Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/05/2022 found the MIAMI CENTER FOR DERMATOLOGY 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 ensure that MCC Potassium Hydroxide in 30% DMSO and Wright Giemsa Stain were not expired before using them for patient testing from 07/01/2022 to 12/05/2022 in 42 patients. Findings include: - During laboratory tour on 12/05/2022 at 09:30 AM, the surveyor found that the laboratory had in use one bottle of MCC Potassium Hydroxide in 30% DMSO with lot # 1109-00 and expiration date 06/30/2022 and one bottle of Wright Giemsa Stain with lot # VWG728 expired on 06/30/2022. -Review of the 2022 Reagent Log revealed that the laboratory had no received any new of the reagents listed above. -Patient log review revealed that the laboratory tested 40 patients with the expired KOH and 2 patients with the expired Giemsa Stain. During an interview on 12/05/2022 at 10:00 AM, the Mohs technician confirmed that the laboratory tested 42 patients with the expired reagents listed above since July 2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --