Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA validation survey conducted at your facility on April 13, 2023. 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. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory records for the 2022 American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, a review of the director approved proficiency testing policy and procedure, and an interview with the laboratory manager, the laboratory failed to retain the testing records for the 2022 test events S-1-Andrology, and S-2-Andrology for a minimum of two years. Findings include: 1. There were no records, including the signed attestation, the result reporting form, and the evaluation of the results from the PT agency, for the 2022 AAB Proficiency test events for S-1-Andrology and S-2-Andrology for the sperm count, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- sperm motility and sperm morphology tests. 2. The director approved proficiency testing policy stated in section V. Record File, "The laboratory's proficiency testing record file should contain the report form copy, procedural documentation, evaluation report, and summary report for each mailing for a period of at least two years." 3. The laboratory manager confirmed the findings during an interview conducted on April 13, 2023 at approximately 11:15 AM. The laboratory performs approximately 240 hematology tests annually. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiency cited herein, the Condition: General Laboratory Systems was not met. The laboratory failed to evaluate proficiency testing performance (Refer to D5215), the laboratory failed to at least twice annually verify the accuracy of tests or procedures it performs that are not included in subpart I (Refer to D5217), and the laboratory failed to document review of and