Conditions and standards for grant of certificate of registration for organ or tissue transplantation centres.

(1) No hospital shall be granted a certificate of registration for organ transplantation unless it fulfills the following conditions and standards, namely:- A. General manpower requirement specialised services and facilities: (a) Twenty-four hours availability of medical and surgical, (senior and junior) staff; (b) twenty-four hours availability of nursing staff (general and specialty trained); (c) twenty-four hours availability of Intensive Care Units with adequate equipment staff and support system, including specialists in anesthesiology and intensive care; (d) twenty-four hours availability of blood bank (in house or access) , laboratory with multiple discipline testing facilities including but not lim ited to Microbiology, Bio-Chemistry, Pathology,-Hematology and Radiology departments with trained staff; (e) twenty-four hours availability of Operation Theater facilities (OT facilities) for planned and emergency procedures with adequate staff, support system and equipment; (f) twenty-four hours availability of communication system, with power backup, including but not lim ited to multiple line telephones, public telephone systems, fax, computers and paper photo-imaging machine; (g) experts (other than the experts required for the relevant transplantation) of 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 for respective organ or tissue transplant shall be available in the transplantation hospital; and (i) Human Leukocyte Antigen (HLA) 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 availability of the accessories, spare-parts and back-up, maintenance and service support system in relation to all relevant equipments. C. Experts and their qualifications: (a) Kidney Transplantation: M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. training in a recognised transplant center in India or abroad and having attended to adequate number of renal transplantation as an active member of team; (b) Transplantation of liver and other abdominal organs: M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. experience in the speciality and having one year training in the respective organ transplantation as an active member of 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 with at least three 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) the hospital registered under Clinical Establishment (Registration and Regulation) Act, 2010 (23 of 2010) shall also follow the minimum standards prescribed in respect of manpower, equipment, etc., as prescribed under that Act; (e) the hospital registered shall have to maintain documentation and records including reporting of adverse events. (2) No hospital shall be granted a certificate of registration for tissue transplantation under the Act unless it fulfills the following conditions and standards, namely:- (a) Cornea Transplantation: M.D. or M.S. or Diploma (DO) in ophthalmology or equivalent qualification with 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 (MD or MS) or equivalent qualification in the respective specialty with three months post M.D. or M.S training in a recognised hospital carrying out respective tissue transplant operations and for heart valve transplantation, and the qualification and experience of expert shall be MCh degree in Cardiothoracic and Vascular Surgery (CTVS) or equivalent qualification with three months post MCh training in a recognised hospital carrying out heart valve transplantation; (c) the Hospital registered under Clinical Establishment (Registration and Regulation) Act, 2010(23 of 2010) shall also follow the minimum standards prescribed in respect of manpower, equipment, etc., as prescribed under that Act; (d) the Hospital registered shall have to maintain documentation and records including reporting of adverse events.