Part A – Business Requirements Document (BRD)

1. Document Purpose

This document defines the business and functional requirements for managing the Truenat testing workflow within the TB Screening Camp application.

The solution shall digitally manage Truenat referrals, test orders, MTB and RIF testing, result capture, repeat testing, clinical referrals, treatment referrals, and End-of-Day (EoD) order closure.

The workflow shall support both:

• Automated result capture from an integrated Truenat device.
• Manual result entry by authorized camp users.

The overall workflow is:

TB Symptoms Screening → Visit Creation → Truenat Referral → Test Order Creation → MTB Test → MTB Result → RIF / Clinical Assessment / No Action / Repeat → RIF Test → Treatment / Clinical Assessment / Repeat → EoD Closure

1. Business Objective

The objective is to ensure that every Truenat referral generated during a TB Screening Camp is:

• Uniquely identified and traceable.
• Linked to the correct Beneficiary and Visit.
• Processed through a controlled test-order lifecycle.
• Supported through both manual and automated result capture.
• Automatically routed to the next appropriate action based on the test result.
• Properly managed when testing is repeated or not conducted.
• Automatically closed at the end of the valid testing day where applicable.
• Available for subsequent re-ordering when an order has been closed.

1. Scope

3.1 In Scope

The solution shall cover:

1. Visit ID creation.
2. Truenat referral.
3. MTB Test Order creation.
4. MTB test result capture.
5. MTB result-based workflow.
6. RIF Test Order creation.
7. RIF test result capture.
8. RIF result-based workflow.
9. Manual result entry.
10. Automated result integration.
11. Invalid/Error repeat testing.
12. Test Not Conducted workflow.
13. Mandatory reason capture.
14. EoD order closure.
15. New order creation after closure.
16. Multiple Test Order IDs under one Visit ID.
17. Order and test history.
18. Audit trail.

1. Key Business Entities

Entity Relationship

Beneficiary

     │

     ▼

  Visit ID

     │

     ├───────────────┐

     ▼               ▼

 MTB Order(s)     RIF Order(s)

     │               │

     ▼               ▼

MTB Result        RIF Result

1. Visit ID Requirement

BR-01 – Visit Creation

A unique Visit ID shall be created against the Beneficiary ID once TB Symptoms Screening based on verbal questions has been completed.

The Visit ID shall act as the parent reference for diagnostic investigations performed during the beneficiary's visit.

Business Rules

• Visit ID shall be linked to the Beneficiary ID.
• The Visit ID shall be available for all subsequent diagnostic referrals.
• Multiple test orders may be created against the same Visit ID.
• Test Order IDs shall not replace or overwrite the Visit ID.

1. Truenat Test Order Creation

BR-02 – New Truenat Referral

For every new Truenat referral generated on the current date, the system shall automatically create a unique Test Order ID under the applicable Visit ID.

The Order shall contain:

• Beneficiary ID
• Visit ID
• Test Order ID
• Test Type
• Order Date
• Order Time
• Order Status

Initial status:

Pending

1. Order Validity

BR-03 – One-Day Order Validity

Every Truenat Test Order ID shall be valid for one calendar day from the date on which it is created.

At EoD, the system shall identify applicable open orders and close them according to the EoD closure rules.

1. Order Status

The system shall support the following three statuses:

Important Rule

An Invalid / Error result shall not result in Completed status.

For an Invalid/Error result:

1. Result is saved.
2. Current order is closed.
3. A new order is created for repeat testing.

1. Test Result Capture

The system shall support two result-capture methods.

Option 1 – Automated Result Capture

Where a Truenat testing device is integrated with the application:

Truenat Device

      │

      ▼

Integration Interface

      │

      ▼

Identify Test Order

      │

      ▼

Validate Result

      │

      ▼

Save Result

      │

      ▼

Apply Business Rules

The result shall be automatically associated with:

• Beneficiary ID
• Visit ID
• Test Order ID
• Test Type
• Result
• Result Date/Time
• Device/Source

Option 2 – Manual Result Entry

Where automated integration is unavailable, an authorized user shall be able to manually enter the result.

Users who may be permitted to enter results

• Lab Technician
• Nurse
• Counsellor

Role-based permissions shall determine which users can perform manual result entry.

Manual Flow

Search Beneficiary

       ↓

Select Visit

       ↓

Select Pending Test Order

       ↓

Select Test Type

       ↓

Enter Test Result

       ↓

Save

       ↓

Apply Business Rules

1. Truenat MTB Test

The system shall support the following MTB results:

1. TB Positive (Detected)
2. TB Negative (Not Detected)
3. Invalid / Error

1. MTB Result-Based Workflow

BR-04 – MTB Positive

When the MTB result is:

TB Positive (Detected)

the system shall:

1. Mark the MTB Order as Completed.
2. Record the MTB result.
3. Automatically refer the beneficiary for a Truenat RIF Test.
4. Create a new RIF Test Order ID.
5. Link the RIF Order to the same Beneficiary ID and Visit ID.
6. Set the RIF Order Status to Pending.

Workflow

MTB Test

   ↓

TB Positive

   ↓

MTB Order = Completed

   ↓

RIF Referral

   ↓

Create RIF Order ID

   ↓

RIF Order = Pending

1. MTB Negative + Normal Chest X-Ray

BR-05 – No Further Action

When:

MTB = TB Negative
AND
Chest X-Ray = Normal

the system shall:

• Mark MTB Order as Completed.
• Record the final result.
• Not create a RIF Order.
• Not create a further diagnostic referral through this workflow.

MTB Negative

     ↓

Check Chest X-Ray

     ↓

Chest X-Ray = Normal

     ↓

No Further Action

1. MTB Negative + Abnormal Chest X-Ray

BR-06 – Clinical Assessment & Diagnosis

When:

MTB = TB Negative

AND Chest X-Ray result is either:

• Abnormal but not TB Presumptive, OR
• TB Presumptive

the system shall:

1. Mark MTB Order as Completed.
2. Record the MTB result.
3. Refer the beneficiary for Further Clinical Assessment & Diagnosis.
4. Record the referral against the Visit ID.

No RIF Order shall be automatically created solely based on this result combination.

1. MTB Invalid / Error

BR-07 – Repeat MTB Test

When:

MTB Result = Invalid / Error

the system shall:

1. Save the Invalid/Error result.
2. Mark the current MTB Order as Closed.
3. Create a new MTB Test Order ID.
4. Link the new Order to the same Beneficiary ID and Visit ID.
5. Store the previous Order ID as the Parent Order ID.
6. Set the new MTB Order Status to Pending.
7. Make the new order available for repeat testing.

Example

Visit V001

    │

    ├── MTB Order M001

    │       │

    │       └── Invalid/Error → CLOSED

    │

    └── MTB Order M002

            │

            └── Repeat Test → PENDING

1. Truenat RIF Test

A RIF Test shall be initiated when the MTB result is:

TB Positive (Detected)

The system shall support the following RIF results:

1. DR TB – Rif Resistance Detected
2. Non-DR TB – Rif Resistance Not Detected
3. Indeterminate
4. Invalid / Error

1. RIF Result-Based Workflow

BR-08 – DR TB

When RIF Result =

DR TB (Rif Resistance Detected)

the system shall:

1. Mark the RIF Order as Completed.
2. Record the RIF result.
3. Flag the beneficiary as a Confirmed DR-TB Case.
4. Generate referral for appropriate TB treatment/DOTS treatment as per program protocol.
5. Record the treatment referral against the beneficiary/Visit.

RIF Test

   ↓

DR TB

   ↓

RIF Order = Completed

   ↓

Confirmed DR-TB Case

   ↓

Treatment Referral / DOTS

1. RIF – Non-DR TB

BR-09 – Confirmed TB Case

When RIF Result =

Non-DR TB (Rif Resistance Not Detected)

the system shall:

1. Mark RIF Order as Completed.
2. Record the RIF result.
3. Flag the beneficiary as a Confirmed TB Case.
4. Refer the beneficiary for appropriate TB treatment/DOTS treatment.
5. Record the referral for follow-up.

1. RIF – Indeterminate

BR-10 – Clinical Assessment & Diagnosis

When RIF Result = Indeterminate:

• RIF Order Status = Completed.
• RIF result shall be saved.
• Beneficiary shall be referred for Further Clinical Assessment & Diagnosis.
• Referral shall be recorded against the Visit ID.

1. RIF – Invalid / Error

BR-11 – Repeat RIF Test

When RIF Result = Invalid / Error:

1. Save the result.
2. Close the current RIF Order.
3. Create a new RIF Test Order ID.
4. Link the new order to the same Beneficiary ID and Visit ID.
5. Store the previous RIF Order ID as Parent Order ID.
6. Set the new RIF Order Status to Pending.
7. Make the new order available for repeat testing.

1. Test Not Conducted

BR-12 – MTB Test Not Conducted

The system shall allow an authorized user to mark an MTB Test as Not Conducted.

Business Rules

• Reason shall be mandatory.
• User shall not be allowed to close the order without entering a reason.
• The reason shall be stored against the Test Order ID.
• Order Status shall be changed to Closed.
• No result-based referral shall be generated.

BR-13 – RIF Test Not Conducted

The same rule shall apply to RIF testing.

• Test Not Conducted option shall be available.
• Reason shall be mandatory.
• Reason shall be saved.
• RIF Order Status shall be Closed.

1. EoD Closure

BR-14 – Automatic End-of-Day Closure

At the end of each camp day, the system shall identify all applicable open Truenat Test Orders.

The system shall close orders where:

• Test was not conducted.
• Test result was not entered.
• Order remains Pending at EoD.
• The final applicable result remains Invalid/Error after the repeat process.

EoD Workflow

                 END OF DAY

                     │

                     ▼

             Identify Open Orders

                     │

            ┌────────┴─────────┐

            ▼                  ▼

        MTB Orders          RIF Orders

            │                  │

            ▼                  ▼

      Check Order Status   Check Order Status

            │                  │

       Pending/Open?       Pending/Open?

            │                  │

            └────────┬─────────┘

                     ▼

                Close Order

                     │

                     ▼

              Status = CLOSED

1. New Order After Closure

BR-15 – Create New Test Order

For any Closed Truenat Test Order, the beneficiary record/card shall provide an option to Create New Test Order where another test is clinically/operationally required.

The new order shall:

• Have a unique Order ID.
• Be linked to the same Beneficiary ID.
• Be linked to the relevant Visit ID.
• Have a new Order Date/Time.
• Have Status = Pending.
• Maintain a reference to the previous Order ID where the new order is a repeat/replacement order.

The closed order shall remain unchanged for historical and audit purposes.

1. Multiple Orders Under One Visit

The application shall support multiple test orders against the same Visit ID.

Example:

                    Visit ID

                       │

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

          ▼            ▼             ▼

      MTB Order     MTB Order     RIF Order

        M001          M002           R001

          │            │              │

       Invalid       Valid          Result

       Closed       Completed

This ensures that repeat testing and sequential testing are fully traceable.

High-Level Business Workflow