In what could eventually raise the bar for quality maintenance in the existing 2,455 blood banks across the country, the Quality Council of India (QCI) plans to award the first set of national accreditation to seven blood banks shortly.

Owing to perennial shortage of blood in the country, the issues related to affordability and access to blood blanks get priority over its quality aspects.

?Maintaining quality and the need to arrest transfusion associated infections such as HIV/AIDS or hepatitis B and C have been accorded low priority till now,? said Giridhar Gyani, secretary general, QCI, an autonomous body under the ambit of ministry of commerce.

National AIDS Control Organisation, which is the technical adviser to the health ministry for blood banks has also strongly recommended adoption of these accreditation standards among public and private blood banks. According to QCI, the first blood banks to receive the guarantee of quality standards include Mool Chand Hospital in New Delhi, International Hospital, Department of Transfusion Medicine in Noida, Escorts Heart Institute and Research Centre in Delhi, Dr Hedgewar Raktapedhi in Akola, NTR Memorial Trust in Hyderabad, Max Blood Bank in Delhi and Wockhardt Hospitals in Mumbai.

According to the World Health Organisation that clubs India in the South Eastern Asian Region?the estimated blood requirement for the region is about 15 million units, the blood collection annually amounts to just over 9 million units, leaving a gap of 6 million units.

With 909 government promoted blood banks, 362 voluntary organisations, 684 blood banks associated with private hospitals and 500 blood banks owned by private charity organisation, the blood bank services sector is highly fragmented in the country unlike in Thailand or Sri Lanka where blood transfusion services are centrally coordinated.

At present, India follows a procedure of mandatory licensing under the Drugs and Cosmetics Rules for blood banks. To operate a blood bank, a government or private organisation must qualify certain government-led criteria that range from quality and variety of the equipment used to the qualification of the working staff, source of procurement of blood and blood components to labelling of blood units or components and minimum area of the premises.

However, it is the medical fraternity that started raising questions on the issues of quality standards among blood banks.

?Probably, 90% of Indian blood banks still do not have the first level quality documents like quality policy and quality manual. Many blood bankers find it difficult to start writing their own quality manual,? N Choudhury of Ahmedabad-based Prathama Blood Centre, said. Choudhury attributes such loopholes partially to the fact that it is not mandatory under the Drugs and Cosmetic Acts to maintain such records.

However, there are second level quality documents like standard operation procedures (SOP) and third level documents including various registers, labels and forms in all blood banks, where these documents are mandatory from the regulatory point of view. ?We do not want to comment on adequacy of SOPs maintained by majority of blood banks/centres,? Choudhury said.

Many a time it is copied from some other blood banks SOPs or from standard books. Though the SOPs are supposed to be displayed in work areas, the document files remains under the closed custody of the blood bank in charge, Choudhury comments in a journal.

Gyani of QCI says although getting accreditation is voluntary in nature for now, sensitization for this process will provide gap analysis of individual blood banks. Blood banks will get an opportunity to know about their deficiencies in first, second, third level documents and also about deficiencies in process control.

He adds, quality, it is the right and duty of every donor and patient. If a donor is not checked for haemoglobin levels before the process of donation it not only compromises with his or her health even the patient who receives that blood will not show desired rise of haemoglobin.