BN™ II System Competency Checklist

BN™ II System Competency Checklist Once an employee has acquired the necessary knowledge and skills to perform basic operation tasks this checklist can be used to observe the employee perform the required tasks for their core job responsibilities and to document demonstrated competency. The observer places their initials and date beside the task when it is performed successfully. Successful completion for each task is determined by the facility. The standards used to evaluate can be documented in the “Criteria” section below. Use the area on the last page to record comments or areas of improvement. If necessary, the observer can record recommended next steps of action for areas of improvement or development opportunities. When all required tasks are completed, the supervisor and employee sign and date this document as a record of completion. Criteria - Standards for successful completion of each task (e.g. Accuracy, Time, Quality, etc.): Observer’s Initials and Completion Date Topic/Tasks System Overview Identify the exterior components Identify and describe the main interior components Products and Assays Identify products and how they are packaged List key information on the product IFU Identify assay protocol data using the Table of Assay Protocols Sample Processing-Barcoded Samples Load and Process samples Enter requests in the Lab Journal Review results Sample Processing- Non Barcoded Samples Program and Process samples Assign rack positions Add a test to a previously processed sample Repeat a test Routine Calibration Enter assigned standard values View assigned values Load reagents Program and process calibration for a classical antisera assay Respond to instrument needs Review calibration curves Quality Control Processing Enter assigned control values View assigned values Request and process controls Determine instrument needs Review control results Daily Maintenance Perform daily maintenance Initialize the System Update the Dilution Well Count Weekly Maintenance Perform weekly maintenance Quality # HILS1918 Effective Date: 06/09/2017 Page 1 of 2 SIEMENS siemens.com/healthineers Healthineers BN™ II System Competency Checklist Monthly Maintenance Perform monthly maintenance Yearly Maintenance Perform yearly maintenance Comments Areas of Improvement Next Steps  Primary Operator  Secondary Operator has been trained on the above documented tasks Supervisor: Employee: Date: Quality # HILS1918 Effective Date: 06/09/2017 Page 2 of 2 SIEMENS siemens.com/healthineers Healthineers