I’m getting hung up on this item in regard to our KB qc:
TRM.40130 Alterative 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
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Are most of you buying qc for Kleihauers? We are still making our own positives by diluting a normal adult CBC tube with cord cells (high and low positive controls) and of course using the normal adult as the negative control. We count patients in duplicate and the two counts must be within 10% of each other. Are we in compliance? Control materials are commercially available, we jut don't use them (yet anyway!). One other question, we have always said the number of fetal cells in the high positive control should be roughly twice the number in the low positive. If still making your own controls, do you all define 'roughly'?
Thanks so much in advance!
Cathy