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 lack of documentation and interview with the Andrology Supervisor, the laboratory failed to establish a competency assessment procedure to assess 2 of 2 General Supervisors (GS) for their supervisory responsibilities performed in 2024. Findings Include: 1. On the day of survey, 05/13/2025, the laboratory failed to provide a competency assessment procedure to assess the competency of GS #1 (CMS 209 personnel #3) and GS #2 (CMS 209 personnel #4) for their supervisory responsibilities performed in the laboratory in 2024. 2. The laboratory failed to provide competency assessment documentation for the supervisory responsibilities of GS #1 and GS #2 when overseeing hematology testing performed in 2024. 3. The Andrology Supervisor confirmed the findings above on 05/13/2025 at 11:33 am D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Andrology Supervisor, the Laboratory Director (LD) failed to specify in writing the responsibilities and duties of 2 of 2 General Supervisors (GS) involved in the preanalytic, analytic, and postanalytic phases of high complexity hematology testing from 07/06/23 to 5/13/2025. Findings include: 1. The Organization policy in the Andrology Laboratory Quality manual states, "Laboratory management ensures duties and responsibilities of laboratory personnel are defined." 2. On the day of survey, 5/13/2025, the laboratory failed to provide the defined list of responsibilities for GS #1 (CMS 209 personnel #3) and GS #2 (CMS 209 personnel #4) involved in the preanalytic, analytic and post-analytic phases of high complexity hematology testing (semen analysis) from 07/06/2023 to 5 /13/2025. 3. The Andrology Supervisor confirmed the above findings on 5/13/2025 at 11:33 am. -- 2 of 2 --