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 Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), review of 2021 and 2022 Complete Blood Count (CBC) Proficiency Testing (PT) attestation sheets and upon interview with the lead testing person, the laboratory failed to ensure proficiency testing was performed by testing personnel (TP) who routinely perform patient testing for 2021 and 2022. The findings include: 1. Review of the form CMS 209 revealed four testing personnel who perform patient testing for CBC. 2. Review of 2021 proficiency testing attestation records for CBC testing revealed only 2 of 4 testing personnel showed participation in testing PT samples. 3. Review of 2022 proficiency testing attestation records for CBC testing revealed only 1 of 4 testing personnel showed participation in testing PT samples. 4. Interview with the lead testing person on 01.19.2023 at 12:45 pm confirmed the laboratory failed to ensure CBC proficiency testing was performed by personnel who routinely perform patient CBC testing in 2021 and 2022. 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 --