clause 5, Technical requirements, is shown in Table 6. Here again, the clause covers the requirements of other accreditation standards, but gives the necessary attention to the realities of the medical environment, including the requirements of the pre- and post-examination phases of the medical laboratory process ŽTable 7.. Annex C ŽTable 8., Ethics in Laboratory Medicine, although it is not part of the normative text, provides further illustration of the special nature of medical laboratories. In particular, it emphasizes that the patient’s welfare is paramount ŽC.2.1. and that the laboratory has responsibilities to the patient, which do not end with the issuing of a test result ŽC.6.3.. When ethical problems are considered, account must be taken not only of legal considerations but also of the patient’s best interests ŽC.9.1..
Table 8 ISOrDIS 15189, extracts from Annex C, Ethics in Laboratory Medicine C.1.1 . . . professional personnel are bound by the ethical codes of their respective profession. Each country may have specific rules or requirements . . . . C.2.1 The general principle . . . is that the patient’s welfare is paramount . . . . C.4.1 All procedures . . . require informed consent . . . . C.6 Reporting of results C.6.1 Results will normally be reported to the requesting physician and may be reported to other parties with the patient’s consent, or as required by law. Results . . . that have been separated from all patient identification may be used for such purposes as epidemiology, demography, or other statistical analysis. C.6.3 . . . the laboratory has an additional responsibility to ensure that as far as possible, the examinations are correctly interpreted and applied in the patient’s best interest. Specialist advice with regard to the selection and interpretation of examinations is part of the laboratory service. C.9 Use of samples for examination purposes other than those requested C.9.1 The use of samples for purposes other than those requested without prior consent should occur only if the residual samples are made anonymous or have been pooled. Laboratoriesrinstitutions should have documented policies on how to handle unrequested information Že.g. follow-up examinations to clarify previous results. from identifiable samples taking into account the legal implications and the patient’s best interests. Relevant national, regional, and local regulatory requirements should be observed.
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
3. ISO r DIS 15190 Csafety management for medical laboratoriesD 5 This draft standard w10x, also produced by ISOrTC 212rWG 1, has been circulated by ISO for comment and voting, with a deadline of 23 April 2001. As DIS, it will then be subject to modification in response to the comments received. This document may be regarded as a supplement to 15189, covering the safety issues which must also be considered in the accreditation of medical laboratories. In addition to the normative text, the document has three Informative annexes. Annex A: Outline plan for the implementation of the standard Annex B: Laboratory Safety Audit wmodel questionnairex Annex C: Decontamination, cleaning and disinfection of medical laboratory equipment.
4. What next? It is expected that new versions of nationalrlocal accreditation standards will be revised so that accredited laboratories will satisfy the requirements of ISO 15189. CPA ŽUK. have already produced a new version of their accreditation standards, based on 15189 and also cross-referenced to ISO 17025 w3x and the EC4 AEssential requirementsB w7,8x. Two new work items for ISOrTC 212rWG 1 have now been approved: Ø AGuidance document on the application of ISO 15189, Quality management in the medical laboratoryB and Ø AQuality Management of point of care testing ŽPOCT.B.
5
Renamed CMedical laboratories—Requirements for safetyD in June 2001 w5x.
125
Criteria for quality systems of Point of Care Testing are included in the EC4 AAdditional essential criteriaB document w7x, which can be used as a source of material for the new draft on this subject.
Acknowledgements Text quoted from ISOrDIS 15189 is used here by permission of ISO, which holds the copyright.
References w1x ISOrIEC Guide 25, General requirements for the competence of calibration and testing laboratories, 3rd edn. International Organization for Standardization, Geneva, 1990. w2x EN 45001, General criteria for the operation of testing laboratories. European Committee for Standardization, Brussels, 1991. w3x ISOrIEC 17025, General requirements for the competence of testing and calibration laboratories. International Organization for Standardization, Geneva, 1999. w4x ISOrDIS 15189, Quality management in the medical laboratory. International Organization for Standardization, Geneva, 2000. w5x ISOrTC 212 N90 Resolutions of the seventh meeting, Dublin, Ireland, 6 and 8 June 2001. International Organization for Standardization, Geneva, 2001. w6x ISO 9001:2000, Quality management systems—Requirements. International Organization for Standardization, Geneva, 2000. w7x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM, Zerah ´ S, Allman B. Essential criteria for quality systems of medical laboratories. Eur J Clin Chem Clin Biochem 1997;35:121–32. w8x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM, Zerah ´ S, Allman B. Essential criteria for quality systems of medical laboratories. Clin Chem Lab Med 1998;36:249–52. w9x Jansen RTP, Kenny D, Blaton V, Burnett D, Huisman W, Plebani M, Queralto JM, Zerah ´ S, van Lieshout J. Usefulness of EC4 essential criteria for quality systems of medical laboratories as guidelines to the ISO 15189 and ISO 17025 documents. Clin Chem Lab Med 2000;38:1057–64. w10x ISOrDIS 15190, Clinical laboratory medicine—Safety management for medical laboratories. International Organization for Standardization, Geneva, 2000.
ISO and CEN documents on quality in medical laboratories Desmond Kenny ) Department of Clinical Biochemistry, Our Lady’s Hospital for Sick Children, Crumlin, Dublin 12, Ireland
Abstract The forthcoming international standard ISO 15189 AQuality management in the medical laboratoryB is a document of great importance for the development of quality systems and accreditation for medicalrclinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. The document takes into account the special requirements imposed by the medical environment and by the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form ŽISOrDIS 15190., deals with safety management for medical laboratories. ISO 15189 Žand probably 15190 also. are expected be adopted by CEN as a European Standard ŽEN.. q 2001 Elsevier Science B.V. All rights reserved. Keywords: Medical laboratories; Clinical laboratories; Quality management; Accreditation; Standards
1. Introduction It is now universally recognized by professional bodies, governments, health care administrators and other interested parties that accreditation ŽTable 1. of clinicalrmedical laboratories is essential in order to ensure the high standards of service which patients and clinicians should be able to take for granted. Until now, accreditation of medical laboratories has been based either on AlocalB standards, e.g. CAP ŽUS., CPA ŽUK., CCKLTest ŽNL., 1 or on international standards which are not particularly suited for the purpose: ISO Guide 25 w1x or its European
)
Tel.: q353-1-409-6434; fax: q353-1-455-9073. E-mail address: [email protected] ŽD. Kenny.. 1 CAPsCollege of American Pathologists; CPA sClinical Pathology Accreditation; CCKL sCoordinatie Commissie voor ¨ Kwaliteitsbewaking in Laboratoria in de gezondheidszorg.
equivalent, EN 45001 w2x, which were designed for accreditation of industrial Acalibration and testing laboratoriesB Žthese documents have recently been replaced by the new standard ISO 17025 w3x.. It should be obvious that there is a fundamental difference between - testing industrial products to see Žfor example. if they comply with the appropriate regulations and - the testing of patient samples which constitutes a large part of the role of the clinical laboratory’s service Žand of course there is more to the clinical laboratory service than merely performing tests and issuing results.; this testing is an integral part of medical treatment, especially with regard to diagnosis and monitoring. There is a need for an international standard which takes into account the special nature of medical laboratories, including such aspects as Ø advising on the use of the service, Ø interpretation of results,
0009-8981r01r$ - see front matter q 2001 Elsevier Science B.V. All rights reserved. PII: S 0 0 0 9 - 8 9 8 1 Ž 0 1 . 0 0 5 0 8 - 3
122
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
Table 1 ISO definition of accreditation
Table 2 Structure of ISOrDIS 15189
Accreditation: AProcedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasksB ŽISOrIEC Guide 2..
Contents: Introduction 1. Scope 2. Normative references 3. Terms and definitions 4.Management requirements . . . 5. Technical requirements . . . Annexes A Žinformative.: Cross reference tables B Žinformative.: Lab Information Systems C Žinformative.: Ethics in Laboratory Medicine D Žinformative.: Bibliography
Ø contributing to clinical audit, Ø organizing the service to meet medical needs, for example with respect to turnaround times and responding to medical emergencies, Ø education and training, not only of laboratory staff but also of medical, nursing and other professional staff Žthis is not an exhaustive list.. To fulfil this need, a newly established ISO Technical Committee, ISO TC 212, began work in 1995 on a draft which is now wDecember 2000x close to acceptance as an ISO standard: ISO 15189 AQuality management in the medical laboratoryB w4x. The document is also being processed by CEN ŽComite´ Europeen ´ de Normalisation. as a draft European Standard. When finalised within ISO, this document will be circulated by ISO and CEN for final vote as an international and European standard. Its adoption as a European standard ŽEN. will give it the status of a national standard in all CEN member countries. 2. ISO r DIS 2 15189 CQuality management in the medical laboratoryD 3 The purpose of this standard is to provide a basis for Quality systems and Accreditation in medicalr
2
DISs Draft International Standard. Since the presentation of this paper in October 2000, the title of this document has been changed to CMedical laboratories— Particular requirements for quality and competenceD. The Introduction and Scope clauses have been slightly modified and Annex A has been normative. In all other respects, the text and format of the document are unchanged as of the date of writing this note ŽJune 2001.. Changes proposed at the meeting of ISOrTC 212rWG 1 in Vancouver, March 2001, were withdrawn by resolution w5x at the meeting of ISOrTC 212 in Dublin, June 2001. 3
clinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. Work on this document started in 1995 in Working Group 1 of ISO technical Committee 212 ŽISOrTC 212rWG 1.. The text discussed here is that agreed at the ISOrTC 212 meeting in Philadelphia in June 2000. The uses of 15189 will probably differ in different countries Ø as a stand-alone accreditation standard in countries which currently use AlocalB standards designed specifically for the accreditation of medical laboratories and in countries which are Table 3 ISOrDIS 15189, extract from the Introduction Introduction This International Standard provides requirements relevant to the quality management of medical laboratories . . . . Medical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel . . . . These services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples with subsequent validation, interpretation, reporting, and advice, as well as safety and ethics of medical laboratory work . . . . Bodies that recognise the competence of medical laboratories may use this International Standard as the basis for their activities. If a laboratory seeks accreditation for a part or all of its activities, it should select an accreditation body that operates in a manner, which takes into account the special requirements of medical laboratories . . . .
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125 Table 4 ISOrDIS 15189, subclause headings of clause 4
Table 6 ISOrDIS 15189, subclause headings of clause 5
4 Management requirements: 4.1 Organization and management 4.2 Quality management system 4.3 Document control 4.4 Examination by referral laboratories 4.5 External services and supplies 4.6 Identification and control of nonconformities 4.7 Corrective action 4.8 Advisory services and resolution of complaints 4.9 Continuous improvement process 4.10 Quality and technical records 4.11 Internal audits 4.12 Management review
5 Technical requirements 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment 5.4 Pre-examination process 5.5 Examination procedures 5.6 Assuring the quality of examination procedures 5.7 Post-examination process 5.8 Reporting of results 5.9 Alterations and amendments of reports
establishing new medical laboratory accreditation systems; Ø as a guidance document for the application of ISOrIEC 17025 Žthe successor to Guide 25 and EN 45001. in medical laboratories in some countries which currently use the Acalibration and testing laboratoryB standards for accreditation of medical laboratories.
Table 5 ISOrDIS 15189, selected subclauses from clause 4 Management requirements 4.1.2 Medical laboratory services, including . . . interpretation and advisory services, shall be designed to meet the needs of patients and . . . clinical personnel . . . . 4.4.4 The referring laboratory and not the referral laboratory shall report . . . results and findings. The report shall include all essential elements . . . without alterations that could effect clinical interpretation. Note: This does not mandate that the laboratory report every word and the exact format of the referral lab report unless required by nationalrlocal laws . . . may provide additional interpretative remarks wauthor must be identifiedx. 4.6.1.c The medical significance of the nonconforming examinations is considered, and where appropriate, the requesting clinician informed. 4.8.2 Appropriate laboratory professional staff shall provide advice on choice of examinations and use of the service . . . where appropriate, interpretation of the results of examinations shall be provided. 4.12.1 . . . management shall review the laboratory’s quality management system and all of its medical services, including examination and advisory activities to ensure continuing suitability and effectiveness in support of patient care.
123
ISOrDIS 15189 includes cross-reference tables showing the correspondence between sub-clauses of 15189 and ISO 9001:2000 w6x and between 15189 and ISOrIEC 17025. ISO 15189 incorporates a large part of the EC4 AEssential criteria for quality systems of medical laboratoriesB w7x and AAdditional essential criteria . . . B w8x. A recent paper, also from EC4, gives details of the correspondences between the AEssential criteriaB documents and ISO 15189 and 17025 w9x. The structure of the draft standard is shown in Table 2. An Introduction followed by clauses 1–3: Scope, NormatiÕe references and Terms and definitions is the usual structure for an ISO standard. The main normative text is in sections 4 and 5 and there are four annexes, which are designated as Ainformative.B 4 Division of the normative text into Management and Technical requirements parallels the structure of ISOrIEC 17025. The Introduction ŽTable 3. clearly places the activities of the medical laboratory in the context of patient care and emphasizes that medical laboratories have special requirements which must be taken into
4
ANormativeB and AinformativeB are terms used in international standards work to distinguish two kinds of text in standards documents. NormatiÕe text is the core of the standard, and contains requirements, which must be satisfied in order to claim compliance with the standard. InformatiÕe text does not contain requirements, and is given for information only. The informative text of a standard includes the Introduction, all text in Notes, and any annexes which are stated to be Informative.
124
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
Table 7 ISOrDIS 15189, selected subclauses from clause 5 Technical requirements 5.1.3 The laboratory shall be directed by a person or persons . . . who have the competence to assume responsibility for the service provided. Note 1: Competence is here understood as the product of basic academic, postgraduate, and continuing education, as well as training and experience of several years in a medical laboratory. 5.1.4 The responsibilities of the laboratory director or designees shall include professional, scientific, consultative or advisory, organisational, administrative, and educational matters . . . . 5.1.10 There shall be a continuing education programme available for all levels of staff. 5.1.13 The personnel making professional judgements with reference to examinations shall have applicable theoretical and practical background as well as recent experience. They shall take part in regular professional development or other professional liaison. 5.4.1 The request form shall contain sufficient information to identify the patient and the authorised requester, as well as providing pertinent clinical data . . . . 5.4.2 Specific instructions for the proper collection and handling of primary samples . . . shall be contained in a primary sample collection manual. 5.5.1 The laboratory shall use examination procedures . . . which meet the needs of the users of laboratory services . . . Procedures published in peer-reviewed texts or journals or as international, national or regional recommended guidelines are preferred. In-house procedures shall be appropriately validated . . . . 5.6.4 The laboratory shall participate in . . . external quality assessment . . . . 5.6.5 wwhere EQA is not available, the laboratory shall develop alternatives such as exchange of samples with other laboratoriesx. 5.7.1 Authorized personnel shall systematically review and authorize the release of results of examinations. 5.8.1 The laboratory management shall be responsible for the formatting of reports . . . to be determined in discussion with the users of the service 5.8.6 wprocedures for notification of results falling within AalertB or AcriticalB intervalsx 5.8.7 . . . turnaround time shall reflect clinical needs.
account when they are being assessed for accreditation. The structure of clause 4, Management requirements, is shown in Table 4. The clause includes all the essential points which are also found in other accreditation standards, but emphasizes the importance and special nature of the patient care environment in which medical laboratories operate ŽTable 5..
The structure of clause 5, Technical requirements, is shown in Table 6. Here again, the clause covers the requirements of other accreditation standards, but gives the necessary attention to the realities of the medical environment, including the requirements of the pre- and post-examination phases of the medical laboratory process ŽTable 7.. Annex C ŽTable 8., Ethics in Laboratory Medicine, although it is not part of the normative text, provides further illustration of the special nature of medical laboratories. In particular, it emphasizes that the patient’s welfare is paramount ŽC.2.1. and that the laboratory has responsibilities to the patient, which do not end with the issuing of a test result ŽC.6.3.. When ethical problems are considered, account must be taken not only of legal considerations but also of the patient’s best interests ŽC.9.1..
Table 8 ISOrDIS 15189, extracts from Annex C, Ethics in Laboratory Medicine C.1.1 . . . professional personnel are bound by the ethical codes of their respective profession. Each country may have specific rules or requirements . . . . C.2.1 The general principle . . . is that the patient’s welfare is paramount . . . . C.4.1 All procedures . . . require informed consent . . . . C.6 Reporting of results C.6.1 Results will normally be reported to the requesting physician and may be reported to other parties with the patient’s consent, or as required by law. Results . . . that have been separated from all patient identification may be used for such purposes as epidemiology, demography, or other statistical analysis. C.6.3 . . . the laboratory has an additional responsibility to ensure that as far as possible, the examinations are correctly interpreted and applied in the patient’s best interest. Specialist advice with regard to the selection and interpretation of examinations is part of the laboratory service. C.9 Use of samples for examination purposes other than those requested C.9.1 The use of samples for purposes other than those requested without prior consent should occur only if the residual samples are made anonymous or have been pooled. Laboratoriesrinstitutions should have documented policies on how to handle unrequested information Že.g. follow-up examinations to clarify previous results. from identifiable samples taking into account the legal implications and the patient’s best interests. Relevant national, regional, and local regulatory requirements should be observed.
D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
3. ISO r DIS 15190 Csafety management for medical laboratoriesD 5 This draft standard w10x, also produced by ISOrTC 212rWG 1, has been circulated by ISO for comment and voting, with a deadline of 23 April 2001. As DIS, it will then be subject to modification in response to the comments received. This document may be regarded as a supplement to 15189, covering the safety issues which must also be considered in the accreditation of medical laboratories. In addition to the normative text, the document has three Informative annexes. Annex A: Outline plan for the implementation of the standard Annex B: Laboratory Safety Audit wmodel questionnairex Annex C: Decontamination, cleaning and disinfection of medical laboratory equipment.
4. What next? It is expected that new versions of nationalrlocal accreditation standards will be revised so that accredited laboratories will satisfy the requirements of ISO 15189. CPA ŽUK. have already produced a new version of their accreditation standards, based on 15189 and also cross-referenced to ISO 17025 w3x and the EC4 AEssential requirementsB w7,8x. Two new work items for ISOrTC 212rWG 1 have now been approved: Ø AGuidance document on the application of ISO 15189, Quality management in the medical laboratoryB and Ø AQuality Management of point of care testing ŽPOCT.B.
5
Renamed CMedical laboratories—Requirements for safetyD in June 2001 w5x.
125
Criteria for quality systems of Point of Care Testing are included in the EC4 AAdditional essential criteriaB document w7x, which can be used as a source of material for the new draft on this subject.
Acknowledgements Text quoted from ISOrDIS 15189 is used here by permission of ISO, which holds the copyright.
References w1x ISOrIEC Guide 25, General requirements for the competence of calibration and testing laboratories, 3rd edn. International Organization for Standardization, Geneva, 1990. w2x EN 45001, General criteria for the operation of testing laboratories. European Committee for Standardization, Brussels, 1991. w3x ISOrIEC 17025, General requirements for the competence of testing and calibration laboratories. International Organization for Standardization, Geneva, 1999. w4x ISOrDIS 15189, Quality management in the medical laboratory. International Organization for Standardization, Geneva, 2000. w5x ISOrTC 212 N90 Resolutions of the seventh meeting, Dublin, Ireland, 6 and 8 June 2001. International Organization for Standardization, Geneva, 2001. w6x ISO 9001:2000, Quality management systems—Requirements. International Organization for Standardization, Geneva, 2000. w7x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM, Zerah ´ S, Allman B. Essential criteria for quality systems of medical laboratories. Eur J Clin Chem Clin Biochem 1997;35:121–32. w8x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM, Zerah ´ S, Allman B. Essential criteria for quality systems of medical laboratories. Clin Chem Lab Med 1998;36:249–52. w9x Jansen RTP, Kenny D, Blaton V, Burnett D, Huisman W, Plebani M, Queralto JM, Zerah ´ S, van Lieshout J. Usefulness of EC4 essential criteria for quality systems of medical laboratories as guidelines to the ISO 15189 and ISO 17025 documents. Clin Chem Lab Med 2000;38:1057–64. w10x ISOrDIS 15190, Clinical laboratory medicine—Safety management for medical laboratories. International Organization for Standardization, Geneva, 2000.