Summary:
Summary Statement of Deficiencies D0000 A recertification survey was completed on 01/06/2026. Noncompliance was found for the following condition level deficiencies: D5020 493.1212 Condition: Endocrinology. D6000 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 the laboratory's policies and procedures, American Association of Bioanalysts -Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, lack of documentation, and interview with laboratory representative (LR); the laboratory failed to maintain a copy of all records related to proficiency testing for four of four Endocrinology testing events from the last event of 2024 through 2025, to the date of the on-site survey, 01/06/2026. Findings include: 1. Review of policies and procedures revealed the procedure titled "Proficiency Testing", under "3: Procedures" and "4. PT Evaluation", which stated, "3.2 Testing and reporting ... - Testing personal must enter test results online and on paper, and document reporting by signing on the paper report form - Lab Director or designee must review the results before submitting the results to ABB, just as patient testing". "3.4Attestation page - The proficiency testing attestation statement is signed by the laboratory director or designee and the individual performing the testing before submission." 2. Review of AAB-MLE PT records revealed the laboratory failed to maintain a copy of the LD signature on attestation documents and laboratory director review of AAB-MLE scores for four of four events from the last event of 2024 through 2025: PT Event: 2024 M3 2025 M1 2025 M2 2025 M3 3. Interview with the laboratory representative, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- on survey date 01/06/2026, at 1:15 pm, confirmed the laboratory failed to maintain a copy of all records related to proficiency testing for four of four endocrinology testing events from the last event of 2024 through 2025, to the date of the on-site survey, 01 /06/2026. D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, lack of documentation, and interview with the laboratory representative (LR); the laboratory failed to perform and document a