Compliance & Accreditation · August 24, 2026
Before You Sign a Blood Bank Declaration
Before your authorised signatory signs a blood bank compliance declaration, obtain the actual state order and test every statement against records your centre can retrieve. At minimum, check the licence conditions, controlled SOPs, personnel authorisations, equipment files, donor and testing trails, inventory movements, issue records and every open deviation that could make a statement inaccurate. Build an indexed evidence pack, record who reviewed each item and place unresolved gaps in front of the signatory. Follow the wording, scope, deadline and prescribed format in the authority’s order before making any declaration.
Start with the actual state order
Get the complete order, circular or notice, including annexures and the prescribed declaration. Record its reference number, issue date, applicability, reporting period, deadline and required signatory. If your centre received only a forwarded message or an extracted form, obtain the issuing authority’s complete document before starting the review.
Turn each sentence in the declaration into a separate row in an evidence matrix. Copy the wording exactly, then assign an owner, identify the supporting records, set the review period and record whether the statement is supported. A broad sentence such as “all licence conditions are complied with” may require evidence from several departments.
Start with the licence your centre actually holds. Rule 122G provides for a licence in Form 28-C, or Form 28-E where blood products are manufactured. Its conditions require the licensee to maintain adequate staff, plant and premises, along with the records and registers specified in Schedule F Parts XIIB and XIIC.1
Schedule F Part XIIB supplies the statutory baseline for a blood centre’s accommodation, personnel, equipment, collection, processing, testing, storage, labelling and records.2 If the state order also refers to NABH, or your accredited centre wants one review to support both exercises, add the current NABH requirements as a separate column in the matrix. The current NABH standards address document control, personnel, equipment, process controls and quality records, but they do not replace the state authority’s declaration wording.3
Use a fixed sequence: obtain the order, map every clause, test the records, resolve or escalate exceptions, and then place the pack before the signatory. If a clause remains unsupported, follow the correction or escalation route in the order instead of silently treating it as complete.
Build the evidence pack by declaration line
Your pack should show more than the existence of a register or PDF. For each declaration line, identify the current controlling document, the operational records created under it and a sample that proves the control worked during the period covered.
| Area to check | Evidence to place in the pack | Failure the review should catch |
|---|---|---|
| Licence and conditions | Licence copy; conditions and endorsements; approved scope; application, renewal and authority correspondence from the licence renewal file | The declaration covers an activity, site or period that the file does not support |
| SOP approval and control | Master SOP list; approval signatures; effective dates; revision history; staff training; withdrawal of obsolete copies under your SOP control system | A technician followed a superseded version during the declaration period |
| Personnel | Appointment records; qualification and experience documents; duty rosters; role authorisations; training and competency records | A record was approved by someone whose authorisation had expired or was absent |
| Equipment and storage | Equipment master list; qualification records; calibration, maintenance and service files; temperature logs; breakdowns; linked cold-chain excursion records | An excursion appears in the temperature log without an affected-unit review |
| Donor and testing trail | Donor record; unit identifier; collection record; test worksheet; kit and reagent lot; result authorisation; status movement; supporting TTI testing records | The final status cannot be traced to an authorised result |
| Inventory and issue | Component record; location and status history; expiry; discard or transfer; request; crossmatch; issue entry; donor-to-recipient traceability where issued | The issue register and closing inventory give different answers for the same unit |
| Deviations | Incident or nonconformity record; investigation; immediate action; corrective action; effectiveness review; closure approval; open-item list | An open deviation contradicts a statement marked as fully supported |
Schedule F Part XIIB section L specifically names the blood donor record, master records for blood and components, the issue register, records of components supplied, anticoagulant-bag records, the diagnostic kit and reagent register, cross-matching reports issued to patients, transfusion adverse reaction records, and purchase, use and stock records for disposables.2 Use that list as the statutory spine of the pack, then add the records needed to prove each statement in the state declaration.
Verify the evidence by tracing and reconciling
A folder containing a donor register, a testing register and an issue register proves that three records exist. It does not prove that the entries agree. Select records from the declaration period and trace them across independent sources.
Trace selected units from collection to final status
For each selected unit, follow the identifier through donor registration, collection, testing, component preparation, inventory status and final issue, transfer or discard. Where components were prepared, the component separation record should preserve the relationship between the parent unit and each component.
Schedule F Part XIIB requires every donation to be tested for HIV-1 and HIV-2 antibodies, hepatitis B surface antigen, hepatitis C virus antibody, VDRL and malarial parasites.2 Your evidence sample should connect the unit identifier to the test record, kit or reagent details, authorised result and subsequent inventory status. An unexplained manual rewrite or missing status change belongs in the gap register.
Reconcile records created by different people
- Match donor and unit identifiers across the donor record, master record, test worksheet, component record and issue register.
- Match kit and reagent lots on testing records with the diagnostic kit and reagent register.
- Reconcile opening inventory, additions, issues, transfers and discards against closing inventory for the period selected.
- Connect each temperature excursion or equipment breakdown to the affected inventory review and deviation record.
- Compare signatures or user activity with duty rosters, training records and role authorisations.
Choose samples that can expose different control failures, including in-house and camp collections, prepared components, issued units, discarded units and records involving an excursion or corrected entry. The state order may prescribe a period or a specific evidence set. Where it does, follow that instruction instead of substituting your own sample.
Check that older records remain retrievable
Rule 122G requires testing records to be maintained for five years from the date of manufacture.1 Schedule F Part XIIB separately states that the records named in section L must be kept for five years, but its closing note does not name a start date.2 Do not borrow the two-year last-entry rule used for licences to sell drugs when reviewing blood-centre records.
Your blood bank record retention schedule should preserve both the required period and the links between records. Finding an old issue entry is insufficient if the corresponding master record or testing trail cannot be retrieved.
Put unresolved deviations in front of the signatory
Give every matrix row a controlled status. Use clear categories so that “documents collected” cannot be mistaken for “statement verified”:
- Supported: the required evidence was reviewed and agrees.
- Pending evidence: a record has been requested but has not been produced or checked.
- Contradicted: the available evidence conflicts with the proposed declaration.
- Not applicable: the declaration wording permits this status and the reason is documented.
A corrective-action plan shows that your centre has responded to a gap. It does not make an inaccurate declaration true on the signing date. Record the affected clause, period, units or records, immediate control, responsible person, target date, closure evidence and effect on the proposed declaration.
If the authority requires a binary declaration and your evidence does not support it, do not invent a qualification or alter the prescribed wording. Escalate the issue through the route stated in the order and seek written direction where the order does not explain how an exception must be handled.
Give the signatory a review, not a document bundle
Place a short control sheet at the front of the evidence pack. It should identify:
- the state order, annexure and declaration version reviewed;
- the centre, licence and period covered;
- each declaration clause and its evidence-matrix reference;
- the reviewers, departments and review dates;
- the sampling basis and records selected;
- every pending, contradicted or not-applicable item;
- the exact declaration placed before the authorised signatory.
If your centre uses RAKT, retrieve the relevant unit trails and registers with the report period, filters and extraction date visible. Software can produce the records, but your centre remains accountable for deciding whether those records support the declaration.
After signature, retain the issued order, completed matrix, evidence index, dated extracts or record references, gap register, internal approvals, authority correspondence and the signed declaration together. That file should let a later reviewer reconstruct what the signatory saw and why each statement was treated as supported.
A defensible declaration begins with the authority’s exact words and ends with retrievable evidence. If your centre cannot connect the two, the review is not ready for signature.