Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on June 17, 2025. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) proficiency testing (PT) attestations from August 2023 through May 2025, a review of the CMS 209 form, and an interview with the Technical Consultant, the laboratory failed to ensure that all testing personnel routinely performing patient testing were performing proficiency testing. Findings include: 1. A review of the PT attestations from CAP revealed that the proficiency testing was not rotated among the testing personnel routinely performing patient testing. 2. A review of the CMS 209 form revealed that testing personnel number one was performing all PT testing events for Hematology Automated Differential. 3. An interview with the Technical Consultant on June 17, 2025 at approximately 11:30 AM confirmed these findings and indicated that testing personnel two through eight perform hematology for patients. The laboratory performs approximately 167,928 hematology tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, a review of the College of American Pathologists (CAP) proficiency testing (PT) documentation, and an interview with the Technical Consultant, the laboratory failed to ensure that the results that were non-graded by the proficiency testing agency were evaluated and documented. Findings include: 1. A review of the laboratory director approved policy titled "Quality Assessment", states that "Ungraded PT results (due to lack of consensus, nonparticipation, or late return of results) are self-graded by the laboratory, using the PT agency's report and summary sheets". 2. A review of CAP PT documentation of the second event of 2023 for Reticulocyte found that educational challenge was not evaluated. 3. A review of CAP PT documentation of the first event of 2024 for Blood Cell ID (BCP) found that educational challenge was not evaluated. 4. A review of CAP PT documentation of the second event of 2024 for BCP found that educational challenge was not evaluated. The laboratory performs approximately 167,928 hematology tests annually. This has been cited previously at a recertification survey performed on July 19, 2023. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's CAP PT evaluations for the Ligand and Reticulocyte PT events from August 2023 through May 2025, and an interview with the Technical Consultant, the laboratory failed to evaluate and document