1. CMGS Clinical ScientistTrainees Meeting 28 th November 2009 QUALITY ISSUES IQC, EQA, CPA Gareth Cross Nottingham Regional Molecular Genetics Service

2. Quality Issues Is a laboratory providing a good service? Who wants to know? –= those responsible Manager Trust Commissioners DH People using the service – doctors, patients –You !

3. Quality? Doing the right tests Interpreting the test results correctly Reporting the results –to answer the clinical question –so that the clinician can understand them –in a “timely fashion” Not mixing up the samples etc.

4. How? Correct tests, interpretation, reporting? –Training –Qualifications, 2 year CS training, registration, FRCPath –Above= appropriate for position Agrees with peers –Best practice guidelines –External Quality Assurance (EQA) scheme Internal Quality Control –Tube transfer checks –Bar-coding –Result and report checking

5. EMQN - Draft Best Practice Guidelines for Laboratory Internal Quality Control – Patton and Stenhouse CMGS – Practice Guidelines for Internal Quality Control within the Molecular Genetics Laboratory Via CMGS website Sample reception –Secure database, backed up –Checking x transfer data –Incomplete data –2 unique identifiers – name,DOB, barcode, H No. –Printed labels –Reduce data transfer –Audit trail x information change –Minimise hand written transfer information

6. Internal Quality Control Sample storage –Stop DNA decay –Duplicate back up x DNA or blood –2 pieces info on DNA tube labels DNA extraction –Dedicated areas and pipettes to reduce contamination risk –Reduce tube to tube transfers – automation –Decide on optimum batch size

7. Internal Quality Control Sample Handling –All tube transfers – checked independently +evidence – or performed in duplicate –Records of batches – troubleshooting –Separate pre and post PCR areas + pipettes Controls –Normals, water, +ves, molecular wt markers –EC: In-Vitro Diagnostic Devices – need CRMs Results –Store all raw data x 5 years minimum (RCPath: 30 years “The retention and storage of pathological records and archives” )

8. Internal Quality Control Reporting –Checked independently –Standard wording templates? –Procedures for telephone, fax etc PND –Maternal contamination –CA repeats Test validation

9. External Quality Assurance NEQAS and EMQN Volunteers At least, annually for each disease, where available 3 DNA samples/disease + clinical story – treat as normal Genotype accuracy Interpretation accuracy

10. EQA Report writing Reassurance + educational + required by CPA Poor performers x genotyping or interpretation (0.7 x average) Persistent PPs – 3/6 or consecutive 2 – per disease - NQAAP (> JWGQA>DH) – HOD www.ukneqas-molgen.org.uk www.emqn.org THESE ARE IMPORTANT TESTS TOO!

11. Convincing our commissioners, managers, and users? Accreditation against standards –Clinical Pathology Accreditation (UK) (CPA) – now owned by the UK Accreditation Service Assessing v standards based on International Standards – ISO 15189 Regional Genetic Laboratories are required to be “CPA accredited” (2003 White Paper) Reports to commissioners, UKGTN etc re reporting target compliance etc.

12. CPA accreditation Labs sign up to complying with 8 standards: –Organisation and Quality Management System –Personnel –Premises and Environment –Equipment, IT systems and materials –Pre-examination processes –Examination processes –Post-examination processes –Evaluation and quality assurance

13. A:Organisation and Quality Management System Appropriate staff + management structure Quality Management System –Procedures and policies in writing and document- controlled –Process records –Control of clinical material –User satisfaction

14. B: Personnel B1.1 Consultant equivalent in charge Staffing –appropriate numbers –Quality, training, health and safety managers –Annual review, job des, staff meetings etc –Induction, training

15. C:Premises and Environment Staff facilities Storage x records, DNAs, bloods, waste, chemicals etc. Health and Safety – protective equipment, fire training, COSHH assessments, scpecimen collection and handling, safety notices, cleanliness

16. D: Equipment, IT systems and materials IT – back-up, confidentiality, adequate Equipment is maintained: –Accurate –Breakdowns –Safe Materials – COSHH – date of receipt etc

17. E: Pre-examination processes User info – leaflets, web site – disease tests, samples needed, TATs etc Request form + adequate information x patient + test request Specimen reception x data collection + staff safety + rejecting specimens Sendaway protocol + records

18. F: Examination processes Need SOPs for all tests –Training –Clear re decisions on, e.g. numbers of controls etc Need IQC procedures

19. G: Post-examination processes SOPs x reporting, telephoning, amending Adequate report x identification, interpretation etc. = managers taking responsibility for decisions Protects YOU

20. H: Evaluation and quality assurance User satisfaction surveys Meet performance targets Internal audit - checking processes by horizontal, vertical and examination audit – i.e. is anything going wrong? External QA – all appropriate – communicated – staff + decisions recorded Quality improvement

21. CPA - 4 year cycle 4 yrs Assessment x Regional assessors + peer assessors 2 yrs Regional assessor Examination audit – training, following SOPs Interview x training, induction, IPR etc Assessment x departmental management Non-compliances always found Painful but necessary (to keep funding!)