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The Transplantation of Human Organs Rules, 1995 - Registration of Hospital

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Indian Laws and Regulations Related to Health

7. REGISTRATION OF HOSPITAL

 (1)   An  application for registration shall be made to the Appropriate Authority as specified in Form 11. The application shall be accompanied by a fee of rupees one thousand payable to the Appropriate Authority by means of a bank draft or postal order.

(2)   The Appropriate Authority shall after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements, grant a certificate of registration as specified in Form 12 and shall be valid for period of 5 years from the date of its issue and shall be renewable.

8. RENEWAL OF REGISTRATION

(1)  An application for the renewal of a certificate or registration shall be made to the Appropriate Authority within a period of three months prior to the date of expiry of the original certificate of registration and shall be accompanied by a fee of rupees five hundred payable to the Appropriate Authority by means of a bank draft or postal order.

(2)  A renewal certificate of registration shall be as specified in Form 13 and shall be valid for a period of five years.

(3)  If, after an inquiry including inspection of the hospital and security of its past performance and after giving an opportunity   to the applicant, the Appropriate Authority is satisfied that the applicant, since grant of certificate of registration the under sub-rule (2) of Rule 7 has not complied with the requirements of this Act and the rules made there under and conditions subject to which the certificate of registration has been granted, shall, for reasons to be recorded in writing, refuse to grant renewal of the certificate of registration.  

(9) CONDITIONS FOR GRANT OF CERTIFICATE OF REGISTRATION

No hospital shall be granted a certificate of registration under this Act unless it fulfills the following requirement of manpower, equipment, specialised services and facilities as laid down below -  

GENERAL REQUIREMENT

1.    Surgical Staff
2.    Cardiology Staff
3.    Nursing Staff
4.    Communication System
5.    Intensivist
6.    Medical Social Worker
7.    Perfusionist

VARIOUS DEPARTMENT

1.    Microbiology
2.    Mycology
3.    Pathology
4.    Virology
5.    Nephrology
6.    Neurology
7.    Psychology
8.    G.I. Surgery
9.    Anaesthesiology
10.  Imaging Facilities
11.  Paediatrics
12.  Physiotherapy
13.  Immunology
14.  Haematology
15.  Blood Bank
16.  Clinical Chemistry
17.  Cardiology

NON-TRANSPLANTATION PROGRAMME TEAM

1.  Neurologist
2.  Neurosurgeon
3.  Medical Superintendent
4.  Any other hospital Staff 

BASIC EQUIPMENT

     Operating Room facilities for routine open heart surgery which includes heart-lung machine and accessories. 

ADDITIONAL EQUIPMENT REQUIRED FOR TRANPLANTATION PROGRAMME

1. Cell Saver
2. Assist devices like IABP, Centrifugal Pump and various assist devices, both pneumatic and electric operated.
3. Mobile C-arm image intensifier for routine biopsies in the street operating room
4. Euct /Alert system for early detection of any infection
5. Radioimmunoassay for measuring Cyclosporin levels.
6. Routine Laboratory facilities for detection of HIV, Australia antigen, CMV, Toxoplasnosis and other Mycology Tests

EXPERTS

(A)  Kidney Transplantation

       M.S. (Gen.) Surgery or equivalent qualification which three years post M.S. training a recognized center in India or abroad and having attended to adequate number of renal transplantation as an active member of team

(B)   Transplantation of Liver & Other Abdominal Organs

       M.S. (Gen.) Surgery or equivalent qualification with adequate post M.S. training in an established center with reasonable experience of performing liver transplantation as an active member of team

        (a) Cardiac, Pulmonary Cardio-Pulmonary Transplantation.

            M.Ch Cardio-thoracic and vascular surgery or equivalent qualification in India or abroad with at least 3 years experience as an active member of the team performing an adequate number of open heart operations per year  and well-versed with coronary by-pass surgery and Heart valve Surgery.

10. APPEAL

       (1) Any person aggrieved by an order of the Authorisation  Committee under sub-section (6) of section 9, or by an order of the Appropriate Authority under sub-section (2) of section 15 and Section 16 of the Act, may, within thirty days from the date of receipt of the order, prefer an appeal  to the Central Government

      (2) Every appeal shall be in writing and shall be accompanied by a copy of the order appealed  against

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