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 record review and staff interview the laboratory failed to ensure that the Testing Personnel (TP) performing the Proficiency Testing (PT) sign the "attestation statement" certifying that PT samples were tested in the same manner as patient samples in the subspecialty of Endocrinology. Findings include: 1. Record review on 6 /18/2025 of the laboratory's PT binder revealed the laboratory performed the PT offered by the "American Proficiency Institute" (API) for the years 2023, 2024 and 2025. 2. Record review on 6/18/2025 revealed lack of documentation of TP signatures on the laboratory's "attestation statement" provided by the API for the following events: a. Two of three events in 2023: 2nd Event and 3rd Event. b. Three of three events in 2024: 1st Event, 2nd Event, and 3rd Event. c. Two of two events in 2025: 1st Event and 2nd Event. 3. Staff interview on 6/18/2025 at 10:47 AM with the Laboratory Director confirmed the findings above.. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --