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More on Validations Using Commercial Plasmas

John Olson, MD, provides his position on the use of commercial plasmas for lot-to-lot validations (rollover) and for establishing reference intervals. Though associated with CAP, Dr. Olson’s opinion does not necessarily reflect the official CAP policy.

“I would not have difficulty with a laboratory using commercial sets for determining reference interval. By far the best would be frozen specimens rather than lyophilized and one would need the assurance that the specimens (say a set of 20) actually came from 20 different individuals, no duplicates. I’m not close enough to the market to know if a normal donor set of lyophilized samples is available. I would be more concerned about such a set. I’m not sure what I would do as inspector. The set would be approved by FDA for the purpose. I would not cite a deficiency, but would recommend the use of frozen rather than lyophilized sets. That scenario is really hypothetical. For reagent change validations, I would be less concerned about lyophilized specimens because the same specimen would be used with both methods.

“Many laboratories in smaller acute care facilities need a commercial source to acquire an adequate number. I am unaware of any requirement that a laboratory use locally prepared set of apparently healthy specimens or that prohibits the use of commercial sets.”

Thanks to Dr. Olson for his information, we recognize he is not speaking directly for CAP.

Comments (1)
Russell Higgins
May 31, 2016 2:51pm

Hello all. I reviewed the
Hello all. I reviewed the CAP requirements for reference ranges. The CAP requires that laboratories verify their reference range against an “appropriate” population. Commercial frozen plasma sets may be adequate for PT and PTT in most populations. Currently I don’t believe there is a regulatory restriction on the use of commercial products for verification of the reference range. I also don’t directly represent the CAP.

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