Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an initial on-site CLIA survey conducted at your facility on April 10, 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. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of the 2023 College of American Pathologists (CAP) Proficiency Testing (PT) records, a review of the laboratory records for training and competency assessment, a review of the completed CMS-209 form, and an interview with the System Manager of Laboratory Compliance conducted on April 10, 2024 at approximately 11:30 AM, the director failed to ensure that initial training and competency assessment was completed for personnel prior to the performance of proficiency testing. Findings include: 1. A review of the 2023 CAP PT records for Ketones event B, Alcohol event C, BNP event C, Cardiac Markers event C, Throat Culture event C, Neonatal Bilirubin event B, and Urine Drug Screens event C were performed by Technical Supervisor number 2 listed on the CMS-209 form. 2. A review of the training and competency assessment records for technical supervisor number 2 listed on the CMS-209 form revealed that there were no documents completed for the personnel to perform testing in this laboratory. The completed 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 -- documents presented were from a separate laboratory (ER at Valley Vista, CLIA number 29D2242731). 3. The findings were confirmed during an interview with the System Manager of Laboratory Compliance conducted on April 10, 2024 at approximately 11:30 AM. The laboratory performs approximately 82044 chemistry tests annually. -- 2 of 2 --