The Transplantation of Human Organ Rules 1995 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, specialized services and facilities as laid down below;-

(A) General Manpower Requirement Specialised Services and Facilities:

1. 24 hours availability of medical and surgical, (senior and junior) staff.

2. 24 hours availability of nursing staff, (general and speciality trained).

3. 24 hours availability of Intensive Care Units with adequate equipments, staff and support system, including specialists in anaesthesiology, intensive care.

4. 24 hours availability of laboratory with multiple discipline testing facilities including but not limited to Microbiology, Bio-Chemistry, pathology and Hematology and Radiology departments with trained staff.

5. 24 hours availability of Operation Theatre facilities (OT facilities) for planned and emergency procedures with adequate staff, support system and equipments.

6. 24 hours availability of communication system, with power backup, including but not limited to multiple line telephones, public telephone system, fax, computers and paper photo-imaging machine.

7. Experts, (other than the experts required for the relevant transplantation) of relevant and associated specialties including but not limited to and depending upon the requirements, the experts in internal medicine, diabetology, gastroenterology, nephrology, neurology, paediatrics, gynaecology, immunology and cardiology etc. should be available to the transplantation center.

(B) Equipments:

Equipments as per current and expected scientific requirements specific to organ or organs being transplanted. The transplant center should ensure the availability of the accessories, spare-parts and back-up/maintenance/service support system in relation to all relevant equipments.

(C) Experts and their qualifications:

1. Kidney Transplantation

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

2. Transplantation of liver and other abdominal organs

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

3. 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.

(d) Cornea Transplantation

M.D./M.S. ophthalmology or equivalent qualification with one year post M.D./M.S. training in a recoginsed hospital carrying out Corneal transplant operations.]

10. Appeal

(1) Any person aggrieved by an order of the Authorisation Committee under sub-section (6) of section9, 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.