Summary:
Summary Statement of Deficiencies D0000 An onsite announced CLIA initial survey was conducted at Epiphany Dermatology of South Carolina on July 28, 2026, by the South Carolina Department of Public Health (SC DPH), Bureau of Nursing Homes and Medical Services. The facility was found to be out of compliance with Conditions of Participation for Clinical Laboratory Improvement Amendments (CLIA) of 1988 requirements found at 42 CFR Part 493. The following STANDARD LEVEL DEFICINCIES were found as a result of the initial survey on July 28, 2026: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 direct observation, lack of documentation and staff interview, the laboratory failed to ensure that equipment has not exceeded their expiration date, has deteriorated, or is of substandard quality for 2 out of 2 years reviewed (2025 and 2026). Findings included: 1. On a tour of the laboratory on July 28, 2026@2:45 pm the surveyor directly observed the following equipment in the laboratory: a. Medline thermometer without verification of performance and/or documentation of expiration date. b. Leica CM1850 Cryostat, Serial : 2201/04.2011 2. A review of Leica CM1850 Cryostat User Manual reveals "air humidity must not exceed 60% high room temperatures and excessive air humidity affect the cooling capacity of the cryostat". 3. The surveyor requested and the laboratory failed to provide documentation of performance verification for the thermometer and humidity device used to measure room temperature and humidity as required for optimal instrument functioning. 4. In an interview on July 28, 2026, at 2:48 pm with the Clinic Supervisor in the receptionist area the above findings were confirmed. 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 --