The Pathology Value Chain and Global Health, part 4

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

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

Hematology Case Study: CBC with >80% Blasts

The patient is a 67 year old male who first visited his dentist at the end of December complaining of pain in the jaw that he had been experiencing since early Dec. He had put off making an appointment because he didn’t want to have to go to the doctor with COVID precautions, but the pain was now radiating to his teeth, so he made a dentist appointment. The dentist found no evidence of abscess or other infection but ‘adjusted his bite’. The patient was advised to take over the counter NSAIDs as needed or pain but no prescriptions was needed. Three weeks later the patient visited an urgent care because he had no improvement of the jaw pain. At this time he relayed symptoms of cough, fever, chills, night sweats and chronic fatigue. Patient history included an active lifestyle with vigorous aerobic exercise several times a week, but the he stated that he had been feeling too fatigued to exercise for over a month. On exam the patient was found to be tachycardic with bilateral tonsillar lymphadenopathy and oropharyngeal exudate. The patient was tested for COVID, influenza and Group A Strep. The COVID-19 was negative, as was the influenza A and B, but the Group A Strep was positive. The patient was sent home with a prescription for antibiotics.

One week later, the patient called his PCP because he still had cough, fever and chills and now was experiencing shortness of breath. The office directed the patient to go to the ER but the patient was reluctant to go to the hospital and stated he would rather be seen at the office. On review of the patients chart, the PCP agreed to see him in the office because he had had a negative COVID test in the past week. Two days later the doctor examined the patient in his office and still suspected COVID-19. He ordered a PCR COVID-19 test along with CBC/differential and erythrocyte sedimentation rate (ESR). We received a routine CBC on the patient. Results are shown below.

The patient had no previous hematology or oncology history and no previous CBC received at our lab. The critical WBC was called to the physician. Based on the WBC and flags on the auto differential, a slide was made and sent to our CellaVision (CV). On opening the slide in CV, we immediately called our pathologist for a pathology review. A rare neutrophil was seen on the peripheral smear, with immature appearing monocytes, few lymphocytes and many blasts.

Image 1. Images from CellaVision.

The pathologist reviewed the slide and the sample was sent for flow cytology studies and FISH. The pathologist’s comment ”Numerous blasts (>60%) consistent with Acute Myeloid Leukemia(AML). Specimen to be submitted for flow cytometry. Hematology consult recommended” was added to the report.

Image 2. Image from CellaVision. Predominately blasts with one neutrophil seen in field of unremarkable RBCs.
Image 3. Image from CellaVision.

The myeloid/lymphoid disorders and acute leukemia analysis by flow cytometry reported myeloblasts positive for CD117,CD33, and CD13. Final interpretation was Acute Myeloid leukemia (non-M3 type).

AML is the most common form of leukemia found in adults. AML was traditionally classified into subtypes M0 through M7, based on the cell line and maturity of the cells. This was determined by how the cells looked under the microscope after a series of special staining techniques, but did not take into account prognosis. It is now known that the subtype of AML is important in helping to determine a patient’s prognosis. In 2016 World Health Organization (WHO) updated the classification system to better address prognostic factors. They divided AML into several broad groups, including AML with certain chromosomal translocations, AML related to previous cancer or cancer therapy, AML with involvement of more than one cell type, and other AML that don’t fall into the first three groups.2 Once a case has been placed in one of these broad groups, the AML can be further classified as poor risk, intermediate risk and better risk based on other test results. Better risk is associated with better response to treatments and longer survival.3 The European LeukemiaNET (ELN) first recommended integrating molecular and cytogenic data into classification to create such a risk classification system for AML in 2010 (ELN-2010). In 2017, this was again revised (ELN-2017) to further improve risk stratification. The ELN-2017 can be used to more accurately predict prognosis in newly diagnosed AML.1

What this means is that AML is now classified by abnormal cell type as well as by the cytogenetic, or chromosome, changes found in the leukemia cells. Certain chromosomal changes can be matched with the morphology of the abnormal cells. These chromosomal changes can help doctors determine the best treatment options for patients because these changes can predict how well treatment will work.

Examples of risk classification include the knowledge that some chromosome rearrangements actually offer a better prognosis. For example, a translocation between chromosomes 15 and 17 [t(15;17)] is associated with acute promyelocytic leukemia (APL or M3). APL is treated differently than other subtypes and has the best prognosis of all the AML subtypes. Other favorable chromosomal changes include [t(8;21)] and [inversion (16) or translocation t(16;16)]. Examples of intermediate risk prognosis are ones associated with normal chromosomes and [t(9;11)]. Poor prognosis is associated with findings such as deletions or extra copies of certain chromosomes or complex changes in many chromosomes.3

The patient was diagnosed with AML, non M3 type. AML prognosis is based on CBC results, markers on the leukemia cells (flow cytometry), chromosome (cytogenic) abnormalities found and gene mutations (molecular abnormalities). In this patient the FISH studies did not demonstrate any chromosome rearrangements, which alone would place him in an intermediate risk group. In addition, our patient was over age 60 and had a WBC over 100,000/mm3 which have both been linked to worse outcomes.

Here’s one more photo for your enjoyment! It’s not often that we see so many blasts in a patient with no previous history. As a side note, I was contemplating titling this blog “Fatigue and Shortness of Breath in the Time of COVID.” I can’t help but wonder if this patient would have been diagnosed 6-8 weeks earlier if this was another year and he had been seen when he first experienced symptoms. This year, emergency rooms and physicians have reported a decrease in numbers of patients being seen for chest pain, ketoacidosis, shortness of breath, strokes and other serious conditions. Many patients are reluctant or afraid of sitting in crowded waiting rooms, fearful they will catch COVID. And many doctors are only offering virtual visits or have reduced the number of patients being seen so it is harder to get appointments. This patient expressed his reluctance to seek medical help because of fears of COVID. He did not want to go out in public and waited almost a month for symptoms to go away on their own before first being seen. After going to the walk in center, he called his PCP a week later and was still averse to going to the ER as suggested by the doctor. Then he waited another 2 days for an office appointment. The doctor still suspected COVID, but fortunately for the patient, ordered a CBC. The flow cytometry and FISH studies were available the following day. The patient was referred for hematology consult but has not been seen again at our hospital.

Image 4. More images from CellaVision.

References

  1. Boddu, P.C., Kadia, T.M., Garcia‐Manero, G., Cortes, J., Alfayez, M., Borthakur, G., Konopleva, M., Jabbour, E.J., Daver, N.G., DiNardo, C.D., Naqvi, K., Yilmaz, M., Short, N.J., Pierce, S., Kantarjian, H.M. and Ravandi, F. (2019), Validation of the 2017 European LeukemiaNet classification for acute myeloid leukemia with NPM1 and FLT3‐internal tandem duplication genotypes. Cancer, 125: 1091-1100. https://doi.org/10.1002/cncr.31885
  2. Mandel, Ananya. Acute Myeloid Leukemia Classification. Medical Life Sciences. https://www.news-medical.net/health/Acute-Myeloid-Leukemia-Classification.aspx
  3. Ari VanderWalde, MD, MPH, MA, FACP; Chief Editor: Karl S Roth, MD. Genetics of Acute Myeloid Leukemia. Medscape. Updated: Dec 17, 2018 
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-Becky Socha, MS, MLS(ASCP)CMBBCM graduated from Merrimack College in N. Andover, Massachusetts with a BS in Medical Technology and completed her MS in Clinical Laboratory Sciences at the University of Massachusetts, Lowell. She has worked as a Medical Technologist for over 40 years and has taught as an adjunct faculty member at Merrimack College, UMass Lowell and Stevenson University for over 20 years.  She has worked in all areas of the clinical laboratory, but has a special interest in Hematology and Blood Banking. She currently works at Mercy Medical Center in Baltimore, Md. When she’s not busy being a mad scientist, she can be found outside riding her bicycle.

The Pathology Value Chain and Global Health, Part 3

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

  1. Porter, M. (1985). The value chain and competitive advantage, Chapter 2 in Competitive Advantage: Creating and Sustaining Superior Performance. Free Press, New York, 33-61.
  2. Histology. Wikipedia. https://en.wikipedia.org/wiki/Histology#:~:text=In%20the%2019th%20century%20histology,by%20Karl%20Meyer%20in%201819.
  3. Thorpe A et al. The healthcare diagnostics value game. KPMG International. Global Strategy Group. https://assets.kpmg/content/dam/kpmg/xx/pdf/2018/07/the-healthcare-diagnostics-value-game.pdf
  4. Digital Pathology Market CAGR, Value Chain Study, PESTEL Analysis and SWOT Study|Omnyx LLC, 3DHISTECH Ltd, Definiens AG. https://www.pharmiweb.com/press-release/2020-06-30/digital-pathology-market-cagr-value-chain-study-pestel-analysis-and-swot-study-omnyx-llc-3dhistec
  5. Friedman B. The Three Key Components of the Diagnostic Value Chain. Lab Soft News. January 2007. https://labsoftnews.typepad.com/lab_soft_news/2007/01/the_three_eleme.html
  6. XIFIN. The Evolution of Diagnostics: Climbing the Value Chain. January 2020. https://www.xifin.com/resources/blog/202001/evolution-diagnostics-climbing-value-chain
  7. Sommer R. Profiting from Diagnostic Laboratories. November 2011. Seeking alpha. https://seekingalpha.com/article/305931-profiting-from-diagnostic-laboratories#:~:text=The%20three%20year%20average%20operating,current%20operating%20margin%20of%2012.9%25.
  8. Cancer Patients Want to Pull Back the Curtain on Pathology. M Health Lab. October 10, 2019. https://labblog.uofmhealth.org/industry-dx/cancer-patients-want-to-pull-back-curtain-on-pathology
  9. Guttman EJ. Pathologists and Patients: Can we talk?. Modern Pathology. May 2003. https://www.nature.com/articles/3880797
  10. Lapedis CJ et al. The Patient-Pathologist Consultation Program: A Mixed-Methods Study of Interest and Motivations in Cancer Patients. Arch Path Lab Med. August 20, 2019. https://meridian.allenpress.com/aplm/article/144/4/490/427452/The-Patient-Pathologist-Consultation-Program-A
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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.

ASCP Releases Two Evidence-Based Recommendations for COVID-19 Testing

COVID-19 testing can be a bit confusing. Recently, ASCP released two recommendations for COVID-19 testing to help clinicians and laboratories sort through the noise and order the right test at the right time. In addition, ASCP has a plethora of COVID-19 resources, including Town Halls, podcasts, journal articles, and more.

A Trilogy of Food, Fun, and Facts: Musings of a Pathologist-in-Training

Pathology is a perfectly blended specialty filled with food, fun and a whole range of factual morphological descriptions!

As a pathology resident, one of the first things that got me intrigued by the specialty was its strong association with many food epithets. From the almond-shaped ovary,1 to the blueberry muffin baby,2 to the coffee bean nuclei in the thyroid,3 fried egg appearance of mast cells,4 grape-like lesions seen in molar pregnancy5 to the flat cake placenta6 and even to the strawberry cervix!7 The list is endless. I found these descriptions so interesting that I kept asking myself, “why do pathologists have to make associations with food for many normal and pathological disease processes we see around?”

Aside from the fun association with food (which I happen to like a lot), getting to learn and understand the pathology of disease processes, genetic and syndromic associations have been a fascinating, humbling, and altogether nerve-wracking experience for me.

It has been fascinating because I totally enjoy learning about the underlying processes that get some people sick while others stay healthy. At the same time, it has also been humbling, because, then I realize that so many disease processes are genetically determined and so out of our control. Along the same lines, the experience has also been neck-wracking, because of the detail and efficiency that goes into mastering different disease morphologies and preparing a comprehensive pathology report. The ability to tell the difference between two very similar disease entities but with different morphological features can drive one crazy, because, sometimes everything just seems to look the same!

I remember my early days as a resident. The first week in residency training to be precise. Then, I got reintroduced to the microscope, which is the power of the pathologist. Looking into the microscope and feigning to see what the senior residents and attendings were seeing felt like outright torture to me. You know why? It’s because everything under the microscope was either blue or pink.

In my few years of training as a resident, I have come to learn that in order to be successful as a pathologist, one must be adept with every single detail. As Pathologists, we deal with the facts. We do not make things up, and strive to present the facts of every case which ultimately supports our rendered diagnoses.

Unlike when I first started my residency training, I now know that not everything under the microscope is just blue and pink, and even if they are indeed blue and pink, the degree of their “blueness” or “pinkness” varies. And the intensity of the hematoxylin and eosin (H&E)/immunohistochemical stains may sometimes tell disease entities apart from one another. So, sometimes when people ask me what type of doctor I am training to be, I tell them, “I am a doctor of colors,” which of course often leaves them confused!

I also tell people that I am training to be a doctor who works from behind the scenes, to make sure they get treated right all the time. And this realization I believe is what has created the greatest impression for me. Realizing that a patient’s choice of treatment may totally be dependent on the pronouncements I make on their disease process, is something that gets me motivated to keep putting in my best into my training in order to become one of the best in my field. Therefore, even though we operate as doctors from behind the scenes, our professional judgments often go a long way in impacting the welfare and outcomes of patients whom we never get to see, which is one of the aspects of the specialty that I truly love.

So, pathology as a specialty has given me a more robust meaning to life. I have learned to value and appreciate the time I spend with those I love, and to make special moments with them count. It has made me realize that there are certain things about life such as genetic diseases, that I have no control over and therefore should only be concerned with giving my very best all the time. Pathology has also made me more detail oriented, by learning to distinguish benign from malignant processes. It has reinforced for me, the importance of being the best person I can be to both my family, neighbors and my community in general. And I would also add that pathology has further reignited my love for good food. So, let the party begin!!!

References

  1. Ignatavicius DD, Workman ML. Medical-Surgical Nursing: Patient-centered collaborative care. Elsevier Health Sciences; 2015. 1735p.
  2. Mehta V, Balachandran C, Lonikar V. Blueberry muffin baby: a pictoral differential diagnosis. Dermatol Online J. 2008;14(2):8.
  3. Oertli D, Udelsman R. Surgery of the thyroid and parathyroid Glands. Springer Science & Business Media; 2012. p. 620.
  4. Bolognia JL, Jorizzo JL, Rapini RP. Dermatology. Gulf Professional Publishing; p. 1438.
  5. Daftary. 100+Clinical Cases In Obstetrics. Elsevier India; 2006. p. 478.
  6. Power ML, Schulkin J. The Evolution of the Human Placenta. JHU Press; 2012. p. 278.
  7. Swygard H, Seña AC, Hobbs MM, Cohen MS. Trichomoniasis: clinical manifestations, diagnosis and management. Sex Transm Infect. 2004 Apr 1;80(2):91–5.

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

Patients and Patience (Part 2)

Holiday season in well behind us and, while we celebrate and coordinate getting our COVID vaccinations (side note: get yours please), I’d like to revisit a piece from a while back called “Patients and Patience.”

Then I talked about how our professionally shared spirit of camaraderie and patient advocacy go hand-in-hand with the ASCP mission. How, regardless of what role we play in patient care, we continue to give as much as we can to make the lives and hopes of patients everywhere a bit brighter. This year especially, as the pandemic continues to take over all frequencies and channels (including this blog, I’m sorry), I think it’s especially poignant to remember how life can be both grand and fragile. You’ve read my musings on how doctors can be patients too, and how we can all be stretch so thin it can affect our health. When you think the experiences of anyone in healthcare this past year you can’t help but reflect on how burnout and compassion really both know no bounds.

This month, I’m dedicating this piece to one of Loyola’s faculty who sadly and unexpectedly passed away just before the New Year, Dr. Stefan Pambuccian. In a caustic reminder of life’s grand fragility, he was an archetype of what it meant to be an accomplished and respected pathologist, physician, teacher, and friend. While he and other faculty here push all of us resident/trainees or fellows to be better, and research, publish, learn, share, and grow, people like Dr. Pambuccian set the tone with years of experience, an open door, and an uncanny ability to give you a differential diagnosis from only peeking at a slide from across the room at 1x—not a typo.

Image 1. You can barely find any posters on our walls (of which there are many) that don’t in some way bear the name or relate to the work or Dr. Pambuccian here at Loyola. His office and door continue to receive new messages of loss, praise, thanks, and sentiment. Losses like these are never easy, but no one here went through this alone.

While the residents were having a great uplifting secret santa exchange a few days after Christmas, we went around praising our anonymous gift recipients and shared some laughs amidst a new warm holiday memory. The same joy that filled our workroom vanished after everyone had heard the awful news, taking time to process and simply be with each other that afternoon and the weeks that followed. That’s exactly the message I think rings true this time around: in order to care for patients, and ourselves, our friends, and our colleagues, we should always have reserves of patience, compassion, and humanity. While there are great wellness programs, and tips and tricks to avoid burnout, that’s for other blogs; sometimes what one really needs is other people. Peers. Friends. Family. I’m relatively new here in this program, but what I could see that day was an immediate working shift from signing out cases to taking the time to make sure everyone was okay—whatever that meant for them. You can promote wellness all day, but you can’t (ethically) pose any actual testing of resilience. The loss of Dr. Pambuccian not only demonstrated the camaraderie and compassion at Loyola Pathology, but made sure we all learned what it means to be a great pathologist.

Image 2. A fun yet fleeting secret Santa. Despite the mood of this day being changed by the news, happy memories are still just as important. Both the sad and happy parts of this day brought us all closer, and stronger, together.

Like I said, my interactions with him were brief at best but he gave the morning didactic at my very first residency interview here and I learned all about his bottomless sense of humor and wit. Since starting, he was always there running the Thursday unknown sessions, where I felt empowered to participate alongside his openness for learners at all levels. I even remember I was on-call one night with him on service, and after checking in with other residents, I gave him a call to say there was nothing much happening tonight—I barely made it past my hello, before he told me to have  good night because he already checked the surgery schedule and was just waiting on me to call. Thanks. I could never do justice in telling stories about him when compared to literally anyone else in my department. There were countless more stories, and tons of experiences my fellow senior residents and faculty all shared about their working with him. I just feel lucky enough to have known him.

Image 3. I volunteered along with one of our fellows to take new faculty and resident photographs for our new website. My cloud photo storage is full of 3-4 similarly posed faces of everyone I work with…except Dr. Pambuccian. He wanted to make this fun, much like everything else he did.

I find myself in the same position as the last time I talked on this topic: at a new chapter in life to start becoming the doctor I set off on this journey to become many years ago. With the addition of excellent faculty mentors, friends and colleagues, and an ongoing, renewed sense of purpose, I’ll keep you all posted.

To read more about Dr. Pambuccian’s life, his love of art and cats, his numerous publications which will undoubtedly crash your computer, please click this link to Loyola Pathology’s in memoriam.

Thank you for reading and letting me take this aside to say, as I have before, that we deserve the same compassion and patience as we extend to our patients and that the values that inspire us to do our best to improve healthcare at large are the same values that can help us build strong, caring relationships with our families, friends, and colleagues.

Take care of yourselves and those around you. Thanks for reading! See you next time!

(And look into how and where to get your COVID vaccine!)

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.

Truth or Consequences: The Wrong Question

It was with sadness that I watched the episode of Jeopardy! which featured Alex Trebek’s final appearance. While I hadn’t watched the game show consistently since 1984 when he first began to host, Alex had certainly become an icon in U.S pop culture and I had enjoyed watching him often. The quiz show has always been different than most- the answer must be given in the form of a question, and it must be the correct question in order to score points. As with most games, contestants don’t always ask the right question. That can happen with lab safety, as well.

I was performing an audit in a laboratory when the manager was bringing a new employee through during her orientation. I was introduced as the Lab Safety Officer, and I described some of my duties like auditing and safety compliance monitoring. The new employee immediately asked, “What happens if you catch someone not doing what they should?” That was the wrong question.

As an experienced lab safety professional, I often see people fail to follow certain lab safety regulations. Unfortunately, you do not have to look far to find lapses in lab safety practices. Vendors and service representatives and other visitors walk into labs across the country and lab staff ignore them. The visitors are not given information about the hazards in the department and they are not offered PPE. A look on social media will reveal multiple pictures of lab workers not wearing PPE as well. Oh- and they are taking those pictures with cell phones they shouldn’t be using (sometimes the hand holding the phone is gloved, other times it is not). While I am concerned about these unsafe behaviors, I am equally concerned about those that witness them and say nothing.

The COVID-19 pandemic has raised the public awareness of an important aspect of personal safety: the unsafe behavior of others can have a direct affect on your own safety. People who refuse to wear masks or who are sick and do not isolate themselves may create situations where the virus is spread to others. In the past year, many people have realized this and have felt empowered to say something to those who are not exhibiting safe behaviors. That realization that they may be in danger has made people feel comfortable speaking up for their safety and that of others around them. Perhaps that is what is needed in the lab setting as well.

Unsafe behaviors in the laboratory can easily have consequences that may affect many 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. When the new lab employee asked the question, “What happens if you catch someone not doing what they should,” I should have had an immediate answer. I should have said that she asked the wrong question. The real question is, “More importantly, what happens to you if you’re not doing what you should?” Teaching staff about the consequences of unsafe lab practices is something that should start on day one, and the awareness of these issues should be raised often and continuously. The truth is, it is important to correct your own unsafe behaviors, but it is also important to feel empowered to correct unsafe issues that are witnessed. The truth is, we all have a responsibility for our safety and that of everyone else who may be in the laboratory. If we own that responsibility, then no one’s safety has to be in…jeopardy.

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 Roller Coaster called 2020

2020 has come to an end. I think we can all agree that it’s been a year like no other! It would be an understatement to say that 2020 has been merely “different.” In the lab, we have seen new things, had new challenges, and, despite the craziness of it all, have learned a few things along the way.

I think the word of the year in our lab and many others for 2020 would be “adaption.” We’ve had to adapt, change our thoughts and processes and be more creative. In the spring, in the first wave of COVID, many labs were struggling with procuring, validating, and performing new COVID tests. With the influx of cases and patients, particularly in some hard hit areas, lab staff were overwhelmed with an unprecedented increase in workload. In the hospital where I work, early on we had very few cases and the lab was impacted in the opposite extreme. With canceled elective surgeries and a huge drop in outpatient work, we found ourselves being asked to take flex time. Workload was down and techs were taking time off to help the lab and hospital adjust to the decreased revenue and to say within budget. Things were pretty slow and calm.

When surgeries resumed and physician offices opened back up, things were busier than ever. Everyone seemed to be coming in for lab work that had been pushed aside for months. In addition to an increased volume in our existing tests, we were bringing on new COVID tests. Procedures had to be written and signed off, validations had to be done and everyone needed to be trained on the new tests. We found ourselves faced with supply issues for the new tests and had to do some juggling acts to get new testing onboard. At the same time, we also had to deal with a lot of other “supply” issues. While the hospital as a whole has done very well to manage PPE distribution, the lab has had to get creative, reaching out to new suppliers for cleaning supplies, lab coats and gloves. Lab coats became and still are very difficult to keep in supply. We’ve gone colorful! We used to have blue gloves and purple lab coats, but now have multi colored gloves and lab coats all over the lab from multiple vendors.

Possibly the worst of our supply issues has been the lack of trained technologists. In a profession that is graduating fewer and fewer new techs, and as our work force is getting older, we have been experiencing a shortage of qualified Medical laboratory Scientists and Technicians across the country for a number of years. This past year, with the current pandemic, we have seen techs who were working way past retirement age decide to finally retire, and others taking early retirement. In the past 5 years I have worked in 2 hospitals that have continuously had revolving open positions. In 2020, om a large number of COVID cases amongst lab staff, but have had a few. We have had many more staff out on quarantine for 2 weeks at a time for exposures, sometimes several at a time. And, after waiting for months with elective surgeries on hold, the minute these were again allowed, we have had several staff on simultaneous leaves of absence for surgeries.

How have we compensated and adapted for these shortages and changes? At a time when visitors have been restricted in the hospital, we have found ourselves with a severe shortage of staff. We are also competing with other hospitals in the area in the same situations so are having a hard time hiring and keeping new employees. We have adapted by conducting Zoom interviews for hiring. We are in the middle of a big chemistry project bringing on new instruments and some of this training has also moved to virtual venues. ASCP and other organizations have held totally virtual conferences and symposiums. But, having been forced to implement these new technologies, we have learned new skills that can be used in the future to broaden our outreach and educational opportunities.

It has been a challenge to train new techs and to simply get the daily work done with ongoing staff shortages. Staffing has been at critical levels. We’ve been resilient. We’ve been creative. We have had to implement an On Call list to help fill critical holes in the schedule. This is not popular, and is still a work in progress, but has helped us to think of other ways to solve the problem at hand. Bonuses for working extra shifts have helped. We have relied on our great technologists to fill in extra shifts. I’m very proud of everyone working together. Team work is helping hold us together and get through this very difficult year!

I think If I had to find any “good” about this pandemic, I’d have to say it’s been the lack of commuter traffic, and the fact that all this talk about COVID testing has shone a little light on our profession. Yet, with all the talk of “testing,” even though the general public has some concept of lab testing, they still know very little about the profession and the people doing these tests. They may recognize the terms PCR, and antigen and antibody but we’re still a hidden profession. What can we all do? Talk about the profession in your community. Community groups, high schools and community colleges often welcome speakers, and now you can even do it online! You’ve all heard people talking about antigens and antibodies and PCR, but you can tell them about the profession and the people who work with these tests every day. It would be very hopeful to say that this pandemic could highlight the Medical Laboratory profession to the point where students would be filling our programs and we’d see a new interest in the field.

Did we ever think this would last this long? in the spring, making hundreds of masks, I thought making holiday masks would be fun. But then I thought to myself, “ I won’t need to make Halloween masks or Christmas masks.” I never thought we’d still be wearing masks at New Year’s! But masks have become so normal that we have even gotten used to them. I took a cold walk a couple days ago and thanked the mask for keeping my face warm!

2020 has had many ups and downs, many challenges. I am proud to say that Medical laboratory professionals have lived up to those challenges and we can and should feel good about our accomplishments and contributions to fighting this pandemic. We’ve been resilient, we’ve adapted and we’ve grown. We’re on a roller coaster ride but we’re still holding on. Hold on tight and wear that mask!

-Becky Socha, MS, MLS(ASCP)CM BB CM graduated from Merrimack College in N. Andover, Massachusetts with a BS in Medical Technology and completed her MS in Clinical Laboratory Sciences at the University of Massachusetts, Lowell. She has worked as a Medical Technologist for over 30 years. She’s worked in all areas of the clinical laboratory, but has a special interest in Hematology and Blood Banking. When she’s not busy being a mad scientist, she can be found outside riding her bicycle.

The Pathology Value Chain and Global Health

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

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

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

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

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

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

References

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

Set the World on Fire, but Don’t Burnout

Hello everyone and welcome back!

So here I am: a med school matriculant, top-choice program matched, doing exactly the training and work I’ve wanted to since before medical school. Totally made it! But before I go all “Fresh Prince of Maywood” on you, there’s a lot to unpack within the word “residency.” I’ve discussed this before, comparing pathology subspecialties with my primary care friend Dr. Raja’s rotation schedule, but you probably already know a little about what pathology residents do. I want to talk about what most folks might not know, why most residents absolutely disappear from their families or loved ones, and why going in with already greying hair isn’t going to make this any better, ha-ha…

Image 1. Me, and me. Look what 6 months of residency can do. Wow. Kidding. It’s an Instagram filter. Or is it…? It is. But what if it isn’t….?

I’m a resident at Loyola Medicine in Maywood, IL; I also went to undergrad (over a decade ago) at Loyola Chicago. So, for me, this is a very cool full-circle experience. I bring this symmetry up because a lot of people talk about the “culture” of an institution when they’re looking for a perfect match. I’ve talked about my experiences with hospitals’ institutional cultures before, at Bronx Care, Staten Island, Mayo Clinic, Danbury, Brooklyn, and more before medical school. I choose to highlight Loyola for you both because it’s already home to me, and also because it has a unique disposition.  When you walk across the stage at graduation, Loyolans are instructed to “Set the world on fire”—a quote from the university’s namesake and patron St. Ignacious Loyola. It follows a Jesuit tradition of valuing education as one of the most powerful tools to address social inequality, injustice, poverty, and whatever ails our society. By being bold and passionate (like a fire, get it…?) true leadership can manifest in graduates’ futures.

Image 2. Me again. Imbued with Jesuit mantras, ready to set the world “aflame.” Notice me in the bottom right, however, not really seeming to pay attention to the stage. Thinking about my poor future colleagues perhaps…

But all graduations are decorated with pomp and circumstance. As graduates sit and wait for their name, they are pontificated at about the importance, poignancy, and grand scale of opportunity that awaits them. But what happens after graduating, college, or graduate school, or medical school? The answer varies widely for many, but I can speak to those who end up with the long white coats. I’ll be honest, allegorically, college is a lesson in walking, graduate school is a lesson in running, medical school is a lesson in cartwheels—after you’ve somewhat mastered this, the world that awaits you demands powerful cartwheels (with tricks) up multiple Mt. Everests, and you might be able to use the bathroom…you might. Haha, a little hyperbole. I mean I am SO glad pathology training isn’t like some other specialties (looking at you surgery…) but the demand is there, nonetheless. I would say ours might be more cerebral because, what we trade in for not having an intern year, we are “gifted” with having to lean 4+ years of material presented as an iceberg tip in medical school.

In a recent Inside the Lab podcast, the topic of burnout was discussed. (Check it out here!) Labratorians—and healthcare staff in every role—have been feeling the COVID push all year. More is expected of us, more is demanded of our system and its output, and there is no relief or break in sight. That prolonged demand on our expertise (and time) puts a significant strain on all our collective psyche’s. Nowhere is that more apparent than in healthcare. Paramedics run long uninterrupted shifts seeing tragic emergency one after another. Nurses do 12hr shifts back to back for days, especially when there isn’t enough staff to support days off (while patient census climbs higher and higher). But in medicine, poor medical school post-graduates are expected to literally “reside” in the hospital, ergo resident. The term came from the training model coined at Johns Hopkins in the early 1900s. And, up until a few years ago, the powers that be decided that residents should log no more than a maximum of 80 hours a week with the longest shift you can work 24 hours. Fun fact: the IRS, yes those guys, defines full-time work as 30-40 hours per week or 130 hours per month. If you work a “full time” job, you probably work 40 hours a week/160 hours a month. So, for young resident physicians: that two full time jobs, coming in hot at just about the average US salary of 55-60k. Outstanding. However, while I find myself lucky and would anecdotally say that I don’t think I’ll be getting any notifications or flags on logging too many hours at the hospital, the reality is that many physician trainees work right up to the maximum (and more). The old guard cites that 80 hours isn’t enough time to train a functioning physician, as they leave patient care at a sensitive time where they effectively abandon their learning. But …burnout. The “reduction” to 80 hours one would think reduces stress and burnout, but lo and behold a paper (from FIFTEEN years ago) says nu-uh. “Changes in parameters of resident and faculty emotional exhaustion, depersonalization, and personal accomplishment did not show statistical significance…Despite successful reductions in resident work hours, measures of burnout were not significantly affected.” (JAMA, 2004)

Image 3. I’m not here to cite stuffy papers and the voluminous research on physician and resident burnout. Instead, I’m here to highlight the motivations those of us in healthcare cite as our driving force to keep at it, especially in a pandemic.

Regardless, those of us in postgraduate medical training are here for a reason. I identify as one of the few who finds himself in a lucky spot, where my institution—and my profession of choice—don’t demand that kind of hourly expectation of me. But many of my other colleges aren’t as lucky. Surgeons, internists, family doctors, and more are working themselves to the limit. And that doesn’t include anything about the COVID pandemic. Whether you’re a graduate of Loyola or not, we’re all expected to “set the world on fire,” I just hope we don’t burn out in the process. Stay in tune with your needs and your support system, learn to recognize signs of burnout as much more than fatigue, and remember to extend compassion to everyone—you never know what load they might be carrying. Remember those things and you can navigate a packed work-week…or a pandemic!

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.