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:[EMAIL PROTECTED] 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 [EMAIL PROTECTED] <http://www.cap.org/apps/docs/images/emailGreenLogo.gif> _______________________________________________ Histonet mailing list [email protected] http://lists.utsouthwestern.edu/mailman/listinfo/histonet
