TTI Testing Records: What Auditors Check

When an auditor selects a donor unit, you should be able to retrieve one linked trail showing the donor or unit identifier, matching sample, test run and controls, every reported TTI result, operator and reviewer, and final inventory disposition. Schedule F, Part XII-B supplies the mandatory testing and record framework.¹ NABH’s current blood-centre standards require controlled testing, traceability and authorised records.² A standalone result is incomplete when nobody can connect it to the sample, valid run, review and stock action.

A complete record is a linked evidence set

Schedule F, Part XII-B requires each donation to be tested for antibodies to HIV-1 and HIV-2, hepatitis B surface antigen, hepatitis C antibodies, syphilis and malarial parasites before use for transfusion.¹ Your testing record must account for every required marker against the correct donor or unit identifier.

For a blood bank audit, the evidence may sit across a worksheet, analyser output, control log, reagent register and inventory record. Each part needs a common identifier or run reference. Your wider Drugs and Cosmetics Act compliance controls depend on that connection.

NABH’s testing standards cover sample identification, controlled examination processes, quality control, result review and traceability.² CDSCO’s blood-bank inspection checklist also puts testing records beside reagent, control, equipment and disposal checks, so an entry cannot be assessed in isolation.³

Retrieve the trail in the order work occurred

Start with the unit selected by the auditor. Match its identifier to the sample, open the associated test run, show the kit and accepted controls, retrieve the recorded results and reviewer action, then match that evidence to the final inventory disposition. If any link fails, document the gap and check the unit’s status under your approved SOP.

This is the laboratory portion of donor-to-recipient traceability. A centre may trace the donation to inventory successfully and still fail at the testing stage because the analyser run was filed by date without a unit-level reference.

Test the reverse route as well. Select a run, identify every unit reported in it, and retrieve each unit’s result and disposition. Controlled testing requires that the evidence remain identifiable in both directions.²

What to capture for the sample and test run

Keep the identifier unchanged

Use the donor or unit identifier exactly as it appears on the collection and inventory records. If an analyser creates a separate sample number, retain an explicit cross-reference. Searching by donor name, collection date or tray position introduces guesswork into retrieval.

When staff correct an identifier, the record should preserve the original value, corrected value, person making the change, time and reason. An overwritten number leaves an assessor unable to establish which sample was actually tested.

Retain evidence that the run was controlled

Record the kit or reagent identity, lot number, expiry, test date, method or platform, run identifier and operator. Keep the actual control observations or analyser control report with the accepted or invalid status defined by your approved procedure.²

A kit lot in the reagent register does not automatically identify which units were tested with it. Connect the lot and control evidence to a run, then connect that run to its unit-level results. That link also lets an inspector compare test activity with reagent records during a licensing inspection.³

Preserve every reported result and review action

Show a distinct result for every mandatory TTI marker. Where your approved SOP leads to repeat or additional testing, preserve the original entry and link each later result instead of replacing the first one.

Reviewer action needs its own identity and date or timestamp. A shared login or unsigned batch printout cannot show who checked the result before the unit’s inventory status changed.

Match testing evidence to inventory disposition

Schedule F connects mandatory testing with whether a unit can proceed for transfusion use, while its record requirements cover issue and disposal evidence.¹ Your audit trail should therefore end at an inventory status, segregation entry or discard record that agrees with the laboratory evidence.

Three contradictions deserve an immediate records review:

• A unit entered tested stock before the reviewer action was recorded.
• A reactive or incomplete record remains under an available inventory status.
• A discarded unit has a disposal entry but no reference back to the test result.

These are often treated as separate laboratory and store-room problems. In practice, they create one broken evidence trail. Similar breaks appear among common blood inventory management mistakes when staff update a register but miss the corresponding system status.

Retain the whole trail, including corrections

The licence conditions under Rule 122G require the licensee to maintain the records and registers specified in Schedule F, and for the test records this article is about, that period runs five years from the date of manufacture.⁴ Schedule F Part XIIB puts the same five-year floor on the donor record, master record and issue register without naming a start date, so where a register stays open for years, holding it until five years after its final entry is prudence rather than the wording of the rule. Write down which of the two your retention policy follows, because an assessor may ask.

If a run report proves kit controls, keeping only the unit result removes part of the testing evidence. Include worksheets, analyser output, reagent and control references, review history and disposition links within your documented retention schedule. The blood bank record retention guide explains how the five-year floor applies across operational records.

NABH’s information-management requirements call for records to remain identifiable, legible, retrievable, protected and subject to controlled correction.⁵ On paper, preserve the original entry and identify the correction. In software, retain the audit history rather than allowing a replacement value to erase what staff first recorded.

Use one-unit retrieval as your daily check

You can turn the audit question into a routine records control:

• Make the donor or unit number the primary search key across collection, testing and inventory.
• Assign a run identifier that connects every result to its kit and control evidence.
• Require operator and reviewer identities instead of shared initials or logins.
• Preserve initial, repeat and corrected entries as a sequence.
• Reconcile the final inventory status with the reviewed laboratory record.
• Check discarded units as well as units in available stock.

Automation helps only when it preserves these links. An interface that imports a result but drops the run, control or reviewer context creates a cleaner-looking incomplete record. When you assess RAKT’s lab analyser automation, use this retrieval test: ask a technician to open one selected unit and produce the complete testing trail without relying on the person who performed the run.

Repeat the exercise with a discarded unit and a corrected result. If each route reaches the sample, run controls, complete panel, reviewer and matching disposition, your TTI testing records can answer the blood bank auditor’s question with evidence rather than explanation.

Sources

1. Drugs and Cosmetics Rules, 1945, Schedule F, Part XII-B, requirements for testing, records and disposal cdsco.gov.in
2. NABH Accreditation Standards for Blood Centres, 3rd Edition, Testing chapter nabh.co
3. CDSCO Blood Bank Inspection Checklist, current version, sections on testing, reagents, records and disposal no public URL
4. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
5. NABH Accreditation Standards for Blood Centres, 3rd Edition, Information Management System chapter nabh.co