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 November 26, 2018. 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. 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 proficiency testing results from the American Proficiency Institute (API) for chemistry for testing year 2017 and 2018 and an interview with the laboratory manager, the laboratory failed to verify the accuracy at least twice annually for all non-regulated analytes performed by the laboratory. Findings include: 1. The laboratory failed to verify at least twice during the 2017 testing year the chemistry test for homocysteine. 2. A review of the API 2017 results for homocysteine found the first event received a score of 100%. The second event results for 2017 found the results for homocysteine received a score of 67%. There were no other events from API for this analyte. 3. The laboratory did not perform other proficiency testing to verify the accuracy of the homocysteine test. This was confirmed by the laboratory manager at approximately 10:30 am on November 26, 2018. The laboratory performs approximately 139,030 patient chemistry 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 --