My supervisor had our QA person check into whether CAP had changed their
stance on using expired Abs or more exactly, on whether it was ok to
extend the expiration date if aliquots were frozen.  Below is the
response she received.

 

Linda A. Sebree 
University of Wisconsin Hospital & Clinics 
IHC/ISH Laboratory 
DB1-223 VAH 
600 Highland Ave. 
Madison, WI 53792 
(608)265-6596 

-----Original Message-----
From: Joan Rose (s) [mailto:jrose@cap.org] 
Sent: Tuesday, October 14, 2008 4:32 PM
To: Haack Lori A.
Subject: CAP Inquiry

Dear Ms. Haack,

 

I have received your CAP inquiry regarding the use of reagents beyond
the manufacturer stated expiration date. The Federal Rules and
Regulations and the College of American Pathologists' Laboratory
Accreditation Program prohibit the use of expired materials for patient
testing. As delineated in multiple CAP Checklists, reagents must not be
used beyond their stated or assigned expiration date. The only exception
is for rare Blood Bank antibodies as stated in the note of the
Transfusion Medicine (TRM) checklist item TRM.31250: Rare reagents
(e.g., anti-Jk(a), anti-Le(a), etc.) may be used beyond their expiration
date if appropriate positive and negative controls are run and react as
expected. This exception is permitted by the FDA. This does not apply to
reagents that are readily available.

 

Please refer to the Federal Register 1992(Feb 28): 7164[42 CFR
493.1205(e)(1)] for more information. You can access the federal
regulations at the web-site
http://www.hcfa.gov/medicaid/clia/cliahome.htm.

 

I hope this information is helpful. If you have any additional
questions, I can be reached at the phone number or e-mail address listed
below.  Thank you for your participation in the Laboratory Accreditation
Program.

 

Sincerely,

 

Joan Rose, MT(ASCP)SH

Technical Specialist

Laboratory Accreditation Program

College of American Pathologists

1-800-323-4040 extension 7257

jrose@cap.org

 

  

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