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Hi Emma, I think a pragmatic approach has to be taken where the decision to repeat all or selected samples since the last QC fail depends on the concentration of such samples, which are evaluated against the level(s) at which the QC fail(s) has occurred.   Identifying the failure point using a truncated critical difference formula can help to objectively and more precisely ID the failure point.  The decision is not ad hoc and has been part of our laboratorys' protocols for some time and ISO 15189:2012 compliant.  I extract from our papers (attached and below) which explain fuller.



Hope that helps



KR, Graham



Dr Graham Lee PhD FRCPath
Consultant Clinical Biochemist/UCD Assistant Clinical Professor
Department of Clinical Biochemistry & Diagnostic Endocrinology
Mater Misericordiae University Hospital and
Cappagh National Orthopaedic Hospital, Dublin
Midland Regional Hospital, Mullingar, University College Dublin
Address: MMUH, Eccles St, Dublin 7
Tel:00353 1 8034983





Graham R. Lee Maria C. Fitzgibbon Paula O'Shea , (2016),"Laboratory services: regaining and maintaining control", International Journal of Health Care Quality Assurance, Vol. 29 Iss 5 pp. 507 -522

Graham R. Lee Maria C. Fitzgibbon Paula O'Shea , (2016),"In control? IQC consensus and statutory regulation", International Journal of Health Care Quality Assurance, Vol. 29 Iss 5 pp. 492 - 506


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From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of TUDDENHAM, Emma (KINGSTON HOSPITAL NHS FOUNDATION TRUST)
Sent: 13 March 2017 16:02
To: [log in to unmask]
Subject: Re-running patient samples after IQC failure


Dear collective brain,



We are reviewing our processes ahead of UKAS inspection and were wondering if anyone has a policy in place for when to re-run patient samples after an IQC failure on random access chemistry/immunoassay platforms.



For example, do you have a set rule that if IQC is >3SD out for an analyte (? on all levels, ? on one level) patient samples run on that analyser since last 'good' IQC are all re-checked? Or is this decision made on an ad-hoc basis? Is a written policy on this required for UKAS?



Any thoughts and experiences on this topic gratefully received!



Emma
Emma Tuddenham
Clinical Scientist
Kingston Hospital
Galsworthy Road
Kingston Upon Thames
KT2 7QB
Tel: 0208 934 3309
Fax: 0208 934 3289
Please note: currently I work Mondays, Wednesdays and Thursdays only





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