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: Based on review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, lack of documentation, review of policy and procedure, and staff interview, the laboratory director failed to complete competency assessments for 4 of 4 general supervisors (GS #1, GS #2, GS #3, GS #4) for 2 of 2 years reviewed (2022, 2023). The findings were: 1. Review of the CMS 209 form showed the responsibilities of the technical supervisor were performed by the laboratory director. The responsibilities of the general supervisor were completed by 4 staff members. Interview with GS #3 on 1/23/24 at 10:08 AM revealed she was the general supervisor of bacteriology, blood gasses, kit testing, the PATHFAST instrument for cardiac markers, and the Diesse instrument for performing erythrocyte sedimentation rates. In addition, GS #2 was responsible for immunohematology and the Vitros chemistry analyzer; and GS #4 was responsible for hematology/coagulation. Interview with the laboratory manager on 1/23/24 at 9:15 AM revealed the previous laboratory manager had resigned in March of 2022 and the testing personnel had assumed the responsibilities of the general supervisor until she was hired in August of 2023. a. Review of the personnel file for GS #1 showed she was hired as the laboratory manager on 8/14/23. There was no evidence an initial or semi-annual competency assessment had been completed. b. Review of the personnel file for GS #2, GS #3, and GS #4 showed no evidence competency assessments had been completed in 2022 and 2023. 2. Interview with the laboratory manager on 1/23 /24 at 11:30 AM confirmed competency assessments for the responsibilities of the general supervisor had not been completed. 3. The laboratory director acknowledged 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 -- the deficiency during a phone interview on 1/23/24 at 4:36 PM. 4. Review of the policy and procedure titled "Laboratory Competency Assessment", with an effective date of 2/4/22, failed to include a procedure for assessing the competency of the general supervisor. 5. Review of the policy and procedure titled "Organizational Structure and Delegation of Duties" with an effective date of October 2017, showed "...The Laboratory Director is responsible for the duties and responsibilities of the Clinical Consultant and Technical Supervisor...The General Supervisor responsibilities are fulfilled by the Laboratory Manager..." -- 2 of 2 --