Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Clemson REDDI Lab on 09/25/2024 by the South Carolina Department of Public Health (SC DPH). The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The facility was found to be out of compliance with the standards of the CLIA program. The following STANDARD LEVEL DEFICIENCES were found to be out of compliance. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on lack of documentation and staff interviews, the laboratory failed to review and evaluate the results obtained on proficiency testing twice annually. Thae laboratory failed to establish acceptable criteria for accuracy of tests for which proficiency test (PT) samples are not available. Reviewed (2022, 2023, and 2024) 3 of 3 years. Findings included: 1. Review of policy and procedures titled "Research and Education in Disease Diagnosis and Intervention (REDDI) Lab Individualized Quality Control Plan" lack documentation of accuracy of proficiency tests. 2. Review of instrument comparison and proficiency testing results revealed no documentation of date performed, accuracy, or evaluation of performance. 3. In an interview with the Laboratory Director (LD), Technical Supervisor (TS), testing personnel (TP), and Compliance Coordinator on 09/25/2024 in the conference room at 4:54 pm the above findings were confirmed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of documentation and testing personnel interviews, the laboratory failed to follow quality assessment policies and procedures to monitor, assess, and correct problems identified with pre-analytical, analytical, and post-analytical laboratory systems of Multiplex RT-qPCR for Detection of SARS-Co V-2 in Raw Saliva. Findings included: 1. Review of policy titled "Research and Education in Disease Diagnosis and Intervention (REDDI) Lab Individualized Quality Control Plan" includes a section under quality assessment lists proficiency testing records, patient results, specimen rejection logs, turnaround time reports, records of preventive measures,