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 observation of the laboratory, review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), American Proficiency Institute (API) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that three of the four total testing personnel who performed patient testing for hematology and chemistry tested PT samples in 2023 and 2024. The findings include: 1. Observation of the laboratory on 10/30/2024 at 8:35 am revealed the Sysmex XN1000 instrument used for patient hematology testing and the Ortho XT3400 used for patient chemistry testing. 2. A review of Form CMS-209 revealed four testing personnel who performed patient testing. 3. A review of the laboratory's following API PT records for 2023 and 2024 revealed that seven of the seven events reviewed were performed by testing person two, resulting in three testing personnel who did not participate in PT events: 2023 Event Three Hematology/Coagulation 2023 Event Three Chemistry-Core 2024 Events One, Two, Hematology/Coagulation 2024 Events One, Two, and Three Chemistry-Core 4. An interview with technical consultant one on 10/30/2024 at 10:30 am confirmed the survey findings. Word key: CLIA- Clinical Laboratory Improvement Amendments 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 --