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The Transplantation of Human Organs Rules, 1995 (2)
Date 19/10/11/03/30  Author Infrosoft Health Content Team  Hits 949  Language Global
G.S.R. 51 (E) - In exercise of the powers conferred by sub-section (1) of Section 24 of the Transplantation of Human Organs Act. 1994(42 of 1994), the Central Government hereby makes the following rules, namely -

 FORM -6

[(See rule 4(2) (b)] 

I..................................................................s/o,d/o,w/o........................................aged.................
resident of................................................................................having lawful      possession of the dead body Sri/Smt/km........................s/o,d/o,w/o....................................................................aged...........
 of........................................................................................................having} known that the deceased has not expressed any objection to his/her organ/organs being removed for therapeutic purposes after his/her death and also having reasons to believe that no near relative of the said deceased person has objection to any of his/her organs being used for therapeutic purposes authorise removal of his/her body organs, namely..............................................

Dated...............................                                                                                              

Signature

Place …………………...  Person in lawful possession of the dead body 

Address..................................................................................
.............................................................................................

 

FORM -7
[(See rule 4(2) (b)] 

I, Mr/ Mrs./Miss.....................................................................having lawful possession of the deadbody of Mr/ Mrs./Miss............................................................son of/ daughter of / wife of ..................... ............ aged .................................. resident of ........................................after having known that the objection was expressed by the deceased to any of his human organs being used after is death for therapeutic purposes and having reason to believe of deceased person has objection to any of the deceased person's organs being used for therapeutic purposes, hereby authorise the removal of the deceased’s organ, namely, ………………………………………………. for therapeutic purposes. 

Signature........................................................

Name..............................................................
Address..........................................................
.......................................................................
Time and Date ……………………………...  

 

FORM - 8
[(See rule 4(3) (a) and (b)]

We the following members of the Board of medical experts after careful personal examination hereby certify that Shri/Smt/Km.......................................................................aged about.......................son of/wife of/ daughter of...........................................................resident of ...................................................................is dead on account of permanent and irreversible cessation of all function of the brain stem. The test carried out by us and the findings therein are recorded in the brain stem death Certificates annexed hereto. 

Dated                                                                         Signature

1. R.M.P Incharge of the Hospital in which brain-stem death has occurred. 
2. R.M.P. nominated from the panel of names approved by the Appropriate Authority
3. Neurologist / Neuro Surgeon nominated. from the panel of names approved by Appropriate Authority.
4. R.M.P. treating the aforesaid deceased person 

BRAIN STEM DEATH CERTIFICATE
 
(A) PATIENT DETAILS :

1. Name of the Patient Mr/Ms. ....................................…….......................... S.O./D.O./W.O. Mr. ........................................ .................... .......... Sex................................ Age .......................

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

3. Hospital Number ..................................................................... . . ....................................................................     
 
4. Name and Address of next of kin or   .....................................................................
person responsible for the patient (if none .....................................................................
exists,this must be specified) ……………………………………………
....................................................................
....................................................................

5. Has the patient or next of kin agreed ....................................................................to any transplant ? .....................................................................

6. In this a police Case ? Yes.............................No............................
 
(A) PRE-CONDITIONS:
 
1. Diagnosis : Did the patient suffer from any illness or accident that led to irreversible brain damage? Specify details ..............................................................................................
...........................................................................................................................................
Date and time of accident/onset of illness ............................................................................
Date and onset of no-responsible coma …............................................................................

2. Finding of Board of Medical Experts : (i) The following reversible causes of coma have been excluded:
 
Intoxication (Alcohol)
Depressant Drugs
Relaxants (Neuromuscular blocking agents)
 
First Medical Examination Second Medical Examination
 
1st               2nd

Primary hypothermia
Hypovolaemic shock
Metabolic or endocrine disorders
Tests for absent of brain stem functions

2) Coma
3) Cessation of spontaneous breathing.
4) Pupillary Size
5) Pupillary light reflexes
6) Doll's head eyes movement
7) Corneal reflexes (Both Sizes)
8) Motor response in any cranial nerve distribution, any responses to simulation of face limb of 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 of first testing ........................................................................
Date and Time of second testing ........................................................................

This to certify that the patient has been carefully examined twice after an interval of about six hours and on the basis of findings recorded above, Mr/Mrs................................................................. is declared brain-stem dead.

1. Medical Administrator Incharge of the hospital  

2. Authorized Specialist
3. Neurologist/ Neuro Surgeon                                                        

4. Medical officer treating patient.

NB. I. The minimum time interval between the first testing and second testing will be six hours.
       II. No.2 and No.3 will bo co-opted by the administrator incharge of the hospital from the panel of experts approved by the appropriate authority.

 

FORM 9
             (See rule 4(3) (b))                

I, Mr/Mrs....................................son of / wife of.......................resident of...........................hereby authorise removal of the organ/organs namely..................................for therapeutic purposes from the dead body of my son/daughter . Mr/Ms...............................................................aged.........................whose brain stem death has been duly certified in accordance with the law
                                                                                             

   Signature..............................

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

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

 Date......................................

 

 

FORM -10 

 APPLICATION FOR APPROVAL  FOR TRANSPLANTATION LIVE DONOR OTHER THAN  NEAR RELATIVE

Whereas I ....................................................S/O, D/O, W/O, L/O.............................aged
residing...................................................................have been informed by my doctor that I am suffering from.......................and may be benefitted by transplantation ......................... into my body.
 and whereas I ......................................................…………………………….. S.O. D.O. W.O......................................... aged .................. residing at..........................................by reason of affection and attachment because : ...............................................................................................
..............................................................................................................................................
(reason to be filled in) would like to donate  my....................................to............................we................................. (donor) and............................................hereby apply to authorization committee for permission      (Recipient) for such transplantation to be carried out.

        We solemnly affirm that the above decision has been taken without any undue pressure, inducement, influence or allurement and that all-possible consequences and options of organ transplantation have been explained to us........................................................................................................................................
............................................................................................................................................
 

Signature and address of prospective                  Signature and address of prospective   donor                                                                      recipient   

 

FORM 11

APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN TRANSPLANTATION

To

The Appropriate Authority for organ transplantation ..............................(State of Union Territory) We hereby apply to be recognised as an institution to carry out organs transplantation. The required data about the facilities available in the hospital are as follows:-

(A) HOSPITAL

1. Name:

2. Location:

3. Govt./pvt. :

4. Teaching/Non Teaching:

5.Approached by:

Road: Yes No

Rail : Yes No

Air : Yes No

6. Total bed strength :

7.Name of the disciplines in the hospital :

8. Annual budget :

9. Patient turn-over/year : 

 

(B) SURGICAL TEAM :

1. No.of beds:

2. No. of permanent staff members with their designations:

3. No. of temporary staff with their designations:

4. No. of operations done per year:

5. Trained persons available for transplantation                                           (Please specify organ for transplantation)

 

(C) MEDICAL TEAM:

1. No. of beds:

2. No. of permanent staff members with their designation:

3. No. of temporary staff members with their designation:

4. Patient turnover per year:

5. No. of potential transplant candidates admitted per year:

 

(D) ANAESTHESIOLOGY

1. No. of permanent staff members with their designation:

2. No. of temporary staff members with their designations:

3. Name and No.of operations performed:

4. Name and No. of equipments available:

5. Total No. of operation theatres in the Hospital:

6. No. of emergency operation theatres:

7. No. of separate transplant operation theatres:

 

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

1. ICU/HDU facilities : Present.....................Not Present..............

2. No. of I.C.U beds .................................................................

3.Trained
Nurses .................................................

Technicians ..........................................

4. Name and number of equipments in ICU

(F) OTHER SUPPORTIVE FACILITIES

Data about facilities available in hospital.

(G) LABORATORY FACILITIES :

No. of permanent staff with their designations

No. of temporary staff with their designations

Names of the investigations carried out in the Dept

Name and number of equipments available

(H) IMAGING SERVICES

1. No. of permanent staff with their designations

2. No. of temporary staff with their designations

3. Names of the investigations carried out in the Dept

4. Name and number of equipments available

(I) HAEMATOLOGY SERVICES

1. No. of permanent staff with their designations

2. No. of temporary staff with their designations

3. Names of the investigations carried out in the Dept

4. Name and number of equipments available

(J) BLOOD BANK FACILITIES: Yes........................... No....................

(K) DIALYSIS FACILITIES Yes........................... No.................…

(L) OTHER PERSONNEL

Nephorlogist                Yes/No

Neurologist                  Yes/No

Neuro-Surgeon            Yes/No

Urologist                      Yes/No

G.I. Surgeon                Yes/No

Paediatrician                Yes/No

Physiotherapist            Yes/No

Social Worker               Yes/No

Immunologists              Yes/No

Cardiologist                  Yes/No

The above said information is true to the best of my knowledge and I have no objection to any scrutiny of our facility by authorized personnel. A Bank Draft/Cheque of Rs. 1,000/- is being enclosed.

sd/-

HEAD OF THE INSTITUTION

 

FORM-12

CERTIFICATE OF REGISTRATION

This is to certify that.....................................Hospital located at..............................…...has been inspected by the Appropriate Authority and certificate of registration is granted for performing the organ transplantation of the following organs

 1.    ...................................................
 2.    ....................................................
 3.    ...................................................
 4.    ....................................................

   This certificate of registration is valid  for a period of five years from the date of issue.
 

Signature                                                           Signature  

 

FORM-13

(See sub-rule 8(2))

OFFICE OF THE APPROPRIATE AUTHORITY

This is with reference to the application, dated..................................from.................... (Name of the hospital) for renewal of certificate of registration for performing organ transplantation under the Act.

After having considered the  facilities and standards of the above said hospital the Appropriate Authority hereby renews the certificate of registration of the said hospital for the purpose of performing organ transplantation for a period of five years.
  

                                                                                    Appropriate Authority..................

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

             
Date..................................

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