Following Maharashtra Food and Drug Administration (FDA) crackdown on blood banks for non- compliance in terms of staff strength and hygiene, blood banks of State run Cama Hospital and St George Hospital have submitted their compliance reports to the state regulator to bring in more accountability towards making safer blood available.
A stop operations notice was served to the blood bank at Cama Hospital last week based on a surprise inspection by the FDA and CDSCO officials. In their report, the inspection team stated that the blood bank and the serology and cross-matching room inside it was in an "extremely unhygienic" condition. Besides this, the blood bank was functioning without a single Blood Transfusion Officer (BTO).
As per rules, a 24/7 blood bank is required to have at least three 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 fatal mistakes.
As per FDA reports, the blood banks have failed to operate efficiently due to lack of monitoring by technically qualified staff and have exhibited non- compliance in terms of staff strength and instrumentation which is violation of Schedule F of Drugs and Cosmetics Act, 1940.
Maharashtra Food and Drug Administration (FDA) had suspended the licenses of 7 blood banks and canceled one based on 369 inspections done during 2013-14 alone across Maharashtra. The state has 303 blood banks and 3 cord blood banks.
Suspensions and cancellations had been made for violation of the provisions of Drugs & Cosmetics (D&C) Act as the blood banks failed to operate efficiently due to lack of technically qualified staff and was also found faltering in terms of maintaining a register of work done duly signed by a medical officer to successfully accomplish the operations of a blood bank.
As per Schedule âFâ, Part XII-B and/or XII-C, the applicant shall 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.
D&C Act also stipulates that the applicant shall provide adequate arrangements for storage of whole human blood, human blood components and blood products. The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of whole human blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished.