Helping lab professionals GoMolecular.

The Quest for Quality in Resource-Limited Markets  

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In this article:

  • Challenges in resource-limited laboratories
  • ISO certification process overview
  • The positive outcomes of higher laboratory standards
 
 

 

High-quality molecular laboratories are crucial in the effort to provide informed, appropriate healthcare to patients around the world. In resource-limited countries and emerging markets in parts of Asia and Africa, there are many challenges to maintaining the quality that is necessary to meet international standards. With dedicated organizations like FHI 360 and leaders like Janet Robinson, molecular laboratories and their staff members are getting the extra help they need to reach these standards.

Janet Robinson is the Director of Research for the Asia Pacific Region and the Global Director of Laboratory Services for FHI 360. Based in Bangkok, she is working to help laboratories in Asia and Africa to achieve International Organization for Standardization (ISO) certification and accreditation in order to improve the efficiency and effectiveness of operations. Through her work, Robinson has faced many challenges and many successes. This interview shares her personal experience. 

 

How did you become involved in FHI 360 and advancing high-quality molecular laboratory services?  

“I started my career as a clinical pathologist in the UK public health system where I specialized in medical microbiology. From there I moved into the pharmaceutical industry where I worked in the clinical trial and regulatory divisions, as well as many years in reproductive health. I left the pharma industry in 2002 and became the head of regulatory affairs for FHI 360’s headquarters in North Carolina.

“In the beginning I mostly worked in western and sub-Saharan Africa. Through this work I started to see the poor quality of laboratories. As a result, the research and health programs were suffering. I started to vocalize my concerns about the quality of these laboratories. In 2007, FHI 360 established a laboratory sciences division to proactively address the quality of laboratories supporting our research and programs. By this time, I was already leading work in the Asia Pacific region. The laboratory sciences division became pivotal in ensuring the quality of what we were doing from a laboratory perspective – not only in Asia, but also in Africa, the U.S. and elsewhere.

“Over the last few years, I’ve been not only trying to build the capacity of the diagnostic laboratories, but the growing number of molecular laboratories that are starting up. With the new diagnostics that are coming out, many of them based on molecular methods, there is the opportunity for better diagnostics. The challenge is doing this in resource-limited settings where the buildings, the people, and really everything, are challenged. We have a particular focus on how to establish high-quality molecular laboratories within the settings that are often really struggling.”

 

Why is ISO certification and accreditation so important for public laboratories in Asia?

“Although FHI 360 has its own laboratory where we provide diagnostic services, most of our work helps the laboratories of others to improve, particularly government and public laboratories. I visited laboratories that were to take part in FHI-supported activities and the conditions were extremely poor. One laboratory was getting 100 percent of their HIV testing wrong. I saw there was great opportunity to build their capacity through simple technical assistance. They didn’t need new equipment — simply raising their knowledge about quality and teaching them to do basic laboratory services not only improved the particular activity, it benefitted the patients.  

“We were starting some important research on influenza funded by the U.S. NIH [National Institutes of Health]. I visited the laboratories that were going to support that research and found them to be quite poor, so I asked the NIH to invest in building the capacity of these laboratories. I believed that the research would suffer because it was reliant on the endpoints based on data from these laboratories. NIH said it would be too expensive and couldn’t be done. I challenged them and asked for a small grant that was linked to the study, which had a big laboratory component. We were working with 12 large infectious disease government hospitals within the region. By the end of the program, it was acknowledged that the additional laboratory capacity building was one of the big successes of the program. We managed to get some of the hospitals — and the first government hospital laboratories in Vietnam and Indonesia — ISO certified.

“Through simple technical assistance we were able to show a model of assessment, capacity building and training. We were able to turn these laboratories around and make them into high-quality laboratories that can achieve international recognition. This program has become one of our mainstay offerings to any laboratory that wants to improve. Through comparative assessment, gap analysis, and capacity building and training, we demonstrated that you don’t need lots of money to improve and achieve accreditation, and it is possible even in the poorest of settings. This program is now used throughout Asia and Africa.”

 

What unique challenges do resource-limited laboratories encounter?

“Asia and Africa have similar challenges, which include lack of knowledge, poor infrastructure, reagent supply, and access and maintenance of high-quality equipment. Asia-Pacific is more affluent, so some services are more available. Challenges are perhaps more extreme in Africa because it isn’t as developed yet. Only South Africa has a high number of quality laboratories at the moment, but that is changing. Some countries like Kenya, Ghana and Nigeria are starting to get high-quality laboratories.

“There are also challenges in finding the right type of people. Laboratory technologist training is quite rare in both Asia and Africa. I’ve been trying to collaborate with local universities and the organizations that are present in each region to try and strengthen pre-service training. I also set up ‘twinning programs’ where you send technologists to a more knowledgeable facility to gain access to the equipment and education before they perform the tests within their own laboratory. We try to identify a high-quality laboratory within a country in a specific diagnostic area that is willing to accept interns from laboratories that want to implement that diagnostic, but don’t have the equipment yet.”
 

What positive outcomes have seen thanks to the FHI 360 program?

“The outcomes are many. One that’s very difficult to measure, however, is how much better healthcare is for patients because samples are processed in a laboratory that conforms to international quality standards. The laboratories are detecting more errors, and when there is a problem they are taking corrective and preventative action.

“It is widely recognized that 70 percent of medical decisions rely on laboratory data. When there are no results, there is either delayed treatment or incorrect treatment. Just being able to provide the right results, better care, and more appropriate interventions offers huge benefits for patients. We can treat infectious diseases; avoid the overuse of antibiotics and anti-malarial drugs; and offer a stable, safer working environment.

“The program also benefits the staff. In government laboratories you often find the staff is paid poorly and they are not motivated to do more. When the staff understands their role better, they seem to be motivated to do a bit extra and enjoy their work more.”

 

When laboratories meet a higher standard of quality, how does it affect public health in that community?

“The ISO certification is a comprehensive quality program. The outcome is that you’re more likely to get reliable results. The communities served by that laboratory will have better health services because the doctors are acting on the results and providing more appropriate evidence-based treatment. You also see improved turn-around times. For people who travel significant distances or have to take time off work to get to the hospital, there are fewer trips to the hospital.

“In addition, as confidence in the laboratory increases, more diagnostics are brought in. At the beginning of many programs, there is often very little confidence in the laboratory results. The results take ages to come out and doctors don’t believe the results. Once you have an ISO-certified laboratory, you find that confidence increases with the customers of these laboratories, which then improves their ability to offer more diagnostics as they become more efficient.

“For example, I was working with one of the biggest infectious disease hospitals in Indonesia. The microbiology laboratory would receive only one or two samples a week, so their reagents often expired. Technologists were losing their skills because they had nothing to practice on, and clinicians weren’t even taking samples because they didn’t believe in the results. As a result, they were treating patients based on symptoms. I was very concerned about the misuse of antibiotics.

“We did a small study with them and had the clinicians treat the patients as they normally would, but asked them to also take samples at the same time. We did a comparison of the treatment based on symptoms vs. the treatment based on the laboratory result. What we found was in more than 60 percent of the cases, they were giving the wrong treatment because they weren’t waiting for the laboratory result. Following the study, the doctors saw the value in the microbiology laboratory and their treatment practices changed. More samples were collected, techs got their skills back, there was better use of reagents … it was a win-win situation.”  

 

Can you explain the ISO certification process? 

“Our process model involves:

• Gap assessment of the laboratory — we look at everything in the laboratory with reference to the ISO standard.  We look at staffing, facilities, equipment, and information systems from pre-analytical to post-analytical.

• List of needed improvements — the list is prioritized by patient care and staff safety.  We recommend specific things they can do to address each of these improvements and identify where they would benefit from training.

• Technical assistance — we help on the first few activities to start with, and provide training in the areas where they need help.

• Process improvement — we work through each of the areas that need help in a cyclical process and provide assistance. We continue with this cyclical process until they have completed everything.

• Pre-accreditation inspection – we behave like an ISO inspector and re-do the assessments. We always find a few things that need fixing.

• Certification completion — we connect them with an international accrediting body to complete the certification.

“Motivated laboratories with adequate time, finances, and people resources can complete this process within a year. Most laboratories will take two to three years to complete this process because they have limited time to focus on it.

“In many cases the documentation is missing. It takes a lot of work to create SOPs [standard operating procedures], quality management systems, and then document the evidence of the implementation.  This is what usually takes the most time.”

 

Why is it so important for FHI 360 to help laboratories around the world gain competence and quality?

“The more organizations and stakeholders who make this a priority, the more improvement we see.  When we first established the division back in 2007, there wasn’t a lot of attention and discussion at a high level about laboratories. I’ve started to see this change over the years. I see governments developing national strategic plans around this, donors making it a component of proposals, and other bodies setting up schemes to improve laboratories. They are realizing the importance of their support.

“Thanks to the FHI 360 laboratory sciences division, about 100 laboratories are now accredited. Some laboratories that we work with don’t want the accreditation — they just want to improve. There have been laboratories in Africa and Asia that decide that if they can’t attain the highest standard, they work toward the standard they know they can manage. They may not get accredited, but they reach their goal. Other laboratories, particularly those associated with research activities, will go for ‘good clinical laboratory practice.’ This is not an ISO certification, but it is a slightly different standard tailored more to research. For any laboratory that is part of the FHI 360 health intervention or FHI research, it is our goal for those laboratories to become as high quality as possible.”