Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 the laboratory's submitted CMS-209 form, review of the laboratory's policy, review of the laboratory's personnel records, and confirmed in interview, the laboratory failed to follow its own policy on assessing the competency for one of one technical supervisor and two of three technical consultants. Findings include: 1. Review of the laboratory's submitted CMS-209 form determined the facility identified one technical supervisor and three technical consultants. 2. Review of the laboratory's policy titled "QUALITY ASSESSMENT", approved by the laboratory director on 05/30/2024 stated: "5. Personnel Competency The laboratory will ensure that all testing personnel are properly trained and are competent prior to testing patient specimens. The Laboratory Director and/or Technical Consultant will review the performance of each employee working in the laboratory annually after the first year and semi-annually in the first year of performing testing to assure employee competency." 3. Review of the laboratory's personnel records determined the laboratory failed to have documentation of assessing the competency of the technical supervisor, technical consultant-2, and technical consultant-3. 4. The Director of Regulatory Compliance confirmed the findings in an interview conducted on 03/05 /2025 at 1020 hours in the office. 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 --