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 June 6, 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. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on a review of the laboratory records for one of one current testing personnel, a review of the laboratory test menu, and an interview with the personnel conducted on June 6, 2024 at approximately 8:45 AM, the personnel did not possess the appropriate certification required by the State of Nevada to perform moderate complexity testing in the laboratory. 1. A review of the laboratory records of one of one testing personnel revealed that the personnel was not certified by the State of Nevada as an Office Laboratory Assistant. The personnel had certification as a Laboratory Assistant. According to the State of Nevada regulation NAC 652.450 (1), a Laboratory Assistant may perform only tests classified as waived tests. 2. A review of the laboratory test menu revealed that the laboratory performed moderate complexity urine drug screen testing on the Thermofisher Indiko chemistry analyzer. 3. The personnel confirmed the finding during an interview conducted on June 6, 2024 at approximately 8:45 AM. The laboratory performs approximately 49,999 toxicology tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --