Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 11/02/2022 found the CLEVELAND CLINIC FLORIDA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to dispose expired reagents since 02/26/2022. Findings Include: -During laboratory tour on 11/02 /2022 at 10:00 AM, the surveyor found the following reagents in the flammable cabinet: one bottle of 16 ounces of Michel's Fixative with lot 076924 expired 02/26 /2022 and 1 bottle of 200 mL of IHC Wash Buffer 10X with lot 00001528 expired 05 /06/2022. -Review of Michel's fixative bottle label revealed that was in use since 10/15 /2021 and no end use documented in the label or the reagent log. -Review of IHC Wash Buffer 10X bottle with expiration date 05/06/2022, revealed no documentation of the opening date and or end use date. -Review of procedure manual signed on 10/20 /2022 the "MOHS Lab Reagent SOP" policy revealed that it said the following: a) On section "Instructions. All reagents are to be labeled with the following information: 1. Reagent name. 2. Expiration date. 3. Dilution concentration (if applicable). 4. Date prepared (if applicable). 5. Temperature for storage (if not room temperature). 6. Hazardous Warning (if applicable). 7. Date received and date opened in permanent black marker. All reagents will be recorded on a receipt log with the following information: 1. Reagent name. 2. Expiration date. 3. Batch and lot number. 4. Date received, date opened, and date discarded." b) On section "Storage, Usage and Handling: 1. Reagents are stored according to manufacturer instructions. 2. Reagents Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- are discarded if unlabeled or past their expiration date." During an interview on 11/02 /2022 at 12:30 PM the laboratory director confirmed that the laboratory failed to remove the expired reagents of reference. -- 2 of 2 --