Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Testing (API) PT (Proficiency Testing) records as well as interview with the Technical Consultant (TC), the laboratory failed to document attestation to the routine integration of the samples into the patient workload using the laboratory's routine methods. FINDINGS: 1. There was no documentation of API testing personnel attestation for the following PT events: a. 2023 Routine Chemistry Third Event. b. 2023 Hematology Second and Third Events. c. 2023 Immunology Second Event. d. 2024 Routine Chemistry First and Third Events. e. 2024 Immunology Second and Third Events. f. 2025 Routine Chemistry Second and Third Events. g. 2025 Hematology Second and Third Events. 2. The TC confirmed the findings on September 24, 2025, at approximately 11:30 A.M. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Standard Operating Procedures (SOPs), lack of API PT records, as well as interview with the TC, the laboratory failed to retain all PT records for at least two years. FINDINGS: 1. There was no documentation of performance and 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 -- verification for API PT 2024 Immunology Third Event and 2025 Hematology Third Event. 2. The current, approved SOPs did not include instructions for performing such activity. 3. The TC confirmed the findings on September 24, 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 the review of SOPs, API PT performance review forms, as well as interview with the TC, the laboratory failed to review and evaluate the results obtained on PT performed. FINDINGS: 1. There was no documentation of Laboratory Director (LD) review and signature for the following APT PT performance review forms: a. 2023 Chemistry Second and Third Events. b. 2023 Hematology Second and Third Events. c. 2023 Immunology Second Event. d. 2024 Hematology Third Event. e. 2024 Immunology Third Event. f. 2025 Hematology Second Event. 2. The current, approved SOPs did not include instructions for performing such activity. 3. The TC confirmed the findings on September 24, 2025, at approximately 11:30 A.M. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of SOPs, API PT summary reports, lack of