Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Temperature Charts (TC) and interview with the Nurse Manager (NM), the laboratory failed to monitor and document Room Temperature (RT) on each day of Mohs testing from 5/6/20 to the date of the survey. The finding includes: 1. Review of TC revealed that the laboratory did not monitor RT from 5/6/20 to the date of the survey on days patient testing was performed. 2. The NM confirmed on 9/7/21 12:30 pm that the RT was not monitored and recorded each day of Mohs testing. 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 --