Post on 27-Jan-2016
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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.
THOA (Amendment) Act 2011THOA (Amendment) Act 2011
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
THOA (Amendment) Act 2011THOA (Amendment) Act 2011
NGOs registered specially to work on
human organ transplantation would
be allowed.
Mandatory to appoint a transplant
coordinator in registered hospitals
THOA (Amendment) Act 2011THOA (Amendment) Act 2011
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
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