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 test proficiency testing (PT) samples in the same manner as routine patient samples in the subspecialty of Bacteriology. Findings include: 1. Record review on 9/13/2022 of the American Association of Bioanalysts (AAB) 2020, 2021 and 2022 Microbiology Throat Culture PT records revealed, 4 of 5 fully testing personnel (TP) did not participate in PT in 2020, 2021 and 2022 to date. 2. Staff interview with TP#1 on 9/13/2022 at 10:00 AM confirmed the above findings. TP#1 stated TP#1 is the only one that read the PT plates. 3. The laboratory performs 1,000 throat cultures annually in the subspecialty of Bacteriology. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and staff interview, the technical consultant (TC) failed to document annual competency of testing personnel (TP) to assess the knowledge and skills necessary to perform throat culture testing in the subspecialty of bacteriology. 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 -- Findings include: 1. Record review on 9/13/2022 of the laboratory's 2020 and 2022 competency records revealed the laboratory did not have documented annual competency records for 5 of 5 TP who read throat cultures. 2. Staff Interview on 9/13 /2022 at 9:15 AM with TP#1 confirmed the laboratory did not have annual 2020 and 2021 competency documentation for 5 of 5 TP who read throat cultures. 3. The laboratory performs 1,000 throat cultures annually in the subspecialty of bacteriology. -- 2 of 2 --