Summary:
Summary Statement of Deficiencies D0000 An onsite initial survey was conducted at Reforme Dermatology and Aesthetics, LLC by South Carolina Department of Public Health (SC DPH) and Bureau of Nursing Homes and Medical Services on June 6, 2025. The facility was found to be out of compliance with the Medicare Condition at 42 CFR part 493 Laboratory Requirements. The following is a list of STANDARD LEVEL deficiencies cited as a result of June 6, 2025, certification survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, lack of documentation and staff interview, the laboratory failed to establish and follow written policies and procedures to assess employee(s) as required 493.1445 for 3 out of 3 years reviewed (2023, 2024,and 2025). Findings included: 1. Review of CMS 209 personnel report reveal 2 testing personnel (TP) for high complexity testing. 2. The surveyor requested and the laboratory failed to provide policies and procedures to assess employee(s) as required 493.1445 for high complexity testing. 3. In an interview on June 6, 2025, at 3:35 pm in the breakroom with the laboratory director and staff member, the above findings were confirmed. 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 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 -- through 493.1236. This STANDARD is not met as evidenced by: Based on policies review, lack of documentation, and staff interview, the laboratory failed to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements as specified in 493.1231 through 493.1236 for the 3 out of 3 years reviewed (2023, 2024, and 2025). Findings included: 1. Review of policy and procedure titled "Quality Assessment Plan" stated "On a quarterly basis the Histotechnician or Director of Laboratory Operations will review 10 percent of cases done during the previous quarter. This process will include pulling the patients' charts, the Mohs log, and slides. They will be checked to make sure that the op-report, map, Mohs log and slides are accurate. If there are any discrepancies it will be noted on the Quarterly QA form and