Summary:
Summary Statement of Deficiencies D0000 An announced onsite CLIA initial survey was conducted on November 19, 2025, at the laboratory of WMG Wellstar Dermatology Aiken 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 standard level deficiencies cited as a result of the November 19, 2025, initial survey: D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory failed to have a written policy for the documentation of personnel competency evaluations for a high complexity laboratory. Findings included: 1. Review of the laboratory policy and procedure manual reveals a lack of a written procedure for the assessment of personnel competency. 2. Review of staff personnel files reveals personnel competency assessments performed annually for 9 out of 9 testing personnel (TP). 3. Review of staff personnel files reveals a lack of initial and 6-month competency assessments for 9 out of 9 TP. 4. In a staff interview conducted on Noevember 19, 2025 at 11:00am in the laboratory office with the Lead Histotechnologist, the findings were confirmed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --