Summary:
Summary Statement of Deficiencies D0000 An on-site announced CLIA initial compliance survey was conducted at the MOHS Laboratory, Columbia Skin Clinic LLC by the South Carolina Department of Health and Environmental Control's (SC DHEC) Bureau of Healthcare Systems and Services on June 19, 2024. The laboratory was found to be out of compliance with 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 lack of documentation and staff interview, the laboratory failed to ensure competency assessments for personnel listed on the CMS-209 form. Findings inlcuded : 1. No competency assessments for the Laboratory Director (LD), Clinical Consultant (CC), and Technical Superevisor (TS). 2. No competency assessments for Testing Personnel (TP) as the General Supervisor (GS) 3. In an interview with the TP in the laboratory on June 19, 2024 at 11:00 am, the 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