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.
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.
“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.
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.
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.
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
Gupta S, Imborek KL, Kraswoski MD. Challenges in transgender healthcare: the pathology perspective. Lab Medicine 2016;47:3;180–188.
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.
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.
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.
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.
-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.
Hello everyone and welcome back! Thank you to all those that read the previous piece on life and loss, personal growth, and—of course—vaccines. This month, let’s explore something relatively new on the horizon that has the potential to change pathology as we know it: The Cures Act.
Okay, well, new-“ish”; the Cures Act (114th Congress, H.R. 34) was signed into law on December 13, 2016…so you snooze, you lose I suppose. But don’t worry, this signed law faded into seeming obscurity and is now resurfacing because it’s being implemented and enforced based on some of the language of the bill. Along with supporting measures in research and innovation, the Cures Act has an aim at empowering patients with health record accessibility.
Image 1. Outlined here in a graphic from The Office of the National Coordinator for Health Information Technology (ONC Health IT), are the three major take-home points of how the Cures Act will affect patient access to health information. (Source: HealthIT.gov)
I will state this plainly. This means that, soon, whether folks like it or not, patients will directly be able to access their medical record en toto without an intermediary office or provider. Pathology reports and other diagnostic materials are not exempt from this. Within the next few months, more hospital systems will implement direct access and release protocols for patients who will now be able to directly read their pathology reports without their primary care physician or specialist’s filter.
Some of you reading are rejoicing and thrilled. Others may be projecting harsh words this way if I’m the first time you’ve seen this. To the former group: If you were a part of the last ASCP Annual Meeting, I was fortunate to be a part of a panel with Dr. Jeffrey Meyers discussing the role “Patient-Facing-Pathology” where he talked about practical applications of involving patients in our work. I discussed concepts like “Pathology Explanation Clinics” and other reimbursable potential encounters we in pathology might soon be involved in. The idea of bringing pathology out of the basement, out from behind the curtain, and in the forefront of the patient healthcare experience has become a large part of our professional discourse for the past few decades—and the Cures Act is an exciting potential catalyst.
Image 2. Excuse the stock-photo watermark, but if you’re expecting encounters like these. Well…you’re half right. (Source Cartoonstock.com)
To the latter group: don’t panic. It’s going to be fine. You’re (probably) not going to get a 03:00 am call from an anxious patient expressing confused consternation over your frozen section report of “low grade oncocytic malignancy” or “defer to permanent…” Well, at least for now. Most programs are implementing a sort of “proofreading delay” before reports are actually released, with enough time to compile addendum reports and amended notes, etc. Even still, the notion that we may be implicated in a tsunami of impending requisite patient demands is indeed daunting.
I’ve spoken to several colleagues inside and outside my department who can’t seem to come to a consensus (very specific joke there) about the nature of how the Cures Act will change our work. Dr. Imran Uraizee, a surgical pathology fellow with me here at Loyola who’s written on here before, shared much of the same sentiment. The double edged sword. The initial hesitation. The problematic “translatability” and readability of our material. The potential benefits… It led to a great discussion, and ultimately, with comparisons to HIPAA rollouts and other large-scale changes in our healthcare delivery, we agreed that there are going to be growing pains. But growing is good right?
And you’re right! Why should we have to add more responsibilities onto our overcrowded plates? We’ve all just accepted the reality of advancing technologies time and time again, adding infinite immunohistochemical capabilities to our testing/send out menus, incorporating as much molecular testing as our department funds can accommodate, and (some of you) painfully tolerating the advent of digital microscopy and—if I may—artificial intelligent software tools. That’s already so much that has changed our landscape. While we figure out ways to get out of the basement so we can finally have windows, why should we change the way we file and release our reports? Or should we? Will we be directly answering the phone calls of exceptionally-involved-in-their-care patients without some kind or reimbursable encounter? Will residents? Think of our administrative support and ancillary staff—we may not have enough phones. When you add more, you expect some burden to shift. This will undoubtedly tax someone’s productivity; we just haven’t figured out who, what, where, or how yet.
But let’s go back to the positives… This is, in fact, a double-edged sword. And while, on the one hand, we might worry over the implications of diving in too deep, this really has potential to advance our profession in such a positive way. First of all, patients’ direct access to pathology reports may do us all a favor an slowly increase the medical literacy challenges we face today. Let’s be honest, pathology reports are not user-friendly and, as much as we may like to admit that our autopsy reports are written so that decedents’ families may find solace or comfort, we’re not writing for them directly. Behind our medico-legalese, our coded clinical content, and high-expert level commentary that far supersedes the standard 7th grade reading level, are decades of evolution in a field of medicine that has catered to fellow clinicians over patients. We write for heralded concepts in high-reliability and high output departments that demand precision, accuracy, and volume. To some, this may have contributed to some of the medical mistrust we face in this country and with increased transparency and open doors, we may even reduce the litigious nature of the patient-physician dynamic. And hey! If we can actually charge for these encounters like our clinical compatriots—which we have the potential too, by the way—then why not? The average CPT reimbursement in 2018 was $75 for a 15 minute encounter. Let’s say a full day of meeting patients includes four of these consults per hour. That’s about $300 per hour, $2,400 per full work day; with a faculty of about 20-30, just a handful doing consults for a day would be nearly $10,000. I can do more math. So could you. But hey we just bought new state-of-the-art IHC stainers and a boatload of shiny clinical analyzers with matching middleware support. Let’s not look a gift horse in the mouth? Wishful budgets aside, I don’t have any definitive answers for you—I know, I usually do, I’m sorry. But if the last two years have taught me anything, it’s that we can’t know what we don’t know unless we figure out what we do know.
We know we’ve been wanting to get out from the “paraffin curtain” for quite some time.
We know we’ve wanted to play a larger part in clinical patient care for decades.
We know we’ve got excellent professionals and experts in every nook and cranny this blog finds readers.
Well… careful what you wish for.
Is the Cures Act a cure all? Probably not. But maybe this is a chance for us to have some positive growth within our profession and an opportunity to connect with patients and simply make healthcare at-large better.
What do you think? Contact me on social media, leave a comment below, or share this piece with your colleagues to spark some conversations in your department.
Thanks for reading, 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.
A 38 year old female with history of endometriosis presented to emergency department complaining of heavy vaginal bleeding for 2 weeks duration. She also reported recent diarrhea, abdominal pain, nausea, fatigue, shortness of breath, fever, and chills. On physical exam, the patient had fever, tachycardia, tachypnea, and abdominal distention with a large, 32-week size uterine mass. She was found to have microcytic anemia (Hgb 9.2 g/dL, MCV 77.1 pg), diabetic ketoacidosis (glucose 522 mg/dL, ketones and glucose in urine, A1c 9.1%), and based on the above vital signs and leukocytosis (WBC 31.75/L)met sepsis criteria.
Abdominal CT revealed multiple uterine leiomyomas (fibroids), with the largest measuring up to 13.2 cm and demonstrating characteristics concerning for pyomyoma (abscess arising in leiomyoma). The patient underwent exploratory laparotomy and myomectomy. Gross images of the resected uterine mass demonstrated a circumscribed whorled nodular lesion with patchy necrosis (Image 1). Histologic examination of the resected lesion demonstrated a bland smooth muscle tumor, devoid of cytologic atypia and mitotic activity, with area of abscess formation showing necrosis and abundant neutrophils leading to a diagnosis of “Leiomyoma with severe acute inflammation, areas of necrosis and abscess formation, consistent with pyomyoma (14 cm)” (Image 2). A tissue Gram stain demonstrates multiple morphotypes of bacteria (image 3). Blood cultures, drawn on admission, flagged positive and the Gram stain revealed gram negative rods and blood, chocolate and Maconkey agars grew creamy gray non-hemolytic colonies that did not ferment lactose. MALDI-TOF mass spectrometry was performed and identified the isolate as Salmonella species. A triple sugar iron agar slant was set up to confirm the phenotype of a non-typhoidal serovar of Salmonella. Growth of the organism demonstrated abundant hydrogen sulfide production, an acidic butt, and an alkaline slant, confirming the nontyphoidal phenotype.
Image 1. Gross image of the resected leiomyoma (fibroid). Formalin fixed, serially sectioned, encapsulated smooth muscle mass with patchy areas of abscess formation and necrosis. Mass measures 14 cm in greatest dimension.Image 2. Histopathologic micrograph of hematoxylin and eosin stained leiomyoma (10x objective). A) shows spindle-shaped smooth muscle cells with admixed neutrophils. Central area of necrosis with abscess formation. B) shows edematous and necrotic smooth muscle with intermixed acute inflammation.Image 3. Tissue Gram stain showing multiple morphotypes of bacilli with poorly staining gram characteristics (40x objective).
Discussion
Pyomyoma, also referred to as suppurative leiomyoma, is an exceedingly rare complication of uterine leiomyoma, which involves infarction of the benign tumor followed by introduction and growth of bacteria.1 Microbes can be introduced by way of ascending genitourinary infection, spread from adjacent structures, or hematogenous or lymphatic spread.2 These infections may be polymicrobial or caused by a single microorganism, and the reported causative agents vary widely, with the most common being Escherichia coli, Staphylococcus species, streptococcal species, enterococcal species, Bacterioides species, Clostridium perfringens, and Candida.3 However, there have been no reported cases of Salmonella species isolated from pyomyoma to date.
Salmonella is a gram negative bacillus belonging to the Enterobacteriacae family.4,5Salmonella enterica, the species responsible for causing disease in humans, is sub-divided into numerous serovars, which can be broadly grouped into typhoid and nontyphoid.4,5 While the typhoid serovars cause enteric fever, the nontyphoid serovars can cause gastroenteritis and bacteremia.5 Most nontyphoid Salmonella infections are foodborne, and approximately 5% of nontyphoid Salmonella infections progress to bacteremia.4 The bacteria gain access to the bloodstream by utilizing multiple virulence factors to invade the epithelial cells of the gut.4Salmonella can be identified in the laboratory from blood culture based on several characteristic biochemical results, including Gram stain, absence of lactose fermentation, motility, hydrogen sulfide and gas production, utilization of citrate, and decarboxylation of lysine and ornithine.
This case presents Salmonella species as the cause of sepsis in the setting of pyomyoma, a very rare entity. It is postulated that gastroenteritis caused by nontyphoid Salmonella may have been the cause of the patient’s recent diarrhea, and uncontrolled blood glucose levels in the setting of diabetes may have contributed to the progression to sepsis. We could hypothesize whether the Salmonella seeded the fibroid precipitating the abscess formation since Salmonella is known to cause abscess formation in unusual sites including having a proclivity for vascular sites (e.g., aortitis). The patient unfortunately experienced complications from her sepsis with concomitant surgery. She became unresponsive despite numerous attempts at resuscitation and died.
References
Azimi-Ghomi O and Gradon J. Pyomyoma: Case Report and Comprehensive Literature Review of 75 Cases Since 1945. 2017. SM Journal of Case Reports. 3(4):1054.
Obele, CC, et al. A Case of Pyomyoma following Uterine Fibroid Embolization and a Review of the Literature. 2016. Case Reports in Obstetrics and Gynecology. 2016:9835412.
Iwahashi N, et al. Large Uterine Pyomyoma in a Perimenopausal Female: A Case Report and Review of 50 Reported Cases in the Literature. 2016. Molecular and Clinical Oncology. 5(5):527-531.
Eng SK, et al. Salmonella: A Review on Pathogenesis, Epidemiology, and Antibiotic Resistance. 2014. Frontiers in Life Science. 8(3):284-293.
Coburn B, et al. Salmonella, the Host and Disease: A Brief Review. 2006. Immunology & Cell Biology. 85(2):112-118.
-Heather Jones is a first year AP/CP resident at UT Southwestern.
-Katja Gwin is an Assistant Professor at UT Southwestern in the Department of Pathology and specializes in gynecologic pathology.
-Dominick Cavuoti is a Professor at UT Southwestern in the Department of Pathology and specializes in cytopathology, infectious disease pathology and medical microbiology.
-Clare McCormick-Baw, MD, PhD is an Assistant Professor of Clinical Microbiology at UT Southwestern in Dallas, Texas. She has a passion for teaching about laboratory medicine in general and the best uses of the microbiology lab in particular.
In this last part of our four-part series on pathology value chain, where we are using the patient’s best outcome as the maximized value, we examine two areas: Marketing/Sales and Service. The former has inherent challenges, some of which were mentioned in the last blog on outbound logistics. The latter is becoming an increasingly important component of oncology care for which many pathology labs are grasping for solutions.
In traditional business budgeting, the first step is for the marketing and sales department of a firm to provide a projection of revenue for a given period based on their knowledge of trends, markets, prior years, competition, competitive advantage, etc. These projections are then paired with costing exercises to shoot for a margin of profit. If we are going to sell $1,000,000 in widgets and it costs us $750,000 in total to make those widgets available to our customers (including costs of goods sold, administrative expense, taxes, and interest), we would have a $250,000 profit to use as retained equity or to distribute to our shareholders. When we look at pathology services for cancer, a new laboratory with no prior history may find this process extremely challenging without an enormous amount of data. An existing laboratory with many years of work may have a much easier time and, short of drastic changes in supply prices, inflation, and taxes, could likely use a simple percentage growth approach for this calculation.
But unlike widgets or iPhones or Quarter Pounders or golf clubs, no one wants to have a tissue biopsy and certainly no one wants to have suspected cancer. If we turn to epidemiological data, we can predict (and do so below) the expected number of patients in a given population to likely have cancer in the coming year (although this is clearly not the only data point we need). For a new laboratory in a place where there are no other laboratories (e.g., a small low- to middle-income country with a new Ministry of Health mandate to fight cancer), such an estimate is important for determining both if we should even have a lab (or use a regional approach) and, if we do have a lab, what our maximum volume would be assuming 100% access. The former part has been addressed previously such that there is a threshold below which is difficult to justify a lab because of the cost per sample. The latter part, however, is crucial because a “marketing campaign” (i.e., patient education and clinician education about cancer, how to diagnosis it, and how labs are part of this process) is the only way to have any volume in this laboratory.
We would except it to start slow and build but we have a finite endpoint for cancer cases in mind. But note, importantly, that the marketing campaign described has nothing to do with the pathology laboratory itself. In an existing, highly-developed market (e.g., Boston, London, Montreal, Sydney), there is a population that we can assume represents our cancer risk pool but there are also many competing laboratories (and health systems), transient use of services (e.g., Ms. Smith from Iowa decides to go to Boston for cancer care), and levels of care (i.e., low-stage cancer care in a community setting versus later-stage cancer with comorbidities in a tertiary care setting). None of these things can a given pathology laboratory control if they are in that market, but must they use all of this information to understand the projected revenue and create their budget? Or can they just assume a percentage increase? From the patient perspective, all of this is irrelevant because patients most commonly do not choose the pathology laboratory that is going to see their biopsy as it is a function of the health system to which they subscribe for their care. In that context, marketing and sales for cancer diagnostic services is largely a negotiation between laboratories and clients (e.g., clinicians, hospitals, health plans) which is often contractual. Such contracts are difficult to negotiate, take a long time, and usually last for an extended period like 1 year or longer. This very concept is contrary to the activities of the marketing and sales department which must constantly pivot, update, and change their strategy to achieve their projected revenue. It is worth noting that in many poorly developed cancer systems, patients do directly take their samples to pathology laboratories of their choice and examples of systems with kick backs to shift these samples away from government laboratories toward private practice facilities (at a much higher cost to patients) are well documented.
In the Value Chain model, service is the after-market activities of a firm to maintain their product(s) for a customer, create customer loyalty and resales, and enhance their competitive advantage through maximized firm-customer relationships. The popularity of subscription services (e.g., Amazon Prime, Netflix, Massage Envy, car leasing) stems from the increased opportunity to interact with customers continuously in low-cost ways that enhance the customer’s experience with the firm. Although a service like rending a definitive pathological diagnosis may appear to be a one-time event, recent evolution in the practice of oncology and increasing research needs have created unique servicing opportunities for pathology laboratories. The emergence of biomarkers that dictate treatment unrelated to the diagnostic process has created gaps in quality due to inefficient systems, entry cost barriers, volume challenges, and intellectual disconnect from the traditional diagnostic process. However, streamlining the biomarker process, for example, can create a competitive advantage for a laboratory and improve client loyalty and rapport.
Marketing and Sales
This activity focuses on “strategies to enhance visibility and target appropriate customers.” This activity in diagnostic anatomic pathology specifically for cancer speaks to the first part of the value chain for the patient; namely, the timely presentation of a patient to the clinical system for evaluation of cancer at the earliest possible time. As such, whether a patient presents incredibly early or very late makes no difference to the pathology laboratory because the customer choosing the pathology service is either an independent clinician or a health system. Private practice pathologists may advertise or market to community hospitals or hospital systems in hopes of capturing their volume (and revenue). Marketing for second opinion review by a pathologist can also occur and may be directly to patients. This activity is challenged from the beginning, however, due to the small market. For every 1,000,000 patients in the United States, there are about 5500 cancers per year. Assuming the accuracy of a clinical decision to obtain a biopsy is around 50% (i.e., the “malignancy rate” – when a clinician decides a biopsy is needed for suspected tumor, 50% of the time it is cancer and 50% of the time it is not), that’s 11,000 suspected cancer biopsies per million per year. Extrapolating to the US population, we get 3.6 million biopsies per year. Given that there are ~10,000 anatomic pathologists, that equates to, on average, 361 biopsies per year per pathologist (or, roughly 1 per day). Since most pathologists could easily sign out 20 cases every other day working Monday – Friday with 4 weeks of vacation annually, that’s a ratio of 1:8 (average:capacity).
The point of all of this math is that the volume of pathology work in the US that is for cancer is small relative to the total biopsies performed (or capable of being performed) by the pathology community and, thus, the market for cancer diagnostic services appears saturated. We can adjust the dial of this to take the malignancy rate to 5% (i.e., massive over biopsy setting), and find that pathology would be overwhelmed at 130% capacity just for suspected cancers; however, as we move back towards 50% malignancy rate, the average capacity is around 25% for volume. If we move on the other side of 50% towards lower biopsy rates or “improved clinical acumen,” capacity quickly drops to below 9% with a great excess of pathologists. With the promise of artificial intelligence to assist pathologists in faster sign out of higher volumes, the capacity for cancer diagnosis increases possibly 10-fold. But if you ask your average pathologist if they are busy, they report that they are. This is because the pathology laboratory, as all laboratorians are aware, processes more than just suspected cancer biopsies. Medical kidney, medical dermatology, screening colonoscopy, colposcopy, breast core needles, melanotic and non-melanotic skin lesions create a huge portion of the volume that is not part of the specific calculation above that adds many millions more samples per year to the pathology revenue stream. One framing of this case pool is that cancer biopsies, because they aren’t technically elective, are cross subsidized by providing all of the other services which are equally billable. However, this large bulk of cases are still not through direct marketing to the patient but rather to providers or health systems.
As we turn this activity towards LMICs, we instantly have a problem. There is no system in most places to support routine services for medical kidney, medical dermatology, screening colonoscopy, colposcopy, breast core needles, melanotic and non-melanotic skin lesions (especially in Black patient populations for the last). Without the cross-subsidization that these billable biopsies bring in, pathology laboratories are left with the low volumes of suspected cancer cases. As mentioned above, these laboratories are often overwhelmed to begin with so the marketing and sales activity, which would theoretically increase volume, is likely not to be a priority. In these settings, however, what will increase volume and improve the quality of care for patients is large pre-analytical efforts by governments and other entities to educate the public and the general practitioner about cancer screening and diagnosis, community awareness about cancer care systems, specimen transport networks from the most rural directly to pathology laboratories, and government spending on prevention of cancer.
Service
This last set of activities are to “maintain products and enhance consumer experience.” For a diagnosis of cancer, once rendered, there are many potential touch points with both the patient and the treating clinician that can enhance the outcomes for the patient. These include maintenance of tissue in repositories for future studies, performance of future studies related to newly available treatments, access to clinical trials, and, as mentioned in the outgoing logistics, increased, and enhanced communications around the diagnosis and subsequent information. In LMICs, there is a great desire to provide such enhancements especially in settings where these activities can facilitate local research and generate much-needed local clinical trials with pharmaceutical and other industry partners. As the other steps of the value chain are improved, the continue service will come into focus and can include such activities as external quality assurance, laboratory accreditation, personnel certification, documented compliance with standards, awards, and other accolades.
To conclude, from the patient framework, the maximum value for a patient with cancer involves the earliest possible detection of the tumor and a rapid, accurate diagnostic report matched to treatment options that lead to survivorship. For a pathology laboratory, the best outcomes for patients and the best revenue model for the laboratory results from a high-volume of small samples (i.e., biopsies) reported with complete clarity. Cross subsidization of cancer diagnostic services (especially those for later staged, complex cancer patients) with other non-cancer, pathology-based reporting is crucial to create a sustainable revenue stream and ensure highest quality outcomes. Competitive advantage in pathology services specific to cancer are currently and will continued to be largely tied to the after diagnostic service and support to keep the patient on the most beneficial cancer journey.
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.
-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.
In the first two installments of this blog series, we looked at inbound logistics and operations in which we can conclude that competitive advantage may be challenging to achieve. Now we turn to outbound logistics or, in simplest terms, the pathology report.
No document can be more terrifying for a patient than a pending pathology report from a biopsy, as it may contain a benign diagnosis, a malignant diagnosis, or something entirely unexpected. These reports are so important that unsuspected (non-malignant) and malignant diagnoses are included as “critical values” requiring a call and documentation to the clinical team as soon as they are discovered. Pathology reports in HIC are often not immediately available to the patient (unlike other laboratory tests) because the reports are often complex, may contain confusing terms, and may use language that patients inappropriately react to without the guidance of their clinician for meaning in their care. For example, cytology reports may be highly informative to a clinician by simply stating, “No evidence of malignancy” but may be stressful to a patient without guidance because there is not a definitive answer to what a lesion was. Similarly, a colon resection that states, “Invasive adenocarcinoma confined to the mucosa” is good news to the clinician but the first two words (and the internet) may be disturbing for the patient. The important point here is that pathology reports are written for clinicians and not written for patients as an audience. To that end, pathology reports should be highly aligned with the clinical decision-making process, an approach which is naturally aided by standardize or synoptic reporting of cancers using guidelines such as those of the College of American Pathologists, the Royal Colleges of the UK and Australia, and/or the International Collaboration on Cancer Reporting (a consortium of CAP, RCUK, RCA, ASCP, and others). These templates for a given cancer are complex, not easily committed to memory, nuanced, and require a high degree of pathology knowledge to apply correctly from the gross to the final histology findings. Thus, the value in these templates is in use by a pathologist directly, making task-shifting in this area nearly impossible without the aid of tools such as whole slide imaging and artificial intelligence (which still require a pathologist to finalize the report). Like operations, we see that a “standard of care” or a “standardized approach” to reporting cancer reduces the variability or uniqueness that can be achieved with a pathology report, infringing on competitive advantage.
Outbound Logistics – This activity covers the distribution of the final product to the consumer. For the maximum value to the patient, a report should be organized to match the treatment plan, available immediately upon completion, and provide an unambiguous answer than can be acted on. Although the first two activities generate the most important information for the patient and do so with “standards of care”, this activity involves communicating the results to the clinical team members who will act on it and, therefore, can open opportunities for competitive advantage. A new diagnosis of cancer is considered a “critical value” and requires a communication with documentation to the clinical team. However, much of pathology’s role in cancer care includes work with existing cancer patients so rapid communication of any result (not just the first cancer diagnosis) can add value. For example, integration of the pathology laboratory information system into the electronic medical record creates immediate results to clinicians. Alert systems including text messages, instant messages, emails, faxes, etc. add value by informing the busy clinician that the result is there. Photographs of the tumor grossly, histologically, or the results of specials studies can be included in printed or digital reports. Pathologists can attend tumor boards or other in-person or virtual meetings to present the results and explain them if there are questions. The more information that is transmitted with clarity to clinicians, the higher value the patient will obtain. The challenge in this activity is that the payment for the laboratory services ends with the diagnostic report and appropriate coding and, thus, laboratories may have to upcharge for their services to add these features. These further communications, which we can see adds value to the patient, does not add value to the laboratory’s revenue model without upcharges. In fact, it likely costs more to have such active communications as it takes pathologists away from the higher volumes which do equate to higher revenue (as we saw in operations). Streamlining these types of communications with electronic systems is key in cost and time savings and is the basis for the laws and regulations, for example, in the USA which require electronic medical records including laboratories. However, as laws, regulations, and guidelines evolved, these electronic communications are becoming standard of care requiring the entire system to increase the costs to have them but eroding the competitive advantage of providing such concierge services. Consider the change COVID-19 has had on communications between patients, clinicians, and the laboratory where a multi-person discussion of a case with images and consensus opinions can be done in a few minutes over a video conference without anyone leaving their office. Has this crisis provided a new way to capture time (and therefore revenue) but still provide concierge services? Or has it (more likely) created a new normal that everyone has to adopt (eroding competitive advantage)?
When we turn to LMICs and observe the activities of the pathology laboratory, communication with clinical teams on the front or back end has been uncommon and traditionally not done. Oncological practices in HIC are filtering down to LMICs including tumor boards, frozen sections (i.e., rapid, in surgery diagnostics), etc. and being instituted with some frequency. These activities improve patient value and outcomes, educate the teams in both directions, and are clearly beneficial to the system. But they take time and effort away from already understaffed systems which detracts from the value of other patients ultimately. However, when we observe these systems, we often find that they lack electronic tools for running the laboratory internally which inhibits tools for reporting externally. Thus, the major needed solution now is that any histology laboratory anywhere in the world should be using an anatomic pathology laboratory information system as it creates internal and external tools for standardized reporting, communication, and management. Furthermore, it creates better opportunities to integrate synoptic (templated) reporting, interdisciplinary team activities, and standardization of requisitions (i.e., upon receipt of samples). Greatly increased value for patients in LMICs can be achieved with electronic APLIS.
Lastly, there are incredible examples of pathologists who make time in their day to meet with patients to discuss their pathology reports. These discussions can only focus on what the reports says and what the words in the report mean, as defined not in context of that patient. Such exchanges can provide patients with helpful questions to ask their clinicians and prepare them to better understand what the clinicians suggests as next steps for treatment. Clearly valuable to the patient, these exchanges are also valued by the pathologists who enjoy the face-to-face interactions with patients that humanize the process. In rare cases (possibly a for-profit situation), these services may generate revenue but under current medical billing rules there is no standard mechanism for the pathologist to be reimbursed. If we have identified this as adding value to the patient in the pathology value chain, should we not try to find ways to build these services into the care model financially? With the ubiquitous use of video conferencing in the COVID-19 era, can this task be of minimal effort to pathologists but still add value for patients?
In our last installment, we will discuss marketing & sales and service, both of which are particularly flawed and fascinating to consider.
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.
-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.
Lablogatory 