Medical Laboratory Observer - August 2025

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Cecil James Buguis, DHSc, MSc, MBA, CTTS, MLS(ASCPi)cm Administrative Laboratory Director, Winkler County Hospital District

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IN THIS ISSUE...

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August 2025 | Vol. 57, No. 6

6

From the editor

CONTINUING EDUCATION

8 14

Test smarter, not harder: Boosting quality and reducing avoidable costs through laboratory stewardship

By Jaime A. Nieto Sierra, DBA, MHA and Apoorv Kumar

EDUCATION

14

2025 UNIVANTS of Healthcare Excellence Award: Nine innovative teams earn recognition

By Colleen Strain, PhD

INFECTION DIAGNOSTICS

16 16

The point…of point-of-care testing

By Maria Paulina Posada-Vergara, MD, MSc and Robert F. Moran, PhD, FCCM, FIUPAC

STATE OF THE INDUSTRY

20

Labs respond to evolving needs in Alzheimer’s/dementia and respiratory testing amid global supply chain uncertainties

By Kara Nadeau

MOLECULAR DIAGNOSTICS

20

24

Evaluating cardiac and renal risks in patients with diabetes: A “sweetheart” diagnostic challenge

By Jim Aguanno, PhD and Justin Jones, PhD

LAB MANAGEMENT

28

High-reliability safety in the laboratory

By Dan Scungio, MLS(ASCP), SLS, CQA (ASQ)

PRODUCT FOCUS

24

32

Rapid & bench top testing

LAB INNOVATOR

34

Rural healthcare through the lab lens

By Christina Wichmann

DEPARTMENTS

30 31 28

Index of advertisers Clinical spotlights

ON THE COVER: Zolnierek/ iStock / Getty Images Plus / Getty Images

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F ROM T HE EDITOR

Recent CLIA updates Form CMS-2567: Statement of Deficiencies and Plan of Correction

On June 18, 2025, CMS published an update to its practices on the release of CMS-2567 in QSO-25-19-All. This form will now be publicly released within 14 days after receipt by the provider, supplier, or lab — this change effectively allows immediate release. Labs generally have ten days to develop and submit a response to the findings, which may include a Plan of Correction (POC) and/or Allegation of Compliance (AOC). This is not changing.

Previous practice by CMS held the public release of

By Christina Wichmann CMS-2567 for up to 90 days after the completion of a Editor in Chief survey or until a POC or AOC had been approved by CMS. CMS-2567 is the record of the survey where the surveyor(s) documents and justifies the determination of compliance for CLIA certification. The information/survey findings serve as the basis for the laboratory to analyze its deficient practices or system failures and to develop plans of correction. CMS-2567 may also document deficient practices identified by means other than an on-site survey (e.g., an off-site review of unsuccessful proficiency testing scores).

Enforcement and Clarification of Personnel Regulations

On June 23, 2025, CMS published circumstances that it will be exercising enforcement discretion (authority of regulatory agencies to determine how and when to enforce regulations) regarding new personnel regulations that went into effect December 28, 2024. The following is communicated in QSO-25-21-CLIA: • CMS will be exercising enforcement discretion in the following limited circumstances with respect to certain regulatory personnel qualification requirements and plans to address these changes in future notice-andcomment rulemaking: CMS will allow laboratory directors qualifying under 42 CFR 493.1405(b)(2) to have either at least one year of experience directing or supervising nonwaived laboratory testing or 20 continuing education (CE) credit hours in laboratory director responsibilities.

• CMS will not require the additional 20 CE credit hours currently required under §493.1405(b)(3)(ii), 493.1405(b)(4)(iv), 493.1405(b)(5)(iv), 493.1443(b)(2) (iii), and 493.1443(b)(3)(iv). As such, any individual previously qualified as a clinical consultant will be able to continue to qualify without taking an additional 20 CE credits.

• CMS will allow for individuals qualified as technical supervisors under §493.1449(f)(2)(i) to qualify as high-complexity laboratory directors for testing in dermatopathology.

• In addition, CMS is clarifying the following and plans to address in future notice-and-comment rulemaking: • “An approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” as required under §493.1405(b) (3)(i)(B)(2), 493.1405(b)(4)(i)(C)(2), 493.1443(b)(3)(i)(B)(2), and 493.1449(c)(4)(i) (C)(2) does not need to be on human subjects, as most research is performed on animal models.

• The requirements under §493.1443(b)(3)(iii) for high-complexity laboratory directors to require a total of two, not four, years of laboratory training or experience and laboratory experience directing or supervising high complexity testing.

These and other CMS memos can be viewed at https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/ policy-memos/policy-memos-states-and-cms-locations.

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

TM

Vol. 57, No. 6

PUBLISHER Chris Driscoll

cdriscoll@endeavorb2b.com EDITOR IN CHIEF Christina Wichmann

cwichmann@mlo-online.com

MANAGING EDITOR Erin Brady

ebrady@endeavorb2b.com

PRODUCTION MANAGER Edward Bartlett ART DIRECTOR Kelli Mylchreest AUDIENCE DEVELOPMENT/LIST RENTALS

Laura Moulton | lmoulton@endeavorb2b.com ADVERTISING SERVICES MANAGER

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

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

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

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

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

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CONTINUING EDUCATION :: DIAGNOSTIC STEWARDSHIP

ID 292617035 © Sheila Fitzgerald | Dreamstime.com

Continuing Education :: Diagnostic stewardship

Test smarter, not harder: Boosting quality and reducing avoidable costs through laboratory stewardship

By Jaime A. Nieto Sierra, DBA, MHA and Apoorv Kumar

H

ospitals across the United States are facing significant financial pressures, with operating margins experiencing fluctuations in recent years. Combined operating margins decreased from 8.9% in 2021 to 2.7% in 2022 before increasing to 5.2% in 2023. However, both combined operating margins and total margins have

remained below 2019 pre-pandemic levels in 2023.1 There are several factors that have contributed to these financial difficulties, including: 1. Lower reimbursement rates: Hospitals have experienced reduced payments from government payers (Medicare/Medicaid) and com-

Earning CEUs

See test online at https://ce.mlo-online.com/courses/test-smarter-not-harder-boostingquality-and-reducing-avoidable-costs-through-laboratory-stewardship/ 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: 1. Define laboratory diagnostic stewardship.

2. Describe outcomes of an organization’s stewardship program.

3. Identify actionable test utilization practices.

Scan code to go directly to the CE test.

mercial insurers, impacting overall revenue streams.

2. Rising labor expenses: Labor costs, which generally account for about half of a hospital’s total expenses, have risen significantly, driven in part by increased dependence on contract labor agencies.2 3. Higher costs for medical supplies and diagnostic equipment: Hospitals have faced increased operational costs due to rising expenses related to prescription drugs and supplies.3 4. Shifts in patient care from inpatient to outpatient settings: The transition to outpatient care has led to reduced inpatient volumes, affecting top line revenues for hospitals.

5. Increased regulatory compliance costs: Hospitals must invest in compliance measures to meet regulatory requirements, adding to operational costs.

Considering these financial constraints, hospital leadership must

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Continuing Education :: Diagnostic stewardship find innovative ways to reduce operating expenses while sustaining and/ or increasing the quality of care that is being offered. One opportunity for cost savings lies in optimizing laboratory test utilization through stewardship programs.

Diagnostic stewardship

Laboratory and pathology diagnostic stewardship refers to the coordinated effort to ensure that diagnostic tests are used appropriately and effectively to reduce unnecessary testing, reduce costs, and maintain or improve patient outcomes. Advancements in laboratory medicine have increased the availability of complex and specialized tests, and overuse of laboratory tests has been a growing problem in hospital settings, contributing to rising healthcare costs.

Factors such as clinical routines, lack of cost transparency, and the convenience of electronic health record (EHR)-based ordering play significant roles in this overutilization.4 By integrating best practices and evidence-based guidelines, laboratory stewardship programs (LSPs) assist hospital systems in managing diagnostic utilization effectively amid tightening financial margins, rising operational costs, and regulatory compliance challenges.

Kaiser Permanente, Greater Southern Alameda Area Network

Kaiser Permanente is one of the largest integrated healthcare systems in the United States, serving over 12 million patients across eight states and a federal district. With over 35 hospitals and over 600 medical offices, it is known for its innovative care models, such as the early adoption of EHRs and value-based care initiatives. The organization is also committed to sustainability, implementing various environmental and healthcare stewardship programs to improve efficiency and patient outcomes.

The organization recognizes the importance of LSPs as a critical strategy for improving healthcare efficiency and reducing unnecessary diagnostic testing. To formalize these efforts, it established the Laboratory & Pathology (L&P) Utilization Committee, which serves as an advisory body dedicated to defining best practices in ordering laboratory diagnostics. The committee’s primary objectives include reviewing test utilization, establishing appropriateness criteria, minimizing variations in diagnostic testing, and reducing external testing costs through evidence-based decision-making.

Stemming from the LSP initiative, Kaiser launched the “Test Smarter, Not Harder” initiative (the Initiative), which focuses on improving laboratory efficiency within its Greater Southern

Kaiser Permanente recognizes the importance of laboratory stewardship programs as a critical strategy for improving healthcare efficiency and reducing unnecessary diagnostic testing.

Alameda Area (GSAA) network. The Initiative has three broad focuses: first, those tests currently being conducted externally that could feasibly be performed within the internal laboratory network; second, tests already being processed internally but which might be achievable at a significantly lower cost through alternative test choice; and third, tests —conducted internally or externally — that may be clinically unnecessary and could be safely avoided all together.

This article summarizes the first focus of the Initiative: leveraging a data-driven approach to identify tests being conducted externally that can be internalized. A key component of the project is to centralize laboratory utilization data that is currently fragmented across multiple laboratory units within the GSAA network and develop an organizational framework for conducting these evaluations regularly.

Initial approach

This project followed a structured, multi-step approach grounded in data analysis and stakeholder engagement.

The initial step involved developing a thorough understanding of the modalities of laboratory test collection and processing across the GSAA network, which include four primary laboratory and pathology centers located in Sleepy Hollow, Union City, Fremont, and San Leandro. We worked with the regional laboratory operations team to collect and collate laboratory test utilization data across all four sites for the 2024 calendar year. Once the data sets were consolidated, we conducted a detailed review to understand how the data had been stratified and whether tests

outsourced to external laboratories could be reliably identified.

We then analyzed the dataset to identify the top 10 tests that were most frequently sent outside the network.

These tests would be selected as priority targets for potential internalization.

With this data in hand, we would then collaborate with the finance team to assess the direct costs associated with outsourcing these tests, providing insights into the financial burden they place on the system.

With this foundational analysis in place, we conducted stakeholder interviews across the laboratory, operations, and finance departments to understand the workflow implications of internalizing these tests. This pro forma assessment aimed to estimate the potential cost savings associated with internalizing the selected tests. Finally, based on the findings from the data analysis and stakeholder consultations, the project would culminate in the development of a scalable recommendations that would enable the health system to replicate this LSP on an annual basis, ensuring ongoing optimization of diagnostic services across the GSAA network.

Laboratory utilization data

When we first looked at the laboratory utilization data from 2024, we observed that the GSAA network had made over four million test orders. Of these tests, we were able to extract that ~41.4% of these tests were classified as “send-in,” and 58.6% of them were “send-out” tests.

Additional data allowed us to stratify the “send out” data into segments which reflected the location where the tests were processed: in-network regional

Location

Grand Total

Other

59,487

Other in-network labs

3,703

In-network regional labs

2,357,437

Total

2,420,627

Table 1. Initial laboratory utilization stratified dataset.

labs, other in-network labs, and other.

From this stratified data, the set that we were most concerned with were the tests classified as “Other,” as these were the tests that were sent to labs outside the health system network.

We determined that only ~2.46% of these tests that were classified as “send out” were actually tests that were sent to reference labs outside the network.

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Continuing Education :: Diagnostic stewardship Table 1 highlights the breakdown of the number of tests and their respective stratification.

With this data in hand, we wanted to get a broad picture of the financial implications of having just shy of 60,000 tests being sent out of the network. In our conversations with the finance team, we were able to determine that a total of $16.5 million was spent across the year on testing by the GSAA unit, of which ~$5.8 million were attributable to tests sent out of the network.

Our analysis unearthed the top ten tests that were being sent out of the network from the GSAA unit. These are listed in Table 2.

Test names

Quantity ordered

Helicobacter Pylori Antigen, Stool

6,225

Gamma Interferon (TB), 1 Tube, CLIA/ IA

5,526

Gamma Interferon (TB), CD4 and CD8 T-Cell Response

4,216

Trichomonas Vaginalis RNA, Amplified Probe

3,432

Reproductive Genetic Carrier Screen Panel

3,115

Calprotectin, Stool

2,694

Vitamin B1 (Thiamine), Blood

2,056

Vitamin B9 (Folic Acid), RBC

1,388

Zinc

1,221

Actin IgG, Qualitative

1,106

Total

30,979

Table 2. Top 10 tests being sent out of the KP network by the GSAA unit.

With this information, we see that these tests account for just shy of 50% of the tests being sent out of the network, and the data collected from the finance team reflected that total expenditure for conducting all these tests was $1.58 million.

Stakeholder interviews

The structured interview with clinicians, laboratory staff, and administrative stakeholders across the GSAA network revealed several recurring themes and nuanced insights regarding laboratory test ordering, data flow, and stewardship practices. The following synthesis highlights the most prominent findings: 1. Limited physician awareness of test routing: A consistent theme was the lack of awareness among physicians regarding where laboratory tests are ultimately processed. Multiple clinicians emphasized that, aside from a few exceptions (notably “miscellaneous reference tests”), they generally do not know whether a test order is fulfilled internally, by a regional lab, an innetwork lab, or to an external reference laboratory. Test routing is largely determined by pre-set options within the EHR system.

2. Reliance on “smart set” test ordering: The interviews revealed a common trend of widespread reliance on standardized order sets or “smart sets” within the EHR system. Physicians across specialties routinely use these smart sets to streamline the ordering process for common clinical scenarios,

such as well-child visits, prenatal care, or standard admissions. These order sets are typically pre-configured by clinical teams and are designed to reduce cognitive burden and improve order processing times by allowing providers to select a comprehensive panel of recommended tests with minimal manual input.

3. Data fragmentation and manual processes: Stakeholders from both laboratory operations and information systems teams highlighted significant challenges in data extraction and consistency. The process of identifying the misclassification of the “miscellaneous reference labs” tests not being captured in a standardized way across the GSAA network reflects this (See Limitations section below). This has led to a reliance on tedious data cleaning and reconciliation, increasing the risk of errors in data analysis.

4. Clinical department–specific ordering patterns and legacy practices: Clinical departments exhibit distinct ordering behaviors: • Pediatrics: Orders a high volume of tests, often to avoid repeat visits for children, which drives up external test utilization numbers for the department. The care model prioritizes minimizing patient inconvenience, sometimes at the expense of test stewardship.

• OB/GYN: Most tests ordered are already conducted internally, apart from state-mandated genetic screenings. For which, genetic counselors or maternal-fetal medicine specialists typically handle external orders, which fall under the “miscellaneous reference lab” test category. In this department there is a formal steering committee overseeing prenatal genetic test orders, and some tests are charged to the genetics team rather than to the L&P team budget.

• Gastroenterology: Relies on long-standing legacy ordering processes. Certain tests (e.g., Prometheus panels) are ordered out of habit, and there is little awareness or incentive to change these patterns.

Over-ordering of specific tests like calprotectin or H. Pylori was noted, with suggestions that more critical evaluation of the clinical necessity of ordering these tests is warranted.

5. Existing stewardship mechanisms: Some departments have implemented stewardship strategies, particularly within the OB/GYN and highrisk pregnancy care. These include: • A combination in the use of smart sets along with a decision support tool in the EHR, designed to streamline ordering and reducing unnecessary tests.

• Hard stops and prompts for certain tests to ensure appropriateness.

• Oversight by genetics teams and steering committees for high-cost or high-volume genetics tests.

Overall, from these insights we can say that the workflow for laboratory test ordering is characterized by a high degree of automation, limited clinician visibility into test routing, and clinical departmental-specific adaptations. The interviews highlight both the efficiency and the opacity of the current system, suggesting that greater transparency and ongoing review of ordering protocols could further optimize test utilization and support laboratory stewardship goals.

Finally, the stakeholder interviews also provided valuable, practical recommendations on which laboratory tests could be prioritized for internalization within the GSAA

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Continuing Education :: Diagnostic stewardship network. Clinicians and administrative staff consistently identified several high-volume or frequently ordered tests that, if brought in-house, could yield significant cost savings and operational efficiencies.

The findings from this project reveal significant and actionable insights into laboratory tests utilization and stewardship within the GSAA network.

The data and stakeholder interviews collectively highlight the dual challenge of optimizing test ordering practices while navigating substantial data and workflow barriers. These challenges are not merely operational inconveniences; they have direct implications for cost efficiency, clinical quality, and the ability to implement sustainable LSPs. Based on the findings, several recommendations have emerged: 1. Standardization and integration of data systems: We recommend that the GSAA network develop systemwide definitions and automated categorization for send-out tests, including “miscellaneous reference lab” tests. This will reduce the administrative burden for reconciliation of volumes, improve cost tracking, and enable more accurate stewardship analysis.

2. Improve clinician cost transparency and decision support systems: Modify EHR interfaces to provide real-time feedback on test routing and costs at the point of order entry. Incorporate decision support systems or “hard stops” for high-cost or high-volume tests, as already piloted in the OB/GYN department, to encourage evidence-based ordering and reduce unnecessary externalization of tests.

3. Prioritize internalization of highvolume ordered tests with predictable order patterns: Focus on internalizing those tests with predictable, high demand - such as cystic fibrosis carrier screening, H. Pylori, and calprotectin. This approach should be supported by clinical consensus.

4. Establish a GSAA multidisciplinary stewardship committee: Create a standing committee with annually rotating representation from clinical, laboratory, information technology, and finance departments to oversee test utilization patterns and monitor impact of stewardship

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Discussion and recommendations

interventions. Regular review (e.g., annual) and feedback cycles are critical for sustaining improvements.

5. Establish clinical department level stewardship committees: To complement the multidisciplinary stewardship committee, establish a structured process for annual review of EHR smart sets by departmental stewardship committees. This approach builds on existing efforts while addressing gaps identified in specialties.

In addition, departmental stewardship committees will provide sub-departmental context to test ordering patterns to ensure there is a weighted criteria-based recommendation when required.

6. Ongoing education and communication: Finally, the GSAA network should implement educational initiatives to inform clinicians about internal testing capabilities and impact of their ordering practices. Foster a culture of stewardship through regular updates and transparent reporting of utilization data.

data. These tests, totaling approximately 2,298, were labeled as miscellaneous and stored in the“send-in”section of the data.

The need for extensive data cleaning introduced a risk of error in data integrity.

In addition, the lack of analysis of this data highlights the possible limitations in the recommendations offered.

Second, the interview sample, while diverse, may not be a complete representation of perspectives of all clinical departments. This means that there needs to be a more representative sample before the insights can be generalized.

Third, the analysis focused primarily on cost and volume outcomes, without direct measurement of clinical impacts such as turnaround times or patient outcomes. Finally, the findings are specific to the GSAA network and may not be fully generalizable to other regions or the entire health system with different organizational structures or EHR configurations.

Conclusion

In summary, this project demonstrated that meaningful LSPs require more than identifying high-cost tests; it demands Limitations investment in data infrastructure, workflow transparency, and interdisThis project faced several limitations.

First, the reliability of quantitative ciplinary collaboration. These findings echo national trends where analysis was constrained by inconsistent data entry and stewardship success is often hard coding, particularly for linked to targeted, depart“miscellaneous reference mental-driven intervenlab”tests. We discovered that tions and strong governance a portion of these tests were structures. Addressing the technically sent outside the highlighted challenges will health system network but not only foster a culture of were not captured in the of- Scan code to go continuous quality improveficial“send-out”section of the directly to the CE test. ment, but it could also result

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Continuing Education :: Diagnostic stewardship in financial savings and care quality excellence. By implementing the recommended strategies, the GSAA network can position itself as a leader in LSPs and set a replicable standard for the rest of the health system and other integrated healthcare systems in the country.

We would like to acknowledge and thank the laboratory staff and leadership team for their work and guidance during the review process, in particular Stacey Aggabao MBA, MSN RN NEA-BC CEN CTACC; Elena Soriano CLS, MLS (ASCP); Susan Tannenbaum CLS (ASCP); and Kathy M. Taylor.

REFERENCES 1. Levinson Z, Godwin J, Neuman T. Hospital margins rebounded in 2023, but rural hospitals and those with high Medicaid shares were struggling more than others. KFF. Published December 18, 2024. Accessed June 24, 2025. https://www.kff.org/health-costs/ issue-brief/hospital-margins-rebounded-in2023-but-rural-hospitals-and-thosewith-high-medicaid-shares-were-strugglingmore-than-others/.

2. Krishnamurthy B. Margin misconceptions: What do break-even hospital margins mean for patient care? American Hospital Association | AHA News. Published August 1, 2023. Accessed June 24, 2025. https://

www.aha.org/news/blog/2023-08-01-marginmisconceptions-what-do-break-evenhospital-margins-mean-patient-care.

3. Costs of caring. American Hospital Association. Published April 2025. Accessed June 24, 2025. https://www.aha.org/costsofcaring.

4. Shaik T, Mahmood R, Kanagala SG, et al.

Lab testing overload: a comprehensive analysis of overutilization in hospital-based settings. Proc (Bayl Univ Med Cent).

2024;37(2):312-316. doi:10.1080/08998280.2 023.2288788.

Jaime A. Nieto Sierra, DBA, MHA is a retired U.S. Air Force veteran and a published, award-winning, social sciences researcher with a rich array of skills and over 17 years of leadership experience in healthcare and life sciences administration.

He currently serves as the Director of Operations for Ambulatory Services and Pathology General at Kaiser Permanente’s Greater Southern Alameda Area.

Prior to joining Kaiser, Jaime served in the U.S. Air Force, where he held leadership positions in various healthcare settings, including academic institutions, clinical lab and investigation facilities, and hospitals of varying sizes, including mid-sized and large facilities. His areas of expertise include business strategy, project management, organizational behavior, organizational learning, and regulatory compliance.

Apoorv Kumar began his career in the heart of preventative medicine— vaccines—working with Bharat Biotech, one of India’s largest vaccine manufacturers.

In this role, he led the commercialization of critical vaccines, including efforts to expand access to the company’s COVID-19 vaccine across global markets. His work included building out supply chains and forging long-term partnerships across Latin America, where he negotiated major contracts with multilateral agencies.

These experiences, though deeply impactful, revealed the immense pressure that infectious diseases place on an already strained health system. This realization spurred Apoorv to explore the healthcare provider segment and its operational challenges more closely. Through consulting engagements with Marin Health and an internship with Kaiser Permanente, he immersed himself in the strategic and financial decision-making processes of health systems. Currently pursuing a dual MBA/MPH at the University of California, Berkeley, Apoorv brings a unique lens that bridges biopharma innovation, public health, and hospital operations. He is passionate about ensuring that high-quality healthcare can be delivered as efficiently as possible to as many people as possible.

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EDUCATION :: UNIVANTS AWARD

Education :: UNIVANTS Award

2025 UNIVANTS of Healthcare Excellence Award: Nine innovative teams earn recognition

By Colleen Strain, PhD

T

he UNIVANTS of Healthcare Excellence program is a prestigious global award program that recognizes integrated clinical care teams who have strategically mobilized insights from laboratory medicine to enable greater outcomes and improved patient care.1,2 In 2025, the UNIVANTS program proudly recognized impressive work from nine integrated clinical care teams who have not only unified across the care continuum, but achieved measurably better outcomes for patients, clinicians, health systems/ administrations, and payors.

All nine of the recently recognized best practices have made measurable improvements to care, including improving wellness, reducing lengths of stay, protecting patient safety, improving patient flow, and more. With three top global winners, three teams of distinction, and three teams of achievement, these innovative initiatives are fueled by laboratory medicine to make a difference. For details on all winners, please visit www.UnivantsHCE.com.

The 2025 top global winners of this prestigious healthcare excellence award include Centre Hospitalier Universitaire of Clermont-Ferrand, Musashino Red Cross Hospital, Complejo Hospitalario Universitario Nuestra Señora de Candelaria.

TBI strategies: Expediting patient flow and reducing length of stay through blood biomarker–guided management of patients with suspected mild traumatic brain injury

An integrated clinical care team from Clermont-Ferrand, France, recognized that patients who present to the emergency department (ED) with a traumatic brain injury (TBI) often require a CT scan, which is typically conducted between 4-8 hours after the injury.

For patients with mild TBI (mTBI), the incidence of complications is low and thus CT scans are often negative. Consequently, patients can spend substantial

French TBI: Pictured (from left to right): Vincent Sapin, Bruno Pereira, Jeannot Schmidt, Damien Bouvier, Charlotte Oris.

time waiting for imaging, compounding ED overcrowding, while being exposed to potentially unnecessary radiation from the CT scan.

With a strong understanding of existing evidence, this integrated clinical care team sought to improve patient flow in the (ED), while reducing length of stay through implementation of a brain biomarker– guided decision pathway to reduce unnecessary CT scans. Their collaborative effort reduced length of stay for mTBI patients by over 3 hours, thus mitigating 2,300 resource hours each year from medical and non-medical staff­as a direct result of expedited patient flow.

The pathway to HCV elimination: Multidisciplinary team effort for improved identification, diagnosis, and treatment of HCV positive patients

Early identification of hepatitis C is a globally relevant and important goal, with the World Health Organization (WHO) global hepatitis strategy aiming to achieve a 90% reduction in

new infections and 65% reduction in deaths by 2030.3 In Japan, an estimated 1.0–1.5 million people have undiagnosed and/or untreated hepatitis C (HCV) infections. 4 The Musashino Red Cross Hospital is a regional core center for liver disease treatment in Tokyo, with initiatives that actively promote and work toward hepatitis elimination, including enhanced recommendations for screening, follow-up, and consultation for patients who test positive for HCV antibodies, in addition to e-alert systems to further encourage clinical action.

Recognizing that identification of patients with untreated HCV requires

For more information on UNIVANTS, the 2025 winners, and/or to apply starting August 1st, please visit www.UnivantsHCE.com.

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Education :: UNIVANTS Award multi-faceted initiatives, the Musashino Red Cross Hospital built upon their previous best practices to implement new processes for follow-up that link patients to care and treatment.

This multi-disciplinary initiative involved laboratory medicine, doctors, nurses, and administrative sta­ff and has reduced the unreferred rate for patients with HCV antibody positivity by 33.7% [from 34.8% (2020) to 1.1% (2024)] and led to an 8.3% reduction [from 10.2% (2022) to 1.9% (2024)] in the number of known HCV positive patients without treatment. Impressively, clinicians in other departments have also changed their behavior thanks to comprehensive educational efforts, enabling a 6.2% increase [from 17.5% (2022) to 23.7% (2023)] in clinical adherence to hospital recommendations for medical history checks, relevant HCV antibody testing and subsequent referrals, as appropriate. Collectively, these e­fforts are mitigating preventable liver cancers, with mitigated costs of approximately 46.4 million yen/year.

Radiation reduction: Increased safety and improved length of stay for patients with suspected mild traumatic brain injury in the emergency department

The importance of TBI management is evident, with a second team receiving top recognition in 2025 for their brain biomarker–guided decision pathway.

The integrated clinical care team from Santa Cruz de Tenerife, Spain, recognized that most of their patients with mTBIs spend an average of 8.7 hours in

Spanish TBI: Pictured (from left to right): María Teresa Concepción Masip, María Cecilia Martín Fernández de Basoa, Carlos Alberto Marichal Hernández, Pilar González Romero, Mónica Fernández del Castillo Ascanio.

the ED waiting, and they are often discharged without the need for significant intervention. With the goal of reducing unnecessary radiation and improving length of stay, this integrated clinical care team incorporated glial fibrillary acidic protein (GFAP) and ubiquitin carboxyterminal hydrolase L1 (UCHL-1), into their decision-making pathway to help rule-out the need for CT scans for patients with suspected mTBI. Since implementation in 2022, this integrated clinical care team has evaluated over 5,000 patients in the ED for mTBI, with an impressive 36% of mTBI patients safely avoiding unnecessary CT scans. This has further enabled a

4.23 hour reduction in ED length of stay for patients who do not require observation.

Congratulations to the top winning care teams and to all integrated clinical care teams receiving recognition in 2025! For more information on UNIVANTS, the 2025 winners, and/or to apply starting August 1st, please visit www.UnivantsHCE.com.

REFERENCES 1. Strain C, Ravalico T. Electric trends of laboratory medicine: Five years of growth, visibility, and opportunity. J Appl Lab Med. 2025;10(2):440-454. doi:10.1093/jalm/jfae152.

2. The UNIVANTS of Healthcare Excellence award program. The UNIVANTS program. Accessed June 25, 2025. www.UnivantsHCE.com.

3. Hepatitis. World Health Organization (WHO). Accessed June 25, 2025. https:// www.who.int/health-topics/hepatitis/ elimination-of-hepatitis-by-2030#tab=tab_1.

4. Tanaka J, Kurisu A, Ohara M, et al. Burden of chronic hepatitis B and C infections in 2015 and future trends in Japan: A simulation study. Lancet Reg Health West Pac. 2022;22:100428. doi:10.1016/j. lanwpc.2022.100428.

Colleen Strain, PhD is a

HCV: Pictured (from left to right): Marina Muneyama, Nobuharu Tamaki, Masayuki Kurosaki, Maki Furuya, Noriko Kubota.

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

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INFECTION DIAGNOSTICS :: POINT-OF-CARE TESTING

By Celso Pupo on Adobe Stock

Infection Diagnostics :: Point-of-Care Testing

The point…of point-of-care testing

By Maria Paulina Posada-Vergara, MD, MSc and Robert F. Moran, PhD, FCCM, FIUPAC

T

he first ‘laboratory test’ was point-of-care! Physicians in ancient Egypt, Greece, and even in neolithic cultures of Amazonia, looked at a patient’s presentation and reasoned that if something inside was wrong, ‘whatever came out’ might help evaluate the cause and suggest a cure.

Urine, stool, sweat, blood, etc. — look, smell, taste — they began to figure things out at the bedside.

Even in the early scientific age (18th & 19th centuries) this was true. It was only in the mid-20th century that clinical medicine became so diverse and analytically high tech that only a central or reference laboratory could manage the increasing demand for clinical testing and analysis. Today ‘s bio-engineered analytical systems, as well as data processing innovation, has allowed us to get back to the original near-patient testing for basic chemistry and cell counts as well as presumptive microbiology. Much of the complexity of routine central lab testing has been simplified such that non-specialists can use measurement systems to measure what took a specialist to perform in the recent past.

POCT versus CCT: While critical care testing (CCT) in the emergency room or intensive care unit is frequently thought of as POCT, we believe that CCT is a singular category in itself — one that typically combines in situ POCT, and central and specialty lab operations geared to most urgent priority testing.1,2,6,8,9,11,16 There certainly are commonalities between de facto POCT and CCT — primarily provision of correct testing results in

a brief time interval. In order for POCT to be a requirement for an institution instead of simply an extension of CCT, one must evaluate the 1) size and scope of the institution (e.g., hospital and clinics, hospital alone, clinics alone); 2) scenarios unique to certain patient populations served; and 3) location relative to other healthcare institutions (urban, rural, remote).

POCT In large healthcare facilities/institutions (LHCF): LHCFs, especially those with campus-like configurations and both hospitalized patients and clinics, are candidates for POC testing. Laboratory leadership, as well as clinical chemists, laboratory technologists, and other analytical and technical specialists must have a seat on institutional planning committees, in addition to medical staff and institutional administration/ownership. A needs assessment must include long-range planning as well as a working philosophy of rapid adaptation to innovative technology and clinical discoveries. Such flexibility can only happen within a broad-based institutional group that has a continuing and real, rather than just pro forma presence in the institution.

For POCT, planners must consider various options for testing efficiencies particularly for care areas with the following characteristics: 1) physically remote from the central laboratory, 2) have patients with either ambulatory or retention difficulties (drug treatment clinics), 3) treat immunocompromised patients (transplant department or HIV-AIDS clinic), 4) OB/GYN clinics. Clinical providers may be concerned not only about the timeliness of test results but also about

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Infection Diagnostics :: Point-of-Care Testing Laboratory result information sources & flow

POC

Institutional Lab-Linked POCs

Report Flow

Central Lab & EHR

Integrated System Reports

POC

Data Flow

Non-Lab-Linked POCs

Off-site Affiliated Labs

Figure 1. POCT is surrounded by different needs and perceptions.

exposing their patients to individuals with other illnesses.

There may also be concerns about the physical or emotional stress of traversing the institution to get lab tests performed and returning for treatment. The central laboratory may be concerned with random interjections of these patients and specimens as ‘stats’ that interrupt their efficient workflow.

In each of these situations, POCT in the clinic is beneficial for clinical care, patient convenience, patient retention, and timely follow-up with the patient.

Under the general aegis of a cross-functional institutional laboratory committee as required under various regulatory bodies, laboratorians must collaborate with clinical staff in the assessment, implementation, and ongoing operation of such laboratories, particularly including the choice, use, and suitability of any information management systems. Specific needs assessment, analytical instrument selection, as well as ongoing central laboratory oversight are essential for success to ensure both the best immediate clinical care but also records/ financials management. (A small reminder here for IT and billing departments — Medicare. Let us make sure the bill and list of services performed is understandable to the patient, too!)

Instrumentation: Specific solutions are dependent on institutional size and physical layout as well as geographical area covered by the institution and so, a description of options goes well beyond the scope of this report. One question to answer might be, do we need a POCT lab or just a phlebotomist and pneumatic tube connection to the central lab? One example of out-of-the-box thinking regarding the types of options to consider for a POCT chemistry system from our own experience with blood gas analyzers (BGAs): If your POCT is not in a pulmonary clinic, why would you even think of a BGA? They are for testing arterial blood and used in the emergency room.

However, did you know that some BGA configurations include sodium/potassium/bicarbonate/ TCO2/glucose/urea (BUN)/creatinine. And the specimen can be venous or arterial blood (one small vacuum tube) without centrifugation. Results are available before the patient rolls their sleeve back after the venipuncture! Little bench space used, and an MD, RN, PA, or a medical assistant (regulations permitting, of course) can

do the test. Easy specimen processing, lightning-fast results, no pneumatic tube system, and no central lab (except for oversight). That’s truly point of care!

Information technology: IT is the link between and among these care areas. While the primary focus must be to provide the clinically necessary information to the caregiver accurately and in a timely fashion, setting up the systems to deliver this requires dedicated laboratory/caregiver/IT interaction as described in earlier Medical Laboratory Observer articles.13,15 For optimization of clinical utility, one must go beyond simply allowing the electronic health record (EHR) of one location to be able to ‘shake-hands.’ Electronics should enable correct rearrangement of information to ease the care being made Specific solutions in each clinical area without corrupting the original source are dependent on of information at any of the institutional size and connected locations.

Specimen characteristics: physical layout as Test results, especially from well as geographical systems that are multiplexed, area covered by the need special attention regarding identification of specimen institution. characteristics (i.e., anatomic source, type of specimen, and measurement basis). We would recommend more consistent and widespread use of IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) specimen characteristic symbols (SCS), specifically the inclusion of these characteristics as part of the measurand name as IFCC recommends.12,15 This information is more important than ever due to the capabilities of multiplexed systems, which report values on single specimens with concentrations based on different volumes within the whole specimen.

One example of this is the blood gas systems that report on the same specimen, total hemoglobin (Hb concentration in volume of whole blood), carboxyhemoglobin (as fraction of total Hb), bicarbonate (concentration in plasma volume), and sodium (as concentration in plasma or in the plasma-water fraction [this last example being a 7% bias]). While the MLO-ONLINE.COM AUGUST 2025 | 17

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Infection Diagnostics :: Point-of-Care Testing laboratorian may know the difference, the caregiver and especially the IT professional may not know or be aware of the significance of the difference. With the advent of more sophisticated testing methods as well as potential for various tissues being subjected to laboratory testing, provisions for more specific

A small reminder here for IT and billing departments — Medicare. Let us make sure the bill and list of services performed is understandable to the patient, too! characterization of each measurand reported result must be made.

Extra institutional testing: Patients receive care in varied settings such as primary care provider/physician offices, urgent care facilities, or a combination of the two independent entities that refer patients to LHCFs. Subsequently, if testing is needed, laboratories will collect new specimens and do additional and frequently duplicative testing, adding costs and patient inconvenience.

Both laboratory management and administration of LHCFs must address facilitation of the incorporation of prior testing information originating in physician offices and urgent care facilities, concomitantly assuring both compliance with legal and regulatory guidelines and simultaneously working to ensure that these results are readily available and part of the electronic health record (EHR) at the LHCF, thus reducing repeat testing and enabling more timely and efficient clinical evaluation (See Figure 1).

Every effort should be made on a local or regional level to encourage this. This should include, as necessary, the changing of institutional policy/procedures and inter-institutional co-operation as well as petitioning authorities on changes/exceptions to any confounding regulations.

Intra- and inter-institutional testing: Within a single institution, laboratory testing for clinical diagnosis and treatment (both POCT and central laboratory) should, from a technical perspective, be overseen by the clinical laboratory and its leadership, but with overall guidance and needs evaluation from a cross-functional institutional committee. Budgetary issues are separate, but

technically and from a legal operational perspective, the laboratory is where the expertise and responsibility reside.

Meeting both the clinical treatment and patient needs for testing, even with an effective and efficient central laboratory, are not always feasible in a single location — and so we have POCT for the wound care clinic, transplant clinic, oncology, HIV/AIDS, and the OB/GYN clinic. Each clinic/care center’s patients can be seen, assessed, and treated as quickly and efficiently without patient inconvenience or disruption in the central lab’s in-patient routine test processing. There is no single best way to do this; for some situations, the clinic may just need a dedicated phlebotomist and a dipstick lab with a pneumatic tube for specimen transport. For other situations, more sophisticated testing may be performed by professional laboratorians, nurses, or medical assistants.

Whatever the choice for your institution’s situation(s), all is linked by the patient health record so a clinic visit is compatible with the rest of the institution and available for reference in case of later, e.g., hospital care.

REFERENCES 1. CLSI- GP26-A4, Quality Management System: A Model for Laboratory Services. Clinical and Laboratory Standards Institute. Wayne, PA. 2. Elser R, Hess D, Moran RF. Assessment of the agreement between duplicate whole blood measurements of blood gases and pH on independently calibrated analyzers.

Methodology and Clinical Applications of Electrochemical and Fiber Optic Sensors.

1990;11.

3. Moran, RF. Computer Standards, Healthcare Management Briefs. 1990.

4. Villanova PA. Standardization of Sodium and Potassium Ion-Selective Systems to the Flame Photometric [Reference Method: Approved Standard NCCLS Document C29-A2.; 2000.

5. Burnett R, Ehrmeyer SS, Moran RF, vanKessel A. Blood gas and pH analysis and related measurements; Approved Guideline. NCCLS C46-A. Published online 2001.

6. Moran RF. Point-of-care vs central Lab “discrepancies”: Getting the message across. J Appl Lab Med. 2017;1(5):595-597. doi:10.1373/jalm.2016.021485.

7.

Moran RF, Liesching TN. The ABC’s of ABG’s: A Cyclopedic Dictionary of the Testing Terms Used in Critical Care.; 2018.

8. Nichols JH, Alter D, Chen Y, et al. AACC guidance document on management of point-of-care testing. J Appl Lab Med. 2020;5(4):762-787. doi:10.1093/jalm/jfaa059.

9. Nichols JH. Utilizing point-of-care testing to optimize patient care. EJIFCC. 2021;32(2):140-144.

10. Moran RF. POC testing and reporting of sodium, and other small molecules need modified IFCC source/type designations to improve operational efficacy and for clinically accurate, unambiguous reporting from LIMS and HIS. EJIFCC. 2023;34(4):271-275.

11. Jenkins J. What can go wrong with point-ofcare testing? CLN. Published July 1, 2023.

Accessed June 25, 2025. https://myadlm.org/ cln/articles/2023/julaug/what-can-go-wrongwith-point-of-care-testing.

12. Moran RF. Moran RF. POC testing and reporting of sodium, and other small molecules need modified IFCC source/type designations to improve operational efficacy and for clinically accurate, unambiguous reporting from LIMS and HIS. EJIFCC. 2023;34(4):271-275.

13. Moran RF. Overcoming data management challenges: The biggest challenge of all is….us. Medical Laboratory Observer.

January 29, 2024. Accessed June 25, 2025. https://www.mlo-online.com/ information-technology/data-management/ article/53081209/overcoming-datamanagement-challenges-the-biggestchallenge-of-all-isus.

14. Moran RF. Point-of-care testing — Managing change when you are not in charge. Medical Laboratory Observer. July 22, 2024. Accessed June 25, 2025. https://www.mlo-online. com/continuing-education/article/55094063/ point-of-care-testing-managing-changewhen-you-are-not-in-charge.

15. Moran RF. Use of IFCC/IUPAC format for specimen and test method display in the electronic health record facilitates increased accuracy of information. J Appl Lab Med. 2025;10(3):738-742. doi:10.1093/jalm/jfae112.

16. Moran RF, Posada-Vergara MP. Critical care testing: The laboratorian in the emergency room. Medical Laboratory Observer. April 21, 2025. Accessed June 25, 2025.

Maria Paulina Posada-Vergara, MD, MSc received her medical degree from the National University of Colombia and her MSc from the University of Sao Paulo, SP, Brazil. She is an Infectious Diseases Fellow from Instituto de Infectologia Emilio Ribas, Sao Paulo, Brazil. Her more than 25 years of clinical practice have included health provider training and service implementations in urban and remote settings.

Dr. Posada-Vergara’s extensive expertise in delivering healthcare in low-income settings across Africa and Latin America has focused on HIV/AIDS, hepatitis, tuberculosis, STIs, and tropical diseases.

Robert F. Moran, PhD, FCCM, FIUPAC is the Principal Scientist at mviSciences, a consulting and educational services organization and President of AccuTest™ Proficiency Testing Services. Dr. Moran served multiple terms on the NCCLS (Now CLSI) Board of Directors and was an active participant or chairholder in several of their blood gas and electrolyte standards-writing teams. Also active in clinical chemistry internationally, he is an appointed Fellow of the International Union of Pure and Applied Chemistry (FIUPAC). He is a retired professor of chemistry and physics from Wentworth Institute of Technology but remains active in consulting work and writing.

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STATE OF THE INDUSTRY :: DISEASE MANAGEMENT

State of the Industry :: Disease Management

ALZHEIMER’S | RESPIRATORY ILLNESSES |

2025 MLO

STATE OF THE INDUSTRY SURVEY ON DISEASE MANAGEMENT

Labs respond to evolving needs in Alzheimer’s/dementia and respiratory testing amid global supply chain uncertainties

By Kara Nadeau

T

he 2025 Medical Laboratory Observer (MLO) State of the Industry (SOI) survey on Disease Management focused on Alzheimer’s/dementia and respiratory testing. With regards to the former, MLO queried medical laboratory professionals about clinical reasons for Alzheimer’s/dementia test ordering, specific biomarkers tested, methodologies used, and number of tests performed over the past year.

As for the latter, participating medical lab professionals responded to questions on respiratory testing volumes, viruses for which they have seen the most positive results, and types of tests their labs are using to diagnose respiratory viruses.

Given the uncertainties related to the global supply chain, MLO also asked medical lab professionals whether geopolitical factors were affecting their labs’ purchasing/inventory management strategies.

Among the survey respondents, nearly half (48%) hold laboratory director, manager, administrator, or supervisor positions and the majority (62%) are employed by health system or hospital labs. The number of employees who work in their labs spanned the spectrum, with 29% reporting 1-10 employees, 23% more than 100, and the others falling in ranges in between.

Alongside the quantitative results, we include commentary from medical lab professionals and vendors in the Alzheimer’s/dementia and respiratory testing spaces.

Alzheimer’s/dementia testing trends

When asked how many tests their labs had performed for Alzheimer’s/dementia in the past 12 months, nearly half of lab professionals (48%) selected the low end of the volume spectrum (0-100 tests) while 9% reported performing high test volumes (500+ tests).

Additionally, 4% of survey respondents performed 101-250 tests and 2% 251-500 tests. More than one-third of lab professionals (36%) indicated they were unsure

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State of the Industry :: Disease Management Clinical reasons for testing

176508630 | S © Pop Nukoonrat | Dreamstime.com

As MLO reported in May 2025, nearly all Americans think early Alzheimer’s diagnosis is essential, according to a survey conducted by Alzheimer’s Association.1 The trend toward early Alzheimer’s/dementia detection and diagnosis was seen in MLO’s SOI survey as well, with 39% of lab professionals citing differential diagnosis as the primary clinical reason “It is expected that the for ordering this testing and 37% citing combination of biomarker early detection as the main reason. tests, early diagnosis, and Additionally, 15% of survey respondents reported monitoring progression and 9% therapy will positively research as the primary clinical reasons impact AD patients and for clinicians ordering Alzheimer’s/dementia testing. their families.”

Zivjena Vucetic, MD, PhD, Chief Medical Officer (CMO) Beckman Coulter Diagnostics, shared her thoughts on the importance of testing for early diagnosis: “Alzheimer’s disease (AD) is a very complex disease where early diagnosis may change the trajectory of the disease by allowing for interventions to slow cognitive decline and improve quality of life. With the number of people over 60 worldwide expected to double by 2050, the development of blood-based AD tests is a global priority.”

how many Alzheimer’s/dementia tests their labs had performed in the past year.

Test modalities

Turning to Alzheimer’s/dementia testing methodologies, the most used among lab professionals surveyed was complete blood count (44%), followed closely by urinalysis (40%), blood glucose (40%), and analysis of thyroid and thyroid-stimulating hormone levels (36%). One-quarter of respondents use drug and alcohol testing (25%), 24% cerebrospinal fluid analysis, and 20% toxicology testing.

More than half of respondents (51%) reported using other testing methodologies. When asked specifically what they used, lab professionals cited heavy metals testing, comprehensive metabolic panel (CMP) blood tests, APO lipoprotein panel, and tests to rule out prion diseases and other conditions.

Several lab professionals commented on how they send Alzheimer’s/dementia tests to reference/referral labs versus performing them in-house, while one noted how they have plans to reinstate this testing in their lab.

Biomarkers tested

Most lab professionals surveyed (63%) reported that their labs test no specific biomarkers for Alzheimer’s/dementia testing. The most tested biomarkers were phosphorylated tau (18%) and APOE genotyping (17%). This was followed by total tau (14%), Aβ42 (12%), and neurofilament light chain (8%). Furthermore, 14% of lab professionals indicated they test other biomarkers, but these were not specified in the survey comments.

Dr. Maria-Magdalena Patru, Scientific Partner for Neurology at Roche Diagnostics, commented on the availability of Alzheimer’s disease (AD) biomarker tests for early detection of amyloid pathology and amyloid-targeting therapies which slow down cognitive decline. She highlights the central role clinical laboratories can play in translating these advancements in clinical practice.

“Evidence indicates that the use of AD biomarkers in the clinical context improves diagnosis accuracy, especially in early stages, when therapies are most effective,” said Dr. Patru. “Currently, the CSF ratio assays are an option for determining patient eligibility for therapy. Once FDA cleared blood-based biomarker tests are integrated in clinical practice, they will complement, but not entirely replace, the need for the CSF ratio assays in confirming AD pathology.”

“By validating scalable AD biomarkers tests, laboratories can address the need for greater access to diagnostics, which in turn facilitates timely therapeutic interventions,” she added. “It is expected that the combination of biomarker tests, early diagnosis, and therapy will positively impact AD patients and their families.”

Dr. Vucetic highlighted the need for testing that is applicable across diverse populations, stating: “To develop accurate, reliable tests, we examine different biomarker levels across different populations. AD’s complex nature, with variations in genetic makeup and progression, means new blood-based tests must consider heterogeneity in biomarker levels across ethnicities and Zivjena Vucetic, MD, PhD races. Global partnerships with organizations like Davos Alzheimer’s Collaborative and Global Alzheimer’s Platform Foundation are essential for accessing diverse patient cohorts. These efforts aim to create equitable and effective diagnostic solutions, ensuring no Alzheimer’s patient is left behind.”

Respiratory testing trends Dr. Maria-Magdalena Patru

Nearly half of laboratory professionals surveyed (48%) have seen a moderate increase in respiratory testing over the past 12 months, while nearly one-third (27%) have MLO-ONLINE.COM AUGUST 2025 | 21

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State of the Industry :: Disease Management experienced a significant increase and nearly a quarter (24%) have seen no increase in this testing category.

Respiratory viruses tested

Figure 1: What is the primary clinical reason for ordering Alzheimer’s/dementia testing in your lab?

Differential diagnosis

When asked which respiratory viruses Early detection have yielded the most positive test results, influenza A/B topped the Monitoring progression list with 82% of survey respondents, followed by COVID-19 at 63%. Over one-third of lab professionals reported Research having the most positive test results for respiratory syncytial virus (RSV), 0 5 10 25% strep A/B, 13% rhinovirus, and 5% pneumonia.

A small percentage of those surveyed (3%) indicated they did not know which decrease in flu and COVID-19 testing. respiratory virus tests had the most The use of molecular respiratory panels positive results in their labs, and other proved to be important for the clinical 5% selected “other” as their response, treatment of respiratory infections.” citing high volumes of positive testing results for tuberculosis and mycoplasma Test modalities (local outbreak).

Turning to test modalities to diagnose reAccording to Leonard Scinto, MS, spiratory viruses, highest on the list was MPA, DLM(ASCP), Technical Consultant nucleic acid amplification test, with 65% at Advancing Health Laboratories, based of survey participants citing how they in South Florida, the past 12 months used this method in their labs. Nearly have been “uneventful for any signifi- half of lab professionals reported using cant respiratory trends” in the state’s rapid immunoassays (49%). Lower on respiratory virus activity for Influenza the list were cultures (13%), serological A/B and COVID-19. He stated: tests (13%), direct fluorescent antibody “Influenza test positivity did not tests (8%), and electron microscopy (1%). show any dramatic spikes compared Edmund Janoszewski, Senior Product to 2023-2024. The same trend was seen Manager, Diasorin, spoke to trends in for COVID-19 over the past 12 months; respiratory test modalities, stating: no dramatic increases were seen.”

“The emergence of respiratory “RSV showed a different testing patterns over the picture in Florida,” he added. past two to three years has “Florida’s RSV season is prompted many laboratories longer than the national to develop integrated testing average, starting in April algorithms that incorporate a and peaking in November. variety of respiratory testing November 2024 showed methods, including rapid significantly higher RSV test antigen tests, point-of-care positivity rates than previ- Leonard Scinto, MS, molecular testing, targeted ous 2023-2024 season. This MPA, DLM(ASCP) molecular assays performed significant positive increase in the lab, and flexible syndromic assays. These related to three factors: Intesting algorithms, based creased RSV circulation in Florida’s elderly population, on diagnostic stewardship, increased use of multiplex aim to accurately identify the causative pathogens, PCR panels now including ensure timely results to RSV targets, and a change in the Florida DOH mandaguide patient treatment, and tory reporting of RSV testing Galit Gelman promote effective management of healthcare costs.” which began in 2024.”

The director of a medical “In simpler terms, labolaboratory based in Maryratories are focused on choosing the right test for land commented on the respiratory virus trends in the right patient at the right her area, stating: time,” Janoszewski contin“We have seen an increase ued. “Additionally, as the customer demand for acin enterovirus/rhinovirus testing with a significant Edmund Janoszewski curate, fast, and affordable

15

20

25

30

35

40

Percentage (%)

tests increases, diagnostic testing companies must carefully design their tests and overall testing portfolios to support the dynamic needs of expanding healthcare systems.”

Galit Gelman, Senior Commercial Marketing Manager, SEKISUI Diagnostics, commented on the benefits of

“As the customer demand for accurate, fast, and affordable tests increases, diagnostic testing companies must carefully design their tests and overall testing portfolios to support the dynamic needs of expanding healthcare systems.” combination testing for multiple respiratory viruses, stating: “Clinicians are choosing carefully how to test for common respiratory illnesses, like Flu A&B and COVID-19, as it can have an impact on the experience their patients have while seeking answers when visiting the clinic. Long-wait times, multiple swabs, and leaving without answers can be frustrating to patients. A benefit of a point-of-care COVID/Flu combo test is a reduction to the discomfort and waiting and can really make a difference for your practice. This is why we are seeing more clinicians opt-in to molecular and antigen combo testing when Flu and COVID-19 are co-circulating.”

Medical lab supply chain strategies

MLO also queried medical lab professionals on whether geopolitical factors were affecting their labs’ purchasing/

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State of the Industry :: Disease Management Figure 2: What types of tests are your laboratory using to diagnose respiratory viruses?

consider tariff protection and nonfinancial penalty exit clauses in new agreement terms.

• Maximize group purchasing organization (GPO) participation.

Is your organization participating in a GPO that maximizes laboratory supply cost savings? Have you aligned your laboratory supply purchases through the GPO, or do you have legacy local vendor contracts? GPO participation often insulates against price increases for the term of the agreement.

Electron microscopy Direct fluorescent antibody tests Culture Serological tests Rapid immunoassays

How can vendors help?

Nucleic acid amplification tests 0

10

20

inventory management strategies. Most (75%) said “no” and the remaining 25% said “yes.” Those responding in the affirmative were asked to elaborate on the impact.

Several survey participates commented on challenges accessing products manufactured in China, with one

Figure 3: Are geopolitical factors affecting your laboratory’s purchasing/inventory management strategy?

25% YES

75% NO

lab professional noting how a vendor asked their lab to switch to an alternative product manufactured elsewhere.

Others cited funding restrictions impacting their purchasing/inventory management strategies, including lack of access to capital budgets, government cutbacks and uncertainty around grants limiting their budgeting and buying ability. One lab professional commented on how it is too soon to tell how geopolitical factors will impact the medical lab supply chain but added that their lab’s GPO cited these factors as one of their top three concerns.

30 40 Percentage (%)

50

60

70

Scinto spoke about the uncertainties ahead, stating: “Currently, the impact has not been felt in supply chain disruption or significant cost increase in our general lab supplies, testing reagents and media.

However, this can change in a matter of weeks to months as we get more clarity on the impact trade tariffs in the U.S. and other global countries will have on specific laboratory testing supplies.”

He recommends lab leaders take an immediate proactive approach to plan for potential supply chain disruptions and testing supply cost increases in three areas: • Identify the manufacturing country of origin. Engage laboratory supply vendors in an open, evidence-based discussion on the materials being purchased in regard to manufacturing country of origin, changes in vendor manufacturing sites and manufacturing delays due to changes in production line modifications.

• Review current vendor agreements and contracts. Review agreements for price adjustment terms.

What are pricing increases tied to: USA Consumer Price Index (CPI), International Bond Rates or some obscure Global Metrix where the manufacturer is based.

Are price increases annual, or can they be adjusted multiple times over 12 months? When does the agreement expire, in the next 3-5 months or 3-5 years? What will be the financial impact to current and future budget expenses and revenue margins? If you’re engaged in current contract negotiations,

MLO asked the laboratory professionals who contributed commentary for this article how manufacturers of testing equipment and supplies could better meet their needs.

“I would like to see our diagnostic manufacturers establish FDA approval for residual patient samples use,” said Scinto. “Manufacturers should seek FDA clearance for residual sample use by validating residual sample stability and performance especially for multiplex PCR. This could greatly enhance patient care, allowing reflexive test orders by clinicians on the primary/ initial collection sample negating the need for patient recollection.

“This would advance both diagnostic and antibiotic stewardship,” he added.

“It is estimated that over 51% of antibiotic use in poorly defined respiratory illnesses is inappropriate. Diagnostic testing through defined reflexive testing algorithms could become focused on local/regional viral prevalence. Leading to overall reduced healthcare costs and accelerated patient outcomes.”

When asked what was on her “wish list” in the realm of testing, the Maryland-based medical laboratory director stated:“We would like to see lower costs for the reagents and analyzers used in the outpatient settings.”

REFERENCE 1. Brady E. Americans’ attitudes toward Alzheimer’s testing. Medical Laboratory Observer. May 9, 2025. Accessed June 27, 2025. https://www.mlo-online.com/disease/ news/55289310/americans-attitudestoward-alzheimers-testing.

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 :: DIABETES AND CARDIAC AND RENAL RISKS

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Molecular Diagnostics :: Diabetes and Cardiac and Renal Risks

Evaluating cardiac and renal risks in patients with diabetes: A “sweetheart” diagnostic challenge

By Jim Aguanno, PhD and Justin Jones, PhD

F

or patients with diabetes, matters of the heart often carry a double meaning. While diabetes is associated with blood sugar, it is heart failure (HF) that increasingly threatens these “sweethearts.” Up to 22% of individuals with type 2 diabetes develop HF, even in the absence of coronary artery disease or hypertension.1 When chronic kidney disease (CKD) is also present, a common comorbidity in this population, the risk rises significantly due to overlapping pathophysiology and cardiorenal interactions. 2 Cardiac biomarkers, such as N-terminal pro-Btype natriuretic peptide (NT-proBNP)

and high-sensitivity troponin (hs-cTn), have demonstrated strong prognostic value in identifying patients at risk for HF before clinical symptoms emerge. 2 The intersection of diabetes, HF, and CKD highlights the need for earlier identification and intervention in asymptomatic patients.

Cardiac biomarkers overview: Troponins and natriuretic peptides

Cardiac biomarkers offer valuable insight into the subclinical processes of myocardial injury and stress that frequently accompany diabetes and

CKD. Their clinical value now extends beyond acute diagnosis into longterm prognostication and chronic disease management.

High-sensitivity troponins

Cardiac-specific troponins reflect myocardial injury. High-sensitivity troponin assays can detect even very low concentrations of circulating troponin, indicative of subclinical cardiac strain. These “minimally elevated” levels, often present in stable patients, are independently associated with increased risk for future cardiovascular events and HF. Notably, troponin levels tend to be

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Molecular Diagnostics :: Diabetes and Cardiac and Renal Risks chronically elevated in CKD yet still retain prognostic significance. In the BiomarCaRE consortium, high-sensitivity cardiac troponin I (hs-cTnI) levels predicted both incident HF and cardiovascular mortality, with thresholds proposed to stratify risk across sexes.3

HF Stage

Clinical Description

Biomarker Role

Recommended Action

A

At risk (e.g., diabetes, CKD, hypertension)

Screen with NT-proBNP and/or hs-cTn annually

Initiate cardioprotective therapy (e.g., SGLTi) if elevated

B

Natriuretic peptides (BNP/NT-proBNP)

Structural heart disease without symptoms

Screen with NT-proBNP and/or hs-cTn annually

Intensify therapy, refer to cardiology, monitor progression

C/D

Symptomatic HF

Biomarkers are often markedly elevated

Standard HF management, consider specialist care

BNP and NT-proBNP are secreted in equimolar amounts by ventricular myocytes in response to increased wall tension and volume overload.4 Despite this shared origin, they differ markedly in pharmacokinetics and clinical utility.

BNP, the biologically active form, has a short plasma half-life of approximately 20 minutes and is cleared primarily by enzymatic degradation (e.g., neprilysin) and receptor-mediated pathways.

In contrast, NT-proBNP is biologically inactive, has a longer circulating halflife of approximately 60 to 120 minutes, and is eliminated almost exclusively via renal excretion.4 These differences contribute to higher NT-proBNP plasma concentrations and greater analytical stability, making it especially useful in outpatient or chronic disease monitoring. While both biomarkers rise with declining renal function, studies have shown that they maintain independent prognostic value in patients with CKD.5

Analytical notes

High-sensitivity assays have enhanced the precision of cardiac biomarker measurement, enabling their use beyond acute care settings and into outpatient and preventive care. However, not all assays are interchangeable. For example, NT-proBNP and BNP differ in metabolism and clearance, with NT-proBNP having a longer half-life (60 to 120 minutes) compared to BNP (~20 minutes). Similarly, troponin I and T assays are distinct and require manufacturer-specific reference values.

Interpretation is further refined by applying sex-specific and, in some cases, prognostic cutoffs to better personalize risk assessment.6

Biomarker roles in prognosis

Initially used to rule in or rule out acute myocardial infarction or HF, these biomarkers are now becoming recognized for their role in chronic disease risk stratification. Serial measurements allow clinicians to track disease trajectory and response to therapy, especially in asymptomatic high-risk groups, such as patients with diabetes and CKD. Their

Heart failure stages and recommended actions in patients with diabetes and CKD

Table 1. Heart failure staging adapted from ADA and ACC guidelines. Annual biomarker testing (NT-proBNP, hs-cTn) is recommended for Stage A/B in patients with diabetes to identify subclinical cardiac stress and guide therapy1,3,7,8. SGLT2i = Sodium-Glucose Co-transporter 2 inhibitors.

use in routine clinical decision-making is increasingly supported by professional society guidance.5

Prognostic value of biomarkers in diabetes and cardio-renal disease

High-sensitivity cardiac troponin assays provide powerful risk stratification in asymptomatic patients with diabetes.

In community-based cohorts without known cardiovascular disease, each log-unit increase in hs-cTnI was associated with approximately a 1.4-fold

The 2024 ADA Standards of Care recommend measuring NP levels (BNP or NT-proBNP) annually in individuals with diabetes to identify those at increased risk of developing symptomatic HF. higher risk of incident HF, independent of traditional risk factors.3 These associations support the use of sex-specific thresholds to refine risk prediction and identify individuals at high risk earlier in the disease course.

Similarly, natriuretic peptides (NPs) offer compelling prognostic value. In the U.S.-based Atherosclerosis Risk in Communities (ARIC) study, NT-proBNP levels were independently associated with increased risk of HF, cardiovascular events, and mortality in patients with type 2 diabetes, even at levels below conventional thresholds.7 Participants with NT-proBNP ≥125 pg/mL had an increased hazard for incident HF and cardiovascular death.

Using hs-cTn and NT-proBNP in combination further improves prognostic

accuracy. Models incorporating both biomarkers have demonstrated excellent predictive performance, with patients exhibiting elevations in both facing significantly greater risk.7 The American Diabetes Association (ADA) now endorses the annual measurement of NT-proBNP or hs-cTn in asymptomatic diabetic patients to identify “Stage A/B” HF and enable early intervention.1

Heart failure stages and screening in diabetes

The 2024 ADA Standards of Care recommend measuring NP levels (BNP or NTproBNP) annually in individuals with diabetes to identify those at increased risk of developing symptomatic HF.1,8 When elevated, these biomarkers warrant follow-up evaluation, such as echocardiography, to assess left ventricular hypertrophy, reduced ejection fraction, or diastolic dysfunction (See Table 1).

Supporting this strategy, both NPs and hs-cTn have demonstrated strong predictive value for identifying patients in Stages A or B who are likely to progress to symptomatic HF or cardiovascular death.1 Annual measurement of either biomarker enables clinicians to risk-stratify patients earlier and implement preventative therapies that may delay or avert progression.

Clinical case scenario: A 58-year-old man with type 2 diabetes, hypertension, and stage 3 CKD (eGFR 45) presents without HF (NYHA Class I). Labs show NT-proBNP at 150 pg/mL (normal <125) and hs-cTnI at 6 ng/L. Interpretation: Elevated NT-proBNP suggests subclinical cardiac stress (Stage B HF), while detectable hs-cTnI reflects low-grade myocardial injury.

Per ADA consensus, this asymptomatic patient is high-risk and should undergo further evaluation, such as echocardiography.1 MLO-ONLINE.COM AUGUST 2025 | 25

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Molecular Diagnostics :: Diabetes and Cardiac and Renal Risks Action: Initiate or optimize cardioprotective therapy—start a sodium-glucose co-transporter 2 (SGLT2) inhibitor, optimize blood pressure (BP) control (e.g., ACEi/ARB), and encourage lifestyle changes. Monitor biomarkers over time to track progression or response.

Key point: Annual NT-proBNP or hs-cTn testing in asymptomatic diabetes can reclassify risk and guide early intervention.1

Guideline-directed therapy and biomarker use: SGLT2 inhibitors and GLP-1 receptor agonists SGLT2 inhibitors:

Large cardiovascular outcome trials— including EMPA-REG OUTCOME, CANVAS, DECLARE-TIMI 58, DAPAHF, and EMPEROR-Reduced—have consistently demonstrated that SGLT2 inhibitors significantly reduce the risk

By integrating prognostic biomarkers into routine clinical workflows, laboratory professionals and clinicians can transition from reactive to proactive care. of HF hospitalization and cardiovascular (CV) death in patients including those with diabetes.9-13 Zinman and colleagues demonstrated consistent benefits across populations, with metaanalyses reporting a 25%–30% relative risk reduction in the composite of CV death or HF hospitalization with SGLT2 inhibitor therapy.9,10 These benefits apply to patients with and without reduced ejection fraction, as well as those with CKD. Notably, reductions in NT-proBNP and stabilization of troponin levels have been observed in clinical trials, supporting the use of biomarker-guided monitoring.13

GLP-1 receptor agonists: GLP-1 receptor agonists, such as liraglutide, semaglutide, and dulaglutide, have shown efficacy in reducing major adverse cardiovascular events in patients with type 2 diabetes. Marso and colleagues demonstrated that these agents improve overall cardiovascular risk profiles in patients with established atherosclerotic cardiovascular disease (ASCVD).14 Their role in HF prevention is less consistent, but they remain a guideline-supported option.

Elevated NT-proBNP or troponin levels may prompt clinicians to intensify therapy and prioritize SGLT2 inhibitors where indicated.

7.

Implementation:

8. American Diabetes Association Professional Practice Committee. 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2024. Diabetes Care.

2024;47(Suppl 1):S179-S218. doi:10.2337/ dc24-S010.

In clinical practice, high-risk patients with diabetes, particularly those in HF Stage A/B or with CKD, should be considered for evaluation for SGLT2 inhibitor therapy. The ADA consensus recommends prioritizing SGLT2 inhibitors in these patients when biomarkers indicate subclinical cardiac stress or injury.1,8

Conclusion

Cardiac biomarkers, such as hs-cTn and NPs, are no longer limited to acute care settings; they are now essential tools for managing chronic diseases. In patients with diabetes and CKD, these markers can unmask silent cardiovascular stress well before symptoms appear. Current guidelines recommend annual screening to enable timely intervention and personalized care.

By integrating prognostic biomarkers into routine clinical workflows, laboratory professionals and clinicians can transition from reactive to proactive care. This approach enables earlier risk reclassification, optimized therapy decisions, and the potential to reduce the long-term burden of HF in high-risk populations.

REFERENCES 1. Pop-Busui R, Januzzi JL, Bruemmer D, et. al. Heart failure: An underappreciated complication of diabetes. A consensus report of the American Diabetes Association. Diabetes Care. 2022;45(7):1670–1690. doi:10.2337/ dci22-0014.

2. Bansal N, Zelnick L, Go A, et al. Cardiac biomarkers and risk of incident heart failure in chronic kidney disease: The CRIC (Chronic Renal Insufficiency Cohort) study. J Am Heart Assoc. 2019;8(21):e012336. doi:10.1161/ JAHA.119.012336.

3. Yan I, Börschel CS, Neumann JT, et al.

High-sensitivity cardiac troponin I levels and prediction of heart failure: Results from the BiomarCaRE Consortium. JACC Heart Fail. 2020;8(5):401-411. doi:10.1016/j. jchf.2019.12.008.

4. Weber M, Mitrovic V, Hamm C. B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide - Diagnostic role in stable coronary artery disease. Exp Clin Cardiol.

2006;11(2):99-101.

5. McCullough PA, Sandberg KR. B-type natriuretic peptide and renal disease. Heart Fail Rev. 2003;8(4):355-8. doi:10.1023/a:1026195332025.

6. Apple FS, Wu AHB, Sandoval Y, et al.

Sex-specific 99th percentile upper reference limits for high sensitivity cardiac troponin assays derived using a universal sample bank. Clin Chem. 2020;66(3):434-444. doi:10.1093/clinchem/hvz029.

Gori M, Gupta DK, Claggett B, et al.

Natriuretic peptide and high-sensitivity troponin for cardiovascular risk prediction in diabetes: the Atherosclerosis Risk in Communities (ARIC) study. Diabetes Care.

2016;39(5):677–685.

9. Zinman B, Wanner C, Lachin JM, et al.

Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128. doi:10.1056/ NEJMoa1504720.

10. Wiviott SD, Raz I, Bonaca MP, et al.

Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;380(4):347–357. doi:10.1056/ NEJMoa1812389.

11. Neal B, Perkovic V, Mahaffey KW, et al.

Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644-657. doi:10.1056/ NEJMoa1611925.

12. Inzucchi SE, Docherty KF, Køber L, et al; DAPA-HF Investigators and Committees.

Dapagliflozin and the incidence of type 2 diabetes in patients with heart failure and reduced ejection fraction: An exploratory analysis from DAPA-HF. Diabetes Care.

2021;44(2):586–594. doi:10.2337/dc20-1675.

13. Verma S, Mazer CD, Yan AT, et al. Effect of empagliflozin on left ventricular mass in patients with type 2 diabetes mellitus and coronary artery disease: The EMPA-HEART CardioLink-6 randomized clinical trial. Circulation. 2019;140(21):1693–1702. doi:10.1161/ CIRCULATIONAHA.119.042375.

14. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322. doi:10.1056/ NEJMoa1603827.

Jim Aguanno, PhD received a Bachelor of Science in Chemistry and a PhD in Biochemistry from Memphis State University. Following his PhD, he did fellowship in Laboratory Medicine at Washington University School of Medicine and Barnes Hospital in St. Louis, Missouri. Dr. Aguanno was Director of the Core Laboratory at Baylor University Medical Center in Dallas, Texas for 24 years. Dr. Aguanno joined Siemens Healthcare Diagnostics in January of 2004 and is currently Medical Science Partner in the Medical and Scientific Affairs group.

Justin Jones, PhD has more than a decade of experience in diagnostics and translational science, including leading assay development projects at Siemens Healthineers. In his current position as a Field Medical Partner, he specializes in cardiac biomarkers and clinical education. Justin holds a PhD in biochemistry and is dedicated to connecting laboratory insights with patient care.

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LAB MANAGEMENT :: LAB SAFETY

ID 94996382 © Mast3r | Dreamstime.com

Lab Management :: Lab Safety

High-reliability safety in the laboratory

By Dan Scungio, MLS(ASCP), SLS, CQA (ASQ)

E

very day, laboratory professionals work in environments where the smallest error can have outsized consequences. Whether handling infectious agents, hazardous chemicals, or complex instrumentation, the stakes are high, and the margin for error is slim. That means that the laboratory workplace should be considered a high-reliability organization (HRO).

To ensure the laboratory embraces the spirit of a HRO, safety must become not just a goal but a way of life.

What is high reliability?

Why does it matter?

High reliability organizations are those that “operate under very trying conditions all the time and yet manage to

have fewer than their fair share of accidents.” The concept was born out of research in fields like aviation, nuclear power, and the military — industries where failure is not an option. These organizations face complex, hazardous systems daily, but through rigorous processes and a relentless focus on safety, they achieve remarkable safety records.

In the laboratory, the parallels are clear. The technologies and products handled are risky, the consequences of error can be severe, and the environment is often unforgiving. Laboratorians cannot afford to learn from catastrophe. Instead, they must proactively manage risk, anticipate failure, and create systems that are resilient to human error.

The five principles of highreliability organizations

To view the lab as a high-reliability organization, five core principles must be observed, grouped into the categories of anticipation and containment. The first principle of anticipation is Preoccupation with Failure. Every small error should be treated as a symptom of a larger issue. Near misses should never be ignored. Instead, report, investigate, and learn from them. Sensitivity to Operations is the second principle of anticipation. Labs need to stay attuned to what is happening on the front lines.

Leaders should spend less time in the office. They need to listen to staff, observe workflows, and be present in the lab. The last anticipation principle

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ID 94996382 © Mast3r | Dreamstime.com

Lab Management :: Lab Safety of a high-reliability organization is the Reluctance to Simplify Interpretations.

The culture of the laboratory should encourage diversity of thought and experience. Avoid oversimplifying problems when they arise, dig deeper to understand the true causes of laboratory incidents.

The first principle of containment is a Commitment to Resilience. It is vital for the laboratory to develop the ability to detect, contain, and recover from errors. When something goes wrong, bounce back quickly and learn from the event. This can be particularly helpful when implementing new technologies or processes and when working in collaboration with other departments.

The second containment principle is known as a Deference to Expertise.

Labs should push decision-making to those with the most relevant knowledge, regardless of their position in the hierarchy. For example, if a department build or remodel is underway, be sure to use an architect with lab-specific experience and include those who work on the front lines when designing the workspace.

Human behavior: The heart of safety

Risk in any environment is a function of both probability and consequence.

While it may not be possible to reduce the consequences of a potential incident (for example, the outcome of a hepatitis exposure), the safety program can work tirelessly to reduce the probability of that incident occurring. By doing so, the lab can be recast as a low-risk department. A place where, despite the dangers, accidents are exceedingly rare.

Unfortunately, even in low-risk environments, human beings are fallible.

Even the best-trained, most conscientious lab professionals make mistakes.

However, high reliability is not about eliminating human error. It is about designing systems that anticipate, catch, and mitigate those errors before they lead to harm.

Dr. James Reason developed a Generic Error Modeling System (GEMS) that describes three performance modes in which errors occur.

While working in the Skill-Based mode, routine tasks are performed on “auto-pilot.” Unfortunately, the more familiar one becomes with a task, the less attention is paid to it. Errors here are slips or lapses, often due to distraction or complacency.

New Items

In Progress

Exposure incident-needs investigation

Collecting lab coat sizes for transition

Water leak behind chemistry analyzer Hematology analyzer down

Completed All electrical cords tied up Accumulation area posters in place

Waiting for part for walk-in refrigerator

Normal blood inventory restored

Figure 1. An example of a laboratory high-reliability board.

In the Rule-Based performance mode, tasks are guided by established rules or procedures. The worker has adequate experience to make decisions about the work performed. Errors here arise from misinterpretation or applying the wrong decision.

The Knowledge-Based mode is in use when new or unfamiliar situations arise and where problem-solving is required. The worker does not have any past experience to go by when making decisions. Typically, errors will stem from making incorrect assumptions or from missing vital information.

The arrival of the Covid pandemic, for example, brought labs several situations in which decisions had to be made with no prior experience.

While a high-reliability organization might have systems in place to reduce risks, humans are still able to make mistakes. In the lab, this means that even experienced staff are vulnerable to error, especially during routine activities.

From blame to systems thinking

When an incident occurs, the natural reaction is to blame the individual. But in high reliability labs, it is always important to look at the system first. What in the lab’s processes, procedures, or environment allowed the error to happen?

Could it have been prevented by better design, clearer communication, or more robust checks?

If someone in the department trips over a loose cord, leadership should not simply ask why they were not paying attention. A system focus would drive questions about why the cord was there in the first place. Is there an existing system for identifying and fixing trip hazards? Are regular safety rounds conducted? This focus can better lead to systemic fixes, which prevent

future incidents and create a stronger culture of safety.

Tools for high reliability: Making safety visible and actionable

Safety in the laboratory must be visible and ever present. This means regular education and training, establishing safety champions in every department, and making safety a standing agenda item in every meeting. When staff see that safety is a priority for leadership, it becomes a priority for them.

Recognize staff who ask questions, suggest fixes, or take initiative to address safety issues. Celebrate stand-out safety performance. This not only reinforces positive behaviors

Conduct regular safety audits and encourage everyone to use their “safety eyes” as they move through the laboratory. Notice issues, follow up quickly, and close the loop on corrective actions. but also encourages a culture where everyone feels responsible for safety.

Leaders must be present in the lab — not just seen but seen doing and asking about safety. Rounding to influence bridges the gap between administrative discussions and front-line realities. It shows staff that leadership cares and is actively looking for ways to improve safety.

Conduct regular safety audits and encourage everyone to use their MLO-ONLINE.COM AUGUST 2025 | 29

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Lab Management :: Lab Safety “safety eyes” as they move through the laboratory. Notice issues, follow up quickly, and close the loop on corrective actions. The faster hazards are addressed, the more trust will be built within the lab team.

A true high-reliability laboratory is a place where safety awareness is high and ever present.

Communication is the lifeblood of high reliability. Daily huddles—whether in person or virtual—keep safety top-of-mind and provide a forum for discussing ongoing issues, new hazards, and progress on corrective actions.

High-reliability boards (see Figure 1), posted in the lab, make safety visible and invite staff to contribute concerns and solutions. When staff see that their input leads to action, engagement soars.

Safety checklists are also a hallmark of high reliability. Sadly, not all

checklists are created equal. Effective safety checklists are concise, focus on critical steps, and use language familiar to staff. They should be tested and refined to ensure they actually improve safety, not just add paperwork. The true value of checklists is cultural—they enhance teamwork, improve communication, and shift responsibility for safety from individuals to the entire department.

Building a safer culture: The high-reliability laboratory

When books are written about highreliability organizations, laboratories are often not mentioned. Given these organizations’ characteristics, however, it is clear that labs belong in that arena.

A true high-reliability laboratory is a place where safety awareness is high and ever present. Incidents are rare, and when they occur, they are thoroughly investigated for systemic causes. Staff feel empowered to speak up about safety concerns. Leaders are visible, engaged, and committed to continuous improvement. Communication is open, frequent, and focused on learning, not blame. If these things exist in your

laboratory, the results will be a safer culture, fewer incidents with injuries or exposures, and a laboratory that truly lives up to its mission of protecting patients and staff alike.

As Mark V. Rosenker, former Chairman of the National Transportation Safety Board, once said, “Safety is not a lucky system. It is a system of science, analysis, and facts.” High-reliability safety in the laboratory does not happen by accident. It requires commitment, vigilance, and a willingness to learn and adapt. By embracing the principles and tools of high reliability, we can create laboratories where safety never sleeps—and where every team member goes home safe, every day.

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

INDEX OF ADVERTISERS Advertiser........................... Web........................................ Page Abbott Diagnostics..........abbott.com............................................5 American Proficiency Institute (API)....................api-pt.com............................................27 Cepheid.............................cepheid.com....................................... C2 Diasorin.............................diasorin.com.........................................7 Diazyme Laboratories.....diazyme.com/cancer-markers.......... C4 Hardy Diagnostics...........hardydiagnostics.com/CTXM.......... C3 Health Care Logistics......GoHCL.com.........................................30 Owen Mumford...............owenmumford.com/us...................... 19 Sure-Tech Diagnostic Associates.........................sure-tech.net........................................13 Sysmex America..............sysmex.com/CellaVision.....................3 Werfen - Hemostasis.......werfen.com......................................... 11 This index is provided as a service.

The p­ ublisher does not assume liability for errors or omissions.

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CLINICAL SPOTLIGHTS

Clinical Spotlights

Alinity ci-series

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

Abbott

Optimize BSI treatment in hours – not days.

LIAISON PLEX® bloodstream infection assays provide the flexibility to only test for clinically relevant targets based on Gram stain of a positive blood culture. Learn more about the panels designed to support your diagnostic and antimicrobial stewardship programs.

Diasorin

CA-Series™ and CS-Series™ Automated Coagulation Analyzers Sysmex’s innovative portfolio of hemostasis analyzers, reagents and controls are designed with quality, reliability and efficiency in mind. We provide advanced hemostasis technology across multiple platforms to match the needs of laboratories of all sizes.

Sysmex America Inc.

Confidence in Capillary Sampling Unistik® 3 Side Activated Safety Lancets are designed to reduce pain for patients during sampling while providing confidence and control during capillary blood sampling. Unistik 3 permanently retracts, helping protect against accidental needlestick injuries, and features etched lot numbers for traceability.

Owen Mumford

Effortlessly upload results from your LIS and eliminate the #1 cause of PT failure--clerical errors.

• No changes to our firewall or security • No interface required or software to install • No additional fees—API DataDirect is free Join the over 9 million results uploaded utilizing DataDirect!

American Proficiency Institute

FDA Cleared: Rapid CTX-M Detection NG-Test® CTX-M Multi is the rapid, FDA-cleared immunoassay detecting CTX-M enzymes (Groups 1, 2, 8, 9, 25). Get results in 15 minutes with minimal training or equipment. Identify key extended-spectrum cephalosporin resistance.

Hardy Diagnostics

Precision in Every Pair Diazyme’s Kappa and Lambda Free Light Chain Assays provide accurate, timely insights for the diagnosis and monitoring of Multiple Myeloma.

Enhance your lab’s performance with trusted, high-quality results. Available on most major clinical chemistry analyzers.

Diazyme Laboratories

Elevating performance for workflow optimization ACL TOP® Family 70 Series Hemostasis Testing Systems optimize workflow with a powerful combination of quality and efficiency—for the entire laboratory network. Offering centralized data management, automation and connectivity, and automated pre-analytical sample checks.

Werfen — Hemostasis

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PRODUCT FOCUS :: RAPID & BENCH TOP TESTING

Product Focus :: Rapid & Bench Top Testing

Benchtop platform for rapid endocrine testing The IDS iSYS Automated System (IS-310400) is a benchtop analyzer that uses chemiluminescent technology for endocrine immunoassays. It offers random access for batch, continuous, and STAT loading, processes up to 120 tests per hour, and delivers results in as little as 25 minutes.

EUROIMMUN (Part of Revvity)

General chemistries + urine drug screens The EasyRA, a USA-made benchtop clinical chemistry analyzer, is wellestablished in many laboratories located in multi-site health systems, oncology clinics, and physician offices. It has a menu of 35 general chemistries and 14 urine drug screens. Training, installation, validation assistance, and warranty included with purchase. 0% financing through 11/2025.

Carolina Liquid Chemistries

Rapid identification and antimicrobial susceptibility testing

Self-contained workstation

The BD Phoenix Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic gram-positive bacteria as well as most aerobic and facultative anaerobic gram-negative bacteria of human origin.

BD

The MicroFlow I Workstation is a ductless carbonfiltered workstation designed to collect small amounts of non-hazardous fumes and odors. It is completely self-contained and has an integral recessed work surface to contain spills. Clear hood surround with safety viewing sash for the user.

HEMCO

Heat, cool specimens in one unit

Intuitive point-of-care CBC analyzer

The MyTemp 65 Digital Incubator (21088) from Health Care Logistics can reach as low as 15º below ambient temperature and as high as 60ºC. Use it to meet USP <797> guidelines that require two temperatures to determine bacterial and fungal results.

Interior features include adjustable shelves and an internal outlet.

Health Care Logistics

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

This compact, easy-tointegrate device supports direct capillary sampling and requires minimal training, offering reliable hematology analysis with fast turnaround in clinical settings.

PixCell Medical

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Product Focus :: Rapid & Bench Top Testing

Critical care analyzer with advanced test menu Stat Profile Prime Plus offers significant clinical value in a blood gas/critical care analyzer by providing the unique critical care tests. Blood oxygenation, tissue perfusion status, acid/base balance, electrolyte balance, fluid balance, glycemic control, and kidney function tests are available from two drops of blood in about 90 seconds at the point of care.

Nova Biomedical

Bench-top automated recapper KapSafe Recapper model 3101-1102-LS is a bench top 24” x 24” footprint for the automatic recapping of sample tubes, of various heights/diameters, at a throughput of 700 Tubes/Hour. KapSafe serves to eliminate exposure to repetitive stress injury during manual recapping. Uses muti-tier caps to fit various tube diameters. Other models available.

LGP Lab Automation

Rapid benchtop drug screening analyzer The Evidence MultiSTAT is a fully automated analyzer, providing simultaneous, semiquantitative detection of up to 29 drugs per sample in <30 minutes.

Designed to screen various matrices with a throughput of up to 176 tests/hour, offering rapid and accurate results. Easy-to-use software is touchscreen-controlled, and results are LIMS exportable.

Randox

Benchtop chemistry & toxicology testing analyzer Pentra C400 Clinical Chemistry Analyzer: • Throughput of 420 tests per hour with ISE • Extensive Moderate Complexity Test Menu with 70+ assays • Capacity of 52 onboard assays • No water system, drain, or special electrical required • Benchtop with small footprint • Pair with ABX Micros 60 Hematology Analyzer and Lite Data Management HORIBA

Trusted quality for mid-volume labs The DxH 690T is a quantitative, multi-parameter, automated benchtop hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Beckman Coulter

COVID/flu testing anywhere & everywhere The Metrix COVID/Flu Test is a highly accurate molecular test with a small footprint and a seamless testing procedure that can accurately detect and differentiate between SARS-CoV-2, Flu A, and Flu B at the point-of-care.

Use this simple, efficient, and affordable testing solution to deliver lab-quality results in 20 minutes.

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RUNNING HEADER :: CONTINUED HEADER

LABORATORY

INNOVATOR

Rural healthcare through the lab lens

By Christina Wichmann

Cecil James M. Buguis, DHSc, MSc, MBA, CTTS, MLS(ASCPi)cm is the Laboratory Director at Winkler County Hospital District in Kermit, Texas. With a multidisciplinary background in clinical diagnostics, health sciences, and healthcare administration, Dr. Buguis brings a strategic and community-centered approach to rural laboratory leadership. He holds a Doctor of Health Sciences, master’s degrees in Medical Laboratory Science and Business Administration, and is certified by the ASCP as an international medical laboratory scientist.

He was recently honored with the United States Public Health Service Award for Excellence in Public Health Pharmacy Award, a national recognition of his dedication to advancing healthcare in underserved communities. Dr. Buguis is currently pursuing a Doctor of Pharmacy degree, with a focused interest in expanding the clinical utility of diagnostic medicine and pharmacogenomics.

In addition to his hospital leadership, he serves as a clinical site coordinator and advisory board member for local college laboratory program. His work reflects a deep commitment to innovation, health equity, and patient-centered care across all facets of the healthcare continuum.

As a rural laboratory, what kind of staffing challenges does the Winkler County Hospital District Laboratory have and what ways do you try to overcome them?

As the Laboratory Director of a rural hospital, I’ve seen firsthand how staffing challenges can deeply impact operations. In our region, one of the main issues is a general lack of awareness about the Medical Laboratory Science profession. This often results in fewer students pursuing this path, and subsequently, a limited pipeline of trained personnel entering the workforce. To

address this, we participate in local career fairs and set up educational booths during community events like Kermit Week. We also distribute ASCP Lab Drawer Kits, hoping to spark curiosity in young minds about the world of diagnostic science.

Beyond outreach, I serve on the advisory committee for the Medical Laboratory Technology and Phlebotomy programs at Odessa College. Our hospital is also a clinical training site for the college, allowing students to gain hands-on experience in real healthcare settings.

Another hurdle is the scarcity of qualified professionals within our geographic area. Many graduates gravitate toward larger cities, so recruitment is an ongoing challenge. In response, I focus on retention—creating a positive, empowered work culture. I’ve eliminated on-call shifts while maintaining 24/7 operations, send staff to external training opportunities, and encourage continued education. Advocacy for their growth is advocacy for the lab’s success.

How do you handle equipment maintenance and technological upgrades in a rural hospital setting?

Equipment maintenance and technological upgrades in rural hospitals often require creativity, planning, and strong vendor relationships. We prioritize preventive maintenance contracts and align our upgrades with broader hospital initiatives or grant opportunities.

Whenever possible, we choose analyzers that are scalable, easy to train on, and supported by remote service capabilities to minimize downtime. Careful review is essential before committing to any new technology. We always conduct a thorough cost-benefit analysis and focus on what matters. We focus on acquiring equipment that serves its intended purpose reliably without placing unnecessary financial strain on the facility.

Building rapport with vendors has also been key; many have provided extended warranties and flexible payment terms in recognition of our rural constraints.

Strategic planning and advocacy at the administrative level help ensure that laboratory priorities are considered

during budget discussions, allowing us to make smart, sustainable investments in technology.

It is also important to plan for the unexpected, as there will be times that a piece of equipment is down. That is why it is important to ensure to have a backup analyzer, or at the very least, point-of-care-testing (POCT) option to continue performing critically important tests such as cardiac markers and other routine chemistry tests.

What efforts has the hospital and laboratory taken to expand healthcare access for its rural patient population?

To expand healthcare access for our rural population, we’ve strengthened our collaboration with the state public health laboratory, enabling us to send out samples for advanced testing at no cost to our patients. This has opened doors to higher-complexity diagnostics while removing financial barriers. We are also pursuing approval to become a Texas Infertility Prevention Project (TIPP) partner, which will allow us to provide free STI testing, specifically for chlamydia and gonorrhea, to uninsured and underinsured individuals. Education, early detection, and access to treatment are at the heart of that initiative.

Beyond the lab, the hospital participates in the Adult Safety Net (ASN) program, offering free immunizations to eligible adults. We also host free smoking cessation classes.

What does being a lab director mean to you?

Being a laboratory director in a rural hospital goes beyond overseeing operations. It means being a champion of quality, a bridge between the diagnostic and the clinical team, and an advocate for access and equity in healthcare. It’s about serving not just patients, but the entire community by ensuring the lab remains a reliable piece of the puzzle towards a healthier life. I take great pride in guiding our team to adapt, grow, and innovate despite limited resources. At the end of the day, our work directly influences patient outcomes, and that’s a responsibility I carry with honor.

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ESBL Detection

with

NG-TEST® CTX-M Multi Hardy Diagnostics releases FDAcleared NG-TEST® CTX-M Multi in the United States. CTX-M Multi is an in vitro, rapid, and visual immunoassay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) for the rapid detection of ESBL’s.

CTX-M-mediated ESBL-producing bacteria, primarily Escherichia coli, have been identified in various settings, including hospitals and long-term care facilities. While initially thought rate, CTX-M enzymes are now recognized as a significant cause of extended-spectrum cephalosporin resistance.

DA F NOW

Using CTX-M Multi provides detection in just 15 minutes from isolated colonies.

Hardy Diagnostics is the exclusive distributor in the U.S. and its territories for the NG Biotech lateral flow assay solutions product line.

Scan to learn more HardyDiagnostics.com/CTXM

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Discover Diazyme’s KAPPA & LAMBDA FREE LIGHT CHAIN ASSAYS Available on all Major Clinical Chemistry Analyzers Clinical Relevance: Proven clinical utility in the diagnosis & monitoring of multiple myeloma.

Efficiency: Seamlessly integrates into major automated chemistry analyzers, delivering rapid results with minimal prep for optimized workflow.

Precision: Delivers high sensitivity and specificity with accurate quantification of free kappa and lambda light chains for reliable results.

Precision in Every Pair.

Contact Diazyme today to request a quote or learn more. www.diazyme.com/cancer-markers | sales@diazyme.com | +1-858-455-4588

510(k) Cleared Health Canada Registered 2797 Diazyme Laboratories, Inc. – Advancing Clinical Diagnostics Worldwide

Scan to Learn More

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