Summary:
Summary Statement of Deficiencies D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and staff interview, the laboratory director (LD) failed to ensure the laboratory (lab) was enrolled in an HHS approved proficiency testing (PT) program in event 1 of 2025 for hematology analytes white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential. Findings include: 1. Review on 1/21/2026 of CASPER 0155D report revealed the lab had no PT scores for white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential. in Event 1 2025 indicating the lab did not participate in PT for event 1 of 2025. 2. Interview on 1/21/2026 at 10: 30 a.m. with Testing Personnel (TP1) responsible for submitting orders for PT enrollment revealed the lab submitted the order for PT enrollment through the lab's institution finance department in 2024 and the finance department canceled the order without notifying the lab. TP1 confirmed the lab had not enrolled in a PT program for white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and white blood cell differential in event 1 of 2025. 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 --