Strategic frameworks for strengthening health laboratories and blood transfusion services
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Strategic frameworks for strengthening health laboratories and blood transfusion services
- 1. Strategic frameworks for strengthening health laboratories and blood transfusion services Agenda item 5(b) 63rd Session of the WHO Regional Committee for the Eastern Mediterranean 36 October 2016, Cairo
- 2. Essential role of health laboratories 2 Strategic frameworks for strengthening health laboratories and blood transfusion services
- 3. Components of a national blood system The blood regulatory system Legislations, regulations, policies, standards and a national regulatory authority The blood transfusion system Hospital blood banks, clinical transfusion services, hospital transfusion committees. The blood supply system Blood banks that collect, test, and process blood 3 Strategic frameworks for strengthening health laboratories and blood transfusion services
- 4. Current laboratory performance: results from the regional external quality assurance (EQA) programme (EQA is a proxy indicator to measure accuracy of laboratory results) • Regional EQA scheme runs since 2005 • 34 laboratories from 20 countries • Central and national public health laboratories, reference laboratories, big hospital laboratories 4 Correct 69% HIV Ab panel (26 labs) At least one result incorrect 31% Correct 65% MERS-CoV panel (17 labs) At least one result incorrect 35% Strategic frameworks for strengthening health laboratories and blood transfusion services
- 5. Preparedness of national laboratory systems for Ebola outbreak: self-assessment of 11 countries 5 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Average assessment indicator of preparedness to EVD outbreak
- 6. Availability, safety and wastage of blood 2.5 14.2 5.2 25.7 13.9 16.9 14.5 29.0 9.3 13.2 12.8 11.0 13.8 2.8 5.3 20.6 12.2 0.7 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 Afghanistan Bahrain Egypt Iran Iraq Jordan Kuwait Lebanon Libya Morocco Oman Pakistan Qatar Saudi Arabia Somalia Sudan Tunisia United Arab Emirates Yemen Units of blood donated per 1000 population Availability - WHO recommended 10 units/1000 population % reactive to TTI HIV 0 – 1% HBV 0.06 – 5% HCV 0.05 – 3.35% Syphili s 0.07 – 5% Only 65.8% collected from voluntary, unpaid (safe) blood donors. Safety 6 Wastage: ½ million units of whole blood/red cells (7%) and 2.8 million units of plasma (70%) discarded ~ 100 million US$ Strategic frameworks for strengthening health laboratories and blood transfusion services Source: Global Database on Blood Safety (2013)
- 7. Uniform quality laboratory and blood services that support the national health care services Operationalizing national regulatory framework Building national regulatory framework for laboratory and blood services Monitoring & evaluation of the framework implementation and effectiveness Regional Strategic Frameworks for Laboratory and Blood Services Role of WHO: Mobilize commitment and resources Technical assistance, guidance and tools Coordinate at regional and country level 7 Strategic frameworks for strengthening health laboratories and blood transfusion services
- 8. Priority interventions Health laboratory services Priority interventions Actions by countries Leadership and governance • National laboratory policy and strategic plan, regulatory system • National quality standards, monitoring and evaluation mechanism Organization and management • Quality management systems in health laboratories • Sustainability, Improved equipment and supply chain management Human resources • Human resource policies, good personnel management • Registration/licensing of laboratory workers • Improved pre- and in-service training, professional development Biosafety and biosecurity • National biorisk policy/guidelines, • Staff training in biosafety and biosecurity Integrated laboratory referral networks • National referral networks to ensure access to laboratory services • Cross-sectoral coordination under “One Health” approach Rational use of laboratory services • Improved communication and information for health care providers • Capacity of laboratory staff to provide advisory services 8 Strategic frameworks for strengthening health laboratories and blood transfusion services
- 9. Priority interventions Blood transfusion services Priority interventions Action by countries Leadership and governance • Develop/update blood policy and strategic plan • Develop appropriate regulatory system Coordination and collaboration • Establish/strengthen a specific organization/unit responsible for coordination of the blood system Provision of safe blood and blood products • Collect 100% of blood from voluntary unpaid donors from low risk populations • Reduce wastage of blood and plasma Appropriate clinical use of blood and blood products • Develop/implement guidelines on clinical use of blood • Establish hospital transfusion committees Quality system management • Implement a national quality management system • Establish a national haemovigilance system 9 Strategic frameworks for strengthening health laboratories and blood transfusion services
- 10. 0 10 20 30 40 50 60 70 80 90 Average total score (%) Implementation of national regulatory framework leads to improvement of laboratory performance Average total score, baseline and repeated (after one year), external audits of health labs in Fiji (n=20) “Secrets” of Fiji success • Strong and visible commitment by Ministry of Health • Quality champions at all levels • Evidence-based planning and realistic budget • Involvement of technical staff as equal partners • Transparency of implementation, constant communication and information sharing 10 Baseline assessment Reported assessment Strategic frameworks for strengthening health laboratories and blood transfusion services
- 11. Whole Blood Donations per 1000 population 15.9 5.8 0 2 4 6 8 10 12 14 16 18 Countries with regulatory mechanism Countries without regulatory mechanism 13.9 6 Countries with national blood policy Countries without national blood policy National policy and regulatory mechanism for blood safety and availability Source: Global Database on Blood Safety (2013) (n=18) 11 Strategic frameworks for strengthening health laboratories and blood transfusion services
- 12. Action needed • The Regional Committee is invited to endorse the strategic frameworks in order to ensure adequate laboratory preparedness and response capacity and a safe blood supply for all 12 Strategic frameworks for strengthening health laboratories and blood transfusion services
- 13. Thank you
Editor's Notes
- Health laboratory services are an essential and fundamental component of any strong and effective health system and its goal to improve health. Over 70% of medical decisions are predicated upon, or confirmed by, or documented by medical laboratory test results (Dighe et al., 2007). Accurate, reliable and timely results from laboratory investigations are crucial in decision-making for both clinical and public health functions including surveillance, diagnosis, prevention, treatment, research and health promotion. In particular, laboratory screening provides information on predisposition to disease (e.g. genetic testing), helps prevent spread of infection (e.g. via blood supply), and ensures continued health and avoiding of disease. Early and accurate laboratory detection of infectious treats and correct diagnosis of communicable and non-communicable diseases ensures that response to an outbreak is prompt and appropriate, while treatment is relevant and cost-effective. Normal results eliminate doubt and rule out unnecessary interventions both in clinical and public health setting. Finally, laboratory provides objective information to determine and monitor treatment and response options that allows to measure the effect of public health interventions on the ongoing outbreaks, reassess and updated therapy in a clinical setting, and manage the treatment according to a patient’s response, such as determining susceptibility to antibiotics. Despite this central role, strengthening nationally coordinated laboratory services has, until recently, received little or inadequate attention in many countries. This has resulted in laboratory services having very low national priority in respect to financing, planning and service delivery.
- The blood system is unique and separate from the laboratory system. Its structure will depend on the organization and level of development of the health-care system. However, all critical activities within a national blood system should be coordinated at national level to promote uniform standards, economies of scale, consistency in the quality and safety of blood and blood products and best transfusion practices. To do that, the three components of a national blood system should be strengthened. Blood must be produced and used in a regulated environment; the regulatory system is the basis for improving the blood supply and transfusion systems. However, only half of the countries in the Region have a regulatory system in place.
- The regional EQA scheme (REQAS) was established in 2005 and since then expanded from 15 to 34 laboratories. The scheme is supported financially and technically by WHO/EMRO and administered by the Oman Central Public Health Laboratory jointly with Iran Reference Health Laboratory. The scheme currently includes the following panels: Bacteriology, Serology, Parasitology and Mycology. MERS-CoV panel was run as a single round in 2015 supported by WHO HQ and administered by the Royal College of Pathologists of Australasia (RCPA). In the Eastern Mediterranean region, out of 23 laboratories that were invited to participate, 17 reported their results for the panel.
- Assessments of the national laboratory systems and central public health laboratories to EVD outbreak was conducted in 2015 as part of Ebola 90 day emergency plan. Modified Laboratory Assessment Tool (WHO, 2012) for system and facility was used. The tool was filled by the PHL focal points in EMR countries. Eleven countries returned the properly filled tool. National health lab systems were assessed across seven areas: (1) coordination and management; (2) structure and organization; (3) regulations; (4) quality of lab system; (5) lab information management; (6) human resources; (7) biorisk management. Bigger graph in the middle shows the average assessment indicator across all seven areas. Smaller graphs underneath show indicators for the areas of regulations, quality of lab system, and biorisk management. As may be seen from the graphs, preparedness of the lab systems to an Ebola outbreak vary widely, with only three country out of 11 who can claim of being relatively prepared (average indicator above 80%). Others are not prepared, with three countries in a really dangerous situation. Analysis of data by assessment area confirms this observation. It is worrisome to see that only one country is above 80% in quality of lab system and in biorisk management, and four countries have no laboratory-related regulation at all.
- This slide is based on Global Database on Blood Safety for 2013 (published in a report in 2016). The information included in the strategic framework is from 2011/12 (corresponding to 2014/2015 report). It takes two years to collect and analyze the data. Availability: The slide shows the rate of blood donation per 1000 population as a crude estimate of supply of blood, which ranges between 0.7 (Yemen) to 29 (Lebanon). Only 12 countries collect more than 10 per 1000 population. The regional average is 11 per 1000 population. Safety: The proportion of blood collected from unsafe blood donors is high (35%), as high as 96% in some countries. Most countries depend on family replacement blood donation. The percentage of blood donations reactive for HBV, HCV, syphilis and HIV are high in some countries. A recent study from Pakistan, showed 25.3% of multi-transfused Thalassemia patients were infected with TTIs (HCV 21.7%, HBV 3.0%), and HIV 0.5%). Wastage: Currently, about seven percent of donations (whole blood/red cells) are discarded due reactive tests and expiry date. Up to 2% is acceptable. Similarly, about 2.8 million (70%) units of plasma were discarded or not used for fractionation to produce plasma derived medicinal products. This is due to the poor quality of plasma produced and the lack of access to fractionation facilities. The financial loss due to discarded units is approximately 100 million USD annually, without including the cost of final disposal of the units. Using its plasma for fractionation instead of buying commercially available products from the market, Iran saved 11.1 million USD in 2011, which increased to 17 million USD in 2015.
- Based on an in-depth situation analysis and extensive consultation with national programmes, national and international stakeholders; and learning lessons from countries with good laboratory and blood services, strategic frameworks for strengthening health laboratories and blood transfusion services were developed. The strategic frameworks have clearly defined goals and objectives as follows: Strengthen governance Strengthen organization and management Improve quality systems Establish sustainable, sufficient and competent human resources Ensure safe and secure laboratory environment Promote effective laboratory and blood bank networks and enhance coordination Promote rational and evidence-based use of laboratory services, blood and blood components The priority interventions and the framework for action have been agreed with Member States and address the gaps identified during the situation analysis. The strategic frameworks have already set indicators and targets for monitoring progress with implementation.
- The Strategic Framework for Strengthening Health Laboratory Services is built around six interrelated strategic goals and corresponding priority interventions. Full implementation of those interventions will allow countries to achieve the vision of the Strategic Framework and ensure that their national lab systems are well-coordinated, sustainable, accessible for all and able to generate safe, reliable and timely results for public health purposes and patient care. These priority interventions include: strengthen leadership and governance of the national laboratory systems; strengthen the organization and management of the national laboratory systems towards quality; establish sustainable, sufficient and competent human resources for laboratory service delivery; ensure safe and secure laboratory environment; promote effective, tiered and integrated laboratory referral networks (in-country and among countries) and enhance coordination; and promote rational and evidence-based use of laboratory services. Each priority intervention requires a number of actions to be taken at both national and regional level. Member States should prioritize these actions based on their national context, capacities and circumstances.
- The strategic framework for strengthening for blood safety and availability is built around the key elements of a national blood system (endorsed by WHO). Full implementation of the priority interventions will allow countries to achieve the goal of the strategic framework vision of the strategic framework by addressing the gaps identified on availability, safety and wastage of blood. It is important to stress the need for an appropriate governance for the blood system. We need to establish and strengthen the regulatory framework including legislations, regulations, policies, standards and national regulatory body/authority. A strong blood regulatory system is vital to improve the blood system. The blood supply system should be nationally coordinated – to collect, test, and process whole blood and components, as well as plasma intended for fractionation, It is important to reduce wastage through increasing voluntary blood donation, quality blood collection, processing, storage and transportation; and, We need appropriate intuitional mechanisms to manage the blood transfusion system in the hospital blood banks and clinical services. This also requires sufficient funds and sustainable financing mechanism; and competent and adequate human resources.
- The graphs illustrate the effect of implementation of the national laboratory policy and national quality standards on the performance of public laboratories in Fiji. The data were collected in 2011-2014. Laboratories were assessed before and one year after beginning the implementation of the policy and standard requirements. Assessment tool was based on the Fiji national quality standards and designed to measure laboratory performance in ten areas: organization and management, quality management system, human resources, accommodation and environment, laboratory safety, laboratory equipment, procurement and supply management, information management, managing laboratory specimens, and customer service. A total of 20 laboratories were assessed, all operated by the Ministry of Health. As may be seen from the graphs, just ONE year of intense implementation resulted in improvement of the average total score across all laboratories from 58.5% to 80.6% (22.1% percentage point increase). The radar diagram also demonstrates significant improvements in average assessment scores that are especially dramatic in the areas of quality management system, laboratory safety, equipment, procurement and supply management, information management, and specimen management. The success of the reform of the health laboratory services in Fiji was due to the following factors: The Ministry of Health initiated and took the lead in the reform process, constantly showed strong commitment to the cause, provided close and interested supervision of the process. The reform process was led by the “quality champions” at both the Ministry and National Reference Lab level. “Quality champions” – enthusiastic and energetic managers – served as driving force for the change. Planning and budget for the improvement activities were based on the evidence collected during external assessments and internal audits, decisions were made transparently and with consultation with lab management at all levels. Laboratory leadership widely involved technical staff as equal partners, thus overcoming resistance to change and creating an atmosphere of collaboration and ownership. The change was facilitated by the constant communication and information sharing with all stakeholders from lab staff to clinical colleagues to Ministry officials. This transparency of implementation helped in building common understanding of goals, objectives and performance targets, as well as exposing and overcoming challenges. The experience and lessons learnt from the implementation of the national regulatory framework in Fiji is summarized in: Tudravu L., Malupo N., Buadromo E., Nahapetyan K. Implementation of Laboratory Quality Management System in Fiji Pathology Laboratory Services. Fiji Journal of Public Health, 2014, Vol. 3 (Issue 1), pp. 43-48.
- These three graphs illustrate link between the availability (and implementation) of a national blood policy and a regulatory mechanism, and availability and safety of blood in 18 countries in the Region. The number of whole blood donations per 100 population is higher in countries with national blood policy and a regulatory mechanism in place. The percentage of blood collected from voluntary, unpaid (safe) donors is also higher in countries with a national blood policy in place.