Maharashtra Shifts Blood Bank Audit Responsibility to Deans and Institution Heads
The State Blood Transfusion Council (SBTC) has revived quarterly blood bank audits across Maharashtra, shifting the ultimate responsibility for these evaluations to institution heads. The decision follows recent regulatory action taken by the Food and Drug Administration (FDA) against the JJ Mahanagar Blood Bank over serious safety lapses, including the improper disposal of blood bags, defective equipment, and inadequate sterilisation in blood component production.
Under the newly revived system, the final responsibility for conducting and submitting the quarterly audits will lie with top administrators. These include the deans of state-run medical colleges, the director of BMC hospitals, and the heads of private, trust-based blood banks. Previously, blood transfusion officers were tasked with these duties, but the ultimate accountability has now been shifted to the heads of these institutions to prevent safety lapses.
The revival of the self-audit practice comes after a decade-long halt. A blood bank officer from a BMC hospital noted that blood transfusion officers had stopped conducting the audits, and the FDA had also stopped asking for them. This was despite the existence of an 11-page checklist document designed for the process.
A recent SBTC circular outlined that the revived audits will require a comprehensive evaluation of both technical standards and available resources within each blood bank. The final reports of these quarterly audits must be submitted to both the FDA and the SBTC.
Among the specific audit guidelines, institutions are required to ensure that processing charges for blood and blood components are transparently displayed in a highly visible spot within the blood bank. This measure is intended to maintain technical standards, ensure proper resource management, and guarantee transparent pricing for patients.
While the quarterly self-audits are now mandatory for institution heads, the FDA will continue to conduct its regular annual inspections of blood banks across the state to ensure compliance.
