AASASS

AASASS

Dr. VIPIN KOUSHALASSISTANT PROFESSOR

PGIMERChandigarh

THE TRANSPLANTATION OF HUMAN ORGANS ACT (1994)

Issues, Challenges and Possible Solutions

Assisted by Dr. Navin Pandey

THOATHOA

Increased awareness

Increasing waiting list

Increased awareness

Increasing waiting list

Illegal tradeExploitation Illegal tradeExploitation

Improved technology

Better medicines

Improved technology

Better medicines

Legal & Ethical issues

Legal & Ethical issues

Prosecution Prosecution

Transplantation is the future of medicine

Transplantation is the future of medicine

Patients requiring transplantation increasing.

No corresponding increase in organ donation

Lead to black marketing & organ trading

Huge susceptible population that can be

exploited

Contd....Contd....

Need for the ActNeed for the Act

Provides for the regulation of :

Removal

Storage

Transplantation

Of human organs & tissues for

therapeutic purposes, and

For the prevention of commercial

dealings in human organs

THOATHOA

Includes donation of tissues.

Organ swapping legalised.

Penalties enhanced.

Grandparents and Grandchildren

included in the list of near relatives.

THOA (Amendment) Act 2011THOA (Amendment) Act 2011

In the absence of a neurologist or neurosurgeon :

An independent surgeon or physician An anesthetist or intensivist Maybe nominated for brain death declaration

Makes it mandatory for a doctor in an ICU to ascertain if a family wants to donate organs

No organs or tissues shall be removed from a mentally challenged person before his death.


Transplantation involving a foreign

national, even if near relatives requires

approval by AC.

National registry of donors and recipients.

Cornea, can be retrieved by a certified eye

technician


NGOs registered specially to work on

human organ transplantation would

be allowed.

Mandatory to appoint a transplant

coordinator in registered hospitals


Two authorities have been formed under the Act:

Appropriate Authority (AA) and

Authorization Committee (AC)

The AuthoritiesThe Authorities

The Central and State Governments

shall appoint, by notification, one or

more officers as Appropriate

Authorities for purposes of this Act.

Constitution of AAConstitution of AA

To grant registration to a hospital

To suspend or cancel such registration.

To enforce standards of registered

hospitals

To investigate any complaint or breach of

any provision of the Act

(Contd....)(Contd....)

Role of AARole of AA

AA has the power to:

Summon any person

Seek production of a document

Issue a warrant for the search of any

place

Suspected to be indulging in unauthorized

transactions in human organs.

Role of AARole of AA

The composition of the AC is such as may be

prescribed by the Central Government.

The State Government and the Union territories shall

constitute,

One or more ACs

Consisting of members nominated by the State

Governments and the UTs.

Constitution of ACConstitution of AC

A senior person officiating as a Director or MS or CMO

2 senior medical practitioners from same hospital who are not part of the team.

2 members being persons of high integrity, social standing & credibility

Secretary health or nominee& DGHS or nominee 2 senior medical practitioners who are residing

in the state but not part of transplant team. 2 senior citizens of nonmedical background.

Approve transplants between unrelated

donors and recipients

NOC from their respective country’s

embassy if the donor or recipient is a

foreign national

NOC from respective domicile states, if

donor or recipient are from different states.

Role of ACRole of AC

For violation of act by medical professionals Imprisonment of 10 years Fine of Rs. 5 lacs Removal from the medical council roll for

two years for the first offence and permanently for any subsequent offence.

Commercial dealings will invite an Imprisonment ranging from 5-10 years Fine between 20 lakh to 1 crore

PunishmentPunishment

Types of donor as per Types of donor as per THOATHOA

DONOR

DONOR

Live related

Live related

Live unrelate

d

Live unrelate

d

‘near relative’ means ‘spouse, son, daughter, father, mother, brother or sister, grandparents & grandchildren

Deceased

donor

Deceased

donor

Swapping

Live donorLive

donor

Medical practitioner certifies that the

donor is in a proper state of health and is

fit to donate

Donor has to give his authorization in

appropriate Form 1(A) or 1(B)

Donor has to submit an application in

(Form 10) jointly with the recipient.

Necessary medical tests to determine the

factum of near relationship.

Live related donor Live related donor

Joint application by donor & recipient

with certificate of proof.

Approval by the authorization

committee.

Spousal donorSpousal donor Rule 4-A(2) Rule 4-A(2)

The AC ensures that there is no commercial

transaction or middle man / tout involved

Financial status of the donor and the

recipient

Next of the kin of the proposed unrelated

donor is interviewed

Seeks an explanation of :

link between the donor and recipient.

Documentary evidence of the link

(Contd....)(Contd....)

Live unrelated donorLive unrelated donor

Authorised medical board has to certify that patient is brain dead.

A medical board comprises of:

Hospital Administrator,

A neurologist or neurosurgeon (an independent

surgeon or physician, and an anesthetist or intensivist.)

And the patient’s treating doctor.

Deceased donationDeceased donation

ORGAN TRANSPLANT IN PGIMER

CASE STUDY 1CASE STUDY 1

INITIATION

Sr. no Organs Year

1 Cornea 1995

2 Kidney 1995

3 Liver 2010

4 Heart , Lung &Heart Lung

2013

Future: Pancreas, Intestines

Prof. A. K. Gupta, MS-cum-Head, Deptt of Hospital Administration, PGIMER, Chd

Secretary Health U.T Admn or his nomineeDirector Health Services U.T Admn or his nomineeDr. (Mrs.)Saroj Sharma, Prof Medical MicrobiologyProf Rajinder Singh HOD, Surgery, PGIMER.Prof. Deepak Bhasin Deptt of Gastro, PGIMERProf.(Retd) KN Pathak Vice Chancellor, Punjab

UniversityMr. P. C. Dogra, DGP (Retd.)

Authorization CommitteeAuthorization Committee

ISSUEISSUE

Initiating the Heart Transplant Program in PGIMER

INFRASTRUCTURE

TRAINED & QUALIFIED MANPOWER

REGISTRATION

ORGAN DONOR

ORGAN RECEIPIENT

CHALLENGES FOR MANAGEMENT

CHALLENGESCHALLENGES

Application in Form 11 justifying the

Infrastructure

Manpower.

Inspection by team from DGHS

Registration granted .

SolutionSolution

Waiting list prepared

5 patients put on the waiting list

Solution : Organ recipientSolution : Organ recipient

Road traffic accident victim in PGIMER on

30th JULY 2013

Potential brain dead donor

Information from the treating doctor about

potential brain death status of patient

Hospital SOP activated

Solution : DonorSolution : Donor

Identifying potential donor Counselling & Motivation

Consent Brain death certification

Arrangements for organ harvesting Liasoning with the police

Arranging for the postmortem, early release of the body & transport.

Recipients and arrangements for transplant.

First successful heart transplant at

PGIMER on 4th august 2013

Solution Solution

ORGAN TRANSLANT &ALLEGATION AGAINST AN

INSTITUTE

Case Study 2

X complained to NHRC that Y who was well known to him took him to PGIMER, Chandigarh .

Y threatened X to donate his kidney for Y’s wife.

Doctors at PGIMER were also involved in this.

ISSUEISSUE

Report sent to NHRC with the followingexplanation:

The centre strictly performs kidney

transplantation from related donors only as per

the provisions of THOA.

The transplant was carried out after approval by

the AC of Bihar state.

FACTSFACTS

X voluntarily registered as the patient’s younger brother and was a willing kidney donor.

The recipient and the donor were evaluated in the Deptt. of Nephrology for medical fitness and establishment of relationship between the donor and the recipient after approval by AC.

SOLUTION : FACTSSOLUTION : FACTS

The complainant had obtained a

travelling concession form for

Chandigarh with a fake name.

A number of doctors, nurses,

technicians, paramedical staff

interacted with the donor and not once

did he complain.

SOLUTION : FACTSSOLUTION : FACTS

NHRC dismissed the case.

Proper documentation saved the day

for PGIMER.

SolutionSolution

CASE STUDY 3

ORGAN TRANSPLANT LIVE AND CADAVERIC

Patient with attempted suicide was admitted at a reputed Corporate Hospital (CH), in Mohali

Patient had a head injury, put on ventilator, poor prognosis explained to family

Family motivated to donate the organs of their young patient.

Transplant team of the institute informed of the family’s decision.

ISSUEISSUE

CH was conducting only living donor

transplants.

CH did not have a Brainstem Death

Certification Committee approved by

the AA

ChallengeChallenge

There was no forensic expert available at the Hospital.

The forensic expert had to be deputed by the AA (civil Surgeon)- this process was time consuming and involved a legal clearance from the government.

CHALLENGECHALLENGE

Patient shifted to PGIMER on request

and the process for organ donation

started

CH informs the institute that one

kidney & liver were required for

patients on their waiting list.

SolutionSolution

PGIMER not in position to do the liver

transplant as recipient not available

The patient’s family decided to donate

only kidneys .

SOLUTIONSOLUTION

Any hospital having live organ transplant program should be prepared for cadaver organ transplant.

Brain stem death certifying committee should be identified and approved by the AA.

Formalities for conducting autopsy should be available as most of brain dead cases are MLC cases.

SOLUTIONSOLUTION

Collaboration with national level NGOs .

Transplant team has to be in a state of alert with a ready updated recipients list .

SOLUTIONSOLUTION

Case Study - 4Case Study - 4

Dolma Bhuti & another ....................PetitionersVs

PGIMER, Chandigarh &others............Respondents

CASE NO : Appeal (Civil) 11977 of 2012 DATE OF JUDGMENT: March 28th , 2008

ORGAN TRANSPLANT & DOMICILE OF

DONOR/RECIPIENT

Petitioner No.1 (resident of Tibet) -

studying in Tibetan Children Village School

at Dharamshala.

Developed CRF due to Nephrotic Syndrome

Petitioner No.2 – A Buddhist monk

(resident of HP) decided to donate his one

kidney out of compassion to save Petitioner

1’s life.

ISSUEISSUE

The patient had reached a stage where she

required daily dialysis at PGIMER.

Only solution was urgent transplant surgery

PGIMER seeks clearance by AC of HP as

the petitioners were residents of HP.

ISSUEISSUE

Is PGIMER under legal obligation to

carry out the kidney transplantation of

petitioner no.1 keeping in view her

critical condition?

Can the AC of PGIMER permit the

transplantation considering that both

were residing in HP?

Challenge Challenge

The petitioners filed a case in the High court.

Court stated that since

the patient is very critical and

transplant is life saving for her,

Taking permission from HP AC will take time.

PGI to examine and clear the case in its AC

( UT-AC) and carry out the transplant as soon

as possible.

SOLUTIONSOLUTION

Case was cleared by the AC of

PGIMER and transplantation was

carried out at PGIMER.

SOLUTIONSOLUTION

Organ Sharing

Case study 5Case study 5

A potential brain dead donor in GMCH 32, Chd

Family wished to donate organs

Patient shifted to PGIMER, Chd

ISSUEISSUE

Heart transplant program not started

No recipient for liver

Recipient for kidney & cornea present

Should heart & liver be allowed to go

unutilised

CHALLENGECHALLENGE

??

No

Explore possibility of organ sharing

No

Explore possibility of organ sharing

COORDINATED

GMCH,CHD

National registry of waiting recipients

Logistic support to transport organs

Coordination among different hospitals

SolutionSolution

Promoting organ donation

Case study 6Case study 6

IssueIssue

Awareness regarding organ donation Converting potential brain dead

donors into organ donors

CHALLENGECHALLENGE

Awareness regarding organ donation IECMass mediaPublic forumsReligious headsNGOsDonor cardHelpline numbersWebsite

SOLUTIONSOLUTION

To increase the conversion rate Identification of brain dead potential

donorsRole of transplant coordinatorsModification of death certificate for

promoting eye donationMaintenance of brain dead potential

donors Inter and intra departmental liasonModification of driving licenseSupport to the donor familyTaking care of myths & misconceptions

SolutionSolution

INITIATVES BY PGIMERINITIATVES BY PGIMER

Initiative by PGIMERInitiative by PGIMER

www.lampoflife.com

Our little effort will make a big change & give life to someone

THANK YOU

AASASS

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