Managing Treatment Orders Processes

Objective

After completing this lesson, you will be able to manage Treatment Order

Managing Treatment Order

This lesson will guide you through the main steps of determining the flow version for a treatment order, reviewing the schedule for it and approving it.

The treatment management process in SAP Cell and Gene Therapy Orchestration encompasses the entire lifecycle of managing individual patient treatments, from initial order request to successful finished product delivery. Once the treatment center has sent a request to deliver a certain therapy for an eligible patient, the processing of this order starts with managing the treatment order. Here, the treatment order manager can determine and confirm the flow version, set and confirm the schedule and review and approve the treatment order.

A flowchart titled Processing a Treatment Order in SAP SAP Cell and Gene Therapy Orchestration outlines the steps involved in processing a treatment order. The process is divided into six main stages:1.Receive Treatment Order: 2.Manage Treatment Order: a)Confirm Flow Version (Treatment Order Manager) b)Confirm Schedule (Treatment Order Manager) c)Approve Treatment Order (Treatment Order Manager)3.Manage Biospecimen Shipment: a) Book Biospecimen Courier (Treatment Order Manager) b) Manage Incoming Biospecimen (Manufacturing Organization) c) Print Hangtag Labels (Manufacturing Organization) d) Confirm Shipment Receipt (Manufacturing Organization) e) Manage Biospecimen Disposition (Manufacturing Organization) 4. Manage Processing Activities: a) Manage Process Order Batch Details (Manufacturing Organization) b) Report Processing Start (Manufacturing Organization) c) Print Finished Product Labels (Manufacturing Organization) d) Report Processing Completion (Manufacturing Organization) e) Manage Finished Product Disposition (Manufacturing Organization) 5. Manage Finished Product Shipment: a)Allocate Batches to Shipment (Manufacturing Organization) b) Book Finished Product Courier (Treatment Order Manager) c) Confirm Shipment Pickup (Manufacturing Organization) 6. Confirm Receipt of Finished Product: .

The first step that a treatment order manager would do, is to determine and confirm the flow version for this particular new treatment order. This is done via the Confirm Flow Version app.

Determine and Confirm the Flow Version

On the landing page of SAP Cell and Gene Therapy Orchestration subscription, we find under the section Treatment Management, the Confirm Flow Version App. In this app, we navigate to the order that we want to determine and confirm the flow version by searching for it using the COI ID. With the selection of the order, the Confirm Flow Version button opens a selection of available flow versions.

The image shows a screenshot of an SAP software interface. The top section displays the main navigation menu with options such as Home, Configuration, Master Data, Treatment Management, Labels, Processing Activities, and CO. Below the navigation menu, there are several icons for different tasks, including Manage Orders, Confirm Flow Versions, Confirm Schedules, Order Overview, and Manage Logistics. The bottom section is a zoomed-in view of the Confirm Flow Versions screen, showing a table with order details. The table includes columns for COI ID, Order ID, Flow Version ID, Flow Version Description, Flow Version Confirmed By, Treatment Center, Therapy, and Country/Region. The COI ID RG42F8ZA2 is selected, and the associated order details are displayed, including the Treatment Center Twin Lakes General Hospital and Therapy Cartus (TH003) in the United States.

Select and Confirm a Flow Version

The available flow versions and associated steps can be reviewed by clicking on the blue flow version IDs in this window. This will open an overview of the steps of the relevant flow version. You can see here the biospecimen collection step with the pick-up location, the biospecimen shipment step to the manufacturing site with the processing activity, and the finished product shipment step to the treatment center.

A screenshot of a software interface displaying a selection of flow versions and their corresponding steps. The top section titled Select a flow version to confirm includes a search bar and a list of flow versions with IDs and descriptions. The flow versions listed are FV0001 (NK Cell Therapy), FV0002 (Flow Version), FV0004 (CMO Cell Therapy), FV0003 (CAR-T MFG), and FV1001 (Flow Version for Scheduling). The flow version FV0004 is selected, and its details are shown in the bottom section titled CMO Cell Therapy (FV0004). This section lists five flow steps with columns for Step ID, Description, Subsequent Step ID, Flow Section Type, Shipment Type, Location Rule ID, Location ID, and Plant. The steps are: 10 (Leukapheresis Pickup Location), 20 (Leukapheresis shipment), 30 (Therapy Manufacturing), 40 (Finished Product Shipment), and 50 (Finished Product Delivery Location).

Once a flow version is selected, the "Confirm Flow Version" button is used to enter the selection into this system. Now that the exact supply chain has been determined, the next action is to review and confirm the schedule for the associated steps of the treatment order.

Confirm the Schedule for a Treatment Order

From the landing page of SAP Cell and Gene Therapy Orchestration subscription, we open the Confirm Schedules app in the Treatment Management section. Here, we search for and navigate to the treatment order that we want to review and confirm the schedule for.

Screenshot of SAP interface showing Treatment Management section. The top part of the image displays the main menu with options: Home, Configuration, Master Data, Treatment Management, Labels, Processing Activities, and CO. Under Treatment Management, there are several tiles: Manage Orders, Confirm Flow Versions, Confirm Schedules, Order Overview, and Manage Logistics. The Confirm Schedules tile is highlighted. The bottom part of the image zooms into the Confirm Schedule screen, showing a search bar with COI ID RG9WY2GU3 entered. Below, a table lists Schedule Confirmations with columns: COI ID, Order ID, Flow Version ID, Flow Version Confirmed By, Schedule Confirmed By, and Schedule Confirmed On. The entry shows COI ID RG9WY2GU3, Order ID 6, Flow Version ID Shared Antigen - CMO (FV0001), Flow Version Confirmed By authorised person.

Confirm the Schedule for a Treatment Order

In the schedule confirmation screen, we can review and edit the dates for the biospecimen shipment, the processing activities and the finished product shipment by selecting the respective tab (not shown here). Once we are ready, we can confirm the schedule for these steps by clicking on the Confirm Schedule button. A pop-up will appear reminding us that the confirmation of the schedule is an irreversible step (you can change the planned dates later, but the treatment order schedule will have the status schedule confirmed from now on). Now that the flow version has been determined and the schedule has been confirmed, we can approve this treatment order.

Screenshot of an SAP application interface showing the Confirm Schedule screen. The top section includes a search bar and filters for COI ID, Order ID, Flow Version Confirmed By, and Schedule Confirmed By. Below, a table lists schedule confirmations with columns for COI ID, Order ID, Flow Version ID, Flow Version Confirmed By, and Schedule Confirmed By. The COI ID RG9WY2GU3 is selected, displaying detailed information below, including Therapy ID, Treatment Center, Order Status, and tabs for General Information, Biospecimen Shipment, Processing Activity, and Finished Product Shipment. An arrow points to the Confirm Schedule button on the right.

Treatment Order Approval in SAP Cell And Gene Therapy Orchestration Subscription: Treatment Order Review

From the landing page of SAP Cell and Gene Therapy Orchestration subscription, we navigate to the Manage Orders app in the Treatment Management section. Here, we can select the relevant order using its COI ID to get to the treatment order view.

Screenshot of the SAP Treatment Management interface. The top navigation bar includes options for Configuration, Master Data, Treatment Management, Labels, Manufacturing, COI/COC, System Admin, and Task and Exception Management. The main section shows various management options such as Manage Orders, Confirm Flow Version, Confirm Schedule, Order Overview, Manage Inbound Logistics, and Manage Outbound Logistics. A zoomed-in section highlights the Manage Orders screen, displaying filters for Editing Status, COI ID, Treatment Center, Therapy, and other shipment details. Below the filters, there is a table listing orders with columns for COI ID, Treatment Center, Therapy, Clinical Trial Subject Number, Country/Region, Order Status, Order Number, and Changed On date. The table shows one order with COI ID RG9WY2GU3, Treatment Center at Summit Hospital, Twin Lakes General Hospital, Therapy DEACAR (TH001), Clinical Trial Subject Number CTSN04, Country/Region United States of America (US), Order Status In Progress, Order Number 6, and Changed On date July 3, 2023, 1:41:27 PM.

Treatment Order Approval in SAP Cell And Gene Therapy Orchestration subscription: Treatment Order Approval Workflow

In this app, all the important information is summarized in the respective tabs and can be reviewed one more time before the order is approved and the execution can start. To approve the order, we click on the Approve button on the bottom right. This opens up a pop-up where your e-signature and a reason is to be provided to enter the approval into the system.

Screenshot of an SAP Order Management System interface displaying details for COI ID: RG0Z55GD1. The order status is In Progress. The screen includes tabs for General Information, Process Flow, Order Dates, Business Partners, Shipments, Processing Activities, Order Texts, Approval Details, PPF Events, Documents, and Logs. The General Information tab is active, showing Order Details, Status, and Admin Data. Order Details include Clinical Trial Subject ID: CT0043, Country/Region: United States of America (US), Patient ID: 6e8eaa2f-1068-483e-b9bb-f1783f572979, Patient Therapy Number: SAPPTN017, Therapy: DEACAR (TH001), Treatment Center: Summit Hospital, Twin Lakes General Hospital (6000000001), Flow Version: FV0001, Order Number: 51, and Order Type: Gene Therapy (SA01). Status shows Overall Status: In Progress (ST021). Admin Data includes Created On: Jul 5, 2023, 10:23:38 AM, Created By: sb-cgt-uaa-cgtdemoprov-prov-b179891, Last Updated On: Jul 5, 2023, 12:24:53 PM, and Changed By: authorized person. The interface includes options to Edit, Create Task, and a search bar at the top.

Treatment Order Approval in SAP Cell And Gene Therapy Orchestration Subscription: E-Signature For Treatment Order Approval

By saving your approval with the e-signature, the order is now approved for execution.

A pop-up window titled E-Signature is displayed. It includes fields for User, which is set to Default User, Password, which is filled with masked characters, Reason Code for E-Signature, which is set to Approval, and an optional Comment field. At the bottom, there are two buttons: Save and Cancel. The background shows a blurred interface with tabs labeled Shipments and other options.

Treatment Order Approval in SAP Cell And Gene Therapy Orchestration Subscription: Review of Treatment Order Approval Status

The new approval status Approved can be verified by reviewing the tab Approval Details of the treatment order.

Screenshot of a software interface displaying approval details for a specific COI ID: RG0Z55GD1. The interface includes tabs for General Information, Process Flow, Order Dates, Business Partners, Shipments, Processing Activities, Order Texts, Approval Details, PPF Events, Documents, and Logs. The Approval Details tab is selected, showing a table with columns for Approval Step, Collection On, Approval Level, Responsible, Approval Status, Rejection Code, Comments, Approval Type, and Active. One row of data is visible, indicating an approval step labeled abc, with an approval level of 2, responsible person with an email address of authorized person, approval status as Approved (ST003), approval type as Order Approval (ORDER_CREATE), and active status as Yes. The interface also includes options to Edit, Create Task, and a search bar.

Managing a Treatment Order

Watch the simulation Managing a Treatment Order to learn more about the system-related activities.

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