Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on touring and observation of the laboratory facility, review of the refrigerator /freezer temperature records, and interview with the testing personnel (TP), it was determined that the laboratory failed to follow the manufacturer's instructions to monitor the digital thermometers, and in a manner that provides test results within the laboratory's stated performance specifications for each test system. The findings included the followings: a. The laboratory selected Fisher Scientific digital thermometers (DT) to monitor the temperature conditions for the laboratory's storage purposes. b. The DT equipped with, but not limited to, the following features: "Lo /Hi", "Min/Max", "current temperature", " Alarm On/Off", "Reset" etc. c. Observed a DT, Ref-2, a LO/Hi were set at -20 to -15 oC, while the Min/Max indicated -21.59 and 14.98. d. The alarm was OFF at the time of survey 1/20/22 @2:45 PM and when turned on, the alarm went off, indicated that in the past (?) the temperature condition was out of the acceptable temperature range the laboratory had established. e. Based on interview of the TP, it appeared that the TP did not familiarize the DT feature and failed to follow the manufacturer's instruction. D5781