Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site initial CLIA certification survey conducted at your facility July 30, 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. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the 2020 and 2021 American Proficiency Institute (API) proficiency testing (PT) Hematology/Coagulation records for the I-STAT Activated Clotting Time (ACT) test, and an interview with the Cardiac Catheterization Laboratory Charge Nurse, the laboratory failed to retain all of the proficiency testing records for at least two years. Findings include: 1. There were no records of proficiency testing for the API 2020 Hematology/Coagulation testing events One, Two, and Three, and for the API 2021 Hematology/Coagulation event one for the I- STAT ACT test available for review at the time of the survey. 2. Results for the 2020 Hematology/Coagulation testing event One for the I-STAT ACT were retrieved from the API website at the time of the survey. 3. The results and attestations for the 2020 Hematology/Coagulation testing events two and three, and the 2021 Hematology /Coagulation testing event one for the I-STAT ACT could not be retrieved from the API website. The results for those events were not submitted by the laboratory for evaluation. 4. The Cardiac Catheterization Laboratory Charge Nurse confirmed the findings during an interview conducted on July 30, 2021 at approximately 10:00 AM. The laboratory performs approximately 360 hematology 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 13 -- D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records for the 2020 and 2021 Hematology/Coagulation I-STAT Activated Clotting Time (ACT), and an interview with the Cardiac Catheterization Laboratory Charge Nurse, the laboratory failed to review and evaluate results from proficiency testing programs (refer to D5211), the laboratory failed to establish a mechanism, and failed to document the means used by the laboratory to verify the accuracy of the test for the events in which the laboratory received a zero score for non-participation in the proficiency testing events. (refer to D5215), and the laboratory failed to establish and follow written policies and procedures to monitor, assess, and correct problems identified in the general laboratory systems (refer to D5291). 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 2020 American Proficiency Institute (API) proficiency testing (PT) Hematology/Coagulation report for the I-STAT Activated Clotting Time (ACT) test retrieved from the API website, a review of the API PT Hematology /Coagulation Event History for the I-STAT ACT 2020 test Events Two and Three, and the 2021 test Event One that was retrieved from the API website, and an interview with the Cardiac Catheterization Laboratory Charge Nurse, the laboratory failed to obtain and review the reports received for the 2020 test Events One, Two and Three, and the 2021 test Event One for the I-STAT ACT test to evaluate the laboratory's performance, and to identify any problems that require