This document discusses cord blood banking standards in India. It provides information on Jeevan Blood Bank, an ISO and NABH accredited cord blood bank, and discusses the regulatory framework for cord blood banking in India set by the DCGI. The document outlines ICMR guidelines for cord blood banking, which cover licensing requirements, certifications, accreditations, screening tests, storage protocols, and comparisons to AABB, NETCORD and other international standards. Jeevan Blood Bank is working towards increasing its cord blood unit inventory to 5000 units by September 2014.

1. Cord Blood Banking Standards in
India
Dr. Saranya Narayan M.D.
Medical Director
Jeevan Blood Bank & Cord Blood bank
www.bethecure.in
ACBS - 03/03/2013

2. Jeevan Blood Bank
• 17 year old not for profit organisation - 1995
• ISO Certified since 1999
• NABH ACCREDITED since 2010 May
• Jeevan Cord Blood Bank – 2007
• ISO 9001 - 2000 certified since 2008
• Several of our processes in the stem cell lab
– NABH accredited.
• EQAS participation covers most of the
processes

3. INDIAN SCENARIO
Regulatory
Framework
DCGI
CORD BLOOD
BANK
Certifying /
GUIDELINES -
Accrediting
ICMR
agencies

5. Scope of the Guidelines
• Registration - Informed consent
• Cord Blood Collection
• Screening tests
• Quality assurance and control procedures
• Documentation
• Donor privacy
• Traceability
• Standard Operating Procedures

7. Licensing Scope
A. General Requirements – Location, premises
B. Cord Blood (CB)– Collection, transport and
storage
C. Personnel
D. Air Handling system
E. Quality Control
F. Screening tests
G. Storage
H. Reference samples
I. Labeling
J. Records / Documentation
K. CB release

8. Certifications & Accreditations
Certification
ISO
Accreditation
National – NABH / NABL
International - AABB & Netcord

9. Comparison of Standards (1)
AABB NETCORD INDIA JCBB
ID Screening Maternal Maternal and Cord Blood Maternal Maternal and CB
HBV, HCV, HIV, HTLV, CMV,
HBV, HCV, HIV,HTLV, HBV, HCV, HIV, HTLV, CMV, HBV, HCV, HIV, HTLV, CMV,
SYPHILIS + any locally
CMV, Syphilis, BACT & SYPHILIS, MALARIA, BACT SYPHILIS , MALARIA, BACT
applicable tests, BACT &
FUNGAL CULTURE & FUNGAL CULTURE & FUNGAL CULTURE
FUNGAL CULTURE
CB - Viability > 90 %
CB - Recovery > 85 %
CB - Sample obtained from
To be done prior to release for Can be outsourced - prior o Sample obtained at the end of
Hemoglobinopathy allogeneic donor or after
all allogeneic units release processing
screening processing
A, B, C, DRBI, & DQB1 - Class 1 and Class 2 – Low /
A , B, DRB1 - molecular molecular typing. DRB1 – High Can be outsourced - prior o Enhanced Res Molecular typing,
CB - HLA Typing
typing Res typing a must prior to release High Res outsourced prior to
release release for unrelated allogeneic
Outsourced - prior to release.
CB - CFU Prior to release At storage and prior to release
Being standardised

10. Comparison of Standards (2)
AABB NETCORD INDIA JCBB
REFERENCE
SAMPLES
2 vials of serum or non 1-2 vials of serum or non
Maternal serum / heparinised plasma stored in heparinised plasma stored in
NA NA
plasma cryo-vials at minus 20 0 C or cryo-vials at minus 20 0C or
lower lower
Material sufficient for at least 50
Maternal DNA NA NA To be started shortly
ug DNA stored
3 segments attached to the bag
2 segments attached to the
0 2 segments EACH of 100 ul must 0 must be frozen at -196 0C for all
bag frozen at -196 C for 2 Segments at - 196 C & one at
CB - Viable cells be frozen at -196 0C for required tests such as Counts,
confirmatory HLA typing / -700 C or lower
viability,CFU& HLA TYPING Viability, Confirmatory HLA
other tests
typing, & CFU
2 segments each containing 1 x
1 (last) segment attached to the
106 cells . One for viability stored
bag to be issued to the transplant
at -196 0 C and for tests other
centre with the CBU.
than viability at -70 0 C or lower.
CB DNA Sufficient to extract 50 ug DNA Sufficient to extract 50 ug DNA
One segment should be attached
CBU on release to the CBU at time of shipment
to transplant centre.

11. Storage endpoints
• The final product must have > 90% viability
with > 600x106 total nucleated cells.
• Final cell concentrations can range between
28-160 x 106/ml in final volume (~25ml) in
cryopreservation bag.
CCBB SOP
• Jeevan – Upward of 28 x 106 /ml ( ~25 ml)

12. Online Search Facility

13. Our journey so far…
• Units stored : Close to 600
• Requests received : 4 – 5 / week
• Matches 4/6 and above - 4
• Transplants –2 ( Sibling donor )

14. The Road ahead…..
To step up Jeevan’s inventory to
5000 before Sept 30th 2014

15. “When we do the best we can, we never
know what miracle is wrought in our life,
or in the life of another.”
Helen Keller