management/administration

The Power of the Pause

The majority of laboratory injuries and exposures are preventable, and most of them occur because staff is not paying close attention to the situation. They lose their situational awareness or were never paying attention to it from the start. Unfortunately, lab safety professionals spend much of their time investigating such incidents rather than being able to prevent them. If laboratory staff could understand the power of the pause, labs would have fewer dangerous incidents.

One illustration of that power can be seen in a simple exercise. A group of people is asked to read aloud quickly a list of words that indicate different colors- green, red, etc. The words themselves, however, are written in different colors, and the colors do not match the words. For example, the word “red” is written in black, the word “blue” is written in green, etc. This first part goes well, you’re just asking them to read the actual words. Next, however, it gets harder. The people are asked to quickly go down the list again, but this time they are asked to say the color of the word, not that actual word. Typically, this does not go well. For the next step, the exercise is repeated at a much slower pace, with a slight pause between each word. Once a pause is placed between each word, the people recite the correct colors. The incongruent words and colors creates what is known as the “Stroop Effect,” first theorized in 1935, but pausing is a means of overcoming this issue in our brains.

When investigating a needle stick incident, the lab safety officer learned the employee completed the draw, attempted to engage the needle safety device, but stuck their finger when grabbing the needle to toss it into the sharps container. She did not notice the safety device did not engage and the needle was still exposed. The employee stated she was busy and in a hurry because there were many other patients waiting. I have always said that when a lab employee is stressed and busy, that’s when stopping for a moment to gain situational awareness is most important. Had this employee paused for a moment to ensure the needle safety device was fully engaged, the incident would never have occurred.

The lab manager had to speak to a chemistry tech after a serum splash exposure to the eyes. When looking at the work area, the manager noticed there was an adjustable face shield in place but that staff moved it into place only when needed. The tech admitted he was busy at the time of the splash and that he neglected to move the shield into place before uncapping specimens. Again, a pause to think about safety here would have helped.

In another situation, a microbiology technologist was eager to start the day and get it done since her vacation began the next day. She quickly went through the daily checklist and checked items off but did not actually perform the checks. Halfway through the day, she noticed it seemed warm and that it was unusually quiet at her biological safety cabinet work station. She decided to look at the gauges and noticed that there was no protective air flow in operation. She had been working with TB samples all morning. When she reported the issue, the manager told her that all employees in the area would need to go to Employee Health and be followed up for TB exposures. Pausing to perform the safety checks at the beginning of the shift would have made a big difference in that outcome for several employees.

Pausing for safety in the laboratory setting can be a powerful tool, even during the busiest moments. In fact, that’s when it works best. Use that pause in your arsenal, and teach maintaining situational awareness with your staff so that future injuries and exposures can be prevented.

–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.

The Impact of Fun

“Never, ever underestimate the importance of having fun,” said Randy Pausch, a professor of computer science at Carnegie Mellon University. Indeed, having fun is an important component of life, and that includes your professional life. However, having fun in the workplace can seem like an impossible task sometimes. There is, after all, lots of work to be accomplished, performance to be measured, and projects to complete. This can make it challenging to find of time and ways to have fun appropriately and constructively.

The benefits of having fun in the workplace are plentiful. Because most fun activities require people to work in groups or teams, the shared experience can increase collaboration, engagement, and foster communication. Having fun fosters motivation and commitment to an organization as people associate the positive feelings and experiences with the workplace. This also increases morale and comradery among the participants, which increases their performance. All these aspects, in turn, foster creativity, innovative thinking, and problem-solving skills. The more creative employees are, the more comradery they feel among themselves, and the better they perform the more turnover is reduced. Having fun in the workplace is incredibly beneficial to both the employees and the organization overall.

In today’s workplace culture, people are generally more aware and considerate of what is appropriate behavior. This also applies to having fun, because if activities are only fun and enjoyable if they are appropriate for everyone involved. It is, therefore, important to establish clear boundaries: what is considered part of this activity and what is not. It is also important to consider different levels of physical, mental, and emotional ability. Having fun is inclusive and collaborative, so it is critical to design activities that everyone can partake in. The activity should also always be optional. Making participation mandatory is not actually fun for people, so make sure that there is an opt-in and opt-out option. Finally, every activity should have some element of learning and education. If you are asking people to participate in a fun activity, ensure that they are learning something about one another or about a specific topic.

There are many different ways in which you can incorporate fun in the workplace. Last year at ASCP, our social committee hosted an ‘Oscar Party” in which we could vote for our colleagues in categories such as “Outside the Box Thinker/Innovator,”, “Outstanding Philanthropist,” and “Rookie of the Year.” Then all staff gathered in the kitchen area of our office that was decorated with a red carpet and we all received a glass of sparkling cider. The winners were announced and cheered on as they walked the red carpet. They gave a short speech after receiving their little Oscar award. It was a simple way to have some collective fun and it felt so great cheering everyone on and recognizing certain employees for their outstanding contribution to the society.

On average, babies laugh about 400 times a day. Adults, on the other hand, only laugh about 35 times a day and significantly less often on weekdays than on weekend (Beard, 2014). Laughter is incredibly important to our overall well-being and performance. In fact, “laughter relieves stress and boredom, boosts engagement and well-being, and spurs not only creativity and collaboration but also analytic precision and productivity”(Heggie, 2018). So, let’s try to incorporate more fun and more laughter in both our personal and our professional lives. Let’s find ways to cheer each other up and create a collaborative, warm, and productive environment that fosters engagement, retention, and analytic precision. After all, laughter is the best medicine.

-Lotte Mulder, EdM, is the Senior Manager of Organizational Leadership and Patient Engagement at ASCP. She earned her Masters of Education from the Harvard Graduate School of Education in 2013, where she focused on Leadership and Group Development. After she graduated, Lotte started her own consulting company focused on establishing leadership practices in organizations, creating effective organizational structures, and interpersonal coaching. She has worked in Africa, Latin America, Asia, and the U.S. on increasing leadership skills in young adults through cultural immersion, service learning and refugee issues, and cross-cultural interpretation. She is currently working toward a PhD in Organizational Leadership.

During the 2019 ASCP Annual Meeting in Phoenix, I noticed a morning workshop session entitled “The Impact of Fun.” The title intrigued me, so decided to take a break from the science and clinical medicine workshops that I would normally attend, and take advantage of the opportunity to listen in.

I have been working as a pathologist and lab director for 30 years, and while I hate to admit it, I had never thought seriously about taking time during the day for playing games with my co-workers. I was always consumed with meetings, deadlines, and getting the clinical work completed.

At the beginning of the course, I was a little unsure what I had gotten myself into. However by the time the workshop concluded, the reality of what I had been missing had set in.

When I returned to work following the meeting, I began to search for fun activities that our lab team could do over a lunch hour. I set a date and promised food to entice the wary into attending the event in the conference room. Once they had assembled, I divided the group into two teams by drawing an imaginary line down the middle of the room. We then played team trivia using a book of questions I had acquired. By the end of the hour, everyone was laughing and having fun. The lab continued to buzz with talk and occasional laughter all afternoon.

We have continued setting aside one noon hour each month where we gather for different types of games. Charades, and Pictionary have been hits. Mostly everyone brings their own lunch, but food or deserts are provided on occasion to keep these events special. There are a few who choose not to participate, but even they occasionally show up to watch and laugh along with the rest. As is pointed out above, you cannot make having fun a mandatory or it ceases to be fun.

Our lab staff really seem to enjoy these events and so does this old pathologist. During our most recent event, one of my young colleagues remarked how much fun these lunches have been, and that they hoped we would continue these going forward. I intend to keep these going as long as I continue working. It has provided me with an opportunity to get to know each of my co-workers much better. I only wish I had learned about the importance of having fun with your co-workers and teammates earlier in my career. I encourage other pathologists, lab directors and section supervisors to learn from my experience and begin finding ways to bring the fun back into the workplace if you have not already done so.

-Dr. Wisecarver is currently Professor Emeritus in the Department of Pathology/Microbiology at the University of Nebraska Medical Center in Omaha, Nebraska. He served as Medical Director of the Clinical Laboratories for Nebraska Medicine, their clinical affiliate from 1996 until 2017. He currently serves as the Director of the Histocompatibility Laboratory for Nebraska Medicine.

A Med Tech Gives a TEDx Talk

Hello again everyone!

After a lot of positive responses and sharing on social media, my article last month got lots of people talking about annual meetings and how great they are for networking, learning, and advancing our profession. Not too long after the ASCP Annual Meeting in Phoenix, I was back in my Manhattan apartment working on my speech and graphics for a real life TEDx session hosted at my medical school.

Let’s pause here: if you either haven’t heard of the TED/TEDx brand or if you binge watch their 18 minute videos and want more links to watch now, now, now!

TED is a non-profit organization whose mission is to share “ideas worth spreading.” They’re about 35 years old and based in NYC stateside, and Vancouver in Canada. Basically, over the last few decades they hold conferences at those flagship sites called “TED talks” where selected speakers present on a myriad of topics. TEDx conferences are officially licensed but off-site events which operate under TED protocol and guidelines. There have even been spin-off conferences like TED MED, which focus solely on healthcare.

Image 1. What’s a TEDx talk? Basically, an off-site, officially sanctioned, “idea sharing” conference.

Some of the students at AUC School of Medicine, organized such a conference with official TED licensing and recruited me to join their list of speakers to deliver talks on their chosen theme: resilience. Officially called TEDxAUCMed, this conference included community members, students, artists, activists, and more discussing the human capacity for resilience in ways not commonly discussed. “Weathering the Storm” was the official event title, as the school located in the island nation of St. Maarten displays daily resilience especially since being hit by Hurricane Irma in 2016. Among their list of incredible speakers, I was humbled to be included! I titled my talk “Unrecognizable Medicine” and wanted to deliver a talk to students, clinicians, and those of us in medicine witnessing first-hand a tidal wave of new technologies and paradigms that redefine the way we discuss health. Oh, and since I’m a huge fan of #GraphicMedicine more and more each day, I hit that hashtag hard and decided to illustrate my whole talk!

So what did I talk about, exactly…and what’s the big deal? I’m not going to re-hash my presentation for you in text—that’d be boring, and I’m obviously going to put a link at the bottom for you to watch it yourself. I got you, lab fam! But essentially, what I set up was a three-tiered template to assess and navigate that tidal wave of tech. Tools, skills, and strengths—three things inherent to the practice of medicine in any specialty.

Image 3. Red back-ligting. So intense. Thanks for coming to my TEDx Talk, literally!

There are untapped topics in medicine which are looming over the horizon. As medicine continues to evolve and change, the problems we face and the needs we must meet will become moving targets. New specialties will emerge, and new technologies will replace centuries old tools we cling to today. A shift in thinking is both proactive and healthy in a profession that mandates our commitment to preserving health and quality of life. I have spent years battling stereotypes in medicine and hope to challenge the fabric that places individuals in professional or academic boxes. Fresh first-years at some schools are already using point-of-care ultrasounds (POCUSes) instead of stethoscopes—which student sounds like they have better info on morning rounds, a student who maybe kinda-sorta heard some non-descript murmur, or a mini-pocket echocardiogram with an ejection fraction of 45%? Stereotypes have too long shaped the way students choose specialties, equating some areas to colloquial high school cliques! No offense to orthopedics or dermatology. Troponins used to be something you could hang your white coat on, but not anymore. What do you do with a new 5^th generation Trop of 39 with a delta of 18? ACS or acute MI? Cancer therapy is exploding with personalized treatments being added every day! Any student right now would impress their heme/onc attending on rounds if they suggested PDL-1 and other immunotherapy testing for patients with newly diagnosed lung cancers. *Deep breath*

Ok. My point is, tomorrow’s medicine is going to have a lot of different therapies, tools, and even vocabulary that schools may never catch up with. How do you prepare for this explosion of knowledge? You look to yourself to take an inventory of your strengths and use those to guide your clinical sails. Addressing stereotypes head-on, learning on the spot, dealing with complex identities in your patients, and always practicing with compassion will lend itself to staying ahead and staying fulfilled.

Image 4. If you’re drawing cartoons of pathologists for an educational series, you probably make them look like you. Or in this case me, I guess. Keep an eye out for my #PathDoodles on social media!

Pretty heavy stuff right? But there’s something else that caught my attention in reflection on the TEDx talk… I’ve searched the TED library of videos, and while there are plenty of doctors, scientists, and pioneers in research discussing medical ideas, I haven’t seen any medical laboratory scientists. If you find any, please correct me. But, as I understand it, it’s just me. And that’s something special.

Image 5. My wife and I check-in for rehearsal at the TEDxAUCMed conference in sunny St. Maarten.

There’s a culture shift in our profession, and a lot of us are talking about it. Pathology and laboratory medicine are stepping out from behind the healthcare curtain and asserting itself as a champion for patients, truth, and the importance of data-driven medicine. Not only do I talk to groups of folks every time I get a stage, but I use social media to reach clinicians and patients! Yes, I’m one of few medical students-turned-residency applicants who didn’t change their name to hide their online presence for the winter. But instead of a secret twitter hibernation, I’ve used social media as a tool to network, engage, and connect.

One of my favorite new projects is something I call #PathDoodles where I break down the aspects of pathology and some specialty topics for those outside of medicine (and sometimes just outside our profession). I’ve already covered things like “what is pathology?” and the importance of autopsies, the role of medical laboratory scientists, and I continue to add more regularly!

Image 6. One of a growing list of #PathDoodles.

Follow me on Twitter (@CEKanakisMD) and check out my TEDx talk:

My talk begins at 5:00:00. Enjoy!

–Constantine E. Kanakis MD, MSc, MLS (ASCP)CM completed his BS at Loyola University Chicago and his MS at Rush University. He writes about experiences through medical school through the lens of a medical lab scientist with interests in hematopathology, molecular, bioethics, transfusion medicine, and graphic medicine. He is currently a 2020 AP/CP Residency Applicant and actively involved in public health and education, advocating for visibility and advancement of pathology and lab medicine. Follow him on Twitter @CEKanakisMD

An Introduction to Laboratory Regulations – Part III (Accreditation)

So far we have reviewed the different federal regulatory agencies responsible for establishing laboratory testing guidelines, a brief overview of the different roles each department plays, as well as a discussion on testing complexity. In today’s post we’ll cover the optional accreditations available to labs, and how accreditation differs from certification.

In the simplest of terms, certification is a mandatory requirement, whereas accreditation is optional. Certification is required in order for laboratories to receive payments from Medicare or Medicaid. Laboratories must meet the minimum requirements set forth by CLIA to earn and maintain their certification status.

Accreditation is an extra additional step that laboratories can take to set themselves apart from neighboring labs by holding themselves to a higher standard. Accredited laboratories must still adhere to the minimum CLIA requirements, but there are additional rules and requirements to be satisfied depending upon the different accreditation agencies.

More rules and paperwork, why would anyone volunteer to take that on? Depending on the size, complexity, and client population that your lab serves, the benefits to obtaining accreditation can greatly outweigh the challenges of maintaining that accreditation status.

One of the requirements to maintaining your CLIA certification is routine inspections to confirm compliance with the rules. Accreditation agencies require inspections as well, but thankfully in most cases your CLIA inspection can be satisfied by your accrediting agency; meaning your lab will receive a single inspection to satisfy both groups. Results will vary for each lab, but generally speaking the accreditation inspections are perceived to be easier to get through than those conducted by the federal inspectors. For example, agencies like The CAP and COLA tend to be more focused on sharing of ideas and good laboratory practices, rather than coming in as the “lab police” and looking only for problems. The explanation of their regulatory requirements tends to be more user friendly and easier to interpret as well, rather than the formal CLIA laws which are legal documents and read as such.

Recognition by an accrediting agency confirms that the laboratory is qualified and competent to perform testing for which it has received the accreditation for. This stamp of approval can help patients and clients feel comfortable in choosing your laboratory for their testing needs. For laboratories that perform testing as part of clinical trial evaluations, this can help reduce the number of requested on-site audits by the client themselves, as the client may choose to rely on the third-party accreditation assessment due to their high standards. It may also help encourage new clients to choose you for their testing needs, as the accreditation confirms your commitment to higher quality standards.

Another possible benefit of having accreditation status is the impact on your laboratory staff. Continually striving to raise the bar on your standards and going above the bare minimum instills a sense of professionalism in your employees. By continually reviewing the regulations and preparing for or responding to inspections, staff are more likely to be committed to complying with your organization’s quality management system and standards of performance. Staff who are familiar with the requirements and the reasoning behind why a certain task is performed or documented, are more likely to comply with those policies and procedures.

There are currently 7 CLIA approved accreditation agencies: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf. Some agencies are focused on a specific discipline, such as AABB for transfusion medicine, and others are more encompassing for all of the laboratory departments. Organizations looking to become accredited should research each option in order to determine which ones would be best to meet their specific needs. It is also common for labs to maintain more than one accreditation at a time, for example AABB and CAP. As always, the regulatory agency with the most stringent rules would be the ones the lab is expected to adhere to. In cases of joint accreditation, multiple inspectors may be needed to complete the biennial inspection; however the agencies will try to coordinate efforts and work together so that the inspections occur simultaneously. Sticking with our AABB & CAP example, CAP will work with AABB to locate an AABB approved inspector for the transfusion medicine checklist, while the remainder of the CAP inspection will be carried out by CAP inspectors. The AABB inspector would then inspect the transfusion medicine department for compliance with both CAP and AABB requirements at the same time.

The accreditation process may be challenging, but once you have obtained that esteemed status, the opportunities for continual education and improvement of your laboratory will be endless.

-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.

Making Meetings Matter

Hello again everyone!

I’m writing to you now back in Manhattan after visiting sunny Phoenix, AZ for this year’s ASCP Annual Meeting. Last month I talked about downtime, pathology emergencies, and introduced you all to our insightful and dynamic colleague, Jalissa Hall. It was great working with her and one of the last things we talked about was getting to go to professional society meetings. We also talked about the upcoming meeting next year in Austin, TX! And that’s exactly what I’d like to talk about with you this time: why going to meetings like ASCP is not only educational, but an excellent way to network with your laboratorian peers from around the country.

Image 1a. My wife and I made it to the Phoenix Hyatt Regency on registration day! ASCP swag on, obviously.

Image 1b. Behind the Scenes – Hosting the ASCP 2019 Facebook Live broadcast with two fantastic colleagues, Dr. K. Mirza and Dr. A. Booth! Did you catch us? But more about social media later…

I couldn’t go to every single session—there’s just too many—but I did learn so much valuable, practical information at the educational sessions. Here are just a mere few insights from the long list of fantastic speakers I had the chance to visit!

I participated in an interactive session on the ASCP/CAP/ASH guidelines for lymphoma workup…

Figure 1. All the multidisciplinary expertise must go through rigorous adjustment and evaluation all the way throughout the process of seeking out and publishing proper guidelines. (Source: ASCP 2019 session 5007-19; Kroft, S., Sever, C., and Cheung, M.)

Drs. Kroft, Sever, and Cheung discussed updates from the WHO 2016 guidelines as well as relating any changes in concurrent literature to appropriate diagnostic accuracy with evidence-based guidelines. If it sounds familiar, it’s because I talked about these guidelines a few months ago! In my month clerkship at The Mayo Clinic in Rochester, MN I presented a therapy-related AML case in the setting of Li-Fraumeni disorder. In my discussion I stressed the utility and importance of having organized and algorithmic guidelines to diagnose patients accurately, effectively, and timely. This time, instead of just talking about the guidelines, I got to listen to some of the folks who actually put them together—and, according to them, it’s no easy task!

I learned about culturally appropriate leadership training…

Figure 2. The panelists each had something insightful and moving to contribute to this wonderful discussion on female empowerment in our profession, and ultimately how it relates to improving patient care! (Source: ASCP 2019 session 8012-19; Mulder, L., Upton, M., Vuhahula, E., Abedl AlThagafi, M., Papas, F., and Sanford, K.)

This year’s ASCP president, Dr. Melissa Upton moderated this fantastic panel and opened with an old proverb: “If you want to go fast, go alone. If you want to go far, go together.” This was definitely a theme for each of the mini-sessions’ discussions. ASCP’s own Lotte Mulder discussed her research on culturally applicable leadership training using her Leadership Institute Initiative. She talked about countries that are culturally different and developmentally different up and down the spectrum can all benefit from leadership development and opportunity. Next came Dr. Edda Vuhahula, an accomplished physician, educator, and advocate in Tanzania. She related her experiences of women in leadership roles, and challenges on the horizon as more women rise to these positions every day. Dr. Malak Abed AlThagafi talked about her “hats:” as an entrepreneur, a medical director, and a researcher in her whirlwind story of empowerment and accomplishment. Finally, medical laboratory scientist and former Philippine Army colonel, Filipinas Papas gave her personal perspectives on sexism, education, bias, and opportunity.

Celebrated my colleagues and my contributions to the 6^th Choosing Wisely list of recommendations…

Figure 3. My totally biased favorite slide from Dr. Lee H. Hilbourne, chair of the ASCP Effective Test Utilization Steering Committee. It’s an honor to be included in this year’s list, alongside so many accomplished contributors.

The Choosing Wisely initiative, partnering with the American Board of Internal Medicine and many other specialty organizations, is one of my favorite programs at ASCP. To date, our lab medicine organization has the highest number of effective test utilization recommendations. ASCP seeks active contributions to our expanding lists of recommendations to eliminate wasteful, unnecessary testing and to improve patient outcomes. This talk was also a great opportunity to honor the ASCP 2019 Choosing Wisely Champions: Dr. Gary W. Procop from the Cleveland Clinic, Dr. Lucy Nam from the Inova Lab best practice team, and Dr. Alyssa Ziman from UCLA Health. Want to read the most updated list of recommendations ASCP made to the Choosing Wisely initiative?

Check it out here: https://www.ascp.org/content/docs/default-source/get-involved-pdfs/istp_choosingwisely/2019_ascp-30-things-list.pdf

I watched some cutting-edge exchanges about cellular therapy…

Image 2. Here I am with laboratorian S. Malakian and Dr. Gastineau with The Mayo Clinic after they discussed the future of complex cell therapies.

One really effective take-home message from this seminar was that, if we’re going to rely on cellular therapy in the future—especially as it relates to “individualized medicine”—then who do you think should be in charge? Who’s got the most experience and knowledge when it comes to cell storage, transfusion protocol, patient outcomes, and high reliability? Short answer: it’s us. Long answer: go back and check out a piece I wrote about high-stakes responsibility in and out of the lab!

Popped into fascinating hematologic cases at our neighboring SHEAHP2019 meeting…

Listen, I like hematopathology, I’ll be the first to tell you that. There were so many people giving presentations in this near standing-room-only meeting, that I recognized from papers, abstracts, and journals that I’ve read in the past year alone! There were so many interesting sessions at this meeting, I wish I could have seen more…

Image 3. Here’s Dr. J. Dalland from Mayo Clinic Pathology discussing a lymphoproliferative disorder with associated eosinophilia. These talks go deep into morphology and photypic patterns, so that Hemepath colleagues have a chance to assess their workup and protocols. It’s also great learning for avoiding pitfalls—this case shows architectural changes in lymph nodes which could cause someone to misdiagnose!

Learned how to create an impactful dialogue with patients directly…

What do you do as a pathologist when a patient wants to speak to you? Yes, you. Not a typo! This was the last talk I went to and it was a great way to close out this awesome conference.

Image 4. Me with (left to right) Dr. K. Sanford from VCU, Patient Champion Anthony Reed, Dr. M. Sitorius from the University of Nebraska, and M. Mitchell. All of these individuals had amazing things to say about bridging the gap between the bench and the bedside!

In their own ways these patient advocates demonstrated that if you want to represent our lab profession as one of accuracy, answers, and hope, we’ve got the skills and resources to do it! Dr. Sanford sees so many patients in her transfusion services and discusses their care plans regularly. Mr. Reed is an ASCP patient champion who, after being diagnosed with ESRD, became a learned lab ally. Dr. Sitorius is a family medicine physician at a pathology conference, talking about empathy and connection! Ms. Mitchell has done fantastic work with her pathology colleagues after beating cancer and fighting for patient education every day! These folks have taken our field of laboratory medicine to its outer edges, touching patients’ lives directly—and I left energized to take it further in the future.

And of course, I learned so much about the utilization of social media as a practical tool for education, advocacy, and outreach…

I can’t list every single session, lecture, keynote, presentation, or panel in this article. This was just a glimpse of what meetings like this have to offer. You will learn, obviously, but you’ll also gain access to new perspectives and meet people who reinvigorate your passion for your profession in ways you didn’t even consider. One of the most fulfilling experiences of this meeting was being on the ASCP Social Media Team! Posting to Instagram, Facebook, and Twitter with the hashtags #ASCP2019, #ASCPSoMeTeam, or the scavenger hunt #ASCPiSpy was a great way to bolster our enthusiastic network. This was my third ASCP Annual Meeting, and I met so many wonderful people I can’t wait for the next one! Here’s a few of my favorite snaps from the meeting:

Image 5. Here’s part of our amazing #SocialMediaTeam: (left to right) A. Odegard from Baptist Health, myself, Dr. S. Mukhopadhyay from the Cleveland Clinic, Dr. A. Booth from the University of Texas, and Dr. K. Mirza from Loyola Chicago!

Image 6. At my first ASCP meeting in California, Jeff Jacobs, ASCP’s Chief Science Officer, gave me some of the best advice for my own personal and professional growth, “Stay Humble” he told me. Nearly 5 years later, he added “Don’t Give Up” on goals, yourself, or anything in life. You can’t pick that up in a path review book. I feel lucky to know people like him.

Image 7. #SoMe FTW (Social Media for the win!) At this great talk, Dr. C. Arnold, Dr. L. Shirley, and Dr. D. Gray III, all from the Ohio State University discussed how to use social media to build a reputation and expand your impact as a pathologist, educator, and advocate!

Image 8: Conferences are a great time to run into old friends and colleagues whom you may have spent a month rotating with! If you read about my time at Danbury Hospital in Connecticut, Drs. O. Olayinka and G. Kuar were part of it and I’m glad to call them friends!

Image 9: Presented by the ASCP Resident and Pathologist Councils, this was a great networking session to discuss fellowships, employment, and how to plan for the first 100 days of working in laboratory medicine from PGY-1 and on! I certainly learned a lot!

Image 10: (left to right) Dr. K. Chaztopoulos from the Mayo Clinic, myself, and K.C. Booth, RN in front of his finalist poster in the scientific category! Another valuable professional connection and friend made through my experiences in laboratory medicine.

Image 11. When one of your mentors (Dr. K. Mirza) is signing copies of The Pathologist magazine that featured him on the cover, you get in line for one …obviously.

Image 12. Dr. M. Upton is an inspirational speaker and insightful individual both on stage and in person. She had words of encouragement for my upcoming residency interview season and made sure I felt I could rely on ASCP for whatever I needed professionally. Thank you, Dr. Upton!

Image 13. Some more colleagues from Mayo Clinic Pathology (left to right): Dr. A. Ravindran, Dr. D. Larson, Dr. J. Dalland, and myself. These folks were very busy with all the great hematology sessions at the SHEAHP2019 meeting.

Image 14: No ASCP Annual Meeting would be complete without the leadership, passion, and vision of our CEO Dr. Blair Holladay. He, his leadership team, and this organization have been integral in my path to pathology and I can’t wait to see what’s in store for the future!

Social media has become so valuable in our field. Not just for networking, but sharing cases, impressions, publications, and more! It’s so easy to rally behind a hashtag and support a cause in so many instances—why not in our profession? Get involved, be an active voice for your own practice as well as your colleagues.

If you want to learn more about the sessions you may have missed, download the ASCP2019 app from the Apple App Store or Google App Store!

Thanks for reading! See you on social media, because when we communicate and collaborate, we are #StrongerTogether! I’m on twitter at @CKanakis, until next time!

–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.

An Introduction to Laboratory Regulations – Part II (Testing Complexity)

Last month we reviewed the different federal regulatory agencies responsible for establishing laboratory testing guidelines, and a brief overview of the different roles each department has. This month we’ll attempt to demystify testing complexity (waived, non-waived, PPM) and why testing classification matters. Still to come, we’ll review the optional accreditations available to labs, and how accreditation differs from certification.

For all in vitro diagnostic tests, the FDA is responsible for categorizing each test based on their perceived complexity during the pre-market approval process. From least to most complex, the categorizations are waived, moderate complexity, and high complexity. The reason this is important is because with each jump in test category, the CLIA rules associated with performing testing will change – as will the permit designation required to perform testing. This includes things such as QC requirements, validation testing, and personnel requirements to define who can perform testing in the first place.

Waived tests are considered easy to use, with little to no chance that the test result will provide wrong information or cause harm if it is done incorrectly. This includes over-the-counter tests such as home use urine pregnancy kits, where if the sample is applied incorrectly or in insufficient volume there will simply be no result obtained at all. Many Point of Care tests fall under this category, with testing performed in a wide variety of locations including physician offices, urgent care clinics, imaging centers and nursing homes. Locations performing waived testing only are still required to obtain an appropriate CLIA Certificate of Waiver. (See the reference links at the end for a list of all FDA approved CLIA-Waived tests.)

For waived testing, laboratories must follow the manufacturer’s instructions for testing, including the stated FDA approved intended use, without any deviation. If the procedure is modified, or the test is used with specimens not approved by the FDA – the complexity classification of the test will change from waived to high complexity. A common situation where this occurs is with fingerstick whole blood glucometers. Most device manufacturers on the market today for point of care glucose testing are not FDA approved for use with critically ill patients. Using these waived meters for patients deemed “critically ill” based on your local institution’s designation would change the complexity of testing from waived, to high, for this population of patients as it would be considered “off-label use” – meaning you are using it against FDA recommendations and approved forms of use for the test/instrument.

Another caveat to be mindful of is your local state regulations. Certain states (NY, especially) have very strict rules regarding testing complexity designation. In NY, all tests performed within the same designated laboratory space will have the same testing complexity designation. Meaning that if you have a moderate complexity CBC analyzer in the same room you perform your waived urine pregnancy tests – both are now considered moderate complexity. Even though you’re following the manufacturer’s instructions for the pregnancy kit, using only approved specimen types, and the kit is on the FDA approved CLIA-Waived list – that test is now moderate complexity just because it is in the same room as other higher complexity tests. That same pregnancy kit is considered waived when kept separate in the emergency department, but becomes moderate complexity (or higher) when used in the central laboratory.

Nonwaived tests refer to both moderate and high complexity testing. After the FDA has approved a marketing submission, their CLIA categorization of the test follows by utilizing a scorecard to grade the test complexity on 7 different criteria. All phases of testing (preanalytic, analytic and postanalytic) are evaluated in these steps:

Knowledge – low scores require minimal scientific and technical knowledge to perform the test, and knowledge needed can be easily obtained through on-the-job instruction.
Training & Experience – low scores require minimal training and limited experience to perform the test.
Reagents & Materials Preparation – low scores have stable and reliable reagents, and require no special handling, precautions, or storage conditions. They typically come prepackaged, premeasured, and ready for use; whereas high scores may include manual steps such as volumetric measurements and/or reconstitution.
Characteristics of Operational Steps – low scores have automatically executed steps (such as dispensing specific volumes of sample/reagent, temperature monitoring, or timing of steps); high scores require close monitoring or control, precise temperatures or timing, accurate pipetting or extensive calculations.
Calibration, Quality Control, and Proficiency Testing Materials – low scores have all required reagents, controls and PT material commercially available and products are stable.
Test System Troubleshooting & Equipment Maintenance – low scores have automatic troubleshooting or self-correction of errors (failed internal QC will automatically repeat), or requires minimal judgement. Equipment maintenance will be performed by the manufacturer or is minimal and easily performed, whereas high scores require decision-making and direct intervention to resolve most issues, or maintenance tasks require special skills and abilities.
Interpretation & Judgement – low scores require minimal interpretation and judgement for resolution of problems or determination of test results.

Low scores indicate low complexity, with tests obtaining a total score of ≤12 being categorized as moderate complexity. Tests with final scores >12 are categorized as high complexity.

PPM: Within the category of nonwaived tests is a subcategory referred to as Provider Performed Microscopy (PPM). These are tests that are performed directly by a clinician during a patient visit, and require the use of a microscope limited to bright-field or phase-contrast microscopy. Based on the nature of the sample obtained, testing must be performed immediately at the time of collection as delays could compromise the accuracy of test results. As controls are typically not commercially available for these tests, the testing is restricted to clinicians only as knowledge and judgment is required to confirm testing accuracy and correlation to the clinical presentation.

Tests allowed under a PPM certificate are mostly related to OB/GYN procedures, with a full list available through CMS here:

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ppmplist.pdf

So why does it matter?

So the next time you receive a request to add a new test at your laboratory, you’ll be armed with a fairly long list of the requirements that come with that test based on its complexity. Coming up next month we’ll discuss the difference between laboratory certification and accreditation, along with the benefits of obtaining accreditation for your lab.

References

Electronic Code of Federal Regulations: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5
CLIA-Waived Analytes: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm
CLIA Complexity Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0
FDA Approved Devices: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

The Disaster Risk Assessment

There are multiple types of risk assessments required when managing a laboratory safety program. OSHA’s Bloodborne and Airborne pathogens standards require assessing the risk of employees’ exposure to particular lab hazards. Risk assessments can be used to determine whether or not to add an emergency eyewash station, and all lab chemicals need to be assessed for the hazards they pose. These are just some assessments that are needed, and there are particular steps to take when performing them. But what about the lab emergency management plan? Should the lab perform a risk assessment for that? The answer is yes, although the terminology used may be different. To prepare a disaster readiness plan for the lab, the risk assessment that is needed is known as a Hazard Vulnerability Analysis (HVA).

The Centers for Medicare & Medicaid Services (CMS) requires that all healthcare facilities use an “all-hazards” approach when considering emergency preparedness and planning. While some laboratories may be included with the facility-wide disaster plan, the lab should absolutely have its own plan with specific instructions that apply directly to the department. That means the lab should also consider an all-hazards approach.

It may seem daunting to try to consider every possible disaster that could occur in the department, but that is not exactly what the directive from CMS dictates. An all-hazards approach means that emergency plans should be scalable or flexible so that it can be used for many types of disasters. The plan should focus on the lab’s ability to continue to offer services, especially those deemed critical, as a disaster situation unfolds.

The first step to the plan creation is the risk assessment- the Hazard Vulnerability Analysis. The HVA can be a table that lists all of the potential types of disaster; natural, man-made, facility-specific, etc. List as many as you can think of, and be sure to include specific disasters that may be particular to your locale (earthquakes, blizzards, etc.). Rate each disaster type by probability, severity of impact, and level of readiness of the lab to respond. Using that data, you can calculate the risk percentage for each emergency type.

One other requirement imposed by CMS is that facilities must include emerging infectious diseases as one potential type of hazard class. With the advent of particular diseases in the past years like Ebola, Zika, and certain influenza types, it is important to consider how an outbreak would affect lab operations and staffing. The risk level of infectious diseases may vary as incidents and outbreaks occur in particular geographic regions or if pandemics arise.

The HVA should be reviewed and updated as necessary each year. Things change that can affect what is on your HVA list. The addition of a nearby airport might make you consider adding airline disaster to the HVA. A change in weather patterns could occur as well. In 2011 a surprise earthquake in Virginia made state facilities re-look at their HVA list of possible emergency situations. Also, the actual list of disasters might not change, but there may be a change in the potential of a particular incident occurring.

If your lab or facility has not yet performed the HVA risk assessment, there is no need to panic. There are several model HVA tools available on line that can be used. As with any risk assessment, be sure to keep documentation readily available, review it each year, and make sure staff are trained about not only the HVA process, but in how to use the emergency management plan as well. There is a great amount of work that can go into preparing for a disaster, and training and drills for your staff will help to facilitate a smoother activation of the plan when the real emergency situation occurs.