Medical Laboratory Observer - July 2026

July 2026 MLO-online.com

TM

The Peer-Authored Management Source for Lab Professionals since 1969

PLUS

LAB INNOVATOR

Phil Englert, Vice President of Medical Device Security Health-ISAC

Diagnostic stewardship and molecular assays Page 18 Reassessing neonatal and pediatric drug testing Page 24

CE:

Scan to Subscribe or Renew!

The hidden liver burden in type 2 diabetes

Page 8

NEW

powered by

Efficiency in every test.

Trust in every result.

THAT’S HEMOSTASIS TESTING WITH THE ACL TOP FAMILY 70 SERIES + HEMOHUB INTELLIGENT DATA MANAGER. Introducing an end-to-end frictionless workflow in Hemostasis testing.

Powerful automation and centralized data management deliver consistent, quality-assured results while reducing manual steps and optimizing workflow.

Efficiency that performs Experience system-wide standardization with the same software and reagents across all instruments, plus automated performance verification and continual loading with no system interruption.

Advanced quality management Streamline quality control (QC) management with real-time HemoHub synchronization. Auto-generated reports ensure audit readiness.

And optical LED technology prevents errors before they happen.

One reagent menu. Total confidence.

The HemosIL comprehensive reagent menu offers the most liquid ready-to-use routine and specialty reagents, including the only FDA-cleared liquid ready-to-use PT reagents.

Scan QR code or visit 70series.werfen.com to learn more

The Werfen logo is a trademark of Werfen. HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil, SynthAFax are trademarks of Instrumentation Laboratory Company, d.b.a Werfen, and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners. ©2025 Instrumentation Laboratory. All rights reserved.

2605MLO_Werfen_Hemostasis_FP.indd 1 2607MLO_C1-C4.indd 2

3/27/26 6/23/26 9:13 1:18 AM PM

HPLC A1c ANALYZER

The Evolution of A1c Testing Tosoh’s legacy of excellence in HPLC A1c testing

• 50-second A1c results

continues with the GR01 A1c Analyzer.

• Hemoglobin variant detection

Gold Standard HPLC technology ensures clear chromatographic separation

• CVs ≤ 1.1% (NGSP Units)

for accurate HbA1c results while

• Compact automated design

detecting most commonly occurring

• Walkaway operation

hemoglobin variants. This ensures a

• Gold Standard HPLC Technology

well-informed diagnosis for proper patient care.

Large touchscreen displays HPLC chromatogram for easy review

TOSOH BIOSCIENCE

Learn More

LBL-02199[1]

2607MLO_TosohBioscienceInc_FP.indd 1 2607MLO_03-04_FTE.indd 3

6/4/26 1:20 8:42 PM AM 6/23/26

F ROM T HE EDITOR

Laboratory-developed tests…continued

O

n May 19, 2026, Representative Neal Dunn, a medical doctor, introduced the Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026 to update the regulation of diagnostic testing services under the Clinical Laboratory Improvement Amendments (CLIA). The bill (H.R. 8890) is a follow-up legislative effort to address laboratorydeveloped test (LDT) oversight after the 2025 court decision in ACLA v. FDA that vacated the FDA’s final rule regulating LDTs as medical devices, reaffirming CLIA as the primary regulatory authority.

By Christina Wichmann Per Rep. Dunn’s press release: “By updating CLIA to reflect modern laboratory science and codifying clear lines of regulaEditor in Chief tory authority, the Enhancing CLIA Act provides regulatory certainty, strengthens accountability, and ensures continued innovation in diagnostic testing.

As a physician, I know firsthand that timely and accurate diagnostic testing is essential to patient care. The Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory developed testing services. This legislation restores confidence in testing services while avoiding duplicative and burdensome requirements that limit patient access and slow scientific progress. We can ensure necessary oversight of the CLIA program without undermining the laboratories that deliver cutting-edge diagnostics to patients across the country.”

Key provisions

• Laboratory operations shall be regulated by the Secretary under Health and Human Services and not under the Federal Food, Drug, and Cosmetic Act. • The Food, Drug, and Cosmetic Act is amended so that the term “device” does not include laboratory developed tests.

• Establishes statutory requirements for performing LDTs that are self-determined by the lab for both: • Analytical validity (whether the test accurately measures what it claims to measure) • Clinical validity (whether the result is meaningfully associated with a clinical condition or outcome) • In addition to the self-determined standard is an optional confirmation that a CMS-approved third party agrees the test meets the standard.

Approved third parties must apply standards CMS judges “sufficiently risk-based, rigorous, and not overly burdensome,” and must agree to notify CMS of adverse findings (false/deceptive claims, or a probable risk of serious adverse health consequences). The FDA is one of the approved third parties. Regulations are further amended so accrediting bodies cannot require the third-party confirmation.

• Two years after enactment, every lab must register each LDT in a CMScentralized database, which will have a public-facing interface on the CMS website and a secure submission portal.

• Two years after enactment, a lab must file a report within five calendar days of becoming aware of an undetected inaccurate result for an LDT that reasonably suggests the test caused serious harm resulting in death or an imminent threat to public health. Less serious-harm events are captured in quarterly reports.

ASCP has indicated that it will initiate a formal review of the legislation and will be working with the laboratory community on this proposed regulation.

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

TM

Vol. 58, No. 6

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

Terry Gann | tgann@endeavorb2b.com ADVERTISING SALES DIRECTOR OF HEALTHCARE Jennifer Hazen 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 CDO Jacquie Niemiec CALO Tracy Kane CMO Amanda Landsaw EVP INFRASTRUCTURE & PUBLIC SECTOR GROUP Kylie Hirko VP OF CONTENT STRATEGY, INFRASTRUCTURE & PUBLIC SECTOR GROUP Michelle Kopier

30 Burton Hills Blvd., Suite 185 Nashville, TN 37215 800-547-7377 | www.mlo-online.com Medical Laboratory Observer USPS Permit 60930, ISSN 05807247 print, ISSN 2771-6759 online is published 9 times annually (January, March, April, May, July, August, September, October, November) 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. $164.80 per year; Canada/Mexico $199.56 per year; All other countries $284.54 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 2026 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.

4 | JULY 2026 MLO-ONLINE.COM

2607MLO_03-04_FTE.indd 4

6/23/26 1:20 PM

IN THIS ISSUE...

FACEBOOK

X

LINKEDIN

facebook.com//MLOMedicalLaboratoryObserver

@MedicalLabMLO

linkedin.com/company/medical-laboratory-observer

JULY 2026 | Vol. 58, No. 6

4 6

From the editor The observatory

CONTINUING EDUCATION

8

The hidden liver burden in type 2 diabetes: A call to action for clinical laboratories

By Anna Loh, MD and Shalini Verma, MD, FCAP

CLINICAL ISSUES

14

Mass spectrometry in the clinical laboratory

By Rajasri Chandra, MS, MBA

LAB MANAGEMENT

18

8

Diagnostic stewardship and molecular assays: A laboratorian’s primer

By John E. Markantonis, DO, D(ABMM), FASCP, FCAP; Nicholas M. Moore, PhD, D(ABMM); Dusten T. Rose, PharmD, BCIDP, FIDSA INFECTION DIAGNOSTICS

22

Better POC testing on the way for group A strep

By Annanya Shetty, PhD

18

EDUCATION

24

Neonatal and pediatric drug testing: Reassessing adult-derived assay cutoffs

By Faon Rodriguez, MS and Dexter Charles Mangio, BSMT, MT(AMT), MLS(FL DOH) BEST PRACTICES

28

From GP17 to QMS28: Why CLSI reframed laboratory safety, and what it means for your program

By Jason P. Nagy, MLS(ASCP)CM, QLS

22

MOLECULAR DIAGNOSTICS

32

New opportunities in cytology education

By Lois E. Rockson, PhD, MPH, MAHEd, SCT(ASCP)

PRODUCT FOCUS

36

Specimen collection

LAB INNOVATOR

38

24

Cybersecurity in the lab

By Christina Wichmann

DEPARTMENTS

40 42

Clinical spotlights Index of advertisers

ON THE COVER: K.Mylchreest / 2785295015 / Shutterstock AI Generator

32 MLO-ONLINE.COM JULY 2026 | 5

2607MLO_05_TOC.indd 5

6/23/26 1:08 PM

THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS

THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS

52129081 | Skin Cancer © Falara | Dreamstime.com

CMS Administrator Dr. Mehmet Oz: “Who watches the watchmen?”

FAST FACTS AAD warns of increased skin cancer risk from misinformation July is UV Safety Awareness Month. The American Academy of Dermatology (AAD) has recently published new data regarding its Practice Safe Sun Survey. Alongside the results, the organization warns that misinformation is impacting skin cancer risk.

AAD attributes the misinformation spread to social media platforms like TikTok. They emphasized that many Americans don’t understand the scope of safe sun practice due to this. Additional key findings from the survey:

57%

of surveyed Americans use sunscreen regularly.

ONE THIRD

have experienced a sunburn in the last 12 months.

>16 MILLION

adults have cut or ceased sunscreen use because of the internet.

> ONE THIRD

of Gen Z Americans follow skincare advice from TikTok influencers.

~ ONE QUARTER

of participants lacked knowledge of sunscreen benefits past preventing burns.

Source: https://www.aad.org/news/misinformation-increasesskin-cancer-risk-for-16-million-americans.

On June 16, the Centers for Medicare & Medicaid Services published the final rule “Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions” effective June 16, 2027. A public comment period is open until August 17, 2026.

What’s in the final rule

Key regulatory changes are as follows: • Establishes new conflict-of-interest requirements for accrediting organizations, including: • Required conflict-of-interest policies and procedures • Annual disclosures from surveyors regarding relationships with accredited facilities • Restrictions on surveyors, owners, and employees participating in accreditation activities involving facilities with which they have current or recent relationships • Restricts fee-based consulting services provided by accrediting organizations to facilities they accredit, including: • Prohibiting consulting before an initial accreditation survey • Prohibiting consulting within 12 months before a reaccreditation survey • Prohibiting consulting related to complaint investigations • Requiring regular reporting of consulting activities to CMS • Requires accrediting organizations to incorporate Medicare Conditions of Participation, Conditions for Coverage, and Conditions for Certification as minimum accreditation standards, while allowing AOs to impose more stringent requirements if desired.

• Strengthens survey process comparability between accrediting organizations and state survey agencies by: • Revising survey methodology requirements • Enhancing survey documentation standards • Strengthening complaint investigation procedures • Revising accreditation decision-making requirements • Requires accrediting organizations to develop detailed crosswalks demonstrating how their accreditation standards meet or exceed Medicare requirements.

• Mandates CMS surveyor training for AO surveyors, requiring completion of applicable CMS online training programs.

• Requires accrediting organizations to submit survey findings to CMS, increasing transparency and facilitating federal oversight.

• Creates new performance measurement and validation standards, including: • New definitions for process and outcome disparity rates • Expanded validation survey activities • Publicly reportable corrective action plans when AO performance falls below CMS standards • Requires accrediting organizations to revoke accreditation within five business days when CMS notifies them that an accredited provider or supplier has been involuntarily terminated from Medicare or Medicaid.

• Creates barriers to reentry for terminated deemed providers and suppliers, requiring: • State survey agency oversight during a CMS-determined reasonable assurance period.

• Demonstration of compliance before Medicare participation is restored.

• Prohibition on using AO accreditation alone to regain participation after termination.

Conclusion

The rule represents CMS’s most significant update to accrediting organization oversight in more than a decade. It aims to improve transparency, reduce conflicts of interest, align AO surveys more closely with state survey agency practices, strengthen performance accountability, and ensure that deemedstatus providers meet Medicare’s health and safety standards.

6 | JULY 2026 MLO-ONLINE.COM

2607MLO_06-07.indd 6

6/23/26 1:08 PM

Out of Line?

When results fall outside acceptable limits, action is critical.

When proficiency testing results raise concern, the right next steps make all the difference.

Additional samples can help you reassess performance to strengthen your corrective action.

API offers flexible off-schedule solutions – including Troubleshooting, Self-Evaluation, and Remedial samples – designed to give you the control and support needed to keep your laboratory moving forward with confidence.

Test. Evaluate. Improve with clarity.

Explore Off-Schedule Sample Options api-pt.info/off-schedule

2607MLO_API_FP.indd 2607MLO_06-07.indd 7 1

6/1/26 6/23/26 10:58 1:08 AM PM

CONTINUING EDUCATION :: TYPE 2 DIABETES

magicmine/iStock / Getty Images Plus /Getty Images

Continuing Education :: Type 2 Diabetes

The hidden liver burden in type 2 diabetes A call to action for clinical laboratories

By Anna Loh, MD; Shalini Verma, MD, FCAP

T

ype 2 diabetes (T2DM) is increasingly recognized as a multisystem cardiometabolic disease extending beyond glycemic dysregulation alone. Contemporary clinical guidelines now emphasize comprehensive assessment of cardiovascular, renal, and hepatic risk, creating new opportunities for the clinical laboratory to play a central role in early disease detection and risk stratification.

Among these emerging priorities, metabolic dysfunction–associated steatotic liver disease (MASLD) has become one of the most common and underrecognized comorbidities in patients with T2DM,1 with the conditions exacerbating each other.2 Driven by insulin resistance, obesity, and chronic inflammation, MASLD and T2DM share overlapping pathophysiologic mechanisms that significantly increase cardiovascular and end-organ risk.3 Reflecting this evolving understanding, clinical management has shifted from a traditional “glucose-centric” focus on HbA1c toward a broader, muti-organ

approach to cardiometabolic risk management. Epidemiologic data show that more than 60% of people with T2DM have MASLD, and up to 30% progress to metabolic dysfunction-associated

steatohepatitis (MASH), increasing the risk of cirrhosis, hepatocellular carcinoma (HCC), and liver-related mortality.1 An observational study employing transient elastography found that over

Earning CEUs

See test online at https://the-hidden-liver-burden-in-type-2-diabetes Passing scores of 70 percent or higher are eligible for 1 contact hour of P.A.C.E. credit.

LEARNING OBJECTIVES

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

Scan code to go directly to the CE test.

1. Describe the relationship between type 2 diabetes mellitus (T2DM), metabolic syndrome, and metabolic dysfunction–associated steatotic liver disease (MASLD).

2. Identify the major clinical complications and risk factors associated with advanced liver fibrosis in patients with T2DM. 3. Compare the characteristics, advantages, and limitations of commonly used non-invasive fibrosis assessment tools, including FIB-4, ELF, VCTE, and MRE. 4. Evaluate the role of the clinical laboratory in fibrosis risk stratification, guidelinesupported testing workflows, and population-based diabetes care management.

8 | JULY 2026 MLO-ONLINE.COM

2607MLO_08-13_CE.indd 8

6/23/26 1:08 PM

Continuing Education :: Type 2 Diabetes 50% of T2DM patients had severe hepatic steatosis, while approximately 20% exhibited advanced fibrosis.4 Because fibrosis is often clinically silent, proactive identification of high-risk patients has become increasingly important.

For laboratories, this shift represents an expanded role in identifying patients at risk before irreversible liver disease develops. Historically, liver biopsy served as the primary method for fibrosis assessment. However, biopsy has recognized limitations and several validated non-invasive tests (NITs), including imaging and blood-based biomarkers, are now incorporated into clinical care pathways and guideline recommendations from organizations including the American Diabetes Association (ADA), American Association of Clinical Endocrinology (AACE), American Association for the Study of Liver Diseases (AASLD), and American Gastroenterological Association (AGA).

Metabolic syndrome and liver disease: Closing the awareness gap

Approximately 65% of patients with T2DM develop metabolic syndrome (MetS), which frequently precedes or accompanies diabetes and is characterized by central obesity, glucose intolerance, hyperinsulinemia, low high-density lipoproteins (HDLs) levels, elevated triglycerides (TGs), and hypertension.

Insulin resistance is the primary driver of both MetS and T2DM.5 The combination of MetS and T2DM creates a prothrombotic (clot-prone) and pro-inflammatory state that accelerates vascular and end-organ damage, contributing to both microvascular and macrovascular complications.5,6 Key complications include the following: • Cardiovascular disease and atherosclerosis • Peripheral arterial disease • Nephropathy • Retinopathy • Neuropathy • Dyslipidemia • Sleep apnea • Polycystic ovarian syndrome (PCOS) This metabolic environment also accelerates progression of liver disease, particularly fibrosis, which is the leading cause of liver-related morbidity and mortality.7 Because advanced fibrosis is associated with increased liver-related and cardiometabolic risk, there is growing interest in incorporating fibrosis assessment into broader chronic

Figure 1. Guideline-Recommended Stepwise Fibrosis Risk Assessment STEP

1

INITIAL RISK ASSESSMENT Blood-Based Screening

FIB-4 Index

• Uses age, AST, ALT, and platelet count • High NPV rules out advanced fibrosis

STEP

2

< 1.3 LOW RISK

1.3 – 2.67 INDETERMINATE

≥ 2.67 HIGH RISK

Manage in Primary Care

Proceed to Step 2

Refer to Hepatology

SECONDARY ASSESSMENT

Assess Risk of Liver-Related Outcomes

ELF Test or VCTE

• ELF Test: Score generated from blood-based biomarker measurement • VCTE: Measures liver stiffness and steatosis

STEP

3

SPECIALIST ASSESSMENT For High-Risk Patients

Consider MRE or Hepatology Referral • MRE: highly accurate staging of liver fibrosis

Goal: Identify risk of advanced fibrosis early to prevent 1 irreversible liver disease and reduce complications. disease management strategies. This shift further expands the importance of scalable, laboratory-supported risk stratification approaches.

The clinical impact of underrecognized liver fibrosis in T2DM

A major challenge in managing MASLD and MASH in patients with T2DM is the silent progression of liver fibrosis.

Unlike acute liver injury, fibrosis often advances without symptoms and may remain undetected until irreversible complications such as cirrhosis, portal hypertension, or HCC develop. Routine liver enzyme testing lacks sufficient sensitivity to reliably identify patients with advanced fibrosis, and normal aminotransferase levels do not exclude clinically significant disease.

Advanced liver fibrosis in patients with T2DM is associated with substantially increased all-cause mortality, driven not only by liver-related outcomes but also by cardiovascular disease and chronic kidney disease. Unlike steatosis, fibrosis severity is the strongest predictor of liver-related and all-cause mortality in MASLD with cardiovascular

being the leading cause of patient death in this population.

From a health system perspective, delayed diagnosis leads to higher utilization of specialty care, emergency admissions, and transplant services. In contrast, early risk stratification enables targeted lifestyle interventions and pharmacologic therapies that may slow or even reverse disease progression. These realities have shifted the clinical focus from detection of steatosis to proactive identification of fibrosis risk, an area where laboratory-based non-invasive tests (NITs) play a pivotal role.

Guideline evolution: What’s new from ADA and AACE

Recent guideline updates increasingly recognize liver disease as a major comorbidity in T2DM. In 2025, the ADA acknowledged that liver health has been overlooked amongst those with prediabetes and T2DM despite the substantially increased prevalence of MASLD and MASH in these populations.

Similarly, the AACE 2026 guidelines for management of adults with T2DM elevate MASLD and MASH to the same level of clinical importance as chronic MLO-ONLINE.COM JULY 2026 | 9

2607MLO_08-13_CE.indd 9

6/23/26 1:08 PM

Continuing Education :: Type 2 Diabetes kidney disease and cardiovascular disease when guiding treatment decisions. This reflects a broader shift away from glucose management alone toward integrated cardiometabolic risk reduction.8 Because fibrosis is the strongest predictor of liver-related and non-liver outcomes in MASLD, both ADA and AACE now recommend structured fibrosis risk assessment using non-invasive testing. Note that AACE guidelines were written in 2022 and use the previous nomenclature of non-alcoholic fatty liver disease (NAFLD) for MASLD. Current guidance recommends initial assessment with the Fibrosis-4 (FIB-4) Index followed by secondary evaluation using the Enhanced Liver Fibrosis (ELF) test or vibration-controlled transient elastography (VCTE) in patients with indeterminate or elevated FIB-4 scores (See Figure 1).

Across professional societies, the convergence toward non-invasive, stepwise fibrosis assessment reflects a shared recognition that traditional referral-based models are insufficient to manage the scale of MASLD in patients with T2DM. Given the high prevalence of disease and limited specialist capacity, guidelines emphasize risk stratification tools that are accessible, scalable, and cost-effective. The recommended two-step approach prioritizes sensitivity to minimize missed cases while reducing unnecessary referrals.

This approach also aligns with population health strategies increasingly adopted by healthcare systems, where early identification of high-risk individuals enables focused intervention.

By embedding fibrosis assessment into routine diabetes care, guidelines aim to shift liver disease management upstream, before irreversible damage occurs.

Non-invasive techniques (NITs): The laboratory perspective

Liver biopsy remains the gold standard for diagnosing MASH, but its invasive nature, cost, and associated risks limit widespread use. NITs, including blood-based biomarkers and imaging modalities are now preferred for identifying patients at low or high risk for advanced fibrosis and are increasingly replacing biopsy in routine clinical pathways.9 Active fibrosis risk stratification of liver disease in T2DM typically follows a stepwise NIT-based approach beginning with simple blood-based screening and progressing to more specialized testing for intermediate- or high-risk patients. This strategy helps identify patients at greatest risk for progression to cirrhosis and associated complications while reducing unnecessary specialty referrals and healthcare costs.10 These modalities differ in accessibility, cost, and performance, allowing their use to be tailored within stepwise clinical pathways.

FIB-4 index.The FIB-4 index is a widely used, non-invasive, and inexpensive blood-based calculation, incorporating age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count to estimate liver fibrosis risk. Its primary strength lies in its high negative predictive value (NPV) for ruling out advanced fibrosis. Of note, it has limited accuracy in diagnosis and a high rate of false positives. Because FIB-4 uses routinely available laboratory testing data, it is especially well suited for automated calculation and large-scale population screening. However, performance of FIB-4 index can be affected by comorbidities, and it may not be accurate in patients over 65 years or in patients with diabetes.11 Patients with FIB-4 scores ≥ 1.3 are recommended for secondary assessment, while those with scores ≥ 2.67 should be considered for hepatology referral.

Enhanced liver fibrosis (ELF) test.The ELF test is a validated blood-based test granted FDA De novo marketing authorization that measures biomarkers associated with extracellular matrix remodeling and fibrosis progression, including hyaluronic acid (HA), procollagen III N-terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase-1 (TIMP-1). ELF scores have demonstrated utility in assessing the risk of advanced fibrosis and provide prognostic information regarding disease progression when interpreted in conjunction with other clinical and laboratory findings.

Because ELF reflects extracellular matrix remodeling and active fibrogenesis, it may provide complementary prognostic information within broader non-invasive fibrosis assessment strategies and support longitudinal risk evaluation in patients with chronic liver disease.

Across professional societies, the convergence toward non-invasive, stepwise fibrosis assessment reflects a shared recognition that traditional referral-based models are insufficient to manage the scale of MASLD in patients with T2DM. Vibration-controlled transient elastography (VCTE).VCTE (Fibroscan) is a non-invasive imaging technology used to measure liver stiffness and fat content (steatosis). It provides a rapid and painless alternative to liver biopsy and is widely used in MASLD assessment, although performance may be limited in patients with ascites, severe obesity, or severe narrow ribs12 (if the probe cannot reach the liver), and it can have significant intra- and inter-operator variability.

Magnetic resonance elastography (MRE).MRE is an advanced, non-invasive imaging modality that uses MRI-based technology to quantitively assess liver stiffness as a surrogate for fibrosis. It provides a highly reproducible and accurate measure of fibrosis across the full disease spectrum and has demonstrated strong diagnostic performance for detecting both significant and advanced fibrosis. Compared with ultrasound-based elastography techniques, MRE offers high diagnostic accuracy and lower operator dependence.

However, its use is limited by cost, availability, and the need for specialized imaging infrastructure, which can restrict access in routine clinical practice.13

Practical considerations for clinical laboratories

Some laboratories have implemented automated fibrosis risk workflows in which FIB-4 calculations are generated directly within laboratory information systems and paired with standardized interpretive comments. In selected care models, elevated or indeterminate results may trigger reflex pathways for secondary assessment using imaging or specialized blood-based fibrosis testing, helping support more consistent risk stratification across large patient populations.

Clinical laboratories support fibrosis risk assessment through their central role in generating the test results used in initial evaluation. Routine metabolic panels already include key analytes used in calculating FIB-4, enabling laboratories to facilitate access to these assessments and support identification of patients who may benefit from further evaluation.

10 | JULY 2026 MLO-ONLINE.COM

2607MLO_08-13_CE.indd 10

6/23/26 1:08 PM

Does your HbA1c test detect variants?

Improved Workflow.

Better A1c Results.

A1c by Sebia

Fully Automated A1c Testing.

Load racks and walk away.

More than A1c: One Platform, Multiple Assays. Consolidate HbA1c, Hb, and Myeloma testing.

Unmatched Resolution: Clearer Results, Superior Hb Variant Detection. Easy-to-interpret patterns when Hb variants are present.

Built-in Safeguards for Smart Reporting. Provide confidence in results and better patient care.

Visit Sebia at ADLM Anaheim, CA

July 28 - 30, 2026 Booth #1139

Sebia | 1705 Corporate Dr # 400 | Norcross, GA 30093 | 1.800.835.6497 | info-ep.us@sebia.com | www.sebia.com Sebia USA

2607MLO_Sebia_FP.indd 2607MLO_08-13_CE.indd 111

SebiaUS

6/9/26 6/23/26 10:12 1:08 AM PM

Continuing Education :: Type 2 Diabetes In clinical practice, patients with indeterminate or elevated fibrosis risk scores may undergo additional non-invasive testing to further inform risk stratification and clinical decision-making, consistent with published guideline approaches. Laboratories may support these workflows Scan code to go by enabling access to additional testing directly to the CE test. and by standardizing reporting formats to improve clarity and consistency of results. Such approaches can help reduce variability in ordering practices and support timely clinical evaluation. Laboratories that have adopted reflex workflows report improved identification of low-risk patients who can be safely managed in primary care, alongside more efficient triage of patients requiring specialty referral.14 Effective implementation requires collaboration with clinical stakeholders to align reporting practices, interpretative language, and integration into existing care pathways.

Electronic health record integration is particularly important to ensure fibrosis risk results are clearly displayed and interpreted within the appropriate clinical context. Interpretative comments accompanying calculated scores or biomarker results may further support clinicians by providing context consistent with current clinical guidance.

From a value-based care perspective, laboratory-supported approaches to fibrosis risk assessment may contribute to more efficient patient identification and appropriate care escalation, with the goal of improving clinical outcomes through earlier evaluation. As new therapeutics for MASH become available, the demand for scalable and clinically integrated approaches to fibrosis assessment is expected to increase, further expanding the laboratory’s role in metabolic disease management.

Looking ahead, the integration of MASLD and MASH into diabetes care pathways is expected to further expand the role of the clinical laboratory in population health management and preventative care. Continued advances in laboratory diagnostics, including novel biomarkers, molecular assays, and digital risk stratification tools, are likely to further refine fibrosis assessment and disease monitoring. Ensuring standardization, appropriate test utilization, and integration into clinical workflows will be essential to realizing the full potential of these approaches in routine diabetes care.

Conclusion

Management of T2DM has evolved beyond HbA1c control toward comprehensive assessment of cardiometabolic risk, including liver disease. As recognition of MASLD and MASH continues to grow, non-invasive fibrosis assessment is becoming an increasingly important component of diabetes care pathways.

This evolution presents a significant opportunity for clinical laboratories. Through implementation of automated fibrosis scoring, coordinated use of non-invasive testing, and standardized reporting practices, laboratories can help support earlier identification of patients at risk for advanced fibrosis and facilitate timely clinical evaluation.

As clinical guidelines increasingly integrate liver fibrosis assessment into routine diabetes management, collaboration among laboratories, primary care providers, endocrinologists, and hepatology specialists will become increasingly important. Clinical laboratories are uniquely positioned to support scalable population-level fibrosis risk stratification through automated workflows, standardized reporting, and integration

of non-invasive testing into routine cardiometabolic care pathways. As metabolic disease management continues to evolve toward multi-organ risk assessment, the laboratory will play an increasingly central role in early disease identification and coordinated patient care.

This article is intended solely for educational and scientific exchange purposes and is not intended as medical advice or to promote any specific product, service, or commercial activity.

REFERENCES 1. American Diabetes Association Professional Practice Committee for Diabetes*. Summary of revisions: Standards of care in diabetes-2026.

Diabetes Care. 2026;49(1 Suppl 1):S6-S12. doi:10.2337/dc26-SREV. 2. Stefan AG, Mitrea A, Clenciu D, et al. MASH in type 2 diabetes: Pathophysiology, diagnosis, and therapeutic management-a narrative review.

Medicina (Kaunas). 2026;62(2):325. doi:10.3390/medicina62020325.

3. Lu X, Xie Q, Pan X, et al. Type 2 diabetes mellitus in adults: Pathogenesis, prevention and therapy. Signal Transduct Target Ther. 2024;9(1):262. doi:10.1038/s41392-024-01951-9.

4. Mohiuddin MS, Neha NT, Mahir JUK, et al. Metabolic dysfunction associated fatty liver disease and type 2 diabetes: Pathophysiological links, epidemiological trends, and clinical implications. Front Endocrinol (Lausanne). 2025;16:1669478. doi:10.3389/fendo.2025.1669478.

5. Asghar S, Asghar S, Shahid S, et al. Metabolic syndrome in type 2 diabetes mellitus patients: Prevalence, risk factors, and associated microvascular complications. Cureus. 2023;15(5):e39076. doi:10.7759/ cureus.39076.

6. Bhatt DL, Szarek M, Pitt B, et al. Sotagliflozin in patients with diabetes and chronic kidney disease. N Engl J Med. 2021;384(2):129-139. doi:10.1056/NEJMoa2030186.

7.

Chan WK, Chuah KH, Rajaram RB, Lim LL, Ratnasingam J, Vethakkan SR. Metabolic dysfunction-associated steatotic liver disease (MASLD): A state-of-the-art review. J Obes Metab Syndr. 2023;32(3):197-213. doi:10.7570/jomes23052.

8. Samson SL, Vellanki P, Blonde L, et al. American Association of Clinical Endocrinology Consensus Statement: Algorithm for Management of Adults With Type 2 Diabetes - 2026 Update. Endocr Pract.

2026;32(4):473-518. doi:10.1016/j.eprac.2026.01.006.

9. Fraczek J, Sowa A, Agopsowicz P, et al. Non-invasive tests as a replacement for liver biopsy in the assessment of MASLD. Medicina (Kaunas).

2025;61(4):736. doi:10.3390/medicina61040736.

10. Chen Y, Dong B, Jin X, et al. Two-step clinical care pathway to predict MASLD-related advanced fibrosis and long-term outcomes in type 2 diabetes. Gut. 2026;75(3):576-587. doi:10.1136/gutjnl-2025-337506.

11. Amer J, Alnees M, Salameh M, et al. The diagnostic utility of FIB-4 as a non-invasive tool for liver fibrosis scoring among NAFLD patients: A retrospective cross-sectional study. Eur Rev Med Pharmacol Sci. 2024;28(8):3104-3111. doi:10.26355/eurrev_202404_36026.

12. Shen M, Lee A, Lefkowitch JH, Worman HJ. Vibration-controlled Transient Elastography for Assessment of Liver Fibrosis at a USA Academic Medical Center. J Clin Transl Hepatol. 2022;10(2):197-206. doi:10.14218/JCTH.2021.00188.

13. Imajo K, Honda Y, Kobayashi T, et al. Direct comparison of US and MR elastography for staging liver fibrosis in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2022;20(4):908-917.e11. doi:10.1016/j.cgh.2020.12.016.

14. Nobes J, Leith D, Handjiev S, Dillon JF, Dow E. Intelligent liver function testing (iLFT): An intelligent laboratory approach to identifying chronic liver disease. Diagnostics (Basel). 2024;14(9):960. doi10.3390/ diagnostics14090960.

Anna Loh, MD serves as a field medical liaison for hepatology with Siemens Healthineers. She is a general physician with 14 years of experience treating patients for a variety of conditions and is certified in the UK, New Zealand, and Australia.

Shalini Verma, MD, FCAP serves as a medical officer with Siemens Healthineers. She also is a diplomate of the American Board of Pathology with active board certifications in molecular genetics pathology, hematopathology and anatomic & clinical pathology.

12 | JULY 2026 MLO-ONLINE.COM

2607MLO_08-13_CE.indd 12

6/23/26 1:08 PM

2607MLO_Kronus_FP.indd 1 2607MLO_08-13_CE.indd 13

6/1/26 6/23/26 10:53 1:08 AM PM

CLINICAL ISSUES :: MASS SPECTROMETRY

13069123 © Martine De Graaf | Dreamstime.com

Clinical Issues :: Mass Spectrometry

Mass spectrometry in the clinical laboratory

By Rajasri Chandra, MS, MBA

M

ass spectrometry (MS) is a method of chemical analysis that measures the mass-tocharge ratio (m/z) of atoms or molecules in a sample. It helps to determine the exact molecular weight of the components in the sample and thereby identify unknown compounds.

Mass spectrometry is often paired with chromatography—gas (GC/MS) or liquid (LC/MS) chromatography, where chromatography separates the components of an unknown compound and mass spectrometry analyzes the components for accurate identification. MS is routinely used in toxicology, endocrinology, newborn screening, microbiology, therapeutic drug monitoring, proteomics, and precision medicine.

Evolution of MS in clinical laboratory

Gas chromatography (GC) mass chromatography (MS) was first used

in clinical laboratories in the 1960s, especially in toxicology and for highly specific diagnostic issues, such as the assessment of rare metabolic diseases like Refsum’s disease. However, it was a complex and demanding procedure.1 The development of electrospray ionization (ESI) and the triple-quadrupole mass spectrometer in the 1980s facilitated the emergence of the tandem mass spectrometry (MS/MS), particularly LC-MS/MS (liquid chromatography– tandem mass spectrometry) in clinical laboratories from the 1990s. From the late 1990s onward, mass spectrometry was being used for the analysis of clinically relevant molecules, including thermo-labile compounds. However, due to the complex nature of the technology and high cost, it was not being routinely used in clinical laboratories globally. In the early 2020s, the first fully automated mass spectrometry system became available.1

Types of mass spectrometers and their major applications

There are different types of mass spectrometers; however, the main components are as follows:2 1. An ionizer that ionizes a sample’s atoms or molecules 2. A mass analyzer 3. A detector that detects or counts the number of ions of a specific mass to charge ratio Various types of mass spectrometers use different ionization sources, mass analyzers, and detectors. Listed below are the six major types of mass analyzers: • Quadrupole mass analyzer – mostly used for analyzing and quantifying small molecules. They are used in biomedical research and clinical applications. 3 • Newborn screening • Endocrine testing • Therapeutic drug monitoring • Targeted proteomics • Clinical and forensic toxicology and • Targeted metabolomics • Time-of-flight (TOF) mass analyzer – has been used for substances with higher molecular masses, such as proteins. MALDI/TOF has extensive usage in the medical field as below:4

14 | JULY 2026 MLO-ONLINE.COM

2607MLO_14-17_Clinical.indd 14

6/23/26 1:08 PM

Clinical Issues :: Mass Spectrometry • Clinical microbiology – identification of bacteria, fungi, viruses, antibiotic resistance, etc.

• Establishing biomarkers for various cancers, diabetes mellitus, etc.

• Study of drug metabolism • Study of proteins and peptides in proteomics research • Magnetic sector mass analyzer, also called high-resolution mass spectrometry (HRMS) – is used in the following: • Pharmaceutical and fermentation industries2 • Environmental analysis 5 • Geochemistry etc.6 • Electrostatic sector mass analyzer – is used in the following: • Plasma diagnostics7 • Space exploration 2 • Quadrupole ion trap (QIT) mass analyzer – is used in the following: • Biomolecule and peptide sequencing8 • Environmental analysis for detecting trace contaminants9 • Detecting volatile organic compounds (VOCs), environmental pollutants, and illicit drugs in complex mixtures10 • For structural elucidation of complex organic compounds9 • Ion cyclotron resonance mass analyzer – is used in the following: • Medical research - in advanced cancer treatment, metabolomics2

Testing procedure of mass spectrometry11

Mass spectrometry analyzes samples through five key stages: ionization, acceleration, deflection, detection, and vacuum maintenance.

1) Ionization

Atoms are ionized by removing an electron to form positively charged cations — the only ion type mass spectrometers analyze. In GC/MS, electron ionization bombards molecules with high-energy electrons (~70 eV), fragmenting them into reproducible, identifiable patterns. LC/MS techniques operate at atmospheric pressure. Electrospray ionization and atmospheric pressure chemical ionization are soft ionization techniques that leave the molecular ion largely intact in the source. Electrospray ionization uses a combination of voltage, heat, and air to produce successively smaller droplets from the liquid, eluting off a chromatographic column.

As the solvent evaporates, the droplets

become more concentrated, significantly increasing charge per unit volume.

Ions accumulated at the droplet surface desorb from the liquid into the gas phase, allowing these gas phase ions to enter the mass spectrometer for analysis. In addition, complete evaporation of the solvent liberates large ions, such as proteins, producing the necessary gas phase ions for analysis. Atmospheric pressure chemical ionization produces ions using a combination of heat to completely vaporize the sample and plasma produced by an electrical discharge, commonly referred to as a corona discharge. The corona discharge ionizes the evaporated solvent, and through physical interaction with gaseous sample components, including the analytes of interest, positive or negative ions are formed.

2) Acceleration

All cations are accelerated to equal kinetic energy through slits in the apparatus, feeding into an ion beam where the mass analyzer begins separating ions by their mass-to-charge ratio (m/z).

3) Deflection

A magnetic field deflects the cations based on their mass and charge. Mass and deflection are inversely proportional, whereas charge and deflection are directly proportional. Therefore, ions with a lower mass are deflected more, and ions with a higher positive charge experience greater deflection. This determines each ion’s mass to charge (m/z) ratio. Since most ions carry a 1+ charge, their m/z value typically equals their molecular weight.

4) Detection

A detector quantifies the positive ions, and the vacuum removes the neutral ions. The most common detection method is the electron multiplier where a series of dynodes with increasing potentials are linked. When ions strike the first dynode surface, electrons are emitted. These electrons are attracted to the next dynode, where more secondary electrons are emitted due to the higher potential of subsequent dynodes. A cascade of electrons is formed at the end of the chain of dynodes, resulting in overall signal amplification on the order of 1 million or greater.

5) Vacuum

Mass spectrometers operate under low pressure, which creates a vacuum effect as there is less probability that

ions collide with one another in the apparatus. This environment enables the proper separation of cations from the neutral ions, as the vacuum removes the neutral molecules.

Advantages of mass spectrometry in clinical applications12

Mass spectrometry, especially in combination with liquid chromatography (LC), has revolutionized clinical chemistry and proved to be a very useful tool in identifying disease biomarkers and quantifying biomolecules for diagnostic and prognostic purposes. The characteristics that set them apart are as follows: 1. High specificity and sensitivity – Clinical mass spectrometry has largely replaced traditional immunoassays for low-concentration analytes by virtue of its high sensitivity (low limit of detection (LoD)/limit of quantitation (LoQ)) and very high chemical specificity that prevents the false positives and cross-reactivity that are common in older immunoassay methods. The LoD of mass spectrometry ranges from picograms to nanograms per milliliter (pg/mL to ng/mL).

2. Multiplexing capabilities – Mass spectrometry (MS) techniques coupled with liquid chromatography (LC-MS) have the capability to simultaneously analyze multiple analytes in a single run, enabling comprehensive metabolomic and proteomic profiling. The ability of MS to detect and quantify many thousands of metabolite features simultaneously has revolutionized the field of metabolomics, allowing for in-depth characterization of complex biological samples.

Using advanced MS-based technology it is now possible to routinely detect and quantify thousands of proteins. Multiplexing capabilities have improved the throughput and quantitative capabilities of MS-based proteomics, enabling the comparison of protein expressions across multiple samples in a single experiment.

3. Versatility – Mass spectrometry (MS) is highly versatile as it can be applied to a wide variety of biomolecules, including proteins, peptides, metabolites, and drugs.

Moreover, coupling with liquid chromatography (LC) or using techniques such as ion mobility spectrometry (IMS), improves the MLO-ONLINE.COM JULY 2026 | 15

2607MLO_14-17_Clinical.indd 15

6/23/26 1:08 PM

Clinical Issues :: Mass Spectrometry Comparing mass spectrometry with other technologies commonly used to quantify analytes in clinical laboratories1 Parameters

Photometry, enzymatic tests

Immunoassays / ligand binding assay

LC-MS/MS

Sensitivity

Low

High to extremely high

High

Specificity and selectivity

Low

Limited

Very high

Multiplexing potential

Not given (one method – one result)

Not given

Extensive multiplexing possible

Susceptibility to analytical interference

High (e.g., hemolysis)

Given (e.g., anti- reagent antibodies)

Minimal

Automation potential

Very high – analysis from crude serum / plasma samples

Very high – analysis from crude serum / plasma samples

Automation is highly demanding

Practicability and user friendliness

Highly convenient auto- analyzers

Highly convenient auto-analyzers

Very high competence requirements for operators

Equipment costs

Low–moderate

Moderate

Very high

Sample throughput

Up to thousands of results per hour and system

Up to hundreds of results per hour and system

Usually well under 100 results per hour and system

Time to first results

In the range of a few minutes

In the range of 10–30 min

Up to several hours for typical batch analyses

Typical workflow

Random access, 24/7

Random access, 24/7

Batch analyses

Complexity of instruments

Moderate – mainly liquid handling and optical detection

Moderate – mainly handling of liquids and solid consumables, optical detection

Very high, including vacuum technology and extensive electronics

separation and analysis of the MS, improving the versatility of MS to increase further.

• Isotope dilution internal standardization – Isotope dilution internal standardization in MS enables highly accurate quantification by compensating for matrix effects in complex biological matrices, such as plasma, serum, and urine.

Recent MS technologies (highresolution accurate-mass (HRAM) spectrometers and tandem MS) have further improved this capability enabling more reliable and reproducible results.

Main areas of application for LC-MS/MS technology in clinical laboratories1

• Newborn screening for inherited metabolic diseases • Therapeutic drug monitoring • Clinical toxicology • Endocrinology • Metabolic disease • Trace elements • Microbial pathogen differentiation

Challenges for the application of LC-MS/MS in routine medical laboratories

• Highly heterogeneous system configurations.

• Multi-step complex workflows with several quantitative pipetting

steps, manual labelling, manual positioning of plates or vials, manual creation of sample lists, etc.

• Highly laboratory-specific workflows, with little process-related standardization.

• A wide range of possible operator errors, in contrast to standard clinical laboratory analyzer systems.

• Result validation requires review of large amounts of metadata, typically under time pressure and without sufficient software support.

• Implementation and maintenance of methods demand profound expert knowledge, and there is a shortage of experts.

• Very high instrument costs, which often cannot be amortized over extended periods.

automated, AI-driven core technology in routine laboratory medicine.

Future trend for mass spectrometry in clinical laboratories

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.

Fully automated LC-MS/MS–based analyzer systems are now available. This has enabled a few mass spectrometry assays such as the Ionify steroid assays and Ionify 25-Hydroxy Vitamin D total test to be designated as moderately complex by the U.S. Food and Drug Administration. With the advancement in robotics and artificial intelligence (AI), it can be envisioned that mass spectrometry (MS) will transition from a niche, expert-dependent tool to a highly

Conclusion

Mass spectrometry has evolved from a complex research tool into an indispensable platform in clinical diagnostics.

Driven by automation and artificial intelligence, it is rapidly shedding its dependence on specialized operators, broadening access across diverse healthcare settings. The emergence of miniaturized, point-of-care MS instruments will soon bring gold-standard analytical accuracy directly to the patient’s bedside.14 Coupled with multiomics integration, mass spectrometry is poised to become the cornerstone of precision medicine — making its universal adoption in clinical laboratories not only inevitable but imminent.

References are available online at mlo-online.com/55383144

16 | JULY 2026 MLO-ONLINE.COM

2607MLO_14-17_Clinical.indd 16

6/23/26 1:08 PM

2607MLO_RocheDiagnosticsCorp_FP.indd 1 2607MLO_14-17_Clinical.indd 17

6/12/26 1:08 1:36 PM PM 6/23/26

LAB MANAGEMENT :: DIAGNOSTIC STEWARDSHIP

54035823 © Syda Productions | Dreamstime.com

Lab Management :: Diagnostic Stewardship

Diagnostic stewardship and molecular assays A laboratorian’s primer

By John Emmanuel Markantonis, DO, D(ABMM), FASCP, FCAP; Nicholas Moore, PhD, D(ABMM); Dusten T. Rose, PharmD, BCIDP, FIDSA

O

ver the last few decades, the healthcare system in the United States has gradually transitioned from a feefor-service to a value-based payment model.1 This has led healthcare organizations to look for ways to optimize medical services they offer in order to deliver improved patient outcomes more cost effectively. Diagnostic stewardship (DxS) is a useful tool to accomplish this task. DxS is the development and application of processes that optimize the use of clinical laboratory testing to improve the diagnosis and subsequent treatment decisions in medical practice. 2-4 Simply: Use the right test for the right patient prompting the right action at the right time. 5,6 Although DxS can occur in all stages of testing, the bulk of successful interventions occurs in the preanalytical phase with limited opportunities in the analytical/postanalytical phases of testing. 2-4 This can make implementation challenging as the bulk of preanalytical processes (e.g., test decision-making/ordering and specimen collection/transport) occur outside of the laboratory.4 Close collaboration with non-laboratorian clinical stakeholders

is necessary to make substantial changes to institutional practices that impact test selection, ordering, and specimen collection/transportation. 3 Molecular assays are likely to deliver the most return on DxS. Molecular testing utilizes genetic information to diagnose disease etiologies, most notably in infectious diseases and oncology. Although molecular testing often has advantages over comparator methods, there are limitations that are underrecognized, leading to negative patient outcomes and significant laboratory costs. Given this, they are excellent candidates for DxS. The purpose of this article is to deliver a practical overview and a pragmatic approach for the development of molecular DxS interventions at the highest yield stage of testing, the preanalytical stage.

Diagnostic stewardship principles

One of the most important, yet challenging, steps when implementing DxS interventions is test assessment.3 It is important to select tests that will yield the highest benefit.

18 | JULY 2026 MLO-ONLINE.COM

2607MLO_18-21_LabManag.indd 18

6/23/26 1:08 PM

Lab Management :: Diagnostic Stewardship The initial step in assessment should be the identification of several candidate tests followed by a rigorous review of institutional data. Potential key areas for data collection to guide which tests to evaluate require close scrutiny (Figure 1).3 High-level discussion with key clinical stakeholders is instrumental to successful identification of high-priority tests following data acquisition.3 Review of this data with key stakeholders is important to ensure the input of the end users is considered prior to implementation of DxS interventions.2-4 Ideally, the composition of stakeholders should include laboratory administration, common clinical users of the testing (both generalists and specialists), healthcare units dependent on the testing results (e.g., antimicrobial stewardship, infection control, information technology, and executive hospital leadership).2-4,7 Further discussions and collaborations with these same stakeholders are key following test selection to ensure successful implementation and monitoring of DxS interventions.3

Pre-analytical interventions lead to downstream success

Following test selection, determining which DxS activity should be implemented is the next challenge. For preanalytical interventions, the most effective measures are focused on optimizing testing decision-making processes.8 Clinician education should be emphasized.2,3 Digitally enabled clinical decision support tools can be effective in guiding appropriate test ordering.9,10 Careful selection of diagnostic tests for use in institutional order sets, and use of best practice alerts during order entry can limit non-indicated testing.6 The use of nudges (educational pop-ups) and framing comments (comments highlighting the positive/negative impact of the test) can be highly effective as well.4,6 In some situations, testing restrictions through cascading (stepwise testing) or conditional (strict testing requirements) can be used to reduce non-indicated For preanalytical testing; however, this could interventions, the lead to unintended restrictions on indicated orders.4,6 most effective When deploying testing measures are focused restrictions using these on optimizing testing methods, it is important to have the ability to offer decision-making streamlined pathologist processes. consultation.2,3,6 For testing that can be challenging to interpret and may result in adverse treatment decisions, strict restrictions can be implemented where orders can only be placed and/or need approval from experts with the knowledge of the testing limitations and with the ability to interpret the results.3,11 This can be accomplished by restricting tests to certain specialties or developing a multi-specialty DxS committee.3,11 Restrictive methods are increasingly employed in molecular testing due to the challenges in interpreting results and increased costs associated with them (e.g., direct test costs, lack of payor reimbursement, unnecessary healthcare resources due to improper interpretation).3,11 DxS interventions for analytic stages of testing are generally centered around ensuring the testing methodology used is the best for the patient population served and clinical performance by the laboratory meets regulatory standards.2-4 Postanalytical stewardship interventions should ensure proper interpretation of

TESTING • Ordering frequency (over/under ordered tests) • Long turnaround time tests • Clinically inappropriate tests • Wrong clinical indication • Inappropriate specimen types CLINICAL MANAGEMENT • Anti-infective utilization patterns • Time to changes of anti-infectives from test result • Untoward consequences of test misintrepretation OTHER • Regulatory considerations • Testing costs • Reimbursement of new tests compared to comparative methodologies Figure 1. Choosing a candidate for diagnostic stewardship.

results by clinicians and appropriate follow-up testing is performed.2-4

Ongoing feedback with non-laboratorians is key

DxS programs are not only most successful when there is multidisciplinary collaboration, but also excel when ongoing clinician education and continuous monitoring with feedback are incorporated.4 Three domains should be considered when deciding which metrics to measure and report to key stakeholders: utilization, diagnostic performance, and clinical impact. These metrics serve as benchmarks informing the success of the intervention. Data collection is about quality, not quantity. The right data should reflect clinical decisionmaking quality, appropriate test utilization, and downstream clinical impact. These metrics may be the same or similar to those collected when determining which candidate tests would be the focus of DxS action (Table 1).

The post go-live phase is where many programs can quietly fail because they stop measuring the right things.

A DxS program is ultimately considered successful when it reduces inappropriate testing, improves diagnostic yield, and positively impacts clinical management without missing disease. This requires continuous monitoring of utilization, yield, appropriateness, and clinical outcomes using structured LIS/EHR data and targeted chart review. If testing volumes do not change, it may mean the intervention is being bypassed.

Conversely, if the intervention is working as intended, it is important to ensure that stable or rising testing volumes are driven by appropriate clinical use, such as shifts in local epidemiology.

DxS in practice: Multiplex PCR for gastroenteritis

The rapid adoption and proliferation of multiplex PCR (mPCR) syndromic panels are a great example of how DxS can improve clinical practice. mPCR gastrointestinal (GI) panels are high-performing tools, but without stewardship, they may lead to clinical confusion and excessive laboratory costs. The panels have broad detection of microorganisms, and there is data which supports that these assays have MLO-ONLINE.COM JULY 2026 | 19

2607MLO_18-21_LabManag.indd 19

6/23/26 1:08 PM

Lab Management :: Diagnostic Stewardship Utilization

Quality

Clinical

Financial

Testing volumes

Rejection rates

Anti-infective use changes in response to test result

Cost avoidance

Repeated testing/ Redundancy

Appropriate change/Understanding of result

Billed charges/ Payor denials

Indication for test

Time to change from result

Adherence to reflex test criteria

Conclusion

Table 1. Metrics for auditing diagnostic stewardship initiatives.

enhanced diagnostic yield and return results more quickly than conventional tests.12-17 These assays have shifted the bottleneck from detection to interpretation and appropriate utilization.

Limitations of these assays include the inability to differentiate between active infection, asymptomatic colonization, and prolonged shedding of nucleic acid. Some laboratories have developed

Limitations of these assays include the inability to differentiate between active infection, asymptomatic colonization, and prolonged shedding of nucleic acid. guidelines to aid clinicians in proper test utilization. These laboratories may utilize duration of illness or other clinical features (e.g., bloody diarrhea, fever, or prolonged duration) to guide clinicians towards testing.18 For patients with hospital-onset diarrhea who have been hospitalized for more than three days, testing by mPCR is generally restricted given the low likelihood of pathogen identification and the risk for Clostridioides difficile detection indicating colonization instead of active infection.19,20 Ultimately, optimizing GI testing requires DxS that aligns test utilization with clinical presentation, patient risk factors, and the likelihood of actionable results; maximizing clinical impact while minimizing unnecessary costs, inappropriate treatment, and diagnostic uncertainty.

DxS in practice: Multiplex PCR for central nervous system infections

When testing cerebrospinal fluid (CSF) specimens utilizing mPCR panels, it is important to note that this is purely

centers incorporating NGS testing.27 Additional considerations include clinician awareness of organisms on targeted NGS menus, optimal collection timing, detection of nonpathogenic organisms increasing diagnostic uncertainty, delayed turnaround time, and testing reimbursement.25,26

adjunctive. Molecular testing is not intended to replace conventional culture and targeted assays for pathogens with high pre-test probability. The strongest pre-analytic measure to screen specimens is requiring objective evidence that demonstrates central nervous system inflammation. Several studies have shown that restricting testing to CSF with demonstrable pleocytosis results in decreased utilization of these assays while showing an increase in test positivity, especially for bacterial pathogens.21-24 Notably, some viral infections may occur without CSF pleocytosis in specific patient populations (e.g., immunocompromised with neutropenia) and stewardship strategies should combine CSF parameters with clinical context rather than rely on white blood count thresholds alone.

Evolving molecular tests may require evolving DxS strategies

As molecular technology continues to evolve, clinical laboratorians should not only employ these same prudent DxS strategies, but may need to adapt to unique practices as they develop.

Next-generation sequencing (NGS) methods are appealing diagnostic solutions due to the exponential increase in the number of pathogens detected compared to fixed mPCR panels and traditional culture; however, few laboratories have the capability to complete NGS testing in-house.25 While formal utilization guidance is currently unavailable, best practice strategies are emerging.

As noted above, clinical microbiologists, infectious disease physicians, and pathologists should build a framework in the pre-analytical phases for developing guidance to identify clinical scenarios, patient populations, sample types, and tiered diagnostic testing to guide optimal NGS testing.3,25-27 NaureckasLi recently described a collaborative process to determine institutional consensus of NGS using a modified Delphi approach that can be instructional for

DxS is essential for clinical laboratories navigating the myriad of clinical advantages alongside the increasing complexities and costs of molecular diagnostics. By leading stewardship efforts with clinicians and health system leadership in the pre-analytical phases of testing, clinical laboratorians are uniquely positioned to influence diagnostic accuracy, patient management, and healthcare value. As molecular technologies expand, laboratorians must continue to embrace DxS ensuring that the right innovative tools are used thoughtfully and equitably at the right time for the right patient prompting the right action.

John Emmanuel Markantonis, DO, D(ABMM), FASCP, FCAP is a clinical pathologist at NYU Langone Health. He is passionate about improving patient care through diagnostic stewardship and responding to the emerging threat of antimicrobial resistance through antimicrobial stewardship.

Nicholas Moore, PhD, D(ABMM) is the associate director of clinical microbiology and an associate professor at Rush University Medical Center in Chicago. His research interests are focused on antimicrobial resistance, diagnostic stewardship, and the implementation of innovative diagnostic technologies to improve patient care and laboratory practice.

Dusten T. Rose, PharmD, BCIDP, FIDSA is a Medical Science Liaison in U.S. Medical Affairs at bioMérieux. He is a board-certified infectious diseases pharmacist with nearly 15 years of inpatient clinical experience.

His interests include antimicrobial stewardship, clinical impact of emerging diagnostics, and antimicrobial resistance.

References are available online at mlo-online.com/55384113

20 | JULY 2026 MLO-ONLINE.COM

2607MLO_18-21_LabManag.indd 20

6/23/26 1:08 PM

Hands-on time is for patients, not testing.

Unlock fast molecular testing and reporting on the LIAISON NES® for confident, time-critical decisions.

Getting respiratory answers should be fast, accurate, and simple. The LIAISON NES® uses an easy 3-step workflow to deliver differential and definitive results within ~15 minutes. That means you can make timely, confident care decisions Cypress, CA

that strengthen antibiotic stewardship and patient outcomes.

p: 800 838 4548 w: diasorin.com

Get to the right treatment faster at diasorin.com/liaison-nes

©2026 DiaSorin Molecular LLC. All rights reserved. LIAISON NES is a trademark of DIASORIN SpA, registered in the US.

2607MLO_LuminexCorp_FP.indd 2607MLO_18-21_LabManag.indd 1 21

BR1187600.US.0426.1

6/5/26 1:08 8:12PM AM 6/23/26

INFECTION DIAGNOSTICS :: GROUP A STREP

1941759922/ iStock / Getty Images Plus,Getty Images

Infection Diagnostics :: Group A Strep

Better POC testing on the way for group A strep

By Annanya Shetty, PhD

S

trep throat may be highly contagious, but a specific diagnosis isn’t as easy to catch. When kids present with a sore throat, the most common cause is viral — but too often pediatricians prescribe antibiotics just in case the infection might be bacterial or to help reassure anxious parents that action is being taken.

Unfortunately, the overuse of antibiotics is a significant contributor to the challenge of antibiotic resistance.

Accurately differentiating bacterial cases of pharyngitis helps to ensure that antibiotics are used appropriately and responsibly. Group A Streptococcus is the most common bacterial cause of strep throat, so it warrants a dedicated testing approach.

But testing for group A Streptococcus has been a logistical challenge in the clinic. For optimal outcomes, patients should be informed of their status while still at the doctor’s office or the urgent care center. Most rapid testing options, though, are antigen-based with limited sensitivity; follow-up testing is often recommended for negative results. Historically, the gold standard for establishing a strep throat diagnosis is throat culture. This process can take at least 24 to 48 hours — too long to get an appropriate treatment started right away, and also longer than ideal if a patient originally prescribed antibiotics is found not to actually need them.

Recent advances in molecular diagnostic testing have led to a new option: point-of-care testing with molecular sensitivity and specificity. Depending on what’s most appropriate for their patient populations, clinical laboratory teams working with outpatient practices can now adjust their algorithms to integrate point-of-care testing options for group A streptococcal infections — and ease the burden on central laboratories.

Snapshot: Group A Streptococcus

Commonly known as group A Streptococcus, this pathogen is the gram-positive w. According to the Centers for Disease Control and Prevention, group A Streptococcus is the cause of strep throat for 20% to 30% of pediatric cases of pharyngitis and in 5% to 15% of cases in adults.1 Symptoms, such as fever and sore throat, tend to overlap considerably with other infectious diseases, making for a challenging diagnosis using only clinical observations. The incubation period is generally two to five days.

Strep throat caused by group A Streptococcus is common in children between the ages of five and fifteen but rare in those younger than three. It is passed through close contact and is commonly transmitted at daycare centers and schools.

Other high-risk settings include homeless shelters and detention facilities.

22 | JULY 2026 MLO-ONLINE.COM

2607MLO_22-23_Infection.indd 22

6/23/26 1:08 PM

Infection Diagnostics :: Group A Strep Concerns about antibiotic-resistant strains of group A Streptococcus have been growing in recent years. Clinical teams have reported finding S. pyogenes strains with limited susceptibility to some of the most commonly used antibiotics used for strep throat, including amoxicillin, ampicillin, and cefotaxime.2 In a study of more than 7,000 genomes sequenced from strains isolated from patients, researchers found 137 strains with genetic mutations that could contribute to antibiotic resistance.2 The authors reported that “many of our strains had decreased susceptibility in vitro to multiple beta-lactam antibiotics,” noting that these strains were geographically widespread.

collected from individuals of all age groups. This will ensure that the point-of-care platform is well-suited to a broad range of patients and that its results are reliable.

Operational impact

Beyond generating accurate results quickly, molecular pointof-care tests for group A Streptococcus should offer additional advantages to laboratory medicine teams. For example, their high sensitivity and specificity mean that results do not need confirmation with throat culture, and during peak strep throat season, this could greatly reduce the volume of follow-up testing sent to busy clinical labs.

1941759922/ iStock / Getty Images Plus,Getty Images

Conventional testing protocols

Traditional group A Streptococcus testing workflows typically rely on two types of tests: rapid antigen and throat culture. The CDC recommends the use of rapid antigen tests for point-ofcare testing so long as negative results are followed up with the more reliable throat culture for children who are at least three years old.1 Rapid tests tend to have good specificity, so positive results usually do not need to be questioned. When in doubt, results from a culture are considered the most reliable.

In 2025, the Infectious Diseases Society of America (IDSA) updated its clinical practice guideline for group A Streptococcus testing.3 The revised guideline includes a recommendation for using a clinical scoring system to identify patients for whom group A Streptococcus testing is appropriate; however, this does not apply to cases of children younger than three.

According to the recommendation, a clinical scoring system is most useful for determining which patients with pharyngitis are least likely to have infections caused by group A Streptococcus. The IDSA advises that high-risk patients, such as those who have had close exposure to another with a group A streptococcalinfection, may warrant testing even if their clinical scores don’t meet set thresholds.

Molecular point-of-care tests

Molecular tests often have a reputation for strong sensitivity and specificity, but they are primarily conducted in clinical laboratories where highly skilled technical experts can oversee their operation. There are several molecular tests for group A Streptococcus, including some rapid lab-based assays that can generate results in an hour or less. While these tests solve certain clinical needs, and allow for much faster results than throat cultures, they do not address the goal of providing testing — and getting answers — at the point of care.

In order to translate the levels of accuracy and reliability seen with molecular tests for use at doctor’s offices, pharmacies, or urgent care clinics, a molecular-based point-of-care testing platform is needed. Fortunately, recent advances in the speed and complexity of molecular testing have enabled the development of these kinds of platforms. Currently, CLIA-waived molecular platforms exist that can be operated at or near the point of care. They deliver highly sensitive, highly specific results in less than 30 minutes — fast enough to deliver results during the patient’s initial visit, enabling timely, informed clinical decision-making while supporting antibiotic stewardship by reducing unnecessary or inappropriate prescribing.

For optimal accuracy, clinical lab teams may want to select a testing platform that had its clinical performance evaluated against an FDA-cleared molecular comparator test rather than against a culture-based test, preferably in a prospective study with a minimum of hundreds of clinical samples

Molecular tests often have a reputation for strong sensitivity and specificity, but they are primarily conducted in clinical laboratories where highly skilled technical experts can oversee their operation.

Ideally, point-of-care tests should connect seamlessly to an institution’s laboratory information system and electronic medical records. Something like a wifi-connected device facilitates an easy flow of data that not only allows for reporting patient results but also makes it possible for the central lab to monitor satellite units for local health trends or consumable needs.

These devices are designed for ease of use, so a good platform will require minimal hands-on time and very little training. For optimal utility, the instrument should work with either operator-collected or self-collected samples, and also function with room-temperature reagents to avoid the need for nearby refrigerated storage. Devices should be quite compact and easily portable.

With molecular point-of-care platforms finally becoming a viable option for group A Streptococcus testing, clinical lab teams have the opportunity to deploy testing instruments more strategically across their health systems to balance their workload and to deliver actionable results to patients in a clinically relevant time frame.

REFERENCES 1. Clinical guidance for group A streptococcal pharyngitis. U.S. Centers for Disease Control and Prevention. November 18, 2025.

Accessed May 28, 2026. https://www.cdc.gov/group-a-strep/hcp/ clinical-guidance/strep-throat.html.

2. Musser JM, Beres SB, Zhu L, et al. Reduced in vitro susceptibility of streptococcus pyogenes to β-lactam antibiotics associated with mutations in the pbp2x gene is geographically widespread. J Clin Microbiol. 2020;58(4):e01993-19. doi:10.1128/JCM.01993-19.

3. Barshak, MB, Linder JA, Watson ME, et al. IDSA clinical practice guideline update on group A streptococcal (GAS) pharyngitis.

October 14, 2025. Accessed May 28, 2026. https://www.idsociety.org/ practice-guideline/streptococcal-pharyngitis2/.

Annanya Shetty, PhD is a translational medicine specialist with more than a decade of experience in infectious diseases and diagnostics. She holds a PhD in medicine from the National University of Singapore and has held global product leadership roles at Abbott and now Diasorin, where she integrates clinical research with the development of decentralized molecular diagnostics.

MLO-ONLINE.COM JULY 2026 | 23

2607MLO_22-23_Infection.indd 23

6/23/26 1:08 PM

EDUCATION :: PEDIATRIC CUTOFF LEVELS

ID 56463226 © Aviahuismanphotography | Dreamstime.com

Education :: Pediatric Cutoff Levels

Neonatal and pediatric drug testing: Reassessing adult-derived assay cutoffs

By Faon Rodriguez, MS; Dexter Charles Mangio, BSMT, MT(AMT), MLS(FL DOH)

N

eonatal and pediatric urine drug screening remains inconsistently standardized across institutions. Many laboratories apply assay urine drug screen (UDS) cutoffs derived from adult or workplace testing, despite key differences in newborn and pediatric physiology and specimens, including collection timing, dilution, and drug metabolite detectability.1 Adult derived thresholds may be too high and miss clinically relevant substance exposure in neonates and pediatric patients. Lower thresholds can improve drug detection but may also reduce false negative findings that may favor more definitive drug confirmations. Although some centers have adopted lower, locally validated pediatric cutoffs, a universal neonatal standard is lacking.Results should be interpreted in clinical context, and definitive or direct mass spectrometry confirmation should be obtained when findings may affect medical care or reporting drugs of misuse.1,5

Current testing strategies in neonatal and pediatric toxicology

UDS cutoffs developed for adults should not be used routinely in neonates because the newborn’s miniature body functions and practical collection issues can distort results.1,6 Neonatal urine is frequently diluted, the first void may be

missed, newborn metabolism differs from adult metabolism, and intrapartum medications can yield misleading positives.

When testing is warranted, cutoffs should be validated for neonatal and pediatric populations rather than adopted from workplace programs. Neonatal toxicology may be performed using urine, meconium, or umbilical cord tissue, and the choice of matrix affects the detection window.2 Urine generally reflects exposure in the hours to days before collection but can be difficult to obtain and is often diluted. Meconium and umbilical cord tissue largely capture third-trimester exposure; meconium can be more sensitive for certain drugs, whereas cord tissue is typically easier and faster to collect at delivery.Because discordant meconium and cord results are well described, findings should be interpreted cautiously and in clinical context.

Testing approaches vary by institution. Many laboratories screen neonatal and pediatric urines with an immunoassay and confirm only presumptive positive results by definitive mass spectrometry; presumptive negatives are typically not confirmed.2,5 Some pediatric centers bypass immunoassays and use direct liquid chromatography tandem mass spectrometry for selected pediatric patients, particularly when results may have significant clinical, legal, or child-protection implications or when broader analyte detection is needed. In

24 | JULY 2026 MLO-ONLINE.COM

2607MLO_24-27_EDU.indd 24

6/23/26 1:08 PM

Education :: Pediatric Cutoff Levels perinatal and neonatal care, definitive or direct confirmation testing is especially important because false positive or false negative results can meaningfully affect management and family outcomes.

Understanding Tier 1 and Tier II drug testing

In this article, Tier I refers to rapid immunoassay screening such as enzyme multiplied immunoassay technique (EMIT) or enzyme linked immunosorbent assays (ELISA). Because these assays have short turnaround times, they are useful for initial assessment and emergency triage; however, results are not definitive and may miss clinically important exposures due to assay limitations. Tier-I EMIT/ELISA urine drug screen results are therefore presumptive.3 Presumptive positives should be interpreted cautiously and confirmed with Tier-II testing when results could affect clinical management, disposition, or referral to social services or child protection. Tier II refers to definitive confirmation of Tier-I findings by gas chromatography mass spectrometry or liquid chromatography tandem mass spectrometry (GC-MS or LC-MS/MS), which offer higher analytical specificity and sensitivity for detecting drugs of misuse. Tier-II can also include a direct LC-MS/MS testing confirmation without prior immunoassay screening (see Table 1).

Qualitative and semiquantitative immunoassay Tier-I UDS remain widely used because they are practical, relatively inexpensive, and provide rapid screening in hospital laboratories, emergency departments, and point-of-care settings. Drug cutoff values are established according to the calibrator concentration used (see Table 2). Accordingly, neonatal and pediatric specimens may be validated and analyzed using lower cutoff thresholds than those applied to adult specimens.9 Many panels target amphetamines, benzodiazepines, barbiturates, cannabinoids (THC), cocaine metabolites, fentanyl, methadone, opiates, oxycodone, and tricyclic antidepressants.However, EMIT and ELISA assays can cross-react with structurally related compounds, producing false positive results.For instance, tricyclic antidepressant assays may cross-react with cyclobenzaprine or some antihistamines, and amphetamine assays may cross-react with drugs such as labetalol or venlafaxine. Conversely, limited assay sensitivity, high adult assay cutoff thresholds, or restricted drug menus can yield false negative results when clinically relevant drugs are present at low concentrations or outside the assay target profile in neonates and pediatric patients.4 Reducing the neonatal and pediatric UDS testing cutoffs in Tier I may result in decreasing false negative results, thereby favoring the definitive drug toxicity confirmation through mass spectrometry in Tier II.

Guidance from ADLM on clinically actionable drug testing

COMPLETE QC FOR RELIABLE HIL TESTING

ADLM QC WORKSHOP HIL MANAGEMENT: A CRITICAL QUALITY PRIORITY FOR LABORATORIES GUEST: AJAY SONIS, SR. LABORATORY MANAGER – CLINICAL CHEMISTRY AT YALE NEW HAVEN HOSPITAL DATE/TIME: WEDNESDAY, JULY 29, 2026, 14:45 – 15:15

LOCATION: THEATRE 1

The Association for Diagnostics & Laboratory Medicine, (ADLM) guidance emphasizes that urine drug testing should be clinically actionable and interpreted with clear knowledge of test menus, sample types, assay cutoffs and limitations.

Immunoassay results should be reported as presumptive or unconfirmed, with accessible cutoff information and interpretive comments addressing potential false positive and false negative findings. The guidance also recommends collaboration among laboratory professionals, clinicians, medical toxicologists, and poison control services to ensure that drug-testing menus reflect local drug-use patterns and patientcare needs. Although the document is focused on emergency

JOIN US AT ADLM 2026 (Booth #3 800) • July 26 th -30 th California •

randox.com

marketing@randox.com

MLO-ONLINE.COM JULY 2026 | 25 2607MLO_RandoxLaboratories_12v.indd 1

2607MLO_24-27_EDU.indd 25

6/3/26 1:23 PM

6/23/26 1:08 PM

Education :: Pediatric Cutoff Levels care, its recommendations are relevant to neonatal and pediatric testing when results may affect clinical management, disposition, or downstream social and legal decisions.5

Neonatal and Pediatric Drug Testing

Evidence supporting LC-MS/MS testing in pediatric patients

St. Louis Children’s Hospital assessed a one-step, broad spectrum LC-MS/MS method for drugs of misuse in pediatric patients, replacing the traditional immunoassay screen-and-confirm workflow.6 In the nursery cohort, only 40% of presumptive positive immunoassay compounds were confirmed by mass spectrometry, with immunoassays over detecting THC and under detecting cocaine exposure. After LC-MS/MS implementation, the nursery positivity rate decreased from 37% presumptive positive by immunoassay to 18% positive by LC-MS/MS, supporting the value of definitive, lower-threshold, broaderspectrum testing when neonatal or pediatric toxicology results may influence clinical or social decisions.

Perinatal and neonatal toxicology testing is evolving as laboratories aim to improve sensitivity, specificity, and detection of emerging novel psychoactive substances (NPS). Compared with traditional Tier-I immunoassays, Tier-II LC-MS/MS can expand compound coverage and increase diagnostic confidence in selected scenarios.

However, deploying rapid Tier-II mass spectrometry testing requires substantial infrastructure, including specialized instrumentation, trained staff, thorough assay validation, robust quality control, and ongoing maintenance.

Tier I: Initial Screen

Tier II: Direct Confirmation

Immunoassays: EMIT/ELISA

Mass Spectrometry: LC-MS/MS Without Initial Immunoassay Screening St. Louis Children Hospital6

Presumptive Results

*Negative

Positive

Tier II: Definitive Toxicity Confirmation *Confirming only presumptive positive UDS may miss false-negative results, especially when adult assay cutoffs are used. Thus, favoring more orders for definitive drug toxicity confirmation.

158605630 © Vasilyrosca | Dreamstime.com

Table 1. Neonatal and pediatric drug testing.

Drug class

Common adult UDS cutoffs used

Lower calibrator cutoffs available

Amphetamines

1,000 ng/mL

300 or 500 ng/mL

Benzodiazepines

200 ng/mL

100 ng/mL

Cannabinoids (THC)

50 ng/mL

20 ng/mL

Cocaine metabolite

300 ng/mL

150 ng/mL

Tricyclic antidepressants (TCA)

1000 ng/mL

300 ng/mL

Table 2. Drug assays available with lower cutoffs.

Cutoff approach

Advantages

Limitations

Practical use

Adult assay cutoffs

Rapid UDS immunoassays; widely available.

May miss low-level neonatal exposure. Adult cutoffs are too high for neonate UDS testing.

Useful only as a preliminary screen pending definitive mass spectrometry confirmation.

Neonatal assay cutoffs

UDS immunoassays may improve detection of low-level exposure and reduce false-negatives. Not too many available.

Not validated for every drug.

Lower cutoffs may increase false negatives favoring definitive drug confirmation.

Cutoffs used only when validated by the laboratory. No neonatal cutoff standards.

Matrix-appropriate cutoffs

Suited for urine, meconium, or umbilical cord tissue for different exposures.

Cutoffs and detection vary by laboratory, method, matrix, and analyte.

Preferred when evaluating prenatal or perinatal exposure in context.

Definitive and direct mass spectrometry (MS) cutoffs

Identifies individual drugs and drug toxicity.

Definite MS: To confirm presumptive positive results.

Direct MS: Drug confirmation without the screening phase.

More costly, slower if sent out, and limited to analytes included in the panel.

Use when results may affect care, discharge planning, family counseling, or child-protection decisions.

Table 3. Adult versus neonatal cutoffs in drugs of misuse.

26 | JULY 2026 MLO-ONLINE.COM

2607MLO_24-27_EDU.indd 26

6/23/26 1:08 PM

Education :: Pediatric Cutoff Levels Mass spectrometry–based testing has important limitations as well.Targeted methods only detect analytes included in the panel, and laboratories may differ in compound coverage and reporting cutoffs. Definitive turnaround time may also be extended when specimens are sent to reference laboratories.

Interpreting results in the context of medications

Neonatal toxicology interpretation should account for medications administered during labor, delivery, and newborn care.For example, fentanyl used for labor epidural analgesia can lead to positive maternal or neonatal toxicology findings.7 Likewise, drugs given directly to the newborn may later be detected in meconium or umbilical cord specimens. Accordingly, results should be reviewed alongside maternal medication history, delivery records, neonatal medication administration, and the clinical presentation.

Addressing standardization and equity in newborn drug testing

The literature also highlights the need for standardized protocols and attention

to potential inequities in newborn drug testing.Racial and ethnic disparities have been reported in neonatal toxicology testing and subsequent involvement of child protective services.8Laboratories and clinical teams should therefore ensure testing criteria are objective, standardized, and clinically justified.

Cutoffs for presumptive positive/negative classification and for triggering confirmatory testing should be appropriate for both adult and neonatal populations (See Table 3). Future developments may include expanded high-resolution mass spectrometry, improved detection of NPS, and more portable analytical platforms. Nevertheless, Tier-I immunoassays will likely remain widely used for initial screening in many institutions because they are simpler to operate and offer rapid turnaround times.

Conclusion

In summary, Tier-I immunoassay based toxicology testing remains a useful screening approach in perinatal and neonatal care, but results are presumptive and subject to analytical limitations.1,3,5 Definitive Tier-II GC-MS and LC-MS/MS testing provides greater

specificity and sensitivity and is particularly important when findings may affect patient management, neonatal evaluation, family counseling, or childprotection decisions.6 Method selection should reflect the clinical question, institutional resources, and an informed understanding of assay limitations and cutoff values used.

Faon Rodriguez, MS has over four decades of experience in clinical chemistry and research.

A former supervisor for AdventHealth Laboratories, he is enjoying retirement and per diem collaboration with chemistry instrumental validations at AdventHealth.

Dexter Charles Mangio, BSMT, MT(AMT), MLS(FL DOH) is a dedicated laboratory supervisor with over 20 years of professional experience in his field. A resident of Central Florida, Dexter enjoys spending his time outside of work with his family.

References are available online at mlo-online.com/55382195

Insight for Clinical Laboratory Professionals and Management

Scan the code to subscribe for free or renew your existing magazine subscription mlo-online.com/subscribe

MLO-ONLINE.COM JULY 2026 | 27

2607MLO_24-27_EDU.indd 27

6/23/26 1:08 PM

BEST PRACTICES :: LABORATORY SAFETY MANAGEMENT

203304191 © Shmeljov | Dreamstime.com

Best Practices :: Laboratory Safety Management

From GP17 to QMS28

Why CLSI reframed laboratory safety, and what it means for your program

By Jason P. Nagy, PhD, MLS (ASCP)CM,QLS

M

ost laboratory safety programs are built on the premise that if you follow the policies and procedures, nothing goes wrong. But anyone who has worked in a clinical laboratory knows that compliance alone does not prevent accidents. The lab’s safety culture, training programs, and knowledge of the hazards have a greater influence on risk reduction.

That is why solely relying on lagging indicators like injury reports and audit scores to judge your safety program rarely leads to improvements. The most impactful safety programs are the ones that seek out hazards and put steps in place before something happens. The Clinical Laboratory and Standards Institute (CLSI) recognized this need

and created a guide to move lab leaders from a reactive mindset to one that is more proactive. One where the lab recognizes the risks upfront and can create a system around those risks to keep them at bay.

Laboratory safety management

In 2025, CLSI took two very successful general procedures (GP), GP17-A3, Clinical Laboratory Safety and GP05A3, Clinical Laboratory Waste Management, and merged them into a new document with a different approach to safety. Enter QMS 28, Laboratory Safety Management. While these earlier guidelines were foundational to safe laboratory operations, they were structured separately, forcing laboratories to

cross-reference multiple documents to build a complete safety program. Labs were required to take different pieces of safety and try to make them fit as a whole, like trying to complete a puzzle using several different sets. By embedding safety within the Quality Management System (QMS) framework, CLSI has provided laboratories with a structure that replaces the splintered sections of safety into a more integrated system that supports the upfront risk management approach that is essential for continuous improvement.

QMS28 does more than just combine safety and waste elements into a single, cohesive framework. It aligns laboratory safety directly with the CLSI QMS model that incorporates safety in the pre-examination, examination, and post-examination phases of laboratory operations, also known as the laboratory path of workflow. CLSI realizes that hazards exist in every stage of laboratory testing, and keeping safety at the forefront is essential for success.

The QMS model is built from 12 Quality System Essentials (QSEs) elements (see Table 1). Each element is

28 | JULY 2026 MLO-ONLINE.COM

2607MLO_28-31_best.indd 28

6/23/26 1:08 PM

critical for a lab to be successful, and when one is missing, the laboratory path of workflow is in jeopardy. Having facilities and safety management included in the QMS model ensures that risk management is embedded in every stage of safety operations, rather than treated as a standalone function.

For laboratory leaders, this shift requires more than updating policies or procedures. It requires a change in perspective. Safety must be viewed not as an obligation, rather a system that can be designed, measured, and improved over time. This may involve rethinking how hazards are identified, and how labs prepare to handle the risks. CLSI made a small, but significant update in QMS28 to aid with this change in thinking. In Chapter 4 of QMS28, Planning for Safety, CLSI added the Identifying and Assessing Hazards section to highlight the importance of a risk assessment.

Before a lab can put steps in place to

The new guideline aligns laboratory safety with international standards such as ISO 15189, 15190, and the Global Harmonizing System (GHS), making it relevant to laboratories worldwide while supporting diverse regulatory environments. remove workplace hazards, the hazards must first be identified. The expanded risk assessment guide found in Appendix A not only offers a risk assessment form, but guides readers in proper risk identification and how to implement control measures that reduce the risk to levels appropriate for staff to work safely.

Perhaps one of the greatest advancements is not how this CLSI guideline can be used, but where. QMS28 expands beyond U.S. specific regulations like OSHA, NFPA, and EPA, to be adaptable across the globe. The new guideline aligns laboratory safety with international standards such as ISO 15189, 15190, and the Global Harmonizing System (GHS), making it relevant to laboratories worldwide while supporting diverse regulatory environments. Rather than prescribing country-specific recommendations, it provides a flexible framework that allows laboratories to apply core safety

2607MLO_28-31_best.indd 29

K-ASSAY ® Replacement Reagents for your chemistry analyzer

WHY SWITCH? Lower cost Expanded test menu Outstanding customer support

a-1 Microglobulin Anti-Streptolysin O Apolipoproteins: AI, AII, B, CII, CIII, E b-2 Microglobulin Complement C3, C4 CRP, hs-CRP Cystatin C D-Dimer Factor XIII Ferritin Fibrinogen H. pylori

Haptoglobin Hemoglobin A1c IgA, IgG, IgM Insulin Krebs von den Lungen-6 Lipoprotein(a) Microalbumin Prealbumin Remnant Lipoprotein Chol.

Rheumatoid Factor Transferrin UIBC

KAMIYA BIOMEDICAL COMPANY A

Group Company

www.k-assay.com 2507MLO_KamiyaBiomedical.indd 1

5/20/25 1:08 10:36 AM 6/23/26 PM

Best Practices :: Laboratory Safety Management principles within their local regulatory structure while still maintaining consistency in approach.

1

Organization and Leadership

7

Process Management

2

Customer Focus

8

Document and Records Management

Waste management

3

Facilities & Safety Management

9

Information Management

4

Personnel Management

10

Nonconforming Event Management

5

Supplier and Inventory Management

11

Assessments

6

Equipment Management

12

Continual Improvement

In GP05, waste was largely addressed through a regulatory lens. Laboratories were guided on classification, labeling, storage, and disposal, all essential components for compliance. Those elements remain in QMS28, but the framing has changed significantly.

By consolidating safety and waste management into a unified structure, QMS28 transforms waste handling into a controllable, auditable process within the broader laboratory system.

It shifts the priority from managing waste downstream to minimizing it upstream. Instead of focusing only on what happens after waste is generated, laboratories are challenged to ask more fundamental questions like “Why is this waste being generated in the first place?” and “What can we do to reduce the amount of waste we generate?”

This change in thinking aligns directly with the hierarchy of controls, prioritizing elimination and substitution over administrative and engineering controls.

Table 1. CLSI Quality System Essentials.

Direct observation

• Return demonstration • Observing staff perform a specific task

Assessment of knowledge

• Use of paper, oral, or computer-based exams/quizzes

Unannounced safety inspections

• Review of safety records • Visual observations • Casual conversations or interviews

Table 2. Methods of assessing competency.

cost burden on a laboratory. Therefore, while this change of focus can result in hazard reduction, there is also potential for cost savings. Laboratories are not just improving waste compliance; they are reducing risks in a meaningful and sustainable way.

Laboratories are encouraged to examine their chemical inventories, identify opportunities to replace hazardous substances with less dangerous alternatives, and redesign workflows to reduce waste generation at the source. Hazardous waste removal can be a significant

FREE MAGAZINE SUBSCRIPTION! 20223 2023 MARCH

• Vol 55 •

No 3 TM

The Peer-Aut

e for Lab

ls since 196 Professiona

hored Managem

ent Sour ce for

Lab Profession

als since 1969

9

MAGAZINE

RY

mlo-online.com/subscribe

WEBSITE

mlo-online.com PLUS

r or rect i ida E ellence Exc ology, w ed Path wer

Scan Here to Subscribe to our FREE Magazine

ntrol Quality co ging and emer ases dise infectious Page 14 opsy Liquid bi s workflow Page 34

NEWSLETTERS

Sign up for daily updates

FACEBOOK

MLOMedicalLaboratoryObserver

X (FORMERLY TWITTER)

@MedicalLabMLO

LINKEDIN

medical-laboratory-observer

30 | JULY 2026 MLO-ONLINE.COM 2607MLO_HealthCareLogisitcs_14sq.indd 1

2607MLO_28-31_best.indd 30

6/3/26 2607MLO_House_Subscribe_14sq.indd 8:31 AM 1

6/16/26 4:31 PM

6/23/26 1:08 PM

Best Practices :: Laboratory Safety Management Competency and education

Another critical advancement in QMS28 is how it reframes education and training. Traditional laboratory safety programs often rely on attendance-based metrics. Staff complete some required training sessions, they sign off on documentation, and move on. Again, while this approach satisfies regulatory expectations, it does not guarantee that safe behaviors are consistently practiced.

QMS28 moves beyond this outdated model by emphasizing demonstrated competence. Chapter 11 establishes a framework that links key moments in education like initial training, competency assessment, and ongoing/refresher training, into a continuous process.

The emphasis is no longer on “did the training occur,” but rather “do staff know how to work safely by demonstrating that on a daily basis.”

The emphasis is no longer on “did the training occur,” but rather “do staff know how to work safely by demonstrating that on a daily basis.”

To support this, QMS28 outlines practical methods for competency assessment, including direct observation, knowledge-based evaluations, and unannounced safety inspections (see Table 2). These assessment tools provide laboratories with real-time insight into how safety performance is actually affecting the lab, not just how it is intended to be.

There is little doubt that this shift has important implications for risk reduction. By evaluating competency continuously, laboratories can identify performance gaps before they lead to incidents.

Instead of reacting to events after they occur, leaders can intervene earlier with targeted coaching, retraining, or process adjustments. Over time, this creates a more resilient safety culture, one that reinforces safe behaviors rather than relying on policy enforcement.

is proactive, measurable, and sustainable. The challenge moving forward is implementation. Laboratories that embrace this systems-based approach may be better positioned to manage risk, support their staff, and adapt to evolving regulatory and operational demands.

The most important change introduced

by QMS28 is not structural, it is cultural.

It shifts the focus from what we tell people to do, to what our systems enable them to do consistently. And in a field where small failures can accumulate into

significant risk, that shift is not just nice to have, it is necessary.

Jason P. Nagy, PhD, MLS (ASCP)CM,QLS is the Laboratory Safety Support Coordinator at Sentara Health, a multi-hospital system in Virgina and North Carolina. Jason brings almost 20 years of laboratory experience to the lab as a medical laboratory scientist (MLS) and more recently in laboratory safety and education roles.

SAFE SOLUTIONS Even with minimal tube volumes, the potential for injury from manual decapping or manual recapping is a real possibility

DECAPPING

RE

C AP

PI N G

Make your goal ZERO repetitive stress injuries From the leader in bench-top solutions for automated decapping and recapping Visit our website for additional information LGPlabautomation.com

1.877.251.9246

Moving forward

QMS28 does not simply replace two legacy documents. It reframes laboratory safety as a core component of quality management. It provides a roadmap for moving beyond compliance towards a model of safety that

You have known about our Pluggo™ decappers Now available; KapSafe™ Recappers in several models to fit any volume needs

Accommodates all major tube sizes and a variety of analyzer racks

Serving laboratories since 2002 | Contact us for literature and sales information sales@LGPlabautomation.com

MLO-ONLINE.COM JULY 2026 | 31 2607MLO_LGPConsulting_12i.indd 1

2607MLO_28-31_best.indd 31

6/8/26 10:27 AM

6/23/26 1:08 PM

MOLECULAR DIAGNOSTICS :: CYTOLOGY EDUCATION

Molecular Diagnostics :: Cytology education

New opportunities in cytology education

By Lois E. Rockson, PhD, MPH, MAHEd, SCT(ASCP)

T

move to graduate-level education is the latest advancement in the education of cytologists, a profession recognized historically for its morphology-based, diagnostic skills.4 With increased demands for advanced diagnostic testing and expansion of roles in laboratory practice, there are new opportunities for innovation in cytology education at a time when the demand for cytology practitioners is increasing.

Graduate level education for cytologists

In 2023, the American Society of Cytopathology’s (ASC) Cytology Program Review Committee (CPRC) mandated that all Commission on the Accreditation of Allied Health Professions (CAAHEP) accredited cytology education programs begin providing master’s-level cytology education programs.5 The “move to the masters” as it is often referred

22626796 © Anyaivanova | Dreamstime.com

he current education of cytologists is a far cry from its humble beginnings.1 Emerging in the late 1950s shortly after the founding of the cytology profession by Dr. George Papanicoloau, cytotechnologists, typically medical technologists, were often recruited in hospitals and medical centers and trained by pathologists. During the 1960s, more structured and formalized education systems were established. 2 Over the last forty to fifty years, the structure of cytology education programs has undergone a tremendous change, with certificate, undergraduate, and graduate programs offered in hospitals and universities. 3 Cytology education programs now deliver education through innovative ways, such as satellite campuses and online programs, with dynamic teaching modalities, such as the incorporation of virtual microscopy in teaching. The

to, centered on curriculum changes designed to prepare cytologists for their expanding scope of practice. One important part of the transition was a name change of the profession from cytotechnologist to cytologist, reflecting roles of higher-level critical thinking more so than performing routine diagnostic testing. While cytology is still primarily a morphology-based practice, cytologists are increasingly performing molecular and other diagnostic tests, including immunohistochemistry, digital pathology, and computer-based image analysis. As critical thinkers, cytologists are ideal for partnering with pathologists on research and other projects leading to evidence-based practice, while becoming leaders in laboratory and pathology practice and impacting and improving patient care and outcomes.

The foundation of the new graduate-level curriculum includes cognitive, affective, and psychomotor learning domains focusing on knowledge, professionalism, and physical practice (e.g., using a microscope, hand pipetting). These domains have always been central to cytology education curriculum, but now graduate coursework in research methods, companion technique applications, and professionalism rooted in the domains is included. Cytology education programs are required to convert programs to the graduate level by 2031. The shift to graduate-level programs was not without some degree of controversy.

One major concern is the decline in the number of educational institutions educating cytologists. Currently, there are 17 US CAAHEP-accredited cytology programs, a decline in number from the over one hundred education programs that existed in the 1970s through 1980s.6 Concerns on the ability of hospital-based programs to restructure, ongoing issues with recruitment, and increasing tuition costs were raised during conversations and discussions on the proposal of the move. It was clear, however, that with changes in professional practice and the increasing demand for the cytologist skill set, a master educated laboratorian was needed. With that, cytology

32 | JULY 2026 MLO-ONLINE.COM

2607MLO_32-35_Molecular.indd 32

6/23/26 1:08 PM

We Have Always Been Here for Your Urinalysis Needs Visit Us at ADLM Booth #1511

A Fully Automated Solution to Your Needs AUTION Bridge System AX-4510 + AX-4060

Complete Urinalysis, Connected.

SEMI-AUTOMATED URINE ANALYZER

AUTION ELEVEN

™

AE-4022

Minimal Effort, Reliable Results.

High Productivity, Proven Technology

877.538.8872 • corelab@arkrayusa.com • www.arkrayusa.com

2607MLO_Arkray_FP.indd 1 2607MLO_32-35_Molecular.indd 33

AN-2871-v1 Rev. 06/26

6/9/26 4:24 6/23/26 1:08 PM PM

Molecular Diagnostics :: Cytology education programs began tailoring education modalities and teaching practices for the next frontier of cytology education.

Education modalities

New frontiers require innovation.

Cytology education programs are actively considering how to implement innovative education methods and the delivery of curriculum in shifting higher education environments. There are four primary models of cytology education programs: traditional, hybrid, satellite, and online. Historically, cytology education occurred in brick-and-mortar institutions, in laboratories, and in colleges and universities across the country. Traditional, in-person programs at colleges and universities are still the primary type of cytology education programs in the United States, comprising 13 of the existing 17 accredited programs.

Traditional programs typically draw students from local and regional colleges and universities, but also an increasing number of international students, as is our experience. Recruitment typically involves partnering with local and regional institutions to establish pathway programs. Graduate-level education partnerships may be more challenging to implement than undergraduate and certificate programs but are nevertheless important to consider as programs convert to graduate degrees.

Hybrid or blended cytology education programs educate cytologists in more than one way. The two main methods are in-person and online (live and/or asynchronous). This model allows flexibility in scheduling for both faculty and students, but there are differences in teaching as well as learning. For example, online asynchronous coursework requires increased self-directed learning that many students may find challenging. Faculty, accustomed to the dynamics of classroom and laboratory teaching now use online discussion boards and chats as teaching tools.

Satellite education programs have emerged as innovative models for cytology education delivery. CAAHEP defines satellite programs as those occurring in off-campus locations, providing both theoretical and laboratory required program content.7 These programs are ideal for providing education in spaces where access to cytology education is lacking. Various teaching strategies have emerged under the satellite campus model, with some programs providing synchronous lectures

by Zoom or other remote technologies

and providing microscopy instruction by mailing glass slides to off-site locations or using virtual microscopy.8 The newest program model is that of solely online education. While no CAAHEP-accredited programs yet exist, there are those on the horizon.9 Similar to the satellite programs, online programs fill the gap of avoiding traditional brick and mortar infrastructure, reaching students where they live. These programs will be charged, however, with delivering all components of the required cytology education curriculum with the same level of quality and reliability that longer-standing education models have achieved.

Regardless of the education model, all programs will now have to tackle the ever-changing technological landscape both in education and cytology practice, demands that faculty hold advanced education degrees, and competition with other career opportunities available for biology and other science degree holders.10

Opportunities for partnership

As mentioned before, the demand for cytology practitioners is increasing while the number of new program graduates is critically low.11 Partnering with colleges and universities, introducing the cytology career to high school students, and collaborating with laboratories to identify bright, lower-level skilled laboratory professionals (cytopreparatory technicians) who may be ideal for cytology careers are just some examples of opportunities to recruit to the profession. One new and exciting possibility for partnerships is through the development of apprenticeship programs through the United States Department of Labor (USDOL). The USDOL has active and robust healthcare apprenticeship programs offering a mechanism to address the workforce shortage while providing support to those in the program. The Rutgers MS Diagnostic Cytopathology program recently became a registered apprenticeship program, providing opportunities to recruit to the program in a unique and dynamic way.12 Programs pivoting to graduate-level education are bound to seek opportunities such as these to ensure stability, expansion of the cytology workforce, and success into the future.

Closing remarks

As cytology education programs look to the future, it will be imperative that education missions, regardless of education

modality, remain rooted in preparing competent cytologists who are highly skilled and valued members of patient care teams. Through collaboration, partnership, and innovative education and teaching models, cytology education programs are bound to continue in the success instituted by the pioneers of cytology education almost a century ago.

REFERENCES 1. Kendall RE. An aid in the teaching of cytology. Tech Bull Regist Med Technol. Apr 1962;32:73–4.

2. Karp R. Perceptions of the impact of baccalaureate degrees for cytotechnologists.

Acta Cytol. 1979;23(4):347–51.

3. Donnelly A, Sturgis C, Goulart R, Sheldon D, Atkison K. Editorial: The evolution of a profession through education: cytotechnology training program curriculum revisions in the United States. J Am Soc Cytopathol. 2021;10(5):459–464. doi:10.1016/j. jasc.2021.06.001.

4. Atkison K, Goulart R, Wilbur D. Forward march: Master’s degree here we come. ASC Bull. 2018;55:7–11.

5. Standards and Guidelines: Cytotechnology. Commission on Accreditation of Allied Health Education Programs.

Accessed May 28, 2026. https:// www.caahep.org/program-directors/ standards-and-guidelines.

6. Find an Accredited Program. Cytology.

Commission on Accreditation of Allied Health Education Programs. Accessed May 28, 2026. https://www.caahep.org/students/ find-an-accredited-program.

7.

A Glossary of Accreditation Terms. Commission on Accreditation of Allied Health Education Programs. Accessed May 28, 2026. https://www.caahep.org/accreditation/ accreditation-glossary.

8. Mukherjee MS, Donnelly AD, DeAgano VJ, Lyden ER, Radio SJ. Utilization of virtual microscopy in cytotechnology educational programs in the United States. J Pathol Inform. 2016;7:8. doi:10.4103/2153-3539.177682.

9. Master of Science in Cytology. Arizona State University. Accessed May 28, 2026. https:// asuonline.asu.edu/online-degree-programs/ graduate/cytology-ms/.

10. Rockson L. Cytotechnology schools: Future outlook. Diagn Cytopathol. Aug 2024;52(8):407–412. doi:10.1002/dc.25281.

11. Satturwar S, Compton M, Miller D, et al.

American Society of Cytopathology’s cytopathology workforce survey in the United States. J Am Soc Cytopathol. 2025;14(2):65– 77. doi:10.1016/j.jasc.2024.12.003.

12. Apprenticeships. United States Department of Labor. Accessed May 28, 2026. https:// www.dol.gov/agencies/eta/apprenticeship.

Lois E. Rockson, PhD, MPH, MAHEd, SCT(ASCP) is an Associate Professor, Department of Clinical and Medical Imaging Sciences, Rutgers School of Health Professions in Newark, New Jersey and the Program Director, MS Diagnostic Cytopathology Programs.

34 | JULY 2026 MLO-ONLINE.COM

2607MLO_32-35_Molecular.indd 34

6/23/26 1:08 PM

W H AT W E DO WH

OEM and private-label quality control and proficiency products

Two trusted names.

One commitment to your lab.

Native and recombinant proteins and enzymes Contract design & manufacturing services Research and development services

With 40+ years of experience serving laboratories worldwide, Aalto Scientific and AUDIT MicroControls deliver complete solutions for today’s labs.

Together, we’re driven by one goal: Delivering the quality, reliability, and responsiveness labs need.

Linearity and Calibration Verification products Daily Quality Control solutions Free online data reduction Fast, personal technical support

2607MLO_AUDITMicroControls_FP.indd 1 2607MLO_32-35_Molecular.indd 35

1-800-748-6674

1-866-252-8348

www.aaltoscientific.com

www.auditmicro.com

sales@aaltoscientific.com

customerservice@auditmicro.com

6/22/26 6/23/26 4:50 1:08 PM PM

PRODUCT FOCUS - SPECIMEN COLLECTION

Product Focus - Specimen Collection

Efficacious urine collection & transfer device Choyce Products’ new RNC-400 urine collection and transport container is one of the safest, most efficacious urine collection and transfer devices. The container contains a recessed needle and a safety-engineered infection control lid to cover the needle aperture. This is the only cup that meets OSHA/CDC requirements for protective sharps safety.

Choyce Products

Mix with confidence. Collect with precision.

The GENESIS Blood Collection Mixer (Model# CM735A) from Globe Scientific provides continuous, uniform mixing of blood with anticoagulant during collection procedures. Its controlled mixing action and dependable performance enhance process consistency while supporting donor safety. Built for durability and ease of operation, it is ideal for fixed and mobile blood collection environments where accuracy, reliability, and efficiency are essential.

Globe Scientific

Safe and hygienic needle-free urine transfer NFT is a closed system for needle-free urine transfer. Needle-free containers feature an integrated transfer unit with pierceable membrane. Following collection with the Urine Monovette using a syringe technique, the membrane reseals ensuring hygienic sample collection. The Urine Monovette then acts as a primary tube for transport, analysis and centrifugation.

SARSTEDT

Low volume, high impact blood tubes

Specimen collection + transport with Puritan

VACUETTE Low Volume Blood Collection Tubes from Greiner BioOne are used for the collection, transport, and processing of blood in the clinical laboratory.

Available in a range of additive types with draw volumes from 1mL to 2.5mL, low volume tubes support patient blood management efforts and reduce unnecessary blood loss.

Greiner Bio-One

Puritan Dry Transport Systems feature sterile swabs, including patented flock and a variety of tip fibers, shapes, and sizes for nasal, nasopharyngeal, throat, and other collection sites. Each swab is packaged with a sterile transport tube to securely transport specimens. Visit us at ADLM Booth #1561.

Puritan Medical Products

Secure specimen storage The Over the Door Lock Box (3737) secures lab specimens and samples awaiting pickup by couriers, nurses or technicians. The metal box features a key lock with two keys, foam-lined interior and hanging hardware. Custom labels and magnets (sold separately) are available for content identification and handling instructions.

Health Care Logistics

Moisture damage resistant cryogenic lab labels The original CryoLabel permanently adheres to glass vials, test tubes, and plates. It easily handles cryogenic temps and LN2 exposure. CryoLabel can adhere to already frozen surfaces. It will resist moisture through repeated freeze and thaw cycles. Sticks well around curves of tight diameter vials. Available in custom and very small sizes.

Electronic Imaging Materials

36 | JULY 2026 MLO-ONLINE.COM

2607MLO_36_prod.indd 36

6/23/26 1:08 PM

Side Activated Safety Lancets

Gentle 30G

The Smart, Comfortable Choice for Capillary Sampling Unistik® 3 Safety Lancets provide solutions for nearly all of your capillary sampling needs. Designed with both you and your patients in mind, Unistik® 3 delivers comfort, reliability, and ease of use.

• Multiple Gauge Sizes & Depths to match virtually every need • Comfort Zone Technology® helps minimize pain for patients1 • Permanently Retracts for added safety and reduced risk Available on contract with major GPOs—plus aggressive contracting and incentives available.

Discover the Value of Unistik®.

Scan to Get a Free Value Analysis!

1. Melzack R, Wall PD. The challenge of pain. Penguin. Harmondsworth. 1982 p233 U3AD25/OMI/0725/1/US

For more information, Visit owenmumford.com/us

2607MLO_OwenMumford_FP.indd 1 2607MLO_36_prod.indd 37

6/11/26 6/23/26 4:43 1:08 PM PM

LAB INNOVATOR :: LABORATORY CYBERSECURITY

LABORATORY

INNOVATOR

Phil Englert is the VP of Medical Device Security at Health ISAC, where he works with medical device manufacturers to strengthen privacy and security while partnering with healthcare delivery organizations to ensure those solutions are practical, deployable, and clinically aligned. He also defines long term vision, leads cross sector initiatives, advances best practices, and delivers programs that improve sector resilience and serves as a subject matter expert and contributor to Health ISAC’s Medical Device Security Council (MDSC). Phil leads Health ISAC’s strategy to strengthen cybersecurity and privacy across the global medical technology ecosystem.

This role directs the organization’s medical device security program, partnering with manufacturers and healthcare delivery organizations to drive practical, secure implementations while shaping regulatory and standards. Phil oversees coordinated vulnerability disclosure efforts with researchers, regulators, and government agencies, and serves as a subject matter expert to the 500-member Medical Device Security Council.

What cybersecurity risks are most unique to laboratory environments compared to other healthcare settings and are labs often overlooked in enterprise security strategies?

Three major risks are as follows: • Legacy instruments — while core lab instruments such as chemistry, hematology, coagulation and increasingly immunochemistry tend to be newer due to the increasing types of assays they can run, other specialty analyzers supporting non-core functions, such as blood

Cybersecurity in the lab

By Christina Wichmann gas, urinalysis, microbiology, flow cytometry, and others may be dated and lack today’s commonly applied security controls.

• Clinical diagnostic analyzers are often supplied through creative funding mechanisms where the operator does not own the devices and have limited say in what controls can be applied, how often they are updated, and if cyber resilience and updating are included in the agreements. These vendor‑managed systems can be a blind spot for healthcare organizations.

• Considering that a small facility laboratory may have 6–8 diagnostic specialties and a large academic or reference lab may support 20 or more specialty departments, the vast array of LIS middleware and interfaces needed to keep data flowing from intake to reporting requires significant work to secure, maintain, and update. The update cycles for disparate components maintained by different parties may not align resulting in development and patching application delays that extend the exposure period of known or even exploited vulnerabilities.

Can you share real‑world examples of how a cyber incident or IT disruption directly affected lab operations, turnaround times, or diagnostic accuracy, and what the downstream impact was on patient care?

A few examples are as follows: In April 2025, a large national laboratory provider reported that a ransomware group gained access to a laboratory database containing patient information, highlighting the vulnerability of laboratory databases as high‑value targets, which may be overlooked in broader health system security architectures.

While interim measures were implemented to allow for the restoration of certain functions, the lab could not estimate the duration or extent of the disruption.

A Netherlands lab was hit with a data breach and ransomware in July 2025 where hackers gained access to 850,000 patient records, demonstrating the scale

of impact when labs systems are compromised. Lab services were suspended while an independent investigation into the IT security systems was conducted resulting in delayed diagnostics.

The FDA issued a warning for a genetic sequencing device regarding a vulnerability that could allow intruders to access or alter genomic information intended for clinical diagnosis and could cause the instruments to provide incorrect results or no results at all.

The company recently agreed to pay a $9.8M settlement. “Failure to adhere to required cybersecurity standards can result in significant damage,” stated a law enforcement officer.

How should laboratory leaders rethink their approach to cybersecurity, from trying to prevent every incident to ensuring continuity of diagnostics when disruptions inevitably occur?

Increasingly, cybersecurity discussions are focused on resilience to include not just protective measures but how to minimize disruptions and restore clinical operations quickly. The best way to do this is to lean into the equipment operators. They are in the best position to identify glitches and anomalies that may indicate a cyber event. Empower them for the Toyota moment when they can hit the stop button and verify nothing is amiss.

The FDA recognizes cyber weaknesses and vulnerabilities as a quality issue. Anytime someone can cause your equipment to operate in an unexpected manner, to cease operating, or impact data integrity, there is a quality issue in the code, configurations, and controls, which were not designed correctly to block that event. Segment the LIS system architecture in such a way that ransomware affecting HR, finance, or email systems from halting diagnostics. Cyber response is focused on containment, not immediate diagnostic continuity.

If a lab has limited budget and staff, what are the top two or three security or resilience improvements that deliver the most immediate risk reduction?

• Ensure LIS configurations, test dictionaries, and historical results are recoverable without network dependency. UC San Diego’s Cen-

38 | JULY 2026 MLO-ONLINE.COM

2607MLO_38-39_lab.indd 38

6/23/26 1:08 PM

Lab Innovator :: Laboratory Cybersecurity ter for Healthcare Cybersecurity unveiled Project CRASHCART — a “hospital IT system in a box” built to restore critical digital infrastructure after ransomware strikes: https://cyberhealth.ucsd.edu/ media-hub/in-the-news.html. The clinical lab is an ideal application for this or similar technologies as lab results support so many other critical patient care workflows.

• Testing downtime workflows; including manual accessioning, result entry, and verification during department meetings or section huddles enables staff to rehearse the exact steps they’d take under pressure, reducing hesitation and errors during real outages, and identifying process gaps early.

• Cybersecurity tabletop exercises (TTXs) are only effective in healthcare when they are intentionally optimized for the clinical reality of tight schedules, competing priorities, patient care risk, and regulatory pressure. Keep them short, focused, and predictable — scoping one operational stress point at a time. Hold them frequently to

turn thought processes into muscle memory, faster decision making, and organizational trust. Center on leadership decisions. Cyber risk is operational risk so surface decisions leaders will face. Resist fixing things and focus on remaining clinical capacity. ‘What care do we continue, modify, or stop right now?’ ‘What do we communicate to whom?’ Key participants should include the lab director and section leaders, nursing leadership, medical director, IT operations, risk management, and IT security as advisors.

Communications-focused TTX should be top of list. Role clarification, authority, and escalation paths are essential for the alignment of operational, clinical, and executive messaging to reduce hesitation and oversharing. Optimized TTXs demonstrate that downtime procedures, incident command structure, and communication channels exist. Capture three to five actionable insights and commit to working them before the TTX. Three to six, 60–90 minute operational rehearsals each year can add real value without disrupting care.

Where are lab directors most likely unaware of their biggest operational or cybersecurity vulnerabilities, and how can they better assess risk without needing deep IT expertise?

One blind spot may be the sheer number of interfaces that exist in the connected clinical laboratory environment. Each boundary must be inventoried and the PHI flow mapped as indicated in the proposed changes to the HIPAA security rules. These interfaces include external connections whether for remote servicing, order entry and reporting, or data transfers to public health monitoring agencies.

In addition, artificial intelligence (AI) tools can significantly increase insider threat risk by amplifying capability, speed, and opacity in ways traditional controls were not designed to handle. AI excels at summarization, transformation, and pattern extraction making large data sets more attractive and more accessible.

FDA explicitly recognizes cybersecurity as a patient safety and data integrity risk. Diagnostic systems can be technically functioning but clinically untrustworthy.

COACHING CORNER with Patty Eschliman, MHA, MLS(ASCP)DLM, CPC

In Coaching Corner, you are invited to ask questions about anything related to teamwork, leadership and personal growth.

Teamwork:

How should I deal with a toxic co-worker?

How can I stay positive when the team seems so negative?

How can I ensure our ideas are heard by leadership?

Leadership:

How do I hold that difficult conversation?

What can I do to change the culture of my team or my organization?

What skills are needed to build a cohesive team?

Personal growth:

What do I need to do to get ahead? How can I ask for a raise?

How can I increase my strengths and work with my weaknesses to be more successful?

What do I need to do to ensure I get that promotion or new job?

Send your questions to editor@mlo-online.com Patty’s answers to your confidential questions will be published in the September 2026 issue.

2605MLO_House_CoachingCorner_12h.indd 1

2607MLO_38-39_lab.indd 39

| 9:08 AM MLO-ONLINE.COM JULY 2026 4/14/26 39

6/23/26 1:08 PM

CLINICAL SPOTLIGHTS

Clinical Spotlights

Alinity ci-series

AUTION Urinalysis Solution Abbott’s Alinity systems are flexible and scalable with an increased throughput and capacity, allowing you to easily add modules as volume grows without having to replace your systems.

Smart transfer systems allow for a compact footprint while allowing full automation through consolidation. The AUTION EYE can be operated stand alone or connected to the AUTION MAX series—resulting in a very small footprint (41.9” x 25.6” x 23.6”).

Abbott Visit us at ADLM booth # 2101

ARKRAY USA Inc. Visit us at ADLM Booth #1511

Your Source for Diabetes Antibody Kits

Better HbA1c Results. Clearer Confidence.

The KRONUS 3-Screen Islet Cell Autoantibody ELISA Kit (KR7780) is for the simultaneous and non-differential detection of autoantibodies to GAD and/or IA-2 and/or ZnT8 in a simple, highlyrobust, and user-friendly assay format.

Unmatched resolution delivers clearer results and superior Hb variant detection with easyto-interpret patterns.

Built-in safeguards ensure confident reporting, while a single automated platform consolidates HbA1c, hemoglobin, and myeloma testing for efficient, walk-away workflow.

KRONUS, Inc.

Sebia, Inc — Visit us at ADLM booth # 1139

Streamline Proficiency Testing Effortlessly upload results from your LIS and eliminate the #1 cause of PT failures— clerical errors.

• No changes to your firewall or security • No interface required or software to install • No additional fees—API DataDirect is free

Join the nearly 10 million results uploaded utilizing API DataDirect!

American Proficiency Institute

Linearity LQ Osmolality Linearity LQ Osmolality is intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for Osmolality.

AUDIT MicroControls

Visit us at ADLM booth #1309

Introducing the Sysmex XR-Series™

Untitled-1 1

You R why we never stop Improving The next generation of automated hematology — engineered for highcomplexity labs that demand uncompromising accuracy, expanded parameters, and throughput that boosts the clinical story.

Sysmex.com/ADLM — Visit us at ADLM booth # 2701

GR01 HPLC A1c Analyzer

6/9/26 10:50 AM

Tosoh’s GR01 HPLC A1c Analyzer is a fully automated analyzer that harnesses Tosoh’s proprietary non-porous ion exchange HPLC column technology to deliver accurate, reproducible A1c results in just 50 seconds — while also detecting the most common hemoglobin variants. The GR01 delivers excellent precision with CVs ≤ 1.1% (NGSP Units).

Tosoh — Visit us at ADLM booth #4000

40 | JULY 2026 MLO-ONLINE.COM

2607MLO_40-42_spotlight.indd 40

6/23/26 1:08 PM

In partnership with

REAL people.

REAL relationships. REAL conversations.

Connecting hospital lab leaders with peers, companies and products Join us for two days of roundtables, networking and solution-based conversations

September 14-16, 2026 | Tucson, Arizona LabDirectorsSummit.com

2607MLO_House_Labs26_FM.indd 2607MLO_40-42_spotlight.indd 41 1

5/27/26 AM 6/23/26 10:47 1:08 PM

Clinical Spotlights

Efficiency in every test.

Trust in every result.

Safe Sampling, Simplified

The Complete Hemostasis Solution features the new ACL TOP Family 70 Series systems, one comprehensive HemosIL reagent menu, HemoCell Specialized Lab Automation and HemoHub Intelligent Data Manager, and specialized service and customer care.

Werfen - Hemostasis — Visit us at ADLM Booth #2937

Revolutionizing healthcare with clinical mass spectrometry Mass spectrometry is revolutionizing healthcare by providing more precise and reliable diagnostics.

This innovative technology accurately measures complex biological samples, offering valuable insights to healthcare professionals.

Roche— Visit us at ADLM booth # 2901

Unistik® Pro Plus safety lancets deliver simple, reliable capillary blood sampling with adjustable depth settings, one-touch activation, and automatic needle retraction. Designed for comfort, safety, and reliability, they help support consistent sample collection while helping to reduce needlestick injury risk.

Owen Mumford — Visit us at ADLM booth # 2419

Simple. Fast. Trusted.

LIAISON NES® enables non-laboratory staff to consistently get accurate results for respiratory illnesses in ~15 minutes.

It’s a simple device that’s easy-to-learn, easy-to-use, and easy-to-maintain.

LIAISON NES® | Diasorin Visit us at ADLM booth # 1701

INDEX OF ADVERTISERS Advertiser........................................................................Web........................................................................................................ Page Abbott Diagnostics.........................................................diagnostics.abbott/us/en/home.html...................................................... C3 American Proficiency Institute (API).............................api-pt.info/off-schedule...............................................................................7 Arkray..............................................................................arkrayusa.com...........................................................................................33 AUDIT MicroControls.....................................................auditmicro.com..........................................................................................35 Diasorin...........................................................................diasorin.com/liaison-nes...........................................................................21 Health Care Logistics......................................................GoHCL.com................................................................................................30 Kamiya Biomedical Company, LLC...............................kamiyabiomedical.com.............................................................................29 Kronus.............................................................................kronus.com................................................................................................13 LGP Consulting...............................................................lgplabautomation.com..............................................................................31 Owen Mumford...............................................................owenmumford.com/us..............................................................................37 Randox Laboratories......................................................randox.com................................................................................................25 Roche Diagnostics Corporation.....................................ADLM.Roche.com......................................................................................17 Sebia................................................................................sebia.com................................................................................................... 11 Sysmex America.............................................................sysmex.com/ADLM.................................................................................. C4 Tosoh Bioscience............................................................tosohbioscience.com...................................................................................3 Werfen - Hemostasis......................................................70series.werfen.com................................................................................ C2 This index is provided as a service. The p­ ublisher does not assume liability for errors or omissions.

42 | JULY 2026 MLO-ONLINE.COM

2607MLO_40-42_spotlight.indd 42

6/23/26 1:08 PM

Spend less time chasing down samples.

Find more time for what matters.

If a hospital performs one million tests per year and loses one in 1,400 tubes1 at a cost of $400–600 per tube2, then the annual cost could be as much as $428K—not to mention the burden on patients and hospital.

Since implementing AlinIQ Indexor, the lab at Mercy Hospital Southeast has not lost a single sample. Now they can trust their tracking and focus on results.

REDEFINE YOUR DAY. AlinIQ Indexor integrates seamlessly into existing laboratory environments and operates independently of current analyzers.

SEE HOW ALINIQ INDEXOR WORKS FOR MERCY HOSPITAL SOUTHEAST

The views and opinions expressed in this testimonial are those of Mercy Hospital Southeast. Any results, findings or conclusions are reflective of the customer’s experience and should not be considered a product claim. Individual results may vary, and this testimonial is not intended to represent or guarantee that any laboratory will achieve the same or similar results.

1

Sandbank, Sharon, Doron Klein, Melvyn Westreich, and Avshalom Shalom. “The Loss of Pathological Specimens: Incidence and Causes.” Dermatologic Surgery, vol.

36, no. 7, 2010, pp. 1084–1086. https://pubmed.ncbi.nlm.nih.gov/20533941/.

2

Osterweil N. Cost of laboratory errors a “real eye‑opener.” Medscape Medical News. Published March 8, 2016. Accessed April 29, 2026. https://www.medscape.com/viewarticle/868957.

© 2026 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. CORE‑26003569 06/26

2607MLO_AbbottDiagnostics_FP.indd 1 2607MLO_C1-C4.indd 3

6/10/26 AM 6/23/26 10:15 1:18 PM

ADLM Booth #2701 Sysmex.com/ADLM

YOU R WHY WE NEVER STOP IMPROVING. R ESULTS-DRIVEN

R IGHT-SIZED

R ELIABLE

Introducing the XR-Series™ The next generation of automated hematology — engineered for highcomplexity labs that demand uncompromising accuracy, expanded parameters, and throughput that boosts the clinical story.

CentralOps™ Command Center Gain real-time visibility across every instrument and site simultaneously — because managing a modern lab means you can’t afford to be the last one to know when something needs your attention.

CN-9000™ Hemostasis Solutions Reliable comprehensive coagulation testing with the throughput and dependability critical care and specialty labs require — fully integrated into the Sysmex ecosystem for seamless patient data continuity.

©2026 Sysmex America, Inc.

2607MLO_SysmexAmerica_FP.indd 1 2607MLO_C1-C4.indd 4

6/2/26 6/23/26 11:27 1:18 AM PM