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: . Through a review of Room Temperature Logs for 2019 and 2020, lack of documentation, and interview with laboratory staff, it was determined the laboratory failed to document room temperature on eleven of ninety days in 2019 and three of fifty days in 2020. Survey findings follow: A. A review of the temperatures logs for 2019 revealed the laboratory failed to document room temperatures on three of twenty- three days in May: one of twenty-seven days in August: four of twenty-seven days in October and three of twenty-two days in November. B. A review of the temperature logs for 2020 revealed the laboratory failed to document room temperatures on one of twenty-five days in February and two of twenty-six days in March. C. In an interview on 3/26/2021 at 10:30 a.m., technical consultant confirmed the laboratory failed to document room temperatures on the days mentioned. 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 --