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 observation and review of the laboratory temperature charts and devices, and interview with the technical supervisor, and laboratory personnel, it was determined that the laboratory failed to understand the digital thermometer features and failed to monitor and recorded the temperature properly. The findings included: a. The laboratory used refrigerators and freezers to store their laboratory reagents, supplies, and patient samples. b. The laboratory used digital thermometers to monitor the temperatures of the storage devices. c. The digital thermometer features "current", "Min", and "Max" temperature, including "Alarm" when the current temperature outside of the acceptable/optimal temperature ranges for storage matter established by the laboratory. d. The laboratory established acceptable/optimal temperature for its freezer is between -15 to -25 degree Celsius (oC) and refrigerators between 2 to 8 oC. e. At the time of survey (3/14/2019 @ 11 AM), a -28 oC observed a digital thermometer for its LC/MS/MS room, which is outside of its laboratory established acceptable storage temperature. f. Further interviewed and observed along with the testing personnel, the alarm was set at "Off" position for the digital thermometer while at the time of the survey (3/14/2019). g. Further review of a Temperature Records for Oct 2017 chart. Readings and records indicated that Refrigerator #1 and 2 were ranged between 2 - 8 oC but temperature were recorded as 36 the entire month, which Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- were out of the set range for 2 - 8 oC. h. Further review of Freezer A thru C in the Oct 2017 temperature chart, where the range for acceptable temperature was between -15 to -25 oC. i. There were freezer temperatures out of -15 to -25 oC recorded as follows: F = freezer; D = date; T = temperature D T D T D T D T F #A 10/2 -27 10/4 -26 10 /23 -26 10/24 -26 F # B 10/2 -24 10/11 -11 10/12 -14 10/13-12 & more F # C 10/2 -13 10/5 -13 10/6 -12 10/13 -13 j. The laboratory failed to detect and monitor properly the temperature within the acceptable temperature range. k. The laboratory failed to take actions taken or documented to correct and maintain the storage temperature within the acceptable/optimal ranges. D5781