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 laboratory policies and procedures; Laboratory Personnel Report (Form 209); and personnel records, and interview with the technical consultant, the laboratory failed to establish and follow written policies and procedures to assess employee and consultant competency. Findings: 1. There were no policies and procedures to assess competency of personnel, based on the position responsibilities. 2. Review of Form 209 revealed that there are persons listed in the following named positions: a. Laboratory Director b. Clinical Consultant (listed as Laboratory Director) c. Technical Consultant (1 person) e. Moderate Complexity Testing Personnel (X 8 persons) 3. There was no documentation to show that the technical consultant's competency was assessed, based on the position responsibilities. 4. On January 21, 2020 at 11:00 AM, the technical consultant confirmed the surveyor's findings. 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 --