Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of waived testing manufacturers' package insert instructions, lack of Quality Control (QC) documentation, as well as interview with the Testing Personnel (TP), the laboratory failed to follow manufacturer's instructions for performing the test. FINDINGS: 1. There was no documentation of Quality Control (QC) performance for the Medline hCG Pregnancy Test strips or the Siemens Clinitest hCG Pregnancy Test cassettes used for patient testing. 2. This is contrary to instructions indicated in the respective manufacturers' package inserts. 3. The TP confirmed the findings on August 19, 2025, at approximately 1:15 P.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 Proficiency Testing (PT) records as well as interviews with the Laboratory Team Leader (LTL) and TP, the laboratory failed to document review and evaluation of the results obtained on PT performed. FINDINGS: 1. There was no documentation of Laboratory Director (LD) review and signature on the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT summary 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 -- document for the 2025 first event. 2. The LTL and TP confirmed the findings on August 19, 2025, at approximately 2:30 P.M. 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 through 493.1236. This STANDARD is not met as evidenced by: Based on review of twice-a-year verification data, Standard Operating Procedures (SOPs) and Quality Assurance (QA) policies, as well as interviews with the LTL and TP, the laboratory failed to comply with SOPs for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements. FINDINGS: 1. Primary post vasectomy semen analysis results were recorded on the twice-a-year verification log sheets for 2023, 2024, and 2025. However, no secondary or confirmatory results were documented to verify the accuracy of post vasectomy semen analysis. 2. This is contrary to instructions indicated in the current approved SOPs as well as QA policies. 3. The LTL and TP confirmed the findings on August 19, 2025, at approximately 2:45 P.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)