Patient Data as QC

One of the most important things we do as a laboratory is run Quality Control (QC) material on every assay we perform in order to ensure that the assay is working correctly and the test results are valid. The importance of QC cannot be overstated, as it allows us to confidently report analyte values that allow correct diagnostic, treatment and treatment monitoring decisions for each patient for which we provide service. And yet every laboratorian knows that running QC is often problematic.

QC material is not true serum, plasma, urine or CSF and as such, it frequently does not act like a patient sample. This is referred to as commutability – the ability of a synthetic or non-human-based material to act like a human sample in a test system. As hard as manufacturers try to make their QC product commutable, problems still exist.  Every tech knows that a shift in QC is not always reflected by a shift in patient sample results, and conversely a shift in patient sample results may not be mirrored by a shift in QC.

In some cases it may be possible to use patient samples as a kind of Quality Control.  For those tests with high volumes, calculating a running mean of all patient data each month can supply a nice overview of the performance of your assay. For example, if you run 5000 sodiums each month, the average of those 5000 will be consistent from month to month, as long as your analysis system is performing consistently. Very high or very low outliers will be smoothed out by the sheer volume of tests in the data set. Our average monthly sodium has run 140 or 139 mEq/L for the last year. If it were to run 142 or 137 one month, I would look at what happened in the system to shift 5000 sodiums enough to cause that difference.

A test that this system has been useful for is tacrolimus.  At roughly 600 tacrolimus tests per month, our rolling patient mean has been stable for the last 6 months at  7.9 ng/mL, with a range of 7.7 – 8.1 ng/mL. In September, the mean dropped to 6.8 mg/mL. The data was still distributed as it had been previously, with no increased number of values around the lower end, suggesting that the shift was systemic. A look back discovered a new calibrator and calibration. None of this had been reflected by a shift in the regular QC.

Use of patient data as QC will not work with low volume tests, or with tests having a wide reportable range, because a low number of outliers will affect the mean too much. For instance, diabetics in crisis with massively elevated glucose can skew a glucose average even if you run a couple thousand per month. Also this method takes a long-term view of the system. It will not pick up an assay failure on a given day. Despite those things, it can be very useful for looking at systemic issues that affect patient data rather than QC data.

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

 

Chutes and Ladders

Mobility in any career can lead you in multiple directions and usually it is up to you which way you go. The laboratory field has become very specialized in the last twenty years and staying a true generalist or a general supervisor is becoming more difficult. I always tell students to stay generalists as long as possible so that your options are open once you get a sound technical foundation of knowledge. This allows them to become supervisors in a number of different areas when the time comes. Much discussion has been made about the proverbial “career ladder” and whether or not the ladder exists as it used to. As an early careerist I am well versed in navigating the ladder and figuring where I fit, and how I plan to climb the rungs as I enter my second decade of my career. I finished my MBA at the beginning of 2013 and put myself into application mode to see what new positions awaited me.

I learned a few things in my quest to climb as many rungs as I could on the ladder. First, if an application states you need a certain amount of experience but you are one or two years short, apply anyway. Employers will at least speak with you if you are a little short. If you wow them with your experience so far in your career and let them know that you don’t just work but you actively observe you can make up that deficit. Second, do not be afraid of lateral moves. If your goal is to be a laboratory director or higher, moving to supervise a different area of the lab can make you a better-rounded candidate once it comes time to go for that higher position. This is especially important if you have become burned out or in need of a change from your current department. Nothing says you have to stay a Hematology supervisor for eight years before you have the supervisory experience to become a laboratory manager/director. One aspect of the lab I find is a good move is to the point-of-care side of the lab. You get out of the lab more and into the hospital as a whole. Usually this role takes on the Quality side of things as well. This role can be a great transition from a technical supervisor to a more general department supervisor where you can learn and grow.

Finally, never be afraid of putting in an application. I find a lot of people talk themselves out of a position before they even apply. Do not be afraid of rejection. In speaking with laboratory professionals, I have heard of a hospital not hiring a candidate for a position but going back and contacting them at a later date for a different position. It never hurts to interview and get your name and face out there. Go on interviews even if you don’t feel the position is a good fit. Practice is the name of the game. When your time comes climb the ladders and avoid those chutes!

Herasuta

Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

Medical Essay Contest

This came across the desks of Lab Medicine’s editors today and we’d like to pass it on. The folks at Hektoen International are running an essay contest.

We invite you to submit an essay of 1,500 to 2,000 words on a subject related to medicine and culture by March 1, 2014. Suggested topics include medicine and art or literature, history of medicine, ethics, music, philosophy, anthropology, linguistics, etc. Clinical studies or case reports are not eligible.

We will be offering two prizes:

  • The Hektoen Grand Prix, for the winner – $1,500
  • The Hektoen Silver Prize, for the runner-up – $1,000

If you’d like more information, please check out the essay contest page.

 

The Poisoner’s Handbook by Deborah Blum–Book Review

I recently read The Poisoner’s Handbook by Deborah Blum, a book about poison and forensic investigation in Jazz-age New York City. Dr. Norris and Dr. Gettler transformed death investigation from a good-old-boy coroner system to one based on science and data analysis. Blum weaves several cases into a narrative that covers several poisons used during the 1920s and ‘30s. Over time, poisoning deaths decreased due to public awareness as well as the realization that murderers were increasingly likely to get caught. Blum discusses Prohibition at length and its contribution to poisoning deaths in New York City. I found this particularly fascinating; not only were people willing to risk their lives to drink alcohol, the government tried to dissuade people from drinking by actively poisoning the supply.

Several of the reviews of this book note Blum’s lack of chemistry knowledge, and I can’t disagree. While my own knowledge base isn’t wide, even I notice a few inaccuracies (HCN isn’t a “potent” acid, for example). One must remember that Blum is a journalist, not a chemist; I tend place blame on the publisher’s fact-checker as well as the author. Because this book is about the evolution of the public perception of forensic toxicology and not just the science behind it, I could overlook the scientific stumbles.

As a laboratory professional, I loved reading about the early days of forensic science and forensic toxicology. While these professions existed in Europe well before 1920, Norris and Gettler forever changed how we treat death, murder, and justice in this country.

 

Swails

Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

 

 

Use of Remembrances, Part Deux

So, I’d like to continue with the thread of thinking on my previous blog post about the use of remembrances–and thank you to those who have either commented on the blog or emailed me. I personally believe that using old questions that I know are questions that will more than likely be recycled on a standardized exam (which is how I define remembrances), is not for me. However, I don’t believe that using other study materials that may give you an idea of topics or styles of questions that may be asked is the same–after all, there is a whole industry devoted to the topic of study materials for specific tests. For me, it’s about the intention more so than the action because I don’t see life in terms of “black and white”. But I understand that it is often difficult to distinguish between these two and that lines may get blurred unintentionally. But writing down the questions after taking a test and using them or passing them down to one’s juniors to use to study for an upcoming version of the test is using a remembrance in my book.

To me, to cheat or not to cheat, that’s a personal choice and I don’t really judge (or honestly, feel it’s worth my effort to do so) and I think we can say we all have different definitions. But for me, the more important question is whether I choose to cheat myself. Multiple times during my medical training, I’ve felt like I’ve had to play catch-up. I think that this is because I didn’t truly take the time and effort when I should’ve to learn the material in a way that I could internalize it enough to stick–and often that may be because I was too stressed to see the “forest through the trees.” But, now I’ve begun to see the outlines of the forest.

Being more of a scientist-trained person and less of a clinical one, I still find myself having to go back and relearn a concept I should’ve learned well during medical school to carry out my resident responsibilities. And while I may internally curse myself for this, I understand that I need to do this–that I may hurt a patient if I just brush under the rug that I’m missing some knowledge, no matter how small a crumb it may be. I might be able to get by without fully understanding it, but I need to participate in their care. First, we need to be self-aware enough to even question ourselves. I believe that starts with at least making the decision to make an effort to ask these questions, which we can all do. And much of that comes from experience. But it also comes from listening to the consistent patterns that percolate throughout the feedback we have been given over time from our mentors and from identifying what characteristics we want to live up to in our role models.

I also believe that this effort should not be one-sided in that all the responsibility is on the trainee. Factors in this equation equally include our residency programs, and specifically, those who serve as our role models and mentors. Even if our attendings may not realize it, they do serve these two roles just as much as they fill the role of being our didactic teachers in their topic area. Also important is the critical thinking or analytical process that we need to learn and make our own. I’ve found that the best teachers, or at least the ones I relate to most, are the ones who lead me through the thinking process–to look first at low power at the architecture and then to move on to high power where I consider the nuclear and cytoplasmic features, chromatin texture, the company that the primary lesional cells keep, and so on, to put together the pieces of the puzzle to come to a reasonable diagnosis and differential. Same process, albeit with different pieces, when it comes to my CP rotations. And I’m slowly but surely attempting to get there.

I also believe that the American Board of Pathology (ABP) who writes our board exams, and even the American Society for Clinical Pathology (ASCP) who writes our resident in-service exam (RISE), have an equal responsibility to help us transform our culture. Pathology and diagnostics are changing at a rapid pace and both organizations need to be up-to-date and reflect this in how they construct our exams. We are (or are training to be) the diagnostics experts and we need to know not only certain facts but also understand the relevant concepts—and truly understand the importance of training ourselves to be life-long learners. If both organizations want to absolve themselves from culpability in maintaining a culture that silently endorses the use of remembrances, must not recycle old questions. Of course, this does not mean writing exams from scratch each and every year. And of course, I am not trying to belittle the efforts that these organizations do make every year on our behalf when they write these exams. I am only entreating them to make honest, focused, and deliberate efforts each year to re-examine the content of these exams and to retire those that may fall under the definition of a remembrance. We need to have these exams truly reflect the knowledge and critical thinking we need as a practicing pathologist—more case based multiple-step questions rather multiple-choice (which I’ve always called “multiple-guess”) might help.

So, fellow residents, figure out how you learn best–and in a nice and respectful way, convey your expectations to your teachers–ask questions, read more books and journal articles, step up and take more responsibility in your rotations for patient care and safety issues and don’t just do the minimum amount of work required.If you are so inclined, get more involved. Next week, I’ll talk about resident engagement in pathology organizations and my recent experience serving as the resident representative on ASCP’s Annual Meeting Steering Committee Education Working Group. I encourage all residents to at least take advantage of the FREE resident memberships from both ASCP and CAP (you get discounts on books, apply to serve on committees, etc).

And also, turn in abstracts to present at their annual meetings, both have their submission period open NOW!

CAP in Chicago, IL Sept 7-10, 2014

ASCP in Tampa. FL during Oct 8-11, 2014

 

Chung

Betty Chung, DO, MPH, MA is a second year resident physician at the University of Illinois Hospital and Health Sciences System in Chicago, IL.

Blood Management: The Power of “Why”

There are five established questions that should always be embedded in our quest for knowledge and review within the ever-changing evidence base in medicine: what, who, when, how and why. Of these very important and inclusive queries, the final question wields the most power. For it is the why we do, or should do something that truly empowers us. “Why,” by definition, represents the cause, reason, or purpose for action.

Considering the rapid evolution of the evidence base in transfusion medicine and patient blood management, once again, these critical questions should be included in our appraisal. The why remains, however, the most important. Once we grasp that quality, safe, responsible transfusion practice is the purpose, then the what, who, when and how should more easily move forward.

The Joint Commission has begun evaluating patient blood management elements as part of a possible certification for hospitals. The AABB recently published a draft document of patient blood management standards for potential use by its participating facilities. The Society for the Advancement of Blood Management just announced a hospital affiliation program to align principles of blood management with the Society’s mission. All of these organizations are pushing the mission of evidence-based transfusion practice in order to promote patient safety and improve outcomes.

It is our duty as healthcare providers to constantly and consistently evaluate practices, whether they represent procedures, devices, pharmaceuticals; whether they are new or time-honored. Hemovigilance i.e. blood management, must also be included in this ongoing assessment.

Time and time again, the literature is pointing us in the direction of restrictive transfusion practices; avoiding unnecessary transfusion and utilizing blood products as part of our armamentarium when truly life-saving. This concept, thus exudes the ideals of appropriate patient care, best practices and stewardship of community resources. Our cause, our reason, our purpose is clearly to improve patient outcomes and well -being.

Embrace it! Get on board! It is the WHY!

Burns

-Carolyn D. Burns, MD, is the Medical Director of Transfusion Services at Strategic Healthcare Group and Assistant Clinical Professor in the Department of Pathology at the University of Louisville in Louisville, Kentucky. She also blogs for TheBloodyTruth.com.

Glucose Meters

There’s been a serious buzz in the laboratory community recently (especially among the Point of Care [POC] community) about glucose meters. Most laboratory professionals know that glucose measurements on the average glucometer are not as reproducible as those performed on the average main lab analyzer. Some of the reason for that is simply related to issues around proper sampling and use of the glucometers. However, glucometers are only required by the FDA to have precisions of ±20%. For that reason, glucometers are not recommended to be used for diagnosing disorders, for monitoring critically ill patients, or for maintaining tight glycemic control. And yet, glucometers are routinely used nearly everywhere for all three of these purposes.

Recently, the FDA began to try to get a handle on the utilization of glucometers by coming out with two draft guidance documents (links below). By releasing these documents they have essentially reclassified glucometers into two categories: those suitable for over-the-counter (ie home) use, and those suitable for by prescription or health-care-setting(ie professional) use. The differences include:

  1. OTC meters – 95% of values within ±15% of reference measurement, 99% within ±20%; Professional – 99% within ±10% or ±7 mg/dL below 70 mg/dL
  2. OTC meters – AMR 50 – 400 mg/dL; Professional – AMR 10 – 500 mg/dL
  3. Professional – should also include neonatal studies
  4. OTC meters – labeling – for use by persons with diabetes for at home monitoring; Professional – labeling – with intended use, but not for use in critically ill or tight glycemic control

Thus the FDA has reiterated that glucometers should not be used for critically ill patients.If they are used for any purpose not specified in the package insert, their use must be classified as a moderate complexity off-label use of the glucometer, requiring the extensive validations specified by CLIA for non-FDA approved tests. These draft guidance documents have already caused the New York State Department of Health to react and send a letter to all laboratory directors stating that “…the use of glucose meters in health fairs, other community screening events, and/or critical care settings must be discontinued” until such time as CLIA validations have been performed. Thus a huge burden has been placed on the POC community in NY to either pull their POC glucometers from their facilities or validate their uses. And the rest of the country is waiting to see how it will all fall out.  Glucometers are ubiquitous in the majority of health care settings and it will not be easy to meet the new FDA draft guidelines.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf.

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.