Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all testing personnel who performed patient testing. This was noted on seven out of seven chemistry PT events and six out of seven hematology PT events performed by Testing Personnel #16 from 2020 to 2021 (a total of 18 Testing Personnel were listed on the CMS - 209 Laboratory Personnel Report who performed patient testing in the laboratory). The findings include: 1. A review of the API PT records determined the following events were performed by Testing Personnel #16: a) 2020 Chemistry and Hematology 1st Event, 2nd Event, and 3rd Event b) 2021 Chemistry and Hematology 1st Event, 2nd Event, and 3rd Event c) 2022 Chemistry 1st Event 2. During an interview on May 5, 2022 at 12:45 PM, Testing Personnel #1 confirmed the above findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: 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 -- Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to document the evaluation and verification activities for PT scores less than hundred percent (100%). This was noted for two out three Microbiology (Molecular Virology- Respiratory) events from 2021 - 2022. The findings include: 1. A review of the API PT records revealed the following events did not have documented