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 record review the laboratory failed to establish and follow written policies and procedures to assess and document the competency of the Clinical Consultant based on the responsibilities of the position. All patients tested at this laboratory have the potential to be affected. Findings Include: 1. Review of the laboratory's competency documentation, on 3/26/18 at 10:41 am, found no completed competency assessment for the Clinical Consultant and Technical Consultant based on responsibilities of that position. 2. Review of policies and procedures, on 3/26/18 at 11:41 am, found that the laboratory failed to establish a policy and procedure to determine Clinical Consultant and Technical Consultant competency based on responsibilities of that position. 3. The Technical Consultant confirmed on 3/26/28 at 12:04 pm that the laboratory failed to establish a policy and procedure to determine Clinical Consultant and Technical Consultant competency based on responsibilities of that position. 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 --