[Histonet] CAP Insitu Hybridization questions

[Stapf, Ross]

Hello everyone:

I'm hoping for some help here since I am new to managing Insitu Hybridization.  2 of the CAP questions are confusing to me.  Keep in mind with responses that we only use FDA approved clones, no ASR's are used in this lab.

ANP.22956  Is there documentation of validation of commercially available probes used?
Does this mean that FDA approved probes must be validated?  If so, what form should this validation take?  I am thinking of pulling 10 positives and 10 negatives and putting them into a report, is this enough?

ANP.22968  Has the laboratory established normal and abnormal reference ranges for each probe used, and are they reviewed at least twice/year, and adjusted if necessary?
I don't even know where to begin with this question.  I have no experience with this.

Thanks in advance for your help.  These things should have been done when these tests were brought in house I guess, but I can find no evidence of it.  With CAP inspection next week I'm doing the best I can.

Ross M Stapf
Histopathology Manager
Baylor University Medical Center
3500 Gaston Ave.
Dallas, TX 75246
214-820-2465 
214-820-4110 fax
RossS <@t> baylorhealth.edu




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