Key takeaways
- Eligible: hospital-based or standalone blood centres with a valid licence, operating for at least six months, with a valid fire NOC, biomedical waste agreement and pollution control certificate.
- Standards: 3rd Edition (June 2016) with amendments, including enrolment in the National Haemovigilance Programme and displayed processing charges.
- Ten NABH quality indicators; the first five (TTI rate, transfusion reactions, wastage, issue turnaround time and component QC failures) are reported to NABH every six months.
- Three-year accreditation with surveillance at 15–18 months. NABH fees by units collected a year: ₹10,000–₹40,000 application and ₹50,000–₹1,00,000 a year, plus GST.
The programme in brief
| NABH blood centre accreditation | |
|---|---|
| Standards | Blood Banks/Blood Centres and Transfusion Services, 3rd Edition (June 2016), with amendments |
| Who can apply | Hospital-based or standalone blood centres with a valid licence |
| Before applying | 6 months of operation; standards implemented for 3 months |
| Validity | 3 years; surveillance at 15–18 months |
| NABH fees | ₹10,000–₹40,000 application + ₹50,000–₹1,00,000 a year, by units collected |
Since the Drugs and Cosmetics Rules were amended in March 2020, the legal term is blood centre; NABH's documents use both names. The licence itself comes from the drug regulators, and our blood centre licence guide explains it. NABH accreditation sits on top of the licence.
Eligibility
NABH lists these conditions:
- a hospital-based or standalone blood centre with a valid licence;
- operating for at least six months when it applies;
- a valid fire NOC from the fire department or state government (Form B in Maharashtra);
- a valid biomedical waste agreement and pollution control board certificate;
- the standards applied to the whole blood centre, not to selected functions.
The centre implements the standards for at least three months before applying.
What the standards cover
The 3rd Edition has eleven sections:
| Section | What it covers |
|---|---|
| 1. Organisation and management | Legal identity, responsibility, ethics, quality management system, policies |
| 2. Accommodation and environment | Space for collection, components and apheresis, donation camps, environment control, safety |
| 3. Personnel | Qualifications of the medical officer, technicians, nurses, technical supervisor and counsellor; training, competence and records |
| 4. Equipment | Selection, validation, calibration, maintenance, storage equipment and computer systems |
| 5. External services and supplies | Supplier selection, inventory control and supplier evaluation |
| 6. Process control | Donor selection and counselling, collection, component preparation, storage, labelling, testing, compatibility testing, transfusion reactions, quality control and proficiency testing |
| 7. Deviations and adverse events | Handling non-conforming blood and components and preventing recurrence |
| 8. Performance improvement | Complaints, corrective and preventive action, continuous improvement |
| 9. Document control | Control, review and electronic documents |
| 10. Records | Identification, quality and technical records, retention periods |
| 11. Internal audit and management review | Audit and review procedures |
NABH's amendments to the 3rd Edition added, among other things:
- enrolment in the National Haemovigilance Programme of India, with regular reporting;
- display of processing charges for blood and components where the public can see them;
- assessment of fire and non-fire hazards and a fire mock drill at least once a year;
- policies on prevention of sexual harassment and on staff grievances;
- pre-donation counselling by trained staff, in privacy.
The ten quality indicators
NABH defines ten indicators and makes the first five mandatory: accredited blood centres report them to NABH every six months.
| # | Indicator | How NABH defines it |
|---|---|---|
| 1 | TTI % | Combined HIV, HBV, HCV, syphilis and malaria-positive cases ÷ donors × 100 |
| 2 | Adverse transfusion reaction rate | Reactions ÷ units issued × 100, classified as per the haemovigilance programme |
| 3 | Wastage rate | Units discarded ÷ units prepared × 100 |
| 4 | Turnaround time of blood issue | From receipt of request or sample to blood cross-matched and available, with separate limits for routine and emergency |
| 5 | Component QC failures | Failures ÷ components tested × 100, for each component |
| 6 | Adverse donor reaction rate | Donors with a reaction ÷ donors × 100 |
| 7 | Donor deferral rate | Deferrals ÷ (donations + deferrals) × 100 |
| 8 | Share of components | Component issues ÷ (whole blood + component issues) × 100 |
| 9 | TTI outliers | Assay deviations beyond ±2 SD ÷ batch assays × 100 |
| 10 | Transfusion delays | Delays beyond 30 minutes after issue, from a monthly sample audit |
Process, cycle and fees
The steps on NABH's programme page are: download the standards, buy the guidebook, implement for three months, apply online with documents and the fee, on-site assessment by NABH assessors, then the accreditation decision or corrective actions, followed by surveillance and renewal. Blood centres submit their quality manual with the application.
Accreditation is valid for three years. NABH conducts surveillance 15–18 months after accreditation and the centre applies for re-assessment six months before expiry.
| Units collected a year | Application | Annual |
|---|---|---|
| Up to 5,000 | ₹10,000 | ₹50,000 |
| 5,001–20,000 | ₹25,000 | ₹75,000 |
| More than 20,000 | ₹40,000 | ₹1,00,000 |
Plus 18% GST. A virtual assessment is ₹2,000, a focus assessment ₹15,000 and a certificate re-issue ₹6,000. The applicant also pays the assessors' travel and stay.
Where blood centres usually need work
- Traceability from donor to recipient for every unit and sample.
- Indicator data for the five mandatory indicators, collected every month well before the assessment.
- Equipment calibration and temperature records for refrigerators, platelet agitators and freezers.
- Haemovigilance: reporting transfusion reactions, not just recording them.
- Licence papers: the blood centre licence, fire NOC and waste agreement all current and in the centre's name.
A hospital that runs its own blood centre includes it in the scope of its NABH hospital accreditation, because NABH accredits every service a hospital offers on an all-or-none basis. Separate blood centre accreditation is a further, voluntary step.
Frequently asked questions
Can a blood bank get NABH accreditation?
Yes. NABH accredits hospital-based and standalone blood banks (blood centres) that hold a valid licence and have operated for at least six months. They also need a valid fire NOC (Form B in Maharashtra), a biomedical waste agreement and a pollution control board certificate, and must apply the standards across the whole centre.
Which NABH standard applies to blood centres?
NABH's Accreditation Standards for Blood Banks/Blood Centres and Transfusion Services, 3rd Edition (June 2016), with NABH's later amendments. They cover organisation and management, accommodation and environment, personnel, equipment, external services and supplies, process control from donor selection to transfusion, deviations and adverse events, performance improvement, document control, records, and internal audit and management review.
What quality indicators must an NABH-accredited blood centre report?
NABH defines ten indicators and requires accredited blood centres to report the first five to NABH every six months: transfusion-transmitted infection rate, adverse transfusion reaction rate, wastage rate, turnaround time for blood issue and component quality-control failures. The other five are adverse donor reactions, donor deferrals, the share of components, TTI outliers and delays in transfusion more than 30 minutes after issue.
What is the NABH fee for blood bank accreditation?
NABH sets fees by units collected a year: up to 5,000 units, ₹10,000 application and ₹50,000 a year; 5,001 to 20,000 units, ₹25,000 and ₹75,000; above 20,000 units, ₹40,000 and ₹1,00,000. A virtual assessment is ₹2,000, a focus assessment ₹15,000 and certificate re-issue ₹6,000, all plus 18% GST.
How long is NABH blood centre accreditation valid?
Three years. NABH conducts surveillance 15 to 18 months after accreditation, and the centre must apply for re-assessment six months before its accreditation expires.
Official sources
Fees and rules change. Always confirm on the official page before you apply.
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