SOTTO – Goa

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Registration of Hospital & Tissue Bank

Check list provided by SOTTO Goa for registering as a transplant hospital as per THOA Rules 2014
  1. Application for registration shall be made to the Appropriate Authority(Secretary Health, Government of Goa) as applicable.
    Form 12 – Registration of organ or tissue Transplant Hospital other than cornea
    Form 13 – Registration of organ or tissue Retrieval Hospital other than cornea
    Form 14 – Registration of Tissue Bank other than eye bank
    Form 15 – Registration of Cornea Transplant Hospital/Cornea Retrieval Centre/Eye Bank
  2. Application shall be accompanied by fee payable to the Appropriate Authority by means of a bank draft drawn in the favour of Director, Directorate of DHS: –
    1. for Organ or Tissue or Cornea Transplant Centre: Rupees Ten Thousand
    2. for Tissue or Eye Bank: Rupees Ten Thousand
    3. for Non-Transplant Retrieval Centre (NTORC): Nil.
  3. Mandatory for the hospital to appoint a transplant coordinator. (Detail documentary proof should be furnished)
  4. General manpower requirement specialized services and facilities.
    *Furnish the particulars specialty – wise, names along with copies of registration certificate of theirrequisite qualification with the Goa Medical Council& experience specified
    **Furnish the particulars specialty- wise, names along with copies of registration certificate of theirrequisite qualification with the Goa Nursing Council& experience specified.
    1. 24 hours availability of medical and surgical (senior and junior) staff.
      Minimum requirement of the following
      1. *One M.S. (General Surgery)
      2. *One M.D. (General Medicine)
      3. *One M.D. (Anaesthesia)
      4. *One Cardiologist
    2. 24 hours availability of nursing staff (**general and **speciality trained)
    3. 24 hours availability of Intensive Care units with adequate equipment’s, staff and support system, including specialists in anaesthesiology, intensive care.
      Minimum requirement of the following
      1. *One M.D. (GM)
      2. *One M.D. (Anaesthesia)
      3. *One Cardiologist
    4. 24 hours availability of laboratory with multiple discipline testingfacilities including but not limited to Microbiology, Bio-Chemistry,Pathology and Haematology and Radiology departments withtrained staff.
      Minimum requirement of the following
      1. *One M.D. (Pathology)
      2. *One M.D. (Bio-Chemistry)
      3. *One M.D (Haematology)
      4. *One D.M.R.D.
      5. **One Perfusionist
      6. **Trained Staff
    5. 24 hours availability of Operation Theatre facilities (OT facilities)for planned and emergency procedures with adequate staff,support system and equipment’s.
      Minimum requirement of the following
      1. **Trained Main Staff Nurses
      2. **Trained Assistants to the Staff Nurses
      3. **Trained Anaesthesia Assistants
    6. 24 hours availability of communication system, with power back-up, including but not limited to multiple line telephones, public telephone systems, fax, computers and paper photo-imaging machine
    7. Experts of relevant and associated specialities 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 at the transplant centre. (Excluding experts required for the relevant transplantation)
      Minimum requirement: *All the specialists mentioned above.
  5. Equipment’s:
    Equipment’s as per current and expected scientific requirement specific to organ or tissue being transplanted. The transplant centre should ensure the availability of the accessories, spare-parts and back-up / maintenance / service support system in relation to all relevant equipment’s. (Furnish the salient features of the equipment’s)
  6. Experts and their qualification:
    1. Kidney Transplantation:
      M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. training in a recognized centre 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 centre 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 Hear -valve Surgery.
    4. Corneal Transplantation:
      M.D. / M.S. Ophthalmology or equivalent qualification with one year post M.D / M.S training in a recognized hospital carrying out Corneal transplant operations.
  7. Every transplantation centre must have its own website.
    The decision of the Authorisation Committee as regards to application for permission to undertake living donor organ transplant in the stated Transplant Hospital should be displayed on the notice board and should reflect on the website of the hospital or Institution within twenty-four hours of taking the decision, while keeping the identity of the recipient and donor hidden. Website may also be used for public information about the transplants done and promote the deceased donor transplant programme
  8. Registration under Clinical Establishment Act
    The Hospital registration 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.
  9. Documentation and Records
    The Hospital registered shall have to maintain documentation and records including reporting of adverse events and submission of the data in formats on a regular basis as specified by the SOTTO-ROTTO-NOTTO of all transplant related activities under the NOTP.

PROCESS OF GRANTING REGISTRATION:
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 16 and it shall be valid for a period of five years from the date of its issue and shall be renewable.

Sr. No Description Download Form
1
APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN OR TISSUE TRANSPLANTATION OTHER THAN CORNEA
(to be filled by head of the institution)
2
APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN/TISSUE RETRIEVAL OTHER THAN EYE/CORNEA RETRIEVAL
(to be filled by head of the institution)
3
APPLICATION FOR REGISTRATION OF TISSUE BANKS OTHER THAN EYE BANKS
(to be filled by head of the institution)
4
APPLICATION FOR REGISTRATION OF EYE BANK, CORNEAL TRANSPLANTATION CENTRE, EYE RETRIEVAL CENTRE UNDER THE TRANSPLANTAION OF HUMAN ORGANS ACT.