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Part A – Business Requirements Document (PRD)

  1. Document Purpose

This document defines the business requirements for managing the Chest X-Ray screening workflow within the TB Screening Camp application.

The functionality will enable the application to:

  • Create and manage Chest X-Ray test orders against a beneficiary's Visit ID.
  • Support both automated and manual Chest X-Ray result capture.
  • Process results based on predefined business rules.
  • Automatically refer beneficiaries for Truenat testing when required.
  • Handle AI Invalid Result through repeat testing.
  • Ensure all open/expired orders are closed at the end of the day.
  • Maintain complete test and order history against the beneficiary and Visit ID.
  1. Business Objective

The objective is to digitally manage Chest X-Ray investigations conducted during TB Screening Camps and ensure that every referred beneficiary is appropriately tracked from:

TB Symptoms Screening → Visit Creation → Chest X-Ray Referral → Order Creation → Test → Result → Truenat Referral / No Action / Repeat Test → EoD Closure

The solution should support both field scenarios:

  1. Automated result capture from an integrated digital Chest X-Ray device.
  2. Manual result entry by an authorized camp user when device integration is unavailable.


  1. Scope

In Scope

  • Visit ID creation after TB Symptoms Screening.
  • Chest X-Ray referral.
  • Chest X-Ray Order ID generation.
  • Order lifecycle management.
  • Manual result entry.
  • Automated result integration.
  • Four Chest X-Ray result types.
  • Result-based Truenat referral.
  • AI Invalid Result and repeat testing.
  • Test-not-conducted workflow.
  • Mandatory reason capture.
  • EoD automatic order closure.
  • Creation of a new order after closure.
  • Multiple Order IDs against one Visit ID.
  • Test/order history and audit trail.

Out of Scope

The following are outside the primary scope of this requirement and may be covered under separate requirements:

  • Detailed Truenat MTB/RIF result workflow.
  • Digital X-Ray device hardware configuration.
  • AI model development/validation.
  • Clinical treatment protocol management.
  • DOTS treatment management.
  1. Key Business Entities

Entity

Description

Beneficiary

Person registered for TB screening

Beneficiary ID

Unique identifier for the beneficiary

Visit ID

Unique identifier for the beneficiary's screening encounter

Chest X-Ray Order ID

Unique identifier for each Chest X-Ray investigation order

Chest X-Ray Result

Final result received through manual or automated mode

Test Attempt

Individual Chest X-Ray attempt associated with an Order ID

Referral

Subsequent diagnostic action, such as Truenat referral

Relationship

Beneficiary

    │

    └── Visit ID

          │

          ├── Chest X-Ray Order ID – 1

          │

          ├── Chest X-Ray Order ID – 2

          │

          ├── Chest X-Ray Order ID – 3

          │

          └── Truenat Order ID(s)

Business rule: One Visit ID can have multiple Chest X-Ray Order IDs.

  1. High-Level Business Workflow

TB Symptoms Screening Completed

             │

             ▼

       Create Visit ID

             │

             ▼

    New Chest X-Ray Referral

             │

             ▼

    Create Chest X-Ray Order

             │

             ▼

       Order = Pending

             │

             ▼

      Chest X-Ray Test

             │

       ┌─────┴─────┐

       │           │

       ▼           ▼

 Automated       Manual

   Result         Result

       │           │

       └─────┬─────┘

             ▼

      Capture X-Ray Result

             │

      ┌──────┼───────────────┬──────────────┐

      │      │               │              │

      ▼      ▼               ▼              ▼

   Normal  Abnormal       TB Presumptive  AI Invalid

             │               │              │

             └───────┬───────┘              ▼

                     ▼                 Close Current

                Truenat Referral          Order

                     │                    │

                     ▼                    ▼

               Create Truenat       Create New Order

                  Order ID           for Repeat Test


  1. Business Requirements

BR-01 – Visit Creation

The system shall create a unique Visit ID against the Beneficiary ID once the beneficiary's TB Symptoms Screening based on verbal questions is completed.

BR-02 – Chest X-Ray Order Creation

For every new Chest X-Ray referral created on the current date, the system shall automatically generate a unique Chest X-Ray Order ID under the relevant Visit ID.

The Order ID shall be associated with:

  • Beneficiary ID
  • Visit ID
  • Investigation Type
  • Order Date
  • Order Status

BR-03 – Order Validity

Each Chest X-Ray Order ID shall be valid for one calendar day.

Any order that remains open at the end of the day shall be processed according to the EoD closure rules.

BR-04 – Order Status

The system shall support the following order statuses:

  1. Pending
  2. Completed
  3. Closed

Status Definitions

Status

Definition

Pending

Order created but test/result has not been successfully completed

Completed

Test conducted and a valid final result recorded

Closed

Order has been closed due to expiry, non-conducted test, or other defined closure condition

An AI Invalid Result does not make the order Completed. The invalid result shall be recorded, the current order closed, and a new order created for repeat testing.

  1. Result Capture Requirements

The application shall provide two mutually exclusive methods for obtaining the Chest X-Ray result.

Option 1 – Automated Result

Where a digital Chest X-Ray device is integrated:

  • The result shall be received automatically.
  • The result shall be mapped to the correct Beneficiary ID and Order ID.
  • The application shall validate and save the received result.
  • The result shall then be processed using the same business rules as manual results.

Option 2 – Manual Result

Where device integration is unavailable:

  • An authorized user shall be able to search for the beneficiary.
  • User shall select the relevant Pending Chest X-Ray Order.
  • User shall manually enter/select the result.
  • The application shall process the result using the same business rules.

Authorized Manual Result Users

Based on operational requirements, manual result entry may be permitted for:

  • Radiographer
  • Lab Technician
  • Nurse
  • Counsellor

Role-based permissions should determine which users can actually perform this action.

  1. Chest X-Ray Result Types

The system shall support four result types:

S No

Result

Business Interpretation

1

Normal

No TB-related diagnostic action required

2

Abnormal but not TB Presumptive

Requires Truenat testing

3

TB Presumptive

Requires Truenat testing

4

AI Invalid Result

Current test result is invalid and requires repeat testing


  1. Result-Based Business Rules

BR-05 – Normal

If Chest X-Ray Result = Normal:

  • Chest X-Ray Order Status = Completed.
  • No Truenat Order shall be created.
  • No further action shall be triggered by this workflow.

Normal

  │

  ▼

X-Ray Order = Completed

  │

  ▼

No Further Action


BR-06 – Abnormal but not TB Presumptive

If Chest X-Ray Result = Abnormal but not TB Presumptive:

  • Chest X-Ray Order Status = Completed.
  • System shall create a new Truenat Test Order.
  • Truenat Order shall be linked to the same:
    • Beneficiary ID
    • Visit ID
    • Chest X-Ray Order ID
  • Truenat Order Status = Pending.

BR-07 – TB Presumptive

If Chest X-Ray Result = TB Presumptive:

  • Chest X-Ray Order Status = Completed.
  • System shall create a new Truenat Test Order.
  • Truenat Order shall be linked to the relevant Beneficiary and Visit.
  • Truenat Order Status = Pending.

BR-08 – AI Invalid Result

If Chest X-Ray Result = AI Invalid Result:

  1. Result shall be saved against the current Chest X-Ray Order.
  2. Current Chest X-Ray Order shall be changed to Closed.
  3. A new Chest X-Ray Order ID shall be generated for repeat testing.
  4. The new Order ID shall have status Pending.
  5. The new order shall reference the same Beneficiary ID and Visit ID.
  6. The relationship between the previous and new Order IDs shall be maintained for traceability.

AI Invalid Result

       │

       ▼

Save Result

       │

       ▼

Close Current Order

       │

       ▼

Create New X-Ray Order

       │

       ▼

Order = Pending

       │

       ▼

Repeat Chest X-Ray


  1. Test Not Conducted

BR-09 – Test Not Conducted

If the Chest X-Ray test is not conducted:

  • User shall select Test Not Conducted.
  • A Reason shall be mandatory.
  • System shall save the reason against the Order ID.
  • Order Status shall be changed to Closed.
  • No result-based referral shall be generated.

Example reasons:

  • Beneficiary unavailable
  • Beneficiary declined
  • Equipment unavailable
  • Technical issue
  • Operational constraint
  • Other
  1. EoD Closure

BR-10 – Automatic EoD Closure

At the end of each camp day, the system shall identify Chest X-Ray Orders that remain eligible for closure.

Orders shall be closed where:

  • Test was not conducted.
  • Result was not entered.
  • Order remains Pending beyond its validity period.
  • Final result remains AI Invalid after the applicable repeat process.

                    END OF DAY

                        │

                        ▼

              Identify Open Orders

                        │

          ┌─────────────┼──────────────┐

          ▼             ▼              ▼

    Not Conducted   No Result      Invalid/Repeat

          │             │              │

          ▼             ▼              ▼

       CLOSED        CLOSED         CLOSED


  1. Re-Order Requirement

BR-11 – New Order After Closure

If a Chest X-Ray Order has status Closed, the system shall provide an option on the beneficiary record/card to create a new Chest X-Ray Order when required.

The new Order:

  • Shall have a unique Order ID.
  • Shall reference the same Beneficiary ID.
  • Shall reference the same Visit ID, where applicable.
  • Shall have status Pending.
  • Shall not overwrite the previous closed order.


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