Medical Laboratory Observer - April 2025

MLO-online.com

April 2025

Vol. 57, No. 3

®

The Peer-Authored Management Source for Lab Professionals since 1969

2025

LAB OF THE YEAR

Department of Laboratory Medicine and Pathology Mayo Clinic Florida

CE: Total system

for preventing lab errors Page 8

LAB INNOVATOR

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Hematology • Hemostasis • Urinalysis • Flow Cytometry • Informatics

A P L BW 2025

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Lab professionals, it’s time to gather together, share stories and have some fun with your fellow happy campers! Camp LabWeek 2025 is a celebration of YOU, the lab heroes who illuminate the path to diagnosis and treatment. Get ready for games, campfire stories, merit badges, science, education and more! It’s our way of saying thanks for your dedication and hard work. #LabWeek2025

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IN THIS ISSUE...

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April 2025 | Vol. 57, No. 3

6

From the editor

CONTINUING EDUCATION

8

A total system for preventing laboratory errors

By Patty J. Eschliman, MHA, MLS(ASCP), DLM, CPC, and Dan Scungio, MLS (ASCP) SLS, CQA (ASQ)

CLINICAL ISSUES

12

Understanding hemostasis and hemostasis testing

By Rajasri Chandra, MS, MBA

LAB MANAGEMENT

8

16

Evolving digital technologies address today’s challenges

By Matt Manley

INFECTION DIAGNOSTICS

18

Quality controls: Essential to laboratory compliance

By Deepa Eveleigh

SPECIAL FEATURE

22 12

Coaching Corner with Patty Eschliman

EDUCATION

24

Biomarker blood test revolutionizes preeclampsia care

By Pascaline Caruhel

LAB OF THE YEAR

26

DLMP, Mayo Clinic Florida

By Christina Wichmann

LAB OF THE YEAR RUNNERS UP

18

31

Mohawk Valley Health System Laboratory

34

NYU Langone Hospital- Long Island Laboratory

By Erin Brady

By Erin Brady

MOLECULAR DIAGNOSTICS

38 22

Syndromic tests expand laboratory’s growing stewardship role

By Martí Juanola Falgarona, PhD

PRODUCT FOCUS

40

Specimen collection

LAB INNOVATOR

42

Thomas P. Slavin Jr., MD, MBA, FACMGG, DABMD

By Christina Wichmann

DEPARTMENTS

40 38

Index of advertisers

ON THE COVER: Courtesy of Mayo Clinic

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F ROM T HE EDITOR

Fifty years of celebrating Lab Week

L

ab Week originated in 1975 by the American Society for Medical Technology (ASMT), now known as the American Society for Clinical Laboratory Science (ASCLS). This year, Medical Laboratory Professionals Week is celebrated April 20–26. This week celebrates the laboratory team, and its impact behind diagnostic medicine. ASMT developed this special week to increase visibility of the laboratory profession, foster pride among laboratory professionals, and inspire future laboratory professionals. Now, ASCLS is one of 18 laboratory medicine organizations responsible for coordinating

By Christina Wichmann this celebration of your profession.

To coincide with this celebration, MLO publishes its Editor in Chief annual Lab of the Year award. This is my favorite issue of the year, and I feel privileged to read through all the amazing applications. Thank you so much to all the labs that submitted thoughtful nominations, and thank you to the judges for their time reviewing and scoring the laboratory applications.

This year’s Lab of the Year is the Department of Laboratory Medicine and Pathology, Mayo Clinic Florida. As you can see from the cover photo, this is a large laboratory — 434 full-time equivalent staff. Patients throughout the world look to the Mayo Clinic for life-saving diagnosis and treatment. And without a doubt, if patients were aware of all the work happening in the DLMP, they would be as impressed as we are. In addition to the laboratory’s strong commitment to its patients, the laboratory team is committed to each other, and it is committed to the education of future laboratorians. In the past year, the lab has done much to improve its productivity including installing overhead cameras in Anatomic Pathology that have significantly reduced the time spent looking for missing specimens by 70%; investing in mass spectrometry has improved the speed of microbial identification so patients are receiving results much faster, often within a few hours; and implementing a new enterprise document control system that has increased efficiency by 25%, allowing lab staff to focus more on critical tasks and less on administrative duties.

The two runners-up for the Lab of the Year award are Mohawk Valley Health System Laboratory in Utica, New York and NYU Langone Hospital—Long Island Department of Pathology and Laboratory Medicine. The Mohawk Valley Health System Laboratory has its own dedicated team of Client Services Representatives who provide service and support to patients, on-staff providers, and local and regional healthcare providers. The Client Services office is staffed throughout the week. The health system recently merged two busy hospitals and laboratories into one very busy hospital and laboratory. This entailed the merging of differing laboratory processes into one more efficient process flow.

NYU Langone Hospital—Long Island Department of Pathology and Laboratory Medicine has a robust education program for its staff. The newly launched Leadership Development Program has the aim of enhancing the skills of current leaders, developing the next generation, and lowering employee turnover. The lab also launched the Hematology Academy to future-proof its lab by empowering the team with the skills, knowledge, and confidence to lead. There are three tiers of leadership in the Academy to cultivate leaders at every level.

So many wonderful nominations came in, and it is not an easy task choosing just three to highlight. I hope you enjoy learning about three of your peers. Thank you for all you do, and Happy Medical Laboratory Professionals Week!

I welcome your comments and questions — please send them to me at cwichmann@mlo-online.com.

Vol. 57, No. 3

PUBLISHER Chris Driscoll

cdriscoll@endeavorb2b.com EDITOR IN CHIEF Christina Wichmann

cwichmann@mlo-online.com MANAGING EDITOR Erin Brady ebrady@endeavorb2b.com PRODUCTION MANAGER Edward Bartlett ART DIRECTOR Kelli Mylchreest AUDIENCE DEVELOPMENT/LIST RENTALS

Laura Moulton | lmoulton@endeavorb2b.com ADVERTISING SERVICES MANAGER

Karen Runion | krunion@endeavorb2b.com ADVERTISING DIRECTOR OF SALES EAST COAST/MIDWEST SALES, CLASSIFIEDS

Carol Vovcsko (941) 321-2873 | cvovcsko@mlo-online.com SOUTH/WEST COAST/ILLINOIS SALES

Lora Harrell (941) 328-3707 | lharrell@mlo-online.com MLO EDITORIAL ADVISORY BOARD John Brunstein, PhD, Biochemistry (Molecular Virology) President & CSO PathoID, Inc., British Columbia, Canada Lisa-Jean Clifford, COO & Chief Strategy Officer Gestalt, Spokane, WA Barbara Strain, MA, SM(ASCP), CVAHP Principal, Barbara Strain Consulting LLC, Formerly Director, Value Management, University of Virginia Health System, Charlottesville, VA Jeffrey D. Klausner, MD, MPH Professor of Preventive Medicine in the Division of Disease Prevention, Policy and Global Health, Department of Preventive Medicine at University of Southern California Keck School of Medicine.

Donna Beasley, DLM(ASCP), Director, Huron Healthcare, Chicago, IL Anthony Kurec, MS, H(ASCP)DLM, Clinical Associate Professor, Emeritus, SUNY Upstate Medical University, Syracuse, NY Suzanne Butch, MLS(ASCP)CM, SBBCM, DLMCM Freelance Consultant, Avon, OH Paul R. Eden, Jr., MT(ASCP), PhD, Lt. Col., USAF (ret.), (formerly) Chief, Laboratory Services, 88th Diagnostics/Therapeutics Squadron, Wright-Patterson AFB, OH Daniel J. Scungio, MT (ASCP), SLS, CQA (ASQ), Consultant at Dan the Lab Safety Man and Safety Officer at Sentara Healthcare, Norfolk, VA CORPORATE TEAM

CEO Chris Ferrell COO Patrick Rains CRO Paul Andrews CDO Jacquie Niemiec CALO Tracy Kane CMO Amanda Landsaw EVP CITY SERVICES & HEALTHCARE Kylie Hirko

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by Endeavor Business Media, LLC. 201 N Main St 5th Floor, Fort Atkinson, WI 53538. Periodicals postage paid at Fort Atkinson, WI, and additional mailing offices. POSTMASTER: Send address changes to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. SUBSCRIPTIONS: Publisher reserves the right to reject non-qualified subscriptions. Subscription prices: U.S. $160.00 per year; Canada/Mexico $193.75 per year; All other countries $276.25 per year. All subscriptions are payable in U.S. funds. Send subscription inquiries to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. Customer service can be reached toll-free at 877-382-9187 or at MLO@ omeda.com for magazine subscription assistance or questions.

Printed in the USA. Copyright 2025 Endeavor Business Media, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopies, recordings, or any information storage or retrieval system without permission from the publisher. Endeavor Business Media, LLC does not assume and hereby disclaims any liability to any person or company for any loss or damage caused by errors or omissions in the material herein, regardless of whether such errors result from negligence, accident, or any other cause whatsoever. The views and opinions in the articles herein are not to be taken as official expressions of the publishers, unless so stated. The publishers do not warrant either expressly or by implication, the factual accuracy of the articles herein, nor do they so warrant any views or opinions by the authors of said articles.

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CONTINUING EDUCATION :: PREVENTING LAB ERRORS

ID 37721889 © Monkey Business Images Ltd | Dreamstime.com

Continuing Education :: Preventing Lab Errors

A total system for preventing laboratory errors

By Patty J. Eschliman, MHA, MLS(ASCP), DLM, CPC and Dan Scungio, MT (ASCP), SLS, CQA (ASQ)

I

n 1999, the healthcare world was shocked into assessing patient safety starting with the Institute of Medicine’s (IOM) transformative report “To err is human.”1 Estimating that as many as 98,000 people die annually due to hospital medical errors, authors Kohn, Corrigan, and Donaldson started a revolutionary approach to identifying, analyzing, and resolving safety risks in

healthcare. We are, after all, humans and not perfect. Gone were the days of finger pointing, highly accusatory and severely punitive error assessment.

Instead, the IOM report brought a new paradigm of thinking focusing not on “bad people” in healthcare but the consideration of “bad systems” that need improvement so good people can make better decisions.

Earning CEUs See test online at https://ce.mlo-online.com/courses/ A-total-system-for-preventing-laboratory-errors/.

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LEARNING OBJECTIVES

Upon completion of this article, the reader will be able to:

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directly to the CE test.

1. Describe the Swiss Cheese model and the factors involved in errors.

2. Discuss human performance and safety using the GEMS model and describe common errors in the modes of this model.

3. Differentiate the key principles of Just Culture as it pertains to laboratory safety.

4. List and describe the factors involved in gaining trust in the reporting of safety issues.

This concept brought forth improved models to assess why errors happen such as the “Swiss cheese theory” defined by James T. Reason.2 Complex systems, such as laboratory medicine, often include numerous safeguards or defense mechanisms to avoid errors. However, many of these defensive layers contain weaknesses or holes that when stacked up like slices of Swiss cheese, can unexpectedly line up to create a pathway for error. Reason’s work described both active and latent causal factors that lead to accidents, or in healthcare: adverse patient events.

Active factors include unsafe actions that can be directly linked to an error while latent factors can lie dormant for long periods of time before contributing.

Plebani, in his article “The detection and prevention of errors in laboratory medicine” describes the laboratory testing defense layers as well-designed procedures and processes, simplification and automation, training, supervision, and effective lab/clinical interface. He goes on to describe the holes in the Swiss cheese as the complexity in total testing processes, behavioral and skill

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Continuing Education :: Preventing Lab Errors differences in professionals, actions outside of the laboratory’s control, staffing shortages, and the increasing complexity of test ordering and result interpretation.3 Reason’s theory points laboratory leaders to exactly where they should begin the investigation of all safety incidents — at the system. In a laboratory, that means not placing the blame for an incident on the staff. Investigations should always first go to written procedures, the physical environment where the incident occurred, and anything else that was directly involved in the event.

That could mean engineering controls (such as a biological safety cabinet), the availability of personal protective equipment (PPE), or checking to see if any equipment was functioning properly.

If these things do not provide obvious causes to the incident, perform a risk assessment of the task or equipment involved and look again for the location of those “holes in the cheese.”

Human performance and safety

James T. Reason also studied errors by categorizing them. Through this research he developed the Generic Error Modeling System (GEMS), a system that contains three performance modes within which errors can occur. These modes are determined by the individual’s familiarity with the task. Based on the familiarity with a specific task, an individual naturally pays a certain level of attention. If an individual is very familiar with a task, for example, their attention level is naturally low. Conversely, if their familiarity with that task is low, they naturally pay more attention to the performance of the task. In the laboratory, that sounds dangerous. The more routine work staff do while handling dangerous chemicals and biohazards, the less focus they have while performing tasks with those dangerous items.

The GEMS model also breaks down errors into three different modes: skill-based, rule-based, and knowledge-based. In the skill-based performance mode, a person does not consciously think about the actions being performed, they are acting from memory. Errors in this performance mode result from slips or lapses in execution due mainly to a lack of attention.

Many lab injuries and exposures fit into this category.

Errors in the rule-based performance mode result from misinterpretation. The worker fails to recognize the changes in the routine task and therefore does not

apply the correct rule to complete the task successfully. For example, when lab employees hear an overhead fire alarm, they close the doors and listen to hear if the fire is nearby in case evacuation is necessary. A mistake here could be a decision not to evacuate soon enough resulting in getting trapped in the department.

Errors in the knowledge-based mode are a result of misdiagnosis. In situations that are unfamiliar to a laboratorian, they do not have or recognize all of the information needed to make an informed decision. People rely on assumptions to guide the decision-making process here, and the chance for errors with missing information and assumptions is very high. Think back to the COVID-19 pandemic — many had never encountered anything like it before. What decisions were made by labs and what incidents occurred that were a direct result of incorrect assumptions?

Humans make mistakes, but that doesn’t mean there is nothing that can be done. By performing risk assessments and focusing on the lab systems first, you can create safety barriers which positively impact how the humans of the lab interact with the hazards handled every day. Putting roadblocks to errors in place — engineering controls, administrative controls, PPE, etc. — will make the lab a safer place to work.

Staffing and safety

As laboratory professionals, we have long been aware of the impact of staffing shortages within our profession. While efforts continue among our supportive professional organizations to increase awareness of laboratory medicine and help recognize the importance of our work, one of the greatest tools we have for our own survival is retention. This means that the environment in which we work and leadership’s accountability for a positive culture is paramount.

As identified in a study completed

by Gallup Inc., employees who receive recognition and praise that are authentic, personalized, and equitable have a positive impact on their teams and their organizations. The study continues to address workplace safety, identifying that if 2 out of 4 employees were to receive recognition or praise for doing a good job in the last week, the organization could see a 22% drop in safety incidents along with a 22% decrease in absenteeism.4 Why does recognition influence safety in the workplace? People who

feel appreciated behave differently and form stronger social bonds. They care about one another and want to perform their tasks safely, not because the rules mandate it but because they care about the friends they work with.4 Receiving recognition also reduces the risk of employees cutting corners. When employees feel like no one cares, they believe no one will notice if they make an unsafe decision. This is one of the holes in the Swiss cheese that can lay dormant if it is permitted to continue.

As an example, who would notice if a scientist were to document controls

One of the best indicators of a strong safety culture is when ‘near miss’ safety events are reported regularly. that were not actually completed? They always work, correct? No, not correct.

Allowing systems to continue without a quality control check can lead to inaccurate patient values and potential patient harm.

How does a lab find these latent errors? Do you have to wait until all the holes line up and wait for something terrible to happen or can laboratories be more proactive? In response to the IOM report, the U.S. Congress formed the Agency for Healthcare Research and Quality (AHRQ) and commissioned them to implement strategies and tools to improve patient safety.

One of the tools identified was taken from military and aviation safety called a “Just Culture.”5

Just culture in the laboratory

Recognizing that placing blame and penalizing individuals who make mistakes only led to underreporting and the inability to fix systematic failures, the AHRQ acknowledged the benefit of creating a Just Culture. According to Outcome Ingenuity, a nationally recognized just culture training organization, a “Just Culture refers to a values-supportive system of shared accountability where organizations are accountable for the systems they have designed and for responding to the behaviors of their employees in a fair and just manner. Employees, in turn, are MLO-ONLINE.COM APRIL 2025 | 9

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Continuing Education :: Preventing Lab Errors accountable for the quality of their choices and for reporting both their errors and system vulnerabilities.”6 This shared accountability for recognizing and taking action for safety events is dependent upon a non-punitive approach to error reporting and requires creating a workplace environment where individuals are encouraged to report mistakes and near-misses without fear of punishment.

The key principles of a Just Culture include accountability without blame, encouragement of reporting, focus on learning and improvement, and distinguishing behaviors.7 These distinguishing behaviors help identify the cause of errors into three categories: human error (an unintentional mistake); at-risk behavior (a choice or action that increases the risk for error); and reckless behavior (a conscious disregard or willful act that deviates from safety practices or procedures).8 You cannot fix what you don’t know. Reporting systems in a Just Culture are the key to understanding the breadth of errors that help identify system malfunctions. In today’s healthcare world, there are many software applications that can help ease the burden of error data management but if you can’t get your employees to report, there is no data to evaluate.

One of the best indicators of a strong lab safety culture is when ‘near miss’ safety events are reported regularly. If that is happening in the lab, you can discern that real events are also getting reported transparently, and there is no punishment or blame when incidents are reported to leadership.

This type of culture also means that the laboratory staff are actively seeking safety issues on a routine basis, and that they care about their safety and that of their co-workers. This part of a Just Culture mindset is something for which all lab leaders should strive.

Trust in reporting safety issues

What causes barriers to error reporting in healthcare? Often, trust is an issue. It will take some time for team members to understand the value of the data to improve patient care and the commitment from leadership to assess errors without blame. Trust within an organization can be looked at in three different ways that can both enhance or prohibit employees from error reporting: organizational, team, and experience factors.9 Organizational factors include the ease and anonymity of the error reporting system as well as leadership style. Every employee can feel the tension from an unauthentic leader who wishes to harm more than understand. Expectations for leadership include self-awareness training, relationship building, and open and honest communication.

Team factors focus on building a positive culture where the team cares for one another (as described previously) and creating mutual understanding of the challenges faced within the team. This understanding enhances the acceptability to report. Team members might feel like they are “tattling” or that their reporting of other’s mistakes will get their friends in trouble. Continuous communication regarding the non-punitive nature of a Just Culture is necessary and must come from the top down.

Finally, the experience factor involves training and confidence. New graduates or team members who lack confidence in their skills often make more errors and unfortunately, are sometimes bullied by more experienced co-workers. There should be zero tolerance in the workplace for bullying. In fact, bullying behavior is one of the latent factors identified that leads to errors and must be reported.

The perceived risk of team retaliation in error reporting must also be addressed by leadership and additional training for struggling team members should be provided. Documenting issues outside of the lab is important too. There are many non-lab professionals in the healthcare setting that don’t understand the laboratory, our processes, and regulatory requirements. Often times, the lab is seen as an obstacle to patient care. We have all received the occasional phone call from someone who is frustrated and may be unprofessional towards the lab. Remember that this is always a response from someone who is focused on their patient and under significant stress by outside forces that you are unaware of.

Remaining kind and professional when dealing with these calls will go a long way to help build that relationship of shared understanding. Placing a report in the error management software will also help the organizations set expectations of behavior for all employees.

Conclusion

There are multiple factors that affect the laboratory’s safety culture, just as there are several system circumstances which can lead to lab accidents. Understanding human behavior and having complete knowledge of the systems in place in the department can have major advantages in establishing a culture where safety is maximized. A focus on leadership training in these areas would be advantageous for any laboratory manager or safety professional.

Leaders who are present in their labs also make a difference. That visibility can affect behaviors and help Scan code to go staff to understand that they are directly to the CE test.

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cared for by their employer. Creating a culture where continuous and open communication is the norm and moving to a stage where even near-miss incidents are reported are the hallmarks of a strong safety culture where fewer incidents prevail.

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REFERENCES 1. Corrigan JM, Kohn LT. Donaldson MS Editors. To Err Is Human: Building a Safer Health System. National Academies Press; 1999.

2. Reason J. Human Error. Cambridge University Press; 1990. doi:10.1017/ cbo9781139062367.

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3. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem. 2010;47(Pt 2):101-10. doi:10.1258/ acb.2009.009222.

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4. Gallup and Workhuman. From Praise to Profits: The Business Case for Recognition at Work. 2023 Gallup, Inc. 5. Boysen PG 2nd. Just culture: a foundation for balanced accountability and patient safety. Ochsner J. 2013;13(3):400-6.

6. Just culture in health care. Justculture. healthcare. Accessed February 18, 2025. http://www.justculture.healthcare/.

7. Mattew M. A Just Culture: Understanding Its Roots and Role in Modern Organizations. Safety Inc. Published online 2024.

8. American Society of Health-System Pharmacists. Just Culture Toolkit. Accessed February 18, 2025. https://www.ashp. org/-/media/assets/pharmacy-practice/ resource-centers/patient-safety/ Just-Culture-Toolkit_-Final.pdf.

9. van Marum S, Verhoeven D, de Rooy D. The Barriers and Enhancers to Trust in a Just Culture in Hospital Settings: A Systematic Review. J Patient Saf. 2022;18(7):e1067-e1075. doi:10.1097/ PTS.0000000000001012.

Patty J. Eschliman, MHA, MLS(ASCP), DLM, CPC is a Certified Professional Coach who specializes in laboratory leadership growth and professional support. As President and CEO of The Lab Leader Coach, Patty coaches many lab professionals in all roles in the areas of building leadership skills, preventing burnout, improving communication, building cohesive teams, and how to be a positive influencer. She has 39 years of experience as a Medical Laboratory Scientist, the last 29 spent in leadership.

Dan Scungio, MT (ASCP), SLS, CQA (ASQ)has more than 25 years of experience as a certified medical tech. He was a lab manager for 10 years before becoming the laboratory safety officer for Sentara Healthcare, a system of 12 hospitals and more than 20 labs and draw sites in Virginia and North Caroline. As “Dan the Lab Safety Man,” he provides consulting, education, and training in the U.S. and Canada.

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CLINICAL ISSUES :: HEMOSTASIS

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Clinical Issues :: Hemostasis

Understanding hemostasis and hemostasis testing

By Rajasri Chandra, MS, MBA

A

s soon as a blood vessel is ruptured following an injury, a series of physiological events, called hemostasis is triggered. Hemostasis is a complex, dynamic mechanism that stops bleeding from damaged or injured blood vessels by balancing procoagulant and anticoagulant forces.1, 2 Parts of the body involved in hemostasis are the circulatory/vascular system that contains the blood vessels; the liver that produces clotting factors; and bone marrow that produces platelets.

Hemostasis is important for the following reasons: • Prevents excessive and uncontrolled blood loss • Helps to maintain homeostasis • Prevents accumulation of blood in internal organs during the bursting of blood vessels internally by quickly checking the bleeding process • Triggers the healing process of the ruptured vessels • Coagulation system works in tandem with the immune system to maintain health and are also involved in various pathological conditions 3

The process of hemostasis

The entire process can be broadly divided into the following stages: Primary hemostasis involves two main physiological events — vasoconstriction and platelet plug formation.

With the rupture of the blood vessel, endothelin-1 (a vasoconstrictor) is released from the damaged endothelium of

the blood vessel that causes vasoconstriction. Other chemical components like sub-endothelial collagen, ATP (adenosine triphosphate), von Willebrand factor (vWF), and inflammatory mediators also get released into the circulatory system, which also promote vasoconstriction The sub-endothelial collagens and von Willebrand factors facilitate platelet accumulation and adhesion in the ruptured site. The attached platelets rupture and release serotonin, ADP (adenosine diphosphate), and thromboxane A2. All these components of the platelets also enhance vasoconstriction.

During the rupture of the blood vessel, local pain receptors initiate reflexes that further promote the vascular spasm.

The platelets bound with collagen and endothelial lining form a temporary seal called the platelet plug. The platelet plug seals the vessels temporarily and prevents or slows down the rate of blood flow. The platelet plug activates the clotting factors and initiates clotting — the secondary hemostasis.

Secondary hemostasis involves sequential activation of procoagulant proteins or coagulation cascade.4 Secondary hemostasis follows two main coagulation pathways, intrinsic and extrinsic, that subsequently converge to form a common pathway that activates the conversion of fibrinogen to fibrin.

The process of secondary hemostasis or coagulation takes place through a series of clotting factors as listed below: The process of secondary hemostasis takes place in the following order:

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Clinical Issues :: Hemostasis 1) Activation of clotting factors, 2) conversion of prothrombin into thrombin, and 3) conversion of fibrinogen into fibrin fiber.

Tertiary hemostasis or fibrinolysis5— Subsequent to the formation of a blood clot, healing of the ruptured vessels begins. Once the blood vessel is completely healed, the fibrin is lysed in a complex process called fibrinolysis. Broadly speaking, fibrinolysis occurs in two steps: • Generation of plasmin by plasminogen activators: Factor XII, protein catabolizing enzymes, and other cofactors activate the plasminogen into plasmin • Digestion of fibrin by plasmin Fibrinolysis can be of two types — primary fibrinolysis, which is the normal body process and secondary fibrinolysis, which is the breakdown of clots caused by a medicine, a medical disorder, or some other cause.

When blood clots are dissolved using medications to treat medical conditions, it is termed as thrombolysis.

After fibrinolysis/thrombolysis, the blood clot is removed, and the blood circulation continues as usual.

Hemostasis disorders

Malfunctioning of hemostasis leads to a bleeding disorder or clotting disorder. Disorders can be due to hypercoagulability (blood clots too much or too easily), hypocoagulability (not enough clotting), or iatrogenic coagulopathy (induced by medicines).

When the disorder is due to hypercoagulability or thrombophilia, it can cause: • Deep vein thrombosis (DVT) — a blood clot in one’s leg or arm that can then travel to the lungs causing pulmonary embolism (PE), an obstruction of blood flow to that area of the lungs • Stroke — a blood clot in the brain • Myocardial infarction or heart attacks — due to a blood clot in the blood vessels of one’s heart Thrombophilia occurs due to the interplay of both genetic and environmental factors. Genetic factors could be factor 5 Leiden mutation, protein C deficiency, protein S deficiency, prothrombin gene mutation, etc. Table 1 lists the genes that are associated with thrombophilia. Environmental factors

Pathway

Clotting factors

Intrinsic pathway or contact activation pathway

I (Fibrinogen), II (Prothrombin), IX (Christmas factor), X (Stuart-Prower factor), XI (Plasma thromboplastin), XII (Hageman factor)

Extrinsic pathway or tissue factor pathway

I, II, VII, and X. Factor VII

Common pathway

I, II, V, VIII, and X

could be oral contraceptive use; obesity; smoking; medical conditions like thyroid disorders, renal disease, abnormal liver function, cancer; surgery; etc.

Hypocoagulability can be caused by hemophilia, von Willebrand disease (deficiency of vWF), and inherited thrombocytopenia (low platelet count), which are genetic disorders.

When one or more clotting factors are deficient or absent, the body cannot produce a clot at the injury site efficiently.

Signs and symptoms of a bleeding disorder7

• Blood in urine or stool • Excessive bleeding that does not stop easily and may start spontaneously, such as with nosebleeds, or after a cut, dental procedure, or surgery • Large bruises and bruising often • Heavy bleeding after giving birth • Heavy menstrual bleeding • Petechiae, or bleeding under the skin causing tiny purple, red, or brown spots • Redness, swelling, stiffness, or pain from bleeding into muscles or joints, which is particularly common with inherited hemophilia • Umbilical stump bleeding that lasts longer than what is typical for newborns — about 1 to 2 weeks after the umbilical cord is cut — or that does not stop

Laboratory testing8,9,10

A wide range of tests of hemostasis are available — from routine coagulation assays to specialized hemostasis assays and platelet function. A summary of screening tests, clotting factor tests, and genetic tests follows.

Gene

OMIM gene Disease

Function

F5 F2 SERPINC1 HRG PROS1 SERPIND1 PROC F13B

612309 176930 107300 142640 176880 142360 612283 134580

Activation of prothrombin to thrombin Coagulation and maintenance of vascular integrity Inhibition of thrombin, regulation of blood coagulation cascade Adaptor protein involved in coagulation, fibrinolysis Prevention of coagulation, stimulation of fibrinolysis Thrombin, chymotrypsin inhibitor Regulation of blood coagulation by inactivating factors Va and VIIIa B subunit of factor XIII, stabilizes fibrin clots

F9 PLAT THBD FGB

300746 173370 188040 134830

FGG

134850

HABP2 MTHFR

603924 607093

THPH2 THPH1 AT3D THPH11 THPH5, THPH6 THPH10 THPH3, THPH4 Deficiency of B subunit of factor XIII THPH8 THPH9 THPH12 Congenital dysfibrinogenemia Congenital dysfibrinogenemia THPH1 THPH1

Activates factor X Involved in tissue remodeling, degradation Regulation of amount of thrombin Beta component of fibrinogen. After vascular injury, fibrinogen is converted into thrombin to form fibrin (major component of blood clots) Gamma component of fibrinogen. After vascular injury, fibrinogen is converted into thrombin to form fibrin (major component of blood clots) Role in coagulation and fibrinolysis systems Conversion of 5,10-methylenetetrahydrofolate to 5-methyltetrahydrofolate

Table 1. Genes associated with thrombophilia.6 MLO-ONLINE.COM APRIL 2025 | 13

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Clinical Issues :: Hemostasis Screening tests

Genetic tests

The following is a list of screening teststo determine if the patient’s blood is clotting properly: • Complete blood count (CBC) measures all blood components including platelets and can indicate presence of platelet disorder, if any.

• Prothrombin time (PT) measures the time it takes for blood to clot, primarily assessing the extrinsic pathway of the coagulation cascade. Normal PT values range from 9 to 13 seconds. Higher PT values indicate a prolonged clotting time, suggesting potential issues with clotting factors such as fibrinogen, factor V, VII, X, and prothrombin. Abnormal PT values may indicate liver disease, vitamin K deficiency, or the presence of anticoagulants.

• Partial thromboplastin time (PTT) measures the intrinsic and common pathways of the coagulation cascade, assessing factors such as VIII, IX, XI, and XII, as well as fibrinogen. Normal PTT values range from 25 to 35 seconds. Prolonged PTT may be due to deficiencies in these clotting factors, hemophilia, or the presence of inhibitors. Shortened PTT, may indicate an increased risk of thrombosis and could be associated with elevated factor VIII levels.

• Activated partial thromboplastin time (aPTT) measures the same coagulation factors as PTT with the addition of an activator, to make it clot faster.

• International normalized ratio (INR) is a standardized measure of PT, ensuring consistency in results across different laboratories. The normal range for INR is around 0.8 to 1.2. Higher INR values indicate a slower clotting time and an increased risk of bleeding. INR is particularly crucial for individuals on oral anticoagulants like warfarin.

• Fibrinogen test measures level of fibrinogen.

• D-Dimer is a marker for fibrin degradation products, indicating ongoing fibrinolysis. Normal D-dimer values are typically less than 500 ng/mL. Elevated D-dimer levels may be due to conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), disseminated intravascular coagulation (DIC), or other conditions associated with increased fibrin turnover.

However, D-dimer is not specific, and elevated levels can also be seen in inflammation, infection, surgery, or pregnancy.

• A mixing test where the patient’s plasma is mixed with an equal amount of normal plasma and tested to determine whether the clotting time prolongation is due to a coagulation factor deficiency or caused by antibodies blocking the clotting factors, such as with autoimmune disorders or acquired hemophilia.

9. Zaidi SRH, Rout P. Interpretation of blood clotting studies and values (PT, PTT, aPTT, INR, anti-factor Xa, D-dimer). In: StatPearls. StatPearls Publishing; 2025.

Clotting factor tests

10. CDC. Diagnosing Hemophilia. May 15, 2024. Accessed February 27, 2025. https://www.cdc.gov/hemophilia/testing/index.html.

A clotting factor test measures the level or the activity of a specific clotting factor in the blood.8 • Von Willebrand factor (vWF) tests measure the amount of vWF in blood.

• Clotting factor VIII tests measure the activity of factor VIII in your blood. Very low levels of clotting factor VIII, may indicate hemophilia A. • The Bethesda test looks for antibodies that may be blocking factor VIII or IX. • Factor XIII antigen and activity assays assess factor XIII deficiency.

FDA-approved molecular tests for factor II and factor V Leiden are available from a few manufacturers.

Quite a few clinical laboratories also offer comprehensive bleeding disorder panels using next-generation sequencing (NGS).

Treatment

Treatment depends on the type of the disorder. There are three general treatment options for bleeding disorders: risk reduction, medications (for example, antifibrinolytic agents, birth control pills, desmopressin, monoclonal antibodies, vitamin K supplements, etc.) and factor replacement therapy (For example: clotting factor concentrate, fresh frozen plasma, bypassing agents).11

Conclusion

Though a wide range of tests and treatment options, including gene therapy, are currently available, with the increasing use of artificial intelligence (AI) in healthcare and emergence of newer technologies like nanotechnology, we can hope to see use of AI in hemostasis. AI will enable more precise monitoring of coagulation and personalized medication for bleeding and clotting disorders, the development of novel hemostatic materials utilizing nanotechnology, and wider adoption of thromboelastography (TEG) for real-time assessment of blood clotting during surgery, which will facilitate better patient care by providing advanced diagnosis and treatment options for bleeding and thrombotic conditions.

REFERENCES 1. LaPelusa A, Dave HD. Physiology, hemostasis. In: StatPearls. StatPearls Publishing; 2025.

2. Sokou R, Parastatidou S, Konstantinidi A, Tsantes AG, Iacovidou N, Piovani D. Stefanos Bonovas, Argirios E. Tsantes, Contemporary tools for evaluation of hemostasis in neonates. Where are we and where are we headed? Blood Reviews. 2024;64.

3. Wilhelm G, Mertowska P, Mertowski S, et al. The crossroads of the coagulation system and the immune system: Interactions and connections. Int J Mol Sci. 2023;24(16):12563. doi:10.3390/ijms241612563.

4. Chaudhry R, Usama SM, Babiker HM. Physiology, coagulation pathways. In: StatPearls. StatPearls Publishing; 2025.

5. Chapin JC, Hajjar KA. Fibrinolysis and the control of blood coagulation. Blood Rev. 2015;29(1):17-24. doi:10.1016/j.blre.2014.09.003.

6. Dautaj A, Krasi G, Bushati V, et al. Hereditary thrombophilia. Acta Biomed. 2019;90(10-S):44-46. doi:10.23750/abm.v90i10-S.8758.

7.

Bleeding Disorders Symptoms. NHLBI, NIH. Updated August 3, 2023. Accessed February 27, 2025. https://www.nhlbi.nih.gov/health/ bleeding-disorders/symptoms.

8. Bleeding Disorders Diagnosis. NHLBI, NIH. Updated August 3, 2023. Accessed February 27, 2025. https://www.nhlbi.nih.gov/health/ bleeding-disorders/diagnosis.

11. Bleeding Disorders Treatment. NHLBI, NIH. Updated August 7, 2023.

Accessed February 27, 2025. https://www.nhlbi.nih.gov/health/ bleeding-disorders/treatment.

Rajasri Chandra, MS, MBA is a global marketing leader with expertise in managing upstream, downstream, strategic, tactical, traditional, and digital marketing in biotech, in vitro diagnostics, life sciences, and pharmaceutical industries. Raj is an orchestrator of go-to-market strategies driving complete product life cycle from ideation to commercialization.

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LAB MANAGEMENT :: DIGITAL TECHNOLOGIES

Lab Management :: Digital technologies

Evolving digital technologies address today’s challenges, promise future value

By Matt Manley

Maximizing operational efficiency

The rising demand for skilled technicians continues to be a major concern for laboratories. With non-supervisory vacancy in specialized core labs closing in on 15% across U.S. hospitals,2 the workforce shortage is expected to worsen as demand for medical laboratory technologists and technicians is projected to increase by 11% between 2020 and 2030.3 Under pressure to identify new and better ways to use limited resources while maintaining quality and reliability, labs are exploring innovative methods that prioritize less labor-intensive workflows. As many labs are discovering, implementation of digital technologies designed to reduce manual processes can increase operational efficiency, streamline daily operations, reduce errors, and free up available staff to complete more complex tasks.

Performing more than 13 million tests annually, Huntsville Hospital in Huntsville, Alabama, is a case in point. Using middleware with automated quality control (QC), the hospital lab reduced manual QC steps and decisions by 62.5%,

sanjeri/E+/Getty Images

T

here is no denying that data has become a driving force in healthcare. Thirty percent of the world’s data volume is generated by the healthcare industry with health data on track to grow by 36% annually.1 With the volume of healthcare data on the rise, digital technologies help create more connected, agile health systems and unlock new possibilities for laboratories to play an even more prominent role in delivering better patient care.

Seizing opportunities to elevate the impact of diagnostic testing begins with understanding how digital solutions can address laboratories’ current and most significant challenges. Universally, labs today are looking for strategies and solutions to help with the following: • Increase efficiency – In light of current staff shortages, labs need simplified workflows that enable them to run more tests with fewer staff while maintaining quality and improving test turnaround times (TATs).

• Improve connectivity – Evolving to minimize siloed data and systems, labs are looking for ways to securely manage and integrate larger volumes of data across core, molecular and pathology labs, as well as point-ofcare settings.

• Positively impact patient care – As partners in informed healthcare decision-making, labs aim to deliver healthcare providers and patients the right insights at the right time to diagnose disease, determine appropriate therapy, and monitor illness.

decreased total clicks by 99%, and improved its routine average TATs by more than 16 minutes.4 While quality control is vital to lab performance and the accuracy of test results, through digital solutions, Huntsville Hospital’s lab was able to simplify time-consuming QC workflows, minimizing impact on staffing.

With pathologists also in high demand, digitization of slides improves how pathology services are delivered as labs face higher volumes and increased histopathology complexity.5 Remote access to whole-slide images not only makes it possible for pathologists to serve more labs but also allows laboratories to employ pathologists located in other geographic areas.

Also related to optimized staffing and streamlined workflows, laboratories with digital pathology solutions have the capacity to image large numbers of glass pathology slides rapidly at high resolution through a digital scanner, eliminating time-intensive manual processes. Comparing a digital pathology scanner with a remote-controlled microscope, a study published in the Journal of Clinical Pathology found the average time to diagnose a case decreased from 19 to 11 minutes using whole-slide images.6 The technology also increased the number of pathology slides scored per hour by more than 15 times compared to the manual process.6

Enabling connectivity and data integration

As laboratory systems become increasingly complex, interoperability challenges are a huge drain. It is estimated that low interoperability, largely the result of disparate, siloed data and systems, costs U.S. healthcare entities more than $30 billion.7 And with laboratory test results supporting more than 70% of medical decisions,8 there is considerable need for intelligent laboratories that can extend the digital impact

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Lab Management :: Digital technologies of every test beyond the reporting of an accurate result. By integrating disparate data streams (think IT systems such as laboratory information systems and electronic health records, as well as third-party devices), digital solutions designed for connectivity create a real advantage by turning operational data into actionable insights, increasing transparency of operational metrics and lifting the veil on opportunities for improvement that drive both business performance and higher-quality patient care.

As digital solutions move to decentralized, point-of-care settings like physician offices, urgent care centers, and emergency rooms—connectivity becomes even more vital. Digitally connected data and systems allow labs to maintain control and help ensure efficient management of both instruments and operators.

Improving healthcare decision-making

As partners with clinicians in decision-making that impacts patient care, laboratories are focused on providing accurate and timely results necessary for providers to diagnose illness and manage patient needs. Diagnostic and medical complexity, coupled with higher volumes of data and information, creates challenges using medical data to enable confident care decisions. A report detailing primary care physicians’ (PCPs) views on healthcare in the U.S. reveals that 76% of PCPs are unsure about the correct use of diagnostics.9 Implying a directive for additional guidance, this level of uncertainty underscores the need for digital tools that can extract medical insights from data to promote better healthcare decisions.

Today’s digital solutions are already enabling this type of clinical insight. Delivering higher medical value to support patient care, digital technology now allows hospitals and labs to set up a single point of access for integrating and consolidating high-value medical algorithms across disease areas.

With these tools, users can combine and analyze data to help make clinical decisions and guide clinical workflows based on current practice guidelines. Through digital solutions that support oncology, for example, clinicians have ready access to tumor board and clinical decision support apps, including treatment guidelines, publication searches, and clinical trial matching that aid in therapy planning and patient monitoring.

Facilitating secure remote access to slides and information, digital pathology solutions connect pathologists to peers and specialists around the world. In a study analyzing the use of expert opinions, 78% of pathologists say that second opinions increase diagnostic accuracy.10 Artificial intelligence (AI) and machine learning further enhance diagnostic capabilities by identifying patterns and anomalies in pathology slides that may be missed by the human eye. This can lead to earlier and more accurate detection of cancer and other diseases. AI-powered tools can also extract valuable insights and patterns from broader patient data to better characterize and inform diagnosis, predict case outcomes, and guide treatment planning. In the diagnosis of sepsis, for example, training AI models using available health data creates the potential for medical algorithms to support more accurate diagnosis of the deadly disease. Finding global patterns in the complexities of sepsis presentation, AI can help illuminate the likelihood that a patient will become septic and/or the potential progressions of the disease.11,12 Because AI algorithms depend on extensive datasets and timely TATs to continuously improve performance, connectivity between digital healthcare platforms is vital to maximizing the utility of AI-based tools.

Digital’s future in diagnostic testing

The potential of digital technology to transform healthcare is both immense and inspiring. Digital solutions are destined to revolutionize diagnostic testing, fundamentally enhancing patient care. By empowering laboratories to achieve peak operational efficiency and provide deeper clinical insights, the contribution of digital advancements to the future of diagnostics is increasingly undeniable. While the journey to digital transformation13 is unique for each laboratory, the adoption of a robust digital infrastructure and advanced technologies equips labs of all sizes to embrace a digital future that promises not only improved operational performance but also significantly better health outcomes for patients.

REFERENCES 1. Forsman RW. Clinical Laboratory Management Association. Nov/ Dec 2022.

2. Garcia E, Kundu I, Kelly M, Soles R. The American Society for Clinical Pathology 2020 Vacancy Survey of Medical Laboratories in the United States. Am J Clin Pathol. 2022;157(6):874-889. doi:10.1093/ajcp/aqab197.

3. Leber AL, Peterson E, Dien Bard J. The hidden crisis in the times of COVID-19: Critical shortages of medical laboratory professionals in clinical microbiology. J Clin Microbiol. 2022;60(8). doi:10.1128/jcm.00241-22.

4. Navify® Lab Operations. Roche Diagnostics. Accessed February 25, 2025. https://diagnostics.roche.com/us/en/products/instruments/ cobas-infinity-central-lab-ins-4113.html.

5. Williams BJ, Bottoms D, Treanor D. Future-proofing pathology: the case for clinical adoption of digital pathology. J Clin Pathol.

2017;70(12):1010-1018. doi:10.1136/jclinpath-2017-204644.

6. Menter T, Nicolet S, Baumhoer D, Tolnay M, Tzankov A. Intraoperative frozen section consultation by remote whole-slide imaging analysis -validation and comparison to robotic remote microscopy. J Clin Pathol.

2020;73(6):350-352. doi:10.1136/jclinpath-2019-206261.

7.

Huynh K, Dzabic N. Industry Voices—Interoperability can cut health costs by $30B. But this needs to happen first. Fierce Healthcare.

Published August 25, 2020. Accessed February 25, 2025. https:// www.fiercehealthcare.com/tech/industry-voices-interoperability-canreduce-healthcare-costs-by-30b-here-s-how.

8. FDA and CMS statement: Americans deserve accurate and reliable diagnostic tests, wherever they are made. Cms.gov. Published January 18, 2024. Accessed February 25, 2025. https://www.cms.gov/newsroom/ press-releases/fda-and-cms-statement-americans-deserve-accurate-andreliable-diagnostic-tests-wherever-they-are.

9. Sirovich BE, Woloshin S, Schwartz LM. Too Little? Too Much? Primary care physicians’ views on US health care: a brief report. Arch Intern Med. 2011;171(17):1582-5. doi:10.1001/archinternmed.2011.437.

10. Geller BM, Frederick PD, Knezevich SR, et al. Pathologists’ use of second opinions in interpretation of melanocytic cutaneous lesions: policies, practices, and perceptions. Dermatol Surg. 2018;44(2):177-185. doi:10.1097/DSS.0000000000001256.

11. Duncan CF, Youngstein T, Kirrane MD, Lonsdale DO. Diagnostic challenges in sepsis. Curr Infect Dis Rep. 2021;23(12):22. doi:10.1007/ s11908-021-00765-y.

12. O’Reilly D, McGrath J, Martin-Loeches I. Optimizing artificial intelligence in sepsis management: Opportunities in the present and looking closely to the future. J Intensive Med. 2023 Nov;4(1):34-45. doi:10.1016/j. jointm.2023.10.001.

13. McClintock D.How should pathology labs embrace digital transformation? Roche Diagnostics. Published October 23, 2024. Accessed February 25, 2025. https://diagnostics.roche.com/us/en/article-listing/ how-should-pathology-labs-embrace-digital-transformation.html.

Matt Manley has 25 years of experience working in the in-vitro diagnostics industry in customer-engaging roles in strategy, marketing, sales, and training. Over the past 15-plus years with Roche, Matt has worked in solution portfolios covering Clinical Chemistry, Immunoassay, Molecular PCR - Point of Care, Coagulation Monitoring, Hospital Glucose POC and IT. During the global COVID-19 pandemic, Matt helped lead Roche’s response, which delivered over 150 million tests at the Point of Care to the U.S. market. Most recently, Matt has assumed a role within Roche as Vice President of Digital Healthcare Solutions in the U.S. MLO-ONLINE.COM APRIL 2025 | 17

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INFECTION DIAGNOSTICS: QUALITY CONTROLS

ID 135972862 © Nd3000 | Dreamstime.com

Infection Diagnostics: Quality Controls

Quality controls: Essential to laboratory compliance

By Deepa Eveleigh

Q

uality control has long been one of the top priorities for clinical laboratory teams. From high-level checks to ensure the quality of lab-generated results to the specific control materials used to verify the consistency of each testing protocol, every effort is made to guarantee the best results for patient care. But now more than ever, quality controls — specifically the control materials used to assess test reliability — are in the spotlight with the new final rule on laboratory-developed tests from the U.S. Food & Drug Administration set to be phased in this year. Barring any changes to the rule or its rollout, this May, labs will need to begin complying with a host of reporting and quality system requirements.

One of the most effective and dependable ways to achieve compliance with these requirements is to incorporate the highest-quality external reference controls as part of a lab’s quality control framework. While there is a broad range of control materials available, there is also quite a range in their reliability, accessibility, and performance.

For clinical lab teams, it’s worth taking a close look at the features of various control materials and considering which

ones best meet their specific needs. This will be a mandatory step if the FDA rule is phased in as expected, but even if it gets delayed or adjusted, the right selection of reference controls will still be important in helping lab professionals generate high-confidence results from the patient samples they receive.

Having independent control materials with known reference values makes it possible to properly measure and contextualize clinical tests, ensuring that tests perform as they should, day in and day out. In addition, high-quality reference materials are important for validating new tests and workflows as well as for training laboratory scientists and technicians.

Commonly used controls

Throughout the clinical test workflow, lab members may use a few different controls for ensuring optimal test performance.

For example, there are positive controls designed to generate positive results no matter what, and negative controls that should always produce negative results. These basic controls can be used at many points in a test workflow and serve as a valuable quality check for the results generated by the analytical test process.

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Other types of controls are designed to assess the reliability of the overall testing process rather than individual test results. Internal controls go through the same testing workflow as the patient sample to provide a quality check on the entire assay. External controls, by contrast, are processed separately, following the same workflow but independent from the patient sample to verify the overall method. For the best view of test validity and performance, both internal and external controls are used together. The earlier that controls can be introduced — even as early as sample collection when appropriate — the more confidence laboratory operators can have in the end results of the testing process.

While there are many commercially available control options, lab professionals often opt for the one that seems most readily available and affordable: residual patient samples left over after a positive test. In the infectious disease realm, these controls introduce a degree of risk that may not be acceptable in all clinical labs. Residual samples, immortalized cell lines created from patient samples, and attenuated viral strains that are also go-to control materials put operators at risk of infection, particularly for highly contagious pathogens. Relying on patient sample materials also means that the supply of necessary controls is unpredictable. For more reliable workflows, labs should have a steadier supply of control materials.

For other types of tests, such as DNA-based molecular diagnostics for oncology or rare genetic diseases, it can be challenging to find a native, easily accessible source of controls that accurately mirror DNA mutations of interest.

Whatever control type is selected by a clinical lab team has to be accessible — not just for running tests on patient samples, but also for the test validation and operator training protocols that are important for overall laboratory quality.

For all of these reasons, commercial sources of control materials may prove to be a better fit for most clinical labs than residual patient samples.

Synthetic molecular controls

For optimal results across a number of testing applications, laboratory professionals may find that synthetic molecular controls best fit the bill. Unlike patient sample remnants, they are readily available from vendors and can be stocked to meet surges in demand for testing, such as during a severe respiratory infection season.

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Infection Diagnostics: Quality Controls

While using synthetic controls for tests of real-life patient samples might seem counterintuitive, these controls can be carefully designed to match key attributes of native samples and can be detected in any type of sample matrix.

Importantly, synthetic molecular controls can match the biology of pathogens without being infectious, offering a safer alternative to residual patient samples.

Synthetic controls undergo rigorous manufacturing techniques in well-controlled environments to ensure consistency from one lot to the next.

As a result, they are ideally suited to cross-harmonization studies conducted at multiple laboratories to benchmark testing results across locations. Another advantage of synthetic controls is their ability to be customized quickly, allowing them to be used even for emerging infectious diseases or novel genetic mutation testing.

Certain synthetic controls have an added feature that allows them to better mimic native biological analytes and to withstand harsh processes in the testing workflow. These “armored” controls are encapsulated and surrounded by a protein layer that protects the inner control from degradation in a variety of biological matrices. This layer of protection means that armored controls are stable enough to be used in any part of the testing protocol, riding alongside the patient sample for a carefully controlled, system-level assessment of the full workflow from start to finish.

These controls are broadly compatible with molecular testing assays.

When evaluating third-party sources of synthetic molecular controls, looking for a few key features beyond armoring

can help to ensure optimal outcomes.

For example, check to see if any of a manufacturer’s control materials have been included in FDA-reviewed in vitro diagnostic tests. Controls that are included in FDA-cleared assays clearly perform well and provide external validation of the manufacturer’s approach to quality control. In addition, look into the method a manufacturer uses to quantify its own materials; this is important for ensuring that a set concentration value of a control matches the concentration in a patient sample. The use of advanced methods such as digital PCR is a good indicator that a manufacturer is as quality-focused as its clinical laboratory customers.

What’s next?

It is difficult to know how the FDA final rule about laboratory-developed tests will play out, with the ongoing legal challenges and a new government administration creating some level of uncertainty. But no matter how things proceed, the well-known clinical laboratory commitment to quality will not change. Evaluating each lab’s selection and use of control materials is an important step that any clinical lab team can take today to ensure that they are ready for whatever compliance requirements are coming their way and that they are generating the highestconfidence results for their patients.

Deepa Eveleigh serves as director of laboratory operations at Asuragen , a BioTechne brand.

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SPECIAL FEATURE :: COACHING CORNER

Coaching Corner

Enis Aksoy / DigitalVision Vectors / Getty Images

Special Feature :: Coaching Corner

W I T H P AT T Y E S C H L I M A N

What kind of attitude should a seasoned MT(ASCP) with an MBA take with a less experienced younger tech who I trained and who now feels she knows more than I do.

I trained her, now she knows it all and acts like my supervisor. Help — this younger gen SUCKS! Unprofessional and arrogant and constantly uses the f-word.

DEAR SEASONED MT(ASCP): What attitude do I recommend? Humility. I believe everyone has something to bring to the table. Whether you are seasoned or of a younger generation, we can all add value. Additionally, if we remain open to our differences, we often learn a lot from each other. Saying a generation different than yours SUCKS, I feel, is unprofessional and arrogant. It has been said that our feelings for another person can sometimes be a mirror into what we, ourselves, need to learn in order to grow.

Generations often express disappointment with the next generation but life marches on. Combining our strengths is always more productive than defining our differences.

Maybe she does know more than you or maybe she is just a new scientist that is insecure, feels your negative energy, and is trying to overcompensate. When you get furious, become curious. Get to know her better, you may have something in common.

By the way — I strongly dislike the word SUCKS, we can be challenged by different things and frustrated by others, but this word has no place in a professional’s vocabulary, which leads me to the f-bomb — the worst of all poor choices in professional expression! Don’t get me wrong — there are several very specific uses of the f-bomb in private or social situations that no other word fits, but never in a professional workplace and certainly not in the lab. I recommend that you do not react the next time the f-bomb is used (so as to manage your own emotional reaction). But on a good day, mention, “Hey ____, Can I share something with you that really bothers me? I notice that you use the f-bomb quite a bit and it doesn’t feel right. To me, it feels offensive and unprofessional. I really want us to have a good working relationship. Can you please not use that word while at work?” If the behavior continues, go to management.

How do I support my team’s development and growth through participating in learning opportunities and stretch/growth assignments while not overburdening them with too much to accomplish during their working hours so that they don’t burn out? The management level above me has told me that it is ok for my team to accumulate overtime to complete the tasks they deem necessary for team development. I feel like a failure as a leader if I task them with more than can be reasonably accomplished within their working hours.

While that can be somewhat controlled or limited, I fear this will leave no space or flexibility to tackle emerging issues and will result in multiple failures across the team or overburdening myself with picking up everything that gets dropped.

DEAR CARING LAB LEADER: You are never a failure as long as you care and show your team that you care about them. I understand the risk of overburdening your team and appreciate your concern for burnout. Burnout, to me, is caused by continuous, prolonged, and unrelenting stress or frustration that leads to physical and emotional exhaustion. If you were to find out from your team the kind of activities they would find fun or engaging, would those activities contribute to stress and frustration or possibly add some freshness to the daily grind and alleviate some of the pressure? I realize that staffing is a challenge but instead of paying overtime, would your administration be open to a part-time or PRN scientist that can help lift some of the day-to-day burden so there is more time for projects?

If you do not already have one, I would recommend a career ladder that you could design with help from your team. A career ladder can consist of different levels of attainment that one can only accomplish on an annual basis thus helping with retention. Level One, the first year, Level Two the next year and so on. Incentives to work on these levels could be financial bonuses (a few hundred dollars) or some type of status recognition.

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Special Feature :: Coaching Corner Each level would include more challenging projects with a higher incentive. If you are not yet connected to a professional organization such as ASCLS or ASCP, I recommend that you do because these peers can be a great source of ideas as you start developing your career ladder. The key is to get staff involved — they are the only ones who can help build the excitement for the things they find of value. Including a public service goal is a great idea to consider! One of the greatest strategies to decrease burnout is to broaden our world, think bigger, and find gratitude around us. Giving back to your community can be as simple as hosting a blood drive or collecting food for your local food pantry. Best of luck!

I have two different microscopes in my lab.

Counting platelets (PLTs) with oil immersion with microscope shows variability. How do I standardize this?

DEAR MICROSCOPE SCIENTIST: As long as you have similar microscopes that are in good repair and you are consistently using the same power (100x) under oil, the variation is probably human, not equipment.

The two greatest issues that cause variability would be the quality of your peripheral smear and the policy you use for counting. Make sure your team knows how to make a good peripheral smear. A perfect smear is a smooth distribution of cells from concentrated to thin with a rainbow edge you can see when you hold it up to the light. No tails, no ridges, no streaks. Anything less needs to be redone. Go through 30 slides if you must. Next, make sure you have a policy that

ensures your team is consistently counting multiple fields (usually 10) within the same area on the peripheral smear and then using whatever calculation you identify to get to a final number. Different labs can recommend different calculations.

There are procedures out there to help or reach out to your professional community.

Justify the purpose of sampling materials in quality control and explain why 100% inspection is not always feasible.

DEAR QC ANALYST: Running quality control on every assay is not only required by our regulatory bodies, it also ensures that the testing system performs appropriately with known values so that when we introduce unknown values (patient samples) we have a 95% confidence rate that these patient values will be reported accurately. Why not 100%? Because we do not live in a perfect world and there will always be multiple types of errors including random error.

Patty J. Eschliman, MHA, MLS(ASCP), DLM, CPC is a Certified Professional Coach who specializes in laboratory leadership growth and professional support.

As President and CEO of The Lab Leader Coach, Patty coaches many lab professionals in all roles in the areas of building leadership skills, preventing burnout, improving communication, building cohesive teams, and how to be a positive influencer. She has 39 years of experience as a Medical Laboratory Scientist, the last 29 spent in leadership.

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EDUCATION :: PREECLAMPSIA

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Education :: Preeclampsia

Biomarker blood test revolutionizes preeclampsia care

By Pascaline Caruhel

T

he U.S. maternal mortality rate has been rising over recent decades and is one of the highest among developed nations, with preeclampsia and hypertensive pregnancy disorders being major contributing factors.1 However, with recent developments, the country is on the brink of experiencing the transformative impact of biomarker-based care in reducing the widespread risks associated with preeclampsia.

In fact, in 2023, the U.S. Food and Drug Administration (FDA) cleared a novel blood test2 to aid in the risk assessment of preeclampsia with severe features (sPE) in hospitalized pregnant women. Though still in its early stages, the test, which consists of two placental biomarker measurements — soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF) — is already paving the way for significant advances in predicting and managing this life-threatening pregnancy complication.

Understanding preeclampsia and the need for early detection

Preeclampsia is a hypertensive disorder related to placental dysfunction, characterized by an angiogenic imbalance between sFlt-1 and PlGF. It typically occurs after the 20th week of pregnancy and can lead to serious complications for both

the mother and baby if not managed properly. Prior to the introduction of the first preeclampsia biomarker test, risk stratification relied mainly on clinical symptoms and basic laboratory tests. This often resulted in delayed diagnosis and intervention or, alternatively, expedited labor and delivery and costly hospital stays due to a lack of definitive measures of risk.

Development of immunoassays for sFlt-1 and PlGF began in 2011. This effort culminated in the PRAECIS (Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification) study,3 the largest multicentric study done in the United States for this disease area. The study was published in November 2022, clearly demonstrating that in women with a hypertensive disorder of pregnancy presenting between 23 and 35 weeks of gestation, measurement of sFlt-1/PlGF ratio provided stratification of the risk of progressing to sPE within the coming two weeks as well as a strong association with adverse outcomes.

The evidence was there: the two biomarkers are biochemically associated with the disease and provide crucial information for the early identification and management of preeclampsia. In May 2023, Thermo Fisher’s sFlt-1/PlGF ratio became the first FDA-cleared biomarker test in the United States. With FDA Breakthrough Designation and clearance, this biomarker-based approach represented a significant

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Education :: Preeclampsia advancement, opening doors for enhanced decision-making and patient-centric care for expectant mothers and their babies.

Adoption of biomarker-based care in the United States

first six months of the baby’s life. These health economics data suggest that besides the significant clinical benefit, the test may impact positively the economic burden related to preeclampsia, helping support a case for broader adoption.

Since its approval, biomarker-based risk assessment has been Paving the way for further integrated into various healthcare settings across the U.S. advancements in prenatal care Adoption rates, however, have varied, with some institutions Current research and development efforts are focused on leading the way in incorporating these tests into their standard improving patient outcomes through continued innovation prenatal care protocols. in personalized prenatal care. The future of prenatal care is One of the first adopters, The University of Chicago, began one in which the use of biomarkers has significantly improved using the test on site in March 2024. Dr. Sarosh Rana, Professor the clinical management of preeclampsia, not just in times of of Obstetrics and Gynecology and Chief Obcrisis or concern, but also in screening from stetrical Transformation Officer at the univerthe first trimester of pregnancy on. There sity, led a study published in July of the same is still a lot of unmet need for pathology Prior to the year cementing the first real-world evidence advancements in this area, as well as for of the test’s validity.4 Study data from the first other pregnancy complications such as introduction of the 65 samples confirmed earlier PRAECIS study gestational diabetes or preterm birth. first preeclampsia results3 and shows the biomarker test helped biomarker test, risk to safely prolong pregnancies and prevent Conclusion possible adverse outcomes.

In two short years, the introduction of the stratification relied One particularly compelling story, the data first immunoassays to receive breakthrough mainly on clinical of which was included in the study by The designation and clearance for the risk asUniversity of Chicago,4 is that of a patient with sessment and clinical management of symptoms and basic chronic hypertension hospitalized for elevated preeclampsia have revolutionized prenalaboratory tests. blood pressure measurements at home. She tal care, offering a new pathway for earlier presented to labor and delivery at 31 weeks detection and personalized care. Continued and 4 days gestation. The clinical evaluation efforts to expand access and educate healthoutlined abnormal liver function, raising the concern of su- care providers are essential to maximize the benefits of this perimposed preeclampsia with severe features, requiring advancement. Encouraging support for ongoing research and immediate delivery. Her measured sFlt-1/PlGF ratio, however, adoption of biomarker-based testing will ensure better health was found to be very low, indicating that the patient was at low outcomes for mothers and babies. risk of developing preeclampsia with severe features in the next two weeks. She was readmitted three weeks later, again REFERENCES with a low sFlt-1/PlGF ratio. With the support of personalized, 1. Trends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population Division. Who.int. biomarker-based care, in addition to standard clinical surveilFebruary 23, 2023. Accessed February 28, 2025. https://www.who.int/ lance, this mother was able to prolong her pregnancy by seven publications/i/item/9789240068759. weeks and delivered near full-term at week 38 weeks and 2 2. Thermo Fisher Scientific announces FDA clearance of breakthrough immunoassays to aid in the risk assessment of preeclampsia. days. Without the test, it is likely she would have delivered Medical Laboratory Observer. May 22, 2023. Accessed February during her first admission and her baby would have been 28, 2025. https://www.mlo-online.com/diagnostics/article/53061210/ highly premature. thermo-fisher-scientific-announces-fda-clearance-of-breakthrough-

Expanding access to improve patient outcomes

Preeclampsia affects 3-4% of all pregnancies in the United States and contributes largely to maternal and fetal morbidity and mortality.5 Early detection through biomarker testing definitively leads to timely intervention, reducing the incidence of severe complications associated with preeclampsia.

It is therefore imperative that continued steps are taken to remove barriers that limit accessibility to, and widespread adoption of, biomarker-based preeclampsia testing.

The most recent study, published in early 2025,6 aimed to evaluate if the sFlt-1/PlGF ratio provides a neonatal cost benefit in the United States, drawing on recently published findings from the PRAECIS3 and real-world evidence4 studies.

The research concludes that the sFlt-1/PlGF test, when used alongside standard care, enhances risk stratification for severe preeclampsia and may lead to significant neonatal cost savings by reducing preterm deliveries and neonatal intensive care admissions.

Indeed, an incremental cost-effectiveness ratio (ICER) calculation showed that prolonging pregnancy by two weeks, as a result of implementing biomarker-based care, led to a theoretical average cost savings of $62,572 per patient for the

immunoassays-to-aid-in-the-risk-assessment-of-preeclampsia.

3. Thadhani R, Lemoine E, Rana S, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid. 2022;1(12). doi:10.1056/evidoa2200161.

4. Burns LP, Potchileev S, Mueller A, et al. Real-world evidence for the utility of serum soluble fms-like tyrosine kinase 1/placental growth factor test for routine clinical evaluation of hospitalized women with hypertensive disorders of pregnancy. Am J Obstet Gynecol. Published online 2024. doi:10.1016/j.ajog.2024.07.015.

5. Burwick RM, Rodriguez MH. Angiogenic Biomarkers in Preeclampsia. Obstet Gynecol. 2024;143(4):515-523. doi:10.1097/ AOG.0000000000005532.

6. Azzi M, Silasi M, Potchileev S, et al. Neonatal cost savings in hypertensive disorders of pregnancy: Economic evaluation of the sFlt-1/ PlGF test with real world implementation of biomarkers. Pregnancy Hypertens. 2025;39(101190):101190. doi:10.1016/j.preghy.2025.101190.

Pascaline Caruhel is the Senior Manager, Prenatal Screening, Thermo Fisher Scientific. She holds a Master of Science in Biochemistry and has been with Thermo Fisher Scientific for more than 15 years supporting R&D and the development of biomarkers for the improvement of maternal and fetal health. She is based in France. For more information on Thermo Fisher Scientific’s commitment to prenatal care, visit https://www.thermofisher.com/us/en/home/clinical/diagnostic-testing/ brahms/prenatal-screening/preeclampsia-screening/.clinical-solutions.html.

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BEST PRACTICES :: 2025 LAB OF THE YEAR

Best Practices :: 2025 Lab of the Year

Department of Laboratory Medicine and Pathology, Mayo Clinic Florida

Innovation, collaboration, and commitment to excellence in patient care

By Christina Wichmann

Engaged and eager, a student delves into the world of hematology under expert guidance at the dual-headed microscope, uncovering the fascinating secrets of blood cells.

and allied health education students and involved in researching innovative solutions to advance healthcare (e.g., hematopathology, cytopathology AI algorithms to improve workflows and standardize interpretations, AI algorithms for renal transplant evaluation).

MLO received many notable nominations for this year’s Lab of the Year recognition.

Lab of theYear nominations are judged on achievements across five categories: customer service, productivity, teamwork, education and training, and strategic outlook. The achievements of the Department of Laboratory Medicine and Pathology at Mayo Clinic Florida follows.

Customer service

The DLMP is strongly committed to partnering with clinicians and improving

patient outcomes at Mayo Clinic Florida.

“At Mayo Clinic, our core values guide everything we do. We believe that the needs of the patient come first, and this principle drives our dedication to respect, integrity, compassion, healing, teamwork, innovation, excellence, and stewardship. These values are not just words on a page; they are the foundation of our daily interactions and the cornerstone of our professional practice,” said Aziza Nassar, M.D., M.P.H., M.B.A., FACHE, the Chair of the Department of Pathology and Laboratory Medicine.

Several initiatives were launched in 2024 to demonstrate DLMP’s commitment to customer service, including the following: • The laboratory is in the process of digitizing its archived anatomic pathology slides. Digitizing Mayo

Images courtesy of Mayo Clinic

M

edical Laboratory Observer’s 2025 Lab of the Year is the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic Florida. The DLMP serves the 304-bed Mayo Clinic Jacksonville, Florida hospital with 434 full-time equivalent staff.

The laboratory’s total test menu is 644 tests within surgical pathology, frozen section, autopsy, hematopathology, cytology, histology, chemistry, hematology/coagulation, flow cytometry, bacteriology, parasitology, infectious serology, mycology, molecular virology, mycobacteriology, blood bank, apheresis, cell therapy, histocompatibility, molecular pathology, and point of care.

In addition to supporting patient care at this renown destination medical center and transplant facility, the DLMP is an educator of graduate medical education

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Best Practices :: 2025 Lab of the Year Clinic’s extensive archive of slides will enhance diagnostic accuracy and efficiency, facilitate research and medical breakthroughs, and improve the in-house educational resources for Mayo Clinic Florida’s staff and learners. Future plans will use the large, diverse datasets to build powerful artificial intelligence models in pathology. The lab validated and deployed Grundium digital pathology scanners. These scanners have been particularly beneficial in reading frozen section slides. The scanners have significantly increased DLMP’s capacity, averaging 28,800 slides per month.

• DLMP expanded its reference lab by 20% and now serves as a reference lab for 40 hospitals in a 10-state service area. The reference lab also now receives renal biopsy and bone marrow specimens, a significant achievement for the laboratory’s Anatomic Pathology department. In 2024, the Anatomic Pathology department also developed 25 additional immunohistochemistry stains and 20 immunofluorescence stains, which were previously sent out for processing.

• The core hospital lab began utilizing the Genomadix CYP2C19 System to identify patients with different metabolizer phenotypes (e.g., poor, intermediate, or ultrarapid metabolizers) for drugs metabolized by the CYP450 2C19 genetic pathway (such as Clopidogrel). By identifying upfront the clinical effectiveness and safety of these drugs, the laboratory is assisting its clinical partners in decreasing management costs and shortening patients’ lengths of stay. The laboratory’s clinical partners have told them this is particularly helpful in emergent neurovascular indications.

• The lab played a crucial role in the launch of gene therapy and tumor infiltrating lymphocyte (TIL) therapy, which involves extracting T cells from a patient’s tumor, expanding them in a laboratory, and reinfusing them back into the patient to target and destroy cancer cells. The lab’s responsibilities included the ex vivo culture and expansion of TIL from tumor nodules. The lab was also involved in processing, storage, and prepa-

ration of the TIL cell product. This involved packaging the collected tumor tissue and shipping it to an external processing facility. Once processed, the TIL cell product was sent back to Mayo Clinic so it could be infused into the patient.

By launching this therapy, the lab has significantly contributed to advancing cancer treatment, providing more personalized and effective options for patients with various types of cancer.

Productivity

DLMP’s productivity has significantly increased through various technological advancements and process improvements that have streamlined workflows and increased accuracy. Notable strides in laboratory processes by implementing new technologies include the following: • Installation of overhead cameras in the Anatomic Pathology department has been a significant advancement in mitigating the issue of missing or lost tissue

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Best Practices :: 2025 Lab of the Year samples. These cameras provide continuous monitoring and recording of the tissue handling process, ensuring that every step is documented and traceable.

The overhead cameras have significantly reduced the time spent looking for missing specimens by 70%, now averaging less than 1 hour per week, compared to the previous 2–3 hours per week.

• The implementation of the VITEK® 2 susceptibility test system with new cards has significantly reduced the time required to get information to the patient. This system can provide results within 24 hours for bacteria and up to 36 hours for yeast. This rapid turnaround time ensures that patients receive timely and accurate information, which is crucial for effective treatment.

Similarly, the VITEK® MS PRIME MALDI-TOF mass spectrometry system has also improved the speed of microbial identification. This advanced technology allows for the rapid and precise identification of microorganisms, significantly reducing the time needed for traditional culture-based methods. As a result, patients can receive their diagnostic information much faster, often within a few hours.

• Automation of the chemistry line significantly enhanced the lab’s productivity and efficiency. By integrating advanced automation technologies, the lab streamlined workflows, reduced manual handling, and minimized errors. The use of automated analyzers and digital systems allowed for continuous processing of samples, resulting in faster turnaround times and higher throughput. This automation also improved the consistency and reliability of test results, ensuring that

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patients received accurate and timely diagnoses. Additionally, standardized protocols and quality control measures were implemented to monitor the performance of the automated systems.

• The implementation and testing of a new enterprise document control system in Florida has been a highly productive initiative for the lab. This system has streamlined the management of documents, ensuring that all records are accurately tracked, easily accessible, and securely stored. By automating many of the manual processes involved in document control, the lab has significantly reduced the time and effort required to manage documentation. This has led to a 25% increase in overall efficiency, allowing lab staff to focus more on critical tasks and less on administrative duties. Additionally, the new system has improved compliance with regulatory standards, ensuring that all documents are up-to-date and properly maintained. This advancement not only enhances operational efficiency but also supports the lab’s commitment to maintaining the highest standards of quality and accuracy in its work. A group of staff called the “Enterprise Document Laboratory Convergence Team” won the Excellence Through Teamwork Award for the development of this document control system. This award recognizes groups that have displayed exemplary teamwork and whose efforts go beyond normal job responsibilities to create positive outcomes for the organization.

• The laboratory transitioned to a weight-based inventory system that automatically orders supplies, significantly improving efficiency and freeing up valuable time previously spent on manual inventory management. This new system, known as PAR BAR, uses scale technology to monitor the weight of individual items stored in plastic bins. Each bin is calibrated to the specific item’s weight, and reorder points (ROP) are set based on historical usage. When the weight of an item reaches its ROP, the system automatically sends an order signal, eliminating the need for manual intervention. This automation has streamlined inventory management practices, allowing staff to focus more on critical tasks rather than spending time on inventory checks and orders. The system’s “grab-and-go” functionality ensures that items are always available when needed, reducing the risk of stockouts and improving overall workflow efficiency.

Teamwork

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2022;122(5):959-967.

2022; 2. Per Pereira et al., Circulaton. 2024;150:e129–e150.

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DLMP considers teamwork a cornerstone of its laboratory’s success. Initiatives such as Morning Operations and Quality Assurance (MOQA) meetings, town hall meetings, and various teamwork and volunteer activities have fostered a collaborative and team-minded working environment. The laboratory’s DEI efforts further enhance the team’s cohesion and inclusivity. Examples of teamwork in the DLMP are as follows: • MOQA daily meetings bring together staff from various laboratory departments to discuss and address any issues that may arise, such as staffing, supplies, safety concerns, and above and beyond recognition. During these meetings, team members actively support each other, whether it’s by sending additional staff to assist in busy areas or by quickly resolving any operational challenges. This spirit of cooperation and mutual support has greatly enhanced the efficiency and ef-

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Best Practices :: 2025 Lab of the Year

Phlebotomy team gathers for their daily huddle, ensuring seamless coordination and top-notch patient care.

fectiveness of the lab, ensuring smooth operations and high-quality patient care.

• The DLMP quarterly town hall meetings in 2024 provided a platform for leadership updates, notable highlights, and discussions on quality priorities for 2025. The town hall meetings covered a range of topics including operational efficiency, staffing levels, and the integration of AI and automation in lab processes. These meetings also featured updates on strategic growth projects, such as the integrated oncology building and the hospital vertical expansion. Overall, the town halls played a crucial role in keeping the staff informed, engaged, and aligned with the lab’s goals and initiatives and were pivotal in fostering communication and collaboration within the lab.

• The DLMP DEI Taskforce provided feedback and resources to the team including a webpage for team members to visit for more information, a group email address, an anonymous suggestion box, and Lab Week events such as “Taste the Globe” with candies from around the world.

• The laboratory implemented several activities to foster teamwork and joy in the workplace, including “Blooms in June,” “Tie Dye July,” and “Caring Canines.” During the “Blooms in June” team-building experience, staff stepped into a room filled with flowers and created their own beautiful arrangements. During “Tie Dye July,” staff got creative and designed vibrant hats, shirts, and socks together. For a calming and uplifting encounter, medical laboratory staff scheduled time to interact with the “Caring Canines” therapy dogs.

• The lab also organized team outings for golf, painting, and a beach bonfire. The lab team also participated in volunteer opportunities to support the local community. Some of these activities included a collection drive for the Alpha-Omega Miracle Home, which provides housing and support for women and children in need; the Walk to Defeat ALS to raise awareness and funds for ALS research; and volunteering at Hope Therapy, a provider of hippotherapy/equine-assisted therapy and activities for children and adults.

Education

Mayo Clinic Florida and the DLMP have a strong commitment to education — for graduate medical education students, its

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Best Practices :: 2025 Lab of the Year own staff, and the future generation of laboratory professionals. Christina Narakorn, MHS MLS(ASCP)CM, PA(ASCP)CM, who is the Manager of Laboratory Education and Instructor in Laboratory Medicine and Pathology, has been instrumental in addressing recruitment and retention challenges in laboratory medicine and pathology. She has implemented a variety of strategies, including personality workshops, laboratory awareness sessions, and hospital lab tours to attract and retain talent in this critical field. She shared,“Witnessing the excitement in students’ eyes during workshops and hospital lab tours reaffirms my commitment to this profession and implementing innovative strategies to attract and retain talent in this vital field. I remember being the student and I am grateful for those who have helped me find my career in the lab.”

Examples of DLMP education initiatives include the following: • To address the lack of awareness about careers in the laboratory field this, Christina participates in career fairs for middle and high school students where she provides hands-on toolkits to spark their interest, such as a practice phlebotomy arm, blood tubes with synthetic blood, microbiology plates, and example slides.

The anatomic pathology toolkits contain preserved organ specimens, histology blocks, and digital images of organs in both healthy and diseased states. Additionally, Christina even arranges mentor sessions for students to learn more from experienced laboratory professionals.

• The development of allied health staff in the lab is a priority, with a strong emphasis on continuing education and professional growth. The lab offers a variety of continuing education opportunities including monthly continuing education sessions, Chemistry CEU, Hematology Conference, Cytology Conference, HLA Journal Club, and the DLMP Book Club. These programs ensure that the allied health staff stay current with the latest advancements in their fields, fostering a culture of continuous learning and excellence.

• The laboratory has a robust GME visitor learner program that includes a new anatomic pathology/clinical pathology residency, a surgical pathology fellowship, student rotation in molecular pathology with Florida Gulf Coast University, and a new Artificial Intelligence Engineering internship for Carnegie Mellon University graduate students pursuing this degree. For allied health education students, the laboratory provides medical laboratory science clinical rotations, histotechnology clinical rotations, cytology clinical rotations, molecular pathology clinical rotations, pathologist’s assistant clinical rotations, specialist in blood bank HLA rotations, and phlebotomy program.

Strategic outlook

The strategic outlook for Mayo Clinic Laboratory in Florida is guided by the enterprise initiative “Bold. Forward.” This initiative encompasses several key areas, including supporting care in any place, immunotherapy manufacturing, transforming transplant processes, and leveraging AI and automation.

By focusing on these areas, the laboratory aims to enhance patient care, improve outcomes, and stay at the forefront of medical innovation. The commitment to providing care anywhere ensures that patients have access to high-quality medical services regardless of their location, while advancements in immunotherapy and transplant processes promise to revolutionize treatment options.

Caring Canines bring joy and comfort to the lab, making every day a little brighter with their wagging tails and warm hearts.

In addition to the enterprise initiative, the DLMP is dedicated to several strategic priorities. These include digital pathology, LIS modernization, innovation and practice transformation, AI and automation, and enhancing educational practices with digital pathology and AI. By embracing digital pathology, the laboratory can improve diagnostic accuracy and efficiency, while LIS modernization ensures that laboratory information systems are up-to-date and capable of handling the demands of modern healthcare. Furthermore, the focus on AI and automation allows DLMP to streamline processes, reduce errors, and enhance overall productivity. By integrating AI into various aspects of laboratory operations, the laboratory can provide faster and more accurate results, ultimately benefiting patient care. Additionally, enhancing educational practices with digital pathology and AI ensures that the next generation of laboratory professionals is well-equipped with the latest knowledge and skills.

Closing

The Mayo Clinic has a renowned reputation as a beacon of hope for patients around the world, and Medical Laboratory Observer is proud to award the 2025 Lab of the Year award to the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic Florida. The lab inspired us with its commitment to continuously improving numerous areas of its lab with the patient always in mind, from testing technologies and procedures so that patients are receiving the best care and treatment possible, staff retention initiatives and activities that foster a supportive and inclusive work environment, and commitment to educating future laboratory professionals.

When we shared the news with the laboratory, its leadership expressed the following sentiments about being recognized as the “Lab of the Year:” “Our department is honored and humbled to receive this award. It could only have been possible because of the unwavering dedication of every DLMP colleague. Together we celebrate.”

- Dr. Dlott, CLIA Director “This recognition is a testament to the relentless hard work, innovation, and commitment to excellence that each member of our department brings to their work every day. I am incredibly proud to lead such a talented and passionate group of individuals. Their unwavering dedication and collaborative spirit inspire me daily. We will continue to push the boundaries of laboratory medicine and pathology, striving for even greater achievements in the future. Thank you for this prestigious honor.” - Dr. Nassar, Chair of the Department of Pathology and Laboratory Medicine

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BEST PRACTICES :: 2025 LAB OF THE YEAR

Photos Courtesy of Mohawk Valley Health System Laboratory

Best Practices :: 2025 Lab of the Year

Mohawk Valley Health System Laboratory evening shift staff.

2025 Lab of the Year Runner Up Mohawk Valley Health System Laboratory

By Erin Brady

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ohawk Valley Health System Laboratory is one of the recipients of Medical Laboratory Observer’s 2025 Lab of the Year Runner Up Awards!

The lab is located in Utica, New York and is part of the Mohawk Valley Health System (MVHS). The health system consists of 3,300 full-time equivalent employees and 16 primary care locations with a wide array of specialties including, but not limited to, women’s health, children’s health, cancer, urology, neurology, etc.1 MVHS’s mission is to “deliver premier healthcare to our region, keeping our patients as the focus of all we do.”Their vision is“be the leading patient-centered medical and healing environment, the employer of choice and the pride of Central NewYork.”They value accountability, respect, teamwork, kindness, and safety.2

With the new Wynn Hospital facility, MVHS identified a need for a Provider Relations Specialist. This new position ensures that MVHS Lab’s current customers are satisfied and helps bring in new customers. 95% of lab testing is done locally, warranting faster turnaround times, reliability, and customer satisfaction.

MVHS Laboratory has their own Client Services Representatives team dedicated to their patients and staff. It is open about 102 hours a week and provides customers with assistance scheduling appointments and clarifying tests. They also maintain the Critical Call list.

Additionally, they maintain specimen integrity by sending medical couriers to STAT and Time Sensitive draws.

Customer service

MVHS Laboratory recently underwent a large merger. Two busy hospitals and laboratories became one. The lab utilized the following technology to streamline the integration process: • Siemens Aptio Automation Line • Four Siemens Atellica Chemistry modules • Two Siemens Atellica Immunoassay modules • Siemens Immulite XPi • Siemens BN II and the Sysmex XN-9000 line which includes 3 XN analyzers, SP-50 stainer, Cellavision DI-60 and the Tosoh G8 HA1C analyzer To improve workflows in different departments, MVHS Laboratory implemented the following technologies: • Atellica Process Manager and Atellica Data Manager

Building on MVHS’s mission, MVHS Laboratory leads with a “patient care first” approach. They understand that each patient is special and take extra care serving them. When it comes to patient care, MVHS Laboratory says, “treat them like you would want your family treated.”

MVHS’s new Wynn Hospital opened at the end of 2023.

When the new facility opened, 225 patients needed to be moved. This was accomplished in 10 hours. The lab staff assisted with the relocation by being present at all MVHS facilities involved and performing timely and accurate tests so hospital staff could use individual ambulances to safely transfer patients to the new location.

Productivity

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Best Practices :: 2025 Lab of the Year Software for the Chemistry department.

• Sysmex Caresphere software for the Hematology department.

• Two Werfen TOP 750s that are connected to the HemoCell Automation Line, utilizing HemoHub software for integration.

• Two Arkray Urinalysis analyzers • Two Beckman DxUS • New Laboratory Information System (LIS) • Epic Rover handheld devices • Medical Courier Elite (MCE) Additionally, MVHS says they are the first lab in the country to: • Implement use of the Tosoh G8 A1c analyzer on the Sysmex Hematology automation line.

• Put the Siemens BN II on the Aptio Automation Line.

The lab runs the following tests daily: chemistry, immunology, urinalysis, hematology, microbiology, blood bank, and coagulation.

Mohawk Valley Health System Laboratory team with Wynn Hospital.

Teamwork

The previously mentioned merger included the integration of two laboratories with separate specialties: St. Elizabeth Medical Center that specializes in cardiac and trauma and Faxton St. Luke’s Healthcare that prioritizes maternity, oncology, and stroke.

Both hospitals did send-out tests while St. Elizabeth specialized in large volume outpatient samples and Faxton St. Luke’s specialized in inpatient basic laboratory tests and performed Microbiology and Anatomic Pathology testing.

When the labs merged, the teams merged their send-out staff. They reviewed each of their processes and created one standardized workflow. They worked together to train each other. MVHS said, “It was truly a blending of cultures, and our staff have joined forces to make our laboratory stronger and better than ever.”

Mohawk Valley Health System Laboratory phlebotomy staff.

Education and training

New staff members receive an orientation and daily training.

Performance is tracked and discussed with employees. Extra training is always accessible if needed. MVHS Laboratory says,“We believe that a well-trained staff is a safer and more efficient staff.”

With all the new equipment MVHS Laboratory added, training was needed for technical staff to learn how to properly use and maintain the equipment. All employees received the same onboarding for the new facility that new employees get. They were also educated on the new LIS, workflows, and Epic EMR. The lab encourages employees to advance in their respected fields. Several staff continue their education outside of MVHS. Additionally, staff are cross-trained so they have the skills needed to apply for higher positions at MVHS if they wish.

MVHS Laboratory said, “Laboratory Administration is fully supportive of these educational endeavors and have, on numerous occasions, made significant changes in an employee’s work schedule to accommodate their education.”

Strategic outlook

MVHS Lab’s strategic outlook focuses on tackling staffing shortages and employee retention. They implemented an international program to bring in medical technologists from around the globe. The program is popular and receives many applications.

Mohawk Valley Health System Laboratory overnight staff.

Additionally, MVHS Lab hires and mentors lab aides who hold science degrees, and it strives to foster their passion for laboratory science and inspire them to continue their education. They’ve helped multiple professionals achieve their medical technologist and medical technician licenses. Many of these employees choose to stay with MVHS Lab. Currently, five staff members are involved in a NAACLS-accredited program to become Medical Technologists or Medical Lab Technicians and a sixth employee joined a program to become a Histotechnician. MVHS said,“Our hospital prides itself on being a teaching institution, and our laboratory maintains affiliations with several medical technology and laboratory science programs, as well as local phlebotomy educational institutions, thus enabling students to obtain their clinical experience requirements at our facility.”

REFERENCES 1. About MVHS. Mohawk Valley Health System. January 5, 2021.

Accessed February 26, 2025. https://www.mvhealthsystem.org/about.

2. Mission, Vision and values. Mohawk Valley Health System. January 8, 2021. Accessed February 26, 2025. https://www.mvhealthsystem.org/ about-mvhs/mission/.

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BEST PRACTICES :: 2025 LAB OF THE YEAR

Photos Courtesy of NYU Langone Hospital—Long Island

Best Practices :: 2025 Lab of the Year

NYU Langone laboratory day shift

2025 Lab of the Year Runner Up NYU Langone Hospital—Long Island Department of Pathology & Laboratory Medicine

By Erin Brady

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YU Langone Hospital—Long Island Department of Pathology & Laboratory Medicine is one of the recipients of Medical Laboratory Observer’s 2025 Lab of the Year Runner Up Awards! NYU Langone’s Department of Pathology and Laboratory Medicine consists of 15 laboratories (10 clinical and 5 anatomic pathology). Quality, point of care, and central processing/critical call departments are also part of NYU Langone. Together, their 200 plus staff members process over 1.5 million samples every year.

NYU Langone—Long Island is located in Mineola, New York.

Education and training

NYU Langone Long Island’s dedication to leadership excellence was one of the reasons they were in the top three running for Lab of the Year.

To enhance its leadership, they launched a Leadership Development Program in 2023. The program has decreased employee turnover and raised their engagement scores.

Inspection results have also improved due to this program.

The lab also launched a Hematology Academy to answer the question “How do we continue to thrive when the world as we know it shifts overnight?”

The academy has three levels of leadership: • Foundation- This beginning level arms participants with crucial skills and comprehension of how the lab functions. This section of the academy focuses on managing reagent inventory, maintaining lot-to-lot consistency, overseeing daily workflows, ensuring quality control, instrument maintenance, and optimizing operations.

• Advanced- Once participants are ready, they progress to the next level of the academy. The advanced level gives them more experience in the technical and managerial sides of leadership. They focus on growth, SOP validation, QC validation, conducting correlation studies, purchasing, instrument calibration, and training employees.

• Executive- Throughout the top level of the academy, participants focus on the highest level of laboratory leadership. They learn to make strategic decisions, develop tests, take initiative in planning and inspections, recruit employees, etc.

Omiba Rama, MHA, MLS, Hematology and Special Hematology Manager said, “The Hematology Academy is more than a program, it’s a commitment to the future of our lab.”

Productivity

NYU Langone Long Island started a Critical Call Task Force after noticing they met their 30-minute critical value reporting time most of the time, but not 100%. This group is a collaboration between healthcare providers and the lab, improving workflow and communication. The new team saw a 7% jump in the first two months after utilizing medical record enhancement software “First Provider.”

The lab also sought to streamline their inspection day documentation filing, so they started using MediaLab’s InspectionProof software. They received positive feedback during their next CAP inspection. NYU Langone Long Island said, “The use of InspectionProof contributed to an 80% decrease in the number of deficiencies and a 60% decrease in

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Best Practices :: 2025 Lab of the Year

NYU Langone Hospital—Long Island night shift.

NYU Langone Hospital—Long Island evening shift.

the percentage of checklist items cited when comparing 2021 and 2024 inspection performance.”

Overcoming challenges

NYU Langone Long Island was a victim of the July 19th CrowdStrike attack that affected millions. They described the night as a “high-stakes crisis.”

The following systems were affected by the outage: • The clinical laboratory system • The hospital pneumatic tube system • Point-of-care • Blood gas analyzers • Hemovacs “Despite the disruption, the response from lab operations was quick and effective, ensuring continuity of services and minimizing downtime,” said Nicole Adler, MD, FACP, FHM, Chief Medical Officer, NYU Langone Health- Long Island.

She described how the laboratory information system (LIS) went into downtime mode early during the outage and how the lab had to prioritize samples.

The LIS was functioning properly by 8AM and the team had all backlog cleared by 11PM that day.“Throughout the event, clinical laboratory services remained uninterrupted thanks to the quick actions and dedication of the team. Despite the challenges of the CrowdStrike outage, the lab minimized interruptions and maintained continuous services, demonstrating the resilience and agility of our operations. The successful response highlights the importance of contingency planning and the ability of our teams to adapt to unexpected disruptions while ensuring patient care remains the top priority,” Dr. Adler emphasized.

NYU Langone- Long Island was also affected by the BD blood culture bottle shortage. When the shortage was first announced, the lab only had a 34-day supply of the blood culture bottles left, causing the need for a quick solution. The team implemented interventions that helped reserve supply.

They were able to explore alternative bottle vendors, validating alternative bottles compatible with their current incubator, and evaluating load-sharing across the health system.

Teamwork

Another area of improvement NYU Langone Long Island worked on was the Mislabeled Specimen Reduction Project.

It was inspired by an analysis of the lab’s 2022-2023 Patient Safety Intelligence Reports (PSIs) that recognized mislabeled blood gasses as a pain point. This project required dedication and teamwork from Respiratory Therapy (RT), Point-of-Care Testing (POCT), Information Technology (IT) and Laboratory Quality. The team first sought to understand how mislabeling

NYU Langone Hospital—Long Island digital pathology team.

specimens can be prevented and applied those best practices.

NYU Langone Long Island changed their manual blood gas patient verification process to a technical one. The team utilized Epic positive patient identification (PPID), an electronic solution that optimized their blood gas testing process.

NYU Langone Long Island said,“This simple, no-cost solution, produced a 67% reduction in mislabeling errors, which has since been sustained. Prior to PPID implementation, an average of 4.2 mislabeling errors per month were documented.

Post PPID go live, two or fewer mislabeled events have been recorded.”The team is continuously monitoring the process and expects the error rate to decline even more.

Strategic outlook

NYU Langone Long Island launched a digital pathology program in January 2025. Many groups worked together to make sure the implementation of digital pathology was smooth. According to NYU Langone Long Island, they “acquired four SG300 scanners for permanent slide imaging and two Glissando Slide scanners for frozen sections. ”They remodeled spaces in the laboratory in collaboration with IT departments to make space for the new equipment.

NYU Langone Long Island is also implementing MALDI-TOF to advance patient care and clinical decision making. They said, “Here at NYU Langone Hospital—Long Island we’re thrilled to have the opportunity to deliver patient care that goes beyond standard practices. By embracing these technological advancements, we’re enhancing both the speed and accuracy of diagnostics, which directly benefits our patients. This commitment to innovation and excellence means that we’re not only supporting better health outcomes but actively contributing to the fight against antimicrobial resistance. As we move forward, we’re excited to set a new standard in microbiology and patient care—one that’s driven by technology, precision, and a dedication to excellence.”

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MOLECULAR DIAGNOSTICS :: SYNDROMIC TESTING

Molecular Diagnostics :: Syndromic Testing

Syndromic tests expand the medical laboratory’s growing stewardship role

By Marti Juanola Falgarona, PhD

Beyond antimicrobial stewardship

The first calls for antimicrobial stewardship rang out 25 years ago.1 Today’s syndromic tests, which simultaneously identify a variety of pathogens that can cause indistinguishable symptoms, such as a fever, runny nose or persistent diarrhea, are game changersin this effort.2 Syndromic tests are multiplex molecular assays. These advanced microbiology technologies discern the cause of that runny nose or diarrhea, identifying not only if the pathogen is viral, bacterial or parasitic, but also the precise pathogen at work. Consider covid versus influenza. Both can present with similar symptoms but are caused by different viral agents for which different antivirals are available.

It is well understood that medical labs enable antimicrobial stewardship. But today, information that can be generated only at the bench positions laboratories as stewards of health system resources and patient care quality as well.

Syndromic testing for GI pathogens aligns with healthcare goals of providing the right test and the right treatment to the right patient at the right time. To understand their powerful impact on healthcare, let’s consider the enormous global impact of “stomach bugs.”

ID 361325299 © Yuri Arcurs | Dreamstime.com

M

edical laboratories stand at the nexus of most clinical decision making. From common respiratory and gastrointestinal (GI) ailments to rare genetic and infectious diseases and cancers, medical laboratories deliver an ever-increasing range of diagnostic information so treating healthcare providers can address each patient’s needs accordingly.

With this extraordinary diagnostic capability comes a greater dependence on laboratories to guide care and an ever-increasing pressure for accurate answers. This dependence increases the responsibility for stewardship by medical laboratories; in other words, with great power comes great responsibility.

Newer assays help squash the stomach bug

GI infections are often referred to as the “stomach flu” but have no relationship to the influenza virus family. In the United States, enteric or GI infections are incredibly common. Per 2019 data, digestive diseases prompted an estimated 19 million emergency department visits, were the underlying cause of nearly 300,000 deaths, and were a contributing or “other” cause of an additional 472,000 deaths. Among these deaths, age-adjusted mortality rates were higher for men versus women, and higher among Black versus White individuals.3 Those most at risk of serious illness or death from GI infections include infants and children, immunocompromised individuals, the elderly, people in long-term care facilities and travelers.

The symptoms are often vexingly nonspecific and overlapping, and they can be caused by a wide variety and class of pathogens, including bacteria, viruses, and parasites.

Nearly indistinguishable on examination, GI Infections also are burdensome to diagnose using traditional stool cultures. They take several days or longer, are labor intensive, look for far fewer pathogens, and delay informed patient management decisions.

Fortunately, advanced molecular diagnostic tests such as syndromic GI panels now offer actionable diagnostic insights in as little as one hour.

And it is reasonable that the workflow is preferable. 200 uL of stool resuspended in Cary-Blair medium, loaded into a diagnostic instrument, with a simple scan-run-results-in-an-hour protocol that looks for 16 pathogens, is easier and far more pleasant for lab personnel than growing bacteria in stool samples over several days.

Labs can guide physicians to the right tests

Syndromic GI panels can test for 16 or more pathogens in one test. But they also come in smaller, targeted panels, seeking the most actionable subset of these pathogens for lower-risk patients.

Medical laboratories are well positioned to work in consultation with ordering doctors to ensure and demand that the science they employ asks the right questions and delivers the right answers — a critical and growing stewardship responsibility.

In the 1940s, Dr. Theodore Woodward coined the expression,“When you hear hoofbeats, think of horses, not zebras.”

Today’s syndromic panels enable the simultaneous search for both, and more. But for average-risk, otherwise healthy individuals, the diagnostic journey should begin with smaller, lower cost assays.

When a small, target panel makes sense

Consider the case of a young adult in good underlying health presenting to

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Molecular Diagnostics :: Syndromic Testing the emergency room after several days of diarrhea, fatigue, and weight loss.

He is ideally suited to the speed and capabilities of a smaller, more targeted GI panel. In this theoretical discussion, let’s say he tests positive for norovirus.

He requires supportive care such as rest and hydration, and specific instructions and precautions to prevent the spread at home to family members, or others in the community. No antibiotics should be prescribed, and an inpatient stay is promptly deemed unnecessary.

Alternatively, negative test results of the five (depending on the panel) most common, actionable pathogens, along with further observation, may lead his care providers to make the informed decision that further diagnostic investigation is warranted for this patient.

When a more comprehensive panel makes sense

Now consider a similar young adult with an established diagnosis of Crohn’s disease, a chronic inflammatory bowel disease that causes symptoms such as diarrhea, cramping, abdominal pain, weight loss, and fatigue. He presents to the emergency department with the same symptoms as the individual above.

Is it an acute flair-up of his otherwise well-controlled Crohn’s? Is he one of the estimated nine million people in America who has a foodborne disease?4 And if so, which one? While he could need a battery of scoping procedures and inpatient care to address an acute flair up of Crohn’s, a full syndromic panel alone could reveal the source of the problem. In this case, let’s assume the patient is diagnosed with E. Coli.

Armed with this information from the laboratory, the specialist can order the appropriate inpatient or outpatient care and avoid unnecessary medications, additional tests and scanning or scoping procedures.

Risks of incomplete tests or false negative results

The wide range of pathogens involved in GI infections has a complementary range of treatment protocols, ranging from fluids and bed rest at home to isolation, and hospital-based care. The consequences of misdiagnosis can be severe, including inappropriate therapy, worsened illness and post-infectious sequelae, unnecessary side effects, and antibiotic resistance and outbreaks.

Patients receiving the wrong therapy can suffer higher relapse rates, carry a potentially infectious illness for longer

than necessary, suffer complications of the wrong treatment, and develop hemolytic uremic syndrome (HUS),5 which can require intravenous fluids and supplements, blood transfusions, and even dialysis to restore normal body function. Misdiagnosis can also lead to more severe illness and post-infectious sequelae such as superinfections, major disruptions to the patient’s gut equilibrium, Guillen-Barre syndrome, C. difficile, rashes, isolation, and other complications.6,7,8 STEC (Shiga-like toxin-producing E. coli) offers an example of how misdiagnosis or a false negative result can cause real patient harm. STEC differentiation is very important for clinical management. People become infected with STEC by eating contaminated foods such as raw or undercooked meat, milk and vegetables and it can cause damage to the colon and kidneys.9,10 STEC is defined by the production of Shiga toxin 1 (stx1) or Shiga toxin 2 (stx2).11 There are more than 400 serotypes of STEC, of which 0157 is the most common.12 Although STEC is a bacterial infection, antibiotics should not be used to treat it. They cause the STEC bacteria to dump these toxins which should be avoided in all cases.

Knowing STEC 0157 is present offers substantial prognostic value, especially for infants and children and others who are at high risk for HUS development.13 It also should trigger additional patient monitoring and prompt precautions to prevent transmission to other patients, hospital staff, family, and other close contacts. STEC can be deftly managed, but a false negative, or no awareness of the STEC infection, runs counter to the laboratory’s stewardship mandate.

The risk of false positives

Just as not identifying a pathogen or a false negative result can hide the actual problem and lead to the wrong treatment, so too can a false positive.

False positives are troubling to medical laboratories and especially to the care providers and patients. A false positive may delay the diagnosis of the actual problem allowing a condition to worsen or prompt unnecessary medical interventions. Norovirus offers an illustrative case in point.

Norovirus is, to be blunt, wildly contagious. It spreads easily and quickly, and although one person may first be infected by a food source, that person will spread billions of norovirus particles, shedding them to food, water, and

surfaces they touch. It takes just a few tiny norovirus particles to make others sick.14,15 Even ubiquitous hand sanitizers and many cleaning products do not work well against norovirus.16 When norovirus is falsely diagnosed it can set in motion a range of unnecessary costs and time-consuming activities in a hospital or long-term care setting. These activities may include isolation protocols or contact precautions for the patient, including the use of personal protective equipment (PPE) gear by treating personnel, which must be donned, removed and then discarded every time patient contact is required. Additionally, changes to room assignments, terminal cleaning – including UV light17 – for any rooms that patient has occupied, laundry and food service protocols, staff health monitoring, visitor monitoring or prohibition, and more may be initiated.18 Not to be discounted, two or more false positives among patients or staff in close proximity could lead to an erroneous reportable event. While individual norovirus diagnoses are not reportable, outbreaks are, and the Centers for Disease Control and Prevention (CDC) and health officials consider two or more similar illnesses resulting from a common exposure that is laboratory-confirmed an outbreak.19 Aside from these preventive measures, ongoing false positives, particularly in a known situation20 may also require the cost and delays associated with additional diagnostic testing to confirm results using another method, including sending samples outside for testing.

As molecular diagnostic science continues its rapid and exciting pace of change, medical laboratories that embrace and invest in newer ways of diagnosing disease will see ever-greater opportunities to provide consultative support. Medical laboratories and the quality of their test results must be trusted by their healthcare partners, and in turn, labs must be able to trust the accuracy, precision, sensitivity, and specificity of the tests they run to build on their growing stewardship role in the healthcare ecosystem.

References are available online at https:// mlo-online.com/55271637.

Marti Juanola Falgarona, PhD

is the Associate Director of Medical Affairs, Infectious Diseases, QIAGEN.

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LABORATORY

INNOVATOR

Distinguished and committed physician, researcher, teacher, and leader

By Christina Wichmann

What genetic education topics are you currently researching and/or teaching?

Thomas P. Slavin Jr., MD, MBA, FACMGG, DABMD is the Chief Clinical Officer, Molecular Oncology and Medical Director, Haystack Oncology at Quest Diagnostics.

Dr. Slavin is a physician-scientist and biotech executive, triple-board-certified in clinical genetics, molecular diagnostics and pediatrics. He previously held the positions of Chief Medical Officer at Myriad Genetics and Chief Scientific Officer at HALO Precision Diagnostics. He was a former assistant professor in the departments of Medical Oncology and Population Sciences at City of Hope National Medical Center.

Dr. Slavin graduated medical school with Alpha-Omega-Alpha-honors from the University of South Florida. He is an active member of the American Association of Cancer Research, the American Society of Clinical Oncology (ASCO), the Collaborative Group of the Americas on Inherited Colorectal Cancer, and he is a fellow of the American College of Medical Genetics and Genomics. He has served on National Comprehensive Cancer Network (NCCN) committees for both the genetics of and screening for colorectal cancer.

Focused on expanding genetics education for cancer care providers, Dr. Slavin is an active faculty member of City of Hope’s hereditary genomics training program. He is a well-respected researcher in the field of medical genetics, publishing over 80 journal articles collectively evaluating genomic data from over 500,000 patients, multiple book chapters, and providing numerous presentations at national and international medical meetings. He has been involved in many national cancer research grants and was a 2018 National Institutes of Health (NIH) K08-career development grant awardee.

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This is an exciting time for cancer research. We are constantly seeing new findings and emerging therapies across a range of areas. There has been a recent focus on cancer genetics – studying how a person’s genes or genetic changes might contribute to cancer development and treatment. Most cancers are caused by genetic changes that occur during a person’s lifetime, and there have been significant advancements made with regards to genetic testing for cancer. I am also very focused on minimal residual disease (MRD). While recurrence rates vary from cancer to cancer, solid tumor cancers like breast cancer can have a 30% chance of patient recurrence. This means nearly one in three patients must contend with the experience of a second wave (or more) of cancer treatment. Given this prevalence, MRD is an important topic to explore and one with potential to impact care for many people.

Please explain minimal residual disease (MRD) testing.

What types of cancer is MRD testing currently used for?

Cancer can recur following treatment due to residual disease that persists after surgery. This remaining cancer, referred to as minimal residual disease (MRD), may consist of no more than a few cancerous cells that remain after surgical removal of a solid tumor. Yet, left untreated, these cells can spur the original cancer to recur or relapse. For this reason, providers can use new MRD technology to closely monitor patients after primary surgical treatment. This monitoring can extend for years afterward. Conventional techniques for spotting residual, recurrent or resistant cancer can be limited in their ability to detect cancer in early stages, but new MRD testing using a simple blood draw can detect residual cancer in the body at low levels, often even before it may

appear on imaging. According to the National Cancer Institute, solid tumor cancers including breast, lung, prostate and colorectal account for about half of all new cancer cases in the United States and are responsible for nearly 50% of all cancer deaths. These are cancers where MRD testing has the potential to make an impact.

How is MRD testing used in clinical practice today?

MRD testing is used by clinicians not only to understand remaining disease after treatment, but also to screen patients long-term to help identify early signs of cancer recurrence. In recent years, circulating tumor DNA (ctDNA) has emerged as a MRD biomarker empowering physicians to assess recurrence risk and patient selection for adjuvant chemotherapy following surgical treatment. ctDNA MRD testing may enable precise monitoring with high levels of sensitivity and specificity.

Personally, I have always wondered how much effect lifestyle factors have on someone’s genetic risk for cancer. Would you please share your view on this?

Cancer is a genetic disease. While genetic changes that increase a person’s risk of cancer can be inherited, this accounts for a small number of cases (only 5-10% of all cancers). Inheriting a cancer-related gene doesn’t mean an individual will necessarily develop cancer – just that the risk is increased. We know from research a number of lifestyle factors can be linked to different cancers. Smoking’s impact on lung cancer is well-documented, just like sun exposure’s relationship to skin cancer. While inherited genetic changes aren’t modifiable, lifestyle factors can be changed to reduce a person’s risk of cancer. Things like a healthy diet, increased physical activity, and lower alcohol consumption may all reduce risk for cancer development.

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