Category: global outreach

The Pathology Value Chain and Global Health

In part 1, we reviewed Michael Porter’s Value Chain and looked at inbound logistics for pathology. Now we will turn to operations, or the production of diagnostic results.

In the United States, almost all cancer diagnosis and care are in the private sector. There are very few examples of diagnostic services that are provided for free. Because laboratories derive revenue from every specimen for the most part, there is a natural desire to increase the volume in the laboratory from management because volume equals revenue. Pathology also has inherent economy of scope and scale such that a basic system that could process 1 case per day for an operating cost of $500,000 per year, could process 200 cases per day for a cost of $4,000,000 per year (a 200-fold increase in volume with only a 8-fold increase in cost). It is important to note in this comparison that in the former, the cost per case is $2000 while in the latter it is $80 (a 25-fold difference). When we consider an allocated or operating budget to run a pathology diagnostic laboratory where revenue is not reflected to laboratory management, this desire to increase volume is lacking directly by laboratory staff (more work but no additional funding) but still may be desired by higher level administration for revenues that pay for other aspects of the system (cross-subsidization). Consider a laboratory that is asked to process 25,000 samples per year, has 6 support staff and 3 pathologists. This would equate to each pathologist signing out ~50 cases per day on average, Monday – Friday, with four weeks of vacation annually. If those pathologists are the direct recipients of the profits of the laboratory, such a high case sign-out rate may be acceptable. If they only receive their allotted salary with no potential for profit sharing, they are unlikely to maintain such a high rate of production. Moreover, they will likely demand higher salary and/or additional staff and will do so much more quickly as volumes increase than would pathologists who share in profits. When we transfer this concept to a public low-resourced laboratory setting in a low- and/or middle-income country where government salaries are lower, there are far fewer skilled personnel, and budgets are smaller, there is essentially no incentive for public/government-funded laboratories to increase volume because it results in more work for the existing staff with no benefit. Yet, with the small volumes we see in LMICs currently, their costs per case are much higher than in HICs. When we turn our lens to the patient and that patient’s maximum value, the profit-sharing model is likely to yield the shortest turnaround time for a given patient. There is a trade-off in this scenario between speed of results and amount of communication/coordination between the clinician and the pathologist. Allocated budgets and public laboratories may produce slower results that are of the same technical quality and, in academic settings, may include additional communication/coordination with clinical teams. Standards exist for a maximum turnaround time goal (i.e., for the College of American Pathologists, it is 3 days). Without external regulation and accreditation, laboratories may fail to provide value to the patient by delaying diagnoses until they essentially are useless. Turnaround times in LMICs may be considered “very good” at 2-weeks, a timepoint that would not be sustainable for HICs laboratories.

Operations – This activity “includes procedures for converting raw materials into a finished product or service”. For the lens of maximum value to the patient, from the moment a biopsy is received in the laboratory to the moment a final report is generated should be minimized and the report itself should adhere to quality standards internally and externally. Once all reagents and supplies are obtained and specimens are received, the operations process can be engaged which includes grossing, processing, embedding, microtomy, staining, special stains, immunohistochemistry, case professional review, and report production. In each step of this stepwise process, specific skilled personnel are needed, matched with specific reagents and supplies to complete the step. Laboratory efficiency and product quality can be dually achieved with highly trained personnel, functioning, well-maintained equipment, optimized workflow, continuous communication and data collection, and highly skilled management to control the process wholly and in parts. One of the challenges for HIC pathology laboratories or health systems are large resections (i.e., mastectomies, colectomies, etc.) and autopsies. The former is integral to cancer care for mid-stage cancers to inform margins and guide treatment; however, they require more personnel time to gross, process, and read, more physical resources to dissect and sample, and may have a series of challenges related to “what’s left in the bucket?” that do not occur when a small biopsy is entirely submitted (although standardization of grossing and reporting can often ameliorate this issue). For the latter (i.e., autopsies), the costs of these procedures are extremely high across the board and there is, to date, no reimbursement or payment for this final procedure in a patient’s medical journey. The value of the autopsy has been explained elsewhere but such value to healthcare systems and to individual and groups of patients is often not delineated enough to make these services a priority, unfortunately. Stepping back from operations, what is commonplace in HICs is that large academic center pathology laboratories most often associated with comprehensive cancer centers are evaluating major cancer surgery specimens as well as autopsies while their private practice and community hospitals focus on small biopsies. There are certainly private practice and community hospitals that evaluate large specimens, but they do so in the context of large biopsy volumes (i.e., cross-subsidization). Tertiary care center pathology laboratories receive referrals (secondary review of biopsies) and surgical samples without the large volumes of primary biopsies to provide off setting revenue. Without high volumes of biopsies to subsidize the costs of large resections, value chain for laboratories becomes quickly degraded and laboratories may even become cost centers, especially if complex immunohistochemical works ups are considered. For patients, care at academic centers and comprehensive cancer centers is viewed as superior with access to clinical trials, multidisciplinary teams, advanced technology, and highly complex diagnosis of rare entities; however, the bulk of pathology services provided, being standardized, are essentially task-shifted from for-profit high volume laboratories that could subsidize the costs to large health systems that cost more to run often without the benefit of the primary diagnostic biopsy material revenue flow.

It is quite easy to see how this part of the value chain can fail in an LMIC because pathology operations are large, complex, and interlocking. For example, if the single embedding center goes offline, manual processes, which are slower and produce poorer quality blocks must be used and efficiency is lost. If the tissue processor goes offline, the entire process is stopped until it is restarted. If there is one pathologist and they go on vacation or immigrate to another country offering better salary, the process is stopped indefinitely. As mentioned above, for a laboratory with a low volume and limited staff, increases in volume are a considered negative because incentivization is lacking. Because these laboratories are often the “only game in town”, they must deal with small biopsies, large resections, and autopsies but without the revenue streams seen in HICs to offset costs or create cross-subsidization (i.e., reimbursement, private pay, etc). This is due to limited access for patients and biopsy rates for the population that may be less than 20% (i.e., of all people that NEED a biopsy, less than 20% receive a biopsy due to access issues). There is a great need to achieve balance in this problem between the minimal volume a lab should process and adequate compensation for laboratory staff to achieve this volume. Modelling and projections expected for a given population can be used to inform governments and market makers about what number of services are needed and, subsequently, public-private partnerships become a primary tool to achieve the balance. For individual gaps such as lack of staff, the value of the operations can be improved with training, telepathology support, visiting pathologists, and management training and improve the overall value improved for the patient.

To summarize this piece, operations for diagnostic pathology has an inherent economy of scope and scale such that an optimal case mix exists which creates maximum value for the patient—shortest turnaround time with most accurate results—and creates a sustainable revenue stream for the laboratory operations (mix of biopsies and resections). Competitive advantage is complex in this space because speed and volume are contrasted with specimen complexity, all of which should be performed through a standard of care.

In the next part, we will look at outbound logistics or the outgoing report to the clinical team.

References

  1. Porter, M. (1985). The value chain and competitive advantage, Chapter 2 in Competitive Advantage: Creating and Sustaining Superior Performance. Free Press, New York, 33-61.
  2. Histology. Wikipedia. https://en.wikipedia.org/wiki/Histology#:~:text=In%20the%2019th%20century%20histology,by%20Karl%20Meyer%20in%201819.
  3. Thorpe A et al. The healthcare diagnostics value game. KPMG International. Global Strategy Group. https://assets.kpmg/content/dam/kpmg/xx/pdf/2018/07/the-healthcare-diagnostics-value-game.pdf
  4. Digital Pathology Market CAGR, Value Chain Study, PESTEL Analysis and SWOT Study|Omnyx LLC, 3DHISTECH Ltd, Definiens AG. https://www.pharmiweb.com/press-release/2020-06-30/digital-pathology-market-cagr-value-chain-study-pestel-analysis-and-swot-study-omnyx-llc-3dhistec
  5. Friedman B. The Three Key Components of the Diagnostic Value Chain. Lab Soft News. January 2007. https://labsoftnews.typepad.com/lab_soft_news/2007/01/the_three_eleme.html
  6. XIFIN. The Evolution of Diagnostics: Climbing the Value Chain. January 2020. https://www.xifin.com/resources/blog/202001/evolution-diagnostics-climbing-value-chain
  7. Sommer R. Profiting from Diagnostic Laboratories. November 2011. Seeking alpha. https://seekingalpha.com/article/305931-profiting-from-diagnostic-laboratories#:~:text=The%20three%20year%20average%20operating,current%20operating%20margin%20of%2012.9%25.
milner-small


-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.

The Pathology Value Chain and Global Health

When Michael Porter conceptualized the Value Chain in 1985, histology as an idea was at least 184 years old and the use of a microtome to cut sections was 155 years old. Now 35 years into value chain as an established lens for markets and firms to approach those markets, numerous publications and reports discuss the value chain of diagnostics, of digital pathology, and of laboratories as profit centers from a variety of sources and as a profitable business model. With the core tool—histology—being such an old technology, easily duplicated, and standardized for skill, quality, and output, can it create competitive advantage or be part of a firm’s value chain? The framework of diagnostic anatomic pathology services (for example, a histology diagnosis for cancer) as a profit model creates ethical questions around what the true value of these services are when the tool is so common. No one chooses to have cancer. Therefore, no one chooses to have a diagnostic procedure for cancer. Stated another way, the consumer’s choice for the product is a potential matter of life and death—that is not true of breakfast cereal. One of the most important features of a capital market is free choice by consumers to choose or not choose products and services. Today, there are people that get by with a flip phone that only makes phone calls and perhaps sends text messages while other people choose essentially supercomputers to carry around in their pocket; however, no one is going to die if they don’t have a telephone on their person. Without a diagnostic procedure for cancer—with histology serving as the primary tool—patients will commonly die from that disease; but with a diagnosis they have a chance of cure, a chance which increases greatly the more rapidly and the earlier in the course of disease the diagnosis is made. One paradigm of healthcare that differs from actual business sectors is an inverse relationship of cost to supply. As competition increases in business, prices are driven downward and reach a level barely above margin which sustains the supply of the goods but often requires the business to diversify or innovate to reach higher margins. In healthcare, costs for the same procedures which are standard of care have gone up, year over year, even while new innovations emerge at higher costs. From a business perspective, creating a feasible value chain around healthcare and, specifically histology, seems unlikely to be sustainable in the long run. However, patients are the center of healthcare and there is high value to patients in having services that meet their medical needs. In applying the concept of “value” and established value chain concepts to anatomic pathology, we shall assume that the maximum value the system can achieve is the shortest time interval from development of cancer in the patient to cure. Fortunately, this value lens mirrors the most efficient pathology laboratory system which would process and sign out large volumes of small biopsies. Coincidentally, that is also the best profit model.

Many countries and large segments of the population in general do not have access to diagnostic histology services due to a range of barriers and challenges that are specific to each site. In some instances, these systems simply do not exist, for example, on many island nations and some nations that are less than 2 million people. The reason for this absence in such settings is due to a massive cost of such services because economies of scope and scale cannot be achieved without a particular threshold of case volume which results in excessively expensive—and thus, unsustainable–services. In larger yet low-resourced countries, private diagnostic histology services with variable quality exist with the main barriers being the out-of-pocket costs of those services to patients although quality could be considered the more important barrier. In high income countries, impoverished patients and patients with insufficient insurance coverage may never be able to access services while others who can access services initially may be inundated with bills related to cancer care that lead to financial disaster. However, all of these “gloom-and-doom” anecdotal observations are not solving the large range of problems that can be found across the patient’s pathology value chain. In order to approach this in the spirit with which Michael Porter intended but framed for a patient, let’s look at the pathology value chain with our value being maximum benefit to the patient, frame it in the context of global health, and assign solutions based on the original Porter activities. This is part 1 of a 4-part series dissecting value chain and pathology in global health. The activities are inbound logistics, operations, outbound logistics, marketing & sales, and service. Let us look at inbound logistics in this part.

Inbound Logistics – This activity encompasses the “receiving, warehousing, and inventory control of a company’s raw materials.” For the lens of maximum value to the patient, from the moment a biopsy is taken until delivery to the laboratory should be minimized and, when the sample arrives, it should be able to be processed immediately with all reagents available. For anatomic pathology, this portion of the value chain includes controlled and uncontrolled raw materials. The controlled raw materials are all of the purchased reagents, supplies, and other consumables that are used in the process of histology and include hazardous materials, flammable materials, and bulky materials such that inventory control should be optimized for both maximum efficiency and value but also maximum safety of staff. “Stock outs”, which are relatively rare in high-income settings, on the laboratory side can include lack of any of the essential reagents and tools to process samples including formalin, alcohol, xylene, paraffin, glass slides, cassettes, etc. Stock outs are the most common challenge in LMICs followed by complete lack of supply chain or lost supply chain. In HIC, bulk purchases, long-term contracts, and volume pricing reduce the cost of the controlled raw materials and can create slight competitive advantage.

Uncontrolled raw materials are the inbound patient tissue samples which can range from minute to whole bodies (in the special case of autopsy) and may be “packaged” by a diverse set of suppliers (i.e., clinical teams) with variable resources. These materials are also “precious” in that they are unique to each customer, cannot be easily reobtained, do not have a fiscal loss value that is easily quantifiable, and may have a large impact on the patient from which they are derived. These materials are also “flawed” because the pre-analytic collection of them by individuals that are not part of the laboratory may create inadequate, insufficient, inappropriate, or damaged materials. In HIC, considerable effort goes into educating clinical teams on collection, creating referral networks, providing collection vessels, etc.; yet laboratories still receive inadequate or insufficient samples. When we consider low- and middle-income countries, observed delays/deficiencies in this part of the value chain are quite common. “Stock outs” on the clinical side can include lack of supplies of clinicians for obtaining biopsies from a specific patient such as sterile biopsy tools, surgical services, and adequate formalin. “Skill lacks” include insufficient training or understanding of the laboratory operations by the clinical team to obtain a biopsy from a patient or properly prepare it for delivery to the laboratory. “System lacks” include an absent or poorly functioning specimen transportation and/or communication system which delays or prevents samples from reaching a laboratory. For a given patient or even population of patients that are to be served by a clinical health system feeding to a specific laboratory, the value chain can be massively depreciated if these inbound logistics are not rectified. When encountered and depending on the specific gap in controlled or uncontrolled raw materials, the solutions can include training of clinical staff; local production of reagents; supplier contract negotiations; bulk ordering; collaborative ordering; cost cross-subsidization; public-private partnerships; capital investment in transportation; and coordination with other convenient transportation networks.

To summarize this part, inbound logistics for a pathology laboratory include controlled and uncontrolled raw materials that have variable costs, safety, inherent value, and flaws that must be considered when planning laboratory operations. With rare exception, these inbound logistics are standardized which leaves little opportunity for major competitive advantage. In LMICs, stock outs (complete or delayed) can invalidate the work of a pathology laboratory by creating significant time delays in diagnosis which make the final diagnosis useless to the individual patient and erode the clinical confidence in the overall system.

In part 2, we will look at operations.

References:

Porter, M. (1985). The value chain and competitive advantage, Chapter 2 in Competitive Advantage: Creating and Sustaining Superior Performance. Free Press, New York, 33-61.

Histology. Wikipedia. https://en.wikipedia.org/wiki/Histology#:~:text=In%20the%2019th%20century%20histology,by%20Karl%20Meyer%20in%201819.

Thorpe A et al. The healthcare diagnostics value game. KPMG International. Global Strategy Group. https://assets.kpmg/content/dam/kpmg/xx/pdf/2018/07/the-healthcare-diagnostics-value-game.pdf

Digital Pathology Market CAGR, Value Chain Study, PESTEL Analysis and SWOT Study|Omnyx LLC, 3DHISTECH Ltd, Definiens AG. https://www.pharmiweb.com/press-release/2020-06-30/digital-pathology-market-cagr-value-chain-study-pestel-analysis-and-swot-study-omnyx-llc-3dhistec

Friedman B. The Three Key Components of the Diagnostic Value Chain. Lab Soft News. January 2007. https://labsoftnews.typepad.com/lab_soft_news/2007/01/the_three_eleme.html

XIFIN. The Evolution of Diagnostics: Climbing the Value Chain. January 2020. https://www.xifin.com/resources/blog/202001/evolution-diagnostics-climbing-value-chain

Sommer R. Profiting from Diagnostic Laboratories. November 2011. Seeking alpha. https://seekingalpha.com/article/305931-profiting-from-diagnostic-laboratories#:~:text=The%20three%20year%20average%20operating,current%20operating%20margin%20of%2012.9%25.

milner-small


-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.

Strategies for Building Successful Global Public Health Partnerships

There is a global shortage of pathology and laboratory professionals, and this phenomenon is especially worse in developing countries.1 Central to combating public and global health emergencies is a functional healthcare system, and at the fulcrum of that is pathology and laboratory services. According to Dr. David Madziwa of the Zimbabwe Association of Pathologists, “the issue is in the tissue.” To effectively address global healthcare challenges like the one currently experienced with the COVID-19 pandemic, Pathologists and laboratory science professionals are needed to develop effective testing and reporting strategies for optimal patient care. One way to address this problem is the development of effective global partnerships across healthcare systems.

However, developing such partnerships requires effective communication and strategies. There are documented instances where attempted efforts by public health professionals from developed nations have been futile in developing countries, because of conflicting priorities and ambiguous goal setting.2 Many public health interventions do not usually involve pathology and laboratory professionals in their planning and execution. And in doing this, they fail to understand the critical role of the lab in any successful healthcare system.

Building successful global health partnerships through effective laboratory services begins with a clear understanding of the healthcare systems in the region of interest.3 Critical questions that need to be answered include, what kind of healthcare model thrives? Is the focus more on preventive or corrective medicine? How important are healthcare issues prioritized in terms of budgetary allocations and other resources?

The purpose of such partnerships should also be well articulated. Partnerships must be guided by a shared vision and purpose that builds trust and recognizes the value and contribution of all members.4 Each partner must understand and accept the importance of the agreed-upon goals. This leads to improved coordination of policies, programs, and service delivery. Shared and transparent decision-making processes are also essential as partners work towards their common purpose.

Successful partnerships depend on shared values, mutual understanding and acceptance of differences-cultural norms, knowledge and ways of thinking or doing things, between both parties.4 When partners respect each other’s contributions and regard each other as equals, then the likelihood for shared goals to be achieved significantly increases.

Functional laboratory services are fundamental to effective healthcare systems. Laboratory professionals can play a huge role in addressing the global burden of disease by partnering with local, national and international communities in addressing the challenges associated with ineffective and sub-standard diagnostic services.

For example, one major factor that has been a huge barrier to effectively addressing the rising scourge of cervical cancer for women in developing countries is ineffective screening programs and the dearth of trained laboratory personnel and pathologists.5 To address this problem, global partnerships can be established in regions with limited resources to provide personnel training in the evaluation and interpretation of cervical pap smears. Mortality from cervical carcinoma will continue to remain a huge public health crisis in these regions if the gap created by a shortage of trained laboratory personnel is not addressed. And as pathologists, we can close this gap by stepping up to the rising health challenges of the 21st Century by becoming more visible and vocal in the global communities that we serve through effective partnerships.

References

1. Fleming K. Pathology and cancer in Africa. Ecancermedicalscience. 2019;13:945. Published 2019 Jul 25. doi:10.3332/ecancer.2019.945

2. Brooks, A., Smith, T.A., de Savigny, D. et al. Implementing new health interventions in developing countries: why do we lose a decade or more?. BMC Public Health 12, 683 (2012). https://doi.org/10.1186/1471-2458-12-683

3. Toth F. Classification of healthcare systems: Can we go further? Health Policy. 2016 May;120(5):535-43. doi: 10.1016/j.healthpol.2016.03.011. Epub 2016 Mar 28. PMID: 27041537.

4. John, C.C., Ayodo, G., Musoke, P. Successful Global Health Research Partnerships: What Makes Them Work? Am. J. Trop. Med. Hyg., 94(1), 2016, pp. 5–7 doi:10.4269/ajtmh.15-0611

5. Catarino R, Petignat P, Dongui G, Vassilakos P. Cervical cancer screening in developing countries at a crossroad: Emerging technologies and policy choices. World J Clin Oncol. 2015;6(6):281-290. doi:10.5306/wjco.v6.i6.281

-Evi Abada, MD, MS is a Resident Physician in anatomic and clinical pathology at the Wayne State University School of Medicine/Detroit Medical Center in Michigan. She earned her Masters of Science in International Health Policy and Management from Brandeis University in Massachusetts, and is a global health advocate. Dr. Abada has been appointed to serve on the ASCP’s Resident’s Council and was named one of ASCP’S 40 under Forty honorees for the year 2020. You can follow her on twitter @EviAbadaMD.

Pathology and Global Public Health

Recently, I interviewed for a subspecialty surgical pathology fellowship, and one of my interviewers posed a question to me: “What has pathology got to do with global health?” She asked me that question because  my resume highlights some of my global health-related activities and interests.

Pathology1 is the foundation upon which other specialties in medicine are situated. However, pathology as a specialty is seldom talked about or even referenced by other colleagues in other clinical specialties. One possible reason for this is that pathologists are often out of the perceptions of other clinicians.

That’s unfortunate, because the roles of pathologists in patient care cannot be overemphasized. Pathologists have a solid understanding of the pathophysiology of various diseases. We can identify when tissues are diseased or free from disease, and can also differentiate between various disease processes. We are also versed in the molecular and genetic basis of diseases. We also develop biomarkers to identify different disease processes. Through the assessment of various histopathologic, immunohistochemical analyses and morphologic features, we can also prognosticate various disease processes, a process that has become more effective with advances in molecular pathology. In addition, through our expertise, we serve as consultants to clinical teams to guide patient management.

However, beyond playing the above critical roles, pathologists can exert their influences by getting involved in public health and global health discussions, to influence policies that ultimately impact the outcome of patients. During the COVID-19 pandemic, the role of pathologists and laboratory professionals has become more critical in healthcare delivery.2 We play a huge role in the development of rapid and effective diagnostic assays, as well as influence the interpretation and delivery of timely test results.  In addition, through the conduct of autopsies on deceased patients, we have been able to describe some of the clinical and morphologic alterations associated with the SARS-CoV-2 (coronavirus).3

In spite of our important roles in the practice and delivery of medical services, it’s not common practice to have pathologists sit on major hospital boards, or participate in policy discussions that impact healthcare delivery. In addition, many low resource settings outside the United States still experience a shortage of effective laboratory services, with its attendant catastrophic effects on patient care.4 And even in the United States, the pathology workforce is gradually shrinking which could portend dire consequences for effective patient care delivery.5 In order to gain more traction to our specialty, it’s time for pathologists, to step out of our comfort zones and become more visible in the communities that we serve.

Pathology and laboratory services in many developing countries are currently suboptimal from a combination of scarcity of trained pathologists to sub-standard laboratory operations. Pathologists can step in to close this gap by developing collaborations that could foster partnerships in care delivery, training and research opportunities. I want to highly commend healthcare institutions that currently have dedicated pathology global health programs.6

This is a call to action for our specialty. If we really want to become more visible, relevant and attract some of the best talents to our specialty, then we should be ready to show that we bring so much more to the table than just peering into the microscope. The value of our pathology reports in the management of patients cannot be over emphasized. However, we must exert our relevance and expertise in healthcare discussions by stepping out into the communities that need us the most. A great place to start is getting involved with local public/global health-related work, including exploring opportunities, offered by the American Society for Clinical Pathology (ASCP) Center for Global Health.7

References

  1. https://www.rcpath.org/discover-pathology/what-is-pathology.html#:~:text=Doctors%20and%20scientists%20working%20in,patients%20with%20life%2Dthreatening%20conditions.
  2. https://www.uab.edu/news/health/item/11259-working-behind-the-scenes-uab-pathologists-play-key-role-in-fighting-coronavirus-pandemic
  3. Calabrese F, Pezzuto F, Fortarezza F, et al. Pulmonary pathology and COVID-19: lessons from autopsy. The experience of European Pulmonary Pathologists. Virchows Arch. 2020;477(3):359-372. doi:10.1007/s00428-020-02886-6
  4. Sayed S, Lukande R, Fleming KA. Providing Pathology Support in Low-Income Countries. J Glob Oncol. 2015;1(1):3-6. doi:10.1200/JGO.2015.000943
  5. Lundberg GD. How Many Pathologists Does the United States Need? JAMA Netw Open. 2019;2(5):e194308. doi:10.1001/jamanetworkopen.2019.4308
  6. https://www.massgeneral.org/pathology/global-health
  7. https://www.ascp.org/content/get-involved/center-for-global-health


-Evi Abada, MD, MS is a Resident Physician in anatomic and clinical pathology at the Wayne State University School of Medicine/Detroit Medical Center in Michigan. She earned her Masters of Science in International Health Policy and Management from Brandeis University in Massachusetts, and is a global health advocate. Dr. Abada has been appointed to serve on the ASCP’s Resident’s Council and was named one of ASCP’S 40 under Forty honorees for the year 2020. You can follow her on twitter @EviAbadaMD.

Casualties of COVID-19: Measuring the Length, Width, and Depth of a Pandemic’s Impact

An editorial in Nature on August 12, 2020 entitled, “How to stop COVID-19 fuelling a resurgence of AIDS, malaria, and tuberculosis” provided four suggested solutions specifically for these diseases in the wake of Sars-CoV-2. For reference, here are the four approaches suggested as written in the editorial (#4 in detail):

  1. Hospitals and health authorities in affected cities and regions must recognize that AIDS, malaria and TB are surging again.
  2. Researchers must continue to refine their models using more real-world data.
  3. There is a need for public-information campaigns
  4. These campaigns cannot on their own keep surgeries and wards open, or equipment functioning. The resurgence of infectious diseases has created a greater demand for tests, treatments and research. All of these need more funding. 

Do those strike you as odd? The entire economy of nations along with the focus of their healthcare has been derailed and distracted by COVID-19 and the solution for these diseases is to recognize them, improve models, inform the public and seek more funding. You are either completely in tuned with the author in seeing that more funding is needed or you are a bit miffed that, in the wake of all that is happening, THESE guys want more money?

The US is a major contributor to the Global Fund for HIV, TB, and Malaria (the largest funder of these activities) and the total pledges to date for the GF approach $69 billion dollars with the US providing $54 billion (92%). From 2008 to 2016, the US contribution increased almost every year from $840 million to $1.65 billion annually until 2015 when it was frozen at $1.35 billion until 2019. In 2020, prior to the COVID-19 pandemic (i.e., during calendar year 2019 when the fiscal year 2020 budget was being planned), the amount from the US dropped to $958 million (2010 levels), representing a 30% drop in funding. So, to recap: The Global Fund started the year down by nearly 30% of what had been available, COVID-19 derailed all activities and drained the fiscal resources of patients and nations, and now, the progress that has been made on these diseases has been set back bay possibly a decade. The situation couldn’t be more desperate and, YES, the program needs a massive increase in funding. But, to be very clear, that massive increase pre-dated COVID-19 and represents something more distressing underneath.

I was fortunate to give the Michelle Rablais lecture at the ASCP Annual Meeting in Phoenix in 2019 where I carefully laid out the costs of controlling JUST malaria (not to mention TB and HIV) and demonstrated for the audience that as the number of cases get smaller and smaller (because your measures are so successful), the cost of finding the remaining cases goes up. As we successfully approach elimination or eradication of a disease, the final push requires at least the same but often more funding to make it across the finish line. This is not an opinion but is based on an enormous amount of data from other diseases as well as from the world’s experience with the first malaria eradication campaign. For HIV, we can’t eliminate it or eradicate it but we have converted it to a chronic disease and, therefore, infrastructure and funding to support patients ongoing is needed and by any form of math has to increase as the population lives longer and more people are added to the disease pool (although those numbers had been greatly reducing). Tuberculosis in its simplest form is a disease of poverty related to lack of access to drugs and healthcare, cramped living conditions, etc. When a pandemic derails the economy and causes the poor to become even more poor, tuberculosis is going to surge.

To the authors of this editorial I offer a gracious thank you and note with a heavy heart that the estimate of $28.5 billion additional dollars being needed to make up the ground lost by COVID-19 does also include the ground they had already lost by defunding principles trending over the last 4 years for global health.

But at least the countries that struggle with these diseases only have HIV, TB, and malaria to worry about, right? Wrong. In almost every low- to middle-income country where HIV, TB, and malaria are or have been major health challenges, hypertension, diabetes, cancer, cardiovascular disease, stroke, and mental health are equivalent or worse health problems than compared with high income countries. Do not be dissuaded by sheer numbers and always consider the outcomes, pre-COVID-19. For cancer, mortality in the US averages around 35% while in Africa it is closer to 80%. In full COVID-19 response mode, cancer programs—fledgling, underfunded, and disorganized—became non-existent and are only now (nearly 6 months after closing) starting to re-open and find their way back to where they were—fledgling, underfunded, and disorganized! Diabetics cannot go 6 months without insulin, hypertensive patients cannot have unregulated blood pressure, etc. While in the safety of a high-income country, makeshift systems, telehealth, contactless visits, etc. were brought on board to keep some semblance of a healthcare system in place, cancer patients were delayed in receiving diagnoses and treatment due to rationing of time and elimination of “elective” procedures.

As the data continues to be tallied and as models continue to be developed to understand just how much we have lost from our failed response to COVID-19 as a world and certainly as a nation, please do not slough off the staggering “additional” deaths that are going to be reported because of patients who didn’t have access to their regular health system. Every person from November 2019 until the end of this pandemic whose death occurred because their regular supply lines were disrupted, their planned treatments were cancelled, their medical supplies were not available, or their access to life-saving interventions were delayed is just as much a casualty from COVID-19 as a directly infected patient who succumbs to the disease. Our recent experience as a nation with the disasters in Puerto Rico around both the confusing death tolls from the hurricanes as well as the total death toll from the fiscal challenges of their medical system (prior to COVID-19) should serve as valuable lessons. Let us not come out of the other side of this pandemic with a similar disregard for the value of every human life or without an understanding of how our individual and collective mistakes as a nation have lead directly to these effects.

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-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.

Practicing Productivity in the time of Pandemic

At this point, you are either somewhat adjusted to working from home (likely taking on new roles and responsibilities while juggling your kids, dog, and spouse), battling COVID on the front lines (caring for patients, providing us with food, or keeping the lights on), or unemployed (yet another victim among a whole host of victims during this extremely trying time). Regardless of where you fall, you have likely been on at least one video conference since January and you will likely be on many more over the next six months. As live, in person meetings of 2500 to 5000 people that we are so used to have come to a screeching halt, the world of associations such as ASCP are carefully and artfully creating virtual experiences that you can be assured will enhance and improve your life but will most definitely be in a virtual format. But the whole world is now experiencing online happy hours, teaching sessions, work meetings, telehealth visits, group therapy sessions, and kid’s birthday parties. Step back from your current situation and ask, “Have I seen MORE or LESS of my friends and peers in the last six months than in the prior year?” That answer is different for each person and carries different emotional baggage. For the constant extrovert who needs that human interaction fuel to spur them on, video conferences may not be hitting the mark. For the ever-quiet introvert who happily recharges among their books and cats and knitting, constantly being required to video chat with people for hours on end may be pushing them toward a steep cliff of insanity. For the “mover and shaker” that loves a problem a minute, thrives in crisis, and gets utter joy out of solving a problem and moving on, facing a day filled with 8 pre-scheduled video conferences or, worse, a day with an empty calendar can be demoralizing. For anyone who had a rhythm to their email usage which involved key time points to check during the day and an internal list of priorities of how to deal with emails on a rolling basis, the extreme uptick in volume of email because everyone is working remotely in the same office (“where is the water cooler chat?”) is dizzying.

It is now July 2020 and we face the uncertainly of what working from home will mean or be or even when it will end (or will we choose this as a permanent solution?). For those of us who have been and continue to report to our work place using social distancing, masks, shift rotations, and the inability to touch anything around us, how can we make this sustainable long-term, do we need to do so, and how do we know when we can end it? For the hundreds of millions of non-laboratorians who are asking, “When will there be a test so we can go back to work?”, the job of the laboratory has long been a mystery but is now suddenly thought to be a miraculous answer to a complex problem of politics, public health, and capitalism. Amidst all of the uncertainty of COVID-19 that we are facing on a continuous basis, the country was already immersed into a “fake news” war between rival political factions that already had the bulk of America either fed up with all new sources, only trusting one “news” source (the bulk of which was political agenda opinion), or simply burying heads in the sand in hopes that this was all just a bad dream. We are halfway through 2020 and the optimists are saying, “It can only get better” and the pessimists are sighing, “what comes next?”. The only people who aren’t complaining are the myriad of investors who didn’t even need a crystal ball to predict the March stock market crash, sold short, and raked in billions—which they then returned to the market buying blue chips at rock bottom (relative) prices to now be showing a 20% return. If only we could all be so lucky?

But there is a light at the end of the tunnel and the sun will come up tomorrow. Nothing lasts forever and this virus will run its course—whether we fight it tooth and nail or ignore it—to a natural conclusion which is harmony within our population. Over the next 6 months, enormous amounts of data on epidemiology, biology, virology, and treatment will emerge. We will learn from our colleagues in Africa what the impacts of early, sustained interventions can do to thwart the virus. Over the next year, vaccines will appear and be available for the population at large. The myriad of tests will have settled around a handful of reliable “winners” that have the sensitivity and specificity we need for each of the valued applications in our systems. The stock markets (and your retirement funds) will have recovered and exceeded pre-COVID-19 levels. However, one aspect of our lives will be permanently changed and that is our dependence and use of video conferencing for the special, the everyday, and the mundane. To that end, let me conclude with some of my (hard earned) lessons from both the last 6 months and the last 20 years of working in global health.

  1. Video conferencing etiquette is a “thing”. Seriously. Tools available to the host can get you so far but nothing says, “we are all in this together” like a team on a video call that is following the rules. Mute yourself when you are not talking. Turn off your computer’s sounds or software that makes frequent sounds. Do not leave your cellphone on your desk on vibrate (computers have great microphones!). If your internet connection is bad, switch off your video. When you are listening, look directly into your webcam (then others feel you are looking directly at them and they feel more connected). Use a virtual background if possible so we do not see your kids making breakfast in the background. Brush your hair (you can totally get away with no pants and not showering but “bed head” is a dead giveaway). Sit within 3 feet of your computer. Rename yourself on the screen if possible, with your full name and organization. Do not take a video call while walking outside.
  2. Your workstation is your productivity cockpit. Make sure it has what you need. In today’s world of multitasking and conferencing, two screens are almost a must. You can use a laptop while traveling but for a home office, having two screens creates a much cleaner canvas to spread out your work, keep resources at your fingertips, take notes while conferencing, etc. Treat your digital workspace like your physical desktop. Keep only what you need on the desktop. File your files in folders you understand and can follow. If your virtual desktop is covered in hundreds of files and icons, your brain is not mentally able to process or prioritize. Use a background picture that sends you to your happy place so that, when you need a break, all windows can be closed, and you can zip to your happy place immediately.
  3. Develop a personal system for communications. Maybe you are a texter, a snapchatter, an emailer, a phone-call-aholic, an instant messenger fiend… Whatever you are comfortable with, the other dozen people you interact with are comfortable with something else. Your team lead may say, “We are using Teams!” or “We are using Basecamp!” or “We are using Sharepoint!” but, let’s face it, it may not fit your style or your work flow. The important thing is to develop a system for whatever communication type you feel most comfortable and work that system to be productive. I have seen the inboxes of people who have 85,000 unopened emails (both personally and professionally) to which I reply, “Delete them!”. If something in those emails was so important, the person will have found another way to contact you. You are never going to read them and, honestly, email just does not work for you. Pick another channel. Texting can work for many people but the organization of texts on a phone and the archiving eventually becomes a challenge such that screen captures or lots of copy/pastes must occur. Whatsapp is a good solution with its archiving function but can still present a permanence problem. Your chosen communication channel is important because it will dictate your productivity style. For example, one of my colleagues takes extensive notes on paper (extensive!) but sometimes takes extensive notes on a tablet. Their work stack (i.e., the collection of items they work through daily) is a combination of pieces of paper and digital notes, but it is disconnected from a communication system. The time required for note translation into understanding and then moving those thoughts to an email, for example, for me would be wasted time. But they remain one of the most productive people I know so this system works for them! Each person must decide what makes them most productive and what keeps them informed and connected; however, a good approach if you are feeling overwhelmed is to use a single system (digital) that moves with you. Microsoft Outlook, Gmail (and calendar), and iCloud all have cross functionality that allow seamless notetaking, email and calendar creation, and file connectivity. Outlooks category function for email can be a massive time saver for the adept user where a preliminary read through of email can allow for classification (for example, I use “Urgent”, “To do – Non-Urgent”, and “Waiting on Reply”) and then priority follow up. At the writing of this blog, I have less than 30 emails in my inbox, all are categorized, and all are calendared for completion.
  4. Go outside and breath. The single most important thing that we can achieve as a society as we emerge from the COVID-19 pandemic is an appreciation for life, freedom, and health and that is difficult to do if you stay in front of your computer for 12 hours a day. More than half a million people have died of COVID-19 and we could have been one of them. Unemployment spike from a flat 4% to more than 14% with many companies, restaurants, and small businesses never planning to reopen. The unfortunate tragedies that continue to befall our black brothers and sisters led to peaceful protests which were then corrupted by riot and ruin across many major cities. Even now, racial and ethnic disparities, especially our Navajo neighbors in the Southwest along with our black communities, cause disproportionately suffering from COVID-19. It is not a time to think, “I’ve been lucky!”. It is a time to say, “What can I do to help today?”And where the help is needed is outside, in your community. Yes, you should wear a mask if you can’t social distance. Be sure to wash your hands frequently. But get out there and be part of the change for the better!
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-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.

Pathology and Histology Services Being Developed at the Biamba Marie Mutombo Hospital (HBMM), Kinshasa, Democratic Republic of the Congo (DRC)

Dikembe Mutombo Foundation

The Dikembe Mutombo Foundation (DMF) was created by NBA Legend Dikembe Mutombo in in 1997 with a mission to improve the health, education, and quality of life for the people in his homeland, the Democratic Republic of the Congo (formerly Zaire).

It took 10 years of intense work and many challenges but in December 2007, the Biamba Marie Mutombo Hospital named in memory of Dikembe’s mother opened its doors to patients in the capital city of Kinshasa, DRC. Dikembe personally contributed more than $23 million to build and equip the hospital. The total cost of the new hospital was $29 million.

The hospital currently has close to 170 beds with an ultimate future capacity of 300 beds. It is a modern facility with state-of-the-art equipment including a new donated CT scanner (the first in the DRC.) This general hospital has the following traditional services: primary care, internal medicine, pediatrics, surgery, OB-GYN, surgical subspecialties such as neurosurgery, orthopedics, urology, and ENT. The goal for the hospital is to provide quality care and to train a cadre of health professionals who in turn will continue to build capacity in the health institutions of the country. Hospital management espouses the following values: respect for the dignity of the patients, professionalism, continuous quality improvement, transparency, and accountability. Currently, the hospital is the most modern, if not the best in the country and to date it has treated close to 500,000 patients.

In 2017, Dikembe Mutombo was honored by the Harvard University Medical School for his ongoing humanitarian efforts and dedication to health care during the Global Health Catalyst Cancer Summit in Boston. The three-day summit, hosted by Dana-Farber Cancer Institute, Brigham and Women’s Hospital (BWH) and Harvard Medical School, brought together African ambassadors, ministers of health, celebrity cancer advocates and global health stakeholders to discuss cancer and examine its global effects on society.

Background

In 2016, the Dikembe Mutombo Foundation successfully implemented a Women’s Oncology Institute at the Biamba Marie Mutombo Hospital (BMMH) in the capital city of Kinshasa. Using classic bedside and surgical teaching methodology, aided by low-cost telecommunications technology, and wise infrastructure investments, the Friends of Africa, Inc. (led by Dr. Groesbeck Parham) has been able to successfully build effective, Congolese-led programs for the early detection and treatment of female cancers at BMMH, thereby providing public access to these critical life-saving services for the first time ever in the DRC. Widespread access to such services is known to result in significant alterations in cancer death rates.

Several months ago, the hospital purchased a new ultrasound machine from GE Healthcare to aid in evaluating breast and abdomino-pelvic abnormalities for the female cancer patients.

Cervical Cancer Early Detection and Treatment Clinic

·     A new Cervical Cancer Early Detection and Treatment Clinic was opened at BMMH in July 2016, under the leadership of the Congolese healthcare providers that were trained in Zambia by Dr Groesbeck Parham.

·     During opening week 8,800 women requested cervical cancer screening services and 3,000 were accommodated

·     To date (July 2016-November 2017), the clinic has screened over 15,000 women for cervical cancer, the largest number ever reported in the DRC.

·     Almost 1,000 women (1 out of every 14 screened) were found to have cervical pre-cancer, all of whom were treated on the same day (the largest number ever reported in the DRC), using modern outpatient techniques.

Through intensive, quarterly, hands-on training demonstrations held at BMMH, a team of board-certified U.S. gynecologic oncologists from the University of North Carolina, Chapel Hill, successfully trained a local cadre of Congolese gynecologists to safely and effectively treat women diagnosed with invasive cervical cancer using oncologic surgical procedures. This novel form of competency-based surgical training was developed in Zambia and is specifically designed to rapidly build surgical proficiency in resource-constrained settings, based on the principles of “Deliberate Practice”, intense replication, and mental narration of a limited repertoire of surgical procedures. 

Using an approach tailored specifically for training surgeons in resource-constrained environments, a team of U.S., board-certified breast surgical oncologists from the University of Arkansas (led by Dr. Ronda Henry-Tillman) successfully trained local Congolese general surgeons to safely and effectively perform surgical procedures that are fundamental to the modern treatment of breast cancer. The training approach was identical to the one used to train gynecologists to perform cervical cancer surgery. To date 81 patients with breast cancer have been treated with surgery by the newly trained team of Congolese general surgeons, under the tutelage of U.S. breast surgical oncologists. All surgeries have taken place in the newly formed Breast Cancer Surgical Unit at BMMH.

In summary, the following has been accomplished:

  1. Developed a local Congolese workforce that has the capacity to provide modern, high quality cervical and breast cancer early detection, diagnostic and treatment services, and to train others
  2. Established two new female cancer (cervix and breast) specialty clinics at BMMH
  3. Established two new female cancer (cervix and breast) surgical units at BMMH
  4.  Leveraged web-based videoconferencing (Skype, Zoom) technology to facilitate continued education and develop an international women’s oncology community of practice, made up of Congolese, Zambians and Americans.
  5. Implemented a women’s oncology data collection system
  6. Designed culturally appropriate health promotion messages
  7. Initiated a cervical cancer prevention outreach program

 Women’s Oncology Care for Africa, known as WOCA. They are the visiting breast and cervical cancer team from the U.S.

Dr. Michael Hicks (L), gynecologic oncologist consultant from Detroit, Michigan, and Dr. Alex Mutombo Baleka (R) from Kinshasa, DRC, performing the first radical hysterectomy ever at BMMH in Kinshasa on a woman recently diagnosed with invasive cervical cancer during a cervical cancer screening program sponsored by the Dikembe Mutombo Foundation and supported by UNFPA.

Pathology and Histology

Histology is the next step that the HBMM hospital is working on establishing. This will provide a needed tool for a more complete diagnostic picture for better patient care. Presently, the hospital is working with 2 different Pathologists to help establish the diagnostic part of the Pathology lab. This is where I have come in to help the Pathologist develop their histology lab needs at BHMM. On my first trip over the hospital selected a team of medical techs to be the core of the histology lab. July 2019, I spent 3 weeks giving formal histology lab classes, organized our equipment and lab area, and started some initial hands-on training on basic histology procedures. On Feb 27th, 2020, I return to the DRC for my second trip to the HBMM hospital. The trip started on the 27th of Feb. in San Jose, Costa Rica. I spent parts of 2 days in Atlanta at the Mutombo Foundation picking up 2 donated microtomes and a double headed microscope to take over for the lab. My first task was to review my previous classroom teachings and spent more time on performing laboratory techniques. With the equipment we now have in the lab we were able to do some valuable training. We worked on tissue embedding, microtome sectioning, floatation bath pickup of the thin cut specimen tissues, and general good laboratory practices with the Pathology Lab. (photos)  Additionally, I was able to spend time visiting and training other histology groups in Kinshasa. I spend one day giving classes at the University of Kinshasa, in the Pathology Dept., to a hand full of Histologists from 4 different labs within the city of Kinshasa. My focus of visiting and presenting classes to those outside of the HBMM hospital was to educate the local labs more about basic histology, to help them to start networking to help each other, and for me to find out the available histological resources within the community. All this will not only help our present histology setup at the HBMM, but it will help the others develop better lab uniformity and quality to help each lab’s patients. We are still short a few things at the HBMM to get histology up and running. We would like to have the lab operational on our next trip to Kinshasa. We had projected the opening of Histology for July – Aug. 2020.  However, due to the COVID-19 pandemic and travel restrictions this timeline may not be met. We are still hoping for the histology\pathology lab opening at HBMM in 2020.

I would like to thank Dr. Dan Milner and Ms. Alpa Pandya from ASCP for their instrumental help in making this lab project possible. This is not the first time they have assisted me overseas and I hope it is not our last program to jointly help.  Additionally, I would like to thank Susan Johnson, Executive Director at DMF in Atlanta, GA, for her tireless support. She made sure everything came together for me. This included the obtaining (twice) a visa for me for the DRC.  This visa was not an easy task, especially for someone living in Costa Rica without a DRC Embassy in all Central America. Last, but of course not the least by any means, I would like to thank the Mutombos for their generosity and compassion for helping the medically underserved people of the Congo.

Each trip I have done overseas that I have provided teaching, basic or IHC lab setups, or fine-tuning of histology labs have all been different, but always rewarding. Just to note, many any of these trips I have done with the support of ASCP. I hope this article stimulates others to go out and help others. We all have something to offer. Please share your knowledge with others who many do not have the opportunities that you have been given. Do not let borders or languages be a deterrent. Remember, everything is possible if approached correctly.

The grounds at Biamba Marie Mutombo Hospital, Kinshasa, DRC.
A portion of one histology class.
Teaching in the lab at HBBM.

-David J. Davis BS, HT(ASCP)QIHC is a certified Histologist and has his qualification in immunohistochemistry with ASCP.  He has been a histologist for the past 38+ years. He has worked in various capacities in 26 countries around the world. Since 1992 he’s been teaching and assisting the international community in histology. He’s retired, but definitely not finished working.

COVID19 and the Lessons We Learned from Prior Pandemics

With recent criticisms in the media, both foreign and domestic, on the United States’ response to COVID19 as well as accusations and summary conclusions that the United States is not a global health power house nor is it as prepared to handle COVID19 as nations around the world that are plagued by infectious challenges daily, it is important to revisit history of recent pandemics and the prior US responses to them to put the current interpretations of “failing” into perspective.

In 2003, the SARS epidemic began in China with the first possible case documented in November 2002. At the time, US relations with China were such that CDC field offices and CDC field officers, including permanent deploys and temporary lead deploys from central CDC in Atlanta, GA, were available to assist the Chinese healthcare system and government with the response to SARS. Through this effort, statements from CDC field directors such as, “This town is going to have a spike and we need 300 more beds,” was answered by the Chinese with a new hospital being built with 300 beds in less than 3 days. Such transparency, collaboration, and communication were possible at the time but relationships have diminished in recent years. During the SARS outbreak, there were 8,098 patients infected (known by positive testing) and 774 deaths (9.5%) which affected 26 countries including the US; however, the US only had 8 to 27 cases (depending on source) and no deaths. Although the first cases traced back to late 2002, the disease was not sequenced and declared until April 2003, but testing was available shortly thereafter. Control measures locally and globally with some help from testing stifled the pandemic in a matter of weeks and the threat was near zero by the end of 2003. No resurgence has occurred. From this outbreak, the US and the world learned how to deal with novel coronaviruses and how to coordinate and collaborate for future potential outbreaks. Such lessons include the need for transparent communication and direct in country collaboration, rapid move to testing distribution, and high-level knowledge of pandemics and who nations should respond.

In 2009, the H1N1 pandemic began. The CDC activated its emergency system within 7 days of the first case, the US and the WHO declared the pandemic within 9 days of the first case, and testing was available within 14 days of the first case. The US had 60.8 million cases (confirmed positive tests) with 274,000 hospitalizations (0.5%) and 12,469 deaths (4.5% of hospitalizations, 0.02% of cases). The incidence from the disease was due to the rapid respiratory spread very similar to routine influenza but on top of a system (including hospital processes and national approaches to testing with integrated public health laboratory systems) that was prepared and able to nimbly adapt. In this case the rapid advent of testing was crucial to controlling case, getting patients on treatment, and tracking the disease. H1N1 was then subsequently included in the annual influenza vaccines.

From 2012-2014, the MERS-CoV virus, originating from and primarily endemic in the Arabian Peninsula, was a challenge for global heatlh because of the high mortality rate (30 to 40%) and the very efficient spread of the virus. All cases arising outside of the Arabian Peninsula were traced to travelers from that region. The first known cases were in April 2012 with the first recognition of the virus causing the disease in September 2012. The CDC developed a test for MERS in 2012 and subsequently an EUA from FDA was granted on June 5, 2013. The first positive cases of MERS in the US occurred in May 2014, almost 1 year after testing had been available. To date, only 2 confirmed cases of MERS have been diagnosed in the US which were traveling healthcare workers who had treated patients in Saudi Arabia.

The Ebola epidemic in West Africa from 2014-2016 had a total global case count of 27,000+ with 11,000+ deaths (46% mortality). However, in the US only 4 patients were ever diagnosed with EBOLA and 11 patients were treated for EBOLA with only 2 total deaths (18% mortality). Why was the case count so low for the US and why was the mortality nearly a 1/3rd of the overall epidemic? Immediate response from the US government to control incoming patients (the only transmission inside the US was from patients who were travelers to healthcare workers) and availability of testing prior to the outbreak (with the CDC). Nigeria was able to diagnose the first case in Lagos (a traveler from Liberia) because a scientist in Nigeria had developed a rapid EBOLA PCR six months before the outbreak occurred. Nigeria only had 8 deaths from 20 confirmed infections (40% mortality). Why did Nigeria get ahead of the game? Immediate response from government and availability of testing. The unfortunate results in Liberia, Sierra Leone, and Guinea were less about lack of response and lack of testing and mostly due to poor infrastructure for health.

The current pandemic of COVID19 started on November 17th (earliest confirmed case in China) and was a reported disease cluster from China to WHO by December 31st, 2019. The first case in the US was documented to have occurred on January 19, 2020. The FDA, in response to information from central administration and pressure from multiple entities, allowed testing for COVID19 through Emergency Use Authorization (EUA) on February 28, 2020 (more than one month after the first US case). As of April 28, 2020, the US has had 1,026,771 confirmed cases (positive testing) and 58,269 deaths (5.7% mortality) affecting all 50 states in the setting of an unprepared system (i.e., insufficient testing, insufficient pandemic planning at the national level, insufficient in country data from source countries). Data has shown in the laboratory that the SARS-CoV-2 virus shares 74 to 90% genetic homology with the original SARS virus but has a 10-fold increased affinity for binding which suggests that its natural biological virulence could be 10x that of SARS. If proper systems, testing, and planning had been in place, we can conservatively estimate that there would currently be 102,667 confirmed cases in the US and 5,827 deaths. These excess cases and excess death are, therefore, a direct result of the lack of systems, testing, and planning (52,442 excess deaths of US citizens).

There are conspiracy theorists that argue SARS-CoV-2 was created or modified from a different virus by human manipulation with a most recent endorsement of HIV Nobel Prize Laureate Luc Montagnier—statements that were almost immediately refuted by other prominent scientists. If there was a credible threat from SARS-CoV-2 when the sequence was released, that would have been an even more convincing argument that preparation was needed. But the threat of SARS-CoV-2 from just the observed medical cases and initial reports should have warranted a brisk and complete response from leadership. That such responses were delayed because of a multitude of failed responses (pandemic planning, testing, situational awareness, field deployments, etc.) can be argued from now until the next pandemic occurs. But our collective prior experience with pandemics (4 of them in 2 decades) provided plenty of evidence and case-studies for how we should have responded.

ASCP along with other organizations reached out to our membership and the community for support of a call for a National Testing Strategy resulting in tens of thousands of letters to elected representatives and a subsequent plan for a National Testing Strategy released by the US government. The CARES Act released this week includes billions for testing.

These efforts are for our membership who are the medical laboratory professionals working 12 hours shifts to provide the testing needed by their patient populations.

These efforts are for our pathologist members who are informing and controlling hospital and government responses around testing through their rapid decisions and their expertise.

These efforts are for our pathologist’s assistance at all levels who keep anatomic pathology running with our pathology trainees despite massive volume challenges.

These efforts are for our PhD members whose expertise in science, design, and evidence acquisition is rapidly leading to new testing and eventually new vaccines.

These efforts are, most importantly, for our patients, the center of all that we do, to ensure that they have access to testing and the peace of mind they need to move forward from this pandemic.

References

  1. https://www.webmd.com/lung/news/20030411/sars-timeline-of-outbreak#1
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1904415/
  3. https://en.wikipedia.org/wiki/2002%E2%80%932004_SARS_outbreak
  4. https://www.fda.gov/media/72313/download
  5. https://www.who.int/csr/sars/testing2003_04_18/en/
  6. https://www.cdc.gov/about/history/sars/timeline.htm
  7. https://www.cdc.gov/flu/pandemic-resources/2009-pandemic-timeline.html
  8. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html
  9. https://www.cdc.gov/coronavirus/mers/about/index.html
  10. https://www.cdc.gov/about/ebola/timeline.html
  11. https://en.wikipedia.org/wiki/Western_African_Ebola_virus_epidemic
  12. https://www.scmp.com/news/china/society/article/3074991/coronavirus-chinas-first-confirmed-covid-19-case-traced-back
  13. https://www.who.int/news-room/detail/27-04-2020-who-timeline—covid-19 https://www.nature.com/articles/s41467-020-15562-9
  14. https://www.worldometers.info/coronavirus/country/us/
  15. https://www.nejm.org/doi/full/10.1056/NEJMoa2001191
  16. https://en.wikipedia.org/wiki/COVID-19_testing
  17. http://www.xinhuanet.com/english/2020-04/21/c_138995464.htm
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-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.

FDA Guidance to Develop Novel Molecular Diagnostic Tests for SARS-CoV-2

A laboratory advisory from the CDC:

The Food and Drug Administration (FDA) issued new guidance on February 29, 2020, for laboratories to be able to develop novel coronavirus (COVID-19) molecular diagnostics tests and begin use prior to obtaining Emergency Use Authorization (EUA). This permits laboratories that are CLIA certified and meet requirements to perform high complexity testing to start offering severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular diagnostic testing after validation is completed as outlined in the guidance. Laboratories should submit an EUA request to the FDA within fifteen business days after validation. FDA will be hosting a webinar to provide more information on March 2, 2020, at 3 pm ET.

Clinical laboratories should contact their state health departments for guidance if they have a suspected COVID-19 case specimen. Clinical laboratories should NOT attempt viral isolation from specimens collected from COVID-19 persons under investigation (PUIs). For interim guidelines for collecting, handling, and testing clinical specimens from PUIs for COVID-19, please see the CDC Coronavirus Disease 2019 (COVID-19) website.

The Crown

Hello again everyone! Welcome back.

No, I’m not talking about Netflix or HRH Queen Elizabeth II, nor am I making references to tiaras, bars, beer brands, or imminently deliverable babies…I am, of course, talking about Coronavirus as it would certainly have caught most of our collective attention in the media by now.

I really enjoyed writing last month’s list of what I think are important things on the horizon for pathology and laboratory medicine this new year, but this month let’s take a more topical turn. So put your surgical masks on, wash your hands, quarantine the next 10 minutes of your time and get ready as I take a shot at the novel 2019 coronavirus outbreak!

***Let’s talk about you and me, Let’s talk about COVID-19…***

Less-Than-Common Cold

A long time ago, in a galaxy far, far away (aka: last year, about 20 minutes north of my apartment in Manhattan) I was in medical school, on rotations on the floors of a hospital in the Bronx. I experienced the surges of two flu-seasons and had a fantastic little mnemonic to remember the viruses that caused colds in most patients. Depending on age and immune system status, you had to think about the principal three viruses we see all the time—I remembered them as: “c-A-r,” note the capital “A.” Let me explain; the letters correspond to coronavirus, adenovirus, and rhinovirus. The are in a general order of when they appear during the months of the year (as coronavirus and rhinovirus kind of switch off in the spring, while adenovirus is around always thus is capital designation). There are a few hundred viruses which contribute to cold/flu-like symptoms in patients and, unless a patient is compromised in some way, we really worry most about one of them. Hint: it’s the one we give shots for annually, more on that in a minute.

Image 1. Okay this is a little better than my seasonal cold “cAr”…Seasonal variations in frequency of selected upper respiratory tract infection pathogens. Funny that, of all the colors, Influenza gets the good ‘ol fashioned “red alert” from the commanders on the USS Medscape. PIV = parainfluenza virus; RSV = respiratory syncytial virus; MPV = metapneumovirus; Group A Strep = group A streptococcus. (Source: Medscape)

As far as this coronavirus outbreak is concerned, this is a “novel” (i.e. new) variant (read: mutation) of a respiratory viral pathogen that is affecting a disproportionate number of patients in higher severity than expected. Its official entity name has now been filed by the World Health Organization (WHO) as COVID-19—corona virus disease of 2019. The actual virus is a relative of the infamous SARS virus from the early 2000s. That was SARS, this is SARS 2.0—literally. This virus is designated SARS-CoV-2. SARS stands for Severe Acute Respiratory Syndrome and is caused by strains of coronavirus found in the remnants of infected individuals’ coughs and sneezes—please wash your hands—and causes a spectrum of symptoms from mild to severe including pneumonia, respiratory disease, and even renal failure.

Image 2. Heeeerrreee’s COVID, well at least a coronavirus model. Named after the crown-like spikes on its envelope surface which act as receptor anchors in order to attach to cells and infect us. The receptors’ favorite target? ACE2 (angiotensin converting enzyme 2) receptors—am I getting your blood pressure up yet? I said renal failure…full circle, right? (Source: Centers for Disease Control and Prevention)

How Does this Even Happen?

Okay, who took a sabbatical to Wuhan, China, and ate a wild fruit-bat salad? No one, that’s not how this works. But, if you’re looking for quick grocery store recommendations at the present moment I’d probably tell you to check out ALDI or a farmer’s market a few spots higher on the list than the Huanan Seafood Wholesale Market in Wuhan which harbored a majority of outbreak case-cause tracings. The bottom line is that COVID-19 and the SARS-CoV-2 have appeared in the world the same way the previous similar outbreaks have—through zoonotic mutations which then spread to humans. This zoonotic transmission is so effective to presenting humans with super infectious entities because it sends us pathogenic material we would have never seen before and our “naïve” immune systems are caught off guard. Now don’t get all panicky; yes, I’ve seen Contagion, Outbreak, and read The Andromeda Strain—in fact, I absolutely love when epidemiological medicine has the media spotlight. It’s a very exciting way to showcase public health, medicine, and—our favorite—laboratory professional work!

Image 3. Okay, no bat salad but this outbreak does involve bats endemic to the regions in question. It also involves, pangolins, kind of like armadillos, which are bought and sold (and trafficked) all around the world for various reasons. The pangolin DNA matches the SARS-CoV-2 genome highly, so scientists assert that its involvement is inherent. The complications in sanitation and animal/food handling are obviously implicated in this and other outbreaks, but dealing with COVID-19 requires a strong public health response. (Source: Osmosis)

Basically, this process of mutation and transmission is the modus operendi of a viral particle. You can’t quite kill them, they’re not quite alive by biological definitions, they’re just packaged proteins on autopilot. They’re kind of like natural robots that want to propagate their species by adapting over time—they’re The Borg or Cybermen, depending on your sci-fi preferences. But both offending automaton predators have a mutual enemy in public health—a doctor (get it? TARDIS pilot and/or Beverly Crusher both work wonders in a pinch…) Anyway, it’s never just physicians, but a whole hard-working team of health advocates that conduct surveillance, field research, epidemiologic studies, and first-hand treatment.

***Side note: if you’re bored, in a hurry, or just don’t like my articles—don’t fret! Go watch that Osmosis video on COVID-19 and you’ll be up to snuff on the current outbreak in no time. Or in 12ish minutes.***

***Hey, you made it this far. Great! Interested to know more about the COVID-19 virus from our very own American Journal of Clinical Pathology? Visit here to learn more about the story of how this pesky coronavirus mutated its way into headlines. Fresh off the AJCP presses this month!***

You Should Update Your Antivirus Software

Image 4. Fake news is the new normal. It’s hard to sift through a sea of garbage. You can’t just ignore it, because sometimes there’s serious situations like war—or viral pandemics! So, you’ve got to update your personal mental anti-spam filter and know how to sniff out suspicious sources. Let’s call it “information hygiene” to be consistent with the zoonotic exposure narrative, yea? (Image source: NPR)
Image 5. Let’s lighten the mood a bit. These situations can drive folks absolutely nuts. People obsess over minutiae and often wrong details when archetypal preventions like hand-washing and isolation are paramount to prevent epidemics. Public health and pandemic situations breed conspiracy thinking—wait, never mind, this is a photo of me explaining the residency match process to my friends and family. Kidding. Kind of. (Source: a popular meme, but originally from It’s Always Sunny in Philadelphia)

No doubt in my mind you’ve probably seen plenty of coverage about SARS-CoV-2 in the media. I’d also be willing to bet a lot of it is either dilute, sensational, or possibly even misleading. Regardless, there are always going to be people that don’t “buy in” to the public health message. If you remember Contagion¸ Jude Law’s character pushes the efficacy of “forsythia,” a homeopathic herb supplement that supposedly mitigates the horrible disease spread from southeastern Asia from improper food handling—if I recall correctly, it was a paramyxovirus that time. In this SARS-CoV-2 epidemic we have no current effective treatments, so prevention is key.

In an effort to address this type of health misinformation the WHO and CDC are actively disseminating as much educational information and graphics as they can write. Trying to dispense advice for the public including proper mask wearing, education videos, and myth-busting (i.e. hand dryers do NOT kill the COVID-19 virus, UV lamps do NOT kill the virus, thermal readers are effective in screening populations for symptoms within limitations, alcohol and chlorine do NOT kill the virus, receiving packages from China is still safe, pets don’t harbor the virus at this time, other vaccines do not affect this virus, saline nose sprays do not affect this virus, garlic/oils/other supplements have no effect on this virus, and all age groups are affected)—good stuff there. The most trusted sources of information regarding epidemics should be the representatives of functional medicine and health outcomes, doing work every day to make people healthier. Often times, politics, misinformation, or complex situations make information delivery harder than you’d think and the risks are increasingly high.

Image 6. BONUS MATERIAL UNLOCKED: Glad you made it this far. I mentioned Netflix’s The Crown above, but if you’re looking for a fantastic series that breaks down public health epidemiology, influenza burden, research and surveillance on emerging pathogens as updated as 2019, check out Pandemic. 5/5 surgical masks would binge again. (Source: Netflix)

A Crown of Thorns: Don’t Forget About the FLU!

Flu vaccine deniers: turn away now or be healed! —or at least exposed to another point of view rooted in evidence-only concepts in medicine and population health. Consider the following: as of this month, COVID-19 has infected 43,000 people and killed 1,000 (approximately 2-3%). Remember SARS? That infected 8,000 and killed 700 (approximately 10%). MERS? 2,500 infected, 860 deaths (approximately 34%). And what about Ebola? 29,000 infectious cases with 11,000 deaths (approximately 40%). That was sourced from the Osmosis video with data from the WHO. Pretty impressive right? Well, not if you look at this: according to the CDC, the 2019-2020 influenza burden statistics include 36,000,000 infectious cases, with 17,000,000 clinical visits, 440,000 hospitalizations, and 36,000 deaths. One might say “hey, Dr. Kanakis, slow down there you’re spitting out all these numbers and the facts won’t lie. Looks like influenza only killed 0.1% of cases.” And you know what, you’re right. 0.1% is lower than the other viral epidemics. But check this out, because of the sheer number of cases, that means more people died of influenza than COVID-19, SARS, MERS, and Ebola COMBINED and those happened in other years. That‘s just this year’s flu season alone. I’ve talked before about recognizing and detecting the common cold vs. influenza before, check it out if you’d like a refresher!

Image 7. What’s a statistical percentage data point if it’s a relative, a loved one, or yourself? Protect yourself, protect others, and let’s find ways to make proper health knowledge available and acceptable to the masses while promoting excellent healthy behaviors, together! (Image source: New York Post)

We have influenza every single year, and it kills so many more people than we realize. If you want to talk about a terrifying, global viral epidemic, we’ve already got one. And it’s closer than you think. So wash your hands, reduce exposures if you’re sick or immunocompromised, get proper rest, eat well, exercise, read my articles every month, but most importantly—and I cannot stress this enough—get your FLU SHOT!

Thank you so much, see you next time!

–Constantine E. Kanakis MD, MSc, MLS (ASCP)CM completed his BS at Loyola University Chicago and his MS at Rush University. He writes about experiences through medical school through the lens of a medical lab scientist with interests in hematopathology, molecular, bioethics, transfusion medicine, and graphic medicine. He is currently a 2020 AP/CP Residency Applicant and actively involved in public health and education, advocating for visibility and advancement of pathology and lab medicine. Follow him on Twitter @CEKanakisMD