Medical Laboratory Observer - August 2026

August 2026 MLO-online.com

TM

The Peer-Authored Management Source for Lab Professionals since 1969

LAB INNOVATOR

Nichole Howard, MBA Chief Executive Officer Diagnostica Stago North America

PLUS

State of the Industry: Disease Management Page 22

UNIVANTS of Healthcare Excellence Winners Page 18

CE:

Essential functions

in U.S. phlebotomy programs Page 8

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F ROM T HE EDITOR

AMR: The laboratory matters more than ever

A

ntimicrobial resistance (AMR) has often been described as a “silent pandemic”—one that doesn’t dominate daily headlines but continues to reshape healthcare in profound ways. Every day, clinical laboratories generate the data that guide physicians toward the right therapy, help infection prevention teams identify emerging threats, and support antimicrobial stewardship efforts designed to preserve the effectiveness of the drugs we still have. As AMR continues to evolve, so too does the laboratory’s role.

This month’s MLO SOI survey offers a snapshot of

By Christina Wichmann where laboratories stand today. Many respondents reported performing large volumes of antimicrobial Editor in Chief resistance testing, while others acknowledged they don’t track testing volume or are unsure how much testing is being performed. That finding alone is telling. It reflects the reality that AMR programs vary tremendously depending on laboratory size, resources, patient populations, and available technology. Yet regardless of these differences, every laboratory contributes valuable information to the broader effort to detect and contain resistant organisms.

Our survey also highlights a profession in transition. Traditional culture-based antimicrobial susceptibility testing remains the backbone of microbiology laboratories, but molecular resistance testing continues to gain momentum. Rapid PCR, automated susceptibility systems, MALDI-TOF, and emerging rapid phenotypic methods are helping laboratories shorten turnaround times and provide clinicians with answers sooner than ever before. At the same time, laboratorians recognize that speed alone is not enough. As several experts in this issue note, genotypic and phenotypic testing answer different—but equally important—clinical questions.

The future will depend on integrating these approaches to provide faster, more complete, and more actionable information.

Recent scientific literature suggests that the next phase of the fight against AMR will require an even broader perspective. Researchers increasingly emphasize that combating resistance will depend not only on discovering new antibiotics but also on advancing rapid diagnostics, artificial intelligence-assisted drug discovery, bacteriophage therapy, antimicrobial peptides, CRISPR-based technologies, and other innovative therapeutic approaches. Equally important is the continued expansion of antimicrobial stewardship in healthcare organizations.

Perhaps the most encouraging message emerging from both our survey and the latest research is that the laboratory is becoming even more central to the solution.

The value of diagnostic testing is no longer measured solely by identifying an organism. Increasingly, laboratories are expected to answer a more complex set of questions: Is the infection bacterial or viral? Which resistance mechanisms are present? Which therapy is most likely to succeed? How should this information inform stewardship efforts across an entire healthcare system?

Those are ambitious expectations—but they also represent an extraordinary opportunity for our profession. As diagnostic technologies continue to advance and laboratory data become increasingly integrated into clinical decision-making, laboratorians will remain indispensable partners in protecting both today’s patients and tomorrow’s antibiotics. That makes the work happening in laboratories every day more important than ever.

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

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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.

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IN THIS ISSUE...

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August 2026 | Vol. 58, No. 7

4 6

From the editor The observatory

CONTINUING EDUCATION

8

Essential functions and technical standards in U.S. phlebotomy programs

By Lori Bane, PhD, MT(ACSP)

CLINICAL ISSUES

14

Build, buy, or borrow risk: Leveraging regulatory review as CLIA modernizes

8

By Erica Livingston, RAC

INFECTION DIAGNOSTICS

16

Allergy testing across the lifespan: What laboratories need to know

By Gary Falcetano, PA-C, AE-C EDUCATION

18

14

2026 UNIVANTS of Healthcare Excellence award winners: Eleven innovative teams recognized

By Colleen Strain, PhD

STATE OF THE INDUSTRY

22

2026 MLO State of the Industry Survey: Laboratories navigate antimicrobial resistance challenges, shifting respiratory testing trends, and ongoing supply chain pressures

By Kara Nadeau

18

LAB MANAGEMENT

28

Artificial intelligence in laboratory information systems: Transforming the future of clinical diagnostics

By Rajasri Chandra, MS, MBA

PRODUCT FOCUS

32

Analyzers

LAB INNOVATOR

34

22

Stago’s vision for hemostasis: Q&A with CEO Nichole Howard

By Christina Wichmann

DEPARTMENTS

31 33

Index of advertisers Clinical spotlights

ON THE COVER: adamkaz/E+/Getty Images

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THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS

THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS

Fast Facts WHO calls for global action to combat rising cancer burden by 2050 The World Health Organization (WHO) has published their joint report with the International Agency for Research on Cancer (IARC), the WHO Global Status Report on Cancer 2026. Alongside the findings, the WHO warns that if urgent action is not taken, new cancer diagnoses could jump to about 35 million a year by 2050.

The report found that inequities are burdening cancer patients in low-income countries. For example, chances of surviving breast cancer at five years post diagnosis in high-income countries is nearly double the amount it is in low-income countries.

Additional key findings from the report:

<35%

of countries include cancer care in their universal health coverage packages.

~45%

of people affected by cancer experience financial hardship, according to WHO’s first survey of this population.

~40%

of cancer cases globally are connected to preventable causes.

82%

of countries now have national cancer control plans.

9% to 54%

of vital cancer medicines are available in low- and lower-middle-income countries.

Source: https://www.who.int/news/item/08-07-2026-who-callsfor-urgent-action-as-new-cancer-cases-are-projected-to-nearlydouble-by-2050

Have you read these online exclusives?

In addition to our print and digital magazines, Medical Laboratory Observer publishes a number of online exclusive articles.

Here are some of our most recent ones: Dear API Abby by Sue Styles, MSI; Danielle Casey, MBA, MLS(ASCP)CM; and Anita Hoeksema, MS, MLS(ASCP)CM: Learn how to navigate proficiency testing requirements for multiple testing sites and methods under a single CLIA license. In the latest Dear API Abby, get practical guidance on selecting a primary PT method, managing alternative assessments, and staying inspection-ready.

As allergy seasons grow longer and more complex, labs are becoming a frontline diagnostic resource by Gary Falcetano, PA-C, AE-C: Climate change is extending pollen seasons, increasing allergen potency, and complicating allergy diagnosis. This online exclusive article explores how clinical labs play a vital role in identifying triggers amidst overlapping exposures and environmental shifts.

Medicare LCD reform back in focus: Congress reintroduces the Timely Access to Coverage Decisions Act by Clarisa Blattner: Congress has reintroduced the Timely Access to Coverage Decisions Act, legislation aimed at increasing transparency, accountability, and consistency in the Medicare Local Coverage Determination (LCD) process. Learn what the proposed reforms could mean for laboratories, diagnostic innovation, and Medicare coverage decisions.

The lab director’s dilemma: Why workflow matters as much as performance by Terry Kelly, PhD: This article emphasizes that while performance metrics like sensitivity and specificity are crucial, laboratory adoption hinges on workflow efficiency, integration ease, and real-world operational considerations, which are often overlooked in evaluations.

These articles and more can be found under the Online Exclusive tab on our website.

UF researchers develop fast, reliable urine test to differentiate prostate conditions, including prostate cancer

A group of researchers from the University of Florida College of Medicine are working to make reliable, non-invasive prostate cancer testing more accessible for patients. They recently developed a test that can differentiate between prostate cancer and other conditions that cause elevated PSA. The test uses urine and the “paper spray” technique. Paper spraying involves running an electric current through paper that contains a patient urine sample in the shape of a triangle.

This results in ionized metabolites.

The test was validated in a study with 40 participants who had various prostate conditions including prostate cancer.

Using a mass spectrometer, the researchers were able to measure the ionized metabolites revealed by paper spraying within 30 seconds. This was achieved without a digital rectal exam.

The researchers are now working to develop “a large-scale test that can be used at home to help make testing more widely available.”

New study measures current COVID-19 vaccine effectiveness

Recently published research measured the effectiveness of the 2025-2026 COVID-19 vaccines. The study is published in JAMA Network Open.

The researchers evaluated more than 85,000 emergency department and urgent care visits and more than 26,000

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THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS hospitalizations in adults considered immunocompetent.

Each participant was seen for a COVID-19–like illness.

According to the study results, the 2025-2026 COVID-19 vaccination protected immunocompetent adults from COVID-19–associated ED/UC encounters by 50% and COVID-19–associated hospitalization by 55%. The authors concluded their paper with a recommendation for the COVID-19 vaccine stating, “Adults can reduce their likelihood of severe COVID-19–associated outcomes by obtaining a 2025-2026 COVID-19 vaccination.”

Study links blood circRNAs to Alzheimer’s symptom onset

A recent study that was funded by the National Institutes of Health (NIH) has found that a blood test could reveal Alzheimer’s symptom risk, according to a news release.

The clues lie in certain circular RNAs (circRNAs), which reveal recent brain activity. Previous research from the Washington University School of Medicine, St. Louis showed a connection between circRNAs in the brain and dementia and neuropathological severity. The researchers wanted to see if these findings extended to blood.

Upon reviewing more than 1,200 participants’ blood data, the researchers were able to connect 34 circRNAs with Alzheimer’s. They then used predictive models to test the associations. The models effectively recognized patients with Alzheimer’s pathology, similar to pTau217.

The circRNAs proved more effective than pTau217 for predicting symptom onset, with levels changing two-four years before they start. Additionally,“circRNAs in the blood nearly tripled patients’ risk of developing symptoms.”

These findings could aid personalized treatment strategies and monitoring.

Cedars-Sinai develops tool to personalize presurgical breast cancer treatment

Cedars-Sinai Health Sciences University researchers have developed new technologies to advance personalized presurgical care for breast cancer patients. A news article written

by Christina Elston describes their new tools.

BRIDGE is a predictive tool that can identify the best presurgical treatment for different breast cancer patients.

It classifies multiple subtypes inside of tumors using biopsy samples collected when the patient received their diagnosis.

Then, it notifies clinicians how the patient will respond to certain treatments.

Additionally, the researchers expanded BRIDGE, creating BRIDGE-Slide, eliminating the need for expensive genetic testing. The artificial intelligence-based tool identifies tumor composition from biopsy images. The scientists aim to test both technologies in clinical trials.

Effective presurgical treatment can impact patient outcomes by shrinking some tumors before surgery, leading to less invasive procedures, and helping prevent recurrence.

CAP to launch new molecular proficiency testing program to prepare labs for measles resurgence

The College of American Pathologists (CAP) is advocating for clinical laboratories to prepare now for the United States to lose its measles elimination status. This could happen in November, according to a May Lancet article.

The CAP’s efforts include the development of their new Measles, Mumps, Rubella and Varicella-Zoster Virus (MMRV) Molecular Proficiency Testing program.

The release of the MMRV program will make CAP “the only provider globally” to offer molecular proficiency testing that includes all four viruses and “closely mirrors real clinical laboratory workflows.” CAP advocates for molecular testing because it “detects the virus directly and can distinguish between vaccine-related reactions and true infection.”

The new program will be available starting August 24.

It aims to help laboratories prepare for future outbreaks, manage testing demand, enhance testing accuracy and performance, and deliver timely results.

AI companies call for strong synthetic DNA and RNA ordering regulation

As artificial intelligence (AI) continues to gain strength, a few of the top AI companies, along with experts in biotechnology, life science, public health, and national security are calling for regulation regarding synthetic DNA and RNA ordering.

They sent an Open Letter to U.S. lawmakers, according to a mobi health news article.

The letter warns against misuse, asking for all synthetic DNA and RNA orders to be screened and tracked. The authors said, “AI systems are improving rapidly, and alongside incredible benefits to science and medicine, there is a real possibility that the knowledge barriers which have historically prevented bad actors from obtaining biological weapons will meaningfully erode.” More than 80 experts signed the letter, supporting ordering regulation. They emphasized the urgency of legislation.

The 2026-2027 edition of Clinical Laboratory Reference is here!

Our annual reference guide, Clinical Laboratory Reference (CLR), has been published. It is the industry’s only complete resource guide providing tables of critical values and high and low critical limits; cutoff concentrations for drug tests; critical limits for therapeutic drug levels; adult reference intervals; and pediatric reference intervals. New this year, are Point-of-Care Testing Critical Limits and Critical Limits for Therapeutic Drug Levels.

CLR is updated annually by industry experts. This resource also features cross references of essential laboratory tests, products, services, and equipment.

CMS seeks public input for updating CLIA regulations to reflect modern laboratory advances

The Centers for Medicare & Medicaid Services (CMS) is seeking feedback from the public to help with the upcoming update of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. Their request for information (RFI) is published in the Federal Register.

Specifically, CMS wants insights on: • Breath testing • Laboratory processes and procedures • Emergency preparedness • Biosafety and biosecurity • Cybersecurity • Specialty testing areas If CLIA regulations are updated, they will reflect the advancements that clinical laboratory testing technologies have undergone since the regulations were first introduced.

Those who would like to submit comments to the CMS must do so electronically or by mail before September 14, 2026.

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CONTINUING EDUCATION :: PHLEBOTOMY EDUCATION PROGRAMS

430218334 © Justlight | Dreamstime.com

Continuing Education :: Phlebotomy Education Programs

Essential functions and technical standards in U.S. phlebotomy programs A qualitative document analysis

By Lori Bane, PhD, MT(ASCP), Jennifer Chin, MLT(ASCP); Patrick Johnson, PhD, MLS(AMT); Brittany Devine, MLS(ASCP); Casonya Cason, Phlebotomist (AMT); Michael D. Todd, DHSc, MS, MLS(ASCP); Pauline Matthews, MHSA, BSMT

P

hlebotomy education programs serve as critical entry points into the clinical laboratory workforce, preparing phlebotomy students to perform venipuncture, capillary collection, specimen handling and processing, and patient interaction across diverse healthcare settings. To safeguard patient safety and ensure competence, programs require phlebotomy students to meet essential functions and technical standards, outlining abilities necessary for successful participation in coursework and clinical experiences.9 However, limited research has systematically examined the content, structure, and implications across programs.

Although essential functions are routinely published by educational institutions, these documents are rarely examined as curricular artifacts reflecting professional values, legal interpretations, and access considerations. Publicly available essential functions and technical standards from phlebotomy programs in the United States were analyzed to identify common domains, professional expectations, and implications for student access, accommodations, and readiness for clinical practice. Five major thematic domains emerged: (1) physical and motor abilities, (2) sensory and observational skills, (3) cognitive and intellectual abilities, (4) communication and interpersonal competence, and (5)

Earning CEUs See test online at https://ce.mlo-online. com/courses/essential-functionsand-technical-standards-in-U.S.phlebotomy-programs.

Passing scores of 70 percent or higher are Scan code to go eligible for 1 contact hour of P.A.C.E. credit. directly to the CE test.

LEARNING OBJECTIVES

Upon completion of this article, the reader will be able to: 1. List and describe the five core domains of essential functions for phlebotomy students with examples from clinical practice.

2. Discuss key methodological features and trustworthiness strategies of the study from the article.

3. Explain how essential functions relate to patient safety, clinical competency, and accommodation considerations.

4. Analyze implications of variability in program technical standards for admissions, clinical readiness, and inclusive educational practices.

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Continuing Education :: Phlebotomy Education Programs behavioral professionalism and safety. Across documents, language emphasized patient safety, infection control, and professional conduct, while variability existed regarding reasonable accommodations and disability inclusion. With increasing emphasis on diversity, equity, inclusion, and compliance with the Americans with Disabilities Act (ADA), analyzing how educational programs articulate functional requirements is both timely and necessary.12

Methods

A qualitative document analysis methodology was employed to systematically examine essential functions and technical standards from publicly available websites. Document analysis is well suited to exploring policy language, professional norms, and implicit assumptions embedded in formal educational documents.4 Documents were drawn from community colleges, technical colleges, and private training institutions across multiple states that were: • NAACLS-accredited or state-approved • Offered as certificates or technical diplomas • Explicitly labeled as “Essential Functions,” “Technical Standards,” or equivalent The programs included in this analysis were geographically diverse, representing the Southeast, Mid-Atlantic, Midwest, and Northeast regions of the United States, with a notable concentration of community college-based programs in North Carolina. A total of nine institutions met the inclusion criteria and were analyzed in this study. Data collection occurred within a defined timeframe from June 2025 through May 2026 to ensure consistency and comparability of retrieved materials. Documents were imported into qualitative analysis software and analyzed using inductive thematic analysis. Initial open coding identified discrete functional requirements. Codes were then grouped into higher‑order categories, which were refined into thematic domains consistent across programs. Analysis was iterative, with repeated comparison to ensure internal consistency and analytic rigor. Credibility was supported through peer debriefing with allied health educators. Dependability was enhanced via an audit trail documenting coding decisions.

Reflexivity was maintained by acknowledging the researcher’s role as an allied health educator.

Results

Analysis of publicly available essential functions and technical standards from U.S. phlebotomy programs revealed substantial consistency across institutions in articulating expectations necessary for student participation in didactic and clinical education. Documents reviewed were obtained from accredited and state‑approved phlebotomy programs and supported by national accrediting and professional guidance.1,9 The domains, while presented individually for clarity, reflect integrated competencies that operate simultaneously in clinical practice, where technical, cognitive, and interpersonal skills are inherently interdependent.

Physical and motor abilities

All reviewed programs required phlebotomy students to demonstrate sufficient physical capability and fine motor dexterity to safely perform phlebotomy‑related tasks. Institutional documents consistently cited manual dexterity for venipuncture and capillary collection, specimen labeling, and equipment handling as essential functions.2,11 Additional expectations included the ability to stand for extended periods,

bend and reach safely, and lift light supplies necessary for clinical procedures. These requirements were closely aligned with national procedural standards for venous blood collection, emphasizing safe needle handling, patient positioning, and infection control.5

Sensory and observational skills

Sensory requirements were a prominent component of essential functions across all reviewed documents. Programs emphasized adequate visual acuity, with or without corrective devices, to identify veins, select appropriate collection tubes, verify patient identifiers, and assess specimen integrity.6,7,13 Tactile sensation was frequently identified as necessary for vein palpation and assessment of vascular accessibility, while auditory ability supported effective patient communication, reception of clinical instructions, and recognition of equipment alarms or environmental cues. These expectations reflect the observational demands inherent in safe phlebotomy practice and error prevention.9

Cognitive and intellectual abilities

Cognitive and intellectual abilities constituted a core domain within all essential functions documents reviewed. Programs required phlebotomy students to interpret test orders, follow multi‑step procedures accurately, and apply critical thinking in specimen collection, handling, and troubleshooting.9,10 Essential functions frequently referred to the ability to recognize errors, prioritize tasks, and respond appropriately to unexpected clinical situations.3 The emphasis on cognitive processing was closely associated with patient safety objectives and workforce readiness, aligning educational expectations with professional competency standards outlined by the ASCP.1

Communication and interpersonal competence

Nearly all reviewed documents underscored the importance of effective communication and interpersonal skills as essential for phlebotomy students. Programs required clear verbal and nonverbal communication with patients, healthcare staff, and instructors, as well as the ability to obtain patient cooperation and explain procedures in a professional and culturally sensitive manner.10,13 Interpersonal competence was frequently framed within a patient‑centered care model, emphasizing respect, empathy, and professionalism in diverse clinical environments.8 These expectations reflect the interpersonal nature of phlebotomy practice and align with national workforce competency guidance.1

Behavioral professionalism and safety

Behavioral professionalism and adherence to safety standards were universally emphasized across all reviewed documents.

Programs highlighted emotional stability, ethical conduct, accountability, and compliance with infection control and safety policies as essential functions for student participation in clinical education.2,9 Institutions explicitly linked these behavioral expectations to workplace readiness and employer requirements, indicating that essential functions extend beyond technical skill to encompass professional identity formation.14 References to ethical behavior, reliability, and stress management were consistent with federal guidance regarding professional standards in healthcare education.12 The five major domains emerged consistently across the analyzed documents. Collectively, these functions encompass accurate patient identification and appropriate specimen MLO-ONLINE.COM AUGUST 2026 | 9

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Continuing Education :: Phlebotomy Education Programs Domain

Description

Examples of required abilities

Physical and motor abilities

Physical capacity and fine motor control to safely perform phlebotomy tasks and related laboratory procedures

• Standing for extended periods • Bending and reaching • Lifting light supplies • Applying tourniquets • Performing venipuncture and capillary puncture • Labeling specimens accurately • Handling collection devices and laboratory equipment with precision

Sensory and observational skills

Sensory abilities to ensure accurate specimen collection and patient safety

• Visual discrimination of veins, tubes, labels, and specimen quality (with or without corrective lenses) • Tactile sensation for vein palpation • Auditory ability to communicate with patients, hear instructions, and recognize equipment alarms

Cognitive and intellectual abilities

Intellectual skills required to interpret information, follow procedures, and apply judgment in dynamic healthcare settings

• Interpreting test orders • Following multi‑step collection protocols • Applying critical thinking to prevent errors • Recognizing inappropriate specimens • Prioritizing tasks • Responding appropriately to unexpected clinical situations

Communication and interpersonal competence

Verbal, nonverbal, and written communication essential for patient care and interprofessional collaboration, including professionalism and cultural sensitivity

• Explaining procedures to patients • Obtaining patient cooperation • Communicating clearly with healthcare staff and instructors • Using appropriate verbal and nonverbal communication • Demonstrating respect, empathy, and cultural awareness

Behavioral professionalism and safety

Professional behavior for clinical education that includes accountability, ethical conduct, and adherence to safety standards.

• Maintaining emotional stability • Following infection control and safety policies • Demonstrating integrity and ethical behavior • Managing stress appropriately • Complying with clinical site rules • Exhibiting punctuality, reliability, and professional demeanor • Complying with HIPAA regulations and maintaining patient confidentiality at all times

Table 1. Essential function domains for phlebotomy students.

collection methods (including correct devices and containers, processing, transport, and storage). Although the domains are presented discretely for readability and policy development, overlap among them is intentional and reflects real‑world laboratory practice, where competencies are integrated rather than isolated (e.g., communication competencies often mani‑ fest through professional behaviors such as confidentiality, ac‑ countability, and teamwork). The analysis of essential functions documents revealed five competency domains required for successful participation in phlebotomy education and clinical practice. Together, they represent the functional expectations necessary to meet accreditation requirements and to ensure patient safety. A summary of these essential function domains and representative examples is presented in Table 1.

Discussion

The findings of this qualitative document analysis demon‑ strate that essential functions and technical standards used across U.S. phlebotomy programs are highly consistent and closely aligned with the cognitive, psychomotor, and behav‑ ioral demands of contemporary clinical practice. Rather than functioning as discrete requirements, the identified com‑ petency domains reflect integrated expectations necessary for safe, effective entry-level performance. The consistency observed across institutions supports the continued use of

essential functions as a defensible and essential component of phlebotomy education.

The inclusion of physical and motor abilities as essential functions is strongly supported by the technical demands in‑ herent to phlebotomy procedures. Venipuncture and capillary collection require precise hand–eye coordination, sustained manual dexterity, and the safe manipulation of collection equipment. Programs consistently emphasized the ability to perform repetitive fine motor tasks, maintain positioning for extended periods, and handle supplies with accuracy, reflect‑ ing procedural expectations established in national practice standards (CLSI, 2023). Importantly, these requirements are appropriately framed as functional outcomes rather than fixed physical characteristics. This distinction reinforces their role in ensuring patient safety while maintaining alignment with disability accommodation principles, allowing phlebotomy students to meet expectations with reasonable supports when appropriate.

Sensory and observational abilities emerged as foundational across all reviewed documents, underscoring their essential role in maintaining specimen integrity and patient safety.

Visual acuity, tactile perception, and auditory processing are integral to critical tasks such as vein identification, patient verification, equipment monitoring, and contextual aware‑ ness in clinical environments. The explicit inclusion of these

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Continuing Education :: Phlebotomy Education Programs functions reflects the well-established connection between observational accuracy and error prevention in laboratory medicine. Notably, many programs acknowledged that sensory requirements may be fulfilled with corrective devices, suggesting an emerging recognition of inclusive practice while preserving performance standards. This approach supports accessibility without compromising clinical competence.

Cognitive and intellectual abilities were consistently positioned as central to phlebotomy practice, reinforcing that technical skill alone is insufficient for safe patient care. The ability to interpret test orders, follow multi-step protocols, recognize errors, and respond to unexpected situations reflects the complexity of clinical decision-making in even entry-level roles. These expectations align with national competency frameworks and highlight the critical role of judgment, adaptability, and procedural understanding in minimizing preanalytical errors. By embedding cognitive expectations within essential functions, programs ensure that phlebotomy students are prepared not only to perform procedures but also to engage in safe and informed clinical reasoning.

Communication and interpersonal competence were emphasized across nearly all documents, reflecting the patient-centered nature of phlebotomy practice. Effective communication is essential for explaining procedures, gaining patient cooperation, and collaborating with healthcare team members. These skills are directly linked to patient outcomes, including procedural success and patient satisfaction. The inclusion of cultural sensitivity and professionalism further reflects evolving expectations in healthcare delivery, where equitable and respectful patient interactions are considered fundamental competencies. Framing communication as an

essential function reinforces its role as a clinical requirement rather than a secondary or “soft” skill.

Behavioral professionalism and adherence to safety standards were the most uniformly articulated expectations across programs. Emotional stability, ethical conduct, accountability, and compliance with infection control protocols were consistently identified as essential to student participation and clinical readiness. These expectations reflect not only institutional policies but also broader regulatory and workforce demands.

By explicitly including professionalism within essential functions, programs emphasize that technical proficiency must be accompanied by ethical responsibility and professional behavior. This integration supports the development of professional identity and reinforces the expectations of healthcare employers.

Although the core competency domains were highly consistent across institutions, variability was observed in how programs addressed reasonable accommodations and disability inclusion. Some documents explicitly acknowledged that essential functions could be met with accommodations, while others omitted this language entirely. This inconsistency represents a critical opportunity for improvement. Standardizing the inclusion of ADA-informed language would enhance transparency for prospective phlebotomy students and promote equitable access to phlebotomy education.

Clear articulation of how accommodations are considered can reduce ambiguity and ensure alignment with federal guidance while maintaining program integrity.

The findings also highlight the dual role of essential functions and technical standards as both educational tools and regulatory documents. These standards serve to communicate

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Continuing Education :: Phlebotomy Education Programs expectations, guide student self-assessment, and support admissions and progression decisions. At the same time, they function as legal and ethical frameworks that institutions must carefully construct to balance inclusivity with patient safety. When framed appropriately, essential functions are not exclusionary but rather define the outcomes necessary for safe clinical practice. Emphasizing functionality, rather than rigid criteria, can support both educational rigor and accessibility.

From a broader perspective, the consistency of domains across diverse institutions suggests an implicit national model of phlebotomy competency, even Scan code to go in the absence of fully standardized directly to the CE test. language. This convergence reflects strong alignment between educational expectations and professional practice requirements. However, the variability in terminology, structure, and clarity indicates that further standardization may enhance usability and accessibility of these documents. Developing shared language frameworks across programs could improve transparency for phlebotomy students and support more equitable admission practices across institutions.

Together, these findings support the continued use of essential functions and technical standards as critical components of phlebotomy education. The identified domains are clearly justified by patient safety requirements, competency expectations, and workforce readiness outcomes. However, strengthening clarity, standardization, and inclusivity—particularly with respect to accommodation language—would further enhance the effectiveness and equity of these documents. As phlebotomy programs continue to evolve within increasingly diverse educational and clinical environments, ongoing evaluation and refinement of essential functions will remain necessary to ensure alignment with both professional standards and inclusive educational practices.

Conclusions

This qualitative document analysis identified consistent expectations across U.S. phlebotomy programs regarding essential functions and technical standards required for student participation and clinical readiness. Five core domains—physical, sensory, cognitive, communication, and professional behaviors—were consistently represented, reinforcing alignment between educational requirements and workforce expectations. These competency domains collectively reflect the multidimensional skill set required for safe phlebotomy practice and reinforce the integration of technical, cognitive, and professional expectations within clinical education.

The findings highlight the importance of essential functions as both educational and regulatory tools that support patient safety and competency development. However, variability in how programs articulate accommodations suggests a need for more standardized and inclusive language consistent with ADA guidelines.

Strengthening clarity, accessibility, and transparency in essential functions documents can enhance equity in admission practices while maintaining academic and clinical rigor. Future research should explore how these standards are implemented in admissions and clinical evaluation processes, as well as their impact on student diversity and success in phlebotomy education.

REFERENCES 1. Phlebotomy technician competencies and scope of practice. American Society for Clinical Pathology. Published 2022. Accessed July 8, 2026. https://www.ascp.org.

2. Phlebotomy technician essential functions and technical standards. Austin Community College. Published 2024.

Accessed July 8, 2026. https://drive.google.com/file/d/1Ez jmnx7xttU71hS-ZSzStMmNza7xEgRm/view.

3. Phlebotomy technician technical standards. Beaufort County Community College. Accessed July 8, 2026. https://www.beaufortccc.edu/wp-content/uploads/2026/04/Phlebotomy-TechnicianTechnical-Standards.pdf.

F S

4. Bowen GA. Document analysis as a qualitative research method. Qual Res J. 2009;9(2):27-40. doi:10.3316/qrj0902027.

5. Collection of Diagnostic Venous Blood Specimens (CLSI GP41). 7 edition.; 2023.

th

6. Essential requirements for the phlebotomy program. Community College of Philadelphia. January 22, 2025. Accessed July 8, 2026. https:// www.myccp.online/sites/default/files/documents/MedicalLaboratoryTechnician/phlebotomy-essential-requirements-20250122.pdf.

7.

Phlebotomy program technical standards. Davidson-Davie Community College. Published 2025. Accessed July 8, 2026. https://www. davidsondavie.edu/wp-content/uploads/2025/09/Phlebotomy-ProgramTechnical-Standards.pdf.

8. Phlebotomy technician technical standards. Mid-State Technical College.

Accessed July 8, 2026. https://www.mstc.edu/sites/default/files/2026-05/ Phlebotomy-Technician-Grouping-Technical-Standards.pdf.

9. Standards for accredited phlebotomy technician programs. National Accrediting Agency for Clinical Laboratory Sciences. Last updated May 2026. Accessed July 8, 2026. https://naacls.org/wp-content/ uploads/2024Standards.pdf.

10. Phlebotomy career studies certificate program: Essential functions.

Northern Virginia Community College. Accessed July 8, 2026. https:// www.nvcc.edu/academics/programs/pbt-essential-functions.html.

11. Essential functions for phlebotomy students. Tower Health.

Accessed July 8, 2026. https://reading.towerhealth.org/ app/files/public/71d2f35a-a41b-4e16-88e5-41d8816a7d38/ phlebotomist-essential-functions.pdf.

12. The Americans with Disabilities Act: Title II technical assistance manual: Covering state and local government programs and services.

U.S. Department of Justice, Civil Rights Division. Published 1993.

Accessed July 8, 2026. https://archive.ada.gov/taman2.html.

ent Source Managem

OF DUSTR ta

13. Phlebotomy program technical standards. Wake Technical Community College. Published 2024. Accessed July 8, 2026. https://www.waketech. edu/sites/default/files/program-page-files/Phlebotomy-technicalstandards.pdf.

14. Phlebotomy essential functions. Western Technical College. Accessed July 8, 2026. https://www.westerntc.edu/sites/default/files/programs/ documents/Phlebotomy_Essential_Functions.pdf.

Lori Bane, PhD, MT(ASCP) serves as the Program Director for Medical Laboratory Tech and Phlebotomy Programs at Chattahoochee Technical (Chatt Tech) College. She is a seasoned public health professional and laboratory scientist with over 30 years of experience spanning federal government and clinical laboratory practice.

R OR ATTO VA OV NO NN IN i, MD Borkowsk ical Dire Med aging and ntral Florid Ce , meriPath Ex Center of torr of the eccto -Empowe AI d an Digital . cs sti est Diagno

Jennifer Chin, MLT(ASCP) serves as the Clinical Coordinator for Chatt Tech College. She is a previous alumnus who has a passion for teaching laboratory technology and helping others.

Patrick Johnson, PhD, MLS(AMT) is an adjunct professor at Chatt Tech with a strong background in medical laboratory science and healthcare administration and holds a doctorate and master’s degrees.

Brittany Devine, MLS(ASCP) is an adjunct professor at Chatt Tech who brings a strong background in blood banking.

Casonya Cason, Phlebotomist (AMT) is a registered phlebotomy technician with over 30 years of experience in phlebotomy and has an MBA in Healthcare Administration and Project Management.

Michael D. Todd, DHSc, MS, MLS(ASCP) is the Director of Laboratory Services at Wellstar Douglas Hospital. He has a long-standing 28-year career in the Medical Laboratory field.

Pauline Matthews, MHSA, BSMT is the Assistant Director of Laboratory Operations Management at Kaiser Permanente.

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CLINICAL ISSUES :: LABORATORY-DEVELOPED TESTS

28852696 © Thittaya Janyamethakul | Dreamstime.com

Clinical Issues :: Laboratory-Developed Tests

Build, buy, or borrow risk

Leveraging regulatory review as CLIA modernizes

By Erica Livingston, RAC

F

ew regulatory questions have unsettled clinical laboratories over the past two years as much as the oversight of laboratory-developed tests.

A final rule issued by the Food and Drug Administration (FDA) in 2024 sought to regulate such tests as medical devices and to phase out, over four years, the longstanding policy of enforcement discretion.1 A federal court vacated that rule in March 2025, and in September 2025 the FDA formally rescinded the rule, restoring the regulatory definition of an in vitro diagnostic product to the language in effect before the rule took hold. 2-4 Oversight of laboratory-developed tests returned to the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, with enforcement discretion intact.

The relief, while real, has been widely misread. Vacatur of the rule did not erase the obligations that govern test validation, nor did vacatur alter the boundary

that separates a research product from a clinical one. Reading the outcome as a green light invites exactly the kind of exposure the rule debate was meant to clarify. A legislative proposal introduced in 2026 by Rep. Neal Dunn, M.D. would, for the first time, place a statutory standard of analytical and clinical validity on laboratory-developed tests, a clear sign that the validation question is far from closed.5 With the threat of FDA oversight currently lifted, one practical question now carries more weight than before: does a given test represent a method that a laboratory developed and validated, or a kit assembled from components shipped in from elsewhere?

What the court decided, and what remained

The reasoning behind vacatur matters as much as the outcome. The court held that a laboratory testing service is a methodology or process rather than an article of commerce, and therefore not

a device subject to regulation under the Federal Food, Drug, and Cosmetic Act.2 The holding was specific and should not be overread. The same decision left undisturbed the agency’s authority over tangible products placed into commerce, a category that includes reagents, specimen collection kits, and the physical or software components distributed for use within a test. While the testing service itself moves outside device regulation, the components that a lab brings in from a supplier do not. The lab, however, still brings in components from a supplier that remain under FDA jurisdiction.

The boundary around research products was never part of the dispute.

A product labeled for research use only must carry a statement restricting use to research, and such a product lacks assurance of the performance characterization, quality system conformity, and manufacturing controls expected of a clinical assay.6 Use of a research-use-only (RUO) product to make a clinical diagnosis falls outside permitted use regardless of how the broader landscape shifts. The jurisdictional line, in short, did not vanish with the rule. The line moved to a familiar place: the difference between a service that a laboratory performs and a product that a laboratory or a supplier ships.

A developed test versus a purchased one

The RUO framework does not assure that a component arrives with the clinical performance work and claims that

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Clinical Issues :: Laboratory-Developed Tests accompany an FDA-cleared in vitro diagnostic (IVD) device. A given supplier may have characterized a great deal or very little; either way, establishing performance for the intended clinical use falls to the lab, and so does the full cost.

Three points sharpen the distinction.

First, the obligation to validate does not transfer with a purchase. Under the Clinical Laboratory Improvement Amendments, a laboratory that introduces any method not cleared or approved by the agency must establish performance specifications for that method, including accuracy, precision, reportable range, and reference intervals appropriate to the population served.7 Establishing those specifications extends to qualifying any research-useonly components incorporated into the test. Purchasing components and following a supplied protocol does not satisfy that obligation, and a laboratory unable to produce a validation file in-house is not, in any meaningful sense, running a laboratory-developed test.

Second, the components remain within the agency’s reach. The research-useonly label is not a formality; it restricts the product to research and does not assure clinical validation.6 Marketing or deploying such a product for patient care has drawn enforcement attention, and warning letters addressing research-useonly reagents promoted for clinical purposes continue to be an issue.8 Regardless of the manufacturer’s claims, the burden of validation still falls on the laboratory.

Third, the direction of policy reinforces the same distinction. The 2026 legislative proposal would establish a statutory standard of analytical and clinical validity and would treat a commercially distributed protocol intended for use by unaffiliated laboratories as outside the definition of a laboratory-developed test, and potentially as a device subject to regulation.5 The developed-versuspurchased boundary, in other words, is being drawn the same way by the proposed statute as by sound laboratory practice.

Viewed through cost and risk together, the assembled-kit position carries the most exposure of available options.

Such an approach carries the expense of purchased components alongside the full burden of in-house validation and clinical liability. It does so without the assurance of manufacturing controls maintained under FDA oversight that accompanies a cleared product, and in some circumstances may heighten regulatory exposure rather than reduce it.

Weighing the three pathways

No single pathway is superior in the abstract; the available pathways differ in the distribution of cost, control, and responsibility. A cleared in vitro diagnostic arrives with validation already reviewed, which lowers the validation burden on the laboratory but raises acquisition cost and limits flexibility to adapt the test to local needs.4 A genuine laboratory-developed test places the validation burden squarely on the laboratory, which raises both the workload and the accountability, yet preserves the flexibility to address unmet clinical needs and to adapt quickly, the very capacity the court sought to protect.2 A research-use-only product is offered for research rather than diagnosis, so the entire diagnostic validation, and its cost, rests with the laboratory that puts it to clinical use.6 An IVD product, by contrast, has been through rigorous analytical and clinical validation before reaching the market, at the expense of the manufacturer.

Where a cleared IVD is available, it offers a validation already established and reviewed against the intended use.

That validation also sits within a broader quality system: under FDA oversight, a cleared product is manufactured under controls for reproducibility, traceability, and lot-to-lot consistency, which is a genuine advantage.

What self-governance now requires

The most consequential control now available to a laboratory is the choice, when a cleared IVD exists for the intended use, to leverage the assurance the manufacturer has already built in. That assurance covers validation established and reviewed against the intended use, and a quality system maintaining reproducibility, traceability, and lot-to-lot consistency under FDA oversight. Choosing the cleared product secures that work at the outset, before the test reaches the bench.

One perspective in the continuing debate deserves mention, offered as a single view among several rather than as settled conclusion. A middle path, in which validations are independently reviewed without the full weight of premarket approval, would pair rigor with access, an arrangement glimpsed during the recent public health emergency. The emergency use pathways were imperfect, but they demonstrated that agency oversight need not come at the expense of innovation or speed. The 2026 legislative proposal contemplates a version

of precisely that arrangement, through a voluntary affirmation of validity by a qualified, CMS-approved third party.5 A laboratory-developed test earns its place when no cleared product exists, preserving the flexibility to meet a clinical need that nothing else addresses. When a cleared IVD is available, the choice carries quiet weight: it brings validation already established and reviewed for the intended use, within a quality system that holds reproducibility, traceability, and lot-to-lot consistency under FDA oversight. None of this lifts the laboratory’s responsibility for the result it reports, but it places much of the groundwork in proven hands before the first sample is run.

REFERENCES 1. Food and Drug Administration. Medical devices; Laboratory developed tests. Federal Register. https://www.federalregister. gov/d/2024-08935.

2. American Clinical Laboratory Association v United States Food and Drug Administration (consolidated with Association for Molecular Pathology v United States Food and Drug Administration). US District Court for the Eastern District of Texas; March 31, 2025.

3. Food and Drug Administration. Regulation identification number 0910-AJ05 medical devices; Laboratory developed tests; Implementation of vacatur. Federal Register. https:// www.federalregister.gov/d/2025-18239.

4. 21 CFR part 809 -- in vitro diagnostic products for human use. Ecfr.gov. Accessed July 8, 2026. https://www.ecfr.gov/current/title-21/ chapter-I/subchapter-H/part-809.

5. Enhancing Clinical Laboratory Innovation and Access Act of 2026. HR 8890, 119th Cong (2026). Introduced May 19, 2026. Accessed July 8, 2026. https://www.congress.gov/ bill/119th-congress/house-bill/8890/titles.

6. Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff. US Food and Drug Administration. November 2013. Accessed July 8, 2026. https://www. fda.gov/regulatory-information/search-fdaguidance-documents/distribution-invitro-diagnostic-products-labeledresearch-use-only-or-investigational-use-only.

7.

42 CFR 493.1253 -- Standard: Establishment and verification of performance specifications. Ecfr.gov. 1253. Accessed July 8, 2026. https://www.ecfr.gov/current/title-42/ chapter-IV/subchapter-G/part-493/subpart-K/ subject-group-ECFRc96daead380f6ed/ section-493.1253.

8. Warning Letters. US Food and Drug Administration. Updated July 7, 2026.

Accessed July 8, 2026. https://www. fda.gov/inspections-complianceenforcement-and-criminal-investigations/ compliance-actions-and-activities/ warning-letters.

Erica Livingston, RAC serves as President of Qualomics LLC, a regulatory affairs and quality management system consultancy for medical laboratories, medical device and in vitro diagnostic developers and manufacturers.

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INFECTION DIAGNOSTICS :: ALLERGY TESTING

Infection Diagnostics :: Allergy Testing

Allergy testing across the lifespan What laboratories need to know

By Gary Falcetano, PA-C, AE-C

F

ood allergies affect approximately 8% of children and 10% of adults1 in the United States. Of food-allergic adults, nearly half1 report that at least one allergy developed during adulthood, not as an extension of a childhood diagnosis, but as a new sensitization to something they had eaten without incident for years. The clinical and operational implications of that for laboratories are real. Allergy testing volumes are not driven by a single patient demographic, and the information a diagnostic test result conveys may have different implications throughout life stages.

Allergy is not a static diagnosis. Both food and environmental allergens emerge and resolve throughout life, and laboratories that treat allergy diagnostics as a fixed workflow rather than a longitudinal one are likely leaving clinical value on the table.

Early life: What the atopic march tells labs about test selections

The atopic march describes how allergic disease typically unfolds from infancy. Atopic dermatitis comes first when the skin barrier is compromised, and allergen proteins can penetrate the dermis and trigger an IgE-mediated immune response before the child has encountered that food through the gut, the route normally associated with tolerance development. Because of this, sensitization may precede any oral exposure, and in many cases, a food allergy that might have been prevented with earlier intervention.

Current guidelines2 support specific IgE testing for peanut in high-risk infants, especially those with severe eczema, as a tool for guiding early food introduction decisions. A high-sensitivity negative result in this context carries strong negative predictive value, giving clinicians confidence to introduce this potentially allergenic food at the recommended window of four to six months. Evidence from the LEAP trial3 and subsequent research supports early introduction as protective against food allergy development.

Test selection at this life stage calls for attention to timing. For example, clinicians may not test for environmental pollens in the first 12 to 18 months of life, since sensitization to seasonal allergens requires repeated seasonal exposure and results ordered too early will not reflect actual clinical status. However, indoor allergens like dust mites, pet dander, cockroach, and/or mold may be present in the home from birth, and sensitization to these allergens can develop early with constant exposure, an important factor for clinicians to be aware of.

Food allergy prevalence in children is approximately 8%, with milk, egg, wheat, and soy account for the most common early sensitizations. By age 12, approximately 64% of children4 with milk allergies have developed tolerance; for egg, roughly 68%5 by age 16; for soy, around 69%6 by age 10; and for wheat, about 65%7 by age 12. Peanut, tree nut, fish, and shellfish follow a different trajectory. Shellfish tolerance arises in only about 4% of cases8 over five to ten years. These patterns carry direct implications for how often a patient should be retested and which component tests make sense to order alongside whole allergen results.

1180814387/ iStock / Getty Images Plus/Getty Imaages

The re-testing gap: Adolescents, adults, and stale diagnoses

Most of the tolerance development that will happen for milk, egg, soy, and wheat happens by early adolescence. That makes teenagers a critical re-testing cohort, and a largely underserved one. A patient diagnosed at age four who is now sixteen likely has a meaningfully different immune profile, and the clinical decision about whether they still need to carry an epinephrine auto-injector or avoid a food entirely should rely on current data, not a ten-year-old result.

Component-resolved diagnostics are particularly useful here. A positive whole allergen result at adolescence indicates sensitization, but it does not tell you whether the sensitization is driven by high-risk storage proteins or by cross-reactive components associated with milder or no clinical symptoms.

This is especially important with peanut, since sensitization to Ara h 2, a storage protein stable to heat and digestion, is strongly associated with true clinical allergy and systemic reaction risk. Sensitization to Ara h 8, a PR-10 protein that cross-reacts with birch pollen, is more commonly associated with oral allergy syndrome or no reaction at all. Treating those two results identically may result in unnecessary food avoidance, unneeded anxiety, and unnecessary emergency preparedness for patients who may not need it.

With milk and egg, specific component markers predict whether tolerance is likely. Higher IgE to ovomucoid in egg and casein in milk have been associated9 with more persistent allergy and a lower probability of natural tolerance development. Knowing that before ordering a food challenge affects both the clinical decision and the downstream lab workflow.

For adults, there’s another consideration. A large population-based survey of more than 40,000 adults10 found that 19% believed they had a food allergy, but when symptom history was examined carefully, only about half, roughly 10%, had convincing IgE-mediated symptoms. The other 9% were carrying a self-reported or empirically assigned diagnosis with no diagnostic confirmation. For laboratories, this gap

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2608ML

Infection Diagnostics :: Allergy Testing is not simply an operational concern, since clinicians ordering allergy diagnostic testing for these adults may be working from assumptions made in childhood or after a single reaction.

Without symptom history, a positive result in an adult who was never properly diagnosed as a child is not confirmation of allergy, it’s confirmation of sensitization. Clear reporting and active communication with ordering clinicians about the difference between sensitization and clinical allergy matter here as much as anywhere else in the lifespan.

How labs can support allergies across the lifespan

Modern food allergy care depends on integrating clinical history, specific IgE testing, and allergen component diagnostics. When used together, these tools help clinicians diagnose more accurately, identify when tolerance has developed, and make more informed decisions about oral food challenges and long-term management.

For laboratories, recognizing that allergic disease evolves across a patient’s lifetime has real operational implications for allergen selection offerings, and how results are reported.

A lifespan-based approach means aligning allergen selection, workflow design, and diagnostic technologies with the reality of how allergic disease develops and progresses across the lifespan.

REFERENCES 1. Facts and Statistics. Food Allergy Research & Education. Accessed July 9, 2026. https://www.foodallergy.org/resources/facts-and-statistics.

2. Togias A, Cooper SF, Acebal ML, et al. Addendum guidelines for the prevention of peanut allergy in the United States: Report of

the National Institute of Allergy and Infectious Diseases-sponsored expert panel. J Allergy Clin Immunol. 2017;139(1):29-44. doi:10.1016/j. jaci.2016.10.010. Accessed from: https://www.niaid.nih.gov/sites/ default/files/addendum-peanut-allergy-prevention-guidelines.pdf.

3. Du Toit G, Roberts G, Sayre PH, et al. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015;372(9):803-813. doi:10.1056/NEJMoa1414850.

4. Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow’s milk allergy. J Allergy Clin Immunol.

2007;120(5):1172-1177. doi:10.1016/j.jaci.2007.08.023.

5. Savage JH, Matsui EC, Skripak JM, Wood RA. The natural history of egg allergy. J Allergy Clin Immunol. 2007;120(6):1413-7. doi:10.1016/j. jaci.2007.09.040.

6. Savage JH, Kaeding AJ, Matsui EC, Wood RA. The natural history of soy allergy. J Allergy Clin Immunol. 2010;125(3):683-6. doi:10.1016/j. jaci.2009.12.994.

7.

Keet CA, Matsui EC, Dhillon G, et al. The natural history of wheat allergy. Ann Allergy Asthma Immunol. 2009;102(5):410-5. doi:10.1016/ S1081-1206(10)60513-3.

8. Will my child outgrow their food allergy? Anaphylaxis UK. Accessed July 9, 2026. https://www.anaphylaxis.org.uk/fact-sheet/ outgrowing-allergy/.

9. Frischmeyer-Guerrerio PA, Rasooly M, Gu W, et al. IgE testing can predict food allergy status in patients with moderate to severe atopic dermatitis. Ann Allergy Asthma Immunol. 2019;122(4):393-400.e2. doi:10.1016/j.anai.2019.01.001.

10. Gupta RS, Warren CM, Smith BM, et al. Prevalence and severity of food allergies among US adults. JAMA Netw Open. 2019;2(1):e185630. doi:10.1001/jamanetworkopen.2018.5630.

Gary Falcetano, PA-C, AE-C is the US scientific manager, Global Medical and Scientific Affairs for Allergy in ImmunoDiagnostics at Thermo Fisher Scientific. A licensed physician assistant with more than 25 years of diverse experience in emergency and disaster medicine, primary care, and allergy and immunology.

One Serum Sample.

66 Answers.

Endless Possibilities.

From sample to result, the Canon AP3600 features: · Fully automated workflow · Up to 66 clinically relevant allergen results · Maximizes walk-away time · Increases laboratory efficiency For over 40 years, we've helped laboratories deliver reliable IgE allergen testing.

Today, as part of Canon Medical Diagnostics USA, we're advancing that legacy through innovation and technology.

A pioneer in allergy diagnostics.

Trusted Canon Performance. https://mdu.medical.canon/

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EDUCATION :: UNIVANTS AWARD

Education :: UNIVANTS Award

1725587753/ iStock / Getty Images Plus / Getty Images

2026 UNIVANTS of Healthcare Excellence award winners Eleven innovative teams recognized

By Colleen Strain, PhD

T

he UNIVANTS of Healthcare Excellence program is a prestigious global award recognizing integrated clinical care teams that harness the power of laboratory medicine to drive measurable improvements in patient care and outcomes. Building on the program’s continued momentum, the 2026 awards celebrate eleven exemplary teams whose initiatives demonstrate how interdisciplinary collaboration and evidence-based laboratory insights can transform healthcare delivery across the globe.

This year’s cohort includes three top global winners, four teams of distinction, and four teams of achievement, each illustrating the criticality of laboratory medicine in improving clinical decision-making, enhancing patient safety, optimizing operational performance, reducing healthcare costs, and more. From maternal–fetal medicine and digital transformation to cardio-oncology, the 2026 winning initiatives underscore the expanding influence of diagnostic innovation across the care continuum.

The 2026 top global winners include KIMSHEALTH Trivandrum (India), Jubail Health Network (Saudi Arabia), and Shandong Cancer Hospital (China). Their work exemplifies how laboratory-guided strategies can meaningfully improve both patient and system-level outcomes.

on definitive antibody identification following initial screening.

Rather than treating all positive screens as equally at-risk, the team differentiated patients based on clinically significant antibodies and antibody titers to guide care and treatment.

Over a six-year period, more than 9,600 antenatal mothers were evaluated, with clear stratification between high- and low-risk individuals. Of which, 109 mothers with positive screens were identified, 31(28.4%) were deemed passive immunizations requiring no further work-up. The remaining 78 (71.6%) cases constituted true alloimmunization, with 62.8%

Improving perinatal outcomes through laboratory-guided risk stratification of antenatal alloimmunization KIMSHEALTH Trivandrum, India

Maternal red cell alloimmunization is a potentially lifethreatening condition in pregnancy, where antibodies against fetal red blood cells can lead to hemolytic disease of the fetus and newborn, resulting in anemia, hydrops fetalis, or even fetal death. Despite its clinical significance, traditional screening approaches often fail to distinguish between high- and low-risk cases, resulting in unnecessary interventions for many patients while still posing risks to those requiring urgent care.

Recognizing an opportunity to improve outcomes and patient care, an integrated care team at KIMSHEALTH implemented a laboratory-driven risk stratification protocol centered

Pictured from left to right: Sanooja Pinki S, Sajith Mohan R, Vidyalekshmy R, Naveen Jain, Prethika PA.

(n=49) identified as high-risk based on clinically significant antibodies. Conversely, 37.1% were identified with benign antibodies (e.g., anti-Leb, anti-Lea) and did not require any specialized fetal intervention.

This approach not only improved perinatal outcomes but also reduced patient anxiety and healthcare costs through more precise resource utilization. By transitioning from simple detection to actionable diagnostic insight, this initiative highlights how laboratory medicine can enable

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Education :: UNIVANTS Award personalized care pathways, improving safety while reducing unnecessary burden on both patients and healthcare systems.

Accelerating diagnostics through digital laboratory transformation Jubail Health Network, Saudi Arabia

Timely laboratory results are essential for effective clinical decision-making, particularly in primary care and chronic disease management. At Jubail Health Network, fragmented workflows, manual processes, and inconsistent specimen transport previously led to significant delays, ranging from days for routine chemistry tests to weeks for specialized assays.

To address these challenges, a multidisciplinary team developed the Aynati Initiative, a comprehensive digital transformation program designed to streamline laboratory operations and improve connectivity between primary healthcare centers and the central laboratory. Leveraging Lean Six Sigma methodologies, the team re-engineered the specimen journey, implementing digital barcoding, real-time tracking, standardized courier systems, and full integration between laboratory and health information systems.

Pictured from left to right: Hussein AlSadiq, Roaa Al-Mousa, Fatimah Al-Humaili, Suad Aman, Ahmed Alenizy, Ahood Al-Ghamdi (not pictured).

The impact was immediate and substantial. Turnaround times for routine chemistry testing decreased from 48–72 hours to less than 8 hours, while hormonal testing improved from weeks to within 24 hours. These gains enabled same-day clinical decision-making, significantly improving clinician confidence and satisfaction, while reducing unnecessary follow-up by 70% and mitigating system inefficiencies.

Beyond operational improvements, the initiative also enhanced patient engagement, increased screening rates, and expanded virtual care utilization. As a scalable model aligned with national healthcare transformation goals, Aynati demonstrates how laboratory modernization can evolve diagnostics into a strategic enabler of proactive, data-driven care.

Reducing cardiovascular mortality in cancer patients through proactive biomarker-guided care Shandong Cancer Hospital and Institute, China

As advances in cancer treatment extend patient survival, cardiovascular complications associated with therapy have emerged as a critical challenge. Often underdiagnosed and identified too late, these complications can significantly impact patient outcomes and mortality.

Pictured from left to right: Tang Xiaoyong, Zhu Hui, Guo Zhijun, Zhao Miaoqing, Guo Hongbo.

At Shandong Cancer Hospital, an integrated clinical care team addressed this issue by implementing a proactive cardio-oncology program guided by high-sensitivity cardiac troponin (hs-cTn) testing. Instead of relying solely on symptom-driven evaluation, the team introduced routine baseline and serial biomarker testing for patients undergoing cardiotoxic cancer treatments. This shift to early detection and continuous monitoring allowed clinicians to identify at-risk patients before complications arose and implement preventive strategies accordingly. Following implementation, the institution reported a 0.38% reduction in rates of immune associated myocarditis, 50% reduction in cardiovascular mortality, and 37.5% reduction (from 8 to 5 cases) in ICU admissions among lung cancer patients with Grade III or higher immune-associated myocarditis.

A key enabler for this initiative included educational programs across departments, enhancing clinician adoption, and fostering greater confidence and consistency in managing cardiovascular risk in oncology patients. This best practice exemplifies how laboratory medicine can extend beyond diagnosis to become a cornerstone of preventive medicine in complex, multidisciplinary care environments.

Advancing healthcare through integrated, laboratory-driven innovation

The 2026 UNIVANTS award winners collectively demonstrate that laboratory medicine is a central driver of clinical excellence, operational efficiency, and health system sustainability.

These initiatives reflect a growing global recognition that unlocking the full value of laboratory medicine is essential to addressing modern healthcare challenges, from chronic disease and cancer to maternal and population health and beyond.

Congratulations to all 2026 UNIVANTS of Healthcare Excellence award recipients for their dedication to transforming care and improving lives. For more information on the UNIVANTS program and this year’s winners, visit www.

UnivantsHCE.com.

Colleen Strain, PhD is a Scientific Manager at Abbott, Core Diagnostics focused on innovation and the value of laboratory medicine to stakeholders outside of the clinical laboratory. Colleen serves as the Scientific Lead for the UNIVANTS of Healthcare Excellence award program, which recognizes, celebrates and amplifies best practices in healthcare that are enabled by laboratory medicine.

20 | AUGUST 2026 MLO-ONLINE.COM

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STATE OF THE INDUSTRY :: DISEASE MANAGEMENT

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State of the Industry :: Disease Management

STATE OF THE INDUSTRY DISEASE MANAGEMENT

Laboratories navigate antimicrobial resistance challenges Shifting respiratory testing trends, and ongoing supply chain pressures

By Kara Nadeau

T

he 2026 Medical Laboratory Observer (MLO) State of the Industry (SOI) Survey on Disease Management focused on antimicrobial resistance (AMR) and respiratory testing. MLO asked medical laboratory professionals about AMR testing volumes, methodologies, operational challenges, clinical applications, and future technology priorities. The survey also explored respiratory testing volumes, pathogens of concern, testing methodologies, and emerging infectious disease preparedness.

Given continued concerns surrounding tariffs, supply chain disruptions, and global economic uncertainty, MLO also asked respondents whether geopolitical factors are affecting their laboratories’ purchasing and inventory management strategies.

Among survey respondents, laboratory leaders continued to represent a substantial portion of participants, with 10% serving as laboratory directors and

21% serving as laboratory managers, administrators, or supervisors. Most respondents (64%) work in hospital or health system laboratories.

Laboratory sizes varied considerably, with 27% reporting 1-10 employees, 21% more than 100 employees, and the remainder distributed across mid-sized organizations. Compared with 2025, workforce distribution remained relatively stable, although slightly more respondents reported working in laboratories with 51-100 employees.

Alongside the quantitative survey findings, MLO included commentary from laboratory professionals and industry experts involved in AMR and respiratory diagnostics.

Antimicrobial resistance testing trends

As antimicrobial resistance continues to pose a significant global healthcare challenge, clinical laboratories play a critical

role in identifying resistant organisms and informing treatment decisions.

However, survey respondents suggest that many laboratories may still struggle to quantify their AMR testing activity.

When asked how many AMR tests or susceptibility assessments their laboratories had performed during the past 12 months, 21% of respondents reported performing more than 1,000 tests. At the same time, one-third (31%) said they were unsure of their testing volume, while another 24% reported that they do not track this information. Only 7% indicated performing between 1- 100 tests annually.

These findings suggest considerable variability in both testing volume and data tracking practices across laboratories.

Testing methodologies

Traditional microbiology methods continue to dominate AMR testing workflows. Culture-based antimicrobial susceptibility testing (AST) was the most used methodology, reported by 40% of respondents, followed by automated AST systems at 30%. Molecular and PCR-based resistance gene detection have gained significant traction, with 27% of laboratories reporting use of these methods. Meanwhile, 25% continue to utilize manual disk diffusion testing.

More advanced technologies remain less common – with 14% of respondents reporting use of MALDI-TOF mass spectrometry, 12% phenotypic confirmatory testing, and 12% rapid AST methods.

Whole genome sequencing (WGS) was reported by only 2% of respondents, highlighting the limited adoption

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State of the Industry :: Disease Management of sequencing-based approaches in routine clinical laboratory settings.

“Clinical judgment alone struggles to reliably distinguish between bacterial, viral, or fungal infections,” said Jeanie Bach, MSN, RN CCRN, senior medical manager for infectious disease at Roche Diagnostics. “For example, because of overlapping clinical symptoms among respiratory viruses, one study showed that only 36% of influenza cases were correctly identified based on symptoms alone, compared with over 98% accuracy when using a rapid PCR test for flu.1 “Similarly, in urgent care settings relying on symptom-based syndromic management for STIs, 68.8% of patients were overtreated with unnecessary antibiotics, while 8.2% were undertreated,” Bach continued.1,2 “This uncertainty leads to the reflexive prescribing of broad-spectrum antibiotics. Broad-spectrum drugs act as a “catch-all,” disrupting the human microbiota, creating harsher side effects, and further driving the cycle of resistance.”

“Antimicrobial resistance is the hardest area to manage operationally,” said Chris Connelly, PhD, director of business segment, molecular, at Streck.

“Molecular methods detect resistance genes quickly, and rapid phenotypic susceptibility testing has started to close the gap from the other side, but the two are answering different questions. A gene result tells you that a known mechanism is present. A phenotype tells you whether the drug will work on that organism, and they don’t always line up.

Genotypic detection only finds what it’s built to look for, so resistance that comes from an untargeted gene variant, reduced permeability from porin loss, or efflux pump overexpression can be missed even when the organism is clearly resistant.

“As panels add targets and the same chemistry is used for community surveillance, speed stops being the limiting factor,” Connelly added. “The harder problem is confirming the assay still detects every target it’s supposed to, which takes characterized control material covering the full set and, for surveillance work, that material mostly doesn’t exist yet. A faster result has little value without a consistent way to ensure reliable and accurate test results.”

AMR testing challenges

Laboratories continue to face a variety of operational and clinical challenges related to AMR testing. Staffing shortages emerged as the most frequently cited concern, selected by 25% of respondents.

Figure 1: What is the biggest challenge your laboratory faces related to AMR testing?

Staffing shortages Turnaround time requirements Cost/reimbursement concerns Keeping up with emerging resistance mechanisms Limited instrumentation or technology Data reporting/integration with stewardship programs Lack of standardized testing protocols Regulatory/compliance requirements Limited clinician understanding or utilization of results No major challenges 0

5

10

15

20

25

Percentage (%)

Cost and reimbursement issues ranked second at 16%, while 11% identified keeping pace with emerging resistance mechanisms as their primary challenge.

Other concerns included turnaround time requirements, limited instrumentation, regulatory compliance requirements, and challenges integrating laboratory data into antimicrobial stewardship initiatives. Notably, 16% of respondents reported no major challenges, suggesting that some laboratories have developed workflows and resources capable of effectively supporting their AMR programs.

Dee Scott, MLS (ASCP)cm, chemistry section head, generalist, laboratory service excellence ambassador for Memorial Hospital in Carthage, IL. commented on the challenges her lab faces in this area – and how they work to overcome them.

“One of the biggest challenges our laboratory faces related to AMR testing is balancing the need for timely, comprehensive susceptibility results with the resource limitations of a rural critical access hospital. Lower testing volumes, staffing constraints, and limited access to advanced molecular testing platforms can make it difficult to perform the same breadth of AMR testing available in larger reference or tertiary care laboratories.

“To address these challenges, we maintain close collaboration with our reference laboratory partners to ensure access to specialized testing and resistance detection methods when needed.

We also work closely with physicians, pharmacists, and infection prevention personnel to promote appropriate culture collection, antimicrobial stewardship, and effective use of susceptibility data.

In addition, we continuously monitor updates to testing guidelines and resistance trends to ensure our microbiology practices support accurate and timely patient care while maximizing the resources available to our facility.”

How AMR results are used

Survey findings reinforce the laboratory’s central role in patient management and infection control. Nearly two-thirds of respondents (62%) reported using AMR test results primarily to guide antibiotic therapy decisions. More than half (52%) use results to support infection prevention and control efforts, while 41% use them to support antimicrobial stewardship programs.

Additional uses include surveillance and trending of resistant organisms (31%), monitoring treatment effectiveness (28%), public health reporting (24%), and outbreak investigations (10%). These findings highlight the growing importance of laboratory-generated AMR data beyond individual patient care.

Future priorities

When asked which AMR-related capabilities they are most interested in expanding during the next one to two years, respondents most frequently selected molecular resistance detection MLO-ONLINE.COM AUGUST 2026 | 23

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State of the Industry :: Disease Management (12%), automation and artificial intelligence tools (10%), and rapid AST (9%).

However, uncertainty was also evident, with nearly one-third (31%) reporting they were unsure what future investments their laboratories might pursue.

“The most impactful trend will be the convergence of pathogen detection, resistance detection, and host-response testing into more actionable diagnostic strategies,” said Ephraim Tsalik, vice president and chief scientific officer, infectious disease & acute care, Danaher.

“The future is not simply faster tests, but better clinical context. An ideal diagnostic result helps answer: Is this bacterial or viral? Is resistance likely?

How sick is the patient? What should the clinician do now? This is more valuable than organism identification alone.”

Respiratory testing trends

Figure 2: How are AMR test results primarily used within your organization?

Guiding antibiotic therapy decisions Supporting antimicrobial stewardship programs Infection prevention and control efforts Surveillance/trending of resistant organisms Outbreak investigation Public health reporting Research purposes Monitoring treatment effectiveness Unsure 0

while broader multiplex panels can be reserved for patients with severe disease, immunocompromised status, atypical presentations, outbreaks, or situations where broader results will be actionable.

Meanwhile, laboratories are rebalancing their infectious disease menus in areas such as STI and viral hepatitis screening, which were deprioritized during the pandemic.”

Respiratory testing remains a major area of activity for clinical laboratories, although survey results suggest testing demand has stabilized compared with recent years.

In 2025, 75% of respondents reported either moderate or significant increases in respiratory testing volumes. In contrast, this year’s survey found that 46% reported no increase in respira- Respiratory pathogens of concern tory testing volume during the past 12 Influenza A/B remained the respiratory months, while 43% reported a moderate pathogen most frequently associated increase and only 11% reported a sig- with positive test results, cited by 55% nificant increase. These findof respondents. However, ings suggest a return toward this represents a substantial more predictable seasonal decline from 2025, when 82% respiratory testing patterns of respondents identified following the heightened influenza as one of the most demand associated with the common positive findings.

COVID-19 pandemic.

COVID-19 also showed a notable decline, falling “As respiratory testing from 63% in 2025 to 32% in demand normalizes, laboMLS the current survey. RSV reratories are shifting from a Dee Scott, (ASCP)cm crisis-response model to a mained relatively stable at more deliberate, clinically 31%, compared with 33% last driven strategy,” said Tsalik. year. Other commonly identiDuring the pandemic, the fied pathogens included Strep priorities were capacity, speed, A/B (19%), rhinovirus (14%), supply continuity, and rapid human metapneumovirus reporting. Now, the ques(8%), and pneumonia-related tion is more nuanced: which infections (9%). Notably, more test provides the most useful Jeanie Bach, than one-quarter of responanswer for a given patient and MSN, RN CCRN dents (27%) reported they care setting?” did not know which respira“Many laboratories are tory pathogens produced the moving toward tiered testing highest number of positive algorithms,” Tsalik continresults in their laboratories. ued. “Targeted assays for The appearance of human high-prevalence pathogens metapneumovirus among reported pathogens may reflect such as SARS-CoV-2, influenza, and RSV may be appropriate increased awareness and testing for a broader range for routine seasonal illness, Chris Connelly, PhD

10

20

30 40 50 Percentage (%)

60

70

of respiratory illnesses as laboratories continue to refine respiratory diagnostic strategies.

Hantavirus preparedness

The survey also explored laboratory preparedness for hantavirus testing.

Relatively few respondents reported currently performing hantavirus testing, with 5% using RT-PCR and another 5% using PCR methodologies. Smaller percentages reported using serology or rapid testing methods. However, 91% indicated that while they do not currently offer hantavirus testing, they are discussing implementation.

While hantavirus remains relatively uncommon in the U.S., the responses suggest some laboratories are evaluating their preparedness for emerging infectious disease threats.

Respiratory testing methodologies

PCR-based testing remains the dominant respiratory testing methodology, with 51% of respondents reporting its use. Rapid antigen and immunoassay testing followed at 37%, while multiplex molecular syndromic panels and sendout testing to reference laboratories were each reported by 26% of respondents.

Point-of-care molecular testing continues to gain traction, reported by 17% of respondents, while next-generation sequencing remains relatively uncommon at 4%. Viral culture, direct fluorescent antibody testing, and serology continue to play supporting roles in selected clinical settings.

Compared with 2025, molecular methods remain the foundation of respiratory diagnostics, although laboratories appear to be utilizing a broader mix of testing options, including syndromic

24 | AUGUST 2026 MLO-ONLINE.COM

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State of the Industry :: Disease Management panels, point-of-care molecular assays, and reference laboratory partnerships.

“Laboratories are increasingly adopting both antigen and molecular testing,” said David Morris, PhD, associate director, product management, SEKISUI Diagnostics. “When the clinical presentation aligns with the antigen assay, rapid tests are often used for quick testing results and operational simplicity. In cases where results are negative but clinical suspicion remains high; labs may use molecular testing. The dual testing modality gives labs more flexibility so they can deliver both rapid and reliable diagnoses.”

Medical laboratory supply chain strategies

Figure 3: Which respiratory viruses has your lab seen the most positive results for?

COVID-19 Human metapneumovirus (hMPV) Influenza A/B Pneumonia Respiratory Syncytial Virus (RSV) Strep A/B Rhinovirus I don’t know

0

10

MLO also asked respondents whether geopolitical factors are affecting their 2025, the qualitative responses suggest laboratories’ purchasing and inventory that supply chain resilience remains a management strategies. The majority priority for many laboratory leaders.

(81%) reported no impact, compared Scott commented on her experience: with 75% in 2025. However, nearly one “Supply chain disruptions, product in five respondents (19%) indicated backorders, rising costs, and other extergeopolitical factors are influencing their nal factors have affected our laboratory’s purchasing decisions. purchasing and inventory management Among those reporting an impact, strategies. As a result, we have increased common themes included backorders, monitoring of inventory levels, adjusted delayed deliveries, rising costs, tariffs, par levels for critical reagents and conand supply shortages. Several sumables, and maintained closer communication with respondents specifically refvendors regarding product erenced challenges obtaining products manufactured overavailability and lead times. seas and concerns regarding “These challenges are amplified by the fact that reimbursement failing to keep pace with increased supply we are a rural critical access costs. Others described the hospital. Unlike larger health need to place orders earlier, Ephraim Tsalik systems that may have mulincrease inventory monitortiple facilities or centralized ing, are carefully balance supply chains, we often have stock availability against exfewer local resources and less flexibility when critical piration risks. laboratory supplies are unOne respondent noted that tariffs and international shipavailable. Delays in receiving reagents or consumables can ping delays have increased supply costs without corhave a significant impact on responding reimbursement David Morris, PhD our ability to provide timely increases. Another described testing services to our patients weekly ordering becoming necessary and community. because of limited storage capacity “To mitigate these challenges, we and unpredictable supply availability. work collaboratively with neighboring Others cited ongoing shortages of labo- hospitals and laboratory partners to borrow reagents and other essential ratory disposable media.

“We have seen customers shift their supplies when shortages occur. Likepurchasing strategy from a cost-based wise, when supply issues prevent our approach to a focus on supply chain reli- neighboring hospitals from performability,”said Morris.“Consistency in labo- ing certain tests, our facility assists by ratory workflows is key for our customers, performing testing on specimens from which is why more are choosing suppliers their patients. These experiences have with products made in the USA.” required a more proactive approach to Although fewer laboratories reported inventory management, contingency geopolitical impacts this year than in planning, and regional collaboration to

20

30

40

50

60

Percentage (%)

ensure continuity of laboratory operations, maintain quality standards, and support uninterrupted patient care.”

Looking ahead

The 2026 MLO State of the State Industry survey illustrates a laboratory community balancing innovation with operating realities. In antimicrobial resistance testing, laboratories continue to rely heavily on traditional susceptibility testing while exploring opportunities in molecular diagnostics, automation, and rapid testing. At the same time, staffing shortages, and reimbursement pressures remain significant concerns.

Within respiratory diagnostics, testing demand appears to be stabilizing, while molecular methods continue to drive laboratory decision-making. Laboratories are also expanding awareness of emerging pathogens and evaluating preparedness for future infectious disease threats.

As healthcare systems continue to confront evolving infectious disease challenges, clinical laboratories remain at the center of efforts to improve patient outcomes, support stewardship initiatives, and strengthen public health surveillance.

Kara Nadeau has 20+ years of experience as a healthcare/ medical/technology writer, having served medical device and pharmaceutical manufacturers, healthcare facilities, software and service providers, non-profit organizations and industry associations.

References are available online at mlo-online.com/55390984

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LAB MANAGEMENT :: AI IN THE LIS

ID 214010857 © Angellodeco | Dreamstime.com

Lab Management :: AI in the LIS

Artificial intelligence in laboratory information systems: Transforming the future of clinical diagnostics

By Rajasri Chandra, MS, MBA

L

aboratory testing plays a very crucial role in patient care. Laboratory test results are believed to influence medical decisions by 70% or more.1,2 Laboratory testing not only helps in diagnosing patients’ ailments but also helps in planning treatments, managing chronic conditions, assessing treatment response, and developing new therapeutics. Central to the functioning of any modern clinical laboratory is the laboratory information system (LIS). The LIS was designed as a “turn-key” computer system that would allow control of daily processing of the laboratory.

The system performs the following 15 major functions: 3 1. Registration of test requests 2. Production of specimen collection sheets

3. Creating identification labels 4. Confirmation of specimen collection 5. Production of aliquot labels 6. Workload inquiry 7. Production of worksheets 8. Manual entry of test results 9. Automated entry of test results 10. Results inquiry 11. Generation of preliminary report 12. Generation of final report 13. Generation of daily activities reports 14. Generation of statistical reports 15. Billing The following are benefits of the LIS: (a) reduced clerical work, (b) better evaluation of workload, (c) faster communication, (d) improvement of information given to the clinician [adapted reference values, interpretation, comments], (e)

improved retrieval operations, and (f) faster billing.3

History and evolution of the laboratory information system

• Pre-1970s: Clinical testing records were handwritten logs, used manual calculations, and paperbased reporting. Work was laborintensive, and the risk of transcription errors was high.4 • Late 1980s: First LIS system emerged that used a centralized on-premise, minicomputer to reduce transcription errors of sample analysis by automating reporting tools.4,5 • 1990s: Evolved to automate workflows and integrate directly with laboratory testing instruments.

Commercial off-the-shelf (COTS)

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Lab Management :: AI in the LIS packages emerged, allowing for structured data management, quality control, and compliance tracking. 5,6 • 2000s: Transitioned from proprietary, isolated systems to dynamic, web-enabled client/server architectures. This era marked the birth of early cloud-based platforms and heavy integrations with enterprise networks, barcode readers, and raw data systems.7 • 2010s: Transitioned from rigid, onpremise software to cloud-based, SaaS-model platforms. There was a shift toward mobile accessibility, the modernization of web portals, and handling massive datasets stemming from the genomics boom and high-throughput screening.7,8 • 2020s: Modern LIS operate as comprehensive Enterprise Resource Planning (ERP) tools. They are now incorporating Artificial Intelligence (AI) for predictive analytics, machine learning for automated result interpretation, and advanced data security to meet evolving HIPAA and global compliance regulations. 5-9

Impact of artificial intelligence in the laboratory information system

The emergence of artificial intelligence (AI) has redefined the LIS - enabling unprecedented levels of automation, accuracy, and clinical intelligence. Artificial intelligence (AI) encompasses a range of technologies — including machine learning (ML), deep learning (DL), natural language processing (NLP), and large language models (LLMs) — each finding a foothold in different domains of the LIS.9 The incorporation of AI in the LIS has transformed clinical laboratories and has helped to considerably enhance lab operations and decision making.

Through integration with external AI-powered platforms, laboratories can now automate pattern recognition, optimize workflows, perform predictive modeling, and make informed decisions. These integrations allow labs to leverage machine learning algorithms for applications like anomaly detection, resource forecasting, and quality control analysis—streamlining complex processes without altering core LIS functionality.

Insight for Clinical Laboratory Professionals and Management

AI-Powered LIS supports several key laboratory functions10

Enables predictive equipment maintenance: AI-powered LIS tracks usage and performance metrics of lab instruments so as to schedule maintenance proactively and minimize equipment downtime.

Detects substandard reagents: It monitors reagent quality and flags those that fall short of quality benchmarks, helping ensure data reliability.

Automates inventory replenishment: AI-powered LIS simplifies inventory control by triggering automatic purchase orders when supply levels drop, ensuring critical items are restocked on time.

Evaluates vendor performance: By storing and analyzing supplier data, AI-powered LIS aids in selecting dependable vendors, building consistent and trusted procurement relationships.

Establishes competitive pricing: It helps optimize pricing strategies by analyzing costs and market data, contributing to improved profitability.

Assesses staff performance: AI-powered LIS captures staff performance data—such as accuracy and speed—enabling comparisons and identifying areas for training and improvement.

LabOS is redefining the modern LIS platform.

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Lab Management :: AI in the LIS Workflow of a typical LIS Sample Registration (Barcode)

Task Allocation

Certificate of Anyalysis (CoA)

Result Registration

Billing & Invoicing

32 2354

1

2

Test Order

3

4

Sample Preparation

5

Sample Testing

6

7

8

Result Validation & Approval

9

10

CoA Release

Source: CloudLIMS. What is a LIMS? May 2025. What is a LIMS (Laboratory Information Management System)? Definition, Purpose, & Benefits of LIMS.

How AI improves data analysis in the LIS

By connecting an LIS with AI-driven analytics tools, labs can extract deeper insights from large volumes of structured data.

AI can help identify trends, outliers, and correlations that might otherwise go unnoticed. This empowers researchers and lab managers to make more informed decisions, enhance experimental design, and accelerate discovery while maintaining rigorous data integrity and traceability.

Because of this capability of AI, AI-powered LIS have become helpful in clinical operations and decision support.

AI-powered LIS in clinical operations and decision support Autoverification and validation

AI within the LIS can perform automated review and release laboratory results without the intervention of a manual technologist. Traditional rule-based autoverification systems, guided by standards such as CLSI AUTO-10, use fixed thresholds for delta checks, critical values, quality control flags, and analytical error detection. However, these static rules are limited in their sensitivity and cannot adapt to complex, multivariate patient pattern.

AI validation in LIS ensures that machine learning algorithms and diagnostic tools are accurate, safe, and reliable before they go live. It involves evaluating model performance, data interoperability, and clinical utility against established laboratory benchmarks.

Predictive analytics and clinical decision support12-14

AI-enhanced LIS platforms are increasingly being integrated with clinical decision support systems (CDSS) to move beyond passive result reporting toward proactive diagnostic intelligence. Machine learning models embedded in or connected to the LIS can analyze patterns across thousands of patient records to predict clinical events such as sepsis, acute kidney injury, or deteriorating coagulation profiles before they reach critical thresholds. Risk stratification algorithms are being developed that combine laboratory results with demographic and clinical data to identify high-risk patients, enabling timely interventions.

Natural language processing of unstructured clinical data15

Clinical laboratories generate enormous quantities of unstructured data — pathologist narratives, microbiology culture comments, and free-text clinical notes — that traditional LIS platforms have struggled to process systematically. NLP is emerging as a critical tool for automating data capture, mapping clinical notes to terminologies, and extracting hidden insights.

A 2024 systematic literature review in the Journal of Medical Internet Research documented the growing use of NLP combined with CDSS across 26 studies, demonstrating how AI-powered text mining can extract clinically actionable information from electronic health records (EHR)s, improving diagnostic accuracy and reducing cognitive burden on laboratory professionals. LIS platforms are beginning to incorporate NLP engines that can parse pathology reports, flag discrepant findings, and intelligently link narrative data to structured laboratory results.

Error detection and quality management16,17

Artificial intelligence transforms LISs by automating quality control, detecting pre-analytical errors, and utilizing machine learning for predictive modeling to flag anomalies in patient data. Integration of these AI error-detection models directly into the LIS workflow represents one of the most promising avenues for improving patient safety.

AI in anatomic pathology and digital imaging18

Beyond the clinical chemistry laboratory, AI is reshaping anatomic pathology through digital pathology platforms connected to the LIS. Deep learning algorithms can analyze whole slide images to detect malignant cells, grade tumors, and identify organisms in microbiology specimens. These systems do not replace pathologist judgment but serve as a powerful computational layer within the LIS reporting workflow.

The Future of the LIS in the age of artificial intelligence

The trajectory of AI in the LIS points toward a future of remarkable capability, though one must also navigate significant challenges in governance, interoperability, and workforce adaptation.

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Lab Management :: AI in the LIS Cloud-native, interoperable AI platforms

The LIS of the future shows a rapid shift toward cloud-native microservices, interoperability via HL7/FHIR standards, and federated learning to ensure HIPAA-compliant, secure diagnostic workflows.19

Large language models and generative AI in the LIS20

Large language models (LLMs) and generative AI represent the next frontier of LIS intelligence. These models can engage in natural language dialogue with laboratory staff, draft interpretive comments for complex test panels, assist in literature-informed clinical interpretation, and support non-expert users in navigating laboratory data. The rapid maturation of multimodal AI — models that process text, images, and structured data simultaneously — will further extend these capabilities to encompass pathology imaging, genomic data, and mass spectrometry outputs within a unified LIS environment.

Autonomous workflows and staffing challenges

The United States Bureau of Labor Statistics projects more than 24,000 vacancies for clinical lab technologists every year for the next decade.21 AI-enhanced LIS platforms that can autonomously manage reflex testing, autoverification, quality control, and result interpretation will be essential to sustaining laboratory operations in this constrained workforce environment.

Challenges: Governance, ethics, and validation

The integration of AI into the LIS is not without challenges.

Regulatory frameworks for AI-powered in vitro diagnostics remain immature in many countries, and the validation requirements for ML-based autoverification systems are still evolving. Bias in training data, lack of model explainability, and cybersecurity vulnerabilities in cloud-based architectures represent real risks. Laboratory professionals and

pathologists must remain actively engaged in the governance and oversight of AI systems embedded in the LIS, ensuring that automated recommendations are auditable, transparent, and subject to regular performance review. The EU AI Act, fully effective through 2026, and evolving FDA guidance on AI/ML-based software as a medical device (SaMD) will shape the regulatory landscape for LIS-embedded AI in the years ahead.

Conclusion

The laboratory information system has undergone a remarkable evolution over six decades — from punched-card mainframe interfaces to cloud-based, AI-enhanced diagnostic platforms. Artificial intelligence is now permeating every functional layer of the LIS: from autoverification and quality management to clinical decision support, NLP-driven narrative processing, and digital pathology interpretation. The data suggests that the pace of AI integration into laboratory informatics will only accelerate. For laboratory managers and pathology informaticists, the imperative is clear: invest in data quality and standardization now, engage proactively in AI governance frameworks, and champion the role of laboratory professionals in the design and oversight of intelligent systems. The LIS of tomorrow will not merely store and report results — it will think, predict, and act as an active partner in the delivery of precision medicine.

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.

References are available online at mlo-online.com/55390593.

INDEX OF ADVERTISERS Advertiser........................................................................Web........................................................................................................ Page American Proficiency Institute (API).............................api-pt.info/new-enhanced-programs.......................................................19 Bruker Molecular............................................................bruker.com.................................................................................................27 Canon Medical Diagnostics USA...................................https://mdu.medical.canon/......................................................................17 Diasorin...........................................................................diasorin.com/cauris.................................................................................. C3 Diazyme Laboratories.....................................................diazyme.com/diabetic-markers................................................................25 Health Care Logistics......................................................GoHCL.com................................................................................................ 11 LabOS..............................................................................https://go.labos.co/LabOS-Learn-More?rb.src=QR.................................29 Sebia................................................................................https://go.zeusscientific.com/difine-family............................................. C2 Sysmex America.............................................................sysmex.com.................................................................................................3 Werfen - Hemostasis......................................................werfen.com/na/en/hemostasis................................................................. C4 This index is provided as a service. The p­ ublisher does not assume liability for errors or omissions.

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PRODUCT FOCUS :: ANALYZERS

Product Focus :: Analyzers

Fully automated benchtop coagulation analyzer STA Satellite Max is a fully automated benchtop coagulation analyzer performing clotting, chromogenic, and immunologic assays. Features include viscosity-based detection, barcode sample identification, continuous loading, removable reagent carousels, primary tube support, onboard sample/reagent traceability, D-dimer and anti-Xa testing, and connectivity to STA Coag Expert for full traceability.

Stago

FDA-cleared clinical drug testing Available on the Evidence MultiSTAT, the FDA 510(k)-cleared Drugs of Abuse Multiplex panel is a 15-drug multiplex rapid testing panel. The pre-filled reagent cartridges offer simultaneous detection of 15 drugs of abuse from urine in just 21 minutes, with a simple three-step testing process.

Randox

Objective data for confident decisions

Hemolysis detection in POC blood gas testing

The T-TAS 01 minimizes the subjectivity of platelet assays by delivering a clear, numerical AUC result with an established clinical cutoff. This provides an objective, reproducible measure of platelet thrombus formation related to primary hemostatic function, empowering labs to deliver consistent, reproducible data that aids confident clinical decision-making.

Diapharma

For the first time in point-of-care blood gas testing, hemolysis is flagged in just 45 seconds on the new GEM Premier 7000 with iQM3. Continuously monitoring the analytical process, before, during, and after each sample measurement, it detects, corrects, and documents sources of error, for qualityassured results.

Werfen

The only FDA-cleared quantitative urinalysis test The FDA-cleared AutoUA is a fully automated, liquid quantitative urinalysis system that replaces traditional qualitative dipsticks. Compatible with the AUA-450 benchtop analyzer, it measures 12 urine analytes, providing creatinine-normalized quantitation to correct for dilutional variance, significantly reducing diagnostic error rates for biomarkers like leukocytes, hemoglobin, and proteins.

Sciteck

Upgraded automation for latent tuberculosis testing The FDA-approved Auto-Pure 2400 liquid handling platform is designed to automate the T-SPOT.TB test, improving laboratories’ productivity while maintaining consistent clinical performance in latent tuberculosis detection.

The Auto-Pure 2400 combines liquid handling with magnetic cell isolation technology, reduces hands-on time, and delivers accurate, high-throughput TB testing — for in vitro diagnostic use.

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CLINICAL SPOTLIGHTS

Clinical Spotlights

Precision in Every Pair Diazyme’s Kappa and Lambda Free Light Chain Assays provide accurate, timely insights for the diagnosis and monitoring of Multiple Myeloma. Enhance your lab’s performance with trusted, high-quality results. Available on most major clinical chemistry analyzers.

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Introducing the Sysmex XR-Series™ 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.

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RUNNING HEADER :: CONTINUED HEADER

LABORATORY

INNOVATOR

Stago’s vision for hemostasis: Q&A with CEO Nichole Howard

By Christina Wichmann

Nichole Howard, MBA serves as Chief Executive Officer of Stago North America, where she leads the organization’s growth strategy, operational excellence, and commitment to delivering innovative diagnostic solutions that improve patient care.

Since joining Stago in 2014, she has held a series of leadership roles across the organization, developing deep expertise in the business and the coagulation diagnostics market.

Nichole is passionate about building high-performing teams, accelerating innovation, fostering customer trust, and developing leaders who drive meaningful impact through accountability, collaboration, and continuous improvement.

Laboratories today are increasingly focused on automation, workforce shortages, and operational efficiency. How is Stago helping laboratories address these challenges while ensuring accurate and reliable hemostasis testing?

Laboratories today are being asked to do more with fewer resources. Staffing shortages, increasing test volumes, and the need for faster turnaround times have made workflow optimization a priority all while maintaining the quality and confidence clinicians depend on for patient care.

At Stago, our focus is on helping laboratories improve efficiency without compromising confidence in their results. That starts with automation through our Max Generation family and extends to digital workflow solutions

such as Connect.One and Coag.One that help standardize testing, reduce manual intervention, simplify complex coagulation workflows such as factor and lupus anticoagulant algorithms, and even add automation to lot conversions with our Accreditation Tools.

Stago’s superpower is our Viscosity-Based Detection System (VBDS), a proven technology that directly measures changes in viscosity during the clot formation rather than relying on optical interpretation.

This enables laboratories to deliver reliable results even with challenging samples affected by hemolysis, icterus, and lipemia.

By combining trusted technology, automation, and digital innovation, Stago helps laboratories improve productivity while maintaining the diagnostic confidence clinicians depend on.

Looking ahead, what emerging technologies, testing needs, or clinical trends do you believe will have the greatest impact on hemostasis diagnostics over the next five years?

I believe three trends will shape hemostasis over the next five years.

First, laboratories will continue to face workforce shortages while testing volumes grow. Technology must do more than automate; it must help preserve expertise and enable less experienced staff to perform increasingly complex testing with confidence.

Second, digital connectivity will become just as important as instrument performance. Laboratories want systems that integrate seamlessly into enterprise workflows, standardize testing across multiple sites, and provide actionable insights from laboratory data.

Finally, we expect continued growth in specialized coagulation testing as precision medicine expands and clinicians increasingly rely on biomarkers to guide therapy. That creates opportunities for new assays and decision-support tools that improve both diagnostic accuracy and patient outcomes.

The companies that succeed won’t simply build better analyzers. They’ll build ecosystems that combine instrumentation, software, data, and scientific expertise to help laboratories operate more effectively.

Stago operates in a highly competitive diagnostics market. What do you believe differentiates Stago most in the eyes of laboratory customers, and how are you building on those strengths as the market evolves?

What truly differentiates Stago is that hemostasis isn’t one part of our business, it is our business. For nearly 80 years, that singular focus has allowed us to build deep scientific expertise, develop technologies like our ViscosityBased Detection System (VBDS), and create one of the industry’s strongest organizations dedicated exclusively to coagulation diagnostics.

But technology alone isn’t what defines us. Our job isn’t simply manufacturing coagulation analyzers. Our job is to help laboratories succeed.

That means helping our customers navigate workforce shortages, improve operational efficiency, standardize complex testing, and ultimately deliver the highest quality patient care with confidence.

That’s why we’re investing just as heavily in our people as we are in our products. We continue to strengthen our global service organization, expand our scientific and clinical support, and enhance our digital solutions to help laboratories automate workflows, improve consistency, and make the most of limited staff resources.

As healthcare continues to evolve, our goal isn’t simply to provide outstanding instrumentation. We strive to be a trusted partner that laboratories can rely on to solve complex challenges, improve performance, and advance patient care. We believe that long-term partnerships, not just products, are what truly set Stago apart.

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MOLECULAR SOLUTIONS

Timely, Reliable Detection to Help Prevent Candida auris Outbreaks Only FDA authorized real time PCR test delivering results in under 2 hours to support fast identification of patients suspected of Candida auris colonization.

Key Advantages • Simple workflow on the LIAISON® MDX: no extraction, flexible run size (1-8 specimens) • Strong performance: PPA 94.8%, NPA 98.7% • Clinically proven, including a peer-reviewed study at University of California, San Diego showing 100% sensitivity and 90% specificity when compared to culture (gold standard) and strong agreement with PCR LDT methods.

Together, these findings confirm the assay’s strong laboratory performance and its suitability for routine C. auris testing initiatives.

Simplexa® C. auris Direct Delivering confidence in infection prevention and control initiatives

Contact Diasorin for details: bit.ly/diasorin-cauris p: +1 (512) 336 3554 w: diasorin.com ©2026 DIASORIN MOLECULAR LLC. All rights reserved.

LIAISON MDX is a trademark of DIASORIN S.p.A., registered in the US and other countries.

PRTA1138000.US.0326

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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.

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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.

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