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 proficiency testing (PT) records for testing performed in the subspecialty of Endocrinology and interview with the technical supervisor (TS-1) on 11/04/25 at 10:30 AM, the laboratory director failed to sign the PT attestation statements for 3 out of 3 PT events during 2025. Findings include: 1. The laboratory performs testing in the subspecialty of Endocrinology with a reported annual test volume of 11,500. 2. The PT attestation statements presented for review for the 1st, 2nd and 3rd testing events of 2025 lacked the signature of the laboratory director. 3. TS-1 interviewed on 11/04/25 at 10:30 AM confirmed that the PT attestation statements indicated above were not signed by the laboratory director. 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 accuracy verification documentation for semen morphology testing and interview with the technical supervisor (TS-1) on 11/04/25 at 10:30 AM, 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 -- the laboratory failed to document