Standards ? What other Standards?

Eddie Welsh EQA Assessment Manager

     Standards written to ILAC-G-13 ISO Guide 43 -1, 43-2 Guidelines for the requirements for the competence of providers of Proficiency Testing Schemes Part 1 – Development and operation of Proficiency testing Schemes Part 2 – Selection and use of proficiency testing Schemes by laboratory accreditation bodies ISO 9000:2001 ISO 17025

 External Quality Assessment and Proficiency Testing are synonymous

EQA Schemes

   40 EQA Providers 140 Schemes registered with CPA UKNEQAS – multiple schemes   16 Histology schemes Pilot schemes not assessed

Titles of Standards

A B C D E F G H Organisation and quality management system Personnel Premises and environment Equipment, information systems and materials Organisation and design of the EQA Scheme Operation of the EQA Scheme Communication with participants Evaluation and improvement

 Full visit every TWO years  No Surveillance visits

Application Form

      Scheme(s) not service is accredited May have multiple Application Forms – one AP for each scheme One CPA Ref No. with suffixes for schemes e.g. EQA 015/0032 Clinical Chemistry EQA 015/0042 Thyroid Hormones EQA 015/0228 Lipid Investigations

Differences in Documentation

 Declaration  EQA Vertical Audit Form  EQA Examination Audit form  EQA standards checklist  NO EQA statement form  EQA Non-compliance/Observation Form

Peer Assessors

 Teams vary depending upon size of scheme  May be ONE assessor One day  May be TWO assessors TWO days  May be multiple sites

Users Meeting

 No User’s Meeting   Anonymised questionnaire is circulated to participants Assessors review returns  Feedback to Scheme Organiser  Organiser receives hard copy edited return

CEO Meeting

 EQA Schemes are business- orientated  ? Awareness of scheme  ? Contractual arrangements  “Top-Slicing” of profits  Security of Scheme

Standard A1.2

 There shall be evidence of contractual relation with parent or host organisation     Period of contract – reviews/meetings Financial arrangements Services provided by Trust/host Commitments by Provider

A7 Quality Manager

 Conflict of interest  Scheme Organiser/Quality Manager

A9 Control of Technical/Quality records        Ethical approval of clinical material Informed consent forms Record of receipt of material from other labs/consultants Clinical details of material Homogeneity records – third party suppliers IQC of batch process Purchase orders for clinical material

A9 (cont’d)

  Records of biohazard status of material i.e. HIV, HbAg Record of return of materials to original source – histology slides

A10 Control of Clinical Material

   Separation of untested and tested “raw” materials i.e. quarantined Separation of “raw” materials from prepared materials Anonymised material

Standard B1

 The EQA scheme shall be directed by an organiser with appropriate scientific training and experience in the field of operation

Standards B7,C4, D1.2

Facilities frequently remote from Trust/host with no support for: B7 – Appraisal C4 – Health & Safety – risk assessments/safety audits, mandatory training D1.2 Electrical safety checks

D3 Management of materials  Similar to Lab Standards – plus  Orders for clinical material e.g. National Blood Service  Third Party Suppliers of clinical material

E Standards

     E1 Participant’s Manual i.e. User’s Manual E2 External Professional Advice – Steering Committee E3 Extent of Participation - Numbers of participants, confidentiality E4 Scheme Design- Number and frequency of samples, EQA values, NQAAP Approval E5 Performance Criteria – PUP,PPP

E6 Sub-contractors and collaborators       Written procedures for: Type of material Technical specifications i.e. quantity, volumes Special preparation of material Specificity/homogeneity details Evidence of accreditation of sub contractor

F Standards

     F1 Preparation of items F2 Documentation and Packaging F3 Receipt of Results (Electronic, Fax, telephone, email, mail)– F3.2 storage/security of results F4 Data Entry and Statistical Analysis F5 Report to Participants

F4 Data Entry and statistical analysis   F4.1 – Validation and checking ? double entry F4.4 Late results - ? processes

G Standards

 G1 Participant’s Manual     G2 Communications and Feedback Communications log Users meetings Histopathology meetings are part of statistical analysis

H Standards

 Identical to Lab Standards - EXCEPT 

No Standard H5 – External Quality Assessment

Status of Scheme(s)



EQA Schemes are either Accredited or Non Accredited



No Conditional Approval or ECA

 Problems with meeting the Standards for smaller providers HISTOPATHOLOGY        Small schemes ? Withdrawal from accreditation Educational Scheme Slide collection – limited no. of circulations Scheme Organiser + secretarial support Low number of participants No Quality Management System

Solutions

      Establish Quality Management System “Buy in “ Quality Manager time – cost implications for scheme/participants – write Quality Manual, perform audits Association with CPA accredited laboratory (contractual agreement) EQA scheme run as sub-section of department ?? Not able to be accredited

Standards

Which Standard

40 35 30 25

%

20 15 10 5 0 A B C D E F G H

Number of Non-Compliances

30

%

25 20 15 10 5 0 45 40 35 5 10 15 20 25

Top Ten Non-Comformities

2 0 6 4 16 14 12 10 8 H3.1

A11.1

A8.1

H2.1

A1.6

D1.2

B2.1

B5.2

A3.1

C4.3

 Conclusion Interpretive EQA Schemes can be accredited  Resource  Educational Process  Commitment to Improvement