A Year in the Life of a Hematology Laboratory

As this year comes to a close and we look forward to celebrating holidays with family and friends, we can also celebrate our accomplishments over the year. Our jobs in the clinical laboratory are vital in helping physicians make clinical decisions and we should celebrate the role we play in healthcare. In hematology, techs are busy doing daily tasks; QC,maintenance, and analyzing all the samples that come into the lab, 24 hours a day, 7 days a week. We work constantly to provide physicians with accurate and precise results in a timely fashion. But, what else goes on in hematology?

This past year has seen many changes and challenges in our hematology lab. In February, we switched our hematology analyzer to a new Sysmex system,and went to autoverification at the same time. This was a process that had begun months before with meetings with the Sysmex team, building rules for WAM,validations, training key operators, as well as site surveys and actual planning for the location of the instrument and water and electrical connections. Before we went live, new procedures had to be written and all techs had to be trained on the new system. Every tech in the department had to do competencies, everything had to be documented and the new procedures had to be signed. This doesn’t stop once the instrument is in use. There has been a continual learning process since then as techs become more familiar with the system.

During all the excitement and work involved with a new instrument, we, as have many labs, have had turnover in staff which has led to its own challenges. Techs have retired, moved out of state, been on maternity leave and have left us for other opportunities both in other areas of our lab and elsewhere. New staff needs to be hired and trained. Students need mentors during their rotations. It’s a cycle we go through every year, a never ending process. And, no sooner had we seemed to have everyone trained, then it was time for 6 month validations and competencies.

In September we moved to new Coagulation instruments, which, fortunately, was not as big a change as our Sysmex analyzers, because the coag instruments are newer versions of instruments we already used. Yet, there were validations to be done, training to be done on the new software, and procedures to write, all at a time when we were about to go live with a new LIS!

Perhaps our biggest project of the year came to fruition in September when we moved to Epic for a hospital wide software system. This was an undertaking which was well over a year in the making. Again, this transition involved many months of meetings, working with Epic and our IT department to create test codes and profiles and to build the system to our needs. We worked with Sysmex and WAM support to verify that there would be a smooth transition from the old system to the new. The month before go live, we did wet and dry testing of every possible scenario and tested every rule in WAM. And then we tested every rule in Epic. Many hours and late nights were spent entering test orders, creating spreadsheets, taking screen shots, and going back and forth to IT for changes and updates. An integral part of this Epic journey was more training for employees. Superusers were trained, training sessions were held for all, and then superusers helped to support other users at Go Live. And, of course, all of this this meant more procedures had to be written. The epic day arrived, and though things didn’t seem too smooth at first, the support teams were and continue to be available to help and make changes as necessary.

These are just a few of our particular challenges this year in the department. Even without these added projects, though, there is a lot that goes into operating a hematology laboratory. Every week, every month and every year, there are ‘extra’ or ongoing projects to be completed in every laboratory department. While we had some major changes this year, there were also many smaller ones. There are always new pieces of equipment that need to be validated, and new procedures or job aids to be written. Quality control has to be monitored, calibrations have to be performed, new lots need to be entered and tested, linearities have to be done. CAP surveys need to be assigned,reviewed and submitted. Inventory needs to be taken, vendors need to be met with or contacted and supplies need to be ordered. Equipment repairs ,troubleshooting and maintenance all need to be addressed. Training doesn’t stop at new hires and students. All techs have to complete annual competencies. Every year instruments have to be validated, new lot crossovers have to be done, and all procedures must be reviewed and updated. We need to get ready for inspections, or perform self-inspections. I’m sure I am leaving out a list of things, but this is a brief overview of all that goes into laboratory operations. It’s certainly more than just analyzing samples!

Who does all these ‘behind the scenes’ tasks? The department supervisor or technical specialist may be designated to make sure these are all completed, but often senior techs or career ladder techs can play an important role in meeting all these requirements. Many hospitals now have career ladders that allow techs to use the designation MLS II or III or MLT II or III. Our laboratory started such a program this year. For anyone interested in moving up the career ladder in their laboratory, there are many opportunities to be involved in lab operations and management. All the tasks that are required to run a lab cannot be done by one person alone. Tier program requirements differ from hospital to hospital but may ask candidates to submit a tier application and complete a list of achievements to show their commitment to the laboratory and their community before being designated a tier II or III.

Tier techs are generally required to meet education and certification requirements. They should be pro-active performers who are seen as leaders with excellent customer service skills. A tier level tech is a proficient performer with strong critical thinking and problem solving skills. They are mentors to coworkers and can train staff and perform competencies. Hospitals often look to these techs to contribute to the growth of the profession outside of the lab, as well. Being laboratory science community ambassadors, performing community service and upholding the mission and values of your facility all constitute qualities a hospital looks for in a tier tech.

Does this sound like you? We are constantly in need of techs to aspire to working in supervisory positions and management. With an increase in age of supervisors, managers and administrators, we are seeing an increase in retirements. We need more techs doing routine bench work to take the initiative and the steps to become tier techs and lead techs. We need aspiring supervisors and managers. Why wait? I encourage you to make a New Year’s resolution to seek out your facility’s tier or career ladder program. If one doesn’t exists, make it a project to see if one can be introduced!

Laboratories are often hidden in the basement, out of sight of visitors and out of mind of the general public. When we mention we work in a hospital, people ask “Are you a nurse?” Even though we may not be a well-known profession, we are a very important group of dedicated scientists and can be very proud of our accomplishments and contributions. I thank my supervisor and mentor, Gene Galligan, for her encouragement and support of the tier program and for all the things she has taught me in this very busy year.

PS: As I wrote this, The Joint Commission team arrived to start their accreditation process. There is never a dull moment in the laboratory!

Happy New Year!

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

Safety for the New Year

While it doesn’t seem possible, another year is drawing to a close. At this time of year, I often ask my clients what they have worked on or what they have accomplished with regard to laboratory safety in the past twelve months. Sometimes they can readily answer, especially if there was a major project that took a big chunk of their time. Other people, though, struggle with an answer wondering if they did indeed accomplish any of their safety goals. I contend that we all have had successes and achievements, though, but we might need to dig a little deeper to find them.

Regulations in the realm of laboratory safety did not stay the same in 2018, and if you kept up with any of them, you made some progress. For many U.S. states, the beginning of the year brought about the Environmental Protection Agency’s Generator Improvement Rule (GIR). Among other things, this new set of regulations changed how labs (and other departments) label their waste containers. All hazardous (chemical) waste containers must now be labeled with the exact words “Hazardous Waste,” and there must be a description of the waste as well as some form of a hazard warning. That warning can be in the form of a pictogram or even a NFPA/HMIS warning legend. The GIR also now allows Small Quantity Generator sites to dispose of larger amounts of waste twice per year without needing to upgrade their EPA status to a Large Quantity Generator.

The College of American Pathologists (CAP) added some standards that affect lab safety practices as well. One new requirement includes the need for a laboratory security policy. Labs need to state how they restrict access of personnel into the area, and they need to spell out how to handle visitors to the department. Other new regulatory standards include the need for the safe handling of liquid nitrogen and dry ice. Labs must provide proper training and PPE for the handling of these dangerous materials, and there is even a new requirement for the placement of oxygen sensors where liquid nitrogen is used. If your CAP inspection window opens soon, you have probably already made these changes.

While keeping up with regulations might be your goal, sometimes lab inspection results can spur you on to making accomplishments for the advancement of safety. In one lab, an inspector found a freezer full of patient samples that were mixed with methanol. The freezer was not designated as explosion-proof as required by NFPA-45, the Standard on Fire Protection for Laboratories Using Chemicals. Upon further investigation, the lab safety officer found a few other freezers and refrigerators which were storing flammable materials inappropriately. This led to re-arranging some materials, and it also led to the purchase of more explosion proof units where needed.

Another lab received an OSHA inspection and received a fine for not following the training requirements of the Bloodborne Pathogens standard. The regulations state that during staff training, there must be an “opportunity for interactive questions and answers with the person conducting the training session.” Most labs offer an annual computer-based training for Bloodborne Pathogens, and that does not satisfy OSHA inspectors. The lab that was cited made a change to how the mandatory training program was offered, and they created a method for which staff could ask questions of the trainer. This was another example of an inspection which helped the lab make safety improvements.

In the world of lab safety, it sometimes feels like simply surviving day-to-day is the accomplishment. We’ve put out fires, we’ve responded to questions, and we’ve submitted our required monthly injury and exposure reports. It may feel like performing the job is simply a reaction to what is going on each day, and that is difficult for the lab safety professional. We realize that being proactive is better, we know that is how we decrease employee harm and improve the safety culture. However, I invite you to take a second look at your past twelve months. Yes, it may be that changes were made because regulatory agencies altered the standards- but there is no way to predict that unless you sit on the decision-making board of those organizations. Yes, you might have had to respond to inspection citations, but isn’t it good to have another set of eyes helping you to make safety improvements? Try not to always think about why safety improvements were made. Instead, remember to view them as positives- they are another step to improving safety the way you do it every year. They are truly accomplishments, and as you approach the new year, you can use them as stepping stones toward your next safety goals.

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.

Lab Value Changes in Transgender Females

For our next edition of transgender laboratory medicine, we will explore how transgender women use hormone therapy to physically transition to their affirmed female gender. While transgender men just take testosterone, transgender women take both estradiol and an anti-androgen. In the United States, that anti-androgen is spironolactone.

Figure 1. I was amazed in freshman biology by how structurally similar these hormones were and how they lead to such dramatically different phenotypes. Spironolactone is quite a bit different with the same cholesterol backbone. Credit Wikipedia

Estradiol is administered either as an oral pill, an injectable liquid or a transdermal patch. The estradiol pills are the cheapest option as they have been made generic for use as birth control. The transdermal can be the easiest to use, but is also the most expensive version and may not deliver as much estradiol as the other routes. Oral estradiol usually starts in adults at a low-dose (2 mg) then is titrated up to 4-6 mg and rarely up to 8mg. The end-point of estradiol titration is not to reach a certain hormone level, but to achieve desired physical traits. Endocrine guidelines do suggest keeping estradiol levels below peak physiologic levels (200 pg/mL).While little evidence currently exists for side effects of supraphysiologic estradiol, blood clots are a serious known side effect.

Part of the reason for anti-androgens in treating transgender women, is that even in women, testosterone levels are orders of magnitude higher. Spironolactone is primarily used as a glucocorticoid analog to block the mineralocorticoid receptor in the kidney to induce diuresis while retaining potassium. The structure of spironolactone is similar enough totestosterone that it also binds the androgen receptor and blocks the effect of testosterone. While enlarged breasts are considered a side effect in heart failure patients, it is an intended effect of spironolactone in transgender women. While hyperkalemia (high potassium) is a well known adverse effect of spironolactone, it seems to manifest more in patients with co-morbid conditions such as heart or kidney failure rather than in healthy patients.2

Table 1. This table describes the time frame of physical traits that manifest in transgender women while taking feminizing hormone therapy. Based on Hembree et al. 2017 (1).

For feminizing hormone therapy, red blood cell indices are the one of the most responsive laboratory parameters. The hemoglobin, hematocrit, and RBC number are all seen to decrease during hormone therapy in transgender women. A previous study of 55 transgender women3 showed that hemoglobin levels decreased significantly from cis-gender male levels to be not significantly different from cis-gender female hemoglobin. With a larger patient group, we were able to confirm this previous finding of decreased hemoglobin, but transgender women’s hemoglobin levels are still significantly different from individuals with sex-assigned female at birth (Figure 2).

Figure 2. A. Figure from Roberts et al 2014. B. TW= Transgender women, Baseline TW= TW with no history of hormone therapy, Baseline TM= transgender men with no history of hormone therapy. ***p<0.0001 Data expressed as interquartile range with median (box) and 2.5th to 97.5th percentile (whiskers).

Roberts et al also found that creatinine levels remain closer to cisgender male levels compared to cisgender female creatinine values3. This brought up the concept that not all lab values change predictably to the reference interval of the opposite gender. We further confirmed this finding in our larger cohort, but we further found a significant difference in transgender women from their baseline levels (Figure 3).

Figure 3. A. Figure from Roberts et al 2014. B. TW= Transgender women, Baseline TW= TW with no history of hormone therapy, Baseline TM= transgender men with no history of hormone therapy. ***p<0.0001 Data expressed as interquartile range with median (box) and 2.5th to 97.5th percentile (whiskers).

Overall, red blood cell and creatinine levels change the most in transgender women taking hormone therapy, but they don’t go as far as being comparable to lab values of individuals of the opposite sex assigned at birth. Our summary of this data will be published soon and interested labs can note what we found to be the central 95th percentile of common lab values including those presented here. I will go into greater detail about some unexpected effects of hormone therapy in following blog posts. I hope you’re looking forward to it as much as I am!

References

  1. Hembree WC,Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer WJ, Murad MH, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society*Clinical Practice Guideline. J Clin Endocrinol Metab. 2017
  2. Roberts TK, Kraft CS,French D, Ji W, Wu AHBB, Tangpricha V, et al. Interpreting Laboratory Results in Transgender Patients on Hormone Therapy. Am J Med. 2014;127:159–62.
  3. Plovanich M, Weng QY,Mostaghimi A (2015). “Low Usefulness of Potassium Monitoring Among Healthy Young Women Taking Spironolactone for Acne”. JAMA Dermatol. 151 (9):941–4. 

-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.

On Lab Medicine: A Model for Quality Improvement

What do gopher holes have in common with quality improvement? More than you might think! In a paper available on Lab Medicine’s advanced access, Dr. Yaolin Zhou writes about a novel framework for quality improvement initiatives called EPIDEM, or “explore, promote, implement, document, evaluate, and modify.”

Read the paper and let us know what you think! 

Working with Traditionalists: How Other Generations Can Adapt

Traditionalists are the oldest working generation in today’s professional environments. They bring a wealth of information, knowledge, and experience with them. Therefore, organizations that work with Traditionalists either on their staff or on their Boards are fortunate to have access to their input. In order learn as much as possible from this generation, while they are still present in the workplace, it is critical to know and understand their preferred way of communicating, leading, and working. It is also important to know how and when to adapt your own preferred communication, behavioral, and leadership styles to meet the needs and preferences of this
generation.

Typically, Traditionalists prefer face-to-face communication. They grew up with limited communication technology and they prefer to connect in person when possible. If you cannot communicate in person, pick up the phone and call them. Not only is this respectful to their own preferences, it will allow you to increase your verbal communications skills when there is no written form used. Having a personal touch is important, so try not to talk business right away but take time to get to know one another.

When meeting with Traditionalists, some formal protocol is appreciated. Have someone else introduce you, or if you are in charge of the meeting make sure to introduce everyone properly. You can add a personal touch if appropriate. For example, say “This is Betty Jones. She is the current President of our Board of Directors and has been a member of our organization for over forty years. She is here to provide us with strategic details about our new direction. Also, she is an avid fly-fisher!” Additionally, pay attention to meeting protocols such as offering something to drink and sending the agenda ahead of time so that they can prepare. This is, of course, good to do with everyone, but Traditionalists respond especially well to such protocol.

Their leadership style is based on a chain of command and creating contingency plans. They dislike indecisiveness, disrespect, profanity, and poor dress. They appreciate a sense of formality and high quality work. I always think about how Traditionalists dressed, and sometimes still dress, when going on a plane. They dressed very formal, especially compared to today’s travelers. Keep this in mind when meeting with them in person. Forego the jeans and sweaters and wear something more traditionally professional. Finally, use formal address, such as Sir, Doctor, and Madam. Again, the more professional protocol you use, especially in the beginning, will set you up for success when working with them.

Personally, I learned and witnessed that if you include this generation in inquiry-based conversations and discussions that you can learn about additional leadership approaches to increase your own adaptability. Learn from other generations as much as possible, especially the ones that are currently leaving the workforce. There is a lot to be gained from generational diversity and increasing your own ability to meet the needs of every generation in the workplace.

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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.


At the ASCP Annual Meeting this October, I had the privilege of facilitating a Roundtable Discussion about diversity in the workplace. I anticipated that we might be talking about issues such as culture, religion, gender, ethnicity, educational level, ability/disability and possibly age and generational issues. I was anticipating a very rich and “diverse” list of topics for this discussion.

To my surprise, generational differences was the primary topic for this Roundtable Discussion. There were nine people at our table with representation from both sub-sets of the Baby Boomer group, as well as, the Gen Xers, and Millennials (Gen Y). There seemed to be a strong disconnect between the Millennials and Gen Xers and the older people in the lab, meaning the Boomers and Traditionalists.

The Traditionalist generation only represents about 5% of the workers in clinical labs, however, the Baby Boomers still represent about half of the work force in the clinical labs. The strongest point of dissention seemed to center on “work life balance.” There was clearly a lack of knowledge and understanding on both parts. Baby Boomers are known for their work ethic and learned well from their Traditionalist’s parents and role models. They identify with their job, profession, and career. This is why we still have Traditionalists and Boomers working in the laboratories. They possess the institutional knowledge, relationships, and a strong sense of loyalty.

The Gen X and Y “work life balance” issue collided with the strong sense of work ethic characterized by the Traditionalists and Boomers. However, once each generation were able to share what they valued, there was a light bulb that appeared at the table and the bridge of understanding began to be built.

So what’s the key to collaboration? It’s all about talking with each other and asking good questions. The Traditionalists can learn from our Gen Xers and Millennials and focus on work life balance. Just as it is important for the Gen Xers and Gen Ys to learn about the institutional knowledge and work practices that can be gleaned from the Traditionalists.

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-Catherine Stakenas, MA, is the Senior Director of Organizational Leadership and Development and Performance Management at ASCP. She is certified in the use and interpretation of 28 self-assessment instruments and has designed and taught masters and doctoral level students.  

In the Line of Fire: Transforming Data into Decisions

Hello everyone. Back again!

This time, I’ve got something to talk about that’s a little more serious. I don’t like to deviate from fun lab-related memes and insights,but every now and then something really strikes a chord. Enough so to talk to all of you about it. Some of you reached out to me after my post discussing clinician burnout and suicide in healthcare and that felt great; connecting with people who had some powerful stories to share really validated that conversation. Today, I want to talk about guns. Specifically, the public health epidemic of gun violence, the current conversation about whose “lane” (read:responsibility) belongs to whom, and what role those of us in laboratory medicine play.

I was horrified to see the recent shooting and murder of three in my Chicago home at Mercy hospital in the Near South Side. I won’t rehash the details that are on the news. Emergency resident physician Dr.Tamara O’Neal, newly minted Chicago Police Officer Samuel Jimenez, and pharmacy resident Dayna Less were all shot and killed point-blank by a gunman in the Mercy Hospital emergency department. A place that is supposed to be for healing, safety, and hope. Senseless.

Image 1. Victims of the Mercy Hospital shooting: (L-R) emergency room Dr. Tamara O’Neal, Chicago police Officer Samuel Jimenez, and pharmacy resident Dayna Less. These were all new to their careers, whose lives were abruptly ended by senseless gun violence. Source: ABC7 Chicago.

This now presses the start button on America’s newest tradition: a very short-lived, ill-timed, and often tone-deaf debate about the firearm subculture in our nation. Okay, bias check: you should know that I am not a fan of guns of any kind. If it were up to me, they would either belong in museums or find more useful lives melted and repurposed as metal used to reinforce hurricane-prone buildings or safe hypodermic needles for patients in need. That said, this isn’t a gun debate article; nor is it an open forum to discuss gun control, the second amendment, the NRA, or anything political. I respect opinions and educated civil discourse, but this piece today is focused on health—public health.

The epidemic of gun violence in America is a problem. The American Public Health Association (APHA) posted on their website extensively on the topic of gun related deaths which “kill more than 38,000 people and cause nearly 85,000 injuries each year. As a longtime advocate for violence prevention policies, APHA recognizes a comprehensive public health approach to addressing this growing crisis is necessary.” (Read their fact sheet here)Furthermore, the American College of Physicians (ACP) published a position paper on the topic in the Annals of Internal Medicine journal (read it here)where they establish a comprehensive set of recommendation from a conglomerate of clinical medical specialty organizations. Increasingly now more than ever does this prevalence of gun related injury and death present itself as a major health concern: a public health epidemic. I could talk to you about the number of mass shootings in our country, or the epidemiologic incidence of gun-related deaths compared to other countries, even the policy discussion around gun ownership and regional policies regarding safety and gun control—it doesn’t matter. All the charts and graphs any recycled article on the subject will just fade into the mist of “yet another shooting.” That’s not okay. I don’t want to drown you in data. Better put, I can’t. See, the problem is you’ll see the same pieces of information regarding the gun debate as you scroll through the news on your social media. Something new I want to add to this conversation is the overwhelming emphasis on the simple truth that this is a public health issue.

Image 2. In the US, we fund approximately as much research for gun violence as we do for drowning and falls. Of the three, mortality related to gun violence is about the same as sepsis—and that’s heavily documented. Source: Journal of the American Medical Association.

This unfortunate new reality is no different from other public health programs that have addressed various issues over the past decades. What do deaths from motor vehicle accidents, fires, smoking-related ung cancer, obesity and type 2 diabetes, heart attacks, antibiotic resistant bacterial infections, and traumatic brain injuries have in common? Per the American Foundation for Firearm Injury Reduction in Medicine (AFFIRM), they were all public health crises that pushed medicine past a breaking point in clinical burden and forced us to invest in research which conclusively provided results to address related mortality and morbidity. AFFIRM is a non-profit organization which is building a coalition in medicine for the purpose of researching and addressing this newest public health issue. They argue that,without medical evidence we won’t be able to find solutions to the senseless loss of life from gun violence. Death from car accidents gave us the seatbelt and tickets for disobeying its required legal usage. Death in home fires got us the smoke detector and regulations surrounding their installation. Lung cancer deaths led to smoking cessation programs, increased taxation, and policy changes regarding access to cigarettes. Sugar-related morbidities created a conversation about healthy diets, public policies addressing food deserts, and taxation programs for drinks with added sugar. Heart attack deaths gave us longitudinal studies for best care practices and lifestyle recommendations.Resistant bugs established a new discussion on antimicrobial stewardship. Brain injuries gave us new guidelines for concussions. I could go on. That’s only the tip of the public health iceberg. The point is that if there is an epidemiological trend where people are literally dying, data married with health metric-oriented research create solutions!  

But let’s add deaths from gun violence to that list. What then do they all have in common, besides the concern for improving public health? Save for the tragically evident lack of a solution, the similarity becomes clear: there is lobby, interest, power, and support. Cars didn’t always have seat belts, cigarettes used to be cheap and doctors used to smoke at work,no one talked about cheeseburgers giving you heart attacks and diabetes decades ago, and helmet-clashing football players didn’t always receive the treatment they needed. Why? Because some entity—corporate, societal, etc.—wasn’t keen on“buying in.” Much like it takes justification and convincing for administration to buy your fancy chemistry analyzer, so do the public and oppositional lobby groups which require swaying toward the intervention(s) being proposed.

Image 3. The Dickey Amendment passed in 1996 was a small rider in a bill that was part of a larger budgetary spending bill. Effectively, it completely disallows public health research into gun related deaths, gun violence, or any publication that would endorse gun control or limitations. Source: 104th Congress.

Often, the data stacks high enough to influence decisions on its own. But that isn’t the case with gun related mortality. I see gun related violence as sort of the opposite of the vaccine debate: with the flu shot there seems to be too much data and not enough stories to convince the anti-vax movement to realize the significant threat being addressed. On the other hand, gun related violence exhibits far too many stories without any significant amounts of data. Possibly, this might be related to the limitations placed upon the CDC since the mid-1990’s that forbid them from using funds “to advocate or promote gun control.” Yes, really. Just last month, I wrote about the newest advancements in influenza testing and the best practice of vaccinating annually.I cited thousands of deaths related to vaccine-preventable or epidemiologic illness; 80,000 dead from influenza last year, thousands from swine flu over a decade ago, etc. But when you try and cite proper, medical data regarding guns in public health, its … not so easy. No data, no research. No research, no change.

Many of you have undoubtedly read about the current social media “discussion” regarding whose “lane” gun violence is to navigate: The National Rifle Association (NRA) asserted in a tweet that doctors, discussing the issue only within their field should leave it to more “qualified” groups like them. That’s been a tinder box of vitriol the medical community, for lack of a better term, is up in arms about. I followed and read tons of comments about this as it unfolded, hearing from endless doctors, nurses, and laboratorians posting with blood spattered scrubs, decimated trauma bays, and emptied blood bank refrigerators that this growing epidemic is enraging clinicians about. Earlier, I highlighted similarities between public health problems and their respective solutions citing that they all shared oppositional lobby groups. What better profession to handle the topic in question than medicine—whose associated lobby power from professional societies like ours to Big Pharma amass one of the largest voices in policy making in America. And another thing, as gun violence is a public health concern, whose literal job is it to address health, mortality, and morbidity? All of ours. Nurse educators lead patients through lifestyle modifications they can employ to curtail some effects of diabetes, physicians manage patient treatment regimens balancing input from pharmaceutical tools to professional guidelines,clinicians like us strive to provide the best resources available by advancing hemoglobin A1c levels or point of care testing. We all play roles in every single healthcare matter that translates to life or death, so why not this one?

So, I touched on it a little here, but what role does the medical laboratory professional play? Besides bullets in tissue section, how does the public health epidemic of gun violence reach the lab? I wasn’t so sure, until I read a story about Dr. Julie Melinek, a forensic pathologist with UC Davis and the Alameda County Sheriff’s Department. In response to the NRA’s“stay in your lane” tweet regarding gun deaths, Dr. Melinek tweeted “Do you have any idea how many bullets I pull out of corpses weekly? This isn’t my lane. It’s my [expletive] highway.” She proceeded to turn her phone off and work for a few hours. When she returned, things were viral. In an interview with Medscape, she discussed this story and the topic at large with editor-in-chief Dr. Eric Topol. She talked about the epidemiologic role clinicians of all specialties play in risk assessment and harm reduction,saying “…if we see something that’s dangerous for the pediatric population,like a toy that breaks apart or is a choking hazard, we report it to the Consumer Product Safety Commission and it gets recalled because it’s a hazard.”She and Dr. Topol explored the ways clinicians can advocate for patients and public health at large, concluding with some poignant words, encouraging those of us in medicine to reach out to elected officials. The internet facilitates such an easy way to communicate, she says that it becomes paramount to voice the opinions held within the medical community to those in policy-making; especially clinicians who may own guns or be active NRA members! Because, ultimately, this isn’t about gun ownership or second amendment rights—its about the health, well-being, and safety of our patients.

Dr. Melinek represents a single voice within the pathology community. You’ve read my posts about lab management values, interdisciplinary team work, attainable goals, and utilization of data to make clinical decisions. Those of us in lab medicine find ourselves at the forefront of translating data into decisions. When quality control measures on instrumentation fail to correct after countless interventions, do we continue running assays? No! We work-up and investigate what root cause is the problem and fix that if possible; thinking outside the box, looking at lesser-than-obvious causes, investigating all possible solutions, etc. In pathology we’re the first to implement new, highly advanced tests and corroborate with other specialties about what the new changes mean for patient care and management of diseases (i.e. 5thgeneration high-sensitivity troponins and evolving to a new standard of care for acute coronary syndromes). We’re also the first to notice trends that impact patient outcomes and the first to provide solutions: think back to the last time you spent a few minutes reading your labs metrics and goals posted somewhere at work. Dr. Melinek collecting bullets from her autopsy patients is no different than forensic pathologists historically noting trends in mortality statistics, iatrogenic, environmental, and other causes of death.And, when those trends get published and presented, they call for further research and investment into public health interventions that may prevent those deaths in the first place. Pathology, public health, epidemiology, and laboratory medicine are built for this. We’re the tangible bridge between what gets discovered and what gets researched. We’re also in a privileged position to have a bird’s eye view of a larger clinical, epidemiologic picture as pathologists see populations of patients.

In a recent Lablogatory post, ASCP’s Lotte Mulder (ASCP Leadership Institute and Patient Champions programs) wrote about Moral Capacity, Courage, and Resiliency. Specifically, she said “It is not enough to understand and recognize a moral dilemma, it is important to act on it… it is critical for leaders to understand that culture influences moral and ethical behavior.” If America’s gun violence problem is one that desperately needs data, then why shouldn’t we, then, be professional and cultural leaders and advocate through data collection, analysis, and translation like we always do? Let’s use our tools and our talent for lab medicine, in partnership with the growing coalition of clinical professional specialties, and cultural humility for the populations we protect, and address this once and for all.

Thank you.

–Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student actively involved in public health and laboratory medicine, conducting clinicals at Bronx-Care Hospital Center in New York City.

Regulatory Inspections: Are You Ready?

Part Three: The inspectors have left – now what?

In the previous 2 blog posts we discussed how to prepare for your inspection, and what to expect during the inspection itself. In the last of our 3 part series on regulatory inspection preparedness, today we’ll be covering what to do after the inspection ends.

Throughout the inspection itself, the inspectors should be communicating any issues or citations they uncover; ensure that your management staff is taking notes on any of these potential findings. Based on these notes, you should start working to address and correct any issues right away. Formal documentation regarding the nature of any official citations can take several weeks to receive back, depending upon the regulatory agency performing the inspection. Waiting for the formal report to begin making corrections will reduce the time you have to form a plan of correction, and can further impact patient care depending upon the citation received.

Have a Plan. Draft a spreadsheet to record: 1) each issue identified, 2) laboratory department(s) it was found in, 3) associated risk factor (patient care or safety issues = 1, regulatory requirements = 2, recommendations = 3), 4) staff member assigned to investigate and correct the issue, 5) due date for investigation response, and 6) status of the investigation (in progress, on hold, completed). Share this spreadsheet with your management team, and review at weekly/monthly staff meetings for updates on progress completion.

Risk 1 Issues. The safety of your patients and staff, along with ensuring accuracy in testing results is the number one priority of a laboratory. If the inspectors identified any weaknesses in these areas, they should be addressed first. This would include items such as staff not adhering to required safety precautions, not following manufacturer requirements for quality control testing or instrument maintenance/calibration, lack of follow-up for QC or proficiency testing failures, along with any other finding which questions the integrity and accuracy of the testing being performed.

Risk 2 Issues. Double check the regulatory standard to ensure you fully understand the requirements, and that you have appropriate evidence of compliance. As the testing activity menu and complexity of testing increases, the amount of documentation requirements can increase as well. Even with a paperless system, it is easy to overlook a signature of review or checkmark on a log. “If it’s not documented, it wasn’t done.” For simple administrative oversights, review your current processes to identify any gaps or areas that can be improved upon to ensure all documentation is properly filled out each month. If the inspectors noted a discrepancy between your current policy and how staff are actually performing a test, review the testing process to see where the true discrepancy is – is the policy outdated and needs to be revised, or do staff need to be retrained on the current policy with competency assessed for compliance?

Risk 3 Issues. Inspections are a great opportunity for further education for all those involved, both the inspector and staff being inspected as well. For some regulations, there is no one set way that must be followed in order to demonstrate compliance with a requirement. Hearing how someone else is meeting the requirements may spark an innovative idea from your own staff on how your current processes can be improved. Be open to hearing new ideas, and find ways to implement those which you feel would be successful at your institution.

Evaluate All Sections of the Lab. When investigating a finding in one laboratory department, ensure that any process improvements are shared across all areas of the lab. Just because microbiology didn’t get caught with expired reagents like hematology did this inspection, doesn’t mean that they aren’t at risk for future inspections.

Focus on the Positives. Congratulate and recognize your staff on their successes in the areas you performed exceptionally well in. It’s a joint effort to ensure the lab is inspection ready; be sure to pass along any compliments received throughout the inspection process to all levels of staffing. Focus on what you’re doing well and how you can continue to maintain those processes and implement them in additional areas.

A little bit of preparation ahead of time will make the inspection process smoother and less stressful for all involved. When viewed as a learning experience and opportunity for improvement rather than a visit from the “lab police”, laboratory inspections can be a useful tool to confirm the quality of your overall laboratory program.

 

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-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.