generalist – Page 25

Our Value Add

As a clinical laboratory scientist or a pathologist, perhaps you have questioned from time to time your value in the backdrop of our current state of healthcare. During my career, I admit to having felt that pathologists and laboratory staff are under-recognized for their contributions to provision of care on a day-to-day basis. Effective, efficient and most importantly, quality laboratory testing is clearly one of the key components for safe patient-centered care.

Laboratory testing is the single highest volume medical activity and lab tests directly affect a majority of medical decisions. Laboratory activity generates significant and potentially expensive downstream costs including prescriptions, imaging studies, and procedures. Although the laboratory most often provides indirect patient care, it is both necessary and critical. In particular, laboratory testing is becoming more intricate and “personalized” and thus brings us the golden opportunity to intervene on behalf of the patient.

A classic and current example is the recent development of novel “target-specific” oral anticoagulants. These drugs certainly provide benefit to patients on several levels, but also are still associated, unfortunately with risks of bleeding (as with all anticoagulants). These drugs came to the market without specific coagulation tests or antidotes, both of which are necessary in the event of bleeding.

Some tests are on the horizon (e.g. dilute thrombin time) and some are available with proper validation/calibration (e.g. anti-factor Xa activity). Late 2013 and early 2014 saw the approval of Kcentra prothrombin complex concentrate for emergent warfarin reversal in patients with active hemorrhage and just a few weeks ago, idarucizimab (Praxbind) was FDA-approved for reversal of dabigatran-associated bleeding. Andexanet, a Factor Xa inhibitor reversal agent is in Phase III trials and we should anticipate its arrival on the market soon. These are, of course, welcome additions to our armament.

Although these drugs and their reversal agents may be housed and released from our pharmacies upon order, the onus is on us as laboratory professionals to stay abreast of these new entities, therapeutics etc. so we can aid in their appropriate use. Our hematology, coagulation and transfusion services, along with pathologists, should be “at-the-ready” to answer questions and guide our clinical colleagues. Protocols for reversal strategies are key and we must take on a prominent role on the committees that develop these.

Never forget the important role YOU play in everyday diagnosis, prognosis and treatment decisions! Each day represents an opportunity for us to step up to the plate and be major players in this ever-changing and challenging healthcare environment. Let’s continue to make our presence and our value known!

Burns

-Dr. Burns was a private practice pathologist, and Medical Director for the Jewish Hospital Healthcare System in Louisville, KY. for 20 years. She has practiced both surgical and clinical pathology and has been an Assistant Clinical Professor at the University of Louisville. She is currently available for consulting in Patient Blood Management and Transfusion Medicine. You can reach her at cburnspbm@gmail.com.

CLSI Publishes a New Document on Management of Critical- and Significant-Risk Results

From the press release:

“The Clinical and Laboratory Standards Institute (CLSI) has published a new document titled Management of Critical- and Significant-Risk Results (GP47-Ed1). This guideline provides current best practice recommendations for developing and implementing a policy and procedures for the identification, reporting, and management of critical- and significant-risk laboratory results. Emphasis is placed on management responsibilities such as development of the policy, the process, procedures, job descriptions, and monitoring systems that ensure effective reporting and compliance with regulatory requirements.

This new document refers to results as critical risk and significant risk, depending on the degree of risk to the patient. The recommendations in the standard are intended to be consistent with best practices for patient safety, and compliant with current, pertinent regulatory and accreditation requirements. GP47 includes an executive summary and appendixes with sample policies, reporting methods, escalation procedures, and monitoring tools.

This document is intended for clinical and laboratory directors, managers, and personnel who develop and implement laboratory policies and processes. The standard is also intended for health care administrators who oversee compliance with regulatory requirements, accreditation, and clinical practice standards related to patient safety. The recommendations cover every laboratory discipline and pertain to clinical laboratories of every size, scope, and complexity.”

Lab Safety: A Deadly Ride?

Mumbai is one of the financial capitals in India, and millions of commuters ride its railway network to and from work every day. However, over the past several years, the available public transportation has not increased in proportion to the city’s rise in population. This has resulted in overcrowded trains and a staggering death toll from accidents and falls. In 2005, a total of 494 passengers lost their lives after falling from running trains. This figure went up subsequently in the coming years and climbed to 901 by 2013. In 2015 nine people a day, on average, lose their lives while on the move.

Knowing these facts, how inclined would you or your lab staff be to take a train ride in Mumbai? Not very. Yet, there are people in that city who willingly get on board every day. These conditions of danger are normal for them. This is their culture. They have become immersed in it, and it has become difficult for them to step back and look at the big picture–even for their own safety. They have to get to work.

In the past, laboratory professionals worked in departments where mouth-pipetting was normal, where eating, drinking and smoking was common, and where working without PPE was accepted. Today we look at old lab pictures of these behaviors and react (I hope) with surprise. But what applies to the commuters in Mumbai might also apply to labs of the past as well—those technologists were immersed in their culture.

Since those times, many lab safety regulations have been put in place, but that hasn’t fixed the safety culture everywhere. There may be, of course, other reasons for unsafe conduct in the laboratory. There may be behaviors that have been held onto after years of practice, there may be a lack of safety education, or safety may simply not be a priority for lab leadership. All of these factors are a part of the lab safety culture. Do you know the culture on your lab?

Assessing the culture in your laboratory is important. If you are in leadership, you should not assume that your singular view of the culture is accurate. There are several ways to evaluate the culture; make a visual assessment, review injury and exposure incidents, or have staff take a written culture assessment.

Provide adequate safety education for your staff. Are they aware that there might be a better, safer way? Do they know where the PPE and engineering controls are? Have they been trained in their use? Is there any safety leadership holding staff accountable so that there are not too many people on the train?

Laboratory professionals have to get to work, but unlike the workers of Mumbai, it’s not necessarily the trip to work that’s an issue; it’s the work places which are not inherently safe. It takes knowledge, education, training and focus to keep people safe in the laboratory. Put safety in its proper perspective: we are not dealing with falling from a train, but we do encounter injuries, exposures, and lab-acquired infections, some of which can be just as deadly as a fall. Know your safety culture, and learn what it will take to make the needed changes so that no one in your lab becomes a statistic.

-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.

One Part Interpreter

I’m thoroughly convinced that in order to change laboratory information systems (LIS) and get the new LIS to work correctly you need a mixture of one part laboratory professional, one part information technology (IT) specialist, and one part interpreter. Add together and then vortex vigorously.

The laboratory professional is a given. It is absolutely necessary to have a person or people who understand the lab tests inside and out, from linear range to reference intervals to instrument capabilities to antibiotic susceptibilities to type and cross-match. There must be people with an understanding of how the tests work and what type of information is needed in order to ensure that when a test result appears in the electronic medical record for the doctor to see, it is an accurate result that makes sense and is interpretable.

The IT specialist is also a given. This person or people must completely understand not only how to program the system, but what type of programming is possible – what the computer system is capable of doing – or not doing. Being currently immersed in changing LIS systems at my institution, I have come to appreciate more and more how these two individual types must be able to communicate with each other and work together to design and implement an LIS that is functional for everyone.

Which brings us to the “interpreter”. Sometimes IT and lab people simply don’t speak the same language. I know I sometimes feel as though the IT people have begun speaking in tongues. I’m occasionally amused by the totally blank looks on the faces around me, and no doubt on my own. Thus what a project like this requires is a facile communicator with enough knowledge of both the lab and the programming to successfully interpret between the experts. I’m calling this person an “interpreter”, but calling him/her a communicator would be just as accurate.

In my institution the interpreter role is most frequently filled by laboratory technologists who have gone over to the Dark Side, otherwise known as Information Technology. Much as I hate to lose them as medical laboratory scientists, they are pretty nearly worth their weight in gold as interpreters when changing LIS systems. To continue the analogy, without their input in the mix, the vigorous vortexing necessary often results in an emulsion, not a smooth mixture. The finished product may not function as desired simply because the programmer did not understand what was needed, or the laboratory professional did not understand the inherent capabilities of the LIS.

With any luck, we have enough interpreters in our mix to end up with a functional LIS we can all live with. I know the current meetings are going as smoothly as they are due to these people’s work.

-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.

Are Feasibility Limits Feasible?

In the laboratory we’re constantly seeking ways to check that the test results that we put out are accurate. Our primary reason for doing this is that we want to make sure the patient is treated appropriately based on the results of the tests we run. Also, it’s nice not to release values that appear to be nonsense. A tool that is sometimes used to help us check results is something called feasibility limits.

Lab computer systems often allow you to enter feasibility limits for your test results or for your test parameters. These are values outside of which you would not expect to find an analyte concentration in a living person. For example, you might expect a serum creatinine of 200 mg/dL (17,680 µmol/L) in a zombie, but you wouldn’t expect to find one in a living human being. Setting feasibility limits helps you catch things that make no sense before the physician calls you on them, for instance if you have a decimal malfunction and mistakenly try to report a plasma calcium value of 90 mg/dL (22.5 mmol/L) instead of 9 mg/dL (2.25 mmol/L). The trick to feasibility limits is deciding on the highest or lowest value you might expect to see in a living human being. In the case of calcium, upper feasibility limits of 20 mg/dL (5 mmol/L) may give you wiggle room without letting you report nonsense. However, feasibility limits have their drawbacks also. One of those drawbacks is that I’ve found that with human beings, nearly anything is feasible, especially in the pediatric realm. I finally removed the feasibility limits from the LIS in my institution, after a couple of different episodes led me to that conclusion.

One was a body temperature on a blood gas analysis. Under normal circumstances one would not expect to encounter a body temperature much below 90° F (32.2 °C) ever. But of course hospitals are not known for their populations being “under normal circumstances”. The body temperature of the patient in question was 70° F (21°C) on a patient who had been cooled down for surgery. The blood gas instrument accepted the temperature, but the lab computer system would not because of the feasibility limits set in the computer. The patient’s blood gas results could not be released in the computer until we took the temperature feasibility limits out.

Another example was with sodium. It would seem reasonable to have an upper feasibility limit of 180 mmol/L for sodium. Yet we had a patient whose sodium was 199 mmol/L when he arrived in the ED. Reasonably expecting some sort of contamination issue, we requested another sample, which had a sodium of 204 mmol/L, followed by 200 mmol/L in the next sample. These were real sodium results and over the course of several days’ time the physicians managed to get the patient’s electrolytes normalized. Again, feasibility limits interfered with result reporting and had to be removed from the computer.

These episodes caused us to remove most of our feasibility limits from the computer. They also helped me to remember and important point: Tools are fine, but you must understand their uses and their limitations in order to use them appropriately. Feasibility limits can be useful as long as you keep in mind that with humans, you often see the unfeasible.

Education Proposals for ASCP’s 2016 Annual Meeting

Are you interested in presenting an education course at ASCP’s 2016 Annual Meeting? If so, the call for proposals is now out. You can find it at the direct link below.

ASCP’s 2016 Annual Meeting will be held at the Mandalay Bay Hotel & Casino in Las Vegas, NV on September 14-16, 2016.

Click here to access the 2016 Call for Proposals submission site

AMP Submitts Written Testimony about LDTs

From the press release:

“The Association for Molecular Pathology (AMP), the premier global, professional society serving molecular diagnostics professionals, yesterday submitted written testimony to the House Energy and Commerce Subcommittee on Health for their hearing on “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” AMP urged the Committee to use AMP’s proposal to modernize the Clinical Laboratory Improvement Amendments (CLIA) at the Centers for Medicare & Medicaid Services (CMS) as the basis for legislation that would preserve innovative patient care by building upon the current CMS-based system for oversight of laboratory developed procedures (LDPs).

‘Molecular pathologists are highly trained professionals and our professional judgment is used throughout the design, validation, performance, ongoing monitoring, and interpretation of test results. It is our mission to ensure that patients have access to innovative, accurate, reliable, and medically useful laboratory testing procedures,’ said Roger D. Klein, MD, JD, AMP Professional Relations Chair. ‘The AMP CLIA Modernization proposal preserves patient access to essential laboratory services that would no longer be offered if a costly FDA-based regulatory system were imposed upon academic medical centers, cancer centers, hospitals and small independent laboratories,’ he added.”

To read the press release in full, visit www.amp.org.

Radiation in the Lab

Radioactivity is no longer common in most clinical laboratories. At one point in my career, radioimmunoassays were commonly found in laboratories, and most labs had institutional radiation safety plans and carefully followed the CAP checklist for handling and dealing with radioactivity. With the advent of enzyme-linked immunoassays, sensitive nephelometers, various fluorescent and chemiluminescent technologies, and then mass spectrometry, radiation was quickly replaced in most clinical labs. The general prevailing thought was: Why deal with radiation if you don’t have to? Now days, radioimmunoassays are essentially only found in reference labs and utilized for esoteric analytes or those which cannot be measured any other way.

Despite that being true, it’s important for a lab to know what to do if radioactive materials should appear in the lab. How likely is that to happen? Perhaps more likely than you may think. Last week a sample shipped to us from an outside institution set off the radioactivity monitor on our hospital loading dock. The package was on a delivery cart with other packages so per protocol, the whole cart went to nuclear medicine where it was determined that the radioactive package was for the lab and it was brought to us. The radioactive sample turned out to be a urine sample for VMA/HVA analysis from a patient on a new cancer treatment protocol. The urine was indeed radioactive.

The shipping institution was contacted and the packaging personnel had no idea either that the sample was radioactive, although they were aware a new protocol was going into place. Working with our nuclear medicine department and the institutional radiation safety group, we have now once again put appropriate processes in place to handle and deal with radioactivity. And we’ve dusted off our old CAP checklist regulations as well.

This episode actually turned out to be a benefit to us, as we discovered that our own nuclear medicine department will be starting this new protocol soon, and had not thought ahead to possible radioactive samples sent to the lab. We are now working closely with them to ensure proper procedures and safeguards, and have a plan of action clearly in place. We also continue to work with the institution that sends us samples. The very next sample from them was properly labeled as potentially radioactive.

Times are Definitely Changing

Just returning from the ASCP 2015 conference in Long Beach, California, I can’t help but reflect on what a wonderful experience I had. The weather was picturesque, attendees at an all time high, and a variety of educational offerings and speakers on point.

The highlight for myself (and I know I am not speaking out of line when I mention the four other amazing ladies) was being recognized as ASCP’s Top Five from the 40 Under Forty program this year. I cannot begin to tell you how refreshing and energizing it is to be a part of an amazing group of five women who are all dedicated to advancement in Pathology and Laboratory Science.

To be honest, I was a little nervous going into the meeting… What would the other honorees be like? What would they think of me? Am I going to be completely out of my league there? Well let me tell you, everyone that I met was wonderful! We discussed a variety of topics, and even tossed around an idea for future collaboration.

Yes, I could go on and on about my new friends, but I think what I want to point out is that it cannot, and should not go unnoticed that the Top 5 this year consisted of all women, all WELL deserving women at that. How were we chosen? Yes, we blogged, but don’t forget that we also submitted CVs and biographies. We wrote essays as well as recorded videos (some of us spending hours re-shooting and cringing at ourselves). Not to mention, votes were cast by a dedicated panel as well as online voters. Your 40 Under Forty, including the Top Five, came from all over the country and represent various specialties in our field.

Unfortunately, at some point I had to come down from the “girl power” high. I returned to Milwaukee and thought to myself, I wonder what the ratio of men to women is in our laboratory alone? A few short minutes later, I crunched the numbers and it was easy to see that women make up 85% of laboratory staff at our organization. The totals are inclusive of all laboratory departments and shifts as well as administrative support, Pathologists, and Directors at Children’s Hospital of Wisconsin.

It was during these thoughts on women in science and recognition, that I remembered an article I had read quite a while back. The article had discussed how historically, women occupied most of the laboratory jobs (the strange term, “lab gals” sticks out in my mind). This was thought to be the case because it was believed that women had more patience, were more detail oriented, and therefore were trained to perform the work that doctors did not want to do. At the same time, men typically occupied the higher-level decision making positions (those that required an advanced degree, PhD, and MD). I thought to myself that even today, it sure does seem that there are more women in the laboratory profession. However, we have come a long way and are seeing an increase in women being honored for their education, professional achievements, and advancements in the field. Every single lead technologist and laboratory manager at our institution as well as the CEO of our health system currently is female. Interestingly, more than HALF of the 40 Under Forty Honorees this year are highly educated women with advanced degrees!

We all know full well that more than 70% of critical medical decisions are based on laboratory results. Therefore, if the field of laboratory professionals is made up of mostly women, it appears that our attention to detail is instrumental in making some major decisions. Yes, there still may be gender gaps when comparing men to women in academia however, what once was a field dominated by the male PhDs and MDs, appears to be shifting majorly as more and more women are making their presence known in Pathology and Laboratory Science.

I applaud everyone who was honored this year as one of ASCPs 40 Under Forty. Women are the past, present, and the future of laboratory science and medicine and it brings a little extra smile to my face to know that so many well deserving women are being recognized by ASCP this year.

2015 ASCP 40 Under Forty Top Five: Amanda Wehler, Tiffany Channer, Jennifer Dawson, LeAnne Noll, and Kimberly Russell

-LeAnne Noll, BS, MB(ASCP)^CM is a molecular technologist at Children’s Hospital of Wisconsin and was recognized as one of ASCP’s Top Five from the 40 Under Forty Program in 2015.

Ammonia and Hyperammonemia

Ammonia is a small molecule that is produced as a part of normal tissue metabolism. Its formation results from the breakdown of compounds containing nitrogen, such as the amino groups in proteins and the nitrogenous bases in nucleic acids. In the tissues, ammonia is stored mainly in the form of amino acids, specifically the amino acid glutamine which has three amino groups. Normally, the body can remove excess ammonia easily via the liver pathway known as the urea cycle. This short, 4-step cyclical pathway converts two ammonia molecules into a small, water soluble urea molecule, making it able to be easily excreted in the urine. Without a functional urea cycle however, the body has no other adequate mechanism for getting rid of the ammonia that is constantly being produced by metabolism.

Liver damage or disease can disrupt the urea cycle, causing blood ammonia levels to rise. This is the most common cause of elevated ammonia in the adult population. In a pediatric patient, elevated ammonia is frequently seen as a consequence of an inborn error of metabolism (IEM). Many IEM, especially those in the urea cycle pathway, will result in elevated blood ammonia levels. In addition, in IEM causes, the ammonia concentrations may be well over 1000 µmol/L, when the normal range of ammonia is generally in the 30 – 50 µmol/L range. Elevated blood ammonia concentrations are serious because ammonia is toxic to the brain. The higher the ammonia concentration is, and the longer it stays high, the more brain damage that will occur.

Interestingly, the concentration of ammonia in the blood may not correlate with the neurological symptoms that are seen. Usually if the ammonia concentration is <100 µmol/L, the person will show no symptoms at all. Concentrations of ammonia in the 100 – 500 µmol/L range are associated with a wide variety of symptoms including: loss of appetite, vomiting, ataxia, irritability, lethargy, combativeness, sleep disorders, delusions and hallucinations. These patients may present with an initial diagnosis of altered mental status, and if there is no reason to suspect an elevated ammonia, the symptoms may lead to drug or alcohol testing. When ammonia concentrations are >500 µmol/L, cerebral edema and coma may be seen, with cytotoxic changes in the brain. Ammonia concentrations in the 1000+ µmol/L range are extremely critical and are treated aggressively with dialysis to pull the ammonia out of the system. In particular, urea cycle defects require close monitoring of ammonia and glutamine concentrations, with immediate response when they rise.

Laboratory testing for ammonia is often problematic as contamination can occur from a number of sources including atmospheric ammonia, smoking and poor venipuncture technique. In addition if the sample is not centrifuged and analyzed promptly, ammonia is formed by the continuous deamination of amino acids and the concentration increases by 20% in the first hour and up to 100% by 2 hours. Consequently samples to be tested for ammonia should be placed on ice immediately after being collected and transported to the lab for analysis as soon as possible. Many minimally elevated ammonia results are a consequence of poor sample handling. However, a truly elevated ammonia is a critical lab finding that should be addressed immediately.