SBTC Inspection vs NABH Assessment Checklist

Prepare two indexed evidence packs, even when both visits review many of the same registers. For an SBTC inspection, anchor the pack to the visit letter and the current circular or checklist issued by your State Blood Transfusion Council.¹ For an NABH assessment, map each document to the applicable clause in the current Accreditation Standards for Blood Centres.²

Keep one statutory core underneath both packs: your licence documents, Rule 122G conditions and the records named in Schedule F Part XIIB. The separate indexes matter. They let you answer the question each visiting team has actually come to examine, without maintaining two uncontrolled copies of the same record.

First confirm who is inspecting your centre

Read the visit letter before assembling files. Record the issuing body, purpose, cited instrument, inspection dates, scope and names of the locations covered. A letter from an SBTC should lead you to that council’s checklist, while an NABH assessment plan should lead you to the standards edition and assessment scope.

Do not treat every state-level visit as an “SBTC inspection”. Where the notice concerns grant or renewal of the blood centre licence, Rule 122-I says the licensing authority or Central Licence Approving Authority causes the establishment to be inspected. Inspectors examine the premises, equipment, processes, testing facilities and qualifications of technical staff.³

This distinction also determines who should answer an observation. An item raised under a state instruction belongs in your SBTC action log. A licensing observation should retain the rule or licence-condition reference, while an NABH nonconformity should retain the applicable standards clause.

Build the common statutory evidence pack

Rule 122G provides for the licence in Form 28-C, or Form 28-E where blood products are manufactured. Its conditions require your centre to maintain adequate staff, plant and premises, along with the records and registers specified in Schedule F Part XIIB and XIIC.⁴

Start with an authority tab containing the current licence, approved scope, relevant correspondence and any licence renewal documents. Follow it with staff qualifications and appointments, duty allocation, equipment records and an index showing where each Schedule F record can be retrieved.

Section L of Schedule F Part XIIB names the following blood centre records.⁵

Index these records by unit identifier wherever one applies. Your TTI testing records should connect the unit to the test entry and the relevant kit or reagent record. Likewise, component separation records should preserve the trail between the parent unit, components and subsequent stock or supply entries.

Schedule F Part XIIB says its listed records must be kept for five years, but its closing note names no start date.⁵ Rule 122G separately requires testing records to be maintained for five years from the date of manufacture.⁴ Your record-retention index should preserve that distinction instead of applying a last-entry trigger that the blood centre provisions do not contain.

Add the SBTC inspection overlay

Your state layer begins with the exact instruction issued for the visit. Put the issuing SBTC, circular or checklist title, reference number, date and revision on the cover. There is no reliable substitute for the instrument applicable to your own state and inspection.¹

Build a crosswalk with one row for every item in that instruction. Against each row, record the file name, register, reporting period, physical location or system report, document owner and status. If the instruction asks for a document outside the statutory core, add it to this overlay rather than silently treating it as a requirement for every blood centre in India.

• Visit authority: Letter, circular, checklist and stated scope.
• Statutory core: Licence documents, staff evidence and Schedule F records.
• State-requested submissions: The exact returns, acknowledgements or supporting records named in the instruction.
• Previous observations: Observation, assigned owner, action taken and closure evidence.
• Activity-specific files: For example, the relevant camp documentation trail when the state checklist includes outdoor collection activity.

Keep a clean copy of what you handed over or displayed. If the visiting team asks for an additional record, enter the request in a query log with the time, person responsible and document produced. That log helps you reconstruct the visit when the written observations arrive.

Add the NABH assessment overlay

NABH accredits blood centres through its Blood Banks and Blood Centres Accreditation Programme. Use the current standards edition available through NABH, confirm the edition against your assessment communication and map each applicable clause to controlled evidence.²

A useful NABH pack combines transaction records with evidence showing how your centre controls its processes. Keep the following sections behind the clause matrix:

• Assessment scope: Application, assessment plan, locations and services included.
• Controlled documents: Quality manual, applicable policies, SOP master list, approval records and revision history.
• Personnel: Qualifications, appointments, induction, training, competency evidence and assigned responsibilities.
• Equipment and environment: Equipment files, maintenance, calibration and monitoring records. Where an exception occurred, retain the investigation and action with your cold-chain excursion records.
• Quality-system evidence: Internal audits, identified nonconformities, corrective actions, management review records and monitored indicators.
• Process trails: Selected donor-to-issue records that can be followed across departments by unit identifier.
• Earlier assessment findings: Finding, clause, root-cause record, action and evidence of closure.

Place the clause number beside the evidence location, not just beside an SOP title. An approved procedure shows what staff were expected to do. The completed register, equipment record, competency record or action log shows what happened during the assessment period.

Use one record set with two indexes

Duplicating registers for each visit creates version problems. Maintain the source record once, then point both evidence-pack indexes to it.

Before either visit, select records from the stated scope and retrieve the complete trail. Check identifiers, dates, responsible staff, corrections, linked equipment or reagent records and the approved document version in force at the time. Record a missing link as a gap and close it through your normal corrective process; never recreate or backdate evidence.

If your centre uses RAKT, its compliance records and reports can support the common evidence pack. Your centre still has to select the applicable SBTC instruction, control the NABH clause map and account for every record presented during the visit.

Sources

1. Current inspection circular or checklist issued by the relevant State Blood Transfusion Council no public URL
2. NABH Accreditation Standards for Blood Centres, current edition nabh.co
3. Drugs and Cosmetics Rules, 1945, Rule 122-I cdsco.gov.in
4. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
5. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB, Section L cdsco.gov.in