1. 1 IBMS Scottish Quality Management Discussion Group Meeting Perth – 20 th May 2008

2. 2  Standards Revision  Some of the New Clauses

3. 3 Standards revision 2 reasons for revision 2 reasons for revision STEG undertook a gap analysis between the CPA standards and the original ISO 15189:2003 STEG undertook a gap analysis between the CPA standards and the original ISO 15189:2003 In addition the revised ISO 15189:2007 was published internationally In addition the revised ISO 15189:2007 was published internationally

4. 4 Standards revision Implementation Implementation CPA published in September 2007 CPA published in September 2007 Regional assessor training December 2007 Regional assessor training December 2007 Peer assessor training April 2008 Peer assessor training April 2008 First assessments April 2008 First assessments April 2008 One year to allow for all laboratories to be compliant One year to allow for all laboratories to be compliant

5. 5 Standards - future There is a revision of ISO 15189 at present There is a revision of ISO 15189 at present Due date for publication was 2009 Due date for publication was 2009 May be a delay as the first edition of the revised standard was rejected a few weeks ago May be a delay as the first edition of the revised standard was rejected a few weeks ago

6. 6 Standards - future CPA has to decide whether to take the step towards assessing to ISO 15189 in future CPA has to decide whether to take the step towards assessing to ISO 15189 in future If agreed it assists with introduction of other related standards e.g. ISO 22870 POCT If agreed it assists with introduction of other related standards e.g. ISO 22870 POCT This in itself is cross referenced to ISO 15189 This in itself is cross referenced to ISO 15189

7. 7 The Revised Standards

8. 8 A1 Organisation and management A 1.4 a) Define the organisation and management of the laboratory, its place in a parent organisation and its relationship to any other organisation with which it may be associated Define the organisation and management of the laboratory, its place in a parent organisation and its relationship to any other organisation with which it may be associated

9. 9 A2 Needs and requirements of users New clause 2.4 New clause 2.4 Where management enters into a formal agreement to provide medical laboratory services, it shall establish a documented procedure for the establishment and review of such agreements… Where management enters into a formal agreement to provide medical laboratory services, it shall establish a documented procedure for the establishment and review of such agreements… Standard does not require formal agreements but if they have been set up a procedure must be in place to comply with clauses a) – h) Standard does not require formal agreements but if they have been set up a procedure must be in place to comply with clauses a) – h)

10. 10 A3 Quality policy A 3.1a) A 3.1a) The scope of the service the laboratory intends to provide. The scope of the service the laboratory intends to provide. A general statement as to the scope of the service provision is all that is required A general statement as to the scope of the service provision is all that is required

11. 11 A8 Document control Note 2 Note 2 If in exceptional circumstance the document control system allows amendments of documents by hand If in exceptional circumstance the document control system allows amendments of documents by hand Procedures and authorities for such amendments are defined, and pending re-issue, documents clearly marked, initialled and dated revised document re-issued as soon as practicable. Procedures and authorities for such amendments are defined, and pending re-issue, documents clearly marked, initialled and dated revised document re-issued as soon as practicable. Must be identified within document control procedure Must be identified within document control procedure

12. 12 B1 Personnel B1 Laboratory Director B1 Laboratory Director Are clauses a) – n) documented eg in job descriptions of Laboratory Director or delegated staff Are clauses a) – n) documented eg in job descriptions of Laboratory Director or delegated staff Evidence of competence is derived from compliance with other standards Evidence of competence is derived from compliance with other standards Inputs v outputs Inputs v outputs responsibility v competence to assume responsibility responsibility v competence to assume responsibility

13. 13 B6 Staff records B 6.2 h) B 6.2 h) A record of competency assessments A record of competency assessments What is a record What is a record where should it be kept where should it be kept links in with B9.3 links in with B9.3

14. 14 B9 Staff training and education (1) B 9.1a) training and education shall be in accordance with the policies of the parent organisation and guidelines from the relevant professional and registration bodies B 9.1a) training and education shall be in accordance with the policies of the parent organisation and guidelines from the relevant professional and registration bodies Access to continuing education and training is important for all grades of staff and has to take cognisance of any parent organisation policies Access to continuing education and training is important for all grades of staff and has to take cognisance of any parent organisation policies

15. 15 B9 Staff training and education (2) B 9.2 B 9.2 The training programme shall, as appropriate, include the following clauses The training programme shall, as appropriate, include the following clauses a) assigned work processes and procedures a) assigned work processes and procedures b) the quality management system b) the quality management system c) applicable computer system(s) c) applicable computer system(s) d) health and safety including the prevention or containment of the effects of adverse incidents and d) health and safety including the prevention or containment of the effects of adverse incidents and e) the ethics and confidentiality of information e) the ethics and confidentiality of information

16. 16 B9 Staff training and education (3) B 9.3 B 9.3 Competency to perform the assigned task shall be assessed following training and periodically thereafter. Retraining and reassessment shall occur when necessary. Records of competency assessments shall be kept Competency to perform the assigned task shall be assessed following training and periodically thereafter. Retraining and reassessment shall occur when necessary. Records of competency assessments shall be kept Laboratory determines what is appropriate for individual staff member Laboratory determines what is appropriate for individual staff member Training programmes to reflect this Training programmes to reflect this

17. 17 C Premises and environment C1.1 note C1.1 note Particular attention should be given to monitoring, controlling and recording environmental conditions as required by relevant specifications or where they may influence the quality of results…….as appropriate to the technical activities concerned. Particular attention should be given to monitoring, controlling and recording environmental conditions as required by relevant specifications or where they may influence the quality of results…….as appropriate to the technical activities concerned. If relevant to the analyses records need to kept If relevant to the analyses records need to kept

18. 18 E Pre-examination process E2 request form E2 request form E2.3 the laboratory shall determine in discussion with users the manner in which requests (including verbal requests) are to be communicated to the laboratory. E2.3 the laboratory shall determine in discussion with users the manner in which requests (including verbal requests) are to be communicated to the laboratory. Evidence of this being discussed with users and the outcomes of these discussion being recorded and acted upon Evidence of this being discussed with users and the outcomes of these discussion being recorded and acted upon

19. 19 E Pre-examination process E5 specimen reception E5 specimen reception E5.3 Authorised personnel shall systematically review requests and samples and decide which examinations are to be performed and the methods to be used in performing them. E5.3 Authorised personnel shall systematically review requests and samples and decide which examinations are to be performed and the methods to be used in performing them. Needs to be clearly defined eg in specimen reception procedure who is authorised to route samples through the laboratory and make decisions about test selection Needs to be clearly defined eg in specimen reception procedure who is authorised to route samples through the laboratory and make decisions about test selection

20. 20 E Pre-examination process E5 Specimen reception E5 Specimen reception Note 1: This includes linking the primary specimen to any sample portions prepared in reception or subsequently. Note 1: This includes linking the primary specimen to any sample portions prepared in reception or subsequently. Appropriate labelling of Appropriate labelling of Aliquots Aliquots Isolates Isolates Histology blocks, slides etc Histology blocks, slides etc

21. 21 E Pre-examination process E6.1 E6.1 Evaluating and selecting referral laboratories and consultants in terms of competence to perform the requested examinations and ensuring that there are no conflicts of interest. Evaluating and selecting referral laboratories and consultants in terms of competence to perform the requested examinations and ensuring that there are no conflicts of interest. Procedure should outline Procedure should outline How referral labs/ consultants are selected. How referral labs/ consultants are selected. What measures of competence are included in selection process What measures of competence are included in selection process What measures are in place to ensure no conflict of interest. What measures are in place to ensure no conflict of interest.

22. 22 F Examination process F2.1h F2.1h Limitations of the examination, including interferences, cross reactions and reportable intervals Limitations of the examination, including interferences, cross reactions and reportable intervals Have the upper/lower assay ranges been identified as opposed to normal reference range? Have the upper/lower assay ranges been identified as opposed to normal reference range?

23. 23 F Examination process Note 1. Note 1. If the laboratory utilises the instructions for use written by the manufacturer, they shall be in accordance with the criteria set out in F2.1. Any deviations shall be validated, reviewed and documented If the laboratory utilises the instructions for use written by the manufacturer, they shall be in accordance with the criteria set out in F2.1. Any deviations shall be validated, reviewed and documented

24. 24 F3 Assuring the quality of the examination F3.1 F3.1 The laboratory shall ensure the quality of examinations by performing them under controlled conditions that include as applicable: The laboratory shall ensure the quality of examinations by performing them under controlled conditions that include as applicable: Fulfilment of the criteria of clauses a) – g) are covered by other standards as indicated in F3.1 Fulfilment of the criteria of clauses a) – g) are covered by other standards as indicated in F3.1

25. 25 F3 Assuring the quality of the examination F3.3 F3.3 The laboratory shall determine the uncertainty of results, where relevant and possible. The laboratory shall determine the uncertainty of results, where relevant and possible. Need to recognise the difference between uncertainty of measurement and uncertainty of results Need to recognise the difference between uncertainty of measurement and uncertainty of results Refers primarily to numeric disciplines Refers primarily to numeric disciplines Includes all factors impacting on assay, eg correct preparation of patient, sample labelling, sample tube, environmental factors in lab etc Includes all factors impacting on assay, eg correct preparation of patient, sample labelling, sample tube, environmental factors in lab etc

26. 26 F3 Assuring the quality of the examination ISO 15189 5.6.2 ISO 15189 5.6.2 The laboratory shall determine the uncertainty of results where relevant and possible. Uncertainty components which are of importance shall be taken into account. Sources that contribute to uncertainty may include The laboratory shall determine the uncertainty of results where relevant and possible. Uncertainty components which are of importance shall be taken into account. Sources that contribute to uncertainty may include Sampling Sampling Sample preparation Sample preparation Sample portion selection Sample portion selection Calibrators Calibrators Reference materials Reference materials Input quantities Input quantities Equipment used Equipment used Environmental conditions Environmental conditions Conditions of the sample and changes of operator Conditions of the sample and changes of operator

27. 27 F3 Assuring the quality of the examination F3.4 F3.4 The laboratory shall have a programme of calibration of measuring systems and verification of trueness designed to ensure that results are traceable, where possible, to SI units or to a stated reference material The laboratory shall have a programme of calibration of measuring systems and verification of trueness designed to ensure that results are traceable, where possible, to SI units or to a stated reference material We recognise that this is major addition to the existing standards and have asked the members of PAC to prepare a discipline specific response We recognise that this is major addition to the existing standards and have asked the members of PAC to prepare a discipline specific response

28. 28 F3 Assuring the quality of the examination ISO 15189 5.6.3 ISO 15189 5.6.3 A programme for calibration of measuring systems and verification of trueness shall be designed and performed so as to ensure that results are traceable to SI units or by reference to a natural constant or other stated reference. Where none of these is possible or relevant other means for providing confidence in the results shall be applied including but not limited to: A programme for calibration of measuring systems and verification of trueness shall be designed and performed so as to ensure that results are traceable to SI units or by reference to a natural constant or other stated reference. Where none of these is possible or relevant other means for providing confidence in the results shall be applied including but not limited to: Participation in a suitable programme of inter laboratory comparisons Participation in a suitable programme of inter laboratory comparisons Use of suitable ref., materials certified to indicate characterisation of the material Use of suitable ref., materials certified to indicate characterisation of the material Examination or calibration by another procedure Examination or calibration by another procedure Ratio or reciprocity type measurements Ratio or reciprocity type measurements Mutual consent current standards Mutual consent current standards Documentation of statements where traceability is provided by the supplier or manufacturer of reagents Documentation of statements where traceability is provided by the supplier or manufacturer of reagents

29. 29 F3 Assuring the quality of the examination F3.5 F3.5 The laboratory shall have a mechanism for ensuring that examinations performed using different procedures or equipment or at different sites give comparable results, throughout clinically appropriate intervals. The laboratory shall have a mechanism for ensuring that examinations performed using different procedures or equipment or at different sites give comparable results, throughout clinically appropriate intervals. What is the mechanism? What is the mechanism? Are results audited? Are results audited? What is clinically appropriate intervals What is clinically appropriate intervals Peer assessors domain Peer assessors domain

30. 30 G Post examination phase G2.3k where possible the identification of person(s) verifying results and authorising the release of the report. G2.3k where possible the identification of person(s) verifying results and authorising the release of the report. Where possible Where possible

31. 31 G Post examination phase G 5 Clinical advice and interpretation G 5 Clinical advice and interpretation G5.4 There shall be systematic communication between laboratory staff and clinical staff to promote effective utilisation of laboratory services and to consult on scientific and logistic matters. Where appropriate a record of such meetings shall be kept. G5.4 There shall be systematic communication between laboratory staff and clinical staff to promote effective utilisation of laboratory services and to consult on scientific and logistic matters. Where appropriate a record of such meetings shall be kept. Evidence to show systematic communication eg MDTs, user fora, newsletters, questionnaires/surveys Evidence to show systematic communication eg MDTs, user fora, newsletters, questionnaires/surveys

32. 32 H Evaluation and quality assurance H5 External quality assessment H5 External quality assessment When a formal inter-laboratory comparison programme is not available, the laboratory shall develop a mechanism for determining the acceptability of procedures not otherwise evaluated. When a formal inter-laboratory comparison programme is not available, the laboratory shall develop a mechanism for determining the acceptability of procedures not otherwise evaluated. If no EQA scheme exists what systems have been put in place? If no EQA scheme exists what systems have been put in place? May include exchange of samples and preparations such as slides and digital images May include exchange of samples and preparations such as slides and digital images

33. 33 H Evaluation and quality assurance H6 Quality improvement H6 Quality improvement H6.1 process for continual quality improvement shall include remedial action, corrective action, preventive action, monitoring of quality indicators and improvement processes H6.1 process for continual quality improvement shall include remedial action, corrective action, preventive action, monitoring of quality indicators and improvement processes What are the laboratories quality indicators and how are they monitored? What are the laboratories quality indicators and how are they monitored?

34. 34 H Evaluation and quality assurance H 6.2 corrective action shall be taken to eliminate the root cause of non conformities. Corrective actions shall be appropriate to the effects of the nonconformities encountered. H 6.2 corrective action shall be taken to eliminate the root cause of non conformities. Corrective actions shall be appropriate to the effects of the nonconformities encountered. Root cause analysis Root cause analysis Results recorded Results recorded

35. 35 H Evaluation and quality assurance H6.4 the laboratory shall establish quality indicators to monitor and evaluate performance…… shall be established prior to implementation H6.4 the laboratory shall establish quality indicators to monitor and evaluate performance…… shall be established prior to implementation Customer, user and worker complaints and satisfaction. Customer, user and worker complaints and satisfaction. Laboratory safety and environment, Laboratory safety and environment, Continuing education Continuing education

36. 36 H Evaluation and quality assurance H7 New Standard H7 New Standard Identification and control of nonconformities. Identification and control of nonconformities. Procedures required to ensure that nonconformities are effectively managed to minimise the risks to users Procedures required to ensure that nonconformities are effectively managed to minimise the risks to users

37. 37 Standards Revision Some of the New Clauses

38. 38 Thank you

39. 39 IBMS Scottish Quality Management Discussion Group Meeting Perth – 20 th May 2008