Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the TS (technical supervisor) 7/27/23, all procedures had not been approved, signed, and dated by the current laboratory director. Findings: Review of the laboratory's policies and procedures revealed the procedures were signed and dated by the TS, the Chair of the Network Cancer Committee, and the Quality/Accreditation Coordinator. The procedures had not been signed and dated by the current laboratory director to indicate review and approval. During interview at approximately 11:10 a.m., the TS confirmed that the current laboratory director had not signed and dated all procedures. He stated they did not realize it was required. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions and review of 2020, 2021, 2022, and 2023 temperature and humidity logs, the laboratory failed to establish acceptable ranges for room temperature and humidity that were consistent with the ranges specified by the manufacturer for operation of the Beckman Coulter FC500 flow cytometer. Findings: Review of manufacturer's instructions for the Beckman Coulter FC500 flow cytometer revealed the manufacturer specifies operation of the analyzer in an environment with a room temperature of 16-32 degrees Celsius and a humidity range of 30-80%. Review of 2020, 2021, 2022, and 2023 temperature and humidity logs revealed the logs did not include acceptable ranges for room temperature and humidity until December 2021. The acceptable ranges added in December 2021 were 15-30 degrees Celsius for room temperature and 20-85% for humidity which were not consistent with manufacturer's instructions for operation of the Beckman Coulter FC500 flow cytometer. D5781