Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Florida Medical Clinic, LLC on 3/29/24. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Personnel (TP) #A, the laboratory failed to perform biannual verification of Mohs slide interpretation for 2 of 2 events in 2023. Findings included: -Review of proficiency test records revealed the TP forwarded representative cases from 3/31/23; 6/30/23; 9/30/23; and 12/31/23 to a secondary reviewer to verify initial diagnosis. The secondary reviewer verified all cases on 2/6/24. -Interview with the TP on 3/29/24 at 10:45 a.m. confirmed that the representative cases from 3/31/23; 6/30/23; 9/30/23; and 12/31/23 were sent to the secondary reviewer some time in 2023, but the secondary reviewer did not verify the cases until 2/6/24. 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. 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 -- This STANDARD is not met as evidenced by: Based on observation, interview with the Mohs Technician, and review of the laboratory's Quality Control (QC) procedures, the laboratory failed to discard 4 of 4 Avantik inking reagents within the manufacturer's expiration date. Findings included: - On 3/29/24 at 9:45 a.m., expired Avantik inking reagents were observed in the cabinet above the counter where tissue from Mohs procedures are processed. -During an interview with the Mohs Technician on 3/29/24 at 9:49 a.m., the Mohs Technician stated that the observed Avantik inking reagents were poured off into smaller containers for use in inking tissue obtained from Mohs procedures. -Review of the laboratory's QC policy revealed that the laboratory must discard all outdated materials. -- 2 of 2 --