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Epic: Truenat Test Order Management and Result-Based Diagnostic Workflow

As a TB Screening Application, I want to create, manage, and process Truenat MTB and RIF test orders against a beneficiary's Visit ID through manual result entry or automated integration with Truenat testing devices, so that the system can determine the appropriate next clinical action based on the test results and ensure all open orders are closed at the end of the day.

1. User Story – Visit ID Creation

US-TR-01: Create Visit ID

As a TB Screening Application,
I want to create a unique Visit ID when General Examination is completed for a beneficiary,
so that all diagnostic investigations performed during that encounter can be linked to the beneficiary's visit.

Acceptance Criteria

  • A unique Visit ID shall be created when General Examination is completed.
  • The Visit ID shall be linked to the Beneficiary ID.
  • The Visit ID shall act as the parent reference for diagnostic orders.
  • Multiple Truenat Order IDs may be created against the same Visit ID.
  • The Visit ID shall remain available for linking subsequent diagnostic activities performed during the same encounter.

2. User Story – Create Truenat MTB Order

US-TR-02: Create Truenat MTB Test Order

As a TB Screening Application, after TB symptoms screening is done,
I want to automatically create a Truenat MTB Test Order ID for a new Truenat referral on the current date, so that the MTB test can be tracked from referral through completion.

Acceptance Criteria

  • A unique Truenat MTB Order ID shall be generated.
  • The Order ID shall be linked to:
    • Beneficiary ID
    • Visit ID
    • Test Type = Truenat MTB
    • Order Date
  • The initial Order Status shall be Pending.
  • The Order ID shall be valid for one calendar day.
  • Multiple Order IDs may be created against the same Visit ID when required.
  • A closed Order ID shall not be reused for a subsequent test.

3. User Story – Capture Truenat Result

US-TR-03: Capture Truenat Test Result

As a Lab Technician/authorized user,
I want to enter the Truenat test result manually or receive it automatically from an integrated Truenat device, so that the application can determine the appropriate next action for the beneficiary.

Acceptance Criteria

The system shall support two methods of result capture:

  1. Manual Entry
  • Authorized user shall search/select the pending Truenat Order.
  • User shall select the applicable test type.
  • User shall enter the result from the permitted result values.
  1. Automated Flow
  • When the Truenat device is integrated with the application, the test result shall be received automatically.
  • The received result shall be mapped to:
    • Beneficiary ID
    • Visit ID
    • Order ID
    • Test Type
  • The automated result shall be processed using the same business rules as manually entered results.

4. Truenat MTB Test

US-TR-04: Process Truenat MTB Result

The system shall support the following MTB results:

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

US-TR-04A: MTB Positive

As a TB Screening Application,
I want to automatically refer a beneficiary for a Truenat RIF test when the MTB result is TB Positive, so that Rifampicin resistance can be assessed.

Acceptance Criteria

When MTB Result = TB Positive (Detected):

  • MTB Order Status shall be updated to Completed.
  • The system shall automatically create a new Truenat RIF Order ID.
  • The RIF Order shall be linked to:
    • Beneficiary ID
    • Visit ID
    • MTB Order ID
  • RIF Order Status shall initially be Pending.
  • The beneficiary shall be made available to the Lab Technician for RIF testing.

Flow

MTB Test

   │

   ▼

TB Positive (Detected)

   │

   ▼

MTB Order = Completed

   │

   ▼

Create RIF Order

   │

   ▼

RIF Order = Pending


5. MTB Negative – Chest X-Ray Based Workflow

US-TR-04B: MTB Negative + Normal Chest X-Ray

As a TB Screening Application,
I want to close the diagnostic workflow when MTB is negative and the Chest X-Ray result is Normal, so that no unnecessary further diagnostic action is initiated.

Acceptance Criteria

When:

  • MTB Result = TB Negative (Not Detected)
  • AND Chest X-Ray Result = Normal

Then:

  • MTB Order Status shall be Completed.
  • No RIF Order shall be created.
  • No further action shall be required through this workflow.

             MTB Negative

                  │

                  ▼

       Check Chest X-Ray Result

                  │

          ┌───────┴────────┐

          │                │

       NORMAL          ABNORMAL /

          │            TB PRESUMPTIVE

          ▼                │

    No Further             ▼

       Action       Clinical Assessment

                       & Diagnosis


6. MTB Negative + Abnormal Chest X-Ray

US-TR-04C: MTB Negative with Abnormal Chest X-Ray

As a TB Screening Application,
I want to refer the beneficiary for further Clinical Assessment & Diagnosis when MTB is negative but the Chest X-Ray indicates an abnormality, so that the beneficiary can receive appropriate clinical evaluation despite the negative MTB result.

Acceptance Criteria

When:

  • MTB Result = TB Negative
  • AND Chest X-Ray Result is:
    • Abnormal but not TB Presumptive, OR
    • TB Presumptive

Then:

  • MTB Order Status shall be Completed.
  • No RIF Order shall be automatically created based only on this MTB result.
  • The beneficiary shall be referred for Further Clinical Assessment & Diagnosis.
  • The referral/action shall be recorded against the Visit ID.

7. MTB Invalid / Error

US-TR-04D: Repeat MTB Test

As a Lab Technician,
I want to repeat the MTB test when the result is Invalid/Error, so that a valid MTB result can be obtained without creating another MTB Order ID.

Acceptance Criteria

When MTB Result = Invalid / Error:

  • The existing MTB Order ID shall remain active.
  • The system shall not create a new MTB Order ID for the repeat test.
  • The repeat MTB test shall be conducted using the same Order ID.
  • The system shall maintain the repeat-test attempt/history against the same Order ID.
  • The new result shall be captured against the same Order ID.
  • If a valid result is obtained, the system shall process it according to the MTB result-based workflow.
  • If the final result remains Invalid/Error at EoD, the Order Status shall be changed to Closed.

MTB Test

   │

   ▼

Invalid / Error

   │

   ▼

Repeat MTB Test

using SAME Order ID

   │

   ▼

New Result

   │

   ├───────────────┐

   │               │

 Valid Result   Invalid/Error

   │               │

   ▼               ▼

Process Result   Close at EoD


8. Truenat RIF Test

US-TR-05: Process Truenat RIF Result

The RIF test shall be performed when the MTB test 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 – DR TB

US-TR-05A: Identify Confirmed DR TB

As a TB Screening Application,
I want to flag a beneficiary as a confirmed DR TB case when the RIF result indicates Rifampicin resistance, so that the beneficiary can be referred for appropriate DR TB treatment.

Acceptance Criteria

When RIF Result = DR TB (Rif Resistance Detected):

  • RIF Order Status shall be updated to Completed.
  • The beneficiary shall be flagged as a Confirmed DR TB Case.
  • The Visit/Beneficiary record shall retain the MTB and RIF results.
  • The beneficiary shall be referred for DOTS treatment / appropriate TB treatment workflow as configured by the program.
  • The referral/action shall be recorded for follow-up.

MTB Positive

     │

     ▼

RIF Test

     │

     ▼

DR TB

(Rif Resistance Detected)

     │

     ▼

RIF Order = Completed

     │

     ▼

Confirmed DR TB Case

     │

     ▼

Refer for DOTS Treatment


9. RIF – Non-DR TB

US-TR-05B: Identify Confirmed TB Case

As a TB Screening Application,
I want to flag a beneficiary as a confirmed TB case when the RIF result indicates no Rifampicin resistance, so that the beneficiary can be referred for TB treatment.

Acceptance Criteria

When RIF Result = Non-DR TB (Rif Resistance Not Detected):

  • RIF Order Status shall be Completed.
  • The beneficiary shall be flagged as a Confirmed TB Case.
  • MTB and RIF results shall be retained.
  • The beneficiary shall be referred for DOTS treatment / appropriate TB treatment workflow.
  • The referral shall be recorded for follow-up.

10. RIF – Indeterminate

US-TR-05C: Refer for Clinical Assessment

As a TB Screening Application,
I want to refer the beneficiary for further Clinical Assessment & Diagnosis when the RIF result is Indeterminate, so that an appropriate clinical decision can be made.

Acceptance Criteria

When RIF Result = Indeterminate:

  • RIF Order Status shall be Completed.
  • The beneficiary shall be referred for Further Clinical Assessment & Diagnosis.
  • No confirmed DR TB flag shall be created solely from an Indeterminate result.
  • The referral shall be recorded against the Visit ID.

11. RIF Invalid / Error

US-TR-05D: Repeat RIF Test

As a Lab Technician,
I want to repeat the RIF test when the result is Invalid/Error, so that a valid RIF result can be obtained using the same Order ID.

Acceptance Criteria

When RIF Result = Invalid / Error:

  • The existing RIF Order ID shall remain active.
  • A new RIF Order ID shall not be created for the repeat test.
  • The repeat test shall use the same RIF Order ID.
  • Repeat attempt details shall be retained.
  • A valid subsequent result shall be processed according to the RIF workflow.
  • If the final result remains Invalid/Error at EoD, the RIF Order Status shall become Closed.

12. Test Not Conducted

US-TR-06: Close MTB Order When Test Is Not Conducted

As an authorized user,
I want to mark the MTB test as Not Conducted with a mandatory reason, so that the system maintains an accurate record of why the test was not completed.

Acceptance Criteria

  • User shall be able to select Test Not Conducted.
  • A reason shall be mandatory.
  • The system shall not allow the Order to be closed without a reason.
  • The MTB Order Status shall become Closed.
  • The reason shall be stored against the Order ID.

Examples of Reasons for not conducting the Truenat Test:

  • Beneficiary unavailable
  • Patient refused/ declined
  • Long waiting time at the camp
  • Fear/Anxiety
  • Insufficient Sample
  • Incorrect sputum
  • Truenat device unavailable
  • Cartridge unavailable
  • Power issue
  • Connectivity issue
  • Technical failure/ issue
  • Lab Techinician unavailable
  • Operational constraint
  • Other

13. Test Not Conducted – RIF

US-TR-07: Close RIF Order When Test Is Not Conducted

The same rule shall apply to the RIF test.

Acceptance Criteria

  • User can mark RIF Test as Not Conducted.
  • Reason is mandatory.
  • RIF Order Status shall become Closed.
  • Reason shall be stored against the RIF Order ID.

14. EoD Auto Closure

US-TR-08: Automatically Close Open Truenat Orders at EoD

As a TB Screening Application,
I want to automatically close eligible open Truenat orders at the end of the day,
so that no expired Truenat Order remains open after its one-day validity period.

MTB orders to be closed at EoD

The system shall close an MTB Order when:

  • Test was not conducted.
  • Result was not entered.
  • Order is still Pending.
  • Final result remains Invalid/Error after repeat attempts.

RIF orders to be closed at EoD

The system shall close a RIF Order when:

  • Test was not conducted.
  • Result was not entered.
  • Order is still Pending.
  • Final result remains Invalid/Error after repeat attempts.

EoD Flow

                         END OF DAY

                             │

                             ▼

                    Identify Pending Orders

                             │

             ┌───────────────┴────────────────┐

             │                                │

         MTB Orders                        RIF Orders

             │                                │

             ▼                                ▼

      Test not conducted              Test not conducted

      Result not entered              Result not entered

      Still Invalid/Error             Still Invalid/Error

             │                                │

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

                             ▼

                     Order Status = CLOSED


15. Re-Order After Closure

US-TR-09: Create New Truenat Order After Closure

As an authorized user,
I want to create a new Truenat test Order ID when an earlier Order ID is closed,
so that the beneficiary can undergo another test when required.

Acceptance Criteria

  • A new unique Order ID shall be generated.
  • The previous Order shall remain Closed.
  • The new Order shall be linked to the same Visit ID and Beneficiary ID.
  • The new Order shall have status Pending.
  • The new Order shall have a new validity period based on its creation date.
  • The closed Order ID shall not be reused.


16. Order Status

The system shall support three Order statuses:

Status

Definition

Pending

Order created but test/result is not yet completed

Completed

Test conducted and valid final result recorded

Closed

Order expired, test not conducted, result not entered, or final result remained Invalid/Error

Status Matrix

Scenario

Status

New MTB Order

Pending

MTB Positive

Completed

MTB Negative

Completed

MTB Invalid – repeat required

Pending

MTB Invalid after final repeat at EoD

Closed

MTB not conducted

Closed

MTB result not entered at EoD

Closed

New RIF Order

Pending

RIF DR TB

Completed

RIF Non-DR TB

Completed

RIF Indeterminate

Completed

RIF Invalid – repeat required

Pending

RIF Invalid after final repeat at EoD

Closed

RIF not conducted

Closed

RIF result not entered at EoD

Closed


17. Complete Functional Workflow

                 

18. Manual vs Automated Result Flow

The system should provide the same business outcome regardless of the result source.

                    TRUENAT TEST

                         │

              ┌──────────┴──────────┐

              │                     │

              ▼                     ▼

  1. Manual Entry B. Automated Flow

       Lab Technician       Truenat Device

              │                     │

              └──────────┬──────────┘

                         │

                         ▼

                  Result Captured

                         │

                         ▼

              Result-Based Workflow

                         │

          ┌──────────────┴──────────────┐

          │                             │

      MTB Result                    RIF Result

          │                             │

          ▼                             ▼

   Next Action Rules              Next Action Rules


 


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