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 procedures and interview with the director of operations, staff A, the laboratory did not establish and follow written policies and procedures to assess the competence for one of one technical supervisor. Findings include: 1. Review of the Form CMS-209 submitted for survey showed one technical supervisor identified, staff B. 2. Review of the competency evaluation records showed no evidence the laboratory director evaluated the competence of staff B in performing their assigned technical supervisor responsibilities. 3. Review of laboratory procedures related to competency assessment showed no evidence of a process for evaluation of the competence of the technical consultant in performing their delegated responsibilities. 4. Interview with staff A on March 24, 2025, at 11:55 AM confirmed the laboratory had not established procedures to evaluate competency for the technical supervisor and the laboratory director had not evaluated the competency of the technical supervisor for their delegated responsibilities. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. 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 surveyor review of competency assessment records and interview with the director of operations, staff A, the technical supervisor did not document semiannual competency for one of two new testing personnel. Findings include: 1. Review of competency assessment records showed no documentation of semiannual competency for staff C. 2. Interview with staff A on March 24, 2025, at 11:30 A M confirmed the technical supervisor did not document semiannual competency for all new testing personnel. -- 2 of 2 --