Summary:
Summary Statement of Deficiencies 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 review of personnel competency evaluation documents, Standard Operating Procedures (SOPs), as well as interview with the Technical Consultant (TC), the laboratory failed to perform and document provider and Clinical Consultant (CC) annual competency evaluations. FINDINGS: 1. Providers and CC were responsible for performing on-site laboratory throat culture testing and result analysis. 2. There was no documentation of provider and CC competency evaluation from 2023 through date of survey. 3. This is contrary to instructions indicated in the current, approved SOPs. 4. The TC confirmed the findings on July 2, 2025, at approximately 11:30 A. M. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) summary reports as well as interview with the TC, the Laboratory Director (LD) failed to document review and date of review for the API bacteriology PT summary reports. FINDINGS: 1. There was no documented API bacteriology throat culture 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 -- summary report LD review and date of review for the first, second, and third events of 2024 as well as the first and second events of 2025. 2. The TC confirmed the findings on July 2, 2025, at approximately 11:00 A.M. 3. It was noted that the laboratory scored 100% for all events in 2024 and 2025. D6043 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(5) (b)(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratorys established performance specifications; This STANDARD is not met as evidenced by: Based on review of analyzer Quality Assurance (QA) records, SOPs, as well as interview with the TC, the TC failed to ensure that remedial actions were taken whenever test systems deviated from the laboratory's established performance. FINDINGS: 1. There was no documentation of