Defining and Using Actions

You can use actions for communication with personnel using an external source data system, or for communication within TMS, about an omission.

This section includes:

• Action Types
  
• Using Actions
  
• Defining an Action
  

Action Types

There are three types of actions: Answerable Actions and Unanswerable Actions (includes Negative List), both of which TMS sends to an external system, and Internal Actions, which are used within TMS.

After you apply an Action of any type to a term, TMS automatically applies the same Action to new occurrences of the same term in the same dictionary/domain combination.

Note:

Before TMS Release 4.6, Answerable actions were known as Conditional actions, and Unanswerable actions were known as Never Expire actions. Internal actions were new in TMS Release 4.6.

For more information, see:

• Answerable Actions
  
• Unanswerable Actions
  
• Internal Actions
  

Answerable Actions

Sometimes a verbatim term cannot be either automatically or manually because the verbatim term itself is flawed. In this case, the person trying to manually classify the term instead associates an Action with the omission and sends it back to the external system requesting that the term be amended and resubmitted to TMS.

For example, TMS does not support combined verbatim terms. TMS can process only one symptom per term in a medical dictionary; either bad headache or nausea, for example, but not bad headache and nausea. In this example, you could apply an Action with the text "Split the term" to the verbatim term bad headache and nausea. A verbatim term may also be ambiguous—too vague; for example, head—or completely garbled due to a typing error. In this case you could apply an Action with the text "Clarify the term" to the verbatim term.

Answerable actions allow a user in the external system to send a comment back to TMS. When that happens, TMS resumes ownership of the omission and a TMS user must take the next step: either classifying the term or sending a discrepancy message back to the external system to respond to the external comment. For example, you assign an Action to the term "Pain" with the text, "This term is too vague. Please be more specific." An external user responds, "The patient did not provide any more information." You see this response in the Classify VT Omissions window, All VT tab, Action Text field. You can use a discrepancy message to respond, for that source term only, "TMS cannot process this term without information about where in the body the pain occurred. Please get additional information."

See Applying a Discrepancy Message for more information about Discrepancy Messages.

Unanswerable Actions

If you assign an Action of type Unanswerable to a term, TMS does not register comments sent back to TMS from the external system. If an external system user replies to the Action text for a particular source term without changing the term itself, TMS sends the same Action text back during the next data exchange job. For example, if you assign an Action definition with the text "This term is too vague. Please be more specific" to the term "Pain" and an external system user responds, "The patient did not provide any more information," this comment never appears in TMS, the omission ownership remains set to the external system, and TMS sends back the original Action text ("This term is too vague. Please be more specific") in the next data exchange with the external system.

Note:

The external system does not "see" and so does not display the Action type. Therefore the external system user does not know whether TMS can read his or her response or not.

Use unAnswerable Actions in cases where you know a particular response is always wrong, or if you do not have the resources to support a dialog.

Negative Lists

Note:

Negative list is added for the TMS 5.3 release.

External Unanswerable actions can be used to prevent a verbatim term from autocode. This is to emulate the simplest solution for a negative list. In order to prevent a dictionary term from being used during autocoding, the dictionary term must be manually added to the Maintain Action Assignment screen and assigned an Action Type of Unanswerable. Reference the installation reference codelist TMS_CONFIGURATION>NEGATIVELIST (default is N) so that there is no change for existing users if you chose not to use the negative list, and there will be backward compatibility.

For example:

1. Pain is in the MedDRA dictionary.
2. A source term is sent into TMS as "Pain" from an external system.
3. "Pain" exists as an action assignment as an unanswerable action type with an Action Text.
4. If the NEGATIVELIST is set to N, during autocoding, a direct match is found, and then a VTA is created.
5. If the NEGATIVELIST is set to Y and Autocoding finds the term Pain as an unanswerable action, an External Action with an Action Text is created and sent to the external system.

Internal Actions

Internal Action definitions are used for the following two purposes:

Action Approval

Use Internal Actions with a base Answerable Action as a mechanism for approving the assignment of a particular Answerable Action to a particular verbatim term. After a TMS user approves the Action assignment, TMS sends the Answerable Action to the external system.

To use Internal Actions as a mechanism for approving the assignment of a particular Answerable Action to a particular verbatim term, do the following:

1. Set up Action approval:

   • In the dictionary/domain combinations where you want to require the approval of Action assignments, check Action Appr Reqd?; see Assigning a Dictionary to a Domain.

   • For each Answerable Action that you may use in a dictionary/domain combination where Action approval is required, define an Internal Action with the Answerable Action as the base Answerable Action. Use a naming convention so that coders can select the correct Internal Action to assign to an omission; see Defining an Action. When you specify the base Answerable Action, TMS supplies its text as the text for the Internal Action. It makes sense to keep them the same.

2. Assign actions to terms. In the Classify VT Omissions window under Omission Management, if you are working in a dictionary/domain combination where Action approval is required, TMS displays only active internal and unAnswerable Actions in the Action drop-down list; see Classifying Terms Manually.

3. In the Approve Action Assignments window under Omission Management, a user with the TMS_APPROVE_PRIV role can approve an Internal Action assignment. TMS then applies the Internal Action's base Answerable Action to the term and sends the term with its Action to the external source data system during the next data exchange (Batch Validation for Oracle Clinical).

   If the user instead rejects the assignment, or assigns a different Action, TMS removes the Internal Action assignment. A record of the Internal Action assignment is available in the status history of the term.

Internal Communication

Use Internal Actions without a base Answerable Action to indicate to other coders that someone is already working on a particular verbatim term.

For example, a coder may need to check with his or her supervisor before classifying a verbatim term. To avoid a duplication of effort, the coder first applies an Internal Action with no base Answerable Action, and with text such as "Inquiry in progress" to the term. When the coder collects the required information, he or she can either classify the term or apply another Action to it.

Any user with the privileges normally required can either classify or apply another Action to the term. TMS then removes the Internal Action without a base Answerable Action from the term.

To use Internal Actions for internal communication only, do the following:

1. Define one or more Internal Actions without a base Answerable Action.
2. Assign actions to terms. In the Classify VT Omissions window under Omission Management, apply an Internal Action without a base Answerable Action to a term; see Classifying Terms Manually.
3. When you are ready, classify the term or assign a different Action to it.

Using Actions

Using actions involves many parts of TMS described elsewhere:

• Defining Actions is described in this section.

• Requiring Approval for Action Assignments. You can require that actions assigned to omissions be approved before they are sent to the external system. You require this approval for a particular dictionary/domain combination; see Assigning a Dictionary to a Domain. Internal Actions are used for this purpose; see Internal Actions for further information.

• Applying Actions to Omissions. You assign actions to omissions in the Classify VT Omissions window; see Apply an Action to a Term for details.

• Applying Actions to VTs Before They Occur. You can apply actions to verbatim terms proactively, even before a verbatim term enters the system. In the Maintain Actions window, you can enter any verbatim term you choose (or any term that you think may be entered as a verbatim term in the future) and assign an Action to it. See Maintaining Action Assignments.

• Viewing Action Assignment History. You can see actions that have been assigned to a term as follows:

  • You can see the actions that have been assigned to a verbatim term in the Distinct VT Actions tab of the Classify VT Omissions window; see Omission Management.

  • You can see the actions that have been assigned to a specific source term in the All VT Actions tab in Classify VT Omissions form; see Omission Management.

  • The Status/Notes window, called from Classify VT Omissions, Approve VTAs, Approve VTA Assignments, or VT History window, shows all term status history information, including actions; see Using the Status/Notes Pop-up Window.

Defining an Action

To create an Action Definition, do the following:

1. From the Definition menu, select Create Action Definitions. The Create Action Definitions window opens.
2. In the Action field, enter a short (no more than 15 characters), descriptive name for the Action. In the bad headache and nausea example above, this might be "Split term."

   Note:

   If you are defining an Internal Action with a base Un/Answerable Action, use a naming convention such as base Answerable Action name _INT to name the Internal Action, so that coders can select the correct Internal Action to assign to an omission. For example, if the base Un/Answerable Action is named SPLIT TERM, name the corresponding Internal Action SPLIT TERM_INT. (Note that if you follow this naming convention, which requires 4 characters for the Internal Action name, base Un/Answerable Actions can have a maximum of 11 characters in their name.)

3. In the Action Type field, select Answerable, Unanswerable or Internal. See Action Types for information.

   When the choice is Internal for the purpose of requiring an Action assignment to be approved before sending to the external system, you must select an option from the Base Un/Answerable Action LOV. This LOV contains all defined Answerable and Unanswerable actions. Each Internal Action can be based on only one Action. Likewise, an Action can be associated with only one Internal Action.

4. Leave the Status field value set to Active. If you need to stop using the Action in the future, you can set the status to Retired. The system then removes all current assignments of the Action.

   Note:

   If an Action has never been applied to a term, you can delete it. After it has been applied, you can only retire it.

5. Base Action. Use this field only if you are defining an Internal Action with a base Answerable or Unanswerable action for use in one or more dictionary/domain combinations where Action approval is required. Specify the Answerable or Unanswerable action to be sent to the external system if the assignment of the Internal Action you are defining is approved.

   An Internal Action can have only one Base Un/Answerable Action (and should have a similar name to the Base Un/Answerable Action's name or text; see above). An Answerable or Unanswerable Action can be associated with only one Internal Action as a Base Un/Answerable Action.

   Note:

   In dictionary/domain combinations where Action approval is not required, you can apply an Un/Answerable Action directly to an omission, even if it is associated with an Internal Action.

6. In the Text field, enter the default text to send to external system users, explaining what they need to change to allow the system to process the term. In the same example, this text might be "Please split this term."

   If you are defining an Internal Action with a base Action, click in the Text field. TMS populates it with the base Un/Answerable Action's text. This text will be sent to the external system associated with a source term after the Action assignment is approved. The person who approves the assignment can modify the text.

7. In the External System field, specify one or more external systems collecting source terms (Oracle Clinical, for example) to which you may want to send this Action.
8. In the Omission Status field, enter the omission status you want the external system to assign to the omission when it returns from TMS. In Oracle Clinical, this status is normally Inv Review (Investigator Review) to indicate that the investigator must take the next step in resolving the discrepancy, but you can enter any valid status.

   An external system-specific LOV is available for this field; you can define this LOV in the Multiple Term Action Omission Statuses LOV field of the Define External Systems window.

   For each external system, select one omission status.

9. Save.