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Does this mean that US regulated laboratories are unable to use panel cells beyond their expiration date even if the facility has a defined policy for exceptions?See checklist below:TRM.31250 Reagent Expiration Dates Phase IIAll reagents are used within their indicated expiration date.NOTE: Rare antisera may be used beyond their expiration date if appropriate positive and negativecontrols are run each day of use and react as expected.For laboratories not subject to US regulations, expired reagents may be used only under the followingcircumstances: 1.The reagents are unique, rare or difficult to obtain; or 2. Delivery of new shipmentsof reagents is delayed through causes not under control of the laboratory. The laboratory mustdocument validation of the performance of expired reagents in accordance with written laboratorypolicy.Evidence of Compliance:✓ Written policy for evaluating reagents that are used beyond their expiration date AND✓ Documentation of attempts to obtain in-date reagentsREFERENCES1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendmentsof 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(d)]2) Food and Drug Administration. Guide to inspections of blood banks, 1994(Sep)3) Food and Drug Administration. Current good manufacturing practice for blood and blood components. Equipment. Supplies and reagents.Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.65(e)]
CAP checklist TRM.31250 Reagent Expiration Dates
in Accrediting Agencies
Posted
This goes along with the New/Revised All Common Checklist
**NEW/REVISED** 07/29/2013
COM.30400 Reagent Expiration Date Phase II
All reagents and media are used within their indicated expiration date.
NOTE: The laboratory must assign an expiration date to any reagents and media that do not have
a manufacturer-provided expiration date. The assigned expiration date should be based on known
stability, frequency of use, storage conditions, and risk of deterioration.
For laboratories not subject to US regulations and military laboratories in overseas locations, expired
reagents may be used only under the following circumstances: 1) The reagents are unique, rare or
difficult to obtain; or 2) Delivery of new shipments of reagents is delayed through causes not under
control of the laboratory. The laboratory must document verification of the performance of expired
reagents in accordance with written laboratory policy.
Laboratories subject to US regulations must not use expired reagents.
Evidence of Compliance:
✓ Written policy for evaluating reagents and media lacking manufacturer's expiration date
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments
of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(d)]