Feedback from EuroGentest Workshop: Annual Management Review, IQC and EQA Berlin 9-10 th Oct 2008 Jeremy Skinner CSci, FIBMS Quality Manager Genetics Centre GSTT (GSTS)‏

OR ‘Quality is doing it right when no- one is looking’

EQA ‘The main objective of external quality assessment is to establish inter-laboratory compatibility’ ‘The main objective of external quality assessment is to establish inter-laboratory compatibility’ External evidence that test gives correct results - Accuracy External evidence that test gives correct results - Accuracy Participate in as many schemes as possible to cover repertoire Participate in as many schemes as possible to cover repertoire Make sure EQA covers Make sure EQA covers –Sample reception –Sample preparation –Key analytical methods –Interpretation

IQC WHO definition (1981)‏ WHO definition (1981)‏ –‘The main objective of internal quality control is to ensure day-to day consistency’ Verifying that test is giving consistent results – precision Verifying that test is giving consistent results – precision Identify potential errors and then define IQC in SOPs Identify potential errors and then define IQC in SOPs Tests precise and accurate

Accuracy and precision Poor accuracy and precision Poor assay, Poor operator Good precision but poor accuracy Poor assay, Good operator Good precision and good accuracy Good assay, Good operator

Annual Management Review Needed to comply with CPA stds A11 (ISO )‏ Needed to comply with CPA stds A11 (ISO )‏ Follow-up on previous objectives Follow-up on previous objectives Review of QMS Review of QMS –Quality policy –Quality manual Overview of QMS Overview of QMS –Audits and NCs/QIs –Complaints –User surveys –Quality indicators

Quality Indicators ‘Quality Indicators for monitoring the laboratory’s contribution to patient care’

Results from AMR Formal action plan Formal action plan –Quality objectives –Improvement to QMS –Improvement to processes –Resources required –Executive summary (for CPA)‏