Blood

HIV poses a significant challenge to the system of transfusion medicine, and access to a safe ad sufficient blood supply has become a vital medical need Blood when not properly screened may transmit serious diseases like malaria, syphilis, hepatitis B, hepatitis C and HIV. By 2001, the transmission of HIV through blood and blood products in India was estimated at 4%. HIV thus poses a significant challenge to the system of transfusion medicine, and access to a safe and sufficient blood supply has become a vital medical need.

The article argues that the formidable task of providing 100% safe blood and blood products may be achieved by providing an effective quality control mechanism. Issues of donors and recipients of human organs are similar to those of blood and blood products transfusion and are used analogously in the article.

In 1996, the entire blood banking system of the country was revamped following directions from the Indian Supreme Court. All blood banks were required to upgrade their centres and obtain licenses from a licensing authority. The Drugs Controller (General) of India and the State Food and Drugs Administration were to monitor the blood banks and ensure quality control. National and State Councils for Blood Transfusion were established to oversee the working of the blood banking system in the country. The National Blood Policy, 2002 lays down guidelines to be followed by blood banks for collection, testing, storage and distribution of blood and blood products. Accordingly, all blood collected must now, be screened for HIV, syphilis, malaria, Hepatitis B and C. However, paucity of resources such as trained and skilled manpower and lack of infrastructure has led to the proliferation of commercial blood and organ donation. Further, in rural areas, blood testing and storage facilities are virtually non-existent. HIV testing also poses unique problems, as it must account for the window period during which a person infected with HIV will test negative for the virus.

Accordingly, this article argues that the motivation, recruitment, selection and retention of voluntary blood donors remain the most viable strategy in insuring a safe and adequate supply of blood. These donors are not paid and are willing to donate on a regular basis, at properly spaced intervals. A properly framed and mandatory donor questionnaire, that poses direct questions on 'risk' behaviour, is also critical in ensuring the recruitment of safe blood donors and addressing the issue of the window period. Blood safety thus hinges on the honesty and integrity of the donor's responses; an issue impacted substantially by the assurance of confidentiality for the information supplied by the donor. In some countries like Australia and Singapore, donors who withhold information or make a false or misleading declaration are liable to be penalised. In India criminal sanctions that are applicable to persons who negligently and malignantly transmit a disease dangerous to life, may be attracted in the case of such donors.

There has been much debate on whether a donor should be informed of test results. It is argued that donors who may be infected should be told of their status to allow them to get timely treatment and take measures to prevent the spread of the infection. Any policy that involves informing donors would have to ensure the enforcement of 'informed consent' standards, which include pre and post test counselling for the donor. A positive test would also require confirmatory tests. Where a blood bank cannot conduct confirmatory tests, donors whose blood has tested positive for HIV should be referred to voluntary counselling and testing centres.

The risk of transmission through contaminated blood is also minimised by the rational application of transfusion medicine and informing the recipient of available alternatives and of risks associated with transfusion. Thus, the need for transfusion should be balanced against the knowledge of unavoidable risks and a risk-benefit analysis and an assessment of alternates must be made before each transfusion. Autologous transfusion maybe recommended. In any case, the medical practitioner has a duty to take the informed consent of the recipient of blood and blood products and inform the recipient of the inherent risks of infection relating to transfusion, prior to transfusion. The recipient has a right to refuse medical treatment, and opt for other alternatives. In case the recipient is infected through contaminated blood or blood products, her/ his positive status should be kept confidential.

The transmission of infected blood has seen attempts by recipients to discover the identity of the blood donor. In Australia and Scotland it has been held that the identity of the donor need not be disclosed, and if disclosed, persons who received such information were subject to strict confidentiality. In India, apart from the provisions of the IPC, the only remedy available to a recipient is to approach the courts. While Indian courts have awarded substantial financial compensation to recipients of contaminated blood, getting such an award usually takes several years.

This article argues that it is the responsibility of the State to provide and ensure a safe and adequate supply of blood and blood products. The State is thus obliged to improve the health infrastructure and modernise blood banks. It is also critical to improve the quality of testing kits such that they are accurate and sensitive enough to furnish a low rate of false negatives. A quality assurance programme that ensures the strict enforcement of quality control procedures that maximise the accuracy of laboratory tests and reduce clinical and technical errors needs to be established. Similarly, issues relating to pathological laboratories, hospital waste management and usage of disposable needles also need to be addressed through legislation. In terms of recipients of contaminated blood, they can ill afford the time and resources required in getting justice through the courts and it may be argued that the State for a failure of its obligation in providing safe blood, should establish a 'fund' to assist such persons.