Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 30, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following 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 laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to establish and follow a policy and procedure to assess competency as required. Findings include: 1. An SOP review revealed there was no policy and procedure to assess competency available at the time of survey. 2. An interview with the MOHS technician, in the office by the lab, on 1/30/25 at 12:00 p.m. , confirmed the lack of a competency policy and procedure at the time of survey. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of laboratory maintenance records and interview with the MOHS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- technician, the laboratory failed to perform and document maintenance of the microscope used to perform the examination of biopsy or surgical specimen from January 2023 through January 2025. Findings include: 1. Review of laboratory records revealed there was no documentation of maintenance being performed on the microscope from January 2023 through January 30, 2025. 2. Microscopes used for testing and/or examination must be maintained and serviced by a professional as directed by the manufacturer. The laboratory must document all maintenance and professional service activities performed on the microscope. 3. Interview with the MOHS technician on 1/30/25 in the office by the lab at 12:30 PM confirmed, that no microscope maintenance records were available for the aforementioned time period. D5781