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 review of personnel competency records, standard operating procedures (SOPs), as well as interviews with the Practice Manager (PM) and Laboratory Director (LD), the laboratory failed to perform and document Testing Personnel (TP) six-month competency evaluations. FINDINGS: 1. There was no documentation of TP six-month competency assessments. 2. The current, approved SOPs did not include instructions for performing such activity. 3. The PM and LD confirmed the findings on December 5, 2024, at approximately 11:00 A.M. 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 --