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 inspection of the temperature logs for the freezer and discussion with the Technical Consultant (TC), the laboratory failed to respond to temperature outliers for the freezer. Findings include: 1. Upon review of the temperature chart for the in house freezer, it was noted that the freezer had been out of the temperature range of less than or equal to -20 degrees Celcius since January of 2019. 2. The TC confirmed that he was aware of this during an interview 6/5/2019 at approximately 1200. 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 --