1 The aim…. ‘to enable assessors to objectively assess a laboratory’s compliance with the new standards’

2 CPA(UK)Ltd Standards and a quality management system

3 A quality management system provides the integration of organisational structure, processes, procedures, and resources needed to fulfil a quality policy and thus meet the needs and requirements of users. CPA(UK)Ltd Standard A4 Quality management system

4

5 A. ORGANIZATION & QUALITY MANAGEMENT SYSTEM A1 Organization and management A2 Needs and requirements of users A3 Quality policy A4 Quality management system A5 Quality objectives and plans A6 Quality manual A7 Quality manager A8 Document control A9 Control of process & quality records A10 Control of clinical material A11 Management review

6 B. PERSONNEL B1 Professional direction B2 Staffing B3 Personnel management B4 Staff orientation and induction B5 Job descriptions and contracts B6 Staff records B7 Staff annual joint review B8 Staff meetings and communication B9 Staff training and education

7 C. PREMISES & ENVIRONMENT C1 Premises and environment C2 Facilities for staff C3 Facilities for patients C4 Facilities for storage C5 Health and safety

8 D. EQUIPMENT, INFORMATION SYSTEMS AND MATERIALS D1 Management of equipment D2 Management of data and information D3 Management of materials

9 E. PRE- EXAMINATION PROCESSES E1 Information for users and patients E2 Request form E3 Specimen collection and handling E4 Specimen transportation E5 Specimen reception E6 Referral to other laboratories

10 F. EXAMINATION PROCESSES F1 Selection and validation of examination procedures F2 Examination procedures F3 Assuring the quality of examinations

11 G. POST EXAMINATION PROCESSES G1 Reporting results G2 The report G3 The telephoned report G4 The amended report G5 Clinical advice & interpretation

12 H. EVALUATION & QUALITY ASSURANCE H1 Evaluation and improvement processes H2 Assessment of user satisfaction and complaints H3 Internal audit of quality management system H4 Internal audit of examination processes H5 External quality assessment H6 Quality improvement

13 Action in quality management

14 The need for evidence… two sides of a coin The laboratory requires evidence in order to reconstruct its examination and other processes The assessors require evidence to be able to assess compliance with standards

15 Evidence of action …

16 Section A… the elements of the quality management system Documentation –quality manual –quality policy –quality plans and objectives –procedures document control control of records and clinical material evaluation and quality improvement etc…..

17 Section H… the records to show that the system of managing quality is working Records – for example… –minutes of meetings –annual management reviews –user complaints and action taken –staff annual joint reviews –audit calendar –internal audits –health and safety audits –non-conformities recorded –participation in appropriate EQAS

18 Section H… the records to show that the system of managing quality is not working Records – for example… –minutes of meetings / cancelled meetings-minutes with no action points –annual management reviews / none held –user complaints & action taken /remain undischarged –staff annual joint reviews / behind schedule –audit calendar / target dates missed –internal audits / no records –health and safety audits / untidy laboratory –non-conformities recorded / not discharged –participation in appropriate EQAS /results not discussed

An overview of assessment processes The assessment process defined What is a non- compliance? The Conduct of CPA(UK)Ltd Medical Laboratory Assessments

20 The assessment process The assessment process involves finding information that enables the assessor to judge whether the laboratory is operating in compliance with the Standards. The findings are recorded as compliances, non- compliances or observations. A report is prepared that enables the accrediting body to decide whether or not to grant accreditation.

21 ‘the failure to fulfil the requirements of a standard, in whole or in part’. Assessors will record two categories of non- compliance… Critical non-compliance and non-critical non- compliance Additionally assessors will record observations What is a non-compliance?

22 ‘ a failure to fulfil the requirements of a CPA Standard to such a degree that, in the opinion of the assessor, there is evidence of a system failure’ Normally, it is evidenced by the failure to comply with the whole of a CPA Standard and is a reason for referral. Critical non-compliance

23 A system failure… is evidenced by the inability of a department to: Meet the agreed needs and requirements of its users OR Ensure a safe environment for staff / patients or visitors OR Ensure the quality of all the laboratory examinations performed

24 Non-critical non-compliance ‘a failure to fulfil the requirements of a CPA Standard at a level that would not lead to a system failure’ Normally this would be evidenced by the failure to comply with a part of a CPA Standard and would result in a Condition being placed on the department. Failure to correct the non-compliance within a specified period of time may result in the removal of accreditation from a department.

25 ‘are records of deficiencies noted by assessors, that have the potential to affect the functioning of the department’ They are reported to the department and form part of the final report. Observations

26 Time management … ‘Sort out the big rocks first’

27 Tools of assessment Horizontal assessment Vertical assessment Examination assessment

28 Tools of assessment

29 HORIZONTAL ASSESSMENTA HORIZONTAL ASSESSMENT focuses on the system for managing quality and assesses individual standards Interviewing the Quality Manager an important part of the process It involves ‘a detailed check of a particular aspect of documentation and its implementation’

30 VERTICAL ASSESSMENTA VERTICAL ASSESSMENT focuses on the pre-examination, examination and post examination process (Section E, G and F) and the management of associated resources (Sections B, D, and C) It involves ‘a detailed check that all the elements associated with a chosen examination are implemented’

31 EXAMINATION ASSESSMENTAn EXAMINATION ASSESSMENT involves witnessing an examination as it is performed The objectives are to ensure that… –what is being done reflects what is described in the procedure AND –That the person carrying out the examination has a good understanding of all aspects of the procedure

32 Examination Assessment form Overall Standards Checklist Vertical Assessment form

33 Overall standards checklist - page 1/2

Recording observations and non compliances 11.1 Definitions-observation and non compliances 11.2 Non compliance 11.3 Recording observations and non compliance/corrective action 11.4 The overall report The Conduct of CPA(UK)Ltd Medical Laboratory Assessments

35 The approach to learning together…  Investigate findings thoroughly, before...  Recording them accurately, before…  Attributing findings to the Standards, before…  Classify the level of non compliance before…  Recording corrective action

36 Investigate findings thoroughly… ‘hospital ID not present on Medical Outpatient sample’ WHAT DOES THIS FINDING MEAN? … Was there a procedure? Did practice follow the procedure? Was this an isolated finding ?

37 ‘audit of blood group demonstrated member of staff had no current evidence of training’ CRYPTIC CLUE FOR TIMES CROSSWORD! Was this an an examination audit of a member of staff? Had that member of staff no training records at all or just no training record in this technique? Recording them accurately…

38 Recording them accurately… ‘only one sex changing room’ ‘RELATE YOUR COMMENTS TO THE STANDARDS’ C 2 Facilities for staff

39 Attributing findings to the Standards… ‘no documented procedure for handling urgent work…’ MAIN STANDARD INVOLVED… –E 5 Specimen reception [5.1 (d)] DOES THIS FINDING RING BELLS? –A 2 Needs and requirements of users –A 5 Quality objectives and plans –F 1 Examination procedures –G 3 Telephoned report –H 2 Assessment of user satisfaction and complaints

40 Classify the level of non compliances This is critical non compliance… ‘No air conditioning in Biochemistry…’

41 Recording corrective action… ‘procedure for vacuum tube transport not present’ ‘check procedure or working instruction and display laminated copy at all stations’ BE CAREFUL NOT TO IMPOSE YOUR IDEA OF CORRECTIVE ACTION! ‘ensure procedure or working instructions are available at appropriate locations’ [E 4.1]

42 Vertical assessment form

43 Selecting the Request for Audit

44 Request Form Searching

45 The Request Form Patient identification details

46 Reprinting the Report

47 Locating the Specimen

48 Specimen Reception

49 Checking Work Book Details

50 The Analyser Relevant to Audit Request

51 Instrument Maintenance Record

52 EQA Performance

53 Observations and non compliances

54 Examination assessment form

55 General overview form