generalist – Lablogatory

Guess Who’s coming to the Lab?

When we enter the laboratory, we know of the dangers that can be encountered. Our training tells us there could be microbes and other potential pathogens in the samples we are about to analyze. We also learned how to protect ourselves; how our behavior while in the lab has consequences. We even know how to dress properly and what engineering controls we have at our disposal to keep us safe. We put on our personal protective equipment (PPE) before we start to work and remove it before leaving the lab. For some, these behaviors are automatic, actions that are done almost without even thinking. But is this the same for all who enter the lab? Do visitors who comes into the department know what they are really walking into or how to keep themselves safe in an environment that may be foreign to them? One common question asked by lab staff regarding visitors is “do they have to adhere to the lab safety policies and if so, why?”.

On a recent safety audit, I visited a lab that happened to be getting a new chemistry analyzer installed. I noticed the vendor team, which consisted of 5 individuals, were not wearing any PPE. There were backpacks, open water bottles, and cell phones sitting on the counters and floors. The new instrument was not hidden in a back corner of the lab far away from the daily work. It was close to the area where the lab process, spins, and runs patient samples. Members of the vendor team were lying on the floor and crawling around. How does that scene make you feel?

Vendors and service representatives are regular visitors in your lab. A laboratory can have a representative on site a dozen times before you even begin to use that piece of equipment. Once it is installed, you can bet you will see them multiple times for preventative maintenance and service calls. How does your lab welcome these guests? Do you let them in and have them get right to work? If they are there to repair an analyzer you are likely eager to have them get started, but do you ask them to wear a lab coat? Did they bring one of their own that was kept in their backpack? If so, do you think that coat is clean or was it used in a different lab, packed up, and brought to your lab? Vendor compliance is a safety issue for many labs because these visitors are not lab employees, yet they are in your department and may be putting themselves and your team at risk. Often vendors are seen with drinks in labs, using cell phones or touching instruments without gloves – behaviors lab folk are told not to follow. So why is it tolerated? It shouldn’t be, and you have the right to speak up and ask them to adhere to your lab policies.

What about other potential laboratory visitors? Do pathologists come in to look at a patient slide in Hematology? Do they just sit down at your bench and look at the slide without gloves or a lab coat? Is lab staff allowed to scan a smear without PPE? Probably not, and no one else should be allowed too either. The microscope has most likely been touched with dirty gloves, and no one else should touch the same scope without gloves. Even lab doorknobs are a consideration. Staff should wash hands before leaving the department. That means no one should use contaminated gloves to open the door.

Speaking up about these safety issues to lab visitors can feel uncomfortable. A conversation with a physician about safe practices in the lab can be daunting, but the cost of not speaking up can be high. Take the opportunity to show you care about visitors and want to keep them protected. Sometimes you know who is coming to the lab, and you feel confident they have been trained and will use the best safety practices. At other times, though, those guests may be unexpected and lacking in safety knowledge. Make sure to treat them with respect, give them the safety training and tools they need so they can leave both happy and healthy.

-Jason P. Nagy, PhD, MLS(ASCP)^CMis a Lab Safety Coordinator for Sentara Healthcare, a hospital system with laboratories throughout Virginia and North Carolina. He is an experienced Technical Specialist with a background in biotechnology, molecular biology, clinical labs, and most recently, a focus in laboratory safety.

Omicron: Variant of High Significance?

Omicron is now the dominant variant in the United States and gained that title faster than any variant before it. I have been tracking variants in the North Texas region since February of this year and detected the first Alpha variant (B.1.1.7). During this time, there were multiple substrains circulating. Some like Epsilon (origin California) rose in prominence then declined to extinction. Rise in Alpha (origin U.K.) and Delta variants (B.1.617.2, origin India) were tracked over the course of weeks, but Omicron has been tracked on a daily basis, since it is rising so quickly.

Many places are using S-Gene Target Failure (SGTF) as a surrogate for Omicron variant (Yale, University of Washington below).

Photo credit @NathanGrubaugh (Yale, Left) and @pavitrarc (UW virology, right)

SGTF occurs when the TaqPath COVID-19 multiplex test has 2/3 targets successfully amplify when the S-gene target does not or “drops out.” This phenomenon was first observed in the Alpha variant, because the probe for this target overlapped a characteristic mutation: S:Del69_70 (deletion of the 69^th and 70^th amino acids in the spike protein from a 6 base pair deletion). This mutation is absent in Delta, but present in Omicron, so has been used as an early tracker of Omicron prevalence.

Most of this discussion is speculative and we won’t ever really know, but given the rate of transmission of this variant, it seems unlikely that it would have acquired so many mutations and not been detected before now. The most recent common ancestor is from over a year ago suggesting it was incubating for a long time.

We’ve seen a case of a person severely immunocompromised with no antibody response to vaccination + booster who still has an unmutated wild type strain in their system. With no immune pressure, the virus has not evolved.

However, in HIV+ patients with variable/ low immunity, there could be enough pressure to drive the immune evasion properties seen in Omicron. Southern Africa has over 30% of their HIV+ patients not on therapy who would be likely candidates for this type of host.

Did we see this coming?

Yes. Other immune evasive variants have arisen in areas with high prevalence of previous infection (Brazil/ S. Africa). Organisms evolve just enough to overcome the challenges in their environment. Thus the level of immunity provided by various immune exposures are approximately:

Previous infection < 2x Vaccine < 2x Vaccine+ previous infection ~ x3 Vaccine

Scientists theorized that either Delta would evolve more immune evasive mutations or a totally new variant would arise. However, I didn’t think it would spread this quickly.

What is the impact?

Therapies. Most antibody therapies are directed as the business end of the spike protein—the receptor binding domain (RBD). The rest of the protein is covered in glycosylation modifications that block much recognition. Thus with many mutations in Omicron compared to the wild type strain (white), most therapeutic antibodies no longer bind/ inactivate viral replication.

Source: https://biorxiv.org/content/10.1101/2021.12.12.472269v1.full.pdf

Only one monoclonal antibody—Sotrovimab from GSK—is effective, because it binds a pan-coronovirus epitope outside of the RBD. However, this antibody is in short supply.

Thus, knowing which variant someone has can direct therapy. Several hospitals in our area are out of Sotrovimab, and only people with the Delta variant can access other options. Thus, knowing the variant in a short time frame has clinical implications.
Whole genome sequencing takes too long, so the FDA has agreed to review PCR genotyping approaches for clinical use. I have described some previous approaches, but many of these methods are useful as a screening method and would not have sufficient specificity to determine whether an omicron variant is present. Next time, I will discuss variant genotyping, why it is important, how it can be done, and what clinical actions can be taken with the knowledge.

Severity. There are signs that it is less severe. Is this due to increase in immune tolerance? We now have been prepared by either previous infection or vaccination to be protected from hospitalization or severe disease.

@Jburnmurdoch https://twitter.com/jburnmurdoch/status/1478339769646166019/photo/1

Or is the decline in severity due to lower pathogenicity? A recent non-peer reviewed study indicates the virus replicates x70 faster than Delta in the upper airways (left), but infiltrates cells 10% as well as the original strain.

From: https://www.med.hku.hk/en/news/press/20211215-omicron-sars-cov-2-infection?utm_medium=social&utm_source=twitter&utm_campaign=press_release

We all hope this will continue to be better news about the severity of Omicron, but from the lab side, I’ve heard of positivity rates >50% at some places. So this can still have a broad impact.

-Jeff SoRelle, MD is Assistant Professor of Pathology at the University of Texas Southwestern Medical Center in Dallas, TX working in the Next Generation Sequencing lab. His research interests include the genetics of allergy, COVID-19 variant sequencing, and lab medicine of transgender healthcare. Follow him on Twitter @Jeff_SoRelle.

Validations/Verifications of Alternative Anticoagulants for Platelet Clumping

Platelet clumping can cause a falsely lowered platelet count on hematology instruments and can be difficult to resolve. With thrombocytopenia, physicians need an accurate count to diagnose, treat, or monitor patients. Clumping can be due to pre-analytic issues with specimen handling, can be caused by medications, or may be an in vitro phenomenon caused by anticoagulants. The clumping makes precise counting impossible and even estimates can be very tricky. If there are clumps, and recollection of the sample still yields platelet clumping, then many labs will have an alternate tube drawn or an alternative method to help resolve clumping.

Many of us have heard of using sodium citrate tubes for patients who have clumped platelets in EDTA. So, if you are having platelet clumping headaches, you can just order some sodium citrate tubes and start using those on your hematology analyzers, right? Not so fast. There are many published references of the use of sodium citrate tubes to resolve EDTA induced thrombocytopenia but we still see samples in which the clumping is not resolved with the sodium citrate tube. Published studies have shown that several other alternate methods have been helpful in resolving platelet clumping issues. These include drawing specimens in CTAD, ACD, or ‘ThromboExact’¹ tubes, or adding amikacin or kanamycin to the EDTA after the specimen is drawn.

So, why can’t we just order one of these other tubes and start reporting results? Hematology analyzers are only FDA approved for EDTA tubes. Before you can use any modified method, and before you can report any patient results, your laboratory must do validation or verification studies to prove that the method produces valid results.

A validation provides objective evidence that a test performs as intended. A validation uses a defined process and is used when setting up and implementing a new test. One example is a laboratory developed test (LDT), which is a test performed by the clinical laboratory in which the test was developed. A LDT can be one that is neither FDA-cleared nor FDA-approved or can be one that is FDA cleared/approved but has been modified by the performing laboratory. The use of sample types or the use of collection devices not listed in manufacturer instructions constitute modifications, by this definition. In a validation, accuracy should be tested with at least 40 samples across the analytical measurement range (AMR). Correlations are then performed. Precision should be tested over approximately 20 days. A verification, on the other hand, uses an abbreviated process and is used when setting up and implementing new tests that are cleared or approved by FDA. Before reporting patient results, the laboratory must demonstrate that a test performs in agreement with prior claims and must demonstrate performance specifications are comparable to the manufacturer’s specifications. Verification therefore is a confirmation that a test method meets specified requirements and would be applied to a method which has already been validated. For a verification, a smaller sample size may be used, and precisions tested over 5 or more days.

So, which would you do if you wanted to use an alternate method for reporting platelet counts? Hematology analyzers are only FDA approved for platelet counts on EDTA, but the by which the sample is analyzed does not change with an alternate tube, so it may be possible to do a limited validation or verification with a smaller sample size. A laboratory needs to prove correlation, accuracy, and precision. Follow your laboratory SOPs for validation/verification and consult with your accrediting agencies, if necessary. A plan needs to be written and signed off by laboratory director. Choose the alternative method you wish to investigate and run correlations for platelet counts on EDTA and the alternate anticoagulant. If your instrument has more than one platelet mode, it is important to run samples in the mode which you would normally use for thrombocytopenia or flagged platelet counts. Apply any dilutional factors and calculate correlations. This data will be Included in your report, which, along with a procedure needs to be signed by the laboratory director.

The most important thing is to write a plan and a follow-up report according to your SOPs and to make sure any requirements of accrediting agencies are included. There can be some differences in interpretation of standards, so it is the laboratory’s responsibility to make sure what you have done meets the standards that apply to your lab.

The use of alternate tubes for platelet counts has been well reviewed in literature. Sodium citrate tubes are the most common, likely because they are the easiest to use and the most cost effective. Remember though that sodium citrate and other methods cannot resolve all case s of pseudothrombocytopenia. There are several special notes to consider. Counts from sodium citrate tubes are known to be stable for approximately 3 hours, after which counts decrease. As well, it has been shown in literature that sodium citrate tubes do show a negative bias. It has been reported that the 10% dilutional factor may be too low. Some studies have been done to determine dilution factors that correlate more closely with EDTA tubes, and researchers have suggested factor of 17%-25%. If your laboratory wishes to determine its own dilutional factor for sodium citrate or other tubes, this will also have to be included in your platelet studies. Lastly, CBCs are calibrated for EDTA, so only the platelet count should be reported from an alternative anticoagulant.

The end of another busy and challenging year is upon us, and at this time of year we can find ourselves rushed to finish ‘end of year’ tasks such as competencies and continuing education requirements. and a response to Sysmex’s recent webinar “Those Sticky, Tricky Platelets – Solving the Puzzle of Platelet Clumping” (Oct.20,2021). After the webinar I had many questions from techs asking, “Do we need to validate our alternative method?” and “How do we go about doing that?” The webinar discusses pseudothrombocytopenia and its causes in more detail than my earlier blog from Oct 2019, “Hematology Case Study: The Story of the Platelet Clump: EDTA-Induced Thrombocytopenia”. The webinar can be found at https://webinars.sysmex.com/webinars/11ae743e-ac99-47e7-acb7-2b24cedc1a1a and is available for CEU, free of charge.

References

Baccini V, Geneviève F, Jacqmin H, et al. Platelet Counting: Ugly Traps and Good Advice. Proposals from the French-Speaking Cellular Hematology Group (GFHC). J Clin Med. 2020;9(3):808. Published 2020 Mar 16. doi:10.3390/jcm9030808
Bizzaro N. (2013): Pseudothrombocytopenia. In: Platelets, Vol. 3, ed Bizzaro N, Elsevier, Amsterdam, pp. 989–997
Chae H, Kim M, Lim J, Oh EJ, Kim Y, Han K: Novel method to dissociate platelet clumps in EDTA-dependent pseudothrombocytopenia based on the pathophysiological mechanism. Clin Chem Lab Med 50, 1387–1391 (2012)
Socha, Becky. Calibration and Calibration Verification: Who, What, Where, When, Why, How & Did I Pass or Fail?. AMT 81^st Educational Program and annual meeting, 2019
Zhou X, Wu X, Deng W, Li J, Luo W: Amikacin can be added to blood to reduce the fall in platelet count. Am J Clin Pathol 136, 646–652 (2011)
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/6065bk.pdf
https://www.cap.org/laboratory-improvement/proficiency-testing/calibration-verification-linearity
https://www.westgard.com/cal-verification-criteria.htm
https://labmedicineblog.com/2019/10/29/ hematology-case-study-the-story-of-the-platelet- clump-edta-induced-thrombocytopenia/

-Becky Socha, MS, MLS(ASCP)^CMBB^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 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.

Where have all the Techs Gone?

Electronic media is replete with articles and editorials of employers lamenting the shortage of workers. Signs offering hiring bonuses hang outside of restaurants, stores, and other retail outlets all across the country.

The inability to find workers has forced employers to take another look at their business model and reevaluate whether the model is still viable in its current form. The power balance in the employer/ employee dynamic has shifted. Employers accustomed to having their choice of applicants now find themselves scrambling to find workers.

No schools, No students

The healthcare industry, including the medical laboratory, is not exempt from the shortage despite healthcare experts and administrators knowing that the trending laboratory employee shortage was inevitable years ago.

Laboratory school administrators and managers have been sounding the alarm about the lack of community college and university medical technology program applications. Many academic medical technology programs are shuttered due to a lack of students. The decrease in the number of students going into the laboratory field and the normal attrition rate of older workers retiring or moving on to higher-paying occupations has led to a high vacancy rate and a loss of expertise.

Burnout

The pandemic has added more pressure on a cohort of employees experiencing the stress of a new and unknown danger. These allied health professionals were (and are) the front-line response to a disease threatening everyone, regardless of economic or social demographics. Lab worker burnout has become a documented phenomenon

We call them heroes, but in reality, these are the same people working every day (pandemic or not), serving patients and delivering quality test results. Labs across the nation are filled with these everyday people. But just like everyone, laboratory workers have families, feelings, and needs they are trying to meet while being asked to give a little more. Many have little left to give and are now leaving the field to pursue other less stressful occupations or to simply enjoy the life they have worked so hard to build.

Start recruiting early

How can healthcare organizations stem the tide of those choosing to leave the lab and simultaneously attract young fresh minds to the unglamorous and less financially rewarding but necessary field of laboratory testing?

Presentations to elementary school children are a great way to introduce the next generation to the laboratory field. What child doesn’t like looking into a microscope to see their own red and white blood cells? Roadshows put on in junior high and high schools are a great way to kindle interest in healthcare just when students are beginning to ponder the question of what they want as a career.

Educational Aid

The cost of college continues to rise. Scholarships are often garnered by high-performing “A” students. But there is a pool of “B” students that could also benefit from financial assistance and would be just as welcomed into clinical laboratories. Broadening and diversifying the qualifications to receive a scholarship and financial aid could conceivably add to the pool of potential laboratory workers. Another unique idea is to allow laboratory workers’ dependents access to unused employee educational benefits.

Wellness in the Lab

Resources should also be dedicated to retaining technicians and technologists who are considering leaving the laboratory field. The level of compensation is meaningful, but studies have shown that employees often leave the job for more esoteric reasons. Reducing stress, supporting a culture of wellness, inclusiveness, and belonging can differentiate one workplace from another. The theme of workplace wellness was extensively discussed at this year’s ASCP 2021 annual meeting in Boston.

The Need is Real

The pandemic has highlighted the importance of the laboratory to the health of the nation. The medical laboratory should use this moment in the spotlight to advocate for more resources and emphasize the necessity for more laboratory programs and students to meet the future testing needs of the nation.

Of course, many lab managers are wondering what to do today to stem the slow leak of personnel. Providing mental health support and financial incentives do work to keep these knowledgeable workers in the lab. Managers realize that laboratory science is a demanding high acuity job with little or no margin for error. To maintain quality, the healthcare industry will need to change its perceptions about the laboratory and address the lack of technicians and technologists with the same interest and retention resources given to nurses and doctors.

-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.

Disruption in Cancer Care: Good or Bad … What’s Next?

The concept of disruption often has negative connotations. Everyone on the planet can understand the phrase, “COVID-19 has disrupted our lives” without explanation. Although this disruption has been global, the disruption and ensuing impact this has had on non-COVID-19 related healthcare and, specifically, oncology, have been dramatic.

Surgeries, chemotherapy and other medical treatments were canceled or delayed by months, and volumes of testing across the cancer landscape dropped to minimums. Existing infrastructure furthered the deployment of telehealth consultations and, eventually, clinics were reopened; however, there is no question that many people with cancer face being diagnosed at a more advanced stage of disease, with worse outcomes.

On 25-26 October, the World Cancer Leaders’ Summit, organized by the Union for International Cancer Control and hosted by the American Society for Clinical Pathology, brought together more than 600 leaders from some 100 countries. One of the major topics of discussion was, “What do we do for oncology after COVID-19?”

In addition to examining heart-wrenching data on disruptions to cancer services, there were also positive discussions about what we have learned from this pandemic, how we have adapted, and what novel approaches we should keep that could create optimal, more efficient, or more impactful cancer care.

The positive side of disruption

When applied to innovative technologies or ways of thinking, “disruption” can be positive, particularly when we consider the many advancements happening so quickly with treatments, including immunotherapies like check-point inhibitors, mRNA cancer vaccines, CAR-T therapy, epigenetic therapies, that the different members of the cancer community are often running to catch up.

Some of these advances are simply operational efficiency (i.e., getting more output from the system by improving the inputs and the usage) while many are transformative innovations (i.e., immunotherapy for lung cancer and melanoma). And some advances are considered “disruptive” because they are not just a new way of doing something better but allow an entirely new approach that previously wasn’t available and that radically improves prevention, diagnosis, treatment or supportive care.

A disruptive revolution in cancer detection

In oncology, a true disruptive innovation is taking place with universal cancer screening (UCS) or multi-cancer early detection (MCED). The earlier a cancer is detected and the patient can start treatment, the higher the chance of survival. The current paradigm for cancer care is suspicion of cancer leads to diagnosis, which leads to treatment. Suspicion rests in either the results of a screening test or when a person shows symptoms, and diagnosis involves a biopsy that must be analyzed.

Primary care doctors and not just oncologists will be able to use UCS and MCED testing platforms. Tests will be performed on a timescale (e.g. annually, every five years) relevant to the person’s age, medical and family history as well as the type of cancer being detected for, rather than wait for a patient to present with symptoms. Furthermore, these platforms will be able to detect 20 to 50 or more cancers from a single sample and for myriad cancer stages, including precursor or pre-invasive cancer, and there is no need for a separate diagnostics phase: the result itself would dictate a treatment because the UCS/MCED platforms not only detect the cancer but can, in theory, give an origin and medical response parameters.

Whereas the current paradigm involves primary care, oncology, surgery, radiology, pathology, nursing, etc., this new paradigm would only involve primary care and an insurance provider.

Innovating, Creating and Breaking Down Barriers

The transition from traditional oncology to such novel platforms – as with all disruptive technologies – will not be smooth as we are talking about entire businesses and careers connected to traditional oncology possibly become obsolete. People with cancer, however, are expected to have shorter, more efficient journeys, likely with better outcomes and at a lower cost.

In LMICs, where oncology care systems are not nearly as developed as in HICs and where governments, unlike the US, are generally assumed or expected to pay for cancer services, UCS/MCED will require fewer dollars and provide better results than investing in the infrastructure required to create traditional cancer care systems. If this theoretical framework (UCS/MCED for cancer) does demonstrate the value in promises, it would set the stage for similar paradigms in other non-communicable diseases for which infrastructure and resources in LMICs are often lacking.

UCS/MCED was a hot topic at the WCLS. The leaders that were involved in the meeting sit on either side of a fence with regards to this innovation. There are those that support this technology’s development as quickly as possible, anticipating better patient outcomes, more efficient systems, less healthcare spending and more revenue. There are also opponents to this innovation, who throw up barriers resulting from fear of losses (revenue, employment, testing volume, referral networks, etc.).

The barriers they present, however, are important only if they are true barriers and not just perceived barriers. Why? True barriers are likely to require the engagement of the traditional oncology system to overcome; yet the act of overcoming those barriers may herald the disruptive innovation they fear. When an existing system must participate in its own creative destruction, can such a disruptive innovation take place?

No doubt the participants of the WCLS will continue to ask this question and let’s hope they find some answers for the sake of our patients.

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

The Anatomy of Lab Safety Design: Handling a Flood

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

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

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

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

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

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

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

Looking into the Pathology Mirror

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

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

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

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

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

“You’re too smart to do pathology.”

“Why would you waste your brain on forensics?”

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

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

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

A COVID Reflection

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

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

Dying Alone

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

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

Unseen Warriors

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

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

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

Needless Death

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

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

Sigh.

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

We are also tired and worn.

Conclusion

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

If you can get vaccinated, please do.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

TRANSforming Healthcare: The Role of The Laboratory

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

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

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

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

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

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

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

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

References

The Yogyakarta Principles. 2017. https://yogyakartaprinciples.org/
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.