Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 18, 2025. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following standard level deficiency was cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 technician, the laboratory failed to perform and document maintenance of the microscope used to perform the examination of biopsy or surgical specimens from March 10, 2023 through February 19, 2025. Findings include: 1. Review of laboratory records revealed there was no documentation of maintenance being performed on the microscope from March 2023 through February 19, 2025. The last professional maintenence performed on the Mckesson ON Series and the Olympus BX41 microscopes was on 05/20/22. 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 microscopes. 3. Interview with the MOHS technician on 2/19/25 in the lab director's office at 12:00 PM confirmed, that no microscope maintenance records were available for the aforementioned time period. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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 -- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory director (LD) failed to specify, in writing, the duties and responsibilities of the Clinical Consultant (CC) and Technical Supervisor (TS). Findings include: 1. SOP review revealed the LD failed to specify, in writing, the duties and responsibilities of the CC &TS. 2. Interview with the MOHS technician in the LD office on 02/19/25 at 11 a.m. confirmed the SOP did not contain a duties and responsibilities policy and procedure for the CC & TS. -- 2 of 2 --