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Living Donor Transplant Checklist

Check List for Application to Authorization Committee
Sr. No Document
1
Application for transplant approval forwarded by the Medical Superintendent (MS)/ Head of the hospital/ Medical Director (MD)/ Hospital Administrator (HA) of the hospital where the transplant surgery is proposed to be carried out to the Chairman of State Authorization Committee with name of donor and recipient, transplant physician and transplant surgeon.
2
Information (as applicable) in: Form No. 1, 2, 3 and Form 11 with respective documents as per the format given in the Transplantation of Human Organs and Tissue Rules 2014.
3
Copy of Form 16/Form 17 - Certificate of Registration/Renewal of the Hospital as a Transplant Hospital.
4
Treatment certificate from Transplant physician and transplant surgeon stating recipient's diagnosis and recommendation for organ transplant and that the recipient, donor and other significant family has been explained about the organ donation/transplant surgery, its possible outcome, complications, need for life long immunosuppressive medication, medical expenses, donor risk and need for regular medical follow up etc. for which they have expressed their willingness and acceptance.
5
Histocompatibility reports of donor & recipient (H.L.A. Cross match, H.L.A. Typing). DNA profiling to establish genetic relationship between living donor and recipient from NABL Accredited Lab, in Form No 5.*(Applicable only for near related)
6
Blood group report of Recipient and donor.
7
Certificate from a registered psychiatrist regarding Psychiatric assessment and fitness of the donor & recipient.
8
FORM 4 For certification of medical fitness of living donor (To be given by the Registered Medical Practitioner)
9
Police verification report of recipient and donor residential address and criminal records if any. The photograph of both recipient and donor should be duly signed across and stamped by the In charge of the police station issuing the verification report. *(applicable for related/unrelated/swap/foreigners within and out of the state/country)
10
Attested True Copy of Ration Card, Passport, Election Card, Identity card, Marriage Certificate, Family Photo, Passport size photo of recipient and donor, Children Birth Certificate, Domicile/ address proof, Aadhar card where necessary. (Original to be shown in the meeting)
11
Affidavit* by recipient on Rs.100/-stamp paper stating his/her complete family tree including self.
12
Affidavit* by recipient on Rs.100/-stamp paper stating the list of his/her family members (near relatives) with age, profession, relation, blood group and giving the reasons why family members(near relatives) cannot donate the kidney/liver with proofs and documents (e.g., medical reports attested by the MS) of near relative if they cannot donate on medical grounds.
13
Affidavit* by Donor on Rs.100/-stamp paper stating his/her complete family tree including self.
14
Affidavit* by donor on Rs.100/-stamp paper giving reasons for organ donation and mentioning the facts & proof in support of reasons.
15
Affidavit* by next of kin* of donor on Rs.100/- stamp paper giving permission/approval for organ donation. *The next of kin in case of female donor is a maternal family member (father, mother, brother, sister) who gives the approval for the organ donation proposed.
16
Affidavit* by next of kin* of recipient on Rs.100/- stamp paper giving permission/approval for organ donation/transplant.
17
All the above affidavits from serial no.11 to 16 should be registered in the notary register and should bear the same registration number. It should also indicate the name and sign of the person (witness) identifying the person making the affidavit.
18
For Maiden name attach marriage certificate, school leaving certificate or Gazette copy of change in name.
19
Income particulars* and vocation of recipient and donor for previous three financial years (as per Judgment of Supreme Court of India, New Delhi dated March 31, 2005) *required only for the donor-other than near relative or recipient if they do not belong to the state/country where transplant hospital identified for operation is located.
20
If recipient or donor or both are not domicile of Goa and are registered in Goa for organ transplant then FORM 20 Verification certificate in respect of domicile status of recipient or donor [To be issued by tehsildar or any other authorised officer for the purpose (required only for the donor - other than near relative or recipient if they do not belong to the state where transplant hospital identified for operation is located)]
21
In the case of foreign nationals registering for transplant in India FORM 21 Certificate of relationship between donor and recipient in case of foreigners (To be issued by the Embassy concerned) In case a country does not have an Embassy in India, the certificate of relationship, in the same format, shall be issued by the Government of that country. *Applicable to all Indian donors consenting to donate organs to a foreign national (who is a near relative), including a foreign national of Indian origin. The Indian living donors wanting to donate to a foreigner other than near relative shall not be considered.
General Instructions to Transplant Coordinator
  • The state authorization committee meetings will be conducted on the first and third Friday of every month. In case the said day is a public holiday, it will be held on the preceding working day.
  • Kindly put all documents as per checklist serially with tags for easy reference.
  • The application shall be accepted for consideration by the concerned Competent Authority / Authorization Committee only if it is complete in all respects and any omission of the documents or the information required in the forms mentioned above, shall render the application incomplete.
  • All the original documents are required for verification at the time of interview.
  • All the concerned family members or next of kin of the donor and recipient should be available for interview by the authorization committee.
  • The interview and meeting proceedings will be videographed.
  • The minutes of the meeting will be documented and circulated to all the committee members.
  • The transplant coordinator of the hospital to be present at the interview to coordinate.
  • The timeline for the process is to be strictly complied with.
TIMELINE FOR FUNCTIONING OF THE STATE AUTHORIZATION COMMITTEE
For permission for living donor organ transplant
Sr. No Steps Timeline Responsible Person
1
Processing of application including communication of deficiencies in documents to donor or/and recipient
10 days
Secretariat of Authorization Committee
2
Donor or/and recipient response time to the deficiencies communicated
07 days & with due consideration the extension may be given for completion
Transplant coordinator with donor or/and recipient
3
Authorization Committee meeting scheduled date
07 days
Secretariat of Authorization Committee
4
Intimation to the applicants/transplant coordinator
03 days
Secretariat of Authorization Committee
5
Circulate the documents to the members of Authorization committee
03 days
Secretariat of Authorization Committee
6 a
Communication of final decision
24 hours*Authorized transplant hospital displays it on their website and the notice board with strictly maintaining the confidentiality of the applicants.
Secretariat of Authorization Committee Who makes the minutes of the interview and also video graphs the interview.
6 b
Communication of deficiencies/clarifications sought by the authorization committee
24 hours
Secretariat of Authorization Committee
6 c
Donor or/and recipient response time to the deficiencies communicated
07 days
Transplant coordinator with donor or/and recipient
7
Deadline for the process above mentioned from 1 to 6
NOT TO EXCEED 6 to 8 WEEKS
8
Verification document Form 20
14 days
Tehsildar
9
Form 21
07 days
Concerned Embassy
10
Appeal
Within 30 days
Aggrieved applicants place complaint with Secretary Health (AA) with copy of decision.
Special Notes:
  1. E-Aadhar verification of the identity of the prospective donor and recipient is mandatory in all cases.
  2. Donation from a Minor living donor shall not be considered without the prior approval of the Appropriate Authority and the State Government. It will be considered strictly as per the Guidelines as may be notified by the MoH&FW, Govt. of India.
  3. No swap transplant between a pair of foreign donor and recipient and a pair of Indian donor and recipient shall be considered by the Authorization committee as under THOTA 1994, no Indian donor can donate to a foreigner unless he/she is a near relative. (Over riding clause)
  4. Validity of the permission is 3 months. If due to some reason, transplant is not performed within 3 months, a fresh new application requesting extension should be submitted citing the reason for not performing the surgery. It is at the discretion of the Chairman, Authorization committee to call for a physical interview or not.
  5. Authorization committee permission is given to the stated transplant hospital as well as to the stated transplant physician & surgeon. Permission is not transferrable. If the applicants wish to change the hospital or/and transplant physician & surgeon, a fresh application will need to be submitted & process repeated.
Forms:

– Form 1 – FOR ORGAN/TISSUE DONATION FROM IDENTIFIED LIVING NEAR RELATED DONOR (to be completed by HIM OR HER)
– Form 2 – FOR ORGAN/TISSUE DONATION BY LIVING SPOUSAL DONOR (to be completed by HIM OR HER)
– Form 3 – FOR ORGAN/TISSUE DONATION BY OTHER THAN NEAR RELATIVE LIVING DONOR (to be completed by HIM OR HER)
– Form 4 – FOR CERTIFICATION OF MEDICAL FITNESS OF LIVING DONOR (to be given by The Registered Medical Practitioner)
– Form 5 – FOR CERTIFICATION OF GENETIC RELATIONSHIP OF LIVING DONOR WITH RECIPIENT (To be filled by. The Head of Pathology Laboratory. certifying relationship)
– Form 11 – APPLICATION FOR APPROVAL OF TRANSPLANTATION FROM LIVING DONOR (to be completed by the proposed Recipient & the proposed Living Donor)
– Form 20 – VERIFICATION CERTIFICATE IN RESPECT TO DOMICILE STATUS OF RECIEPIENT OR DONOR {(To be issued by tehsildar or any other authorized officer for the purpose (required only for the donor-other than near relative or recipient if they do not belong to the state where transplant hospital identified for operation is located)}
– Form 21 – CERTIFICATE OF RELATIONSHIP BETWEEN DONOR AND RECIPIENT IN CASE OF FOREIGNERS (To be issued by the Embassy concerned)