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 May 25, 2021. 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. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of College of American Pathologists (CAP) Proficiency Testing (PT) results for 2019 and 2020, a review of the director approved proficiency testing policy, and an interview with the Director of the Cardiopulmonary & POCT department, and the Supervisor of Respiratory Therapy, the laboratory failed to PT review results that were ungraded or received exception codes accoding to the participant summary, and to document the findings of the review. Findings include: 1. The 2019 first testing event, AQI-A, specimen AQI-02 results for PCO2, Total CO2, Hematocrit, and Hemoglobin were not graded. The exception code for PCO2, Total CO2, and Hemoglobin indicated that the results were outside the analytical range of the I-Stat analyzer. The exception code for Hematocrit indicated that the reported result was qualified with a greater than or less than sign, so was unable to be evaluated. There was no documentation of laboratory review. 2. The 2019 third testing event, AQI-C, specimen AQI-13 results for PCO2, Total CO2, Hematocrit, and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Hemoglobin were not graded. The exception code for PCO2, Total CO2, and Hemoglobin indicated that the results were outside the analytical range of the I-Stat analyzer. The exception code for Hematocrit indicated that the reported result was qualified with a greater than or less than sign, so was unable to be evaluated. There was no documentation of laboraory review of the ungraded results according to the participant summary to evaluate the laboratory's performance compared to the peer group to ensure the accuracy of the PT results, and to perform