Summary:
Summary Statement of Deficiencies D0000 An announced CLIA exempt-state validation survey was performed on April 24, 2024, by CMS Boston CLIA federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The laboratory was found to be in compliance with standard-level CLIA requirements. The findings were reviewed with the laboratory director during an exit conference at the conclusion of the survey. 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, written laboratory policies and procedures, and interview with the laboratory director (LD), the laboratory failed to have a written clinical consultant competency policy based on the position responsibilities for one of two clinical consultants. Findings include: 1. Record review on 04/24/2024 of the Laboratory Personnel Report (Form CMS-209) signed by the Laboratory Director on 04/23/2024 included two clinical consultants for the laboratory. 2. Record review on 04/24/2024 of 2023 and 2024 personnel competency records revealed no evidence for one of two clinical consultant competencies based on job responsibilities. 3. Review of the laboratory's competency assessment policy on 04/24/2024 revealed no evidence of a written policy to assess the clinical consultant based on job responsibilities. 4. Interview on 04/24/2024 at 12:35 pm with the LD confirmed the findings above. 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 --