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Karnataka dept of health cancels organ transplant license of Fortis

Our Bureau, BangaloreSaturday, September 17, 2011, 08:00 Hrs  [IST]

Karnataka’s department of health and family welfare has cancelled the license given to Fortis Hospital, Bannerghatta Road, to conduct liver and kidney transplants and homograft.

The license cancellation order came in response to a complaint lodged by Retd. Major Pankaj Rai whose wife Seema Rai, succumbed after a pancreas transplant surgery carried out on her by the hospital after her admission in May 2010.

Following Major Rai’s complaint , the State department of health and family welfare on September 12 cancelled the license under the Transplantation of Human Organs Act 1994 for violation of the same.

The patient underwent kidney and pancreas transplant procedures on May 2, 2010, and died four days later of septic shock. Maj. Rai alleged that the hospital had neither taken his consent for the pancreas transplant nor did it have the license to do the complicated procedure.

Officials from the department of health and family welfare said that action was taken after the charges levelled by Maj. Rai was proved to be true after an inquiry.

This is the second setback for the hospital in the last fortnight. The Lokayukta, which had also probed the issue, submitted report on September 2 that Dr Raju, member secretary of the Appropriate Authority for Human Organs Transplantation, had misled the Karnataka Medical Council about the facts of the case.

The Lokayukta report said Dr Raju had said on oath that Fortis was licensed to carry out transplant of the pancreas. He had said the hospital had the licence to carry out liver transplant. As “liver also includes the pancreas and other abdominal organs” the hospital had done nothing illegal, he said. Finding validity in Maj. Rai's charges, the Lokayukta had served a show cause notice to Dr Raju while also asking for a response from his parent department of Health and Family Welfare.

Like the Health and Family Welfare Department, a Health Foundation constituted by the Lokayukta also submitted that the hospital is not authorized to perform pancreas transplant, and by conducting the procedure on Seema Rai, it had violated Sections 12 and 13 of the Transplantation of Human Organs Act.

The Lokayukta also found that the doctor who conducted the procedure had no previous experience.

In a statement, Fortis Hospital said that it did have permission to conduct liver and other abdominal organs including pancreas transplantation. The interpretation of the transplant rules under the act by the department has been inconsistent and varied as per the understanding of the person implementing the rules. It is unfortunate that the Department which has all through held and testified that Fortis Hospital has a license has reversed its stand and has now cancelled the license. Fortis hospital is aggrieved by this action and will be making appropriate representation to the Government and will be seeking legal remedy if necessary.

The hospital had applied via separate applications dated January 18, 2010 to Karnataka, Health & Family Welfare Services, for Certificate of registration to conduct Transplantation under rules, 1995, as amended in 31st July, 2008. These were for Kidney Transplantation, Transplantation of Liver and other abdominal organs and cardiac, pulmonary, cardio-pulmonary transplantation.

The inspection of the facilities and manpower at Fortis Hospital were carried out by a Committee on 11/03/2010. After satisfying itself that all the required facilities and manpower were available, the Appropriate Authority gave the Certificate of Registration (MDM/26/09-10) dated 25/03/2010. The Certificate authorized the Hospital to conduct transplantation under the categories as requested by the Hospital, stated Dr Lloyd Nazareth, COO Fortis Hospitals.

 
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