Meaningful Metrics

Performance improvement (PI) metrics are a great way to assess the overall quality of your laboratory program. They allow you to track vital data related to CMS outcome measures, which can directly impact the financial well being of your organization. However, labs should be careful when choosing which metrics to monitor, and should routinely evaluate if the metrics they’re using are still meaningful to them.

Even a small laboratory will generate a ton of data throughout the year. The key questions to ask yourself are: 1) What do I want to know? 2) What will I do about it once I have the answer?

There may be different sets of metrics that laboratories will have to monitor and report, depending upon who the target audience of the final data analysis will be. Metrics and reports can be generated for your patients/customers, internal laboratory staff, management, and senior leadership. You may also be called upon to share your metrics with regulatory agencies as well to prove the effectiveness of your quality assurance program.

Ensure your reports are relevant and meaningful to the audience they are being shared with. Customer/Patient centered metrics can include items such as satisfaction survey results, average waiting time for outpatient blood drawing locations, and average cost/revenue per test. Internal laboratory staff metrics can include turnaround time reports for STAT tests, compliance with critical call notifications to providers, and percent completion for required monthly maintenance tasks. Higher level metrics that can be reported to management and administration may include performance on proficiency testing surveys, regulatory inspection results, and percent of corrected reports that were issued.

If goals have been met and sustained consistently, consider raising the bar and challenging yourself even further. Each metric should have 3 goals: 1) Minimum Threshold (must be achieved each review period), 2) Annual Goal (desired overall goal to account for monthly fluctuations in the data), 3) Stretch Goal (motivational tool, achievable but not guaranteed a high rate of success). Increase your minimum threshold limits to be closer to your stretch goals, and see what your particular organization can realistically meet and sustain. Be careful to not set unrealistic expectations, as this can lower morale and result in misleading interpretations of the data. Work with your clinicians and regulatory agencies to determine appropriate, and realistic goals, and utilize national benchmark standards when available.

Metrics that were added to address and monitor a specific known issue or problem should be evaluated for necessity once the issue is corrected. Consider reducing the monitoring of these items from monthly down to quarterly, semi-annually, or annually until you have confidence that it no longer requires monitoring.

When issues are identified, a root cause investigation should be performed with the intent of identifying the true cause of the problem – not to point blame to a particular person. The depth and intensity of your investigation will depend upon the specific metric which failed to meet its goal.

Properly identify the problem. To learn from our mistakes, we must first properly identify them. What may seem like an obvious root cause, may not be the real reason for an issue. For example, turnaround time metrics – if you did not complete STAT troponin tests in <45 minutes, simply purchase a new instrument that is faster. Well, it’s not quite that simple.

Break it down further into pre-analytic, analytic, and post-analytic times. Is the bulk of your 45 minute window taken up in the pre-analytic phase? Are samples being held in a central receiving area for 20 minutes and batched before being brought to the chemistry department? Are you testing serum (which needs to first clot before being spun) or plasma (which can be spun down immediately)? Is there a delay in verifying/releasing results into your LIS where autoverification would improve this process?

Before attributing instrument downtime as a cause, confirm that the outliers were in fact during the time period when the instrument was down. There’s a higher chance you have a pattern of poor TAT performance around change of shifts or meal breaks, than during a 6hr downtime on a single day in the month. Also look at how you are analyzing your metrics to ensure they are accurate. Are you including add-on tests based on their original received time, or based on when the troponin was added to the original order?

Develop a corrective action/preventive action plan. Based on what you identified to be the true root cause(s) that contributed to poor PI metrics, develop a plan for addressing these weaknesses. Identify who specifically will be responsible for performing each step in the action plan, and who will be held accountable for ensuring it was performed.

Implement the plan(s). Document the date the corrections were fully implemented, along with any delays or obstacles encountered.

Collect and analyze more data. Depending on the severity of the failed metric, you may want to begin analyzing the effectiveness of your improvement plan immediately. If there was a spike in the number of employee safety incidents reported last month due to ongoing construction in a department, the work conditions should be monitored daily/weekly for improvements.

Conversely, looking at data too soon may not paint an accurate picture of the true effectiveness of your corrective actions. Some corrective action plans may require several steps or phases for full implementation. For example, a process change will require an update to your procedure manual, retraining of all staff, and then rolling out the new process. This may take several days-weeks before 100% implemented and improvements can be detected.

Monitor the results. Check for sustainability of your corrections – staff may be on their best behavior the first week after being spoken to, but can return to old habits after that. They may not fully understand that although one process is easier for them, it is adversely affecting the overall performance of the entire lab team.

If you are consistently struggling to meet your metrics, consider looking for ways to implement lean process changes. Upgrading to a STAT spin centrifuge may save you 5 minutes on the pre-analytical side; but you may still have room for improvement. Do you consistently receive 20 samples at a time, meanwhile your centrifuge will only hold 8 tubes? Do you receive tubes of different sizes (adult vs pediatric), and is your centrifuge capable of quickly and easily interchanging inserts to accommodate both types?

Ultimately, be sure to engage your frontline staff and listen to their opinions on what is working, and what could be improved upon. They are the ones doing the tasks day in/day out, and are your subject experts on where some of the shortfalls may lie. Even if the answer is simply not having enough staff available, having detailed analytical metrics can help management justify the cost of adding additional team members, and also pinpoint the exact days and times where the help is needed most.

Bio

Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years, and is currently employed at Northwell Health Laboratories on Long Island, NY. In her current position as a Laboratory Supervisor for the Northwell Consulting Team, she transitions between performing laboratory audits across the entire Northwell Health System, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards and acting as supervisor and mentor in labs with management gaps.

-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

Albumin Values in Transgender Men and Women

This month our study results were published in a special edition of Clinical Chemistry describing how laboratory values in transgender men and women when taking hormone therapy. While retrospective, we hope that this information will help improve transgender medicine.

There were many interesting results found in the study and I hope to describe bits of them in greater detail each month.

We wondered what we might find if we took a broad, unbiased approach comparing all laboratory parameters commonly measured by physicians. Just because there are no sex-specific differences in analytes, changes could still occur secondary to exogenous hormone use.

Albumin, which is the principle protein in our blood, was found to be decreased in transgender women after taking at least 6 months of estradiol therapy (p<0.0001)1. This was unexpected, because one reference range for albumin is used for cisgender males and females.

Frequently, changes in lab values move in opposite directions for transgender patients taking estradiol vs. testosterone (ex. hemoglobin goes up with testosterone and down with estradiol). We wondered if a similar opposite change might occur in albumin for transgender men taking testosterone. However, there was no change in albumin levels from baseline for transgender men.

The cause of decreased albumin was not readily available, but several factors could be influential. Albumin levels reflect the long term nutritional status of a patient as it has a long half life for turnover (t½= 3-4 weeks). Thus, the change in albumin could reflect a dietary change in transgender women. However, in the chart review there was nothing to suggest a substantial change in diet. While several of the patients would go on diets and lose weight, the weight loss was (unfortunately) often short lived (< 1 year). Looking towards a more objective reflection of dietary changes, the body mass index was nearly the same for transgender women pre-hormone therapy vs. while on hormone therapy (BMI: 27 vs 29, p>0.05).

Some studies have shown an increased prevalence of disordered eating behaviors among transgender individuals2, which could affect overall nutritional status as reflected in albumin. However, this should be controlled for by the control group, which is just transgender patients who haven’t taken hormones previously. 

Another consideration is that body composition changes in transgender patients such that transgender women lose lean mass and have an increase in body fat percent3. Although this could affect the metabolic profile (which it didn’t in our study), changes in fat percent don’t explain altered albumin levels.

Albumin levels are also low in patients with chronic liver disease, but this would be inconsistent with the patients’ medical history or other lab results. Frank nephrotic syndrome is unlikely as there were no reports of this disease within our population, but we did not have data on urinalysis, so we can’t say for certain.

One study did show that males (TW baseline equivalent) have higher albumin than females at younger ages (<60 y.o.) that equilibrates in later decades4. This sex-specific difference shows how estradiol decreases albumin to cisgender female levels. However, the reverse effect (increased albumin) does not occur with testosterone in transgender males. This demonstrates how sex-specific reference intervals cannot be simply reversed for transgender patients.

In a normal set of outpatients in the UK, oral contraception use (which includes estradiol) in women decreased their albumin levels by 0.2 g/dL, which is a smaller magnitude than found in our study, but supports a hormonal basis for sex-specific differences in albumin4.

Although the decrease in albumin for our cohort was not clinically significant (did not pass lower limit of normal albumin reference interval), it would be important to monitor albumin levels in older or elderly transgender females on hormone therapy. Elderly patients are at increased risk of hypoalbuminemia, especially when hospitalized5.

Summary:

  1. Albumin is decreased in transgender women taking estradiol therapy.
  2. Albumin levels do not fall below normal ranges.
  3. This could be more important in older or elderly transgender patients who are already at risk of hypoalbuminemia.

References

  1. SoRelle JA, Jiao R, Gao E et al. Impact of Hormone Therapy on Laboratory Values in Transgender Patients. Clin Chem. 2019; 65(1): 170-179.
  2. Diemer EW, Grant JD, Munn-Chernoff MA et al. Gender Identity, Sexual Orientation, and Eating-Related Pathology in a National Sample of College Students. J Adolesc Health. 2015; 57(2):144-9.
  3. Auer MK, Cecil A, Roepke Y et al. 12-months metabolic changes among gender dysphoric individuals under cross-sex hormone treatment: a targeted metabolomics study. Sci Rep. 2016; 6: 37005.
  4. Weaving G, Batstone GF, Jones RG. Age and sex variation in serum albumin concentration: an observational study. Annals of Clinical Biochemistry 2016, Vol. 53(1) 106–111.
  5. Cabrerizo S, Cuadras D, Gomez-Busto F et al. Serum albumin and health in older people: Review and meta analysis. Maturitas. 2015; 81(1):17-27.

-Jeff SoRelle, MD is a Molecular Genetic Pathology fellow at the University of Texas Southwestern Medical Center in Dallas, TX. His clinical research interests include understanding how the lab intersects with transgender healthcare and advancing quality in molecular diagnostics.

Over the River and Through the Woods…

Specimen handling and transport is a vital training topic in the realm of Laboratory Safety. There is much to consider here that affects specimen quality and integrity, and ultimately affects patient results. There are also considerations involving employee safety at every step of these processes. One group of employees that can easily be overlooked when it comes to proper safety training is lab couriers. They perform the important role of properly and safely transporting specimens for testing, but without the proper education and tools, these team members can quickly fall into situations of harm.

The courier was running late, and she had one last stop on her route at a medical office building with multiple physician offices and drop boxes. It was cold, and she decided to leave the vehicle running while she went inside to pick up more specimens and deliver lab reports. The car was also left unlocked. When she came back outside, the car was gone. It was found hours later in am empty field, but it had been set on fire. There were lab specimens and reports strewn all over the field and into the nearby woods.

Couriers need to be trained about the importance of their role, and that training should include information about security and protected health information (PHI). Be sure to include HIPAA training for all courier staff. When discussing security, enforce specific processes such as always turning off vehicles before exiting and properly securing all patient specimens and any paperwork being transported. Whether couriers use company vehicles or their own personal transportation for the job, making sure harm does not come to the vehicle nor any contents being transported is key.

The courier knew he had a long drive ahead of him because of the toll bridge, and he had several specimens that needed to be delivered as frozen. He went to the lab’s cooler and scooped a large pile of the dry ice into a big box using his hands. It was cold, but it helped to wake him up a bit. He placed the specimens in the box and placed it in the back seta of his vehicle. It wasn’t very warm out, so as he began his drive, the courier made sure the heat was on high and that all windows were closed. After a few miles, the courier began to fell very tired. He struggled to stay awake, and he couldn’t figure out why. After sitting in traffic on the bridge for a time, he pulled off the road and called the dispatcher to let them know he could not continue. When he got out of his vehicle, he began to feel better.

CAP regulations require that laboratory staff have dry ice safety training, but that requirement extends to anyone who may acquire the dangerous substance in the lab. Make sure staff are aware of the need for proper PPE use when handling dry ice. Insulated gloves, the use of a scoop or tongs, and face protection are necessary when scooping ice into a container. Couriers should carry no more than three pounds of dry ice in a vehicle, and there should always be adequate ventilation, including open windows in the vehicle when transporting dry ice. Dry ice converts rapidly from a solid state to a gas, and that gas rapidly displaces oxygen in the air making it difficult to breathe or stay conscious. High volumes of dry ice in a car can create a very deadly road situation in a short amount of time.

The courier was transporting pathology specimens in a cooler, but was unaware that the lid had popped off of one of the specimens and formaldehyde was splashing all over the inside of the cooler. As time went by, the courier began to feel queasy. After realizing that something did not smell right in the vehicle, she eventually stopped the van and pulled to the side of the road to investigate. She opened the cooler and quickly pulled out dripping specimens and set them on the carpet before feeling too sick to continue cleaning up the mess. She had to be taken to the Emergency Room for formaldehyde exposure symptoms while the Lab safety Officer had to bring spill clean-up supplies to the van to neutralize the formaldehyde. The carpet had to be removed and disposed of properly.

Courier vehicles need to be equipped with spill clean up supplies that can handle whatever types of spills could occur during transport. If formaldehyde is transported, couriers need training in the proper transport and clean up of that chemical. Biological spill kits should be available as well, and spill training should be a regular part of overall courier safety training.

I wish I could say that these were imaginary stories, but sadly, that is not the case. The stories, though, illustrate clearly what can happen when proper safety management and training are lacking. Every part of the laboratory pre-analytical process is important, and every lab team member involved in the process needs to be considered. Employ complete safety training, and assess safety competency on a regular basis. By providing the proper tools and safety training to couriers, you can ensure the quality of lab results, and you can prevent incidents like these with your employees.

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.

Solutions, Not Resolutions

The turn of the year is a quasi-inspiring time for many people who attempt to change something about themselves or their situation with “New Year’s Resolutions.” When my friends and I were heading to brunch on New Year’s Day in southern California, there were many people running (alone or in groups) which I hadn’t seen before and my one thought was, “How long will that last?” When I returned to Chicago after the holidays, I dusted off my gym membership card and logged some treadmill time—my one thought was, “I hope this lasts!” But we are all too familiar with the breaking of these resolutions by most of us, and the ultimate regret we feel in the latter part of the year when our hopes and dreams of thinness/money/power/rare pokemon/fame have been dashed by the collision with our actual lives and the limited time we have to get done what needs to be done. Fortunately, we are human beings and we are allowed to be disappointed with ourselves over this (or these) tiny failings as long as our life trajectory is heading the way we want*. Then there are those handful of people that each of us will ultimately know who stick to their resolution and shed the weight, get a new job, or (hopefully with increasing numbers!) quit smoking! And we are more inspired by their actual doing of these things than by our lack of resolve.

As individuals, this trivial annual mindset is acceptable and even entertaining. But as a society, empty promises and feigned changes are simply unacceptable. To certain things, we must as a society—and as individuals in that society—commit. Recycling, for example, is a strategy that is both an economic and environmental boon. But as of January 2018, our major “solution” for plastics (especially from the West) that was China has now ended. Other nations willing to take these recyclables stopped their acceptance as well towards the end of 2018. What can we do to solve (not resolve) this situation permanently? Each country should consider first the role of plastics in their society and perhaps, like many African nations, simply ban the product(s). Secondly, encouraging personal recycling and reuse of plastics, for example through water filters to refill plastic bottles or fees on reusable grocery bags, can minimize impact. But, ultimately, each nation needs a sustainable recycling plan that represents a balance of production and utilization, creating a negative plastic total impact (i.e., no new plastic created).

In pathology, the theme of recycling is very important for any laboratory but can have major benefits for laboratories in developing nations. Formalin, xylene, alcohol, and paraffin (the four principle reagents for pathology processing), can be recycled using devices or process plans that can have minimal capital costs to set up. Consider that a given country may have shipping challenges such that an order placed today for 10 gallons of neutral buffered formalin may take 6 weeks to 6 months to arrive and cost 3 to 5 times the price in another country. In that setting, recycling formalin is clearly a superior approach and extrapolates to xylene and alcohol. Process approaches to paraffin (e.g., collecting waste paraffin from trimming and lids, using minimized mold sizes, lateral flow to minimize contamination) can optimize the use of the wax and reduce costs.  As these four reagents represent core elements to the process, efficient utilization, reuse, and management can keep costs low and processes running. But the laboratory must commit to this process and adhere to it every moment of every day to change patient’s outcomes for the better.

Similarly, core histology equipment (unlike many clinical laboratory machines) is almost indestructible when properly managed and maintained. Laboratories in developed nations may replace this equipment when it is several years to a decade old when the equipment may have another decade (or sometimes two) left of life. Decisions to replace functional equipment are left to the individual laboratory; however, once this process occurs, functional equipment should not be left to collect dust and should be moved to a new location where it can be of value. Every laboratory considering the replacement of older equipment must ask the question, “What is the remaining functional life of this device?” If that number is many years or the often stated 70%, a plan for donation of the equipment is highly suggested.  It is this philosophy that inspired the ASCP Center for Global Health program along with many other groups to actively seek out donated, functional equipment and transfer it to nations and colleagues who desperately need it to maintain their pathology services (Do you have equipment for donation? Email us!). This is especially important because the perceived demand for histology equipment in many low-income countries is so low that manufacturers and distributors refuse to become involved with the equipment (especially with trade and tariff barriers standing in the way). But, in truth, the demand is the same per population as in any other country with at least one high volume, functional pathology laboratory needed for every 1 to 3 million people (depending on population age structure and clinical utilization).

As we begin a new year together, reflecting on what we did (and didn’t) do in 2018 and what we can (and should) do in 2019 is an iterative process that can guide us through many decisions. I hope that everyone reading this blog takes a few moments (or even an hour if you can spare it!) to delve into 2018 and really plan for 2019 with true solutions in mind for any challenges you identify. And, lastly, always take some time every day to think outside yourself and even your laboratory to others in your local community or in foreign lands. Consider what little (and big) things you can do that may improve the life of just one person other than yourself and commit to those things.

*If your life trajectory is not going the way you want, consider performing a personal SWOT (strengths, weaknesses, opportunities, threats) analysis and think outside the box about where you are and where you want to be. Don’t be afraid to make life changes or new life choices that give you a better piece of mind and stronger sense of self and self-awareness. A room full of happy people who are self-aware and emotionally intelligent can solve problems at light speed because their personal issues (good or bad) don’t get in the way. So, for 2019, I strongly encourage everyone to consider really solving (not resolving) the problems you perceive in your life so that we can all work together to solve (not resolve) the challenges we face as a society moving into the next decade.

milner-small

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

Opposites Attract

Welcome back! Thank you for the messages and shares for last month’s post about how medical professionals like us should be leading the charge to address gun violence as a public health issue. It’s a hot-button topic, but I was really glad to engage in some great conversations. I want to stick with the theme of using data to improve patient outcomes, but this time I’d like to shift focus just a little bit.

This is a longer one but, to me, there’s a lot of interesting stuff I wanted to share with all of you!

(TL;DR Path and Psych aren’t too different, but they are. There are interesting overlaps, and doing research right is really critical.)

The last month of 2018 has me rotating through my psychiatry clerkship in medical school. With that, I’ve had an interesting opportunity to look at pathology from a very distant lens. (Very distant; think diminutive picture of Earth from Mars far…) During one grand rounds session, Dr. Owen Muir, the medical director of Brooklyn Minds said something to the effect of, “[people say] Psychiatry is different, so much so that we’re the most removed from our tissue of concern.” That was pretty poignant. He was talking about the brain; in testing, treatment, and practice, it’s virtually inaccessible without a major neurologic undertaking and almost unreachable between pharmaceutical and external therapeutic interventions. Here’s the same thought another way: a neuropathologist can show you what parts of the brain do what in a particular pathologic process grossly and microscopically, while psychiatry focuses on pharmacologic, cognitive, and comprehensive behavioral therapies. A microscope versus a telescope—but both a way to focus on a problem. When I compared that to some things I heard during my orientations, it became clear that Psychiatry and Pathology might be very different animals.

I’ll get back to Dr. Muir and the Brooklyn Minds’ work with cutting-edge deep Transcranial Magnetic Stimulation (dTMS)—yes magnets—in just a minute. First I want to show you that, despite being light-years apart in distance, these two specialties overlap more than people realize. No, not with regard to behavioral stereotypes; read my previous post on stereotypes in lab medicine, and let’s get that out of the way right off the bat. The foundational concept which continues to bring every specialty closer together is translational research. Consider the following, if the field of Medicine was a tree, specialties would be complex branches and basic scientific principles would be the roots of knowledge. And what connects the roots to the branches? All the years of scientific research that translates data gathered from experimentation in fields like physiology, microbiology, or chemistry into specialties like nephrology, infectious disease, or endocrinology. Wait! That’s pretty much our job—duh. Cool, so since we translate the data, we’re all the junk in the trunk! So within the realm of research in medicine, I want to show you examples of cutting edge limitations, intersectional data sharing, and shortcomings in translational research.

Cutting edge or the bleeding edge?

So, I mentioned Brooklyn Minds. Sounds dramatic, like a movie title; but you won’t find any groundbreaking 90’s soundtrack by Coolio or a Michelle Pfeiffer-driven story about inner city youth. Instead, what their webpage outlines very nicely is the important and impactful work they do in psychiatry which includes repetitive or deep therapeutic magnetic stimulation (rTMS/dTMS). I promised I would explain the magnets thing, okay so here goes. Essentially, dTMS is a pulsatile magnet-driven energy wave directed at specific regions of a patient’s head. The energy works like a magnetic field to activate or inhibit (think “polarize” or “depolarize”) small patches of neurons within the brain, penetrating beyond the bony cranial vault and centimeters into the parenchyma of brain tissue. Using a premise which is basically similar to an MRI, patient’s brains are “mapped” for functional region analysis—a new, subtler way of looking into focal deficits. Two major mental illness that dTMS has literature supporting treatment include Major Depressive Disorder (MDD) and Obsessive Compulsive Disorder (OCD). So first, you have to understand one thing: neurons are basically our electrical circuitry, conducting energy potentials as signals back and forth translating and calculating motion, sensory input, and position. If nerves are electrical wires, think of myelin as a conductive insulator for higher signaling strength. The conduction potentials of certain mapped regions of the brain demonstrate decreased activity in particular areas with corresponding anatomical locations where we know disease processes can occur. For example, we understand the changes in brain chemistry to treat it pharmacologically, but depression has visible impacts on the hippocampus and prefrontal cortex. Why not treat this directly, like the way a surgeon would treat a hernia?

Image 4: Let’s take depression, for example. In the PET scan on the right, you can see what a “normal” brain functional status is mid-scan. On the left, however, would be a “depressed” brain. With cortisol in surge-mode and a poverty of available serotonin and norepinephrine in the brain, you can see widespread variable activity from the amygdala, hippocampus, prefrontal cortex, and beyond. (Source: Mayo Clinic)

This seems like some next-level Doctor Who science, right? So, the biggest question here would be: does this work? Since TMS (of which there are multiple types, with special equipment—not important for this discussion) is a medication-free treatment, doesn’t this sound almost perfect? Combine that with the fact that dTMS treatments often potentiate positive response for follow up treatment since the “rewiring” promotes future effectiveness and this might sound too good to be true. Studies are being published by the pound hailing this type of therapy as a potential life-saver for psychiatry which has been struggling to contribute longitudinal positive outcomes for patients. Evidence is strong for the use of dTMS in a variety of mental health issues, but it’s still early—you might find studies with large number of subjects, but you might not find ones with long-term analyses. So the research today is overwhelmingly positive and there are multiple studies in published literature about the effectiveness of this therapy in depression resistant to medication, or the utility as a maintenance therapy in an outpatient setting, or even potential use for substance use disorders. But, there are skeptics just as vocal as supporters. (Side note: If Dr. Oz does a story on a treatment like TMS, do we have to abandon it and move on completely?) As an emerging therapy, Psychology Today published a consumer report of sorts which discussed issues like access, refractory response, and more proven standard therapy like ECT (electroconvulsive therapy). Although it is FDA approved and non-invasive (minus some potential headaches), questions about TMS address things like how to get insurance to cover it, should it be reserved as a last resort after things like medications/ECT, and since it’s a relatively new treatment should we pursue more longitudinal studies first?

Image 5: Have a seat! This instrument has the potential to treat a myriad of psychiatric illnesses by using magnetic fields aimed at “adjusting” improperly firing neurons in the brain. Research still remains outstanding as to whether dTMS can affect someone’s …magnetic personality. (Source, except for my pun: Cognitive Psychiatry of Chapel Hill)

Taking it back to the source

Way back in the beginning of 2018—if you can remember such a time—an article was quietly published in the journal Science. This was a large collaboration funded by the National Institute of Mental Health (NIMH) among many other supporters, with a team that spanned from UCLA, to Denmark, to Chicago (woot!). Printed in the section header “Psychiatric Genomics,” it was called “Shared Molecular Neuropathology Cross Major Psychiatric Disorders Parallels Polygenic Overlap”—wait, what? Yes, among some major psychiatric disorders we all know, love, and read about in the DSM-5, some of them share specific genetic mutations. Full stop. Pivot. Let’s leave our Freudian couch and walk over to the lab…

Image 6: Experimental rationale and design where section (A) illustrates the model of proposed psychiatric disease pathogenesis and the authors’ (B) experimental process which they concluded was “highly suggestive of a causative genetic component” (Source: Gandal et al. 2018, Science 359, 693–697)

What these authors suggest is that five major psychiatric disorders—autism spectrum disorders (ASD), schizophrenia (SCZ), bipolar disorder (BD), major depressive disorder (MDD), and alcohol abuse disorder (ADD)—all share specific gene-expression changes which indicate transcriptional dysregulation (i.e. mutations) at single nucleotide polymorphism (SNP) locations which is very consistent with inheritable genetic variants. In short, small, specific mutations seem to be identifying features for those five disorders, which might reveal genetic risk and potential future treatment targets. Even more than this, what we see commonly as overlapping features in patients’ clinical presentations may actually be explained by overlapping genetic expression and penetrance. We’ve long had historical evidence supporting the hypothesis of mental illness as an inheritable disorder. Twin studies have shown the increased probability of expressed diseases like bipolar disorder or schizophrenia in monozygotic twins compared to dizygotic ones—but the twins’ clinical presentations don’t always yield 100% confidence there. Clinicians are acutely aware of the genetic component present in diseases like these, but targetability has proven difficult. According to the National Institute(s) of Health and Mental Health (NIH/NIMH), “strong evidence may exist for genetic susceptibility, but no specific gene has been unambiguously identified for common forms of mental disorders,” and “the estimate of the influence of environmental factors on the disorder provides an index of how difficult the search will be.” (Source: NIH/NIMH Genetics and Mental Disorders: Report of the National Institute of Mental Health’s Genetics Workgroup – Mental Disorders and Genetics: What We Know Today) That was in 1997! A similar paper to this one published in The Lancet in 2013 addressed these same five psychiatric disorders correlating some genetic components to a region on Chromosome 3 against almost 30,000 normal/wild-type patients. The NIH responded then saying that though there were significant correlations presented therein, there isn’t enough evidence to show the risk associated with the mutation and further research is necessary. Fast forward to some further research and we now see evidence of overlap between particular mental illnesses as well as cell-to-cell signaling as a specific neuropathological mechanism of disease. Is it enough for a Nobel Prize? No. But think of it somewhere between a paper titled “We’ve Discovered Insulin!” and “Patients with Diabetes Often Have Elevated Blood Glucose.”

Image 7: Evidence to suggest that certain gene expression patterns overlap which demonstrates transcriptosome similarity between various two-disease combinations/overlaps (A) and that there seems to be a spectrum or progression of disease intensity relating to a gene’s mutability (B). However, gene expression can both show that normal biologic function can be associated with these variants (C) and that, even though disease overlap implies correlation, ASD seems to mutate independent from the rest (D). (Source: Gandal et al. 2018, Science 359, 693–697)
Image 8: Hub genes are targets of research because of they are modeled as functionally significant markers of genetic variation and/or mutability. In this abbreviated data infographic, the top 20 gene hubs were collected for their association with gene activity in each of the five diseases. The functional aspects represent mutations (colored circles) in various aspects of neuronal cells including receptor activity (dark blue), mitochondrial structure (green), immune response/regulation (yellow-green), mitochondrial metabolism (purple), neuronal activity (pink and light blue), cellular architecture and growth (tan), and other neuronal metabolism (yellow). The lines connecting these mutations are a representation of Eigengene networking, which illustrate gene co-expression and functional relationships. (Source: Gandal et al. 2018, Science 359, 693–697)
Image 9: What’s the take-home message here? Basically, the final conclusion is this: take all these demonstrated mutations as functional pieces of mental health and down-regulated neuronal expressions of genes highlight potential risk stratification. Genome-wide association studies (GWAS) shows high concentrations for SCZ, ASD, and BD variants (A) and those variants presence in the neuronal model for various nerve cell types is shown (B). The main lesson here is the projected diagnostic liability and risk assessments for patients who have these specific mutations (C & D) which may be correlated to this research’s co-expression models. (Source: Gandal et al. 2018, Science 359, 693–697)

Correlation does NOT imply causation, but isn’t it so tempting!

While promising articles like these offer amazing potential insights into a deeper understanding of clinical diagnostics for psychiatry, articles are as numerous and complex as patients. An article published this month from the Journal of the American Medical Association (JAMA) Psychiatry correlated an association between hospitalization and subsequent mental disorders in children. Anything that purports to associate new causality between disease entities and trends is always worth a read. And, like any other experienced clinician, you go straight to the title and design methods to determine your gut feeling about this paper before continuing. The title: “A Nationwide Study in Denmark of the Association between Treated Infections and the Subsequent Risk of Treated Mental Disorders in Children and Adolescents;” the number of patients studied: over 1 million. What? That’s amazing! 1 million cases, what amazing data, what amazing insights, what …a statistical nightmare. Finding results in a million is both exhaustively comprehensive and statistically problematic. Black holes are rare. But if you search the entire universe you’ll find millions. “With a large enough sample size, rare things become common…” this was said with a pregnant pause and the normal gravity delivered by astrophysicist Neil DeGrasse Tyson, PhD, during a live taping of Star Talk my wife and I attended a month ago.

Image 10: From Star Talk, November 14th at the Beacon Theatre in NYC, left to right: co-host and comedian Eugene Mirman, actress Ellie Kemper, comedian John Mulaney, scientist Julie Huber from Woods Hole Oceanic Institution, scientist Kevin Hand from the NASA Jet Propulsion Lab, and co-host and astrophysicist Neil DeGrasse Tyson. The show discussed life on other worlds, and the realistic expectations of research and what to look for when you’re looking for life in space. The most poignant point of the night came during Dr. Tyson’s conclusion where he talked about different specialties growing apart and coming together over the last few hundreds of years—we used to have an isolated biologist and astronomer, where today astro-biology is a new exciting front!

What came up during that show was the same theme I’m discussing today: it’s very important to do research, collect data, and translate that data appropriately. Especially in medicine, where conclusions and results from research can affect patient outcomes, lab professionals like us need to be leaders.

Back to this paper, the authors report a strong significant correlation between hospitalization events requiring antibiotics and the prevalence of mental illness later in life. Analyzing the hazard risk ratio (HRR) for these patients reveals values usually over 1.0 which show that they are above the regular risk when compared to patients not under these conditions. The authors associate treated infections with childhood/adolescent mental disorders, but include a very important remark at the very end which is ever-present in most good research. They address the fact that results and conclusions from their data may be explained by other, non-studied causes directly because of otherwise not understood pathophysiology. And, like 99% of pathology reports I’ve seen end with a dogmatic “suggest clinical correlation,” this paper closes with something similar to “further research is needed.”

Image 11: Hazard risk ratios (HRRs) here demonstrate that individuals requiring hospitalization for infection were increased (with high confidence analysis) for having a hospitalization for any mental disorder and for redeeming a prescription for any psychotropic medication. (Source: JAMA Psychiatry 2018. doi:10.1001/jamapsychiatry.2018.3428)
Image 12: You can find tons of funny causation-correlation infographs on the internet. They prove a great point: we have to be careful how we translate our data. Without arguing that because higher global temperatures melt the icecaps pushing more sailors to a life of pillage and plunder, these two findings are assuredly non-related.

So that’s it! Using data is great! It’s the best. Translating direct and clinically relevant findings from the bench to the bedside is what we do best. Consulting with our clinical colleagues, those of us in laboratory medicine have a responsibility to make sure of four main things. First, we have to make sure that the results we obtain are clear. Pre-to-post analytical analysis is paramount to testing efficacy and we’re the experts on standard procedures and accountability. Second, the interpretation of results whether it comes from a research lab or hematology bench must be valid. Protocols and metrics are great, and using them to ensure effective use of information is critical. Third, the conclusions we reach should be meaningful. If it’s a cancer staging diagnosis biopsy report or a groundbreaking publication on shared genetic variants, the implications must provide the best information for patients. Because finally, we do what we do for them. Our work and efforts always go back to improving patient outcomes, and giving each person the best chance at maximum health and quality of life. Pathology and psychiatry might be worlds apart, but only in vocabulary at best. We’re on the same team. And, despite finding each other as great neighbors in most Medscape physician job reports, we both work very hard to lead the charge in protecting, healing, and advocating for our patients.

Wishing you good mental health! Even outside the Seattle area, fictional Dr. Frasier Crane’s “I’m listening” catch phrase is great advice toward patients, colleagues, and generally everyone. Leadership is a great responsibility, but it’s worth nothing if you don’t pay attention to what needs to get done.

Thank you, and happy holidays!

Contextual Factors of Work

Work is central to the human experience, even though the actual practice of work has continuously changed through the decades. These changes impact personal life as well, since there is a strong correlation between work life and life outside of formalized productivity. There are certain factors that influence how work is practiced that impact people’s approach to work.

The first factor is technology. Technology has significantly altered the practice and implications or work. For example, try to compare what office work was like 50 years ago compared to now, or how laboratory diagnostics were different back then. In today’s age, the majority work tasks are conducted on the computer or through technological advances: emailing, writing, analyzing, diagnosing. Fifty years ago, such tasks were conducted via phone, typewriters, or by hand. Technology has also increased the amount of information available to workers. This information allows organizations to prepare to lead in a VUCA world, namely one that is volatile, uncertain, complex, and ambiguous.

The second factor that influences work is globalization. Through the increase in technology and information as mentioned above, cultural, linguistic, and national boundaries do not impact the work environment as much as they did. Such lack of confines pushes both organizations and individual workers to be more competitive due to reduced market and job security, respectively. On the other hand, it also increases collaborations and opportunities to help others. For example, through telepathology, we are now able to provide diagnostics to people in places that do not have access to local laboratory services.

The third factor that has an impact on work is the psychological contract between worker and employer. During the industrial age, this contract was mostly stable and predictable and was based on the assumption that if workers performed well, had integrity, and were responsible their work created a sense of connection. In today’s work culture, this contract has shifted towards a focus on self-development, experience, and personal long-term goals instead of a long-term relationship between worker and employer.

Lastly, a factor that influences work is the knowledge gap. Since many of the unskilled jobs are now conducted by computerized machines, employers will rely more on workers with specific skills and knowledge. However, educational opportunities are not equally distributed and the lower classes are at a clear disadvantage.

It is important to understand these factors when working with people from different educational, technological, and cultural backgrounds. All these factors influence people and how they perform their jobs.

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-Lotte Mulder earned her Master’s of Education from the Harvard Graduate School of Education in 2013, where she focused on Leadership and Group Development. She’s currently working toward a PhD in Organizational Leadership. At ASCP, Lotte designs and facilitates the ASCP Leadership Institute, an online leadership certificate program. She has also built ASCP’s first patient ambassador program, called Patient Champions, which leverages patient stories as they relate to the value of the lab.

Training and Competency: They’re the Same Thing, Right?

As a fitting end to my previous 3-part series on how to prepare for and survive your regulatory inspections, one of the hospitals we provide consulting services to was just visited by The CAP. Overall we did great and I’m proud of everyone there, but the inspectors found a weak area for us to improve upon that others may be struggling with as well: documentation of training and competency.

It is a common misnomer that training and competency are equivalent and essentially the same thing. Whether you’re subject to CLIA, CAP or your local state DOH requirements, you will be required to provide proof (documentation) of both training AND competency for each employee, for each task that they perform. This is not just limited to your technical staff, but also includes non-technical personnel (phlebotomists, lab assistants, LIS personnel,transport couriers, etc.), as well as staff outside of the immediate laboratory testing area (respiratory clinics with blood gas analyzers, Point of Care testing, etc.).

Simply put, training is coaching, mentoring, and teaching someone step-by-step how to perform a specific task. Proper documentation of this training includes:

  • Objectives for the training (i.e., “After completing training, staff will understand howto successfully perform maintenance tasks on the hematology CBC analyzer.”)
  • Identification of the methods to be used during the training (direct observation, monitoring recording & reporting of results, review of worksheets & preventive maintenance records, evaluation of problem solving skills)
  • Identification of the materials to be used during the training (cleaning agents, QC samples, previously tested & scored proficiency testing material)
  • Criteria used to assess the effectiveness of the training (minimum score of 90% on critical thinking quiz, ±10% correlation with previously tested sample)
  • Signature of both the trainee and trainer confirming that training was completed, and when

In addition to the obvious routine tasks a lab professional will need to perform (running QC, instrument maintenance, running patients), don’t forget to document their training for the low frequency tasks performed as well. Based on an employee’s job description, they may be involved in additional tasks such as specimen handling, safety precautions, packing and shipping of samples to reference labs, computer system training, telepathology training, and supervisory functions. These tasks too will require documentation of training.

Documentation of all of these tasks can be organized through the use of a departmental orientation checklist. This will help you keep track of what each staff members’ specific job junctions will include that they need to be trained on, and which tasks have been completed by each trainer. Depending on the task, training can be completed quickly after several minutes of demonstration (waived urine hCG testing), or may take several weeks for staff to fully understand and master the task (flow cytometry leukemia work-up). Keep in mind that until a staff member has documented training followed by successful assessment of competency of that task, they should not be permitted to perform or result patient testing independently of their trainer.

Once training has been completed and documented, you must then assess each staff member’s ability to successfully perform these tasks. This is their competency, where you assess if the training was successful and staff are able to perform each assigned task correctly. To fully demonstrate successful competency of non-waived tests, all 6 of the following elements must be documented for each employee, for each task:

  1. Direct observation of patient test performance, including patient identification, specimen collection, handling, processing and testing.
  2. Monitoring the recording & reporting of test results, including when appropriate the handling of critical results.
  3. Review of testing worksheets, QC records, proficiency testing results, and preventive maintenance records.
  4. Direct observation of performance of instrument maintenance and function checks.
  5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
  6. Evaluation of problem-solving skills.
  7. Observation of compliance with safety protocols (based upon your specific local state DOH regulations).

The documentation of your competency elements should include the date each item was evaluated, as well as a way to identify and recreate the test performance if asked by an inspector. This is most easily accomplished with the specimen ID number, or PT survey name so records can be located or reprinted.

Be mindful of your local state regulations regarding the specific requirements for who can perform a competency assessment. In many cases, assessors will need an additional supervisor competency for themselves to confirm they are able to successfully assess the performance of their peers. If weaknesses are identified during the competency assessment, additional training should be performed with appropriate corrective actions documented. Competency should be reassessed to ensure staff are correctly performing all duties, prior to them resuming patient testing.

So to summarize:

During training, I am showing you how to do something. I will document all aspects of the training steps that I reviewed with you. When I assess your competency, you are showing me that you know how to do the task correctly. You will document your results as you were trained how to do, and I will validate the accuracy of your work.

-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.