Critical Values is the go-to resource for the entire laboratory team, providing insight and information on the latest research, information, and issues within pathology and laboratory medicine. The print and online magazine invites submissions on topics including, but not limited to, advocacy, education, technology, global health, workforce, workplace best practices, and leadership.
E. Blair Holladay, PhD, MASCP, SCT(ASCP)CM
Chief Executive Officer
Molly Strzelecki Editor
Susan Montgomery Contributing Editor
Martin Tyminski Creative Director
Jennifer Brinson Art Direction and Design
The routine practice of standard-of-care anatomic pathology in the United States conflicts with the current trends and approaches to global health intervention models, particularly those commonly utilized in low- and middle-income countries (LMICs). This creates challenges in achieving quality in cancer diagnosis in the setting of low-resourced settings.
ASCP Chief Medical Officer Dan A. Milner, MD, MSc (Epi), FASCP, MBA, recently outlined this conflict in a series of Grand Rounds talks as he made the case that quality in anatomic pathology in low- and middle-income countries can be achieved but it requires understanding the context and having a feasible framework. To build current U.S.-styled quality systems would require significant financial investment, but possibly not be achievable or hold the same value. Improving the quality of care for patients in low- and middle-income areas is at stake; thus, finding solutions that create quality in a context that is feasible and can be sustained without continued expenditure of funds is paramount.
“In standard-of-care anatomic pathology, it is required that we have highly skilled staff and medical doctors,” Dr. Milner says. “Histology and cytology require specific reagents and supplies. You must have automated tissue processing and access to high quality paraffin (wax) for best results. When you don’t have automated tissue processors, it can take days to weeks to process a piece of tissue, whereas an automated tissue processor can perform the same task, consistently, in a couple of hours. The quality of the resulting histology slides between the two is worlds apart.”
Task shifting for better processes
Standard anatomic pathology also requires functioning pre-analytical and post-analytical processes. In other words, someone must collect samples from the community population, and someone receives the reports and acts on the diagnosis.
On the global health side, the leading thinkers in the field of global health (mainly in the U.S. and Europe) have sought solutions to disease challenges using “task shifting” for the past few decades. In task shifting, a set of repetitive tasks that are typically performed by a highly trained individuals (who can accomplish many different tasks) are passed to less trained individuals who can focus on that component of care because it is so common. For example, the review of a stool or blood smear to screen for parasites is a skill that can be imparted to individuals who have not completed a full course of laboratory training. Clinical breast examination can be taught to community healthcare workers rather than being performed by a physician. Because the test is in high demand, this task shift allows more people to be diagnosed using a medium complexity test or approach. And the tasks are often repetitive for continuing care or screening processes so that observed deviations or positive results can be referred to high level care. But task shifting for anatomic pathology does not work. The technical team grossing and processing tissues into glass slides must be very well trained, understand the troubleshooting of each of the more than eight steps, and master a large range of tissue types and staining techniques. Moreover, only a pathologist can read tissue slides and issue a diagnosis.
Global health leaders in the U.S. and Europe want to develop and employ point-of-care approaches wherever possible, but this has not been feasible for anatomic pathology. “You cannot go into the field and perform histology,” Dr. Milner says. “Histology means we must use a tissue processor and use stains to look at tissue under a microscope. It is a 24-hour process! The exception is cytology, where you can perform the technique faster, but you still need a highly skilled pathologist to read the slide.”
The silo concerns
Aside from the need for skilled staff and supplies, another challenge is the historic development of silos of care. The pathology laboratory, like the radiology unit, can make thousands of different diagnoses, almost all of which occur at a low frequency in the population. To open a pathology laboratory in low- and middle-income countries, the laboratory needs to perform a high volume of testing (at least 10,000 samples per year) which means a catchment population of at least 1,000,000 people. It is not reasonable to install an entire pathology laboratory but then only diagnose, for example, breast cancer—it would be both ethically and economically infeasible.
To maintain quality in laboratories in low- and middle-income countries, these laboratories must maintain the level of quality that is required in standard pathology. Quality, in standard pathology and laboratory medicine practice, comprises three components: quality control, quality assurance, and quality improvement. In the laboratory, pathologists and laboratory professionals are required to follow certain quality control steps to make sure that the results come out correctly. It is not optional. A test is invalid without quality control.
Quality assurance requires the laboratory staff to document that they have performed quality control at every step, from documenting that all staff are trained to ensuring that all equipment is up to date. Documentation and data collection are critical in this step.
Most important is quality improvement, which involves taking all the assurance data and looking at it for trends on a routine basis. For example, is something going well? If something is not going well, is there a need to examine root causes? Quality improvement is the systematic review of quality control to identify if there is a problem and, if so, to identify ways to solve it. Having a very active QC/QA/QI program with a culture of quality not only reduces errors but increases the opportunity to improve outcomes.
The challenge is that maintaining quality requires a prevention cost (ie, what we pay to have quality management systems in our laboratory) since quality assurance and quality improvement require steps that are not related to producing a diagnostic test result. That type of documentation and analysis takes time. In LMICs, with short staffing and very thin budgets, how can these costs be paid?
There are two kinds of prevention costs: People’s time/training and stuff (eg, software, equipment). These prevention costs are required to prevent errors and ensure quality. But in the pursuit of quality results, there are also failure costs (i.e., what we pay if we do not deliver quality). In the United States, there are very high and variable costs associate with failures. If a poorly executed laboratory test delivers bad results, it will negatively impact the laboratory’s bottom line through competitive loss, lawsuits, and compliance failure with payer systems. That will ultimately impact the laboratory’s ability to compete with other laboratories, and that results in what Dr. Milner calls “failure costs.”
A laboratory that has high costs of failure will want to bring their risk down, so they start investing in prevention costs. Where those two costs converge is where quality is achieved.
“In the laboratory, we have to push more toward the perfect quality side,” Dr. Milner explains. “Human lives are at stake, so we are willing to pay higher prevention costs.”
How failure costs translate
But what are the failure costs in places like Africa? “If you are the only laboratory in a region in Africa, there may be no competition so there are no perceived failure costs. Staff will not lose their jobs if you don’t deliver a great test. People will still use your laboratory,” Dr. Milner says. “So, anything that you do for preventive costs, you are adding to the overall bottom line. There is no benefit to the laboratory. That investment would benefit the patients but not the laboratory. There is no motivation.”
However, a private laboratory in a low-income country would have clients who have money and are willing to pay higher fees to have quality. Those laboratories may invest in quality assurance and quality improvement to provide a competitive advantage.
Therein lies the challenge. What is the motivation for a laboratory in Africa to spend more money to ensure quality testing when there is no perceived benefit for the laboratory? More importantly, these laboratories often do not have enough staff or extra funds to engage in these activities even if they want to.
There is also a lack of systems; there are often no government policies requiring laboratories to be inspected. Government policies regarding quality standards for the laboratory, laboratory personnel, and specific resulting activities create a potential for a failure cost (ie, non-compliance). Without such regulation, laboratories are free to do and report what they like—all at the cost to the patient. However, with such regulation, the laboratories still need to expend time and funds to be compliant.
Dr. Milner argues that in Africa, there are no failure costs and, thus, laboratories are not held accountable.
“Some laboratories are investing, but my point for anatomic pathology, in general, is that this is not happening well,” Dr. Milner says.
He pulls his argument together with the concept that impactful quality can be achieved in Africa, but only with tools in Africa that make sense. High-income countries have certification of personnel, accreditation of laboratories, and sub-specialization of pathologists. Neither certification or accreditation guarantee that a laboratory is producing quality results but remain required in the U.S., for example, for compliance with billing and competitive advantage. Sub-specialization is, in fact, a very important tool for quality, but it requires high volume laboratories or referral services to achieve optimal outcomes. This is often not achievable or feasible in LMICs.
Dr. Milner maintains that consensus conferences, very common in the U.S., offer an excellent solution for LMICs. Consensus conferences allow pathologists to share cases, discuss findings, and reach an agreed upon diagnosis. Consensus conferences beget tumor boards and other clinicopathological conferences, all of which produce better quality results for patients. In LMICs where staffing is highly limited, consensus conference approaches using telepathology and videoconferencing create sustained quality, networking, and education.
Another approach to quality in the U.S. that could be adjusted for LMICs is external quality assurance, which is part of accreditation but a separate process. In the U.S., external quality assessment (EQA) is expensive because the service must be subscribed to from a provider and requires shipping and receiving infrastructure. In LMICs, models for EQA that are self-supporting using vetted materials by consensus conference and a mixture of laboratories (internal to a country or with a group of several countries) are proposed that would be extremely low cost but provide documented quality results. Lastly, there is accountability-based quality improvement where, in high income countries, every member of the team interacts with their data and tries to identify any problems. But honestly, such systems are difficult to achieve even in the U.S. due to staffing shortages and competing tasks.
In LMICs, the first most important step for quality is vetted training and education in modern laboratory practices along with adequate staffing and budget to meet the workload. If we are not investing sufficient funds into our laboratory for it to function normally, how can we overlay a quality scheme?
When labs are adequately trained, funded, and staffed, setting benchmarks for performance that are feasible within the cultural milieu are required. While a three-day turnaround time may be possible in the U.S. (and the accreditation standard), perhaps five to seven days should be provided for turnaround times in Africa, recognizing that transportation, business hours, process, and culture are different. As mentioned, telepathology consultations using pathologists from abroad or from neighboring countries would provide laboratories in low-income countries with access to subspecialists, consensus tools, additional education, and networking. Lastly, a functioning quality management system is needed. Much outreach to train laboratories in quality management systems (QMS) has been attempted, but until staffing and funding are optimized, these systems cannot function as they need to.
Although there are as many different models and examples of laboratory service provision as there are countries and cities in Africa, three simple models, based on payment structure, can assist with driving up the level of quality for patients. In a purely private model, multiple private laboratories, in competition with each other, provide all services for paying customers and to subsidized patients through government vouchers. The private laboratories bear all the infrastructure and reagent costs but still achieve a margin while the government spends a smaller amount of money over the long run to support certain patients. In a purely government model, the government installs laboratories across the country that are standardized and organized in a tiered system and allows patients to access it for smaller fees. Pools of money including insurance, community contribution strategies, etc. are available for high-cost patients (eg, cancer) so that no one patient is destitute paying such costs. Lastly, there are hybrid models, which are the most commonly encountered, where both public and private laboratories exist for a population. What is uncommon is coordination between these laboratories which could harmonize services, shift expensive services to private labs where they can absorb the costs while still achieving their marge, and ensure 100 percent coverage for all patients.
Anatomic diagnostic laboratories, especially for cancer, were neglected for the last several decades in many LMICs which resulted in disuse, decimated staffing, and aging or failing equipment. This neglect was due to the massive shadow of infectious diseases and, for Africa, post-colonial abandonment with transitions or transfer of knowledge. As cancer grows in burden in LMICs and awareness is creating a movement towards diagnosis and treatment for the most underserved populations, it is crucial that this cancer care is of highest quality. Investments in the required tools and training for anatomic pathology along with support for adequate staffing and sustained budgets are the most important step to achieving this quality.
Where such investments have been made, outstanding cancer services are being provided and patients surviving and thriving.