CAP checklist item FLO.23706

Kimberly A. Pacella kimberly.pacella at healthnetworklabs.com
Fri Jan 4 15:34:45 EST 2008


While we are on CAP checklist questions. Can anyone tell me how they are addressing the following question:

Is the performance of reagents and staining procedures verified periodically by the use of positive controls?
This would seem to be easy enough to answer "yes, we run a positive control/patient when we do our lot-to-lot QC"

However, when you read farther into the commentary it says: "The source (type) of positive control(s) and their frequency of evaluation will vary by the particular flow cytometric application.  The frequency should be:  1, each day of analysis for lymphocyte subset and CD34+ stem cell measurements, regardless of whether one- or two-platform methods are used; and 2, at least monthly for leukemia/lymphoma immunophenotyping. The source of control material should be 1, external positive controls (e.g. normal or commercial control(s)) for lymphocyte subset, CD34+ stem cell quantitations, and leukemia/lymphoma samples; or 2, internal positive controls only for leukemia/lymphoma samples.	Such internal control cells are the variable numbers of residual normal cells in the patient's sample.  Like the external controls, there must be written guidelines defining objective criteria for acceptable performance of the internal controls, and written documentation of the evaluation of the actual periodic performance"

How do people define positive. Is 5-8% of CD117+ or CD25+ cells in a bone marrow enough?
How do you document that you checked this?

Thanks,


<mailto:kimberly.pacella at healthnetworklabs.com>
Kimberly A. Pacella, MT(ASCP)QCYM
Manager, Immunology & Flow Cytometry
Health Network Laboratories
ph: (610)402-5593
e-mail:kimberly.pacella at healthnetworklabs.com
________________________________
From: Montgomery, Roberta J [mailto:Roberta.Montgomery at hcmed.org]
Sent: Wednesday, January 02, 2008 4:24 PM
To: cyto-inbox
Subject: CAP checklist item FLO.23706


Can anyone provide any further information on the new checklist item for CAP, FLO.23706 which reads "Are gated dot plots and histograms retained for at least 10 years?"

I'm wondering if this refers to paper and electronic, or either one/or the other, and is it for all applications? For example, I have more than 10 years electronically for CD4 counts, but I don't have paper records that far back. I thought the requirement for CD4 counts was two years, and paper or electronic, not necessarily both. I have both for leukemia/lymphoma (since the beginning) so that isn't a concern for me.

Robbi Montgomery, MLS, MT(ASCP)SI, CLS(NCA)
Director of Education
Clinical Laboratories
Hennepin County Medical Center
701 Park Ave, P4
Minneapolis, MN 55415
612-873-3022
612-904-4229 fax
roberta.montgomery at hcmed.org  (new email)



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