Schedule F Part XIIB Blood Centre Records

Schedule F Part XIIB requires your centre to maintain nine record groups: blood donor records; master records for blood and components; the issue register; records of components supplied; anticoagulant-bag records; the diagnostic kits and reagents register; cross-matching reports issued to patients; transfusion adverse-reaction records; and purchase, use and stock records for disposables. Its closing note requires all nine groups to be kept for five years.¹ Build your register set around those named particulars. The Rules assign no numbered transaction form to these records, so a locally numbered register, worksheet or software screen is useful only when it reproduces the required record clearly.¹

The record map in Schedule F Part XIIB

Your register set sits within the blood-centre licensing framework established by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.² Rule 122G makes maintenance of the records and registers specified in Schedule F Part XIIB a condition of the licence.³

Use this map to compare the Schedule’s names with the work performed at your centre:

The first two columns follow the Schedule. Use the third as an internal retrieval test, not as additional statutory wording.

Walk through the records in workflow order

Donor selection and collection

Begin at the donor desk with the blood donor record. Open an earlier record before completing a returning donor’s registration, especially where a previous outcome needs attention. A deferral written in a separate notebook has little operational value if the registration team never sees it, so include your donor deferral records in this retrieval check.

Collection adds two record classes named separately by the Schedule: records of anticoagulant bags, and purchase, use and stock records for disposables.¹ Ask the collection and stores teams to produce both. A single stock balance does not show that both named record groups are available.

Testing

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.¹ Your register map must therefore cover the master records for blood and its components as well as the register of diagnostic kits and reagents used.¹

For a practical check, select one donation and retrieve its recorded results together with the relevant kit or reagent entry. The TTI testing record trail should still work after the unit has left current inventory.

Rule 122G gives testing records a specific retention condition: they must be maintained for five years from the date of manufacture.³ Keep that trigger visible in your retention schedule rather than assigning it from a general register convention.

Component preparation

The Schedule names master records for blood and its components.¹ Your local component separation record can sit beneath that master record, provided staff can follow the donation identifier into every component prepared from it.

Test the trail in both directions. Start with a donation and find its components, then start with one component and return to the donation record. Current stock alone is an incomplete test because it excludes components that have already been supplied or otherwise removed from available inventory.

Issue, supply and cross-match

At this stage the Schedule names three outputs: the issue register, records of components supplied, and the cross-matching report issued to the patient.¹ Treat them as separate items in your register index even when one system creates all three.

Pull one issued unit and ask the technician to produce every applicable output without reconstructing the event from loose slips. Your component dispatch record should preserve the unit trail when the supply moved beyond the immediate issue counter.

Transfusion adverse-reaction records

Transfusion adverse-reaction records are a named Schedule F Part XIIB record group.¹ For one completed case, retrieve the reaction file from the unit identifier and then return to the issue and cross-matching records. This is also the point where your blood transfusion inquiry records reveal whether the archive works as one trail or several unrelated files.

Apply the correct five-year retention rule

For blood bank record retention, Schedule F Part XIIB closes with the wording that the above records shall be kept by the licensee for a period of five years. The Schedule gives no general start date for that five-year period.¹

Testing records have the specific Rule 122G trigger: five years from the date of manufacture.³ Rule 65(7), which refers to two years from the last entry, governs licences to sell, stock or distribute drugs and defers where the Rules make a specific provision. It is not the retention rule for a blood centre’s Part XIIB records.⁴

Write these provisions separately in your archive SOP. If every register receives an automatic “five years from last entry” disposal date, your testing files can acquire the wrong clock.

Run a register-set gap check

A register index can look complete while one named record exists only as an uncontrolled worksheet. Run the check against actual outputs:

1. List every local record. Include bound registers, controlled worksheets, software reports and archived files.
2. Map each item to the nine groups. Record its owner, location and retrieval method.
3. Trace a completed donation. Follow donor selection, collection, testing, component preparation and issue where applicable.
4. Test the less frequent records. Retrieve a component-supply record and an adverse-reaction file where your centre has examples.
5. Repeat the test in the archive. A recent record proves current entry; an older record tests retention and retrieval.

One system may cover several named groups, while one group may use several controlled records. The useful question is whether your staff can produce each required view without guessing where part of the trail was filed.

If your centre uses RAKT’s compliance workflows, map the configured outputs to these nine groups and repeat the sample trace after a workflow change. Your centre remains accountable for completing, retaining and producing the records required as a condition of its licence.³

Sources

1. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB, including Section L cdsco.gov.in
2. Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 cdsco.gov.in
3. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
4. Drugs and Cosmetics Rules, 1945, Rule 65(7) cdsco.gov.in