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

 

 

 

 

 

 

 

 

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

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