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 July 30, 2024. 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 2023 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the office manager, the laboratory failed to ensure that the attestation statements provided by the PT program were signed by the analyst and/or the director documenting that the samples were tested in the same manner as patient samples. Findings include: 1. A review of the 2023 API Miscellaneous Chemistry test event one records revealed that the attestation form was not signed by the laboratory director and was not signed by the personnel who performed the testing. 2. A review of the 2023 API Miscellaneous Chemistry test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- event two records revealed that the attestation form was not signed by the personnel who performed the testing. 3. The findings were confirmed during an interview with the office manager on July 30, 2024 at approximately 10:00 AM. The laboratory performs 105,456 routine chemistry and toxicology tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of laboratory temperature logs between the months of June, 2022 and June, 2024, and an interview with the office manager, the laboratory failed to ensure that the room and refrigerator temperatures were documented each day the laboratory was open. Findings include: 1. A review of the laboratory temperature logs revealed that the room and refrigerator temperature were not documented each day the laboratory was open: A. During the month of June 2022, the room and refrigerator temperatures were not documented on four of 24 dates that the laboratory was open. B. During the month of August 2022, the room and refrigerator temperatures were not documented on ten of 23 dates that the laboratory was open. C. During the month of November 2022, the room and refrigerator temperatures were not documented on eight of 20 dates that the laboratory was open. D. During the month of January 2023, the room and refrigerator temperatures were not documented on eight of 21 dates that the laboratory was open. E. During the month of May 2023, the room temperature was not documented on five of 22 dates that the laboratory was open. The refrigerator temperature was not documented on four of 22 dates that the laboratory was open. F. During the month of August 2023, the room and refrigerator temperatures were not documented on eight of 23 dates that the laboratory was open. G. During the month of April 2024, the room and refrigerator temperatures were not documented on one of 22 dates that the laboratory was open. H. During the month of May 2024, the room and refrigerator temperatures were not documented on three of 22 dates that the laboratory was open. I. During the month of June 2024, the room and refrigerator temperatures were not documented on two of 20 dates that the laboratory was open. 2. The findings were confirmed during an interview with the office manager conducted on July 30 at approximately 10:45 AM. The laboratory performs 105,456 routine chemistry and toxicology tests annually. D5785