Download Quality Pathology and Laboratory Diagnostic Services Are Key to

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