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: Through a review of the Siemens Dimension CKI/MBI Calibrator manufactureer's instructions for storage, a review of temperature records for the laboratory's freezer for 2017 and 2018, and interviews with staff, it was determined the laboratory failed to maintain freezer temperature that was consistent with manufacturer's instructions for 34 of 62 days in December 2017 and January 2018. Survey findings follow: A. The package insert for the Siemens Dimension CKI/MBI Calibrator defines a storage temperature range of -15 degrees C. to -25 degrees C. B. Review of temperature records for the laboratory freezer revealed that the temperature was recorded as less than - 25 degrees C. on 11 of 31 days in December 2017 and 23 of 31 days in January 2018 and the temperature was recorded as less than -25 degrees C for 34 consecutive days during that period.. C. In an interview at approximately 1400 on 4/4/18, laboratory personnel #3 (as listed on the form CMS-209) confirmed the acceptable temperature range for Siemens Dimension CKI/MBI Calibrator was -15 degrees C to -25 degrees C., that the freezer was outside of acceptable range during the time period identified above, and that Siemens Dimension CKI/MBI Calibrator was stored in the freezer during that period. 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 --