Summary:
Summary Statement of Deficiencies D0000 An initial survey was completed on 5/15/2023 at Orlando Health Medical Group Inc. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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, and interview, the laboratory failed to establish a competency assessment policy for Technical Consultants (TC) and complete an initial competency assessment for 1 of 2 Technical Consultants in 2023, (TC A). Findings included: 1. Review of the Laboratory Personnel Report indicated employee D was a TC (A) and testing person. 2. Review of the CLIA job responsibilities policy had no specific description of what the duties of a TC were regarding their laboratory. 3. Review of "Point of Care Testing: Administration and Quality Management" Section Personnel signed by laboratory director on 1/30/2023 read, "C. Each qualified team member performing laboratory testing will receive a documented New Operator training and competency assessment, a 6 month competency assessment during their first year of testing (nonwaived testing only) and annual competency assessments specific to each test being performed." The policy contained no written documentation of an assessment for the Technical Consultant. 4. Review of Point of Care Testing Competency Assessment Records revealed TC A had signed off on 3 out of 4 six month competency assessments for testing personnel in 5/8/2023. TC A had no initial evaluation for the position of TC in 2023. 5. During an interview on 5/15/2023 at 12: 48 PM, the Nursing Operations Manager confirmed the initial competency assessment and policy was not completed for TC A. 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 --