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 the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interviews with three technical consultants and the laboratory manager on July 8, 2026, the laboratory failed to attain at least 80 percent acceptable responses, resulting in unsatisfactory performance for White Blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin (Hgb), Hematocrit (Hct), and WBC differential analytes/tests across multiple 2024 Hematology specialty events. The findings include: 1. Review of the AAB-MLE PT documentation for 2024 revealed that the laboratory received an unsatisfactory scores of multiple analytes/tests in different event periods. The results are as followed: a. RBC 60% - 2024 first testing event; b. Hct 40% - 2024 first testing event; c. Hgb 60 % - 2024 first testing event; d. WBC 60% - 2024 first testing event; e. WBC differential 60% - 2024 second testing event; f. WBC 0% - 2024 third testing event. 2. The technical consultants and laboratory manager confirmed in an interview on July 8, 2026 at approximately 10:40 a.m. that the laboratory received the unsatisfactory scores in 2024. 3. According to the testing declaration form submitted at the time of the survey, the laboratory performed and reported approximately 3,800 patient samples annually for Hematology specialty that included the WBC, RBC, Hgb, Hct, and WBC differential analytes/tests including the period when the unsatisfactory scores were obtained. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, eight randomly chosen patient records from January 19, 2024 to June 25, 2026, lack of personnel competency documentation, and interviews with the three technical consultants and laboratory manager on July 8, 2026, as specified in the personnel requirements in subpart M, the laboratory failed to perform the personnel competency assessment prior to patient testing. The findings include: 1. The laboratory's policy was to conduct competency assessments for all testing personnel at least annually. The template presented at the time of the survey included an option for initial for any new personnel. 2. The surveyor reviewed eight patient records from January 19, 2024 to June 25, 2026 wherein the tests were performed by the multiple testing personnel (TP). The laboratory lacked competency assessment records for the years 2024, 2025 and 2026, and that no