AngelaNlincoln

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)]

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 II All reagents are used within their indicated expiration date. NOTE: Rare antisera may be used beyond their expiration date if appropriate positive and negative controls 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 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 validation of the performance of expired reagents in accordance with written laboratory policy. Evidence of Compliance: ✓ Written policy for evaluating reagents that are used beyond their expiration date AND ✓ Documentation of attempts to obtain in-date reagents 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)] 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)]