Every year June 14 is globally celebrated as the World Blood Donor Day. The occasion serves to pay homage to the voluntary blood donors who donate blood throughout the year to save and benefit human lives without any remuneration or gain. The Day also aims to attract and motivate the healthy members of the society to come forward and become regular voluntary blood donors. But one of the most important objectives of celebrating the WBDD is to sensitize and call attention to the governments and the development partners about the significance of investing in the establishment of national blood systems through the development of national blood policies, legislation and regulation based on actionable evidence and ethical foundations. Only a service delivery system functioning through such a WHO recommended model can ensure sufficient and timely access to safe blood and blood products to meet the transfusion needs of all in any country.

Blood transfusions are the most common lifesaving medical intervention carried out in any hospital anywhere in the world. But the demand for blood transfusion, unmet need, and access to timely transfusion, source of donated blood, quality and safety of collected blood and the patients who need blood transfusions varies worldwide.

According to WHO, 112.5 million blood donations are collected annually in the world, however about half of these donations are collected in the developed countries which are home to only 19% of the world’s population. This means that in the developing world, where almost 80 % of the population resides, there are many patients who do not have adequate access to blood transfusion and thus lives are lost or affected. Blood transfusions are a vital component of emergency and routine medical and surgical cases. The patient age group that requires transfusion varies among countries. In the developed countries, most of the blood transfusions are provided to patients over the age of 65 who have undergone advanced surgical procedures, or as supportive care for solid and soft tumor management. But in the developing countries most of the blood is consumed in transfusions to obstetric related cases, trauma or to children suffering from malaria and thalassaemia.

The safest blood donors are the regular voluntary donors who donate blood every few months and thus repeatedly go through the process of behavioural, physical and serological screening every time they donate blood. Such donors are largely free of any risk factors that can possibly have any adverse effect on their or the recipient’s health. The transfusion needs of any country can be easily covered if 1-3 % of the national population donates blood on a regular basis. This small pool of national donors can ensure not only adequacy of blood supplies but also optimal safety. Unfortunately only 74 countries in the world have greater than 90 % reliance on regular non-remunerated blood donors. The other countries predominantly rely on the not so safe ‘Family Replacement Donors’ and in some countries to some extent even on the completely unsafe ‘Paid Blood Donors’.

A key element in ensuring blood safety is quality assured screening for transfusion transmissible infections for HIV, Hepatitis B and C and syphilis (and also malaria). But many developing countries are unable to ensure recommended screening of blood due to lack of a national system, inadequate resources, irregular supplies, lack of trained staff and most significantly poor quality screening kits. A contaminated blood transfusion is the most efficient mean of transmitting infections.

A single unit of whole blood donation must be processed into at least three different blood components; red blood cell concentrates, platelet concentrates and plasma. And instead of a ‘Whole Blood’ transfusion, patients should be transfused with only the required blood component. In other words at least three lives can be saved from a single unit of donated blood. In the developed world 97% of the donated whole blood is further processed for blood components, but in the developing countries blood is often not processed and about half of the blood is transfused as ‘whole blood’ exposing patients to unnecessary risks.

Inspite of the shortages of blood, expense involved, risks of infections and adverse effects unnecessary transfusions are common. There are alternate treatment options which are equally effective but are not always preferred. In addition, rationale use of blood is also not practiced in many settings thereby exposing patients to unnecessary risks and wastage of resources.

Pakistan has a demand driven fragmented blood transfusion system in which the service providers have conveniently outsourced the responsibility of mobilizing blood donations to the family and friends of those who need transfusions. The large and medium size hospitals have their own blood banks which mainly cater to the hospital’s own needs. In addition, private stand-alone blood banks also operate with varying standards of quality. Most of the small sized hospitals including Tehsil Headquarter Hospitals and District Headquarter Hospitals do not have proper blood banks and therefore blood has to be procured by the affected families from the outside blood banks and transported to bedside without necessarily maintaining the cold chain. The urban cities meet their transfusion needs from the blood banks in the large tertiary care hospitals and private NGO blood banks. Access to blood in smaller cities and rural areas is often limited. Availability of blood is thus not equitable across the country.

It is estimated that 2.75 million blood donations are collected in Pakistan annually from approximately 600 blood centers of varying workload. In a fragmented blood transfusion system with only an incipient culture of voluntary donations, a heavy reliance on family replacement donors, and the lack of systematic screening strategy, the infection risks are at an upper end. As a result even blood from high risk donors is collected increasing manifold the risk of transmission of infections through transfusions. The trend of component therapy is increasing but still majority of the collected blood is transfused as whole blood. Due to the uneven access to blood in the presence of largely insufficient regulation, exploitation of the patients and families occurs and unsafe practices transpire. In some cases, this involves pilferage of blood especially from the public sector blood establishments.

Safety of blood has particular relevance in Pakistan where hepatitis B and C infections are widespread, dengue epidemic is a regular phenomenon and HIV/AIDS is present in the form of a ‘concentrated epidemic’ with instances of spill over in the general population as in Larkana recently. In many blood banks, including of tertiary care hospitals, poor qualiy cheap rapid manual devices are used for screening and unsafe practices followed. Such manual kits cannot detect infections due to poor sensitivity and specificity. Without universal quality assured serological screening the cumulative effect is increase in the number of infected individuals in the country. Allocation of resoures for therapeutics especailly the treatment of Hepatitis B and C patients without national efforts to check the spread of hepatitis epidemic thorugh contaminated blood transfusions is thus a losing battle.

To address these structural issues of the blood sector in the country, the government initiated blood safety systems reforms in 2010 through the platform of the German government funded ‘Safe Blood Transfusion Programme (SBTP)’. The reforms aimed at converting the scattered system of public and private blood establishments into a centralised system of blood collection and processing that is consistent with WHO standards to increase quality and safety of blood products and improve cost-effectiveness.

Accordingly, the SBTP embarked upon developing a nationwide network of modern ‘Regional Blood Centers (RBCs)’ and converting the existing linked Hospital Blood Banks (HBBs) as storage and dispensing facilities. Thus, in the new centralised blood banking system RBCs are the mother ships, responsible for performing donor collection, component preparation, blood processing including blood grouping and infectious disease testing. Blood components are delivered to the linked HBBs according to their needs. At HBB level, blood products are only stored and compatibility testing of patient and donor blood is performed. This network has been developed in all the provinces and regions and the size and scope of the project is being further expanded. The national coverage through the new system is currently 15% of the entire national workload and is expected to be doubled by the end of 2020.

The Programme has also worked to strengthen the regulatory oversight through the operationalization of the largely dormant provincial and regional blood transfusion authorities. As a result, now all the Blood Transfusion Authorities (BTAs) in the country are vibrant and functional. Blood centers across the country are now registered, licensed and reasonably well regulated. The BTAs endeavour to ensure that all blood establishments adhere to the basic minimum criteria for licensing including the equipment, HR, practices and resources required for quality assured work. Earlier, the transfusion system was functioning without any regulatory oversight though the blood transfusion legislations existed in all federating units and blood transfusion authorities were notified. The SBTP reviewed and revised the existing blood safety legislation, updated it and made it uniform and ensured its enactment in Punjab, KP and Sindh. The Islamabad Blood Transfusion Authority (IBTA) was the first Authority to be revived and it has emerged as an effective model regulatory system. The IBTA also coordinates with the provincial counterparts and has strengthened their capacity to introduce the model regulation system in all parts of the country. The IBTA efforts are widely appreciated by the national stakeholders, provinces and also the international partners. The World Health Organization has recommended the Pakistan BT regulation model to the regional countries.

Despite the manifold groundbreaking achievements of the pioneering blood safety project in Pakistan the reforms process has not achieved universal coverage yet or reached a state of irreversibility. The German support to the SBTP since 2010 has been the driving force of the blood safety systems reforms in the country but this support is coming to an end now. It is thus the responsibility of the state and stakeholders to ensure that the reforms process continues uninterrupted through national resources and commitment until universal blood safety coverage is achieved and sustained in the country.