Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure Hematology proficiency testing (PT) samples from two of four Blood Cell Identification PT events from late-2020 through 2021 were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory at 12:05 p.m. on 04/07/22. 2. The laboratory performed PT in 2020 and 2021 using the College of American Pathologists (CAP) proficiency testing provider. 3. The Proficiency Testing Procedure found in the 2022 CAP manual indicated PT samples would be tested in the same manner as patient specimens. 4. The Blood Cell Identification (BCP) samples were tested by multiple testing personnel (TP) for two of four PT events reviewed from late- 2020 through 2021 as indicated on attestation statements, survey result forms, and handwritten result documents. See below. 2021 KP-A Samples: BCP-01 through BCP- 06 Tested by: TP1 and TP7 2021 KP-C Samples: BCP-11 through BCP-16 Tested by: TP1 and TP5 5. In an interview at 2:10 p.m. on 04/07/21, TC1 indicated patient samples would not be handled in this manner and confirmed the above finding. . 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 --