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For those of you out there running TEG 6s instruments, since Haemonetics does not have 2 levels of commercial QC available how do you satisfy this requirement:  

HEM.20090 Alternative Control Procedures Phase II

If the laboratory performs test procedures for which control materials are not commercially available, there are written procedures for an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be recorded.

NOTE: "Performance" includes elements of accuracy, precision, and clinical discriminating power. Examples of alternative procedures may include split sample testing with another method or with another laboratory, the testing of previously tested patient specimens in duplicate, testing of patient specimens in duplicate, or other defined processes approved by the laboratory director.

Evidence of Compliance:

Written procedures for alternative quality control AND
Records of alternative control procedures

 

Thanks!!!

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For the normal we use a known normal donor, for both the GH cartiledges and the PLT map cartiledges. There is a manufacture control for the abnormal  GH cartiledges. For the PLT mapping abnormal we had to establish our own range-by first determining the donor was normal and then spiking the normal donor sample and running. Also had write up an IQCP.

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