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 January 14, 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. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) proficiency testing reports for testing years 2017 and 2018 for Plasma Cardiac Markers and Hematology, a review of the laboratory responses to unacceptable proficiency testing results and an interview with the laboratory manager, the laboratory failed to review and evaluate the results of proficiency testing. Findings include: 1. The laboratory failed to develop a