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 August 30, 2022. 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. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) Policy, review of reference laboratory and corresponding laboratory reports compiled for QA activities, review of laboratory quarterly meeting minutes, and interview with technical consultant, the laboratory director failed to ensure that the established QA program was maintained to assure the quality of laboratory services provided. Findings include: 1. The Quality Assessment Policy was amended on 10/16/2020 and approved by the laboratory director on 11/01/2020 to include: "Additional items: (quarterly) 1) A mix of pos/neg screening reports will be evaluated vs the confirmation testing data issued by the reference lab. At minimum, 10 reports/quarter. 2) Lab meetings with director, technical consultant & testing personnel will be held and documented. This will constitute an opportunity to discuss ongoing lab operations and possible areas of improvement, as noted by any party present." 2. Review of the reference laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and corresponding laboratory reports compiled for the QA activity for 2021 and 2022 revealed that the laboratory failed to evaluate 10 reports quarterly to ensure that the screening test results correlated with the confirmatory test results. The incoming technical consultant confirmed the findings on 8/30/2022 at approximately 4:00 PM. 3. Review of the laboratory meeting minutes revealed that there was no documentation of quarterly meetings held in 2022. The laboratory provided the quarterly meeting minutes for 2021 by electronic mail on 8/31/2022. The laboratory performs approximately 30,000 toxicology tests annually. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on review of the training records for the technical consultant, review of laboratory quality control (QC) records, review of QC Problem Logs, review of the analyzer QC printouts for the Viva Pro-E chemistry analyzer, and interview with the technical consultant, the laboratory director failed to ensure that the technical consultant was trained on the chemistry analyzer to provide appropriate consultation and properly supervise the testing personnel. Findings include: 1. There were no training records for the previous technical consultant for the Viva Pro-E chemistry analyzer. 2. Review of the laboratory and analyzer QC records for 6 Acetyl Morphine (6AM) and the QC Problem Logs from January 2021 to August 2022 revealed that this analyte, more than any other analyte, experienced QC problems and there were several days when the test results could not be reported due to QC failure. No investigation or