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 the laboratory's Standard Operating Procedures (SOP) manual, American Proficiency Testing (API) PT (Proficiency Testing) records, as well as interview with the Office Manager (OM), the laboratory failed to document attestation of the individual testing or examining the samples to the routine integration of the samples into the patient workload using the laboratory's routine methods. FINDINGS: 1. There was no documentation of testing personnel attestation for the following PT events: a. 2024 Routine Chemistry First and Third events. b. 2025 Routine Chemistry First and Second events. 2. This is contrary to instructions included in the current, approved SOP, "Proficiency Testing Samples". 3. The OM confirmed the findings on February 3, 2026, at approximately 10:30 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 laboratory's SOPs, API PT summary reports, as well as interview with the OM, the laboratory failed to document review and evaluation for 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 -- the results obtained on PT performed. FINDINGS: 1. There was no documentation of Laboratory Director (LD) review and signature for the 2024 Routine Chemistry Third event APT PT performance. 2. This is contrary to instructions included in the current, approved SOP, "Proficiency Testing Samples". 3. The OM confirmed the findings on February 3, 2026, at approximately 10:30 A.M. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)