Yes, have prepared this summary for each newly validated AB over the past
couple of years, with the included statement and signature of the medical
director.
Joelle Weaver MAOM, HTL (ASCP) QIHC
From: wanda.borow...@sanfordhealth.org
To: histonet@lists.utsouthwestern.edu
Date: Tue, 13 Jan 2015 21:02:53 +0000
Subject: [Histonet] How are you applying this?
Hi All,
Below is a copy of the revised COM.40000 CAP checklist question. Now that
Anatomic Pathology is having to comply with the All Common checklist, how are
you applying this to your Immunohistochemistry ASR’s which are not FDA
approved. We do new antibody validation and parallel testing with new lot
numbers and clones. Is this enough? Can’t really see how the highlighted area
pertains to this. Any advice would be appreciated. Thank.
REVISED** 04/21/2014
COM.40000
Method Validation/Verification Approval
Phase II
There is a summary statement, signed by the laboratory director (or designee
who meets CAP director qualifications) prior to use in patient testing,
documenting evaluation of validation/verification studies and approval of each
test for clinical use.
NOTE: This checklist item is applicable only to tests implemented after June
15, 2009.
The summary statement must include a written assessment of the
validation/verification study, including the acceptability of the data. The
summary must also include a statement approving the test for clinical use with
the approval signature such as, "This validation study has been reviewed, and
the performance of the method is considered acceptable for patient testing."
For an FDA-cleared/approved test, a summary of the verification data must
address analytic performance specifications, including analytic accuracy,
precision, interferences, and reportable range, as applicable.
In addition, for modified FDA-cleared/approved tests or LDTs, the summary must
address analytical sensitivity, analytical specificity and any other parameter
that is considered important to assure that the analytical performance of a
test (e.g. specimen stability, reagent stability, linearity, carryover, and
cross-contamination, etc.), as appropriate and applicable.
If the laboratory makes clinical claims about its tests, the summary must
address the validation of these claims.
See the Method Performance Specifications section for details concerning
validation/verification.
Evidence of Compliance:
✓ Summary of validation/verification studies with review and approval
REFERENCES
1)
Lawrence Jennings, Vivianna M. Van Deerlin, Margaret L. Gulley (2009)
Recommended Principles and Practices for Validating Clinical Molecular
Pathology Tests. Archives of Pathology & Laboratory Medicine: Vol. 133, No. 5,
pp. 743-755
Wanda Borowicz HT(ASCP)
Histology Supervisor
Sanford Health North
1720 S. University Dr.
Route 1902
Fargo, ND 58103
Ph-701 417 4930
Fax-701 417 4399
wanda.borow...@sanfordhealth.org<mailto:wanda.borow...@sanfordhealth.org>
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