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 review of logs of ambient humidity recordings for the laboratory including where the Roche Integra 400+ chemistry analyzer is utilized to run patient specimens and interview with the technical consultant for the sub-specialty of routine chemistry, the laboratory failed to clearly define an acceptable humidity range for the laboratory. 1. The ambient humidity logs only indicated that the acceptable humidity of the laboratory be less than 60%. 2. Chemistry Analyzers such as the Roche Integra 400+ have specific manufacturer's ranges for acceptable ambient humidity for the instrument's operational environment. 3. The technical consultant acknowledged that laboratory had not established a specific ambient humidity range that was within manufacturer's instructions. 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 --