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, review of procedure and interview with the Technical Consultant, the laboratory failed to follow written policies and procedures to assess semi-annual competency for 2 of 27 testing personnel performing microscopic moderate complexity testing. The laboratory performs approximately 100 microscopic moderate complexity tests per year. Findings include: 1. Record review of competency documentation revealed the laboratory failed to document semi-annual competency for 2 out of 27 testing personnel for microscopic moderate complexity testing. 2. Review of "MG0099 Medical Group Testing Education, Training, and Competency Requirements" procedure states: " Each provider performing microscopic moderate complexity testing will need to complete a competency assessment upon hire, a semi-annual competency assessment and an annual competency assessment as well as biannual proficiency tests thereafter for compliance with CLIA regulations". 3. An interview with the Technical Consultant on 8/21/2025, at approximately 12:45 p.m. confirmed failure to follow written policies and procedures to assess semi-annual competency for 2 of 27 testing personnel performing microscopic moderate complexity testing. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Consultant, the Laboratory Director failed to ensure 7 of 27 testing personnel received the appropriate training prior to testing patient samples for microscopic moderate complexity testing. The laboratory performs approximately 100 microscopic moderate complexity tests per year. Findings include: 1. Review of Testing Personnel training and competency documentation revealed the Laboratory Director failed to ensure initial training for 7 out of 27 Testing Personnel for microscopic moderate complexity testing since the lab began testing in July 2024. 2. Interview with the Technical Consultant on 08/21/2025 at approximately 12:45 P.M., confirmed the Laboratory Director failed to ensure initial training for 7 out of 27 Testing Personnel for microscopic moderate complexity testing. -- 2 of 2 --