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 surveyor review of the submitted Centers for Medicare and Medicaid Services (CMS) Form CMS-209 (Laboratory Personnel Report), competency evaluation records and interview with the laboratory director and technical consultant, staff B, the laboratory did not establish and follow written policies and procedures to assess the competence for one of one clinical consultant and one of one technical consultant that was not the laboratory director. Findings include: 1. Review of the Form CMS-209 submitted for survey showed one clinical consultant identified, staff A, and one technical consultant, staff B, that was not the laboratory director. 2. Review of the competency evaluation records showed no evidence the laboratory director evaluated the competence of staff A and staff B in performing their assigned consultant responsibilities. 3. Interview with staff B on June 25, 2024, at 9:45 AM stated the facility had a general delegation procedure for consultant roles but were not specific for individuals filling the roles and had no process for evaluation of the competence of the clinical and technical consultants in performing their delegated responsibilities. 4. Interview with the laboratory director on June 25, 2024, at 9:45 AM confirmed the laboratory had not established procedures to evaluate competency for the clinical and technical consultants and the laboratory director had not evaluated the competency of the clinical and technical consultants for their delegated responsibilities. 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 --