Gujarat FDCA Serves Closure Notices To Three Blood Banks For Putting Patient Safety At Risk

Mumbai, 7 Aug 2018: The Gujarat Food and Drug Control Administration (FDCA)'s inspections on 17 blood banks which was meant to address the growing challenge of blood safety finally culminated into three blood banks being served closure notices for endangering patient safety. 

Out of the 17 inspections carried out, 12 were joint inspections conducted in association with Central Drugs Standard Control Organisation (CDSCO) to check whether the blood transfusion officers (BTO) and other technical staff were deputed besides the equipment and testing modalities in the state wide inspection drive over the past three months.

“There are 150 blood banks in the state of Gujarat and there is an urgent need to address issues related to patient safety as Gujarat FDCA detected reactive units of blood after rigorous testing in an NABL accredited lab. It was learnt that blood banks were faltering on account of dispatching these units to healthcare centres without following testing procedures to check for infection and reactivity contrary to patient safety,” explains Gujarat FDCA commissioner Dr H G Koshia. 

The state regulator had earlier served show cause notices to five blood banks for supplying unsafe blood to hospitals in Ahmedabad, Banaskantha, Porbandar and Amreli.

Blood banks inspections revealed critical points in the compliance reports submitted and were re-verified based on re-inspections. The inspections threw startling revelations that some of these blood banks did not properly test the blood samples and supplied it with no concern for patient safety.

As per the Rules, a 24/7 blood bank is required to have at least three blood transfusion officers (BTOs) working in shifts. It is also mandatory that collecting and transfusing of blood and its components such as plasma, white blood cells etc be done in the presence of a BTO to avoid any error.

Schedule ‘F’, Part XII-B and/or XII-C of Drugs & Cosmetics Act, 1940 requires that the blood banks should provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. It also mandates to provide and maintain adequate technical staff as specified in the law.

The state has 150 blood banks and 134 blood storage centres. In order to ensure consistent and safe blood to the patients, the state regulator also rolled out a series of campaigns to sensitise blood donors and recipients to strengthen blood safety in the state. Pharmabiz