Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review of the laboratory's testing personnel (TP) competency records and interview with TP1 and the Technical Consultant (TC), the TC failed to ensure TP had yearly competency to ensure their ability to perform test procedures accurately in the subspecialty of Bacteriology. Findings include: 1. Record review on 9/25/2023 of the laboratory's 2022 and 2023 to date TP competency records revealed: a. The laboratory's TP competency records consisted of two of eight TP performing proficiency testing (PT) in 2022 and 2023 to date. The TP that performed the PT did not have documented competency for the other 5 required elements. b. Six of Eight TP did not have documented competency for 2022 or 2023 to date. 2. Staff interview on 9/25/2023 at 12:00 PM with TP1 and the TC: a. Confirmed the above findings. b. The TC stated, "Most TP work at both locations. There is only one competency book for both labs and TP only have competency done at one location. TC is not sure which lab the competency sheets are from unless they did a proficiency testing sample." The TC also stated, "That is they way it was done when the TC took over." 3. The laboratory performs 500 tests annually 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 1 --