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(1)

Current Achievements and plans in China

Yong Liu, M.D.

Ministry of Health, China

Organ transplantation in China has taken place since the 1960s, and is now one of the largest organ transplant programmes in the world.

About 300,000 patients suffer organ failure each year, but only around 10,000 transplants are performed annually due to a lack of donors.

Different from other medical

technologies, an organ transplant requires a donated transplantable organ, and the donation and allocation are embedded in social issues such as culture, tradition, ethics, and law.

China strongly support and follow the WHO Guiding Principles and the Declaration of Istanbul.

Stricter Management and supervision.

Since the Consultation Meeting on Transplantation with National Health Authorities in the Western Pacific Region, held by WHO in Manila, Philippine on 2005. We have faced squarely to Otx practice relying on death-row inmate’s organs and demonstrated China’s political will and next- steps in reforming Otx legislation and practice.

The changes started from Transparency

Consultation Meeting on Transplantation with National Health Authorities in the Western Pacific Region

( Manila, Philippine on 2005)

Regulations on Human Organ Transplantation (Mar. 21, 2007)Paved the way for a legal framework to guide the organ transplantation in China.

Legal Framework

(2)

Amendment(VIII) to the Criminal Law of the People’s Republic of China

In May of 2011, Eighth Amendment of Criminal Law passed, which eliminating death penalty for 13 offenses, but added a new crime under criminal charge: organ trading.

China Organ Donation and Transplantation System

Organ Donation Register System,

Organ Procurement and Allocation Network, Organ Transplantation Clinical Service System, Post-Organ-Transplantation Register System.

The National Human Organ Transplantation Working Meeting was successfully held in Shanghai on August 25, 2009. Some key issues on organ transplantation, such as the source of organs, establishment of an organ donation system and organ allocation mechanism, were constituted.

Organ donation initiative (August 25th, 2009 Shanghai China)

1. China Category I (C-I):

Organ Donation after Brain Death-DBD.

2. China Category II (C-II):

Organ Donation after Circulatory Death-DCD.

3. China Category III (C-III):

Organ Donation after Brain Death followed by Circulatory Death-DBCD.

Classification of Deceased Organ Donation in China

(MOH Hospital Administration Division, Issue(2011), No.62.Appendix I)

5912

8577 9001

7739 7417

8112 9116

0.24% 0.19% 0.21% 0.81%

3.47%

13.12%

24.22%

0%

5%

10%

15%

20%

25%

30%

0 2500 5000 7500 10000

2007 2008 2009 2010 2011 2012 2013

47.5%

The rising of deceased Organ Donation in China

The Number of Transplant in 2007-2013

Kick-off meeting for Nationwide DCD program (Feb 25th, 2013 Beijing)

If China is to sustain

a successful program

of deceased organ

donation, the Chinese

people must trust a

national system that

must be clean, fair,

transparent and

equitable.

(3)

Any accredited transplant hospital that fail to develop a deceased organ donation program will have their transplant license and OPO license revoked Doctors who use the organs

other than those obtained from the centralized sharing network will be disqualified.

The local Health Authorities have the compulsory responsibly and mandate to enforce the implementation of the regulation.

11th OTC meeting of NHFPC (Sep 17th, 2013 Beijing)

Picture of OTC meeting

The Regulation further enforce the regulation of health authority on the follow issues:

1. Mandatory enforcement of national implementation of China national organ allocation computer system, namely China Organ Transplant Response System (COTRS).

2. Defines qualification and responsibilities of organ donation coordinators.

3. Defines qualifications and responsibilities of OPO

共五章24款

The National Regulation on Human Organ Procurement and Allocation

21,August 2013

China Organ Transplant Response System

Media:More than 1500 DCD, a major breakthrough in the development of China organ donation system

On February 25

th

, 2013, the former Ministry of Health and Res Cross Society of China jointly initiated national-scale deceased organ donation program.

As of February 12nd, 2014, the program has seen 4,065 organs from 1,500 donors (including 1,222 livers, 2763 kidneys, 57 hearts, and 12 lungs, 9 pancreas, 2 intestines).

Challenges Ahead

Amendment of the national Regulation on Otx (legal framework)

National working structure and Mechanism for Otx OPO and Coordinator

Community effort and reflection of deceased organ donation is a community effort and reflection of the solidarity of Chinese people to benefit their fellow man.

China should refer to its own traditional culture and present socio-economic condition and learn from the international transplant community in establishing China’s organ transplantation system and show “the responsible big country” image on the world stage.

The Future

(4)

A Call to Action

More than 450 years before the birth of Christ, Confucius said: ‘What I hear, I forget; what I see, I remember; what I do, I understand.’

Let’s do it together.

We’ve heard what we have to do. We’ve seen what we need to do. Now is the time to do it.

Thank you!

(5)

GENERAL INFORMATION – FOR ORGANS GENERAL INFORMATION – FOR ORGANS

COUNTRY: JAPAN INFORMATION PROVIDED BY:

Name: Naoshi Shinozaki Position: Executive Director Organization: Japan Organ Transplant Network

Address: ORIX Akasaka Nichome Bldg. 2F, 2-9-11, Akasaka, Minato-ku, Tokyo, JAPAN E-mail: shinozaki@jotnw.or.jp

- Is there a functioning* transplantation programme? Yes

- Is there a functioning* programme for organ donation from deceased persons? Yes - Is there a functioning* programme for organ donation from living donors? Yes

*Functioning: programme performing or able to perform its regular function

ORGANIZATIONAL SYSTEM - ORGANS ORGANIZATIONAL SYSTEM - ORGANS

1. Is there a Government recognized authority responsible for overseeing donation and/or transplantation at national level?

Yes No

- If Yes, for Donation, Transplantation or Both? _____Both__________________

2. Is there a specific organization, institution or agency responsible for organ donation and/or transplantation matters at national level?

Yes No

- If Yes, Does it report to the Ministry of Health? Yes No 3. Are organ procurement and / or transplantation expenses covered by? :

State Private Health Insurance Recipients

Other specify: _____Social Health Insurance of the patients and parts of donation i_______

4. Are recipients paying for post - transplant care and drugs?

Yes If yes: Total or Partial Social Health Insurance system No

ORGANIZATIONAL SYSTEM - ORGANS ORGANIZATIONAL SYSTEM - ORGANS

Transplants performed abroad:

5.Is there any cooperation framework or agreement to allow patients to be transplanted abroad?

Yes No

If yes, comment under which programmes and specify the countries:

_____________________________________________________________________________________________________

_____________________________________________________________________________________________________

6.In case of recipients travelling abroad to be transplanted (under a cooperation framework or not): Is the recipients’

follow-up assured in the country of origin upon their return?

Yes No

7.Do recipients and living donors travel abroad together?

Yes, always Yes, sometimes No

8.Is the living donor follow-up assured upon his/her return?

Yes No

ORGAN LEGISLATION ORGAN LEGISLATION

9.Are any aspects of organ donation and /or transplantation covered by any legal requirement?

Yes Time of Enactment:_____1996、2009________________________

No

If Yes, Does it cover the following aspects?

Organ donation from deceased persons Organ donation from living persons (Society)

Allocation

Organ Transplantation

Organ Trafficking

10.The government is currently intending to adopt new or revise any legal requirement on these subjects and/or on missing/unforeseen subjects:

Yes No

11. Is there a legal requirement to report to the government the transplants performed within the country and the deceased donors?

Yes No

12. Is the type of consent required for donations from deceased persons specified in any legal requirement?

Yes No

ORGAN LEGISLATION ORGAN LEGISLATION

13. Are incentives to obtain the consent of the families of the deceased person (in the form of any monetary payment or other reward of monetary value), legally permitted?

Yes No Living donation:

14.Is unrelated living donation legally permitted?

Yes No

15. Are financial incentives legally permitted for living organ donation?

Yes; Are they specifically regulated by the government?

No; Are they nonetheless offered or provided to potential living donors?

Comment: ____Monetary incentives are prohibited by law______

16. Is there any kind of explicit prohibition of organ trafficking / transplant commercialism?

Yes. Are there penalties? 5 years in sentences and/or 5,000,000 yen (~$50,000-) fine No

What is specifically prohibited?___

__Organ trafficking, failing post-mortem inspection by physician________

DONATION &TRANSPLANTATION ACTIVITY DATA FOR ORGANS

(data for 2012)

DONATION &TRANSPLANTATION ACTIVITY DATA FOR ORGANS

(data for 2012)

ACTUAL DECEASED DONORS - Total actual deceased organ donors:_110__

- Actual DBD donors: _45__

- Actual DCD donors: _65__

KIDNEY Tx

- Total Kidney from deceased donors:_193__

- Kidney from DBD:_ 77 - Kidney from DCD:_116 - Total Kidney from Living donors:_1412_

- Unrelated kidney :____(less than 1% ) - Related kidney :____

LIVER Tx:

- Total Liver From deceased donors:__40 (including 1 liver-kidney) - Liver from DBD:__40_

- Liver from DCD:__ 0 _ - Liver From Living donors:______

HEART Tx: __28___

LUNG Tx:___33__

PANCREAS Tx:___27_(including 18 kidney-pancreas)__

SMALL BOWEL Tx:__0___

TRANSPLANTS ABROAD

- Number of resident patients, known to have been transplanted abroad:______

Destination country/ies:_____________________

- Number of resident living donors, known to have travelled abroad to donate:____

Destination country/ies:_____________________

WAITING LIST

Number of patients with (ESRD) on dialysis treatment:_309,946______

(6)

DONATION &TRANSPLANTATION ACTIVITY DATA FOR ORGANS

(data for 2013)

DONATION &TRANSPLANTATION ACTIVITY DATA FOR ORGANS

(data for 2013)

ACTUAL DECEASED DONORS - Total actual deceased organ donors:_84__

- Actual DBD donors: _47__

- Actual DCD donors: _37__

KIDNEY Tx

- Total Kidney from deceased donors:_155__

- Kidney from DBD:_ 88 - Kidney from DCD:_ 67 - Total Kidney from Living donors:____

- Unrelated kidney :____

- Related kidney :____

LIVER Tx:

- Total Liver From deceased donors:__38 (including 1 liver-kidney) - Liver from DBD:__38_

- Liver from DCD:__ 0 _ - Liver From Living donors:______

HEART Tx: __38_(including 1 heart-lung)__

LUNG Tx:___41_(including 1 heart-lung) PANCREAS Tx:___33 (including 24 kidney-pancreas)___

SMALL BOWEL Tx:__0___

TRANSPLANTS ABROAD

- Number of resident patients, known to have been transplanted abroad:______

Destination country/ies:_____________________

- Number of resident living donors, known to have travelled abroad to donate:____

Destination country/ies:_____________________

WAITING LIST

Number of patients with (ESRD) on dialysis treatment:_309,946______

“Plans for increasing organ donation in Japan “

“Plans for increasing organ donation in Japan “ “Plans for increasing organ donation in Japan “

“Plans for increasing organ donation in Japan “ “Plans for increasing organ donation in Japan “

“Plans for increasing organ donation in Japan “ “Plans for increasing organ donation in Japan “

“Plans for increasing organ donation in Japan “

Naoshi Shinozaki Naoshi Shinozaki Naoshi Shinozaki Naoshi Shinozaki

Executive Director; Japan Organ Transplant Network (JOT), Executive Director; Japan Organ Transplant Network (JOT), Executive Director; Japan Organ Transplant Network (JOT), Executive Director; Japan Organ Transplant Network (JOT),

Secretariat;

Secretariat;

Secretariat;

Secretariat; Japanese Japanese Japanese Society Japanese Society Society Society for for for Transplant for Transplant Transplant (JST Transplant (JST (JST (JST)))) Medical Advisory Board; Eye Bank Association of America Medical Advisory Board; Eye Bank Association of America Medical Advisory Board; Eye Bank Association of America Medical Advisory Board; Eye Bank Association of America ((((EBAA) EBAA) EBAA) EBAA)

Expert Advisory Panel; World Heal Organization (WHO) Expert Advisory Panel; World Heal Organization (WHO) Expert Advisory Panel; World Heal Organization (WHO) Expert Advisory Panel; World Heal Organization (WHO) International Technical Consultation on Cell, Tissue and Organ

JAPAN JAPAN JAPAN JAPAN JAPAN JAPAN JAPAN JAPAN

Population;

126,000,000

JOT HQ East branch Middle branch West branch

Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan

1964 First Kidney, Lung Transplant 1964 First Kidney, Lung Transplant 1964 First Kidney, Lung Transplant 1964 First Kidney, Lung Transplant 1968

1968 1968

1968 First Heart Transplant First Heart Transplant First Heart Transplant First Heart Transplant 1996

1996 1996

1996 Law for Organ Transplantation Law for Organ Transplantation Law for Organ Transplantation Law for Organ Transplantation 2009

2009 2009

2009 Revise the law Revise the law Revise the law Revise the law

History History History

History History of of of of Transplant Transplant Transplant Transplant History History

History of of of of Transplant Transplant Transplant Transplant

■ ■

■ 1963 1963 1963 1963 First Liver, Lung First Liver, Lung Tx First Liver, Lung First Liver, Lung Tx Tx Tx. . . .

■ ■

■ 1964 1964 1964 1964 First Kidney First Kidney Tx First Kidney First Kidney Tx Tx Tx. in Japan . in Japan . in Japan . in Japan

■ ■

■ 1964 1964 1964 1964 First Liver First Liver Tx First Liver First Liver Tx Tx. In Japan Tx . In Japan . In Japan . In Japan

■ ■ ■

■ 1967 1967 1967 1967 First Heart First Heart Tx First Heart First Heart Tx Tx Tx. . . .

■ ■ ■

■ 1968 1968 1968 1968 First Heart First Heart Tx First Heart First Heart Tx Tx Tx. In Japan . In Japan . In Japan . In Japan (Wada

(Wada (Wada (Wada Tx Tx Tx.) Tx .) .) .)

■ ■

■ 1963 1963 1963 1963 First Liver, Lung First Liver, Lung Tx First Liver, Lung First Liver, Lung Tx Tx Tx. . . .

■ ■

■ 1964 1964 1964 1964 First Kidney First Kidney Tx First Kidney First Kidney Tx Tx Tx. in Japan . in Japan . in Japan . in Japan

■ ■

■ 1964 1964 1964 1964 First Liver First Liver Tx First Liver First Liver Tx Tx. In Japan Tx . In Japan . In Japan . In Japan

■ ■ ■

■ 1967 1967 1967 1967 First Heart First Heart Tx First Heart First Heart Tx Tx Tx. . . .

■ ■ ■

■ 1968 1968 1968 1968 First Heart First Heart Tx First Heart First Heart Tx Tx Tx. In Japan . In Japan . In Japan . In Japan (Wada

(Wada (Wada (Wada Tx Tx Tx.) Tx .) .) .)

Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan Legislation in Japan

1964 First Kidney, Lung Transplant 1964 First Kidney, Lung Transplant 1964 First Kidney, Lung Transplant 1964 First Kidney, Lung Transplant 1968 1968

1968 1968 First Heart Transplant First Heart Transplant First Heart Transplant First Heart Transplant 1996

1996 1996

1996 Law for Organ Transplantation Law for Organ Transplantation Law for Organ Transplantation Law for Organ Transplantation 2009

2009 2009

2009 Revise the law Revise the law Revise the law Revise the law

(7)

Dialysis Patients in Japan Dialysis Patients in Japan Dialysis Patients in Japan Dialysis Patients in Japan Dialysis Patients in Japan Dialysis Patients in Japan Dialysis Patients in Japan Dialysis Patients in Japan

2153019491828363161499245130691801022579270483223136397422234797853017599116631072537805538863483221 103296116303123926134298143709154413

167192175988195322197213205134219183229539237710248165257765264473

0000 50000 5000050000 50000 100000 100000100000 100000 150000 150000150000 150000 200000 200000200000 200000 250000 250000250000 250000 300000 300000300000 300000

686868

68 696969 7069707070 71717171 727272 73727373 7473747474 75757575 767676 7776777777 78787878 79797979 80808080 81818181 828282 83828383 8483848484 858585 86858686 8786878787 888888 89888989 90899090 9190919191 929292 93929393 9493949494 95959595 969696 9796979797 98989898 99999999 0000 1111 2222 3333 4444 5555 6666 (社)日本透析医学会統計調査委員会調べ

東京歯科大学市川総合病院 東京歯科大学市川総合病院 東京歯科大学市川総合病院 東京歯科大学市川総合病院 角膜センター角膜センター角膜センター角膜センター

Kidney Transplantation per Country pmp versus Human Development Index (HDI)

Medium High

Low

8% 66% 26% Population

0,02% 31% 69% Kidneytransplants

0 10 20 30 40 50 60 70

0.4 0.5 0.6 0.7 0.8 0.9 1

HDI

k id n e y t x / p m p

AFRO

AMRO EMRO EURO SEARO WPRO

Japan Organ Transplant Network Japan Organ Transplant Network Japan Organ Transplant Network Japan Organ Transplant Network 539539539

539 423 423 423 423

520 520 520

520 516516516516 495495495495

273 273273 273

226226 226226

277 277 277

277 279279279279 280280280280 180

180180

180 153153153153 190190190190 191191191191

439 439439 439

253253 253253 177

177 177 177

147147 147147 128

128128 127 128 127 127127 136 136136 122 136 122 122 134 122 134134

134 96969696

0000 100100100 100 200 200200 200 300300300 300 400 400400 400 500500500 500 600 600600 600

200820082008

2008 2009200920092009 2010201020102010 2011201120112011 2012201220122012 2013201320132013 4747 4747 45 45 45 44 45 4444 13 44

1313

1396969696 989898987777 3232323281818181 68686868 65656565 37373737

Donor info. IC # and Donation #

(((( 2008 ~ ~ ~ ~ 2013 ))))

(year)

(cases)

All info.

Effective info.

I.C. family

Donation DBD DCD

Council for promotion of organ transplantation Council for promotion of organ transplantation Council for promotion of organ transplantation Council for promotion of organ transplantation Council for promotion of organ transplantation Council for promotion of organ transplantation Council for promotion of organ transplantation Council for promotion of organ transplantation

The Ministry of Health, Labour & Welfare

The Minister of Health, Labour and Welfare appointment;

Discussing & make decisions how to promote organ transplantation.

Driver’s License Driver’s License Driver’s License Driver’s License Driver’s License Driver’s License Driver’s License Driver’s License

Since 2010 Since 2010 Since 2010 Since 2010

B BB

Back of the license is ack of the license is ack of the license is ack of the license is used to show the will used to show the will used to show the will used to show the will of organ donation of organ donation of organ donation of organ donation By 2015, ALL the By 2015, ALL the By 2015, ALL the By 2015, ALL the license become IC license become IC license become IC license become IC card with donor card card with donor card card with donor card card with donor card

Social Health Insurance Card Social Health Insurance Card Social Health Insurance Card Social Health Insurance Card Social Health Insurance Card Social Health Insurance Card Social Health Insurance Card Social Health Insurance Card

The most of health care The most of health care The most of health care The most of health care insurance group is changing insurance group is changing insurance group is changing insurance group is changing to IC card

to IC card to IC card to IC card

Back side of IC card is used Back side of IC card is used Back side of IC card is used Back side of IC card is used to show the will for organ to show the will for organ to show the will for organ to show the will for organ donation.

donation.

donation.

donation.

(8)

Installation of In Installation of In Installation of In

Installation of In- - - -house coordinator house coordinator house coordinator house coordinator Installation of In

Installation of In Installation of In

Installation of In- - - -house coordinator house coordinator house coordinator house coordinator

1. Hospital Audit Organization of Japan 1. Set the donor information flow standards 2. On site inspection questionnaire

2. MOH research group

1. In-house coordinator education 2. Quality Management Seminar

May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム

Quality Management seminar Quality Management seminar Quality Management seminar Quality Management seminar Quality Management seminar Quality Management seminar Quality Management seminar Quality Management seminar

Aim Aim Aim Aim

To establish donor detection system in each hospital, educating in To establish donor detection system in each hospital, educating in To establish donor detection system in each hospital, educating in To establish donor detection system in each hospital, educating in----house house house house Coordinators and managing the system in hospitals.

Coordinators and managing the system in hospitals.

Coordinators and managing the system in hospitals.

Coordinators and managing the system in hospitals.

2012 2012

2012 2012----2014 MOH research group form the seminar 2014 MOH research group form the seminar 2014 MOH research group form the seminar 2014 MOH research group form the seminar Corroborators;

Corroborators;

Corroborators;

Corroborators;

Japan Emergency Medicine Society Japan Emergency Medicine Society Japan Emergency Medicine Society Japan Emergency Medicine Society Clinical Emergency Medicine Society of Japan Clinical Emergency Medicine Society of Japan Clinical Emergency Medicine Society of Japan Clinical Emergency Medicine Society of Japan Japan Neurological Medicine Society Japan Neurological Medicine Society Japan Neurological Medicine Society Japan Neurological Medicine Society Emergency Nurse Society Emergency Nurse Society Emergency Nurse Society Emergency Nurse Society Japan Organ Transplant Japan Organ Transplant Japan Organ Transplant Japan Organ Transplant Network Network Network Network 4 days seminar;

4 days seminar;

4 days seminar;

4 days seminar;

TPM Japan, National Committee to support individual hospital TPM Japan, National Committee to support individual hospital TPM Japan, National Committee to support individual hospital TPM Japan, National Committee to support individual hospital

Education of Hospital Management Education of Hospital Management Education of Hospital Management Education of Hospital Management Education of Hospital Management Education of Hospital Management Education of Hospital Management Education of Hospital Management

May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム

Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar

May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム

Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar Quality Management Seminar

May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム

2 2 2

2 nd nd nd nd Seminar 2013 Seminar 2013 Seminar 2013 Seminar 2013 2

2 2

2 nd nd nd nd Seminar 2013 Seminar 2013 Seminar 2013 Seminar 2013

(9)

May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム

2 2

2 2 nd nd nd nd Seminar 2013 Seminar 2013 Seminar 2013 Seminar 2013 2 2

2 2 nd nd nd nd Seminar 2013 Seminar 2013 Seminar 2013 Seminar 2013

May 16, 2012 第25回日本脳死脳蘇生学会 シンポジウム

2 2 2

2 nd nd nd nd Seminar 2013 Seminar 2013 Seminar 2013 Seminar 2013 2

2 2

2 nd nd nd nd Seminar 2013 Seminar 2013 Seminar 2013 Seminar 2013

Education of In Education of In Education of In

Education of In- - -house Coordinator - house Coordinator house Coordinator house Coordinator Education of In

Education of In Education of In

Education of In- - -house Coordinator - house Coordinator house Coordinator house Coordinator

TPM Japan seminar 2013 TPM Japan seminar 2013 TPM Japan seminar 2013 TPM Japan seminar 2013 TPM Japan seminar 2013 TPM Japan seminar 2013 TPM Japan seminar 2013 TPM Japan seminar 2013

Needs Needs Needs

Needs for for for for Professional Professional Professional Professional Education Education Education Education Needs

Needs Needs

Needs for for for for Professional Professional Professional Professional Education Education Education Education

Medical Staff

Attitudes towards donation:

all CCU staff

92%

84%

92%

52%

69% 70%

35%

45%

14% 11%

0 20 40 60 80 100

'support donation, in

general'

'would donate own organs'

'would donate adult relative's organs'

'would donate child's organs'

'donation helps families coping with grief'

%

Europe Japan

P<.0001

P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001

(10)

Confidence levels - all CCU staff*

54%

40%

31% 31%

23%

12% 7% 9% 6% 4%

0 10 20 30 40 50

'comforting grieving families..'

'notifying a TC..'

'explaining brain death..'

'introducing the subject of donation..'

'asking relatives to

make a decision..'

%

Europe Japan

P<.0001

P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001

*with exclusion of those not involved in donation related tasks

Received specific training - all CCU staff

26%

21%

16%

10%

5% 3%

2% 2%

0 5 10 15 20 25

brain death donor management

family grief counseling

making donation request

%

Europe Japan

P<.0001

P<.0001 P<.0001P<.0001 P<.0001P<.0001 P<.0001P<.0001

69.3

8

22.7 11.6

30.6

57.8

0 10 20 30 40 50 60 70

% yes % no % don't know, no

answer

%

Europe Japan

“Donation helps families coping with grief”

Presented at 3rdInternational DA meeting (5thSep. 2004/ Vienna)

30% of people don’t believe donation helps families coping with grief

Medical Staff

Needs Needs Needs

Needs for for for for Professional Professional Professional Professional Education Education Education Education Needs

Needs Needs

Needs for for for for Professional Professional Professional Professional Education Education Education Education

Transplant Coordinators

Transplant Coordinator

Their human skills and donation rate

Consent rate on Routine Referral System (RRS)

Co # IC # Cons. # Cons. Rate

1 762 114 15.0 %

2 28 7 25.0 %

3 806 113 14.7 %

4 485 36 7.4 %

5 110 7 6.4 %

ABCDE -20

-20 -20 -20 0 00 0 20 20 20 20 40 40 40 40 6060 6060 808080 80 100 100100 100 120 120 120 120 140 140 140 140 160160 160160

140-160 120-140 100-120 80-100 60-80 40-60 20-40 0-20 -20-0

Human skills

Scores of Recognition factors

(11)

Scores for high consent rate staff

A 0

20 40 60 80 100 120 140 160

A B C Ave.1

Scores and average for low consent rate staff

0 20 40 60 80 100 120 140

160 D

E Ave.2

New Project from 2014 New Project from 2014 New Project from 2014 New Project from 2014 New Project from 2014 New Project from 2014 New Project from 2014 New Project from 2014

Major Change in items Major Change in items Major Change in items Major Change in items

Activity fund for each pref. Co was cut Activity fund for each pref. Co was cut Activity fund for each pref. Co was cut Activity fund for each pref. Co was cut New project fund for

New project fund for New project fund for New project fund for

・・・・ Prefectural committee for Prefectural committee for Prefectural committee for Prefectural committee for 1111) supervise prefecture activities ) supervise prefecture activities ) supervise prefecture activities ) supervise prefecture activities 2222) local PR ) local PR ) local PR ) local PR

・・・・ Individual Hospital development Individual Hospital development Individual Hospital development Individual Hospital development

Japan Organ Transplant Network Japan Organ Transplant Network Japan Organ Transplant Network

Executive Director; Naoshi Shinozaki Japan Organ Transplant Network

Feb. 6, 2014

2014 Business plan

Prefectural Promotion Committee and In house system establishement

Japan Organ Transplant Network Japan Organ Transplant Network

Promotion of pref. activities

Each pref. committee will supervise multiple authorized donating institution

Local government, Pref. Co. Kidney Bank, eye bank, Volunteer groups will link public and hospitals.

Data collection with Uniform platform for target hospitals and JOT will manage the data to make action plans with medical societies.

Japan Organ Transplant Network Japan Organ Transplant Network

Sharma of Pref. promotion

JOT branch JOTbranch JOTbranch

JOT HQ

Pref. Co

KB Co EB Co

Local gov.

In-house com. In-house com.

Branch Co.

Volunteers In-house Co

(12)

Japan Organ Transplant Network Japan Organ Transplant Network

Pref. Committee model

JOT HQ

JOT branch

Public

Education

Hospital Education

Local Gov.

Kidney Bank Pref. Co Eye Bank Eye Bank Co

Volunteer

Local Gov.

Pref. Co Kidney Bank

Bank Co.

In-house Co Tx. Support office Local PR

Official Institute Evants

Hospital Information

In ward patients infor.

Donor detection Donor management

Japan Organ Transplant Network Japan Organ Transplant Network

Transplant Services Support Project

JOT HQ JOT branches

Pref. Organ Transplant Promotion Public education

Local action plan and monitoring the action

Cooperation with local government, the team will produce effective PR Periodic committee for evaluation

Plan the events and do

With the Volunteer group, public education will be planed and monitor Pref. Team

Japan Organ Transplant Network Japan Organ Transplant Network Produce Action Plan for hospital development in Pref.

Hospital and potential donor information will be collected in uniform format and install the donor detection system for each hospitals

Routine meetings by the team to;

1. Update the hospital information and process of hospital development 2. Identify the milestone for each step and monitor

3. Evaluating the patients flow in hospital and make action plan

Transplant Services Support Project Pref. Organ Transplant Promotion

Public education

JOT HQ JOT branches

Pref. Team

Japan Organ Transplant Network Japan Organ Transplant Network

Hospital Development Program

JOT HQ produce the uniform platform for data base on patients flow in hospitals. Local member will work together with JOT HQ & branch to furnish in-house system.

Each institute will use uniform platform, but detection and/or management could be tailor-made.

Each institute must be evaluated their activities by local committee in statistical manner.

Japan Organ Transplant Network Japan Organ Transplant Network Pref. Co

In-house Co Emergency

Tx support office

Boards

Admin.

Nurse dep.

・system audit

・will check at patients admission

・manuals for severe patients

・Quality Management seminar

・Donor Action & TPM Japan

・Brain Deaths tests simulation

・setting-up Tx support office in hsp.

・manual for ICU round

・RRS install

・setting up committee and stair ICU・CCU

Hospital Development Program

JOT branch JOTbranch JOTbranch

JOT HQ

Uniform formatting

Uniform formatting

Uniform formatting

Uniform formatting

Uniform formatting

Uniform formatting

Uniform formatting

Uniform formatting

(13)

49

北多摩北部 北多摩北部 北多摩北部 北多摩北部

北多摩南部 北多摩南部 北多摩南部 北多摩南部 北多摩西部 北多摩西部 北多摩西部 北多摩西部

南多摩 南多摩 南多摩 南多摩 西多摩 西多摩 西多摩 西多摩

区東部 区東部 区東部 区東部

東葛北部 東葛北部 東葛北部 東葛北部

東葛南部 東葛南部 東葛南部 東葛南部 区東北部

区東北部 区東北部 区東北部 区

区 区 区西 西 西 西北部 北部 北部 北部

区 区 区 区西南 西南 西南 西南部 部 部 部 区 区 区 区西 西 西 西部 部 部 部

区 区 区 区中央 中央 中央部 中央 部 部 部 区 区 区 区南 南 南部 南 部 部 部

General Hospital (>200 beds)

3 8

6 7 8

12 13 13

10 20

6 9

16

平均:10.1 11

0 5 10 15 20 25

Univ. Hospital

0 3

0 0

2 4

3 3

4 12

2 1

3 2 平均:2.8

0 2 4 6 8 10 12 14

Emergency & Trauma Center

1 2

1 1

3

2 2 2 2

4

1 1

2

1

平均:1.8

0 1 2 3 4 5

Cancer Center

1 1

0 0

2 2

1 1

2 6

0 0

3 3

平均:1.6

0 1 2 3 4 5 6 7

54

(14)

55

56

57

過去 過去 過去 過去のののの提供数提供数提供数提供数 などのなどの などのなどの実績実績実績実績 病院基本情報 病院基本情報 病院基本情報 病院基本情報

病院特化情報 病院特化情報 病院特化情報 病院特化情報

58

59

Electric registry for Kidney Transplant

Sample view Electric registry for

Kidney Transplant Sample view

Sept. 2008

(15)

Japan Renal Transplantation Registry System (JARTRE)

Registry forms

( donor ・ recipient )

(16)

Follow-up registry

( for recipients )

Follow-up registry

( for Living donor )

(17)

MOH research group

2007 – 2009 “Promotion of Social Infrastructure for Organ Transplant” suggested the transparency &

registry system of OTC.

2009 – 2011 “1

st

phase” of Takahara group started kidney transplant registry by web system.

2011 – 2013 “2

nd

phase” of Takahara group finalize the registry system for ALL organ transplant

Keys to the success of global system Keys to the success of global system Keys to the success of global system Keys to the success of global system Keys to the success of global system Keys to the success of global system Keys to the success of global system Keys to the success of global system

• WHO leadership with TTS

• Uniform system on OTC and any medical products of human origin

• Corroboration between societies and entities

• Clear & simple rules of data input

• Global agreement of use & analyze data

• Authorization & support from the Health authorities

Global coding system Global coding system Global coding system Global coding system Global coding system Global coding system Global coding system Global coding system w

ww

will provide ill provide ill provide ill provide 1.

1.

1.

1. pppprohibition of unethical donation and rohibition of unethical donation and rohibition of unethical donation and rohibition of unethical donation and transplantation

transplantation transplantation transplantation 2. 2.

2. 2. bbbbest practice on transplantation est practice on transplantation est practice on transplantation est practice on transplantation 3. 3.

3. 3. Safe guards for transplantation with Safe guards for transplantation with Safe guards for transplantation with Safe guards for transplantation with real

real

real real----time traceability time traceability time traceability time traceability

Thank you Thank you Thank you Thank you Thank you Thank you Thank you Thank you

• For more information

Naoshi Shinozaki

shinzoaki@jotnw.or.jp

(18)

Service Delivery and Safety 4

Service Delivery and Safety 5

Kidney Liver Heart Lung Pancreas

77818 23986 5935 4359 2423

2012 GKT/ GODT

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012

≈ 114,690 organs transplanted (≈ 10% of estimated global needs)

≈ 1.81 % increase over 2011

109 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

Transplants & Waiting List in the EU, 2012

(Newsletter Transplant, 2013)

TRANSPLANTS W.L.

19.085 50.397

6.973 6.603

2.143 3.273

1.756 2.005 ---

29.957 62.278 TOTAL

For many, the waiting continues

…more than 3.773 patients died while wating to be transplanted in 2012

Newsletter Transplant 2013 http://www.ont.es/publicaciones/Documents/NEWSLETTER2013.pdf

(19)

Service Delivery and Safety 7

Service Delivery and Safety 8

Service Delivery and Safety 9

Service Delivery and Safety 10

Service Delivery and Safety 11

2012 GKT/ GODT

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012

≈ 114,690 organs transplanted (≈ 10% of estimated global needs)

109 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

Kidney Liver Heart Lung Pancreas

77818 23986 5935 4359 2423

Service Delivery and Safety 12

2012 GKT/ GODT

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2012

≈ 114,690 organs transplanted (≈ 10% of estimated global needs)

109 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

Kidney Liver Heart Lung Pancreas

77818 23986 5935 4359 2423

Living Donor

32350

Living Donor

4222

42,5% 17,8%

(20)

Service Delivery and Safety 13

Service Delivery and Safety 14

Risks of living donations

Service Delivery and Safety 15

Service Delivery and Safety 16

Reduction in waiting time 22

vs

344 days

Better outcomes Reduction in mortality (HC)

Lo CM, Fan ST, Liu CL, Chan SC, Ng IO, Wong J.

Living donor versus deceased donor liver transplantation for early irresectable hepatocellular carcinoma.

Br. J. Surg. 2007; 94: 78–86.

Shorter Cold Ischemic times

Shaked A, Ghobrial RM, Merion RM et al.

Incidence and severity of acute cellular rejection in recipients undergoing adult living donor or deceased donor liver transplantation.

Am. J. Transplant. 2009; 9:301–8.

< ACR and Graft loss

Service Delivery and Safety 17

Service Delivery and Safety 18

(21)

Service Delivery and Safety 19

Service Delivery and Safety 20

Complications of Living Donor Hepatic Lobectomy

M. M. Abecassis, R. A. Fisher, K. M. Olthoff, C. E. Freise, D. R. Rodrigo, B. Samstein, I. Kam, R. M. Merion, the A2ALL Study Group American Journal of Transplantation, 12: 1208–1217. doi: 10.1111/j.1600-6143.2011.03972.x

Complications of Living Donor Hepatic Lobectomy

M. M. Abecassis, R. A. Fisher, K. M. Olthoff, C. E. Freise, D. R. Rodrigo, B. Samstein, I. Kam, R. M. Merion, the A2ALL Study Group American Journal of Transplantation, 12: 1208–1217. doi: 10.1111/j.1600-6143.2011.03972.x

760 living donors A2ALL cohort study Donor morbidity assessed over a 12-year period

20 procedures aborted - 740 completed

40% had complications (557 complications among 296 donors),

grade 1 (minor, n = 232)

grade 2 (possibly life-threatening, n = 269)

grade 3 (residual disability, n = 5)

grade 4 (leading to death, n = 3)

Hernias (7%) and psychological complications (3%) occurred >1 year postdonation.

Complications risk did not decline with the increased center experience with LLD.

The probability of complication resolution within 1 year was overall 95%, but only 75% for hernias and 42% for psychological complications

Service Delivery and Safety 21

It has been estimated that early and delayed death from transplant-related causes can be expected of approximately one in every 200–500 right lobe donors, with permanent disability of a significant number of others.

Service Delivery and Safety 22

Service Delivery and Safety 23

Chain Donation Following Good Samaritan

http://www.nytimes.com/2012/02/19/health/lives-forever-linked-through-kidney-transplant-chain-124.html?_r=2&nl=todaysheadlines&emc=tha2 February 2012

Chain Donation Following Good Samaritan

http://www.nytimes.com/2012/02/19/health/lives-forever-linked-through-kidney-transplant-chain-124.html?_r=2&nl=todaysheadlines&emc=tha2 February 2012

Service Delivery and Safety 24

Safety of the Living Donor

http://www.nypost.com/p/news/local/bronx/montefiore_transplant_nightmare_PVO4SBjhXjgX3LGynvMRbJ?utm_medium=rss&utm_content=Bronx

6 June 2012

Safety of the Living Donor

http://www.nypost.com/p/news/local/bronx/montefiore_transplant_nightmare_PVO4SBjhXjgX3LGynvMRbJ?utm_medium=rss&utm_content=Bronx

6 June 2012

(22)

Service Delivery and Safety 25

Service Delivery and Safety 26

Service Delivery and Safety 27

Kidney Liver Heart Lung Pancreas

76118 23721 5741 4278 2564

Living Donor

32350

Living Donor

4222 42,5% 17,8%

2008 GKT/ GODT

≈ 112,600 organs transplanted (≈ 10% of estimated global needs)

103 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2011

Global Observatory on Donation and Transplantation

Organs Transplanted Globally in 2011

Service Delivery and Safety 28

Global Observatory on Donation and Transplantation

Kidneys Transplanted Globally 2008-11

Global Observatory on Donation and Transplantation

Kidneys Transplanted Globally 2008-11

64000 66000 68000 70000 72000 74000 76000 78000

2008 2009 2010 2011

Service Delivery and Safety 29

Global Observatory on Donation and Transplantation

Kidneys Transplanted Globally 2008-11

Global Observatory on Donation and Transplantation

Kidneys Transplanted Globally 2008-11

10000 15000 20000 25000 30000 35000 40000 45000

2008 2009 2010 2011

37300

39303 40985

43768

32000 32797 32194 32350

Year n

DD LD Absolute number

Service Delivery and Safety 30

Global Observatory on Donation and Transplantation

Kidneys Transplanted Globally 2008-11

Global Observatory on Donation and Transplantation

Kidneys Transplanted Globally 2008-11

30 35 40 45 50 55 60

2008 2009 2010 2011

53.8 54.6 56.1 57.5

46.2 45.4

43.9 42.5

Year

% Percentage

DD

LD

(23)

Service Delivery and Safety 31

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

18000 19000 20000 21000 22000 23000 24000

2008 2009 2010 2011

n

Year

Service Delivery and Safety 32

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

0 2000 4000 6000 8000 10000 12000 14000 16000 18000 20000

2008 2009 2010 2011

17265 17896 18486

19499

3035 3279 3116

4222

Year

Absolute number n

DD LD

Service Delivery and Safety 33

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

0 10 20 30 40 50 60 70 80 90

2008 2009 2010 2011

85 84.52 85.48 82.2

15 15.48 14.42 17.8

Year Pecentage

%

DD LD

Service Delivery and Safety 34

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

Global Observatory on Donation and Transplantation

Livers Transplanted Globally 2008-11

8 9 10 11 12 13 14 15 16 17 18

2008 2009 2010 2011

15 15.48

14.42 17.8

Living donors

Year

%

Service Delivery and Safety 35

Service Delivery and Safety 36

(24)

Service Delivery and Safety 37

Service Delivery and Safety 38

ELIGIBLE DCDDONOR A medically suitableperson who has been declared dead based on the irreversible absence of circulatory and respiratory functions as stipulated by the law of the relevant jurisdiction, within a time frame that enables organ recovery.

POTENTIAL DBDDONOR A person whose clinical condition is suspected to fulfill brain death criteria.

ELIGIBLE DBDDONOR A medically suitable person who has been declared dead based on neurologic criteria as stipulated by the law of the relevant jurisdiction.

Critical pathways for organ donation*

POSSIBLE DECEASED ORGAN DONOR

A patient with a devastating brain injury or lesion OR a patient with circulatory failure AND apparently medically suitable for organ donation

UTILIZED DCDDONOR An actual donor from whom at least one organ was transplanted.

Reasons why a potential donor does not become a utilized donor System

•Failure to identify/refer a potential or eligible donor

Brain death diagnosis not confirmed (e.g. does not fulfill criteria) or completed (e.g. lack of technical resources or clinician to make diagnosis or perform confirmatory tests)

•Circulatory death not declared within the appropriate time frame.

•Logistical problems (e.g. no recovery team)

•Lack of appropriate recipient (e.g. child, blood type, serology positive)

Donor/Organ

•Medical unsuitability (e.g. serology positive, neoplasia)

•Haemodynamic instability / unanticipated cardiac arrest

•Anatomical, histological and/or functional abnormalities of organs

•Organs damaged during recovery

•Inadequate perfusion of organs or thrombosis Permission

•Expressed intent of deceased not to be donor

•Relative’s refusal of permission for organ donation

•Refusal by coroner or other judicial officer to allow donation for forensic reasons POTENTIAL DCD DONOR

A.A person whose circulatory and respiratory functions have ceased and resuscitative measures are not to be attempted or continued.

or B.A person in whom the cessation of circulatory

and respiratory functions is anticipated to occur within a time frame that will enable organ recovery.

Donation after BrainDeath (DBD) Treating physician

to identify/refer a potential donor

ACTUAL DBDDONOR A consented eligible donor:

A. In whom an operative incision was made with the intent of organ recovery for the purpose of transplantation.

or B. From whom at least one organ was

recovered for the purpose of transplantation.

UTILIZED DBDDONOR An actual donor from whom at least one organ was transplanted.

ACTUAL DCDDONOR A consented eligible donor:

A. In whom an operative incision was made with the intent of organ recovery for the purpose of transplantation.

or B. From whom at least one organ was

recovered for the purpose of transplantation.

Donation after Circulatory Death (DCD)

*The “dead donor rule” must be respected.That is, patients may only become donors after death, and the recovery of organs must not cause a donor’s death.

40

Service Delivery

Strengthening Health Systems

and Innovation

40

Professionals Authorities

The Magnificent Seven, John Sturges,1960

Service Delivery and Safety 41

Legal framework

Opting in Opting out

Service Delivery and Safety 42

Legal framework

Opting in Opting out Legal framework

Opting in Opting out

Type of donor Living

Deceased

(25)

Service Delivery and Safety 43

Legal framework

Opting in Opting out

Type of donor Living

Deceased

Organizational Structure National

OPO

Service Delivery and Safety 44

Service Delivery and Safety 45

Participants in the Madrid Consultation urged WHO, its Member States and professionals in the field to regard organ donation and transplantation as part of every nation’s responsibility to meet the health needs of the population in a comprehensive manner, addressing the conditions leading to transplantation from prevention to treatment.

Every country, in light of its own level of economic and health system development, should progress towards the global goal of meeting patients' needs on the basis of resources obtained within the country, for that country’s population, and through regulated and ethical regional or international cooperation when needed.

The strategy of striving for self-sufficiency encompasses the following features: actions should (i) begin locally; (ii) include broad public health measures both to decrease the disease burden in a population and to increase the availability of organ transplantation;

(iii) enhance cooperation among the stakeholders involved and (iv) be carried out on the basis of the WHO Guiding Principles and the Declaration of Istanbul, in particular emphasizing voluntary donation, non-commercialization, maximization of donation from the deceased, support for living kidney donation, and meeting the needs of the local population in preference to “transplant tourists”.

Service Delivery and Safety 46

Deceased donors per million population vs Human Development Index

GODT 2012

Self-Sufficiency begins locally and is

adapted to the local reality

Croatia Spain

US

Canada

Paraguay

Uruguay

South Africa Thailand Iran Brasil

Belarus

Service Delivery and Safety 47

EVERY COUNTRY SHOULD MAKE A DIAGNOSIS OF ITS SITUATION AND FIND THE MOST ADEQUATE WAY

TOWARDS SELF - SUFFICIENCY

WELL PROVEN SUCCESSFUL MODELS (BIG AREAS – SUSTAINED INCREASE) MAY BE TAKEN AS A REFERENCE

…THERE IS NO UNIQUE FORMULA

Delmonico FL, Domínguez-Gil B et al. Lancet 2011

Service Delivery and Safety 48

COORDINATION NETWORK SPECIAL PROFILE INSIDE THE HOSPITALS

BRAIN DEATH AUDIT

HOSPITAL REIMBURSEMENT

TRAINING OF PROFESSIONALS

ATENTION TO THE MEDIA

(26)

Service Delivery and Safety 49

Actual donors from deceased persons, 2012

Service Delivery and Safety 50

22409

22905

24280

25776

26523

20000 21000 22000 23000 24000 25000 26000 27000

2008 2009 2010 2011 2012

DECEASED DONORS (ABSOLUTE NUMBERS)

VARIATION BETWEEN 2008 AND 2012 = 18.4 %

Service Delivery and Safety 51

3.66

18.5 0.48

12.1 9.71

15.28 13.04 4.48 3.33

11.21 6.67 1.26

7.2

18.86 1.7

2.81 3.06 2.12 1.82 0.76

4.63

23.5 0.61

15.46 12.42

20 17.27 6.21

4.68

16.06 10 1.95

12.35

34.77 3.62

6.98 9.44 7.46 6.67 3.16

0 5 10 15 20 25 30 35 40

Turkey Slovenia Malaysia Australia Lithuania Finland Latvia Kuwait Venezuela (Bolivarian Republic of)

Poland Iceland Thailand Brazil Croatia Ecuador Iran (Islamic Republic of)

Republic of Korea Paraguay Panama

Peru DDPMP2012 DDPMP2008

DECEASED DONORS PMP: YEARS 2008 AND 2012 COUNTRIES WITH THE BIGGEST INCREASE

Service Delivery and Safety 52

To improve is to change;

to be perfect is to change often ”

Winston Churchill

53

Service Delivery

Strengthening Health Systems

and Innovation

Thank you

noell@who.int nunezj@who.int

http://www.who.int/transplantation/en/

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