Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 07/13/2023 and concluded on 07/13/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 document review and interview, it was determined that the laboratory did not evaluate competency for individuals who served as the clinical consultants. Findings included: Review of the "[Laboratory name] Policy and Procedure Manual Laboratory 2013" approved by the Laboratory Director and dated 08/13/2013, revealed the facility had no documentation in place for the evaluation of competency for individuals who served as the clinical consultants. Review of the "Laboratory Personnel Report (FORM CMS-209)" signed by the Laboratory Director and dated 07 /11/2023, revealed two employees (Clinical Consultant #1 and Clinical Consultant #2) held the position of clinical consultant. Review of Clinical Consultant #1's and Clinical Consultant #2's personnel files revealed no evidence of an assessment of their competency as required. In an interview 07/13/2023 at 2:30 PM, the Practice Manager, Technical Supervisor/General Supervisor/Testing Personnel (TP) #3 and TP #4, revealed the staff were unaware that competency assessments were to be performed for individuals who served as clinical consultants. 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 --