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 staff interview and record review on 9/7/2021, the laboratory failed to monitor and document the humidity in the laboratory from 09/6/2019 through 09/6 /2021. Findings include: 1. Humidity was not monitored and recorded from 09/6/2019 through 09/06/2021. 2. The laboratory staff acknowledged in an interview at 10:38 AM on 09/07/2021, the laboratory failed to have a system in place to ensure the humidity was monitored and documented daily, using the manufacturer's recommended range of zero percent (0%) to eighty percent (80%). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --