Summary:
Summary Statement of Deficiencies D0000 An Initial Survey was initiated on 02/03/2026 and concluded on 02/03/2026. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, interview, and facility policy review, the facility failed to ensure 1 of 1 microscope was monitored and inspected by an outside contractor for preventative maintenance. Findings included: During an observation on 02/03/2026 at 2:10 PM revealed a single testing microscope,Olympus IX5 microscope. The microscope did not have a preventative maintenance (PM) sticker. A facility policy titled, "Monitoring The Lab Environment," effective 06/2025, revealed, "Electric Devices: All electrical equipment in the laboratory is monitored and inspected by an outside contractor. Documentation of inspections is archived in the equipment binder." During an interview on 02/03/3026 at 3:13 PM, the LD acknowledged the laboratory's policy and procedures for preventative maintenance stated that the electrical equipment in the laboratory was monitored and inspected by an outside contractor. The LD acknowledged the laboratory failed to ensure the laboratory microscope was monitored and inspected by an outside contractor. 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 --