Summary:
Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, and interview with the Technical Consultant (TC) on July 29, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte for the specialty Hematology in 2024. The findings included: 1. It was the practice of the laboratory to perform moderate complexity testing in the subspecialty of hematology and the laboratory enrolled in the American Proficiency Institute (API) proficiency testing (PT) program for hematology using the Abbott Cell- Dyn -1800 Analyzer. 2. According to the API evaluation report, the laboratory received unsatisfactory scores of 20% in the third event of 2024 for Hematocrit as follows: Sample Reported Result Exp. Result HEM-11 30.8 26.4-29.9 HEM-12 50.5 43.6-49.3 HEM-13 39.5 33.8-38.2 HEM-15 45.3 39.3-44.5 3. On July 29, 2025, at approximately 3:30 pm, the TC confirmed that the laboratory received the above unsatisfactory proficiency scores, with test values exceeding the expected range, indicating a potential systematic error. 4. The laboratory's testing declaration form, signed by the laboratory director on July 24, 2025, stated that the laboratory performed approximately 582 hematology tests annually. D6043 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(5) (b)(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratorys established performance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- specifications; This STANDARD is not met as evidenced by: Based on the review of the laboratory's monthly Quality Control (QC) chart for Hematocrit and an interview with the Technical Consultant (TC) on July 29, 2025, it was determined that the Technical Consultant did not resolve technical problems or ensure timely remedial actions for deviations in quality control material from the established range. 1. On July 29, 2025, at approximately 3:30 pm, the TC affirmed that QC results for all three QC levels had shifted above the upper limit on the QC chart for the hematocrit analyte from August 2024 to December 2024. 2. The laboratory demonstrated an unsatisfactory proficiency (PT) report for Hematocrit during the period of shifted QC. See D2121. -- 2 of 2 --