Ruby Hall says it wasn't told of new rules

Replies to show-cause notice govt issued after inspection panel reported irregularities

Replies to show-cause notice govt issued after inspection panel reported irregularities

Taking exception to an inspection committee's report that the Ruby Hall Clinic flouted norms under Section 16 of the Human Organ Transplantation Act, 1994, in connection with live and cadaver kidney transplants that had taken place at the hospital, the premium healthcare facility has filed a reply denying all accusations.


We object: The reply by Ruby Hall to the show-cause notice

In their reply to a show-cause notice issued by the government, authorities at the Ruby Hall Clinic have said that they were not even notified until March 23 this year about the change made in 2008 in the law related to organ transplants.

MiD DAY has a copy of the four-page reply that Ruby Hall Clinic filed with the Directorate General of Health Services on April 11. The reply covers seven crucial points, from the method of establishing relationship during the interview of kidney recipients and donors to permissions from the regional or state-level authorisation committee. The hospital has defended its stand while indirectly blaming government authorities.

Two weeks ago, a minister had alleged in the state assembly that Ruby Hall was flouting various norms while carrying out organ transplants. The state health directorate appointed a four-member committee of experts, who visited the hospital between March 24 and 28 and submitted its report aftyer an inspection of the records. Based on the report, the state authority sent a show-cause notice to Ruby Hall Clinic on April 5.

A source at Ruby Hall Clinic said that the notice mentioned that the hospital didn't follow various rules, especially those that had been recently amended and included in the Human Organ Transplantation Act, 1994, that guides transplants.

"The main allegation was that hospital doesn't do enough to establish the relationship of donor and recipient. In live transplants, it is important for both of them to be related. In its reply, the hospital has said that it interviews both parties and video-records these sessions. Relationship is established through documentary evidence like PAN card, passport, voter's I-card, marriage photographs, among other things," said the source. "While maintaining that these are standard procedures for verifying relationship, the hospital has asked for direction on additional steps required."

In its reply to the question of tracing the family tree of patients, the hospital said that it needed directions on how many generations of the patient should be traced.

The amended rules also require that patients be evaluated by a psychiatrist prior to procedure and also that a no-objection certificate be obtained from the concerned authorisation committee before doing the procedure.
"The reply states that the hospital was unaware of both these rules and will comply from now on. However, the reply has put the blame on government authorities by pointing out that inspections were carried out on four different occasions from November 2010 to January 2011, but lacunae in respect of compliance of amended rules of 2008 was never brought to the notice of the hospital," he said.

The letter states that a re-registration certificate was also issued on February 10 this year, after the inspections. It says on three to four different occasions that change in rules wasn't communicated until the day prior to the inspection committee's visit.