Moving Beyond Data to Action

On October 6th, 2021, the Lancet Commission on Diagnostics launched the “Transforming access to diagnostics” commission report with a virtual program and release of several publications. One of the publications included a study led by Dr. Sue Horton on access to diagnostics using data from 14 countries, mostly in Africa, from 2004 to 2018 with single timepoint data used to evaluate the relationship of access to diagnosis with a variety of factors. The diagnostics that were evaluated did not include histopathology, crucial for the diagnosis of cancer; however, the study did show importantly that income and population density had demonstrable relationships with access to diagnostics at the primary care level. For hospital-based access, there was no relationship which led the authors to conclude, among many other and relevant points, that access to diagnostics in “primary health care is the diagnostic so-called last mile and particularly affects poor, rural, and marginali[z]ed communities globally; appropriate access is essential for equity and social justice.” In the Commission report, the authors describe a tiered system with three levels that countries should incorporate into a national laboratory strategy and suggest that the burden of affording this system should fall on the governments. Moreover, they demonstrate the extremely important data around use of global markets to show that while the top four countries supply nearly 50% of all diagnostics, those same four countries only supply 24% of pharmaceuticals. In the opening statements to the Lancet Commission launch, Dr. John Nkengasong espoused very strongly the importance of manufacture of diagnostics WITHIN LMICs as one much needed solution.

For example, I was assisting a colleague with access to immunohistochemistry antibodies for which they were currently paying $700 USD for one vial of CD20. I traced the manufacture back to the US supplier (where the antibody was produced) and attempted to buy a vial as a private citizen with a credit card and was surprised to see that I could do so for $220 USD. This is the exact same vial of CD20 antibody. Why was my colleague paying a 218% markup? When I inquired with the company of manufacture, they reported that they had existing contracts to supply 2nd, 3rd, and 4th party vendors that they could not violate (i.e., they could not sell directly to a purchaser on the continent of Africa). The local supplier charging the $700 USD suppled a very large number and breadth of medical supplies including other diagnostic tests and reagents. Those reagents were reasonably priced, and several were on sustained government contracts. However, the CD20 antibody was not. Why is that the case? Let’s assume you are a supplier of widgets and wobbles. Your demand for widgets is huge and you sell more than 100,000 widgets per month to 20 different consumers. For wobbles, one person orders one wobble once per year. Your widgets ship room temperature but your wobbles require a cold chain, lest they be destroyed. What would you do? You could choose not to sell wobbles. You could choose to charge a ridiculous price for wobbles so that the excess time, energy, and expense of getting one wobble to your consumer is worth the effort. But you would not sell the wobbles for a similar profit margin as your widgets. It just wouldn’t make business since. Now imagine that the wobbles are manufactured in a country other than your own and to get them, you buy them from a country supplier who buys them from a regional supplier. So, wobbles already come with additional markups. You do have a third choice which is to manufacture wobbles locally, cut out the middle people, and charge much less but still make more profit. This is a great model if wobbles can be easily manufactured; however, when wobbles require an enormous capital investment, is it worth it to sell a couple of wobbles a year? Of course not. This business-based example is one of the drivers for a $700 USD vial of CD20. If a local manufacturer, in country or in a neighboring country, could manufacture and sell, this reagent would be more affordable and feasible as an available diagnostic. Specifically, patients with lymphoma would have access to rituximab for CD20.

But note the Commissions finding that almost 50% of diagnostics are made in the top 4 countries. This means, naturally, that the pricing for these reagents and supplies will be based on that economy and/or GDP, not on the economy or GDP of every country down to the lowest on any given scale. Consider the Big Mac Index, which looks at buying power relative to the US dollar. The only African country used in the Big Mac Index is South Africa and it is third from the bottom. To be clearer, if you have 100 South African Rand, you could get about $6.69 USD if you exchanged it directly (ignoring fees). If you want to buy a Big Mac in the USA, the average consumer price is $5.65; however, in South Africa, it’s 33.50 Rand. Based on the Dollar:Rand exchange rate, we are paying only $2.24 USD in South Africa for the same sandwich that would cost us $5.65 in the US. So, the Rand is undervalued. Now, let’s look at our vial of CD20 (not revealing the country to protect identities). According to the current exchange rate, you get $4.34 USD for every 10,000 units of this countries currency. Based on this model, if the CD20 was being EVENLY exchanged with cash (as opposed to being undervalued or discounted as we saw with South Africa), it should cost 450,586 units of this country’s currency. Instead, it is costing them 1,612,053 units. If we assume that this country could/should achieve a Big Mac Index equivalent discounted of the CD20 as we see with the Big Mac itself in South Africa, it should cost them 307,057 units or $133 USD. The difference? The Big Mac is manufactured and locally distributed directly to the customer in South Africa. The CD20 is not. So, one step to achieving an equitable pricing structure in healthcare for LMICs, especially in Africa, needs either direct discounted by US- and European-based manufacturers—unlikely to occur because of fear of alternative market access—or these products need to be manufactured and supplied locally.

What I have trouble agreeing with completely and, in some cases, even it part, is the concept of all healthcare costs falling on the government of a population with the expectation that they deploy a “one size fits all” approach to any aspect of healthcare. When we consider the US and Europe (again, the top four producers of diagnostics), we find one as a largely private commercial system driven by government pricing for elder care and the other a socialist system with universal healthcare enhanced by private care. For both systems, there is a huge economic base which either drives capitalism across the system from raw materials to final product or an enormous tax base that can cover the bulk of the costs of the systems. As we move from these four down the GDP ladder to LMICs, we don’t see, despite that we would like to nicely categorize countries into clear groups, a solution that would work “globally” because major pieces of economic development are needed as pre-requisites for a capitalist open market or one payer system. Each country has a unique set of circumstances (e.g., history, genetic diversity, geography, natural resources, tourism, disease burden, language, population size, etc.) that cannot be reduced to simply a GDP value or Big Mac Index factor. Moreover, it is wholly within the realm of colonialism, which we supposedly abandoned 70 to 80 years ago, to think that we can propose a system for “all countries” that would even remotely approach the solving the problems of these countries. Although it is an excellent mental exercise to idealize a healthcare system as having something as simple as three tiers and trying to allocate what tools and resources are needed at each level to accommodate the population, the reality is that such a framework is only a starting point with a lot of work needed to fully realize what type of system would be best for a given country. Very small islands and small nations may have only one hospital to serve its entire population and insufficient patients of a given type to justify the expense of certain tools. Extremely large countries with large populations will need a myriad of systems with their own tiers that support patients based on location, socioeconomic status, language, etc. and these systems likely overlap in geography. And the expertise to best determine that system is the health and government leadership of that country, not an external set of non-specific instructions. The external set of instructions, however, are extremely important, as noted, as a starting point, but each country that identifies a gap in their diagnostics, for example, has to assess their specific situation. At the heart of this problem is the need to stop talking about the challenges of global healthcare and start (or continue) directly working on fixing them.

At ASCP, we approach our global outreach through assessment, gap identification, implementation planning, and execution (AGIE). Through that approach, we have deployed and/or support 19 sites in 15 countries with telepathology; however, in an additional 10 countries, we have active programs that have not yet reached a point of telepathology deployment. Had we said, from the beginning, “We are going to give everyone telepathology”, we would have wasted an enormous amount of time and money. By following an AGIE approach, we have navigated to the specific problems of each site with whom we collaborate and attempted to solve them. And we do so with more than 80 collaborative partners. The Lancet Commissions on Diagnostics most recent launch is an excellent first alert for those who have not been engaged in global health for the last 20 years that there are still major challenges and problems in global healthcare and diagnostics. Our hope is that funders, governments, industry, health system members, patients, and advocates will view this as a rallying cry to direct resources and energy to join those of us who have been engaged in this work to move the needle even further. Access to diagnostics for every patient everywhere. It is ASCP’s simple mantra, and we hope, together, we can achieve that goal.

References

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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.

The Anatomy of Lab Safety Design: Handling a Flood

Most laboratories are designed with eyewash stations and at least one safety shower depending on the size of the department. The use of these safety showers is not common, but it does happen, and the staff needs to be prepared for such an event. That preparation not only involves testing and training on equipment use, but also in making sure the physical space is ready for a potential deluge of water that can pour down into the department for potentially up to fifteen minutes. Other flooding incidents may occur as well. A floor drain can back up, a water line connected to an analyzer might break, or water might even come through the ceiling from a pipe above the department. Being prepared and responding efficiently to these types of flooding events should be part of the overall lab safety program.

One reason safety specialists and some regulatory agencies require that items in the lab not be stored directly on the floor is so they will not be damaged in the event of a departmental flood. It is generally acceptable to store plastic items (waste bins, etc.) on the floor since they cannot be damaged by water. Cardboard, computer hard drives, and other like items should be stored on palettes or shelves. Securing electrical wires and raising multi-plug adaptors off the floor is also a best practice.

When designing or remodeling a laboratory, consider the possibility of floods when choosing the type of flooring to be installed. The best laboratory flooring is monolithic, like a sheet vinyl that has few seams. It should bend up to the walls to create a coved base that is integral with the floor. This design (recommended by the CDC and CLSI) keeps liquids from going under tiles or through walls which will create more problems (like mold) down the road.

Floor drains where safety showers exist are not required, and many labs have showers where there is no drain at all. Remember that in a typical situation where a shower would be used, hazardous chemicals are involved. Any hazardous waste that might go into the sanitary sewer should be routed through a neutralization station or into a hazardous waste collection tank. The ANSI requirements for a safety shower include the ability to deliver 20 gallons of water per minute for 15-20 minutes. That’s a total of 400 gallons. The requirements also state that the water pattern must be at least 20” in diameter and 60” above the floor. Therefore, a majority of the water will not even travel to the drain. It will go to the lowest point of the floor in the department. The bottom line is, if the safety shower must be used, a flood should be expected.

In order for the lab to be prepared for a flood emergency, materials should be on hand that will help contain large amounts of water. Those materials may include large volume spill kits with booms or dikes that are capable of holding water back. Staff should be trained how to use these materials as spill training is provided, and drills should be conducted so they can use the supplies comfortably. Make sure these spill materials are easily accessible and that signage clearly indicates where they are stored.

What does the physical anatomy of your lab look like? Is it designed for safety in the event of a hazardous material spill or exposure? Is the department set up to handle a sudden flood situation, and can staff identify the steps to take to respond efficiently and safely? Take a look around your lab today, and make any necessary corrections so that all will be ready should a laboratory flood occur for any reason.

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

Looking into the Pathology Mirror

Conversing with people early in their career has always been an exciting experience for me and, I hope, for those with whom I have spoken. I tend to get enthusiastic in discussing all the possibilities that lie ahead and try to keep the conversation focused on the individual in question. I try to avoid talking about my own career path unless someone specifically asks—but I keep it brief. One-on-one conversations tend to be very productive for the individual because we can delve deep into their questions, fears, concerns, hopes, and goals. Group discussions often end up being more informative for me, and I have learned a ton from listening to dynamic young people. I was recently gifted with the opportunity to lead 9 focus groups as part of a grant-funded project which included several groups with medical students and pathology residents. Although our focus was on forensic pathology, the groups were quite diverse. I would call the experience overall very positive and enlightening for all of us, but I was struck by a few observations that I felt the need to explore further on my own—so, you get to read a blog about it.

Pathology is a fascinating specialty after medical school that covers a large range of diseases and patient types, an even larger range of scopes of practice, and includes some of the lowest and highest paid jobs in the field. At the same time, the practices of pathology and medicine are evolving at an extremely rapid rate while medical knowledge is expanding exponentially. There is an entire industry based around paraphrasing the current literature for a given specialty because, even within a specialty, you can’t read every new study or follow every new development. It is this expansion that has created the demand by pathologists in the last 2 decades to be sub-specialists so that a focus on one particular area of practice will keep their expertise sharp, their diagnoses hyper-accurate, and their risk profile minimal. This expansive phenomenon in medicine in general but specifically in pathology is an excellent indicator that the field of knowledge is ripe for a disruptive innovation. It is common knowledge that the practice of anatomic pathology, for example, is based on a technique that is more than 100 years old—histology; however, what is not common knowledge is that the amount of data generated by reviewing a histology slide from, for example, a tumor, is 1/1000th or less than the data generated by performing genetic sequencing of that same tumor. Add to the mix the ability to perform transcriptional analysis, mass spectroscopy, metabolomics, lipidomics, phospholipidomics, glycobiological analysis, etc. and it becomes clear that what is contributed by an H&E pales in comparison to what we can know about a piece of tissue. There are barriers, you say? Cost, integration of information, usable outputs, or process:volume ratios? All true. But the technological ability to characterize a tumor across all these different attributes and mathematically reduce that to a multiplex assay which can perfectly classify and predict therapeutic responsiveness exists. Still don’t believe me? A collection of companies is focused on testing that has been variably called, “Universal Cancer Screening”, “Multi-cancer Screening”, and “Multi-cancer Early Detection”. These systems currently use sequencing across multiple loci to detect from 20 to 50 different cancer types. One such company can do so with stool to look for gastrointestinal cancer and is on the market today. Why am I going down this path of which many of you are already aware? Because when I was talking to a trainee recently, they told me that they originally wanted to go into forensic pathology but were talked out of it and were now considering doing GI pathology. Let’s break this down so you can understand my frustration.

GI pathology as a career is largely generating revenue through colonoscopy from screening. Yes, the field is diverse and the most complicated parts like liver, pancreas, IBD, etc. are part and parcel to the practice. But, from a C-suite perspective, the fiscal bulk of the value of the service is in biopsy reads from screening. Because of the interest in the field in the last two decades (increase in pathologists in GI) juxtaposed to the much-needed control and reduction of 88305 reimbursement (due to rampant misuse and overuse), there are a lot of GI pathologists in the United States. So many, in fact, that jobs for GI pathology are sort of hard to find. Add to the mix a product, already on the market, that can detect colon cancer in stool without screening colonoscopy and its risks, which is only the harbinger of a group of products that will arrive on the market which can do the same for many other cancers from stool, blood, etc., and one gets nervous about where GI pathology’s current revenue volume is headed. But then there is the recent recommendation that the screening age for colonoscopy be reduced to 45 (from 50). The increase in volume of biopsies from screening (if everyone was 100% compliant) would overwhelm some practices. Where is GI pathology as a specialty going? Do we have too many and should we be concerned about disruptive innovations to screening decimating revenue generating volumes? Or are we facing an overwhelming number of biopsies with the new screening guidelines? I wouldn’t dare try to predict where this is headed but there is clearly some “uncertainty” in the practice of GI pathology. And a practicing pathologist talked a resident out of forensics and into GI??

Let’s contrast this with forensic pathology so my point is clear. There are currently only about 500 FPs in the United States and there is a need—to meet minimum requirements for coverage—of 1200 FPS. That’s a difference of 700 FPs, all of which must be board certified pathologists. There are more than 50 current open full-time positions for FPs that are funded (i.e., actively recruiting to hire today) that were identified on the most common sites for these listings. Seven of these programs offer tuition repayment for FPs from $100,000 to $250,000. Outside of those seven programs, there are three federal programs that specifically offer loan repayment for FPs and a fourth for which they are also eligible. Doing the math, basically, anyone wanting to practice forensic pathology likely qualifies for a loan repayment program (hint: that’s not true for the majority of pathology jobs). Although the average salary for an FP is often reported as ~$110,000 (about half of the average salary for a pathologist according to publicly available data), the current open positions I mentioned have an average of $240,612 (with a range of $175,000 to $350,000). The work of forensic pathologists includes death scene investigation, varying levels of postmortem examination (e.g., chart review, external examination, complete autopsy, etc.), medicolegal reporting including court appearances, participation in public health investigations, participation with local government, etc. This role is vital to the functioning of society and is required by law to be performed. Stated another way, we will always need FP (and we desperately need them now!). It is very difficult to imagine a disruptive innovation or even a transformative innovation that will replace this role in the next several decades. That same can’t be said for other parts of pathology (see my GI example above). And yet, we struggle to find FPs. Why?

Certainly not the only reason but a valid and real reason that we struggle is the presence of microaggressions in the medical community. These are common for pathology in general but can be extremely harsh and rampant for forensics (even coming from other pathologists!). The real example I have given you of the resident selecting GI after being talked out of forensics is a true story. And, more importantly, it was reiterated by nearly every medical student and resident (and fellow) with whom we talked about their experiences. Considers these statements (which are direct quotes):

“You’re too smart to do pathology.”

“Why would you waste your brain on forensics?”

“You’re too good with people and patients to be a pathologist.”

“Forensics is a dead specialty (pardon the pun)”.

Excuse me?? Are you kidding? It’s not that these microaggressions are inappropriate because they are damaging to a young person’s passions and interests. It is that these microaggressions, which are heard repeatedly, are simply wrong. Pathology, if nothing else, is a data and knowledge heavy specialty where we spend most of our time thinking, solving problems, and receiving, processing, interpreting, and synthesizing data into a useful answer on which a clinician can act. And we don’t do it one patient at a time. We produce literally thousands if not tens of thousands of tests results per day in an average laboratory. Forensics requires highly intelligent, detail-oriented individuals who can not only synthesize an entire patient’s life and death into a succinct story—but they have to defend their opinion in court. Every day! I’d like you to ask your primary care doctor if every decision he/she made for each of their patients in one day they would be comfortable defending in court. Every decision! It requires a special person who is not only amazing with data and knowledge but extremely talented at interacting with people—many of which are trying to prove you wrong. Moreover, few medical specialties call upon the physician to routinely deal with families at the lowest point in their lives in every single encounter. A person that is good with people and patients is exactly the person that can become a successful forensic pathologist—one that provides meaningful care when care is most needed. And lastly, forensics is thriving as a job market (as I described). And yet, our “mentors” who train our medical students and pathology residents continue to provide microaggressions (or outright rebuke) for those brave, brilliant individuals who would choose forensics as a career. Considering the state of the field and the perks of the practice at the moment, forensics seems like a pretty smart choice today. But stepping back from this rhetoric to a 10,000 foot view—because, remember, this is me thinking through a problem and forcing you to read about it—the overall observation I have is that the field of pathology (internally) needs to understand where it is going, what its scope of practice will look like tomorrow, 5 years, and 10 years from now, and, more importantly, what the needs of our patient community are (alive or dead). Without a global view of the total need in pathology, how can we possibly have meaningful conversations with individuals early in their career that both enhance their passion and meet the needs of the community of practice?

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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.

Lab Safety Whiplash

The world seemed like a brighter place just a few short weeks ago. The pandemic seemed to be nearing an end, and life was returning to normal. In laboratories, the COVID-19 testing volumes decreased, wearing surgical masks all day long at work was no longer the norm, and the workday had that old feeling of familiarity again. Then, suddenly, it all came roaring back. The COVID-19 Delta Variant, loading its victims with over 1000 times more viral particles than the original could, came to visit. Now masking and social distancing are back with a vengeance, and everyone holds their collective breath as we wait to see what other cancellations and restrictions will come our way. It is almost worse this time because we know what the future will bring, and it isn’t pretty.

So how do we deal with it in the laboratory? How do we manage our lab safety program as our staff deals with this physical and mental whiplash? Many labs already saw the fatigue workers exhibited in the past 18 months. People stopped distancing from each other, they became less diligent about hand hygiene in the department, and PPE use became a bigger compliance issue than it had been when the pandemic began.

Fortunately, this is not a new challenge for lab safety professionals. Even without a pandemic, maintaining an awareness for the importance of lab safety has been a consistent need. Those who have been in the field for years and have never had a chemical exposure or a needle stick become complacent about the hazards where they work. Formaldehyde is treated like it was water, and contaminated blood tubes are handled with no gloves. This “disease” spreads also, when new employees observe these poor safety behaviors and emulate them. A poor safety culture does not have to become a pandemic, however, there is a cure, even in times such as these.

First, determine where your lab safety culture lies on the spectrum- is it very broken, or does it just need a little boost? Make an assessment of the overall culture using surveys or by talking to lab staff and leadership directly. Review your findings with the staff so that they are clear about why you are tackling the issues. That act alone raises awareness in the department. If possible, obtain a commitment from staff to improve the overall safety culture. Find safety champions who will work with you on the on-going project. Be sure safety is being discussed daily and is placed in front of the staff. Use huddles, e-mails and safety boards to promote a positive culture.

Unsafe behaviors in the laboratory can easily have consequences that may affect others in the department. Spills and exposures are just some incidents that may occur. Messy lab areas can create trips or falls, and improper storage of chemicals or hazardous wastes can be dangerous as well. Perhaps laboratory staff don’t think enough about the dangerous consequences because there isn’t enough training about them. Perhaps they don’t think about the potential consequences to others because they haven’t been told about the possible physical, environmental, or financial consequences. Maintaining awareness of these issues is always key.

The COVID-19 pandemic and its apparent rebound has made for some very long months for employees in healthcare, and the struggles do not appear to be ending anytime soon. As safety leaders, it is important for us to do what we can to help staff build resilience against the whiplash and to reinvigorate them to continue with good safety practices. We must remind them that despite all of the changes in safety guidelines in the recent past that the basics – PPE use, using engineering controls and work practice controls- are there to help us get safely through the day so that we can still go home healthy and to be able to enjoy our lives so that we can see the end of these unusual times.

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

A COVID Reflection

Usually, I talk about some of the more administrative happenings in the laboratory world (accreditation, competency, etc.). Today, however, as there is seemingly a glimmer of light at the end of the nation’s pandemic tunnel, I thought I would reflect on what we have collectively experienced.

 Like much of the nation, it has been a difficult journey for laboratorians. It has been particularly trying for those who were asked, who were required, to rise up and meet the unprecedented challenges of the times while suffering from the same burdens of fear, uncertainty, and physical ailments as those they were serving.

Dying Alone

One year ago, my uncle died from COVID-19. He died alone and afraid in the nursing home where he never wanted to be. We visited him after being given special permission from the president of the company operating the nursing home. After being told about how unusual it was to be allowed to see him, we dressed in full PPEs and went into his room. We found him curled in a fetal position, dead and cold to the touch. It was so unfair.

I think about all of the laboratorians who had to endure similar or worst experiences: those who lost close family members and even those who themselves suffered through the disease.

Unseen Warriors

Laboratorians have always been the silent warriors in the life-long battle to defeat pain and disease. More often, nurses and doctors received public gifts of admiration and praise for their service to patients. With quiet satisfaction, laboratory technologists, technicians, and support personnel are dedicated 24 hours a day, seven days a week, to providing the information on which 70% of medical decisions are based. Information that no other group of professionals can provide.

I think about all of the effort and skill required in the mad rush to set up tents and collection sites needed across the nation. And then, too, there were the laboratories needing to scale up testing or create entirely new testing areas with new instruments and new tests kits. The chaos was magnified by constantly changing guidelines, reagent shortages, and a lack of trained personnel.

Amid all the confusion, misinformation, and anger, laboratorians were themselves experiencing disease, death, and social isolation. Yet still, they delivered the results the nation needed to understand the pandemic’s depth and breadth.

Needless Death

Now the Delta variant has taken hold just when the nation thought the disease, if not bested, had at least been brought under some semblance of control. Unfortunately, the refusal of many to get vaccinated contributes to the virus’s persistence. More will suffer, and more will die.

How many needless deaths will the nation have to experience? Will there ever be a point when everyone who can be vaccinated will be? Or, two years later, will we be mourning preventable COVID-19 deaths. Will we still have to watch our loved ones perish with a tube down their throat, or worst, alone in a room far away surrounded by cold walls and quiet indifference?

 Sigh.

Regardless of where this pandemic leads or how the nation reacts, laboratorians will continue to remain steadfast in their dedication to their profession and their patients. We have often considered ourselves the stepchild of the healthcare industry because, despite the criticality of what we do, we go unnoticed and unremarked on as long as we deliver the results our patients need. We are okay with that.

We are also tired and worn.

Conclusion

Thanks, fellow laboratorian, for reading this minor soliloquy of frustration and sadness. I will probably be back next quarter discussing inspections, competency, or some other administrative aspect of laboratory operations. I hope, also, to discuss how the nation has reached or is close to reaching the theoretical goal of herd immunity because of high vaccination levels. However, if I were honest, I know the likelihood of this happening is disappointingly low.

If you can get vaccinated, please do.

-Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), has been an ASCP Medical Technologist for over 30 years and has been performing CAP inspections for 15+ years. Dr. Elzie provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara Healthcare system.

The Red Queen’s Gambit: Helping the Lab Avoid Burnout

In Lewis Carroll’s book Through the Looking Glass, Alice is being given a tour of Looking-Glass Land by the Red Queen when this happens:

Alice never could quite make out, in thinking it over afterwards, how it was that they began: all she remembers is, that they were running hand in hand, and the Queen went so fast that it was all she could do to keep up with her: and still the Queen kept crying “Faster! Faster!” but Alice felt she could not go faster, though she had not breath left to say so.

However, after running until Alice feels absolutely exhausted she looks around in surprise to find that they are exactly in the same place where they had begun.

Carroll, Lewis (1991) [1871]. “2: The Garden of Live Flowers”. Through the Looking-Glass (The Millennium Fulcrum Edition 1.7 ed.). Project Gutenberg.

“Well, in our country,” said Alice, still panting a little, “you’d generally get to somewhere else—if you ran very fast for a long time, as we’ve been doing.”

“A slow sort of country!” said the Queen. “Now, here, you see, it takes all the running you can do, to keep in the same place. If you want to get somewhere else, you must run at least twice as fast as that!”

Laboratory medicine is one of many areas of healthcare where more is constantly expected to be done with less, where the inhabitants of our looking-glass land have to run as fast as we can just to maintain the status quo. Also like many areas of medicine, our already strained workforce suddenly became victims of an unprecedented global COVID-19 pandemic stressing and stretching our capabilities. The gamble then, is expecting members of our incredible laboratory medicine community to run so fast that they ultimately burn themselves out.

From the December 2020 New York Times article on laboratory workers in the time of COVID-19 titled, “‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand“:

Morale in the labs has flagged as the country continues to shatter records for caseloads, hospitalizations and deaths. The nation’s testing experts know these statistics better than anyone: They count the numbers themselves, sample by sample. But they are also easy targets of criticism and complaint.

“There is always this undercurrent of, it’s never good enough,” said Dr. Abbott, of Deaconess Hospital in Indiana. “It’s devastating. We’re working as hard as we can.”

In April 2020, just a few weeks after COVID-19 was officially declared a global pandemic, the April issue American Journal of Clinical Pathology opened with two timely editorials, one from Dr. Jeanette Guarner discussing the three emergent coronavirus diseases of the past two decades (SARS, MERS and COVID-19) and the next by Dr. Steven H Kroft titled “Well-Being, Burnout, and the Clinical Laboratory.”

In this issue were three different articles, the results of extensive surveys conducted by the ASCP to determine the job satisfaction, well-being and burnout prevalent among 1) pathologists, 2) pathology residents and fellows, and 3) laboratory professionals. Knowing now what clinical laboratories, leaders and trainees were about to go through thanks to COVID-19, made these publications about the stress and satisfaction felt by those in lab medicine was timely (if not grimly ironic).

What is shown in those excellent publications, and what we can only assume has become more true, is “burnout,” (the “combination of emotional exhaustion, depersonalization, and loss of sense of personal accomplishment”) prevalent in laboratory medicine, with the majority of pathologists, residents and fellows, and professionals reporting having experienced it if not experiencing it as an ongoing problem.

There is no single solution to burnout in the laboratory. As Dr. Kroft outlines in his editorial, these surveys can be seen as initial steps to understanding the problem and plotting potential courses forward (“a roadmap for what workplace landmines to try to avoid.”). But several meaningful pieces of data emerged from these surveys as well: Overwhelmingly, pathologists and lab professionals enjoy their work (91% and 86%) and feel valued by their colleagues (79% and 71%). Also telling is the fact that while well over 90% of laboratory professionals reported “a little bit of stress” to “a lot of stress,” 2/3rds of them reported feeling either “somewhat satisfied” or “very satisfied” with their jobs. Clearly, no one knows the value of laboratory medicine better than those of us doing it. But recognition and support coming from within the laboratory space should be seen as a good first step to acknowledging these contributions.

Recognition is needed from outside lab leadership as well, and especially should be accompanied by both stress-reducing measures (filling labor gaps, adequate compensation and benefits etc.) and opportunities to feel ownership and personal investment in the contributions we make to healthcare. Healthcare leaders, professional organizations, and all of those who were vocal supporters of labs’ contributions during the worst of the pandemic, should continue to advocate on behalf of laboratory staff’s well-being.

Even as vaccines and other mitigation efforts are providing more widespread pandemic relief in the United States, it’s clear that we are now through a COVID-19 looking glass. The lab was already running as fast as it could, but to get us to where we are now, many of us started running twice as fast. Hopefully we will both continue to run and also be supported in that ongoing race to stay where we are.

-Dr. Richard Davis, PhD, D(ABMM), MLS(ASCP)CM is a clinical microbiologist and regional director of microbiology for Providence Health Care in Eastern Washington. A certified medical laboratory scientist, he received his PhD studying the tropical parasite Leishmania. He transitioned back to laboratory medicine (though he still loves parasites!), and completed a clinical microbiology fellowship at the University of Utah/ARUP Laboratories in Utah before accepting his current position. He is a 2020 ASCP 40 Under Forty Honoree.

TRANSforming Healthcare: The Role of The Laboratory

In 2006, an international group of human rights experts assembled in Yogyakarta, Indonesia to address patterns of discrimination and abuse of individuals related to sexual orientation and gender identity. This document, The Yogyakarta Principles: Principles on the application of

international human rights law in relation to sexual orientation and gender identity, has been widely accepted as setting the standards for fundamental human rights for all, with specific attention to sexual orientation and gender identify. It is worth studying, as it articulates rights in many domains of everyday life. Of direct relevance to our Profession are Principle #12, The Right to Work; Principle number #17, The Right to the Highest Attainable Standard of Health; and Principle #18, Protection from Medical Abuses.1  It is the goal to “Adopt the policies, and programmes of education and training, necessary to enable persons working in the healthcare sector to deliver the highest attainable standard of healthcare to all persons, with full respect for each person’s sexual orientation and gender identity.”

Because the medical laboratory provides critical data for patient management, laboratory professionals and pathologists must be able to evaluate laboratory and biopsy results wisely and appropriately.  Yet we often lack fundamental and essential information necessary to support optimal and personalized care for patients on cross-sex hormones.

The number of individuals who self-identify as transgender has risen significantly in the past decade. Transgender people face discrimination, harassment, abuse, and denial of legal rights. They often feel unsafe, and a high proportion face bullying at school or at work. The Centers for Disease Control (CDC) estimates that about 2% of high school students in the U.S. identify as transgender; among them, 35% attempt suicide. Transgender adults are twice as likely of being homeless, four times more likely to live in poverty, four times as likely as being HIV-infected, and twice as likely to be unemployed compared to the general population.2 Individuals without access to appropriate care may purchase hormones from unreliable sources, so that the dose, drug contents, and potential side-effects are poorly controlled or even toxic.

Healthcare systems often fail the transgender community. First, given the high rate of poverty, unemployment, and homelessness, access to basic health services is not available for many individuals. Second, even in those healthcare institutions that serve the uninsured, appropriate services are often lacking, including the absence of knowledgeable providers and the lack of cultural competency in the institution. The few academic hospitals with services and clinics oriented to serving transgender patients struggle to provide optimal care, because there are important gaps in knowledge regarding how best to care for transgender patients. Many health care clinics and professionals lack training in asking all patients “What pronouns do you prefer to use in referring to yourself?” This is a straightforward way to acknowledge gender diversity and sets the first stage of a potentially trusting relationship.


Examples abound regarding information gaps in managing patients on cross-sex hormones. For instance, there are only a handful of papers in the literature addressing care of elderly patients, and little is known about the risks or health benefits of long-term cross-sex hormone use. For children who elect to start puberty blockers so that their development in adolescence is more appropriate to their self-identified gender, long-term effects on bone health are poorly understood. A number of laboratory tests have different reference ranges for “men” and “women,” such as n-telopeptide as a marker of bone turnover. Most labs have not established appropriate reference ranges for patients on cross-sex hormones, nor are there good long-term studies to help guide management of bone health in this setting. And there may be times when the managing health care professionals do not realize that a patient is taking cross-sex hormones.

Patient identifiers are often incomplete. Many patients on cross-sex hormones have not had surgery to remove their gonads. Therefore, a trans-man can present to the Emergency Room with severe abdominal pain, but those managing his care may not suspect ovarian torsion, ectopic pregnancy, or other conditions of the fallopian tubes, ovaries, uterus, and cervix. Similarly, trans-women may have testes and prostates. Most patient registration systems lack the ability to record sex chromosomes and gender identity separately. Also, many individuals identify as non-binary; some are not taking cross-sex hormones at all. These factors affecting presentation are currently captured poorly. If at all, in the medical record but may have profound implications for care. Otherwise, implicit biases can adversely affect patient care.

Finally, we all have work to do to ensure that our patients and colleagues feel welcomed and respected in our labs, training programs, and hospitals. One important step is for each of us to gain self-awareness of our attitudes and biases, and to educate ourselves. A good starting place is Gupta’s article in Lab Medicine;3 another is the book Trans Bodies, Trans Selves by psychologist Laura Erickson-Schroth.4 Second, we must continue to foster inclusive workplaces, to stand up when we witness abuses or so-called “microagressions.” Third, we must work directly with patients to hear their concerns, and to provide the information needed regarding our lab results and pathology reports. We must respond to the gaps identified by our patients, do the research necessary to get better answers, and partner with other health care professionals to address the needs of our patients.

References

  1. The Yogyakarta Principles. 2017. https://yogyakartaprinciples.org/
  2. Meerwijk EL, Sevelius J. Transgender population size in the United States- a Meta-Regression of Population-Based Probability Samples. Am J Public Health 2017; 107(2):e1-e8. PMID 28075632
  3. Gupta S, Imborek KL, Kraswoski MD. Challenges in transgender healthcare: the pathology perspective. Lab Medicine 2016;47:3;180–188.
  4. Erickson-Schroth L. Trans Bodies, Trans Selves: A Resource for the Transgender Community. 2014, Oxford University Press.

-Dr. Upton is board certified in Anatomic Pathology and Cytology and directed an autopsy service and forensic pathology fellowship program at Beth Israel Deaconess Medical Center in Boston, Massachusetts. She has also practiced cytopathology and general surgical pathology, and has focused on genitourinary pathology, head and neck pathology, and gastroenterology (GI) and liver pathology. From 1982-85 and 1987-2002, Dr. Upton lived in Boston and taught at Tufts, Boston, and Harvard Universities. Since 2002, she has been at the University of Washington in Seattle, where she formerly directed the GI and Hepatic Pathology Service the Pathology Residency Program and the UW GI and Hepatic Pathology Fellowship. Currently Emeritus Professor of Pathology, she continues to practice Surgical Pathology, Autopsy Pathology, and Cytopathology, and she is one of the specialists at UW in the areas of GI, liver, and pancreatic pathology.

AIDS/HIV, the LGBTQ Community, and PRIDE Month: A Reflection

This reflection is dedicated with gratitude to the many LGBTQ activists who courageously engaged with politicians, scientists, and health leaders to advance the care of patients worldwide.

Forty years ago this month, near the end of my second year in Pathology Residency, Morbidity and Mortality Weekly Report reported a small case series in its June 5, 1981 issue describing Pneumocystis pneumonia in 5 homosexual men. Soon there were additional reports of gay men affected by P. carinii (now renamed P. jiroveci) pneumonia, Kaposi sarcoma, and other unusual opportunistic infections. These riveting descriptions signaled a new disease entity, soon known as Acquired Immunodeficiency Syndrome (AIDS). Initially some labeled AIDS “the gay disease” or “the gay cancer,” and the fear and stigma associated with AIDS led to discrimination, including evictions from housing, threats of evictions of clinics that served AIDS patients, and fear among some people of even casual contact with people affected by the disease.

At that time, I was training in a tight-knit cohort of residents who studied and socialized together. In those days we performed autopsies in street clothes, with only plastic aprons and gloves as “protective gear”- no masks, no face shields or goggles, no scrub suits. Within a few months of the MMR report, after AIDS fatalities in our training hospital, many of us went to the Autopsy room to observe the unusual findings at our gross organ review rounds, which were same-day examinations of fresh tissue. The next year, in the summer of 1982, I was married in a small ceremony that included only family and a few of my parents’ closest friends. Several years later two men who attended my wedding died of AIDS, and two of my fellow residents, and their partners, also died of AIDS.

By December, 1982, AIDS had been reported in a baby who had received multiple blood transfusions, and in January, 1983, AIDS was documented in women who had been sexual partners of men with AIDS and in people injecting drugs. These reports dispelled the idea that AIDS was unique to the gay community and suggested that the disease was likely due to an infectious agent that could be transmitted through blood, blood products, and sexual contact. Then in my Fellowship, still performing many autopsies, I was amazed at the dramatic change in protocols that appeared nearly overnight, as we were now required to use personal protective equipment for any work involving blood and fresh tissues. We gowned, double-gloved, wore masks and face shields, scrubs, and shoe covers when performing autopsies; and we were trained more diligently in managing needles and scalpel blades, as well as safety in procedures.

Pathologists and laboratory professionals soon learned to identify opportunistic infections that previously had been extremely rare outside the setting of severe immunosuppression. Multiple concurrent opportunistic infections were so common that it became second nature to scan any microscopic tissue section for cytomegalovirus, toxoplasmosis, fungal infection, atypical Mycobacteria, Kaposi sarcoma, and other findings. I learned from firsthand experience that there may not always be a single unifying diagnosis, in the sense that an immunocompromised patient may suffer with multiple infectious agents. By 1987, as a young attending pathologist on weekend call, I had to learn to perform by hand special rapid Gomori methenamine silver stains on any cases that required them. (As case numbers increased, the service began to employ histotechnologists to cover the weekends.)

Discovery of the causative infectious agent, Human Immunodeficiency Virus (HIV), by groups led by Montagnier (1983) and by Gallo (1984), was a critical step for the development of an accurate serologic test (1985) to detect pre-symptomatic disease. Publication of the retroviral sequence later facilitated the development of treatments, such as AZT, which was approved in 1987, and later to Highly Active Antiretroviral Therapy (HAART) in 1997. The development of effective antiretroviral therapies along with accurate and sensitive laboratory tests for HIV offered the opportunity to test and treat asymptomatic people before they developed severe immunosuppression and opportunistic infections.  

This abbreviated summary greatly understates the devastating toll that the pandemic has wreaked and continues to wreak. Millions of young and middle-aged people across the globe, of all nationalities, in all communities, have died. Many children were orphaned. Those of my generation continue to mourn the losses of the people we loved and wonder in grief at the creativity and potential contributions also lost to our society and culture.

And, sadly, HIV rages on. Intravenous drug users and men who have sex with men continue to face discrimination and abuse in many countries. Access to preventive therapy and lifesaving (but not yet curative) antiretroviral treatment is still denied or unavailable to many patients. Efforts to develop an effective vaccine have been unsuccessful to date. Work to address the global nature of this pandemic have required international cooperation and coordinated efforts, that continue to this day. The current extensive global health activities of ASCP stem greatly from the Society’s early invitation to set up HIV testing for the PEPFAR (President’s Emergency Plan for AIDS Relief) effort, which has also led to engagement in laboratory quality improvement efforts and workforce training worldwide. Finally, as we honor our LGBTQ colleagues, patients, and family members during PRIDE month, it is important to acknowledge that members of LGBTQ Community have been at the forefront of health care advocacy since the HIV pandemic first emerged. The tremendous progress in treatment, testing, and global strategies are results of their continuing energy, initially in the U.S. and now around the world to help other communities. We are all indebted to HIV/AIDS activists, such as the Gay Men’s Health Crisis and ACT UP, who have engaged politically, staged public awareness-building efforts, and challenged political and health care leaders and research scientists to address the emergency posed by the infection. Their efforts led to greatly accelerated treatment trials and effective treatments, and they have fought to have drug costs lowered to increase access. They can take great PRIDE in their lasting contributions to help patients everywhere.

-Dr. Upton is board certified in Anatomic Pathology and Cytology and directed an autopsy service and forensic pathology fellowship program at Beth Israel Deaconess Medical Center in Boston, Massachusetts. She has also practiced cytopathology and general surgical pathology, and has focused on genitourinary pathology, head and neck pathology, and gastroenterology (GI) and liver pathology. From 1982-85 and 1987-2002, Dr. Upton lived in Boston and taught at Tufts, Boston, and Harvard Universities. Since 2002, she has been at the University of Washington in Seattle, where she formerly directed the GI and Hepatic Pathology Service the Pathology Residency Program and the UW GI and Hepatic Pathology Fellowship. Currently Emeritus Professor of Pathology, she continues to practice Surgical Pathology, Autopsy Pathology, and Cytopathology, and she is one of the specialists at UW in the areas of GI, liver, and pancreatic pathology.

Keeping Abreast of the Times

Hello again everyone and welcome back! Pardon the absolutely cheesy title, but this month I’d like to share parts of a clinical case and discuss some pretty important topics in pathology practice in 2021. While last month’s brief primer on the Cures Act is a definite part of the future of medicine, there are a lot of things developing in our profession—and we should all keep up!

*** Disclaimer: Please note that if/when I share cases or clinical content, they are not current, already signed out, completed and done in compliance full patient privacy guidelines. Always. ***

So let’s dive right in. A rather young male patient was sent to us from an outside facility for mildly painful, uncomfortable bilateral breast lumps. He was noted to have bilateral gynecomastia clinically and was to be evaluated via mammogram and localized needle biopsy. An ultrasound guided core needle biopsy of the left breast was collected from a mass identified on mammography.

Figure 1. Not the typical visual presentation noted on mammography. Biopsy clip marking the location of where the core biopsies were obtained. Male patients can have histologically identical cases of breast carcinoma when compared to females and are often associated with germline mutations, high-risk BRCA1 & 2 status, and Klinefelter syndromes.

Most commonly, when evaluating gynecomastia in a male and considering the diagnostic algorithms including malignancy one worries most about ductal carcinoma: invasive, unspecified type and ductal carcinoma in situ (DCIS) pretty much round off the differential for male breast cancer. Important rule outs include clinical, hormone-related gynecomastia or otherwise relating to germ-line or chromosomal abnormalities (i.e. XXY in Klinefelter), myofibroblastoma, or unrelated distant metastases. So without too much clinical information or history—since this was an outside referral—the differential of potential considerations was pretty short therein.

The biopsy was completed shortly after mammography and was signed out as: fibroadenoma.

Wait. What?

Fibroadenomas are benign and, along with potentially malignant phyllodes tumors, come from mammary tissue, demonstrate biphasic cellular components of benign epithelium (or low-grade stroma).

Translation: to have one of these entities you need mammary tissue, specifically terminal ductal/lobular units to form the necessary architecture changes.

Simpler translation
: fibroadenomas need breast tissue to be fibroadenomas.

Okay, there definitely appears to be breast tissue here to form this entity, however, it is incredibly rare for a male patient (outside of the previously mentioned conditions) to have anatomically functional lobular units. With the other etiologies ruled out, further investigation into the patient’s history was warranted. It was discovered that this patient, although male by indication on referring paperwork, actually identified as female and was on gender affirming hormone therapy for several years. A considerably simple explanation for the confounding biopsy result.

Transgender medicine and transgender pathology considerations have been talked about more in recent years than ever before. While these patients have always existed, societal changes in the last decade alone have brought to light many disparities in medical care and practice habits overall. Here on Lablogatory, there have been between 20-30 mentions of transgender patients since 2018 with entire pieces dedicated to transgender endocrinology, clinical chemistry, etc. Specific examples have included the complicated intersection of transgender care and electronic medical records, various lab values in trans patients, and an excellent overview of laboratory medicine and trans patients by Dr. Jeff SoRelle. There he discusses approaches, literature, and—most importantly—the purposeful vocabulary of transgender medicine as an empowering and informative practice.


Image 2. A 2016 paper in Laboratory Medicine highlights this patient population’s challenges to quality and equity in healthcare and establishes that gatekeepers to data—including us—should consider new ways to create inclusive laboratory medicine practices to maintain our high standard of care. Read it here.

While, this case was rather straightforward after the discovery of the patient’s history of gender affirming therapy, there are still several critical points to highlight here. First, it’s critically important in the setting of medical care to correctly and compassionately include gender identity in patient records—within the caveat of appropriate confidentiality and patient autonomy. Patient care, health management, and diagnostic efforts like ours may rely on a simple biological indication of how this patient presents and experiences their identity with relation to their clinical course. This further strengthens relationships between trans patients and their primary care providers, as well as non-patient-facing specialists like us who often put pieces of the puzzle together without an entire history at our disposal. How does this impact patient care? Simple: a trans male patient may always carry a residual indolent risk of breast cancer, while a trans female patient may need to be included in future mammogram screening. The bottom line should consider treating who you have, and screening with what you have to. Since this patient was sent because of breast lumps, as a male patient a biopsy report of “fibroadenoma” would be exceedingly rare and confounding because of normal physiology outside of specific genetic conditions. But with the right information at the right time, better patient-centered care is possible.

Finally, as a note about proper terminology, vocabulary, and available guidelines in the literature, there is both a paucity of effective transgender medical guidelines as well as a poor grasp on the terminology. Dr. SoRelle does a fantastic job with a short vocabulary outline, but we should all do better. The experiences of our trans patients is challenging to say the least, so as we continue to become stronger and closer advocates for patients in pathology and laboratory medicine, we must become familiar with their experience and advocate for the progress of inclusive medical care.

Trans patients are special, and we are specialists.

Making sure they received the highest level of care alongside all our other patients should be guaranteed. Whether in our clinical chemistry labs or surgical pathology sign outs, we already know how to create an environment of accuracy and enduring inclusion for all our patients—let’s keep it going!

Thank you for reading, I’ll see you next time!

Constantine E. Kanakis MD, MSc, MLS(ASCP)CM is a first-year resident physician in the Pathology and Laboratory Medicine Department at Loyola University Medical Center in Chicago with interests in hematopathology, transfusion medicine, bioethics, public health, and graphic medicine. He is a certified CAP inspector, holds an ASCP LMU certificate, and xxx. He was named on the 2017 ASCP Forty Under 40 list, The Pathologist magazine’s 2020 Power List and serves on ASCP’s Commission for Continuing Professional Development, Social Media Committee, and Patient Champions Advisory Board. He was featured in several online forums during the peak of the COVID pandemic discussing laboratory-related testing considerations, delivered a TEDx talk called “Unrecognizable Medicine,” and sits on the Auxiliary Board of the American Red Cross in Illinois. Dr. Kanakis is active on social media; follow him at @CEKanakisMD.

Making Lemonade from Lemons: Our Laboratory Lives after COVID-19

Laboratorians struggled through 2020 but successfully navigated a difficult situation while maintaining and improving our high-quality service to our patients. By laboratorian, I mean all of us—medical, public health, research, industry, etc.—because, across all sectors, anyone working in a laboratory (our family) was pushed to the limits to do more with less, work harder with fewer people, provide results with challenging procedure standard, and save lives while risking our own. It is quite easy to go into a clinical laboratory that is providing COVID-19 testing and find heroes that were there before, excelled during this pandemic, and will be there tomorrow. But there were heroes in every laboratory. Our public health laboratorians spent tireless hours trying to provide testing, coordinate testing, disseminate information, and relay the best current epidemiology to leadership to keep the country running. Our research laboratorians developed and delivered data, new information, novel biology, and potential interventions for the novel coronavirus. Our industry laboratorians were crucial components to vaccine development and delivery. And, unlike most of the country, our laboratorians were not able to “work from home” because, well, there are laws against having certain things in your house that might escape and kill your neighbors. It is good to be essential, but it has it pain points. Our laboratorians have felt that pain by still commuting to their benches to get the work done every day. But they did it and did it well! And what is often forgotten is that every single one of these laboratorians already had a “day job” in delivering a full catalog of laboratory-based services to which they added a successful COVID-19 response. If you see a laboratorian after you read this blog, you should want to hug them and say thank you.

Vaccination is spreading and will overtake and conquer this virus in parallel with our continued social distancing, hand washing, and mask wearing. In the background, testing will continue and will drive how our leaders make decisions more than anything else. We can see an end to this bedlam and are now facing, perhaps, one of the most difficult questions we have ever faced as a global laboratory community: “What do we do now?”

Our pathologists, long awaiting the day when digital telepathology was the norm, were thrust headfirst into that practice during the pandemic under emergency conditions. Many of them had already started (sometimes in a big way) but others were pushing glass routinely. Many of us have leapfrogged to a place from which we cannot return. We need to evaluate the virtual practice of the past year to determine the error rates and see if it is comparable (or better) than our routine glass slide practice. Is eBay or LetGo going to be overwhelmed with microscopes while high resolution monitors go into backorder? We must still contend with the requirement of “presence” and the moniker of “CLIA”, which was temporarily separated from a pathologist’s role in care during the pandemic. These new digital practices may address our long-standing workforce shortages. Working from home was not a possibility but a requirement for much of the last year. Care continued and work was done. What evidence would argue that working in an office is “better” than working from home when we consider the practice of pathologists? The financial implications of cost per square foot of overhead when taking up space in an academic medical facility is more than sufficient for a CFO to argue that pathologists working from home is great. But this is assuming that the workstation, the workflow, and the outputs were optimized. Not all pathology laboratories went fully digital and there was a great deal of slide shipping/couriering. On the other side of this pandemic, much like the 6 to 10 different platforms found in a clinical lab to perform a COVID-19 test, we will find that many practices are not sustainable, can be replaced and optimized, and will require more upheaval and pivot from our pathologists. To clarify, before COVID-19, pathologists practiced basically the same anywhere in the world; namely, review of glass slides in slide folders with a connected case file. During COVID-19, a whole new set of options emerged for how we would do that routine work that were uncontrolled and ad hoc. Now on the other side, we must separate the practices that are best for patient care from those that got the work done in a crisis to find our way forward. If the optimal model is (and I am not saying that it is) digital telepathology from anywhere, we must work hard to define “anywhere” for the sake of our patient’s care and safety. Monitor or other devices standards, which have long been the bane of the telepathology community, are still not standards. CLIA is specific about what constitutes a laboratory and its four walls. Accreditation teams do not inspect people’s home offices. On the other side of this pandemic, how do we find a common, best practice in a virtual age? We must return to a state of highest possible quality for our patients without giving up the advances we made in this crisis.

I once wrote up a laboratory revision plan for a firm that had 9 hospitals. Each had its own pathology laboratory employing 1 to 3 pathologist and similar staff for grossing, histology, and admin. Each laboratory had a volume of less than 3000 samples per year (and referred complex cases to a tertiary care center out of network). Based on our revision, in formalin concentration and recycling alone, the system would save $100,000. With a centralized laboratory (easily capable of handling 30,000 samples per year) and a digital pathology strategy, the work could be done by half the number of pathologists. Most importantly, the reagent/supply savings from having one laboratory rather than 9 was astronomical. The bottom line was an increase in revenue of nearly $1,000,000 with a cost savings of more than 75%. The key element of this plan that is important here is the digital telepathology component that reduces the number of staff needed and the office space needed which, at the time of the revision proposal, was “innovative” but thought too new to be reasonable. COVID-19 has tested that one aspect of the model and found it to be more than reasonable. More importantly, laboratory management and organizational leadership has had to take a hard look at costs, cost centers, and fixed expenses in such a way that the model above now becomes not lucrative but essential to staying in operation. We are trained in the laboratory to always be working on quality improvement, but COVID-19 has pushed us to always be working on fiscal improvement as well.

As we return to our “new normal” after COVID-19, the lessons we learned from this pandemic are going to translate into mergers, acquisitions, consolidations, closings, and restructurings of all types of businesses and services with the laboratory being no exception. The concept of surge capacity, for example, for testing of a new infectious agent that has emerged, has been a trial by fire, and there are many important lessons to learn from this as well. Should our approach to the next pandemic be to divert our staff from regular laboratory operations and bring into our facilities 6 to 10 new platforms for testing? Perhaps we should consider using temporary warehouse space offsite from our existing laboratory as well as backfill or relocating staffing for this crisis management to prevent complete disruption of our workflow and our policies. This is the type of solution that can exist when contingency planning is a routine part of operations. Those many facilities that were forced to bring in extra platforms are going to be facing a different crisis as test volumes crash; namely, what to do with the equipment. The firms that produce and sell that equipment have a similar challenge of expanding their platform beyond COVID-19 testing and making it relevant and competitive for the laboratories that have their extra platforms. Although I am not sure eBay or LetGo will be full of microscopes just yet, I am sure you are going to be able to pick up some nifty analyzers for an incredibly low price very soon. Will the memorial to the half-a-million we have lost in this country to COVID-19 be the useless bodies of laboratory devices that we so desperately needed in 2020? I think we owe them a lot more than that. Let us actively rethink our strategies in the laboratory and across our healthcare system so that such memorials are never needed again.

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.