Summary:
Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) (a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on surveyor review of the federal Certification and Surveyor Provider Enhanced Reporting (CASPER) reports,. laboratory and proficiency testing (PT) records, and interview with the Laboratory Director, the laboratory did not report proficiency test results to Health and Human Services (HHS) for four of four non- waived programs since ordering PT samples from the American Proficiency Institute (API) on June 9, 2025. Findings include: 1. Surveyor attempts on February 2, 2026, to create a CASPER report 0155D (Individual Laboratory Profile) showing PT results for this laboratory were unsuccessful, there were no records available for this laboratory in the federal database. 2. Review of the laboratory's records from 2025 showed the laboratory reported non-waived test results in chemistry, hematology, mycology and urinalysis. 3a. Review of the API "2025 Order Confirmation" report for this laboratory showed the confirmation included the following statement, "CLIA number not on file - please call customer service at 800-333-0958". 3b. Review of the API "2026 Order Confirmation" report for this laboratory showed the confirmation included the following statement, "CLIA number not on file - please call customer service at 800-333-0958". 4. Interview with the Laboratory Director on February 4, 2026, at 9:15 AM confirmed the laboratory performed non-waived testing in hematology, chemistry, mycology, and urinalysis and confirmed the laboratory had not provided the CLIA number to API to allow reporting of the PT results to HHS. D6019 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved