Madhya Pradesh act 0218 of 2014 : The amendement-2014 Human organ transplantation act 1994

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MINISTRY OF HEALTH AND FAMILY WELFARE

NOTIFICATION

New Delhi, the 27th March, 2014.

G.S.R. 218 (E).— In exercise o f the powers conferred by section 24 o f the Transplantation o f Human Organs Act, 1994 (42 o f 1994) and in supersession o f the Transplantation o f Human Organs Rules, 1995, except as respects things done or omitted to be done before such supersession, the Central Government hereby makes the fo llow ing rules, namely:-

1. Short title and commencement — (1) These rules may be called the Transplantation o f Human Organs and Tissues Rules, 2014.

(2) They shall come into force on the date o f their publication in the O ffic ia l Gazette.

2. Definitions: - In these rules unless the context otherwise requires,—

(a) "Act" means the Transplantation o f Human Organs Act, 1994;

(b) " cadaver(s)" , " organ(s)" and " tissue(s)" means human cadaver(s), human organ(s) and human tissue(s), respectively;

(c) " competent authority" means the Head o f the institution or hospital carrying out transplantation or committee constituted by the head o f the institution or hospital fo r the purpose;

(d) "Form" means a Form annexed to these rules;

(e) National Accreditation Board fo r Testing and Calibration Laboratories (N ABL) means the autonomous body established under the aegis o f Department o f Science and Technology, Government o f India w ith the objective to provide Government, Regulators and Industry w ith a scheme o f laboratory accreditation through third-party assessment fo r form ally recognising the technical competence o f laboratories and the accreditation services are provided fo r testing and calibration o f medical laboratories in accordance w ith International Organisation fo r Standardisation (ISO) Standards;

(f) " the technician who can enucleate cornea" means the technician w ith any o f the fo llow ing qualifications and experience who can harvest corneas (enucleate eyeballs or excise corneas), namely:-

(i) Ophthalmologists possessing a Doctor o f Medicine (M .D) or Master o f Surgery (M .S) in Ophthalmology or Diplom a in Ophthalmology (D.O .); and

(ii) registered Doctors from a ll recognised systems o f medicine, Nurses, Paramedical Ophthalmic Assistant, Ophthalmic Assistant, Optometrists, Refractionists, Paramedical W orker or Medical Technician w ith recognised qualification from a ll recognised systems o f medicine, provided the person is duly trained to enucleate a donated cornea or eye from registered, authorised and functional eye Bank or Government medical college and, the training certificate should mention that he has acquired the required skills to independently conduct enucleation o f the eye or removal o f cornea from a cadaver;

(g) words and expressions used and not defined in these rules, but defined in the Act, shall have the same meanings, respectively, assigned to them in the Act.

3. Authority for removal of human organs or tissues.— Subject to the provisions o f Section 3 o f the Act, a liv ing person may authorise the removal o f any organ or tissue o f his or her body during his or her life tim e as per prevalent medical practices, fo r therapeutic purposes in the manner and on such conditions as specified in Form 1, 2 and 3.

4. Panel of experts for brain-stem death certification.— For the purpose o f certifying the brain-stem death, the Appropriate Authority shall maintain a panel o f experts, in accordance w ith the provisions o f the Act, to ensure efficient functioning o f the Board o f M edical Experts and it remains fu lly operational.

5. Duties of the registered medical practitioner.— (1) The registered medical practitioner o f the hospital having Intensive Care U n it fac ility , in consultation w ith transplant coordinator, i f available, shall ascertain, after certification o f brain stem death o f the person in Intensive Care Unit, from his or her adult near relative or, i f near relative is not available, then, any other person related by blood or marriage, and in case o f unclaimed body, from the person in law fu l possession o f the body the follow ing, namely:-

(a) whether the person had, in the presence o f two or more witnesses (at least one o f who is a near relative o f such person), unequivocally authorised before his or her death as specified in Form 7 or in documents like driving license, etc. wherein the provision fo r donation may be incorporated after notification o f these rules, the removal o f his or her organ(s) or tissue(s) including eye, after his or her death, for therapeutic purposes and there is no reason to believe that the person had subsequently revoked the aforesaid authorisation;

(b) where the said authorisation was not made by the person to donate his or her organ(s) or tissue(s) after his or her death, then the registered medical practitioner in consultation w ith the transplant coordinator, i f available, shall make the near relative or person in law fu l possession o f the body, aware o f the option to authorise or decline the donation o f such human organs or tissues or both (which can be used fo r therapeutic purposes) including eye or cornea o f the deceased person and a declaration or authorisation to this effect shall be ascertained from the near relative or person in law fu l possession o f the body as per Form 8 to record the status o f consent, and in case o f an unclaimed body, authorisation shall be made in Form 9 by the authorised o ffic ia l as per sub-section (1) o f section 5 o f the Act;

(c) after the near relative or person in law fu l possession o f the body authorises removal and gives consent for donation o f human organ(s) or tissue(s) o f the deceased person, the registered medical practitioner through the transplant coordinator shall in form the authorised registered Human Organ Retrieval Centre through authorised coordinating organisation by available documentable mode o f communication, fo r removal, storage or transportation o f organ(s) or tissue(s).

(2) The above mentioned duties shall also apply to the registered medical practitioner working in an Intensive Care U n it in a hospital not registered under this Act, from the date o f notification o f these rules.

(3) The registered medical practitioner shall, before removing any human organ or tissue from a liv ing donor, shall satisfy him self -

(a) that the donor has been explained o f a ll possible side effects, hazards and complications and that the donor has given his or her authorisation in appropriate Form 1 fo r near relative donor or Form 2 fo r spousal donor or Form 3 fo r donor other than near relative;

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(b) that the physical and mental evaluation o f the donor has been done, he or she is in proper state o f health and it has been certified that he or she is not mentally challenged and that he or she is f it to donate the organ or tissue:

Provided that in case o f doubt regarding mentally challenged status o f the donor the registered medical practitioner may get the donor examined by a psychiatrist and the registered medical practitioner shall sign the certificate as prescribed in Form 4 fo r this purpose;

(c) that the donor is a near relative o f the recipient, as certified in Form 5, and that he or she has submitted an application in Form 11 jo in tly w ith the recipient and that the proposed donation has been approved by the competent authority as defined at rule 2(c) and specified in Form 19 and that the necessary documents as prescribed and medical tests, as required, to determine the factum o f near relationship, have been examined to the satisfaction o f the registered medical practitioner and the competent authority;

(d) that in case the recipient is spouse o f the donor, the donor has given a statement to the effect that they are so related by signing a certificate in Form 2 and has submitted an application in Form 11 jo in tly w ith the recipient and that the proposed donation has been approved by the competent authority under the provisions o f sub-rule (2) o f rule 7;

(e) that in case o f a donor who is other than a near relative and has signed Form 3 and submitted an application in Form 11 jo in tly w ith the recipient, the permission from the Authorisation Committee fo r the said donation has been obtained;

(f) that i f a donor or recipient is a foreign national, the approval o f the Authorisation Committee fo r the said donation has been obtained;

(g) liv ing organ or tissue donation by minors shall not be permitted except on exceptional medical grounds to be recorded in detail w ith fu ll justification and w ith prio r approval o f the Appropriate A uthority and the State Government concerned.

(4) A registered medical practitioner, before removing any organ or tissue from the body o f a person after his or her death (deceased donor), in consultation w ith transplant coordinator, shall satisfy him self the follow ing, namely:-

(a) that caution has been taken to make inquiry, from near relative or person in law fu l possession o f the body o f a person admitted in Intensive Care Unit, only after certification o f Brain Stem death o f the person that the donor had, in the presence o f two or more witnesses (at least one o f whom is a near relative o f such person),unequivocally authorised before his or her death as specified in Form 7 or in documents like driving license etc. (wherein the provision fo r donation may be incorporated after notification o f these rules), the removal o f his or her organ(s) or tissue(s) after his or her death, fo r therapeutic purposes and it has been ascertained that the donor has not subsequently revoked the aforesaid authorisation, and the consent o f near relative or person in law fu l possession o f the body shall also be required notwithstanding the authorisation been made by deceased donor:

Provided that i f the deceased person who had earlier given authorisation but had revoked it subsequently and i f the person had given in w riting that his organ should not be removed after his death, then, no organ or tissue w ill be removed even i f consent is given by the near relative or person in law fu l possession o f the body;

(b) that the near relative o f the deceased person or the person law fu lly in possession o f the body o f the deceased donor has signed the declaration as specified in Form 8.

(c) that in the case o f brain-stem death o f the potential donor, a certificate as specified in Form 10 has been signed by a ll the members o f the Board o f M edical Experts referred to in sub-section (6) o f section 3 o f the Act:

Provided that where a neurologist or a neurosurgeon is not available, an anesthetist or intensivist who is not part o f the transplant team nominated by the head o f the hospital duly empanelled by Appropriate Authority may certify the brain stem death as a member o f the said Board;

(d) that in the case o f brain-stem death o f a person o f less than eighteen years o f age, a certificate specified in Form 10 has been signed by a ll the members o f the Board o f M edical Experts referred to in sub-section (6) o f section 3 o f the Act and an authority as specified in Form 8 has been signed by either o f the parents o f such person or any near relative authorised by the parent.

6. Procedure for donation of organ or tissue in medicolegal cases.— (1) A fter the authority fo r removal o f organs or tissues, as also the consent to donate organs from a brain-stem dead donor are obtained, the registered medical practitioner o f the hospital shall make a request to the Station House O fficer or Superintendent o f Police or Deputy Inspector General o f the area either directly or through the police post located in the hospital to facilitate tim ely retrieval o f organs or tissue from the donor and a copy o f such a request should also be sent to the designated post mortem doctor o f area simultaneously.

(2) I t shall be ensured that, by retrieving organs, the determination o f the cause o f death is not jeopardised.

(3) The medical report in respect o f the organs or tissues being retrieved shall be prepared at the time o f retrieval by retrieving doctor (s) and shall be taken on record in postmortem notes by the registered medical practitioner doing postmortem.

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(4) Wherever it is possible, attempt should be made to request the designated postmortem registered medical practitioner, even beyond office tim ing, to be present at the time o f organ or tissue retrieval.

(5) In case a private retrieval hospital is not doing post mortem, they shall arrange transportation o f body along w ith medical records, after organ or tissue retrieval, to the designated postmortem centre and the post mortem centre shall undertake the postmortem o f such cases on p rio rity, even beyond office tim ing, so that the body is handed over to the relatives w ith least inconvenience.

7 Authorisation Committee.— (1) The medical practitioner who w ill be part o f the organ transplantation team for carrying out transplantation operation shall not be a member o f the Authorisation Committee constituted under the provisions o f clauses (a) and (b) o f sub-section(4) o f section 9 o f the Act.

(2) When the proposed donor or recipient or both are not Indian nationals or citizens whether near relatives or otherwise, the Authorisation Committee shall consider a ll such requests and the transplantation shall not be permitted i f the recipient is a foreign national and donor is an Indian national unless they are near relatives.

(3) When the proposed donor and the recipient are not near relatives, the Authorisation Committee shall,-

(i) evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person;

(ii) prepare an explanation o f the lin k between them and the circumstances which led to the offer being made;

( iii) examine the reasons why the donor wishes to donate;

(iv ) examine the documentary evidence o f the link, e.g. proof that they have lived together, etc.;

(v) examine old photographs showing the donor and the recipient together; (v i) evaluate that there is no middleman or tout involved; (v ii) evaluate that financial status o f the donor and the recipient by asking them to give appropriate evidence o f their vocation and income fo r the previous three financial years and any gross disparity between the status o f the two must be evaluated in the backdrop o f the objective o f preventing commercial dealing; (v iii) ensure that the donor is not a drug addict;

(ix ) ensure that the near relative or i f near relative is not available, any adult person related to donor by blood or marriage o f the proposed unrelated donor is interviewed regarding awareness about his or her intention to donate an organ or tissue, the authenticity o f the lin k between the donor and the recipient, and the reasons fo r donation, and any strong views or disagreement or objection o f such kin shall also be recorded and taken note of.

(4) Cases o f swap donation referred to under subsection (3A) o f section 9 o f the A ct shall be approved by Authorisation Committee o f hospital or d istrict or State in which transplantation is proposed to be done and the donation o f organs shall be permissible only from near relatives o f the swap recipients.

(5) When the recipient is in a critica l condition in need o f life saving organ transplantation w ith in a week, the donor or recipient may approach hospital in-charge to expedite evaluation by the Authorisation Committee.

8. Removal and preservation of organs or tissues.— The removal o f the organ(s) or tissue(s) shall be permissible in any registered retrieval or transplant hospital or centre and preservation o f such removed organ(s) or tissue(s) shall be ensured in registered retrieval or transplant centre or tissue bank according to current and accepted scientific methods in order to ensure v ia b ility fo r the purpose o f transplantation.

9. Cost for maintenance of cadaver or retrieval or transportation or preservation of organs or tissues.— The cost fo r maintenance o f the cadaver (brain-stem dead declared person), retrieval o f organs or tissues, their transportation and preservation, shall not be borne by the donor fam ily and may be borne by the recipient or institution or Government or non-Government organisation or society as decided by the respective State Government or Union territory Adm inistration.

10. Application for living donor transplantation.— (1) The donor and the recipient shall make jo in tly an application to grant approval fo r removal and transplantation o f a human organ, to the competent authority or Authorisation Committee as specified in Form 11 and the papers fo r approval o f transplantation would be processed by the registered medical practitioner and administrative division o f the Institution fo r transplantation.

(2) The competent authority or Authorisation Committee shall take a decision on such application in accordance w ith the rule 18.

(3) I f some State wants to merge Form 11 w ith Form 1, Form 2 or Form 3, they may do so, provided the content o f the recommended Forms are covered in the merged Form and the same is approved by the State Government concerned.

11. Composition of Authorisation Committees.— (1) There shall be one State level Authorisation Committee.

(2) Additional Authorisation Committees in the districts or Institutions or hospitals may be set up as per norms given below, which may be revised from time to time by the concerned State Government or Union territory Adm inistration by notification.

(3) No member from transplant team o f the institution should be a member o f the respective Authorisation Committee.

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(4) Authorisation Committee should be hospital based i f the number o f transplants is twenty five or more in a year at the respective transplantation centres, and i f the number o f organ transplants in an institution or hospital are less than twenty-five in a year, then the State or D istrict level Authorisation Committee would grant approval(s).

12. Composition of hospital based Authorisation Committees.— The hospital based Authorisation Committee shall, as notified by the State Government in case o f State and by the Union territory Adm inistration in case o f Union territory, consist of,—

(a) the M edical D irector or M edical Superintendent or Head o f the institution or hospital or a senior medical person offic ia ting as Head - Chairperson;

(b) two senior medical practitioners from the same hospital who are not part o f the transplant team - Member;

(c) two persons (preferably one woman ) o f high integrity, social standing and credib ility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre o f police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals o f repute such as lawyers, chartered accountants, doctors o f Indian M edical Association, reputed non-Government organisation or renowned social worker - Member;

(d) Secretary (Health) or nominee and D irector Health Services or nominee from State Government or Union territory Adm inistration - Member.

13. Composition of State or District Level Authorisation Committees.— The State or D istrict Level Authorisation Committee shall, as notified by the State Government in case o f State and by the Union territory Adm inistration in case o f Union territory, consist of,—

(a) a M edical Practitioner o fficiating as Chief M edical O fficer or any other equivalent post in the main or major Government hospital o f the D istrict - Chairperson;

(b) two senior registered medical practitioners to be chosen from the pool o f such medical practitioners who are residing in the concerned D istrict and who are not part o f any transplant team - Member;

(c) two persons (preferably one woman) o f high integrity, social standing and credib ility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre o f police service or who have served as a reader or professor in U niversity Grants Commission approved University or are self-employed professionals o f repute such as lawyers, chartered accountants, doctors o f Indian M edical Association, reputed non-Government organisation or renowned social worker - Member;

(d) Secretary (Health) or nominee and D irector Health Services or nominee from State Government or Union territory Adm inistration-M em ber :

Provided that e ffort shall be made by the State Government concerned to have most o f the members' ex-officio so that the need to change the composition o f Committee is less frequent.

14. Verification of residential status, etc.— When the liv ing donor is unrelated and i f donor or recipient belongs to a State or Union territory, other than the State or Union territory where the transplantation is proposed to be undertaken, verification o f residential status by Tehsildar or any other authorised officer fo r the purpose w ith a copy marked to the Appropriate A uthority o f the State or Union territory o f dom icile o f donor or recipient for their inform ation shall be required, as per Form 20 and in case o f any doubt o f organ trafficking, the Appropriate Authority o f the State or Union territory o f dom icile or the Tehsildar or any other authorised officer shall in form police department fo r investigation and action as per the provisions o f the Act.

15. Quorum of Authorisation Committee.— The quorum o f the Authorisation Committee should be minimum four and the quorum shall not be complete w ithout the participation o f the Chairman, the presence o f Secretary (Health) or nominee and D irector o f Health Services or nominee.

16. Format of approval of Authorisation Committee.— The format o f the Authorisation Committee approval should be uniform in a ll the institutions in a State and the format may be notified by the respective State Government as per Form 18.

17. Scrutiny of applications by Authorisation Committee.— (1) Secretariat o f the Authorisation Committee shall circulate copies o f a ll applications received from the proposed donors and recipients to a ll members o f the Committee along w ith a ll annexures, which may have been filed along w ith the applications.

(2) A t the time o f the meeting, the Authorisation Committee should take note o f a ll relevant contents and documents in the course o f its decision making process and in the event any document or inform ation is found to be inadequate or doubtful, explanation should be sought from the applicant and i f it is considered necessary that any fact or inform ation requires to be verified in order to confirm its veracity or correctness, the same be ascertained through the concerned officer(s) o f the State Government or Union territory Administration.

18. Procedure in case of near relatives.— (1) Where the proposed transplant o f organs is between near relatives related genetically, namely, grandmother, grandfather, mother, father, brother, sister, son, daughter, grandson and granddaughter, above the age o f eighteen years, the competent authority as defined at rule 2(c) or Authorisation Committee (in case donor or recipient is a foreigner) shall evaluate;

(i) documentary evidence o f relationship e.g. relevant b irth certificates, marriage certificate, other relationship certificate from Tehsildar or Sub-divisional magistrate or Metropolitan Magistrate or

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(ii) documentary evidence o f identity and residence o f the proposed donor, ration card or voters identity card or passport or driving license or PAN card or bank account and fam ily photograph depicting the proposed donor and the proposed recipient along w ith another near relative, or sim ilar other identity certificates like AAD H AAR Card (issued by Unique Id en tifica tion A u th o rity o f Ind ia).

(2) I f in the opinion o f the competent authority, the relationship is not conclusively established after evaluating the above evidence, it may in its discretion direct further medical test, namely, Deoxyribonucleic Acid (DNA) Profiling.

(3) The test referred to in sub-rule (2) shall be got done from a laboratory accredited w ith National Accreditation Board fo r Testing and Calibration Laboratories and certificate shall be given in Form 5.

(4) I f the documentary evidences and test referred to in sub-rules (1) and (2), respectively do not establish a genetic relationship between the donor and the recipient, the same procedure be adopted on preferably both or at least one parent, and i f parents are not available, the same procedure be adopted on such relatives o f donor and recipient as are available and are w illing to be tested, fa iling which, genetic relationship between the donor and the recipient w ill be deemed to have not been established.

(5) Where the proposed transplant is between a married couple the competent authority or Authorisation Committee (in case donor or recipient is a foreigner) must evaluate the factum and duration o f marriage and ensure that documents such as marriage certificate, marriage photograph etc. are kept for records along w ith the inform ation on the number and age o f children and a fam ily photograph depicting the entire fam ily, b irth certificate o f children containing the particulars o f parents and issue a certificate in Form 6 (fo r spousal donor).

(6) Any document w ith regard to the proof o f residence or dom icile and particulars o f parentage should be relatable to the photo identity o f the applicant in order to ensure that the documents pertain to the same person, who is the proposed donor and in the event o f any inadequate or doubtful inform ation to this effect, the Competent Authority or Authorisation Committee as the case may be, may in its discretion seek such other inform ation or evidence as may be expedient and desirable in the peculiar facts o f the case.

(7) The medical practitioner who w ill be part o f the organ transplantation team fo r carrying out transplantation operation shall not be a competent authority o f the transplant hospital.

(8) The competent authority may seek the assistance o f the Authorisation Committee in its decision making, i f required.

19. Procedure in case o f transp lant other than near relatives.— Where the proposed transplant is between other than near relatives and a ll cases where the donor or recipient is foreign national (irrespective o f them being near relative or otherwise), the approval w ill be granted by the Authorisation Committee o f the hospital or i f hospital based Authorisation Committee is not constituted, then by the D istrict or State level Authorisation Committee.

20. Procedure in case o f foreigners.— When the proposed donor or the recipient are foreigners;

(a) a senior Embassy o ffic ia l o f the country o f orig in has to certify the relationship between the donor and the recipient as per Form 21 and in case a country does not have an Embassy in India, the certificate o f relationship, in the same format, shall be issued by the Government o f that country;

(b) the Authorisation Committee shall examine the cases o f a ll Indian donors consenting to donate organs to a foreign national (who is a near relative), including a foreign national o f Indian origin, w ith greater caution and such cases should be considered rarely on case to case basis:

Provided that the Indian liv ing donors wanting to donate to a foreigner other than near relative shall not be considered.

21. E lig ib ility o f applicant to donate.— In the course, o f determining e lig ib ility o f the applicant to donate, the applicant should be personally interviewed by the Authorisation Committee which shall be videographed and minutes o f the interview shall be recorded.

22. Precautions in case o f woman donor.— In case where the donor is a woman, greater precautions ought to be taken and her identity and independent consent should be confirmed by a person other than the recipient.

23. Decision o f A u thorisa tion Com m ittee.— (1) The Authorisation Committee (which is applicable only fo r liv ing organ or tissue donor)should state in w riting its reason fo r rejecting or approving the application o f the proposed liv ing donor in the prescribed Form 18 and a ll such approvals should be subject to the fo llow ing conditions, namely:-

(i) the approved proposed donor would be subjected to a ll such medical tests as required at the relevant stages to determine his or her biological capacity and com patibility to donate the organ in question;

(ii) the physical and mental evaluation o f the donor has been done to know whether he or she is in proper state o f health and it has been certified by the registered medical practitioner in Form 4 that he or she is not mentally challenged and is f it to donate the organ or tissue:

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Provided that in case o f doubt fo r mentally challenged status o f the donor the registered medical practitioner or Authorisation Committee may get the donor examined by psychiatrist; ( iii) a ll prescribed forms have been and would be fille d up by a ll relevant persons involved in the process o f transplantation;

(iv) a ll interviews to be video recorded.

(2) The Authorisation Committee shall expedite its decision making process and use its discretion judiciously and pragmatically in a ll such cases where, the patient requires transplantation on urgent basis.

(3) Every authorised transplantation centre must have its own website and the Authorisation Committee is required to take fina l decision w ith in twenty four hours o f holding the meeting fo r grant o f permission or rejection fo r transplant.

(4) The decision o f the Authorisation Committee should be displayed on the notice board o f the hospital or Institution immediately and should reflect on the website o f the hospital or Institution w ith in twenty four hours o f taking the decision, while keeping the identity o f the recipient and donor hidden.

24. Registration of hospital or tissue bank.— (1) An application fo r registration shall be made to the Appropriate Authority as specified in Form 12 or Form 13 or Form 14 or Form 15, as applicable and the application shall be accompanied by fee as specified below, payable to the Appropriate Authority by means o f a bank draft, which may be revised, i f necessary by the Central or State Government, as the case may be:-

(i) fo r Organ or Tissue or Cornea Transplant Centre: Rupees ten thousand;

(ii) fo r Tissue or Eye Bank: Rupees ten thousand; ( iii) fo r Non-Transplant Retrieval Centre: N il.

(2) The Appropriate Authority shall, after holding an inquiry and after satisfying itse lf that the applicant has complied w ith a ll the requirements, grant a certificate o f registration as specified in Form 16 and it shall be valid fo r a period o f five years from the date o f its issue and shall be renewable.

(3) Before a hospital is registered under the provisions o f this rule, it shall be mandatory fo r the hospital to appoint a transplant coordinator.

25. Renewal of registration of hospital or tissue bank.— (1) An application fo r the renewal o f a certificate o f registration shall be made to the Appropriate Authority at least three months prio r to the date o f expiry o f the original certificate o f registration and shall be accompanied by a fee as specified below, payable to the Appropriate Authority by means o f a bank draft, which may be revised, i f necessary by the Central or State Government, as the case may be,-

(i) fo r Organ or Tissue or Cornea Transplant Centre: Rupees five thousand;

(ii) fo r Tissue or Eye Bank: Rupees five thousand; ( iii) fo r Non-Transplant Retrieval Centre: N il.

(2) A renewal certificate o f registration shall be as specified in Form 17 and shall be valid fo r a period o f five years.

(3) If, after an inquiry including inspection o f the hospital or tissue bank and scrutiny o f its past performance and after giving an opportunity to the applicant, the Appropriate Authority is satisfied that the applicant, since grant o f certificate o f registration under sub-rule (2) o f rule 24 has not complied w ith the requirements o f the Act and these rules and the conditions subject to which the certificate o f registration has been granted, shall, fo r reasons to be recorded in w riting, refuse to grant renewal o f the certificate o f registration.

26. Conditions and standards for grant of certificate of registration for organ or tissue transplantation centres.— (1) No hospital shall be granted a certificate o f registration fo r organ transplantation unless it fu lfills the fo llow ing conditions and standards, namely:-

A. General manpower requirement specialised services and facilities:

(a) Twenty-four hours ava ilab ility o f medical and surgical, (senior and jun ior) staff;

(b) twenty-four hours ava ilability o f nursing staff (general and specialty trained);

(c) twenty-four hours ava ilab ility o f Intensive Care Units w ith adequate equipment staff and support system, including specialists in anesthesiology and intensive care;

(d) twenty-four hours ava ilab ility o f blood bank (in house or access) , laboratory w ith m ultiple discipline testing facilities including but not lim ited to M icrobiology, Bio-Chemistry, Pathology,-Hematology and Radiology departments w ith trained staff;

(e) twenty-four hours ava ilab ility o f Operation Theater facilities (OT facilities) fo r planned and emergency procedures w ith adequate staff, support system and equipment;

(f) twenty-four hours ava ilab ility o f communication system, w ith power backup, including but not lim ited to m ultiple line telephones, public telephone systems, fax, computers and paper photo-imaging machine;

(g) experts (other than the experts required fo r the relevant transplantation) o f relevant and associated specialties including but not lim ited to and depending upon the requirements, the experts in internal medicine, diabetology, gastroenterology, nephrology, neurology, pediatrics, gynecology, immunology and cardiology, etc., shall be available in the transplantation centre;

(h) one medical expert fo r respective organ or tissue transplant shall be available in the transplantation hospital; and

(i) Human Leukocyte Antigen (H LA ) matching facilities (in house or outsourced) shall be available.

B. Equipments:

Equipments as per current and expected scientific requirements specific to organ (s) or tissue (s) being transplanted and the transplant centre should ensure the availab ility o f the accessories, spare-parts and back-up, maintenance and service support system in relation to a ll relevant equipments.

C. Experts and their qualifications:

(a) Kidney Transplantation:

M.S. (Gen.) Surgery or equivalent qualification w ith three years post M.S. training in a recognised transplant center in India or abroad and having attended to adequate number o f renal transplantation as an active member o f team;

(b) Transplantation o f live r and other abdominal organs:

M.S. (Gen.) Surgery or equivalent qualification w ith three years post M.S. experience in the speciality and having one year training in the respective organ transplantation as an active member o f team in an established transplant center;

(c) Cardiac, Pulmonary, Cardio-Pulmonary Transplantation:

M.Ch. Cardio-thoracic and vascular surgery or equivalent qualification in India or abroad w ith at least three years' experience as an active member o f the team performing an adequate number o f open heart operations per year and well-versed w ith Coronary by-pass surgery and Heart-valve surgery;

(d) the hospital registered under C lin ical Establishment (Registration and Regulation) Act, 2010 (23 o f 2010) shall also fo llow the minimum standards prescribed in respect o f manpower, equipment, etc., as prescribed under that Act;

(e) the hospital registered shall have to maintain documentation and records including reporting o f adverse events.

(2) No hospital shall be granted a certificate o f registration for tissue transplantation under the Act unless it fu lfills the fo llow ing conditions and standards, namely:-

(a) Cornea Transplantation:

M .D . or M.S. or Diploma (DO) in ophthalmology or equivalent qualification w ith three months post M .D . or M.S or DO training in Corneal transplant operations in a recognised hospital or institution;

(b) Other tissues such as heart valves, skin, bone, etc.:

Post graduate degree (M D or MS) or equivalent qualification in the respective specialty w ith three months post M .D . or M.S training in a recognised hospital carrying out respective tissue transplant operations and fo r heart valve transplantation, and the qualification and experience o f expert shall be MCh degree in Cardiothoracic and Vascular Surgery (CTVS) or equivalent qualification w ith three months post MCh training in a recognised hospital carrying out heart valve transplantation;

(c) the Hospital registered under C lin ical Establishment (Registration and Regulation) Act, 2010(23 o f 2010) shall also fo llow the minimum standards prescribed in respect o f manpower, equipment, etc., as prescribed under that Act;

(d) the Hospital registered shall have to maintain documentation and records including reporting o f adverse events.

27. Conditions and standards for grant of certificate of registration for organ retrieval centres.—

(1) The retrieval center shall be registered only fo r the purpose o f retrieval o f organ from deceased donors and the organ retrieval centre shall be a hospital having Intensive Care U n it (ICU) facilities along w ith manpower, infrastructure and equipment as required to diagnose and maintain the brain-stem dead person and to retrieve and transport organs and tissues including the fa c ility for their temporary storage.

(2) A ll hospitals registered as transplant centres shall automatically qualify as retrieval centres.

(3) The retrieval centre should have linkages w ith nearby Government hospital designated for post-mortem, for retrieval in medico-legal cases.

(4) Registration o f hospital fo r surgical tissue harvesting from deceased person and for surgical tissue residues, that are routinely discarded, shall not be required.

28. Conditions and standards for grant of certificate of registration for tissue banks.—

A. Facility and premises:

(1) Facilities must conform to the standards and guidelines laid down fo r the purpose and the States and Union territories may have separate registration fee and procedure to keep track o f their tissue bank activities.

(2) The respective State or Union territory Appropriate Authority may constitute an expert committee for advising on the matter related to tissue specific standards and related issues.

(3) The tissue bank must have written guidelines and standard operating procedures for maintenance o f its premises and facilities which include-

(a) controlled access;

(b) cleaning and maintenance systems;

(c) waste disposal;

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(d) health and safety o f staff;

(e) risk assessment protocol; and

(f) fo llow up protocol.

(4) Equipments as per scientific requirements specific to tissue (s) being procured, processed, stored and distributed and the tissue bank should ensure the availab ility o f the accessories, spare-parts and back-up, maintenance and service support fo r a ll equipments.

(5) A ir particle count and m icrobial colony count compliance shall be ensured fo r safety where necessary.

(6) Storage area shall be designated to avoid contact w ith chemicals or atmospheric contamination and any known source o f infection.

(7) Storage fa c ility shall be separate and distinguish tissues, held in quarantine, released and rejected. B. Donor screening:

(8) Complete screening o f donor must be conducted including medical or social history and serological evaluation fo r medical conditions or disease processes that would contraindicate the donation o f tissues and the report o f corneas or eyes not found suitable fo r transplantation and their alternate use shall be certified by a committee o f two Ophthalmologists.

C. Laboratory tests:

(9) Facility fo r relevant Laboratory tests fo r blood and tissue samples shall be available and testing o f blood and tissue samples shall begin at Donor Screening and continue during retrieval and throughout processing.

D. Procurement and other procedures:

(10) Procurement o f tissue must be carried out by registered health care professionals or technicians having necessary experience or special training.

(11) Consent fo r the procurement shall be obtained.

(12) Procurement records shall be maintained.

(13) Standard operating procedure fo r fo llow ing shall be followed, namely :-

(a) procurement or Retrieval and transplantation;

(b) processing and sterilisation;

(c) packaging, labeling and storage;

(d) distribution or allocation;

(e) transportation; and

(f) reporting o f serious adverse reactions.

E. Documentation and Records:

(14) A log o f tissue received and distributed shall be maintained to enable traceability from the donor to the tissue and the tissue to the donor and the records shall also indicate the dates and the identities o f the staff performing specific steps in the removal or processing or distribution o f the tissues.

F. Data Protection and Confidentiality:

(15) A unique donor identification number shall be used fo r each donor, and access to donor records shall be restricted.

G. Quality Management:

(16) The Quality Management System shall define quality control procedures that include the fo llow ing, namely:-

(a) environmental monitoring;

(b) equipment maintenance and monitoring;

(c) in -process controls monitoring;

(d) internal audits including reagent and supply monitoring;

(e) compliance w ith reference standards, local regulations, quality manuals or documented standard operating procedures; and

(f) monitoring work environment.

H. Recipient Information:

(17) A ll tissue recipients shall be followed up and prompt and appropriate corrective and preventive actions taken in case o f adverse events.

29. Qualification, role, etc., of transplant coordinator.— (1) The transplant coordinator shall be an employee o f the registered hospital having qualification such as:

(a) graduate o f any recognised system o f medicine; or

(b) Nurse; or

(c) Bachelor's degree in any subject and preferably Master' s degree in Social work or Psychiatry or Sociology or Social Science or Public Health

(2) The concerned organisation or institute shall ensure in itia l induction training followed by retraining at periodic interval and the transplant coordinator shall counsel and encourage the fam ily members or near relatives o f the

(3) The transplant coordinator or counselor in a hospital registered fo r eye banking shall also have qualification specified in sub-rule (1).

30. Advisory committee of the Central or State Government to aid and advise appropriate authority.— (1)

The Central Government and the State Government, as the case may be, shall constitute by notification an Advisory Committee under Chairpersonship o f administrative expert not below the rank o f Secretary to the State Government fo r a period o f two years to aid and advise the Appropriate Authority and the two medical experts referred to in clause(b) o f sub-section(2) o f section 13A o f the Act shall possess a postgraduate medical degree and at least five years' experience in the fie ld o f organ or tissue transplantation.

(2) The terms and conditions fo r appointment to the Advisory Committee are as under:

(a) the Chairperson and members o f the Committee shall be appointed fo r a period o f two years;

(b) the Chairperson and members o f the Committee shall be entitled to the air fare and other allowances to attend the meeting o f the Committee equivalent to the officer o f the level o f the Joint Secretary to the Government o f India;

(c) the Central Government or State Government or Union territory Adm inistration shall have fu ll powers to replace or remove the Chairperson and the members in cases o f charges o f corruption or any other charges after giving a reasonable opportunity o f being heard;

(d) the Chairperson and members can also resign from the Committee fo r personal reasons;

(e) there shall not be a corruption or crim inal case pending against Chairperson and members at the time o f appointment;

(f) the Chairperson or any o f the members shall cease to function i f charges have been framed against him or her in a corruption or crim inal case after having been given a reasonable opportunity o f being heard.

31. Manner of establishing National or Regional or State Human Organs and Tissues Removal and Storage Networks and their functions.— (1) There shall be an apex national networking organisation at the centre, as the Central Government may by notification specify.

(2) There shall also be regional and State level networking organisations where large number o f transplantation o f organ(s) or tissue (s) are performed as the Central Government may by notification specify.

(3) The State units would be linked to hospitals, organ or tissue matching laboratories and tissue banks w ith in their area and also to regional and national networking organisations.

(4) The broad principles o f organ allocation and sharing shall be as under,—

(a) The website o f the transplantation center shall be linked to State or Regional cum State or National networks through an online system for organ procurement, sharing and transplantation.

(b) patient or recipient may get registered through any transplant centre, but only one centre o f a State or region ( if there is no centre in the State) and his or her details shall be made available online to the networking organisations, who shall allocate the registration number, which shall remain same even i f patient changes hospital;

(c) the allocation o f the organ to be shared, is to be decided by the State networking organization and by the National networking organization in case o f Delhi;

(d) a ll recipients are to be listed fo r requests o f organs from deceased donors, however p rio rity is to be given in fo llow ing order, namely:-

(i) those who do not have any suitable liv ing donor among near relatives;

(ii) those who have a suitable liv ing donor available among near relatives but the donor has refused in w riting to donate; and

( iii) those who have a suitable liv ing donor available and who has also not refused to donate in w riting;

(e) sequence o f allocation o f organs shall be in fo llow ing order: State list----Regional L is t-----National L is t— Person o f Indian O rigin ----Foreigner;

(f) the online system o f networking and framework and formats o f national registry as mentioned under rule 32 shall be developed by the apex networking organisation which shall be followed by the States Governments or Union territory Administrations and the allocation criteria may be State specific which shall be finalised and determined by the State Government, in consultation w ith the State level networking organisation, wherever such organisation exists:

Provided that the organ sharing and networking policy o f States or locations o f hospitals shall not be binding on the Armed Forces M edical Services (AFMS) and the armed forces shall be free to have their own policy o f organ or tissue allocation and sharing, and the D irector General Armed Forces M edical Services shall have its own networking between the Armed Forces M edical Services hospitals, who shall be permitted to accept organs when available from hospitals w ith in their State jurisdiction.

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(5) The networking organisations shall coordinate retrieval, storage, transportation, matching, allocation and transplantation o f organs and tissues and shall develop norms and standard operating procedures fo r such activities and fo r tissues to the extent possible.

(6) The networking organisations shall coordinate w ith respective State Government fo r establishing new transplant and retrieval centres and tissue banks and strengthening o f existing ones.

(7) There shall be designated organ and tissue retrieval teams in State or D istrict or institution as per requirement, to be constituted by the State or Regional networking organisation.

(8) For tissue retrieval, the retrieval teams shall be formed by the State Government or Union territory Adm inistration where ever required.

(9) Networking shall be e-enabled and accessible through dedicated website.

(10) Reference or allocation criteria would be developed and updated regularly by networking organisations in consultation w ith the Central or State Government, as the case may be.

(11) The networking organisation(s) shall undertake Inform ation Education and Communication (IEC) A ctivities fo r promotion o f deceased organ and tissue donation.

(12) The networking organisation(s) shall maintain and update organ or tissue Donation and Transplant Registry at respective level.

32. Information to be included in National Registry regarding donors and recipients of human organ and tissue.— The national registry shall be based on the fo llow ing, namely:-

Organ Transplant Registry:

(1) The Organ Transplant Registry shall include demographic data about the patient, donor, hospitals, recipient and donor fo llow up details, transplant waiting lis t, etc., and the data shall be collected from a ll retrieval and transplant centers.

(2) Data collection frequency, etc., w ill be as per the norms decided by the Advisory Committee which may preferably be through a web-based interface or paper submission and the inform ation shall be maintained both specific organ wise and also in a consolidated format.

(3) The hospital or Institution shall update its website regularly in respect o f the total number o f the transplantations done in that hospital or institution along w ith reasonable detail o f each transplantation and the same data should be accessible fo r compilation, analysis and further use by authorised persons o f respective State Governments and Central Government.

(4) Yearly reports shall be published and also shared w ith the contributing units and other stakeholders and key events (new patients, deaths and transplants) shall be notified as soon as they occur in the hospital and this inform ation shall be sent to the respective networking organisation, at least monthly.

Organ Donation Registry:

(5) The Organ Donation Registry shall include demographic inform ation on donor (both liv ing and deceased), hospital, height and weight, occupation, primary cause o f death in case o f deceased donor, associated medical illnesses, relevant laboratory tests, donor maintenance details, driving license or any other document o f pledging donation, donation requested by whom, transplant coordinator, organs or tissue retrieved, outcome o f donated organ or tissue, details o f recipient, etc.

Tissue Registry:

(6) The Tissue Registry shall include demographic inform ation on the tissue donor, site o f tissue retrieval or donation, primary cause o f death in case o f deceased donor, donor maintenance details in case o f brain stem dead donor, associated medical illnesses, relevant laboratory tests, driving license or any other document pledging donation, donation requested by whom, identity o f counsellors, tissue(s) or organ(s) retrieved, demographic data about the tissue recipient, hospital conducting transplantation, transplant waiting lis t and p rio rity lis t fo r critica l patients, i f these exist, indication(s) fo r transplant, outcome o f transplanted tissue, etc.

(7) Yearly reports in respect o f National Registry shall be published and also shared w ith the contributing units and other stakeholders

Pledge for organ or tissue donation after death:

(8) Those persons, who, during their lifetim e have pledged to donate their organ(s) or tissue(s) after their death, shall in Form 7 deposit it in paper or electronic mode to the respective networking organisation(s) or institution where the pledge is made, who shall forward the same w ith the respective networking organisation and the pledger has the option to withdraw the pledge through intim ation.

(9) The Registry w ill be accessible on-line through dedicated website and shall be in conformation to globally maintained registry (ies), besides having national, regional and State level specificities.

(10) National or regional registry shall be compiled based on sim ilar registries at State level.

(11) The identity o f the people in the database shall not be put in public domain and measures shall be taken to ensure security o f a ll collected information.

(12) The inform ation to be included shall be updated as per prevalent global practices from time to time.

33. Appeal.— (1) Any person aggrieved by an order o f the Authorisation Committee under sub-section (6) o f section 9 or by an order o f the Appropriate Authority under sub-section (2) o f section 15 or sub-section (2) o f section 16 o f the Act, may, w ith in th irty days from the date o f receipt o f the order, prefer an appeal to the Central Government in case o f the Union territories and respective State Government in case o f States.

(2) Every appeal shall be in w riting and shall be accompanied by a copy o f the order appealed against.

FORM 1

For organ or tissue donation from identified living near related donor

( to b e c o m p le te d b y h im o r h e r ) ( S e e r u le s 3 a n d 5 ( 3 ) ( a ) ) M y fu ll name (proposed donor) is and this is my photograph T o b e a f f i x e d h e r e . Photograph o f the Donor

(Attested by Notary Public

across the photo after a ffix ing)

M y permanent home address is

Tel:

M y present address fo r correspondence is Tel:

Date o f b ir th ........................................................................................................... (day/month/year)

I enclose copies of the following documents: (attach attested photocopy of at least two of following relevant documents to indicate your near relationship):

• Ration/Consumer Card number and Date o f issue and place:............................................. and/or

• Voter's I-Card number, date o f issue, Assembly constituency......................................... and/or

• Passport number and country o f issue.................................................................................... and/or

• D riving License number, Date o f issue, licensing authority................................................... and/or

• Permanent Account Number (PAN )..................................................................................................................... and/or

AAD H AAR No..............

and/or

Any other valid proof o f identity and address reflecting near relationship

I authorise removal fo r therapeutic purposes and consent to donate m y ................................. (Name o f organ/tissue) to my re la tive ....................................... (Specify son/daughter/father/mother/ brother/sister/grand- father/grand-mother/grand-son/grand-daughter), whose particulars are as follows and name is

...................................................................................................... and who was born on ..................................................(day/month/year) :

T o b e a f f i x e d h e r e .

Photograph o f the Recipient

(Attested by Notary Public

across the photo after a ffix ing)

The copies of following documents of recipient are enclosed (attach attested photocopy of at least two relevant documents to indicate your near relationship):

• Ration/Consumer Card number and Date o f issue and place:......................................... and/ or

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Voter's I-Card number, date o f issue, Assembly constituency and/or

Passport number and country o f issue

and/ or

D riving License number, Date o f issue, licensing authority.. and/or

Permanent Account Number (P A N )................................................................... and/or

AAD H AAR No (Issued by Unique Identification Authority o f India).

and/or

A n y other valid proof o f identity and address reflecting near relationship

I solemnly affirm and declare that:

Sections 2, 9 and 19 o f The Transplantation o f Human Organs Act, 1994 have been explained to me and I confirm that:

1. I understand the nature o f crim inal offences referred to in the sections.

2. No payment as referred to in the sections o f the A ct has been made to me or w ill be made to me or any other person.

3. I am giving the consent and authorisation to remove m y ................................................(name o f organ/tissue) o f my own free w ill w ithout any undue pressure, inducement, influence or allurement.

4. I have been given a fu ll explanation o f the nature o f the medical procedure involved and the risks involved fo r me in the removal o f my ........................................... (name o f organ)/tissue). That explanation was given by .......................................................... (name o f registered medical practitioner).

5. I understand the nature o f that medical procedure and o f the risks to me as explained by that practitioner.

6. I understand that I may withdraw my consent to the removal o f that organ at any time before the operation takes place.

7. I state that particulars fille d by me in the form are true and correct to the best o f my knowledge and be lie f and nothing material has been concealed by me.

Date Signature o f the prospective donor

(Full Name)

Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing the affidavit(s) signs(s) on the Notary Register, as well.

FORM 2

For organ or tissue donation by living spousal donor

(T o b e c o m p le te d b y h im /h e r ) ( S e e r u le s 3 , 5 ( 3 ) ( a ) a n d 5 ( 3 ) ( d ) ) M y fu ll name (proposed donor) is ............................................................................................ and this is my photograph

Photograph o f the Donor T o b e a f f i x e d h e r e

(Attested by Notary Public

across the photo after a ffix ing)

M y permanent home address is

M y present address fo r correspondence is Tel:

Date o f b irth (day/month/year)

I authorize removal fo r therapeutic purposes and consent to donate my ..............................(Name o f organ) to my husband/wife................................................................ whose particulars are as follows and fu ll name is ............................................................................................................................ and who was born on (Day/month/year):

T o b e a f f i x e d h e r e

Photograph o f the Recipient

(Attested by Notary Public

across the photo after a ffix ing)

I enclose copies o f the fo llow ing documents (attach attested photocopy of at least two of following relevant documents to indicate the spousal relationship):

• Ration/Consumer Card number and Date o f issue and place:.............................................. and/or

• Voter's Identity-Card number, date o f issue, Assembly constituency and/or

Passport number and country o f issue...................................... and/or

D riving License number, Date o f issue, licensing authority.. and/or

Permanent Account Number (PAN)

and/or

AADHAAR No. (issued by Unique Identification Authority o f India) and/or

Any other proof o f identity and address establishing spousal relationship I submit the fo llow ing as evidence o f being married to the recipient:-

(a) A certified copy o f a marriage certificate

OR

(b) An affidavit o f a 'near relative' confirm ing the status o f marriage to be sworn before Class-I Magistrate/Notary Public.

(c) Fam ily photographs

(d) Letter from Head o f Gram Panchayat / Tehsildar / B lock Development O fficer/Member o f Legislative Assembly/Member o f Legislative Council (M LC)/Member o f Parliament w ith seal certifying factum and status o f marriage.

OR

(e) Other credible evidence I solemnly a ffirm and declare that sections 2, 9 and 19 o f the Transplantation o f Human Organs Act, 1994 (42 o f 1994), have been explained to me and I confirm that

1. I understand the nature o f crim inal offences referred to in the sections.

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2. No payment o f money or money' s worth as referred to in the Sections o f the Act has been made to me or w ill be made to me or any other person.

3. I am giving the authorisation to remove m y ........................................... (organ) and consent to donate the same ,o f my own free w ill w ithout any undue pressure, inducement, influence or allurement.

4. I have been given a fu ll explanation o f the nature o f the medical procedure involved and the risks involved for me in the removal o f my ........................................... (organ). That explanation was given by .......................................................... (name o f registered medical practitioner).

5. I understand the nature o f that medical procedure and o f the risks to me as explained by that practitioner.

6. I understand that I may withdraw my consent to the removal o f that organ at any time before the operation takes place.

7. I state that particulars fille d by me in the form are true and correct to to the best o f my knowledge and nothing material has been concealed by me.

Signature o f the prospective donor Date

(Full Name)

Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing the affidavit(s) signs(s) on the Notary Register, as well

FORM 3

For organ or tissue donation by other than near relative living donor

(T o b e c o m p le te d b y h im /h e r ) ( S e e r u le s 3 , 5 ( 3 ) ( a ) a n d 5 ( 3 ) ( e ) ) M y fu ll name is ................

and this is my photograph

Photograph o f the Donor^{To be affixed here} (Attested by Notary Public

across the photo after a ffix ing) M y permanent home address is Tel:

M y present address fo r correspondence is ..................................................................... .....................................................................................................................................Tel:

Date o f b irth (day/month/year)

I enclose copies of the following documents: (attach attested photocopy of at least two of following relevant documents to prove your identity):

• Ration/Consumer Card number and Date o f issue and place:............................................. (Photocopy attached)

and/or

• Voter's I-Card number, date o f issue, Assembly constituency......................................... (Photocopy attached)

and/or

• Passport number and country o f issue (Photocopy attached)

and/or

• D riving Licence number, Date o f issue, licensing authority. (Photocopy attached)

and/or

PAN

• A A D H A A R N o......................................................... and/or

• Other proof o f identity and address....................... Details o f last three years income and vocation o f donor (enclose documentary evidence) I authorize removal fo r therapeutic purposes and consent to donate my . .......................... (Name o f organ/tissue) to a person whose fu ll name is .......................................... and who was born on ..................................................(day/month/year) and whose particulars are as follows:

Photograph o f the Recipient

(Attested by Notary Public across the T o b e a f f i x e d

Photo after a ffixing) h e r e

(attach attested photocopy of at least two relevant documents to prove identity of recipient)

• Ration/Consumer Card number and Date o f issue and place:...................................... (Photocopy attached)

and/or

• Voter's I-Card number, date o f issue, Assembly constituency..................................... (Photocopy attached)

and/or

• Passport number and country o f issue..................................... (Photocopy attached)

and/or

• D riving Licence number, Date o f issue, licensing authority.. (Photocopy attached)

and/or

• PAN and/or

• AAD H AAR No and/or

• Other proof o f identity and address ......................................................................................... I solemnly a ffirm and declare that sections 2, 9 and 19 o f the Transplantation o f Human Organs Act, 1994 (42 o f 1994), have been explained to me and I confirm that

1. I understand the nature o f crim inal offences referred to in the Sections.

2. No payment o f money or money' s worth as referred to in the Sections o f the A ct has been made to me or w ill be made to me or any other person.

3. I am giving the consent and authorisation to remove m y ................................................(name o f organ/tissue) o f my own free w ill w ithout any undue pressure, inducement, influence or allurement.

4. I have been given a fu ll explanation o f the nature o f the medical procedure involved and the risks involved fo r me in the removal o f my ........................................... (name o f organ/tissue). That explanation was given by ....................................................... (name o f registered medical practitioner).

5. I understand the nature o f that medical procedure and o f the risks to me as explained by the practitioner.

6. I understand that I may withdraw my consent to the removal o f that organ at any time before the operation takes place.

7. I state that particulars fille d by me in the form are true and correct to the best o f my knowledge and nothing material has been concealed by me.

Signature o f the prospective donor Date

(Full Name)

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Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing the affidavit(s) signs(s) on the Notary Register, as well.

FORM 4

For certification of medical fitness of living donor (To be given by the Registered Medical Practitioner)

[See proviso to rule 5(3)(b)] I, D r..................................................... possessing qualification o f .........................................registered as medical practitioner at serial no.......................... by the ....................................................................................................... M edical Council, certify that I have examined Shri/ Smt./ Km ........................................................... S/o, D/o, W /o Shri .................................................. aged ................ who has given informed consent fo r donation o f his/her ............................................... (Name o f the organ) to Shri/Smt./Km ............................................................. who is a 'near relative' o f the donor/other than near relative o f the donor and has been approved by the competent authority or

Authorisation Committee (as the case may be) and it is certified that the said donor is in proper state o f health, not mentally challenged * and is medically f it to be subjected to the procedure o f organ or tissue removal.

P lace:.................................. ..................................................

Signature o f Doctor

Date: Seal

To be affixed To be affixed

(pasted) here (pasted) here

Photograph o f the Donor Photograph o f the recipient

(Attested by doctor) (Attested by the doctor)

The signatures and seal should partia lly appear on photograph and document w ithout disfiguring the face in photograph * In case o f doubt fo r mentally challenged status o f the donor, the Registered M edical Practitioner may get the donor examined by psychiatrist.

FORM 5

For certification of genetic relationship of living donor with recipient

(T o b e f i l l e d b y th e h e a d o f P a th o lo g y L a b o r a to r y c e r t i f y in g r e la t io n s h ip )

[See rules 5(3)(c) and 18(3)]

I, D r./M r./M r/M iss....................................................................... working as ........................................... at ........................................................ and possessing qualification o f ..................................... certify that Shri/ Smt./ Km. ............................................................ S/o, D/o, W /o Shri/ Smt.................................................................................................. aged ...................... the donor and Shri/ Smt.......................................................................................... S/o, D/o, W /o Shri/Smt....................................................aged ................. the prospective recipient o f the organ to be donated by the said donor are related to each other as brother/sister/mother/father/son/daughter, grandmother, grandfather, grandson and

granddaughter as per their statement. The fact o f this relationship has been established / not established by the results o f

the tests fo r DN A pro filing . The results o f the tests are attached.

(To be signed by the Head o f the Laboratory) Seal

Place ..................................... D a te ......................................

FORM 6

For spousal living donor

( to b e f i l l e d b y c o m p e te n t a u th o r i t y * a n d A u th o r i s a t io n C o m m i t t e e ,o f th e h o s p i ta l o r d i s t r i c t o r s ta te in c a s e o f fo r e ig n e r s )

[See rule 18(2)]

I, D r./M r./M rs/M iss.................................................................. possessing qualification o f ..................................... registered as medical practitioner at serial No. ......................................... by the

......................................................................................M edical Council, certify that:-

M r........................................................................ S/o................................................................................aged..........................resi dent o f ............................................................................................. and M rs..............................................D/o, W /o........................................................................... aged.......................resident o f

...................................................................................... are related to each other as spouse according to the statement given by them and their statement has been confirmed by means o f fo llow ing evidence before effecting the organ removal from

the body o f the said Shri/Sm t/........................................................................ (Applicable only in the cases where considered necessary).

OR

In case the C lin ical condition o f Shri/Smt........................................................... mentioned above is such that recording o f his/her statement is not practicable, reliance w ill be placed on the documentary evidence(s). (mention documentary evidence(s) here)....................................................................................................................... a. Marriage certificate indicate date o f marriage

b. Marriage photographs

c. Date when transplantation was advised by the hospital ( to be compared w ith duration o f marriage):

d. Number and age o f children and their b irth certificates

e. Any other document

Signature o f c o m p e te n t a u th o r i t y * /A u th o r i s a t io n c o m m i t te e in c a s e o f f o r e i g n e r s a lo n g w i th S e a l /S ta m p Place .....................................

D a te ......................................

*D irector or M edical Superintendent or In Charge o f the hospital or the internal committee o f the hospital formed fo r the purpose.as defined under the rules o f Transplantation o f Human Organ Act, 1994(42 o f 1994).

FORM 7

For organ or tissue pledging

(T o b e f i l l e d b y i n d i v id u a l o f a g e 1 8 y e a r o r a b o v e )

[See rule 5(4)(a)]

ORGAN(S) AND TISSUE(S) DONOR FORM

(To be filled in triplicate) Registration Number (To be allotted by Organ Donor Registry)...........................

I ...........................................................................S/o,D/o,W /o............................................................... aged................................. ....and date o f b irth ........................................................................ resident o f

....................................................................................in the presence o f persons mentioned below hereby unequivocally authorise the removal o f fo llow ing organ(s) and/or tissue(s), from my body after being declared brain stem dead by the

board o f medical experts and consent to donate the same fo r therapeutic purposes.

Please tick as applicable

(Follow ing tissues can also be donated after

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brain stem death as w ell as cardiac death) Heart □ Corneas/Eye Balls □

Lungs □ Skin □

Kidneys □ Bones □

Liver □ Heart Valves □

Pancreas □ Blood Vessels □

Any Other Organ (Pl. specify) Any other Tissue (Pl. specify) A ll Organs □ A ll Tissues □

M y blood group is ( if known)...................................................... Signature o f Pledger...................................... Address fo r correspondence......................

Telephone No........................................

Em ail : ..........................................

Dated:

(Note: In case o f online registration o f pledge, one copy o f the pledge w ill be retained by pledger, one by the institution where pledge is made and a hard copy signed by pledger and two witnesses shall be sent to the nodal networking organisation.)

(Signature o f Witness 1)

1. Shri/Smt./Km....................................................................S/o,D/o,W /o................................................................................ aged......................... resident o f.............................................................................Telephone No.................................................. Em ail:........................................................

(Signature o f Witness 2)

2. Shri/Smt./Km....................................................................S/o,D/o,W /o................................................................................ aged......................... resident o f ......................................... Telephone

No........................................ Em ail:................................ is a near relative to the donor a s ..................................... Dated..............................

Place ...............................

Note: (i) Organ donation is a fam ily decision. Therefore, it is important that you discuss your decision w ith fam ily

members and loved ones so that it w ill be easier fo r them to fo llow through w ith your wishes.

(ii) One copy o f the pledge form/pledge card to be w ith respective networking organisation, one copy to be retained by institution where the pledge is made and one copy to be handed over to the pledger. ( iii) The person making the pledge has the option to withdraw the pledge.

FORM 8

_For Declaration cum consent

(T o b e f i l l e d b y n e a r r e la t i v e o r la w fu l p o s s e s s o r o f b r a in - s t e m d e a d p e r s o n )

[See rules 5(1)(b), 5(4)(b) and 5(4)(d)]

DECLARATION AND CONSENT FORM

I ...........................................................................S/o,D/o,W /o................................................................................ aged......................... resident o f ....................................................................................in the presence o f persons mentioned below, hereby declare that:

1. I have been informed that my relative (specify re la tio n )....................................................... S/o,D/o,W /o............................................................................... aged..........................has been declared brain-stem dead / dead.

2. To the best o f my knowledge (Strike o ff whichever is not applicable):

c. There are reasons to believe that no near relative o f the said deceased person has objection to any o f his/her organs/tissue being used fo r therapeutic purposes.

3. I have been informed that in the absence o f such authorisation, I have the option to either authorise or decline donation o f organ/tissue/both including eye/cornea o f .................................... (Name o f the deceased) for therapeutic purposes. I also understand that i f corneas/eyes are not found suitable fo r therapeutic purpose, then may be used fo r education/research.

4. I hereby authorise / do not authorize removal o f his/her body organ(s) and/or tissue(s), namely (A n y o r g a n a n d t i s s u e / K id n e y / L i v e r / H e a r t / L u n g s / I n t e s t i n e /C o r n e a / S k i n / B o n e / H e a r t V a lv e s / A n y o th e r ; p l e a s e s p e c i fy ) ..................................................................... fo r therapeutic purposes. I also give permission fo r drawing o f a blood sample fo r serology testing and am w illin g to share social/behavioural and medical history to facilitate proper

screening o f the donor fo r safe transplantation o f the organs/ tissues.

Date.............................. Signature o f near relative /person in law fu l possession o f the dead body, and address for correspondence*.

P lace............................... Telephone No..................... E m a il:.................................

* in case o f the m inor the declaration shall be signed by one o f the parent o f the m inor or any near relative authorised

by the parent. In case the near relative or person in law fu l possession o f the body refuses to sign this form, the same

shall be recorded in w riting by the Registered M edical Practitioner on this Form.

(Signature o f Witness 1)

1.Shri/Smt./Km....................................................................S/o,D/o,W /o................................................................................ aged......................... resident o f.............................................................................Telephone No.................................................. E m a il:........................................................

(Signature o f Witness 2)

2.Shri/Smt./Km....................................................................S/o,D/o,W /o................................................................................ aged......................... resident o f ......................................... Telephone

No........................................ Em ail:................................

F O R M 9

For unclaimed body in a hospital or prison

(T o b e c o m p le te d b y p e r s o n in la w fu l p o s s e s s i o n o f th e u n c la im e d b o d y ) I s e e r u l e 5 ( 1 ) ( b ) l

I .......... .................S/o,D/o,W /o.......................

aged.................. ..re s id e n t o f ...................... having law fu l possession o f the dead body o f Shri/Smt./Km

S/o,D/o,W /o..... ........................... a g e d ...................... resident o f ..a n d having known that no person has come forward to claim the body

o f the deceased after 48 hours o f death and there being no reason to believe that any person is like ly to come to claim the body I hereby, authorise removal o f his/her body organ(s) and/or tissue(s),

namely..................................................................... fo r therapeutic purposes.

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Signature, Name, designation and Stamp o f person in law fu l possession o f the dead body. Dated..................Place....................

Address fo r correspondence...................................................................... Telephone No........................................ .Email

(Signature o f Witness 1)

1 .Shri/Smt./Km................................................................... S/o,D/o,W /o............ aged......................... resident o f.................................................................... Telephone No.................................................. E m a il...................................................... (Signature o f Witness 2)

2.Shri/Smt./Km................................................................... S/o,D/o,W /o............ aged......................... resident o f ......................................... Telephone No. Email

FORM 10

_For certification of brain stem death

(T o b e f i l l e d b y th e b o a r d o f m e d ic a l e x p e r t s c e r t i f y in g b r a in - s t e m d e a th )

[See rules 5(4)(c) and 5(4)(d)]

We, the fo llow ing members o f the Board o f medical experts after careful personal examination hereby certify that Shri/Sm t./Km .................................................................................... aged about................................ _son o f /w ife o f / daughter o f .................................................................Resident o f is dead on account o f permanent and irreversible cessation o f a ll functions o f the brain-stem. The tests carried out by us and the findings therein are recorded in the brain-stem death Certificate annexed hereto.

Dated........................ Signature................................................

1. R.M.P.- Incharge o f the Hospital 2. R.M.P. nominated from the panel o f In which brain-stem death has occurred. Names sent by the hospitals and approved by the Appropriate Authority.

3. Neurologist/Neuro-Surgeon 4. R.M.P. treating the aforesaid deceased person (where Neurologist/Neurosurgeon is not available, any Surgeon or Physician and Anaesthetist or Intensivist, nominated by M edical Adm inistrator Incharge from the panel o f names sent by the hospital and approved by the Appropriate Authority shall be included)

BRAIN-STEM DEATH CERTIFICATE

(A) PATIENT D E TA ILS ..........................

1. Name o f the patient: M r./M s................................................................. S.O./D.O./W.O. M r./M s................................................................... Sex...............................Age.....................................

2. Home Address: .....................................................................................

3. Hospital Patient Registration Number (CR No.):

4. Name and Address o f next o f kin or person....... responsible fo r the patient .................... ( if none exists, this must be specified) .............

5. Has the patient or next o f k in agreed ............................................................ to any donation o f organ and/or tissue? ............................................................

6. Is this a Medico-legal Case? Yes.............................N o ......................

(B) PRE-CONDITIONS:

1. Diagnosis: D id the patient suffer from any illness or accident that led to irreversible brain damage?

Specify details......................................................................................................................

2. Findings o f Board o f M edical Experts:

_____________________________________ First M edical Examination Second M edical Examination

(1) The fo llow ing reversible causes o f coma have been excluded:

Intoxication (A lcohol)

Depressant Drugs

Relaxants (Neuromuscular blocking agents)

Primary Hypothermia

Hypovolaemic shock

Metabolic or endocrine disorders

Tests fo r absence o f brain-stem functions

(2) Coma

(3) Cessation o f spontaneous breathing

(4) Pupillary size

(5) Pupillary ligh t reflexes

(6) D o ll's head eye movements

(7) Corneal reflexes (Both sizes)

(8) M otor response in any cranial nerve distribution, any responses to stimulation o f face, lim b or trunk.

(9) Gag reflex

(10) Cough (Tracheal)

(11) Eye movements on caloric testing bilaterally.

(12) Apnoea tests as specified.

(13) Were any respiratory movements seen?

Date and time o f firs t testing: ........................................................................................................................... Date and time o f second testing: ........................................................................................................................... This is to certify that the patient has been carefully examined twice after an interval o f about six

hours and on the basis o f findings recorded above,

M r./M s............................................................................ is declared brain-stem dead. Date:

Signatures o f members o f Brain Stem Death (BSD) Certifying Board as under:

1. M edical Adm inistrator Incharge o f the hospital 2. Authorised specialist.

3. Neurologist/Neuro-Surgeon 4. M edical O fficer treating the Patient. Note.

I. Where Neurologist/Neurosurgeon is not available, then any Surgeon or Physician and Anaesthetist or Intensivist, nominated by M edical Adm inistrator Incharge o f the hospital shall be the member o f the board o f medical experts fo r brain-stem death certification.

II. The minimum time interval between the firs t and second testing w ill be six hours in adults. In case o f children 6 to 12 years o f age, 1 to 5 years o f age and infants, the time interval shall increase depending on the opinion o f the above BSD experts.

III. No.2 and No.3 w ill be co-opted by the Adm inistrator Incharge o f the hospital from the Panel o f experts (Nominated by the hospital and approved by the Appropriate Authority).

FORM 11

APPLICATION FOR APPROVAL OF TRANSPLANTATION FROM LIVING DONOR

(T o b e c o m p le te d b y th e p r o p o s e d r e c ip ie n t a n d th e p r o p o s e d l i v in g d o n o r )

[See rules 5(3)(d), 5(3)(e) and 10]

To be self attested To be self attested across the affixed across the affixed photograph photograph

w ithout disfiguring w ithout disfiguring face face

Photograph o f the Donor Photograph o f the recipient

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Whereas I ............................................................... ................. S/o, D/o, W /o, Shri/Smt. ............................................................ aged ............. residing at ......................... have been advised by my

doctor .................................................................... that I am suffering from ............................................................................................ and may be benefited by transplantation o f ..................................................................into my body.

And whereas I ..................... .............. S/o, D/o, W /o, Shri/Smt.

........... aged ... ......................... residing at

................................................................................................by the fo llow ing reason(s):-

a) by virtue o f being a near relative i.e ............................................................

b) by reason o f affection/attachment/other special reason as explained below :-

I would therefore like to donate my (name o f the organ) ...................................................... to Shri/Smt. W e .....................................................................and ........................................................................ (Donor) (Recipient)

hereby apply to competent authority / Authorisation Committee fo r permission fo r such transplantation to be carried out. We solemnly a ffirm that the above decision has been taken w ithout any undue pressure, inducement, influence or allurement and that a ll possible consequences and options o f organ transplantation have been explained to us.

Instructions for the applicants:-

1. Form 11 must be submitted along w ith the completed Form 1 or Form 2 or Form 3 as may be applicable.

2. The applicable Form i.e. Form 1 or Form 2 or Form 3 as the case may be, should be accompanied w ith a ll documents mentioned in the applicable form and a ll relevant queries set out in the applicable form must be adequately answered.

3. Completed Form 5 must be submitted along w ith the laboratory report.

4. The doctor's advice recommending transplantation must be enclosed w ith the application.

5. In addition to above, in case the proposed transplant is between unrelated persons, appropriate evidence o f vocation and income o f the donor as w ell as the recipient fo r the last three years must be enclosed w ith this application. It is clarified that the evidence o f income does not necessarily mean the proof o f income tax returns, keeping in view that the applicant(s) in a given case may not be filin g income tax returns.

6. The application shall be accepted fo r consideration by the competent authority / Authorisation Committee only i f it is complete in a ll respects and any omission o f the documents or the inform ation required in the forms mentioned above, shall render the application incomplete.

7. When the donor is unrelated and the donor and/or recipient belong to a State/Union Territory other than the State/Union Territory, where the transplant is intended to take place, then the Tehsildar or the officer authorised for the purpose o f the dom icile state o f the donor or recipient as the case may be, would provide the verification certificate o f dom icile o f donor/recipient as the case may be as per Form 20. The approval fo r transplantation would be considered by the authorisation committee o f the State/District/hospital (as the case may be) where the transplantation is intended to be done. Such verification Certificate w ill not be required fo r near relatives including cases involving swapping o f organs (permissible between near relatives only).

We have read and understood the above instructions.

Signature o f the Prospective Donor Signature o f Prospective Recipient

Address fo r correspondence: Address fo r correspondence:

Date : Date :

Place : Place :

FORM 12

APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN OR TISSUE

TRANSPLANTATION OTHER THAN CORNEA

(To be filled by head of the institution) (See rule 24(1))

To The Appropriate Authority fo r organ transplantation..................... (State or Union territory)

We hereby apply to be registered as an institution to carry out organ/tissue transplantation. Name(s) o f organ (s) or tissue (s) fo r which registration is required............................................... The required data about the facilities available in the hospital are as follow s:-

(A ) HOSPITAL:

1. Name:

2. Location:

3. Government/Private:

4. Teaching/Non-teaching:

5. Approached by:

Road: Yes No Rail: Yes No A ir: Yes No

6. Total bed strength:

7. Name o f the disciplines in the hospital:

8. Annual budget:

9. Patient turn-over/year:

(B) SURGICAL FACILITIES:

1. No. o f beds:

2. No. o f permanent staff members w ith their designation:

3. No. o f temporary staff w ith their designation:

4. No. o f operations done per year:

5. Trained persons available fo r transplantation (Please specify Organ fo r transplantation):

(C) M ED IC AL FACILITIES:

1. No. o f beds:

2. No. o f permanent staff members w ith their designation:

3. No. o f temporary staff members w ith their designation:

4. Patient turnover per year:

5. Trained persons available fo r transplantation (Please specify Organ fo r transplantation):

6. No. o f potential transplant candidates admitted per year:

(D) ANAESTHESIOLOGY:

1. No. o f permanent staff members w ith their designations:

2. No. o f temporary staff members w ith their designations:

3. Name and No. o f operations performed:

4. Name and No. o f equipments available:

5. Total No. o f operation theatres in the hospital:

6. No. o f emergency operation-theatres:

7. No. o f separate transplant operation theatre:

(E) I.C .U./H .D.U . FACILITIES:

1. I.C .U./H .D.U . facilities: Present....................................... Not present.

2. No. o f I.C .U . and H.D.U. beds:

3. Trained:-

Nurses:

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Technicians:

4. Name o f equipment in I.C.U.

(F) OTHER SUPPORTIVE FACILITIES:

Data about facilities available in the hospital:

(F1) LABORATORY FACILITIES:

1. No. o f permanent staff w ith their-designations:

2. No. o f temporary staff w ith their designations:

3. Names o f the investigations carried out in the Department:

4. Name and number o f equipments available:

(F2) IM AG IN G FACILITIES :

1. No. o f permanent staff w ith their-designations:

2. No. o f temporary staff w ith their designations:

3. Names o f the investigations carried out in the Department:

4. Name and number o f equipments available:

(F3) HAEM ATOLOGY FACILITIES:

1. No. o f permanent staff w ith their-designations:

2. No. o f temporary staff w ith their designations:

3. Names o f the investigations carried out in the Department:

4. Name and number o f equipments available:

(F4) BLOOD BA N K FACILITIES ( Inhouse or access): Y e s ..................................No (F5) D IALYSIS FACILITIES : Y e s ..................................N o........................... F 6. Transplant coordinators (Eye Donation Counselors, in case o f Cornea Transplantaion):

Yes No

Number Posted :

Number Trained

(F 7) OTHER SUPPORTIVE EXPERT PERSONNEL:

1. Nephrologist Yes/No

2. Neurologist Yes/No

3. Neuro-Surgeon Yes/No

4. Urologist Yes/No

5. G.I. Surgeon Yes/No

6. Paediatrician Yes/No

7. Physiotherapist Yes/No

8. Social W orker Yes/No

9. Immunologists Yes/No

10. Cardiologist Yes/No

11. Respiratory physician Yes /No

12. Others..................................... .... Yes / No The above said inform ation is true to the best o f my knowledge and I have no objection to any scrutiny o f our fa c ility by authorised personnel. A Bank Draft/cheque o f Rs. 10000/ (fo r new registration) and Rs. 5000 (fo r renewal) in favour o f _______ is enclosed.

Sd/-

HEAD OF THE INSTITUTIO N

FORM13

APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN/TISSUE RETRIEVAL OTHER THAN EYE/CORNEA RETRIEVAL

(To be filled by head of the institution)

(See rule 24(1))

Note: Retrieval Hospitals may also be identified based on pre-defined criteria and registered as retrieval hospital by the appropriate authority.

To

The Appropriate Authority fo r organ transplantation.....................

(State or Union territory)

We hereby apply to be registered as an institution to carry out organ/tissue retrieval. The required data about the facilities available in the hospital are as follow s:-

(A ) HOSPITAL:

1. Name:

2. Location:

3. Government/Private:

4. Teaching/Non-teaching:

5. Approached by:

Road: Yes No Rail: Yes No A ir: Yes No

6. Total bed strength:

7. Name o f the disciplines in the hospital:

8. Annual budget:

9. Patient turn-over/year:

(B) SURGICAL FACILITIES:

1. No. o f beds:

2. No. o f permanent staff members w ith their designation:

3. No. o f temporary staff w ith their designation:

4. No. o f operations done per year:

5. Trained persons available fo r retrieval (Please specify Organ and/or tissue fo r retrieval):

(C) M ED IC AL FACILITIES:

1. No. o f beds:

2. No. o f permanent staff members w ith their designation:

3. No. o f temporary staff members w ith their designation:

4. Patient turnover per year:

5. Trained persons available fo r retrieval (Please specify Organ and/or tissue fo r retrieval):

6. N o.of critica l trauma cases admitted per year.

7. N o.of brain stem death declared per year.

(D) ANAESTHESIOLOGY:

1. No. o f permanent staff members w ith their designations:

2. No. o f temporary staff members w ith their designations:

3. Name and No. o f operations performed:

4. Name and No. o f equipments available:

5. Total No. o f operation theatres in the hospital:

6. No. o f emergency operation-theatres:

7. No. o f separate retrieval operation theatre:

(E) I.C .U./H .D.U . FACILITIES:

1. I.C .U./H .D.U . facilities: Present....................................... Not present.

2. No. o f I.C .U . and H.D.U. beds:

3. Trained:-

Nurses:

Technicians:

4. Name o f equipment in I.C.U.

(F) OTHER SUPPORTIVE FACILITIES:

Data about facilities available in the hospital:

(F1) LABO RATO RY FACILITIES:

1. No. o f permanent staff w ith their-designations:

2. No. o f temporary staff w ith their designations:

3. Names o f the investigations carried out in the Deptt.:

4. Name and number o f equipments available:

(F2) IM AG ING FACILITIES:

1. No. o f permanent staff w ith their-designations:

2. No. o f temporary staff w ith their designations:

3. Names o f the investigations carried out in the Deptt.:

4. Name and number o f equipments available:

(F3) HAEM ATO LO G Y FACILITIES:

1. No. o f permanent staff w ith their-designations:

2. No. o f temporary staff w ith their designations:

3. Names o f the investigations carried out in the Deptt.:

4. Name and number o f equipments available:

(F4) BLOOD BANKFAC ILITIES: (in house or access) Y e s .......... ..........N o............. (F 5 ) Transplant coordinators: Yes No

Number Posted:

Number Trained

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The above said inform ation is true to the best o f my knowledge and I have no objection to any scrutiny o f our fa c ility by authorised personnel. I hereby give an undertaking that we shall make the facilities o f the hospital including the retrieval team o f the hospital available fo r retrieval o f the organ/tissue as and when needed. Sd/-

HEAD OF THE INSTITUTIO N

FORM 14

APPLICATION FOR REGISTRATION OF TISSUE BANKS OTHER THAN EYE BANKS

(To be filled by head of the institution)

(See rule 24(1))

To The Appropriate Authority fo r organ transplantation..................... (State or Union Territory)

We hereby apply to be registered as Tissue bank , Name :

Name(s) o f tissue (s)(Bone, heart valves, skin, cornea etc) fo r which Registration is required The required data about the facilities available in the institution are as follow s:-

A. General Inform ation :

1. Name

2. Address

3. Government/Private/NGO

4. Teaching /Non- teaching

5. Approached by:

Rail: Yes No Road: Yes No A ir: Yes No 5.Information Education and Communication ( IEC) fo r Tissue Donation 6.Type o f tissue bank: Auto Logons /Allograph/Both

B. DONOR SCREENING

REM O VAL OF TISSUE AND STORAGE:

1. A va ilab ility o f adequate trained and qualified Yes/No Personnel fo r removal Tissue

( annex detail).

2. Names, qualification and address o f the doctors/technician who w ill be doing removal o f Yes/No tissue.

(annex details)

3. Facilities fo r removal o f Tissues Yes/No

4. Whether register o f recipient waiting lis t available. Yes/No

5. Telephone arrangement available. Yes/No ( Telephone Number..................... )

6. A va ilab ility o f ambulance/ vehicle or funds to Pay taxi fo r collecting tissue from outside: Yes/No

7. Sets o f instruments fo r removal o f tissue Yes/No

8. Facilities fo r processing o f tissue Yes/No

9. Refrigerator fo r preservation o f tissue Yes/No

10. Special containers fo r preservation o f tissue during transit. Yes/No

11. Suitable preservation media Yes/No

12. Any other specific requirement as per tissue Yes/No

C.PRESERVATIONS OF TISSUE

Arrangement o f preservation o f Tissue Yes/No

D.RECORDS

1. Arrangement fo r maintaining the records Yes/No

. 2. Arrangement fo r registration o f cases, donors Yes/ No and fo llow up o f cases.

E. EQUIPMENT:

Instruments specific fo r the tissue Yes/No F. LABORATORY FA C IL IT IE S (If the inform ation is exhaustive please annex it) a. Names o f the investigations carried out

in the department.

b. Facility fo r testing fo r :

i. Human Immunodeficiency V irus Type I and II . Yes/No

ii. Hepatitis B Virus - HBc and HBs

iii. Hepatitis C Virus - HCV

iv. Syphilis - VDRL c. I f no where do you avail it ? Please mention name and address o f institute.

d. Facility fo r culture and sensitivity o f tissue Yes/No

G. OTHER PERSONNEL

1. No. o f permanent staff member w ith their designation.

2. No. o f temporary staff w ith their designation

3. No. o f trained persons

A N Y OTHER INFO RM ATIO N

The above said inform ation is true to the best o f my knowledge and I have no objection to any scrutiny o f our fa c ility by authorised personnel. A Bank Daft/cheque o f Rs. 10000/ (for new registration) and Rs. 5000 (fo r renewal) in favour o f _______ is enclosed.

Sd/-

HEAD OF THE INSTITUTIO N

FORM 15

APPLICATION FOR REGISTRATION OF EYE BANK, CORNEAL TRANSPLANTATION CENTRE, EYE

RETRIEVAL CENTRE UNDER TRANSPLANTATION OF HUMAN ORGANS ACT

[See rule 24(1)]

I. EYE BANKING:

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e. Special bottles w ith stands fo r preservation o f Yes/No Eye balls/ cornea during transit.

f. Suitable preservation media Yes/No

g. Biomedical Waste Management. Yes/No

h. Uninterrupted Power supply. Yes/No

C Manpower

1. Incharge / D irector (Ophthalmologist) -1

2. Eye Bank Technician- 2

3. Eye Donation Counselors (EDC)-2 per attached HCRP (Hospital Cornea Retrieval Cornea Programme) Hospital, who w ill be posted at eye Bank.

4. M u lti task Staff(MTS) -2 D. Space requirement fo r eye Banks Yes/No (400sqft minimum)

E. RECORDS

1. Arrangement fo r maintaining the records Yes/ No

2. Arrangement fo r registration o f pledges,/ donors Yes/ and maintenance o f u tilization report No

3. Computer w ith internet fa c ility and Printer Yes/ No

F. EQUIPMENT:

1. S lit Lamp Biomicroscope-1 Yes/No

2. Specular Microscope fo r Eye Bank-1

3. Laminar flow(Class II)-1

4. Sterilization fa c ility ( In-house or outsourced)

5. Refrigerator w ith temperature monitoring fo r preservation o f eye balls/Cornea-1

G LABORATORY FACILITIES

1. Facility fo r H IV , Hepatitis B and C testing. Yes/No

2. I f no where do you avail it? Please mention Name and address o f institute.

3. Facility fo r culture and sensitivity o f Corneoscleral ring. Yes/No

H RENEW AL OF REGISTRATION:

Period o f renewal 5years after last registration. M inim um o f 500 corneas to be collected in 5 years. Maintenance o f eye bank standards( as per Guidelines)

II. EYE RETRIEVAL CENTRE (ERC):

A. RETRIEVAL CENTRE- A Centre a ffilia ted to an Eye Bank

1. Name

2. Address

3. Government/Private/Voluntary

4. Teaching /Non- teaching

5. Information, Education and Communication A ctivities fo r Eye Donation

6. Name o f Eye Bank to which ERC is affiliated.

B REM OVAL OF EYE BALLS AND STORAGE:

1. Manpower : Adequate trained and qualified personnel fo r removal o f eye balls/cornea (annex detail):

a. Incharge / D irector) -1

b. Technician -1

c. MTS ( M u lti task Staff) -1

2. Transport fa c ility ( or outsource) w ith storage medium C Names, qualification and address o f the personnel who w ill be doing enucleation/ removal o f cornea.

(annex details)

D A V A IL A B IL IT Y OF FOLLOW ING:

1. Telephone. (Number..................... )

2. Ambulance/ vehicle or funds to pay taxi fo r collecting eyeballs from outside:

3. Sets o f instruments fo r removal o f Eye Balls/cornea

4. Special bottles w ith stands fo r preservation o f

5. Eye balls/ cornea during transit:

6. Suitable preservation media

7. Waste Disposal (Biomedical waste Management)

8. Space requirement: Designated area

E RECORDS

1. Arrangement fo r maintaining the records

F EQUIPMENT:

1. Sterilization fa c ility

2. Refrigerator temperature control 24 hrs fo r preservation o f Eye balls/Cornea.(power back up) - 1

3. The retrieval centre is a ffilia ted w ith an Eye bank and Eye Bank is only authorised to distribute corneas.

III. CORNEAL TRANSPLANTATION CENTRE

A 1. Name o f the Transplant Centre /hospital:

2. Address:

3. Government/Private/Voluntary:

4. Teaching /Non- teaching:

5. IEC fo r Eye Donation: Yes/No

6. Name o f the registered Eye Bank fo r procuring tissue:

B Staff details:

1. No. o f permanent staff member w ith their designation. (Note : Eye Surgeon' s Experience : 3 month post M D/M S/DNB/DO)

2. No. o f temporary staff w ith their designation

3. Trained persons fo r Keratoplasty and Corneal Transplantation w ith their names and qualifications: 2 (one Corneal Transplant surgeon should be on the pay ro ll o f the Institute) C Equipment : S lit lamp, C lin ical Specular, Keratoplasty or intraocular instruments D OT facilities

E Safe Storage fa c ility

F Records Registration and fo llow up

G Any other inform ation

The above said inform ation is true to the best o f my knowledge and I have no objection to any scrutiny o f our fac ility by authorised personnel. A Bank draft/cheque o f Rs. 10000- fo r new registration and Rs 5000/ fo r renewal o f registration drawn in favour o f ______ is enclosed.

Head o f the Institute

(Name and designation)

FORM 16

CERTIFICATE OF REGISTRATION FOR PERFORMING ORGAN/TISSUE TRANSPLANTATION/RETRIEVAL AND/OR TISSUE BANKING

( S e e r u le 2 4 ( 2 ) ) This is to certify th a t....................................... Hospital/Tissue Bank located at...................................... has been inspected and certificate o f registration is granted fo r performing the organ/tissue retrieval/transplantation/banking o f the fo llow ing organ(s)/tissue(s) (mention the names) under the Transplantation o f Human Organs Act, 1994 (42 o f 1994):-

1.....................................................................

2.....................................................................

3 .................................................................

4 .................................................................

This certificate o f registration is valid fo r a period o f five years from the date o f issue. This permission is being given w ith the current facilities and staff shown in the present application form. Any reduction in the staff and/or fa c ility must be brought to the notice o f the undersigned.

Place............................................. Signature o f Appropriate A uthority.............................. S eal:....................................................

Date

FORM 17

Certificate o f Renewal o f Registration

(To be given by the appropriated authority on the letter head) [See rule 25(2)]

This is w ith reference to the application dated.............................. from ............................ (Name o f the hospital/tissue bank) fo r renewal o f certificate o f registration fo r performing organ(s)/tissue(s) retrieval/transplantation/banking under the Transplantation o f Human Organs Act, 1994 (42 o f 1994). A fter having considered the facilities and standards o f the above-said hospital/tissue bank, the Appropriate Authority hereby renews the certificate o f registration o f the said hospital/tissue bank fo r a period o f five years.

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This renewal is being given w ith the current facilities and staff shown in the present application form. Any reduction in the staff and/or fa c ility must be brought to the notice o f the undersigned. Place............................................. Signature o f Appropriate A uthority.............................. Date.......................................... Seal.............................................................................................

FORM 18

Certificate b y th e A u th o r i s a t io n C o m m it te e o f H o s p i t a l ( I f H o s p i t a l A u th o r i s a t io n c o m m i t te e i s n o t a v a i la b le th e n th e A u th o r i s a t io n C o m m it te e o f th e d is t r i c t / S ta t e ) w h e r e th e t r a n s p la n ta t io n h a s to ta k e p la c e (T o b e i s s u e d o n th e l e t t e r h e a d )

[See rules 16 and 231

T h is i s to c e r t i fy th a t a s p e r a p p l i c a t io n in f o r m - 1 0 f o r t r a n s p la n ta t io n o f _____________________( N a m e o f O r g a n / t i s s u e ) f r o m l i v in g d o n o r , o th e r th a n n e a r r e l a t i v e / s w a p d o n a t io n c a s e s / a l l f o r e i g n e r u n d e r th e T r a n s p la n ta t io n o f H u m a n O r g a n s A c t ,1 9 9 4 (42 o f 1994) s u b m i t t e d o n ..................................b y th e d o n o r a n d r e c ip ie n t , w h o s e d e ta i l s a n d p h o to g r a p h s a r e g iv e n b e lo w , a lo n g w i th t h e i r id e n t i f i c a t io n s a n d v e r i f i c a t io n d o c u m e n ts , th e c a s e w a s c o n s id e r e d a f t e r th e p e r s o n a l in te r v ie w o f d o n o r a n d r e c ip ie n t ( i f m e d ic a l l y f i t to b e in te r v ie w e d ) a n d th e i r r e la t i v e s a s a p p l i c a b le b y th e A u th o r i s a t io n C o m m it te e in th e m e e t in g h e ld o n . . . d a t e d ................................................. D e ta i l s o f R e c ip i e n t D e ta i l s o f D o n o r

N a m e .............................................. N a m e : .................................................

A g e ................................................. A g e .....................................................

S e x ................................................ S e x .....................................................

F a th e r / H u s b a n d N a m e .............. F a th e r / H u s b a n d n a m e ....................

A d d d r e s s : A d d r e s s :

H o s p i t a l R e g . N o ........................... H o s p i t a l R e g . N o .

R e la t io n o f d o n o r w i th R e c ip i e n t .................................................................................. R e c ip i e n t D o n o r

( P h o to o f r e c ip ie n t a n d d o n o r m u s t b e s i g n e d a n d s t a m p e d a c r o s s th e p h o t o a f t e r a f f ix in g ) P e r m is s io n is g r a n te d , a s to th e b e s t o f k n o w le d g e o f th e m e m b e r s o f th e c o m m it te e , d o n a t io n i s o u t o f lo v e a n d a f f e c t i o n a n d th e r e i s n o f i n a n c i a l t r a n s a c t io n b e tw e e n r e c ip ie n t a n d d o n o r a n d th e r e is n o p r e s s u r e o n / c o e r c io n o f th e d o n o r . P e r m is s io n is w i th h e ld p e n d in g s u b m is s io n o f th e f o l l o w i n g d o c u m e n t s .............................................. P e r m is s io n is n o t g r a n t e d f o r th e f o l l o w i n g r e a s o n s

( M e m b e r ) (M e m b e r ) (M e m b e r ) ( M e m b e r )

N a m e a n d D e s ig n a t io n N a m e a n d D e s ig n a t io n N a m e a n d D e s ig n a t io n N a m e a n d D e s ig n a t io n ( M e m b e r ) (M e m b e r ) ( S ig n o f C h a ir m a n w i th s ta m p )

H e a l th S e c r e ta r y D H S o r N o m in e e N a m e a n d D e s ig n a t io n

O r N o m in e e N a m e a n d D e s ig n a t io n

D a te a n d p l a c e ...............

* I n c a s e o f S W A P tr a n s p la n t s , d e ta i l s a r e to b e a n n e x e d

FORM 19

Certificate by competent authority [as defined at rule 2(c)] For Indian near relative, other than spouse, cases (In case o f spousal donor, Form 6 w ill be applicable)

[See rule 5(3)(c)]

(Format fo r the decision o f Competent Authority) This is to certify that as per application in Form-11 fo r transplantation o f_______________________(Name o f Organ or Tissue) from liv ing donor who is a near relative o f the recipient under the Transplantation o f Human Organs Act, 1994(42 o f 1994), submitted on...................................... by the donor and recipient, whose details and photographs are given below, along w ith their identifications and verifications documents, the case was considered after the personal

Name.................................. Name:................................

Age..................................... A g e ...................................

S ex..................................... S ex...................................

Father or Husband Name Father or Husband name

Adddress: Address:

Hospital Reg. N o ............................... Hospital Reg. No

Relation o f donor w ith R ecip ient............................................................................... Recipient Donor

(Photo o f recipient and donor must be signed and stamped across the photo after a ffix ing) Permission is granted, as to the best o f knowledge o f the members o f the committee, donation is out o f their being near relative and there is no financial transaction between recipient and donor and there is no pressure on / coercion o f the donor.

Permission is w ithheld pending submission o f fo llow ing documents....................................... Permission is not granted fo r the fo llow ing reasons

(Signature and stamp o f competent authority)

Date and place...............................................

FORM 20

Verification certificate in r e s p e c t o f d o m ic i l e s ta tu s o f r e c ip ie n t o r d o n o r [ T o b e i s s u e d by tehsildar or any other authorised officer f o r th e p u r p o s e ( r e q u i r e d o n ly f o r th e d o n o r - o th e r th a n n e a r r e la t i v e o r r e c ip ie n t i f th e y d o n o t b e lo n g to th e s ta te w h e r e t r a n s p la n t h o s p i ta l id e n t i f i e d f o r o p e r a t io n i s lo c a te d ) ]

[See rule 14] Part I (To be filled by applicant donor or recipient separately in triplicate)

In reference to application fo r verification o f dom icile status fo r donation o f__________________________ (Name o f organ/Tissue) from liv ing donor (other than near relative) or recipient under Transplantation o f Human Organ Act, 1994 (42 o f 1994), submitted on (date)...................................... by the applicant donor or recipient, w ith fo llow ing details and photograph , along w ith his or her identification and dom icile status fo r verification

Details o f Applicant Recipient or Donor

Name....................................................

Age.......................................................

S ex......................................................

Father or Husband N am e................

Address:

Hospital Reg. No

(Recent Photo o f Applicant must be signed by him or her across the photo after a ffix ing it)

The detail o f my donor or recipient are as under and I have enclosed his or her self-signed recent photograph :

Name....................................................

72

HTTT d^{T TTtdT : VlT/TT}

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Age..................................... S ex..................................... Father or Husband Name

Address:

Hospital Reg. N o ...............................

Signature of Applicant Enclosure : Self signed copy of the donor or recipient for the applicant (to be enclosed ) Part II (To be filled by the certificate issuing authority):

T h e a b o v e r e q u e s t h a s b e e n e x a m in e d a n d i t i s c e r t i f i e d th a t th e d o m ic i l e s ta tu s o f th e a p p l i c a n t d o n o r o r r e c ip ie n t m e n t io n e d a s a b o v e h a s b e e n v e r i f i e d a s u n d e r :

N a m e .............. S o n o r D a u g h te r o r W ife o f .............................

r e s id e n t o f v i l la g e o r w a r d ............... ,.................. ,T e h s i l o r T a lu k a ........................ D is t r i c t ................... S ta te o r

U T ......................

a n d f o u n d c o r r e c t o r in c o r r e c t D a te ........................P lace............................. Authorised Signatory Reference No Name and Designation

O ffice Stamp

2. The authorised signatory w ill hand over this verification certificate to the applicant or his or her representative fo r submission to the Chairperson o f the Authorisation Committee o f the hospital or d istrict or state (as the case may be), where transplantation has to take place.

3. The authorised signatory shall keep one copy o f the above verification certificate fo r his records and send a copy to the Secretary, Health and Fam ily W elfare o f the State Government (Attention Appropriate authority fo r organ transplant) fo r information.

4. In case o f any suspicion o f organ trading, the authorised signatory mentioned above or Appropriate Authority o f the state may inform police fo r making enquiry and taking necessary action as per the Transplantation o f Human Organs Act, 1994 (42 o f 1994).

FORM 21

Certificate o f relationship between donor and recipient in case o f foreigners (To be issued by the Embassy concerned)

[See rule 20(a)]

The embassy o f _______________ (Name o f Country) in India, is in receipt o f an application received from ___________________________ (Name o f Organ donor and recipient) on _____________ (Date) recommended by_________________________ (Name o f Government Department o f country o f orig in) fo r facilita tion o f donation o f __________________________ (Name o f Organ or Tissue) from liv ing donor ________________________ (Name o f donor) to the recipient ____________________________ (Name o f recipient) fo r therapeutic purposes under the Transplantation o f Human Organ Act, 1994(42 o f 1994). The details o f donor and recipient and photographs are as given below.

Details o f Recipient Details o f Donor

(Photo o f recipient and donor must be signed and stamped across the photo after a ffix ing) 1, This is to certify that relationship between donor and Recipient is ............................................

2. The authenticity o f fo llow ing enclosed identification and verification documents is certified a. __________________________________________________

b. ___________________________________________________

'No objection certificate' is granted, as to the best o f my knowledge, the donor is donating out o f love and affection or affection and attachment towards the recipient, and there is no financial transaction between recipient and donor and there is no pressure on or coercion o f the donor.

(Signature o f Senior Embassy O ffic ia l)

Date: N am e:..............................

Place: Designation...............................

[No S.12011/28/2012-MG/MS]

ARUN K. PANDA, Jt. Secy.

Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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