Category: generalist

New Developments in Zika Testing

Two companies have recently announced development and/or release of Zika virus assay. MD Biosciences has released a rapid assay to detect the virus in human blood and urine samples, and Luminex is partnering with University of São Paulo, Brazil to validate an assay that detects multiple infectious agents, including Zika.

If you’d like to learn more, read the MD Biosciences and GenArraytion press releases.

Edit 3/11/2016: Turns out FDA has something to say about the MD Biosciences test. Read about it in the Minneapolis Star-Tribune.

ASCP’s 40 Under Forty

ASCP’s 40 under Forty program recognizes forty pathologists, lab professionals, and residents under the age of 40 who are making significant contributions to the fields of Pathology and Laboratory Science. If that sounds like someone you know (or maybe it’s you!) head over the nomination page and start the process. Good luck!

Listen: Zika Virus Podcast

Dr. Diamond from the Washington University School of Medicine talked with Lab Medicine about all things Zika Virus: a brief history of the virus, modes of transmission, and the implications for laboratory professionals and pathologists.

Give it a listen.

The “Safety Eyes” Epiphany

The manager walked into the lab to talk to Joan about the schedule. Joan was working with Mike, an older technologist who never seemed to follow the safety regulations of the laboratory. Joan was glad her manager was coming, because today Mike was wearing mesh sneakers and he was chewing gum! She couldn’t wait to see the manager chewing him out about that. However, the manager walked quickly to Joan, asked her a question and went immediately back to the office. She never said a word to Mike.

There are several things to be said about a scenario like this. First, why doesn’t Joan say something to Mike herself? Why doesn’t she feel empowered to speak up for safety? Has anyone ever taught her how to coach her peers for safety? Second, does the manager realize how much damage was just done to the lab’s safety culture? Intended or not, her ignoring Mike’s behavior is tantamount to permitting it, and therefore promoting it.

I was a laboratory manager before I became a Lab Safety Officer. When I moved to the safety role, I was lucky to have the previous safety officer still on site to provide orientation. As we walked through the labs, my predecessor noticed several safety issues and corrected them. I was very disheartened since I didn’t notice any of them myself. I wondered if I could do the job. Not long after that, I had a “safety epiphany.” I realized I could not see those safety issues because I had not trained myself to see them. I had not yet learned how to use my “Safety Eyes.”

Since then, I have been training lab people that “Safety Eyes” is a super-power that all laboratorians have. It is a latent ability and it must be honed in order for it to be effective. In order to do that, you need to know what to look for- be aware of the lab safety regulations so you can discern between right and wrong when it occurs. Next, you need to practice. That is the most effective development method for “Safety Eyes.” Knowing where to start can be difficult, so it is best to start by focusing on one safety topic at a time.

Begin by looking at Bloodborne Pathogens issues. For example, are people wearing correct PPE? Are waste receptacles properly labeled? Are spill kits in place and not expired? Next, look at chemical hygiene issues. Are secondary containers labeled correctly? Are acids and bases stored near the floor? There are a large variety of safety items under each topic that can be checked visually in the laboratory. Move to fire safety and on to other topics. Choose one area per week to start, and over time you will become proficient in spotting safety issues with your now-powerful “Safety Eyes.”

During the first year of my role as a Lab Safety Officer, I would become angry with the lab managers who didn’t seem to support the safety program- those who would walk through their labs and not see what I considered to be obvious safety issues. Then I had to remember my days as a manager- did I pay attention to those things? No, I didn’t. In part that was because I had so many things on my plate that I was focused elsewhere- just like the manager talking to Joan about the schedule. I also did not have any Safety Eyes training, so I simply wasn’t equipped to see all of the problems.

Today, I provide Safety Eyes training to lab managers. I use photographs of safety issues- pictures taken of real issues in the lab. Using these visual aids hones their ability to see the issues the next time they walk through the lab, and it raises safety awareness for everyone. If you lead a laboratory, and if you do not focus on safety, I understand that. However, you should understand that is important to make a change- develop those Safety Eyes and advance your safety culture in a way your staff can appreciate and support.

 

Scungio 1

-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.

Zika Virus

If you’re an infectious disease geek and you’ve been following the news, you know that the Zika virus is causing a pandemic in Central and South America and is linked to cases of microcephaly in those regions. It’s gotten bad enough fast enough that the CDC has issued travel warnings for pregnant women and women of child-bearing age.

If you’d like to get up-to-date on this outbreak, check out Maryn McKenna’s blog on National Geographic. Also, the CDC has great information for clinicians and laboratory professionals.

 

 

So Long …

I decided to take this year-end opportunity to say good bye for a while. It’s with some regret that I hang up my blogging hat for now. My next year is going to extraordinarily busy, as I take on the role of President of AACC. As much as I have enjoyed writing posts to this blog for the last 2 ½ years, I’m afraid blogging routinely will have to take a back seat for 2016. I do hope to get an occasional post in, but we’ll see.

It has been my distinct pleasure to write posts for Lablogatory. I encourage any of you who have any inclination at all to write about lab related issues, to take up blogging for this feature. Putting your thoughts on paper is one of the best ways I know to clarify those thoughts. Writing about something is somewhat akin to teaching it; doing so helps you to understand and learn it yourself. It has also let me see just how clearly I can express the concepts I’m trying to get across.

Another thing that blogging has clearly taught me is to be sure of my facts. Seeing something in writing always gives it so much more weight than simply hearing it. I have always been surprised by the number of things that I “know” to be fact from my laboratory years of experience, that I cannot find backing or literature support for. Thus when I’m blogging about a topic, I often find myself suddenly questioning, exploring and confirming things that I’ve always assumed were “fact”. And if I can’t find supporting references, I clearly express that it is an opinion and where that opinion arises from.

And lastly, writing posts for this blog has allowed me to interact with a wide variety of people I would not have met otherwise, starting with Kelly Swails, who often tweaked my posts into something better, and continuing on with people who have responded, both online, and in person. Even one of my hospital administrators in Risk Management stopped me one day in the hall to say, “Oh! I read your blog about dilutions!”

Posting articles for this blog has given me the opportunity to think about a variety of topics, to clarify my thoughts by putting them into writing, and to interact with some great people. I hope to be able to pick this back up after my term of office. In the meantime, many thanks to everyone who has read my posts. See y’all on the other side!

 

-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.

 

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.

 

Scungio 1

-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.