Medical Laboratory Observer - May 2026

May 2026 MLO-online.com

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The Peer-Authored Management Source for Lab Professionals since 1969

CE: From informatics

to AI: Building intelligent laboratory quality systems Page 8

State of the

Industry Lab Management Best Practices Page 24

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F ROM T HE EDITOR

Six essentials of positive mental health

L

ast month, the first study to achieve international consensus on what constitutes positive mental health was published in Nature Mental Health. Since May is Mental Health Awareness Month, a time to promote mental wellness, I thought it would be valuable to share some findings from this study with you.

The authors surveyed 122 global experts across 11 disciplines relevant to positive mental health, includ‑ ing economics, medicine, psychiatry, psychology, public health, sociology, and theology. With feedback from the global experts, the authors have defined positive mental

By Christina Wichmann health as follows: “Positive mental health is a personal and subjective experiEditor in Chief ence, where we are content with our lives, feel good, function well, and view ourselves favorably. Our level of positive mental health can vary over time and is influenced by the way we adapt to the problems and opportunities we face. It’s impacted by many factors such as our environment, life experiences, cultural background, biology, and behaviors. Many people have some level of positive mental health, and we can improve it by taking action using a variety of means, even when we experience a mental health condition.”

The authors achieved agreement (75%+ consensus) on 19 dimensions, with near‑unanimous agreement (90%+ consensus) on six dimensions that are es‑ sential to positive mental health. This consensus provides a unified framework for promoting and measuring mental well-being, helping to align research, practice, and policy worldwide.

The six dimensions that achieved exceptional consensus (exceeding 90% agree‑ ment among experts) as either essential or important for positive mental health are as follows: 1. Meaning and purpose – feeling life is worthwhile and goal‑directed 2. Life satisfaction – overall evaluation that your life is good 3. Self‑acceptance – positive and non-judgmental view of self 4. Connection – close, caring relationships with others 5. Autonomy – feeling in control of choices and self‑expression 6. Happiness – frequent positive mood and cheerfulness The 19 dimensions that are considered either an outcome or a driver of positive mental health are as follows: 11. Fun 1. Acceptance 12. Happiness 2. Achievement 13. Life satisfaction 3. Activities and functioning 14. Meaning and purpose 4. Autonomy 15. Optimism 5. Belonging 16. Safety 6. Calmness 17. Self-acceptance 7. Competence 18. Self-congruence 8. Connection 19. Vitality 9. Development 10. Engagement According to the primary author, Dr. Matthew Iasiello,“Positive mental health is less about feeling good all the time, and more about having the right combination of factors to cope, live well, and experience life as meaningful. When people can better recognize which parts of their well-being are strong, and which might need support, it gives them a clearer sense of where to focus their efforts” I welcome your comments and questions — please send them to me at cwichmann@mlo-online.com.

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Vol. 58, No. 4

EDITOR IN CHIEF Christina Wichmann

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MAY 2026 | Vol. 58, No. 4

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From the editor The observatory

CONTINUING EDUCATION

8

From informatics to AI: Building intelligent laboratory quality systems

By Nancy Ross MS, MT(ASCP)cm, CQIA (ASQ), CLC (AMT), CQM/OE (ASQ); Irwin Z. Rothenberg; and Graham K. Mafela, MLS (ASCP), MBA CLINICAL ISSUES

12

From imaging to blood: Alzheimer’s diagnostics evolve

By Rajasri Chandra, MS, MBA

8

LAB MANAGEMENT

16

The risks of in vitro hemolysis and the importance of early detection in critical care medicine — an ICU clinician’s perspective

By Christina Wichmann

INFECTION DIAGNOSTICS

20

Q&A: Tackling antimicrobial resistance in resource-constrained laboratories

12

By Chris Armstrong and Christina Wichmann

STATE OF THE INDUSTRY

24

Operational efficiency, financial visibility, and workforce pressures shape laboratory best practices in 2026

By Kara Nadeau

MOLECULAR DIAGNOSTICS

30

A new era for oncology testing: Early detection with 5hmC profiles

16

By Jeffrey Venstrom, MD

EDUCATION

32

Positive results: Urinalysis as a competitive advantage

By Tahir Haque, MD

PRODUCT FOCUS

36

Rapid/bench top testing

20

LAB INNOVATOR

38

Preparing cytotechnologists for the future

By Christina Wichmann

DEPARTMENTS

34

Index of advertisers

ON THE COVER: xavierarnau / E+ / Getty Images

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THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS

THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS

Fast Facts Survey reveals Americans’ colorectal cancer screening preferences Guardant Health via The Harris Poll recently asked more than 1,000 colorectal cancer screening-eligible American adults about their screening preferences.

Key findings are reported in a press release.

The survey respondents were asked about multiple screening methods like traditional colonoscopies, blood tests, and stool tests. Here is what they said:

>90%

would like to see blood-based colorectal cancer screening be covered by insurance.

71%

are anxious about undergoing a colonoscopy.

77%

bymuratdeniz / iStock / Getty Images Plus / Getty Images

said they would likely follow through with screening without delay if the U.S. Food and Drug Administration (FDA) approved a blood test for colorectal cancer screening.

85%

reported willingness to receive a follow-up colonoscopy if a blood test revealed need.

54%

said they are grossed out by stool tests.

Source: https://investors.guardanthealth.com/press-releases/ press-releases/2026/New-Guardant-HealthHarris-Poll-Survey-Show s-92-of-All-Eligible-Americans-Believe-Colorectal-Cancer-Bloo d-Tests-Should-be-Accessible-and-Covered-Similar-to-Medicare/ default.aspx.

Connection found between vitamin D and tau protein

A recent study may have discovered an effective way to minimize dementia risk, according to the American Academy of Neurology (AAN). The organization reported on the Neurology study in a press release, emphasizing that future studies are still needed.

The pathway is a connection between vitamin D and tau.

Middle aged individuals who have higher vitamin D blood levels were found to also have less tau protein in the brain. It is important to note that the findings don’t prove “that vitamin D levels lower the level of tau and the risk of dementia; it only shows an association.”

Nearly 800 dementia-free adults participated in the study.

They were given brain scans 16 years after their vitamin D blood levels were measured. The authors concluded,“Higher vitamin D levels were associated with lower levels of the Alzheimer’s biomarker tau protein years later.”

Martin David Mulligan, MB BCh BAO, of the University of Galway in Ireland told AAN, “These results suggests that higher vitamin D levels in midlife may offer protection against developing these tau deposits in the brain and that low vitamin D levels could potentially be a risk factor that could be modified and treated to reduce the risk of dementia.

Of course, these results need to be further tested with additional studies.”

Can a widely accessible vaccine reduce Alzheimer’s risk?

In a recent Neurology-published study, scientists have discovered a connection between flu vaccine dosing and Alzheimer’s risk in adults over 65 years of age.

The researchers analyzed more than 160,000 individuals over 65 with no cognitive impairment at the start of the trial.

Most of the participants received a high-dose flu vaccine, while about 44,022 received the standard dose. After being followed up with for three years, the researchers found that the group who received the high dose had a lower chance of developing Alzheimer’s for about two years after getting vaccinated, particularly the women participants.

AHA announces new insights in cholesterol management

The American Heart Association (AHA) has announced the discontinuation of the 2018 AHA/ACC Guideline on the Management of Blood Cholesterol. Clinicians should now follow the 2026 Guideline on the Management of Dyslipidemia, according to the AHA. The new document covers “atherosclerotic cardiovascular disease (ASCVD) risk associated with atherogenic lipoproteins beyond low-density lipoprotein cholesterol (LDL-C), including triglyceride-rich remnant particles and lipoprotein(a) [Lp(a)].”

Additionally, it emphasizes: • Utilizing the American Heart Association PREVENTASCVD equations for clinical decision-making regarding primary-prevention lipid-lowering therapy.

• Screening patients for Lp(a) at least once and then measure selective apolipoprotein B (ApoB) to evaluate risk and aid treatment decisions.

• The re-emergence of “LDL-C and non-high-density lipoprotein cholesterol (HDL-C) treatment goals.” Patients at high risk should have lower targets.

• The broader “use of coronary artery calcium (CAC) scoring to reclassify risk.”

Suggestions were derived from clinical evidence as late as 2024.

New sepsis care guidelines emphasize prehospital testing and early intervention

Drs. Hallie Prescott from the University of Michigan and Massimo Antonelli from Catholic University in Rome, Italy have co-led the first sepsis care guidelines update in five years, according to the University of Michigan.

Included in the update are suggestions for testing high-risk patients in the ambulance before they reach the hospital.

69 international experts worked on the new guidelines. Key suggestions:

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THE OBSERVATORY :: NEWS :: TRENDS :: ANALYSIS • Patients should be screened for sepsis risk on their way to the hospital with a standard sepsis screening tool.

• If a patient has a longer ambulance ride to the hospital and is diagnosed with probable sepsis and low blood pressure, they should receive antimicrobial therapy before they arrive.

• If an antibiotic is administered to a patient, it “should be more carefully considered.”

• Empiric anti-fungal therapy should only be used in “rare case-by-case situations in patients are at very high risk of fungal infection.”

The authors emphasized that the updates do not cover all clinical questions and those should be the subject of future research.

The full guidelines are published in Critical Care Medicine.

Researchers develop rapid, portable POC test for multiple STIs

The first rapid, portable point-of-care (POC) for the diagnosis of four sexually transmitted infections (STIs) has been developed by Peter Doherty Institute for Infection and Immunity scientists and could be ready for routine clinical use over the next five years, according to an announcement.

The test aims to accelerate treatment and help stop the spread of common STIs. Key features: • Utilizes next-generation CRISPR technology • Can diagnose syphilis, herpes, chlamydia and gonorrhoea at the same time • Produces results within an hour • Identifies potential gonorrhoea antibiotic-resistance • Self-collected specimens can be used The test’s developers are working to “move the device into implementation trials, aiming for routine clinical use within the next five years.”

New personalized treatment option for tumors

Adaptive radiation therapy has been added to Roswell Park Comprehensive Cancer Center’s treatment offerings. They are the first in the region to provide the precision treatment, according to an announcement.

The therapy utilizes advanced technology “to enable a linear accelerator” and artificial intelligence (AI) to directly attack cancer. It allows oncologists to shift treatment to keep up with changing tumors. It also generates fewer side effects and requires less radiation.

Roswell Park says this pathway is “most beneficial for patients with tumors in areas of the body that may change or shift due to treatment or day to day life.”

Blood test could lead to personalized breast cancer treatment in women over 70

A group of UPMC Hillman Cancer Center and University of Pittsburgh School of Medicine researchers have discovered that a blood test could lead to personalized breast cancer treatment for women over 70, according to an announcement.

Participants were all 70 years of age or older, had estrogen receptor–positive breast cancer, and underwent blood testing.

The scientists looked for circulating tumor DNA (ctDNA) in the blood. They discovered that those without ctDNA before treatment or after starting endocrine therapy “were more likely to have stable disease or tumor shrinkage.”The opposite was found in participants with ctDNA. The researchers emphasized that this could mean those

who are ctDNA-negative won’t benefit from surgery and radiation, while those who are ctDNA-positive might, but larger studies are needed to confirm these results.

CDC test directory updates

The Centers for Disease Control and Prevention’s (CDC) infectious diseases laboratories accept specimens from state public health laboratories and other federal agencies for analysis.

Effective March 30, 2026, the CDC updated several test orders in its directory according to an update on its website.

New test orders: • Brucella Species Antimicrobial Susceptibility Testing – CLIA • New World Hantavirus Testing – Non-CLIA • Deleted test orders (no longer performed at CDC): • Filariasis Serology – CLIA • Toxocariasis Serology – CLIA Numerous tests have been temporarily paused (see examples below). The reason given for some is that commercial diagnostic testing is available.

• Adenovirus Molecular Detection – CLIA • Poxvirus Molecular Detection – CLIA • Poxvirus Serology – CLIA • Rabies Antibody Titer (Human) – CLIA • Rabies Antemortem Human Testing – CLIA According to the New York Times, “layoffs, hiring freezes and resignations have shrunk the number of qualified scientists who can assist state labs. The CDC’s rabies and pox virus teams have lost many of their members. By July, the rabies team will be down to just one person with the clinical expertise to advise state and local officials, and the pox virus team will have none,” according to an anonymous source.

Study questions routine colorectal cancer screening for seniors over 75

UC San Diego Health recently led a study weighing the risks and benefits of screening adults over 75 for colorectal cancer, the cutoff age for recommended screening. The university’s Dr. Samir Gupta spearheaded the research of U.S. veterans, according to a release.

The more than 90,000 participants were all over the age of 75 and had previous colonoscopies. The researchers found that “the risks of older adults developing colorectal cancer from previous adenomas was much lower than their risks of dying of causes other than colorectal cancer.”They noted that older adults should speak with their physicians about receiving a colonoscopy and that they may need to focus on other health concerns rather than surveillance.

Mayo Clinic validates safe at-home cancer care model

A recent Mayo Clinic study has validated the health system’s at-home cancer care model, according to an announcement.

Treatment involves home chemotherapy.

10 participants received IV chemotherapy infusions in the comfort of their homes. Of the 93 administered infusions, none resulted in any safety events or catheter-related infections. The safety of the home treatment was comparable to receiving treatment in-clinic.

Mayo Clinic’s Cancer CARE Beyond Walls (Connected Access and Remote Expertise) model aims to reduce some of the burden on cancer patients. Study participants reported satisfaction with their home care and “said they would recommend the model to others.”

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CONTINUING EDUCATION :: ARTIFICIAL INTELLIGENCE AND LABORATORY QUALITY

ID 322055824 | Ai © Anatolii Savitskii | Dreamstime.com

Continuing Education :: Artificial intelligence and laboratory quality

From informatics to AI: Building intelligent laboratory quality systems

By Nancy Alers MS, MT(ASCP)cmp, CQIA (ASQ), CLC (AMT), CQM/OE (ASQ); Irwin Z. Rothenberg; Graham K. Mafela, MLS(ASCP), MBA

C

linical laboratories have always been quality-driven organizations, but the way quality is achieved is changing quickly. For much of the twentieth century, the center of gravity for quality management was the analytical phase: accuracy, precision, and reproducibility demonstrated through quality control materials, calibration verification, proficiency testing, and routine instrument maintenance. This approach established the laboratory’s reputation

as a scientific environment where performance could be measured, controlled, and improved.

Over the past two decades, however, the definition of quality has expanded well beyond analytic performance. The modern quality management system (QMS) must encompass the entire total testing process, from ordering and specimen collection through accessioning, analysis, verification, reporting, and clinician response. In practice, many of today’s quality failures originate outside

Earning CEUs See test online at https://ce.mlo-online.com/FromInformatics-To-AI-Building-Intelligent-LaboratoryQuality-Systems. Passing scores of 70 percent or higher are eligible for 1 contact hour of P.A.C.E. credit.

LEARNING OBJECTIVES

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

Scan code to go

directly to the CE test.

1. Differentiate between analytical, pre-analytical, and post-analytical phases of laboratory testing.

2. Describe the evolution of laboratory quality management systems by explaining the shift from reactive, QC-focused models to proactive models.

3. Discuss concepts of digital and informatics-driven quality management through examples of standardized, auditable workflows.

4. Discuss the importance of the role of artificial intelligence and real-time quality indicators in modern laboratory practice by including predictive analytics, data readiness, and team involvement.

the analytical phase—in specimen labeling, transport delays, interface mapping errors, or communication breakdowns.

Informatics has therefore become a core discipline of quality management, designing workflows that prevent errors, standardizing decisions, reducing variability, and capturing evidence automatically.

The next step in that evolution is the potential introduction of artificial intelligence (AI) and machine learning (ML) into laboratory quality management.

While fully AI-driven quality systems are still emerging in most clinical laboratories, informatics-driven workflows are already transforming how laboratories monitor quality and manage risk.

AI is not a replacement for scientific judgment, nor is it a shortcut to quality.

Its real value lies in its potential to make quality systems more proactive by helping detect patterns that humans may not easily see in real time. Used thoughtfully, AI can help laboratories transition from a reactive “inspect-andcorrect”model to a proactive, data-driven “predict-and-prevent” approach.

From paper logs to smart data systems: The quiet revolution in laboratory quality

A useful way to understand the present moment is to look at how dramatically laboratory quality work has already

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Continuing Education :: Artificial intelligence and laboratory quality changed. In the not-so-distant past, quality programs relied heavily on paper logs, manual temperature recordings, phone calls for critical values, handwritten corrective action notes, and retrospective audits to confirm compliance.

The quality manager’s quality tools were often a collection of binders—QC records, maintenance logs, reagent inventories, competency checklists, and incident reports.

Today, middleware rules enforce autoverification thresholds, delta checks, specimen integrity flags, and instrument-specific quality hard stops. Digital traceability can capture time-stamped events from collection through reporting.

When a critical value is resulted, the preferred pathway is no longer a manual phone call with variable documentation; it is an integrated, closed-loop communication workflow that documents notification automatically. These systems reduce transcription risk, improve documentation reliability, and generate structured data that laboratories can analyze to identify improvement opportunities.

Informatics is the bridge between regulatory mandates and future quality systems, making the measurement of laboratory quality truly continuous.

This shift—from paper to digital workflow—represents the real foundation on which future AI capabilities will build.

For modern laboratory quality management terms, see Figure 1.

A practical example of informatics-enabled quality improvement: Epic Secure Messaging and critical value closed-loop communication

The benefits of informatics become clearest when viewed through a real quality problem. Critical value reporting has historically been one of the most labor-intensive and failure-prone post-analytic processes. Phone calls can be delayed by busy clinical units, unavailable clinicians, and inconsistent documentation. Implementing Epic Secure Messaging can help laboratories transition from manual communication to a closed-loop process that documents when a message is sent, opened, and acknowledged. This approach improves compliance, reduces transcription risk, and creates reliable data that can be analyzed for continuous quality improvement.

A laboratory’s implementation of Epic Secure Messaging illustrates what

Term

What it means in the clinical lab

Why it matters for quality

Informatics

Integration of analyzers, middleware, LIS, and EHR so data flows reliably across the total testing process

Creates continuous visibility into specimen flow, turnaround time, and quality events

Intelligent Workflow

Rule-based processes that route specimens, trigger reflex testing, flag exceptions, and document events automatically

Reduces variability, prevents errors, and creates auditable quality evidence

Artificial Intelligence (AI)

Tools that can assist with pattern recognition and predictive analytics using large data sets

May help identify emerging risks earlier and support proactive quality management

Machine Learning (ML)

Algorithms that learn from historical lab data to improve predictions over time

Can support anomaly detection in QC trends, workflow bottlenecks, and instrument performance

Closed-Loop Communication

Automated systems that document when critical values are sent, received, and acknowledged

Improves compliance, patient safety, and documentation reliability

Real-Time Quality Monitoring

Dashboards showing TAT, backlog, recollections, analyzer uptime, and notification performance

Allows intervention before patient impact occurs

Predict-andPrevent Quality

Moving from retrospective audits to proactive detection of risk patterns

Aligns with modern QMS goals of continuous improvement

Figure 1. The new language of laboratory quality.

intelligent quality looks like in practice.

Instead of relying on manual call chains, the system routes the result directly to the responsible provider, captures the exact time and user acknowledgment, and places the documentation automatically into the medical record.

The workflow becomes standardized, auditable, and measurable transforming a historically inconsistent process into a controlled quality system.

Closed-loop communication reduces documentation gaps and produces structured data that laboratories can

QSE area

How AI & informatics help

Organization & Supervision

Real-time dashboards reveal risk trends, support workload forecasting, and help leaders detect conditions that increase error risk.

Personnel

Workflow analytics identify where errors cluster, enabling targeted, individualized training instead of generic annual refreshers.

Equipment

Predictive maintenance detects drift and performance changes early, reducing downtime and preventing workarounds.

Purchasing & Inventory

Forecasting tools predict reagent needs, prevent stockouts, and identify unusual consumption patterns.

Documents & Records

Automated documentation, version control, and audit trails reduce missing records and strengthen compliance.

Process Control

Patient-based data and anomaly detection complement QC charts and identify problems earlier.

Information Management

AI depends on clean data—standardized identifiers, reliable interfaces, and structured fields become critical quality priorities.

Occurrence Management

Pattern recognition identifies trends in mislabels, recollections, specimen integrity issues, and workflow delays.

Assessment

Continuous monitoring replaces “audit panic,” allowing audits to focus on real risk areas.

Customer Service

Closed-loop communication tools (e.g., Epic Secure Messaging) improve clinician experience and patient safety.

Process Improvement

Faster measurement and trend detection accelerate Plan-DoStudy-Act cycles.

Facilities & Safety

Environmental monitoring and safety analytics support proactive safety management.

Figure 2. How AI and informatics impact quality system essentials and reshape the entire QMS. MLO-ONLINE.COM MAY 2026 | 9

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Continuing Education :: Artificial intelligence and laboratory quality analyze by unit, service line, or time of day to identify trends and improvement opportunities. The benefits are not only faster notification, and better notification, but improved patient safety.

Real-world examples of emerging AI applications in laboratory quality

A common myth to be dispelled is that AI will replace laboratorians. In the clinical laboratory, AI can be a tool that supports—not replaces—professional judgement. It refers to tools that assist with pattern recognition, anomaly detection, and predictive analytics. Machine learning models can be trained on historical data to identify emerging trends in instrument performance, specimen integrity, or workflow bottlenecks. Informatics integrates systems so that data flows reliably between analyzers, middleware, LIS, and EHR environments. Intelligent workflows combine these capabilities into rule-based or analytics-supported processes that route specimens, flag exceptions, and document key quality events automatically.

Several legitimate AI-supported use cases are already emerging in laboratory medicine. Patient-based, real-time quality control approaches use statistical and machine learning methods to detect subtle analytical drift. Digital pathology tools use image recognition to support diagnostic consistency and workload triage. Hematology image-analysis systems assist with abnormal cell detection. Predictive maintenance analytics are being explored to identify patterns that precede analyzer downtime.

Natural language processing tools can analyze incident reports to identify recurring quality risks.

These applications are not yet universal, but they illustrate how AI may build upon existing informatics-driven quality systems. See Figure 2 for how AI impacts quality system essentials (QSE).

Real-time data as the new quality indicator

In the traditional model, quality indicators were often reviewed monthly or quarterly. That cadence can still be useful, but it is insufficient for an environment where specimen flow and analyzer demand can change hour by hour.

Modern laboratories increasingly depend on real-time visibility: turnaround time distributions, specimen queue backlogs, analyzer uptime, pending lists, incident trends, etc. This

processes, documenting visibility changes quality performance, and improvculture. Instead of discovering problems in a retroing continuously. What spective audit, teams can changes in the AI era is the intervene during the shift. laboratory’s ability to sense The goal is to make correcits own operation in real tions before patient impact time, detect risk earlier, and occurs. When this is done Scan code to go optimize faster. well, it creates operational directly to the CE test.

Informatics and intelliexcellence. Staff see the sysgent workflows are already tem’s behavior, understand transforming quality manwhere bottlenecks arise, and actively agement by automating data capture, intervene to prevent impact. standardizing decisions, and creating This mirrors how high-performing closed-loop evidence of compliance. industries outside healthcare operate. AI will build upon that transformaConsumer technology organizations tion by adding predictive surveillance, continuously measure engagement and pattern detection across the total testing performance to optimize systems. The process, and operational optimization laboratory equivalent is not “engage- that reduces variability and error risk. ment”—it is patient safety, timeliness, The laboratory of the future is not and reliability. The goal is the same: simply automated—it is intelligent, use data as a feedback engine to opti- continuously learning from its own mize outcomes. data and monitoring its systems, where technology strengthens rather than reWhat must be in place before places professional judgment. In that environment, quality management AI improves laboratory quality The most common barrier to AI-enabled becomes what it has always aspired to quality improvement is not the model be: proactive, adaptive, continuous, and itself. It is the laboratory’s readiness in built into the workflow by design. informatics fundamentals. If LIS-to-EHR Nancy Alers MS, MT(ASCP)cmp, interoperability is inconsistent, if speciCQIA (ASQ), CLC (AMT), CQM/ men identifiers are not unified across OE (ASQ) is a U.S. Navy–trained systems, or if workflow steps are not clinical laboratory scientist with captured as discrete events, AI has little over 20 years of experience in stable ground to stand on. Laboratories hospital, reference, and must first modernize data capture and academic laboratory settings. interface integrity before AI can deliver She is the founder of Improov Consulting, Inc., a laboratory consulting company focusing on meaningful quality gains.

Another common barrier is metric performance improvement and quality. overload. The QMS must prioritize indiIrwin Z. Rothenberg MBA, MS cators that are actionable and tied to imCLS (ASCP) has over 40 years of experience in laboratory provement responsibilities. ISO-aligned medicine. He previously worked thinking helps here: quality indicators as the technical writer / quality should systematically monitor and advisor at COLA Resources, evaluate contributions to patient care, Inc. and is now a not become an endless list of numbers. freelance technical writer for Improov. Irwin has Finally, culture matters. Building a contributed articles to several professional data-driven culture is not about sur- publications including Physician Office Resources; veillance, it is about transparency and AAFP-PT POL Insight; Medical Laboratory creating a learning environment. Quality Observer; and COLA Insights. improves when staff can see how the Graham K. Mafela, MLS(ASCP), system works, trust the fairness of meaMBA has over 20 years of surement, and are trained to interpret experience in laboratory medicine and has been AI/informatics tools alongside their providing consulting services professional judgment. When teams unsince 2012. He is ASCP derstand how the tools work—and how board-registered as a Medical to question them appropriately—they Laboratory Scientist and holds an MBA from solve problems more effectively and Indiana Wesleyan University. He is the Chief make decisions with greater confidence. Operations Officer for Improov Consulting.

Conclusion: The future of laboratory quality is intelligent

Clinical laboratory quality has always been about discipline: controlling

References are available online at mlo-online.com/55368729.

10 | MAY 2026 MLO-ONLINE.COM

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CLINICAL ISSUES :: ALZHEIMER’S TESTING

ID 367426134 © Iryna Kushnarova | Dreamstime.com

Clinical Issues :: Alzheimer’s Testing

From imaging to blood: Alzheimer’s diagnostics evolve

By Rajasri Chandra, MS, MBA

A

lzheimer’s disease (AD) is the major cause of dementia world‑ wide that leads to morbidity, long‑term care utilization, and sig‑ nificant healthcare costs. At present, over 7 million Americans are living with AD which is projected to reach nearly 13 million by 2050.1 Health and long-term care costs for people living with dementia are projected to reach nearly $1 trillion in 2050.1 Dementia is caused due to damage or changes in the brain, dementia can also be caused due to other reasons in‑ cluding vascular dementia, Parkinson’s disease, dementia with Lewy bodies, and frontotemporal dementia. Severe head injury and a few less common causes such as Huntington’s disease, leuko‑ encephalopathies, Creutzfeldt-Jakob disease, some cases of multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS), and multiple-system atrophy.2 With the emergence of newer thera‑ pies, accurate and earlier diagnosis has

become increasingly important. Hence, laboratory testing, along with clinical evaluation, plays a very crucial role in confirming Alzheimer’s disease.

Evolution in AD diagnosis

The diagnosis of Alzheimer’s disease has evolved from subjective, post-mor‑ tem autopsy examinations in the early 20th century to objective, biomarkerdriven, and imaging-based techniques (amyloid PET, cerebrospinal fluid) that detect the disease in living patients decades before symptoms appear.

This shift has enabled diagnosis in the preclinical stage rather than only at advanced dementia stages.

In November 1906, Dr. Alois Al‑ zheimer, a clinical psychiatrist and neu‑ roanatomist first reported this disease as “a peculiar severe disease process of the cerebral cortex” by identifying amyloid plaques and neurofibrillary tangles (NFTs) in brain tissue postmor‑ tem. His colleague and mentor, Emil

Kraepelin subsequently named this disease as Alzheimer’s disease in 1910.3 In 1984, the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer’s Disease and Related Disorders Association (ADRDA) first standardized a diagnostic framework based on clinical, cognitive, and be‑ havioral symptoms as: “Probable,” “Possible,” and “Definite.”4,5 In 2011, the National Institute on Aging (NIA) and the Alzheimer’s Asso‑ ciation (AA) convened three workgroups that published separate recommenda‑ tions for the diagnosis and evaluation of Alzheimer’s disease in its preclini‑ cal, mild cognitive impairment (MCI), and dementia phases.6-9 Biomarkers were incorporated into the diagnostic algorithm to facilitate early and more accurate detection. These biomarkers included amyloid (positron emission tomography) PET imaging, CSF Aβ42, CSF t-tau and p-tau, glucose metabolism

LE

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©2026.

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Clinical Issues :: Alzheimer’s Testing on fluorodeoxyglucose PET, and characteristic patterns of cortical atrophy on structural MRI.6,8 Nevertheless, significant barriers to the use of biomarkers in clinical settings due to lack of standardization, variability in interpretation, and limited availability, led the NIA-AA criteria to not recommend biomarkers for routine diagnostic purposes.

Subsequently the Alzheimer’s Association had a series of recommendations for AD diagnosis. In 2012, an NIA-AA workgroup published a consensus document on the neuropathologic diagnosis of AD;10,11 in 2018, they published a research framework; and in 2024, a revised criteria for diagnosis and staging of Alzheimer’s disease were published.12,13 The 2018 research framework emphasized that it was intended solely for research purposes and not designed for clinical use.12 However, the 2024 diagnostic criteria are intended for use in actual clinical practice.13

Tests for diagnosing AD

Physicians use several diagnostic tools, medical history and other information, including neurological exams, cognitive and functional assessments, brain

imaging (MRI, CT, PET) and cerebrospinal fluid or blood tests to make an accurate diagnosis for Alzheimer’s disease.14

Biomarkers for AD

Biomarkers can indicate early signs of AD and enable early intervention in the disease process. Biomarkers like amyloid PET imaging, CSF Aβ42, CSF

Biomarkers can indicate early signs of AD and enable early intervention in the disease process. t-tau and p-tau, glucose metabolism on fluorodeoxyglucose PET, and characteristic patterns of cortical atrophy on structural MRI were incorporated into the diagnostic algorithm in the NIA-AA 2011 recommendation. However, due to the lack of standardization, they were not recommended for routine diagnosis.6,8 In the revised criteria for diagnosis and staging of AD published in 2024 by the Alzheimer’s Association, biomarkers were broadly classified as follows:15

Advancing Research in Neurodegenerative Diseases Through a Robust Menu of High-Quality Biomarkers Available on

1. Core biomarkers of Alzheimer’s disease neuropathologic change (ADNPC) 2. Non-specific biomarkers that are important in Alzheimer’s but are also involved in other brain diseases 3. Biomarkers of diseases/conditions that commonly co-exist with Alzheimer’s/co-pathology Table 1 lists the three classes of biomarkers and their associated tests.5 These tests have high accuracy in diagnosing the etiology of cognitive impairment, informing appropriate treatment and care planning, offering prognostic insights,16,17 and identifying eligibility for emerging amyloid-targeting therapies.18,19

Emergence of blood‑based biomarkers (BBMs)

Alzheimer’s disease (AD) diagnosis traditionally relied on positron emission tomography (PET) with radiotracers that bind to amyloid plaques or insoluble tau aggregates, or on cerebrospinal fluid (CSF) assays that measure biomarkers like amyloid beta (Aβ)42, Aβ40, total tau (t-tau), and phosphorylated tau (p-tau).20 Despite the high diagnostic accuracy of

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• pTau 181

• NfL

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Clinical Issues :: Alzheimer’s Testing Biomarker category

CSF or plasma analyte

Imaging

Amyloid (Aβ proteinopathy)

Aβ42

Amyloid PET

Tau 1 (T1) (phosphorylated and secreted AD tau)

p-tau217, p-tau181, p-tau231

Core 1

Core 2 Tau2 (T2) AD tau proteinopathy)

Microtubule-binding region (MTBR) MTBR-tau243, other p-tau forms (e.g., p-tau205), non-phosphorylated mid-region tau fragments

Tau PET

Biomarkers of non-specific processes involved in AD pathophysiology Neurodegeneration (N) (injury, dysfunction, or degeneration of neuropil)

Neurofilament light chain (NfL)

Inflammatory/immune mechanism (inflammation, astrocytic activation)

Glial fibrillary acidic protein (GFAP)

Anatomic MRI, Fluorodeoxyglucose (FDG) PET

Non-specific biomarkers of AD and Co-pathology Vascular brain injury (V)

Alpha-synucleinopathy (S)

Infarction on MRI Or White matter hyperintensity (WMH) on CT Alpha-synuclein seed amplification assay (αSyn-SAA)

Table 1. Biomarker classification system and associated tests.

these methods, PET scan is expensive and not widely available and the CSF test is both invasive and impractical for widespread use in clinical practice.21,22 Blood-based biomarkers (BBMs) have now emerged that are less expensive and more accessible and acceptable for patients compared to PET and CSF tests. Multiple BBMs—such as Aβ42/Aβ40 and tau phosphorylated at different sites (p-tau181, p-tau217, and p-tau231)—have been shown to strongly correlate with AD pathology.23 Additionally, BBMs are uniquely positioned to address the growing diagnostic demands driven by the introduction of amyloid-targeting therapies.24 Several BBM tests are now commercially available, however their diagnostic performance differs across assays, 25,26 and their use in clinical settings remains unstandardized. Currently two FDA-cleared BBM tests are available for AD: • Fujirebio’s Lumipulse G pTau217/ β-Amyloid 1-42 plasma ratio test, which measures the ratio of specific tau (pTau217) and amyloid-beta (β-Amyloid 1-42) proteins in the plasma and is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease. 27 • Elecsys pTau181 plasma test, developed by Roche, is intended for use in adult patients, aged 55 years and older, presenting with

signs or symptoms of cognitive impairment. This tests assesses the likelihood of amyloid plaques to help primary care physicians determine which patients do not require Alzheimer’s-related follow-up tests, such as PET scans or cerebrospinal fluid analysis. 28 Even though blood-based biomarkers are rapidly advancing, they are still not used as a standalone confirmatory test for AD diagnosis due to issues with low accuracy in diverse populations, lack of standardization, and high rates of false positives compared to gold-standard methods. That said, they are highly promising for screening or triaging and confirming Alzheimer’s diagnosis with robust methods like cerebrospinal fluid (CSF) analysis or PET scans.29,30 Dr. Yonghong Li and his colleagues at Quest Diagnostics performed a study to determine the efficacy and cost-effectiveness of using blood-based biomarker as a triage in Alzheimer’s disease testing. Dr. Michael K. Racke, Medical Director of Neurology at Quest Diagnostics and a co-investigator of this study summarized their findings as below: “This research demonstrates the efficacy and cost-effectiveness of blood-based biomarker testing in assessing Alzheimer’s disease pathology. PET scans, which are often less accessible for many, are more expensive and invasive.

In this study, we examined two methods of diagnosing patients with cognitive decline: performing blood testing before confirming diagnosis with a PET scan and

proceeding straight to a PET scan without blood testing first. Results showed that, whether PET scans are limited or readily available, blood testing is still less expensive. This is why we believe the future of assessing risk or diagnosing AD will likely include a variety of testing modalities and biomarkers, including blood, to help clinicians identify patients in the early stages of disease progression.”

Conclusion

It can be expected that continued refinement and standardization of plasma assays with robust validation in diverse population powered by artificial intelligence (AI) to enable wider use of blood‑based biomarkers in primary care and community settings in the very near future. Moreover, with the rapid advancements in imaging technology coupled with AI, we can expect to see less expensive, portable imaging systems at the point-of-care to enable rapid and early diagnosis of Alzheimer’s disease.

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/55369340.

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In the time it takes to read this headline, you could scan in 120 samples using AlinIQ Indexor.

If a hospital performs one million tests per year and loses one in 1,400 tubes at a cost of $400–600 per tube, then the annual cost could be as much as $428K—not to mention the burden on patients and hospital.1 By implementing Indexor, you can trace samples starting at patient draw, monitor key quality indicators during transportation, and automate time-consuming lab operations.

STREAMLINING YOUR PRE-ANALYTICS STARTS HERE.

1. Wiwanitkit, V. Types and frequency of preanalytical mistakes in the first Thai ISO 9002:1994 certified clinical laboratory, a 6-month monitoring. BMC Clin Pathol 1, 5 (2001). © 2025 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.

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LAB MANAGEMENT :: IN VITRO HEMOLYSIS

Lab Management :: In Vitro Hemolysis

The risks of in vitro hemolysis and the importance of early detection in critical care medicine — an ICU clinician’s perspective

By Christina Wichmann

A

ID 325077804 © Prostockstudio | Dreamstime.com

s the number one source of preanalytical error, hemolysis occurs when red blood cells rupture and falsely elevate potassium levels up to 152%.1,2 Despite its prevalence throughout different areas of the hospital, hemolysis is not visible in whole blood and can go unrecognized. In the intensive care unit (ICU), hemolysis rates of up to 5% have been reported, potentially impacting management of critical patients. 3,4 We recently connected with Dr. Ramzy Rimawi, a specialist in critical care medicine and infectious diseases at Emory University School of Medicine to discuss the impact of in vitro hemolysis on the ICU. Last year, Dr. Rimawi co-authored a paper titled “Handling hemolytic blood samples from high-risk clinical areas: A call to action,”5 which focused on the need for greater education, detection, and prevention of in vitro hemolysis. The paper, published in The Journal of Applied Laboratory Medicine, was authored by eight experts: Drs. Alan Wu, Jerrold Levy, Frank Peacock, Ramzy Rimawi, Manuel Sanchez Luna, Christopher Farnsworth, Hugo Stiegler, and Robert Christenson.

Learn more about in vitro hemolysis and its impact on patient care in Dr. Rimawi’s own words.

MLO: As an ICU physician, what are your biggest concerns related to in vitro hemolysis?

Dr. Rimawi: My greatest concern with in vitro hemolysis in the ICU is that it directly delays or misdirects care. When a sample sent for potassium testing is hemolyzed, it’s unclear whether the value reflects the patient’s true condition or is a compromised specimen. That uncertainty forces a difficult choice — act on a potentially inaccurate result or delay treatment while waiting for repeat testing. In critically ill patients, either option carries real risk, exposing critically ill patients to real harm.

MLO: What are the risks of inaccurate potassium results in the ICU? Dr. Rimawi: One risk is treating a patient for an elevated potassium when, in fact, their true level is actually normal.

For example, administering medication to lower potassium, based on an inaccurate result, can subject them to critically low potassium levels.

In many cases, this happens when potassium appears falsely elevated due to hemolysis. Potassium directly controls the heart’s electrical activity. If a clinician lowers potassium when the true level is normal, the heart’s electrical signals can become unstable. That instability can trigger dangerous rhythm disturbances or cause the heart to stop all together.

In ICU patients—many of whom already have heart or kidney disease—even small shifts in potassium can disrupt electrical conduction and lead to life-threatening arrhythmias.

MLO: What are the risks of high potassium, and how can clinicians determine whether an elevated result reflects true hyperkalemia or hemolysis?

Dr. Rimawi: Ultimately, the most common and serious risk is cardiac arrhythmia. High potassium disturbs the heart’s electrical activity, which can slow the heart rate, change its rhythm, or cause the heart to stop all together. These effects can occur quickly, especially in patients with kidney disease or underlying heart conditions.

High potassium can also cause muscle weakness, paralysis, respiratory failure, and worsening kidney function by contributing to acidosis. However, cardiac complications remain the most immediate and life-threatening concern.

The challenge is that mild or moderate hyperkalemia often has no obvious clinical signs. EKG changes typically appear

16 | MAY 2026 MLO-ONLINE.COM

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Lab Management :: In Vitro Hemolysis late, when potassium levels are already dangerous. If clinicians wait for symptoms or EKG abnormalities, the patient may already be at high risk for cardiac arrest. That is why accurate laboratory results are essential, and why in vitro hemolysis represents such a serious patient safety issue.

MLO: What needs to be done to reduce the prevalence of preanalytical errors, including hemolysis?

Dr. Rimawi

MLO: Do you feel there is enough education and awareness about the issue of in vitro hemolysis in hospitals across the country?

Dr. Rimawi: No, there is not enough education or awareness.

Many clinicians rely entirely on the laboratory to identify hemolysis, rather than actively questioning results that don’t align with the clinical picture. In my own analysis of 100 patients with elevated potassium, later confirmed to be due to in vitro hemolysis, I found that approximately half were treated for hyperkalemia that was not real. That represents unnecessary treatment and avoidable risks for patients.

MLO: How can technology be helpful when it comes to hemolysis detection?

Dr. Rimawi: Speed—it’s the single most important factor. If I can detect in vitro hemolysis faster at the point of care, using technology like the GEM Premier 7000 with iQM3, I can make decisions faster. I can repeat testing sooner, when needed, or ignore a compromised result without delay. This can reduce unnecessary treatments, repeat blood collection, and delays in care, all of which are especially important in critically ill patients.

Dr. Rimawi: In vitro hemolysis will never be completely eliminated. The more important issue is how quickly it is detected. A hemolyzed sample is far less dangerous if it is recognized immediately. The real risk arises when hemolysis isn’t identified until hours later, after clinical decisions have already been made.

Faster detection can prevent unnecessary treatment, repeat testing, and patient harm. I often compare it to a car problem: if smoke is coming from the engine, waiting for the check-engine light, means damage has already happened.

People may keep driving, unaware there’s an issue, until the car ends up in the shop. In healthcare, we need a better way for that warning light to come on sooner. Early recognition of in vitro hemolysis allows clinicians to intervene before harm occurs.

MLO: How can we make reduced prevalence and increased detection the standard of care?

Dr. Rimawi: Education and access are key. Clinicians need to understand that rapid hemolysis-detection tools exist and how to use them in real time. These technologies should not be limited to large academic centers. Because in vitro hemolysis occurs in all hospitals, early detection should be widely available to become a true standard of care.

References are available online at mlo-online.com/55369801.

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

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

Teamwork:

How should I deal with a toxic co-worker?

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

How can I ensure our ideas are heard by leadership?

Leadership:

How do I hold that difficult conversation?

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

What skills are needed to build a cohesive team?

Personal growth:

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

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

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

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

18 | MAY 2026 MLO-ONLINE.COM

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INFECTION DIAGNOSTICS :: ANTIMICROBIAL RESISTANCE

ID 349229141 © Andrej Mitin | Dreamstime.com

Infection Diagnostics :: Antimicrobial Resistance

Q&A: Tackling antimicrobial resistance in resource-constrained laboratories

By Chris Armstrong, Christina Wichmann

C

linical laboratories are at the forefront of detecting and responding to antimicrobial resistance (AMR), yet they face mounting pressure from staffing shortages, rising test volumes, and cost constraints. In this Q&A, Chris Armstrong, president of the microbiology business at Thermo Fisher Scientific, discusses how laboratories can adapt workflows, improve efficiency, and strengthen their response to emerging threats such as multidrug-resistant fungi, without compromising quality or timeliness.

Antimicrobial resistance continues to evolve rapidly. From your perspective, what is changing most for clinical laboratories today?

Chris Armstrong: What’s changed is the pace and complexity of the threat, combined with the operational realities labs are dealing with. We’re seeing more multidrug-resistant organisms, including emerging fungal pathogens like Candida auris, which bring both clinical and infection prevention challenges.1 At the same time, laboratories are under real strain with fewer experienced staff, increasing workloads, and pressure to deliver faster results.

That combination means laboratories may need to move beyond traditional one-size-fits-all workflows that were designed for a different era. The question is no longer just

“Can we detect this organism?” but “Can we detect it quickly, consistently, and with the resources we actually have?”

How do staffing shortages specifically impact a lab’s ability to respond to AMR?

Chris Armstrong: Staffing shortages affect both capacity and capability. Many labs are operating with fewer highly experienced microbiologists, while newer staff are being asked to take on more complex tasks earlier in their careers.2 That has two implications. First, processes that depend heavily on expert interpretation become harder to sustain.

Second, variability can increase—between shifts, between individuals, and even between sites in larger networks.

So, addressing AMR today isn’t just about having the right tests. It’s about designing workflows that are more intuitive, more standardized, and less dependent on scarce expertise, while seeking to maintain accuracy.

Cost pressures are also significant. How should laboratories balance cost control with the need to improve AMR detection?

Chris Armstrong: Cost is often viewed narrowly, typically at the level of individual consumables or tests. But in practice, laboratories operate as systems. Decisions made at the

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Infection Diagnostics :: Antimicrobial Resistance front end of the workflow can have downstream consequences for labor, turnaround time, repeat testing, and even patient management.

For example, if a method requires additional confirmatory steps or increases interpretation time, that has a real cost in terms of staff effort and reporting delays. In contrast, methods that streamline decision-making or reduce ambiguity may help offset higher downstream costs.

The shift we’re seeing is toward evaluating total workflow impact rather than unit price alone. That’s especially important in the context of AMR, where delays or inconsistencies can have broader clinical and operational implications.

Emerging pathogens like Candida auris are a growing concern. What makes them particularly challenging for laboratories?

Chris Armstrong: C. auris is a good example of how AMR is evolving. It’s not just resistant; it’s also difficult to identify using some conventional methods, and it can spread within healthcare settings.3,4 That creates a dual challenge: accurate detection and timely reporting. Laboratories need to be confident in their presumptive identification so that appropriate infection control measures can be initiated quickly, while also ensuring confirmatory methods are in place.

It also highlights the importance of surveillance. Detecting colonization and tracking spread, within validated laboratory protocols, are just as critical as diagnosing infection, and that can place additional demands on laboratory workflows.

What role do new workflow tools play in addressing these challenges?

Chris Armstrong: Clinical microbiological tools are often undervalued, but they’re critical. They shape how samples are processed, how results are interpreted, and how efficiently the lab operates overall.

In the context of AMR, innovative technologies, as well as optimally deployed existing methods, may support improved differentiation, reduce ambiguity, or support faster identification and — very relevant to AMR — antimicrobic susceptibility. This can then support efforts to inform outbreak management and clinical decision-making.

New products may help prioritize samples, reduce follow-up workload in

some settings, and contribute to more consistent processes.

Importantly, these tools don’t replace confirmatory methods like MALDI-TOF mass spectrometry or molecular assays.

Instead, they complement them by improving the efficiency and effectiveness of the overall workflow.

How can laboratories ensure consistency in results despite variability in staffing and experience levels?

Chris Armstrong: Consistency comes from a combination of standardization and simplification. Standardized protocols, clear decision criteria, and methods that are easier to perform and interpret can all contribute to more reproducible results.

Automation also plays a role, particularly in larger laboratories, but it’s not the only answer. Even in less automated settings, choosing methods that reduce subjectivity can help ensure that results are consistent, regardless of who is performing the test.

Ultimately, the goal is to make high-quality microbiology more repeatable across shifts, across teams, and across different levels of experience.

What practical steps can laboratory leaders take to strengthen their AMR response today?

Chris Armstrong: There are a few key areas to focus on: • Evaluate workflows holistically: Look beyond individual tests to understand where time, effort, and variability are introduced.

• Prioritize methods that reduce complexity: Especially in highvolume labs or when the stakes are high, like for multi-drug-resistant organisms. Differentiate technologies and use the right one for the job, as opposed to complementing existing routines to fill gaps.

• Invest in training and standardization: Ensure staff are supported with clear protocols and ongoing education.

• Align analytical strategies with clinical needs: Consider how laboratory results feed into infection prevention and patient management decisions.

These steps don’t necessarily require large-scale transformation. Often, incremental changes as part of a validated diagnostic workflow design can have a significant impact.

Looking ahead, what will define successful laboratories in the fight against AMR?

Chris Armstrong: Laboratories that are able to adapt may be better positioned, both technically and operationally. They’ll combine robust detection capabilities with efficient, scalable workflows that reflect the realities of modern healthcare.

AMR is a growing healthcare challenge, and our response needs to evolve.

Laboratories that take a proactive approach, continually evaluating and refining how they work, will be best positioned to meet the challenge.

Conclusion

As antimicrobial resistance continues to evolve, clinical laboratories must balance accuracy, speed, and efficiency in increasingly constrained environments.

By focusing on workflow design, standardization, and practical front-end improvements, laboratories can strengthen their response to emerging threats while maintaining operational sustainability.

REFERENCES 1. WHO fungal priority pathogens list to guide research, development and public health action. Who.int. October 25, 2022.

Accessed April 2, 2026. https://www.who.int/ publications/i/item/9789240060241.

2. Heggeness ML, Zambrana CE, Ginther DK. Workforce trends: The future of microbial sciences. Asm.org. May 30, 2023. Accessed April 2, 2026. https://asm. org/getmedia/9ec71b59-0c57-4f14-9e5304c88717f0d8/workforce-report.pdf?ext=.pdf.

3. CDC. Clinical overview of candida auris.

Candida auris (C. auris). February 26, 2026.

Accessed April 2, 2026. https://www.cdc.gov/ candida-auris/hcp/clinical-overview/index.html.

4. Rapid risk assessment: Candida auris in healthcare settings – Europe. European Centre for Disease Prevention and Control. April 23, 2018. Accessed April 2, 2026. https:// www.ecdc.europa.eu/en/publications-data/ rapid-risk-assessment-candidaauris-healthcare-settings-europe.

Chris Armstrong serves as president of the microbiology business at Thermo Fisher Scientific. He has extensive experience in the healthcare industry and laboratory workflow optimization, with a focus on improving diagnostic efficiency and supporting laboratories in addressing emerging infectious disease challenges.

Christina Wichmann, Editor in Chief, Medical Laboratory Observer | Endeavor B2B

22 | MAY 2026 MLO-ONLINE.COM

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STATE OF THE INDUSTRY :: BEST PRACTICES IN LAB MANAGEMENT

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State of the Industry :: Best Practices in Lab Management

STATE OF THE INDUSTRY BEST PRACTICES IN LAB MANAGEMENT Operational efficiency, financial visibility, and workforce pressures shape laboratory best practices in 2026 MLO’s State of the Industry survey finds laboratories prioritizing efficiency, automation and cost control as reimbursement tracking and system integration challenges persist.

By Kara Nadeau

M

edical laboratories continue to operate under mounting pressure to balance operational efficiency, financial stability and quality performance. Results from the 2026 MLO State of the Industry (SOI) survey on lab management best practices highlight how labs are prioritizing process improvement and cost control while navigating persistent challenges with reimbursement visibility and system integration.

One of the most notable findings is the emphasis on operational efficiency.

Nearly two-thirds of respondents (63%) said technology investments are

primarily aimed at improving efficiency or reducing costs, while 56% reported prioritizing replacement of aging equipment. Automation remains central to operational performance, with 40% of laboratories adopting analyzers that enable walkaway testing to reduce staff demands.

At the same time, financial visibility remains a concern. Only 32% of respondents said they can track whether reimbursement fully covers their testing costs, down from 33% in 2025 and 45% in 2024. Data integration appears to be a major stumbling block, with 33% of laboratory professionals citing lack of interoperability between laboratory information systems (LIS) and revenue cycle platforms as barriers to tracking reimbursement levels.

Operational performance metrics also remain central to laboratory management strategies, with 63% of respondents reporting they regularly review turnaround time to identify improvement opportunities.

Also new to this year’s survey, MLO asked laboratory professionals a series of questions on proficiency testing, revealing a mix of traditional manual processes and growing use of proficiency testing data for training, quality

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State of the Industry :: Best Practices in Lab Management citing it as a strategy, it dropped from 48% in 2025. The percentage of laboratory professionals citing partnerships with local colleges and tech schools to offer internships also dropped at 37% in 2026, down from 46% last year.

Daily huddles with peer recognition remained a popular recruitment and retainment strategy, at 35% of respondents (36% in 2025), along with clinical ladders at 32% (33% in 2025), utilizing outside laboratory recruitment services/agencies at 24% (26% in 2025) and succession-planning processes at 20% (22% in 2025).

Offering employee perks (free parking, on-site gym, on-site day care, reimburse public transportation costs) remained the least cited strategy at 16% (17% in 2025).

Sheridan M. Voshake, MS, MLS(ASCP)cm, laboratory manager for Memorial Hospital and Adjunct Professor at Carl Sandburg College, both located in Carthage, Ill., offered her insights on laboratory workforce challenges today – and best practices for addressing them: “Recruitment and retention remain challenging, particularly as medical laboratory training programs continue to close, Sheridan M. Voshake, cm reducing the pipeline of qualified professionals entering the MS, MLS(ASCP) field. Today’s candidates are prioritizing workplace culture, flexibility, and meaningful opportunities for growth. We are intentionally focused on strengthening employee engagement and supporting career advancement with pathways from phlebotomists to medical laboratory technicians and medical laboratory scientists. This educational commitment has been instrumental in driving stronger retention outcomes within our laboratory department and organization.”

Reimbursement

improvement, and identifying instrument or method bias.

The respondents

This year, MLO gathered responses from 362 medical laboratory professionals, with 41% in director, manager, administrator, or supervisor positions and most employed by hospital/health system laboratories (66%). Respondents again represented a broad range of laboratory sizes and testing volumes.

Workforce

Recognizing the ongoing staffing challenges facing U.S. laboratories, MLO asked medical laboratory professionals about the strategies they are using to retain and recruit staff. Continuing education topped the list at 46% (same as 2025). This was followed closely by a new answer option for this year’s survey — team building/celebration activities (43%).

Leveraging shift changes to offer scheduling flexibility (e.g., 12-hour shifts, weekends) increased in popularity at 39%, up from 33% in 2025.

While financial incentives remained high on the list with 37% of respondents

When asked whether their laboratories had taken steps to ensure reimbursement covers testing costs, the top response was standardization strategies, with 53% of respondents citing standardized instrumentation workflows and checklists (53% in 2025) and 53% citing the creation of standard lab processes and staff education materials (52% in 2025).

A focus on efficiency and accuracy was evidenced by 40% of respondents naming the adoption of analyzers that provide walkaway testing to reduce staffing and FTE hours as a strategy to balance costs and reimbursement (37% in 2025) and 36% naming the use of IT solutions to reduce human error (46% in 2025).

New for this year, MLO queried laboratory professionals on whether they evaluate reimbursement for all participating insurance providers to ensure rates will cover costs before implementing a test. Over one-third of respondents (33%) acknowledged leveraging this approach.

Other steps laboratories reported taking to ensure reimbursement covers costs include: • 24% incorporating IT solutions to help keep current with regulations • 23% adopting processes to review savings opportunities, such as evaluating analyzers, on a regular schedule • 20% implementing ongoing waste and efficiency studies to find potential savings in overhead • 19% bringing health screening tests in house • 13% implementing ongoing efforts to reduce coding frustrations and modifications Only 32% of laboratory professionals surveyed indicated their laboratories could ensure reimbursement covers their costs. The biggest stumbling block cited was lack of interoperability between laboratory information system (LIS) and revenue cycle management software at 33%. This was followed closely by lack of staff time to perform this task at 30%.

The focus on inadequate technology and staffing was also reflected in the high ranking of other stumbling blocks: 29% do not have software to automate tracking/ analysis of costs and 25% don’t have enough IT staff time/resources.

Lastly, 6% of respondents cited not enough barcoded testing supplies as a challenge to tracking whether reimbursement covers their costs.

LigoLab RCM Product Manager Aram Avakyan commented on how laboratories are leveraging modern LIS platforms to improve operational visibility across testing, billing, and reporting workflows: “Modern laboratory information systems enhance operational visibility by using configurable rules and workflow tags to track activity across the laboratory MLO-ONLINE.COM MAY 2026 | 25

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State of the Industry :: Best Practices in Lab Management process. As a case or specimen moves through the lab, the LIS can apply tags that indicate status, progress, exceptions, or required follow-up actions, allowing teams to quickly see where work is occurring and where delays may exist. Because each tag captures structured workflow data, laboratories can also use them for reporting and operational analysis to identify bottlenecks and monitor key performance metrics.”

“Modern LIS platforms provide laboratories the data visibility needed to connect operational activity with financial performance,” Avakyan added.

“One of the most important capabilities is flexible reporting and analytics, including preconfigured reports that track metrics across testing activity, billing status, and reporting performance. Systems that allow labs to create dynamic reports tied to workflow data also make it easier to identify revenue gaps, monitor payer behavior, and understand how operational decisions affect reimbursement outcomes.”

Test quality and efficiency

Nearly two-thirds of laboratory professionals (63%) reported reviewing turnaround time to identify opportunities to improve test quality and efficiency.

This was a new question answer option provided this year.

Other popular strategies to improve test quality and efficiency are staff or committee reviews of standard operating procedures (SOP) (50%), leveraging standardized test ordering procedures and formularies (47%), and evaluating temperature monitoring equipment and procedures (42%).

Fewer cited the implementation of evidence-based test utilization backed by data (18%) or pre-approval programs for tests that are send-outs (16%).

Maine Molecular Quality Controls (MMQCI) Manager of Discovery Dr. Stehen Pelsue, PhD commented on the quality control challenges most common today in molecular or specialized testing, and how can laboratories strengthen validation and ongoing monitoring: “QC challenges for molecular assays can be driven by rapid technology development and complex assay targets that evolve faster than available guidance and availability of proper controls. External Dr. Stehen Pelsue

Figure 1: What steps have you taken to improve the quality and efficiency of testing?

Review results turnaround time for improvements

63%

Staff or committee reviewing SOPs

50%

Standardized test ordering procedures and formularies

47%

Evaluated temperature monitoring equipment and procedures

42%

Implemented evidence-based test utilization backed by data

18%

Implemented a pre-approval program for tests that are send-outs

16%

N/A

11%

quality assessment options remain sparse for many NGS LDTs, particularly for rare or complex variants. End to end validation should evaluate all specimen types and pre analytic steps, laboratory process, and the bioinformatics workflow, with documented sensitivity/specificity for each relevant variant type, as not all variants may be available.”

“Labs can use QC performance data strategically to improve reliability, not just as a compliance requirement,” he added. “For example, monitoring longitudinal QC data for gradual performance drifts instead of reacting only to out‑of‑range calls. Evaluating trends over time can identify subtle shifts linked to lot changes, instrument issues, or environmental conditions before they affect patient results.”

Figure 2: How do you prioritize the technology needs in your capital budget?

Technology needed to be more efficient/reduce costs

63%

Technology needed to cover broken/older equipment

56%

Technology needed to improve quality of patient care

49%

Technology needed to standardize processes

40%

Technology needed to cover staff shortages with automated equipment

33%

Technology needed to remain competitive

30%

Other

9%

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Proficiency testing

This year’s MLO SOI on laboratory best practices explored a new topic: proficiency testing. Respondents were asked how their laboratories ensure all required analytes and methods are appropriately enrolled in proficiency testing. The majority (77%) responded with manual review of test menu.

Responses on other ways to ensure all required analytes and methods are appropriately enrolled in proficiency testing: • 17% PT provider recommendations • 13% external consultant/accreditation support • 9% middleware or analytics software • 8% LIS-based test mapping • 8% unsure/unclear • 7% other Laboratory professionals were asked how their laboratories track and analyze proficiency testing performance over time.

The most common response was reviewing manually after failures (62%), followed by trending across multiple events (51%).

Over one-third of survey respondents selected event-byevent review only (38%) or integrated into QA dashboards (35%), while 7% reported their proficiency testing performance was not routinely analyzed.

The final question on this topic asked how their laboratories use proficiency testing data beyond pass/fail review.

Over three-quarters of respondents (79%) reported using this data for staff training and competency assessment, followed by identifying method or instrument bias (61%) and quality improvement initiatives (56%). Far fewer selected required documentation only (10%), while 7% reported not using PT data beyond compliance.

WSLH Proficiency Testing Lab AssoTracy Servey, MT ciate Director Tracy Servey, MT (ASCP) (ASCP) commented on practices that can help labs move beyond simply meeting proficiency testing requirements to using results as a tool for continuous improvement: “We see lab leaders focus on the final evaluation scores and ignore the other details that accompany the report. For example, the standard deviation Index (SDI) should not be ignored when reviewing quantitative results on the evaluation report. That is, although your evaluation report may list a passing score, a positive or negative bias reflected by your SDIs should be investigated to avoid potential systemic errors.”

When what common gaps or misconceptions exist in how laboratories select, manage or interpret proficiency testing programs — and how can organizations strengthen their approach — Servey stated: “There is a balance between PT program scope and laboratory need. With different types of testing devices entering the market, test menus between different laboratories have become far more diverse but the PT programs may have limitations in offerings out of necessity. Time should be taken to assure the lab’s test menu is aligned with the PT programs being used to assure the test instruments are being fully challenged.”

Technology

To better understand which factors influence new technology investments, MLO asked laboratory professionals how they prioritize the needs for their capital budgets. The most reported factor was technology needed to be more efficient/ reduce costs (63%).

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State of the Industry :: Best Practices in Lab Management The next top response was technology needed to cover broken/older equipment (56%), followed by technology needed to improve quality of patient care (49%).

The need for standardization and efficiency was again reflected in the next two factors on the list: technology needed to standardize processes (40%) and technology needed to cover staff shortages with automated equipment (33%). A further one-third of respondents cited technology needed to remain competitive (30%).

When examining best practices for adopting new tools for laboratory automation, the responses were similar to last year’s survey, with nearly half of respondents reporting they analyzed workflow processes for proper space planning (46%, up from 44% in 2025), 39% involved the IT department early in the process (40% in 2025), 30% ensured system integration for seamless process and data flows (36% in 2025) and 18% designated a project manager to coordinate short- and long-term planning and implementation with the vendor (21% in 2025). More than one-third (36%) selected N/A. With regards to training staff on new software, the most reported best practice by laboratory professionals was the creation of standard workflows for all lab employees (61%). Nearly half reported creating a train-the-trainer model (48%).

More than one-third reported using vendor-hosted in-house or online training (34%), an annual online education refresher (32%) or LIS training of a lab staff member to develop an in-house expert (32%). Other best practices for training staff on new software included developing mandatory training for new lab employees led by the IT department (20%) and lunch-and-learn training sessions (16%).

Contracting and supply chain

Laboratory professionals were asked what best practices they had implemented to streamline their vendor contracting process. The highest percentage of respondents (65%) reported working with supply chain management on supplies that are on group purchasing organization (GPO) contracts that offer additional savings.

The second most commonly reported best practice for vendor contracting (40%) was the development of good relationships with supplier support personnel that provide access to training and product optimization suggestions. This was followed by adoption of ongoing reviews of reference lab costs and contracts (35%) and the signing of longer contracts (20%).

Figure 3: Beyond pass/fail review, how does your laboratory use proficiency testing data?

Staff training and competency assessment

79%

Identifying method or instrument bias

61%

Quality improvement initiatives

56%

Required documentation only

10%

We do not use PT data beyond compliance

7%

Other

6%

The best practice that topped the list for improving inventory control and consumable supply costs was the evaluation of inventory levels for basic supplies, such as assays and controls/reagents (66%). More than one-third of laboratory professionals (38%) reported developing supply utilization tracking and record keeping.

Responses on other ways to improve inventory control and consumable supply costs: • 19% secured access to electronic inventory tracking from the supply chain/ materials management department • 18% implemented lease agreements that do not include volume commitments • 17% worked with other members of the organization, such as the CMO (Chief Medical Officer) and physicians, to standardize test ordering throughout the organization • 16% developed ongoing review comparing supply reports to the number of invoiced tests • 13% implemented vendor-managed ordering • 11% this is handled by a different organization/location Looking at best practices to address supply chain issues, the most reported practices were implementing standing orders (instead of just in time) for crucial supplies (54%) and establishing relationships with multiple vendors (50%).

More than one-third of laboratory professionals reported they are not currently experiencing supply chain issues 34%.

Reported use of several best practices have declined: utilizing multiple testing platforms (20% in 2026, down from 27% in 2025, 30% in 2024), laboratory-developed tests (LDT) (6% in 2026, down from 13% in 2025), working with state public health officials to gain access to needed testing supplies (5% in 2026, down from 12% in 2025 and 16% in 2024).

The best practice of switching to reusable types of personal protective equipment, such as moving from disposable to reusable lab coats, increased only slightly year-over-year (17% in 2026, 16% in 2025, 20% in 2024).

Conclusion

Taken together, the survey findings suggest laboratories are increasingly focused on operational efficiency, financial visibility, and workforce sustainability. As laboratories continue adopting automation and data-driven management practices, addressing interoperability, reimbursement tracking, and workforce development will remain critical priorities in the years ahead.

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.

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MOLECULAR DIAGNOSTICS :: ONCOLOGY TESTING

A new era for oncology testing: Early detection with 5hmC profiles

By Jeffrey Venstrom, MD

C

linical laboratory teams have been familiar with methylation analysis for years, particularly for diagnosing imprinting disorders such as Prader-Willi and Angelman syndrome.1 But more recently, epigenetic profiling has become quite useful for early detection of cancer. Key advances in epigenomic analysis and machine learning tools have enabled new tests that can detect some of the earliest biological signs of cancer from a simple blood sample.

These epigenetic assays add to the growing universe of liquid biopsy tests. Unlike their predecessors, which aimed to analyze genetic variants in circulating tumor cells or DNA, epigenetic blood tests scan for the regulatory instructions governing the underlying genome. Methylation pattern changes can reveal which genes are turned off and which are activated, providing useful information that may be more directly linked to the biology of cancer activity than variants in the otherwise static genome.

As these tests have been developed, they have largely been commercialized in two broad categories: single-cancer detection tests or multi-cancer detection tests. Some are intended for screening, while others aim to provide early detection of cancer in individuals with high risk factors. In some cases, these blood-based tests have been developed specifically for cancers for which no widely available early detection technique exists, particularly for high-mortality cancers, including pancreatic and ovarian.

The 5hmC difference: A new view of methylation

Traditional methylation analysis targets 5-methylcytosine (5mC), the regulatory mechanism that silences gene activation and is found widely in CpG dinucleotides across the

human genome. It is the most common type of methylation and consequently the most comprehensively characterized.

In the past decade, scientists have turned their attention to a different type of methylation known as 5-hydro­ xymethylcytosine (5hmC). This is intriguing for disease detection and classification purposes because it doesn’t silence genes; in fact, it marks the genes that are turned on. Given that more of the genome is silenced than activated, the ability to focus on active genes through 5hmC signals offers two key advantages. First, it is a better measure of active biology — especially the upregulated biological changes associated with growing cancer — than methylation designed to repress transcription. Second, it dramatically narrows the amount of epigenomic data needed for analysis, so any biological signal is less likely to be drowned out by noise.

On a technical note, 5hmC analysis does not require the bisulfite conversion process used to detect 5mC; as a result, it does not damage DNA during analysis. Indeed, the bisulfite conversion process converts 5hmC and 5mC identically, making it impossible to distinguish 5hmC signals in DNA prepared this way.

Nearly a decade ago, scientists at Stanford University reported that they had successfully tracked 5hmC profiles in circulating cell-free DNA.2 Their interest in 5hmC stemmed from its previously established links to the onset of cancer; in this proof-of-concept work, the epigenetic mark was analyzed in samples representing several different types of cancer.

The team identified 5hmC signatures associated with specific types and even stages of cancer — data that subsequently informed the development of early detection tests based on 5hmC profiles. Since then, this epigenetic data has also been shown to enable the identification of a tumor’s tissue

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MOLECULAR DIAGNOSTICS :: ONCOLOGY TESTING of origin.3 Taken together, 5hmC analysis makes it possible to detect cancer very early — even earlier than many imaging modalities — and to determine its location and stage for optimal clinical utility.

Single-cancer tests

There are now a number of methylation-based tests available for detecting individual cancers, including tests focused on cancers of the lung, bladder, liver, colon, and pancreas, among others.4-6 5mC analysis continues to be of interest in the biomedical research community, with techniques that have been used for a variety of cancer types.7 But mounting evidence demonstrates the added value of an approach based on 5hmC. For instance, researchers in the UK compared 5mC and 5hmC data for colorectal cancer, finding that changes in 5hmC were commonly found at stage 1, suggesting that this type of methylation could be more powerful than 5mC for enabling early detection of cancer.8 In a larger study focused on pancreatic cancer, scientists analyzed 5hmC data from cell-free DNA, comparing results from a cancer cohort to a non-cancer cohort.9 They identified specific genes for which 5hmC epigenetic patterns were relevant to early detection of pancreatic cancer and used tissue-derived 5hmC information to further classify results found in cell-free DNA. An important advantage of single-cancer tests is that their focused nature allows diagnostic developers to hone their algorithms for one specific type of cancer and its associated epigenetic signals. This typically leads to higher sensitivity and specificity performance. These tests also provide the benefit of a well-established pathway for diagnostic follow-up in clinical settings.

Multi-cancer tests

A new type of early detection test has emerged in cancer diagnostics recently, and that’s the multi-cancer test. Some of these tests are already commercially available and promise to detect dozens of different types of cancer from a single assay.

While the tests are based on a variety of underlying biomarkers and technologies, some have incorporated epigenetic data to boost sensitivity, particularly for early stage cancers. With so many alternatives, though, there is considerable range in accuracy and reliability for these tests.

Even in these early days, though, a few things are fairly certain about multi-cancer tests. One is that they are gaining interest among the general public, with more people paying out-of-pocket to get these results. This interest will likely increase as Medicare is set to begin covering multi-cancer tests starting in 2028, thanks to the recently passed Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act. Also worth noting about multi-cancer tests: they may be a much-needed tool for high-mortality cancers that currently have no widely used screening method, such as pancreatic, ovarian, and liver cancer. While multi-cancer tests that claim to detect dozens of cancer types typically struggle with low sensitivity rates, a narrower test that focuses on unscreened cancers could in theory achieve better sensitivity due to a more targeted approach.

In one study, scientists evaluated 5hmC signals for five cancers: breast, colon, lung, ovarian, and pancreatic.3 They analyzed hundreds of tumor samples, comparing them to normal tissues, as well as cell-free DNA samples from more than 1,000 individuals with cancer and nearly 1,700 healthy

individuals. In addition to revealing broad-scale redistribution of 5hmC in early-stage tumors — a signal that could be tracked into later-stage tumors as well — they also found tissue-specific epigenetic patterns. Those patterns made it possible to train a classifier that could predict the tissue of tumor origin with excellent accuracy.

Already, multi-cancer tests are at the heart of a study funded by the National Cancer Institute to learn more about how these tests could be implemented. The Vanguard Study, which aims to enroll as many as 24,000 participants between the ages of 45 and 75, will evaluate the performance of two multi-cancer tests.10,11 Both are based on methylation detection, but one was designed to look for 5mC while the other looks for 5hmC.

Looking ahead

The ability to use 5hmC patterns to detect the earliest signs of cancer — whether that’s focused testing for a single type of cancer or a multi-cancer test designed to look for several types of cancer at once — could significantly alter how highrisk patients are monitored. A simple blood test enabling early cancer detection could make it possible to diagnose cancer sooner, shifting patients to more treatable stages for potentially better outcomes. It is an exciting time for early cancer detection, with new options for clinical laboratories to consider for their own test menus.

REFERENCES 1. Elhamamsy AR. Role of DNA methylation in imprinting disorders: an updated review. J Assist Reprod Genet. 2017;34(5):549-562. doi:10.1007/ s10815-017-0895-5.

2. Song CX, Yin S, Ma L, et al. 5-Hydroxymethylcytosine signatures in cell-free DNA provide information about tumor types and stages. Cell Res. 2017;27(10):1231-1242. doi:10.1038/cr.2017.106.

3. Xue Y, Ning Y, Friedl V, et al. 5-hydroxymethylcytosine analysis reveals stable epigenomic changes in tumor tissue that enable cancer detection in cell-free DNA. Commun Biol. 2025;8(1):1613. doi:10.1038/ s42003-025-09017-4.

4. Rendek T, Pos O, Duranova T, et al. Current challenges of methylation-based liquid biopsies in cancer diagnostics. Cancers (Basel). 2024;16(11):2001. doi:10.3390/cancers16112001.

5. Pharo H, Vedeld HM, Sjurgard IV, Pinto R, Lind GE. From concept to clinic: A roadmap for DNA methylation biomarkers in liquid biopsies.

Oncogene. 2025;44(49):4814-4831. doi:10.1038/s41388-025-03624-5.

6. Chowdhury S, Kesling M, Collins M, et al. Analytical validation of an early detection pancreatic cancer test using 5-hydroxymethylation signatures. J Mol Diagn. 2024;26(10):888-896. doi:10.1016/j. jmoldx.2024.06.007.

7.

Chowdhury B, Cho IH, Irudayaraj J. Technical advances in global DNA methylation analysis in human cancers. J Biol Eng. 2017;11:10. doi:10.1186/s13036-017-0052-9.

8. Puddu F, Johansson A, Modat A, et al. 5-methylcytosine and 5-hydroxymethylcytosine are synergistic biomarkers for early detection of colorectal cancer. Commun Med (Lond). 2026;6(1):15. doi:10.1038/ s43856-025-01278-8.

9. Guler GD, Ning Y, Ku CJ, et al. Detection of early stage pancreatic cancer using 5-hydroxymethylcytosine signatures in circulating cell free DNA. Nat Commun. 2020;11(1):5270. doi:10.1038/s41467-020-18965-w.

10. The Vanguard Study: Testing a new way to screen for cancer. ClinicalTrials.gov. April 13, 2026. Accessed April 13, 2026. https://clinicaltrials. gov/study/NCT06995898.

11. NCI selects two assays for the Vanguard Study on multi-cancer detection tests. National Cancer Institute. January 7, 2025. Accessed April 13, 2026. https://prevention.cancer.gov/news-and-events/news/ nci-selects-two-assays-vanguard-study-multi-cancer-detection-tests.

Jeffrey Venstrom, MD serves as chief medical officer at ClearNote Health. After completing his clinical training and practice in medical oncology, he spent the last decade working in the diagnostic and drug development industry, overseeing research and development of more effective drugs and tests for cancer.

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EDUCATION :: URINALYSIS

Positive results: Urinalysis as a competitive advantage How standardization and innovation are transforming urinalysis for patients, clinicians, and laboratories

By Tahir Haque, MD

A

n elderly patient is admitted to a hospital with confusion, nausea, and generalized weakness. These symptoms could be concerning for a variety of different conditions, including a urinary tract infection, pneumonia, dehydration, gastrointestinal infection or medication toxicity—each requiring a different treatment plan. Unfortunately, the patient is unable to provide a detailed history.

In this situation, the clinician’s ability to rely on accurate, timely diagnostics to determine the underlying cause is critical to driving treatment decisions.

As a non-invasive, cost-effective sample to collect, urine can provide a wealth of information to guide patient care.

Through visual inspection, chemical analysis, and microscopy, urinalysis supports the detection and monitoring of numerous conditions, including urinary tract infections (UTIs), kidney disease, diabetes, liver disorders and exposure to drugs or other toxins. As such, it’s one of the most widely used data points in clinical decision-making. But the reality is that the value of these insights is fundamentally dependent on the quality of the specimen and the speed with which results are available to the clinician.

As care delivery becomes more complex and time-tointervention more critical, laboratories are uniquely positioned to serve as strategic partners that can help define success.

Proactively setting standards for urine collection, preservation, transportation and testing helps ensure urine continues to deliver its full clinical value. And importantly, the labs that do this well gain operational excellence—fewer recollections and delays, reduced risk of exposure to bodily fluids, and workflows that scale as demand and test complexity increase.

Here’s a closer look at some pain points in urine testing today and how adhering to best clinical practices and standardizing workflow can offer clear advantages for the lab, the clinical team and patients.

Preanalytical variability: A hidden risk in urine testing

Accurate results start with a high-quality sample, yet the preanalytical phase remains the most common source of laboratory error and avoidable rework. In fact, upward of 70 percent of laboratory testing errors happen during the preanalytical phase.

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EDUCATION :: URINALYSIS For urine testing, practices can vary widely across care settings and collection workflows. Common issues involve improper collection techniques, such as not following handwashing protocols or failing to give a patient proper instructions. One facility may utilize an open container, such as a paper cup, while another may provide a sterile cup built to allow closed-system sample transfer.

Open container collection introduces risk for contamination, and once bacteria enters the sample, it can reproduce rapidly. For example, E. coli can double every 20 minutes in unpreserved urine.

After a sample is collected, how it is transported to the lab for testing matters.

In that process, factors like temperature and time delays can impact the quality of the sample that eventually lands on the lab bench. If containers are not closed and leak-resistant, urine can spill during transit, potentially exposing staff to bodily fluids and creating operational disruption as affected areas must be cleaned and sanitized. Leaks during pneumatic tube transport, for example, can require decontamination and cause testing delays. And once the sample reaches the lab, manual preparation steps

can further consume staff time that could otherwise be spent on other activities.

What does this mean for the patient and clinician waiting for the results of each sample sent to the lab? If a sample is contaminated, the clinician may ask their patient to return to provide another sample. Recollecting the sample and re-running the test can delay necessary care or even translate to prolonged hospitalization. Alternatively, if contamination causes an erroneous result, the provider may prescribe an antibiotic that their patient doesn’t need, which can result in unnecessary treatment and increase antimicrobial resistance.

Fortunately, many of these issues can be avoided through adhering to best clinical practices and standardizing workflows.

Optimizing preanalytical practices, standardization and automation for superior results A better collection process

Multiple studies have shown significant reduction in contamination rates when proper education and collection tools are provided to both patients and staff. To help promote the best sample

integrity, both the Clinical Laboratory Standards Institute (CLSI) and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) offer comprehensive clinical practice guidelines. This includes guidance on the use of personal protective equipment (PPE) and proper specimen collection and handling techniques. For example, patients should be provided with the appropriate supplies and receive clear instructions about handwashing and collecting a first void or mid-stream sample. Healthcare providers must wear gloves when handling containers and should document relevant information including collection time and method and storage conditions on the label.

A better specimen

Standardization is most effective when it is paired with fit-for-purpose tools designed to support the intended downstream use of urine—whether for chemistry, particle analysis, microbiology, or molecular testing.

To reduce contamination and preserve sample integrity, guidelines emphasize using a validated collection and transport system with preservative

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EDUCATION :: URINALYSIS agents as needed to minimize specimen exposure and reduce handling steps.

Preservatives support sample integrity by maintaining bacterial levels and cellular structures. These tools can be foundational to sustaining reliable urine diagnostics at scale.

Additionally, samples should be transported promptly. Guidelines emphasize the importance of transporting samples to the lab within two hours after collection. Delayed specimens should be refrigerated or collected within a validated preservative system appropriate for the intended analyte.

stations, resulting in labor-intensive processes and long turnaround times.

Now, much of the workflow can be automated, which improves the quality of interpretation. Modern diagnostics systems can process everything from up-front steps like labeling to visual inspection and handling of sedimentation to microscopic analysis. As automation continues to evolve and include AI-enabled capabilities, laboratories can realize improved efficiency and reliability.

A better workflow

As awareness continues to grow around the impact of accurate and timely urinalysis on patient outcomes, the industry is accelerating its investment in new technologies and digital‑first approaches that both mitigate preanalytical risk and expand the clinical value of urine beyond traditional use cases. Advances in urine‑based nucleic acid amplification testing, for example, have made urine a widely recommended option for chlamydia and gonorrhea screening in many populations, particularly supporting diagnosis in asymptomatic

Laboratories that align urine collection practices with automation and digital workflows will be better positioned to meet rising demand without increasing cost or complexity. By partnering with providers to have samples sent for analysis in automation-compatible tubes, labs can position samples to seamlessly integrate, minimize, or even eliminate entire steps from their workflow.

Historically, urinalysis involved several manual steps like centrifugation and transferring samples between lab

Looking ahead: The future of urinalysis

patients. At the same time, urine‑based biomarkers are increasingly being used to help risk‑stratify patients for prostate cancer and other oncologic conditions. Incorporation of machine learning algorithms with urine testing may enable more personalized risk assessment for certain conditions. Increased adoption of point‑of‑care testing further underscores the need for quality sampling as care continues to move toward decentralized and personalized testing models.

Ongoing advances in collection practices and technology are unlocking the full informational value of urine diagnostics to better support clinical decision-making and laboratory efficiencies.

Tahir Haque, MD serves as a director of Medical Affairs at BD, faculty member at Harvard Medical School, and an attending physician at Brigham and Women’s Hospital, where he holds dual appointments in the Division of Medicine and the Division of Global Health Equity. With more than a decade of experience at the intersection of medicine, industry and academia, Dr. Haque is a pioneer in digital health and innovative care delivery.

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Extensive test menu on high-speed benchtop The DZ-Lite c270 is an exceptionally versatile benchtop analyzer, offering over 60 moderate-complexity assays including general chemistries, special chemistries, lipid panels, cardiac markers, cancer markers, and a full toxicology menu. It’s compact and versatile — ideal for Physician Offices, Pain Clinics, Oncology Clinics, or a backup analyzer for Reference/Hospital Labs.

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Ductless workstations The MicroFlow Family of Workstations are a Class 1 ductless carbon-filtered workstation equipped with a particle pre-filter and Activated Carbon filtration ideal for fumes, odors, and non-hazardous chemical vapors. Typical applications include general chemistry, individual workstations, school demonstration workstations, and forensic applications.

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

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Intuitive point-of-care CBC analyzer The HemoScreen CBC Analyzer delivers labgrade, FDA-cleared 5-part differential results at the point of care.

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Product Focus :: Rapid/Bench Top Testing

We have you covered Sebia pairs the dIFine Automated Microscope with the dIFine P30 Processor. The P30 is our easy-to-use, efficient walk-away benchtop instrument for IFA slide processing. The dIFine Automated Microscope is the next-generation in IFA imaging, interpretation, and pattern recognition of Sebia IFA ANA HEp-2, dsDNA and ANCA slides.

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FDA cleared clinical drug testing Available on the Evidence MultiSTAT, the FDA 510(K) cleared Drugs of Abuse Multiplex panel is the most advanced rapid testing panel on the market. The pre-filled reagent cartridges offer simultaneous detection of 15 drugs of abuse from urine in just 21 minutes, with a simple 3 step testing process.

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Objective data for confident decisions 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.

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Modern diagnostic efficiency at your fingertips ​The LIAISON NES system is Diasorin’s first CLIAwaived point-of-care molecular solution that brings fast, reliable PCR testing with simple workflow and same-​visit results. Patient samples load directly into ready-to-use cartridges with simple sample preparation, eliminating traditional molecular setup.

A guided, walk-away workflow transforms advanced testing into an efficient point-of-care experience.

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Heat, cool specimens in one unit The MyTemp Mini Digital Incubator (20910) can reach as low as 15º below ambient temperature and as high as 60ºC, with a digital temperature control panel that removes the need for external thermometers. Its compact size saves surface space, while its interior includes an internal outlet and 2 removable shelves.

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RUNNING HEADER :: CONTINUED HEADER

LABORATORY

INNOVATOR

Preparing cytotechnologists for the future

By Christina Wichmann

As Program Director of the MS in Diagnostic Cytopathology program at Rutgers School of Health Professions, how are you evolving curriculum and training to prepare cytotechnologists for increasingly digital and molecular-driven workflows?

Lois E. Rockson, PhD, MPH, MAHEd, SCT(ASCP) is an associate professor and director of the masters in Diagnostic Cytopathology program at Rutgers School of Health Professions in Newark, New Jersey.

Dr. Rockson completed a BS in Biology from Rutgers Newark College of Arts and Sciences in 1989 and a certificate in Cytotechnology from the University of Medicine and Dentistry of New Jersey (UMDNJ)-School of Health-Related Professions in 1993. She holds two masters’ degrees, an MS in Health Professions Education, a joint degree from Seton Hall University and UMDNJ-School of Health Professions in 2000 and an MS in Public Health, Epidemiology concentration from the UMDNJ School of Public Health in 2008.

In 2020, Dr. Rockson completed her PhD in Urban Systems with a concentration in Urban Health, a joint degree with the Rutgers School of Nursing, New Jersey Institute of Technology School of Architecture and Rutgers Graduate School, Newark. Dr. Rockson’s research interest is in cancer health disparities among immigrant groups from the Caribbean and Central America.

She currently serves as vice president of the Society of Black Pathology and is a member of the Cancer Institute of New Jersey’s Center for Cancer Health Equity as well various cytopathology organizations.

In her spare time, Dr. Rockson enjoys fishing, gardening, knitting, and beekeeping.

Our curriculum is designed to prepare cytologists for the transition to precision-guided treatments driven by innovations in digital pathology and molecular diagnostics. Our graduate-level curriculum has two dedicated courses in molecular diagnostics. In one of the two courses, students become certified on a molecular platform, ensuring they are prepared for work on day one of employment. Digital pathology is also a part of our curriculum. Our students are provided with foundational knowledge of the role and value of digital technology in diagnostic decision-making.

Workforce challenges continue to impact laboratories nationwide—how are you addressing recruitment, retention, and diversity within cytopathology training programs?

I use a multipronged approach to share information about the laboratory professions, and the cytology profession in particular, in my recruitment strategy.

Recruitment includes virtual and inperson information sessions, connecting with regional college health career advisors, using social media to post news and information about events, and having one-on-one conversations with folks I meet in coffee shops and in my community about opportunities in the laboratory professions.

Looking ahead, what skills or competencies do you believe will define the next generation of successful cytopathology professionals, and how can current laboratorians begin to adapt now?

Cytologists engaging in research and publishing. One of the important components of our graduate-level curriculum is the research courses, which train our students to add to the body of

evidence on cytology practice. Cytologists looking to advance our practice must be the ones leading the way in research on all levels of cytology practice, writing papers, and sharing information.

Cytologists are critical thinkers engaged in high-complexity testing. There are opportunities to expand our scope of practice, but we must lead the way.

Through your leadership with the Society of Black Pathologists, how are you working to build mentorship pipelines for underrepresented students entering laboratory medicine?

The Society of Black Pathology offers free membership to medical students and those in training in a laboratory professional program, such as ours here at Rutgers School of Health Professions.

Our student members become part of the SBP network, where mentor-mentee connections are made. Many of the SBP members are also part of the other laboratory and pathology mentorship programs and bring those connections to our student and trainee members. Recently, the SBP held a Day of Culture, an event I chaired. The theme was “Pathology Across the Diaspora.”This in-person event, held in Atlanta, Georgia, celebrated the Society of Black Pathology’s 5th anniversary. A social networking event was part of the celebration, during which we deliberately gathered information to establish mentorship relationships.

What lessons from your own career path have most influenced how you mentor and develop the next generation of cytopathology professionals?

I have been a cytologist for over thirty years. The lesson for me is recognizing opportunities. There are opportunities to branch out while remaining rooted in cytology. This is one of my main messages to potential students looking to join the profession, and to my students.

I never imagined that my cytology training would lead me to a career in academia, but here I am twenty-five years later, educating cytologists who become integral members of patient care teams.

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SHINE A LIGHT ON A HIDDEN PROBLEM HEMOLYSIS ACCOUNTS FOR UP TO 70% OF PREANALYTICAL ERRORS.1

The NEW GEM Premier 7000* with iQM3 is the first and only blood gas system to provide lab-quality hemolysis detection right at the point of care.2 Hemolysis elevates potassium by up to 152%—tackle the #1 preanalytical error and elevate patient care.3–5 NEW

Express Hemolysis Detection Blood gas results with hemolysis detection in 45 seconds at the point of care, which may reduce the need to send samples to the lab for recheck, saving blood and time.6

Effective and efficient Whole blood hemolysis detection can help reduce unnecessary sample collection, delays, and inappropriate treatment. Ultimately, it can help optimize staff time, reduce costs, and improve patient management.5,7–10 Track-to-Train Go beyond detection. Lower preanalytical error rates due to hemolysis with GEMweb® Plus 500 Custom Connectivity by tracking operators and locations to identify where further training is required. Plus, Werfen Academy can provide the necessary content for instruction.

Illuminate hemolysis and enhance patient care at hemolysisdetection.werfen.com References 1. Lippi G, Salvagno GL, Favaloro EJ, Guidi GC. Survey on the prevalence of hemolytic specimens in an academic hospital according to collection facility: opportunities for quality improvement. Clin Chem Lab Med. 2009;47(5):616–618. doi:10.1515/CCLM.2009.132. 2. Balasubramanian S, McDowell EJ, Laryea ET, et al. Novel in-line hemolysis detection on a blood gas analyzer and impact on whole blood potassium results. Clin Chem. 2024;70(12):1485-1493. doi:10.1093/clinchem/hvae135. 3. Lippi G, Fontana R, Avanzini P, Sandei F, Ippolito L. Influence of spurious hemolysis on blood gas analysis. Clin Chem Lab Med. 2013;51(8):1651–1654. doi:10.1515/cclm-2012-0802. 4. Lippi G, von Meyer A, Cadamuro J, Simundic A-M. Blood sample quality. Diagnosis. 2018;6(1):25–31. doi:10.1515/dx-2018-0018.

5. O’Hara M, Wheatley EG, Kazmierczak SC. The impact of undetected in vitro hemolysis or sample contamination on patient care and outcomes in point-of-care testing: a retrospective study. J Appl Lab Med. 2020;5(2):332–341. doi:10.1093/jalm/jfz020. 6. Werfen. GEM Premier 7000 with iQM3 Operators Manual. P/N 00000026407. Rev 00. Aug 2023. 7. Phelan MP, Hustey FM, Good DM, Reineks EZ. Seeing red: blood sample hemolysis is associated with prolonged emergency department throughput. J Appl Lab Med. 2020;5(4):732–737. doi:10.1093/jalm/jfaa073. 8. Wilson M, Adelman S, Maitre JB, et al. Accuracy of hemolyzed potassium levels in the emergency department. West J Emerg Med. 2020;21(6):272–275. doi:10.5811/westjem.2020.8.46812. 9. Milutinović D, Andrijević I, Ličina M, Andrijević L. Confidence level in venipuncture and knowledge on causes of in vitro hemolysis among healthcare professionals. Biochem Med. 2015;25(3):401–409. doi:10.11613/BM.2015.040. 10. Phelan MP, Ramos C, Walker LE, et al. The hidden cost of hemolyzed blood samples in the emergency department. J Appl Lab Med. 2021;6(6):1607–1610. doi:10.1093/jalm/jfab035.

Learn about hemolysis detection

GEM, Premier, and iQM are trademarks of Instrumentation Laboratory Company (d.b.a. Werfen). The Werfen logo is a trademark of Werfen. ©2025 Instrumentation Laboratory. All rights reserved. *Not available in all countries.

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