Summary:
Summary Statement of Deficiencies D0000 An onsite announced CLIA initial survey was conducted at Charleston Dermatology on July 13, 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 Amendment (CLIA) of 1988 requirements found at 42 CFR Part 493. The following STANDARD LEVEL DEFICINCIES were found to be out of compliance as a result of the initial survey on July 13, 2026: D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on policies and procedures reviewed, lack of documentation, and staff interview, the laboratory failed to establish and/or follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements specified at 493. 1231 through 493.1236 for 3 out of 3 years reviewed (2024, 2025, and 2026). Findings included: 1. Review of QC/QA Charleston Dermatology, Berkely Mohs Lab records reveal documentation of task performed for high complexity testing: a. Cryostat temperature recorded b. Cryostat cleaned c. Eyewash pluming checked d. HE Stain changed e. HE Stain acceptance 2. The surveyor requested and the laboratory failed to provide what quality indicators would be monitored, how frequently, and threshold of acceptance for each key performance indicator. "Mohs Quality Assessment Procedure states a review of the Mohs log against the surgery schedule for accuracy and completion. In addition, remedial action would be taken." On the day Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- of survey, the laboratory lacks documentation of any investigation(s),or identification (s) of problems, and resolution of problems, followed by development of any policies that will prevent recurrence. 3. In an interview on July 13, 2026, at 2:51 pm with staff the above findings were confirmed. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of