NAMS task force report on Organ donation and transplantation

Organ Deceased Donor Organ Donation & Transplantation (DDOT)

Close

Figure 5:

States shown in green have well-established Deceased Organ Donation programs (dark green states) to expand DDOT in emerging states (light green, orange states).

Source: National Organ & Tissue Transplant Organization (NOTTO).

Export to PPT

Total Transplants in India (2020)

Close

Figure 6:

Distribution of total transplantation in Different Regions of India 2020

Source: National Organ & Tissue Transplant Organization (NOTTO).

Export to PPT

Total Transplants in India (2021)

Close

Figure 7:

Distribution of total transplantation in Different Regions of India

Source: National Organ & Tissue Transplant Organization (NOTTO).

Export to PPT

*2021 data is tentative (before submission to WHO-GODT 2021) as some of the states may make minor changes in their data.

Organ Donation Statistics

Current situation in the country

• About 160,000 deaths happen annually due to road traffic accidents in India – even if 10% (16,000) of these are converted as Organ donors, that will generate an average of 3 Organs per donor (as per Zonal Transplant Coordination Centre (ZTCC) Mumbai data), resulting in 45,000 Organ transplantations (livers, kidneys, hearts, lungs, pancreas, and small bowel).

• CVA is another common cause of BSD in India, and these could also add to the deceased donor pool in our country (ZTCC Mumbai donor data).

• The Organ donation rate (the number of deceased donors per million population) in the country increased from 0.27 in the year 2013 to 0.65 in 2018, however, it dipped to 0.52 in 2019. And are far less than compared to a maximum of around 48 in Spain.

• There is an estimated need for 175,000 kidney and 50,000 each liver, heart, and lung transplants in India. 80% of kidney and liver transplants and 95% of heart, lung, and pancreas transplant services are in private hospitals where the cost is prohibitive for the common man with end-stage Organ failure.

• Currently, it is estimated that only 10% of kidney failure patients get some form of renal replacement therapy (dialysis or transplant) due to the problems of access to tertiary care and financial constraints. However, the growth of healthcare and provision of dialysis facilities in all the 773 districts in the country by GoI, would mean a spurt in the patients requiring access to transplants.

• India is the third country in the world after the USA and China, in terms of the total number of transplants done in a year.

• The total number of transplants done in the country has increased from 4990 in 2013 to 12,666 in 2019, indicating a marked improvement in infrastructure for undertaking transplants in the country and this was mostly due to the growth of private healthcare.

• Organ transplantation in India to date relies predominantly (80.3%) on living donor procedures for kidney and liver transplantation. Heart, lung, pancreas, and small bowel transplants are therefore less frequent.

Current infrastructure, facilities, technologies, policies, programs, etc. in the country in context of the problem/health issue

• A total of 618 hospitals undertaking transplantation or retrieval in the country are now registered with NOTTO for networking and National Registry. This indicates significant progress in the establishment of an organized system in the country for Organ procurement from deceased donors and their distribution and transplantation to the needy citizens of the country. However, the data entry by the hospitals in the National Registry remains incomplete.

• The number of persons who have pledged for Organ and/or tissue donation with NOTTO is now more than 1.4 million, out of which more than 300,000 have been registered online. This indicates a significant improvement in awareness about Organ donation.

• Capacity for undertaking rare transplants, e.g., pancreas, intestine, hand, limbs, lung, and uterus has developed within the country, besides a significant enhancement in capacities for undertaking relatively common transplants of kidney, liver, and heart.

• Some transplant centers, including PGIMER Chandigarh, have also developed capacities for undertaking donation after cardiac death.

Current budget

The following is the grant in aid under the National Organ Transplantation Program (NOTP) available for the promotion of Organ transplantation.

Close

ROTTO: Regional Organ & Tissue Transplant Organization; SOTTO: State Organ & Tissue Transplant Organization; TC: Transplant Coordinator

Export to PPT

Summary of total budget for Organ donation and transplantation

(Tentative year-wise distribution for 2021–2022 to 2025–2026 as per proposed outlay in lakhs of rupees)

Deficiencies in the program

• Lack of brain stem death identification, certification and maintenance of Organs for donation

• Shortage of manpower in government as well as private hospitals.

• Lack of infrastructure/suboptimal utilization of infrastructure in the government sector.

• The provision of Non-Transplant Organ Retrieval Centers (NTORC) in the law has also not been optimally utilized.

• Guidelines related to donation after circulatory death are lacking.

• Non-utilization of the grant under various heads of the National Program.

• There is a regional imbalance. The Organ donation should happen in all the regions and should not remain concentrated in any geographical region. This creates problems with equity and the allocation of Organs.

• Manpower working in SOTTO/ROTTO is having additional charge of SOTTO/ROTTO so adequate time cannot be devoted to Organ donation-related activities. It would be better to have such posts on full-time basis to devote more time to Organ donation rather than just giving additional charge of SOTTO/ROTTO posts.

Recommendations made to bridge the critical gaps/deficiencies in this aspect

1. Brain death

   • There should be a uniform declaration of death with a mode of death being brain stem death (BSD)/cardiopulmonary death (circulatory death).

   • The declaration of “Brain Stem Death” should be made mandatory for all hospitals, both private and government. The THOTA Rules provide for the same, however, the rule is not being followed in letter and spirit.

   • The hospital staff in medical colleges, district hospitals, and other retrieval centers that have ICU and ventilator facilities should be trained in the concept of BSD. There should be regular training programs on BSD for staff from medical colleges, district hospitals, and major corporate hospitals.

   • All BSD certifying specialists should be registered with local authorities.

   • The procedure for the donation of Organs in Medico Legal Case (MLC) should be streamlined and nation/state wise SOPs to be made.

   • Monthly audit of BSD must be done regularly by the concerned SOTTOs. The data pertaining to the declaration of BSD should be online as well as re-certification process should have a mandatory review of the number of brain deaths identified and audit reports of such activities from the ICU.

   • Training of ICU staff in family conversation for end-of-life care should be regularly conducted. The number of trained staff in the ICU for end-of-life conversations should be introduced in a phased manner. SOP for donation procedure within the hospital should be a mandatory requirement for certification

2. Regulatory bodies

   • There are around 618 registered transplant centers and only 140 non-transplant retrieval centers. The retrieval centers must proportionally be increased by incentivizing them.

   • Registration of Non-Transplant Organ Retrieval Centers (NTORC): The process for registration of NTORCs should be simplified. The hub and spoke model can be followed with big hospitals as hubs and NTORCs as spokes. Registered transplant hospitals can be tied up with trauma centers. In fact, all the trauma centers in the country should be registered.

   • All the medical colleges and hospitals can be identified as NTORCs.

   • Written SOPs with clear guidelines regarding manpower and equipment requirements should be shared with these NTORCs.

   • Apex National Body: Empowered and robust NOTTO with more financial powers should be there to work in the field of Organ donation and transplantation.

   • The Appropriate Authority should be a designated senior official only handling Organ donation and transplant on a full-time basis.

   • Independent oversight committee with representation of Appropriate Authority (AA) & Apex National Body.

   • Monthly activities of NOTTO, SOTTO, and ROTTO should be notified on the website including future workshops.

   • The performance of SOTTOs should be assessed on a regular basis with a possibility of transfer if found unsatisfactory.

3. Hospitals and ICU:

   Death audits

   • Monthly audits of death, including BSD must be done on a regular basis by the concerned SOTTOs to find out the missed opportunities and possible solutions. The data pertaining to the declaration of BSD should be reported online on a central NOTTO interface.

   • Training of ICU staff in family conversation for end-of-life care should be regularly conducted and made mandatory.

   • SOP for donation procedure within the hospital should be a mandatory requirement for certification.

   • Re-certification process for a transplant license should have a mandatory review of

     • ○

       Number of brain deaths identified and audit reports of such activities from ICU.

     • ○

       SOPs for Organ donation pathways.

     • ○

       Family conversation for end-of-life care workshops conducted.

     • ○

       The number of trained staff in ICUs for end-of-life conversations should be introduced in a phased manner. Re-certification should consider the performance in this aspect.

Grief counselors/Transplant coordinators

• At least four existing staff in the hospitals can be identified, trained, and designated as transplant coordinators.

• The transplant coordinators for deceased donor family counseling should be different from those handling transplant recipients.

Role of police

• The police must designate nodal officers to coordinate Organ donation-related activities.

• The investigating officers/station house officer of the police station under which the hospital falls should be directed to assist in Organ procurement as mandated in the THOTA Act.

• The respective governments must be directed to instruct police chiefs to hold regular awareness meetings for all investigating officers/station house officers.

• The police also need to be sensitized about the importance of Organ donation and medico-legal issues should be eased.

Education and training

• Organ transplant units should be there in all medical colleges and All India Institute of Medical Sciences (AIIMS) institutions. Such units should have faculty with expertise in the field of Organ transplantation and at least should become Organ retrieval centers in the first phase and have a brain death certification committee wherever possible. Multi-organ retrieval teams should be available in all major hospitals.

• State governments should identify one medical college in their state that can become a center for excellence as a multi-organ transplantation hospital to help with the training of manpower and growth of the program.

• Advanced transplant centers should be there in all INIs with individual Organ subdivisions. These centers should have a common ICU so that it could be managed with less logistics and manpower. Specialized departments for cardiac, lung, and Hepato Pancreato Biliary (HPB) surgery, and liver transplants should be created in all INIs to enhance the seriousness of multi-organ transplants. Stress must be laid on the recruitment of people with passion in the field of Organ transplantation to give a fillip to the program.

• Training related to Organ transplant and prospective donors after the declaration of BSD should be given to all concerned physicians/surgeons.

• All postgraduates should be trained in BSD like they are being trained in BLS and ALTS regularly. It would increase awareness and strengthen the concept of BSD, and make the foundation strong.

• More consultants should be systematically trained in the field of Organ transplantation.

• Transplant Societies and non-government organizations could help in the training of ICU professionals and surgeons in multi-Organ transplants. The competence of the transplant surgeons and the team should be objectively assessed.

• A letter from the Secretary of Health, Director General of Health Services (DGHS), or National Medical Commission (NMC) may go to different states and medical colleges to start donor action programs.

• Trauma centers should be better equipped to handle brain deaths (ventilators, Arterial Blood Gas (ABG) machines, and other equipment). This would help in both saving lives and early identification of brain deaths.

• Fellowships as well as short-term attachments should be available/started at transplant centers.

• A pool of certified transplant surgeons must be created for capacity building in the field of Organ donation and transplantation.

• The curriculum/training on BSD should be imparted to all residents, faculty, and nurse staff. Organ donation chapters should be included in the curriculum. Besides, public awareness should be increased.

Infrastructure

• All medical colleges, district hospitals, and trauma centers should be actively involved in transplant-related fields.

• INIs should have transplant departments for multi-organ transplants and have permission for fellowships training in transplant.

• A dedicated Department of Intensive Care Medicine should be created in all medical colleges and major government hospitals.

• Dedicated infrastructure must be created in the Public Sector for Organ Transplantation on lines of IKRDC-ITS Ahmedabad, ILBS New Delhi, and PGIMER: Chandigarh. Few ICU beds can be dedicated for Organ donation in government hospitals. In all INIs dedicated ICUs and HDUs should be made as per standard protocol. This will strengthen the infrastructure for Organ transplantation from the beginning and new AIIMS will have accountability for Organ transplantation.

• To maximize the utilization of deceased Organs, particularly extended criteria Organs, a provision should be made to do machine perfusion of Organs and for that, a clause should be added in THOTA Rules 2014 or a circular should be issued by GoI.

• Organ transplant units should be formed in all medical colleges and AIIMS-like institutions. At least they should become Organ retrieval centers in the first phase and have a brain death certification committee. Such units should have faculty with expertise in the field of Organ transplantation and plan to have multi-organ retrieval team in all major hospitals.

• Separate departments for multi-organ transplantation need to be created in one medical college of each state to promote Organ donation and transplantation. Advanced transplant centers should be there in all INIs with individual Organ subdivisions. These centers should have a common ICU so that it could be managed with less logistics and manpower. Departments of HPB Surgery & Liver Transplant and Department of Hepatology should be created in all INIs to enhance the seriousness towards liver transplant. The same should be adopted for other Organs as well. Stress must be laid on the recruitment of people with passion in the field of Organ transplantation.

NOTTO and financial aspect

• The Government of India has earmarked funds for setting up a transplant center but this needs to be widely publicized and centers pushed to accept these funds with financial accountability. The fund utilization in this field is sub-optimal.

• The grant allocated for various components should be visible at the level of NOTTO, ROTTO, and SOTTO. There should be a separate finance officer at the national or regional level for the grant and processing of the payments.

• NOTTO could be made more robust by recruiting new officers with varied backgrounds like finance, etc. and SOPs should be made for the use of grants allocated for various components under NOTTO.

• A full-time designated official in top positions (at NOTTO, ROTTO, and SOTTO) with a keen interest in Organ transplantation and donation should be appointed. Lateral entry for suitable candidates with experience in the field should be allowed with no age bar.

• Audit should be conducted at the level of NOTTO to evaluate the work done by ROTTO and SOTTO and they should be made accountable.

• There is an urgent need to make Organ donation and transplantation affordable. Drugs like immuno-suppressants, preservative solutions for Organ transportation, and other consumables required for Organ transplantation should be made tax-free.

• The inclusion of Organ transplantation under Ayushman Bharat PMJAY by GOI is a good step and financial support from corporates through Corporate Social Responsibility and Crowd Funding should be encouraged for poor patients. The post-transplantation expenditure should also be taken into account.

• States that have not adopted Transplantation of Human Organs and Tissues Act 1994 (THOA) should be requested to do so. Letters from Director Genertal of Health Services (DGHS) enumerating all funds should be sent to all state Directorate of Health Services (DHS) for setting up SOTTO in their states and registering all licensed transplant centers and retrieval centers. Enhancement and improvement of the National Registry into computerized data collection and automatic computerized allocation to have a transparent allocation.

• Incentives to hospitals – who provide complete data to health authorities such as SOTTO/NOTTO.

·Regular meetings by AA for reviewing the progress from time to time of SOTTO/ROTTO and NOTTO.

• Regional Directors of the Government of India Health and Family Welfare should be involved in facilitating the operationalization and implementation of various schemes of NOTP.

• Greater involvement of the neuro critical care team of hospitals to enhance donor identification and Organ donation. They may be the preferred nodal officers of the hospital for all Organ donations and transplant-related matters.

• Conferences of these specialties should have a session on Organ donation and transplantation.

• Annual conferences should be organized by NOTTO/ROTTO/SOTTO and widely published.

National THOTA and NOTP Cell

• It has the role of representing and renewal of all Organ and tissue transplant centers and monitoring transplants and retrieval in respective states and UTs.

• Give consultancy on transplant law and program-related matters.

• Facilitating National Organ Donation/World Organ Donation Day.

• Looking after technical, administrative, and financial matters of NOTP, implementation and monitoring of its various components.

Organ transportation

• Organ transportation by air can be taken up as a Corporate Social Responsibility (CSR) by corporates, the Indian Airforce can be involved in addition to the Ministry of Civil Aviation. Organ transportation by drones can also be considered.

• Facilities for Organ transportation by road/air ambulances should be available at subsidized rates.

Tissue donation

• Tissue donation has to be promoted. The tissue donation needs to be looked at by an independent Apex Technical Committee constituted for this purpose.

Best practices

• Best practices from state Government Orders (G.O.) to facilitate deceased organ donation may be compiled and evaluated, and later adopted based on merit.

• A modified The United Network for Organ Sharing (UNOS) model has been in practice in Maharashtra for over 20 years should be looked into and implemented.

Recommendations made to bridge the critical gaps/deficiencies in this aspect in THOTA rules of 2014

Current problem in Form 13: The requirements for infrastructure and manpower are almost similar to those for registration of a transplant center. There is no need to change Form 13 for recognition of NTORC. There is a need to simplify the process and a MoU can be signed.

• All BSD certifying specialists should be registered with local authorities.

• If there is a deceased donor in a non-registered hospital and the family is willing to donation of Organs and or tissues, then “In such non-registered hospital the death will be certified by two certified specialists from the registered transplant hospital or NTORC and retrieval of Organs and tissues can be done at the same hospital by teams from registered transplant hospital or shifted to a registered NTORC or transplant hospital”. In such cases, donor-specific/time-specific permission by Appropriate Authority may be granted when the family comes forward to donate the Organs.

• Alternatives/Ancillary tests to Apnea test. BSD certification in a person where either:

  1. Apnoea test cannot be done due to hemodynamic instability or

  2. Cranial nerve reflexes cannot be tested due to eye/facial injuries, where actions to be taken.

Use ancillary tests to document the absence of cerebral blood flow as per international practices: BSD certifying specialist to decide the tests to be performed e.g., 4-vessel cerebral angio/CT cerebral Angio/MR angio/Trans Cranial Doppler/Isotope scan, depending on availability of facilities.

Any other

• In all cardiac deaths, the option of tissue donation should be offered.

• Role of digitization: the digitization of the Organ Donation Registry to avoid man-made errors.

• 24-hour call center at NOTTO.

• Tree plantation drives in the name of donors and other ways to honor their families.

• Awareness in schools and colleges on Organ donation.

• National Health Insurance for Organ Transplantation.

• Orientation and sensitization of various stakeholders like judges, legal experts, police, and traffic personnel, etc. on Organ donation and transplant centers.

Increasing awareness:

• More full-time manpower and budget should be allocated to NOTTO and NOTP.

• Creation of modified UNOS model of Organ Procurement and Transplantation Network (OPTN) and Organ Procurement Organisations (OPOS) as being practiced in Maharashtra (ZTCCs) having financial self-sufficiency to be looked into.

• There is a need to increase awareness about Organ transplantation among medical professionals.

• Awareness posters about Organ donation should be installed at all hospitals (trauma center and ICU) and prominent places (such as shopping malls, railway stations, government offices, and banks). The “Ang Daan Jeevan Daan” posters having toll-free numbers should be installed at important places in all hospitals.

• If any Organ donation and transplantation is being performed, such an event may be displayed on LED or as a blinking light on dashboards at NOTTO, ROTTO, SOTTO offices, and other prominent places to sensitize the public at large.

• There should be a provision in the driving license about willingness to donate Organs in all states.

• Smart cards should be issued to Organ donors.

Key actions

• Adoption of THOTA by states who have not accepted as yet.

• Establish SOTTO in each state to develop an effective and organized system of Organ procurement.

• Govt institutions – augment infrastructure for Organ donation and transplant (identify medical colleges without infrastructure).

• Register all trauma centers as Organ retrieval centers.

• Have transplant coordinators in each hospital.

• Make intensivists and critical care doctors as Nodal officers.

• Creation of independent AA in each state.

• Reporting of long-term transplant recipient and donor outcomes to NOTTO should be mandated.

• Organ transplantation from deceased donors after cardiac death is underutilized in India and should be promoted.