Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial certification survey was conducted at Ankle and Foot Associates PA on 11/13/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 personnel report, laboratory policy, and personnel records and interview with the Laboratory Coordinator, the Laboratory Director failed to follow written policy to assess employee competency for one of one General Supervisor. Findings included: Review of the Laboratory Personnel Report, signed and dated by the Lab Director on 11/11/2024, revealed Employee A was designated as the General Supervisor. Review of the laboratory policies, approved by the Laboratory Director on 6/1/2024, revealed competency evaluations are required for all personnel, will be completed by the Laboratory Director, and maintained in the employee's personnel file. Review of personnel files revealed no documentation of a competency evaluation for Employee A. Interview with the Laboratory Coordinator on 11/13/24 at 1:50 pm confirmed the policy was not implemented and a competency evaluation was not completed for Employee A, the General Supervisor. 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 --