Organ transplantation Act

1. AASASS
PGIMER, Chandigarh
TRANSPLANTATION OF HUMAN ORGANS AND TISSUES ACT
(THOA -1994)
Issues, Challenges and Possible Solutions
Dr. Pranay Mahajan

2. THOA
Increased awareness
Increasing waiting
list
Illegal trade
Exploitation
Improved
technology
Better medicines
Legal & Ethical
issues
Prosecution
Transplantation is the future
of medicine

3. Patients requiring transplantation increasing.
No corresponding increase in organ donation.
 Lead to black marketing & organ trading.
Huge susceptible population that can be
exploited.
Contd....
Need for the Act

4. Provides for the regulation of :
 Removal
 Storage
 Transplantation
Of human organs & tissues for therapeutic
purposes, &
For the prevention of commercial dealings
in human organs.
THOA

5. Includes donation of tissues.
Organ swapping legalised.
Penalties enhanced.
Grandparents and Grandchildren included
in the list of near relatives.
THOA (Amendment) Act 2011
Contd....

6. In the absence of a neurologist or neurosurgeon :
An independent surgeon or physician
An anesthetist or intensivist
May be 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 2011
Contd....

7. Transplantation involving a foreign national,
even if near relatives requires approval by AC.
National registry of donors and recipients.
(NOTTO, ROTTO & SOTTO)
Cornea, can be retrieved by a certified eye
technician
THOA (Amendment) Act 2011
Contd....

8. NGOs registered specially to work on human
organ transplantation would be allowed.
Mandatory to appoint a transplant coordinator
in registered hospitals
Donation after Cardiac Death (DCD)
Organ swapping
THOA (Amendment) Act 2011

9. Two authorities have been formed under the Act:
 Appropriate Authority (AA)
(THOA : Chapter IV , Rule 13)
 Authorization Committee (AC)
(THOA : Rule 7 , Sec 1)
The Authorities

10. The Central and State Governments shall
appoint, by notification, one or more officers as
Appropriate Authorities for purposes of this Act,
that is DGHS.
Constitution of AA

11.  To grant registration to a hospital (5 years)
 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....)
Role of AA

12.  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 AA

13. The composition of the AC is such as may be
prescribed by the Central Government.
The State Government & Union territories shall
constitute
 One or more ACs
 Consisting of members nominated by
the State Governments and the UTs.
Constitution of AC

14. A senior person officiating (Director / MS / CMO)
2 senior medical practitioners
(from same hospital ; not part of transplant team)
2 members being persons of high integrity, social
standing & credibility
Secretary Health or nominee & DGHS or nominee
2 senior medical practitioners
(from same state ; not part of transplant team)
2 senior citizens of nonmedical background.

15. 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 AC

16. For violation of act by medical professionals
Imprisonment : 10 years
Fine : Rs. 5 lacs
Removal from Medical Council roll for :
Two years : 1st offence
Permanently : Subsequent offence
Commercial dealings will invite an
Imprisonment : 5-10 years
Fine : 20 lakh to 1 crore
THOA : Chapter VI , Rule 18 - 23
Punishment

17. Types of donor as per THOA
DONOR
Live
related
Live
unrelated
‘near relative’ means
‘spouse, mother, father,
son, daughter, brother or
sister, grandparents &
grandchildren
Deceased
donor
Swapping
Live
donor

18. 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 or 2
Donor has to submit application in (Form 11)
jointly with the recipient.
Necessary medical tests to determine the factum
of near relationship.
Live related donor

19. Joint application by donor & recipient with
certificate of proof.
Approval by the authorization committee.
Spousal donor Rule 4-A(2)

20. 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
Live unrelated donor

21. Authorised medical board has to certify that
patient is brain dead (Form 10).
A medical board comprises of:
a. Hospital Administrator
b. Neurologist or Neurosurgeon /
Anesthetist or Intensivist
c. Independent Surgeon or Physician
d. Treating doctor
Deceased donation

22. CASE STUDIES

23. ORGAN TRANSPLANT
IN
PGIMER
CASE STUDY 1

24. Prof. A. K. Gupta MS-cum-Head,
Dept of Hospital Admn
Secretary Health U.T Admn or his Nominee
Director Health Services U.T Admn or his Nominee
Dr. (Mrs.) Saroj Sharma Prof Medical Microbiology
Prof. Rajinder Singh HOD, Surgery, PGIMER.
Prof.(Retd) KN Pathak Vice Chancellor, P.U.
Mr. P. C. Dogra, DGP (Retd.)
Prof. H.S. Kohli Dept. of Nephrology
Authorization Committee

25. Sr. no Organs Year
1 Cornea 1995
2 Kidney 1995
3 Liver 2010
4 Lung & Heart 2013
5 Pancreas 2014
Future: Intestines , Hand
* Source : PGIMER Hosp Admn Est - I.
INITIATION

26. PGIMER Organ Donation Statistics
Last two Decades (1996 – 2016)
0
20
40
60
80
100
120
140
160
Kidney
Liver
Heart
Pancreas
144
30
4 4
Cadaveric Donations
Cadaveric
Donations
Kidneys
2445
Live Donation
Unrelated
Related
57
2388
Live Kidney Donation
"Related vs Unrelated"
* Source : PGIMER Hosp Admn Est - I.

27. 0
500
1000
1500
2000
2500
3000
3500
* Source : Advenced Eye Centre
3474
2644
Donations
Transplants
CORNEA DONATION IN PGIMER
2003-2016
76 %

28. ISSUE
Initiating the Heart Transplant
Program in PGIMER

29. INFRASTRUCTURE
TRAINED & QUALIFIED MANPOWER
REGISTRATION
ORGAN DONOR
ORGAN RECEIPIENT
CHALLENGES FOR MANAGEMENT
CHALLENGES
THOA : Chapter V , Rule 14 & 15

30. Application in Form 12 justifying the
 Infrastructure
 Manpower (Trained 15 persons)
Fee of 5000 /-
Inspection by team from DGHS
Registration granted (6 months)
Solution

31. First Heart Transplant
at PGIMER on
4th august 2013

32. IMPACT

33. Enhancing
Cadaveric Organ Donation
PGIMER
CASE STUDY 2

34. 1. Identification of Potential
‘Brain Dead Donor’
2. NOC from Police
3. CONSENT from the Next of Kin
4. Brain Dead Certification Committee
5. Investigations and Expenses
ISSUES

35. Potential Brain Dead Donor
ISSUE 1
THOA : Chapter I , Rule 3 , Sec 2(d)

36. Timely Identification
Timely Information
Ventilator Support
Proper Maintenance
CHALLENGE

37. SOLUTION
 Appointment of TX Coordinators
 Daily reporting of M 1 status
 Daily rounds by TX Coordinators
 Coordination between different Departments
 Active monitoring by Higher Authorities
 Prioritization in ICUs
 Technology use by High Power Committee

38. NOC from Police
ISSUE 2
THOA : Chapter II , Rule 7 , Sec 6(b)

39. Attitude
Awareness & Motivation
Logistics
Role conflict
Liaison with officers
Post Mortem
CHALLENGE

40. SOLUTION
 Role of MS
 Efficient role of TX Coordinators
 Involvement of Higher Police Authorities
 Awareness Programmes and Events
 Digital Consent
 Hassel free arrangements for police
proceedings (like MLR, Forensic proceeding)
 Priority basis Post Mortem

41. Consent from Next of Kin
ISSUE 3
THOA : Form 8

42. CHALLENGE
Availability of next of kin
Conflict in decision making
Interference of relatives / friends
Mode of consent

43. SOLUTION
 Show Concern
 Breaking News
 Counseling Rooms
 Awareness and Motivation of next of kin
 Provision of services
 Involvement of MS / higher authority
 Involvement of influential personalities
 Telephonic consent

44. ISSUE 4
Brain Dead Certification Committee
THOA : Chapter II, Rule 6

45. Registration
Odd-Hours
Time constraints & Denials
Logistics
CHALLENGE

46. SOLUTION
 Registration of willing faculty
 Involvement of Departmental Heads
 Monthly Rosters
 Provision of logistics
 Awareness, Motivation & CME
 Liaison by Hospital Administration
 SOPs

47. ISSUE 5
Investigations and Expenses
THOA Amendment 2011 : Clause 9

48. CHALLENGE
Non Availability
Priority
Funds for outside investigations
Timely reporting
Billing and waive of

49. SOLUTION
 Provision of Investigations round the clock
 Priority
 Donor - Free Stamp
 Circulars
 Outside Billings cleared from MS Office
 Timely reporting
 Dedicated Hospital Attendant
 Revolving Fund

50. IMPACT
2 2
4
8 8
10
14
20
14
52
2 3
5
2
17
1 1 1
1 2
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Kidney Liver Heart Pancreas
Cadaveric Organ Donations
PGIMER

51. Cornea Donation
Case study 3

52. Improving Cornea Donation
ISSUE

53. CHALLENGES
Awareness
Motivation
Modifications in Death Certificate
Infrastructure

54. Solution
 Direct Supervision by MS
 Appointment of Counselors
 Public Forums
 Hospital Committees
 Feedback
 Modification in Death Certificate
 Use of Technology : DSS

55. 178 182 165 170
200 210 220
249
206
251
273
340
190
226 216 220
250
278
338
306 320 306 318
506
0
100
200
300
400
500
600
TRANSPLANT DONATIONS
CORNEA donations at PGIMER
IMPACT

56. Organ Sharing
Case study 4
THOA Amendment 2011 : Clause 31

57. Organ Donation / Transplantation not possible in
the Hospital with Potential Brain Dead Donor
ISSUE
“NO ORGAN SHOULD BE WASTED”
Organ Sharing
Explore the possibility of

58. CHALLENGE
Non registration
Non availability of Recipient
Unwilling Recipient
Cross Match Failure
Logistics

59.  National registry of waiting recipients.
NOTTO, ROTTO & SOTTO established.
PGIMER regularly reports to NOTTO.
 Logistic support
 Coordination among hospitals
Solution
GREEN CORRIDOR

60. GMCH-32 to PGIMER 8 Km 7 Minutes
Usual Time for covering this distance : ~15 to 20 min
PGIMER Green Corridors :
Mock drill conducted on 7th August 15
Actual Green Corridor for
organ shifting on 14th Jan 16
PGIMER to Airport 20 Km 12 Minutes
Usual Time for covering this distance : ~ 45 - 50 min
Airport to R & R + AIIMS Delhi
TWI
N

61. 14th Jan 2016
Other Hospital to
PGIMER
R&R , New
Delhi
AIIMS, New
Delhi

64.  10 to Army R&R Hospital, Delhi.
 01 to ILBS, Delhi.
 02 to AIIMS, Delhi.
 02 Received from Command Hosp.
 Potential organ donors received from other
Govt. & Pvt. Hospitals.
IMPACT

65. Promoting organ donation
Case study 5
THOA 1994

66. Issue
Donor Crisis

67. Issue

68. Awareness regarding organ donation
CHALLENGE

69.  Govt. Initiatives
 Mass media
 Public forums
 Religious heads
 NGOs
 Donor card
 Helpline numbers
 Website
 Modification of driving license
& ID Cards
SOLUTION

72. www.lampoflife.com

73.  More than 5000 people pledged their organs.
 2500 have pledged online at www.lampoflife.com
 “I am an Organ Donor”
incorporated in PGIMER ID Cards &
UT Driving Licence.
IMPACT

75. “P.M.’s Mann Ki Baat”
25th OCTOBER 2015
“ तेन त्यक्तेन भुञ्जीथा “

76. THANK YOU

77. Prof A K Gupta
MS cum HOD
Dept of Hospital Administration
Dr Ashok Kumar
Addl. Prof.
Dept of Hospital Administration
Mr. Atul Rai
Medical Social Worker
ACKNOWLEDGEMENT
S
Ms Baljeet Kaur
PGIMER Hospital
Administration
Establishment I
Advanced Eye Centre
PGIMER
PGIMER Eye Bank &
Counselors