Subject: | | Legal requirements for using pooled patient serum |
From: | | "Elizabeth Macnamara, Department of Diagnostic Medicine, Jewish General Hospital, Montreal, Quebec, Canada" <[log in to unmask]> |
Reply-To: | | Elizabeth Macnamara, Department of Diagnostic Medicine, Jewish General Hospital, Montreal, Quebec, Canada |
Date: | | Tue, 08 Jun 1999 10:04:06 -0400 |
Content-Type: | | text/plain |
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As with most laboratories the limitations of liquid or lyophylized QC
material, or the complete absence of QC, becomes a problem from time to
time. To overcome these problems we use means, SD's and histograms of
patient data, to check for shifts in population results, repeats of
patients between analyzers and frozen pooled patient samples. Recently when
we asked for HIV, hepatitis C and B to be analyzed on our pooled sera, the
microbiologists were horrified. In Quebec it is the laboratories
resonsibility to notify the requesting physician of a positive HIV result,
if there is no requesting physician then they do not do the test. They felt
very uncomfortable with doing analysis on pooled serum, especially when one
lot of it came back positive. In addition they felt that if we really
wanted to check for the pooled sera being negative then we should be doing
PCR and not antigen/body screens.
I was wondering how other laboratories deal with this and what are the
various legal requirements that exist in the different countries.
Thank you for your help
Elizabeth Mac Namara
Jewish General Hospital, Montreal, Quebec
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