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FDA sees red at Cama Hospital blood bank

The administration issues a stop activity order to the blood bank for not having an FDA-approved blood transfusion officer

The Food and Drug Administration (FDA) issued a stop activity order to the blood bank at The Cama & Albless Hospital after it was found functioning in the absence of a Blood Transfusion Officer (BTO).


The Cama & Albless Hospital at Fort. FILE PHOTO

“An official from the Central Drugs Standard Control Organisation (CDSCO), a state government official and Dr Jayashree Sharma from KEM Hospital’s blood bank inspected Cama Hospital, and found that an FDA-approved BTO wasn’t present,” said ST Patil, joint commissioner (drugs), FDA. He also added that the blood bank looked unhygienic and paint peeled off from the walls. The order was passed at the CDSCO’s recommendation.

As per FDA norms, a BTO needs to be present at the blood bank 24x7 to monitor the cross-matching of blood and maintain records of bags of blood collected during blood donation camps. In the BTO’s absence, a hospital’s blood bank can provide blood transfusions to in-house patients, but it isn’t allowed to collect additional blood bags through camps or store new ones, explained an FDA official.

On December 22, 2013, the FDA had issued a show cause notice to the blood bank after it was found that its blood bank had only one BTO, Dr Vikas Maindad, and two FDA- approved lab technicians. “The other technicians weren’t approved by the FDA and it was found the blood bank wasn’t being maintained well. We decided to act and issue the stop activity order.

We are now waiting for the compliance letter from the hospital. If they agree to get another BTO approved by us and maintain standard hygiene standards, they will be allowed to collect blood bags,” said Patil. Despite repeated attempts, Dr Rajashree Katke, medical superintendent of the hospital, remained unavailable for comment.

(Inputs by Dimple Bhavsar) 

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