Blood Banks and Transfusion Centres To Enrol In HvPI To Get NABH

New Delhi, 8 March 2019: Blood banks and transfusion centres may soon have to enrol in the Haemovigilance Programme of India (HvPI) and follow the National Blood Transfusion Council (NBTC) guidelines on donor selection criteria to obtain the stamp of approval from the National Accreditation Board for Hospitals and Healthcare Providers (NABH).

The national body for certifying blood banks is learnt to be incorporating additional clauses in its regulatory requirements to make them on par with the parameters set by the NBTC, the health ministry arm for monitoring blood transfusion services at the national level.

As per the proposed amendments to NABH standards, blood centres would have to register with ‘e-Raktakosh’, a government initiative to connect and digitise the workflow of blood banks. Once the amendments come into force, registering with respective state blood transfusion councils and periodic reporting of adverse events also will be compulsory to obtain the quality certification. 

The average annual blood collection in India is around 7-8 million units. The availability of safe blood is crucial as the country is facing a shortage of blood and blood components. The NABH standards for blood banks, applicable to public and private sector facilities, have been drafted by a technical committee to provide a framework for quality assurance and patient safety.

“The norms call for continuous monitoring and comprehensive corrective action to build quality culture at various levels. The number of NABH- accredited blood banks remains low as the process is voluntary. But the count is rising and we currently have 100-odd recognised facilities,” NABH Assistant Director Bindu Madhav told Pharmabiz. “The board is reviewing suggestions from clinical establishments, industry associations and consumer groups. The new norms will be finalised on the basis of their inputs,” he added.

The NABH suggests pre-donation counselling by an employee with appropriate qualification to inform donors about transfusion transmitted infections (TTI), modes of transmission and window period. If a blood bank is doing bulk transfer, record of traceability and testing -- including TTI, blood group serology and cross matching -- should be maintained throughout the process.

Launched to improve the safety of donors and recipients, the HvPI has been facing hurdles as most blood banks are reluctant to enrol in it. Making HvPI enrolment compulsory to gain accreditation will act as an additional motivation for these facilities, say health activists. Nearly six years after its launch, only 900-odd licensed blood banks are registered with the HvPI. 

A 2017 assessment by the health ministry has revealed that a majority of blood banks functioning in the country are neither inspected regularly nor do they comply with the best healthcare standards. However, in recent times, the ministry has adopted certain measures to streamline blood transfusion services, including an amendment to the Drugs and Cosmetics (D&C) Rules of 1945 to make regulations rigorous. The amendment to Part XB of the D&C Rules proposes to revise licensing procedures, tweak infrastructure requirements and set clear-cut eligibility criteria of personnel manning them.Pharmabiz