Chemotherapy Template Management - Requirements

1. Chemotherapy Template Management - Requirements Functional Requirements (The processes the system must support): • A user SHALL be able to approve, modify, suspend, reactivate, or delete a chemotherapy template based on user privileges and the status of the template. • A user SHALL be able to create a new chemotherapy template based on an existing chemotherapy template. • A user SHALL be able to create a new chemotherapy template based on a blank template.

2. Chemotherapy Template Management – Requirements (cont’d) • A user SHALL be able to modify an active, inactive, or draft chemotherapy template. • A user SHALL be able to add, change, or remove components when modifying a chemotherapy template. • Any attempt to change the chemotherapy drugs, including their dose level, administration route, or the duration of the chemotherapy cycles of an active or "used" chemotherapy template SHALL require creating a different chemotherapy template.

3. Chemotherapy Template Management – Requirements (cont’d) • Adding or changing concomitant medications, pre-medications, or chemotherapy drugs SHALL require checking for contraindications. • The existing Local Template Name of a chemotherapy template SHOULD be copied as a Reference Template Name when it is changed as part of modification. • A chemotherapy template SHALL be able to be located based on diagnosis group, chemotherapy drug name, local template name, standard template name, and/or template status.

4. Chemotherapy Template Management – Requirements (cont’d) • A user SHALL be able to select a chemotherapy template after a query for templates has returned results. • A user SHALL be able to suspend an active chemotherapy template. • A user SHALL be able to reactivate a suspended chemotherapy template. • A user SHALL be able to approve a draft chemotherapy template and make it active.

5. Chemotherapy Template Management – Requirements (cont’d) • A user SHALL be able to delete a draft chemotherapy template. • A user SHALL be able to delete a template that has not been used for patients as determined by the documented list of patients. • An attempt to delete a chemotherapy template that has been used for patients SHALL cause the template to be suspended. • Query based on reference (needs further development)

6. Chemotherapy Template Management – Requirements (cont’d) Information Requirements (The information the system must support) • Each Chemotherapy Template Query SHALL be able to include a: • Diagnosis Group, • Local Template Name, • Standard Template Name, • Clinical Trial Indicator, • Template Status, • and Chemotherapy Drug Name(s).

7. Chemotherapy Template Management – Requirements (cont’d) • Each Chemotherapy Template SHALL include at a minimum : • Local Template Name, • Standard Template Name, • Diagnosis Group, • Clinical Trial Identifier, • Template Status, • Cycle Quantity, • Cycle Duration, • Chemotherapy Drug Name, Chemotherapy Drug ID, Chemotherapy Drug Route, and Chemotherapy Dose Level, Administration Instructions, and Timing.

8. Chemotherapy Template Management – Requirements (cont’d) • Each Chemotherapy Template Response SHALL indicate whether any templates were found. • Each Chemotherapy Template Result with one or more templates SHALL include: • Local Template Name, • Standard Template Name, • Diagnosis Group, • Clinical Trial Indicator, • Template Status, • Template Description, and • Chemotherapy Drug Name(s).

9. Chemotherapy Template Management – Requirements (cont’d) • Each Chemotherapy Template SHALL be given a Standard Template Name based on the Diagnosis Group, Clinical Trial Indicator, chemotherapeutic agents, Dose Level, number of cycles, days per cycle, and Cancer Stage, as available. • The Diagnosis Group shall be able to use descriptions from ICD-9, ICD-10, and SNOMED-CT • The Clinical Trial Indicator will either include the recognized identifier for the clinical trial or a value that means "Not a Trial“

10. Chemotherapy Template Management – Requirements (cont’d) • The Chemotherapy Agent Name will be retrieved from standard terminology from RxNorm or the NCI Thesaurus (NCIt) unless no current value exists

11. Chemotherapy Template Management – Requirements (cont’d) From the Ambulatory Oncology Functional Profile (AO-FP) • The system SHALL provide the ability to make site-specific modifications to standard care plans, protocols, and guidelines obtained from outside sources. • The system SHOULD capture research protocol deviations information including verbatim text of protocol deviation (created by the author of the deviation).