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 record review and staff interview the laboratory failed to ensure proficiency testing (PT) was rotated amongst all testing personnel (TP) in the specialties of Hematology and Microbiology. Finding include: 1. Record review on 12/13/2024 of the laboratory's 2023 and 2024 Hematology PT records revealed: a. Two of seven TP did not participate in Hematology PT in 2023. b. One of seven TP did not participate in Hematology PT in 2024. c. Two of seven TP did not participate in Hematology PT in 2023 or 2024 2. Record review on 12/13/2024 of the laboratory's 2023 and 2024 Hematology competency records revealed: a. The section referring to PT performance was checked off as completed. b. The competency records were signed as reviewed by the Technical Consultant (TC). 3. Record review on 12/13/2024 of the laboratory's 2023 and 2024 Microbiology PT records for the GC/Chlamydia test placed into service on 9/30/2023 revealed: a. Six of seven TP did not participate in Microbiology PT in 2023 and did not perform a previously analyzed or blind sample. b. Four of Seven TP did not participate in Microbiology PT in 2024. 4. Record review on 12/13 /2024 of the laboratory's 2023 and 2024 Microbiology competency records revealed: a. The section referring to PT performance was checked off as completed. b. The competency records were signed as reviewed by the TC. 5. Staff interview on 12/13 /2024 at 11:00 AM with the TC confirmed: a. The above TP did not participate in PT in 2023, 2024 or both years, yet it was marked as completed on the TP 2023 and 2024 competency forms. 6. The laboratory performs 1,000 tests annually in the specialty of Hematology and 700 tests annually in the specialty of Microbiology. 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 --