Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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: A. Based on lack of documentation, record review and staff interview with the Point of Care Coordinator (POCC), the laboratory failed to establish a competency assessment procedure for the Technical Consultant (TC) regulatory responsibilities. Findings include: 1. Record review on 02/02/2024 of the laboratory's employee competency records revealed the laboratory did not document competency assessment of the TC for 2022 and 2023. 2. Record review on 02/02/2024 of the laboratory's procedure manual revealed the laboratory did not have a procedure for assessing the TC based on their regulatory responsibilities. 3. Staff interview on 02/02/2024 at 11: 30 PM with the POCC confirmed the above findings. 4. The laboratory performs 8,500 Hematology tests annually. B. Based on lack of documentation, record review and staff interview with the Point of Care Coordinator (POCC), the laboratory failed to follow it's approved competency assessment procedure for Testing Personnel 1 (TP1) in the specialty of Hematology. Findings include: 1. Record review on 02/02 /2024 of the laboratory's "Competency Assessment Program Policy" revealed: a. "After an individual has performed his/her duties for one year, competency must be assessed annually." b. "Competency assessment is delegated by the Laboratory Director, to individuals meeting the qualifications of a Hematology Technical Consultant and/or Lead Technologist" 2. Record review on 02/02/2024 of the laboratory's competency documentation revealed the laboratory did not document competency assessment of TP1 for 2022 and 2023. 3. Staff interview on 02/02/2024 at 11:30 AM with the POCC confirmed the above findings. The POCC stated, "They did not perform the competency assessments for 2022 and 2023. This is what they used 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 -- for competency - the training on the new instrument." 4. The laboratory performs 8,500 Hematology tests annually. 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 lack documentation, record review and staff interview with the Point of Care Coordinator (POCC), the Technical Consultant (TC) failed to perform competency assessment evaluation of Testing Personnel 1 (TP1) in 2022 and 2023. Refer to 5209. -- 2 of 2 --