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 observations and review of the laboratory temperature records, devices, and the laboratory facility, and interview with the laboratories. quality assurance (QA) and the testing personnel (TP). It was determined that the laboratory failed to follow the manufacturer's instructions and in a manner that provided the thermometer to perform and to ensure the storage conditions within the laboratory's stated performance specifications. The findings included: a. The laboratory used various types of refrigerators and freezers to store reagents, samples, and the laboratory supplies to ensure the stability and validity of the reagents, samples, and the laboratory supplies. b. The laboratory selected digital thermometers (DT) to monitor and maintain the storage devices in optimal/acceptable conditions. c. The DT features and provides the following information: 1) current temperature, 2) under Min/Max mode the temperature indicates the lowest and/or highest temperature conditions encountered in the past, but not know exact when, 3) under Lo/Hi mode the temperature indicates the acceptable/optimal temperature range set by the laboratory for the storage proper conditions, 4) Alarm with on/Off when the temperature reached outside of the acceptable range, the device should sound to alert the laboratory personnel to take actions. d. On 12/27/2019 @ 12:05 PM, touring the laboratory facility, the surveyor, QA and TP observed and noticed the digital thermometer used for F1 freezer showed a 10 oC for "Lo", 30 oC for "Hi" mode and Alarm was at Off position. d. The QA and TP indicated that the acceptable temperature range established by the laboratory for a freezer should be between -15 and -25 oC e. While the TP turned Alarm to "On" 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 -- position, the digital thermometer sound off. to indicate sometime in the past, there was a temperature condition outside of the acceptable range for that F1 freezer. f. The TP pushed the "Mode" bottom and the digital thermometer showed "Min" and "Max" with a "Max" temperature of 6 oC, which was outside of -15 to -25 oC acceptable range, also outside of the 10 to 30 oC indicated when at first sight when began to tour the facility. g. While interview with the QA and TP for the use of the digital thermometer device, it appeared to the surveyor that the laboratory personnel were not familiar the exact functions of the *DT, and/or failed to follow the manufacturer's instructions in a manner that meet the laboratory's performance specifications. 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 observations and review of the laboratory temperature records, devices, and touring the laboratory facility, and interview with the laboratory's quality assurance (QA) and the testing personnel (TP). It was determined that the laboratory failed to define criteria for those conditions that were essential for proper storage of reagents and specimens and failed to monitor following the manufacturer's instructions for storage temperature conditions. The findings included: a. The laboratory used various types of refrigerators and freezers to store reagents, samples, and the laboratory supplies to ensure the stability and validity of the reagents, samples, and the laboratory supplies. b. The laboratory selected and used digital thermometers (DT) to monitor and maintain the storage devices in optimal/acceptable temperature conditions. c. On 12/27/2019 @ 12:05 PM, touring the laboratory facility, the surveyor, QA and TP observed and noticed the DT used for F1 freezer showed a 10 oC for "Lo", 30 oC for "Hi" mode. d. The QA and TP indicated that the acceptable /optimal temperature range established by the laboratory for a freezer should be between -15 and -25 oC and the refrigerator should be between 2 to 8 oC. e. The Lo /Hi at the time of survey (12/27/2019 @12:05 PM) for most of the DT indicated 10 to 30 oC for either refrigerators or freezers. D5781