|Year : 2020 | Volume
| Issue : 4 | Page : 321-332
Establishing a deceased donor transplantation program and its impact in a public sector hospital in India – A single centre experience from India
JIPMER Deceased Donor Transplantation Committee (JDDTC)
Members of the Committee and the Writing Group are Listed in Alphabetical Order at the End of the Article, India
|Date of Submission||25-Jun-2020|
|Date of Acceptance||07-Aug-2020|
|Date of Web Publication||30-Dec-2020|
Source of Support: None, Conflict of Interest: None
Introduction: Organ transplantation is growing in India but is mostly dependent on living donors. Deceased donor organ procurement has grown in certain parts of the country in the past decade. However, brain death certification and organ procurement predominantly happen in private health-care sector, with less contribution from public sector hospitals. Expanding the infrastructure for deceased donor transplantation program, especially in the public sector hospitals, is likely the most important step toward improving deceased donor organ donation rates in a country like India. Methods: Here, we describe our experience with setting up a deceased donor program in a public sector hospital and its outcomes. Results: We harvested organs and tissues from 42 deceased donors between December 2013 and March 2020. The deceased donor program has helped in establishing a multi-organ transplantation program at our center, including liver and hand transplantation, in addition to kidney and corneal transplantation. Conclusion: Gathering a committed team of direct stakeholders with domain expertise, creating an organizational system, and establishing clear standard operating procedures (SOPs) are critical for success, in addition to physical infrastructure.
Keywords: Brain death, deceased donors, organ transplantation, public sector, tissue and organ procurement
|How to cite this article:|
JIPMER Deceased Donor Transplantation Committee (JDDTC). Establishing a deceased donor transplantation program and its impact in a public sector hospital in India – A single centre experience from India. Indian J Transplant 2020;14:321-32
|How to cite this URL:|
JIPMER Deceased Donor Transplantation Committee (JDDTC). Establishing a deceased donor transplantation program and its impact in a public sector hospital in India – A single centre experience from India. Indian J Transplant [serial online] 2020 [cited 2021 Jan 25];14:321-32. Available from: https://www.ijtonline.in/text.asp?2020/14/4/321/305431
| Introduction|| |
Demand for organ transplantation is steadily growing in India. In the year 2018, a total of 10,340 organ transplantation operations were performed in India, second only to the USA. Living donors continue to be the primary source of organs in India. However, in recent years, many states have made significant strides in establishing deceased donor organ procurement and transplantation programs.,,, Many nongovernmental organizations (NGOs) and health-care organizations have contributed significantly to the success of the deceased donor program. The deceased donor organ donation rate has increased from 0.26 per million population (pmp) in 2012to–0.8 pmp in 2014.
In India, organ procurement mostly happens in the private health-care sector, except for a handful of public sector hospitals. This is a cause of concern because of the public perception that the program is inaccessible to the common man can be detrimental to the long-term viability of the program. Hence, there are enabling provisions in India's organ allocation rules to ensure sharing of organs with public sector hospitals when the procurement happens in private hospitals. Needless to say, there is a need to promote deceased donor organ procurement and transplantation programs in public sector institutions.
In the context of limited infrastructure for management of the deceased donor and brain death certification, organ donation awareness activities among the public may not translate into better organ donation rates., Irrespective of the public awareness activities, developing infrastructure, training medical professionals, and putting “systems” in place in hospitals with a large burden of head injuries are reported to facilitate deceased donor transplantation activities.
Our center, a tertiary care academic institute in the public sector, provides highly subsidized medical care, catering to an underprivileged population. However, the hospital lacked many subspecialty services till the year 2010. The institute embarked upon expansion of its academic, research, and clinical care facilities since 2010, and various subspecialty services were established. A regular living donor kidney transplantation program was established in 2012. In the absence of well-equipped neurosurgery services in the adjacent districts, a large volume of patients with head injury were being referred to our center. Realizing the potential for deceased donor organ donation, we initiated a program which resulted in regular deceased donor kidney transplants in the public sector accessible to patients from underprivileged background.
We describe our unique model of establishing a deceased donor program in a public sector hospital in South India, facilitating a significant number of donations from deceased donors and leading to a significant expansion of the kidney transplantation program, which eventually inspired establishing a multi-organ and tissue transplantation program at our center.
| Methods|| |
The preparatory phase – Notification of brain death certification committee
Till 2013, there was no deceased donor organ procurement program in the state of Puducherry. There was no regulatory framework in the state for brain death certification, and rules were not framed for registering patients on transplantation waiting list, organ allocation, or sharing of organs between institutions or states. First, a CME on brain death certification and organ donation was conducted in collaboration with the NGO MOHAN Foundation. Following this, a small group of JIPMER faculty from stakeholder departments such as Nephrology, Urology, Surgical Gastroenterology, Neurology, Neurosurgery, and Anaesthesiology and Critical Care started an informal consultative process to start a deceased donor organ procurement and transplantation program. A team of specialists in neurosciences (neurologist, neurosurgeon, neuroanesthesiologist, and intensivist) prepared a draft SOP document for certification of brain death at our hospital. A structured brain death certification form to be used at the bedside was drafted. Documents required for various medicolegal formalities related to brain death certification, organ procurement, and organ allotment were adapted from the various government orders of the government of Tamil Nadu, our neighboring state which had an active deceased donor program.
Since brain death certification for the purpose of organ procurement has to be performed by members of a panel of doctors approved for that purpose by the competent authority (Director General of Health Services, New Delhi, for the Union Territory of Puducherry), a panel entirely composed of JIPMER faculty from relevant specialties was proposed and notified by the DGHS.
The initial phase of organ donations and organizational reforms
In anticipation of the deceased donor program, the kidney transplantation service (nephrology, urology, and anesthesiology and critical care) had framed rules for enrolling patients and had started registering patients with end-stage renal disease on the deceased donor kidney transplantation waiting list in the year 2013. In the absence of in-house complement-dependent cytotoxicity (CDC) crossmatch facilities, arrangements were put in place to send samples to the city of Chennai (24 × 7) 150 km away for the test in the event of a deceased donor.
On December 4, 2013, the kidney transplantation team received a call from the neurosurgeon on duty in the emergency medical services department (EMSD) about a patient with severe head injury who was potentially brain dead. Kidneys and corneas were procured, and transplants were performed on December 5, 2013, at our hospital after formal brain death certification and other medicolegal formalities. This was the first instance of organ procurement and transplantation from a deceased donor in the state of Puducherry.
This was followed by a second deceased donor on December 7, 2013, and kidneys and corneas were procured, and transplantation operations were performed at JIPMER. A debriefing meeting held after the first two instances of organ procurement discussed the challenges faced by the team and possible solutions and decided to establish an institutional mechanism to sustain and streamline the program.
Streamlining, personnel, and training
Early in the year 2014, an organizational structure for the deceased donor transplantation program was established and the workflow in the program was defined at our center [Figure 1] and [Figure 2]. Our SOP was to shift the potentially brain-dead patient to the critical care unit under the Department of Anaesthesiology and Critical Care for invasive monitoring, bedside investigations, and brain death certification. Availability of operation theatres was ensured by utilizing additional operation theaters (OTs) for transplantation in addition to regular emergency OTs. All the supporting staffs were mobilized to cater these OTs.
The medical superintendent supervised the program and chaired the Deceased Donor Kidney Transplantation Committee (DDKTC). A faculty who was a significant stakeholder in the program and had domain expertise in the field of transplantation (nephrologist) and prior experience with deceased donor organ donation was appointed as “Nodal Officer” to coordinate among the various transplantation teams and transplant coordinator and with statuary agencies like National Organ and Tissue Transplant Organization (NOTTO).
For the first 2 years of the program, in the absence of dedicated personnel, a faculty and a dialysis technician who was re-designated as “transplant coordinator” from the Department of Nephrology counseled the families of potentially brain-dead patients. They also coordinated brain death certification with the impanelled team of doctors, the medicolegal formalities, and other logistic arrangements related to the deceased donor (police inquest, autopsy, transportation, etc.). A dedicated team of three transplant coordinators (a trained nurse, a medical social worker, and a trained dialysis technician) were employed by the institute exclusively for the deceased donor program in the year 2015. All the newly recruited transplant coordinators received formal training in grief counseling and other aspects of the deceased donor program from NOTTO and were coordinating the deceased donor-related activities under the supervision of the Nodal Officer, since then.
The DDKTC framed rules for allocation of kidneys and prepared a format for reporting each instance of deceased donor organ procurement [Appendix 1] and allocation of kidneys [Appendix 2] and held debriefing meetings after each instance of donation. The report on the brain death certification was prepared by the team of transplant coordinators and the Nodal Officer. The report on organ allocation was prepared by the kidney transplantation team. This was felt to be an important step toward ensuring complete transparency in brain death certification and organ allocation process by the committee.
In addition to coordinating activities during brain death certification and organ procurement, the Nodal Officer organized a formal farewell function on behalf of the institute, for the family of the deceased donor after the process of organ procurement was completed, every time.
The institute organized an annual function on the anniversary of the program to honor the families of the deceased donors in the preceding year. In the same function, all personnel involved with the program, including all cadres of hospital staff, nurses, residents, and faculty members directly involved with the program were felicitated by the hospital administration.
Expansion of the program
Following the success of the deceased donor kidney transplantation program, the institute decided to expand the program by starting other organ and tissue transplantation programs to ensure maximum utilization of available organs and tissues from deceased donors. This was also prompted by the absence of rules for sharing of organs in the state and uncertainties about the how the un-utilized organs such as liver, heart, and lungs should be shared. In the absence of formal rules, it was felt that in-house utilization of organs and tissues, as far as feasible, was the best strategy. The DDKTC was reconstituted and expanded with inclusion of members from the liver transplantation and hand transplantation teams and was renamed the Deceased Donor Transplantation Committee (DDTC). Another committee with faculty from various existing and proposed transplantation programs (liver, hand and tissue, heart, and lungs) was constituted and tasked with the effort of creating infrastructure required for a multi-organ transplantation program. JIPMER created infrastructure for multi-organ procurement and transplantation, including creating more ICUs, procuring equipment, and training its personnel in undertaking liver and hand transplantation. JIPMER applied for permission from the competent authority to perform liver transplantation and transplantation of hands and tissues and was granted permission for both, after formal inspection of facilities by the authorities, in the year of 2017.
Variables were presented as mean and stan- dard deviation or as frequencies (percentage). Continuous variables were analyzed using Student's t-test or ANOVA. Kolmogorov– Smirnov test was used for testing normality. Nonparametric variables were compared using Mann–Whitney U or Kruskal–Wallis tests as appropriate. The Pearson's χ2 test or Fisher's exact test was used for categorical variables. P < 0.05 was considered to indicate a statistically significant difference. The statistical analysis was performed using Epi infoTM Version 7.1, Division of Health informatixs and surveillance, Center for Disease Control, Atlanta, USA.ext.
Declaration of patient consent
The patient consent has been taken for participation in the study and for publication of clinical details and images. Patients understand that the names, initials would not be published, and all standard protocols will be followed to conceal their identity.
Institute ethics board EC registration number (JIP/Neph/Dir/2017/01, dated 03.04.2017) approved renal registry. All protocols as per Declaration of Helsinki were followed.
| Results|| |
Deceased donor organ procurement, transplantation, and sharing
Between December 2013 and March 2020, organs and tissues were harvested from 42 deceased donors at JIPMER, Puducherry. The cumulative number of organs and tissues harvested at JIPMER is summarized in [Table 1]. Majority of the donors were from the state of Tamil Nadu (n = 33) and the rest from Puducherry (n = 10). Most of the kidney transplant recipients were from the state of Tamil Nadu (n = 39) and Puducherry (n = 36), with a few patients from other states such as West Bengal (n = 8), Assam, Bihar, Orissa, and Kerala (1 each). Kidneys from deceased donors account for 40% of kidney transplants at our center. The outcomes of deceased donor kidney transplantation at our center are summarized in [Table 2]. Even in the absence of a formal regulatory framework for sharing of organs with other centers in Puducherry, several organs were shared with other centers and the state of Tamil Nadu when the organs could not be utilized at our center [Table 3]. Data on all deceased donors from whom organs and tissues were harvested at our institute are summarized in [Table 4].
|Table 4: Age, gender, cause of brain death, MLC/non-MLC, organs, and tissues harvested|
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Wider impact of the deceased donor program
In preparations for the program, faculty, nurses, and a transplant coordinator from the Department of Plastic Surgery visited Amrita Institute of Medical Sciences, Kochi, Kerala, where hand transplants were already being performed. The hand transplantation team (Departments of Plastic and Reconstructive Surgery, Orthopaedics, Physical Medicine and Rehabilitation, and Anaesthesiology and Critical Care) at JIPMER performed transplantation of both hands from a deceased donor to an 18-year-old man who had lost his hands from accidental electrocution, August 2, 2017. This was the first time both hand transplantation was successfully performed at a public sector hospital in India. Encouraged by the experience, the hand transplantation team went on to perform both hand transplantation in two more amputees in the subsequent 2 years. Immunosuppression protocol used for deceased donor kidney transplantation was followed for the hand transplant recipient as well. The Department of Plastic and Reconstructive Surgery also harvested skin from a deceased donor and used it for treatment of patients with extensive burns.
Upgradation of infrastructure and training of faculty, transplant coordinator, and nurses were undertaken by the liver transplantation team at JIPMER as part of preparations to start the program. Nurses and transplant coordinator underwent training at Apollo Hospital, Chennai, and a team of faculty from the Department of Surgical Gastroenterology, Anaesthesiology and Critical Care, and Pathology received hands-on training at Institute of Liver and Biliary Surgery, New Delhi. The liver transplantation team at JIPMER (Departments of Surgical Gastroenterology, Medical Gastroenterology, and Anaesthesiology and Critical Care) performed the first deceased donor liver transplantation August 28, 2017. The team went on to perform five liver transplantation operations successfully over the next 2 years.
Proposal for institute of organ transplantation
After realizing the potential and the feasibility of a regular deceased donor program at JIPMER, the institute decided to scale up the program by significantly enhancing the scope and capacity of multi-organ transplantation program. A proposal for establishing a dedicated multi-organ transplantation center, which will provide comprehensive transplantation services under one roof along with facilities for promoting research, collaboration, and educational activities related to the science of transplantation, was submitted to the government of India and in-principle approval for the same has been obtained.
| Discussion|| |
Our institute established the first deceased donor organ procurement and transplantation program in the union territory of Puducherry, and the program has some unique features and faced multiple challenges.
Unique features of the program
The program was established in the absence of a formal framework in the Union Territory for sharing organs from deceased donors or brain death certification. Hence, an organizational structure involving the highest authorities of the institute was put in place for overseeing the program and to liaise with state health authorities. The program was driven by a team of direct stakeholders involved in brain death certification, management of the deceased donor, and transplantation services, with grief counseling performed by a team of transplant coordinators employed under the office of the medical superintendent. The absence of rules for organ sharing between hospitals in the state prompted the institute to follow a policy of utilization of organs and tissues in-house with sharing only when this was not possible. This proved to be a significant boost for establishing a multi-organ and tissue transplantation program, including liver and hand transplantation. In-house utilization of the organs also resulted in minimal cold ischemia period for harvested organs with attendant salutatory effect on graft function (minimal incidence of delayed graft function). Transplantation operations were performed free of charge and hence were accessible to patients from any financial background. Since there was no restriction on allocation of organs based on nativity, patients from different states received organs, farthest being a patient from Lakhimpur in Assam state (2800 km from Puducherry). The institute did not make any capital investment on new infrastructure for deceased donor organ and tissue procurement; the program was operationalized using existing infrastructure with only organizational changes. The only additional expenses incurred in the deceased donor organ procurement were salary for newly recruited transplant coordinators (3 nos.) and procurement of organ perfusion solution (HTK solution).
Even though the program has come a long way, the DDTC feels that we have not realized the full potential of the program due to complex challenges.
Overwhelming of emergency and neurosurgery services
Despite having upgraded the facilities and streamlined functioning of the EMSD, the facility is overwhelmed by large volumes of patients on any average day. Usually, there is a 100% occupancy of ICU with most patients on life support, and there is a constant inflow of patients with head injury requiring emergency services. This situation is not ideal for activities related to deceased donor program because ensuring optimal clinical care for patients with head injury is an essential requirement before discussing brain death and possibility of organ donation with the patient's family. The JDDTC's assessment is that further upgrading the infrastructure of emergency medical services department commensurate with the case burden will go a long way in further promoting the deceased donor transplantation program at JIPMER.
Shortage of workforce
Almost all the key departments involved with the deceased donor program suffer from shortage of workforce, including primary stakeholders like Departments of Neurosurgery, Anaesthesiology and Critical Care, and Neurology and Kidney Transplantation Team. There are only a small number of neurologists at our center, and this results in frequent call duties for each of them for brain death certification. This has resulted in resentment among the brain death certification panel members. Regular positions for transplant coordinators do not exist in the institute, and the coordinators are employed on a contract basis. This results in a high attrition rate of transplant coordinators hampering the smooth functioning of the program. Optimizing workforce resources in various cadres is expected to have a salutatory effect on the deceased donor program at our center.
Police procedure-related issues
Almost all the instances of patients developing severe brain injury at our center were the result of road traffic accidents. The regulations require that the police from the locality where the road traffic accident happened (and not the police from the area where our hospital is located) should complete inquest procedure after brain death certification is completed for the organ procurement to proceed. Patients from far-flung areas are often referred to our center for neurosurgery care. This results in logistic difficulties and inevitable delay in police personnel from the concerned police station reaching the hospital and completing inquest. This delay can jeopardize organ procurement, especially when the status of deceased donor is unstable, in addition to resulting in serious inconveniences to the organ procurement team. The geographical location and the referral pattern to our hospital result in majority of our patients coming from the adjacent state of Tamil Nadu, while the hospital is in the state of Puducherry. Inherent complexities involved in coordination between police forces of two states preclude an inquest being carried out by the local police when the road traffic accident took place elsewhere.
Complement-dependent cytotoxicity crossmatch
The Kidney Transplantation Program at our center is largely self-sufficient, except for immunological investigations. Due to logistic hurdles, the institute has not been able to start transplant immunology services including CDC crossmatch and HLA typing on a regular basis. During each instance of deceased donor organ procurement, irrespective of the time of the day or holiday, samples of the deceased donor and the prospective recipients are sent to a lab offering CDC lymphocyte crossmatch test in the city of Chennai located 150 km away and the transplantation operations are performed after the results are conveyed to the team electronically. In-house availability of CDC lymphocyte crossmatch test will eliminate delay and an element of uncertainty during deceased donor organ procurement and transplantation.
Limitations of the study
The numbers are less as it is a short duration study. Also the donation after circulatory death is not available at our centre and hence was not studied.
| Conclusions|| |
In the presence of strong administrative intent, it is possible to establish a successful deceased donor program in the public sector. Gathering a committed and cohesive team with members who have domain expertise and who are significant stakeholders in the program, creating an organizational system, and establishing clear SOPs are crucial for success. Except for the salary paid to the team of JIPMER transplant coordinators, JIPMER did not make any additional capital investments to establish the deceased donor organ procurement program, demonstrating that it was an organizational change that was required, rather than more investment. However, having a well-equipped emergency service is essential for any successful deceased donor program and further upgrading it can possibly boost our program further.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
Members of the committee and writing board members in alphabetical order
JIPMER Deceased Donor Transplantation Committee & Brain Death Certification Panel members
Adinaraynan S, Additional Professor1; Aggarwal, Rakesh, Director; Ambroise MJE, Technical consultant6; Babu, Ramesh, Professor14; Badhe, Ashok Shankar, Medical Superintendent; Balachander J, Medical Superintendent (retired); Balasubramanian, Mukilan, Assistant Professor1; Bammigatti, Chanvaeerappa, Additional Professor7; Barath, J, Additional Professor; Bethou, Adhisivam, Additional Professor10; Bidkar, Prasanna Udupi, Additional Professor1; Chandran, Sai, B.V., Professor3; Cherian, Anusha, Additional Professor1; Dorairajan, Lalgudi Narayanan, Professor20; Elakkumanan, Lenin Babu, Additional Professor1; Friji M.T., Additional Professor18; Gnanasekaran S., Assistant Professor1; Gopalakrishnan, M. S, Additional Professor; Gupta, Sumanlata, Additional Professor1; Jha, Ajay, Assistant Professor1; Jindal, Bibekanand, Professor16; Keepanaserril, Anish; Additional Professor13; Kubera N.S., Additional Professor13; Kuberan, Aswini, Assistant Professor1; Kumar, Dinesh, Additional Professor18; Kumar, Sadish, Additional Professor4; Madhugiri, Venkatesh12; Mohan V. K., Associate Professor1; Manikandan, R., Additional Professor20; Mohapatra, Devi Prasad, Additional Professor18; Mondal, Nivedita, Additional Professor10; Nair, Pradeep Pankajakshan, Additional Professor11; Narayan, Sunil, Professor11; Mishra, Sandeep Kumar, Additional Professor1; Parameswaran, Narayanan, Professor15; Parameswaran, Sreejith, Additional Professor9,21; Parija, S. C., Director (retired); Parida, Satyen, Additional Professor1; Mohan, Pazhanivel, Associate Professor8, MGE; Pottakkat, Biju, Professor19, SGE; Rajesh, N. G., Additional Professor17, Pathology; Ramesh A. S., Additional Professor12, Neurosurgery; Ravikumar T. S., Director (Retired); Rajan, Sakthi, Additional Professor1; Rajeswari, Chitra, Associate Professor1; Rudingwa, Priya, Associate Professor1; Rustagi, Anita, Additional Medical Superintendent6; Sahoo, Jayaprakash, Additional Professor4; Saravanan, A. K., Transplant Coordinator6; Satheesh, Santhosh, Professor2; Sathia Prabhu A, Associate Professor12; Satyaprakash, M.V.S., Additional Professor1; Senthilnathan, M., Assistant Professor1; Shaha, Kusa Kumar, Professor5; Srinivas, B. H., Additional Professor17; Srinivasan S., Associate Professor1; Stalin V., Additional Professor1; Sreerag K.S., Associate Professor20; Venkatesh, C, Associate Professor15; Venkateswaran R, Associate Professor7; Wadvekar, Vaibhav, Additional Professor11;
Departments of 1Anaesthesiology and Critical Care, 2Cardiology, 3Cardio-Vascular and Thoracic Surgery, 4Endocrinology, 5Forensic Medicine, 6Hospital Administration, 7Medicine, 8Medical Gastroentorology, 9Nephrology, 10Neonatology, 11Neurology, 12Neurosurgery, 13Obstetrics and Gynaecology, 14Ophthalmology, 15Paediatrics, 16Paediatric Surgery, 17Pathology, 18Plastic Surgery, 19Surgical Gastroenterology, 20Urology, JIPMER, Puducherry. 21Nodal Officer, NOTTO, JIPMER, Puducherry
The members of the Writing Working Group: Elakkumanan, Lenin Babu; Nair, Pradeep Pankajakshan; Parameswaran, Sreejith, Pottakkat, Biju, Ramesh A. S.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]