Summary:
Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of testing personnel competency records and interview with a technical consultant (staff A), the technical consultant did not evaluate and document semiannual competency assessment of testing performance during the first year the individual performed moderate complexity patient testing for one of two new testing personnel. Findings include: 1. Review of testing personnel competency records for staff B revealed initial competency assessment documented on the "Laboratory Skills Checklist" on June 14, 2024, and annual competency assessment documented on the "Direct Observation/Competency Evaluation Form" on November 7, 2025. Further review revealed no documentation of a semiannual competency evaluation. 2. Interview with staff A on March 11, 2026, at 11:00 AM confirmed the technical consultant did not evaluate and document semiannual competency assessment for Staff B during the first year staff B performed moderate complexity patient testing. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on surveyor review of testing personnel competency records and interview with 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 -- a technical consultant (staff A), the technical consultant did not evaluate and document annual competency assessment of moderate complexity patient testing for one of nine testing personnel. Findings include: 1. Review of testing personnel competency records for staff C revealed annual competency assessment documented on the "Direct Observation/Competency Evaluation Form" on May 28, 2024. Further review revealed no documentation the technical consultant performed annual competency assessment of staff C in 2025. 2. Interview with staff A on March 11, 2026, at 11:00 AM revealed staff C performed moderate complexity patient testing January 10, 2025, July 25, 2025, August 19, 2025, and August 22, 2025. Further interview confirmed the technical consultant did not evaluate and document annual competency assessment of moderate complexity patient testing for staff C in 2025. -- 2 of 2 --