Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 31, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 American Association of Bioanalysts (AAB) proficiency testing records for hematology complete blood count testing and interview with the Clinical Team Leads, the Laboratory Director failed to ensure proficiency testing attestation statements were signed by the testing personnel. Findings: 1. Review of proficiency testing records revealed that the Laboratory Director had signed the AAB proficiency testing attestation statements; however, the required testing personnel signatures were missing for hematology complete blood count Proficiency Testing Events 1 and 2 in 2025 and Event 1 in 2026. 2. During an interview with the Clinical Team Leads, in the radiology suite, on August 31, 2026, at 12:00 p.m., it was confirmed that the testing personnel had not signed the AAB proficiency testing attestation statements for the identified Proficiency Testing Events. 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 --