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AJCP / Editorial Quality Pathology and Laboratory Diagnostic Services Are Key to Improving Global Health Outcomes Improving Global Health Outcomes Is Not Possible Without Accurate Disease Diagnosis African Strategies for Advancing Pathology Group Members* Am J Clin Pathol March 2015;143:325-328 DOI: 10.1309/AJCP6K0DZCNVCSCI As the health care needs of populations change in low- and middle-income countries, the demand for affordable, accurate, and timely diagnostic testing will increase substantially. The need for such testing is threefold: (1) to guide treatment of patients, (2) to improve standards of practice in health care systems, and (3) to monitor the health of populations through accurate data collection and analysis. To inform public policy decision making, increased access to quality pathology laboratory diagnoses will require a broader and more holistic approach than has been attempted in the past. This will include addressing workforce development, quality and practice standards, education and training, laboratory infrastructure, resourcing, and advocacy for services. Changing Needs for Health Care Services As many nations undergo sustained economic growth, improvements in health care systems and delivery of services, increased population, and increased longevity, the focus of health care is shifting from a recent emphasis on infectious diseases such as human immunodeficiency virus (HIV), tuberculosis (TB), and malaria to include noncommunicable diseases (NCDs) such as cancer and cardiovascular diseases.1 As governments and other development partners continue to implement the Millennium Development Goals, addressing the impact of NCDs on the health of populations will grow in importance.2,3 In addition, populations within these nations are beginning to expect improved access to routine health care for all age groups, including care for diseases and conditions that, until recently, have received little © American Society for Clinical Pathology attention. Increased urbanization in many areas, combined with increased personal income, raises exposure to risk factors for many chronic diseases, which will further drive the need for improved access to quality health care. In addition to the growing demand for access to health care in general, there is a growing demand for improved laboratory and pathology diagnostic services, including better clinical laboratory tests, appropriate point-of-care tests, tests for cancer screening, and surgical pathology and cytopathology services, which are especially important for cancer care. As patients have increasing access to modern treatments, particularly in cancer care and other NCDs, so will they need access to the most up-do-date laboratory diagnostic tests to allow for personalized health care. Thus, for example, in cancer care, a first and specific goal should be that no patient be treated for cancer without a pathologic diagnosis. Although limited to certain areas, available data indicate that we are far from reaching this goal. In one study during 1994-1996 in Uganda, only 64.5% of patients in an HIV cohort and 68.9% of cancer registry patients had a tissue diagnosis.4 A subsequent study by the same authors, the Kampala Cancer Registry Report for 2007-2009, showed a tissue diagnosis rate of only 58.6%.5 A subsequent goal, one that depends on meeting the first goal, is that all patients with cancer receive appropriate clinical and pathologic tumor staging prior to therapy. As these goals are met, patient care will improve, and the data collected will support multidisciplinary tumor boards, cancer registries, and accuracy in death certification. As the quality and amount of data collected increase, both allocation of health resources and public policy can be improved.6 In the long term, the use of quality diagnostics, particularly accurate pathologic Am J Clin Pathol 2015;143:325-328325 DOI: 10.1309/AJCP6K0DZCNVCSCI ASAP Group / Improving Global Health Outcomes diagnosis, helps create the foundation for developing and implementing population-specific research efforts. Many countries, however, still are unable to provide this type of access to their populations. The problem is particularly evident in sub-Saharan Africa. The World Health Organization’s (WHO’s) 2006 World Health Report emphasizes the disparity between population and access to health care providers: although this region bears more than 24% of the global burden of disease, it has only 3% of the world’s health care workers and less than 1% of the world’s financial resources.7 For the 847,000,000 persons living in sub-Saharan Africa, there are only 1.1 doctors and nurses per 1,000 population.8 This is in stark contrast to the United States and United Kingdom, where there are 12.3 and 12.7 doctors and nurses per 1,000 population, respectively.8 Access to pathologists in sub-Saharan Africa is even more limited: several countries have no pathologists, and the ratio of pathologists to population is less than 10% of that in the United States and United Kingdom.9 By one estimate, at current rates of training in sub-Saharan Africa, it will take more than 500 years for the number of pathologists per 1,000 population to reach the levels that currently exist in the United States and United Kingdom (K. Fleming, personal communication). In addition to the issue of access to pathology and laboratory services, the issue of quality of these services remains of grave concern. Although there are sites in sub-Saharan Africa where regulation and resources yield services of high quality, this is not true in most areas. In perhaps the best-studied area, again Kampala, Uganda, the variability of quality in clinical laboratories is striking. In this study of clinical laboratories, the investigators identified and surveyed 954 laboratories, of which only 45 (5%) “met or surpassed the lowest quality standards defined by the WHO/AFRO-derived laboratory strengthening tool.”10 Despite efforts through the President’s Emergency Plan for AIDS Relief (PEPFAR) and other programs, which have resulted in important progress in improving laboratory quality and rates of accreditation, major gaps remain throughout sub-Saharan Africa.11 The emphasis on the development and use of rapid pathology diagnostic tests for treating patients with HIV/ AIDS, TB, and malaria—through programs such as PEPFAR and the Global Fund—was successful and appropriate because of the way those diagnostic and treatment programs were designed and implemented. That approach, however, is not practicable for addressing the many noncommunicable and other diseases and conditions of public health importance throughout the world. The multiplicity of NCDs such as cancer, as well as the many types and complexity of tests needed for contemporary cancer diagnosis and treatment, precludes simple rapid diagnostic testing at this time. Even with emerging technologies, it is unlikely that affordable, high-quality rapid diagnostic tests can be made available on a 326 Am J Clin Pathol 2015;143:325-328 DOI: 10.1309/AJCP6K0DZCNVCSCI global basis in the near future. It is, however, possible to provide accurate and cost-effective pathology diagnostic testing for many NCDs by simply improving and extending existing laboratory services to populations that currently lack access to them. But it is clear that no single approach can be expected to be successful in all areas. What is lacking is the evidence to guide policy makers to make informed decisions as to how to improve laboratory and diagnostic services, and therefore health care, on a country-by-country basis. Pathology Matters: Advocating for Improved Diagnostic Services In the past, pathologists and other laboratory professionals have been unable to provide accurate and timely diagnoses due to a lack of resources and insufficient contact with (and encouragement from) clinicians. As a result, the clinicians, facing high numbers of patients with acute infectious diseases, trauma, childbirth, and other urgent or emergent conditions, have learned to practice medicine with limited, often poorquality laboratory diagnostic services. This contrasts with services that are readily available and the standard of best practice in high-income countries. In many regions, poor-quality services have created a degree of professional cynicism among clinicians and providers. For all these reasons, clinicians have not advocated for improved laboratory diagnostic testing, nor have patients and the public demanded it. Outside of the recent emphasis on treating HIV/AIDS, TB, and malaria guided by quality diagnostic testing, little or no emphasis has been placed on pathology testing as a critical component of health care. As governments, clinicians, and patients begin to move toward improved health care for larger patient populations, it is clear that the current state of diagnostic testing must change dramatically. There is a clear need for advocacy: to encourage governments, ministries of health, and their development partners to allocate much-needed resources for pathology and for clinicians to advocate with the government and hospital and clinic administrators to resource and improve access to diagnostic testing. There is also a need for advocacy to increase pathology education and training programs to provide adequate numbers of pathologists and other laboratory professionals. Importantly, patients should advocate for access to quality pathology laboratory diagnostic services within the context of their right to good health care. The Road Ahead Providing access to quality pathology services on the scale needed will not be an easy or inexpensive undertaking. In addition to the need for effective advocacy, major gaps © American Society for Clinical Pathology AJCP / Editorial exist in infrastructure, laboratory quality assurance and testing standards, education and training, and workforce development. There is a lack of coordination of efforts within and between countries in many regions. Leveraging resources and efforts between organizations and programs remains an elusive concept due to a multiplicity of funding streams, divergent interests, nonalignment of goals, and a historic unwillingness or inability of many governments to provide oversight and leadership. Perhaps the biggest obstacle to date has been the absence of a vision and a plan for making necessary changes. That has now changed. At a meeting held in Siena, Italy, in June 2014, a diverse group of stakeholders, consisting of experts in histopathology, cytopathology, microbiology, laboratory management, public health advocacy, funding, and process improvement, met to define a vision for increasing and improving pathology diagnostic services in sub-Saharan Africa. The outcome of the meeting was optimistic but also sobering. There is optimism because of a clear consensus that the lack of quality and accessible pathology diagnostic services is an issue that is not insurmountable and can be resolved using current technology. It was sobering because of the scale of the issue, the urgent need to develop largescale and sustainable funding mechanisms, and the need for longer-term efforts to ensure that any improvements are capable of being replicated. Ultimately, the African Strategies for Advancing Pathology (ASAP) Group envisions a future in which the importance of pathology in sub-Saharan Africa is recognized at local, national, regional, continental, and international levels, with a competent pathology workforce and a number of expert centers and networks that are supported by a highquality sustainable delivery system to improve the quality of life of persons living in sub-Saharan Africa. The ASAP Group has generated a high-level strategic plan that delineates strategies to improve the framework for pathology in sub-Saharan Africa, including: • Create and implement an advocacy strategy for pathology. • Generate an economic case for pathology. • Raise the pathology profile in the medical community. • Build networks for teaching and training. • Define and develop standards for acceptable practices. • Build, strengthen, and maintain operational laboratories. • Leverage private, research, and commercial sectors for pathology. The goal of the Siena meeting was to create a vision, strategy, and structure. The way forward will be long and difficult. It should not be underestimated. But as one historian wrote about seemingly insurmountable matters, © American Society for Clinical Pathology “Whatever the new challenges and problems, constructive individuals with a combination of insight and enterprise [are] entirely capable of coping with them.”13 The ASAP Group has come together to provide a framework for such individuals to take up the challenge. Key Messages • Global need for access to high-quality health care is increasing; the increase is driven by social, economic, and demographic factors. • High-quality health care is not possible without the availability of accurate and timely diagnosis of diseases and conditions. • Direct patient care, epidemiology, resource allocation, and public health policy also require more accurate and timely diagnosis of diseases and conditions. • Because major gaps in the availability of pathology and laboratory services exist in many regions, and current efforts to improved access to these services are insufficient, new strategies to increase capacity are needed. • The ASAP Group has provided the framework of such a new strategy and will be working with committed individuals and partners to deliver them. Contributors and Sources This article’s provenance is from a meeting held in Siena, Italy, during June 2014. The meeting was to develop strategic plans for increasing access to pathology and diagnostic laboratory services in sub-Saharan Africa; the intent was not to develop specific implementation projects. The authors fall into two broad groups: African pathologists and non-African pathologists along with several non-African members with expertise as described in this article. *African Strategies for Advancing Pathology (ASAP) Group Members include: Akin Abayomi, Cape Town, South Africa; Adekunle Adesina, Houston, TX; Dan Berney, London, England; Carla Carillo, Maputo, Mozambique; Rita D’Angelo, Detroit, MI; Isidore Diomande, Abidjan, Cote D’Ivoire; Sambe Duale, Washington, DC; Rosemary Emodi, London, England; Alexia Eslan, Denver, CO; Andrew Field, Sydney, Australia; John Flanigan, Baltimore, MD; Kenneth Fleming, Oxford, England; Martin Hale, Johannesburg, South Africa; Alec Howat, London, England; Yawale Ilyasu, Zaria, Nigeria; Sebastian Lucas, London, England; Dan Milner, Boston, MA; Ann Nelson, Washington, DC; Louis Ngendehayo, Bujumbura, Burundi; Francis Omaswa, Kampala, Uganda; Tim Rebbeck, Philadelphia, PA; Julia Royall, Washington, DC; Shahin Sayed, Nairobi, Kenya; Edda Vuhahula, Dar es Salaam, Tanzania; Michael L. Wilson, Denver, CO; Richard Zarbo, Detroit, MI. Am J Clin Pathol 2015;143:325-328327 DOI: 10.1309/AJCP6K0DZCNVCSCI ASAP Group / Improving Global Health Outcomes References 1. World Health Organization. 2008-2013 Action Plan for the Global Strategy for the Prevention and Control of Non-Communicable Diseases. Geneva, Switzerland: World Health Organization; 2009. 2. Alleyne G, Binagwaho A, Haines A, et al, on behalf of The Lancet NCD Action Group. Non-communicable diseases 1: embedding non-communicable diseases in the post-2015 development agenda. Lancet. 2013;381:566-574. 3. Scott KW, Jha AK. Putting quality on the global health agenda. N Engl J Med. 2014;371:3-5. 4. Parkin DM, Wabinga H, Nambooze S. Completeness in an African cancer registry. Cancer Causes Control. 2001;12:147152. 5. Wabinga H, Parkin DM, Nambooze S. Kampala Cancer Registry Report for the Period 2007-2009. Kampala, Uganda: Kampala Cancer Registry; 2012. 6. Roberts DJ, Wilson ML. Improving diagnostic pathology capacity for global cancer care: where to start. Am J Clin Pathol. 2014;141:150-151. 328 Am J Clin Pathol 2015;143:325-328 DOI: 10.1309/AJCP6K0DZCNVCSCI 7. World Health Organization. The World Health Report 2006— Working Together for Health. Geneva, Switzerland: World Health Organization; 2006. 8. World Health Organization. WHO global health workforce statistics. http://www.who.int/hrh/statistics/hwfstats. Accessed January 27, 2015. 9. Adesina A, Chumba D, Nelson AM, et al. Improvement of pathology in sub-Saharan Africa. Lancet Oncol. 2013;14:e152-e157. 10. Elbireer AM, Jackson JB, Sendagire H, et al. The good, the bad, and the unknown: quality of clinical laboratories in Kampala, Uganda. PLoS One. 2013;8:e64661. 11. Schroeder LF, Amukele T. Medical laboratories in sub-Saharan Africa that meet international quality standards. Am J Clin Pathol. 2014;141:791-795. 12. Weinberg GL. A World at Arms. New York, NY: Cambridge University Press; 1994. © American Society for Clinical Pathology