R1R2

A good place to start would be to call your state public heath department with questions about CLIA requirements.

Our facility became the Transfusion Service for 2 smaller hospitals. In addition to supplying their blood products, I reviewed all their procedures that pertained to blood transfusion/sample collection.

There is no quality control that I am aware of.

agreed!

So how is the patient? Did she have any immediate transfusion reaction symptoms?

A validation is not necessary in my opinion. Would run a few patient samples with current and new panel and results should be comparable or better than the current to be acceptable.

Transfusion hx and diagnosis?

ABOUT #1 - just wondering why can't you change a QC result? Are you allowed to change patient reaction results?

Congrats!

Fly the W!

Anyone using Telcor and clinitek?

IS that for initial validation or your semiannual comparison?

also known as method comparison. This is the CAP checklist item: **NEW** 04/21/2014 COM.04250 Comparability of Instruments/Methods Phase II If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results. NOTE: This requirement applies to tests performed on the same or different instrument makes/models or by different methods. The purpose of the requirement is to evaluate the relationship between test results using different methodologies, instruments, or testing sites. This comparison is required only for nonwaived instruments/methods accredited under a single CAP number. The laboratory must establish a written procedure for this check that includes acceptance criteria. This requirement is not applicable to calculated parameters. Quality control data may be used for this comparison for tests performed on the same instrument platform, with both control materials and reagents of the same manufacturer and lot number. Otherwise, the use of human samples, rather than stabilized commercial controls, is preferred to avoid potential matrix effects. The use of pooled patient samples is acceptable since there is no change in matrix. In cases when availability or pre-analytical stability of patient/client specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated (when applicable) to have the same response as fresh human samples for the instruments/methods involved. This requirement only applies when the instruments/reagents are producing the same reportable result. For example, some laboratories may use multiple aPTT reagents with variable sensitivity to the lupus anticoagulant. If these are defined as separate tests, then this requirement does not apply unless each type of aPTT test is performed on more than one analyzer. For Microbiology testing, this requirement applies when two instruments (same or different manufacturers) are used to detect the same analyte. Two or more detectors or incubation cells connected to a single data collection, analysis and reporting computer need not be considered separate systems (e.g. multiple incubation and monitoring cells in a continuous monitoring blood culture instrument, two identical blood culture instruments connected to a single computer system, or multiple thermocycler cells in a real time polymerase chain reaction instrument). This checklist requirement does not apply to multiple analytical methods (e.g. antigen typing versus culture or detection of DNA versus a biochemical characteristic) designed to detect the same analyte. Evidence of Compliance: ✓ Written procedure for performing instrument/method comparison AND ✓ Records of comparability studies reflecting performance at least twice per year with appropriate specimen types EFERENCES 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Fed Register. 2003(Jan 24):5236 [42CFR493.1281(a)] 2) Podczasy JJ, et al. Clinical evaluation of the Accu-Chek Advantage blood glucose monitoring system. Lab Med. 1997;28:462-466 3) Ross JW, et al. The accuracy of laboratory measurements in clinical chemistry: a study of eleven analytes in the College of American Pathologists Chemistry Survey with fresh frozen serum, definitive methods and reference methods. Arch Pathol Lab Med. 1998;122:587-608 4) Miller WG, Myers GL, Ashwood ER, et al. State of the Art in Trueness and Inter-Laboratory Harmonization for 10 Analytes in General Clinical Chemistry. Arch Pathol Lab Med 2008;132:838-846 5) Clinical and Laboratory Standards Institute. Verification of Comparability of Patient Results within One Healthcare System: Approved Guideline (Interim Revision). CLSI Document EP31-A-IR. Clinical and Laboratory Standards Institute, Wayne, PA; 2012. 6) Miller WG, Erek A, Cunningham TD, et al. Commutability limitations influence quality control results with different reagent lots. Clin Chem. 2011;57:76-83

Hi all, How many patient comparison examples do you include for your semiannual comparison study?

I don't think those numbers are unreasonable but I am not familiar with AAP nomogram.

Hi all, Just wanted to get an idea of what you are doing to review monthly QC on waived iSTAT testing? Currently, I make sure that cartridges were QC'd monthly and before any patient testing on new lot and results were acceptable.

I do review an annual summary of blood warmer function checks supplied by my BIOMED guys and gals.

I may be opening a can of worms but I would not have done any validation and left it up to biomed to do their function and temp checks according to manufacturer's specs. Do you validate IV pumps or rapid infusers?

Agree with Gwyn.

I do not consider this a test but a task and would not use the 6 elements. You should have some sort of documentation of yearly training IMO.

Time to genotype?

Just curious, can you not pool before issue?

1 hour + for TAS on Provue depending on how many samples are tested.

I would not routinely use them in place of manufactured reagent antisera. I think it would be fine for screening purposes but would confirm with manufacturer reagent antisera.

You may be able to run a report from your LIS that will indicate those moms who need RHIG/FMST. You could have this report run daily and make it routine for techs to review on a daily basis.