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 review of temperature records since the Abbott Cell Dyn Emerald was installed on 2/16/2022 and an inteview with the laboratory director/technical consultant (LD/TC) at 2:00 p.m. on 11/16/2022, the laboratory failed to monitor and document the room temperature where hematology testing was performed. Findings include: 1. Observation of the laboratory room where hematology testing was performed revealed no thermometer to monitor the room temperature for optimal performance of the Cell Dyn Emerald hematology analyzer. 2. Cell Dyn Emerald manufacturer's instructions require: a). The Cell Dyn Emerald reagent, lyse and detergent should be stored at a temperature range of 18-32 degrees Celsius (C). b) Operating specifications for the Cell Emerald hematology analyzer require a room temperature of 18- 32 degrees C. c). Quality control and calibration materials for the Cell Dyn Emerald must be allowed to come to room temperature before testing. 4. The LD/TC in an interview at 2:00 p.m. on 11/16/2022 confirmed no room temperatures were being monitored and documented. 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 --