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 a review of the temperature logs, the manufacturer's storage requirements for the Hematology quality control (QC) vials, and an interview with Diagnostic Manager, the surveyor determined the laboratory failed to ensure QC was stored at 2- 8 degrees Celcius (C) as per manufacturer's requirements on eleven out of seventeen days in September 2020. The findings include: 1. Storage requirements on the vials of QC for the Abbott Cell Dyn Emerald Hematology analyzer specified a temperature range of 2-8 degrees C (or 35.6-46.4 degrees F [Fahrenheit]). 2. A review of the September 2020 temperature logs on 9/17/2020 revealed refrigerator temperatures were greater than 46 degrees F eleven out of seventeen days. 3. During the exit interview on 9/17/2020 at 3:30 PM, the surveyor reviewed and confirmed the the high QC storage temperatures with the Diagnostic Manager; the surveyor explained improper QC storage could be one contributing factor to the numerous QC problems the laboratory has had with the Cell Dyn Emerald (refer to D5793). . 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 3 -- (b) The analytic systems quality assessment must include a review of the effectiveness of