APHL's vision statement: A healthier world through quality lab practice

Lucy Maryogo-Robinson is the director of global health at the Association of Public Health Laboratories (APHL). The association provides strategic planning, training, infrastructure development, and other related services to support development of integrated laboratory systems in 20 countries worldwide. She answers several questions about APHL global activities that are sure to enlighten readers.

MLO: As the national association representing
laboratories and laboratory leaders in public health, what are APHL's
global interests? What prompted this interest, and when did it begin? Is
APHL planning to open overseas offices?

Lucy Maryogo-Robinson: APHL's Global Health
Program provides customized technical assistance to strengthen national
laboratory systems for health promotion. We provide support to
in-country health officials and laboratorians in resource-constrained
nations to help them achieve their own goals. Usually, this means
building up the physical and human laboratory infrastructure so that it
is eventually self-sustaining, and we are no longer needed. While
HIV/AIDS testing has been a big focus for us, we try to transfer
knowledge and institute quality systems that will carry over to all the
work of the laboratory.

APHL's interest in global laboratory capacity
building began more than 10 years ago. The association responded to a
request from the U.S. Centers for Disease Control and Prevention (CDC)
to help improve capacity for HIV testing in India. Our next big project
was to help reconstruct the laboratory systems in the Caribbean nations
devastated by hurricanes Mitch and Georges in 1998. In addition to
laboratory renovations, though, APHL consultants helped to instill the
concept of public-health laboratory practice in countries like Haiti
that had only a quasi-public-health lab. When the project ended in 2002,
the laboratory leaders in the region established their own public-health
laboratory association. We could not have been happier.

At this moment, APHL has one overseas office in
Mozambique, which is the base of operations for two full-time
consultants. We also have full-time consultants working in Lesotho and
Haiti — but without separate brick-and-mortar APHL facilities We would
like to establish offices, at least regionally, so we can readily
provide technical assistance on an “as needed” basis. It is challenging
to do that from the United States when most of our clients are in
Africa.

MLO: What are the major differences between
laboratory systems in the United States and in the developing nations
where APHL works? Is government oversight of private laboratories the
norm?

Maryogo-Robinson: Obviously, challenges vary
somewhat from country to country. In general, though, human resource
challenges are significantly more severe in developing nations than in
the United States. We see a huge shortage of trained laboratory
personnel, and this is one area where we try to help.

The other major challenge we see is laboratory
infrastructure. For example, in some countries, you may not have
functioning equipment or even power to turn on your equipment. If you do
have functioning equipment, you may not know how to use it; it may have
been donated and dropped off without training or even a manual.

Let us say you do have equipment and know how to
operate it. You still may be stymied, because you do not have reagents
because of all the procurement issues in the country. Procurement is
often centralized in the national government, and there can be
challenges navigating that bureaucracy.

In addition, many countries lack a strategic plan to
provide focus and direction to their laboratory operations. I also think
there is a lack of professional networking of the kind that is fairly
well established here in the United States. And in some countries, there
are systems development issues. You may be getting requisitions on
random pieces of paper, and there may be no standardized results
reporting or quality-assurance/quality-control programs.

Government oversight of private labs differs from
country to country, but, generally, I do not think it is the norm in
those countries where we work.

MLO: How is APHL working to advance laboratory
systems in developing countries? How does this work differ from domestic
APHL initiatives? And how has APHL involved commercial vendors in its
overseas work?

Maryogo-Robinson: The first and probably most
profound way we address issues in developing countries is through
technical assistance. APHL is lucky to have a pool of experts among our
membership. We also hire non-member consultants, some of whom are
stationed in-country for a year or longer and others who fly in to
address a specific need. Our primary activities are knowledge transfer,
problem-solving, and systems development.

An exciting new program APHL is participating in has
to do with laboratory accreditation in Africa. The program is being
spearheaded by the CDC and the World Health Organization's Regional
Office for Africa (WHO AFRO). The idea is to promote quality laboratory
improvement using a tiered accreditation system giving laboratories
something for which to strive. APHL is one of the program partners.

Since the project was just begun in summer 2009, we
are still in the initial phase. Right now, we provide
laboratory-management training and targeted training in laboratory
information systems (LISs) and equipment-maintenance programs. As the
program moves forward, we expect to support efforts to establish
quality-management systems, develop standards for facility
infrastructure, conduct strategic planning, develop laboratory policies,
and strengthen national reference laboratories.

Another interesting APHL activity is what we call our
“twinning program.” This program, also supported by the WHO, links
overseas national laboratories with U.S. public-health labs to improve
quality laboratory practices and international infectious-disease
surveillance. The Guyana National Public Health Reference Laboratory,
for example, is “twinned” with the North Carolina Public Health
Laboratory. We have four twinning agreements so far and hope to
establish many more.

APHL partnered with the architecture and engineering
firm CUH2A on laboratory design projects in Tanzania and in Mozambique.
The Abbott Foundation is sponsoring the Tanzania project, which involves
renovation work in all 23 of the country's regional laboratories.

MLO: Can you share some success stories?

Maryogo-Robinson: We are fortunate to have many
success stories. In Ethiopia, we had a consultant on-site on and off for
about two years. She helped establish an EQA [External Quality
Assessment] program for HIV serology chemistry, CD4, and hematology
testing. She is now long gone, but the processes are in place to carry
on that important work.

APHL has been most active in Mozambique, where we are
supporting more than 25 laboratories with all kinds of assistance from
equipment and reagent procurement to LIS implementation. APHL is
committed to continuing its support until a critical mass of Mozambique
laboratories are performing consistent quality work in critical areas.

Just last year, APHL and Miami Dade College
collaborated on a training program in medical laboratory science for 12
biologists from Mozambique. We flew the biologists to Miami for a
three-month intensive course of study, and for two months of practical
training in a state public-health laboratory.

The program was such a success that APHL and Miami
Dade College formalized its relationship early this year. This kind of
training program is desperately needed given the enormous human
resources challenges in Mozambique and other resource-constrained
countries. Mozambique, for example, has only one laboratory-technician
training program, and it admits only one cohort of students every four
years, meaning that it graduates students only once every four years.
APHL also offers regular training in Mozambique on topics such as
laboratory management and quality systems.

In addition, APHL has developed a highly successful
process for identifying information-management solutions for
laboratories. We have used that process in six countries so far. First,
we work with local laboratory leaders to analyze and standardize the
usually paper-based systems in use. Then, local leaders establish
high-level LIS requirements. We translate these into a detailed, posted
RFP [Request for Proposal], to which vendors can respond. In-country
leaders choose what they deem to be the best solution from among those
presented. Tanzania, for example, has a customized electronic LIS.

MLO: What personal and professional challenges do
APHL representatives face when working on-site in developing countries?
What are the personal and professional rewards of this work?

Maryogo-Robinson: APHL always works with the
national Ministry of Health and the local CDC office. One of the biggest
challenges is making sure we are following national priorities; that is,
working within the Ministry of Health guidelines and agenda for any
given country.

Another challenge is finding experts who can commit
to long-term assignments. We often have requests for technical
assistance that require a longer-term assignment, and finding experts
who can stay on-site for three to six months or longer is difficult.

On the ground, our biggest challenges are
transportation — especially when we are working outside of the capital
city — and lack of reliable power and Internet access. We have tried to
come up with creative solutions, such as using cell phones to report
data between labs. We are also looking into solar-power solutions for
remote sites. Since we only go into a country when it is absolutely
safe, political strife is generally not a concern.

In terms of rewards, I think our consultants find it
very satisfying to help set the public-health agenda for another
country. That is what we are doing when we contribute to a national
five-year strategic plan for a country's laboratory system. We are
really shaping and molding the laboratory field.

Building sustainable laboratory systems that can
accurately diagnose diseases like HIV and tuberculosis saves lives and
offers people hope.

MLO: How does the quality of laboratory systems
in developing nations impact the United States? What opportunities are
available to U.S. laboratorians who want to contribute to APHL's global
work?

Maryogo-Robinson: It is important to have
high-quality, laboratory-based disease surveillance in developing
countries, because diseases do not respect borders. Influenza is a
recent example. With globalization, we are more and more interconnected,
for better or worse. APHL's vision statement — “A healthier world
through quality laboratory practice” — reflects a worldwide focus;
without quality laboratory systems in place in every region of the
world, we are simply less prepared for emerging pathogens and,
potentially, for global epidemics. It matters to us whether or not
Tanzania can detect influenza.

APHL is always looking for qualified individuals
interested in international public-health work — in the United States or
overseas. We need people who can provide training in subjects like
biosafety, laboratory management, HIV rapid testing, and EQA for ASB
[acid-fast bacilli] smear microscopy.

MLO readers who want more information should send
e-mail to [email protected] , or visit
www.aphl.org  and
go to the Global Health page under Programs.

Note: This article also appears as an International Corner
feature in November's LABline. American companies with an
international presence can contact MLO's editor at
[email protected]  for information on how to participate.

Strengthening lab quality in sub-Saharan Africa

Lee H. Hilborne, MD, MPH

What would you do if you were asked to improve care
for millions of patients in the developing world who have limited access
to the high-quality diagnostic laboratory services that we in the United
States take for granted? What if treatments for some of the world's most
challenging diseases affecting these patients, such as HIV/AIDS,
malaria, and tuberculosis, were increasingly available — but the tests
to make diagnoses from which to determine therapy were not?

Recently, as an advisor to an international
conference to launch an ambitious laboratory-accreditation project, I
was in the unique position of helping to point a dozen countries — which
include Botswana, Cameroon, Cote d'Ivoire, Rwanda, Ethiopia, Kenya,
Malawi, Nigeria, Senegal, Tanzania, Uganda, and Zambia — in the right
direction to continuous improvement in quality testing.

Held in July 2009 in Kigali, Rwanda, the conference,
“Strengthening Laboratory Management,” represented the culmination of
years of dedicated effort by laboratory professionals and supporters
from the World Health Organization (WHO), the U.S. Centers for Disease
Control and Prevention (CDC) Global AIDS program, the William J. Clinton
Foundation, and the American Society for Clinical Pathology (ASCP), to
assist medical laboratories in sub-Saharan Africa achieve accreditation
of their laboratory services through task-based training and expanded
diagnostic-test capacity. One hundred forty host-government laboratory
personnel, health experts, and policymakers from these 12 countries met
for the first-ever World Health Organization Regional Office for Africa
(WHO-AFRO) accreditation program.

Fortunately, over the last few years, the seeds for a
five-step accreditation process had been planted and have started to
bear fruit with this historic meeting. The ASCP, American Society for
Microbiology, the Clinical and Laboratory Standards Institute, and the
Association of Public Health Laboratories and their volunteers,
supported by the CDC, have worked in the sub-Saharan African countries
to provide basic training and infrastructure development support to
laboratory professionals and laboratories. Countless others have been
involved to date, both from the United States and other developed
countries.

The immediate goal for the conference was not to
adopt an accreditation model where laboratories would immediately be
evaluated by the standards presently existing in developed countries.
Rather, our goal was to establish a multicountry commitment to adopt and
progressively move closer to fulfilling a new set of standards.

The WHO-AFRO African accreditation program will
operate with support from the U.S. President's Emergency Plan for AIDS
Relief, or PEPFAR, program. This accreditation process is unique in
that, instead of being a “pass or fail” system, the program is divided
into tiers, allowing laboratories to move up the tiers incrementally as
the percentage of benchmarks met increases, ultimately, to reach the
point where they would qualify for full, internationally recognized
accreditation.

But the intermediate steps are essential; nobody
wants to set these laboratory professionals and country health leaders
up for failure — the goal is to establish a roadmap for success.
Laboratory professionals truly can change the world.

Lee H. Hilborne, MD, MPH, is medical director, Quest
Diagnostics Southern California, and deputy director, Global Health,
RAND Health, in Santa Monica, CA. An expert in laboratory quality
standards, Dr. Hilborne was president of ASCP in 2008, and is a
professor in the Department of Pathology at the UCLA School of
Medicine-Los Angeles, associate director, UCLA Medical Center; and
director, UCLA Center for Patient Safety and Quality, UCLA Healthcare.

HIV/AIDS garner attention in December

Dec. 1 celebrated as World AIDS Day
The 2009 World AIDS Day theme for 2009 was “Universal
Access and Human Rights.” UNAIDS estimates calculate that 33.2 million
people now live with HIV, including 2.5 million children. Around half of
all people who become infected with HIV do so before they are 25 and are
killed by AIDS before they are 35. In a follow-up to its report on
women's health, the World Health Organization announced that the AIDS
virus is the leading cause of death and disease among women between the
ages of 15 and 44. The first World AIDS Day was celebrated in 1988, and
the organization is focused on raising money, increasing awareness,
fighting prejudice, and improving education.

U.S. entry ban lifted for those living with HIV
On Nov. 3, President Barack Obama announced the
repeal of a travel ban that required everyone entering the United States
to admit that they do not have a communicable disease, alongside not
being a terrorist, a Nazi, or a criminal. The rule to lift the ban was
published in the Federal Register Nov. 2, wherein HIV will be
dropped from the list of diseases barring visitors from entering the
country, effective Jan. 1, 2010. The announcement paralleled the signing
by President Obama of the fourth reauthorization of the Ryan White CARE
(Comprehensive AIDS Resources Emergency) Act. Ryan White, diagnosed with
AIDS at age 13, was an Indiana teenager with hemophilia who contracted
the disease through a blood transfusion. He died in 1990 at 18, just a
few months before Congress passed the AIDS bill that bears his name.

HIV care/prevention supported by federal stimulus funds
Researchers at the University of California-San
Francisco were recipients of two $1 million National Institutes of
Health (NIH) grants to study the use of Web-based, patient-controlled
personal-health records to improve health and HIV-prevention outcomes
for HIV-positive patients. These studies, funded through The American
Recovery and Reinvestment Act, will 1) examine using mobile phone text
messages linked to a Web-based personal-health record to assist HIV
patients maintain timely pill-taking, and 2) to test the feasibility and
acceptability of a Web-based strategy designed to reduce drug and
alcohol use and accompanying HIV risk behaviors, as well as to improve
HIV-positive patients' adherence to taking antiretroviral medication.

The University of Alabama-Birmingham School of Public
Health received $11.5 million from NIH to explore new ways of
identifying adolescents and young adults infected with HIV and link them
to medical care. These grants support the university's coordination of
the Adolescent Medicine Trials Network for HIV/AIDS Intervention (ATN).
A spokesman from UAB's School of Public Health and ATN indicated that,
in America, one-third of all new HIV infections are in those under age
30.

FDA HIV/AIDS news
In October, the U.S. Department of Health and Human
Services (HHS) marked the recent approval of the 100th antiretroviral
drug in association with the President's Emergency Plan for AIDS Relief
(PEPFAR), aimed at the prevention, treatment, and care of people
infected with and affected by HIV/AIDS worldwide. To date, more than 100
products that have been assessed by the Food and Drug Administration
(FDA) and either fully or tentatively approved in association with the
PEPFAR program. Of these, 29 have been new products and 71 have been
generic copies of previously authorized antiretroviral products in the
United States. Twenty-two of these are new combinations or regimens that
have not previously been authorized in the United States. In addition,
there are seven new pediatric products considered innovative for
patients in developing economies.

The PEPFAR program is a cooperative effort that
involves the FDA and other HHS agencies, the State Department's Office
of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other
federal agencies, host country governments, and many other international
partners. For more information visit www.pepfar.gov .

In September, the FDA approved Abbott's Prism HIV O
Plus assay, a new screening tool designed to detect the presence of
antibodies to the two types of the virus that cause AIDS, HIV 1 and HIV
2. Both types can be transmitted by sexual contact, through blood, and
by mother-to-child transmission. The assay detects antibodies to HIV
type 1, groups M and O, and HIV type 2. It is the second donor-screening
test licensed for the detection of antibodies to HIV type 1, group O,
and is licensed to screen donated blood and blood specimens from other
living donors (e.g., organ or tissue donors) for these specific types of
HIV and subgroups of HIV type 1. The assay is also licensed to screen
specimens from organ donors when specimens are obtained while the
donor's heart is still beating and from cadavers. Positive results from
the screening test require confirmation from supplemental tests.

New guidelines for HIV-exposed/HIV-infected kids
New guidelines, published by the National Institutes
of Health (NIH) and the Centers for Disease Control and Prevention
(CDC), are available through the AIDSinfo website to assist healthcare
workers in preventing and treating the secondary infections that can
afflict U.S. children exposed to or infected with HIV. The guidelines
provide a reference manual for the treatment of secondary infections
related to HIV, describe warning signs of potentially hazardous
interactions between drugs used to treat HIV and its secondary
infections, describe current standards for treating the inflammation
accompanying immune-system recovery made possible by new anti-HIV drugs,
and provide guidance about when to discontinue preventative treatment no
longer needed after the immune system has recovered. For more details,
visit
www.aidsinfo.nih.gov/Guidelines/Default.aspx?MenuItem=Guidelines.