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 May 14, 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. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on a random audit of seven patients between the dates of May 26, 2023 and April 18, 2025 and an interview with the technical consultant, the laboratory failed to ensure that daily quality control records for the urine drug screens were retained for each day of patient testing. Findings include: 1. A random patient audit of seven patients tested between the dates of May 26, 2023 and April 18, 2025 revealed that the daily quality control records were not retained on one of seven days of patient testing. There was no print out of the daily quality control for the Thermo Fisher Indiko Plus on the date of November 8, 2024. The laboratory was not able to retrieve the control data from the instrument on the date of the survey. 2. The findings were confirmed during an interview with the technical consultant conducted on May 14, 2025 at approximately 10:45 AM. The laboratory performs approximately 80,000 chemistry tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a random audit of seven patients between the dates of May 26, 2023 and April 18, 2025 and an interview with the technical consultant, the laboratory failed to ensure that daily maintenance was performed and documented on each day of patient testing. Findings include: 1. A random patient audit of seven patients tested between the dates of May 26, 2023 and April 18, 2025 revealed that the daily maintenance was not performed and documented on one of seven days of patient testing. There was no documentation of the daily maintenance for the Thermo Fisher Indiko Plus on the date of November 8, 2024. The technical consultant stated that nine patients had been run on that date. On the maintenance log, documentation indicated that no testing was performed between the dates of November 8, 2024 and November 12, 2024. 2. The findings were confirmed during an interview with the technical consultant conducted on May 14, 2025 at approximately 10:45 AM. The laboratory performs approximately 80,000 chemistry tests annually. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on a review of the director approved quality assessment procedure, a review of the monthly quality assurance records, and an interview with the technical consultant and the laboratory director, the director failed to ensure that the monthly quality assessment reviews were documented in accordance with the established policy and procedure. Findings include: 1. There was no documentation of the monthly review of quality assessment measures between the dates of April, 2023 and May, 2025, in accordance with the director approved policy and procedure. 2. The director approved quality assessment policy stated, "A monthly review of particular quality assurance measures will be performed and documented by the laboratory director or supervisor." 3. The findings were confirmed during an interview with the laboratory director and the technical consultant conducted on May 14, 2025 at approximately 10:30 AM. The laboratory performs approximately 80,000 chemistry tests annually. -- 2 of 2 --