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 record review, and an interview with Lab Technician, the laboratory failed to establish and follow a written policy and procedure to assess competency of the Clinical Consultant (CC), Technical Supervisor (TS) and General Supervisor (GS), as specified in the personnel requirements in subpart M. All patients tested at this laboratory have the potential to be affected. Findings Include: 1. Review of the laboratory's CMS-209 Personnel Report form, approved and signed by the Lab Director on 1/15/19, found one person serving as CC, TS and GS. 2. Review of the laboratory's "Quality Assessment" policy and procedure failed to find a policy and procedure for assessing the competency of the CC, TS and GS based on the responsibility of those roles. 4. An interview with the TS, on 12/19/19 at 1:52 pm am, confirmed that the lab did not have policy or procedure for assessing the competency of CC, TS and GS based on the responsibility of those roles. 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 --