Summary:
Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted on September 5, 2024, at the clinical laboratory of McLeod Pediatrics-Dillon by the South Carolina Department of Public Health's (SC DPH) Bureau of Nursing Homes and Medical Services. 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 cited: 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 laboratory personnel documented on the CMS 209 form, review of policy and procedures, and staff interview, the laboratory failed to have a written procedure for evaluating personnel competency. Findings included: 1. Review of laboratory personnel documented on the CMS 209 form reveals the lack competency assessments for 6 out of 6 testing personnel. 2. Review of the laboratory's policy and procedure manual reveals a lack of a written procedure for asessing the competency of employees. 3. In a staff interview with testing personnel (TP1) on September 5, 2024 in the laboratory conference room at 1:00pm, the 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 review of laboratory policy and procedures and staff interview, the laboratory failed to have a written policy and procedeure for quality assessments. Findings included: 1. Review of laboratory documents reveals a form entitled "Monthly Quality Assessment Review". 2. Review of laboratory policy and procedure reveals a lack of a written procedure for conducting Quality Assessments. 3. In a staff interview with TP1on September 5, 2024 at 12:00pm in the laboratory conference room, the findings were confirmed. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require