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 record review and staff interview, the laboratory failed to ensure proper temperature of reagents and PACs prior to use. Findings include: 1. Record review on 4/30/18 of the laboratory's temperature logs from 6/15/16 to 4/30/18 revealed: a) Acceptable room temperature range is 22-28 degrees Celsius (C). b) Recorded room temperature was out of range 51 of 135 working days from 6/15/16 to 12/30/16. c) Recorded room temperature was out of range for 115 of 248 working days in 2017. d) Recorded room temperature was out of range for 67 of 80 working days in from 1/1 /18 to 4/30/18. e)