Blood safety system reforms in Pakistan

The Islamic Republic of Pakistan is the sixth most populous country in the world with a population of 180 million¹. Literacy rate is 49.5% and the population growth rate is 2.03%. Urdu is the national language but English is also widely spoken and understood. Islamabad is the federal capital and the total country area is 796,095 km². The health care system in Pakistan faces numerous challenges and operates through a three-tier delivery structure and a variety of public health interventions. The role of private sector is growing and according to an estimate its share has reached 75%². The overall health regulatory framework is weak and inadequate³. The total expenditure on health is 2.5 % of the GDP⁴. Following the implementation of the 18^th amendment of the constitution in June 2011, all the functions related to health were devolved to the provincial/state health departments⁵. The public health system is deficient in terms of human and physical infrastructure to match the needs of the growing population and the challenges faced by natural and man-made disasters including terrorism occurring with increasing frequency in the recent past.

Blood transfusion system

The blood transfusion system (BTS) in Pakistan reflects the dynamics of a country in development. After independence in 1947, the system had to cater for the needs of some 33 million inhabitants while now the population is estimated to be 180 million. The rapid growth of the BT system in a country building up its post-independence structures was not guided by national blood transfusion standards or overseen by blood transfusion authorities or a national blood transfusion programme. The back-bone of the system was “multifunctional” hospital blood banks, complemented by an ever increasing number of private blood bank laboratories. From the 1970s until today there has been a steady growth of the sector especially through non-governmental organizations (NGOs)/blood donor organizations (BDOs), which are only remotely acquainted with existing policies, standards and guidelines and which in their majority are not licensed for the services they are providing, mostly under humanitarian principles. Currently the BTS in Pakistan is fragmented and mostly hospital based with no functional separation of the processes into production and utilization. The hospital blood banks (HBBs) cover the entire process of vein-to-vein transfusion chain, including blood collection, screening, compatibility testing and transfusion. The large and medium size hospitals have their own blood banks which cater to the hospital needs while private blood banks also operate with varying standards of services. This results in suboptimal standards for donor selection, inadequate practices for manufacturing, laboratory testing, storage, transport and transfusion and compromise the donor and patient safety. In addition to the private sector, several not-for-profit BDOs are operating at various levels of intervention (management of online donor databases; blood collection; blood processing; transfusion services for specific target groups, such as thalassaemia patients). These BT services are operating under variable levels of control and harmonization. The total annual blood collection in these centres is approximately 3 million units⁶ mainly driven by a high incidence and prevalence of thalassaemia, consuming a significant proportion of these blood collections (approximately 1/3^rd). The total number of blood centres is estimated to be 1,830 with a major contribution by the private/NGO sector (85%).

Screening for transfusion-transmissible infections (TTIs) is a critical part of the process of ensuring that transfusion is as safe as possible. In Pakistan, with an only incipient culture of voluntary donations and the lack of systematic screening, the infection risks are at the upper end. The blood is routinely tested for five TTI markers, i.e. HBV, HCV, HIV, malaria and syphilis. According to 2011 data, the sero-prevalence of HBV, HCV, HIV, malaria and syphilis in blood donors is reported at 2.2%, 3.9%, 0.01%, 0.6% and 0.1% respectively⁷. As the testing procedures are not quality assured, it is likely that these figures may be more in reality. A large community of thalassaemic patients in the country (6% carrier rate)⁸ is facing an imminent risk with accumulating higher percentages of HBV (8.4%) and HCV (56.8%)⁹. As they receive regular transfusions, most of these infections are acquired by blood transfusion. Since the last few years, dengue outbreaks have become an annual recurring event in Pakistan and it is now evident that Dengue has become a regular epidemic phenomenon in Pakistan. The national healthcare system including the blood transfusion services have made preparations to play their due role in the management of this public health issue.

In 2010, the Government of Pakistan with the support from the Government of Germany initiated the blood safety systems reforms in Pakistan. The reforms included the formulation of a national blood policy and strategic framework and the establishment of blood transfusion programmes at the national and provincial levels. At the federal level, the safe blood transfusion programme (SBTP) performs the role of central coordinating body to oversee policy planning, provide strategic guidelines, set standards, monitor and evaluate programmes, liaise with development partners and report on international commitments. SBTP is supported by the Government of the Federal Republic of Germany through its technical and financial cooperation components. The technical cooperation (TC) component is funded by German agency for international cooperation (GIZ) and is part of the GIZ health sector support programme while the financial cooperation (FC) component of the project funded by KfW, the German development bank, is responsible for the development of the new infrastructure which consists of constructing and equipping a network of regional blood centres (RBCs), and renovation and refurbishment of the existing hospital blood banks (HBBs).

The SBTP, operating at the federal level, is providing a facilitation role, while local expertise is activated and captured and interactive knowledge management processes take place in lieu of traditional external inputs. The goal of the STBP is to establish the core elements of an independent rational structure of a national blood transfusion system that will ensure adequate, efficient and safe blood supply, in a cost effective manner. Working groups and task forces (TF) have been formed to develop key documents. This approach is expected to enhance both local ownership and integration of experience and evidence, thus increasing local users’ expertise and capacity. Working with and through local actors facilitate various levels of local networking, which could reinforce trainings and allow all participants to become part of a more permanent information flow rather than being exposed to individual and singular “events”. The SBTP has also developed a model business plan, which will be used as a decision-making tool. The core elements of this plan are cost and revenue estimates (indicating the viability and sustainability of the BTS). Based on this plan, strategies will be finalized about the funding and financial management of RBCs on the one hand and their interaction with HBBs on the other hand.

The scope of the concept of the project is to be expanded through the establishment of partnerships between the public, private and NGO sectors. BDOs would be encouraged to support RBCs in the collection of safe blood from voluntary donors, but possible working relations between public and private sectors in blood collection and blood consumption have to be explored as well. One model could be the emulation of a centralized RBC-HBB structure also in the private and NGO sector. The private sector with its access to considerable technological, human, and financial resources also could become a driver of the system reform across the sector. The reforms in key intervention areas are described below.

Legal and regulatory framework

The key issue in the blood transfusion sector of Pakistan remains a lack of governance and regulatory setup. Blood safety legislations, though approved in each of the provinces during the time period from 1997 to 2004¹⁰, have never been fully implemented. The SBTP has drafted a new blood safety act through consultation with all stakeholders that is expected to result in uniformity after approval and implementation. In the current post-devolution institutional environment, the provincial blood transfusion programmes are striving to assume more responsibility to enhance commitment and engagement for the regulatory reform process. The process requires strong advocacy to move forward on the regulatory reform agenda.

The national blood policy and strategic framework (2008–2012)¹¹ was developed through technical support from GIZ and provided fundamental principles by identifying clear priority areas that need to be focused in a coordinated manner so that it could be implemented successfully within a set time frame. The overarching priorities regarding BT services that are addressed in this document included: equity; the development of leadership, planning and management capacity; quality of care and monitoring and evaluation. A revision of the “National blood policy and strategic framework (2008–2012)” is proposed for the first quarter of 2014 and will be based on a joint evaluation of the achievements under this governance tool. The new policy will take into account devolution and decentralization issues and acknowledge the role of BDOs. The strategic part of the policy will be formulated in a way to have more precise public-private partnership models and take into account that devolution has created a new scenario of relatively independent blood programmes, which now would have to agree on alignment and harmonization mechanisms in order to avoid the risk of institutionalizing diversity and creating structures which would lead towards permanent fragmentation.

At federal and provincial levels, blood transfusion authorities (BTAs) have been notified to regulate both the public and private sector blood banks but in the presence of a fragmented BT system, these authorities have not been able to produce the desired impact, as the fragmented blood transfusion system is difficult to regulate. Through the SBTP, organizational charts have been developed for the BTAs and a comprehensive training programme will be imparted to BTA staff once the new structures are in place.

Blood donation

The fragmented blood transfusion system in the country lacks a reliable and healthy donor base and a registry of voluntary non-remunerated regular donors. Blood donors are mostly replacement donors, as the rate of voluntary blood donations is low, which increases the risks of transfusion transmitted infections. According to the data collected from 324 blood banks for WHO global database on blood safety, there were 15.4% voluntary non-remunerated blood donations while 84.6% were replacement/family donations in the year 2011⁷. The median age in Pakistan is 22.2 years¹ and in fact this group of individuals is potentially large enough to provide blood transfusion organisations with sufficient blood for patient care in Pakistan.

The national blood policy and strategic framework lacked a well-defined blood donor policy. Therefore, with the objective of harmonization in donor management and ensuring blood safety, a national donor policy was developed by SBTP in 2011¹², to be adopted by all institutions involved in blood collection. This policy document is based on national (to incorporate local requirements), regional (economic cooperation organization [ECO] countries) and international expertise (to provide expertise from international models). The document was drafted by a working group of the First National VNRBD Workshop and later approved by the SBTP and by the National Steering Committee. The adoption of the VNRBD concept had already been recommended in the (Draft) Pakistan Blood Safety Act of 2012. This paradigm shift will require major efforts in community awareness building, for which the SBT Programme has laid one of the foundation stones through a thorough analysis of the knowledge, attitudes and practices (KAP) of a key segment of the society, which are young adults.

In Pakistan, BDOs are mostly university based voluntary organizations managed by students. On the one hand, these organizations form the backbone of (voluntary) donor mobilization and blood collection in Pakistan. On the other hand, they are working independently, without an agreed governance or communication framework. The potential importance of BDOs in the BT system reform process, however, lies in the fact that they are collecting the majority of the voluntary blood donations in the country through their donor motivation and mobilization programmes. BDOs have agreed to establish a network, with the aim of interchanging experience and best practices, and are also open to policy advice from the national programme and joint strategies and actions for the promotion of blood donation and the advancement of blood safety. The networking process is currently “under construction”. In 2012, BDOs from all parts of the country were contacted and the relevant data were collected in order to learn more about their existing strategies and potentials. The information gathered is being used for the elaboration of a “first national inventory of blood donor organizations” to be published under the SBTP¹³.

Education and training

Education and training is fundamental to every aspect of blood safety. In Pakistan, the lack of uniformity and standardization in formal and informal education for blood bank staff has resulted in a wide variation in quality in the vein-to-vein transfusion chain. Although blood banking is often perceived to be a relatively unattractive field among medical subspecialties, it is critical to standardize educational courses across provinces and diploma/degree programmes to achieve the goal of safe blood. However, opportunities for training are often least available for those who most need it, particularly for staff working in small hospital blood banks without easy access to training institutions. In addition, there is extremely diverse educational background of blood bank technicians (either formally educated or just trained on the job in pathology laboratories and blood banks). The system reform in Pakistan, which has begun to take roots, not only in the form of a structural reform (functional separation of RBCs-HBBs), but also regulatory (law, blood transfusion authority, policy) and quality (standards, guidelines, standard operating procedures, management information system) reforms, will require well-qualified staff, educated and trained in the various aspects of the vein-to-vein transfusion chain. Through the SBTP, a network of “key stakeholders” has been created involving quality training centres such as Aga Khan University, Dow Medical University, Baqai Medical University, all of which are ISO certified. This networking approach would guide the implementation of blood transfusion system reform in terms of capacity development. A matrix for all staff categories of RBCs and HBBs has been developed with a view of future training requirements. The SBTP has deepened the analysis of the curriculum development required and focused on strategies of standardization, while the actual development of training curricula remains pending. The curriculum will be based on an appropriate needs analysis of the blood transfusion modules in Pakistan and ground work in this regard has been initiated in consultation with the higher education commission (HEC) of Pakistan. A demand driven development in the blood transfusion (BT) educational sector of Pakistan, therefore, may not be a very distant reality.

Blood transfusion management information system (MIS)

In Pakistan’s healthcare system, the management approach and the arrangement of public sector systems are not very supportive¹⁴. With regards to blood transfusion services, the sector lacks efficient tools for information and knowledge management and process automation. In many private and some public sector blood banks, state of the art management information systems are in place but are not integrated with other blood centres. A centralized management information system (MIS) is not available and the human and technical resources required for BT System data analysis at the national and provincial level are not likewise available. One of the key elements of the BT reform process in Pakistan includes the introduction of a harmonized computer based MIS. This MIS system will become a key tool for monitoring and decision making at system level, allowing for a national monitoring of blood safety indicators. The SBTP has developed a training module on “Information Management and Management Information” following field surveys in several blood banks (public and private). This module is intended for blood bank managers. Similarly, another module on “Data Management” was developed for the BTAs.

Quality management system (QMS)

The implementation of a quality management system (QMS) requires the development of national standards and guidelines and Quality Manual. The National Standards and Guidelines, published and widely distributed in 1999, remained unimplemented due to various reasons. These guidelines were produced taking as a basis the British committee for standards in haematology (BCSH) - Blood Transfusion Task Force - Guidelines¹⁵. The lack of reflection and awareness on the local situation appears to be an important reason for their non-implementation, while there seem to have been also organizational, systemic, and governance problems. The revision of the national standards was assigned to the TFs based at the National Steering Committee. While lack of baseline data limits the capacity to modify international standards and guidelines on the basis of objective evidence, an effort is being made to keep the local circumstances under consideration. To enhance the comprehension of these guidelines, the structure is being modified to separate minimum/essential standards, compulsory by the legislation of Pakistan, from the operational guidelines on the methods of achieving those standards, which may be helpful but not compulsory.

Standard operating procedures (SOPs) are considered one of the key elements of quality systems and used to ensure consistency in performing blood transfusion processes. A national SOP manual was first developed and disseminated by the National AIDS Control Programme, Ministry of Health in 2007. The manual remained unimplemented, without bringing about improvements in the transfusion practice. Gaps in documentation of essential SOPs along the vein-to-vein transfusion chain, adoption in their entirety from the SOPs prepared for another country and lack of training of the relevant staff in the use of the manual were important reasons for their non-implementation. A flyer providing a structured listing of the SOPs along the entire vein-to-vein transfusion chain was first developed, segregating the essential SOPs in terms of their application in the relevant structures (RBCs, HBBs, Hospital Wards) as well as their functional areas. For the elaboration of SOPs, a participatory approach with future users was chosen and mixed working groups (with a nationwide selection of members) were established, covering each of twelve defined key areas. The “inclusive” process, facilitating inputs from everyone with capacity and interest in the procedure’s success, may be somewhat time consuming, but “exclusive” technical write-ups (i.e. developed only by the project team) could miss essential points required by the blood banks’ operational staff. An “inclusive approach” has fostered teamwork among technical and managerial staff. The SOPs manual developed is planned to be pre-tested with the objective of assessing its applicability both in the future RBCs and the existing HBBs, taking into consideration that HHBs’ functions will gradually be reduced.

Clinical use of blood

An essential measure towards improving the quality of the transfusion process is the rational clinical use of blood. It is estimated that in the world 50.8% blood is not separated into components and transfused as whole blood⁷. Physicians are not trained in haemotherapy as the medical curricula lack transfusion medicine as a specialty and therefore, prescription practices are more oriented on whole blood than on blood components (BCs). Hospital transfusion committees (HTCs) exist in a few hospitals only. It is also noteworthy that in Pakistan BC preparation is lacking in most of the public sector blood banks and therefore, BC availability is also an issue, even if the demand arises. The prescription of whole blood is widespread and the documentation system is not standardized as the QMS is lacking and therefore there is no standard blood request form and transfusion reaction reporting forms are likewise not available. There is no coherent and centralized system in place as yet for data collection, transmission, reporting and evaluation. National or regional haemovigilance systems for monitoring and investigating side effects of blood transfusion are not in place. The concept of “rational clinical use of blood” needs to be promoted to overcome the blood shortages.

The national guidelines on Clinical use of blood, first developed in 1999 by an expert group of haematologists, remained unimplemented. For the revision of the 1999 guidelines, a TF was established, comprising the users of the guidelines (clinicians) in addition to haematologists. The TF included at least one member from each of the medical associations of Pakistan dealing with haemotherapy. The TF was composed of a core group, based in Lahore (the second largest city), and corresponding members from all over the country. The revision process took six months drawing on local expertise in haematology and clinical care. The next step is the dissemination of these guidelines to all users and implementation of a training plan for clinicians and nurses. The training plan will make sure that clinicians have easy access to key information related to their specialty. One of the options is the development of a small pocket brochure supported by a full handbook for further reference. It is also envisaged to include a list of reference persons and institutions available for further advice. HTCs will play a key role in the dissemination and adoption of the guidelines. HTCs are very suitable for this purpose, as their members typically include blood bank, hospital management and clinicians, and their regular meetings allow a well-documented follow-up and learning process under the concepts of best transfusion practices, patients’ safety and haemovigilance. The concept of haemovigilance has taken momentum in Pakistan and in February 2013, Pakistan became a member of International Haemovigilance Network (IHN).

International collaborations

The SBTP leadership has interacted proactively with the international BT community and developed strong linkages with many international partners. These include technical collaborations with the World Health Organization (WHO), International Society of Blood Transfusion (ISBT), Asian Association of Transfusion Medicine (AATM), International Haemovigilance Network (IHN), Global Blood Foundation (GBF), etc. WHO collaboration focus primarily on prevention of transfusion transmissible infections and activities conducted so far include quality management training workshops, development of national screening strategies and conducting national baseline survey on TTI screening system. The United States agency for international development (USAID) has sponsored the procurement of TTI screening kits for all Pakistan’s needs for two years. Training activities have been conducted in collaboration with ISBT and AATM for all levels of professionals. The SBTP is also negotiating to receive support from the GBF. In addition, there is regular participation from the Programme leadership in international conferences, seminars, etc. Foreign experts also regularly visit Pakistan, through the TC and FC component, and provide inputs on various aspects of the Programme development.

Conclusion

Since its establishment in 2010, the SBTP, with the support of the German partners, has been able to deliver a series of outputs which have significantly contributed to the development of the BTS’s reform process. Key target audiences for these outputs include:

1. blood bank technicians (operational guidelines, tools and instructions);

2. hospital administrations (HTCs);

3. clinicians in the field of haemotherapy (clinical use of blood);

4. academia (institutes of education and training and their regulatory bodies);

5. BT sector governance bodies (laws, policies), and

6. the general public (awareness on voluntary versus replacement donation).

The Programme has been able to establish strong bonds with the stakeholders from the entire country. These include the technical level of blood bank laboratory staff, the public health administrations of provinces, representatives of the regulatory bodies for medical sciences and blood transfusion, but also the broad spectrum of private organizations, many of which are dealing with the heaviest burden for the BTS in the country, represented by thalassaemia patients. The SBTP has been able to bring the stakeholders on a joint platform (e.g. concerning VNRBD, MIS, the basic design of RBC and HBB, and recently also concerning legislation and BTAs). The interaction with the different stakeholders has deepened the SBTP’s understanding of the existing “diversity” in terms of structures, technology, human resource capacity and overall organization.

The SBTP is successfully progressing despite the various challenges; furthermore, the new infrastructure development work involving construction and equipment procurements have already commenced. The first phase of this development work is expected to be completed by the end of 2014. In the meantime, the technical cooperation component is proceeding ahead with the training activities, aimed at creating a suitably qualified workforce, able to adequately operate both in the new system and in the current reality. The establishment and strengthening of the “Pakistan haemovigilance network” and the “BDO network” are currently on the priority list of the Programme. The Programme, since its inception in 2010, has been regularly publishing a monthly e-newsletter with activities and updates on transfusion medicine from across the country. The second 5-year phase of the project is to be initiated in last quarter of 2014 and will be implemented in parallel with the first phase which will be completed soon. Among the near future priority plans prepared for the second phase of the project starting from next year, are included a project for setting an inspection of blood establishments with the support of EuBIS Academy and the development of blood supply management systems on the lines of the international recommendations.

With the establishment of the “blood transfusion programmes” at the national and provincial levels, the foundation has been laid in Pakistan for a system which will ensure adequate and nationwide access to safe, effective and sustainable blood supply.