NOTTO

TRANSPLANT
MANUAL

NATIONAL ORGAN AND TISSUE TRANSPLANT

ORGANIZATION
DIRECTORATE GENERAL OF HEALTH SERVICES
MINISTRY OF HEALTH & FAMILY WELFARE
GOVERNMENT OF INDIA
4TH & 5TH FLOOR, NIOP BUILDING
SAFDARJUNG HOSPITAL CAMPUS, NEW DELHl-110029
 NOTTO Transplant Manual

Editors

Dr. Krishna Kumar

Dr. Avnish Seth

Dr. Ravi Mohanka

Dr. Ashish Sharma

Dr. Vivek Kute

Dr. Archana Kumari

Dr. Amay Banker

 Table of Contents
Chapter Name Author Page
Section 1: Introduction and Overview
1 History and current status of organ donation and transplantation Dr. S K Mathur 1
2 Registration and renewal of a hospital or tissue bank Dr. Avnish Seth 22
3 Developing an organ donation program Dr. Avnish Seth 27
4 Overview of deceased donor transplantation Dr. Archana Kumari 35
Dr. Amay Banker 41
5 Overview of live donor transplantation
Dr. Ravi Mohanka
6 Setting up of organ transplantation center / tissue bank Dr. S K Mathur 43
Section 2: Abdominal Organ Transplants
7 Kidney transplant Dr. Vivek Kute 44
Dr. Ravi Mohanka 52
8 Liver transplant
Dr. Amay Banker
Dr. Ashish Sharma 62
9 Pancreas transplant
Dr Deepesh B Kenwar
10 Intestinal transplant Dr. Gaurav Chaubal 67
Dr. Vineet Mishra 72
11 Uterus transplant
Dr. Smit Bharat Solanki
Section 3: Thoracic Organ Transplants
12 Heart transplant Dr. Milind Hote 75
Dr. Unmil Shah 81
13 Lung transplant Dr. Shankarganesh K
Dr. Sandeep Attawar
Section 4: Tissue Transplantation and Banking
14 Vascularized Composite Tissue Transplants: Limbs / Hands Dr. Vinita Puri 88
15 Eye Banking and Corneal Transplantation Dr. Radhika Tandon 91
16 Skin Banking and Transplantation Dr. Sunil Keshwani 96
Dr. Rajesh Malhotra 99
17 Bone Banking
Dr. Vijaykumar Digge
18 Financial support for organ donation and transplant Dr. Anil Kumar 103
Appendix 1 Transplantation of Human Organs and Tissues Act (THOTA) 106
Appendix 2 Transplantation of Human Organs and Tissues Rules (THOTR) 122
Appendix 3 Legal Forms as Provisioned under THOTA Rules 2014 140
Appendix 4 Application form for Prime Minister National Relief Fund 164
Appendix 5 Application form for Rashtriya Arogya Nidhi 166
Appendix 6 Sample format for deceased donor information 169
Appendix 7 Photographs 171
 Contributions (Alphabetical)
Dr. Anil Kumar Dr. Krishnan Kumar
Director NOTTO Programme lead- National Organ
Ministry of Health and Family Transplant Program
Welfare, GOI Programme lead- National
Programme for Prevention &
Management of Trauma
Programme lead- BTS Program

Dr. Archana Kumari

Consultant NOTTO
Ministry of Health and Family
Welfare, GOI

Dr. Amay Banker Dr. Ashish Sharma

Clinical Fellow Professor and Head
Department of Hepatobiliary Sciences Dept of Renal Transplant Surgery
and Liver Transplantation PGIMER
Sir HN Reliance Hospital Chandigarh
Mumbai

Dr. Avnish Seth Dr. Deepesh Kenwar

Professor and Head Professor
Gastroenterology and Hepatology Dept of Renal Transplant Surgery
Manipal Hospital PGIMER
New Delhi Chandigarh

Head, Manipal Organ Sharing and

Transplant (MSOT)

Dr. Gaurav Chaubal Dr. Milind Hote

Director Professor
Multiorgan Transplant Surgery Department of Cardiovascular and
Global Hospital Thoracic Surgery
Mumbai AIIMS
New Delhi
Dr Radhika Tandon Dr. Rajesh Malhotra
Professor of Ophthalmology Clinical Lead and Senior Consultant
AIIMS Orthopedics
Delhi Indraprastha Apollo Hospitals
New Delhi
Chairperson National Eye Bank

Dr. Ravi Mohanka Dr. Sandeep Attawar

Director, Program director and Chair
Liver Transplant and HPB Surgery Thoracic Organ Transplantation
Sir HN Reliance Hospital KIMS Hospitals
Mumbai Hyderabad

Dr. Shankarganesh K Dr. Smit Bharat Solanki

Transplant Manager & Chief Department of Obstetrics and
Transplant Coordinator Gynecology,
Heart & Lung Transplant Program Nitya Maternity and Nursing Home,
KIMS Hospitals
Hyderabad Ahmedabad

Dr S K Mathur Dr. Sunil Keswani

President ZTCC Mumbai Plastic and Cosmetic Surgeon
Member Apex Technical Committee & Breach Candy Hospital
Digitalisation Committee NOTTO Mumbai

Member, Executive Committee, ROTTO Medical Director - National Burns

SOTTO west Centre

Dr. Vineet Mishra Dr. Vinita Puri

Director Professor and Head
Department of Obstetrics and Department of Plastic Surgery
Gynecology KEM Hospital
Institute of Kidney Diseases and Mumbai
Research Center
Dr. H L Trivedi Institute of
Transplantation Sciences
Ahmedabad
Dr. Vijaykumar D Dr. Vivek Kute
Additional Professor Professor
Faculty incharge of Bone Bank Nephrology and Transplantation
Department of Orthopedics Institute of Kidney Diseases and
AIIMS Research Center
New Delhi Dr. H L Trivedi Institute of
Transplantation Sciences
Ahmedabad

Dr. Unmil Shah

Consultant Transplant Pulmonologist
KIMS
Secunderabad
 Abbreviations
1. Appropriate Authority (AA)

2. Authorization Committee (AC)

3. Best Corrected Visual Acuity (BCVA)
4. Board of Medical Experts (BME)
5. Brain Death (BD)
6. Brain Death Committee (BDC)
7. Cavitronic Ultrasonic suction aspirator (CUSA)
8. Central Industrial Security Force (CISF)
9. Composite Tissue Allotransplantation (CTA)
10. Computed Tomography (CT)
11. Continuous Renal Replacement Therapy (CRRT)
12. Deceased Donor Liver Transplant (DDLT)
13. Director General of Civil Aviation (DGCA)
14. Director of Health Services (DHS)
15. Directorate General of Health Services (DGHS)
16. Donation after Brain Death (DBD)
17. Donation after Circulatory Death (DCD)
18. End Stage Liver Disease (ESLD)
19. End Stage Renal Disease (ESRD)
20. Endoscopic Retrograde Cholangiography (ERC)
21. Endoscopic Ultrasound (EUS)
22. Expanded Criteria Donors (ECD)
23. Extracorporeal Membrane Oxygenation (ECMO)
24. Eye Bank Training Center (EBTC)
25. Eye Retrieval Center (ERC)
26. Food and Drug Administration (FDA)
27. Forced Expiratory Volume in one Second (FEV1)
28. Forced Vital Capacity (FVC)
29. Global Observatory on Organ Donation and Transplantation (GODT)
30. High Efficiency Particulate Absorbing (HEPA)
31. Hospital Cornea Retrieval Process (HCRP)
32. Human Immunodeficiency Virus (HIV)
33. Human Leukocyte Antigen (HLA)
34. Intensive Care Units (ICU)
35. Intra-aortic Balloon Pump (IABP)
36. Intravenous Urogram (IVU)
37. Kerala Network for Organ Sharing (KNOS)
38. Langerhans Cell Histiocytosis (LCH)
39. Living Donor Liver Transplant (LDLT)
40. Living-Donor Lobar Lung Transplantation (LDLLT)
41. Lymphangioleiomyomatosis (LAM)
42. Magnetic Resonance Imaging (MRI)
43. Micturating Cystourethrogram (MCU)
44. Model for End-Stage Liver Disease (MELD)
45. Multi-Disciplinary Team (MDT)
46. National Organ and Tissue Transplant Organization (NOTTO)
47. National Organ Transplant Program (NOTP)
48. Non-Governmental Organizations (NGOs)
49. Non-Transplant Organ Retrieval Centers (NTORC)
50. Operating Theatres (OT)
51. Organ Retrieval and Banking Organization (ORBO)
52. Regional Organ and Tissue Transplant Organization (ROTTO)
53. State Organ and Tissue Transplant Organization (SOTTO)
54. Total Parenteral Nutrition (TPN)
55. Transplant Authority of Tamil Nadu (TRANSTAN)
56. Transplant Coordinator (TC)
57. Transplantation of Human Organs Act (THOA)
58. Zonal Coordination Committee of Karnataka (ZTCCK)
59. Zonal Transplant Coordination Committee (ZTCCs)
 Chapter 1: History and status of Organ Donation and Transplantation
Brief Introduction and common terminology
Transplantation is the process where a cell, tissue or organ (called graft) is transferred from one person
(the donor) to (a) another site either in the same person (auto-transplant) or (b) another individual (the
recipient). The recipient may be genetically identical – a twin (iso-transplant), another person of the
same species (homo-transplant / allo-transplant) or another species (xeno-transplant). The recipient’s
immune system does not react against auto or iso-transplants but mounts an immune response against
allo or xeno-transplants. Such an immunological response is called rejection and may be prevented or
controlled by medications that lower immunity (immunosuppressive medicines). If the patient’s immune
system does not mount a rejection response, it is called tolerance.

Most common type of transplants are allo-transplants. The organ may be donated by a deceased donor
(died due to either brain death or suffered a circulatory death) or a living donor. While heart and lungs
are always from deceased donors, kidneys, liver, and uterus transplants are performed either from living
or deceased donors. The graft may be placed at the anatomical location of the organ in the recipient
(orthotopic) (e.g. heart, liver, etc.) or in a different place (heterotopic) (i.e. kidney, pancreas).

Table 1: Mythological, religious, and historical literature of transplant

Year Landmark achievement
12th Century BC Lord Ganesha, the son of Parvati and Shiva was beheaded by his father while
guarding the bath of his mother. An elephant’s head was attached to Ganesha’s
body, bringing him back to life and making him the recipient of a successful xeno-
transplant.
2500 – 3000 BC Sushruta described techniques for skin grafts from a patient’s buttock or chin for
reconstruction of mutilated noses (auto-transplant).
400 BC Greek mythology mentions gods, heroes and beasts with chimeric anatomy.
Chimera di Arezzo was a monstrous fire-breathing creature with the head of a
lion, body of a goat, and backside of a snake.
310 BC Chinese physician Pien Chiao exchanged hearts between a man of strong spirit
but weak will and another man of weak spirit but strong will to achieve a balance
in both (allo-transplant).
st
1 Century AD Bible mentions:
● Jesus of Nazareth restored a servant’s ear that had been severed in battle by
Simon Peter
● Saint Peter reimplanted breasts of Saint Agatha who was injured by torture
● Saint Mark reimplanted a battle-amputated hand of a soldier
348 AD Jacopoda Varagine’s Leggenda Aura describes the replacement of the
gangrenous leg of the Roman deacon Justinian with the leg of a dead Ethiopian
man by Saints Damian and Cosmas, the ‘‘miracle of the black leg’’ (allo-
transplant).

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Photograph 1: Sushrutha widely regarded as the father of Indian cosmetic surgery.

Table 2: Modern History of Human Organ and Tissue Transplants Globally

Year Landmark achievement
1760 John Hunter transplanted teeth and coined the term “Transplant”.
1823 Carl Bunger performed the first successful skin transplant in Germany.
1881 Macewen described the use of allogenic bone tissue.
1905 Eduard Konrad Zirm performed the first successful corneal transplant in Olomouc,
Moravia, Czech Republic.
1912 Alexis Carrel (Nobel Prize) described the technique of vascular suturing and
anastomosis using fine needles and sutures at Rockefeller Institute, USA. He
demonstrated that autografts were successful, but homografts were not.
1933 Yuri Voronoy performed the first kidney transplant in Kiev, USSR using a kidney procured
6 hours after the donor’s death and transplanted it across a major blood group
mismatch.
1944 ● R Townley Paton established the world’s first eye bank in New York.
● First successful cadaveric skin transplant was performed at the Valley Forge General
Hospital, Pennsylvania.
1950 Richard Lawler performed a kidney transplant in Chicago which functioned for 2
months, but had to be removed after 10 months.

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1951 ● Kuss, Dubost and Bomget led two separate teams and performed 9 kidney
transplants by placing kidneys retroperitoneally. Eight donors were guillotined
criminals, none of whom survived. The 9th donor was the patient’s living mother,
wherein the graft was rejected after 3 weeks.

● Peter Medawar described that skin grafts between monozygotic twins were
tolerated.
1951 – 53 David Hume performed nine kidney transplants in Boston, USA from donors who had
died during surgery or had nephrectomy of a normal kidney to enable ventriculo-
ureteric shunt for treatment of hydrocephalus. One kidney functioned for 5.5
months before rejection.
1954 Joseph Murray and John Merrill performed the first successful living donor kidney
transplant between monozygotic twins (Nobel Prize).
1958 ● Jean Dausset (Nobel Prize) described the human leukocyte antigen (HLA).
● Joseph Murray treated 12 genetically non-identical kidney transplant patients with
sub-lethal total body irradiation (TBI), 11 of whom received bone marrow and died
within a month whereas the 1 patient who was not given bone marrow maintained
good graft function for 20 years.
● Jean Hamburger performed a kidney transplant between fraternal twins in Paris.
The patient died 26 years later with a functioning kidney.
● Gertrude Elion and George Hitchings developed 6-mercaptopurine (6-MP).
1960 – Jean Hamburger and Rene Kuss performed 4 successful transplants in non-twin
1962 recipients with TBI + steroids ± 6-mercaptopurine (6-MP).
1962 Gertrude Elion and George Hitchings (Nobel Prize) developed Azathioprine.
1963 ● Thomas Starzl observed > 70% 1-year renal graft survival using prednisone and
azathioprine in Denver, USA.
● Thomas Starzl performed the first liver transplant in Denver, USA.
● James Hardy performed the first lung transplant in Jackson, Mississippi.
1964 ● Terasaki developed the micro cytotoxicity assay for histocompatibility matching.
● Ralph Deterling performed the first intestinal transplant in Boston.
● Surgeons in Ecuador performed the first hand transplant, but without the benefit of
modern immunosuppression the allograft was rejected within a few weeks.
1966 ● Peter Medawar (Nobel Prize) induced tolerance by acquired chimerism to prevent
graft rejection in London.
● Richard Lillehei and William Kelly performed the first successful pancreas transplant
at the University of Minnesota.
1967 ● Thomas Starzl performed the first successful liver transplant in Denver, Colorado,
USA using ALS (anti-lymphocyte serum).
● Christiaan Barnard performed the first heart transplant in Cape Town, South Africa.
1968 ● Brain Death i.e. irreversible loss of brain function was accepted as death based on
Harvard ad hoc Committee’s recommendation.
● Uniform Anatomical Gift Act legalized organ / tissue donation for transplantation
in the USA.
● Denton Cooley performed the first heart-lung transplantation at Stanford, California.
1969 ● Denton Cooley implanted the first totally artificial heart as a bridge to transplant.
● Geoffrey Collins developed the Collins solution for cold preservation of kidneys.
1971 Fritz Derom performed the first successful lung transplant in Belgium.

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1972 Medicare funding was approved for dialysis of patients with end-stage renal disease
increasing widespread access.
1977 Hartmann Stahelin and Jean-Francois Borel from Basel, Switzerland discovered the
immunomodulatory properties of Cyclosporine.
1979 Roy Calne and Thomas Starzl (with steroids) reported significantly better transplant
outcomes with Cyclosporine.
1980 Collins' solution was modified by the Euro-transplant Foundation to produce the Euro-
Collins Solution.
1981 ● Shumway and Bruce Reitz performed the first successful heart-lung transplantation
at Stanford University, California.
● First monoclonal antibody against T lymphocytes (OKT3) was successfully used
clinically.
1983 ● The National Institutes of Health (NIH) accepted liver transplantation as a
therapy for patients with end-stage liver disease.
● Cyclosporine was approved by the Food and Drug Administration (FDA).
● Hans Sollinger at the University of Wisconsin described bladder drainage technique
for pancreatic transplants.
1984 Henri Bismuth performed a reduced size (left lobe) liver transplant.

1986 Joel Cooper performed the first successful double lung transplant.

1987 ● Folkert Belzer and James Southard introduced the University of Wisconsin (UW)
solution for organ preservation.
● Deltz performed the first successful intestinal transplant in Germany.
1988 ● First living donor liver transplant was reported by Silvano Raia from Brazil.
● David Grant performed the first successful liver-intestine transplant at London
Health Sciences Center, Ontario, Canada.
● Pichlmayr performed the first split-graft liver transplant.
1989 ● Russel Strong and Christoph Broelsch independently performed the first successful
left lobe living donor liver transplant in Australia and Chicago, USA at the same
time.
● Thomas Starzl reported further improvement in transplant outcomes with
Tacrolimus.
1990 First successful living donor lung transplant in Japan.

1994 ● Hashikura performed the first left lobe living donor liver transplant.
● Yoshio Yamaoka, performed the first adult right lobe living donor liver transplant
at Kyoto, Japan.
1995 Mycophenolate was FDA approved.

1997 ● Dacluzimab (anti-CD25) was FDA approved.

● Rituximab (anti-CD20) was FDA approved.
1998 ● Jean-Michel Dubernard and team performed the first successful hand transplant in
Lyon, France.
● Basiliximab (anti-CD25) was FDA approved.
1999 ● Sirolimus was FDA approved.
● Alemtuzumab (anti-CD52) was FDA approved.

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2000 Jean-Michel Dubernard and team performed the first double hand transplant.

2005 Bernard Devauchelle, Benoit Lengelé, and Jean-Michel Dubernard performed the first
successful partial face transplant.
2010 ● Juan Barret performed the first successful full-face transplant.
● Everolimus was FDA approved.
2011 Cavadas performed the first successful double leg transplant.

2014 First Uterus transplant successfully performed in Sweden.

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Photograph 2: Alexis Carrel described the technique for vascular suturing which awarded him the Nobel Prize

Photograph 3: John Murray who is credited with the first successful kidney transplant in history.

6
Photograph 4: Thomas Strazl performed the first successful liver transplant.

Photograph 5: Christiaan Bernard is credited with the first attempted heart transplant in the world.

7
Photograph 6: Dr. PK Sen performed the first deceased donor kidney transplant and the first heart transplant in
India.

Current status of organ donation and transplants globally

Data from 91 countries in the GODT (Global Observatory on Organ Donation and Transplantation),
suggests that in 2021, there were 38,156 deceased donations, out of which 29,611 were after brain
deaths and 8,545 were donations after circulatory death. Organs from deceased and living donations
led to ≈ 1,44,302 transplants (92,532 kidneys, 34,694 livers, 8,409 hearts, 6,470 lungs, 2,025 pancreas
and 172 intestines). Although there was a 10% increase in the number of transplants, it is estimated
that they served ≤ 10% of global needs. The mortality risk on the waiting list for these patients with
end-stage organ failure is estimated to be > 20%, therefore there is a need to increase the number of
organ donations and transplants across the world.

Table 3: History of Human Organ and Tissue Transplants in India

Year Landmark achievement
1948 Dr. RES Muthayya performed India's first corneal transplant at the Regional Institute of
Ophthalmology and Government Ophthalmic Hospital, Chennai
1965 Dr. PK Sen performed the first deceased donor kidney transplant at King Edward VII
Memorial (KEM) Hospital, Mumbai in May 1965
1968 ● Dr. PK Sen performed the first heart transplant at KEM Hospital, Mumbai
● Dr. RA Bhalerao performed the first liver transplant was performed by at KEM
Hospital, Mumbai
1971 Dr. Johny and Dr. Mohan Rao performed the first successful living donor kidney transplant
was performed by at Christian Medical College (CMC) Hospital, Vellore
1978 Dr. MH Keswani established the first skin bank (by storing and using skin of live patients
and donors) at Wadia Children’s Hospital in Mumbai
1990 First pancreas transplant was performed at Institute of Kidney Disease and Research
Center (IKDRC), Ahmedabad
1994 ● The Transplantation of Human Organs Act (THOA) was passed by the parliament.
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 Year Landmark achievement
● Dr. P Venugopal performed the first heart transplant at All India Institute of Medical
Sciences (AIIMS), Delhi on 3rd August 1994
1995 ● THOA Rules were published
1998 ● Dr. KC Tan performed the first successful cadaveric liver transplant at Apollo Hospitals,
Chennai on 5th November 1998
● Dr. MR Rajasekhar and Dr. Arvinder Singh Soin performed the first successful living
donor liver transplant on 15th November 1998
1999 ● First double-lung and first combined heart–lung transplants were performed at
Madras Medical Mission Hospital at Chennai in May 1999
● First deceased donor simultaneous pancreas kidney (SPK) transplant was performed at
IKDRC in Ahmedabad on 17th July 1999
2000 Dr. Madhuri Gore started the first Cadaveric Skin Bank in India at LTMGH, Sion, Mumbai
2004 First successful Simultaneous Pancreas Kidney Transplant was performed at AIIMS by Dr.
Sandeep Guleria
2007 First deceased donor Intestinal transplant was performed at Madras Medical Mission,
Chennai
2011 The THOA was amended to include tissues and other aspects
2012 Dr. AS Soin and Dr. Ravi Mohanka performed the first successful intestinal
transplant at Medanta, the Medicity, Gurgaon, India on 24th November 2012
2014 Revised Rules in accordance with THOTA 2014 published
2015 First bilateral hand transplant was done by Dr. Subramanium Iyer and team at Amrita
Institute of Medical Sciences at Kochi on 13th January 2015
2017 Dr. Shailesh Puntambekar performed the first living donor Uterus transplant at Galaxy Care
Private Hospital in Pune on 18th May 2017
2020 First combined deceased donor small bowel and abdominal wall transplant was performed
at Apollo Hospital in Chennai in March 2020
2020 Dr. Gaurav Chaubal performed the first successful living donor intestinal transplant at
Jupiter Hospital in Pune on 5th November 2020

Transplantation of Human Organs Act and Rules

Transplantation of Human Organs Act (THOA) was introduced in 1994 to regulate all transplant activities
in India, curb organ trading and enable deceased donor transplants (Appendix 1). The Act laid down the
regulatory framework with the following authorities, defined their composition and roles:

● Appropriate Authority (AA) to regulate hospitals and personnel related to organ and
tissue transplant, including granting license, monitoring, renewal and deregistration.
An Advisory Committee assists the AA.
● Board of medical experts for certification of brain death (commonly called as brain
death committee)
● Authorization Committee (AC) for scrutiny of living donor liver transplants

The Act defined all relevant terms, fixed the responsibility of all organ donation and transplant activity
with the registered medical practitioner and restricted organ donation for therapeutic purposes only.
The Act gives the AA powers equivalent to a civil court under the Code of Civil Procedure. While the Act
protects acts of good faith and outlines the appellate mechanism, it also defines penalties for any
offenses. The THOA was amended in 2011 to include tissues, the corresponding Rules (THOTR) were
published in 2014 (Appendix 2) https://notto.mohfw.gov.in/WriteReadData/Portal/images/THOA-
Rules-2014.pdf the differences with the amendment are highlighted in table below in table 4:
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Table 4: Updates in THOA Act and Rules
THOA 1994 & Rules 1995 THOTA 2011 & THOTR 2014
Cadaveric Donation
Brain death declaration Restricted to hospitals registered for Allowed in any hospital with ICU
organ transplantation
Non-Transplant Retrieval Not included Provision for NTROC added
Only Centers (NTROC)
Neuro-physician Mandatory for declaration of brain Not mandatory, Declaration of brain
/ Neuro-surgeon death death permitted by intensivist or
anesthetist
Counseling for organ Not mandatory Mandatory
donation
Medico-legal donations Complicated Simplified
Donor Maintenance and No clarity To be borne by the recipient or
Organ retrieval charges Institution or government or
non-government organization
Transplant coordinators in Optional Mandatory; qualifications specified
hospitals
Organ Procurement and Not included Mandate given to the Central
Distribution System Government to establish NOTP
Eye / Cornea procurement Not permitted Permitted
by trained technician
Provision for tissue Not included Included
donation, tissue
transplantation and Tissue
Bank
Living Donation
Near Relative Definition Restricted to parents, siblings, Expanded to include grandchildren
spouse and children and grandparents
Swap Donation Not included Included
Other Amendments
Penalty Penalty of up to 10 years or Rs. 20 Provision for higher penalties (up to
lakhs 10 years or minimum Rs. 1 crore)

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Table 5: Court judgements and government orders (GOs) related to organ donation and transplant.
Issuing Authority, Highlights
Year
Principal Secretary, The GO outlines the procedures for brain death certification, clarifies
Government of Kerala certain technical aspects of the same, including the role of ancillary tests
2020 and ability and clarifies that the cardiorespiratory support may be
discontinued after
brain death certification
st
High Court of Delhi1 Sadhna Bhardwaj vs. Department of Health & Family Welfare. The court
September 2011 ruled that the NOC could be issued even if the donor and the recipient
W.P.(C) 6105/2011 may not be related to each other

High Court of Andhra Smt. Kamala Devi vs. The Director of Medical Education & Chairman,
Pradesh, 30th March Authorization Committee for Organ Transplantation, Hyderabad.
2009 W.P.(C) Authorization Committee approval is required only from the place of
5618/2009 intended transplant and not from the Authorization Committee of the
place of domicile of donor or recipient
High Court of Madras Dr. M. Anoop Vs. State of Tamil Nadu. Authorization Committee approval
2009 is required only from the place of intended transplant and not from the
MANU/TN/2691/2009 Authorization Committee of the place of domicile of donor or recipient
High Court of Gujarat Vidya Ramesh Chand Shah vs. State of Gujarat
2022 The court ruled that patients should be registered for a cadaveric
transplant without the need for a domicile certificate
2016 (9) SCC 749 State of Uttar Pradesh and others v. Dinesh Singh Chauhan
There cannot be two waiting lists in one state
2018 SC Constitution Bench holds passive euthanasia, living wills permissible.
Right to dignity includes right to refuse treatment and die with dignity
2022 SC judgment eases procedures for terminally ill patients to withdraw
medical treatment

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National Organ Transplant Program (NOTP) and National Organ andTissue
Transplant Organization (NOTTO)
The THOA mandated establishing the National Organ Transplant Program (NOTP) and the transplant
registry. The NOTP was launched in 2013 under which the National Biomaterial Center (Tissue Bank) and
the National Human Organ and Tissue Removal and Storage Network were set up. The National Organ
and Tissue Transplant Organization (NOTTO) is the apex organization set up under the Directorate
General of Health Services (DGHS), Ministry of Health and Family Welfare at New Delhi. NOTTO directly
monitors and coordinates all transplant activities in Delhi NCR and through the 5 Regional Organ and
Tissue Transplant Organization (ROTTO) and 35 State Organ and Tissue Transplant Organization (SOTTO)
levels organizations (ROTTO: NOTTO: Rotto Details (notto.mohfw.gov.in) across India.

The NOTP envisages financially supporting additional regional and state level centers. It also aims to set
up new organ transplant and retrieval facilities, train and hire transplant experts especially at medical
colleges and trauma centers. Moreover, it also plans to support donor families for funeral and transplant
patients for immunosuppressive drugs. NOTTO and the network disseminate information about organ
donation to public through their website (https://notto.mohfw.gov.in) a 24x7 tollfree helpline
(1800114770) and awareness programs such as seminars, workshops, debates, sports events,
walkathons, marathons, nukkad nataks, social media platforms and an annual celebration of the Indian
Organ Donation Day.

Current status of organ donation and transplants in India

Although the THOA and Rules provided the legal backing for both deceased donor and living donor
transplants, they were few and far between, due to limited expertise, infrastructure and deceased organ
donation and allocation systems in India. Several non-governmental organizations (NGOs) voluntarily
took up this cause, promoted cornea donation, brain death, organ donation, transplant coordinators
training and set up allocation systems in parts of India. Organ Retrieval and Banking Organization (ORBO)
in Delhi, MOHAN Foundation in Chennai and several others started organ donation awareness
campaigns and transplant coordinator training programs. Similarly Zonal Transplant Coordination
Committee (ZTCCs) in Maharashtra, Zonal Coordination Committee of Karnataka (ZCCK), Transplant
Authority of Tamil Nadu (TRANSTAN), Kerala Network for Organ Sharing (KNOS), Jeevandan in Telangana
and many others started organ allocation systems. Many government and private hospitals started
kidney transplant programs and established cornea, tissue and bone banks. After the initial success,
many hospitals started liver, heart, lungs, pancreas and intestinal transplant programs.

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 Currently India performs the 3rd largest number of organ transplants (about 9%), and the largest
number of living donor transplants in the world (Table 6, 7).

Figure 1: Proportion of all transplants done globally (only includes countries with more than 1000
transplants / year)
Iran (Islamic Mexico, 2,141 , 2% Argentina, Saudi Arabia, 1,541 ,
Japan, 2,393 , 2%
Australia, Republic of), 1,902 ,
1% 1% 1,466 ,
2,885 , 2% Canada, 2,857 , 2% 1%
Germany, 3,561 , 3%
Italy, 3,902 , 3%
Republic of Korea, United States of
4,126 , 3% America, 43,037 , 34%
United
Kingdom, Spain, 4,850 , 4%
4,283 ,
3%

Turkey,
4,952 , China, 19,386 , 15%
4%
India, 12,277 , 10%
France,
5,346 , 4%
Brazil, 7,205 , 6%

Comparative numbers are given in Table 4 (https://www.transplant-observatory.org/).

Table 6: Comparative numbers of transplantation between India and the global scenario
2019 2020 2021
Data presented as absolute numbers India Global (data from India Global (data from India Global (data from
(pmp) in brackets 84 countries) 93 countries) 79 countries)
Actual deceased donors (DD) 715 (0.52) 41,686 (7.00) 351 (0.25) 36,100 (5.8) 552 (0.4) 37,653 (6.86)
Actual DD after brain death (DBD) 715 (0.52) 32,444 (5.45) 347 (0.25) 27,934 (4.49) 552 (0.4) 29,111 (5.31)
Actual DD after circulatory death (DCD) (-) 8,999 (1.51) 4 (0) 8,166 (1.31) (-) 8,503 (1.55)
Total kidney transplants 9,751 (7.12) 102,403 (17.18) 5,486 (3.98) 80,926 (13) 9,105 (6.53) 89,244 (16.27)
Deceased kidney transplants 1,138 (0.83) 64,091 (10.75) 516 (0.37) 55,258 (8.88) 830 (0.6) 56,487 (10.30)
Living kidney transplants 8,613 (6.29) 38,312 (6.43) 4,970 (3.6) 25,668 (4.12) 8,275 (5.94) 32,755 (5.97)
Total liver transplants 2,592 (1.89) 36,745 (6.16) 1,780 (1.29) 32,586 (5.24) 2,847 (2.04) 33,105 (6.03)
Deceased liver transplants 599 (0.44) 28,131 (4.72) 291 (0.21) 25,285 (4.06) 482 (0.35) 26,333 (4.80)
Living liver transplants 1,991 (1.45) 7,610 (1.28) 1,487 (1.08) 6,663 (1.07) 2,363 (1.7) 6,748 (1.23)
Heart transplants 187 (0.14) 8,848 (1.48) 89 (0.06) 8,101 (1.3) 151 (0.11) 8,232 (1.50)
Lung transplants 114 (0.08) 6,807 (1.14) 67 (0.05) 5,940 (0.95) 133 (0.1) 6,301(1.15)
Pancreas transplants 22 (0.02) 2,352 (0.39) 14 (0.01) 1,970 (0.32) 19 (0.01) 1,986 (0.36)
Small bowel transplants (-) 146 (0.02) 7 (0.01) 158 (0.03) 4 (0) 172 (0.03)
Total organ transplants 12,666 (9.25) 157,301 (26.39) 7,443 (5.39) 129,681 (20.84) 12,259 (8.8) 139,040 (25.34)

13
Although the overall number of transplant centers, organ donations, kidney, liver, heart and lung
transplants are increasing every year, there are a lot of geographic variations in the overall number of
organ donations and various types of transplants across the country (Figures below).

Figure 2: Density of transplant centers and deceased donor transplantation in India

14
Figure 3: The year wise trend of deceased donation in

15
Figure 4: The year wise trend of total transplantations in

Figure 5: Year wise trend of heart, lung, pancreas and small bowel transplantation in India

16
Table 7: Total number of living donor transplants globally in 2021 (only countries with total >
transplants / year)

Country Kidney Liver Total

India 8275 2363 10638

United States of America 5971 567 6538
Turkey 3077 1387 4464
China 2462 811 3273
Republic of Korea 1480 1157 2637
Japan (includes 19 living donor lung transplants) 1647 361 2027
Mexico 1499 11 1510
Saudi Arabia 953 355 1308
Pakistan 1003 131 1134
Iran (Islamic Republic of) 682 100 782
United Kingdom 733 21 754
Canada 502 93 595
Germany 475 54 529
France 502 20 522
Netherlands 452 28 480
Brazil 337 50 387
Italy 341 36 377
Israel 327 9 336
Spain 323 1 324
Syrian Arab Republic 315 0 315
Argentina 221 40 261
Philippines 256 0 256
Bangladesh 228 0 228
Colombia 145 69 214
Sudan 205 0 205
Australia 202 1 203
Jordan 197 3 200
Nigeria 199 0 199
Sri Lanka 172 3 175
Kazakhstan 124 37 161
Kenya 160 0 160
Switzerland 122 2 124
Sweden 118 1 119
Thailand 81 32 113

17
Figure 6: Year wise trend of deceased donor kidney, live donor kidney and total kidney transplantation
in India

Figure 7: Year wise trend of deceased donor liver, live donor liver and total liver transplantation in India

18
Figure 8: Density of various organ transplantation in

India

Despite the increasing and large number of transplants in our country, we are unable to meet
the needfor the even larger and increasing number of patients who need organ transplants (Table 8).
The estimated need is largely perceived, but the actual need may not be very different. There are
opportunities to increase organ donation and transplant activities in underserved regions and
government hospitals.

Table 8: Estimated / perceived need for various organ transplantation in India.

Kidney Liver Heart Lung Pancreas Intestine
Estimated need 1,75,000 40 – 50,000 50,000 50,000 2,500 1,000
Current transplants (2022) 11,423 3,718 250 138 24 4
Number of registered centers 579 231 155 86 56 22
Estimated % in public sector 20% < 5% < 5% < 5% < 10% < 5%
Type of donor LL>>>DD LL>>>DD DD DD DD DD > LD

The NOTTO is committed to achieving self-sufficiency in transplants, transplant registry and uniform
patient registration and organ allocation policies. Transplants in India also provide a very good balance
between cost and quality compared to most countries and is therefore the preferred destination for
international transplant tourism from countries in the Indian sub-continent (Pakistan, Bangladesh, Sri
Lanka, Myanmar, Nepal, Mongolia), Middle East (Oman, Saudi Arabia), Africa (Kenya, Tanzania, Nigeria,
Sudan) and Commonwealth of Independent States countries (Uzbekistan, Tazakistan) and many others.

Chapter 1 References
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3. Singh V. Sushruta: the father of surgery. Natl J Maxillofac Surg. 2017; 8(1):1–3.
4. DeVaragine J. Legenda Aurea. Leipzig: Impensis Librariae Arnoldiane; 1850.)
5. Kristen D. Nordham, BA and Scott Ninokawa, BS. The history of organ transplantation. PROC
(BAYL UNIV MED CENT) 2022;35(1):124–128.

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6. C. J. E. Watson and J. H. Dark. Organ transplantation: historical perspective and current
practice. British Journal of Anaesthesia 2012;108 (S1): i29–i42.
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transplantation in modified recipients. Ann Surg. 1962;156(3):337–355.
8. Hardy JD, Webb WR, Dalton ML Jr, Walker GR Jr. Lung homotransplantation in man. J Am Med
Assoc 1963; 186: 1065–74
9. Welch C. A note on transplantation of the whole liver in dogs. Transplant Cull. 1955;2:54–55
10. Starzl TE, Demetris AJ. Liver transplantation: a 31-year perspective. Part I. Curr Probl Surg.
1990;27(2):49–240
11. Starzl TE, Marchioro TL, Vonkaulla KN, Hermann G, Brittain RS, Waddell WR.
Homotransplantation of the liver in humans. Surg Gynecol Obstet. 1963;117:659–676
12. Starzl TE, Groth CG, Brettschneider L, et al. Orthotopic homotransplantation of the human liver.
Ann Surg. 1968;168(3):392–425.
13. Calne RY, Williams R, Dawson JL, et al. Liver transplantation in man. II. A report of two orthotopic
liver transplants in adult recipients. Br Med J 1968; 4: 541–6.
14. Barnard CN. The operation. A human cardiac transplant: an interim report of a successful
operation performed at Groote Schuur Hospital, Cape Town. S Afr Med J. 1967;41(48):1271–
1274.
15. Dubernard JM, Petruzzo P, Lanzetta M, et al. Functional results of the first human double-hand
transplantation. Ann Surg. 2003;238(1): 128–136. doi:10.1097/01.SLA.0000078945.70869.82.
16. Barret JP, Gavalda J, Bueno J, et al. Full-face transplant: the first case report. Ann Surg.
2011;254(2):252–256.
17. Squifflet, Jean-Paul & Gruessner, Rainer & Sutherland, D. (2008). The History of Pancreas
Transplantation: Past, Present and Future. Acta chirurgica Belgica. 108. 367-78.
18. Guleria S, Aggarwal S, Bansal VK, Varma MC, Kashyap L, Tandon N, Mahajan S, Bhowmik D,
Agarwal SK, Mehra NK, Misra MC. The first successful simultaneous pancreas-kidney transplant
in India. Natl Med J India. 2005 Jan-Feb;18(1):18-9.
19. Hamilton DNH, Reid WA. Yu Yu Vjronoy and the first human kidney allograft. Surg Gynecol
Obstet 1984;159:289-94
20. Kuss R, Teinturier J, Millieez P. Quelques essais de greffe rein chex l'homme. Mem Acad Chir
1951;77:755-64.
21. Dubost C, Oeconomos N, Nenna A, et al. Resulstats d'une tentative de greffe renale. Bull Mem
Soc Med Hop Paris 1951;67:105-6.
22. Michon L, Hamburger J, Oeconomos N, et al. Une tentative de transplantation renale chez
l'homme aspects medicaux et biologiques. Presse Med 1953;61: 1419-23.
23. Merrill JP, Murray JE, Harrison JH, et al. Successful homotransplantation of the human kidney
between identical twins. JAMA 1956;160:277-82.
24. Murray JE, Merrill JP, Dammin GJ, et al. Study of transplantation immunity after total body
irradiation. Clinical and experimental investigation. Surgery 1960;48:272-84.
25. Murray JE, Merrill JP, Dammin GJ, et al. Kidney transplantation in modified recipients. Ann Surg
1962;156:337-55.
26. Merrill JP, Murray JE, Harrison JH, et al. Successful homotransplantation of the kidney between
non-identical twins. N Engl J Med 1960;262:1251-6.
27. Hamburger J, Vaysse J, Crosnier J, et al. Transplantation of a kidney between non-monozygotic
twins after irradiation of the receiver: good function at the fourth month. Presse Med
1962;67:671-4.
28. Starzl TE, Groth CG, Brettschneider L, et al. Extended survival in 3 cases of orthotopic liver
homotransplantation of the human liver. Surgery 1968;63(4):549-63.

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29. Barnard CN. The operation. A human cardiac transplant: an interim report of a successful
operation performed at Groote Schuur Hospital, Cape Town. S Afr Med J 1967;41(48):1271-4.
30. Kelly WD, Lillehei RC, Merkel FK, et al. Allotransplantation of the pancreas and duodenum along
with the kidney in diabetic nephropathy. Surgery 1967;61(6):827-37.
31. Hardy JD, Webb WR, Dalton ML Jr. Lung homotransplantations in man. JAMA 1963;186:1065-
72.
32. Cooley DA, Bloodwell RD, Hallman GL, et al. Organ transplantation for advanced
cardiopulmonary disease. Ann Thorac Surg 1969;8(1):30-46.
33. Cooper JD, Pearson FG, Patterson GA, et al. Technique of successful lung transplantation in
human. J Thorac Cardiovasc Surg 1987;93(2):173-81.
34. Cooper JD, Patterson GA, Grossman, et al. Double-lung transplant for advanced chronic
obstructive lung disease. Am Rev Respir Dis 1989;139(2):303-7.
35. Bergan A. Ancient myth, modern reality: a brief history of transplantation. J Biocommun.
1997;24(4):2-9.
36. Shayan H. Organ transplantation: from myth to reality. J Invest Surg. 2001;14(3):135-138
37. Carrel A. The operative technique for vascular anastomoses and transplantation of viscera. Lyon
Med. 1902;98:859.
38. Carrel A, Guthrie CC. Functions of a transplanted kidney. Science. 1905;22(563):473
39. Ono SJ. The birth of transplantation immunology: the Billingham-Medawar experiments at
Birmingham University and University College London. 1951. J Exp Biol. 2004;207(pt 23):4013-
4014.
40. Moffatt SL, Cartwright VA, Stumpf TH. Centennial review of corneal transplantation. Clin
Experiment Ophthalmol 2005;33:642-57
41. Linden PK. History of solid organ transplantation and organ donation. Crit Care Clin 2009;25:165-
84.
42. Barker CF, Markmann JF. Historical overview of transplantation. Cold Spring Harb Perspect Med
2013;3:a014977
43. Kelly WD, Lillehei RC, Merkel FK, Idezuki Y, Goetz FC. Allotransplantation of the pancreas and
duodenum along with the kidney in diabetic nephropathy. Surgery 1967;61:827-37.
44. Ortega F. Organ Transplantation in the 21st Century. In stem cell transplantation. In:
López?Larrea C, López?Vázquez A,Suárez?Álvarez B, editors. Germany: Springer Science; 2012.
45. Dubernard JM, Lengelé B, Morelon E, Testelin S, Badet L, Moure C, et al. Outcomes 18 Months
after the First Human Partial Face Transplantation. N Engl J Med 2007;357:2451-60

21
 Chapter 2: Registration and renewal of a hospital or tissue bank

To be a part of the organ donation, tissue bank or transplant program, it is necessary to first register the
hospital / facility with the state AA. Registration can be done as either of the following:

1. Transplant Center: For any hospital wishing to undertake organ transplantation.

2. Non-Transplant Organ Retrieval Centers (NTORC): For hospitals wishing to partake in deceased
donor organ donation only. These centers are not authorized to perform transplant surgery
itself.
3. Tissue Bank other than cornea: For centers aiming to function as tissue banks such as skin
bank, bone bank, etc.
4. Corneal transplantation, cornea retrieval and eye bank: For hospitals and centers wishing to
perform corneal transplantation or function as an eye / cornea bank.

Figure 1: A flowchart of the registration process

Sensitize hospital administration, doctors and nurses

towards the need for organ or tissue transplantation /

Apply
for Registration Transplant
Center - Form 12
Nontransplant Organ Retrieval
Center - Form 13 Tissue Bank other than

Inspection of

Receive registration

Apply for renewal after 5

22
 How to register a hospital as a transplant center
A hospital registered under the Clinical Establishment (Registration and Regulation) Act can apply for a
transplant center license to perform organ retrieval and transplant surgery. The process of registration
is as follows:

● Fill FORM 12 and submit to the state AA or Director of Health Services (DHS) office as
appropriate.The information required to fill form 12 includes:
○ Annual hospital budget, specialties available in-house, number of beds, annual patient
turnover, number of surgeries done per year.
○ Number of routine, emergency, and transplant operating theater (OT) s and
anesthesia machines
○ Laboratory / radiology / hematology equipment, staff and investigations performed.
○ Dialysis
○ Access to, or inhouse blood bank
○ Temporary, permanent, and trained surgical / anesthesia / intensive care (ICU) /
dedicated transplant / ICU nurses and technicians.
○ Transplant coordinators
○ Availability of nephrologist, neurologist, Urologist, gastrointestinal surgeon,
Pediatrician, physiotherapist, social worker, cardiologist, immunologist, pulmonologist,
and others.
● Once the form is submitted and the application fees are paid (ten thousand is prescribed in
THOTR, although currently variable fees are charged in each state or union territory at the
discretion of the respective AA [Rule 24]), the AA appoints an inspection team that visits the
hospital, scrutinizes relevant documents of the hospital, transplant teams and documents of
association with other organizations, meets key transplant team members, and visits relevant
facilities at the hospital. They generally look for the following during the visit (as per Rule 26 of
THOA):
○ Availability of medical, surgical, anesthesia, intensive care, and nursing staff including
one medical expert for respective organ or tissue transplant. The qualifications of
organ specific experts are defined in THOA (Rule 27), although having a dedicated full-
time in-house team is not mandatory, may be desirable.
○ Availability of experts in internal medicine, diabetology, gastroenterology, nephrology,
neurology, pediatrics, gynecology, immunology, cardiology, etc.
○ A dedicated transplant coordinator.
○ Adequately equipped and staffed ICU, blood bank (in house or access), OTs
○ Adequately equipped and staffed microbiology, hematology, biochemistry laboratories
○ Human Leukocyte Antigen (HLA) laboratory and tissue crossmatch facilities (in house
or outsourced).
○ Radiology department with availability of appropriate imaging modalities, experts and
staff.
○ Communication systems with power backup.
● Once the facilities are deemed appropriate by the inspection team, a certificate of registration
(Form 16), valid for five years, is granted to the hospital. The center can then register patients
for deceased donor transplants on the waiting list and perform both deceased donor and living
donor transplants of that organ.

How to register a hospital as a Non-Transplant Organ Retrieval Center?

Centers that wish to conduct organ donations, but not the transplant surgery itself can register as
NTORCs, the requirements for which are fewer.

23
 ● Centers wishing to register as NTORC must fill From 13 and submit to appropriate DHS.
Information required to fill form 13 includes:
○ Annual hospital budget, specialties available in-house, number of beds, annual patient
turn-over.
○ Availability of surgical, anesthesia, intensive care, and nursing staff and trained personnel
for retrieval.
○ Availability of staff who have completed NOTTO certified course on transplant
co- ordination.
○ Availability of OTs, anesthesia machines.
○ Availability of trained ICU staff.
○ Number of surgeries done, critical trauma cases admitted and brain-dead declarations per
year.
○ Adequately equipped and staffed microbiology, hematology, biochemistry laboratories.
○ Access to, or in-house blood bank.
○ Other supportive facilities.
● There are no application fees for registering as a NTORC (Rule 24).
● Once the form is submitted the AA will appoint an inspection team to visit the site. Generally,
the inspection team scrutinizes documents of the hospital, key team members, documents of
association with other organizations and visits all key facilities at the hospital. The inspection
team looks for the following at the hospital visit (per Rule 27 of THOA):
○ Availability of OT to perform the retrieval.
○ Availability of trained personnel (physician, intensivist, surgeon) to maintain the brain-
dead person and perform the retrieval.
○ Facilities for temporary storage and transport of the organ.
○ Tied up with nearby government hospital for post-mortem in medicolegal deaths.
○ A dedicated transplant coordinator.
● Once the facilities are deemed appropriate by the inspection team, a certificate of registration
(Form 16), valid for 5 years, is granted to the hospital. Once a certificate of approval is granted,
the center can apply for approval of a brain death committee to state AA. Once approved, the
NTORC is authorized to declare brain stem death and undertake organ retrieval.

How to register a tissue bank (other than cornea)?

Centers who wish to function as tissue banks (e.g. skin bank or bone bank) should apply as under:

● Fill Form 14 and submit to appropriate DHS. Information required to fill form 14 includes:
○ Details of available personnel / technicians qualified for tissue removal.
○ Facilities and instruments for removal / processing and storage of tissues.
○ Containers and preservation media for transport and storage.
○ Availability or access to a laboratory for tests such as Human Immunodeficiency Virus
(HIV) / Hepatitis B core and HBsAg / Hepatitis C / Syphilis / culture and sensitivity
● Once the form is submitted and the application fees are paid (ten thousand is prescribed in
THOTR, although currently variable fees are charged in each state or union territory at the
discretion of the respective AA [Rule 24]), the AA will appoints an inspection team to visit the
site who scrutinizes documents of all key team members and the facility, documents of
association with other organizations, review the protocols, selected case files, visit key
facilities at the tissue bank and looks for the following (per Rule 28 of THOA)
○ Written guidelines and standard operating procedures for procurement of tissues,
maintenance of its premises and facilities, and for record documentation and quality
control procedures.
○ Equipment specific to tissue being procured, processed and stored.
○ Facilities for relevant laboratory tests for blood and tissue sample screening.

24
 ○ Transplant coordinator
○ Generally, the inspection team will.
● Once the facilities are deemed appropriate by the inspector, a certificate of registration, valid
for 5 years, is granted to the tissue bank after which it can function as a Tissue Bank.

How to register a cornea retrieval, cornea transplant center or eye bank?

No registration / approval is required for cornea donation alone. It can be done within 6 to 8 hours of
death from home or any hospital. A family of a deceased person wishing to do cornea donation should
inform a nearby eye bank directly or through the hospital staff, irrespective of the time of the day. The
staff on duty should request the family to donate cornea after every death in hospital. The team will
check for any contraindications and if suitable, give some basic easy to follow instructions while they
reach the facility for retrieval.
The process for registration of a center for cornea transplantation and eye banking is as follows:

● Fill Form 15 and submit to AA.

● Information required to fill form 15 includes:
○ Details of an affiliated general or ophthalmic hospital for an eye bank.
○ Names and qualifications of the personnel performing the retrieval.
○ Availability of the instruments / facilities / preservative media and ancillary equipment
to perform cornea or eye-ball retrieval.
○ Availability or access to a laboratory for tests such as HIV / Hepatitis B and C / culture
and sensitivity.
○ Details of patient records management system.
● Once the form is submitted and the application fees are paid (ten thousand is prescribed in
THOTR, although currently variable fees are charged in each state or union territory at the
discretion of the respective AA [Rule 24]), the AA will appoint an inspection team to visit the
site, who scrutinizes documents of all key team members and the facility, documents of
association with other organizations, review the protocols, selected case files, visit all key
facilities and looks for the following (Rule 28):
○ Details of personnel which include one ophthalmologist, two coordinators, two eye
bank technicians and two multi-task employees for an eye bank.
○ Two trained people, one of whom is a corneal transplant surgeon are essential for
registration of a corneal transplant center.
○ Minimum 400 sq. ft. space.
○ Instruments and equipment required for procurement of cornea / eyeballs which must
include one slit lamp biomicroscope, specular microscope, laminar flow (class II),
sterilization facility (inhouse or access) and a 24-hour temperature-controlled
refrigerator.
○ Written guidelines and standard operating procedures for procurement of tissues,
maintenance of its premises and facilities, and for record documentation and quality
control procedures.
○ Facilities for relevant laboratory tests for blood and tissue sample screening.
○ Facilities for preservation and transport of cornea and eye globe as appropriate.
● Once the facilities are deemed appropriate by the inspector, a certificate of registration, valid
for 5 years, is granted to the eye bank / cornea transplant center after which the center can
function as an eye bank or a cornea transplant center, respectively.

How to renew the registration of a hospital or tissue bank?

25
After approval, the center requires renewal every five years. Centers can apply for renewal by submitting
Form 17 and paying the application fees (five thousand is prescribed in THOTR, although currently
variable fees are charged in each state or union territory at the discretion of the respective AA [Rule
24]). The steps are:

● Fill Form 17 and submit to AA.

● The AA appoints an inspection team that visits the site, scrutinizes documents of all key team
members, documents of association with other organizations, review the protocols and selected
records of previously retrieved and transplanted tissues and organs and visit all key transplant
facilities. Past performance is scrutinized and if satisfactory, renewed for five years.
● For renewal of an eye bank ideally minimum 500 corneas need to be collected within five years.
If falling short of this number, may continue to function as an eye retrieval Center affiliated to
a registered eye bank. In routine practice however, for educational institutions such as
government medical colleges providing residency training in ophthalmology, sometimes this
requirement is condoned.

26
 Chapter 3: Developing an Organ Donation Program
Organ transplantation has been one of the greatest advances of modern medicine. Transplantation
would not be possible but for organ donation. Developing a robust organ donation program has to be
driven by sustained efforts from the entire hospital administration and staff.

Figure 1: A flowchart of the process to develop an organ donation program.

Sensitize hospital administration, doctors and nurses

towards the need for deceased organ donation and

Register as an NTORC

Application for approval of Brain Death Committee (BDC) to

AA

Refresher course for transplant

coordinators on soft skills, counseling and
documentation

Organize workshop for critical care team on early

identification & declaration of brain death and donor
optimization protocol.

The steps required to start an organ donation program in brief are:

● Register the hospital as a transplant Center or NTORC.

● Create awareness regarding organ donation within the hospital and also the community.
● Sensitization of the hospital administration and staff towards organ donation. A score to assess
the preparedness of the hospital for deceased donation is attached (Figure 1).
● Organize workshops for critical care specialists on the process of deceased organ donation
which includes- identification & declaration of brain death (BD) and donor maintenance.

27
 ● Regular refresher courses for transplant coordinators on soft skills, counseling and
documentation.
● Hospitals must apply for approval of the Brain Death Committee (BDC) to the DHS or State AA
as applicable. All specialists in the hospital, other than those associated with transplant teams,
can be a part of the BDC. The composition of the board is specified in THOA 1994 and its 2011
amendment.
● Once these conditions are met, a Center may begin its organ donation program.

What is brain death?

BD is the total and irreversible loss of all brain function (including involuntary activity necessary to
sustain life) and the condition under which the donation of vital organs most commonly takes place.

BD is defined as an irreversible, catastrophic brain injury, which causes total cessation of all brain stem
functions. BD is to be differentiated from coma where some brain stem function may be present.
When a person is brain dead, he / she may be declared as legally dead.

BD is usually caused by:

● Trauma
● Stroke
● Lack of oxygen to the brain (e.g. after a heart attack)
● Brain tumor

BD should be suspected in all patients who have a Glasgow Coma Score of 3 (out of 15) with non-
reactive pupils and absent brainstem reflexes. A formal evaluation of brain stem death is commenced
after an appropriate observation period to ensure irreversibility of the pathological process.

What to do when there is a potential donor in your hospital? -Brain death

certification

In India, brain stem death is determined in the hospital by a Board of Medical Experts (BME) which
comprises a panel of four physicians that includes the treating physician, a physician representing the
treating hospital, an independent specialist, and a neurologist or neurosurgeon, not associated with
the transplant team. As per the 2011 amendment to THOA, an intensivist or anesthetist may declare
BD in absence of a neurosurgeon / neuro physician. The tests to determine BD are done twice with a
minimum gap of six hours (Figure 2).

Once a potential brain-dead person is identified by the intensive care team, the following protocol is
followed:

● The reversible causes of coma mentioned in Form 10 must be excluded.

● The BME must conduct two sets of tests minimum 6 hours apart and document complete and
irreversible cessation of brain stem function.
● After the first set of tests indicate brain death, the family is counseled regarding organ
donation and the local organ allocation body or SOTTO is informed.
● After the second set of tests, if a patient fulfils all the criteria, BD is certified by the BME and
Form 10 is filled.
● After BD certification, no charges can be billed to the donor family.

28
Consent for organ donation
Every brain-dead patient is a potential organ donor. Under the THOTR 2014, counseling regarding
organ donation is mandatory for all BD patients (required request). This counseling is usually
performed by a transplant coordinator along with the intensive care team.
● As soon as the first set of investigations suggest BD, the family is counseled regarding organ
donation. If the family agrees to donate, the local organ allocation body / SOTTO is notified as
per the local prescribed format (Appendix 3).
● When the second set of investigations conducted 6 hours apart also confirm BD, consent for
organ donation is obtained from the next of kin in accordance with the prescribed consent form
(Form 8).
● If the brain stem death case is unclaimed, the consent of the administrative head of the
institution should be obtained before procurement is performed.
● After both form 8 and 10 are filled, the organ may be allocated to a patient as per the local
rules and allocation criteria.
● In cases of medicolegal deaths, the corresponding police state is first notified about the
potential organ donor.
● The police officials, after conducting due diligence then provide the authorization to conduct
the organ retrieval.

29
Figure 2: A flowchart of the process to conduct organ donation.

Identification of potential
brain dead donor by the critical

Exclusion criteria

First set of investigations

done to determine brain

Family counselled
AA / SOTTO / ROTTO / NOTTO informed as appropriate

Second set of investigations done 6 hours later to

confirm brain death
Family counselled

Declaration of brain death by filling Form 10

Consent for Organ Donation taken by filling Form 8

Organ Allocation by local organ

allocation body / SOTTO / ROTTO / NOTTO

Completion of medicolegal
requirements Multi - organ and tissue
retrieval done

Donor Maintenance
Once a BD is declared, the ICU team of the hospital maintains the BD patient in optimum condition till
multi-organ procurement takes place. Various international and Indian professional societies have
published guidelines and protocols for donor maintenance (Zirpe 2022, Pandit 2017). Familiarity with
these protocols is vital for the success of deceased donor transplantation.

● Management of a prospective brain-dead donor is usually done under the guidance of trained
intensivists in each hospital.
● In case such expertise is not available at any hospital, guidance can be provided by the local
organ allocation body or SOTTO.
● Records related to brain death and transplantation should be maintained / preserved as per
the existing state government rules. Donor hospital will maintain records of brain stem death
and retrieval for 15 years.

30
 Organ Retrieval
Once BD is certified and the consent is documented, multi-organ procurement may commence. This
involves a lot of coordination between the various organ transplant teams and is regulated by the
local organ allocation body / SOTTO / ROTTO / NOTTO.

● The allocated transplant team may travel to the donor hospital and perform retrieval surgery.
● The transplant coordinator coordinates between the donor hospital and retrieval teams to
ensure timely hand over of the donor body back to the family.
● All medico legal formalities are completed, and the body is handed over to the relatives for
their last rites (Figure 3 in case of medicolegal deaths attached).

Figure 3: A flowchart of the process in case of medicolegal deaths.

Brain death certified in Form 10
and consent documented in Form

Application to police requesting permission for organ

retrieval

Police
clearance obtained

O
rgan Retrieval

Certificate from one of the

surgeons stating organs are
procured

Postmortem (may be waived)

31
 Administrative and Humane Aspects of Organ Donation
It is important for the hospital to provide full support, care, information and advocacy to donor
families and transplant recipients. For each noble act of organ donation, it is vital that the donor and
his / her family be given the highest respect. The hospital shall ensure that words of sympathy and
gratitude are conveyed to the grieving family, that they are suitably looked after in a lounge / vacant
hospital room and there is no delay in operating room and in handing over of the body for last rites.

● Ensure that the grave prognosis is communicated to the family with a consistent message
from the hospital care team, mentioning that everything is being done to save the life of the
patient.
● The privilege of informing the family about occurrence of brain death lies with the treating
team.
● The counseling on organ donation should begin at an appropriate time, having allowed the
family time to grieve and accept the loss of a loved one.
● The counseling for organ donation should be done in a dedicated counseling room. Pictures
and stories of various past organ donations and the lives saved should adorn the walls.
● Suitable material indicating the requirement of organs and tissues in the country may be
displayed.
● Security staff should be instructed to allow access to the family to the ICU beyond visiting
hours and to a designated room / lounge. Water and light refreshments may be provided.
● Transplant Coordinator to remain in touch with the donor family to ensure coordination and
smooth execution of all requirements. Sympathy and gratitude are the feelings to be always
conveyed to the family.
● The identity of the donor shall be kept confidential from the recipients and the two families
should not be allowed to interact in the hospital.
● A dedicated staff must be with the family throughout the donation process, and for handing
over the body to the family. Necessary logistics to be ensured for the donor and the family
to their home and till the last rites.
● A wreath may be placed on behalf of the hospital to honor the deceased.
● A donor is commonly honored by the hospital staff by lining up and showering flower petals on
the deceased as the body is carried out of the hospital. Arrangements for transporting the body
to their native place and funeral arrangements are also sometimes made by the hospital.
● In case the family says no to organ donation, one must respect their decision and not make
them feel guilty in any way.

Responsibilities of key stakeholders

Transplant Coordinator: Training, Grief Counseling, Soft Skills
Any individual who has a (a) graduate of any recognized system of medicine, or (b) nurse, or (c)
bachelor’s degree in any subject (preferably master’s degree in social work, psychiatry, sociology, social
science or public health) may be employed as a transplant coordinator. The duties of a transplant
coordinator include:

i. To help identify potential donors and to counsel the family regarding organ donation.
ii. Once a potential donor is declared, it is the coordinators’ job to communicate effectively
with all concerned parties (SOTTO / ROTTO / Transplant Team) to ensure effective organ
allocation and retrieval.
iii. To maintain all documentation and data related to organ transplantation.
iv. To maintain constant interaction with the family during the process of organ retrieval and
ensure dignified dispatch of the corpse to the mortuary.
v. To coordinate all efforts to felicitate families of deceased organ donors including letter /
certificate of appreciation.

32
 vi. Maintain donor registry and print organ donor cards to promote organ donation.
vii. Ensure handing over of appropriate documents and completion of handing-taking over
certificate if any organ is being shared with another hospital.

Hospital In Charge (Medical) i.e. Dean, Medical Director

The medical director of the hospital would be the nodal officer for all dealings with NOTTO / ROTTO
/ SOTTO and should lead all activities related to organ donation in the hospital. The duties of the
medical director of the hospital include:

i. Ensuring registration as a Transplant Center, NTORC or Tissue Bank as appropriate

ii. Ensure availability of adequately trained and motivated staff.
iii. Raise the topic of organ donation and tissue donation with various stakeholders regularly
and ensure early reporting of potential donors.
viii. Ensure that there is seamless coordination of various agencies within the hospital once the
family has indicated a positive inclination towards organ donation.
ix. To ensure that billing activity is ceased, if applicable, from the time the family consents to
organ donation.
x. To obtain MLC clearances and arrange for postmortem.
xi. To provide ambulance for transportation for postmortem in MLC patients and provide
hearse for transportation of body to their home.
xii. Supervise all media coverage related to organ donation.

Head of Department- ICU

The intensivist in-charge of the ICU plays a crucial role in any successful deceased donor transplant
program. The intensivist is involved in all aspects of organ donation right from identifying a potential
BD patient, diagnosing and declaring BD and maintaining the donor in optimum condition till organ
procurement may commence. Roles of the intensivist may include, but is not limited to the following:

i. To screen and identify potential donors.

ii. Conduct the preliminary tests for brainstem reflexes once brain-death is suspected, based
on signs like fixed dilated pupils, and a GCS score of 3/15. No consent is required from
family for the conduct of brain-death tests as these are part of routine end of life care in
the ICU.
iii. To ensure that brain-death is recognized at the earliest and the treating team, hospital in-
charge and transplant coordinator are informed.
iv. To exclude reversible causes of brain death and contraindications to organ donation.
v. To inform the family about brain-death after the first set of tests.
vi. To be present along with the transplant coordinator at the time of initial counseling to
answer any questions related to medical aspects of brain-death.
vii. To initiate donor maintenance protocol and ready the ICU for donation after circulatory
death in case the donor crashes.

Chapter 3 References:
1. Zirpe KG, Tiwari AM, Pandit RA, Govil D, Mishra RC, Samavedam S, et al. Recommendations for
Evaluation and Selection of Deceased Organ Donor: Position Statement of ISCCM. Indian J Crit
Care Med 2022;26(S2):S43–S50
2. Pandit RA, Zirpe KG, Gurav SK, Kulkarni AP, Karnath S, Govil D, Abhram B, Mehta Y, Gupta A,
Hegde A, Patil V, Bhatacharya P, Dixit S, Samavedan S, Todi S. Management of Potential Organ
Donor: Indian Society of Critical Care Medicine: Position Statement. Indian J Crit Care Med. 2017
33
May;21(5):303-316.

34
 Chapter 4: Overview of Deceased Donor Transplantation
How to register a patient on the transplant wait list?
Patients may register on a local, state or regional organ waiting list or transplant through a registered
transplant center. As per the current guidelines, for routine registration:

● Patients must first be evaluated and found medically fit for undergoing the transplant by a
multidisciplinary team (MDT).
● An application form is filled in by the patient and the transplant coordinator and verified by
the transplant team before it is sent to the local organ allocation body / SOTTO.
● Every patient also needs a NOTTO ID for registration, which can be obtained by registering on
NOTTO website.
● The listing criteria for each organ is covered in the respective sections of this book. The listing
criteria for every organ may also differ in each state, although uniform national registration
and allocation policy is envisaged.
● The application form is accompanied by supporting documents such as
○ Valid ID card (Aadhar card or passport).
○ All medical reports with supporting scores are submitted for review.
○ For patients requiring multivisceral transplant, the primary application may be made
for the organ of priority (heart, lung, intestine, liver, pancreas, kidney, composite
tissue, uterus in that order), although the policy is variable across states.
○ Contraindications for transplant such as active systemic malignancy, active
uncontrolled systemic infection, severe irreversible systemic diseases, unresolved
psychiatric illness, lack of social family support and high risk of compliance to long
term immunosuppression should be ruled out before application.
● The application is verified by the local organ allocation body / SOTTO at the time of registration.
● Once the application is suitable, the patient is registered on the local organ wait list.
● Patients listed for transplantation are usually eligible to receive an organ allocation offer after
a minimum buffer period.
● A patient can be registered through only one transplant center in one state.
● The patient may transfer to their hospital through which they are registered on the waiting list
at any stage. In some, but not all, states, the patient’s position on the waiting list is maintained
across hospitals during transfer.
● To maintain the registration patients are required to send regular clinical updates, reports and
status (whether they are active or medically unfit for transplant, suspended / inactive on the
list, or if they have undergone a transplant or passed away).

For patients requiring an urgent transplant, most local allocation bodies / SOTTO / ROTTO / NOTTO
maintain a separate “Super Urgent” or “Urgent” or “Priority One” transplant list.

● To register a patient in this category, they must fulfill a set of criteria which differ between
various organs and between states.
● If a patient satisfies these criteria, the transplant coordinator must fill the appropriate form
and submit the form to the local allocation bodies / SOTTO / ROTTO / NOTTO.
● Such applications may be subject to review by an expert committee after which the patient is
listed in this category, wherein they receive a priority during organ allocation.
● Hospitals are generally required to send daily / frequent updates for such patients.

35
To transfer registration between hospitals:
Patients who wish to change their registration from one hospital to another must submit a
written application through the new hospital.
● The patient must also send an intimation to the previous hospital.
● The transfer is usually in effect after a buffer period.
● After transferring their registration, patients may continue to maintain their position on the
waiting list, especially if under the same SOTTO.

Figure 1: A flowchart of the process to conduct deceased donor transplantation.

Identification of patients who need
Deceased Donor Organ Transplantation

Application to enter the patients name on the local

organ allocation body / SOTTO / ROTTO / NOTTO organ
waitlist as appropriate

Regular updates to be sent till organ is allocated

Organ Allocation by local organ allocation body / SOTTO /

ROTTO / NOTTO as appropriate

Once organ allocation is done, patient is called to the

hospital to send pre-operative investigations

Deceased donor transplantation done if organ is accepted

by the retrieval team and the recipient is fit for surgery

36
 How is organ allocation done?
NOTTO has defined allocation rules for each organ. However, most states follow different allocation
systems, which may be chronological from the date of registration, hospital-wise rotation or disease
severity based. In most systems, the following broad principles are usually followed:

Priority is given to:

● Urgency of transplant (Super-urgent / Urgent / Priority One followed by Routine)

● Organ donations within a transplant hospital are considered to be “in-house” and generally
patients on the hospital’s waiting list are given priority, except one kidney that is shared to the
city pool, to encourage organ donation.
● Blood group compatibility: allocation done in the following order:
○ Blood group identical
○ Blood group compatible
○ ABO incompatible
● All organs are allocated in the following order:
○ In-house to the donor hospital’s waiting list.
○ Local AA list
○ State list
○ Regional list
○ NOTTO list
● In cases of multivisceral transplants, the patient is primarily listed for the organ with highest
priority and is allocated the organ accordingly.
● Generally, there is a provision for payback for any organ allocated out-of-turn for a super-
urgent patient.

What to do when your hospital gets an organ offer?

● Once BD is very likely (based on 1st apnea test) at a transplant center or a NTROC, the
transplant coordinator alters the local organ allocation body / SOTTO about the potential
organ offer by filling and circulating a donor alert form (Appendix 3).
● The local organ allocation body / SOTTO confirms that the potential contra-indications to
organ donation are ruled out and the alert is circulated to the transplant centers.
● Once an organ is offered to a transplant center, the decision about its acceptance usually must
be made quickly.
• Kidney offers are usually provisional pending a negative tissue crossmatch report. Offers to all
other organs are final and binding.
• Transplant teams may change their decision to accept / reject the organ in case new donor
information becomes available.
• Hospitals / transplant teams / patients may refuse an organ offer for reasons such as:
• Logistics and financial readiness.
• Recipient medical reasons.
• Donor reasons (donor age, malignancy, infection, instability, organ quality, etc.).
• Once a refusal has been communicated by the hospital, and the organ has been allocated to
the next recipient, the allocation cannot be reversed.
• A few standby recipients are kept ready to avoid wastage of organs in case of any last-minute
changes to the patient’s condition.

What to do once the organ offer is accepted?

Once the organ offer is accepted by the transplant center, two things must happen in parallel. The
patient who is allocated the organ is called to the transplant center to be prepared for surgery.

37
Simultaneously the transplant team prepares a team to retrieve the organ. The retrieval is always
done at the donor hospital and the organ is transported back to the transplant center. The
transplant surgery is then performed at the respective transplant centers.

Organ Retrieval
● The retrieval time is decided by the donor hospital after taking the logistics of the various
transplant teams and donor family’s requests into consideration.
● The transplant team usually sends their respective retrieval teams, commonly consisting of the
transplant coordinator, retrieval surgeon, transplant anesthetist, scrub nurse, OT technician and
with all the consumables required for the surgery. However, the team may accept a recognized
trained surgeon from another center to retrieve the organ on their behalf.
● The retrieval process requires extensive communication with the (local organ allocation body /
SOTTO / ROTTO / NOTTO) to ensure coordination between the various transplant teams. This
coordination is generally handled by the transplant coordinator.
● Once all the teams arrive at the retrieval center, the multi-organ procurement surgery begins.
● If the retrieving team wishes to reject the organ:
○ They should immediately alert the local organ allocation body / SOTTO / ROTTO /
NOTTO.
○ Retrieval teams from standby recipient hospitals must go to the donor hospital for
assessment or retrieval.
○ The primary retrieval team can leave only after handing over retrieval to the standby
team in person or if mutually acceptable, complete the retrieval on their behalf.
○ The team that finally accepts / agrees to use the organs bears the cost of the perfusion
fluid in such a scenario, even if the organs are not ultimately used.
● If the retrieving team accepts the organ, it is packed and transported to the transplant center
in a temperature regulated ice box.
○ To ensure a smooth and quick transit of the retrieved organ back to the transplant
center. All efforts are made to minimize the transport time since they influence
patient outcomes.
○ Transport may be done using a chartered airplane, in which case attempts may be
made to share the available seats to reduce travel costs.
○ Transportation by a commercial flight requires close coordination with the airlines,
Central Industrial Security Force (CISF) at the airport, as extra seats may have to be
booked on the flight for the organ box and liquid is generally not allowed through
security in the aircraft cabin. There are guidelines by the Director General of Civil
Aviation (DGCA) which should be followed. A letter by the hospital explaining the need
to carry the organ with the preservative solution and ice, certifying that it is not
infectious may help minimize delays.
○ For road transport, the transplant coordinator should coordinate with the local police and
authorities to create a “Green Corridor”.
● Once the organ reaches the transplant center, the organ is transplanted into the patient.
● The transplant coordinator sends a form with details of the organ quality and characteristics
back to the local organ allocation body / SOTTO after retrieval.
Transplant Surgery
● After being allocated the organ, the patient is called to the surgery to complete the relevant
investigations and clearances prior to surgery.
● Usually once the decision is made by the retrieval team to accept the organ, the patient is
wheeled into the operating room for surgery.
● Specific requirements pertaining to each organ are mentioned in the respective chapters of
this book.

38
 Transport of the Organ
Packaging
Packaging an organ in preparation for transport is a medical activity that must be performed under the
advice and guidance of a qualified doctor.

● The doctor undertaking responsibility for preparing and packaging an organ for transport must
be appropriately trained and experienced in the role.
● Organs must be prepared for packaging in three bags in line with international guidelines. All
organs should be prepared for packaging as follows:
○ Each organ is submerged in sufficient cold preservation solution in the first bag.
○ The second bag is filled with cold saline.
○ A small amount of fluid (sufficient to ensure there is no air in the bag) is between the
second and third bags.
○ Each bag is firmly tied after adequate deairing.
● Before an organ is packed in the organ transport box, the following must be confirmed:
○ Which organ is being handed over e.g. right kidney, left kidney, liver lobe.
○ That the organ has been surrounded by perfusion/preservation fluid and bagged
according to the agreed procedure.

The prepared and packaged organ must be packed immediately inside the organ transport box. The
following actions should be taken for all organs:

● The organ must be contained and covered by melting water ice.

● The box should be closed but not sealed until all required blood, tissue samples and
documentation have been placed inside and are ready for transportation.
● Before transportation, the box must be sealed on both sides with tie wrap straps/cable ties.

Labeling
All tissues and blood samples required to support transplantation of a donor organ must be labeled with the
patient’s name and 3 points of identification:

● In-patient department (IPD) number

● Date of birth/date of admission
● Hospital name and place

Tissue samples must be placed into tissue sample containers filled with sterile saline. In addition to
identification labeling, each container should be labeled with details of the specific tissue contained
within it. Blood vessels, if required, must be placed into appropriately labeled sterile blood vessel
containers filled with preservation/perfusion fluid. The containers must be always kept sterile.

The organ transport box must then be clearly labeled to show that an organ is being transported. The
following must be visible on the box:

● “Human Organ / Tissue for Transplant”

● The name of the hospital where the retrieval took place.
● Date and time of departure from the retrieval center.
● Identification of which organ is inside the organ transport box / donor identification form.
● Identification of the destination recipient center, including the address.
● Specific instructions on the required transport conditions e.g., keep upright.
● The transport box must be labeled using either a plasticized luggage label / marker or the Organ Box
Sticker.

39
 Green Corridors
Organs may need to be shifted from one state to the other and this may sometimes involve long-
distance travel. To reduce the travel time and avoid traffic congestions and delays the green corridor
concept is being utilized where the ambulance carrying the organs is given priority passage by traffic
police so that organs can reach the destination in the shortest possible time. Similarly, facilities to
airlift the organs are also being provided in the form of an air ambulance so that organs can be
transported between far off places in a short time when matching recipients are not present in the
state or the region.

Airport Transfer:
The civil aviation ministry issued standard operating guidelines to facilitate transfer of organs by
providing priority to commercial aircraft carrying an organ for transplantation. The following is
required for airport transfer:

A letter from the retrieval team hospital (on its letterhead) (3 copies) with the following:
● Specifications and contents of the box and graphic depiction of packaging
● Requesting the airport authorities and airlines to facilitate the team’s travel (including any
transfers) in the aircraft and at the airport and allow flexibility in baggage weight, dimensions
(The organ box is exempt from security scanning)
● Declaration letter stating that organ box and contents are “Non-infectious” / free from
pathogens and packaging and sealing under appropriate supervision.
● A request letter by the recipient hospital on organ viability & quicker organ transference to the
aircraft
● A letter by the donor hospital on carrying organ and by whom the organ is carried (with
his/her contact details)
● Declaration letter by the recipient hospital about team traveling in flight - Name, Contact
details, Flight number, PNR & ETD
● IDs and hospital IDs of all team members
● Travel documents (Photo ID proof / Itinerary / Boarding passes / vaccination certificates, etc.)
● Organ box should be labeled AVSEC circular (01/2017).

40
 Chapter 5: Overview of Live Donor Transplantation
Since there is a wide gap between the number of patients who need transplants and organs from
deceased donations available in India, a living donor transplant is done for organs such as kidney, liver
and other organs to minimize the risk of mortality on the waiting list. The time required for preparation
and permission for a living donor transplant is very short compared to a deceased donor transplant and
can be done electively at the discretion of the patients, family and the medical team.

Who can be a live donor?

An individual who satisfies the following criteria can apply to become a live donor:

● Should understand all possible side effects, hazards and complications of the surgery and give
authorization out of his/her own free will.
● Should be physically and mentally evaluated and found to be medically fit to undergo the
surgery.
● Should be a near relative of the patient in most cases.
● Donations from a non-near relative may be done after permission from the AC.

Donor evaluation
Donor evaluation constitutes a major step in live donor transplantation. The evaluation is usually done
by a multidisciplinary team. The goal of the evaluation is to certify the fitness of the donor to undergo
the surgery. It is usually a multi-step process which evaluates the patient as follows:
● Basic tests for the general health of the patient.
● Tests specific to the concerned organ to evaluate for surgical compatibility.
● Tests for other organ systems of the body and evaluation of fitness for general anesthesia.

How to go about permission for living donor transplant?

● The center must be registered as a transplant center.
● Patient as well as the donor must first be evaluated and found medically fit for undergoing the
transplant by an MDT. The fitness of the donor must be certified in Form 4 by the transplant
team.
● The donor and the recipient must jointly fill Form 1 (Living near related donor) / 2 (Living
spousal donor) / 3 (Other than near related living donor) as appropriate and submit an
application (Form 11) to an AC for approval.
● For centers performing more than 25 transplants in a year a hospital appointed AC may grant
approval. For centers performing less than 25 transplants a year, approval of the district or
state AC is mandatory. The composition and responsibilities of the AC are mentioned in Rules
12 -23 of the THOTR 2014.
● In case the proposed transplant is at a state different to the residency of either the donor or
the recipient, Form 20 along with verification of the residence by the Tehsildar is required.

Once all the relevant documents are ready, the AC must evaluate the following (Rule 7):
○ Documentary evidence of the relationship between the donor and the
recipient.
○ Documentary evidence of the identity and residency of the proposed donor and
recipient.
○ If not satisfied by the documentary evidence, the AC may request for a genetic test to
prove the relationship (Form 5).
○ In cases of spousal donors, AC must certify the marriage in Form 6.
○ In cases of female donors, additional precautions are taken to safeguard her best
interests.
○ There is no commercial transaction involved.
41
 ○ The circumstances under which the offer to donate organs is made and examine the reasons
why the donor wishes to donate.
○ After evaluating all the necessary documents, the AC must approve the application for
transplantation by filling Form 19 or state its reasons for rejecting an application in
writing.
● If the proposed transplantation is between non-near relatives, the hospital-based AC may refer
to the District or State AC. In these conditions approval is granted in Form 18.
● Once approval is granted by the AC, the center may proceed for transplantation at the
discretion of the medical team.

Figure 1: A flowchart of the process to conduct live related donor transplantation.

Sensitize hospital administration, doctors and nurses
towards the need for live donor organ transplantation

Apply for a Hospital Authorization Committee if

number of transplants exceeds 25 in one year

Identify patients with need for live

donor

Identify potential live donor and certify fitness

in

Application for Live Donor Transplantation to

be
made to the AC jointly by the Donor and Recipient

Meeting with the AC which is video recorded.

Approval granted by the AC with Form 18 /

Transplant

42
 Chapter 6: Setting up of Organ Transplantation Center

Setting up an organ transplant center can be a complex and challenging process that requires a lot of
planning, resources, and coordination. In addition to fulfilling the legal requirements as laid out by THOA
and mentioned in the preceding chapters, various other factors need to be considered to ensure the
success of the transplant program.

● Outreach and Education:

○ Developing outreach and education programs to promote organ donation is crucial
especially in India where there is a lot of apprehension still regarding organ donation.
○ Raising awareness regarding the need for organ transplantation is also necessary since
there are many patients who succumb to organ failure because of lack of knowledge or
access to organ transplantation.
○ This may involve working with community organizations, schools, and other
stakeholders.
○ Catering to the needs of the local community may benefit the transplant program.
● Funding:
○ Determining the financial requirements for establishing and operating an organ
transplant center is crucial.
● Infrastructure:
○ Identifying and acquiring suitable infrastructure for the transplant center.
○ The requirements of different organ transplants differ and must be considered
while planning to begin the journey of setting up a transplant center.
● Staffing:
○ Recruiting and hiring of experienced and skilled professionals to run the transplant
center, including transplant surgeons, transplant coordinators, nurses, and
administrative staff is of paramount importance since they form the cornerstone of
the transplant program.
○ Regular refresher courses to ensure that they are up to date with the latest transplant
protocols and procedures are also required.
● Policies and Procedures:
○ Developing comprehensive policies and procedures for organ donation,
transplantation, and follow-up care.
○ This should include criteria for organ selection, organ allocation, and ethical guidelines.
● Quality Control:
○ Developing and implementing quality control measures to ensure that the transplant
center meets the highest standards of patient care, safety, and quality.

Once these systems are in place, there is adequate administrative support and enthusiasm, one may
begin the process of registration and embark on the journey to start their transplant program.

43
Chapter 7: Kidney Transplant
Introduction
Kidney transplants can be performed either from a living donor or a deceased donor. In the former, a
family member who is medically suitable is the donor whereas in the latter the kidney is donated by a
deceased person’s family. The living donor’s surgery is conventionally done by a lumbar incision but is
increasingly being done by laparoscopic or robotic approach. The recipient’s native kidneys are not
removed, and the new kidney is commonly transplanted retroperitoneally through a groin incision,
although few Centers do robotic implantation of the kidney.

Figure 1: Renal transplantation

Who needs a kidney transplant? indications and eligibility?

Common indications of a kidney transplant are:

● Diabetes

44
 ● Glomerulonephritis
● Hypertensive nephrosclerosis

Rarer indications for kidney transplant are:

● Pyelonephritis
● Polycystic kidney disease
● Obstructive uropathy
● Congenital urinary tract abnormalities
● Alport’s disease
● Reflux nephropathy
● Interstitial nephritis
● IgA nephropathy
● Goodpasture’s syndrome
● Hemolytic uremic syndrome
● Chemical nephrotoxicity
● Renal artery emboli
● Sickle cell nephropathy

Exclusion criteria for kidney transplant

● Inoperable malignancy
● HIV
● Active urinary tract infection, active tuberculosis
● Irreversible heart, lung or liver failure
● Active systemic diseases such as lupus, sickle cell disease etc.

Other factors such as the following constitute relative exclusion criteria for kidney transplantation:

● Hepatitis B or C infection
● Morbid obesity
● Uncontrolled hypertension
● Lack of adequate social or family support
● Significant non-compliance with medical regimen
● Atherosclerosis
● Significant coronary artery disease
● Severe malnutrition/cachexia

NOTTO has outlined the minimal listing criteria and allocation policy for deceased donor kidney
transplant.

Listing Criteria

● Any patient who is on maintenance dialysis for more than three months on a regular basis is
eligible to register on the kidney wait list.
● Patients with the following are placed on an “Urgent List” which is reviewed by an advisory
committee every three months.
○ Patients who no longer have dialysis access and thus cannot be maintained on dialysis.
○ Patients with end stage renal disease (ESRD) who are unlikely to get a donor with
a negative crossmatch such as > 90% Panel Reactive Antibody.

45
Since there is a disparity between number of recipients requiring kidney transplant and the deceased
organs available, NOTTO has developed a scoring system for priority of allocation:

Table 1: Scoring system for priority of allocation.

S No Criteria for scoring Points allotted
1 Time on dialysis +1 for each month on dialysis
2 Previous immunological graft failure within 3 months of + 3 for each graft failure
transplantation
3 Age of recipient + 3 for age less than 6 years
+2 for age between 6 to 12 years
+1 for age between 12 to 18 years
4 Patients on temporary vascular access
(a) With failed all AV fistula sites +2
(b) With failed AV graft after all failed AVF sites +4
5 PRA (Panel Reactive Antibody) +0.5 for every 10% above 20%
6 Previous living donor now requiring kidney transplant +5
7 Near relative (as per definition of THOTA) of previous +5
deceased donor now requiring kidney transplant

Allocation Principles

Once there is a call for a possible kidney donor, the allocation process begins. In case of an ‘inhouse
donor’ one kidney is allocated to the hospital wait list while the other goes to the city pool. The
hospital wait list must also follow the below mentioned criteria for allocation:

● Priority is given to patients on Urgent List

● This is followed by patients requiring multivisceral transplants.
● Lastly, the kidney is allocated to patients on routine wait lists.

Within each of these priority segments, the patients are allocated the kidney as per the above-
mentioned scoring system. If two patients have the same score, allocation is done as per the time on
the waitlist.

In the case of living donor transplant, what are the eligibility /

acceptance criteria for the donor?
They should be patients near relatives and must be approved by an AC.

Absolute Exclusion Criteria

● Age <18 years

● Hypertension in someone younger than 50 years old, evidence of end organ damage, or on
three or more anti-hypertensive medications
● Diabetes (diagnosis of diabetes) or abnormal glucose tolerance test
● History of thrombosis or embolism
● Psychiatric contraindications
● Obesity: BMI >35 kg/m2
● Coronary artery disease or symptomatic valvular disease
● Peripheral Vascular Disease
● Chronic lung disease with impairment of oxygenation or ventilation
● Recent malignancy, or cancer with long times to recurrence e.g., breast cancer

46
 ● Significant urologic abnormalities of donor kidney
● Proteinuria > 300 mg/24 hours
● HIV infection

Relative contraindications:

● Hepatitis C Virus Infection

● Hepatitis B Virus Infection
● Age 18-21 years old; elderly donors especially those without significant comorbid disease
● Obesity (BMI 30-35)
● Kidney stones
● Distant history of cancer
● Past history of psychiatric disorder
● Renovascular disease
● Thin basement membrane disease
● Prior valve surgery
● Moderate cardiac valvular disease with otherwise normal echocardiographic findings
● Mild sleep apnea without pulmonary hypertension

There are several published guidelines for living donor selection and evaluation. After exclusion criteria
have been ruled out, the compatibility of the donor kidney should be ascertained with blood group
typing, HLA typing, and a cross match. A comprehensive psychiatric evaluation should be done to ensure
that the prospective donor comprehends the risks, benefits and potential outcome of the donation for
herself or himself and the recipient.

In case of deceased donor transplant, what are the eligibility /

acceptance criteria for the donor?
The criteria for a deceased organ donor are:

● Normal renal function

● No hypertension requiring treatment.
● No diabetes mellitus
● No malignancy other than a primary brain tumor or treated superficial skin cancer.
● No generalized viral or bacterial infection
● Acceptable urinalysis
● Negative assays for syphilis, hepatitis, HIV, & Human T Lymphoproliferative Virus.

In order to meet the increasing demand of cadaveric kidneys, some exceptions can be made in above
listed criteria, resulting in the adoption of “Expanded Criteria Donors” (ECD).

● Donor less than 6 years of age

● Donors with age more than 60 years; can be accepted if other parameters are normal.
● Donors 51 to 59 years old with any two of the following risk factors
○ Cerebrovascular death
○ HTN
○ Serum creatinine > 1.5 mg/dl
The contra-indications criteria for deceased donor kidney transplantation are:

● Chronic renal disease

47
 ● Age >70 years; can be accepted if other parameters are normal.
● Potential metastasizing malignancy
● Severe hypertension
● Current intravenous abuse
● HIV positive
● Oliguric acute renal failure
● Untreated bacterial sepsis
● Juvenile onset diabetes

Post-operative course and follow-up

Patients are under follow-up with the nephrologist life-long to evaluate for graft function and survival,
generally with blood tests. Patients with any abnormality in kidney function may need an ultrasonogram
(USG) or kidney transplant biopsy.

What are the specific requirements for a kidney transplant Center?

Running a kidney transplant program is a complex undertaking. It requires investment with regards to
manpower, infrastructure as well as equipment (Table 2).

Manpower
The primary members of the multidisciplinary team consist of urologists or general surgeons,
nephrologists, anesthesiologists, and physicians. The surgeons as well as the physicians must be
qualified as per THOTR 2014 and trained in a renal transplant team.

Ancillary specialists including but not limited to cardiologists, psychiatrists, psychologists,

pulmonologists, infectious diseases, neurologists, nutritionists, physiotherapist, radiologists,
pathologists aid in achieving good patient outcomes.

Dedicated nursing staff for transplant patients are crucial. THOTR 2014 rules have made transplant
coordinators mandatory and other support staff are also required to facilitate counseling,
documentation and follow-up of the patients.

Infrastructure
Two well equipped OTs are required for running a successful live donor transplant program or when
there is a kidney offer from an in-house donor. Facilities for emergency OT must also be present. Since
kidney transplants (particularly liver donor nephrectomy) are increasingly being done with minimal
access, availability of laparoscopic trolleys / surgical robots may benefit the program in the long term.
This is not mandatory.

A dedicated post renal transplant ward with at least one isolation room with a high efficiency
particulate absorbing (HEPA) filter is desirable.

Any successful renal transplant program must have facilities for dialysis. Ideally separate dialysis
equipment for sero-positive patients is desirable. The water used for dialysis should be periodically
tested for chemicals and frequently for bacteria and endotoxin. Dedicated dialysis staff and facilities
for emergency dialysis are also required.

A functional radiology department with in-house access to equipment like ultrasonography with
doppler, intravenous urogram (IVU), micturating cystourethrogram (MCU) and computed tomography
(CT) are essential. Other essential facilities such as magnetic resonance imaging (MRI), Nuclear
medicine or a cath lab for donor angiographies may be outsourced.

48
Other departments such as routine hematology, microbiology, biochemistry, etc. should be well
equipped to ensure 24-hour availability. It is also preferable to have facilities for HLA testing and cross-
match in-house.

Table 2: Minimum requirements of a kidney transplant program.

Outpatient Department Requirements

Overall OPD patient turnover □ > 300 per year
□ > 30 per month (in case of a new center not
completed one year)

Number of potential transplant candidates Number of patients undergoing dialysis

□ > 50 per year
□ >5 per month (in case of a new center not
completed one year)
OPD Rooms □ 2 or more
Minor procedures area □ Present
Counselling / Conference Room with Video recording □ Present, with facilities for storage of data for 10
*Data to be sent to NOTTO after 10 years years
Inpatient Department
Total number of IPD admissions □ >150 per year
□ > 15 per month (in case of a new center
not completed one year)
Total number of hospital beds □ > 50
Post-Transplant Beds □ Isolation rooms available
Intensive Care Department and Facilities
ICU Beds - Total □ >5 available
Transplant ICU beds □ At least one isolation bed with HEPA filter
ICU Infrastructure □ At least one bed with access to renal
replacement therapy
□ Central suction / oxygen ports

ICU Equipment □ Multimodal ventilators

□ Multipara monitors
Also refer to □ Dialysis / SLED machines
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085818/ □ Intubation trolley
□ Crash cart
□ Syringe pumps / infusion pumps
*Equipment (e.g. ECMO machine, dialysis machine, etc.)
□ 12 lead ECG machine
may be shared between the ICU / OR / other departments
□ Defibrillators
of the hospital □ Access to ABG facility
□ Glucometer
□ Access to portable USG and Doppler Machine
□ Access to portable X-ray

Surgical Department and Facilities

Annual number of Surgeries □ >100 per year
□ >10 per month (in case of a new center not
completed one year)

OTs - Total □ 2 or more

Emergency OT □ Available
OT Infrastructure □ HEPA Filter
□ 2 Dome OT lights with a standalone light for back
*https://nhsrcindia.org/sites/default/files/Guidelines-on- table OR 3 Dome OT lights
OT.pdf □ Meeting requirements laid out by National
Health Mission – Indian Public Health Standards

49
Table 2: Minimum requirements of a kidney transplant program.
OT Instruments / Equipment □ Meeting requirements laid out by National
Health Mission – Indian Public Health Standards
*https://nhsrcindia.org/sites/default/files/Guidelines-on- □ General Surgery Instrument set with self
OT.pdf retaining retractors
□ Vascular surgery set
*Equipment (e.g. ECMO machine, dialysis machine, etc.) □ Microsurgery set
may be shared between the ICU / OR / other departments □ Diathermy machines (unipolar and bipolar) x2
□ Suction machines x2
of the hospital
□ Defibrillator
□ Syringe Pumps
□ Cystoscopy Set
□ Access to intraoperative USG and Doppler
□ Laparoscopy set (optional)
□ Fluid warmers (optional)

Radiology Department
Must be present in-house □ X-Ray
□ USG with Doppler and 2D Echo
□ CT Scan with angiography
Desirable (may be outsourced) □ MRI
□ Nuclear Medicine
□ Cath Lab

Supporting Laboratories
Access = Formal MoU with outsourced laboratory ensuring □ Biochemistry - inhouse
24-hour availability □ Hematology - inhouse
□ Microbiology - inhouse
□ Pathology with Frozen Section - inhouse or
access
□ Immunology with HLA testing - inhouse or access
Blood Bank
*Only MoU with a blood bank not sufficient □ Inhouse
□ Blood and blood components storage facilities
Nephrology Department
Dialysis units □ 5 or more dialysis / SLED units
□ CRRT units (optional)
Dialysis unit dedicated to seropositive patients □ 1 or more
Monthly endotoxin level and bacteria testing □ Inhouse lab □ Outsourced
Gastroenterology / Hepatology Facilities / Equipment
*In-house Endoscopy suite with necessary equipment -
Pulmonology Facilities / Equipment -
Cardiology Facilities / Equipment -

Manpower Requirements
Transplant Surgery team
Transplant Surgeons □ Full-time # □ Visiting #
*At least one full time surgeon who is part of the
transplant team mandatory
Other Surgeons □ Full-time # □ Visiting #
*At least two qualified surgeons mandatory
Transplant Physicians team
Physician □ Full-time # □ Visiting #
*At least one full time physician who is part of the
transplant team mandatory
*At least two qualified physicians overall
Intensivist -

50
Table 2: Minimum requirements of a kidney transplant program.
Anesthesia Team □ Full-time # □ Visiting #
*At least one full time anesthetist who is part of the
transplant team mandatory
*At least two full time anesthetists overall
Transplant coordinators / Social workers □ Posted # □ Trained #
Nurses □ Floor nurse # □ Trained ICU Nurses #
Other Supportive Personnel - Must
*May be employed full-time or on consulting basis □ Neurologist
ensuring 24-hour availability □ Nephrologist
□ Cardiologist
□ Respiratory Physician
□ Radiologist
□ Pediatrician (If pediatric transplantation planned)
□ Psychiatrist / Psychologist
□ Physiotherapist
□ Social Worker

Other Supportive Personnel - Desirable not mandatory

*May be employed full-time or on consulting basis □ Urologist
□ Neurosurgeon
□ GI Surgeon
□ Neurosurgeon
□ Dietician
□ Immunologist
□ Hematologist

51
Chapter 8: Liver Transplant
Introduction

Liver transplant is a surgical procedure which removes the diseased or failed liver and replaces it with a
whole new or a part of healthy liver from a donor. It is the only potentially curative treatment of liver
failure, which may present as end stage liver disease (ESLD) or as sudden failure of a previously healthy
liver (also called acute or fulminant liver failure).

In a liver transplant surgery, the native liver along with the gallbladder is removed and is sent for
histopathological analysis. The new liver (either from a live donor or a deceased donor) is then
implanted in its place.

Depending on the clinical urgency, a living donor (LDLT) or deceased donor (cadaveric) liver transplant
(DDLT) may be more suitable. For a LDLT, both the patient and the donor undergo detailed evaluation
and if found suitable are scheduled for a transplant. LDLT cases are assessed and approved by the AC.
The advantage of LDLT lies in the fact that the transplant can be scheduled as per the patient’s clinical
condition and convenience. In this scenario a willing near relative may choose to donate up to 60-70%
of his / her liver to the patient. The liver with its regenerative potential recovers 100% of its function
within a few weeks. The donor resumes normal activity after approximately one month and suffers
from no long-term implications due to donation.

For DDLT, the patient is registered on the waiting list with the local AA and SOTTO. The hospital’s
transplant coordinator periodically updates the local authority and SOTTO about the patient’s medical
condition while they are on the waiting list. When a deceased donor’s family consents for organ
donation, the local authority is informed. Liver Function Tests and some other blood tests and USG are
done on the donor, although additional tests may be required. The transplant coordinator, who
maintains the allocation waiting list, informs the hospital transplant coordinator about the donation and
clinical details and reports, who in turn informs patients on the DDLT waiting list. Patients who are
medically suitable and willing for transplant are called to the hospital. Once the donor liver is found
suitable, the recipient’s surgery (to remove the liver) is simultaneously started. Retrieval itself involves
assessment by an experienced surgeon and safe surgery to avoid any injury to the graft. After retrieval
the liver is rapidly transported to the transplant center and the liver is implanted / transplanted into the
recipient.

Figure 1: Living donor liver transplantation.

52
Figure 2: Deceased donor liver transplant

Indications and Eligibility

The indications for liver transplantation are vast, individualized and depend on each Center’s selection
criteria. A few common indications of liver transplant are mentioned in Table 1.

Table 1: Common indications of liver transplant

Table 1: Common Indications of Liver Transplant
Chronic Liver Failure
Viral Infections
Hepatitis B
Hepatitis C
Alcohol
Non-Alcoholic Steatohepatitis (NASH) / Steatotic Liver Disease (SLD)
Caused by increased fat deposition in the liver. Patients with obesity, diabetes, increased
cholesterol, are at a high risk.
Autoimmune Liver Disease
Autoimmune Hepatitis
Primary biliary Cirrhosis
Primary sclerosing cholangitis
Congenital Liver Diseases (abnormal development of the liver)
Biliary Atresia
Metabolic Diseases
Hemochromatosis (excess deposition of iron in liver)
Wilson Disease (excess deposition of copper in liver)
Vascular Abnormalities
Budd Chiari Syndrome (Blood cannot drain back to the heart because of hepatic vein obstruction)
Acute Liver Failure
Viral Infections
Hepatitis A
Hepatitis E

53
Paracetamol Overdose
Rat Poison Overdose
Pregnancy-induced Liver Failure
Malignancies
Hepatocellular Carcinoma (Most common liver cell malignancy in adults)
Hepatoblastoma (Most common liver cell malignancy in children)

54
In cases of LDLT, the minimum criteria to recommend transplantation have not been specified. They
depend on each transplant center's individual practices. For DDLT, the minimal listing criteria for
registering a patient on the Liver Transplant Wait list are state specific at present. However, India
envisages a universal organ registry soon. Under the NOTTO rules, the criteria are as follows:

1. Minimal Listing Criteria for Super Urgent listing

● Primary Non-Function (PNF) of liver allograft
● Living liver donor who develops life threatening liver failure.
● Early Hepatic Artery Thrombosis (HAT) needing re-transplant.
● Fulminant Hepatic Failure (FHF) meeting the King’s College Hospital criteria.

2. Minimal Listing Criteria for Routine Waitlist

● MELD score > 15 in patients aged more than 12 years.
● HCC – within USCF criteria
● Patients with metabolic disorders and for those with quality-of-life issues who do not have
the minimum required model for end-stage liver disease (MELD) score e.g. chronic hepatic
encephalopathy, intractable pruritus and polycystic liver disease are not eligible.

3. Contraindications of Liver Transplant

● MELD Score <15
● Severe cardiac or pulmonary disease, who is unfit for general anesthesia.
● AIDS
● Hepatocellular carcinoma beyond UCSF criteria
● Uncontrolled sepsis
● Intrahepatic Cholangiocarcinoma
● Extrahepatic malignancy

55
Figure 3: A flowchart of the entire process of liver transplantation

In the case of a live donor, what are the eligibility and acceptance criteria for a donor?
The demand for organs far exceeds the supply. This has led to the development of living donor
programs wherein the wait time is bypassed. This is particularly useful in sicker patients who may not
be able to wait till an organ becomes available. The donor evaluation protocol is exhaustive, usually
involving a multitude of laboratory tests, liver imaging and expert consultations.

● The donor’s liver should not be fatty.

● The donor’s liver should be large enough so that part of it should be sufficient for the donor
after part removal and the other part enough to meet the metabolic needs of the recipient.
● The surgical team should approve of the vascular and biliary anatomy.
● A multidisciplinary team must document fitness for surgery.

56
 In cases of deceased donors, what are the eligibility and acceptance criteria for donors?
In cases where a live donor is not available, the only alternative is to wait for a deceased donor organ
offer. The exclusion criteria for accepting a donor liver are:

● HIV
● Malignancy other than primary brain and non-malignant skin tumors
● Organs may also be rejected after assessment of the retrieval surgeon for
○ Fatty liver
○ Size mismatch
○ Significant intrahepatic cholestasis
○ Changes of cirrhosis, etc.

What are the specific requirements of a Liver Transplant Center?

Setting up a liver transplant program requires commitment and dedication from the hospital
administration, as well as the medical, surgical and ancillary teams (Table 2).

Manpower
The primary members of the multidisciplinary team consist of surgeons, hepatologists,
anesthesiologists, and intensivists. Ancillary specialists such as cardiologists, psychiatrists,
psychologists, pulmonologists, infectious diseases specialists, neurologists, nutritionists,
physiotherapist, radiologists, and pathologists are desirable. Transplant coordinators and other
support staff are required to facilitate evaluation, follow-up and counseling of the patients.

Infrastructure
Two large sized OTs are required for a LDLT or for a DDLT from an in-house donor. Preferably these
should be dedicated and always kept clean and ready for an emergency transplant or re-exploration.
OT tables should be electrically operated with vertical and tilting movements. There should be 3
overhead OT lights in the recipient OT, if not in both, with additional mobile lights for benching
surgery.

In the in-patient department there should be dedicated beds in wards, and ICU with trained nurses
and staff, separate for liver disease patients under hepatology and transplant patients under the
surgery teams, respectively. ICU and isolation rooms should have a HEPA filter.
A few rooms should have both positive and negative pressure capability for patients with high risk of or
known infections. While patients with ESLD and living donors may share rooms, post-transplant patients
should be in a single room. Appropriate barrier nursing and infection control protocols should be
instituted and enforced in all these areas.

Day care services are required for minor procedures such as ascitic fluid tapping, liver biopsy or albumin
or antibiotic injections with vital signs and adverse reactions monitoring for ESLD patients on the
waiting list or post-transplant patients, under supervision of trained medical staff.

A typical endoscopy suite in a liver transplant program has equipment such as high-definition
endoscopes, endoscopic ultrasound (EUS), endoscopic retrograde cholangiography (ERC) and biliary
stenting, biopsy forceps, snares, and hemostatic devices, for safe and effective procedures.

A well-equipped radiology department with essential imaging modalities such as USG, CT machines must
be present along with access to MRI, positron emission tomography (PET) scan and others. The
equipment should be supported with various proprietary software required for calculation of liver
volumes for donor evaluation or magnetic resonance elastography for initial evaluation and long term

57
follow up of transplant recipients. Access to a dedicated interventional radiology department with a
well-equipped cath lab is desirable.

Access to a histopathology department with automated tissue processors, paraffin embedding stations,
microtomes, special stains and other equipment are required along with access to high- quality
diagnostic services, including drug levels for immunosuppressive drugs and antibiotics. In addition, HLA
testing to confirm genetic relationships is more frequently being used across the country.

Specific Equipment
A complete set of instruments for donor, recipient and bench surgery are required including dissectors,
scissors, vascular clamps and needle holders in addition to a good general surgery set. Long instruments
are often required as the abdominal cavity can be very deep in some patients. A robust self-retaining
upper abdominal retractor set is essential with both donor and recipient sets. Monopolar
/ Bipolar electrosurgery or energy sources such as ultrasonic shears are commonly used for dissection
and hemostasis. For LDLT, a cavitronic ultrasonic suction aspirator (CUSA) or hydrojet may be required
for parenchymal transection.

A well-equipped anesthesia machine with central gases and suctions are required, although it is
desirable to have additional standalone suction machines. A portable c-arm machine is required for
intraoperative cholangiography. While an operating microscope is often desirable, it is not
mandatory, as most surgeons use surgical loupes.

Any large volume center would gain an advantage by having a hybrid operating room for high-risk cases,
such as recipients with portal venous thrombosis or pediatric transplantations, that may require
interventional radiological procedures during the transplant.

Intraoperative management of these patients requires meticulous monitoring. For this purpose, it is
desirable to have a multiparameter monitor for hemodynamic monitoring. In addition, cardiac output
monitoring using arterial pulse contour analysis (Flotrac© or PiCCO©) is usually used for guiding
hemodynamic and fluid management. Rapid infusers and cell savers for management of massive blood
loss, depth of anesthesia monitors (Bispectral index© or Entropy) to titrate anesthetic agents,
viscoelastic testing using devices such as TEG© or ROTEM© for coagulation monitoring, point of care
arterial blood gas monitors (e.g. iStat©), patient warming devices (Forced air warmers, fluid warmers,
warming mattresses), patient positioning devices such as silicone or gel pads to prevent pressure sores
in prolonged surgery are desirable components of the operation theater armamentarium.

A continuous renal replacement therapy (CRRT) machine and a dialysis port are desirable for high-risk
transplants. Point of care testing and laboratory testing with rapid turnaround time is desirable to
enable appropriate monitoring and correction during the transplant.

Table 2: Requirements of a Liver Transplant Center

Outpatient Department Requirements

Overall OPD patient turnover □ > 300 per year
□ > 30 per month (in case of a new center not
completed one year)

Number of potential transplant candidates □ > 10 per year

□ >1 per month (in case of a new center not
completed one year)
OPD Rooms □ 2 or more
Minor procedures area □ Present

58
Table 2: Requirements of a Liver Transplant Center
Counseling / Conference Room with Video recording □ Present, with facilities for storage of data for 10
*Data to be sent to NOTTO after 10 years years
Inpatient Department
Total number of IPD admissions □ >150 per year
□ > 15 per month (in case of a new center not
completed one year)

Total number of hospital beds □ > 100

Post Transplant Beds □ Positive and negative Isolation rooms available
Intensive Care Department and Facilities
ICU Beds - Total □ >10 available
Transplant ICU beds □ At least two isolation beds with HEPA filter
ICU Infrastructure □ At least one bed with access to renal replacement
therapy
□ Central suction / oxygen ports
ICU Equipment □ Multimodal ventilators
□ BiPAP machine
Also refer to □ Multipara monitors
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085818 □ Advanced cardiac monitoring
/ □ Dialysis / SLED machines
□ Intubation trolley
□ Crash cart
*Equipment (e.g. ECMO machine, dialysis machine, etc.)
□ Syringe pumps / infusion pumps
may be shared between the ICU / OR / other departments
□ 12 lead ECG machine
of the hospital □ Defibrillators
□ Access to ABG facility
□ Glucometer
□ Access to TEG / ROTEM testing
□ Access to portable USG and Doppler Machine
□ Access to portable X-Ray

Surgical Department and Facilities

Annual number of Surgeries □ >100 per year
□ >10 per month (in case of a new center not
completed one year)

OTs - Total □ 2 or more

Emergency OT □ Available
OT Infrastructure □ HEPA Filter
□ 2 Dome OT lights with a standalone light for back
*https://nhsrcindia.org/sites/default/files/Guidelines-on- table OR 3 Dome OT lights
OT.pdf □ Meeting requirements laid out by National
Health Mission – Indian Public Health Standards
□ Access to intraoperative dialysis facilities - optional

59
Table 2: Requirements of a Liver Transplant Center
OT Instruments / Equipment □ Meeting requirements laid out by National Health
Mission – Indian Public Health Standards
*https://nhsrcindia.org/sites/default/files/Guidelines-on- □ General Surgery Instrument set with self-
OT.pdf retaining retractors
□ Vascular surgery set
*Equipment (e.g. ECMO machine, dialysis machine, etc.) □ Microsurgery set.
may be shared between the ICU / OR / other departments □ Diathermy machines (unipolar and bipolar) x2
of the hospital □ Suction machines x2
□ Defibrillator
□ Syringe Pumps
□ CUSA / Waterjet / Hydrojet machine (for LDLT)
□ TEG / Rotem Machine
□ Advanced cardiac monitors
□ Fluid warmers
□ Access to intraoperative USG and Doppler
□ C-Arm machine
□ Point of care testing devices (eg. iSTAT) - optional
□ Rapid infusers - optional
□ Laparoscopy set - optional.
□ CP Bypass machine - optional

Radiology Department
Must be present in-house □ X-Ray
□ USG with Doppler and 2D Echo
□ CT Scan with angiography
□ MRI
□ Cath Lab

Desirable (may be outsourced) □ Nuclear Medicine

Supporting Laboratories
Access = Formal MoU with outsourced laboratory ensuring □ Biochemistry - inhouse
24-hour availability □ Hematology - inhouse
□ Microbiology - inhouse
□ Pathology with Frozen Section - inhouse or access
□ Immunology with HLA testing - inhouse or access
Blood Bank
*Only MoU with a blood bank not sufficient □ Inhouse
□ Blood and blood components storage facilities
Nephrology Department
Dialysis units □ 2 or more dialysis / SLED units
□ CRRT units (optional)
Dialysis unit dedicated to seropositive patients -
Monthly endotoxin level and bacteria testing □ Inhouse lab □ Outsourced
Gastroenterology / Hepatology Facilities / Equipment
*In-house Endoscopy suite with necessary equipment □ UGI Scopy
□ Colonoscopy
□ ERCP
□ EUS - optional
Pulmonology Facilities / Equipment -
Cardiology Facilities / Equipment □ Cath lab

Manpower
Transplant Surgery team
Transplant Surgeons □ Full-time # □ Visiting #
*At least one full time surgeon who is part of the
transplant team mandatory

60
Table 2: Requirements of a Liver Transplant Center
Other Surgeons □ Full-time # □ Visiting #
*At least two qualified surgeons mandatory

Transplant Physicians team

Physician □ Full-time # □ Visiting #
*At least one full time physician / hepatologist who is
part of the transplant team mandatory
*At least two qualified physicians overall

Intensivist □ Full-time # □ Visiting #

*At least one full time intensivist mandatory
Anesthesia Team □ Full-time # □ Visiting #
*At least one full time anesthetist who is part of the
transplant team mandatory
*At least two full time anesthetists overall

Transplant coordinators / Social workers □ Posted # □ Trained #

Nurses □ Floor nurse # □ Trained ICU Nurses #
Other Supportive Personnel - Must
*May be employed full-time or on consulting basis □ Neurologist
ensuring 24-hour availability □ Nephrologist
□ Cardiologist
□ Respiratory Physician
□ Radiologist
□ Gastroenterologist
□ Pediatrician (If pediatric transplantation planned)
□ Dietician
□ Psychiatrist / Psychologist
□ Physiotherapist
□ Social Worker

Other Supportive Personnel - Desirable not mandatory

*May be employed full-time or on consulting basis □ Urologist

□ Neurosurgeon
□ GI Surgeon
□ Neurosurgeon
□ Immunologist
□ Hematologist
□ Interventional radiologist
□ Infectious disease

61
 Chapter 9: Pancreas Transplant

Introduction
A pancreas transplant is a surgical method performed to replace a pancreas that is not working correctly
with a healthy pancreas from a deceased donor. Most pancreas transplants are done for patients with
type I diabetes. This offers a potential cure for a patient with this condition. However, a pancreas
transplant is usually reserved for patients with severe complications of diabetes because the side
effects of this transplant can be significant.

There are different ways in which pancreas transplant is performed depending upon the situation and
conditions from which the patient is suffering. Below are some of the conditions which may require you
to go for pancreatic transplant:

● Pancreas alone: Patients of diabetes who suffer from hypoglycemia unawareness and early or
no kidney disease may be a candidate for pancreas transplant alone.
● Simultaneous kidney-pancreas transplant (SKP): Surgeons may consider performing kidney-
pancreas transplants for patients with diabetes who have concomitant kidney failure. Most
pancreas transplants are performed at the same time as a kidney transplant. The main goal of
this approach is to give the patient a healthy pancreas and kidney that are not likely to
contribute to diabetes-related kidney damage in the future.
● Pancreas-after-kidney transplant: For patients waiting long for both a donor pancreas and
kidney to become available, a kidney transplant may be suggested first if a living- or
deceased-donor kidney becomes available. After the kidney transplant is done, a pancreas
transplant may be attempted once a donor pancreas becomes available.

Figure 1: Pancreas transplantation types

1: Isolated pancreas transplant 2: Simultaneous kidney-pancreas transplant

Indications and Eligibility

At present NOTTO guidelines for pancreas transplantation are being formed. However, many state
specific guidelines exist. An example of the Maharashtra guidelines is:

Minimal listing criteria: pancreas transplant alone (PTA) or pancreas after kidney transplant
(PAK)

Each candidate registered on the pancreas waiting list must meet ANY ONE of the following
requirements:

62
 ● Be diagnosed with diabetes:
○ For type I diabetes mellitus:
■ Frequent episodes of hypoglycemia unawareness
■ Brittle diabetes
■ Secondary complications of diabetes
■ Poor quality of life with insulin
○ For type II diabetes mellitus:
■ Insulin dependent
■ Age < 55 years
■ BMI < 28 kg/m2
■ No or minimal coronary risk or with corrected coronary disease and therefore
low cardiac risk.
● Have pancreatic exocrine insufficiency.
● Require the procurement or transplantation of a pancreas as part of a multiple organ
transplant for technical reasons.

Minimal listing criteria for a SKP transplant

● Must meet ANY ONE of the following requirements:

• Must be diagnosed with diabetes with renal insufficiency.
● Should have pancreatic exocrine insufficiency with renal insufficiency.

Registration

A patient may be listed for pancreas transplantation for either a pancreas transplant alone or for a SKP
transplant. A patient listed for SKP will also be listed on the kidney transplant list. The patient will be
listed according to the kidney listing policy and points given as per kidney listing criteria.

Who can donate pancreas?

Any individual who satisfies the below criteria are eligible for donation after brain death:

Pancreas Specific Donor Criteria

• Age ≤ 55 years
• BMI ≤ 28 kg/m2
• No history of Diabetes Mellitus
• No history of alcohol abuse
• Donor hyperglycemia (high blood sugars) due to current acute illness (BD, dextrose
infusions, steroids, brain injury can lead to hyperglycemia in donors) may be
acceptable.
• HbA1C ≤ 7
● Normal Serum Amylase and Serum Lipase

Contraindications For Pancreas Donation

• History of diabetes mellitus

• History of chronic alcohol abuse (allowed for islet cell transplant retrieval)
• History of pancreatitis, pseudocyst, pancreas surgery (allowed for islet cell transplant
retrieval)

63
 How is pancreas allocation done?
Provisional allocation will be done in the following order:

● SPK:
o Type 1 diabetes will get preference over Type 2
o Waiting time + Kidney Listing points
● Pancreas after kidney:
o Type 1 diabetes will get preference over Type 2
o Waiting time
● Pancreas alone:
o Type 1 diabetes will get preference over Type 2
o Waiting time Apart
from this order,

● Final allocation is done to patients with a negative cross match.

● If a patient on SPK list undergoes a living donor kidney transplant, he / she keeps their position
on the pancreas alone transplant list.
● If the patient on SPK list gets an offer for a kidney while on the kidney waiting list, the patient
can choose to accept the kidney and place their name on the pancreas alone list and can use his
/ her pancreas waiting time to go on the pancreas alone list. This is to encourage SPK patients
to use the offer of a good living donor or a good kidney from a deceased donor and to also
encourage more pancreas alone to be utilized.

What are the specific requirements of a Pancreas Transplant Center?

All Centers approved for kidney or liver transplant may meet the minimum required criteria
for pancreas transplant also.

Table 1: Requirements of a pancreas transplant center

Outpatient Department Requirements
Overall OPD patient turnover □ > 300 per year
□ > 30 per month (in case of a new center not completed
one year)
Number of potential transplant candidates Number of patients undergoing dialysis
□ > 50 per year
□ >5 per month (in case of a new center not completed one
year)
OPD Rooms □ 2 or more
Minor procedures area □ Present
Counseling / Conference Room with Video recording □ Present, with facilities for storage of data for 10 years
*Data to be sent to NOTTO after 10 years
Inpatient Department
Total number of IPD admissions □ >150 per year
□ > 15 per month (in case of a new center not completed
one year)
Total number of hospital beds □ > 50
Post-Transplant Beds □ Isolation rooms available
Intensive Care Department and Facilities
ICU Beds - Total □ >5 available
Transplant ICU beds □ At least one isolation bed with HEPA filter
ICU Infrastructure □ At least one bed with access to renal replacement therapy
□ Central suction / oxygen ports
ICU Equipment □ Multimodal ventilators
□ Multipara monitors
Also refer to □ Dialysis / SLED machines

64
Table 1: Requirements of a pancreas transplant center
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085818/ □ Intubation trolley
□ Crash cart
*Equipment (e.g. ECMO machine, dialysis machine, etc.) □ Syringe pumps / infusion pumps
may be shared between the ICU / OR / other departments □ 12 lead ECG machine
of the hospital □ Defibrillators
□ Access to ABG facility
□ Glucometer
□ Access to portable USG and Doppler Machine
□ Access to portable X-ray
Surgical Department and Facilities
Annual number of Surgeries □ >100 per year
□ >10 per month (in case of a new center not completed one
year)
OTs - Total □ 2 or more
Emergency OT □ Available
OT Infrastructure □ HEPA Filter
□ 2 Dome OT lights with a standalone light for back table OR
*https://nhsrcindia.org/sites/default/files/Guidelines-on- 3 Dome OT lights
OT.pdf □ Meeting requirements laid out by National Health Mission
– Indian Public Health Standards
OT Instruments / Equipment □ Meeting requirements laid out by National Health Mission
– Indian Public Health Standards
*https://nhsrcindia.org/sites/default/files/Guidelines-on- □ General Surgery Instrument set with self-retaining
OT.pdf retractors
□ Vascular surgery set
*Equipment (e.g. ECMO machine, dialysis machine, etc.) □ Microsurgery set.
may be shared between the ICU / OR / other departments □ Diathermy machines (unipolar and bipolar) x2
□ Suction machines x2
of the hospital
□ Defibrillator
□ Syring Pumps
□ Cystoscopy Set
□ Access to intra-operative USG and Doppler
□ Laparoscopy set (optional)
□ Fluid warmers (optional)

Radiology Department
Must be present in-house □ X-Ray
□ USG with Doppler and 2D Echo
□ CT Scan with angiography
Desirable (may be outsourced) □ MRI
□ Nuclear Medicine
□ Cath Lab
Supporting Laboratories
Access = Formal MoU with outsourced laboratory ensuring □ Biochemistry - inhouse
24-hour availability □ Hematology - inhouse
□ Microbiology - inhouse
□ Pathology with Frozen Section - inhouse or access
□ Immunology with HLA testing - inhouse or access
Blood Bank
*Only MoU with a blood bank not sufficient □ Inhouse
□ Blood and blood components storage facilities
Nephrology Department
Dialysis units □ 2 or more dialysis / SLED units
□ CRRT units (optional)
Dialysis unit dedicated to seropositive patients -
Monthly endotoxin level and bacteria testing □ Inhouse lab □ Outsourced
Gastroenterology / Hepatology Facilities / Equipment
*In-house Endoscopy suite with necessary equipment
Pulmonology Facilities / Equipment -
Cardiology Facilities / Equipment
Manpower
Transplant Surgery team

65
Table 1: Requirements of a pancreas transplant Center
Transplant Surgeons □ Full-time # □ Visiting #
*At least one full time surgeon who is part of the transplant
team mandatory
Other Surgeons □ Full-time # □ Visiting #
*At least two qualified surgeons mandatory
Transplant Physicians team
Physician □ Full-time # □ Visiting #
*At least one full time physician who is part of the transplant
team mandatory
*At least two qualified physicians overall
Intensivist -
Anesthesia Team □ Full-time # □ Visiting #
*At least one full time anesthetist who is part of the
transplant team mandatory
*At least two full time anesthetists overall
Transplant coordinators / Social workers □ Posted # □ Trained #
Nurses □ Floor nurse # □ Trained ICU Nurses #
Other Supportive Personnel - Must
*May be employed full-time or on consulting basis □ Neurologist
ensuring 24-hour availability □ Nephrologist

□ Endocrinologist
□ Cardiologist
□ Respiratory Physician
□ Radiologist
□ Pediatrician (If pediatric transplantation planned)
□ Psychiatrist / Psychologist
□ Physiotherapist
□ Social Worker
Other Supportive Personnel - Desirable not mandatory
*May be employed full-time or on consulting basis □ Urologist
□ Neurosurgeon
□ GI Surgeon
□ Neurosurgeon
□ Dietician
□ Immunologist
□ Hematologist

66
Chapter 10: Intestine Transplant
Introduction
An intestinal transplant is a complex undertaking which involves implanting an appropriate length of
intestine from a donor (predominantly deceased, rarely living) into a patient suffering from short gut
syndrome.

Intestinal transplantation may be performed as an isolated intestine transplant or as a part of a multi-

visceral transplant (e.g. liver-intestine). Like all organ transplants, the recipients are placed on the
intestine wait list for deceased donor transplantation. Once they are allocated the intestine the surgery
is performed. At present, the long-term outcomes of intestinal transplant are not favorable. However,
with continued research and advancements in the field of transplantation, the outcomes may improve.

Figure 1: Small bowel transplantation

What are the indications of intestinal transplantation?

Most patients with short gut syndrome or pseudo-obstruction are eligible for intestinal transplant. A few
common conditions leading to short gut are:

Pediatric

● Necrotizing enterocolitis
● Gastroschisis
● Midgut volvulus
● Malabsorption syndromes

Adults

● Midgut volvulus
● Mesenteric ischemia
67
 ● Desmoid tumors involving the root of mesentery.
● Total parenteral nutrition (TPN) Induced complications.
○ Impending liver failure due to TPN related liver injury
○ Multiple episodes of catheter related sepsis
○ Thrombosis of two or more central veins
○ Episodes of severe fungal sepsis, septic shock or acute respiratory distress syndrome
because of TPN

A patient with extensive porto-mesenteric thrombosis is to be eligible for a liver-intestine transplant.

What are the eligibility criteria for intestine donation?

Intestinal transplantation is usually performed after a deceased donation. However, very rarely a live
donor may choose to donate a part of his / her intestine. The selection criteria for intestine donation
include:

1. Deceased donor
● Blood group compatible
● Less than 45 years
● Minimal Inotropic requirement
● Negative blood cultures
● CDC & flow crossmatch negative
● The donor weight should be 20 % less than recipient weight.

2. Living donor
● Blood group compatible
● < 50 years
● CDC and flow crossmatch negative

Allocation
At present allocation is done chronologically. Patients who require liver-intestine transplants are
given priority over isolated intestine transplants.

What are the requirements of an Intestinal Transplant Center?

A center performing intestine transplants has similar requirements to a kidney or liver transplant
center.

Table 1: Requirements of an intestine transplant center

Outpatient Department Requirements
Overall OPD patient turnover □ > 300 per year
□ > 30 per month (in case of a new center not completed
one year)
Number of potential transplant candidates Number of patients undergoing dialysis
□ > 50 per year
□ >5 per month (in case of a new center not completed one
year)
OPD Rooms □ 2 or more
Minor procedures area □ Present
Counselling / Conference Room with Video recording □ Present, with facilities for storage of data for 10 years
*Data to be sent to NOTTO after 10 years
Inpatient Department

68
Total number of IPD admissions □ >150 per year
□ > 15 per month (in case of a new center not completed
one year)

69
Table 1: Requirements of an intestine transplant center
Total number of hospital beds □ > 50
Post-Transplant Beds □ Isolation rooms available
Intensive Care Department and Facilities
ICU Beds - Total □ >5 available
Transplant ICU beds □ At least one isolation bed with HEPA filter
ICU Infrastructure □ At least one bed with access to renal replacement therapy
□ Central suction / oxygen ports
ICU Equipment □ Multimodal ventilators
□ Multipara monitors
Also refer to □ Dialysis / SLED machines
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085818/ □ Intubation trolley
□ Crash cart
□ Syringe pumps / infusion pumps
*Equipment (e.g. ECMO machine, dialysis machine, etc.)
□ 12 lead ECG machine
may be shared between the ICU / OR / other departments
□ Defibrillators
of the hospital
□ Access to ABG facility
□ Glucometer
□ Access to portable USG and Doppler Machine
□ Access to portable X-ray

Surgical Department and Facilities

Annual number of Surgeries □ >100 per year
□ >10 per month (in case of a new center not completed one
year)
OTs - Total □ 2 or more
Emergency OT □ Available
OT Infrastructure □ HEPA Filter
□ 2 Dome OT lights with a standalone light for back table OR
*https://nhsrcindia.org/sites/default/files/Guidelines-on- 3 Dome OT lights
OT.pdf □ Meeting requirements laid out by National Health Mission
– Indian Public Health Standards
OT Instruments / Equipment □ Meeting requirements laid out by National Health Mission
– Indian Public Health Standards
*https://nhsrcindia.org/sites/default/files/Guidelines-on- □ General Surgery Instrument set with self-retaining
OT.pdf retractors
□ Vascular surgery set
□ Microsurgery set.
*Equipment (e.g. ECMO machine, dialysis machine, etc.)
□ Diathermy machines (unipolar and bipolar) x2
may be shared between the ICU / OR / other departments
□ Suction machines x2
of the hospital □ Defibrillator
□ Syringe Pumps
□ Cystoscopy Set
□ Access to intraoperative USG and Doppler
□ Fluid warmers (optional)

Radiology Department
Must be present in-house □ X-Ray
□ USG with Doppler and 2D Echo
□ CT Scan with angiography
Desirable (may be outsourced) □ MRI
□ Nuclear Medicine
□ Cath Lab
Supporting Laboratories
Access = Formal MoU with outsourced laboratory ensuring □ Biochemistry - inhouse
24-hour availability □ Hematology - inhouse
□ Microbiology - inhouse
□ Pathology with Frozen Section - inhouse or access
□ Immunology with HLA testing - inhouse or access
Blood Bank
*Only MoU with a blood bank not sufficient □ Inhouse
□ Blood and blood components storage facilities
Nephrology Department

70
Table 1: Requirements of an intestine transplant center
Dialysis units □ 2 or more dialysis / SLED units
□ CRRT units (optional)
Dialysis unit dedicated to seropositive patients -
Monthly endotoxin level and bacteria testing □ Inhouse lab □ Outsourced
Gastroenterology / Hepatology Facilities / Equipment
*In-house Endoscopy suite with necessary equipment □ UGI Scopy
□ Colonoscopy
□ ERCP
□ EUS - optional
Pulmonology Facilities / Equipment -
Cardiology Facilities / Equipment -
Manpower
Transplant Surgery team
Transplant Surgeons □ Full-time # □ Visiting #
*At least one full time surgeon who is part of the transplant
team mandatory
Other Surgeons □ Full-time # □ Visiting #
*At least two qualified surgeons mandatory
Transplant Physicians team
Physician □ Full-time # □ Visiting #
*At least one full time physician who is part of the transplant
team mandatory
*At least two qualified physicians overall
Intensivist -
Anesthesia Team □ Full-time # □ Visiting #
*At least one full time anesthetist who is part of the
transplant team mandatory
*At least two full time anesthetists overall
Transplant coordinators / Social workers □ Posted # □ Trained #
Nurses □ Floor nurse # □ Trained ICU Nurses #
Other Supportive Personnel - Must
*May be employed full-time or on consulting basis □ Neurologist
ensuring 24-hour availability □ Gastroenterologist
□ Cardiologist
□ Respiratory Physician
□ Radiologist
□ Pediatrician (If pediatric transplantation planned)
□ Psychiatrist / Psychologist
□ Physiotherapist
□ Social Worker

Other Supportive Personnel - Desirable not mandatory

*May be employed full-time or on consulting basis □ Urologist
□ Neurosurgeon
□ GI Surgeon
□ Neurosurgeon
□ Dietician
□ Immunologist
□ Hematologist

71
Chapter 11: Uterine Transplant
Introduction
Uterus transplantation is a complex, multi-step process that involves a uterus donor, uterus recipient,
and genetic father (figure 1). The uterus recipient is also the genetic mother, as embryos are created
using her eggs and the genetic father's sperm prior to the transplantation procedure. Surgical removal
of the donor uterus requires a radical-type hysterectomy. Uterus transplantation involves extensive
vascular surgery. The discussion below highlights key points specific to uterus removal and
transplantation.

Figure 1: Steps required for uterine transplantation.

Who needs a Uterine Transplant?

Indications
Any couple suffering from uterine factor infertility is eligible for transplantation.

The absolute indications include diseases which the treatment is only adoption, surrogacy, or uterus
transplantation:

72
 ● Uterine agenesis or hypoplasia
● Hysterectomy done for leiomyoma, postpartum bleeding or for cervical neoplasia.

Uterine transplant may also be considered as a last-line treatment for the following relative
indications:

● Intrauterine adhesions
● Unicornuate, didelphic, septate, bicornuate or arcuate uterus
● Leiomyomas

Figure 2: Uterine transplantation

Eligibility
A female with any of the above medical conditions is then assessed for the following:

● The female should be of reproductive group with no medical contraindications to

transplantation.
● Has documented congenital or acquired uterine factor infertility that has failed all current gold
standards and conservative therapy.
● Has a personal or legal contraindication to surrogacy
● Has no psychological comorbidity that interferes with workup or treatment.
● Does not have frank unsuitability for motherhood.
● Is likely to take antirejection medication and follow-up with the treating team in a responsible manner.
● Is responsible enough to give consent and make proper decisions.

Once a female satisfies all the above, the inclusion and exclusion criteria are checked:

Inclusion Criteria

● Age 24-38 (or 40 if eggs frozen before 38 years of age)

● No medical illness
● BMI <30 kg/m2
● Has a long-term partner
● Has her own ovaries and eggs.

73
 ● Fluent in Hindi/English

Exclusion Criteria

● Previous children
● Previous major abdominal / pelvic surgery
● Previous severe endometriosis
● If h/o cancer: cancer-free for less than 5 years
● H/o psychiatric illness involving hospitalization.
● Requirement of donor eggs or donor sperm
● Insufficient embryo quality / quantity (<10 satisfactory embryos).

Any female satisfying all of the above is offered a uterine transplant.

What is the eligibility / acceptance criteria for the donor?

Uterine transplantation may be done with live or cadaveric donations.

1. For a cadaveric donor, the selection criteria are:

a. Age less than 50 years.
b. No uterine pathology.
c. Have a complete obstetric history available.

It is important to note that the uterus is the last organ to be procured after the heart, lungs, intestine,
liver, and kidney. So, this would increase the ischemia time of the organ and may lead to organ rejection
and failure of transplant.

2. For a live donor

a. Age less than 60 years or less,
b. Related to recipient (mother, sister or daughter),
c. Have normal uterus,
d. Normal obstetric history.

Donor uterine retrieval may be performed laparoscopically / open or robotic assisted and the ischemic
time may be reduced from to less than 2.5 hours. This may improve surgical outcomes.

What are the requirements of a Uterine Transplant Center?

A center performing uterine transplants has similar requirements to a kidney transplant center.
Additionally, a gynecologist is desirable to care for the patients in the post-operative course for in-
vitro fertilization.

74
Chapter 12: Heart Transplant
Introduction
In India, there are many patients who are in end-stage heart failure or severe pulmonary failure. Both
these serious medical conditions require organ transplants. Heart transplant is the gold standard
treatment for end stage heart failure.

Heart transplant is an operation in which a recipient patient’s diseased heart is replaced with a healthy
donor heart. Before a heart transplant option is offered to a patient as a treatment, all other possible
medical or device options should have been carefully chosen and offered to the patient. If, despite other
treatments, the heart failure is severe and the patient is very symptomatic, he / she is then listed for
heart transplant. The purpose of heart transplant operation is to extend the lifespan of the recipient and
to enable him / her to live an active productive life free of symptoms.

10-year survival following heart transplant is more than 60 percent and patients lead a good active life
if they are under close medical supervision. Continuous and close follow-up of heart transplant
recipients in specialized centers can mitigate most of the complications which may arise out of this
endeavor.

Figure 1: Heart Transplantation

Who needs a heart transplant?

Common cardiological diagnoses for which heart transplants are done include – Dilated cardiomyopathy
(approx. 45 %) and Ischemic cardiomyopathy (approx. 45 %). Some other rare causes for which heart
transplant may be required include - some tumors of the heart, malignant ventricular arrhythmias and
severe congenital heart anomalies.

Minimal listing criteria for heart transplant

3 categories are proposed for the listing of a patient on the heart transplant wait list –

● Priority 1 (emergency): These are patients on ventricular assist devices such as intra-aortic
balloon pump (IABP) and are critical. These recipients will get priority based on blood group and
size matching. Their status needs to be confirmed on a weekly basis.

75
 ● Priority 2 (semi emergency): These are patients in intensive care units for at least a week and
not maintaining hemodynamics without inotropes support. Their category needs to be updated
every 48 hours. Prior to allocation, their condition is confirmed by three members of the heart
subcommittee.
● Priority 3 (elective): These are patients electively waiting for transplantation. Their status needs
to be confirmed or changed as per their progress on a monthly basis.

What is the eligibility / acceptance criteria for the donor?

The only option for heart donation is post donor death donation. Presently all heart donations in our
country are after brain death. In some countries, some heart donations are done after cardiac death
(DCD). The laws and modalities to start DCD are being worked out by NOTTO.

Apart from the general criteria for donors, the following criteria are needed:

a) Age less than 60 years. If the donor is more than 40 years, coronary angiogram is desirable to
exclude asymptomatic coronary artery disease.
b) No history of heart disease and echocardiogram showing good cardiac function and no
anatomical abnormalities.
c) Maintaining good hemodynamics and not on high doses of inotropes
d) Cardiac arrest – donors revived after a brief cardiac arrest must be assessed extra carefully;
but can be considered if the cardiac function is normal.

How is allocation done?

After a brain-dead patient gives consent for heart donation, NOTTO is informed by the TC about donor
details and important investigations.

● Height, weight, blood group are very important parameters.

● For heart specific donation, troponin values, total and differential leucocyte counts, and most
importantly, echocardiography of the heart is done, and information is sent to NOTTO.
● The echo is done by a cardiologist / intensivist and approximately a 1-minute video is recorded
which can then be seen by the heart recipient teams.
● Due to dye-load-on-kidney concerns, usually coronary angiography of the donor is not carried
out; but it is ideally to be done on donors above the age of 40 years.

Matching of heart and Lungs are done based on blood group matching, size matching and geographical
distance. There should not be more than a 20 percent size mismatch between the donor and the
recipient heart / lung. Larger hearts can go to smaller patients and more mismatches are acceptable in
children. Most problems occur with small hearts in large recipients.

For heart or heart – lung transplant

● If deceased donor organs are harvested in a transplantation Center, the heart and one lung go
to that Center (both lungs may be used in one patient at the discretion of the Transplant team).
The other lung goes to the general pool. If the hospital does not have recipients, then the heart
and both lungs go to the general pool.
● If deceased donor organs are harvested in a NTROC, the heart and both lungs go to the
general pool.
● Within the general pool organs are distributed based on the priority levels. If multiple patients
are there in each category, then the heart is distributed in chronological order. If the donor is
CMV positive, and there is a recipient who is CMV positive, they are matched provided there
are no waiting patients in priority 1 and 2.

76
 What are the Requirements of a Heart Transplant Center?
Infra-structural / Equipment
A heart transplant center requires substantial infrastructural investments (Table 1).

2 dedicated ORs for carrying out transplant and non-transplant surgeries with all the advanced facilities
and equipment such as extracorporeal membrane oxygenation (ECMO) machines. Additional
equipment which are specific to a heart lung center includes:
● Echo machine with trans esophageal echo probe
● Thromboelastography (TEG) machines
● Activated clotting time (ACT) machine.
● Blood gas analyzers
● Heart Lung machine
● Nitric oxide delivery system
● Doppler machine
● Pacemaker machine
● Defibrillator machine with pads
● cell savers
● Sternal saw with/out battery
● Self-retaining thoracic retractor set.
● Suction anchor

For the post-operative management of heart-lung transplant patients, a bronchoscopy suite with
facilities to perform check endoscopies, stenting, biopsies should be available.

An advanced ICU with essential equipment such as ECMO machines, multimodal ventilators, ACT
machine, AIRV machines, defibrillator machines, nitrous oxide machine, chest vibrators, ports for
dialysis, intra-aortic balloon pump (IABP), blood gas analyzers, advanced cardiac monitors with cardiac
output modules, and single / dual chamber pacemakers in addition to the usual ICU set up are important
to achieve good outcomes.

These key areas of the hospital should be supported by well-equipped and well-staffed departments
such as radiology, biochemistry and hematology laboratories, pathology departments with expertise in
biopsy interpretation and more. The remaining areas such as consulting rooms, video-conferencing
rooms, floor beds are like the requirements for any other transplant center.

Manpower Requirement
A cardiothoracic surgeon trained in heart transplant and an experienced pulmonologist with exposure
to transplantation and competence in endobronchial procedures are key personnel in a heart-lung
transplant center. A cardiac anesthetist with training in transplantation should be available to handle
the intra-op care and post-op care in heart and lung transplantation They should be supported by a
trained intensivist with knowledge and experience in handling prolonged ventilation and ECMO care.

In addition to this core team, trained transplant nurses, dedicated ICU nurses, and OT support staff are
crucial to the success of a transplant program. A specific requirement of a heart-lung transplant center
is the availability of a perfusionist trained in operating extracorporeal circulation equipment (heart- lung
machine) and ECMO installation, initiation, and evacuation along with organ perfusion and preservation.
Physiotherapists trained in cardio-pulmonary rehabilitation are also desirable. Other supportive expert
personnel may include a Psychiatrist, Gynecologist, Gastroenterologist, Nephrologist, and a Clinical
nutritionist to achieve optimum outcomes.

77
Table 1: Minimum requirements of a heart transplant Center

Outpatient Department Heart

Overall OPD patient turnover □ > 500 per year
□ > 50 per month (in case of a new center not completed
one year)

Number of potential transplant candidates □ > 5 per year

□ >1 every 3 months (in case of a new center not
completed one year)
OPD Rooms □ 5 or more
Minor procedures area □ Present
Counseling / Conference Room with Video recording □ Present, with facilities for storage of data for 10 years
*Data to be sent to NOTTO after 10 years
Inpatient Department
Total number of IPD admissions □ >300 per year
□ > 30 per month (in case of a new center not completed
one year)

Total number of hospital beds □ > 100

Post Transplant Beds □ Positive and negative Isolation rooms available
Intensive Care Department and Facilities
ICU Beds - Total □ >10 available
Transplant ICU beds □ At least two isolation beds with HEPA filter
ICU Infrastructure □ At least one bed with access to renal replacement
therapy
□ Central suction / oxygen ports

ICU Equipment □ Multimodal ventilators

□ BiPAP machine
Also refer to □ Multipara monitors
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085818 □ Advanced cardiac monitoring
/ □ Dialysis / SLED machines
□ Intubation trolley
□ Crash cart
*Equipment (e.g. ECMO machine, dialysis machine, etc.)
□ Syringe pumps / infusion pumps
may be shared between the ICU / OR / other departments □ 12 lead ECG machine
of the hospital □ Defibrillators
□ ECMO Machine
□ CP Bypass machine
□ Hemotherm
□ Echo machine with TEE probe
□ ACT machine
□ AIRV machine
□ IABP machine
□ Chest vibrators
□ Nitrous oxide delivery machine
□ Single / dual pacemaker machine
□ Access to ABG facility
□ Glucometer
□ Access to TEG / ROTEM testing
□ Access to portable USG and Doppler Machine
□ Access to portable X-Ray

Surgical Department and Facilities

Annual number of Surgeries □ >100 per year
□ >10 per month (in case of a new center not completed
one year)

OTs - Total □ 2 or more

Emergency OT □ Available

78
Table 1: Minimum requirements of a heart transplant center
OT Infrastructure □ HEPA Filter
□ 2 Dome OT lights with a standalone light for back table
*https://nhsrcindia.org/sites/default/files/Guidelines-on- OR 3 Dome OT lights
OT.pdf □ Facilities for ECMO
□ Facilities for CP Bypass
□ Meeting requirements laid out by National Health
Mission – Indian Public Health Standards
OT Instruments / Equipment □ Meeting requirements laid out by National Health
Mission – Indian Public Health Standards
*https://nhsrcindia.org/sites/default/files/Guidelines-on- □ General Surgery Instrument set with self-retaining
OT.pdf retractors
□ Vascular surgery set
*Equipment (e.g. ECMO machine, dialysis machine, etc.) □ Microsurgery set.
□ Sternal saw
may be shared between the ICU / OR / other departments
□ Diathermy machines (unipolar and bipolar) x2
of the hospital
□ Suction machines x2
□ Defibrillator
□ Syringe Pumps
□ ECMO Machine
□ CP Bypass machine
□ Hemotherm
□ Echo machine with TEE probe
□ ACT machine
□ Nitrous oxide delivery machine
□ Pacemaker machine
□ Advanced cardiac monitors
□ Fluid warmers
□ TEG / Rotem Machine - optional
□ Cell saver - optional
□ Point of care testing devices (eg. iSTAT) - optional
□ Rapid infusers - optional

Radiology Department
Must be present in-house □ X-Ray
□ USG with Doppler and 2D Echo
□ CT Scan with angiography
□ Cath Lab
Desirable (may be outsourced) □ MRI
□ Nuclear Medicine
Supporting Laboratories
Access = Formal MoU with outsourced laboratory ensuring □ Biochemistry - inhouse
24-hour availability □ Hematology - inhouse
□ Microbiology - inhouse
□ Pathology with Frozen Section - inhouse or access
□ Immunology with HLA testing - inhouse or access

Blood Bank
*Only MoU with a blood bank not sufficient □ Inhouse
□ Blood and blood components storage facilities
Nephrology Department
Dialysis units □ 2 or more dialysis / SLED units
□ CRRT units (optional)
Dialysis unit dedicated to seropositive patients -
Monthly endotoxin level and bacteria testing □ Inhouse lab □ Outsourced
Gastroenterology / Hepatology Facilities / Equipment
*In-house Endoscopy suite with necessary equipment -
Pulmonology Facilities / Equipment □ Bronchoscopy suite for transbronchial cardiac biopsies
□ Portable bronchoscope
Cardiology Facilities / Equipment □ Cath lab

79
Table 1: Minimum requirements of a heart transplant Center
Manpower
Transplant Surgery team
Transplant Surgeons □ Full-time # □ Visiting #
*At least one full time CVTS surgeon who is part of the
transplant team mandatory
Other Surgeons □ Full-time # □ Visiting #
*At least two qualified surgeons mandatory

Transplant Physicians team

Physician □ Full-time # □ Visiting #
*At least one full time cardiologist who is part of the
transplant team mandatory
*At least two qualified physicians overall

Intensivist □ Full-time # □ Visiting #

*Desirable
Anesthesia Team □ Full-time # □ Visiting #
*At least one full time cardiac anesthetist who is part of
the transplant team mandatory
*At least two full time anesthetists overall

Transplant coordinators / Social workers □ Posted # □ Trained #

Nurses □ Floor nurse # □ Trained ICU Nurses #
Other Supportive Personnel - Must
*May be employed full-time or on consulting basis □ Neurologist
ensuring 24-hour availability □ Nephrologist
□ Respiratory Physician
□ Radiologist
□ Gastroenterologist
□ Pediatrician (If pediatric transplantation planned)
□ Dietician
□ Psychiatrist / Psychologist
□ Physiotherapist
□ Perfusionist
□ Social Worker

Other Supportive Personnel - Desirable not mandatory

*May be employed full-time or on consulting basis □ Nephrologist

□ Neurosurgeon
□ Neurosurgeon
□ Vascular Surgeon
□ Immunologist
□ Hematologist
□ Interventional radiologist
□ Infectious disease

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Chapter 13: Lung Transplant
Introduction
The only option left for patients with advanced lung diseases is lung transplantation. When the doctor
has exhausted all other therapeutic options, the surgery is performed as a life-saving measure for these
individuals. The diseased lungs are surgically removed, and usually, a healthy human lung from a
deceased donor is placed in its place. Rarely, in cases of living donor lobar transplantation, a lung lobe is
removed from one or two living donors. Following a lung transplant operation and successful recovery,
patients who were unable to live without oxygen even when on bedrest can live a supplemental oxygen
free life and with proper rehabilitation, can lead an active normal life. With improvements in science and
an increase in expertise of centers for conducting lung transplants, the 5- and 10-year survival figuresafter
this operation are steadily improving.

Figure 1: Lung transplantation

Who needs a lung transplant?

Indications
There are situations where a lung transplant is advised. Chronic and progressive end-stage lung
disorders that persist despite receiving the maximum amount of medicine, pulmonary rehabilitation,
and oxygen therapy are the most frequent reason for lung transplantation. The indications of lung
transplant are as follows:

● Interstitial lung disease (ILD)

● Chronic Obstructive Pulmonary Disease (COPD)
● Cystic Fibrosis

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 ● Emphysema – Alpha 1 antitrypsin deficiency
● Bronchiectasis
● Sarcoidosis
● Pulmonary Arterial Hypertension
● Lymphangioleiomyomatosis (LAM)
● Langerhans Cell Histiocytosis (LCH)
● Acute Respiratory Distress Syndrome

Eligibility
For someone who needs a lung transplant, a prompt referral is important. The clinical team will be
able to make better decisions with the help of a thorough patient history that includes the
aforementioned elements. Careful evaluation will be done to determine whether the patient is a
candidate for lung transplantation. The patient will go through several tests and consultations as part
of this "Pre-Lung Transplant Assessment," including physical and psychological evaluations. If the
patient is determined to be healthy enough to have a lung transplant, they will be listed in the state
(SOTTO) and national (NOTTO) organ registries after the MDT specialists meeting.
The eligibility for lung transplantation should include:
● All forms of treatment including medical, bronchoscopic, and surgical treatments have been
exhausted.
● A life expectancy of fewer than 2 years without a transplant
● Abstinence from nicotine dependency & substance abuse
● Should have demonstrated drug adherence with good compliance to the treatment and
regular cardiopulmonary rehabilitation.
● The patient's end-stage disease is not likely to recur within the next 5 years.
● There should not be any major comorbid illness like heart, kidney or liver ailments limiting 5-
year survival.
● They should not have any long-term active infection like hepatitis B or C.
● There should not be a history of any recent or active malignancy.
● There should be a reliable social support system.
● There should not be any untreatable psychiatric or neurological issues.

What are the eligibility criteria for deceased donor lung donation?
Unlike other organs, there are many limitations to accepting a donor for lungs. The following criteria are
to identify a pair of compatible lungs for the prospective recipient and to increase the best possible
outcome.

● Age <55 years

● No history of severe active lung disease
● No history of prior thoracic surgery on the side of organ harvest
● Cigarette smoking history of less than 20 pack years
● Compatible blood group
● Mechanical ventilation less than 5 days
● Normal chest radiography or CT scan of the chest
● PF ratio >300 with a peep of 5-8cm H20
● Absence of major chest trauma
● No evidence of aspiration or severe sepsis

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 ● Negative screens for HIV, HbsAg, and HCV antibodies
● No history of active or recent malignant neoplasm except cutaneous cell carcinomas and
localized malignancies with low metastatic potential.
● Normal bronchoscopy with negative gram stain in bronchial washings
● Ischemic time less than 330 minutes
● Size compatibility

Important information / investigations which determine the suitability of a pair of lungs to be accepted
for donation include – Number of days on ventilator, sepsis markers like TLC, procalcitonin, endotracheal
tube and blood cultures, bronchoscopy alveolar lavage gram staining and bronchoscopy findings and
Chest CT scan for lung window (HRCT scan may be done, without dye). The acceptance rate of lungs for
donation is much less than that for hearts.

Extended Donor Criteria:

Finding a donor who satisfies all of the aforementioned requirements is, however, exceedingly difficult
because of the small donor pool and lengthy transplant waiting list. And because of this, the medical
community is sometimes required to accept Extended Criteria Donors (ECD) in order to preserve the
lives of patients who are on life support systems like ventilators and ECMO.

Donors were classified as extended if they fulfilled at least one criterion:

● age >55 years

● PF ratio <300 at 5-8 PEEP
● Tobacco history >20 pack years
● Inhalational drug abuse
● Presence of infiltration on chest X-ray
● Purulent secretions at bronchoscopy
● Mechanical ventilator > 5 days
● Ischemia time > 330 minutes

What are the eligibility criteria for living donor lung transplants:
Living-donor lobar lung transplantation (LDLLT) was developed to offset the mismatch between supply
and demand for those patients awaiting deceased donor lung transplantation (DDLT). LDLLT can be
applied to both pediatric and adult patients with restrictive, obstructive, infectious, and vascular lung
diseases when the size matching is acceptable. The eligibility criteria for the recipient are the same as
those of receiving deceased donor transplantation. In standard LDLLT, the right and left lower lobes are
retrieved from two healthy donors and are implanted in a single recipient.

Donor selection criteria:

● Living donors must be between the ages of 20 and 60

● ABO blood types must match that of the recipient.
● Third-degree relatives or a spouse should be potential donors.
● The arterial oxygen tension on room air should be more than 80 mm Hg.
● The predicted values for forced vital capacity (FVC) and forced expiratory volume in one
second (FEV1) should be at least 85% of the actual values.

How is allocation done?

Matching of heart and lungs is done based on blood group matching, size matching and geographical
distance. There should not be more than 20 percent size mismatch between the donor and the

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recipient heart / lung. Larger hearts can go to smaller patients and more mismatches are acceptable
in children. Most problems occur with small hearts in large recipients.

For heart or heart – lung transplant

● If deceased donor organs are harvested in a transplantation center, heart and one lung is
allotted to that center (both lungs may be used in one patient at the discretion of the
Transplant team). The other lung goes to the general pool. If the hospital does not have
recipients, then the heart and both lungs go to the general pool.
● If deceased donor organs are harvested in a NTROC, the heart and both lungs go to the
general pool.
● Within the general pool organs are distributed based on the priority levels. If multiple patients
are there in each category, then the heart is distributed in chronological order. If the donor is
CMV positive, and there is a recipient who is CMV positive, they are matched provided there
are no waiting patients in priority 1 and 2.

For isolated lung transplant

● If deceased donor organs are harvested in a transplantation center, one lung goes to that
center (both lungs may be used in one patient at the discretion of the Transplant team) and
the other lung goes to the general pool.
● If deceased donor organs are procured from a NTROC, both lungs will go to the general pool.

What are the Requirements of a Heart Transplant Center?

A lung transplant Center has the same requirements as that of a heart transplant Center (Table 1).

Table 1: Minimum requirements of a lung transplant Center

Infrastructural Requirements
Outpatient Department Lungs
Overall OPD patient turnover □ > 500 per year
□ > 50 per month (in case of a new center not completed
one year)
Number of potential transplant candidates □ > 5 per year
□ >1 every 3 months (in case of a new center not
completed one year)
OPD Rooms □ 5 or more
Minor procedures area □ Present
Counseling / Conference Room with Video recording □ Present, with facilities for storage of data for 10 years
*Data to be sent to NOTTO after 10 years
Inpatient Department
Total number of IPD admissions □ >300 per year
□ > 30 per month (in case of a new center not completed
one year)

Total number of hospital beds □ > 100

Post Transplant Beds □ Positive and negative Isolation rooms available
Intensive Care Department and Facilities
ICU Beds - Total □ >10 available
Transplant ICU beds □ At least two isolation beds with HEPA filter
ICU Infrastructure □ At least one bed with access to renal replacement
therapy
□ Central suction / oxygen ports

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Table 1: Minimum requirements of a lung transplant Center
ICU Equipment □ Multimodal ventilators
□ BiPAP machine
Also refer to □ Multipara monitors
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085818/ □ Advanced cardiac monitoring
□ Dialysis / SLED machines
*Equipment’s (e.g. ECMO machine, dialysis machine, etc.) □ Intubation trolley
may be shared between the ICU / OR / other departments □ Crash cart
□ Syringe pumps / infusion pumps
of the hospital
□ 12 lead ECG machine
□ Defibrillators
□ ECMO Machine
□ CP Bypass machine
□ Hemotherm
□ Echo machine with TEE probe
□ ACT machine
□ AIRV machine
□ IABP machine
□ Chest vibrators
□ Nitrous oxide delivery machine
□ Single / dual pacemaker machine
□ Access to ABG facility
□ Glucometer
□ Access to TEG / ROTEM testing
□ Access to portable USG and Doppler Machine
□ Access to portable X-Ray

Surgical Department and Facilities

Annual number of Surgeries □ >100 per year
□ >10 per month (in case of a new center not completed
one year)
OTs - Total □ 2 or more
Emergency OT □ Available
OT Infrastructure □ HEPA Filter
□ 2 Dome OT lights with a standalone light for back table
*https://nhsrcindia.org/sites/default/files/Guidelines-on- OR 3 Dome OT lights
OT.pdf □ Facilities for ECMO
□ Facilities for CP Bypass
□ Meeting requirements laid out by National Health
Mission – Indian Public Health Standards

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Table 1: Minimum requirements of a lung transplant Center
OT Instruments / Equipment □ Meeting requirements laid out by National Health
Mission – Indian Public Health Standards
*https://nhsrcindia.org/sites/default/files/Guidelines-on- □ General Surgery Instrument set with self-retaining
OT.pdf retractors
□ Vascular surgery set
*Equipment’s (e.g. ECMO machine, dialysis machine, etc.) □ Microsurgery set.
may be shared between the ICU / OR / other departments □ Sternal saw
□ Diathermy machines (unipolar and bipolar) x2
of the hospital
□ Suction machines x2
□ Defibrillator
□ Syringe Pumps
□ ECMO Machine
□ CP Bypass machine
□ Hemotherm
□ Echo machine with TEE probe
□ ACT machine
□ Nitrous oxide delivery machine
□ Pacemaker machine
□ Advanced cardiac monitors
□ Fluid warmers
□ TEG / Rotem Machine - optional
□ Cell saver - optional
□ Point of care testing devices (eg. iSTAT) - optional
□ Rapid infusers - optional

Radiology Department
Must be present in-house □ X-Ray
□ USG with Doppler and 2D Echo
□ CT Scan with angiography
□ Cath Lab
Desirable (may be outsourced) □ MRI
□ Nuclear Medicine
Supporting Laboratories
Access = Formal MoU with outsourced laboratory ensuring □ Biochemistry - inhouse
24-hour availability □ Hematology - inhouse
□ Microbiology - inhouse
□ Pathology with Frozen Section - inhouse or access
□ Immunology with HLA testing - inhouse or access

Blood Bank
*Only MoU with a blood bank not sufficient □ Inhouse
□ Blood and blood components storage facilities
Nephrology Department
Dialysis units □ 2 or more dialysis / SLED units
□ CRRT units (optional)
Dialysis unit dedicated to seropositive patients -
Monthly endotoxin level and bacteria testing □ Inhouse lab □ Outsourced
Gastroenterology / Hepatology Facilities / Equipment

*In-house Endoscopy suite with necessary equipment -

Pulmonology Facilities / Equipment □ Bronchoscopy suite for tracheal biopsies, tracheal
stenting, etc.
□ Portable bronchoscope
Cardiology Facilities / Equipment □ Cath lab

Manpower

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Table 1: Minimum requirements of a lung transplant Center
Transplant Surgery team
Transplant Surgeons □ Full-time # □ Visiting #
*At least one full time CVTS surgeon who is part of the
transplant team mandatory

Other Surgeons □ Full-time # □ Visiting #

*At least two qualified surgeons mandatory
Transplant Physicians team
Physician □ Full-time # □ Visiting #
*At least one full time pulmonologist who is part of the
transplant team mandatory
*At least two qualified physicians overall

Intensivist □ Full-time # □ Visiting #

*Desirable
Anesthesia Team □ Full-time # □ Visiting #
*At least one full time cardiac anesthetist who is part of
the transplant team mandatory
*At least two full time anesthetists overall
Transplant coordinators / Social workers □ Posted # □ Trained #
Nurses □ Floor nurse # □ Trained ICU Nurses #
Other Supportive Personnel - Must
*May be employed full-time or on consulting basis □ Neurologist
ensuring 24-hour availability □ Nephrologist
□ Cardiologist
□ Radiologist
□ Gastroenterologist
□ Pediatrician (If pediatric transplantation planned)
□ Dietician
□ Psychiatrist / Psychologist
□ Physiotherapist
□ Perfusionist
□ Social Worker

Other Supportive Personnel - Desirable not mandatory

*May be employed full-time or on consulting basis □ Nephrologist
□ Neurosurgeon
□ Neurosurgeon
□ Vascular Surgeon
□ Immunologist
□ Hematologist
□ Interventional radiologist
□ Infectious disease

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 Chapter 14: Hand / Limb Transplant
Introduction

Hand transplants (upper limbs) are vascularized composite allografts that contain multiple tissue types
(skin, muscle, bone, nerves, and blood vessels) and are categorized as composite tissue
allotransplantation (CTA). Transplantation of body structures composed of multiple tissues, derived from
ectoderm and mesoderm, is known as CTA. Like solid organs, they are harvested from a brain- dead
individual and transplanted as a composite anatomical unit to perform the same functions in the
recipients as in the donor and are susceptible to ischemia and allograft rejection. They require
immunosuppression lifelong. Since vascularized composite allotransplantation is similar to organ
transplant and not to tissue transplantation vascularized composite allografts of the limbs, are recognized
as organs.

The Upper limb is harvested from the brain-dead donor under tourniquet control so that there is no blood
loss and there is no hemodynamic instability to the donor, as other solid organs are also to be harvested.
Once the stump is closed, the donor is fitted with prosthetic limbs which the harvesting team carries with
them. These help to maintain a feeling of wholeness of the donor’s body when the body is handed over
to the relatives. The harvested limbs are perfused with a perfusing solution and carried in iceboxes to the
recipient hospital. Four teams work simultaneously to save time – one each on the recipient stump and
one each on the donor limb dissection. Once all are ready two teams go ahead with connecting all the
structures starting with fixing bones, then the tendons / muscles, veins, arteries and nerves, finally closing
the skin flaps.

Post operatively the patient must undergo intensive therapy to obtain good results.

Figure 1: Hand transplant

Indications and Eligibility

A. Indications for hand transplant:

Patients with an amputated upper limb (unilateral or bilateral at levels distal to mid- arm) are offered a
hand transplant. These patients must have

(i) Significant functional limitation despite using prosthesis.

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(ii) Loss of hand or part of upper limb not suitable to any other surgical procedure for near

89
 complete hand function for activities of daily living.

Patients with the following are usually excluded from receiving a hand transplant:

(i) Congenital absence of limb (relative contraindication)

(ii) Severe cardiac cachexia: nephropathy, neuropathy etc.
(iii) Diabetes with end organ diseases
(iv) Baseline GFR < 30 ml/min.
(v) Severe cerebrovascular disease
(vi) Malignancies with expected life span < 10yrs
(vii) Active infectious disease
(viii) Severe obesity (BMI > 30)
(ix) Severe primary pulmonary disease
(x) Pulmonary hypertension PASP > 50 mmHg unresponsive to vasodilator challenge
(xi) Active drug addict
(xii) Recent major psychiatric illness
(xiii) Sero-positive status: HIV, hepatitis B or C positive
(xiv) Medically non-compliant, financially unstable & non-supportive family structure.

It is an essential and of importance that the donor hand (upper limb) should reach the recipient hospital
within the limit of total cold ischemia time for hand which is maximum of 6 hrs. Consideration of travel
distance, mode of travel, cost of travel from retrieval to transplant hospital and level of transplant are
important and require appropriate planning.

What is the eligibility / acceptance criteria for donors?

Hand transplants are always done through cadaveric donations. In addition to the general donor
criteria, the specific criteria applicable for hand transplantation are:

a) Hemodynamically Stable with optimal inotropic support

b) No sepsis
c) No malignancy
d) ABO compatibility
e) Weight / size Matching
f) No trauma to that limb
g) No neurological disease or deformities in that hand
h) No vascular issues in the limb
i) No implant inside the limb

What are the specific requirements of a Hand Transplant Program?

Infrastructure
To have a hand transplant center, a solid organ transplant program should be already running in the
hospital for a few years with a minimum of 10 successful (with minimum 2 years long term follow-up)
solid organ transplants.

For the hand retrieval standard basic diagnostic facilities, ICU for donor maintenance, operation
theater and therapeutic services are required with minimum as below:

● Laboratories - Biochemistry, Hematology, Pathology, Microbiology.

● Radiological: X ray of upper limb, Color Doppler to know about vascular status of the upper
limb.
● Intensive care unit which is fully equipped
● OT which is fully equipped

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For the hand transplant surgery, high end diagnostic facilities, ICU for post-transplant management,
high end modular operation theater and therapeutic services are required as below:

● Laboratories - Biochemistry, hematology, pathology, microbiology.

● Radiological: X ray of upper limb, color doppler to know about vascular status of the upper
limb, USG, CT scan, MRI, digital subtraction angiography (DSA) facilities.
● Transplant Intensive care unit which is fully equipped with isolation barrier nursing.
● OT which is fully equipped
● Blood bank
● Physiotherapy and occupational therapy departments with experience in hand therapy

Manpower
A hand transplant center requires high-volume plastic surgery and orthopedic practice. Trained
anesthetists, along with the plastic and orthopedic surgeons constitute the core transplant team.
Additionally, a nephrologist with adequate experience in renal transplantation and transplant
immunology is crucial to good outcomes.

This core team is supplemented by various supportive disciplines like microbiology, pathology,
biochemistry, and radiology. Monitoring of the hand requires multiple skin biopsies. Hence a skin
biopsy protocol should be available with the team.

For function, dedicated physical therapy would be needed. Occupational therapists and
physiotherapists who are trained in hand transplantation are required for the post operative
rehabilitation of the patients.

Specific Requirements
It is the responsibility of the transplant team to provide suitable prostheses for the donor after
retrieval of the donor upper limbs. Hence these need to be always available with the transplant team.

There should be a fully developed nephrology / immunology team of physicians who have adequate
experience in dealing with solid organ transplants. The transplant team must have printed Standard
Operating Procedures (SOPs) for the surgery, pre-op procedures, and the post-op immunology and
rehabilitation.

The OR must ideally be equipped with triple-dome OT lights and at least one extra standing light,
tourniquet pumps and basic general surgery, plastic surgery, and orthopedic instrument sets. In
addition, to perform microvascular surgery, two operating microscopes are desirable. Microsurgical
instrument sets are needed to perform the anastomosis. Many surgeons prefer using loupes to
enhance their vision while performing hand transplantation. A fully equipped ICU (with multipara
monitors with invasive pressure monitoring multimode ventilators, point of care testing and
defibrillators) are also needed for the immediate post operative care.

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 Chapter 15: Eye Banking and Corneal Transplantation
Introduction
Eye banks are organizations or institutions responsible for harvesting, processing and providing
corneas to surgeons for transplantation. In India, a 3-tier system of eye banking has been
established:

● Eye retrieval centers (that are linked to an eye bank)

● Eye banks and
● Eye bank training centers.

Eye Retrieval Center (ERC)

An eye retrieval center must be affiliated to a registered eye bank, and provides the following services:

● Public and professional awareness about eye donation

● Coordination with donor families and hospital patients to motivate them eye donation.
● Harvesting corneal tissue (from the community and the hospital where they are based) along
with collection of blood from the deceased donor, for serology.
● Safe storage and transportation of tissue maintaining cold chain (2-80C) to the retrieval
Center/eye bank.

Eye Bank

It is an institution / organization that in addition to the above,

● Processes, preserves and evaluates the collected tissue.

● Distributes the corneal tissue in an equitable manner for Keratoplasty.

Eye Bank Training Center (EBTC)

These centers are apex institutes that perform all the eye bank functions plus training for all levels of
personnel in eye banking and research.

Figure 1: Structure of the eye bank program in India

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 What is eye donation?
Eye/Cornea donation is undertaken from deceased donors only. The corneas remain viable for up to 6-
8 hours after death, but this time limit can be extended in very cold climatic conditions or by donor
refrigeration such as in a mortuary for medico legal cases.

Eye/cornea donation broadly is facilitated by either of these processes.

● When the near relatives of deceased donors contact the nearest eye bank after death and the
eye bank team visits the home for the retrieval. This is generally referred to as family-initiated
donation.
● In case of hospital deaths when a grief counselor or eye donation counselor approaches the
relatives to request for the donation. This is known as the Hospital Cornea Retrieval process of
program (HCRP).
● After BD when multi-organ donation is being offered and the families are counseled for eye or
cornea donation. In such situations, the eyes or corneas are procured after all organs.
Figure 2: Cornea transplantation

What is the process of cornea retrieval and transplantation?

Once a potential donor is identified by the eye donation counselor, an alert is given to the eye bank.
The eye bank then sends a retrieval team to the donor hospital / residence to initiate the process of
eye banking.

The standard set of instructions given to the family include:

● Switch of fan to prevent drying of eye,

● Close the eyes of the deceased,
● Cover eyes with wet cotton or gauze to prevent dryness,
● Elevate head by 45 degrees to prevent swelling in eyes.

Retrieval
● The potential donor is first screened by detailed medical and social history, local examination
and serological screening for blood borne infections.
o Minimum Testing: Blood (serum or plasma) must test non-reactive to the following
required infectious diseases:

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 ▪ Human Immunodeficiency Virus Types 1 and 2: anti -HIV-1, anti-HIV-2
▪ Hepatitis C Virus (HCV): anti-HCV
▪ Hepatitis B Virus (HBV): HBsAg
▪ Syphilis
▪ COVID-19
o The exclusion criteria for eye donation are mentioned in detail in the DGHS Eye Banking
manual and it includes medical, social, behavioral and laboratory criteria
(https://dghs.gov.in/WriteReadData/userfiles/file/books/Eye%20Banking%20Book%20
(3)%20(1).pdf).
● After determining suitability, written informed consent is documented from the legal next of
kin. Consent is taken according to the Medical Standards of Eye Banking in India 2020
published by National Program for Control of Blindness and Visual Impairment, DGHS,
MOHFW, GOI (www.mohfw.nic.in/www.npcbvi.gov.in) .
● After appropriate documentation, cornea retrieval can be initiated.
● Generally, apart from a blood sample for serological screening, only the cornea is retrieved (in
situ excision) and directly placed in the corneal storage medium for immediate preservation.
● In certain situations, the whole eyeball (enucleation) is harvested and placed in a moist
chamber, transferred to the eye bank and then dissected under a laminar flow hood to
preserve the cornea and sclera.
● After retrieval, the donor corneas/whole globes along with donor blood samples are
transported to the eye bank (maintaining cold chain of 2-80C) where it is processed and
evaluated for suitability for transplant, stored under refrigeration and distributed to corneal
transplant Centers as per the waiting list.

Evaluation and Storage

● First, a slit lamp microscopic examination for epithelial and stromal pathology and in particular
endothelial disease is done.
● Then a specular microscopic for endothelial cell density and morphology is performed.
● The following criteria indicate poorly functioning donor endothelium and precludes the cornea
for optical penetrating keratoplasty or endothelial keratoplasty procedures:
o Cell density less than 2000 cells per square millimeter
o Extreme polymegathism or pleomorphism.
o Presence of significant guttata.
o Presence of many non-hexagonal or abnormally shaped cells.
o Presence of inflammatory cells, bacteria, or debris on endothelial surface.
o Numerous vacuolated cells.
o These corneas can be used for globe salvage in emergency tectonic or therapeutic
keratoplasty or anterior lamellar keratoplasty procedures.
● After evaluation for suitability, the cornea / tissue is stored in a temperature-controlled
environment in a specific preservative solution.
● It is then transported to a corneal transplant center for use.

Listing and Allocation of Corneas

Patients of any age who suffer from a corneal disease treatable by keratoplasty are eligible to be
registered by a corneal transplant surgeon. NOTTO has also laid out criteria for urgent listing for
cornea transplant which included patients with:

● Advanced corneal ulcers

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 ● Infectious keratitis with progressive worsening
● Relentless progression
● Impending perforation
● Perforation

Broadly,

● First priority is given to patients on the Urgent List

● Second priority is given for visually handicapped patients with best corrected visual acuity
(BCVA) less than 6/60 and > 3/60 or patients with endothelial keratoplasty with good
prognosis.
● Third priority is given for unilateral blindness with a good prognosis for visual gain and
graft survival.
● Fourth priority is for unilateral blindness with poor prognosis for vision and graft survival.

Within each priority segment, the cornea is allocated to the patient with the highest score in a scoring
system devised by NOTTO.

Table 1: Allocation criteria for cornea

S No Criteria for scoring Points
allotted
1 Visual disability
Bilateral blindness i.e., BCVA in better eye < 3/60 +3
Economic blindness i.e., BCVA in better eye < 6/60 +2
Visual disability i.e., BCVA in better eye < 6/18 +1
2 Bullous keratopathy or endothelial failure such as Fuchs dystrophy eligible for +3
endothelial keratoplasty with good visual prognosis
3 Primary donor failure +4
4 Age of recipient
< 6 years +3
6 – 12 years +2
12 – 18 years +1
5 Associated diseases affecting inferior outcomes.
Healed keratitis with deep vascularized if > 2 quadrants or adherent leucoma -2
Associated with uncontrolled glaucoma. -2
Expected poor visual potential due to posterior segment pathology / squint -2
6 Emergency graft with potential for good prognosis* such as impending +4
perforation, perforation, progressive infective keratitis

What are the specific requirements of an eye bank training center, eye
bank, and an eye retrieval center?
Manpower
Director General of Health Services (DGHS) has laid out minimum criteria of manpower for these
institutes which is as follows:

Table 2: Manpower requirements of an eye bank training center, eye bank and eye retrieval center
Manpower (staff) EBTC EB ERC
Board of directors Yes Yes No
Medical director and backup medical director Yes Yes No
In-charge / director No No Yes

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 Executive director / eye bank manager / equivalent post Yes Yes No
Eye bank technician Yes Yes Yes
Eye donation counselor Yes Yes Yes
An eye bank can designate and delegate multiple responsibilities to a person as appropriate if
necessary

The roles and responsibilities of each of the manpower is described in the DGHS Eye Banking Standard
Rule 3.

Infrastructure and Equipment

The Eye Bank or eye retrieval center should have adequate space, equipment, and supplies to perform
the required laboratory and tissue transportation services with accuracy, efficiency, asepsis, timeliness
and safety.

Documented procedures should be established to maintain all equipment that may affect the safety
and/or quality of tissue or reagents (critical equipment).

Each eye bank must have the following equipment and facilities:

Table 3: Infrastructural requirements of an eye bank

Infrastructure EBTC EB ERC
Equipment’s
Slit lamp and specular microscope for tissue evaluation Required Required Not required
Refrigerator for staring donor tissue, blood samples and kits Required Required Required
Laminar flow hood / biohazard cabinet Required Required Not required
Autoclave for sterilizing Required Access Access
Retrieval instruments set Required Required Required
Serology Labs
Required Access Not required
Tissue processing lab
Required Required Not required
Instrument cleaning lab and storage area
Required Required Required

The complete detailed information for all requirements and explanations of terminology, procedures,
and protocols for setting up and operating eye banks/retrieval Centers/transplant Centers are provided
in the document Medical Standards of Eye Banking in India 2020 published by National Program for
Control of Blindness and Visual Impairment, DGHS, MOHFW, GOI
(https://dghs.gov.in/WriteReadData/userfiles/file/books/Eye%20Banking%20Book%20(3)%20(1).pdf)

It should be noted that apart from cornea, donor sclera is also processed and preserved by eye banks
and provided for transplantation to surgeons requiring the tissue for scleral patch graft or for fixation
of glaucoma drainage devices. In addition, several eye banks are procuring amniotic membrane from
patients undergoing elective cesarean section after serology screening with informed consent,
processing and preserving the harvested membrane for transplantation in various ocular surface
reconstruction procedures such as chemical burns, symblepharon release and ocular surface
reconstruction, limbal transplants for limbal stem cell deficiency, persistent epithelial defects,
neurotrophic ulcers etc.

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Chapter 16: Skin Banking and Transplantation
Introduction
Transplantation of skin allografts and skin banking has made great progress in the past century within
the clinical setting. These stored skin allografts became useful as temporary biological dressings for
treatment of severely burned patients, whose autografts were insufficient to provide coverage to their
extensive wounds. These allografts act as a biological dressing and prevent infections, reduce pain and
give mechanical protection. They accelerate the process of healing and result in fewer scars,
contractures and minimize permanent disfigurement.

A skin bank is a facility which functions to procure the skin from deceased donors, processes it and
stores the allograft for up to five years, for future use.

Skin allograft transplant differs from organ transplantation as skin grafts are meant to provide only
temporary protection and are not expected to survive in the recipient permanently. Therefore, neither
ABO blood group nor HLA matching is required for allograft skin transplantation.

The source of skin allograft is from either a BD deceased donor or within 6 hours of cardiac death.
This skin is then processed and stored in a skin bank. It is usually used to cover major skin wounds in
patients with

● Severe burns
● Orthopedic Trauma patients,
● Non-Healing Ulcers,
● Pressure-Sores
● Exfoliating Skin Disorders (TENS).

Figure 1: Skin grafting

Who can donate skin?

Any individual above the age of 18 not suffering from communicable diseases such as AIDS, HIV,
Hepatitis B and C, Tuberculosis, Jaundice, Sexually Transmitted Diseases, skin cancer, active skin disease
and septicemia is eligible to donate skin.

What is the process of skin donation?

Skin is procured from a BD patient or from a patient within 6 hours of cardiac death. In most cases, the

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donation process begins when the skin bank is contacted by either a transplant coordinator or a near
relative of the deceased.
The skin bank then sends a retrieval team to the donor’s location and begins the process of skin
retrieval.

● The potential donor is first screened by a detailed medical and social history, local examination
and serological screening for blood borne infections.
● Appropriate consent is documented from the nearest of kin.
● The donor area is properly shaved and cleaned prior to skin retrieval.
● During harvesting, only the epidermis and a part of the dermis is taken from thighs, legs and
back. Only 0.3mm thickness of the skin is harvested using a dermatome.
● After skin harvesting, the donor surface area is properly covered with bandages and sterile
dressings.
● The procured allograft is temporarily preserved in 50% glycerol with added antibiotics and is
then transported to the skin bank and preserved at a temperature of 4-8 ℃.
● The harvested skin is further processed only if the serology reports are negative or else the
skin is discarded as per standard biomedical waste disposal protocol.
● The allograft is then transferred from 50% to 85% glycerol within 48 hours of harvesting.
● After the transfer of skin, the allograft container is kept in a shaking incubator at 33℃. After the
incubation period, the allograft is stored at 4-8 ℃ for 21 days.
● After the 21 days of long incubation period, each stored allograft strip is meshed, calculated
for dimensions and stored in sterile bottles containing fresh 85% glycerol.
● All the processed skin is stored at 4-80C in a cold room.
● Bits of skin are sent of bacterial and fungal cultures and if negative, the skin is ready for use.

What are the requirements of a skin bank?

Infrastructure
Table 1: Equipment requirement

Name of the instrument Use

Bio Safety Cabinet For maintaining a sterile environment while skin processing

Vehicle/Ambulance For transportation.

BOD Incubator For incubation of microbiology samples
Sealer For sealing bags before autoclave.
Mesher For meshing the skin.

Shaking Incubator For better lubrication of skin strips in glycerol and incubation at
particular temperature.
Dermatome For harvesting the skin

Walk in cold room / refrigerator For storing the skin

Hot Air Oven For sterilization
R O Water purifier Water purification

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Manpower
Skin Bank Director

● For overall in charge of the skin bank (A medical professional)

Skin Bank coordinator

● For coordinating the skin donation call and other skin bank activities

Skin retrieval team-

● For going to the place of death and skin retrieval (One doctor, two paramedics, one support
staff)

Skin processing team

● Two biotechnologists and two lab assistant.

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Chapter 17: Bone Banking
Introduction

In 1881, Macewen first described the use of allogeneic human bone tissue. Then onwards the use of
bone allograft increased in orthopedic surgery and much has changed in terms of regulation,
infrastructure development, donor selection, processing and storage and at the same time hygiene
maintenance of the graft is emphasized. Currently, it is standard practice to use bone allograft with
standard guidelines in place unlike before.

In India, bone and tissue banking has been carried out largely in an unorganized manner. Over the last
decade, bone banking has become a highly sophisticated activity with the implementation of THOTA
2014 which has increased awareness and provided clear guidelines with respect to bone tissue allograft
and has made bone bank a more or less organized facility. However, the act needs more exclusive
guidelines to establish the bone tissue bank and handling of the tissue to ensure the safety of the
recipients. Establishing a bone bank for storing fresh-frozen bone is not expensive. The recurring costs
are primarily those of the screening tests for donors. The setting up of an institutional bone bank in a
major hospital of a metropolitan city could be the start of such a program. While it is not necessary to
have more than one bone bank within the same city, the aim should be to have one in every city.

The design and management of an orthopedic bone bank as a tissue bank is a complex procedure
involving teamwork of medical organization and involvement of legislation. Bone banks have been
established with the aim of supplying suitable, safe and sterile bone and tissue allografts.

Who needs a Bone Tissue / Bone allograft transplant?

There are numerous conditions where there is bone loss in the limb because of complex trauma or after
excision of tumor needs to be reconstructed with a biological option which is cost effective and provides
excellent long-term results. With advancement in hip and knee replacement surgeries and increase in
life expectancy of an individual, many would need revision replacement surgeries wherein there is bone
loss which needs to be filled or augmented using structural bone allograft.

Any adult patient irrespective of age who has bone loss due to any cause needs biological/ structural
allograft for reconstruction is a candidate for bone allograft recipient. There is no upper limit to receive
the bone structural allograft as it does not require any special post operative measures such as
immunosuppressive therapy with respect to bone tissue allograft transplantation.

The usage of bone allograft can include the following:

● Orthopedic surgery: To replace damaged or diseased bone (Arthroplasty).

● Demineralized bone matrix may be used for non-union or fusion surgeries.
● Trauma surgery: To manage bone loss in open fractures or dislocations.
● Reconstructive, maxillofacial, spinal or dental surgery: To reconstruct bone lost or damaged as
a result of disease or trauma.

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Figure 1: Bone grafting and use

In the case of living donor transplant, what are the eligibility /

acceptance criteria for the donor?
In orthopedic surgeries like hip and knee replacement surgeries are required for non-infectious
etiologies (e.g. AVN hip). Here the bones are resected and replaced with metal and polyethylene
synthetic material. These resected bones were routinely discarded as a human waste. With the advent
of bone banking these resected bones are preserved and used when necessary.
Exclusion criteria for living bone donors include:

● Age <15 years and >60 years

● Medical history of systemic infection
● History of systemic diseases such HIV, Hepatitis, SLE, RA or other autoimmune diseases,
tuberculosis or malignancy, CNS disease
● History of High dose/ long duration steroid intake, drug abuse or human derived growth factor
hormone use
● History of High-risk sexual lifestyle, tattoos

In case of deceased donor transplant, what are the eligibility/acceptance

criteria for the donor?
Bone may be retrieved from brain dead or from cadaveric donor. In all cases, written informed consent
is a must from the donor or the next of kin for tissue donation as well as for performing the laboratory
investigations. Extensive history and thorough physical examination must be performed to rule out any
possibility of disease or infection transmission.

Exclusion criteria for bone donors include the same criteria as living donors with the addition of:

● Ventilatory supports > 72 hours before death.

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 What is the process of bone retrieval and banking?
After a potential bone donor is available,

● The bone retrieval process is typically done during an autopsy in a surgically sterile
environment or in a sterile operation theater.
● Lower limb bones and upper limb bones are harvested along with both the hemi pelvis.
Various tendons may also be harvested depending upon available expertise.
● The cadaveric body is then reconstructed using a hinged bamboo dowel, cut at optimum length
as the length of the limb with a nail or screw at one end driven into the ankle. Adequate cotton
is used to prevent the blood spillage and to create adequate girth, contour and proper shape
to the limb.
● The bone tissue is then processed to clean and remove the soft tissue, disinfected, and
packaged for transport and storage.
● Bone tissue is tested for transmissible diseases such as HIV and hepatitis.
● The removed tissue is also sent for histopathological analysis to rule out any malignancy.
● It is then washed thoroughly with antibiotic solution or subjected to absolute alcohol
treatment for at least 8-10 minutes. If the results are unsuitable the tissue is discarded. If
suitable the tissue is then prepared for sterilization.
● The bone allograft is sterilized by radiation before transplantation. The process uses a sublethal
dose of gamma rays to kill any bacteria, viruses, or other microorganisms that may be present
on the tissue. The process is typically performed by specialized facilities that are licensed and
certified by the regulatory authorities. The typical dose of radiation used for sterilization is safe
and does not affect the structural integrity of the bone. On its return from irradiation the tissue
is now stored in a ready-to-use section of the freezer.

What are the requirements for the establishment of a Bone Bank?

Requirements to establish a functioning bone bank explained in the following subheadings.

● Infrastructure
● Human resources or Manpower
● General and specific instruments.

A. Infrastructure
Having a dedicated physical facility for the bone bank within the hospital premises, preferably in the
operating theater premises of the orthopedic department is recommended. The room with adequate
space for two freezers, two racks for record keeping, bone retrieving equipment and reconstruction
material is necessary. The designated facility is required to avoid contact with chemicals, atmospheric
contaminants, and any source of infection. The facility should have controlled access, cleaning &
maintaining system and waste disposal provision. The establishment should be well connected by road,
rail, and air travel facility. The bone bank facility should have a devoted telephone connection with all
the necessary contact numbers boldly displayed in the facility being set up.

The deep freezer, the workhorse of the bone bank, should have a temperature of −80°C with a
continuous temperature registration mechanism. A 24-hour power supply with a backup generator to
maintain the temperature of the freezer is required with dedicated staff. In case the temperature falls
outside the acceptable range of −90 and −70°C, an alarm system should give off a warning signal,

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guaranteeing 24-hour security against temperature-induced damage to the tissue. Standard Operating
Protocols (SOPs) should be in place to ensure maintenance of optimum temperature of the freezer.

Efforts can be made to digitalize the documentation and necessary digital requirements as needed
should be ascertained with trained staff to make the bone bank facility state of the art service.

Hospitals which are applying for bone bank registration should have 24 hours ICU care, blood bank
facility, laboratory facility with adequate medical, nursing and paramedical support staff. Hospitals
should also have experts in all the specialties of the medical and surgical field.

B. Manpower
Bone banks require doctors or surgeons with knowledge of orthopedics or related fields to oversee the
selection of donors, processing of bone tissue and implantation of bone tissue allograft in the recipient
patients. The Head/chairman of the Department of Orthopedics is typically in-charge of the bone bank
and is assisted by faculty members of the Department of Orthopedics. Knowledge of handling the bone
bank with adequate surgical exposure to retrieve and the processing of the bone are necessary. The
bone bank team also supervises the storage and processing (e.g. irradiation of the graft) with the help
of nursing staff of the bone bank.

Nursing working in the operation theater can be assigned the job of administration, storage and
allocation of donor bone. At least two Nursing staff dedicated to the bone bank should be part of the
team. They also oversee the documentation of tissue allograft and maintenance of the donor and
recipient records. Nursing staff are also trained by the faculty members for maintaining the instruments,
equipment and overall maintenance of the bone bank.

A transplant coordinator is mandatory for any bone bank. The main job of the transplant coordinator is
the counseling of the potential organ donors and to create awareness regarding bone donation. The
transplant coordinator must have adequate knowledge about retrieval, reconstruction and use of bone
tissue allograft so that he/she can effectively counsel the donor/ donor relatives to donate the bones.

Laboratory technicians with knowledge of microbiology and tissue processing are required to take
samples and clean, sterilize, and store bone tissue. Hospitals having microbiology and pathology
departments need not have exclusive staff for the above said work. However, respective departments
should be taken into confidence to provide the necessary service to carry out the functioning of the bone
bank. If necessary, they should be included in the bone bank team.

There should be adequate manpower to run ICU and Operation theaters and staff for administrative and
logistic support is also required to run the bone bank in the hospital.

C. Instruments (General and Specific)

Bone retrieval from cadavers requires general surgical instruments as well as specialized instruments for
processing and cleaning the retrieved bones. Surgical instruments such as scalpels, saws, and drills may
be used to retrieve bone tissues from a cadaveric donor and for reconstruction. Specialized instruments,
(diamond shaped, triangle shaped, and comma shaped) for the soft tissue removal are required. Convex
& concave shaped reamers for cartilage removal make cleaning the retrieved bone easy. There should
be an adequate quantity of sterile sample collection bottles, sterile containers, and reconstruction
materials such as cotton wool and wooden dowels / sticks with screws/nails at the end.

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 Chapter 18: Financial support for organ donation and transplant
Under NOTP

Amount
ROTTO: Recurring grant per annum Rs. 1.05 crore
SOTTO:
1. Non-recurring grant for setting up SOTTOs. Rs. 36 lakhs
2. Recurring grant for manpower Rs. 48 lakhs

Retrieval center: For setting up Rs. 75 lakhs

Transplant center: For setting up Rs. 1.50 crore
Upgradation of existing retrieval / transplant unit Rs. 75 lakhs
Transplant coordinators:
1. Govt. institutes- 2 TCs Rs 35,000/- per month
2. Pvt. Centers – 1 TC per transplant
3. Identified Govt. Trauma Centers- 1 TC coordinator
Bio-material Center (only for ROTTO) Rs. 1.0 crore
Immuno-suppressant therapy for BPL transplant recipients in Rs. 10,000/- per
government hospitals month
Dignified funeral of deceased donor Rs. 10,000/- per
deceased person
Maintenance of bodies of deceased donor Rs. 1,00,000/- per
donation

Government schemes
Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PM-JAY)
Eligibility for the scheme is checked through the National Health Authority portal and application is
made via the same:

● Log in to their official website: mera.pmjay.gov.in

● Enter your mobile number and the captcha code given on the screen.
● Enter the OTP that is sent to your registered mobile number, it will then take you to the PMJAY
login screen.
● Select the state from where you are applying for this scheme.
● Select how you want to check for your eligibility criteria: Mobile number, Name, Ration card
number, or Rashtriya Swasthya Bima Yojana (RSBY) URN number.
● Your name will be reflected on the right-hand side of the page (if you are eligible).
● You can also check the beneficiary details by clicking on the 'Family Members' tab.

It provides a cover of Rs. 5 lakhs per family per year for secondary and tertiary care hospitalization
across public and private empaneled hospitals in India. The benefits of INR 5,00,000 are on a family
floater basis which means that it can be used by one or all members of the family. It covers up to 3
days of pre-hospitalization and 15 days post-hospitalization expenses such as diagnostics and
medicines.

● There is no restriction on family size, age or gender.

● All pre–existing conditions are covered from day one.

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 ● Benefits of the scheme are portable across the country i.e. a beneficiary can visit any
empaneled public or private hospital in India to avail cashless treatment.
● Services include approximately 1,393 procedures covering all the costs related to treatment,
including but not limited to drugs, supplies, diagnostic services, physician's fees, room charges,
surgeon charges, OT and ICU charges etc.

Rashtriya Arogya Nidhi (RAN)

The RAN was set up to provide financial assistance to patients living below the poverty line and who
are suffering from major life-threatening diseases. The financial assistance to such patients is released
in the form of ‘one-time grant’, which is released to the Medical Superintendent of the Hospital in
which the treatment has been/is being received. To avail financial assistance under RAN, the patient is
required to submit:

● Application form in prescribed proforma (Annexure 5-

https://main.mohfw.gov.in/sites/default/files/RAN_Guidelines_2018-20_0.pdf) duly signed by
the treating doctor and countersigned by the Medical Superintendent of the Government
hospital/institute.
● Copy of the income certificate.
● Copy of the ration card.
● Revolving Funds have been set up in 13 Central Government Hospitals/Institutes and funds
up to Rs. 50 lakhs (Rs. 90 lakhs in case of AIIMS, New Delhi) are placed at their disposal for
providing treatment up to Rs. 2 lakhs in each case.
● Cases involving treatment beyond 2 lakhs are referred to the Ministry of Health & Family
Welfare, Government of India for providing funds.

Pradhan Mantri National Dialysis Program (PMNDP)

Pradhan Mantri National Dialysis Program (PMNDP) launched in 2016-17 ensures availability of
dialysis services free of cost to Below Poverty Line (BPL) beneficiaries at the district hospitals in the
country.

Under PMNDP, 1350 dialysis centers have been established in the country. The district wise details of
hemodialysis centers set up in the country are available in the link: https://nhsrcindia.org/pradhan-
mantri-national-dialysis-program.

Prime Minister's National Relief Fund (PMNRF)

Prime Minister’s National Relief Fund (PMNRF) was initially established with public contributions to
assist displaced persons from and to render immediate relief to families of those killed in natural
calamities like floods, cyclones and earthquakes, etc.

Assistance from PMNRF is also rendered, to partially defray the expenses for medical treatment like
heart surgeries, kidney transplantation, cancer treatment and acid attack etc. The fund consists
entirely of public contributions and does not get any budgetary support. The corpus of the fund is
invested in various forms with scheduled commercial banks and other agencies. Disbursements are
made with the approval of the Prime Minister.

Applicants can apply for grant of financial assistance through an application [Annexure 4
(https://pmnrf.gov.in/assets/uploads/downloads/PMNRF-Assistance-form-English.pdf)] addressed to
the Prime Minister. Applicants, applying for grant of financial assistance for medical treatment, are
required to enclose two passport size photographs of patient (one pasted on application, another

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stapled with application), copy of residence proof, original medical certificate mentioning the type of
disease and estimated cost of expenditure and copy of his income certificate.

List of private hospitals empaneled with the PMNRF is posted separately at the PMNRF website which
could be used by the applicant for reference at the time of applying for grant (All government hospitals
are already empaneled with PMNRF). After receipt of application, the same is considered and
disbursements are made at the sole discretion of the Prime Minister, keeping in view availability of funds
and prior commitments of the PMNRF.

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 Appendix 1: THE TRANSPLANTATION OF HUMAN ORGANS
AND TISSUES ACT, 1994
Source: https://notto.mohfw.gov.in/WriteReadData/Portal/images/THOA-ACT-1994.pdf
THE TRANSPLANTATION OF [HUMAN ORGANS AND TISSUES] ACT, 1994
ACT NO. 42 OF 1994
[8th July 1994.]

An Act to provide for the regulation of removal, storage and transplantation of [human organs and
tissues for therapeutic purposes and for the prevention of commercial dealings in human organs and
tissues] and for matters connected therewith or incidental thereto.

WHEREAS it is expedient to provide for the regulation of removal, storage and transplantation of
[human organs or tissues or both] for therapeutic purposes and for the prevention of commercial
dealings in [human organs or tissues or both].

AND WHEREAS in Parliament has no power to make laws for the States with respect to any of the
matters aforesaid except as provided in articles 249 and 250 of the Constitution.

AND WHEREAS in pursuance of clause (1) of article 252 of the Constitution, resolutions have been
passed by all the Houses of the Legislatures of the States of Goa, Himachal Pradesh and Maharashtra
to the effect that the matters aforesaid should be regulated in those States by Parliament by law.

BE it enacted by Parliament in the Forty-fifth Year of the Republic of India as follows:

Chapter I: Preliminary
1. Short title, application and commencement:

(1) This Act may be called the Transplantation of [Human Organs and Tissues] Act, 1994.

(2) It applies, in the first instance, to the whole of the States of Goa, Himachal Pradesh and
Maharashtra and to all the Union territories and it shall also apply to any other State which adopts
this Act by resolution passed in that behalf under clause (1) of article 252 of the Constitution.

(3) It shall come into force in the States of Goa, Himachal Pradesh and Maharashtra and in all the Union
territories on such date as the Central Government may, by notification, appoint and in any other State
which adopts this Act under clause (1) of article 252 of the Constitution, on the date of such adoption;
and any reference in this Act to the commencement of this Act shall, in relation to any State or Union
territory, means the date on which this Act comes into force in such State or Union territory.

2. Definitions:

In this Act, unless the context otherwise requires,

(a) “advertisement” includes any form of advertising whether to the public generally or to any section
of the public or, individually to selected persons.

(b) “Appropriate Authority” means the Appropriate Authority appointed under section 13.

107
(c) “Authorization Committee” means the committee constituted under clause (a) or clause (b) of sub-
section (4) of section 9.

(d) “Brain-stem death” means the stage at which all functions of the brainstem have permanently and
irreversibly ceased and is so certified under sub-section (6) of section 3.

(e) “Deceased person” means a person in whom permanent disappearance of all evidence of life
occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has
taken place.

(f) “donor” means any person, not less than eighteen years of age, who voluntarily authorizes the
removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2)
of section 3.

(g) “hospital” includes a nursing home, clinic, medical Center, medical or teaching institution for
therapeutic purposes and other like institutions.

(h) “Human organ” means any part of a human body consisting of a structured arrangement of tissues.
which, if wholly removed, cannot be replicated by the body.

[(ha) “Human Organ Retrieval Center” means a hospital, -

(i) which has adequate facilities for treating seriously ill patients who can be potential donors of organs
in the event of death; and
(ii) which is registered under sub-section (1) of section 14 for retrieval of human organs.

(hb) “minor” means a person who has not completed the age of eighteen years;]

[(i) “near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather,
grandmother, grandson or granddaughter;]

(j) “notification” means a notification published in the Official Gazette.

(k) “payment” means payment in money or money’s worth but does not include any payment for
defraying or reimbursing— (i) the cost of removing, transporting or preserving the [human organ or
tissue or both] to be supplied; or (ii) any expenses or loss of earnings incurred by a person so far as
reasonably and directly attributable to his supplying any human organ from his body.

(l) “prescribed” means prescribed by rules made under this Act.

(m) “recipient” means a person into whom any [human organ or tissue or both] is, or is proposed to be,
transplanted.

(n) “Registered medical practitioner” means a medical practitioner who possesses any recognized
medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956 (102
of 1956), and who is enrolled on a State Medical Register as defined in clause (k) of that section.

(o) “Therapeutic purposes” means systematic treatment of any disease or the measures to improve health
according to any particular method or modality.
[(oa) “tissue” means a group of cells, except blood, performing a particular function in the human
body.

(ob) “Tissue Bank” means a facility registered under section 14A for carrying out any activity relating to
108
the recovery, screening, testing, processing, storage and distribution of tissues, but does not to include
a Blood Bank;]

(p) “transplantation” means the grafting of any human organ from any living person or deceased person to some
other living person for therapeutic purposes.

[(q) “transplant coordinator” means a person appointed by the hospital for coordinating all matters
relating to removal or transplantation of human organs or tissues or both and for assisting the
authority for removal of human organs in accordance with the provisions of sections 3.]

Chapter II: Authority for the removal of human organs or tissues or both
3. Authority for removal of [human organs or tissues or both]: (1) Any donor may, in such a manner
and subject to such conditions as may be prescribed, authorize the removal, before his death, of any
[human organ or tissue or both] of his body for therapeutic purposes.

[(1A) For the purpose of removal, storage or transplantation of such human organs or tissues or both,
as may be prescribed, it shall be the duty of the registered medical practitioner working in a hospital,
in consultation with transplant coordinator, if such transplant coordinator is available,

(i) to ascertain from the person admitted to the Intensive Care Unit or from his near relative that such
person had authorized at any time before his death the removal of any human organ or tissue or both
of his body under sub-section (2), then the hospital shall proceed to obtain the documentation for such
authorization.

(ii) where no such authority as referred to in sub-section (2) was made by such a person, to make aware
to that person or near relative for option to authorize or decline for donation of human organs or tissues
or both.

(iii) to require the hospital to inform in writing to the Human Organ Removal Center for removal,
storage or transplantation of human organs or tissues or both of the donor identified in clauses (i) and
(ii) in such manner as may be prescribed

(1B) The duties mentioned under clauses (i) to (iii) of sub-section (1A) from such date, as may be
prescribed, shall also apply in the case of a registered medical practitioner working in an Intensive Care
Unit in a hospital which is not registered under this Act for the purpose of removal, storage or
transplantation of human organs or tissues or both.]

(2) If any donor had, in writing and in the presence of two or more witnesses (at least one of whom is a
near relative of such person), unequivocally authorized at any time before his death, the removal of any
human organ of his body, after his death, for therapeutic purposes, the person lawfully in possession of
the dead body of the donor shall, unless he has any reason to believe that the donor had subsequently
revoked the authority aforesaid, grant to a registered medical practitioner all reasonable facilities for
the removal, for therapeutic purposes, of that [human organ or tissue or both] from the dead body of
the donor.

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(3) Where no such authority as is referred to in sub-section (2), was made by any person before his
death but no objection was also expressed by such person to any of his [human organs or tissues or
both] being used after his death for therapeutic purposes, the person lawfully in possession of the dead
body of such person may, unless he has reason to believe that any near relative of the deceased person
has objection to any of the deceased person’s [human organs or tissues or both] being used for
therapeutic purposes, authorize the removal of any [human organ or tissue or both] of the deceased
person for its use for therapeutic purposes.

(4) The authority given under sub-section (1) or sub-section (2) or, as the case may be, sub-section (3)
shall be sufficient warrant for the removal, for therapeutic purposes, of the [human organ or tissue or
both]; but no such removal shall be made by any person other than the registered medical practitioner:

[Provided that a technician possessing such qualifications and experience, as may be prescribed, may
enucleate a cornea.]

(5) Where any [human organ or tissue or both] is to be removed from the body of a deceased person,
the registered medical practitioner shall satisfy himself, before such removal, by a personal
examination of the body from which any [human organ or tissue or both] is to be removed, that life is
extinct in such body or, where it appears to be a case of brain-stem death, that such death has been
certified under sub-section (6).

(6) Where any [human organ or tissue or both] is to be removed from the body of a person in the
event of his brain-stem death, no such removal shall be undertaken unless such death is certified, in
such form and in such manner and on satisfaction of such conditions and requirements as may be
prescribed, by a Board of medical experts consisting of the following, namely:

(i) the registered medical practitioner in charge of the hospital in which brain-stem death has
occurred.

(ii) an independent registered medical practitioner, being a specialist, to be nominated by the

registered medical practitioner specified in clause (i), from the panel of names approved by the
Appropriate Authority.

(iii) a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified

in clause (i), from the panel of names approved by the Appropriate Authority.

[Provided that where a neurologist or a neurosurgeon is not available, the registered medical
practitioner may nominate an independent registered medical practitioner, being a surgeon or a
physician and an anesthetist or intensivist subject to the condition that they are not members of the
transplantation team for the concerned recipient and to such conditions as may be prescribed;]

(iv) the registered medical practitioner treating the person whose brain-stem death has occurred.

(7) Notwithstanding anything contained in sub-section (3), where brain-stem death of any person, less
than eighteen years of age, occurs and is certified under sub-section (6), any of the parents of the
deceased person may give authority, in such form and in such manner as may be prescribed, for the
removal of any [human organ or tissue or both] from the body of the deceased person.

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4. Removal of [human organs or tissues or both] not to be authorized in certain cases: (1) No facilities
shall be granted under sub-section (2) of section 3 and no authority shall be given under sub- section
(3) of that section for the removal of any [human organ or tissue or both] from the body of a deceased
person, if the person required to grant such facilities, or empowered to give such authority, has reason
to believe that an inquest may be required to be held in relation to such body in pursuance of the
provisions of any law for the time being in force.

(2) No authority for the removal of any [human organ or tissue or both] from the body of a deceased
person shall be given by a person to whom such a body has been entrusted solely for the purpose of
interment, cremation or other disposal.

5. Authority for removal of [human organs or tissues or both] in case of unclaimed bodies in hospital
or prison: (1) In the case of a dead body lying in a hospital or prison and not claimed by any of the near
relatives of the deceased person within forty-eight hours from the time of the death of the concerned
person, the authority for the removal of any [human organ or tissue or both] from the dead body which
so remains unclaimed may be given, in the prescribed form, by the person in charge, for the time being,
of the management or control of the hospital or prison, or by an employee of such hospital or prison
authorized in this behalf by the person in charge of the management or control thereof.

(2) No authority shall be given under sub-section (1) if the person empowered to give such authority
has reason to believe that any near relative of the deceased person is likely to claim the dead body even
though such near relative has not come forward to claim the body of the deceased person within the
time specified in sub-section (1).

6. Authority for removal of [human organs or tissues or both] from bodies sent for post-mortem
examination for medico-legal or pathological purposes: Where the body of a person has been sent for
post-mortem examination -

(a) for medico-legal purposes by reason of the death of such person having been caused by accident or
any other unnatural cause; or

(b) for pathological purposes,

the person competent under this Act to give authority for the removal of any [human organ or tissue or
both] from such dead body may, if he has reason to believe that such [human organ or tissue or both]will
not be required for the purpose for which such body has been sent for post-mortem examination,
authorize the removal, for therapeutic purposes, of that [human organ or tissue or both] of the
deceased person provided that he is satisfied that the deceased person had not expressed, before his
death, any objection to any of his [human organs or tissues or both] being used, for therapeutic
purposes after his death or, where he had granted an authority for the use of any of his [human organs
or tissues or both] for therapeutic purposes, after his death, such authority had not been revoked by
him before his death.

7. Preservation of [human organs or tissues or both]: After the removal of any [human organ or tissue
or both] from the body of any person, the registered medical practitioner shall take such steps for the
preservation of the [human organ or tissue or both] so removed as may be prescribed.

8. Savings: (1) Nothing in the foregoing provisions of this Act shall be construed as rendering unlawful
any dealing with the body or with any part of the body of a deceased person if such dealing would have
been lawful if this Act had not been passed.

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(2) Neither the grant of any facility or authority for the removal of any [human organ or tissue or both]
from the body of a deceased person in accordance with the provisions of this Act nor the removal oil
any [human organ or tissue or both] from the body of a deceased person in pursuance of such authority
shall be deemed to be an offense punishable under section 297 of the Indian Penal Code (45 of 1860).

9. Restrictions on removal and transplantation of [human organs or tissues or both]: (1) Save as
otherwise provided in sub-section (3), no [human organ or tissue or both] removed from the body of a
donor before his death shall be transplanted into a recipient unless the donor is a near relative of the
recipient.

[(1A) Where the donor or the recipient being near relative is a foreign national, prior approval of the
Authorization Committee shall be required before removing or transplanting human organ or tissue or
both:

Provided that the Authorization Committee shall not approve such removal or transplantation if the
recipient is a foreign national and the donor is an Indian national unless they are near relatives.

(1B) No human organs or tissues or both shall be removed from the body of a minor before his death
for the purpose of transplantation except in the manner as may be prescribed.

(1C) No human organs or tissues or both shall be removed from the body of a mentally challenged
person before his death for the purpose of transplantation.

Explanation. For the purpose of this subsection,

(i) The expression “mentally challenged person” includes a person with mental illness or mental
retardation, as the case may be.

(ii) The expression “mental illness' ' includes dementia, schizophrenia and other mental conditions that make a
person intellectually disabled.

(iii) the expression “mental retardation” shall have the same meaning as assigned to it in clause (r) of
section 2 of the Persons with Disabilities (Equal Opportunities, Protection of Right and Full
Participation) Act, 1995 (1 of 1996).]

(2) Where any donor authorizes the removal of any of his [human organs or tissues or both] after his
death under sub-section (2) of section 3 or any person competent or empowered to give authority for
the removal of any [human organ or tissue or both] from the body of any deceased person authorizes
such removal, the [human organ or tissue or both] may be removed and transplanted into the body of
any recipient who may be in need of such [human organ or tissue or both].

(3) If any donor authorizes the removal of any of his [human organs or tissues or both] before his death
under sub-section (1) of section 3 for transplantation into the body of such recipient, not being a near
relative, as is specified by the donor by reason of affection or attachment towards the recipient or for
any other special reasons, such [human organ or tissue or both] shall not be removed and transplanted
without the prior approval of the Authorization Committee.

[(3A) Notwithstanding anything contained in sub-section (3), where -

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(a) any donor has agreed to make a donation of his human organ or tissue or both before his death to
a recipient, who is his near relative, but such donor is not compatible biologically as a donor for the
recipient; and

(b) The second donor has agreed to make a donation of his human organ or tissue or both before his
death to such recipient, who is his near relative, but such donor is not compatible biologically as a
donor for such recipient; then.

(c) the first donor who is compatible biologically as a donor for the second recipient and the second
donor is compatible biologically as a donor of a human organ or tissue or both for the first recipient and
both donors and both recipients in the aforesaid group of donor and recipient have entered into a single
agreement to donate and receive such human organ or tissue or both according to such biological
compatibility in the group,

the removal and transplantation of the human organ or tissue or both, as per the agreement referred
to above, shall not be done without prior approval of the Authorization Committee.]

[(4) (a) The composition of the Authorization Committee shall be such as may be prescribed by the
Central Government from time to time.

(b) The State Government and the Union territories shall constitute, by notification, one or more
Authorization Committee consisting of such members as may be nominated by the State Government
and the Union territories on such terms and conditions as may be specified in the notification for the
purposes of this section.]

(5) On an application jointly made, in such form and in such manner as may be prescribed, by the donor
and the recipient, the Authorization Committee shall, after holding an inquiry and after satisfying itself
that the applicants have complied with all the requirements of this Act and tile rules made thereunder,
grant to the applicant’s approval for the removal and transplantation of the human organ.

(6) If, after the inquiry and after giving an opportunity to the applicants of being heard, the
Authorization Committee is satisfied that the applicants have not complied with the requirements of
this Act and the rules made thereunder, it shall, for reasons to be recorded in writing, reject the
application for approval.

Chapter III: Regulation of hospitals

10. Regulation of hospitals conducting the removal, storage or transplantation of [human organs or
tissues or both]: (1) On and from the commencement of this Act,

(a) no hospital, unless registered under this Act, shall conduct, or associate with, or help in, the
removal, storage or transplantation of any [human organ or tissue or both;]

(b) no medical practitioner or any other person shall conduct, or cause to be conducted, or aid in
conducting by himself or through any other person, any activity relating to the removal, storage or
transplantation of any [human organ or tissue or both] at a place other than a place registered under
this Act.

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(c) no place including a hospital registered under sub-section (1) of section 15 shall be used or cause to
be used by any person for the removal, storage or transplantation of any [human organ or tissue or
both] except for therapeutic purposes; [and]

[(d) no Tissues Bank, unless registered under this Act, shall carry out any activity relating to the
recovery, screening, testing, processing, storage and distribution of tissues.]

(2) Notwithstanding anything contained in sub-section (1), the eyes or the ears may be removed at any
place from the dead body of any donor, for therapeutic purposes, by a registered medical practitioner.

Explanation. For the purposes of this subsection, “ears” includes ear drums and ear bones.

11. Prohibition of removal or transplantation of [human organs or tissues or both] for any purpose
other than the therapeutic purposes: No donor and no person empowered to give authority for the
removal of any human organ shall authorize the removal of any [human organ or tissue or both] for
any purpose other than therapeutic purposes.

12. Explaining effects, etc., to donor and recipient: No registered medical practitioner shall undertake
the removal or transplantation of any [human organ or tissue or both] unless he has explained, in such
manner as may be prescribed, all possible effects, complications and hazards connected with the
removal and transplantation to the donor and the recipient respectively.

Chapter IV: Appropriate Authority

13. Appropriate Authority: (1) The Central Government shall appoint, by notification, one or more
officers as Appropriate Authorities for each of the Union territories for the purposes of this Act.

(2) The State Government shall appoint, by notification, one or more officers as Appropriate
Authorities for the purposes of this Act.

(3) The Appropriate Authority shall perform the following functions, namely:
(i) to grant registration under sub-section (1) of section 15 or renew registration under sub-section (3)
of that section.
(ii) to suspend or cancel registration under sub-section (2) of section 16;

[(iii) to enforce such standards, as may be prescribed,

(A) for hospitals engaged in the removal, storage or transplantation of any human organ:

(B) for Tissue Banks engaged in recovery, screening, testing, processing, storage and distribution of
tissues;]

(iv) to investigate any complaint of breach of any of the provisions of this Act or any of the rules made
thereunder and take appropriate action.

[(iva) to inspect Tissue Banks periodically;]

(v) to inspect hospitals periodically for examination of the quality of transplantation and the follow-up
medical care to persons who have undergone transplantation and persons from whom organs are
removed; and

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(vi) to undertake such other measures as may be prescribed.

[13A. Advisory Committees to advise Appropriate Authority: (1) The Central Government and the
State Governments, as the case may be, by notification, shall constitute an Advisory Committee for a
period of two years to aid and advise the Appropriate Authority to discharge its functions.

(2) The Advisory Committee shall consist of—

(a) one administrative expert not below the rank of Secretary to the State Government, to be

nominated as Chairperson of the Advisory Committee.

(b) two medical experts having such qualifications as may be prescribed.

(c) one officer not below the rank of a Joint Director to represent the Ministry or Department of Health
and Family Welfare, to be designated as Member-Secretary.

(d) two eminent social workers of high social standing and integrity, one of whom shall be from
amongst representatives of the women’s organization.

(e) one legal expert who has held the position of an Additional District Judge or equivalent; (f) one
person to represent non-governmental organizations or associations which are working in the field of
organ or tissue donations or human rights.

(g) one specialist in the field of human organ transplantation, provided he is not a member of the
transplantation team.

(3) The terms and conditions for appointment to the Advisory Committee shall be as may be
prescribed by the Central Government.

13B. Powers of Appropriate Authority: The Appropriate Authority shall for the purposes of this Act
have all the powers of a civil court trying a suit under the Code of Civil Procedure, 1908 (5 of 1908)
and, in particular, in respect of the following matters, namely:

(a) summoning of any person who is in possession of any information relating to violation of the
provisions of this Act or the rules made thereunder.

(b) discovery and production of any document or material object.

(c) issuing search warrant for any place suspected to be indulging in unauthorized removal,

procurement or transplantation of human organs or tissues or both; and (d) any other matter which
may be prescribed.

13C. National Human Organs and Tissues Removal and Storage Network: The Central Government
may, by notification, establish a National Human Organs and Tissues Removal and Storage Network at
one or more places and Regional Network in such manner and to perform such functions, as may be
prescribed.

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13D. National registry: The Central Government shall maintain a national registry of the donors and
recipients of human organs and tissues and such registry shall have such information as may be
prescribed to an ongoing evaluation of the scientific and clinical status of human organs and tissue.]

Chapter V: Registration of hospitals

14. Registration of hospitals engaged in removal, storage or transplantation of [human organs or
tissues or both]: (1) [No hospital (including Human Organ Retrieval Center)] shall commence any
activity relating to the removal, storage or transplantation of any [human organ or tissue or both] for
therapeutic purposes after the commencement of this Act unless such hospital is duly registered
under this Act:

Provided that every hospital engaged, either partly or exclusively, in any activity relating to the
removal, storage or transplantation of any [human organ or tissue or both] for therapeutic purposes
immediately before the commencement of this Act, shall apply for registration within sixty days from
the date of such commencement:

Provided further that every hospital engaged in any activity relating to the removal, storage or
transplantation of any [human organ or tissue or both] shall cease to engage in any such activity on the
expiry of three months from the date of commencement of this Act unless such hospital has applied
for registration and is go registered or till such application is disposed of whichever is earlier.

(2) Every application for registration under sub-section (1) shall be made to the Appropriate Authority
in such form and in such manner and shall be accompanied by such fees as may be prescribed.

(3) No hospital shall be registered under this Act unless the Appropriate Authority is satisfied that such
hospital is in a position to provide such specialized services and facilities, possess) such skilled
manpower and equipment and maintain such standards as may be prescribed.

[(4) No hospital shall be registered under this Act, unless the Appropriate Authority is satisfied that
such hospital has appointed a transplant coordinator having such qualifications and experience as may
be prescribed.]

[14A. Registration of Tissue Bank: (1) No Tissue Bank shall, after the commencement of the
Transplantation of Human Organs (Amendment) Act, 2011 (16 of 2011), commence any activity relating
to the recovery, screening, testing, processing, storage and distribution of tissues unless it is duly
registered under this Act:

Provided that any facility engaged, either party or exclusively, in any activity relating to the recovery,
screening, testing, processing, storage and distribution of tissues immediately before the
commencement of the Transplantation of Human Organs (Amendment) Act, 2011 (16 of 2011), shall
apply for registration as Tissues Bank within sixty days from the date of such commencement:

Provided further that such facility shall cease to engage in any such activity on the expiry of three
months from the date of commencement of the Transplantation of Human Organs (Amendment) Act,
2011 (16 of 2011), unless such Tissue Bank has applied for registration and is so registered, or till such
application is disposed of, whichever is earlier.

(2) Every application for registration under sub-section (1) shall be made to the Appropriate Authority
in such form and in such manner and shall be accompanied by such fees as may be prescribed.

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(3) No Tissue Bank shall be registered under this Act unless the Appropriate Authority is satisfied that
such Tissue Bank is in a position to provide such specialized service and facilities, possess such skilled
manpower and equipment and maintain such standards as may be prescribed.]

15. Certificate of registration: (1) The Appropriate Authority shall, after holding an inquiry and after
satisfying itself that the applicant has complied with all the requirements of this Act and the rules
made thereunder, [grant to the hospital or to the tissue Bank, as the case may be,] a certificate of
registration in such form, for such period and subject to such conditions as may be prescribed.

(2) If, after the inquiry and after giving an opportunity to the applicant of being heard, the Appropriate
Authority is satisfied that the applicant has not complied with the requirement of this Act and the
rules made thereunder, it shall, for reasons to be recorded in writing, reject the application for
registration.

(3) Every certificate of registration shall be renewed in such manner and on payment of such fees as
may be prescribed.

16. Suspension or cancellation of registration: (1) The Appropriate Authority may, Suo motu or on
complaint, issue a notice to any [hospital or Tissue Bank, as the case may be,] to show cause why its
registration under this Act should not be suspended or canceled for the reasons mentioned in the
notice.

(2) If, after giving a reasonable opportunity of being heard to the [hospital or Tissue Bank, as the case
may be,] the Appropriate Authority is satisfied that there has been a breach of any of the provisions
of this Act or the rules made thereunder, it may, without prejudice to any criminal action that it may
take against such [hospital or Tissue Bank, as the case may be,] suspend its registration for such period
as it may think fit or cancel its registration:

Provided that where the Appropriate Authority is of the opinion that it is necessary or expedient to
do so in the public interest, it may, for reasons to be recorded in writing, suspend the registration of
any [hospital or Tissue Bank, as the case may be,] without issuing any notice.

17. Appeals: Any person aggrieved by an order of the Authorization Committee rejecting an
application for approval under sub-section (6) of section 9, or any hospital [or Tissue Bank, as the case
may be,] aggrieved by an order of the Appropriate Authority rejecting an application for registration
under sub-section (2) of section 15 or an order of suspension or cancellation of registration under sub-
section (2) of section 16, may, within thirty days from the date of the receipt of the order, prefer an
appeal, in such manner as may be prescribed, against such order to—

(i) the Central Government where the appeal is against the order of the Authorization Committee
constituted under clause (a) of sub-section (4) of section 9 or against the order of the Appropriate
Authority appointed under sub-section (1) of section 13; or

(ii) the State Government, where the appeal is against the order of the Authorization Committee
constituted under clause (b) of sub-section (4) of section 9 or against the order of the Appropriate
Authority appointed under sub-section (2) of section 13.

Chapter VI: Offenses and penalties

18. Punishment for removal of human organ without authority: (1) Any person who renders his
services to or at any hospital and who, for purposes of transplantation, conducts, associates with, or
helps in any manner in, the removal of any human organ without authority, shall be punishable with

117
imprisonment for a term which may extend to [ten years and with a fine which may extend to
twenty lakh rupees].

(2) Where any person convicted under sub-section (1) is a registered medical practitioner, his name
shall be reported by the Appropriate Authority to the respective State Medical Council for taking
necessary action including the removal of his name from the register of the Council for a period of
[three years] for the first offense and permanently for the subsequent offense.

[(3) Any person who renders his services to or at any hospital and who conducts, or associates with
or helps in any manner in the removal of human tissue without authority, shall be punishable with
imprisonment for a term which may extend to three years and with fine which may extend to five
lakh rupees.]

19. Punishment for commercial dealings in human organs: Whoever -

(a) makes or receives any payment for the supply of, or for an offer to supply, any human organ.

(b) seeks to find a person willing to supply for payment any human organ.

(c) offers to supply any human organ for payment; or

(d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or
for an offer to supply, any human organ.

(e) takes part in the management or control of a body of persons, whether a society, firm or company,
whose activities consist of or include the initiation or negotiation of any arrangement referred to in
clause (d); or

(f) publishes or distributes or causes to be published or distributed any advertisement, (a) inviting
persons to supply for payment of any human organ; (b) offering to supply any human organ for
payment; or (c) indicating that the advertiser is willing to initiate or negotiate any arrangement
referred to in clause (d);

[(g) abets in the preparation or submission of false documents including giving false affidavits to
establish that the donor is making the donation of the human organs, as a near relative or by reason
of affection or attachment towards the recipient, shall be punishable with imprisonment for a term
which shall not be less than [five years but which may extend to ten years and shall be liable to fine
which shall not be less than twenty lakh rupees but may extend to one crore rupees].

[19A. Punishment for illegal dealings in human tissues: Whoever—

(a) makes or receives any payment for the supply of, or for an offer to supply, any human tissue; or

(b) seeks to find a person willing to supply for payment and human tissue; or

(c) offers to supply any human tissue for payment; or

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(d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or
for an offer to supply, any human tissue; or

(e) takes part in the management or control of a body of persons, whether a society, firm or company,
whose activities consist of or include the initiation or negotiation of any arrangement referred to in
clause (d); or

(f) publishes or distributes or causes to be published or distributed any advertisement— (i) inviting
persons to supply for payment of any human tissue; or

(ii) offering to supply any human tissue for payment; or

(iii) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to

in clause (d); or

(g) abets in the preparation or submission of false documents including giving false affidavits to
establish that the donor is making the donation of the human tissues as a near relative or by reason of
affection or attachment towards the recipient,

shall be punishable with imprisonment for a term which shall not be less than one year, but which may
extend to three years and shall be liable to fine which shall not be less than five lakh rupees, but which
may extend to twenty-five lakh rupees.]

20. Punishment for contravention of any other provision of this Act: Whoever contravenes any
provision of this Act, or any rule made, or any condition of the registration granted, thereunder for
which no punishment is separately provided in this Act, shall be punishable with imprisonment for a
term which may extend to [five years or with fine which may extend to twenty lakh rupees].

21. Offenses by companies: (1) Where any offense punishable under this Act has been committed by
a company, every person who, at the time the offense was committed was in charge of, and was
responsible to, the company for the conduct of the business of the company, as well as the company,
shall be deemed to be guilty of the offense and shall be liable to be proceeded against and punished
accordingly:

Provided that nothing contained in this subsection shall render any such person liable to any
punishment, if he proves that the offense was committed without his knowledge or that he had
exercised all due diligence to prevent the commission of such offense.

(2) Notwithstanding anything contained in sub-section (1), where any offense punishable under this
Act has been committed by a company and it is proved that the offense has been committed with the
consent or connivance of, or is attributable to any neglect on the part of, any director, manager,
secretary

22. Cognizance of offenses: (1) No court shall take cognizance of an offense under this Act except on a
complaint made by—

(a) the Appropriate Authority concerned, or any officer authorized in this behalf by the Central
Government or the State Government or, as the case may be, the Appropriate Authority; or.

119
(b) a person who has given notice of not less than sixty days, in such manner as may be prescribed, to
the Appropriate Authority concerned, of the alleged offense and of his intention to make a complaint
to the court.

(2) No court other than that of a Metropolitan Magistrate or a Judicial Magistrate of the first class shall
try any offense punishable under this Act.

(3) Where a complaint has been made under clause (b) of sub-section (1), the court may, on demand of
such person, direct the Appropriate Authority to make available copies of the relevant records in its
possession to such person.

Chapter VII: Miscellaneous

23. Protection of action taken in good faith: (1) No suit, prosecution or other legal proceeding shall lie
against any person for anything which is in good faith done or intended to be done in pursuance of the
provisions of this Act.

(2) No suit or other legal proceeding shall lie against the Central Government or the State Government
for any damage caused or likely to be caused for anything which is in good faith done or intended to be
done in pursuance of the provisions of this Act.

24. Power to make rules: (1) The Central Government may, by notification, make rules for carrying out
the purposes of this Act.

(2) In particular, and without prejudice to the generality of the foregoing power, such rules may
provide for all or any of the following matters, namely:

(a) the manner in which and the conditions subject to which any donor may authorize removal, before
his death, of any [human organ or tissue or both] of his body under sub-section (1A) of section 3.

[(aa) the human organ or tissues or both in respect of which duty is cast on registered medical
practitioner the manner of obtaining documentation of authorization under clause (i) of sub-section 3.

(ab) the manner of informing the Human Organ Retrieval Center under clause (iii) of sub-section (1A)
of section 3.

(ac) the date from which duties mentioned in sub-section (1A) are applicable to registered medical
practitioners working in an unregistered hospital under sub-section (1B) of section 3.

(ae) the qualification and experience of a technician under the proviso to sub-section (4) of section 3;]

(b) the form and the manner in which a brain-stem death is to be certified and the conditions and
requirements which are to be satisfied for that purpose under sub-section (6) of section 3.

[(ba) the conditions for nomination of a surgeon or a physician and an anesthetist or intensivist to be
included in the Board of medical experts under the proviso to clause (iii) of sub-section (6) of section
3;]

(c) the form and the manner in which any of the parents may give authority, in the case of brain-stem
death of a minor, for the removal of any [human organ or tissue or both] under sub-section (7) of
section 3.

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(d) the form in which authority for the removal of any [human organ or tissue or both] from an
unclaimed dead body may be given by the person in charge of the management or control of the
hospital or prison under sub-section (1) of section 5.

(e) the steps to be taken for the preservation of the [human organ or tissue or both] removed from the
body of any person, under section 7.

[(ea) the manner of removal of human organs or tissues or both from the body of a minor before his
death for transplantation under sub-section (1B) of section 9.

(eb) the composition of the Authorization Committees under sub-section (4) of section 9;]
(f) the form and the manner in which an application may be jointly made by the donor and the
recipient under sub-section (5) of section 9.

(g) The manner in which all possible effects, complications and hazards connected with the removal
and transplantation is to be explained by the registered medical practitioner to the donor and the
recipient under section 12.

(h) the standards are to be enforced by the Appropriate Authority for hospitals engaged in the
removal, storage or transplantation of any [human organ or tissue or both] under clause (iii) of sub-
section (3) of section 13.

(i) the other measures as the Appropriate Authority shall undertake in performing its functions under
clause (vi) of sub-section (3) of section 13.

[(ia) the qualifications of medical experts and the terms and conditions for appointment to the
Advisory committee under sub-sections (2) and (3) of section 13A.

(ib) the power of the Appropriate Authority in any other matter under clause (d) of section 13B.

(ic) the manner of establishment of a National Human Organs and Tissues Removal and Storage
Network and Regional Network and functions to be performed by them under section 13C.

(id) the information in the national registry of the donors and recipients of human organs and tissues
and all information under section 13D;]

(j) the form and the manner in which an application for registration shall be made and the fee which
shall be accompanied, under sub-section (2) of section 14.

(k) the specialized services and the facilities to be provided, skilled manpower and the equipment to
be possessed and the standards to be maintained by a hospital for registration, under sub-section (3)
of section 14.

[(ka) the qualifications and experience of a transplant coordinator under sub-section (4) of section 14.

(kb) the form and the manner in which an application for registration shall be made and the fee which
shall be accompanied, under sub-section (2) of section 14A.

(kc) the specialized service and the facilities to be provided, skilled manpower and the equipment to
be possessed and the standards to be maintained by a Tissue Bank, under sub-section (3) of section
14A;]

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(l) the form in which, the period for which and the conditions subject to which certificate of
registration is to be granted to a [hospital or Tissue Bank], under sub-section (1) of section 15.

(m) the manner in which and the fee on payment of which certificate of registration is to be renewed
under sub-section (3) of section 15.

(n) the manner in which an appeal may be preferred under section 17.

(o) the manner in which a person is required to give notice to the Appropriate Authority of the alleged
offense and of his intention to make a complaint to the court, under clause (b) of sub-section (1) of
section 22; and

(p) any other matter which is required to be, or maybe, prescribed.

(3) Every rule made under this Act shall be laid, as soon as may be after it is made, before each House
of Parliament, while it is in session, for a total period of thirty days which may be comprised in one
session or in two or more successive sessions, and if, before the expiry of the session immediately
following the session or the successive sessions aforesaid, both Houses agree in making any
modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter
have effect only in such modified form or be of no effect, as the case may be; so, however, that any
such modification or annulment shall be without prejudice to the validity of anythingpreviously done
under that rule.

25. Repeal and savings: (1) The Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes)
Act, 1982 (28 of 1982) and the Eyes (Authority for Use for Therapeutic Purposes) Act, 1982 (29 of 1982)
are hereby repealed.

(2) The repeal shall, however, not affect the previous operation of the Acts so repealed or anything
duly done or suffered thereunder.

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 Appendix 2: The Transplantation of Human Organ and
Tissues Rules (THOTR) - 2014
Source: https://notto.mohfw.gov.in/WriteReadData/Portal/images/THOA-Rules-2014.pdf
MINISTRY OF HEALTH AND FAMILY WELFARE
NOTIFICATION
New Delhi, the 27th of March, 2014.
G.S.R. 218 (E). In exercise of the powers conferred by section 24 of the
Transplantation of Human Organs Act, 1994 (42 of 1994) and in supersession of the
Transplantation of Human Organs Rules, 1995, except as respects things done or omitted to
be done before such supersession, the Central Government hereby makes the following
rules, namely:-
1. Short title and commencement
(1) These rules may be called the Transplantation of Human Organs and Tissues Rules, 2014.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. Definitions
In these rules unless the context otherwise requires,
(a) “Act” means the Transplantation of Human Organs Act, 1994.
(b) “Cadaver(s)”, “organ(s)” and “tissue(s)” means human cadaver(s), human organ(s)
and human tissue(s), respectively.
(c) “Competent authority” means the Head of the institution or hospital carrying out a
transplantation or committee constituted by the head of the institution or hospital for
the purpose.
(d) “Form” means a Form annexed to these rules.
(e) National Accreditation Board for Testing and Calibration Laboratories (NABL) means
the autonomous body established under the aegis of Department of Science and
Technology, Government of India with the objective to provide Government,
Regulators and Industry with a scheme of laboratory accreditation through third-party
assessment for formally recognizing the technical competence of laboratories and the
accreditation services are provided for testing and calibration of medical laboratories
in accordance with International Organization for Standardization (ISO) Standards;
(f) “The technician who can enucleate cornea” means the technician with any of the
following qualifications and experience who can harvest corneas (enucleate eyeballs or
excise corneas), namely:
(i) Ophthalmologists possessing a Doctor of Medicine (M.D) or Master of
Surgery (M.S) in Ophthalmology or Diploma in Ophthalmology (D.O.); and
(ii) registered Doctors from all recognized systems of medicine, Nurses,
Paramedical Ophthalmic Assistant, Ophthalmic Assistant, Optometrists,
Refractionists, Paramedical Worker or Medical Technician with recognized
qualification from all recognized systems of medicine, provided the person is duly
trained to enucleate a donated cornea or eye from registered, authorized and
functional eye Bank or Government medical college and, the training certificate
should mention that he has acquired the required skills to independently conduct
enucleation of the eye or removal of cornea from a cadaver;

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 (g) words and expressions used and not defined in these rules, but defined in the Act,
shall have the same meanings, respectively, assigned to them in the Act.
3. Authority for removal of human organs or tissues
Subject to the provisions of Section 3 of the Act, a living person may authorize the removal
of any organ or tissue of his or her body during his or her lifetime as per prevalent medical
practices, for therapeutic purposes in the manner and on such conditions as specified in
Form 1, 2 and 3.
1. Panel of experts for brain-stem death certification
For the purpose of certifying the brain-stem death, the Appropriate Authority shall maintain
a panel of experts, in accordance with the provisions of the Act, to ensure efficient
functioning of the Board of Medical Experts and it remains fully operational.
5. Duties of the registered medical practitioner
(1) The registered medical practitioner of the hospital having Intensive Care Unit facility, in
consultation with transplant coordinator, if available, shall ascertain, after certification
of brain stem death of the person in Intensive Care Unit, from his or her adult near
relative or, if near relative is not available, then, any other person related by blood or
marriage, and in case of unclaimed body, from the person in lawful possession of the
body the following, namely:-
(a) whether the person had, in the presence of two or more witnesses (at least
one of who is a near relative of such person), unequivocally authorized before his or
her death as specified in Form 7 or in documents like driving license, etc. wherein
the provision for donation may be incorporated after notification of these rules, the
removal of his or her organ(s) or tissue(s) including eye, after his or her death, for
therapeutic purposes and there is no reason to believe that the person had
subsequently revoked the aforesaid authorization;
(b) where the said authorization was not made by the person to donate his or
her organ(s) or tissue(s) after his or her death, then the registered medical
practitioner in consultation with the transplant coordinator, if available, shall make
the near relative or person in lawful possession of the body, aware of the option to
authorize or decline the donation of such human organs or tissues or both (which
can be used for therapeutic purposes) including eye or cornea of the deceased
person and a declaration or authorization to this effect shall be ascertained from the
near relative or person in lawful possession of the body as per Form 8 to record the
status of consent, and in case of an unclaimed body, authorization shall be made in
Form 9 by the authorized official as per sub-section (1) of section 5 of the Act;
(c) after the near relative or person in lawful possession of the body authorizes
removal and gives consent for donation of human organ(s) or tissue(s) of the
deceased person, the registered medical practitioner through the transplant
coordinator shall inform the authorized registered Human Organ Retrieval Center
through authorized coordinating organization by available documentable mode of
communication, for removal, storage or transportation of organ(s) or tissue(s).
(2) The above-mentioned duties shall also apply to the registered medical practitioner
working in an Intensive Care Unit in a hospital not registered under this Act, from the
date of notification of these rules.
(3) The registered medical practitioner shall, before removing any human organ or
tissue from a living donor, shall satisfy himself

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 (a) that the donor has been explained of all possible side effects, hazards and
complications and that the donor has given his or her authorization in appropriate
Form 1 for near relative donor or Form 2 for spousal donor or Form 3 for donor other
than near relative.
(b) that the physical and mental evaluation of the donor has been done, he or
she is in proper state of health, and it has been certified that he or she is not mentally
challenged and that he or she is fit to donate the organ or tissue:
Provided that in case of doubt regarding mentally challenged status of the donor the
registered medical practitioner may get the donor examined by a psychiatrist and
the registered medical practitioner shall sign the certificate as prescribed in Form 4
for this purpose.
(c) that the donor is a near relative of the recipient, as certified in Form 5, and
that he or she has submitted an application in Form 11 jointly with the recipient and
that the proposed donation has been approved by the competent authority as
defined at rule 2© and specified in Form 19 and that the necessary documents as
prescribed and medical tests, as required, to determine the factum of near
relationship, have been examined to the satisfaction of the registered medical
practitioner and the competent authority;
(d) that in case the recipient is spouse of the donor, the donor has given a
statement to the effect that they are so related by signing a certificate in Form 2 and
has submitted an application in Form 11 jointly with the recipient and that the
proposed donation has been approved by the competent authority under the
provisions of sub-rule (2) of rule 7.
(e) that in case of a donor who is other than a near relative and has signed Form
3 and submitted an application in Form 11 jointly with the recipient, the permission
from the Authorization Committee for the said donation has been obtained.
(f) that if a donor or recipient is a foreign national, the approval of the
Authorization Committee for the said donation has been obtained.
(g) Living organ or tissue donation by minors shall not be permitted except on
exceptional medical grounds to be recorded in detail with full justification and with
prior approval of the Appropriate Authority and the State Government concerned.
2. A registered medical practitioner, before removing any organ or tissue from the body
of a person after his or her death (deceased donor), in consultation with transplant
coordinator, shall satisfy himself the following, namely:
(a) that caution has been taken to make inquiry, from near relative or person in
lawful possession of the body of a person admitted in Intensive Care Unit, only after
certification of Brain Stem death of the person that the donor had, in the presence
of two or more witnesses (at least one of whom is a near relative of such
person),unequivocally authorized before his or her death as specified in Form 7 or
in documents like driving license etc. (wherein the provision for donation may be
incorporated after notification of these rules), the removal of his or her organ(s) or
tissue(s) after his or her death, for therapeutic purposes and it has been ascertained
that the donor has not subsequently revoked the aforesaid authorization, and the
consent of near relative or person in lawful possession of the body shall also be
required notwithstanding the authorization been made by deceased donor:
Provided that if the deceased person who had earlier given authorization but had
revoked it subsequently and if the person had given in writing that his organ should
not be removed after his death, then, no organ or tissue will be removed even if

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 consent is given by the near relative or person in lawful possession of the body.
(b) that the near relative of the deceased person or the person lawfully in
possession of the body of the deceased donor has signed the declaration as specified
in Form 8.
(c) that in the case of brain-stem death of the potential donor, a certificate as
specified in Form 10 has been signed by all the members of the Board of Medical
Experts referred to in sub-section (6) of section 3 of the Act:
Provided that where a neurologist or a neurosurgeon is not available, an anesthetist
or intensivist who is not part of the transplant team nominated by the head of the
hospital duly empaneled by Appropriate Authority may certify the brain stem death
as a member of the said Board.
(d) that in the case of brain-stem death of a person of less than eighteen years
of age, a certificate specified in Form 10 has been signed by all the members of the
Board of Medical Experts referred to in sub-section (6) of section 3 of the Act and an
authority as specified in Form 8 has been signed by either of the parents of such
person or any near relative authorized by the parent.
6. Procedure for donation of organ or tissue in medicolegal cases
(1) After the authority for removal of organs or tissues, as also the consent to donate
organs from a brain-stem dead donor are obtained, the registered medical practitioner
of the hospital shall make a request to the Station House Officer or Superintendent of
Police or Deputy Inspector General of the area either directly or through the police post
located in the hospital to facilitate timely retrieval of organs or tissue from the donor
and a copy of such a request should also be sent to the designated post mortem doctor
of area simultaneously.
(2) It shall be ensured that, by retrieving organs, the determination of the cause of
death is not jeopardized.
(3) The medical report in respect of the organs or tissues being retrieved shall be
prepared at the time of retrieval by the retrieving doctor (s) and shall be taken on record
in postmortem notes by the registered medical practitioner doing postmortem.
(4) Wherever it is possible, an attempt should be made to request the designated
postmortem registered medical practitioner, even beyond office timing, to be present
at the time of organ or tissue retrieval.
(5) In case a private retrieval hospital is not doing postmortem, they shall arrange
transportation of body along with medical records, after organ or tissue retrieval, to the
designated postmortem Center and the postmortem Center shall undertake the
postmortem of such cases on priority, even beyond office timing, so that the body is
handed over to the relatives with least inconvenience.
7. Authorization Committee
(1) The medical practitioner who will be part of the organ transplantation team for carrying
out transplantation operation shall not be a member of the Authorization Committee
constituted under the provisions of clauses (a) and (b) of sub-section (4) of section 9 of
the Act.
(2) When the proposed donor or recipient or both are not Indian nationals or citizens
whether near relatives or otherwise, the Authorization Committee shall consider all
such requests and the transplantation shall not be permitted if the recipient is a foreign
national and donor is an Indian national unless they are near relatives.

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 (3) When the proposed donor and the recipient are not near relatives, theAuthorization
Committee shall,
(i) evaluate that there is no commercial transaction between the recipient and
the donor, and that no payment has been made to the donor or promised to be
made to the donor or any other person.
(ii) prepare an explanation of the link between them and the circumstances
which led to the offer being made.
(iii) examine the reasons why the donor wishes to donate.
(iv) examine the documentary evidence of the link, e.g. proof that they have
lived together, etc.
(v) examine old photographs showing the donor and the recipient together.
(vi) evaluate that there is no middleman or tout involved.
(vii) evaluate the financial status of the donor and the recipient by asking them to give
appropriate evidence of their vocation and income for the previous three
financial years and any gross disparity between the status of the two must be
evaluated in the backdrop of the objective of preventing commercial dealing.
(viii) ensure that the donor is not a drug addict.
(ix) ensure that the near relative or if near relative is not available, any adult
person related to donor by blood or marriage of the proposed unrelated donor
is interviewed regarding awareness about his or her intention to donate an organ
or tissue, the authenticity of the link between the donor and the recipient, and
the reasons for donation, and any strong views or disagreement or objection of
such kin shall also be recorded and taken note of.
(4) Cases of swap donation referred to under subsection (3A) of section 9 of the Act
shall be approved by the Authorization Committee of hospital or district or State in
which transplantation is proposed to be done and the donation of organs shall be
permissible only from near relatives of the swap recipients.
(5) When the recipient is in a critical condition in need of life saving organ
transplantation within a week, the donor or recipient may approach hospital in-charge
to expedite evaluation by the Authorization Committee.
8. Removal and preservation of organs or tissues
The removal of the organ(s) or tissue(s) shall be permissible in any registered retrieval or
transplant hospital or Center and preservation of such removed organ(s) or tissue(s) shall be
ensured in registered retrieval or transplant Center or tissue bank according to current and
accepted scientific methods in order to ensure viability for the purpose of transplantation.
9. Cost for maintenance of cadaver or retrieval or transportation or
preservation of organs or tissues
The cost for maintenance of the cadaver (brain-stem dead declared person), retrieval of
organs or tissues, their transportation and preservation, shall not be borne by the donor
family and may be borne by the recipient or institution or Government or non-Government
organization or society as decided by the respective State Government or Union territory
Administration.

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10. Application for living donor transplantation.
(1) The donor and the recipient shall jointly make an application to grant approval for
removal and transplantation of a human organ, to the competent authority or
Authorization Committee as specified in Form 11 and the papers for approval of
transplantation would be processed by the registered medical practitioner and
administrative division of the Institution for transplantation.
(2) The competent authority or Authorization Committee shall take a decision on such
an application in accordance with rule 18.
(3) If some State wants to merge Form 11 with Form 1, Form 2 or Form 3, they may do
so, provided the content of the recommended Forms are covered in the merged Form
and the same is approved by the State Government concerned.
11. Composition of Authorization Committees
(1) There shall be one State level Authorization Committee.
(2) Additional Authorization Committees in the districts or Institutions or hospitals may be
set up as per norms given below, which may be revised from time to time by the
concerned State Government or Union territory Administration by notification.
(3) No member from the transplant team of the institution should be a member of the
respective Authorization Committee.
(4) Authorization Committee should be hospital based if the number of transplants is
twenty-five or more in a year at the respective transplantation Centers, and if the
number of organ transplants in an institution or hospital are less than twenty-five in a
year, then the State or District level Authorization Committee would grant approval(s).
12. Composition of hospital-based Authorization Committees
The hospital-based Authorization Committee shall, as notified by the State Government in
case of State and by the Union territory Administration in case of Union territory, consist of
–
(a) the Medical Director or Medical Superintendent or Head of the institution orhospital
or a senior medical person officiating as Head – Chairperson.
(b) two senior medical practitioners from the same hospital who are not part of the
transplant team – Member.
(c) two persons (preferably one woman) of high integrity, social standing and
credibility, who have served in high-ranking Government positions, such as in higher
judiciary, senior cadre of police service or who have served as a reader or professor in
University Grants Commission approved University or are self-employed professionals
of repute such as lawyers, chartered accountants, doctors of Indian Medical
Association, reputed non-Government organization or renowned social worker –
Member;
(d) Secretary (Health) or nominee and Director Health Services or nominee from State
Government or Union territory Administration – Member.

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13. Composition of State or District Level Authorization Committees
The State or District Level Authorization Committee shall, as notified by the State
Government in case of State and by the Union territory Administration in case of Union
territory, consist of,
(a) a Medical Practitioner officiating as Chief Medical Officer or any other equivalent
post in the main or major Government hospital of the district – Chairperson.
(b) two senior registered medical practitioners to be chosen from the pool of such
medical practitioners who are residing in the concerned District and who are not part
of any transplant team– Member.
(c) two persons (preferably one woman) of high integrity, social standing and
credibility, who have served in high-ranking Government positions, such as in higher
judiciary, senior cadre of police service or who have served as a reader or professor in
University Grants Commission approved University or are self-employed professionals
of repute such as lawyers, chartered accountants, doctors of Indian Medical
Association, reputed non-Government organization or renowned social worker -
Member.
(d) Secretary (Health) or nominee and Director Health Services or nominee from State
Government or Union territory Administration–Member:
Provided that an effort shall be made by the State Government concerned to have most of
the members’ ex-officio so that the need to change the composition of the Committee is less
frequent.
14. Verification of residential status, etc.
When the living donor is unrelated and if donor or recipient belongs to a State or Union
territory, other than the State or Union territory where the transplantation is proposed to
be undertaken, verification of residential status by Tehsildar or any other authorized officer
for the purpose with a copy marked to the Appropriate Authority of the State or Union
territory of domicile of donor or recipient for their information shall be required, as per Form
20 and in case of any doubt of organ trafficking, the Appropriate Authority of the State or
Union territory of domicile or the Tehsildar or any other authorized officer shall inform police
department for investigation and action as per the provisions of the Act.
15. Quorum of Authorization Committee
The quorum of the Authorization Committee should be minimum four and the quorum shall
not be complete without the participation of the Chairman, the presence of Secretary
(Health) or nominee and Director of Health Services or nominee.
16. Format of approval of Authorization Committee
The format of the Authorization Committee approval should be uniform in all the institutions
in a State and the format may be notified by the respective State Government as per Form
18.
17. Scrutiny of applications by Authorization Committee
(1) The secretariat of the Authorization Committee shall circulate copies of all applications
received from the proposed donors and recipients to all members of the Committee
along with all annexures, which may have been filed along with the applications.

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(2) At the time of the meeting, the Authorization Committee should take note of all
relevant contents and documents in the course of its decision making process and in
the event any document or information is found to be inadequate or doubtful,
explanation should be sought from the applicant and if it is considered necessary that
any fact or information requires to be verified in order to confirm its veracity or
correctness, the same be ascertained through the concerned officer(s) of the State
Government or Union territory Administration.
18. Procedure in case of near relatives
(1) Where the proposed transplant of organs is between near relatives related genetically,
namely, grandmother, grandfather, mother, father, brother, sister, son, daughter,
grandson and granddaughter, above the age of eighteen years, the competent
authority as defined at rule 2(c) or Authorization Committee (in case donor or recipient
is a foreigner) shall evaluate.
(i) documentary evidence of relationship e.g. relevant birth certificates,
marriage certificate, other relationship certificate from Tehsildar or Sub-divisional
magistrate or Metropolitan Magistrate or Sarpanch of the Panchayat, or similar
other identity certificates like Electors Photo Identity Card or AADHAAR card; and
(ii) documentary evidence of identity and residence of the proposed donor,
ration card or voters identity card or passport or driving license or PAN card or
bank account and family photograph depicting the proposed donor and the
proposed recipient along with another near relative, or similar other identity
certificates like AADHAAR Card (issued by Unique Identification Authority of
India).
(2) If in the opinion of the competent authority, the relationship is not conclusively
established after evaluating the above evidence, it may in its discretion direct further
medical test, namely, Deoxyribonucleic Acid (DNA) Profiling.
(3) The test referred to in sub-rule (2) shall be done from a laboratory accredited with
the National Accreditation Board for Testing and Calibration Laboratories and
certificate shall be given in Form 5.
(4) If the documentary evidences and test referred to in sub-rules (1) and (2),
respectively do not establish a genetic relationship between the donor and the
recipient, the same procedure be adopted on preferably both or at least one parent,
and if parents are not available, the same procedure be adopted on such relatives of
donor and recipient as are available and are willing to be tested, failing which, genetic
relationship between the donor and the recipient will be deemed to have not been
established.
(5) Where the proposed transplant is between a married couple the competent
authority or Authorization Committee (in case donor or recipient is a foreigner) must
evaluate the factum and duration of marriage and ensure that documents such as
marriage certificate, marriage photograph etc. are kept for records along with the
information on the number and age of children and a family photograph depicting the
entire family, birth certificate of children containing the particulars of parents and issue
a certificate in Form 6 (for spousal donor).
(6) Any document with regard to the proof of residence or domicile and particulars of
parentage should be relatable to the photo identity of the applicant in order to ensure
that the documents pertain to the same person, who is the proposed donor and in the
event of any inadequate or doubtful information to this effect, the Competent

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 Authority or Authorization Committee as the case may be, may in its discretion seek
such other information or evidence as may be expedient and desirable in the peculiar
facts of the case.
(7) The medical practitioner who will be part of the organ transplantation team for
carrying out transplantation operations shall not be a competent authority of the
transplant hospital.
(8) The competent authority may seek the assistance of the Authorization Committee
in its decision making, if required.
19. Procedure in case of transplant other than near relatives
Where the proposed transplant is between other than near relatives and all cases where the
donor or recipient is foreign national (irrespective of them being near relative or otherwise),
the approval will be granted by the Authorization Committee of the hospital or if hospital-
based Authorization Committee is not constituted, then by the District or State level
Authorization Committee.
20. Procedure in case of foreigners
When the proposed donor or the recipient are foreigners.
(a) a senior Embassy official of the country of origin has to certify the relationship
between the donor and the recipient as per Form 21 and in case a country does not have
an Embassy in India, the certificate of relationship, in the same format, shall be issued by
the Government of that country.
(b) the Authorization Committee shall examine the cases of all Indian donors consenting
to donate organs to a foreign national (who is a near relative), including a foreign national
of Indian origin, with greater caution and such cases should be considered rarely on case-
to-case basis:
Provided that the Indian living donors wanting to donate to a foreigner other than a near
relative shall not be considered.
21. Eligibility of applicant to donate.
In the course of determining eligibility of the applicant to donate, the applicant should be
personally interviewed by the Authorization Committee which shall be video graphed, and
minutes of the interview shall be recorded.
22. Precautions in case of woman donor
In cases where the donor is a woman, greater precautions ought to be taken and her identity
and independent consent should be confirmed by a person other than the recipient.
23. Decision of Authorization Committee
(1) The Authorization Committee (which is applicable only for living organ or tissue donor)
should state in writing its reason for rejecting or approving the application of the
proposed living donor in the prescribed Form 18 and all such approvals should be
subject to the following conditions, namely:
(i) The approved proposed donor would be subjected to all such medical tests
as required at the relevant stages to determine his or her biological capacity and
compatibility to donate the organ in question.
(ii) the physical and mental evaluation of the donor has been done to know
whether he or she is in proper state of health, and it has been certified by the

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 registered medical practitioner in Form 4 that he or she is not mentally challenged
and is fit to donate the organ or tissue:
Provided that in case of doubt for mentally challenged status of the donor the
registered medical practitioner or Authorization Committee may get the donor
examined by psychiatrist.
(iii) All prescribed forms have been and will be filled in by all relevant people
involved in the process of transplantation.
(iv) all interviews to be video recorded.
(2) The Authorization Committee shall expedite its decision-making process and use its
discretion judiciously and pragmatically in all such cases where the patient requires
transplantation on an urgent basis.
(3) Every authorized transplantation Center must have its own website and the
Authorization Committee is required to take a final decision within twenty-four hours
of holding the meeting for grant of permission or rejection for transplant.
(4) The decision of the Authorization Committee should be displayed on the notice
board of the hospital or Institution immediately and should reflect on the website of
the hospital or Institution within twenty-four hours of taking the decision, while keeping
the identity of the recipient and donor hidden.
24. Registration of hospital or tissue bank
(1) An application for registration shall be made to the Appropriate Authority as specified
in Form 12 or Form 13 or Form 14 or Form 15, as applicable and the application shall be
accompanied by fee as specified below, payable to the Appropriate Authority by means
of a bank draft, which may be revised, if necessary, by the Central or State Government,
as the case may be:
(i) for Organ or Tissue or Cornea Transplant Center: Rupees ten thousand.
(ii) for Tissue or Eye Bank: Rupees ten thousand.
(iii) for Non-Transplant Retrieval Center: Nil.

(2) The Appropriate Authority shall, after holding an inquiry and after satisfying itself
that the applicant has complied with all the requirements, grant a certificate of
registration as specified in Form 16 and it shall be valid for a period of five years from
the date of its issue and shall be renewable.
(3) Before a hospital is registered under the provisions of this rule, it shall be mandatory
for the hospital to appoint a transplant coordinator.
25. Renewal of registration of hospital or tissue bank
(1) An application for the renewal of a certificate of registration shall be made to the
Appropriate Authority at least three months prior to the date of expiry of the original
certificate of registration and shall be accompanied by a fee as specified below, payable
to the Appropriate Authority by means of a bank draft, which may be revised, if
necessary, by the Central or State Government, as the case may be,
(i) for Organ or Tissue or Cornea Transplant Center: Rupees five thousand.
(ii) for Tissue or Eye Bank: Rupees five thousand.
(iii) for Non-Transplant Retrieval Center: Nil.

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 (2) A renewal certificate of registration shall be as specified in Form 17 and shall be valid
for a period of five years.
(3) If, after an inquiry including inspection of the hospital or tissue bank and scrutiny of
its past performance and after giving an opportunity to the applicant, the Appropriate
Authority is satisfied that the applicant, since grant of certificate of registration under
sub-rule (2) of rule 24 has not complied with the requirements of the Act and these
rules and the conditions subject to which the certificate of registration has been
granted, shall, for reasons to be recorded in writing, refuse to grant renewal of the
certificate of registration.
26. Conditions and standards for grant of certificate of registration for organ
or tissue transplantation Centers
(1) No hospital shall be granted a certificate of registration for organ transplantation unless
it fulfills-
A. General manpower requirement specialized services and facilities: the following
conditions and standards, namely:
(a) Twenty-four hours availability of medical and surgical, (senior and junior)
staff.
(b) twenty-four hours availability of nursing staff (general and specialty
trained).
(c) twenty-four hours availability of Intensive Care Units with adequate
equipment staff and support system, including specialists in anesthesiology and
intensive care.
(d) twenty-four hours availability of blood bank (in house or access), laboratory
with multiple discipline testing facilities including but not limited to Microbiology,
Biochemistry, Pathology, Hematology and Radiology departments with trained staff.
(e) twenty-four hours availability of Operation Theater facilities (OT facilities)
for planned and emergency procedures with adequate staff, support system and
equipment.
(f) twenty-four hours availability of communication system, with power
backup, including but not limited to multiple line telephones, public telephone
systems, fax, computers and paper photo-imaging machine.
(g) experts (other than the experts required for the relevant transplantation) of
relevant and associated specialties including but not limited to and depending upon
the requirements, the experts in internal medicine, diabetology, gastroenterology,
nephrology, neurology, pediatrics, gynecology, immunology and cardiology, etc.,
shall be available in the transplantation Center.
(h) one medical expert for respective organ or tissue transplant shall be
available in the transplantation hospital; and
(i) Human Leukocyte Antigen (HLA) matching facilities (in house or outsourced)
will be available.
B. Equipment:
Equipment as per current and expected scientific requirements specific to organ (s) or
tissue (s) being transplanted and the transplant Center should ensure the availability of

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 the accessories, spare parts and back-up, maintenance and service support system in
relation to all relevant equipment.
C. Experts and their qualifications:
(a) Kidney Transplantation:
M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. training in
a recognized transplant center in India or abroad and having attended to an
adequate number of renal transplantations as an active member of the team.
(b) Transplantation of liver and other abdominal organs:
M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. experience
in the specialty and having one year training in the respective organ transplantation
as an active member of a team in an established transplant center.
(c) Cardiac, Pulmonary, Cardio-Pulmonary Transplantation:
M.Ch. Cardio-thoracic and vascular surgery or equivalent qualification in India or
abroad with at least three years’ experience as an active member of the team
performing an adequate number of open-heart operations per year and well-versed
with Coronary by-pass surgery and Heart-valve surgery.
(d) The hospital registered under Clinical Establishment (Registration and
Regulation) Act, 2010 (23 of 2010) shall also follow the minimum standards
prescribed in respect of manpower, equipment, etc., as prescribed under that Act.
(e) The hospital registered shall have to maintain documentation and records
including reporting of adverse events.
(2) No hospital shall be granted a certificate of registration for tissue transplantation under
the Act unless it fulfills the following conditions and standards, namely:
(a) Cornea Transplantation:
M.D. or M.S. or Diploma (DO) in ophthalmology or equivalent qualification with
three months post M.D. or M.S or DO training in Corneal transplant operations in a
recognized hospital or institution.
(b) Other tissues such as heart valves, skin, bone, etc.:
Post graduate degree (MD or MS) or equivalent qualification in the respective
specialty with three months post M.D. or M.S training in a recognized hospital
carrying out respective tissue transplant operations and for heart valve
transplantation, and the qualification and experience of expert shall be MCh degree
in Cardiothoracic and Vascular Surgery (CTVS) or equivalent qualification with three
months post MCh training in a recognized hospital carrying out heart valve
transplantation.
(c) The Hospital registered under Clinical Establishment (Registration and
Regulation) Act, 2010(23 of 2010) shall also follow the minimum standards
prescribed in respect of manpower, equipment, etc., as prescribed under that Act.
(d) The Hospital registered shall have to maintain documentation and records
including reporting of adverse events.

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27. Conditions and standards for grant of certificate of registration for organ
retrieval Centers
(1) The retrieval Center shall be registered only for the purpose of retrieval of organ
from deceased donors and the organ retrieval Center shall be a hospital having
Intensive Care Unit (ICU) facilities along with manpower, infrastructure and equipment
as required to diagnose and maintain the brain-stem dead person and to retrieve and
transport organs and tissues including the facility for their temporary storage.
(2) All hospitals registered as transplant Centers shall automatically qualify as retrieval
Centers.
(3) The retrieval Center should have linkages with nearby Government hospitals
designated for post-mortem, for retrieval in medico-legal cases.
(4) Registration of hospitals for surgical tissue harvesting from deceased persons and
for surgical tissue residues that are routinely discarded, shall not be required.
28. Conditions and standards for grant of certificate of registration for
tissue banks
A. Facility and premises:
(1) Facilities must conform to the standards and guidelines laid down for the purpose
and the States and Union territories may have separate registration fees and
procedures to keep track of their tissue bank activities.
(2) The respective State or Union territory Appropriate Authority may constitute an
expert committee for advising on the matter related to tissue specific standards and
related issues.
(3) The tissue bank must have written guidelines and standard operating procedures
for maintenance of its premises and facilities which include-
(a) controlled access.
(b) cleaning and maintenance systems.
(c) waste disposal.
(d) health and safety of staff.
(e) risk assessment protocol: and
(f) follow up protocol.
(4) Equipment as per scientific requirements specific to tissue (s) being procured,
processed, stored and distributed and the tissue bank should ensure the availability of
the accessories, spare-parts and back-up, maintenance and service support for all
equipment.
(5) Air particle count and microbial colony count compliance shall be ensured for safety
where necessary.
(6) The storage area shall be designated to avoid contact with chemicals or atmospheric
contamination and any known source of infection.
(7) Storage facilities shall be separate and distinguish tissues, held in quarantine,
released and rejected.
B. Donor screening:

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 (8) Complete screening of donor must be conducted including medical or social history
and serological evaluation for medical conditions or disease processes that would
contraindicate the donation of tissues and the report of corneas or eyes not found
suitable for transplantation and their alternate use shall be certified by a committee of
two Ophthalmologists.
C. Laboratory tests:
(9) Facility for relevant Laboratory tests for blood and tissue samples shall be available
and testing of blood and tissue samples shall begin at Donor Screening and continue
during retrieval and throughout processing.
D. Procurement and other procedures:
(10) Procurement of tissue must be carried out by registered health care
professionals or technicians having necessary experience or special training.
(11) Consent for the procurement shall be obtained.
(12) Procurement records shall be maintained.
(13) Standard operating procedure for following shall be followed, namely:
(a) procurement or Retrieval and transplantation.
(b) processing and sterilization.
(c) packaging, labeling and storage.
(d) distribution or allocation.
(e) transportation; and
(f) reporting of serious adverse reactions.
E. Documentation and Records:
(14) A log of tissue received and distributed shall be maintained to enable
traceability from the donor to the tissue and the tissue to the donor and the records
shall also indicate the dates and the identities of the staff performing specific steps in
the removal or processing or distribution of the tissues.
F. Data Protection and Confidentiality:
(15) A unique donor identification number shall be used for each donor, and
access to donor records shall be restricted.
G. Quality Management:
(16) The Quality Management System shall define quality control procedures
that include the following, namely:
(a) environmental monitoring.
(b) equipment maintenance and monitoring.
(c) in –process controls monitoring.
(d) internal audits including reagent and supply monitoring.
(e) compliance with reference standards, local regulations, quality manuals or
documented standard operating procedures; and
(f) monitoring the work environment.
H. Recipient Information:

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 (17) All tissue recipients shall be followed up and prompt and appropriate
corrective and preventive actions taken in case of adverse events.
29. Qualification, role, etc., of transplant coordinator
(1) The transplant coordinator shall be an employee of the registered hospital having
qualification such as:
(a) graduate of any recognized system of medicine; or
(b) Nurse; or
(c) Bachelor’s degree in any subject and preferably master’s degree in social work or
Psychiatry or Sociology or Social Science or Public Health
(2) The concerned organization or institute shall ensure initial induction training followed
by retraining at periodic intervals and the transplant coordinator shall counsel and
encourage the family members or near relatives of the deceased person to donate the
human organ or tissue including eye or cornea and coordinate the process of donation
and transplantation.
(3) The transplant coordinator or counselor in a hospital registered for eye banking shall
also have qualification specified in sub-rule (1).
30. Advisory committee of the Central or State Government to aid and advise
appropriate authority.
(1) The Central Government and the State Government, as the case may be, shall constitute
by notification an Advisory Committee under Chairpersonship of administrative expert not
below the rank of Secretary to the State Government for a period of two years to aid and
advise the Appropriate Authority and the two medical experts referred to in clause(b) of sub-
section(2) of section 13A of the Act shall possess a postgraduate medical degree and at least
five years’ experience in the field of organ or tissue transplantation.
(2) The terms and conditions for appointment to the Advisory Committee are as under:
(a) The Chairperson and members of the Committee shall be appointed for a period of
two years.
(b) The Chairperson and members of the Committee shall be entitled to the air fare and
other allowances to attend the meeting of the Committee equivalent to the officer
of the level of the Joint Secretary to the Government of India.
(c) The Central Government or State Government or Union territory Administration
shall have full powers to replace or remove the Chairperson and the members in
cases of charges of corruption or any other charges after giving a reasonable
opportunity of being heard.
(d) The Chairperson and members can also resign from the Committee for personal
reasons.
(e) there shall not be a corruption or criminal case pending against the Chairperson and
members at the time of appointment.
(f) The Chairperson or any of the members shall cease to function if charges have been
framed against him or her in a corruption or criminal case after having been given a
reasonable opportunity of being heard.

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31. Manner of establishing National or Regional or State Human Organs and
Tissues Removal and Storage Networks and their functions
(1) There shall be an apex national networking organization at the Center, as the Central
Government may by notification specify.
(2) There shall also be regional and State level networking organizations where a large
number of transplantations of organ(s) or tissue (s) are performed as the Central
Government may by notification specify.
(3) The State units would be linked to hospitals, organ or tissue matching laboratories and
tissue banks within their area and also to regional and national networking
organizations.
(4) The broad principles of organ allocation and sharing shall be as under,
(a) The website of the transplantation center shall be linked to State or Regional cum
State or National networks through an online system for organ procurement, sharing
and transplantation.
(b) a patient or recipient may get registered through any transplant Center, but only
one Center of a State or region (if there is no Center in the State) and his or her
details shall be made available online to the networking organizations, who shall
allocate the registration number, which shall remain the same even if patient
changes hospital.
(c) The allocation of the organ to be shared is to be decided by the State networking
organization and by the National networking organization in the case of Delhi.
(d) all recipients are to be listed for requests of organs from deceased donors, however
priority is to be given in following order, namely:
(i) those who do not have any suitable living donor among near relatives.
(ii) those who have a suitable living donor available among near relatives, but
the donor has refused in writing to donate; and
(iii) those who have a suitable living donor available and who have also not
refused to donate in writing.
(e) sequence of allocation of organs shall be in following order: State list Regional
List-----National List---Person of Indian Origin Foreigners.
(f) the online system of networking and framework and formats of national registry as
mentioned under rule 32 shall be developed by the apex networking organization
which shall be followed by the States Governments or Union territory
Administrations and the allocation criteria may be State specific which shall be
finalized and determined by the State Government, in consultation with the State
level networking organization, wherever such organization exists:
Provided that the organ sharing and networking policy of States or locations of
hospitals shall not be binding on the Armed Forces Medical Services (AFMS) and the
armed forces shall be free to have their own policy of organ or tissue allocation and
sharing, and the Director General Armed Forces Medical Services shall have its own
networking between the Armed Forces Medical Services hospitals, who shall be
permitted to accept organs when available from hospitals with in their State
jurisdiction.
(5) The networking organizations shall coordinate retrieval, storage, transportation,
matching, allocation and transplantation of organs and tissues and shall develop norms
and standard operating procedures for such activities and for tissues to the extent
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 possible.
(6) The networking organizations shall coordinate with respective State Government for
establishing new transplant and retrieval Centers and tissue banks and strengthening
of existing ones.
(7) There shall be designated organ and tissue retrieval teams in the State or District or
institution as per requirement, to be constituted by the State or Regional networking
organization.
(8) For tissue retrieval, the retrieval teams shall be formed by the State Government or
Union territory Administration wherever required.
(9) Networking shall be e-enabled and accessible through a dedicated website.
(10) Reference or allocation criteria would be developed and updated regularly by
networking organizations in consultation with the Central or State Government, as the
case may be.
(11) The networking organization(s) shall undertake Information Education and
Communication (IEC) Activities for promotion of deceased organ and tissue donation.
(12) The networking organization(s) shall maintain and update organ or tissue Donation and
Transplant Registry at respective levels.
32. Information to be included in the National Registry regarding donors
and recipients of human organs and tissue.
The national registry shall be based on the following, namely:
Organ Transplant Registry:
(1) The Organ Transplant Registry shall include demographic data about the patient, donor,
hospitals, recipient and donor follow-up details, transplant waiting list, etc., and the
data shall be collected from all retrieval and transplant centers.
(2) Data collection frequency, etc., will be as per the norms decided by the Advisory
Committee which may preferably be through a web-based interface or paper
submission and the information shall be maintained both specific organ wise and also
in a consolidated format.
(3) The hospital or Institution shall update its website regularly in respect of the total
number of the transplantations done in that hospital or institution along with
reasonable detail of each transplantation and the same data should be accessible for
compilation, analysis and further use by authorized persons of respective State
Governments and Central Government.
(4) Yearly reports shall be published and also shared with the contributing units and other
stakeholders and key events (new patients, deaths and transplants) shall be notified as
soon as they occur in the hospital and this information shall be sent to the respective
networking organization, at least monthly.
Organ Donation Registry:
(5) The Organ Donation Registry shall include demographic information on donor (both
living and deceased), hospital, height and weight, occupation, primary cause of death
in case of deceased donor, associated medical illnesses, relevant laboratory tests, donor
maintenance details, driving license or any other document of pledging donation,

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 donation requested by whom, transplant coordinator, organs or tissue retrieved,
outcome of donated organ or tissue, details of recipient, etc.
Tissue Registry:
(6) The Tissue Registry shall include demographic information on the tissue donor, site of
tissue retrieval or donation, primary cause of death in case of deceased donor, donor
maintenance details in case of brain stem dead donor, associated medical illnesses,
relevant laboratory tests, driving license or any other document pledging donation,
donation requested by whom, identity of counselors, tissue(s) or organ(s) retrieved,
demographic data about the tissue recipient, hospital conducting transplantation,
transplant waiting list and priority list for critical patients, if these exist, indication(s) for
transplant, outcome of transplanted tissue, etc.
(7) Yearly reports with respect to the National Registry shall be published and also shared
with the contributing units and other stakeholders.
Pledge for organ or tissue donation after death:
(8) Those persons, who, during their lifetime have pledged to donate their organ(s) or
tissue(s) after their death, shall in Form 7 deposit it in paper or electronic mode to the
respective networking organization(s) or institution where the pledge is made, who
shall forward the same with the respective networking organization and the pledger
has the option to withdraw the pledge through intimation.
(9) The Registry will be accessible on-line through a dedicated website and shall be in
conformation to globally maintained registry(ies), besides having national, regional and
State level specificities.
(10) National or regional registry shall be compiled based on similar registries at State level.
(11) The identity of the people in the database shall not be put in public domain and
measures shall be taken to ensure the security of all collected information.
(12) The information to be included shall be updated as per prevalent global practices from
time to time.
33. Appeal
(1) Any person aggrieved by an order of the Authorization Committee under sub-section (6) of section 9 or by
an order of the Appropriate Authority under sub-section (2) of section 15 or sub-section (2) of section 16 of
the Act, may, within thirty days from the date of receipt of the order, prefer an appeal to the Central
Government in case of the Union territories and respective State Government in case of States.

(2) Every appeal shall be in writing and shall be accompanied by a copy of the order
appealed against.

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 Appendix 3: Legal Forms as Provisioned under THOTA Rules 2014

Source: https://notto.mohfw.gov.in/download-forms.htm

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Source: https://notto.mohfw.gov.in/download-forms.htm

Source: https://notto.mohfw.gov.in/download-forms.htm

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Appendix 4: Application form for Prime Minister’s National Relief Fund
(PMNRF)

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Source: https://pmnrf.gov.in/assets/uploads/downloads/PMNRF-Assistance-form-English.pdf

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Appendix 5: Application form for Rashtriya Arogya Nidhi

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 Appendix 6: Sample format for donor information
● Name & place of the hospital:
● Name of Donor:
● Age/Sex:
● Blood Group:
● Height/Weight:
● Chest circumference:
● Date of Admission:
● MLC/non-MLC:
● If MLC, NOC (Obtained / Awaited)
● Cause of brain death:
● PR
● BP
● Diagnosis
● No. of days in ICU
● Days on ventilator:
● Inotropes:
● Noradrenaline
● Vasopressin
● Dopamine
● Urine output
● 1st apnea (time and date):
● ABG Reports (Pre & Post)
● 2nd apnea (time and date):
● ABG Reports (Pre & Post)
● Family consented for organ donation: Yes/No
● Consent: Verbal / Written
● Consent for: Organs, Tissues
● Contact person: Doctor in ICU (Name and Mobile no)
● Contact person: Donor Hospital - TC (Name and Mobile no)
● Investigations:
● CBC
● KFT
● LFT
● INR
● S. Electrolytes
● Viral Markers
● HIV
● HBSAg
● HCV
● Inflammatory Markers
● Procalcitonin
● CRP
● Xray Chest PA
● Special Investigations (as relevant):

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● CT Chest
● Broncho Alveolar Lavage (BAL) RTPCR- for Lung
● Echo cardiography – For Heart
● Coronary Angiography – For Heart
● COVID-19-RTPCR Report:
● Rapid Antigen Test:
● Expected retrieval (time and date):
● Body handover (time and date):

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Appendix 7: Photographs
Biotem / Viscoelastic Tests

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Dialysis

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ICU setup

174
Endoscopy

175
CUSA Machine

Operation Theatre with two dome

176
Anesthesia machine

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Bone bank

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