Organ Donation Program in Kerala – Why the Current Developments are Regressive for the Program

Kerala since the year 2102 has been at the forefront of the deceased donation program in the country with a donation rate in 2016 that was over 2 per million population. This was three times the national average and above Tamil Nadu which has been considered the leader in the program and on whose model the Kerala deceased donation program was constructed. The public and media have been highly supportive of the program in the state. Many donations have originated spontaneously from the public wishing to donate the organs of their loved ones at the time of extreme grief and tragedy when their loved ones are brain dead in the intensive care units. The spirit of giving by the people of Kerala are being lauded by other states who have watched the growth of this program since 2012.

There are examples of selfless act of donations from the likes of Father Davies  Chiramel and Mr. Kochouseph Chittilappilly, Chaiman of V-Guard. Father Davis Chiramel has been responsible for half a million people in India pledging their organs and he walked the talk by setting an example for universal brotherhood and compassion—by donating his kidney to a man of the Hindu faith. Chittilapilly donated one of his kidneys to a stranger - a truck driver. He started an organ donor chain - where one of the family members of the recipient had to donate an organ thereby forming a donor chain. Following these donations there are examples of many bishops and nuns donating one kidney to a needy patient and also towns having 100% record of organ pledging. MOHAN Foundation, a NGO that promotes organ donation receives the maximum number of online organ pledges in the country from the state of Kerala through its website that promotes organ donation.  

The developments in the last 6 months, however have been regressive for the program and there are various issues that have been brought up in the public domain by some concerned citizens of the state. Some of the issues raised are as follows –

1.   Concept of brain death declaration is being challenged.

2.   The currently laid out brain death certification methods as in the Transplantation of Human Organ Act of 1995 of the country are considered  inadequate or not valid.

3.   Ancillary tests for brain death certification are being asked to be made compulsory in all the cases to certify brain death.

4.   Private hospitals are deemed to be making money from these donation and transplantation surgery.

5.   Transparency in the program for allocation of organs are being challenged.

Since August 2012 to May 2017 the state of Kerala has had 257 deceased organ donors who have donated 1132 critical organs and tissues as follows -

Kidney                                 438

Liver                                     201

Heart                                    45

Lungs                                     3

Pancreas                                5

Small Intestine                      3

Corneas                              370

Heart Valves                         60

Hand                                        2

Total Organs & Tissues       1037

Besides Kidney today Kerala has developed expertise in liver, heart and even complex double hand transplantation surgery. Kerala is the only state in whole of Asia to have performed hand transplant surgery.

Neurological Criteria of Death

Brain death concept has been accepted internationally for almost 50 years and in this time more than a million organs and tissues have been retrieved and transplanted in many countries. In India, the concept was first accepted in 1995 and since then over 5000 organs and tissues have been transplanted in the country.

Brain death was never invented for organ donation, however due to the artificial support that keeps the heart and lungs functioning and hence preserving the organs and tissues to be kept perfused these cadavers became an important source of scarce organs. However the demand for organs has far exceeded the number of organs procured from these donors. To overcome this short supply many countries set up systems like ‘presumed consent’ ( where the state presumes the citizen is a donor , unless it is expressed otherwise) and ‘mandated choice’ on the driving license to ensure that organs in brain death situation are optimally utilized to save lives of organ failure patients. The possibility of getting organs from brain death also lessened the pressure on the living donation program in many countries.

The brain death or neurological concept of death was first accepted in 1968 following advancement in the techniques of ventilation in the intensive care and at the same time the imaging techniques. All deaths in human and many animals eventually resides in the brain, as the neuron (brain cells) cannot be revived or re-generated once they die. Generally everyone understands that a person dies when they stop breathing and the heart comes to a stop. But if the heart is revived through resuscitation techniques, then a person can come alive after being dead for a few minutes. However if there are delays,  the brain cells die due to lack of circulation ( as a result there is no supply of fresh oxygen and glucose) and this results in irreversible death as the brain is akin to the computer’s mother board of the human body. Once the mother board is gone rest of the computer cannot work – it is the same with the human body and the brain. Once brain death occurs, the patient is dead because all the physiology of organs of the body is controlled by the brain. The death of the brain means the person cannot breathe on their own, cannot regain consciousness, the temperature of the body cannot be regulated and all the control on the hormones secretions is lost. The person cannot see, hear, swallow, move on their own and this is indicated by the loss of reflexes.  This form of death was first discovered in in Paris in 1959, where the state was called coma de passé  ( beyond coma).

Brain death declaration requires certain clinical conditions to be excluded and certain criteria’s to be fulfilled and there needs to be an established cause for such a death. Once these criteria are met, brain death declaration can proceed by using standard clinical testing methods. The gold standard test for brain death declaration is called  “Apnea test’’ through which it is established that the person has lost the capacity to breathe on their own.

In India, the government accepted brain death as form of death in 1995 through the enactment of the ‘Transplantation of Human Organ Act’ for the purpose of organ donation. Unlike standard definition of death where only one doctor is required to certify death, in brain death four doctors are required for certification and this is required to be done twice at six hours apart.

The requirements for certifying brain death is well defined by the Indian law too and is as per international standards and guidelines. There have been no documented case where a person has either regained consciousness or has started breathing on their own without ventilator support, where brain death certification has been done by following the laid down standard guidelines and criteria.

Recently with the advent of internet there are stories that have tried to discredit this neurological criteria of death and a lot of misinformation is floating around about brain death. In some of these reported cases brain death diagnosis was done in haste and the right tests were not conducted. In India, the govt. of India has been doubly cautious and has required the test to be done twice at 6 hours apart in presence of four doctors. No country follows such strict testing criteria for brain death certification. The American Neurological Association guidelines requires testing to be done only once to certify brain death.   

New Standards to Certify brain death in Kerala

The recent G.O. (Ms.) No.16/2017/H&FWD dated 01.02.2017 from Kerala requires the following to be done where brain death certification is to be conducted  –

1.   Brain stem death testing by a team of 4 doctors of which at least 2 doctors must be from outside the hospital. One of them must be a doctor from the government service who is empanelled by the appropriate authority.

2.   Real time ( timed and stamped) Videography of both the brain stem death certification must by produced of both the apnea tests

3.   A peripheral nerve stimulation test must be carried out to rule out residual neuromasucular blockade through pharmacologic agents.

Videography of brain stem death testing of apnea test  – This violates the principles of medical ethics (confidentiality and privacy) of the patient. Most are likely to be done on the mobile phones. The implications of any such videos getting leaked on social media and going viral is immense. How can the Govt. GO ensure total confidentiality in such situations where there are multiple people and doctors involved.

Conduct peripheral nerve stimulation - to look for muscle relaxants is not mentioned in the Transplantation of Human Organs Act and Rules and therefore this requirement contravenes the law. Other points to be considered are – Do all the ICU’s use these stimulators and are they available in all the iCU’s. What minimum settings are acceptable for the test.

Have the presence of four doctors for declaring brain death including two from outside the hospital and one being from government service - To get an government doctor twice for the test was one of the deterrents and hence the 2011 amendments act has allowed anyone not necessarily a neurologist or a neurosurgeon like an anaesthetist, surgeon or physicians can certify brain death. This was done to get more doctors in the panel. Most hospitals will find it difficult to get a government doctor to be made available twice, especially in non- transplantation organ retrieval centres. This will greatly restrict donations even if the family is willing to donate.

All these new provisions has already had an effect on the programme. In 2017 the number of brain death declared has come down dramatically. Less than 10 donations have happened in the past 5 months.      

There have been suggestions by some concerned citizens to include EEG and  angiograms of the brain for such certifications. The current law in India does not require these ancillary tests to be conducted. EEG test is fraught with fallacies and are only advised to be done in children in case of any doubt. Angiograms are difficult to conduct in a brain death situation as these cadavers are intrinsically very unstable  and they do not tolerate shifting with all the ventilator and inotropic supports to the radiology suite of a hospital. These tests are seldom required as most cases in India are due to road traffic accidents and a prior CT or MRI scans already has defined the extent of brain injury and its irreversible nature. Such facilities may not be available in non-transplant retrieval centres. It also adds unnecessarily to the costs of care.    

 The problem with the Kerala approach is as follows –

1.   It builds distrust in the program. The requirements of the G.O. will undermine the credibility of the medical profession in the eyes of the public and will create a fear factor in the minds of the doctors.

2.   None of these provisions are defined by the law of the land

3.   It is regressive to overall growth of the program

Steps that can be taken to Safeguard the Program Against Malpractice within the purview of the current Law

If there are concerns about brain death testing, there are far easier methods that can be incorporated to safeguard the program and includes –

a.           Conduct an audit of brain deaths over the last two years through appointment of external doctors from other states. All case sheets can be made available to these doctors. Most cases are generally from road traffic accidents where there is severe head injury and all would have a CT Scan of the brain too.

b.           The private hospitals should submit all case histories, brain death certificates and investigation copy to KNOS within a week of donation – for regular ongoing audit.   

c.        Review the registry data on how many organs have gone out of Govt. hospital to private hospitals and how many have been received by the Govt. Hospital from private sector – the GO’s in 2012 were framed so that the Govt. hospitals receive more organs from private hospitals. This information needs to be put in the public domain.    

d.        If a liver or heart is donated from Govt. hospital to a private hospital, then the private hospital should do one in two or three case of govt. hospital patient at a low fixed cost.  

e.        To stop the perception of commercialisation of deceased donor organs, the body of the brain dead patient should not be moved from one hospital to another for the purpose of organ donation. The Non transplant organ retrieval centres have made a significant contribution to the deceased donation programme in Kerala and they should be strengthened.

f.         In Tamil Nadu getting outside Govt. empanelled doctors for brain death certification was one of the deterrents that did not allow the program to progress. The current 2011 law and rules too does not have any such requirement. Instead one representative from KNOS office can be made available during brain death testing in a private hospital.

There is much misinformation that has been brought into the public domain in Kerala without any evidence of such mal-practices. Most steps have been taken because of hearsay concerns of individuals who rely on their information from Internet resources and have neither worked in the program nor understand the basis of neurological criteria of death.

Kerala today is the only state in the world where these requirements needs to be met to certify brain death. All the current steps are regressive to the deceased donation program and policy makers really need to get a meeting of national and international experts before such rules are framed or implemented.