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 review of the personnel roster (CMS form 209), hematology proficiency testing (PT) records for 2017 and 2018, and interview with the technical supervisor, the laboratory failed to include one of two testing personnel who routinely perform patient testing in the PT process. Findings: 1. Review of the CMS form 209 revealed two full-time testing personnel perform hematology testing on patient samples. 2. Review of hematology PT records for 2017 revealed testing personnel # 1 performed all PT for the first, second and third events. 3. Review of hematology PT records for 2018 revealed testing personnel #1 performed all PT for the first, second and third events. 4. The laboratory did not have attestation documentation to show testing personnel #2 participated in PT for 2017 and 2018. 5. Interview with the technical supervisor on February 5, 2019 at 3:00 PM confirmed the laboratory failed to include testing personnel #2 in the PT process during 2017 and 2018. 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 --