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 surveyor review of SensoScientific logs and interview with the general supervisor, the laboratory did not monitor and document temperatures to ensure proper storage of reagents in the main laboratory refrigerator on 10 of 73 days from September 2019 through November 23, 2019. Findings include: 1. Record review of the "SensoScientific Current Status and Battery Status Monitoring" log from September 2019 through November 23, 2019 revealed the testing personnel did not monitor and document temperature recordings daily: September 2019: Four of twenty- four days had no recorded documentation of temperatures October 2019: Four of twenty-seven days had no recorded documentation of temperatures November 2019: Two of twenty-two days had no recorded documentation of temperatures. 2. Interview with the general supervisor on January 13, 2020 at 2:15 PM confirmed the laboratory did not monitor and document temperatures on 10 of 73 days from September 2019 to November 23, 2019 in the main laboratory refrigerator to ensure proper storage of reagents. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (b) The analytic systems quality assessment must include a review of the effectiveness of