Lab management best practices Page 28
CE: Critical care testing Page 8 LAB INNOVATOR
Petra Furu, PhD
General manager of reproductive health, Revvity PLUS Laboratory decontamination practices Page 18 Project management in the laboratory Page 24
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care testing: The laboratorian in the emergency room By Robert F Moran, PhD, FCCM, FIUPAC and Maria Paulina Posada-Vergara, MD, MSc CLINICAL
laboratory-developed test rule is vacated By Tim Bickley MLS(ASCP), CPHIMS, MBA
Keeping it clean: The latest in laboratory disinfection practices By Dan Scungio, MLS(ASCP), SLS, CQA (ASQ)
By Santhosh Nair
management in the clinical laboratory: A hybrid approach By Nathalie Austin, MBA, MLS(ASCP) and Autumn Vela, MHA, MLS(ASCP)CM SHCM
Navigating the medical lab landscape: Key trends in costs, contracting, staffing, and technology By Kara Nadeau
the silent epidemic: How molecular pointof-care testing can revolutionize STI care By Tamar Tchelidze, MD, MPH; Karissa Culbreath, PhD; and Ronak Shah, MD
Christina Wichmann
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By Christina Wichmann Editor in Chief
In this issue, we are featuring the results of our State of the Industry Survey on Lab Management Best Practices. Thank you to all who responded to this survey. One of the primary issues in laboratory management is recruiting and retaining staff. We asked readers about their organizational benefits that are offered to retain and recruit staff.
This year’s survey saw increases in financial incentives, such as sign-on bonuses, merit allowances, and retention bonuses (48%, up from 42% in 2024); succession-planning processes by offering additional responsibilities to top performers (22%, up from 19% in 2024); and partnerships with local colleges and tech schools to offer internships in their labs (46%, up from 38% in 2024). Benefits that showed decreases included continuing education offerings (46%, down from 50% in 2024); clinical ladders/structures to encourage professional development, such as from novice to expert (33%, down from 40% in 2024); and shift changes to offer employee scheduling flexibility (33%, down from 44% in 2024).
I recently watched a webinar, “The Workforce Crisis: Innovative Strategies to Strengthen and Support Healthcare Teams,” in which panelists discussed strategies they are using at their healthcare organizations for recruitment and retention. The panelists indicated that staff turnover is stabilizing following “the Great Resignation” and “quiet quitting;” however, healthcare staffing is still plagued by complexity and uncertainty. A significant pressure on many healthcare organizations is that the patient populations they serve are becoming older and sicker, placing more demands on organizations and their staff. Leaders are devoting a 50/50 percent of resources toward immediate staffing (retention and building a long-term path forward) and future staffing (recruiting high school, community college, and college students).
The CEO of a rural Iowa hospital, Michelle Majerus, shared that staffing agencies have struggled attracting laboratory professionals to rural environments. This hospital, Avera Holy Family Hospital, has found that international technologists have helped fill laboratory positions and reduce frustrations amongst the existing staff since laboratory coverage is needed 24/7. This CEO indicated that more rural hospitals are moving to this model.
An executive from Banner Health, Margo Karsten, shared that she received a grant to recruit high school and community college students. All panelists agreed that pipeline development was absolutely necessary, in addition to up-training existing staff. More efforts are going into developing the middle manager roles and agile leaders who are technologically focused and can drive change forward. The panelists hear “loud and clear” that tuition reimbursement is important to current staff and potential candidates.
The on-boarding process is given deeper thought these days. Organizations are starting to see it as a 12-month investment, i.e., a 12-month program. Instead of providing a series of modules to introduce and immerse new staff into the organization, on-boarding is thought of as more of a (work) cultural experience. Speaking of culture, it is increasingly recognized that this is what keeps people in an organization. At Banner Health, they recognize the power of connection (whether virtual or in-person) to improve employee retention and their sense of purpose. Culture, engagement, and connection can give staff a joy for their work.
I welcome your comments and questions — please send them to me at cwichmann@mlo-online.com.
Vol. 57, No. 4
PUBLISHER Chris Driscoll cdriscoll@endeavorb2b.com
EDITOR IN CHIEF Christina Wichmann cwichmann@mlo-online.com
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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
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CALO Tracy Kane
CMO Amanda Landsaw EVP CITY SERVICES & HEALTHCARE Kylie Hirko 30 Burton Hills Blvd., Suite 185 Nashville, TN 37215 800-547-7377 | www.mlo-online.com
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By Robert F. Moran, PhD, FCCM, FIUPAC; Maria Paulina Posada-Vergara, MD, MSc
See test online at https://ce.mloonline.com/courses/criticalcare-testing-the-laboratorianin-the-emergency-room
Passing scores of 70 percent or higher are eligible for 1 contact hour of P.A.C.E. credit.
LEARNING OBJECTIVES
Scan code to go directly to the CE test.
Upon completion of this article, the reader will be able to:
1. List those involved in shared understanding and implementation of caring for those in critical care areas.
2. Discuss the characteristics of the critical care patient and the proper planning of the laboratory environment in nonideal situations.
3. Differentiate critical homeostatic laboratory testing required for the care of critical patients.
4. Discuss back-up laboratory testing for critical care patients in unsuitable environments, such as surge situations or environmental tragedies.
Critical tests versus urgent ones cannot be defined simply by a set of measurands or objective criteria, but on personal understanding of both critical care requirements and laboratory capabilities by laboratorians and caregivers alike. Certain aspects of which can only be found through a working, experiential knowledge. Critical care test portfolios require planning for emergency conditions, since, if critical, certain tests must always be available. Planning for instrument malfunction is basic. Planning for more severe environmental situations that could be possible at your location may be just as critical. Since testing and treatment technology advances are dynamic, continuous re-evaluation and integration with overall goals of an institution and its environment is essential. While core critical and urgent test lists may not change significantly, differences in technology may influence the results leading to the need for more specificity in identifying results on specimens obtained in critical/urgent areas and seamless incorporation into the patient record.
Critical care testing is personal (a few anecdotes)
After a brief stint as a laboratory glassware technician (i.e., dishwasher), the pathologist realized I was a college senior and chemistry major. Shortly thereafter, he decided he needed a new glassware technician, and I would be trained to be a
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References
1. Lippi G, Salvagno GL, Favaloro EJ, Guidi GC. Survey on the prevalence of hemolytic specimens in an academic hospital according to collection facility: opportunities for quality improvement. Clin Chem Lab Med. 2009;47(5):616–618. doi:10.1515/CCLM.2009.132.
2. Balasubramanian S, McDowell EJ, Laryea ET, et al. Novel in-line hemolysis detection on a blood gas analyzer and impact on whole blood potassium results. Clin Chem. 2024;70(12):1485-1493. doi:10.1093/clinchem/hvae135. 3. Lippi G, Fontana R, Avanzini P, Sandei F, Ippolito L. Influence of spurious hemolysis on blood gas analysis. Clin Chem Lab Med. 2013;51(8):1651–1654. doi:10.1515/cclm-2012-0802.
4. Lippi G, von Meyer A, Cadamuro J, Simundic A-M. Blood sample quality. Diagnosis. 2018;6(1):25–31. doi:10.1515/dx-2018-0018. 5. O’Hara M, Wheatley EG, Kazmierczak SC. The impact of undetected in vitro hemolysis or sample contamination on patient care and outcomes in point-of-care testing: a retrospective study. J Appl Lab Med. 2020;5(2):332–341. doi:10.1093/jalm/jfz020. 6. Werfen. GEM Premier 7000 with iQM3 Operators Manual. P/N 00000026407. Rev 00. Aug 2023. 7. Phelan MP, Hustey FM, Good DM, Reineks EZ. Seeing red: blood sample hemolysis is associated with prolonged emergency department throughput. J Appl Lab Med. 2020;5(4):732–737. doi:10.1093/jalm/jfaa073. 8. Wilson M, Adelman S, Maitre JB, et al. Accuracy of hemolyzed potassium levels in the emergency department. West J Emerg Med. 2020;21(6):272–275. doi:10.5811/westjem.2020.8.46812. 9. Milutinović D, Andrijević I, Ličina M, Andrijević L. Confidence level in venipuncture and knowledge on causes of in vitro hemolysis among healthcare professionals. Biochem Med. 2015;25(3):401–409. doi:10.11613/BM.2015.040. 10. Phelan MP, Ramos C, Walker LE, et al. The hidden cost of hemolyzed blood samples in the emergency department. J Appl Lab Med. 2021;6(6):1607–1610. doi:10.1093/jalm/jfab035.
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GEM, Premier, GEM Premier ChemSTAT, ChemSTAT, GEMweb, iQM, Hemochron, VerifyNow, Avoximeter, and ROTEM are trademarks of Instrumentation Laboratory Company (d.b.a. Werfen) and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. The Werfen logo is a trademark of Werfen and may be registered in the Patent and Trademark Offices of jurisdictions throughout the world. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners. ©2025 Instrumentation Laboratory. All rights reserved. *Not available in all countries.
weekend/night technician along with a pre-med senior who had already started. From April through September (fulltime), intense training covered more than the college chemistry/biology/ physics labs to which we were accustomed. Training included blood, urine, serum, spinal, etc. fluids; chemistries; cell counts/differentials; microscopy; and planting cultures — some automated, but mostly manual methods. No blood gases back then, but we did pH on a Beckman model G, TCO2 on a Natelson, typing and crossmatching, and EKG’s and blood volumes by isotope dilution. It was a hectic summer! After four-and-a-half months of on-the-job training, were the two newbies ready??
Our schedule of alternate weekends and nights in a small hospital gave us a lot of free time to study p-chem or atomic structure — except we mostly spent spare time in the emergency room watching and talking with support and
Critical care, for our purposes, relates to the patient as brought into a trauma center in extremis or becomes that way inside the institution.
medical staff and helping them out with various tasks, including starting IV’s, restraining patients, etc. There were also times when there was hardly enough time to breathe because something had hit the fan! Incidents such as these:
• An 18-year-old high school track star who was four years younger than me was brought in from the practice field one afternoon, lethargic and near-comatose. I called up to the ER. I had trouble getting blood — it was flowing very slowly into the Vacutainer. I tried a new tube- the same result. Finally, I got enough blood and went back to the lab. I started spinning the hematocrit and began prepping the manual cell count. Looking at the hematocytometer grid – way too many cells! Was the diluent mislabeled? I prepared fresh lysing fluid from scratch. By this time, the hematocrit had finished spinning, and I saw that the buffy coat was huge! Quickly, I looked at the
stained differential and immediately called the emergency room and asked the treating doctor to come to the lab. I knew he would not believe me unless he saw it. I still remember the look on Dr B. Shavitz’s face when he looked in the microscope.
• The fourteen eight-year-old kids, walking hand-in-hand to church after school, were mowed down when a driver had an myocardial infarction and died at the wheel. Each child had the same injuriesbroken legs and concussions/headbleeding. All but two were brought into our emergency room on a Friday after the day crew left. Dr. Shavitz and another pediatrician, Dr. R. Abrams were there. A busy night with repeated blood collections, crossmatches, hemaglobin and hematocrit, and area reporters’ and hospital administrator’s questions!!! All the kids survived the night; I went home Saturday at 7:00 AM to hug my kid.
• A 55-year-old pre-surgical man with a leaky (blood) pyloric ulcer. (My father had the same condition and surgeon.) Blood had been crossmatched for the next day’s surgery, and we had 12 units of that type in the bank. But when the patient’s ulcer ‘popped’ at 4:30 that Sunday afternoon, I was alone in the lab. That ulcer did not just bleed fast. The patient nearly exsanguinated, using more than 40 units of blood in the five hoursbefore Dr. Latimer stopped the bleeding.
These situations all happened in the first months of covering the nights and weekends in the laboratory of a small hospital. The point of these Untold Stories of Critical Care Testing helped in understanding what critical really means and how interrelated testing and direct patient care are in the critical environment. Our experiences — in the lab, at
the bedside, and in the field (from urban teaching hospitals to remote settings in Africa and the Amazon) — taught us how crucial it is to break down the silos and stereotypes that too often prevail. (Think ‘Abby’ from NCIS or ‘Nurse Ratchet’ from One Flew Over the Cuckoo’s Nest.)
Without a shared understanding between laboratory scientists, clinicians, and caregivers, (and even legislators/ regulators), we risk losing what ‘critical’ truly means in patient care. In our view, in-service teaching, training, and continuing education courses must significantly involve the interdependent professions in course design and attendance, including on-the-job training! At a minimum, bench supervisors and those aspiring to those or higher positions must be well grounded in their soft skills. For the characteristics of a critical patient, see Figure 1
Critical care, for our purposes, relates to the patient as brought into a trauma center in extremis or becomes that way inside the institution for whatever reason. The intervention mantra is Airway, Breathing, and Circulation (ABC). Simultaneously with provision of the initial ‘AB’ by caregivers, laboratory tests for assessing circulation (the ‘C’) and critical underlying pathology are paramount, as is the need to assess/ reassess patient status during critical initial care.
Our intent is primarily to point out some considerations that each institution should address when preparing/ developing and periodically reassessing critical/urgent test lists and planning for the delivery of needed results. Planning is not ‘one-and-done.’ It must be accomplished in a joint administrative/ medical/nursing/laboratory/information technology team, a group with an established and ongoing understanding of the critical and urgent clinical and laboratory environments that can facilitate the evaluation of changing needs.
This team of providers must set the requirements jointly based on established and shared goals for the levels and types of care needed and the technology available. Since critical care is 24/7/365.25, its laboratory support must be as well. Consequently, provision for staffing having broad-based competency must be available or obtainable 24/7/365.25 to support the technology available including routine and back-up technology. The key element is the developed plan and its implementation, not the location for the testing. Then, when a critical/ urgent test is required, it is available in a timely fashion even under less-thanoptimal conditions.
Several of this year’s editions of MLO present the tests of the critical homeostatic systems, so they will not be explained here. In summary, these tests consist of measurements reflective of the triad of integrally related metabolic systems that are critical for both the near- and long-term maintenance of life (See Figure 2). While not all tests shown in Figure 2 are always critically needed, it is significant to recognize that CO-oximetry is a requirement in the emergency department and a standout in critical care testing. Even though peripheral or ‘pulse’ oximetry is usually suitable for other critical care areas, it is generally unable to detect dyshemoglobins (e.g., carboxyhemoglobin [COHb] and methemoglobin [MetHb]) necessary for the emergency room. In part due to this common over-reliance on peripheral oximetry, as well as misinterpretation of some of the electrolyte results, we assert
testing plan. Currently, the tests available rapidly are good but not definitive.
that the laboratory must have oversight into all tests performed on body tissues if the results are used for diagnostic or therapeutic intervention.
Blood products and critical/urgent care: Following completion of the laboratory role in the ‘circulation’ part of ABC, type and crossmatch and provision of blood products are obvious items to be included in the critical test environment, as well as the impact of the blood products on the measurands themselves.
Critical and urgent care interface: Immediately following upon and integral with ABC above must be laboratory testing for infectious disease, hematology/immunohematology, coagulation testing, and organ/organ system chemistries. Consider as a criterion that if a physician will make a care decision/ action immediately based on the test result and the technology available to perform the test, then the test should be a candidate for your laboratory critical/urgent test list since triaging to the correct care area is an urgent need to ensure the primary areas are ready for the next critical patient.
Infectious disease testing in critical/ urgent care: Stat cultures once meant simply planting specimens and reading them later, but innovation—accelerated by COVID-19—has transformed microbial testing. When available, tests including molecular techniques, gas chromatography (GC), mass spectrometry (MS), mathematical transforms, and AI-driven data analysis significantly expedite identification and sensitivity testing. As antimicrobial resistance rises, effective antibiotic stewardship depends on faster, more precise results, which must be in the laboratory’s critical/urgent
A list suitable for most institutions can be easily prepared to meet testing for critical homeostatic systems. Most important, however, is to consider the need for back up when either specific analytical systems fail, or when other unfavorable conditions arise. If, for example, the blood gas in the emergency room malfunctions can an operational replacement blood gas system elsewhere in the institution be accessed 24/7/365.25, even if it is in another department- make sure that a smooth transition is built into the plan.
Further, plan for both surge situations (COVID) or environmental tragedies, such as those in western North Carolina in 2024 or Kentucky and Tennessee in 2025. Planning for the latter type of disruption can benefit from lessons learned in settings where power outages and lack of clean water are routine challenges. In many parts of Africa, where we have worked, healthcare facilities must adapt and innovate to continue providing essential services despite these constraints. These experiences
As antimicrobial resistance rises, effective antibiotic stewardship depends on faster, more precise results, which must be in the
laboratory’s critical/ urgent testing plan.
highlight the importance of resilience, resourcefulness, and contingency planning—principles just as critical in high-resource settings when the unexpected occurs.
The following are some back-up plan suggestions:
General: In disaster situations, several clinical issues are prominent: stress, penetrating trauma, crush injuries, infectious diseases, and ambient toxins such as carbon monoxide or cyanide from fires. What are the critical tests needed to address these clinical situations?
Also, institutional power may be severely limited in quantity and quality.
You may need to rely on intermittent generators or battery power or no power. Do you need a separate portable generator for the lab’s basic operational equipment (e.g., blood gases/incubators/refrigeration/microscopy)? What about reagent stability? You may need portable refrigerators and iced coolers.
Chemistry and hematology: Do you have basic colorimeters that can operate reliably on unstable electrical current or battery power? Of the essential tests, are there procedures set up using the reagents at hand to perform the tests under these conditions? Who knows how to make the reagents and do the tests? Are there worries about the FDA and lab-developed test protocols in these conditions? If they are portable, enhanced blood gas systems with electrolytes, urea/creatinine, and glucose may be a viable choice if the system can operate on generator power.
Since critical care is 24/7/365.25, its laboratory support must be as well.
that there is no ambiguity in the meaning of reported results on the electronic displays throughout the institution and on the electronic health record (EHR) itself.
1. Moran RF, Grenier RE. The effects of “standard” Blood gas transport and storage conditions on electrolyte results with observations on reported hemoglobin measurement anomalies. In: Methodology and Clinical Applications of Ion Selective Electrodes. Vol 10. ; 1988:57-64.
2. Moran RF. Combined Blood Gas, Electrolyte, and total hemoglobin measurements; implication of pre analytical variables on apparent performance of the analyzer. Xes Journees de Biologic Medical. Published online 1989.
3. 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.
4. 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.
5. Moran RF. Overcoming data management challenges: The biggest challenge of all is….us. Medical Laboratory Observer. January 29, 2024. Accessed March 25, 2025. https://www.mlo-online.com/ information-technology/data-management/article/53081209/ overcoming-data-management-challenges-the-biggest-challenge-ofall-isus.
Cell counts (blood, cerebrospinal fluid) using a hematocytometer and white cell differential using Gram stain should be a requirement in back-up planning. Also, your back-up plan should include a spun hematocrit and/or standalone hemoglobin on a simple colorimeter powered by a less-thanelectrically-clean generator or a marine battery.
Coagulation: Train emergency staff to use bleeding and clotting times as back up or to validate unexpected results.
Critical organ function tests: While troponin, myoglobin, and creatine kinase are the optimal tests for cardiac assessment, consider testing by less specific methods in emergency situations. For less-than-favorable conditions brought on by environmental disruption, consider the ‘manual’ colorimetric methods that are available and use the colorimeter mentioned above.
Infectious disease tests: If the lab is without electricity, relying on manual techniques, chemical reactions, or visual interpretation become crucial for any back-up plan. Microscopy-based tests (manual staining and examination); rapid diagnostic tests, e.g., lateral flow assays, agglutination, and serological tests (manual visualization/ interpretation); and even culture-based tests with minimal electrical requirements can be done (e.g., candle jars or CO2-generating systems).
The critical care laboratory in any institution may be uniquely placed in the emergency department, central laboratory, or both. Still, its operation and staffing must be uniquely tuned to what critical means. For critical patients, the testing must take precedence over other laboratory activities and cannot be considered a disruption — it is why we are here. We suggest that the critical care lab be prepared to sustain operations when services are limited. Evaluate what your back-up plan looks like.
Finally, in tune with the latest technology, the results provided by the fully operational critical care lab must be completely comparable to those provided in the central lab, and specimens must be uniquely identified to ensure
Scan code to go directly to the CE test.
6. Moran RF. Point-of-care testing — Managing change when you are not in charge. Medical Laboratory Observer July 22, 2024. Accessed March 25, 2025. https://www. mlo-online.com/continuing-education/article/55094063/ point-of-care-testing-managing-change-when-you-are-not-in-charge.
7. 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. 2024:jfae112. doi:10.1093/jalm/jfae112.
8. Moran RF. Electrolytes in Blood (and water): Measurement and clinical overview. Medical Laboratory Observer February 24, 2025. Accessed March 25, 2025. https://www. mlo-online.com/diagnostics/hematology/article/55263357/ electrolytes-in-blood-and-water-measurement-and-clinical-overview.
9. Point-of-care tests: rapid diagnosis in emergency situations. Medica-tradefair.com. January 6, 2021. Accessed March 25, 2025. https://www.medica-tradefair.com/en/medtech-devices/ Point-of-care_tests_rapid_diagnosis_in_emergency_situations.
10. Tran NK, Godwin Z, Bockhold J. Point-of-care testing at the disaster-emergency-critical care interface. Point Care 2012;11(4):180-183. doi:10.1097/POC.0b013e318265f7d9.
11. Elrobaa IH, Khan K, Mohamed E. The role of point-of-care testing to improve acute care and health care services. Cureus. 2024;16(3):e55315. doi:10.7759/cureus.55315.
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.
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.
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By Tim Bickley MLS(ASCP), CPHIMS, MBA
In a stunning turn of events, the U.S. District Court for the Eastern District of Texas ruled in favor of the Association for Molecular Pathology (AMP) and vacated the U.S. Food & Drug Administration’s (FDA) final rule that would have regulated laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. “The Laboratory Plaintiffs contend that FDA’s final rule must be vacated under the Administrative Procedure Act because it exceeds FDA’s statutory jurisdiction, authority, or limitations.”1
regulation of laboratory-developed tests (LDTs). While it represents a notable outcome for those advocating LDT autonomy, it also underscores the evolving nature of clinical laboratory oversight. 2 Given the heightened awareness surrounding LDT regulation, it’s likely that additional policy developments will emerge in the coming months or years. Regardless of the outcome, laboratories should remain
The court’s decision halts the FDA’s planned phaseout of its long-standing enforcement discretion. For now, laboratories are no longer required to follow the new five-stage compliance framework that had been published in May 2024. But this ruling doesn’t eliminate the concerns that motivated the FDA’s push: patient safety, regulatory clarity, and modernization of lab practices. This ruling marks a pivotal moment in the ongoing conversation about the
proactive — reinforcing their quality systems, strengthening documentation, and modernizing validation practices to meet both current expectations and future regulatory demands. 2
This ruling represents a significant victory for proponents of LDT independence. There are potential next steps the FDA could take:
• Appeal by the FDA: The U.S. Department of Justice may appeal the decision to the Fifth Circuit Court of Appeals, which could potentially reinstate the rule.
• Legislative action: Congress may
pass legislation explicitly authorizing FDA oversight of LDTs, such as a future version of the VALID Act. The VALID Act, also referred to as the IVCT-In Vitro Clinical Test Development Act of 2023, is a bill that requires the FDA to regulate in vitro clinical tests (IVCT). This act would define the FDA’s authority to regulate LDTs. A separate category will be created that separates products from tests from medical devices. The aim of the VALID Act is to ensure that any test, no matter where it is developed, meets the same quality and performance standards. 3 Given these possibilities, clinical laboratories should remain proactive in strengthening their quality systems and validation processes to ensure continued compliance and excellence in patient care.
While the court’s decision to vacate the FDA’s LDT rule removed the immediate regulatory pressure, the importance of data integrity and rigorous validation processes in the clinical laboratory remain as critical as ever. Regulatory uncertainty will likely continue, whether through future FDA actions, new legislation, or evolving payer expectations. In the meantime, the intent behind the rule — improving quality, increasing transparency, and protecting patient safety — still resonates throughout the industry.
The regulatory structures of CLIA and FDA are different in focus, scope and purpose, but the two regulatory structures are meant to complement each other. CLIA requires labs to validate key performance characteristics of LDTs — such as accuracy, precision, sensitivity, specificity, and reportable range — based on their own staff, equipment, and patient population. These validations are lab-specific and not transferable.4
See Table 1 for a summary of CLIA and CAP (College of American Pathologists)
Verification requirements for FDA-approved/cleared tests
Requirement CLIA5
Accuracy (Trueness)
Precision (Reproducibility)
Required
Required
Reportable Range (AMR) Must be verified to confirm instrument can report results within the claimed analytical range
Reference Interval (Normal Ranges)
Analytical Sensitivity/ Specificity
Interference Studies (e.g., COM.40500)
Carryover / Cross-contamination
Must verify for your patient population or document use of manufacturer’s range if appropriate
Not typically required if manufacturer data is used
Not required for FDA-approved tests
Not specified
Documentation Required
Notes:
CAP6
Required (with documentation and approval by lab director)
Required
Required: May also require linearity studies if not provided by the manufacturer
Required: At least 20 healthy individuals or a reference method (can be adopted if justified)
Generally not required unless lab-specific changes or issues arise
Must be reviewed and documented — either accept manufacturer claims or verify locally
May be required depending on test type (e.g., molecular, infectious disease, blood bank)
Required, with validation summary reviewed and signed by laboratory director
If a test is used exactly as the manufacturer intended, then verification (not full validation) is required. If a modification is made (e.g., specimen type, algorithm, reporting units), then full validation is required, even for FDA-cleared devices.
Table 1. CLIA and CAP verification requirements for FDA-approved tests.
verification requirements for FDAapproved/cleared tests. See Table 2 for a summary of CLIA and CAP validation requirements for LDTs.
This is a prime opportunity for labs to future-proof their processes. Investing in better validation tools, strengthening documentation, and modernizing quality systems will not only reduce audit risk but also accelerate innovation, improve patient care, and prepare your lab for whatever comes next. As regulatory expectations grow, now is the time for laboratories to explore tools that not only reduce the burden, but also enhance quality — all while freeing up staff to focus on other high-impact initiatives.7
Next-generation software example for verifying and validating instruments and assays
A cloud-hosted, software-as-a-service (SaaS) solution can automate laboratory verifications and validations. Labs that previously relied on spreadsheets and manual processes can now centralize their quality efforts with auditable workflows, significantly reducing the risk of human error.
Here’s an example of a modern, web-based solution designed specifically to reduce the burden of validation and verification studies. With an intuitive interface and built-in workflows, platforms like this have helped laboratories complete validation and verification studies up to six times faster than
Requirement CLIA5
Accuracy Required: Must establish trueness of results compared to known standards
Precision (Reproducibility)
Analytical Sensitivity
Analytical Specificity
Reportable Range (AMR)
Required
Required: Ability to detect low levels of analyte
Required: Ability to exclude interferences
Required: Verify results can be accurately measured across expected range
Reference Interval Required: Must be established or verified for local population
CAP6
Required: Must be documented and reviewed by the laboratory director
Required
Required
Required
Required: May include linearity studies
Required: Often based on ≥20 healthy individuals unless otherwise justified
Interference Testing Not explicitly required by CLIA Required (COM.40500): Must evaluate common interferences or review manufacturer data
Carryover/Crosscontamination Not specified May be required depending on methodology
Specimen Stability Not specifically required Often recommended, especially for LDTs
Documentation Required
Revalidation After Changes Not clearly specified
Table 2. CLIA and CAP validation requirements for LDTs.
traditional tools (See Figures 1 and 2).
Note: This example is for illustration purposes only and does not endorse a specific vendor.
Required: Must be approved by the laboratory director
Required: Changes in reagent, platform, or method may trigger partial or full revalidation
Key benefits with advanced validation/verification software:
• Cut costs significantly across departments.
• Save valuable staff time — from hours and days to just minutes.
• Boost quality across every aspect of your lab’s operations.
• Go fully paperless — store results and reports indefinitely. Say goodbye to binders!
• Verify instruments and assays in minutes or hours — not days or weeks.
• Launch new labs up to 10x faster.
• Standardize and centralize your process — making audits and accreditation surveys smooth and stress-free.
• Scale effortlesslywith unlimited user licenses — easily train new staff and expand operations as needed.
Summary
Even without a federal mandate, laboratories face ongoing scrutiny from
accrediting organizations, healthcare systems, and patients. Prioritizing data quality, automating validation, and committing to continuous improvement are not just about meeting regulatory expectations — they are essential to delivering accurate, high-quality diagnostics that support better patient care.
At the same time, efforts to improve oversight must strike a thoughtful balance: safeguarding patient safety without creating unnecessary barriers to timely, cost-effective access to critical laboratory services.
This author does not endorse either position.
1. Association for Molecular Pathology. LDT opinion. March 31, 2025. Accessed April 1, 2025. https://www.amp.org/AMP/assets/ File/advocacy/FDA%20Final%20Rule/ LDT_Opinion_3_31_2025.pdf?.
2. Association for Molecular Pathology. Association for Molecular Pathology celebrates U.S. District Court’s decision to vacate FDA rule on laboratory-developed test procedure regulation. Published March 31, 2025. Accessed April 1, 2025. https://www.amp. org/about/newsroom/press-releases/2025/ association-for-molecular-pathologycelebrates-u-s-district-courts-decisionto-vacate-fda-rule-on-laboratorydeveloped-test-procedure-regulation/.
3. Allen J, Lacasse L. Better lab test standards can ensure precision medicine is truly precise. STAT. November 30, 2022. Accessed April 1, 2025. https:// www.statnews.com/2022/11/30/ valid-act-improve-standards-lab-testsprecision-medicine/.
4. Centers for Medicare & Medicaid Services (CMS). LDT and CLIA Frequently Asked Questions. Accessed April 1, 2025. https:// www.cms.gov/Regulations-and-Guidance/ Legislation/CLIA/Downloads/LDT-andCLIA_FAQs.pdf.
5. Centers for Medicare & Medicaid Services (CMS). Clinical Laboratory Improvement Amendments (CLIA). Updated January 16, 2025. Accessed April 1, 2025. https:// www.cms.gov/Regulations-and-Guidance/ Legislation/CLIA.
6. College of American Pathologists. All Common Checklist. Updated 2023. Accessed April 1, 2025. cl-com.pdf.
7. Interpretive- BYG4lab. Validation Manager: Toward Smarter Verifications. Accessed April 1, 2025. https://finbiosoft.com/ ebook-towards-smarter-verifications/.
Tim Bickley MLS(ASCP), CPHIMS, MBA has more than 25 years of experience in the laboratory and diagnostics industry. He is the Vice President of U.S. sales for BYG4lab, Inc
Tim is a board-certified Medical Laboratory Scientist, MLS(ASCP) and has a BS degree in Medical Technology from the Medical College of Virginia/VCU, a BA degree from The University of Alabama, an MBA degree from Averett University, and is a Certified Professional in Health Information Management Systems by HIMSS.
Manual entry of proficiency testing results is a time-consuming process and prone to errors. DataDirect utilizes the ability of your LIS to run a report and create a data file which is then uploaded onto API’s website. This process removes the need for manual entry, saves time, and eliminates the number one cause of proficiency testing failures, clerical errors!
By Dan Scungio, MLS(ASCP), SLS, CQA (ASQ)
Laboratory professionals know that a clean workspace is a safe workspace. Disinfection practices are at the core of maintaining a contamination-free environment, ensuring compliance, and protecting personnel, specimens, and the environment. But with evolving guidelines and new products entering the market, are you up to date with the best practices for laboratory decontamination? It is worthwhile to explore the latest in laboratory disinfection, from routine cleaning to selecting the best chemical germicides and understanding why some methods, like UV light, are less effective for bacterial or viral disinfection.
Decontamination basics
Decontamination is defined as minimizing the overall pathogenic microbial presence. For clinical and research laboratories, that microbial presence may exist in the form of bloodborne pathogens, bacteria, viruses, and even prions. The primary purpose of decontamination is to reduce the number of these contaminants in order to eliminate the probability of transmission or infection.
Cleaning and disinfection should be part of every lab’s daily routine. The goal is not just to wipe down surfaces,
but to ensure that all potentially hazardous pathogens are eliminated. Work surfaces, benchtops, biosafety cabinets, and equipment should be disinfected at the beginning and end of each shift, as well as immediately following any spills or contamination events. Keep documentation of the workspace disinfection that occurs in each department.
High-touch areas such as door handles, keyboards, and centrifuge lids should also be included in routine cleaning schedules. The key is consistency: laboratory safety officers should implement and enforce standard operating procedures (SOPs) that outline when, where, and how disinfection should occur. Remember that all lab surfaces should be considered contaminated. That’s why gloves and lab coats are a must when working in the department, but disinfection practices should also be routine.
Not all disinfectants are created equally. Laboratories handle a variety of pathogens, and the effectiveness of a disinfectant depends on its active ingredients and proper use. A breakdown of commonly used chemical germicides includes the following:
• Alcohols (ethyl or isopropyl, 70–90%): Effective against many bacteria and viruses but not sporicidal. These
work well for quick disinfection but evaporate quickly, which can reduce contact time.
• Quaternary ammonium compounds (Quats): Common in hospital settings, these are good general disinfectants but may not be effective against all pathogens, particularly non-enveloped viruses. These are often used in labs where employees may have allergies to bleach products.
• Hydrogen peroxide (3–7%): A strong oxidizing agent that works well against a broad range of microorganisms, including bacteria, viruses, and fungi.
• Phenolics: These are effective against bacteria and some viruses but they do leave an unwanted residue.
• Glutaraldehyde: A high-level disinfectant commonly used for sterilizing medical and laboratory instruments. However, it is hazardous and requires proper ventilation.
Sodium hypochlorite, or bleach, remains the gold standard for laboratory disinfection. A 10% bleach solution is highly effective against bacteria, viruses, fungi, and even spores
Laboratories handle a variety of pathogens, and the effectiveness of a disinfectant depends on its active ingredients and proper use.
when given adequate contact time. The key to proper bleach disinfection is ensuring an adequate contact time—the amount of time the disinfectant remains on a surface before being wiped away or drying. For general disinfection, and to remove most bloodborne pathogens (HIV, HBV, HCV), at least one minute of drying time is necessary. To remove bacterial spores (e.g., Clostridium difficile), an extended dry time of ten to thirty minutes may be needed.
One major consideration with bleach is its corrosive nature. Frequent use on metal surfaces can lead to deterioration over time. This can be mitigated by using bleach alternatives, such as stabilized bleach solutions or hydrogen peroxide-based disinfectants that offer similar effectiveness with reduced corrosivity. Bleach use may also be followed by a water rinse in order to prevent damage to any surfaces.
Another disinfection consideration is the presence of prions in the lab. Prions are abnormally folded proteins which can be found in the spinal fluid and tissues of patients who have Creutzfeldt-Jakob disease (CJD), a rare but fatal, and rapidly progressive neurodegenerative disorder. While low-risk specimens containing prions may be handled and tested using standard precautions, spills of these specimens must be handled differently. Because prions are more difficult to inactivate than other bloodborne pathogens, spills should be soaked in undiluted bleach or a 1N sodium hypochlorite (NaOH) solution for at least one hour.
To ensure compliance with safety standards, laboratories should reference the EPA-registered disinfectant list (https://www.epa.gov/pesticide-registration/selected-eparegistered-disinfectants). This list categorizes disinfectants based on their effectiveness against specific pathogens, including emerging viral threats. Always check that the
disinfectant being used is approved for the specific organisms of concern in your laboratory.
Ultraviolet (UV) light has been marketed as a powerful decontamination tool, but it comes with limitations that make it less ideal for bacterial or viral disinfection in routine lab use. UV light has limited surface penetration, it disinfects only the areas it directly reaches, meaning that shaded or covered spots remain unsterilized. UV light also exhibits inconsistent effectiveness. Bacterial spores and some viruses exhibit resistance to UV exposure, requiring long exposure times and precise conditions. Making matters worse, direct UV exposure can be harmful to human skin and eyes, making its use in occupied laboratory spaces a risk. While UV technology has applications in molecular and DNA decontamination and some high-level sterilization processes, it should not replace chemical disinfection as a primary method.
In histology laboratories, formaldehyde remains a critical disinfectant due to its ability to fix tissues and inactivate pathogens. However, it is also a carcinogen and respiratory hazard, requiring strict handling precautions. Formaldehyde should only be used in well-ventilated areas, preferably under fume hoods. Laboratory personnel must wear gloves, lab coats, and appropriate respiratory protection when handling formaldehyde solutions. Some histology equipment manufacturers recommend using formaldehyde as a disinfectant, but as with UV light, labs should consider
safer substitutes that offer better disinfection without the associated health risks.
In order to ensure that the best laboratory decontamination practices are in place, consider following a routine cleaning schedule and ensure all surfaces are disinfected regularly and immediately after contamination or spill events. Choose the right disinfectant for the job. Match the disinfectant to the specific pathogens present in your lab environment. Be sure to let disinfectants remain on surfaces for the proper recommended contact time. A disinfectant is only effective if given enough time to work — don’t wipe it away too soon. Keep containers of disinfectants and wipes closed when not in use. Evaporation occurs quickly in the lab environment, and partially evaporated products lose effectiveness quickly. Make sure the disinfectants used in the lab are EPA-approved for their intended purpose.
Bleach is a corrosive chemical, so use it safely. While effective, bleach should be handled with care to prevent skin contact and damage to equipment and surfaces. Ensure a proper dilution of bleach mixtures. Check the concentration of undiluted bleach and calculate a proper 10% solution dilution. Not all bleach products are alike. If you make a bleach solution in your laboratory, be sure to make it fresh daily.
Maintaining a clean and contamination-free laboratory isn’t just about following the rules—it’s about creating a culture of safety and accountability. By staying informed on the latest disinfection practices, choosing the right germicides, and adhering to best practices, laboratory professionals can ensure a safer working environment while protecting the integrity of their work. The key to effective disinfection isn’t just what you use — it’s how you use it. Stay diligent, stay informed, and keep your lab clean!
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.
By Santhosh Nair
For many individuals living with autoimmune diseases, the road to diagnosis is long, frustrating, and often isolating. Symptoms like fatigue, joint pain, brain fog, and muscle weakness can appear sporadically, sometimes worsening without warning and other times fading just enough to cause doubt. Many patients go years without answers, cycling through doctor visits, tests, and misdiagnoses, all while knowing that something isn’t right with their body.
The nature of autoimmune diseases themselves is a challenge. Conditions such as rheumatoid arthritis, celiac disease, and connective tissue diseases are on the rise globally, placing increasing pressure on healthcare systems to provide timely and accurate diagnoses. The global prevalence of autoimmune conditions has been steadily increasing, with an estimated 5-10% of the population affected by one or more autoimmune diseases.1 This growing trend has added a significant burden to healthcare systems, compelling them to respond effectively.
Autoimmune diseases occur when the immune system mistakenly attacks the body’s own tissues. They often present with overlapping symptoms like fatigue, joint pain, muscle weakness, and skin rashes. They also vary between patients and evolve over time, making it even more challenging for laboratory professionals and healthcare providers to pinpoint the exact condition. However, there is yet another layer of complexity to be considered, and that is the fact that autoimmune patients often have their flare-ups and periods of remission. Flare-ups can be severe and may require immediate medical intervention, while remissions can be deceptive; patients may have no symptoms but still have disease activity. During remission, lab values may look normal although the disease is still present on the molecular level, which results in diagnostic delays.
Another major problem with autoimmune diseases is polyautoimmunity, which is the development of multiple autoimmune diseases in patients with primary autoimmune diseases. In fact, 13.5% of patients with autoimmune thyroiditis have been reported to have polyautoimmunity.2 Also, it has been estimated that 25% of patients with one autoimmune disease may develop another, which further complicates the diagnosis and management of the condition.3
Therefore, in patients, early identification and the continual tracking of symptoms are vital to avoid long-term complications. However, conventional diagnostic techniques may fail to capture these changes, underscoring the need for new strategies that combine technology, workflow, and laboratory operations.
Advancements in technology, such as automated immunoassays and systems, play an essential role in improving autoimmune disease detection. By combining medical history, symptom analysis, molecular test results, and advanced diagnostic hardware,
laboratory professionals and clinicians can gain deeper insights, enabling faster and more informed decision-making.
Today’s advanced immunoassays, such as fluorescence enzyme immunoassay (FEIA) technology, are transforming autoimmune disease detection by improving diagnostic accuracy. Further, introducing automated instrumentation can increase lab efficiency, enhance test consistency, and reduce human error, resulting in more reliable results. These advancements streamline laboratory workflows while providing a crucial balance between specificity and sensitivity, ensuring precise and dependable diagnostics.
Beyond their technical accuracy, FEIA and other advanced assays become even more powerful when paired with medical history and symptoms. When diagnostic test results are analyzed with the symptom history in mind, healthcare providers can reach deeper insights, enabling more informed, personalized decision-making. By integrating these diagnostic tools with clinical evaluation, providers can create more effective treatment strategies that improve long-term patient outcomes.
These exciting new tools and advancements can improve diagnostics and streamline workflows, allowing laboratory personnel to increase efficiency and output by consolidating testing instruments and automating key tasks such as sample preparation, analysis, and result reporting. This ultimately reduces mistakes and minimizes the need for manual interventions enhancing both speed and accuracy. But new technology is not always immediately embraced.
Resistance to change and vendor consolidation often stems from concerns about costs, potential disruptions to established workflows, and the need for extensive training. For laboratory professionals, the fear of workflow interruptions and the potential for increased complexity in their day-to-day jobs can be significant barriers. Additionally, there is often pressure
to demonstrate the value of new technologies and ensure a smooth transition with minimal impact on ongoing operations. To effectively address these challenges, it is essential to provide comprehensive training and support, as well as clearly articulating the long-term benefits of optimized workflows. To improve technology adoption, strategies should include customized, practical trainings that address specific needs and step-by-step implementation plans. It is also important to have dedicated support teams at the ready to provide technical assistance during the transition phase, so choosing a partner who prioritizes high-quality service, including exceptional training and outstanding customer support, is critical. Clearly communicating the long-term benefits of the new technologies, such as increased efficiency, accuracy, and overall improvements in workflow is also crucial. Demonstrating how these benefits outweigh the temporary inconveniences can help build buy-in from staff, which is integral to the successful implementation of this technology.
The growing prevalence of autoimmune diseases has highlighted the urgent need for more efficient and accurate diagnostic methods. Traditional approaches, while valuable, only capture a small piece of the complexities around these diseases, with their fluctuating symptoms and molecular activity. New assays, advanced software systems, and automation represent the future of autoimmune disease diagnosis. For patients, this means quicker diagnoses and more accurate treatment plans, which can significantly improve their
quality of life. The frustration of living with undiagnosed or misdiagnosed autoimmune diseases — often involving years of doctor visits and symptom management — can be alleviated with the precision of advanced diagnostic tools. With faster interventions, patients can avoid the progression of the disease, reduce the severity of flare-ups, and potentially minimize the impact on their daily lives, leading to better long-term health outcomes.
1. GAI. The global landscape of autoimmune disease. Global Autoimmune Institute. February 20, 2024. Accessed March 28, 2025. https://www.autoimmuneinstitute.org/articles/ the-global-landscape-of-autoimmune-disease/.
2. Botello A, Herrán M, Salcedo V, et al. Prevalence of latent and overt polyautoimmunity in autoimmune thyroid disease: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2020;93(4):375-389. doi:10.1111/cen.14304.
3. Yagnik KJ, Chhabria P, Bhanderi H, Fish PN. Unveiling the uncommon: a captivating case of multiple autoimmune syndrome. Arch Clin Cases 2024;11(3):83-85. doi:10.22551/2024.44.1103.10293.
Santhosh Nair is the President of ImmunoDiagnostics (IDD) at Thermo Fisher Scientific, leading the growth and innovation of allergy and autoimmunity diagnostics since June 2023. Prior to this, he was Vice President and General Manager of qPCR Platforms at Thermo Fisher. Before joining in 2019, Santhosh held senior leadership roles at Intel and GE Healthcare. He holds an MBA from Kellogg School of Management, Northwestern University, and a Bachelors in Electronics and Telecommunications Engineering from the College of Engineering, in Trivandrum, India.
By Nathalie Austin, MBA, MLS(ASCP); Autumn Vela, MHA, MLS(ASCP)CM SHCM
Clinical laboratory leaders are often tasked with implementing change. Whether a simple process revision, or a more complicated initiative, these changes can quickly develop into complex projects. The approaches taken to managing these projects can significantly impact their success. Administrative leaders in the clinical laboratory typically oversee four common disciplines: financial management, quality management, personnel management, and operations management. However, where does project management fit in, and how do we begin to plan for it?
In the clinical laboratory, projects, although temporary in nature, are part of the continuous process of quality assurance and initiatives. Laboratorians have not always consistently defined what we know as fundamental routine work as “projects.” However, we have always taken a measured and systematic approach when performing these tasks to ensure expected outcomes. “In general, a project is defined as a
one-time activity that has to be completed within a limited time and has a well-defined outcome.”1 Examples of common clinical laboratory projects include new instrument installations, test method validations and verifications, and process quality improvements. Each of these initiatives requires strict planning and project oversight, and for many projects, there will inevitably be some obstacles to overcome. We can mitigate these challenges by applying a standard method of project management that has been proven to work in other industries.
Two common methods exist in project management: Waterfall and Agile methods. While both have been proven to work successfully in project development, they follow different methods of working through and completing the project. The Waterfall and Agile project management methods originated in technical industries like engineering and software development. However, with the constant need for change
and improvement in healthcare, these methods, or a hybrid of the two, are becoming more popular with industry leaders.2 Below, we will discuss some key differences in the methods, show examples of how each could work in the clinical laboratory, and discuss which type we have found successful in laboratories.
So, how are the two project management methods different, and why should you choose one over the other? The key difference between the two styles is how the project tasks are worked through. The Waterfall method is a way to tackle the project with a more methodical, defined, and rigid structure, and is sometimes referred to as the classical linear method or predictive approach. This is because it adheres to a strict timeline and completes each project phase before moving to the next. Whereas the Agile method allows the project to develop organically with more flexibility and in a team-driven environment.3 The Agile method segments and assigns each of the larger portions of the project to different teams to tackle the project in a manageable way together.4
For example, let’s assume a hospital laboratory is implementing a new laboratory information system (LIS), and “go-live” is expected 12 months from today. With the Waterfall method, the project may be constructed as follows:
• Build the specimen processing module in months 1 and 2.
• Build the core lab (hematology/ coagulation/chemistry/urinalysis) module in months 3, 4, and 5.
• Build the microbiology module in months 6 and 7.
• Build the blood bank module in months 8 and 9.
• Build the histology/anatomic pathology module in month 10.
• After constructing each of the lab section modules, testing of these modules will commence in months 11 and 12.
Whereas the Agile approach (also referred to as “adaptive” project management) for implementing this same LIS may look completely different. This approach is commonly used when there is a high level of understanding of the outcome, but the best way to achieve that outcome is not strictly defined.5 Using this method with the LIS example, each of the lab section modules builds could be assigned to teams to tackle
Smart transfer system allows for a compact footprint: The AUTION EYE connects with the AUTION MAX AX-4060, and results in a very small footprint (41.9" x 25.6" x 23.6").
their sections simultaneously. With the Agile method, the project may be constructed as follows:
• All sections in the laboratory work on building their assigned modules.
• All sections build their reference ranges.
• All sections run test samples to ensure the LIS is working appropriately.
While both Waterfall and Agile methods have seen success in different industries, after talking with other laboratory leaders, we have found that a hybrid of the two methods works better for laboratory projects than just specifically using Waterfall or Agile alone. The hybrid project management model combines the most advantageous parts of the Waterfall and Agile methods to fit the project’s needs. “Many hybrid projects use a Waterfall framework at a high level and apply Agile approaches to specific deliverables as appropriate.” 5 Marie Cole, Clinical Laboratory Administrative Director overseeing multiple sites in the San Antonio, Texas area spoke about a recent project that required adding new pathology services at one of her laboratories. After the project started, she stated, “The team started working hard and solving problems; however, things would pop up that we hadn’t thought about. So, we had to be flexible enough to be able to address them (Agile approach).” However, Marie also said that “although time is one of her biggest obstacles when managing a project, it is imperative to stay on top of it and stick to your deadlines (Waterfall approach).” Marie’s methods of blending these project management styles indicated she was using a hybrid approach to project management, and this was consistent with other laboratory leaders in the area. Without labeling as such, the combination or “hybrid” of the Waterfall and Agile project management methods appears to be a common practice used in the clinical laboratory today. Below, we will highlight an example employing the hybrid project management method.
Using the hybrid method in the laboratory
Basic project management mainly involves planning, scheduling, executing, and controlling.1 A strategic approach could be to use the hybrid method on our LIS implementation project, while also incorporating these four key elements to ensure the project runs smoothly. We can use the Agile method
Figure 1. In this diagram, we show how to apply the Hybrid model to our LIS implementation example. Notice the LIS module builds (activities) are performed in the first 90 days, all at once using the Agile method. Then, once the LIS module builds are complete, we’ll use the Waterfall method to complete the next two phases of the project.
to complete the builds of each laboratory section module and then use the Waterfall approach to test the module builds. Let’s take our LIS implementation example from earlier and apply the hybrid approach with the four key elements of project management.
Step one – Planning: Identify key stakeholders, develop a team, and define activities
Not all clinical laboratories have the resources to hire a project management professional or team to develop, implement, and oversee their projects. Marie Cole said she “first approaches any project by identifying the key stakeholders and developing a team.” Developing a team can be difficult for some laboratories with more technical staff than administrative help, so having a well-thought-out plan is critical. In our LIS example, our laboratory director first announces to all stakeholders (all laboratory staff) that the laboratory will transition to a new LIS in 12 months. After the initial announcement, the laboratory director also formed the project team and held face-to-face conversations with each of the laboratory section leaders to recruit their help in building their assigned laboratory section modules (activities). Now that all stakeholders have been identified, the project team has been created, and the project activities are defined, the project can now move forward to outlining time expectations.
Using our LIS implementation project example, the laboratory director and the newly developed team of laboratory section leaders decided to perform the laboratory section module builds in 90 days, with checkpoints at days 15, 30, 45,
Both Waterfall and Agile methods have seen success in different industries.
60, and 75. The team also decided that the next 90 days would be used to make necessary adjustments to their module builds, and the last 180 days would be dedicated to testing the system.
Now that the project schedule is finalized, the project can officially launch. Because we’re applying the hybrid method to this LIS implementation, each of the laboratory section modules is being built at the same time. Then, the project management team will continue testing the functionality and accuracy of each module build (Figure 1). However, remember that a characteristic of the Agile approach is that it offers more flexibility than the classic linear Waterfall method. So, our project management
team included time considerations to accommodate unexpected changes (Agile method), while staying within the allotted timeframe before moving on to the testing phase (Waterfall method).
“To keep project progress as per the plan, a project requires a certain level of control.”1 The checkpoints that were defined during the scheduling phase were included to give the project team an opportunity to assess their progress and identify additional needs. These checkpoints also provided a forum for team collaboration and project status and momentum updates. At the end of the project, we must determine its success. Were deadlines met? Did the project accomplish the goal that was set? Are stakeholders satisfied with the result? Each project will have unique circumstances that may require a more structured format, a more fluid approach, or a hybrid of the two. Either way, applying the four key elements of project management with the hybrid method can result in effective and efficient outcomes.
In conclusion, while project management methods are not routinely discussed in clinical laboratories, many laboratories will unintentionally employ one method, or a combination of methods. The Waterfall method involves a more rigid, time-driven approach, whereas the Agile method is more adaptive and allows for more flexibility. Speaking to various clinical laboratory leaders revealed that a hybrid of the two methods seems to be a common practice. Although the term “project management” may be an unfamiliar concept in the clinical laboratory, the opportunity to apply these techniques — Waterfall, Agile, or a hybrid of the two, can be a useful tool. Therefore, clinical laboratory leaders could benefit from exploring the use of these methods to organize and streamline future projects.
1. Bansal, V. Project Management: Planning and Scheduling Techniques. Routledge; 2023.
2. Bianchi MJ, Conforto EC, Rebentisch E, Amaral DC, Rezende SO, De Padua R. Recommendation of Project Management Practices: A Contribution to Hybrid Models. IEEE Transactions on Engineering Management. 2022;69(6):3538-3571.
3. Portny, J.L., Portny, S.E. Project Management for Dummies. John Wiley & Sons, Inc.; 2022.
4. Institute, P. The Guide to the Project Management Body of Knowledge (PMBOK® Guide): Seventh Edition. Project Management Institute; 2021.
5. Dionisio, C.S., Hybrid Project Management John Wiley & Sons, Inc.; 2023.
Nathalie Austin, MBA, MLS(ASCP) is currently a Clinical Assistant Professor at Texas State University’s Medical Laboratory Science program. Over the past 23 years, Nathalie has focused on quality management and held leadership positions in the clinical laboratory ranging from technical supervisor of a microbiology department to multi-site laboratory director.
Autumn Vela, MHA, MLS(ASCP) CM SHCM is a Clinical Assistant Professor at Texas State University, where she teaches courses in the Medical Laboratory Science program. She has a strong background in the clinical laboratory, having held various roles, including her last position as a multi-site manager overseeing three clinical hospital laboratories.
By Kara Nadeau
As U.S. medical laboratories adapt to evolving challenges, both ongoing (e.g., staffing issues and cost pressures) and emerging, respondents to the 2025 MLO State of the Industry (SOI) survey on lab management best practices remain steadfast in some priorities and practices while shifting focus in others.
This year, MLO gathered responses from 180 clinical laboratory professionals, with 43% of respondents in director, manager, administrator, or supervisor positions, and most employed by hospitals (59%). Although respondents spanned labs of different sizes and testing volumes, there was a notable increase in those in labs performing more than 2,000,000 tests annually (20% in 2025, up from 12% in 2024).
Alongside the quantitative survey results, MLO presents commentary from medical laboratory professionals and technology solutions providers.
• Costs and reimbursements: Standardized instrumentation workflows, checklists, lab processes, staff education, and IT solutions to reduce human error were cited as top best practices in ensuring reimbursement covers lab costs. Adoption of processes to review sav-
ings opportunities (e.g., regular analyzer evaluations) dropped in best practices rankings.
• Contracting : More labs are working with their supply chain management teams to identify group purchasing organization (GPO) contract savings opportunities, with a marked increase over last year. Fewer view relationship building with supplier support personnel and associated opportunities for training and product optimization suggestions as a best practice for streamlining contracting processes.
• Supply chain : More than one-third (32%) of survey respondents report they are not experiencing supply chain issues, which begs the question, “Are the remaining 68% still facing issues?”
• Staffing and labor : Financial incentives, continuing education offerings and partnerships with local colleges and tech schools were cited as key best practices for recruiting and retaining lab staff. Several professionals commented on international recruiting. Less prevalent this year was reported shift changes to offer employee scheduling flexibility.
• Technology priorities : Labs prioritize technology needed to cover broken/older equipment or improve
quality/reduce costs in their capital budgets. Fewer give precedence to technology needed to cover staff shortages with automated equipment this year compared with last.
• Laboratory-developed tests (LDTs): More than half of lab professionals surveyed do not have LTDs in their labs.
Among those with LDTs, nearly one-third were still evaluating how to comply with Stage 1 of the U.S. Food and Drug Administration’s (FDA) final rule.
Reimbursement, revenue, and contracting trends
To ensure reimbursement covers their costs, more than half of laboratory professionals surveyed have standardized instrumentation workflows and checklists (53%, down from 58% in 2024) or created standard lab processes and staff education materials (52%, down from 56% in 2024). Close to half have incorporated IT solutions to reduce human error (46%, down from 50% in 2024).
More than one-third have adopted the use of analyzers that provide walkaway testing to reduce staffing and full-time equivalent (FTE) (37%, down from 41% in 2024) and nearly one-third report incorporating IT solutions to help keep current with regulations (29%, down from 37% in 2024).
Close to one-quarter of respondents have adopted processes to review savings opportunities, such as evaluating analyzers on a regular schedule (23%, down from 36% in 2024), or implemented ongoing waste and efficiency studies to find potential savings in overhead (23%, down from 24% in 2024).
Others report having brought health screening tests in house (17%, down from 26% in 2024) or have implemented ongoing efforts to reduce coding frustrations and modifications (17%, down from 21% in 2024).
Additionally, 16% of lab professionals indicated they have implemented other steps to ensure reimbursement covers their costs. In their comments, some manually perform this work, including staff audits of service fees, reimbursement, reasonable cost and nursing billing for transfusions and point of care testing (POCT) performed.
Others noted how this work is done at a corporate level or by another department outside of the lab. One survey respondent wrote how their lab evaluates whether reimbursement pricing for participating insurance will cover costs before implementing new tests.
For those labs that cannot track whether reimbursement covers their costs, common stumbling blocks include:
• 34%: Not having software to automate tracking/analysis of costs (up from 27% in 2024)
• 29%: Lack of interoperability between laboratory information system (LIS) and revenue cycle management software (up from 24% in 2024)
• 26%: Not having enough lab staff time (down from 34% in 2024)
• 23%: Not having enough IT staff
time/resources (new answer option for this year)
• 4%: Not having enough barcoded testing supplies (down from 6% in 2024)
Juan Munoz, Director of Technical Solutions, Electronic Imaging Materials, commented on barcode trends and considerations, stating:
“Barcode labeling in the laboratory is indispensable and there are many factors to contemplate. The overall application and environmental conditions will have an impact on what type of label should be utilized (matte/gloss finish, adhesive type, etc.).”
Munoz went on to present the factors that influence barcode symbology and size, including the “amount of data, the printable real estate available, and the scanning technology being used.”
“If printing in-house, the size of the barcode and the symbology to be printed will determine what the printer’s resolution will need to be,” Munoz explained. “And as mentioned, the scanning technology must be compatible with the barcode symbology.”
An additional 15% of lab professionals surveyed cited other reasons for why they cannot track whether reimbursement covers their costs, including lack of expertise in report writing for near-real-time tracking, delays in being reimbursed to reconcile records, and the inability to easily differentiate which diagnostic-related group (DRG) costs should be assigned to the lab.
One respondent noted how management performs this tracking and does not share information with the team unless needed. Another wrote how their team looks at reimbursement coverage when they are offering a new test/method and/or an auditor alerts them to a potential major change in reimbursement.
When it comes to best practices in streamlining the contracting process, 64% have worked with supply chain management to identify supplies on group purchasing organization (GPO) contracts that offer additional savings (up from 55% in 2024).
Among write-in comments, one lab professional explained how their supply chain team is bringing in suppliers with less expensive products for the lab team to evaluate. Another wrote how they are working with supply chain on contract review and optimization to renegotiate existing contracts based on current spending.
Other best practices in the survey included the development of good relationships with supplier support personnel to secure access to training and product optimization suggestions (44%, down from 61% in 2024), and adoption of ongoing reviews of reference lab costs and contracts (41%, up from 39% in 2024).
Additionally, 21% of survey respondents indicated they have signed longer contracts (for example, 7 years instead of 1–3 years) up from 16% in 2024, while one lab professional in their write-in comments noted how their lab is securing shorter contact terms due to declining payments terms.
Given ongoing shortages of qualified medical laboratory personnel, MLO asked its readership what practices they have implemented and benefits they have offered to retain and recruit staff.
Topping the list were:
• 48%: Financial incentives, such as sign-on bonuses, merit allowances and retention bonuses (up from 42% in 2024)
• 46%: Continuing education offerings (down from 50% in 2024)
• 46%: Partnerships with local colleges and tech schools to offer internships in their labs (up from 38% in 2024)
Next in the top-ranking practices and benefits employed were:
• 36%: Daily huddles with peer recognition (unchanged from 2024)
• 33%: Clinical ladders/structures to encourage professional development, such as from novice to expert (down from 40% in 2024)
• 33%: Shift changes to offer employee scheduling flexibility (down from 44% in 2024)
Further down on the list were:
• 26%: Utilizing outside laboratory recruitment services/agencies (new answer option for this year)
• 22%: Succession-planning processes by offering additional responsibilities to top performers and measuring results (up from 19% in 2024)
• 17%: Perks, such as free parking, on-site gym, on-site day care, reimbursed public transportation costs (unchanged since 2024)
Among lab professionals indicating the application of other practices and benefits to retain and recruit staff (17%), several wrote they are recruiting and hiring internationally by leveraging H1B visa sponsorship. One survey respondent wrote how their lab offers an employee assistance program (EAP), while another offers employees health services, such as free flu and HBV vaccines.
“While automation has helped in the lab, it hasn’t eliminated the need for qualified talent,” said Liz Nesladek, Chief Commercial Officer (CCO), Conexus MedStaff.“Many labs find that talent planning with international staff can fill the talent gap. Some might argue that the visa process takes too long, but the reality is most cases don’t take any longer than hiring and retaining domestic staff.”
“As the immigration sponsor, Conexus takes the burden off our lab clients,
finding and hiring the right qualified MLS for their needs, and we continue to provide support for the duration of each international MLS’ three-year employment term, including immigration, training, and credentialing,” she added.
More than one-third (32%) of survey respondents report they are not experiencing supply chain issues. Compared with the 2024 survey results, more lab professionals are implementing standing orders (instead of just in time) for crucial supplies (49%, up from 37% in 2024).
There were slight dips in respondents who report working with state public health officials to gain access to needed testing supplies (12%, down from 16% in 2024), utilizing multiple testing platforms (27%, down from 30% in 2024), and switching from disposable to reusable types of personal protective equipment (16%, down from 20% in 2024).
There was no change year-overyear in lab professionals who report using LTDs to address supply chain issues (13%).
When asked what steps they have taken to improve inventory control and
0 1020304050
consumable supply costs, evaluation of inventory levels for basic supplies, such as assays and controls/reagents, topped the list (64%, down from 69% in 2024). The second highest percentage of responses was for the development of supply utilization tracking and record keeping (38%, down from 46% in 2024). This was followed by:
• 18%: Secured access to electronic inventory tracking from the supply chain/materials management department (down from 20% in 2024)
• 17%: Worked with other members of the organization, such as the Chief Medical Officer (CMO) and physicians, to standardize test ordering throughout the organization (down from 24% in 2024)
• 16%: Developed ongoing review comparing supply reports to the number of invoiced tests (down from 19% in 2024)
• 15%: Implemented vendor-managed ordering (up from 12% in 2024)
• 11%: Implemented lease agreements that do not include volume commitments (down from 14% in 2024)
• 9%: N/A this is handled by a different organization/location (down from 12% in 2024)
Since the FDA published its Final Rule on LDTs on April 29, 2024, medical laboratory professionals and other industry stakeholders have raised questions around the impact of the regulation. A month after readers responded to this survey, the U.S. District Court for the Eastern District of Texas granted AMP’s motion for summary judgment and vacated the FDA rule that would have regulated LDTs.
MLO had asked survey participants how they prepared for Stage 1 of the FDA’s final rule, which would have required a medical device report for device malfunction, failure, or inadequate design. Over half of respondents (53%) indicated they do not have LTDs in their labs.
For those with LTDs:
• 28% were still evaluating how to comply with Stage 1
• 13% developed procedures to guide staff for potential reporting events related to LDTs
• 13% have a documentation system in place for storage and retrieval of LDT records
• 8% developed procedures to handle complaints about an LDT
• 6% trained staff to submit the reports to the FDA Comments provided by respondents included:
• “We improve all testing for better results even though it may differ from the manufacturer’s instructions.”
• “We are developing a plan to comply but there remain many unanswered questions.”
• “[We have] incorporated [LTD compliance] into nonconformance and risk management.”
• “[We’ve had] LDTs for several years now, submitted for approval to regulatory agencies, and conduct and perform proficiency testing.”
• “We have identified our procedures and are in the process of implementation.”
When it comes to steps labs are taking to improve the quality and efficiency of their overall testing, half of those surveyed have staff or committee members review their standard operating procedures (SOP) for testing (50%, up from 48% in 2024), and nearly half
Figure 2: What best practices have you implemented to address supply-chain issues?
Worked with state public health of cials
Implemented standing orders
Utilized multiple testing platforms
Laboratory-developed tests
Switched to reusable types of personal protective equipment
Not currently experiencing supply chain issues Other
Note: Respondents selected all that applied.
have implemented standardized test ordering procedures and formularies (48%, down from 52% in 2024).
“Quality control is not just a requirement - it is the foundation of laboratory excellence,” said Dr. Stephen Pelsue, Manager of Discovery, Maine Molecular Quality Controls (MMQCI). He explained:
“In molecular diagnostic laboratories, quality controls ensure the accuracy and reliability of laboratory results necessary for high quality patient care. Best practices include validated reagents, routine instrument calibration, and standardized protocols and regular proficiency testing, internal and external controls, and contamination prevention to safeguard results. By integrating these measures, labs minimize errors, improve patient outcomes, and uphold trust in diagnostics.
“Troubleshooting and recovery after an out-of-control condition have always been difficult topics for labs to address,” said John C.Yundt-Pacheco, Senior, Principal Scientist/Scientific Fellow, Bio-Rad Laboratories Quality Systems. “This year, we anticipate emerging industry trends may help with these issues.”
Elaborating on these trends, he stated:
“I think we will see increased adoption of best practices such as estimating how many patient samples are likely to be outside quality specifications given
Percentage (%)
the magnitude of the error condition; identifying the point of failure; suggesting a recovery approach - either spot checking a critical list of samples or back-testing; guidance on how much back-testing is required; and which samples need correction.”
Following close behind are those who have evaluated temperature monitoring equipment and procedures (42%, up from 39% in 2024). Further down on the list, 20% have implemented a pre-approval program for send-out tests (up from 14% in 2024), and 19% have implemented evidence-based test utilization backed by data (down from 28% in 2024).
Ray Almgren, CEO, Swift Sensors, commented on trends in temperature monitoring, stating:
“Historically, temperature monitoring was accomplished by lab techs physically reading thermometers throughout the lab and recording temperatures in a written log on a schedule. Over the years, wired sensors tied to internal networks automated some of the manual tasks and provided some data management capabilities.”
“Modern temperature compliance solutions combine wireless temperature sensor technology, advanced networking protocols, AI and cloud-based software platforms to improve usability, convenience, accuracy and
Figure 3: If your laboratory has laboratory-developed tests (LDTs), how have you prepared for Stage 1 of the FDA’s nal rule, which will require a medical device report for device malfunction, failure, or inadequate design?
Developed procedures to guide staff for potential reporting events related to LDTs.
Developed procedures to handle complaints about an LDT.
Documentation system in place for storage and retrieval of LDT records.
Trained staff to submit the reports to the FDA.
Evaluating how to comply with Stage 1.
Other
Note: Respondents selected all that applied.
* This survey was taken before the FDA's rule was vacated.
reliability,” he added. “It’s the right time to upgrade due to these technology advancements.”
Technology trends
Turning to best practices lab professionals have implemented for adopting new tools for laboratory automation:
• 44% have analyzed workflow processes for proper space planning (up from 43% in 2024)
• 40% have involved their IT department early in the process (up from 37% in 2024)
• 36% have ensured system integration for seamless process and data flows (up from 33% in 2024)
• 21% have designated a project manager to coordinate short- and long-term planning and implementation with the vendor (unchanged since 2024)
Ed Nesbitt, Vice President of Service, CompuGroup Medical, commented on how laboratory information system (LIS) interoperability has “significantly evolved since the early days of lab management,” stating:
“In the past, a laboratory may have relied on a single, standing Health Level 7 (HL7) interface to facilitate communication with other healthcare systems. Today, laboratories navigate a complex web of interoperability demands including
multiple data exchanges with various electronic health records, billing systems, and public health agencies.”
“A successful implementation requires expert planning,” he continued. “Each implementation should be tailored to meet unique customer
Quality control is not just a requirement — it is the foundation of
lab excellence.
needs and specific vendor requirements. The goal is to create an optimal, patient-centered outcome with a foundation around data accessibility and accuracy.”
Among best practices labs have developed to train staff on new software:
• 55% have created standard workflows for all lab employees (up from 52% in 2024)
• 48% have created a train-the-trainer model (down from 54% in 2024)
• 37% have employed vendor-hosted in-house or online training (up from 30% in 2024)
• 32% have had a lab person receive LIS training to develop an in-house expert (unchanged since 2024)
• 24% have developed mandatory training for new lab employees that is led by the IT department (unchanged since 2024)
• 19% have developed lunch-andlearn training sessions (down from 22% in 2024)
Among lab professionals providing write in comments, one noted how basic training is given by fellow lab employees and another wrote how their lab has created detailed SOPs for lab techs to follow, along with practice cases to learn new workflows.
When asked how their labs prioritize technology needs for their capital budgets, 59% prioritize technology needed to cover broken/older equipment (down from 60% in 2024) and 57% prioritize technology needed to improve quality/reduce costs (down from 62% in 2024).
Slightly more respondents report prioritizing technology needed to remain competitive (38%, up from 35% in 2024), while there was a drop in those prioritizing technology needed to cover staff shortages with automated equipment (29%, down from 40% in 2024).
Other priorities cited include:
• Technology to standardize processes
• Technology to better reimbursement and reduced costs
• Technology needed to improve quality of patient care
• Cost-per-test contracts and duplicate analyzers to provide state-ofthe-art testing capabilities
The findings from the 2025 MLO State of the Industry survey on lab management best practices highlight both persistent and shifting priorities among medical laboratories as they navigate financial constraints, staffing shortages, and regulatory changes.
As the industry moves forward, laboratories will need to remain agile in their approach to workforce management, financial sustainability, and compliance with evolving regulations.
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.
By Tamar Tchelidze, MD, MPH; Karissa Culbreath, PhD; Ronak Shah, MD
Sexually transmitted infections (STIs) are a significant and growing public health challenge worldwide. Despite continued efforts to raise awareness and improve prevention, STI rates are on the rise, with young adults, adolescents, and underserved communities being disproportionately affected.1 Traditional diagnostic methods, which rely on centralized laboratory testing, are often slow, costly, and inaccessible, contributing to delayed treatment, rising healthcare costs, and missed opportunities for early intervention. Antimicrobial resistance (AMR) in STIs, particularly in Neisseria gonorrhoeae (NG), is compounding this challenge. NG is increasingly resistant to first-line antibiotics, making timely and precise diagnosis more crucial than ever. 2 In this article, we explore how molecular point-of-care (mPOC) testing can increase accessibility and improve treatment outcomes by offering a faster and more affordable approach to STI care. Insights from Dr. Shah and Dr. Culbreath, both leading experts in infectious disease management, underscore the potential of mPOC to transform STI care.
The current state of STI testing: A time-consuming process
Conventional STI testing often involves sending patient samples to centralized laboratories, which can be located far from the care setting. This process typically results in a waiting period of up to four days. Such delays can be problematic in terms of both diagnosis and treatment. Dr. Shah explained, “The current system of sending samples off to a lab creates significant challenges for clinicians. The waiting period not only makes follow-up difficult but also increases the chances of patients being lost to follow-up. Additionally, patients may be started on broad-spectrum antibiotics before receiving definitive results, which can contribute to over-treatment.”
Over-treatment is a significant concern in STI management.3 This occurs when antibiotics are prescribed before a confirmed diagnosis, leading to the risk of unnecessary prescriptions. Overuse of antibiotics contributes to antibiotic resistance, a growing global health threat. NG, in particular, has exhibited increasing resistance to multiple classes of antibiotics, including cephalosporins, macrolides, and fluoroquinolones, making treatment more difficult and reinforcing the need for accurate, timely diagnostics. However, if providers don’t treat while the patient is in the office, there is a risk of untreated STIs, which can have serious health consequences, including infertility, chronic pain, and increased risk of HIV transmission.4 These risks and complications could be mitigated with faster, more accurate diagnostic methods.
mPOC testing provides a much-needed solution for certain populations who require immediate results instead of the delayed outcomes associated with traditional lab-based diagnostics. Unlike conventional tests that require samples to
be sent off for analysis, mPOC technology allows clinicians to perform tests directly in the clinic, delivering real-time results within a single healthcare visit. This approach significantly reduces the waiting period and enables immediate action.5
Dr. Culbreath pointed out,“The primary advantage of mPOC testing is speed. With these tests, clinicians get immediate feedback, allowing them to begin treatment right away. This reduces the chance of a patient being lost to follow-up and prevents further transmission of infections.”
For healthcare providers, the speed of mPOC testing also contributes to more precise treatment decisions. By eliminating the uncertainty and wait time of lab-based diagnostics, clinicians can more confidently prescribe the appropriate treatments, reducing the likelihood of over-prescribing antibiotics. Moreover, mPOC testing aids in antibiotic stewardship by potentially reducing antibiotic overuse for the treatment of STIs. By offering real-time diagnostic results, mPOC testing ensures that antibiotics are only prescribed when truly necessary, thereby contributing to better stewardship of these critical resources.
One of the key advantages of mPOC testing is its ability to bring diagnostics directly to communities with limited healthcare access, especially in rural or underserved urban areas. mPOC can be deployed in places like schools, mobile health units, and pop-up clinics, making testing accessible to populations that might otherwise face delays. Dr. Shah explains, “Instead of patients having to travel to a lab, mPOC allows healthcare
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providers to bring the diagnostic process to them, which is especially valuable for remote communities or those facing barriers to regular healthcare.”
Dr. Culbreath adds, “We’re creating new access points because current ones are stretched beyond capacity. Placing tests in existing health systems, like at PCPs and mobile clinics, will relieve
Looking to the future, mPOC testing is set to become a cornerstone of STI management.
stress on resources and meet community needs.” Community-based testing, successful in areas like respiratory virus testing, could be adapted for STIs, improving access to diagnoses, treatment, and reducing stigma.
Operational efficiencies and cost savings through decentralized STI testing
In addition to a high burden of STIs for individuals with limited access to regular healthcare services, the cost of accessing care is an additional barrier for broadening STI diagnosis and treatment. Dr. Shah noted that “Cost is probably the biggest barrier for a lot of individuals in coming back to an urgent care setting or hospital-based setting for re-testing.” He goes on to explain that sending samples from an urgent care clinic to a hospital or reference lab for centralized molecular testing can result in very expensive patient bills, especially for individuals with increasingly common high-deductible health insurance plans or those who are uninsured. He continues that these costs for the individual “might disincentivize patients to even seek further care.”
Alternatively, if mPOC solutions were available in these decentralized settings, such as local clinics, urgent care centers, or mobile units, there may be an opportunity to reduce the potential downstream costs to the patients, provide immediate care, and reduce loss to follow-up.
While mPOC testing is cost-effective in many settings, it may not always be the most appropriate choice for every situation. In some cases, traditional lab tests may still be necessary for their accuracy or comprehensive panels. Nonetheless, for many patients, mPOC testing represents an affordable, efficient solution.
While mPOC testing holds great potential, several barriers exist to its widespread adoption, particularly the need for proper training. Healthcare workers must be skilled in specimen collection, handling, and test interpretation. Dr. Shah stresses, “Training is essential. Healthcare workers must be familiar with the proper use of mPOC tests, the importance of maintaining a clean testing environment, and accurate interpretation of results. This ensures the tests deliver reliable outcomes and that patients receive the best possible care.”
Additionally, clear clinical guidelines must be established to ensure consistency in the use of mPOC testing across various healthcare settings.4,6 As mPOC tests become more widespread, it is important to standardize protocols to ensure their correct application.
Extragenital testing for sources, including the throat or rectum, is another critical issue. Dr. Culbreath notes, “Without extragenital testing, we risk missing a significant portion of infections, especially in high-risk populations. Ensuring these tests are available is vital to capturing the full scope of STI transmission.” She adds, “Extragenital sampling is crucial, as up to 50% of infections can be found in these areas.”
The process of adopting new technologies can be complex for hospital administrators. While the clinical value of these tests is clear, the evaluation and consideration of new technologies often involve a careful balance between clinical benefits and financial implications. Dr. Shah shares,“There are times when physicians advocate for specific tests, but administrators may be slow to adopt them due to financial constraints. However, as we move forward, mPOC testing is proving to be a cost-effective investment.”
The rising demand for easier-to-use, rapid turn-around time testing means that healthcare systems are increasingly interested in adopting mPOC tests. This is particularly true in urgent care centers, where clinicians need rapid, accurate results for a wide range of conditions.
The future of molecular point-ofcare testing in STI management
Looking to the future, mPOC testing is set to become a cornerstone of STI management. As technology improves,
the cost of these tests will continue to decrease, making them even more accessible. This will expand opportunities for early detection and intervention, helping to reduce the incidence of STIs and associated complications. Dr. Culbreath concludes, “The future of STI care will be shaped by rapid, point-of-care diagnostics. With the continued development of mPOC technology, we can look forward to a world where testing and treatment are faster, more efficient, and more widely accessible, leading to better public health outcomes.”
Conclusion: A new era in STI testing mPOC testing is transforming the landscape of STI diagnosis and treatment. By providing fast, accurate results at the point of care, mPOC tests can improve patient outcomes, enhance access to care, and reduce the overall burden on the healthcare system. As we move forward, the integration of mPOC testing into routine STI care holds the promise of a more effective, equitable approach to tackling the silent epidemic of STIs.
With proper training, guidelines, and implementation strategies, mPOC testing can become a powerful tool in the fight against STIs, ultimately leading to healthier communities and better healthcare outcomes for all.
Tamar Tchelidze, MD, MPH and DrPH Candidate (GWU) is a Disease Area Partner for Infectious Disease in Medical and Scientific Affairs at Roche Diagnostics Corporation . She has a wealth of experience in global health management, with expertise in academic, private, and government environments.
Karissa Culbreath, PhD is the Medical Director of Infectious Diseases at TriCore Reference Laboratories.
Ronak Shah, MD is the Associate Medical Director at Mass General Brigham Urgent Care.
References are available online at https://mlo-online.com/55278303
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What is newborn screening (NBS)?
Newborn screening (NBS) is a crucial public health program that tests infants shortly after birth for rare but serious genetic and metabolic disorders. Analyzing a dried blood spot (DBS) sample collected by a heel prick for various biomarkers allows for the detection of conditions like phenylketonuria (PKU), maple syrup urine disease, spinal muscular atrophy (SMA), and other inborn errors of metabolism before symptoms appear. Early detection is vital, as it allows for prompt intervention, potentially preventing severe developmental delays, health complications, or even death.
Why is NBS so important for public health?
Firstly, it allows for early detection and treatment of serious conditions that may not be immediately apparent at birth, enabling timely treatment and significantly improving outcomes for affected infants. By identifying these conditions before symptoms appear, healthcare providers can initiate treatment when it’s most effective.
By Christina Wichmann
Secondly, early detection and treatment often result in better health outcomes and reduced healthcare costs over the child’s lifetime. As a result, NBS is a cost-effective way to improve population health. In the United States, it is estimated to save about 1 billion dollars annually.1 While the conditions screened for are rare individually, collectively they affect a significant number of newborns. It is estimated that over 40,000 lives are saved every year thanks to NBS.
Lastly, NBS programs provide valuable data for research and public health planning, helping to improve our understanding of these conditions and refine screening and treatment protocols over time.
What are the global differences in NBS?
Global differences in NBS are significant and reflect a complex interplay of economic, cultural, and healthcare system factors. Alarmingly, only 1 in 3 children worldwide receive any form of newborn screening, highlighting a major global health disparity.
Developed countries typically have more comprehensive NBS programs, but the number of conditions screened for can vary significantly. For instance, the United States recommends screening for 35 core conditions and consideration of 26 secondary conditions, with many states screening for far more, while the United Kingdom screens for only 9 disorders.
These differences reflect varying approaches to healthcare delivery, resource allocation, and risk assessment. For example, some countries may prioritize conditions that are more prevalent in their population or those for which they have established treatment protocols, while others focus on the ethical implications and overall impact on the healthcare system. Additionally, cultural attitudes towards genetic testing and data privacy also play a role in shaping these policies.
Moreover, the infrastructure required for follow-up care and treatment of identified conditions is a crucial consideration. A country might choose not to screen for a condition if it lacks the resources to provide appropriate care for affected infants.
Therefore, while the number of conditions screened can be an indicator of a program’s comprehensiveness, it’s essential to consider the broader context of each country’s healthcare system, population needs, and ethical frameworks when evaluating NBS programs.
What makes a successful NBS screening program?
A successful NBS program is characterized by several key factors, with speed, security, connectiveness, and the ability to expand being crucial elements.
• Speed: Receiving rapid results is critical in NBS programs. Programs must have efficient sample collection, transportation to the laboratory, analysis, and reporting. Ideally, results should be available within 5–7 days of birth. This speed allows for early intervention in affected infants, which can be lifesaving in many cases.
• Security: Given the sensitive nature of genetic information, robust data security measures are essential. This includes secure handling of physical samples, encrypted data transmission, and strict access controls for patient information. Programs must comply with relevant data protection regulations and maintain patient confidentiality.
• Connectiveness: A well-connected system ensures seamless communication between various stakeholders — hospitals, laboratories, primary care providers, and specialists. Integrated health information systems can facilitate rapid result reporting and initiation of follow-up care. This connectedness
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also supports tracking of long-term outcomes, which is crucial for program evaluation and improvement.
• Ability to expand: Flexibility to incorporate new screenings as scientific knowledge advances is vital. This includes the capacity to adapt to new technologies, such as genomic sequencing, and the ability to add new conditions to the screening panel. A scalable infrastructure that can accommodate increased testing volume and complexity is key to a program’s long-term success.
The field of NBS has seen significant advancements in recent years, particularly in testing methodologies and the range of detectable conditions. Two notable advances are:
• Mass Spectrometry for expanded screening panels such as lysosomal storage disorders and amino acid disorders: Tandem mass spectrometry (MS/MS) has revolutionized NBS for many previously un-detectable disorders. This technology allows for the simultaneous detection of multiple disorders from a single dried blood spot sample. MS/MS can measure enzyme activities or specific biomarkers such as Pompe disease, Fabry disease, and Gaucher disease. The high sensitivity and specificity of MS/MS have made it possible to include these rare but serious conditions in NBS panels, enabling early detection and treatment.
• Molecular testing for spinal muscular atrophy (SMA): The introduction of molecular testing for SMA in NBS programs allows for the detection of deletions or mutations in the SMN1 gene, which is responsible for SMA. Early detection of SMA is crucial because new treatments, such as gene therapy, are most effective when administered before symptoms appear.
The future of NBS is poised for significant advancements, with newborn genetic sequencing emerging as a potentially transformative technology. Newborn sequencing can be approached either by sequencing the entire genome or exome,
or through a specified panel of genetic conditions. Despite their abilities to detect a much broader range of genetic conditions than current screening methods, sequencing has yet to replace the simpler biochemical approaches.
Other future changes include expanding the number and types of diseases that are being screened for; integrating the genetic information gathered at birth to inform personalized health strategies throughout an individual’s life; improving the accuracy of testing; and working toward standardizing NBS practices globally to ensure that more children have access to comprehensive screening regardless of where they are born. All of these potential advancements need to be carefully considered as to their ethical and safety implications, including data privacy, informed consent, and the right not to know certain genetic information.
NBS is an integral part of a broader continuum of reproductive health care that spans from preconception through pregnancy and into early childhood. Information learned from NBS could show increased risks for having a child with certain genetic conditions. This information could then inform decisions regarding carrier screening, prenatal testing, and/ or the desire to have additional children for the couple and their extended family. Additionally, NBS serves as a crucial bridge between prenatal care and pediatric care. It complements prenatal testing by detecting conditions that may not be identifiable prenatally or by identifying conditions that develop or become detectable only after birth, in order to allows for early interventions and ongoing pediatric care.
NBS ensures that health risks are monitored and addressed at multiple stages, while the early identification of issues allow for parents to make more informed choices about their child’s healthcare.
1. Aap.org. Accessed March 18, 2025. https://publications. aap.org/pediatrics/article-abstract/125/2/e324/72968/ Cost-effectiveness-of-Expanding-the-National.
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