Revised CPA Standards Eddie Welsh EQA Assessment Manager

1. 1  Revised CPA Standards Eddie Welsh EQA Assessment Manager

2. 2 A1 Organisation and management Notes Deputies should be appointed for all key functions. Individuals may have more than one function. The standard says “should”. Not mandatory but if appointed must appear in organograms and roles included in job descriptions. NOTES are there to help apply Standard any NCs raised are removed by head office Self Explanatory If mandatory Standard would indicate SHALL God practice in any case May not be possible in all cases NOTES are there to help apply Standard any NCs raised are removed by head office Self Explanatory If mandatory Standard would indicate SHALL God practice in any case May not be possible in all cases

3. 3 A2 Needs and requirements of users 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… 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) Qualifier is where USER involvement will appear consistently throughout these revions Qualifier is where USER involvement will appear consistently throughout these revions

4. 4 A3 Quality policy A 3.1a) 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 CPA view is as described above. The laboratory will provided a diagnostic ………….. CPA view is as described above. The laboratory will provided a diagnostic …………..

5. 5 A6 Quality manual A 6.2d) Description of the roles and responsibilities of laboratory management (including the quality manager), involved in ensuring compliance with these Standards. A statement regarding the roles and responsibilities indicating key functions and these should be included in job descriptions of the individuals concerned Again self explanatory Many Labs already doing this Not looking for inclusion of whole job description in Quality Manual Condensed version of salient factors of JD Again self explanatory Many Labs already doing this Not looking for inclusion of whole job description in Quality Manual Condensed version of salient factors of JD

6. 6 A8 Document control Note 2 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. Must be identified within document control procedure Again NOTES are there to help apply Standard If in exceptional circumstances amendments allowed. No mention of major/minor changes or number Clear indication of what we would wish to see set in the procedure in 2 paragraph Again NOTES are there to help apply Standard If in exceptional circumstances amendments allowed. No mention of major/minor changes or number Clear indication of what we would wish to see set in the procedure in 2 paragraph

7. 7 A11 Management review A 11.1 Laboratory management shall conduct an annual review of the laboratory's quality management system (including the quality policy and objectives) and all its services. The review shall include: A11.1 h) quality indicators that monitor the laboratory’s contribution to patient care Cross reference to H 6 note 3 Quality Indicators Customer, user and worker complaints and satisfaction Laboratory safety and environment CPD SEE NEXT SLIDE Cross reference to H 6 note 3 Quality Indicators Customer, user and worker complaints and satisfaction Laboratory safety and environment CPD SEE NEXT SLIDE

8. 8 A11 Management review cont’d Is there evidence that these have been reviewed as part of the AMR what is a quality indicator an established measure used to determine how well an organisation meets user requirements and operational and performance targets e.g. error rates / TAT, customer, worker and user complaints and satisfaction, laboratory safety, continuing education. Remember we are talking about YOUR User requirements YOUR operational and performance targets NOT CPAs Remember we are talking about YOUR User requirements YOUR operational and performance targets NOT CPAs

9. 9 B1 Personnel B1 Laboratory Director or designee(s) 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 Inputs v outputs responsibility v competence to assume responsibility SPEAKERS BE AWARE SLIDE HAS A BULLET POINT RE B1.4 SLAS DISCUSS WITH CB Completely revised Competence demonstrated by academic, postgraduate and continuing education and by evidence of continuing practice and experience that may be demonstrated by successful annul joint review Lab Director would be expected to have medical consultant status or equivalent and have competence at the level of the MRCPath or equivalent Exceptions may occur for highly specialised services SPEAKERS BE AWARE SLIDE HAS A BULLET POINT RE B1.4 SLAS DISCUSS WITH CB Completely revised Competence demonstrated by academic, postgraduate and continuing education and by evidence of continuing practice and experience that may be demonstrated by successful annul joint review Lab Director would be expected to have medical consultant status or equivalent and have competence at the level of the MRCPath or equivalent Exceptions may occur for highly specialised services

10. 10 B5 Job descriptions and contracts B 5.1f) A requirement for participation in staff annual joint review Self explanatory So if not already included at your next AJR and when reviewing JD suggest include AJR not to be confused with KSF and John Wood will elaborate on this further laterSo if not already included at your next AJR and when reviewing JD suggest include AJR not to be confused with KSF and John Wood will elaborate on this further later

11. 11 B6 Staff records B 6.2 h) A record of competency assessments What is a record where should it be kept links in with B9.3 Competency is for the laboratory to determine Records must be kept for all staff Remember there NHS guidelines for retention of Records Competency is for the laboratory to determine Records must be kept for all staff Remember there NHS guidelines for retention of Records

12. 12 B8 Staff meetings B8.1 note The information should cover all aspects of the laboratory service and in particular the effectiveness of the quality management system. Quality Policy, Quality Manual EQA, Complaints, communications Outcome of audits Not expected to be part of every meeting but when discussed must be noted. NOTES are There to help apply the standard Mentioned including Quality Policy Quality Manual revisons Quality objectives and Plans EQA/IQC NOTES are There to help apply the standard Mentioned including Quality Policy Quality Manual revisons Quality objectives and Plans EQA/IQC

13. 13 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 Access to continuing education and training is important for all grades of staff and has to take cognisance of any parent organisation policies Next three slides indicates in much more detail what is required to be included in staff training programmes particularly with respect to the maintenance of competency records Next three slides indicates in much more detail what is required to be included in staff training programmes particularly with respect to the maintenance of competency records

14. 14 B9 Staff training and education (2) B 9.2 The training programme shall, as appropriate, include the following clauses a) assigned work processes and procedures b) the quality management system c) applicable computer system(s) d) health and safety including the prevention or containment of the effects of adverse incidents and e) the ethics and confidentiality of information New Clause but elements already covered in existing standards ? Peer assessor to determine appropriatenessNew Clause but elements already covered in existing standards ? Peer assessor to determine appropriateness

15. 15 B9 Staff training and education (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 Laboratory determines what is appropriate for individual staff member Training programmes to reflect this No time scales standard silent YOUR competency Practical Knowledge based theoretical No time scales standard silent YOUR competency Practical Knowledge based theoretical

16. 16 C Premises and environment 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. Storage of reagents at room temperature If relevant to the analyses records need to kept NOTES are there to help apply Standard the note indicates that particular attention should be paid to sterility dust EMI radiation humidity electrical supply temperature sound and vibration AS APPROPRIATE Links to factors influencing uncertainty of results NOTES are there to help apply Standard the note indicates that particular attention should be paid to sterility dust EMI radiation humidity electrical supply temperature sound and vibration AS APPROPRIATE Links to factors influencing uncertainty of results

17. 17 D Equipment, Information Systems, and Materials D1 Procurement and management of equipment D1.1 Note 1 In those cases where the laboratory needs to use equipment outside its permanent control eg, POCT, management should ensure that the requirements of the Standard are met. Eg Equipment backup in cases of downtime

18. 18 D Equipment, Information Systems, and Materials D1.2 Laboratory management shall establish a procedure(s) for the procurement and management of equipment that include: e) preventive maintenance, service and repair f) calibration and monitoring of the instruments, reagents and analytical systems As a minimum description within the procedure covering the manufacturer’s instructions Risk assessment for Old equipment and equipment NOT if Trust Policy NOT to maintain What equipment needs attention outside normal limits Risk assessment for Old equipment and equipment NOT if Trust Policy NOT to maintain What equipment needs attention outside normal limits

19. 19 D Equipment, Information Systems, and Materials D1.4 The programme for preventive maintenance, calibration and monitoring of function shall be documented and at a minimum follows manufacturer’s recommendations Note 1, 2 Note 1 As a minimum description within the procedure covering the manufacturer’s instructions Note 2 energy and future disposal (care of the environment) Note 1 As a minimum description within the procedure covering the manufacturer’s instructions Note 2 energy and future disposal (care of the environment Note 1 As a minimum description within the procedure covering the manufacturer’s instructions Note 2 energy and future disposal (care of the environment

20. 20 E Pre-examination process 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. Evidence of this being discussed with users and the outcomes of these discussion being recorded and acted upon Self explanatory Again emphasis on User involvement Has the matter been discussed with Users Are the outcomes recorded Have they been implemented Need to be audited and reviewed Self explanatory Again emphasis on User involvement Has the matter been discussed with Users Are the outcomes recorded Have they been implemented Need to be audited and reviewed

21. 21 E Pre-examination process E3 Specimen collection and handling E3.3 The laboratory shall periodically review its sample volume requirements for phlebotomy (and other samples such as CSF) to ensure that neither insufficient nor excessive amounts of sample are collected Evidence of review and communication to users if any changes made Self explanatory Self explanatory

22. 22 E Pre-examination process E4 Specimen transportation E4.1c ensuring that the specimens arrive within a time frame appropriate to the nature of the requested examinations and protects the specimen from deterioration Evidence laboratories have identified appropriate timescales Communicated these to users and specimen transportation personnel Audited the process Needs to be in the procedure Emphasised appropriate Communication Audit Included in procedure Emphasised appropriate Communication Audit Included in procedure

23. 23 E Pre-examination process 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. 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 CPA view is Lab and assessors need to approach this pragmatically . eg Could be the MLA in specimen reception who is following a clearly defined protocol as to the actions required for a specific sample. Or May indeed require intervention from more senior staff Ultimately Laboratory's call CPA view is Lab and assessors need to approach this pragmatically . eg Could be the MLA in specimen reception who is following a clearly defined protocol as to the actions required for a specific sample. Or May indeed require intervention from more senior staff Ultimately Laboratory's call

24. 24 F Examination process F2.1h 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? Mainly applies to numeric disciplines but not exclusively Mainly applies to numeric disciplines but not exclusively

25. 25 F3 Assuring the quality of the examinations F3.1 The laboratory shall ensure the quality of examinations by performing them under controlled conditions that include as applicable: Pre examination processes Staff, premises, equipment and materials IQC Uncertainty of result Traceability Framework standard – indicated links to other F standards Peer assessors domain As applicable get out of jail card If not applicable why not? Framework standard – indicated links to other F standards Peer assessors domain As applicable get out of jail card If not applicable why not?

26. 26 Assuring the Quality of Examinations Evidence frequently already available: User Handbook Procedures for phlebotomy Procedures for transport and reception of specimens Examination procedures (calibration, reference limits, IQC, Mechanisms for corrective action

27. 27 F3 Assuring the quality of the examination (1) F3.3 The laboratory shall determine the uncertainty of results, where relevant and possible. 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 Uncertainty of measurement part of next review – so will change CPA not looking for huge swathes of evidence ISO 15189 5.6.2 See NEXT SLIDE Not suggesting all Results need to have uncertainty of result determined BUT Lab and PA need to understand all factors involved Labs need to put steps in place to minimise the effect ASK JOHN WOOD TO EXPLAIN ABOUT BLOOD SUGAR ANALOGY Uncertainty of measurement part of next review – so will change CPA not looking for huge swathes of evidence ISO 15189 5.6.2 See NEXT SLIDE Not suggesting all Results need to have uncertainty of result determined BUT Lab and PA need to understand all factors involved Labs need to put steps in place to minimise the effect ASK JOHN WOOD TO EXPLAIN ABOUT BLOOD SUGAR ANALOGY

28. 28 F3 Assuring the quality of the examination (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 Sampling Sample preparation Sample portion selection Calibrators Reference materials Input quantities Equipment used Environmental conditions Conditions of the sample and changes of operator

29. 29 Examples of uncertainty

30. 30 Examples of uncertainty

31. 31 F3 Assuring the quality of the examination (1) 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 ISO 15189 5.6.3 See next slide 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 Use of suitable ref., materials certified to indicate characterisation of the material Examination or calibration by another procedure Ratio or reciprocity type measurements Mutual consent current standards Documentation of statements where traceability is provided by the supplier or manufacturer of reagentsISO 15189 5.6.3 See next slide 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 Use of suitable ref., materials certified to indicate characterisation of the material Examination or calibration by another procedure Ratio or reciprocity type measurements Mutual consent current standards Documentation of statements where traceability is provided by the supplier or manufacturer of reagents

32. 32 F3 Assuring the quality of the examination (2) 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: Participation in a suitable programme of inter laboratory comparisons Use of suitable ref., materials certified to indicate characterisation of the material Examination or calibration by another procedure Ratio or reciprocity type measurements Mutual consent current standards Documentation of statements where traceability is provided by the supplier or manufacturer of reagents

33. 33 Calibration and Traceability Traceability is defined as the property of the result of a measurement or the value of a standard whereby it can be related to the stated references, national or international standards, through an unbroken chain of comparisons all having stated uncertainties.

34. 34 SI base units of measurement

35. 35 Primary reference standards Generally held by: National Physical Laboratory National Institute for Biological Standards Laboratories should ensure an unbroken chain back to reference material

36. 36 Examples of calibrated materials

37. 37 Traceability CE marked manufacturer’s kit information Laboratory risk assessment of importance of accuracy of a measuring system “in house “ measuring systems - any apparatus and reagents used must be of appropriate quality

38. 38 F3 Assuring the quality of the examination 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. What is the mechanism? Are results audited? What is clinically appropriate intervals Peer assessors domain Eg Single managed structure with Different platforms across different sites Can result in different reference ranges Patients may have to move staff interpreting results may work on different sites How are critically appropriate intervals determinedEg Single managed structure with Different platforms across different sites Can result in different reference ranges Patients may have to move staff interpreting results may work on different sites How are critically appropriate intervals determined

39. 39 G Post examination phase G1.1e Mechanisms for notifying the requester when an examination is delayed (Note 1) This does not mean that the clinical personnel are to be notified of all delays but only where the delay could compromise patient care. Procedure should be developed in collaboration between clinical and laboratory personnel Self explanatory NOTE Self explanatory NOTE

40. 40 G Post examination phase G1.2 The laboratory shall in consultation with users, establish turnaround times for each examination that reflect clinical needs and have a mechanism for monitoring non conformities and recording remedial or corrective action Self explanatory Have the users been consulted? Are the outcomes recorded? Audits available ?

41. 41 G Post examination phase G2 The report G2.3i highlighting of abnormal results and/or inclusion of critical limits And/or situation Abnormal results need not be highlighted if critical limits are included in the report

42. 42 G Post examination phase G2.4d when examination results from a referral laboratory need to be transcribed by the referring laboratory there are instructions for verifying the correctness of transcription. Procedure for above Is the process audited? Clause does not say shall be However if Laboratory determines results shall be transcribed then procedure needs to be in palceClause does not say shall be However if Laboratory determines results shall be transcribed then procedure needs to be in palce

43. 43 G Post examination phase 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. Evidence to show systematic communication eg MDTs, user fora, newsletters, questionnaires/surveys Shall be – must therefore happen WHERE APPROPRIATE!!!! As an assessor if no record is kept what evidence can you provide to show it has happened? Shall be – must therefore happen WHERE APPROPRIATE!!!! As an assessor if no record is kept what evidence can you provide to show it has happened?

44. 44 H Evaluation and quality assurance 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. 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 Onus on lab if no EQA scheme is available Onus on lab if no EQA scheme is available

45. 45 H Evaluation and quality assurance 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 What are the laboratories quality indicators and how are they monitored? Explained Remedial action – actions taken to mitigate the immediate effect of a non conformance Corrective – Actions taken to remove the Root cause of NC Preventive - actions taken to prevent NC in first place Explained Remedial action – actions taken to mitigate the immediate effect of a non conformance Corrective – Actions taken to remove the Root cause of NC Preventive - actions taken to prevent NC in first place

46. 46 Evaluation and Quality Assurance Remedial action – immediate action taken to control a non-conformity Corrective action – action taken to stop a non-conformity happening again Preventive action – action taken to stop non-conformity happening in the first place

47. 47 H Evaluation and quality assurance 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. Laboratory safety and environment, Continuing education

48. 48 H Evaluation and quality assurance H7 New Standard Identification and control of nonconformities. Procedures required to ensure that nonconformities are effectively managed to minimise the risks to users