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 record review and interview with the Manager, the laboratory failed to document humidity for Blood Gas Analyzer ABL 800 Flex for 2 out of 2 years ( 2017- 2019 ) reviewed. Findings Included: Review of maintenance records from 05/02/17 through 05/02/19 found no humidity documented for the Blood Gas Analyzer ABL 800 Flex. Review of the manufacturer's instructions showed that the equipment required an environment of humidity from 20% to 80%. During an interview on 05/02 /19 at 10:30 AM, the Manager confirmed that there was no humidity documented. 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 --