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 October 14 and 18, 2019. 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. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random audit of patient laboratory testing requisitions and final reports from 10/24/17 through 9/05/19 and an interview with the laboratory manager, the laboratory failed to follow director approved policy to ensure positive identification of information from the time of the sample collection through the completion of testing and the reporting of the results. Findings include: 1. A random audit of patient test requisitions and patient final test reports from 10/24/17 through 9/05/19, revealed that the laboratory failed to ensure that the patient and sample information that was recorded on the patient requisition matched the information that was on the patient final test report. 2. A random patient on 5/7/18 had a recorded collection time of 12 noon on the test requisition and a collection time of 8:00 AM on the patient final test report. 3. A random patient on 10/03/18 had a recorded collection time of 12:56 PM on the test requisition and a collection time of 5:16 PM on the patient final test report. 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 -- This was confirmed by the laboratory manager on October 18, 2019 at approximately 2:30 PM. The laboratory performs approximately 346,400 patient laboratory tests annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the proficiency testing reports for all non-waived tests performed by the laboratory from July 2017 through October 2019 and an interview with the laboratory manager, the laboratory failed to verify the accuracy, at least twice a year, for non-regulated non-waived laboratory tests that were not included in a Health and Human Services (HHS) approved proficiency testing program. Findings include: 1. The laboratory failed to verify the accuracy of 15 toxicology confirmation analytes, at least twice a year, for testing years 2018 and 2019. 2. The laboratory failed to verify the accuracy, at least twice a year during testing years 2018 and 2019, for the following toxicology confirmation analytes in which patient testing was performed: 2-Hydroxyethylflurazepam, 4-Hydroxyalprazolam, 4-Hydroxymidazolam, 7-Aminoflunitrazepam, Chlordiazepoxide, Desipramine, Estazolam, MDEA, Methylphenidate, Naloxone, Naltrexol, Naltrexone, Norhydrocodone and PCP. This was confirmed by the laboratory manager on October 14, 2019 at approximately 1:30 PM. The laboratory performs approximately 340,000 patient Chemistry tests annually. D5785