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 Guidelines for the requirements for the competence of providers of Proficiency Testing Schemes Part 1 – Development and operation 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 Part 2 – Selection and use of proficiency testing Schemes by laboratory accreditation bodies ISO 9000:2001 ISO 9000:2001 ISO ISO 17025

External Quality Assessment and Proficiency Testing are synonymous External Quality Assessment and Proficiency Testing are synonymous

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

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

Full visit every TWO years Full visit every TWO years No Surveillance visits No Surveillance visits

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

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

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

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

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

Standard A1.2 There shall be evidence of contractual relation with parent or host organisation There shall be evidence of contractual relation with parent or host organisation Period of contract – reviews/meetings Period of contract – reviews/meetings Financial arrangements Financial arrangements Services provided by Trust/host Services provided by Trust/host Commitments by Provider Commitments by Provider

A7 Quality Manager Conflict of interest Conflict of interest Scheme Organiser/Quality Manager Scheme Organiser/Quality Manager

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

A9 (cont’d) Records of biohazard status of material i.e. HIV, HbAg Records of biohazard status of material i.e. HIV, HbAg Record of return of materials to original source – histology slides 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 untested and tested “raw” materials i.e. quarantined Separation of “raw” materials from prepared materials Separation of “raw” materials from prepared materials Anonymised material Anonymised material

Standard B1 The EQA scheme shall be directed by an organiser with appropriate scientific training and experience in the field of operation 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 Similar to Lab Standards – plus Orders for clinical material e.g. National Blood Service Orders for clinical material e.g. National Blood Service Third Party Suppliers of clinical material Third Party Suppliers of clinical material

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

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

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

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

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

H Standards Identical to Lab Standards - EXCEPT Identical to Lab Standards - EXCEPT No Standard H5 – External Quality Assessment No Standard H5 – External Quality Assessment

Status of Scheme(s) EQA Schemes are either Accredited or Non- Accredited EQA Schemes are either Accredited or Non- Accredited No Conditional Approval or ECA No Conditional Approval or ECA

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

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

Standards

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