Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on April 24, 2026, at the laboratory of Coastal Dermatology Institute LLC of Myrtle Beach by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA requirements for laboratories. The following is a list of the the Standard Level deficiencies cited as a result of the recertification survey of April 24, 2026. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on records review, personnel files, and staff interview, the laboratory director failed to include initial and 6 month competency assessments in the laboratory's personnel competency policy and procedure. Findings included: 1. Review of the personnel competency policy and procedure reveals no requirement for initial and 6 month competency assessments for new hires. 2. Review of personnel files for personnel listed on the CMS 209 form reveals no documentation of initial and 6 month competency assessments. 3. In an staff interview on April 24, 2026 at 2:30pm in the laboratory office with the office manager, the findings were confirmed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on records review, personnel files, and staff interview, the technical supervisor (TS) failed to ensure that 6 month competency assessments were performed for new hires. Findings included: 1. Procedure manual review of the laboratory's QA plan reveals a lack requiremenmt for 6 month competency assessments for new hires. 2. Review of personnel files for personnel listed on the CMS 209 form reveals no documentation of initial and 6 month competency assessments performed by the TS. 3. In an staff interview on April 24, 2026 at 2:30pm in the laboratory office with the office manager, the findings were confirmed. -- 2 of 2 --