Atellica® Data Manager Traceability Overview Video

In this video we will learn about the Atellica data manager DM Trace ability tab, and view some common workflows within the tool. The atellica DM trace ability feature enables the capture of consumable information for reagents, calibrations, quality control, QC lots, and other consumables associated with the generation of a patient. Result and maintains trace ability for auditing purposes. The Trace Ability tab has four main areas of focus configuration. Enables the operator to review and manage the status of reagent lots, calibration lots, and consumable lots. Patient results. Enables the operator to identify which consumables were involved in the generation of a patient's result. Expiration alerts displays list of soon to expire and expired. Consumables for reagent QC, calibration, and consumable lots, and trace alerts. An optional feature to raise a warning. When insufficient trace information is associated with the result. Let's explore trace abilities. First tab configuration. The Configuration tab enables operators to review and manage the status of reagent calibration and other consumable lots. Instruments that upload reagent lot information may be automatically configured, but to facilitate full trace ability of your laboratory instruments. Patient results, configuration of reagent calibration, and other consumable lots must be manually set up as well as lot expiration information. That enables use of trace abilities alert functionality. For example, let's manually create a reagent lot an add a method link. To begin, we must select the menu icon from the command bar and navigate to routine. Then reagent lots. Oh reagent, lots window opens under the Utilities tab, select new. Specify the lot serial number, name, expiration time and any necessary comments, then select OK. To add a method linked to the created reagent lot, navigate back to the Trace Ability Configuration tab and verify the reagent life. Sub Tab is selected. Then select add method link from the methods area of the screen. You can select the desired method or methods to be linked by moving them from the available to selected field using the right arrow button. Additionally, the search field can be used to filter the available field by a specific test. Then from the reagent lots area of the screen you can link a new reagent lot by selecting the create new radio button or link an existing reagent lot by selecting the desired reagent lot or lots to be linked by moving existing lots to the selected field using the right arrow button. Finally, select apply an information popup window appears notifying you that a link has been created between methods and reagent lots. Additionally, from the Configuration tab, lots can be filtered by selection criteria or by status active waiting and or inactive. Now let's identify all reagent lots for cholesterol. To begin, verify the reagent Slots tab is selected. Then enter cholesterol 2 into the test field and select apply. The display field is updated listing all reagent lots and associated information. Additionally, three agent Lot status column indicates if a reagent lot is active, waiting or inactive. Once the set of lots is displayed, the status of a lot or a set of lots can be changed between active and inactive by selecting the appropriate lot and selecting the set active or set an active button. Trace abilities second tab. Patient results. Enables operators to search for and identify which instrument and consumable materials were involved in the generation of a patient's results and identify all patient results generated for a specific consumable. To understand the capabilities of the patient results tab better, let's review a couple of scenarios. Let's begin by identifying the consumables used to process a sample. Start by expanding the filter panel. Enter the sample identifier into the sample ID field and select apply. The display field is updated listing all the consumables used to process the sample. Now let's identify all patient samples processed using a specific reagent. Begin by re displaying the filter panel, then select the... in the reagent lot field to search for reagent locate and select the reagent. Then press select. Then select apply in the filter panel. The display field is updated listing the patient samples processed using the specific reagent. Additional sample information can also be found by selecting a patient sample and selecting the view details button. Trace abilities Third Tab expiration alerts. Generates expiration alerts for reagent calibration and consumable lots that have expiration times configured. As previously mentioned, during the Configuration tab overview. The expiration Alert screen has two main areas, the alerts field and the methods field. The alerts field displays a list of colored cards with the name of the soon to expire and or expired reagent. QC, calibration and consumable lots. Yellow cards indicate soon to expire lots and red cards indicate expired lots and since expired alerts are more severe than soon to expire alerts. Expired alerts are prioritized and placed at the top of the alerts field. From this screen, operators can remove alerts by selecting a card in the alerts field, selecting a test method, and then selecting set inactive. Additionally, operators can choose to replace the expired lot with a new lot by selecting a card in the alerts field, selecting a test method, and then selecting replace lot from the replace lock window. Operators can select an existing lot, existing waiting lot or create a new lot for the test method or methods which the soon to expire or expired lot applies to. In this example, we will replace an expired consumable lot with a new lot to begin. Select the create new radio button, then enter lot information for the new consumable lot, including lot number, serial number, name and expiration time. Next, select the right arrow to create the consumable lot and select OK. Finally, let's review the last Trace Ability tab. Trace alerts. This optional feature generates a warning when insufficient trace information is associated with the result and enabled at the method level. For example, a test result is received, but it has no associated active QC reagent consumable or calibration lock created within atellica DM. A trace alert would occur if configured on the method. And optional trace severity TS column is now available on the review and Edit Window. To display the assign trace severity and identify those results held in review status. Due to missing trace information. If trace severity is configured on the method and the trace severity assigned is equal to or greater than the trace severity limit, then the result is held in review status and the work order download is disabled for the method. To remove an alert, the operator must assign a lot to the patient result by selecting assign lot and selecting a new life for the patient result. Trace alerts can also be resolved by validating patient results in the review and Edit tab. For example, let's view that raise alerts for creatinine and manually assign a consumable lot to one of the two samples to begin, select the creatinine two Trace Alert card, verify the correct patient result line is selected and select assign lot. From the lot assignment window, select the select existing radio button, select the desired existing lot and select the right arrow. Then select OK a message appears notifying you that a link has been created between the result and consumable lot. This completes the overview of Italica data managers. Trace ability tab.

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