Overview of the Biotherapy Protocol and Treatment Plan Builder/Editor

Biotherapy Templates and Orders—The Biotherapy Protocol and Treatment Plan Builder/Editor is a tool for authorized staff to define and maintain templates for ordering the collection, processing, and release of biotherapy products for treatment of oncology patients. These templates define the parameters for ordering each treatment. Providers write orders using Biotherapy Order Entry (BOE), which presents the templates based on the patient’s OnCore registration. Orders are transmitted to the Biotherapy Product Availability Application (BPAA). Using  BPAA, nurses in the collection areas document the start and completion of collections. Laboratory staff use BPAA to document analysis and processing results, as well as the status of products requested for release. BOE and the BPAA are focused on efficient and accurate communication between clinicians and the labs, emphasizing patient safety, and facilitating regulatory compliance.

Non-oncology—As of 11/06/2018, the Biotherapy applications have been enhanced to allow non-oncologists to write orders to collect, process, and release product. There are two builder/archives for each lab site, one for oncology and the other for non-oncology. Check the top of the view to determine which you have open.

Protocols and Treatment Plans—Protocols are defined as investigational courses of biotherapy; a treatment plan is a standard course of care that has been accepted by the provider institutions of Dana-Farber Harvard Cancer Care as best practice.

Product Cell Types—The cell types to be used in therapy are defined for each protocol and treatment plan. Defined product cell types currently include hematopoietic progenitor cells (HPC) collected by apheresis, marrow aspiration, or cord blood harvest, and therapeutic cells (TC) collected by apheresis or tumor harvest. A protocol or treatment plan can call for one or more product cell types. If there is more than one cell type, the ordering clinician selects based on the clinical situation.

Product cell count—The BOE Steering Committee authorized the change of product cell count exponent notation to reflect the new industry standard notation. The change was implemented on 7/25/2023. Before the update, cell count exponents displayed as 1.0 x 10e6, for example; the change displays that cell count as 1.0 E6. See Product Cell Count - impacts.

Templates—Order templates are built for each product cell type included in a protocol or treatment plan. Each template has as many as three (3) parts, one for each type of order for the product: collection, processing, and release. For each order type, the builder selects the elements ("Options" that may be required or optional) to include in the order. Each order type can include the following:

• Comments: As of 11/17/2020, builders can include comments for a template. Comments are included in the builder view of the template, but do not print; comments carry over when a new version of the template is created. Comments cannot be seen by ordering providers.
• Drop-down lists, such as donor type, collection location, or product collected: This information is required for the both the template and the order. The builder selects which items to include in the list, and can set one of the items as the default selection. The ordering clinician must select only one option.
• Donor/recipient weight, height, and/or blood type: The builder can select these items with each donor type option when the data is required by the treatment  For donations other than autologous, this information can be required for the donor, the recipient, or both.
• Maximum number of collections: When added to the template by the builder, this information is required for the order. The maximum defined by the cell type determines the options available to the builder. The builder selects a maximum from a drop-down list as the default. The ordering provider can enter a different maximum, but this cannot be more than the number defined by the cell type.
• Checkbox options, no additional information needed, such as methods for thawing or release: These elements may be required or optional for the template, depending on the cell type. The builder selects which options to include in the order, and can set each as pre-selected. The ordering clinician can check or uncheck the option as needed.
• Checkbox options, Select All That Apply (additional information needed if selected), such as Cryopreservation-Select All That Apply : The builder selects the option and which parameters to present if the option is selected. Both the option and/or one or more parameters can be pre-selected as needed. When checked in the order, options labeled Select All That Apply are presented as a subgroup of checkbox parameters.
• As of 10/19/2021, the preselect checkbox has been added for Product Collected, Cell dose required for infusion, and Cell Dose per Bag/Vial for process orders in the builder. Preselecting requires the ordering provider to include the option in the order.
• Multi-select lists: The builder can set up a list with up to 10 items, and opt to allow the ordering provider to select more than one option. One or more of the options can be set as preselected. The provider can also edit the parameters of the option.
• Free-text entries: Several options for orders include a free-text field for the parameters. When text is typed or changed in a free-text field, the colors of the background and the Save button change as a reminder to save the update. As of 7/20/2021, text from these entries can be copied from the detail view of a template and then pasted into the free-text field of any template.
• Instructions for collection, administration, processing, or release: The builder can enter text as the default for these instructions. The ordering clinician can edit this information.
• Guidance instructions: The builder enters text instructions that are presented in a message to the clinician on writing, editing, approving, or activating orders. The clinician can display these instructions from the order, but cannot change them.

For step-by-step instructions, see Building a New Protocol or Treatment Plan.

Copying Default Templates—Default templates are built to be copied when building or editing a protocol or treatment plan. The defaults are grouped by plan number and named as applicable: for example, Adult Defaults for Protocols. Default templates must be verified before they can be copied; once copied, the orders in the template can be edited as needed. Instructions for using a default template are included in Building a New Protocol or Treatment Plan. Also, see Building a Default Template and Verifying a Default Template.

Prompts for Additional Orders—The three types of orders for biotherapy are for the collection, processing, and release of product. While any of these can be written singly, providers often write the related orders all at once. Depending on the treatment, it might be more intuitive for a provider to begin with the process order, which is written on the recipient, or the collection order, which begins by identifying the donor. Each order requires the same basic information: the donor type, protocol - treatment plan, cell type,  template, and patients. Templates can be set up to prompt a provider to order a process order after the collection is signed, or a collection after the process is signed. The shared information is carried over automatically if the ordering provider opts to continue with the order when prompted. See Building Templates - Prompts for Additional Orders.

Viewing and Printing—Builders can view and print a detailed display of the options and related parameters for all of the orders in a template. See Viewing and Printing a Template.

Editing—Protocols and treatment plans can be edited in several ways:

• Product cell types can be added or deleted
• New templates can be added to each selected product cell type
• Activated templates can be versioned for editing, or inactivated (archived), or deleted
• Inactivated (archived) templates can be versioned for editing, or re-activated, or deleted
• Templates that have not been activated can be edited, but not versioned (see below, Building a new template by versioning an existing template)

For step-by-step instructions, see Editing a Protocol, Treatment Plan, or Template.

Pending Activation—As of 11/17/2020, templates can be flagged as pending activation when they are ready. Templates that are flagged as pending are listed in the Pending Approval/Activation tree, and from there can be activated. From the main builder tree, templates that are flagged as pending activation can be activated or edited as usual, including unchecking the Pending box to change the status back to Started. See Sending a Template to the Pending Activation Queue.

Activation—Templates must be activated to be available for ordering biotherapy in BOE. See Activating a Pending Template. Several rules apply:

• The template must include at least one of the three types of orders: collection, process, and release.
• At a minimum, the required Options (elements) must be included for each order type.
• In addition, for each Option (element) included that has more than one possible parameter, at least one parameter must be included. (Some Options do not have more than one parameter available.)
• For activation, the builder automatically checks the orders—collection, process, and release—for mismatches and missing requirements. If a mismatch is found that would cause ordering malfunctions in Biotherapy Order Entry (for example, if options that are required for the order type, such as the donor type, are missing), you are prompted to correct the mismatches, which are listed on the message. The template cannot be activated until you make the corrections. If a mismatch is found that would NOT cause ordering malfunctions in Biotherapy Order Entry (for example, if the collection and process orders do not have the same collection locations or do not have the same product collected, or if the collection, process, and/or release orders do not have the same donor types), you are prompted to correct the mismatches, which are listed on the message. You have the option to continue and activate the template as is.

Activated templates are flagged as ACTIVATED. Activated templates are stored in the builder, and can be inactivated (archived) or deleted, but not edited. Activated templates can be versioned for editing (see below).

Inactivation—To remove a template from use, it can be inactivated, which moves the template to the Archive in the builder. See Inactivating (Archiving) a Template. Inactivated (archived) templates are flagged as INACTIVATED.  Inactivated templates are stored in the builder, and can be deleted, but not edited or versioned. See Accessing the Template Archive.

Reactivation—As of 7/20/2021, if a template is archived in error, it can be reactivated. See Reactivating an Archived Template.

Building a new template by versioning an existing template—Both activated and inactivated (archived) templates can be versioned as the basis for a new template. The version number of the new template is automatically incremented. Both the name and the version number can be changed. To use the new version as a replacement, inactivate the current template, and then activate the new version. To use the new version as an additional template for the product cell type in the protocol or treatment plan, rename the new version as a unique template, and then activate it.  See Building a New Version of a Template.

Copying Active Templates—As of 7/20/2021, builders can create a copy of any protocol, treatment plan, incoming cell type, or activated/reactivated template in the main builder tree, to use the content as the basis for a new item of the same type. Once pasted, copies of activated/reactivated templates are pasted as inactive templates, which can be edited and activated as needed. See Copying a Protocol or Treatment Plan or Copying a Product Cell Type or Template for instructions.

Copying Free-Text—As of 7/20/2021, builders can copy free-text entries such as instructions from the detail view of a template, and then paste that copied text into the free-text field in any template. See Copying Free-Text Entries.

Deleting—Protocols, treatment plans, and templates can be permanently removed from the builder by deleting. See Deleting a Protocol or Treatment Plan.

Notifications—At DFCI, each template can be assigned to one or more functional groups, that is, a group of providers who a responsible for confirming orders written on the template. See Build a New Protocol or Treatment Plan > Set Up the Template.

Builder Tree Icons

Archive Icons

 Test mode

Active template available

Closed; no active templates

Searching for templates by content—The builder/editor search allows authorized users to find templates for protocols or treatment plans or both, in any status or one (Activated, Building, or Maintenance), which have or do not have particular options or values. The search results include links to display the detail view of each template fond, and can be exported to Excel. See Searching for Templates by Content.

Searching for templates by name—This search uses the name of a protocol, treatment plan, default group, or template as criteria. Once you find it, you can go to the item in the builder, copy the search criteria and results to a spreadsheet or PDF, or view and print details of a template. See Searching for Templates by Name.

Biotherapy application access—Biotherapy is available to authorized users via the start menu Applications folder, and requires login with a user name and password. In addition, as of April 17, 2018, providers can access BOE as an activity in Digital Health eCare (Epic). Biotherapy is an option in the Epic menu, under MGB Applications, for BWHC, DFCI, and MGH. After launching, Biotherapy is listed in the Recent menu as well. The user name and password for Epic login is used to access BOE via Epic, so no additional login is needed. The options to choose a biotherapy application and site are available to authorized users. Patient context in not maintained between Epic and BOE; a patient must be selected in BOE when needed.

Reporting a Problem—As of September 18, 2020, an enhancement to the suite of Biotherapy applications allows users to create and send an incident ticket to ServiceNow directly from the application. A few clicks capture all of your contact information, as well as data and a screen shot for the process in progress. All you need to do is indicate how you would prefer to be contacted, and include any additional information you think is relevant. See Sending a ServiceNow Ticket for instructions.

• See also:

• Options for the Protocol / Treatment Plan Builder / Editor
• Tip sheet for the Builder (PDF)