Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of laboratory supplies during the laboratory tour, and interview with the laboratory director (LD), the laboratory failed to ensure laboratory supplies were not used when they had exceeded their expiration date. Findings: 1. Observation of laboratory supplies during the laboratory tour on August 11, 2025 showed one opened bottle of Platinumline Liquimount by Mercedes Scientific lot# 120269, expiration April 30, 2023 still in use. 2. Interview with the LD on August 11, 2025 at 1:30 PM confirmed the laboratory failed to ensure laboratory supplies were not used when they had exceeded their expiration date. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of microscope, review of microscope maintenance and interview with the laboratory director (LD), the laboratory failed to establish maintenance protocol to ensure the laboratory microscope was providing accurate and 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 -- reliable test results in 2024 and to date August 11, 2025. Findings: 1. Observation of the Accu-Scope microscope showed preventive maintenance check performed on August 20, 2023. 2. Review of the microscope maintenance showed no documentation of maintenance for 2024 and to date August 11, 2025 for the Accu-Scope microscope. 3. Interview with the LD on August 11, 2025 at 1:30 PM confirmed the laboratory failed to establish maintenance protocol for the laboratory microscope. -- 2 of 2 --