Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on February 5, 2026, at the laboratory of Anderson Skin & Cancer Clinic 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, Requirements for Laboratories. The following is a list of Standard level deficiencies as a result of the recertification survey of February 5, 2026. 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 records review, lack of documentation, and personnel files, the laboratory failed to follow its own policy and procedure for documentation of educational credentials and competency assessment of testing personnel listed on the form CMS- 209. Findings included: 1. Records review of the competency assessments for the employees listed on the CMS-209 reveals 12 out of 25 lack documentation of proper educational criteria. 2. Records review of the competency assessments reveals lack of proper documentation of personnel competency assessments in 21 out of 25 testing personnel. 3. In an interview with the laboratory director (LD) on February 5, 2026, in the laboratory office at 1:00pm, the findings were confirmed. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and personnel files, the laboratory director failed to provide leadership and guidance to ensure documentation of proper training and competency assessments of the laboratory staff. Findings included: 1. Records review of the competency assessments for the employees listed on the CMS- 209 reveals 12 out of 25 lack documentation of proper educational criteria. 2. Records review of the competency assessments reveals lack of proper documentation of personnel competency assessments in 21 out of 25 testing personnel. 3. In an interview with the laboratory director (LD) on February 5, 2026, in the laboratory office at 1:00pm, the findings were confirmed. -- 2 of 2 --