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Anna Maria Niewiadomska
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55th anniversary celebration
By Christina Wichmann
Editor in Chief
As you know, MLO is celebrating its 55th anniversary this year. As the first magazine created for laboratorians, we are very proud of our history. This issue is the big celebratory issue we wanted to put together for you this month.
Our annual salary survey is featured on page 24. Two hundred twenty lab professionals took part in the survey, and forty-six percent of the respondents have more than thirty years of experience in the laboratory industry. However, with so many seasoned laboratory professionals reaching retirement age in the next ten or so years, there could be even more pressure on a field facing current staffing shortages. Much discussion is occurring on this present and future problem.
Casey Schroeder, PhD, MLS(ASCP), MB, SM, SLS provided us an article for the online-exclusive section of the MLO website (https://www.mlo-online.com/ online-exclusives) titled,“How U.S. Army microbiologists and medical laboratory technicians contribute to civilian laboratories: Insights for hiring managers.” Dr. Schroeder is the Director of Microbiology at the Texas Department of State Health Services Public Health Laboratory. He also has served 11 years in the Army National Guard and the Army Reserves in Microbiology and Health Services Administration. I think he provides an “outside the box” perspective on an important issue.
On page 48, we are featuring “55 under 55” honorees as a way to celebrate our anniversary and readers. We received so many nominations for very talented, committed lab professionals. Some characteristics of the honorees are as follows:
• Collaborative leader who likes to discuss challenges and then problem solve with others.
• Looks for ways to optimize workflows and lessen burden on staff.
• Active participation in professional associations and conferences in order to stay informed about the latest trends and best practices.
• An MLT who has been in the laboratory for 35 years in chemistry, phlebotomy, and hematology.
• Abstract and poster selected as an American Society for Clinical Pathology (ASCP) blue ribbon top five finalist.
• Many medical laboratories prospered because of her attention to both sides of the business that causes many others to look the other way. Under her leadership, 100% of laboratories passed their regulatory surveys, even those hovering at condition-level deficiencies.
• Orchestrated pivotal advancements, notably transitioning the laboratory’s certification from a CLIA Certificate of Waiver to a Certificate of Compliance.
• Dedication to serving an underserved community in Texas, enhancing healthcare outcomes, and fostering educational and professional growth in medical laboratory science through partnerships with local schools and serving as a hub for professional development.
• Her commitment to quality is at the forefront of the services we deliver. As one of the leading laboratories in our region, our pursuit of quality and continuous improvement ensures other laboratories must meaningfully invest in quality initiatives to stay competitive.
• Has played a pivotal role in enhancing our laboratory procedures, notably through his adeptness in maintaining and troubleshooting sophisticated laboratory instruments.
These are just a few examples. But you probably know better than me how many wonderful lab professionals there are in the country!
I welcome your comments and questions — please send them to me at cwichmann@mlo-online.com.
PUBLISHER Chris Driscoll cdriscoll@endeavorb2b.com
EDITOR IN CHIEF Christina Wichmann cwichmann@mlo-online.com
MANAGING EDITOR Erin Brady ebrady@endeavorb2b.com
PRODUCTION MANAGER Edward Bartlett
ART DIRECTOR Kermit Mulkins
AUDIENCE DEVELOPMENT/LIST RENTALS
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DIRECTOR OF SALES EAST COAST/MIDWEST SALES, CLASSIFIEDS Carol Vovcsko (941) 321-2873 | cvovcsko@mlo-online.com
SOUTH/WEST COAST/ILLINOIS SALES Lora Harrell (941) 328-3707 | lharrell@mlo-online.com
MLO EDITORIAL ADVISORY BOARD
John Brunstein, PhD, Biochemistry (Molecular Virology) President & CSO PathoID, Inc., British Columbia, Canada
Lisa-Jean Clifford, COO & Chief Strategy Officer Gestalt, Spokane, WA
Barbara Strain, MA, SM(ASCP), CVAHP Principal, Barbara Strain Consulting LLC, Formerly Director, Value Management, University of Virginia Health System, Charlottesville, VA
Jeffrey D. Klausner, MD, MPH Professor of Preventive Medicine in the Division of Disease Prevention, Policy and Global Health, Department of Preventive Medicine at University of Southern California Keck School of Medicine. Donna Beasley, DLM(ASCP), Director Huron Healthcare, Chicago, IL
Anthony Kurec, MS, H(ASCP)DLM, Clinical Associate Professor, Emeritus , SUNY Upstate Medical University, Syracuse, NY
Suzanne Butch, MLS(ASCP)CM, SBBCM, DLMCM Freelance Consultant, Avon, OH
Paul R. Eden, Jr., MT(ASCP), PhD, Lt. Col., USAF (ret.) (formerly) Chief, Laboratory Services, 88th Diagnostics/Therapeutics Squadron, Wright-Patterson AFB, OH
Daniel J. Scungio, MT (ASCP), SLS, CQA (ASQ), Consultant at Dan the Lab Safety Man and Safety Officer at Sentara Healthcare, Norfolk, VA
CORPORATE TEAM
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EVP CITY SERVICES & HEALTHCARE Kylie Hirko 30 Burton Hills Blvd., Suite 185 Nashville, TN 37215 800-547-7377 | www.mlo-online.com
Medical Laboratory Observer USPS Permit 60930, ISSN 0580-7247 print, ISSN 2771-6759 online is published 10 times annually (Jan, Feb, Mar, Apr, May, Jul, Aug, Aug CLR, Sep, Nov) by Endeavor Business Media, LLC. 201 N Main St 5th Floor, Fort Atkinson, WI 53538. Periodicals postage paid at Fort Atkinson, WI, and additional mailing offices. POSTMASTER: Send address changes to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. SUBSCRIPTIONS: Publisher reserves the right to reject non-qualified subscriptions. Subscription prices: U.S. $160.00 per year; Canada/Mexico $193.75 per year; All other countries $276.25 per year. All subscriptions are payable in U.S. funds. Send subscription inquiries to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. Customer service can be reached toll-free at 877-382-9187 or at MLO@ omeda.com for magazine subscription assistance or questions. Printed in the USA. Copyright 2024 Endeavor Business Media, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopies, recordings, or any information storage
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Rapid sequencing workflows deliver comprehensive respiratory pathogens results, faster
By Anna Maria Niewiadomska
Respiratory pathogen testing is always a challenge, from the notoriously unpredictable demand to a rapidly evolving reimbursement model surrounding a broad range of testing options. Each year, clinical laboratories must make their best guesses about testing needs for the upcoming flu and cold season and decide how much of each test to stock.
To complicate matters further, pathogen testing is also an urgent challenge, as results must be reported very quickly.
Earning CEUs
For generally healthy patients, rapid results provide valuable information that can help them take reasonable precautions to avoid transmitting the microbe to others while doing what’s appropriate for their own recovery. For critically ill patients in the hospital, rapid results have an even bigger impact. Some of these patients may be given broad-spectrum antibiotics as a preventive measure, and getting a clinical lab report of a positive viral pathogen test allows physicians to stop the
See test online at https://ce.mlo-online.com/courses/ rapid-sequencing-workflows-deliver-comprehensiverespiratory-pathogens-results-faster/ Passing scores of 70 percent or higher are eligible for 1 contact hour of P.A.C.E. credit.
LEARNING OBJECTIVES
Upon completion of this article, the reader will be able to:
1. List the challenges identified in seasonal respiratory pathogen testing.
2. List the major advantages and disadvantages to molecular-based respiratory pathogen testing.
3. Discuss findings and outcomes in nanopore-based molecular testing.
4. Discuss findings and outcomes in metagenomic workflow techniques.
unnecessary treatment sooner — ideally before the patient’s natural microbiota have had a chance to develop resistance to the therapy. Without rapid results, patients might be treated with inappropriate antibiotics for days, increasing the risk of contributing to the growing crisis of antimicrobial resistance. Many clinical labs have adopted molecular viral tests. These are generally part of targeted panels (typically covering influenza A/B, SARS-CoV-2 and respiratory syncytial virus) or of much broader syndromic panels that cover all common respiratory infection culprits. Molecular tests have the great advantage of speed, often delivering results in a matter of hours. But they can only look for known targets, making it harder to find rare or unexpected pathogens. With targeted panels, it is also more difficult to spot cases of co-infections.
Advanced DNA sequencing technologies may overcome these challenges. While some platforms require workflows that can take multiple days, others have been demonstrated in rapid workflows that can return results within a single day. A sequencing-based approach also allows for an unbiased view, enabling discovery of co-infections and
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unexpected or unculturable pathogens. In some cases, sequencing data can be used to evaluate genotypic markers of antimicrobial resistance, making it a useful technique for ensuring appropriate treatment for patients. The following sections take a deeper dive into these latest developments in sequencing-based pathogen testing.
Rapid results
Respiratory pathogen results offer the most value in supporting needed interventions, from isolation protocols to treatment selection, when they are delivered quickly — ideally within a single day. Clinical teams have reported success with this tight time frame using a nanopore sequencing-based approach.
At Guy’s & St. Thomas’ NHS Foundation Trust in London, researchers developed a whole-genome analysis pipeline for influenza A virus that allowed them to report results with a 24-hour turnaround time.1 In one study, they analyzed 128 nasopharyngeal samples known to be positive for influenza A. The samples had been collected from patients who were admitted to the hospital or who visited the emergency department during the winter of 2022–2023. In 75% of samples, all segments of the flu genome were accurately captured through the sequencing workflow, and the clinically important hemagglutinin gene was fully recovered in more than 90% of samples.
While a major goal of the study was achieved in establishing the feasibility of a 24-hour turnaround time for whole genome sequencing of influenza, the data generated also made it possible to track clusters of infections by phylogeny. Among 19 patients previously reported to have hospital-acquired infections, results showed two separate infection clusters in a single hospital ward and refuted the idea that transmission had occurred across wards. The identification of nosocomial transmission events can lead to the implementation of pharmaceutical and non-pharmaceutical interventions to prevent further spread of infections.
In Bangladesh, scientists at the International Centre for Diarrhoeal Disease Research developed a culture-free, amplicon sequencing workflow to perform whole genome sequencing of influenza A and report all flu subtypes from a clinical sample.2 In 19 samples studied, the workflow led to 100% coverage of all genome segments and took only 24 hours to complete. The
team noted that this method, based on a portable sequencing platform, is “ideal for resource-limited clinical settings, aiding in real-time surveillance, outbreak investigation, and the detection of emerging viruses and genetic reassortment events.” Accessible and affordable sequencing platforms also help increase the number of genomic sequences from low- and middle-income countries, which can bias vaccine strain selection as they are often underrepresented in genomic sequence databases.
Subsequent studies have demonstrated that nanopore sequencing technology can be used to report results even faster. Members of the same team at Guy’s & St. Thomas’ NHS Foundation Trust deployed a metagenomic workflow that enabled same-day reporting of results for nearly all samples tested, with the median turnaround time clocking in at 6.7.3
Of course, getting results quickly is not helpful if they aren’t accurate. Based on a broad number of clinical research studies, a team of reviewers noted that nanopore-based sequencing methods “have been shown to be as accurate as PCR-based methods with regard to common viral [respiratory tract infections], with the crucial advantage of generating real-time data whilst also being more portable and requiring less laboratory infrastructure.”4
Metagenomic sequencing
The metagenomic study mentioned above was designed to enable broad pathogen detection, rather than a singular focus on influenza. The idea was to use a metagenomic technique — the same concept used for assessing communities of microbes living in soil or on plants — to identify all microbes found in a clinical sample. With appropriate filtering based on population thresholds, scientists reasoned that it should be possible to quickly eliminate harmless members of the patient’s natural microbiome and home in on the pathogen or pathogens responsible for the respiratory infection.
In a pilot study, researchers analyzed 128 samples collected from 87 patients who were believed to have lower respiratory tract infections.3 All samples were evaluated with the sequencing-based respiratory metagenomic workflow. Compared to routine testing, the technique was found to have sensitivity of 93% and specificity of 81% for detecting clinically relevant pathogens. With same-day reporting of results for almost
all samples, the study had a significant impact on patient care. In nearly half of cases, the metagenomic results led to changes in treatment selection, with 26% de-escalated and 22% of cases being escalated; the latter was based on species identification or detection of genes indicating acquired resistance to certain treatments. Interestingly, the workflow enabled discovery of unexpected or fastidious organisms in 21 samples. These included a dozen anaerobes as well as Mycobacterium tuberculosis, cytomegalovirus, Tropheryma whipplei, and Legionella pneumophila, among others.
Building on this pilot project, the UK government recently allocated £3 million to expand access to the respiratory metagenomic approach in intensive care units across many British hospitals.5
Antimicrobial resistance testing
Genomic analysis of microbes — whether through whole genome sequencing or metagenomic workflows — also enables the detection of genetic mechanisms associated with resistance to certain classes of therapy.
In one example, researchers associated with the Oxford University Hospitals National Health Service (NHS) Foundation Trust used metagenomic analysis to investigate 180 respiratory samples collected during respiratory illness season, comparing a novel sequencing-based workflow to standard molecular diagnostic tools.6 In all H1N1 and H3N2 subtypes analyzed, the team found a known mutation in the M2 protein that confers some level of resistance to the antiviral amantadine therapy. One H3N2 genome encoded a worrisome mutation associated with resistance to oseltamivir, also known as Tamiflu.
The same approach has been validated for respiratory pathogens beyond influenza. In a study of lower respiratory tract infections caused by bacteria, researchers at the University of California, San Francisco, turned to sequencing-based metagenomics to detect pathogens and identify genes associated with antimicrobial resistance.7 As part of the study, they evaluated the combination of Cas9 enrichment with nanopore sequencing in samples from 10 patients suffering from acute respiratory failure. Compared to standard short-read sequencing workflows, the Cas9-plus-nanopore method made it possible to enrich for antimicrobial resistance genes by more than 2,500-fold using a technique known as FLASH (short for finding low abundance sequences by hybridization).
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These target genes “could be identified within 10 [minutes] of real-time nanopore sequencing, suggesting a potential turnaround time of less than 6 [hours] for a single sample,” the team reported. That’s substantially less time than clinical antibiotic susceptibility testing, which takes more than 72 hours, and also less than standard short-read sequencing workflows, which take at least 24 hours, according to the researchers.
Surveillance and epidemiology
Going beyond individual patient results, sequencing-based analysis can also support broader public health goals such as population-scale influenza surveillance. Clinical research teams have already demonstrated the effectiveness of this approach.
At the National Institute of Health in Pakistan, scientists carried out a national flu surveillance program.8 They used nanopore-based sequencing to study influenza A viruses circulating in the population from January 2020 to January 2023. Based on the whole genome sequences they generated for 126 virus isolates, they identified several amino acid changes in the hemagglutinin genes and in other gene segments of an H1N1 subtype and an H3N2 subtype circulating at this time. This validation study allowed them to prepare for real-time monitoring of flu viruses to support epidemiological analysis and public health responses.
Researchers across the UK used a similar approach to conduct flu surveillance in the winter of 2022-2023; this included targeted surveillance at a hospital in Oxfordshire as well as a UK-wide household study.9 For the hospital arm of the study, the team sequenced 292 residual materials left over after molecular diagnostics had been performed on nasal or throat swab samples, with positive results for influenza A. The hemagglutinin segment was fully sequenced in 69% of samples, and that data was used as the foundation for phylogenetic comparisons. Researchers focused particularly on 88 samples flagged as infections that may have been acquired within the hospital, analyzing ward-based clusters and other potential transmission occurrences.
For the broader UK study, the scientists analyzed 130 samples that had previously tested positive for influenza A (a subset of nearly 15,000 swabs randomly selected from participants in the national household study). The flu-positive samples came from people in England, Scotland, Northern Ireland, and Wales. They were analyzed by PCR, and for 113 samples with enough material, also with sequencing. Again, they ran phylogenetic analysis to track potential chains of transmission. As expected, the circulating flu strains were very similar at the genomic level, both within the hospital and across the UK.
“While we show good concordance between circulating and vaccine strains for A/H3N2, A/H1N1, and B/Victoria and a low frequency of anti-viral resistance, our approach could also be used to provide surveillance in future seasons where this might not be the case,” the UK team reported in a paper describing the study.9
Surveillance efforts could be even more useful when expanded to other sample types, as demonstrated in an air sampling study from scientists in Wisconsin and Minnesota. They deployed a metagenomic approach with nanopore-based sequencing for air samples collected in community settings between July 2021 and December 2022.10 This supported the goal of routine pathogen monitoring, allowing the team to detect human respiratory viruses including influenza A
and C, SARS-CoV-2, rhinovirus, and more. The approach is based on sequence-independent single-primer amplification designed to capture common and rare RNA viruses. Of the 22 samples analyzed, 19 were positive for human viruses. This unbiased method allows for non-invasive community surveillance, enhancing our ability to monitor and respond to public health threats.
Effective, comprehensive flu testing
As these studies illustrate, the use of a rapid, long-read sequencing platform can help clinical laboratory teams achieve their flu testing goals. This approach can deliver whole genome or metagenomic sequencing data in less than a day, enabling same-day reporting of results to guide clinical interventions. Genetic resistance mechanisms can also be reported, further honing treatment selection and helping to avoid the inappropriate use of antimicrobial therapies. At the institutional or population level, sequencing-based flu testing supports influenza surveillance programs as well, and at a global level, having this genomic data available has far-reaching implications such as early outbreak detection of novel pathogens, or future vaccine strain selection.
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REFERENCES
1. Williams TGS, Snell LB, Alder C, Charalampous T, et al. Feasibility and clinical utility of local rapid Nanopore influenza A virus whole genome sequencing for integrated outbreak management, genotypic resistance detection and timely surveillance. Microb Genom 2023;9(8):mgen001083. doi:10.1099/mgen.0.001083.
2. Miah M, Hossain ME, Hasan R, Alam MS, et al. Culture-Independent Workflow for Nanopore MinION-Based Sequencing of Influenza A Virus. Microbiol Spectr. 2023;15;11(3):e0494622. doi:10.1128/ spectrum.04946-22.
3. Charalampous T, Alcolea-Medina A, Snell LB, Alder C, et al. Routine Metagenomics Service for ICU Patients with Respiratory Infection. Am J Respir Crit Care Med. 2024;15;209(2):164-174. doi:10.1164/ rccm.202305-0901OC.
4. Chapman R, Jones L, D’Angelo A, Suliman A, et al. Nanopore-Based Metagenomic Sequencing in Respiratory Tract Infection: A Developing Diagnostic Platform. Lung. 2023;201(2):171-179. doi:10.1007/ s00408-023-00612-y.
5. New £3 million funding to expand rapid genetic testing to more patients. Guy’s and St Thomas’ NHS Foundation Trust. Accessed July 19, 2024. https://www.guysandstthomas.nhs.uk/news/ new-ps3-million-funding-expand-rapid-genetic-testing-more-patients.
6. Xu Y, Lewandowski K, Downs LO, Kavanagh J, et al. Nanopore metagenomic sequencing of influenza virus directly from respiratory samples: diagnosis, drug resistance and nosocomial transmission, United Kingdom, 2018/19 influenza season. Euro Surveill. 2021;26(27):2000004. doi:10.2807/1560-7917.ES.2021.26.27.2000004.
7. Serpa PH, Deng X, Abdelghany M, et al. Metagenomic prediction of antimicrobial resistance in critically ill patients with lower respiratory tract infections. Genome Med. 2022;14(1). doi:10.1186/ s13073-022-01072-4.
8. Badar N, Ikram A, Salman M, Saeed S, et al. Evolutionary analysis of seasonal influenza A viruses in Pakistan 2020-2023. Influenza Other Respir Viruses. 2024;18(2):e13262. doi:10.1111/irv.13262.
9. Cane J, Sanderson N, Barnett S, Vaughan A, et al. Nanopore sequencing of influenza A and B in Oxfordshire and the United Kingdom, 2022-23. J Infect. 2024;88(6):106164. doi:10.1016/j.jinf.2024.106164.
10. Minor NR, Ramuta MD, Stauss MR, Harwood OE, et al. Metagenomic sequencing detects human respiratory and enteric viruses in air samples collected from congregate settings. Sci Rep. 2023;4;13(1):21398. doi:10.1038/s41598-023-48352-6.
Anna Maria Niewiadomska serves as Global Public Health Segment Manager at Oxford Nanopore Technologies
Immunoassay Past innovations and future potential in diagnostic medicine
By Michael Salvati, MS and Jason Owens, PhD
Immunoassays, biochemical tests used to detect the presence of an analyte—antibody or antigen—using labeled antibodies, are used to aid in the diagnosis of diseases from infectious diseases such as HIV to neurodegenerative diseases such as Alzheimer’s Disease. This essential, cost-effective technology can be found in diagnostics laboratories around the world. New research demonstrates the potential of breakthrough innovations in immunoassay that can accelerate diagnosis and improve clinical outcomes. Although the immunoassay (IA) was invented over 65 years ago,1 the technology, along with the implementation of the technology, has continuously evolved. Current state-of-theart embodiments of IA on fully automated analyzers can deliver highly sensitive results in a timely and consistent manner, which greatly facilitate the ability to diagnose and manage disease. The progression from that earliest radioimmunoassay (RIA), which could take days to deliver a result, to the current assays, which can be completed in minutes, has been steady; however, certain inventions stimulated quantum leaps forward in the technology. The most notable paradigm shifts in IA were from the inventions of monoclonal antibodies, 2 enzyme mediated amplification, 3 paramagnetic microparticles,4 and chemiluminescence 5 (including all the various forms of triggering—e.g., enzymatically, chemically, electrochemically).
Advancements in IA
Enzyme mediated amplification of immunoassay (EIA) utilizes the catalytic capability of an enzyme to act on a substrate to cause a detectable, quantifiable signal change. A common version of EIA implemented in microtiter plate assays is the use of horse radish peroxidase (HRP) and the substrates
hydrogen peroxide and tetramethylbenzidine (TMB). HRP rapidly catalyzes the oxidation of the TMB by the reduction of hydrogen peroxide to create a blue color that can be easily measured. The major advancement afforded by EIA was to make IA much more accessible through the elimination of radioisotopes and all their associated negatives (health, storage, etc.). The introduction of paramagnetic microparticles (PMP) greatly facilitated the ability to automate IA. Due to the small size of the particles (and the iron particles contained within) the particles could be easily suspended, separated in a magnetic field, then resuspended, making them ideal for automation. Advances in the surface chemistries of the PMP have helped to allow convenient covalent attachment of specific proteins (e.g., capture monoclonal antibodies) and minimized non-specific adsorption.
Chemiluminescence, one of the most recent advancements in IA, has dramatically elevated the level of sensitivity that can be achieved. Chemiluminescence is the generation of light—since there is no light generation in biological samples (low background) and there are very good methodologies available for detecting light (high sensitivity)—chemiluminescence, when properly implemented, can push the limits of detection to levels not readily achievable with other technologies.
As advanced as IA has become, there is still significant progress being made. Continual efforts, incorporating the latest scientific advancements, are directed toward improving sensitivity, shortening time-to-results, minimizing variability, increasing robustness, improving safety, and making IAs more sustainable. It is possible that some of these advances will be considered as paradigm shifts when reflected upon by future generations.
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Monoclonal antibody to recombinant expression platforms
Another significant shift in immunoassay technology was the implementation of monoclonal antibodies (mAbs), which allowed one specific antibody to be produced, purified, and incorporated in the IA. Until this breakthrough, all IAs used either polyclonal antisera, total polyclonal antibody, or antigen-specific affinity purified antibody. The introduction of mAbs brought a level of specificity and reproducibility that had not been readily achievable with polyclonals and removed the reliance on a specific polyclonal-producing animal.
Recent advancements in monoclonal antibody development and production have moved production from traditional hybridoma methods to recombinant expression platforms. Traditional hybridoma technology is labor intensive and relies upon an inherently variable biological system, which may not grow or produce an antibody sufficiently well to support large-scale monoclonal antibody production. These limitations resulted in hurdles to obtaining high-quality, highly specific, and sensitive monoclonal antibodies that function well in immunoassay formats. Recombinant technologies, on the other hand, build from the base knowledge of the genetic makeup of the protein (in this case a mAb) and utilize a high-expression host cell system, such as Chinese Hamster Ovary (CHO) or Human Embryonic Kidney (HEK) cell lines, to express the protein at higher levels and in a more consistent and controlled environment (for a review on recombinant antibody production, please see Kunert and Reinhart6).
In addition to improvements in yield, cost, and manufacturability / scale-up, the shift to recombinant production techniques has also opened doors to myriad strategies not only for novel techniques in antibody discovery, but also for protein engineering; that is, modifying the antibody at a genetic level to achieve improvements in expression, or function, processing, or even to create fusion proteins with multiple functions.
Advancements in antibody discovery and engineering
In the field of antibody discovery, recombinant approaches have enabled the following: rapid evaluation of thousands of antibodies directly from the B-cells of immunized animals, without the need for hybridoma formation and screening; sequencing of monoclonal antibodies from hybridoma cell lines that either can no longer support the manufacturing scale required or even that are no longer recoverable from cryopreservation, thereby “rescuing” mAbs that may have otherwise been lost forever; creation of antibodies from libraries of binders from novel species (e.g., camelid VHH phage libraries); and more.
Antibody engineering involves manipulation of the amino acid sequence of the antibody at the genetic level. One application of antibody engineering is affinity-maturation, in which numerous point mutations (single amino acid substitutions) may be evaluated to improve antibody performance. Another application is isotype or subtype swapping, where, for example, an IgG1,k antibody can be converted to an IgG2a,l antibody without impacting the antibody’s binding profile.7 Further, the constant region of an antibody can be changed to a different species; for example, a mouse IgG antibody may be converted into a chimera antibody containing the mouse variable regions and human constant regions,8,9 which may result in favorable performance improvements. Tags can be added to proteins to facilitate purification or other downstream processing, or fusion proteins can be created that provide unique binding partners. These are just a few examples of the vast and ever-expanding
sets of tools that immunoassay developers can leverage to build higher quality, more sensitive, and faster immunoassays.
AI-powered research & development enabling future breakthrough
Above, we briefly touched on some of the efforts underway to improve the “I” (immune) part of the IA, but that is just one piece of a much larger puzzle. There is groundbreaking work on every aspect of the IA process including not only the assay but also instrumentation and analysis software incorporating the latest developments in science and engineering. For example, chemists are actively trying to create chemiluminescent substrates with a higher quantum efficiency that generate significantly more light. New detection technologies continue to be developed—an interesting example is direct mass detection using thin-film acoustic resonators that are an off-shoot of the cell phone industry. Newer instruments include the latest monitoring technologies to ensure all steps in the process are completed as intended.
An exciting, more recent advancement is the implementation of artificial intelligence (AI). In one embodiment, researchers are using AI to improve diagnosis of neurological diseases such as Alzheimer’s, Parkinson’s, and amyotrophic lateral sclerosis (ALS),10,11 (for a review on using AI in neurodegenerative diseases, please see T u an et al.12), which are extremely difficult to diagnose in their early stages when treatment may be more effective. Another key area of AI implementation is in the de novo design of specific binding proteins (here, antibodies, for a review of AI-guided antibody design see Gallo13 and Kim et al.14).
Can AI design a binding protein with the same affinity and specificity as Mother Nature? Not yet, but it would be foolish to bet against this eventuality. Did Drs. Benson and Yarlow realize in 1959 what their invention would lead to? Did the Nobel Prize committee realize in 1977 when it awarded the Medicine prize for this work how IA would continue to help revolutionize modern medicine for the next 46 years? There does not appear to be an end or a limit in sight for IA. While both the “I” and the “A” continue to evolve, the need to specifically measure biomolecules will most likely remain constant. Efforts underway today continue to build on the rich scientific history associated with IA, helping to improve everyone’s quality of life.
REFERENCES
1. YALOW RS, BERSON SA. Assay of plasma insulin in human subjects by immunological methods. Nature. 1959;21;184 (Suppl 21):1648-9. doi:10.1038/1841648b0.
2. Köhler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975;256(5517):495-497. doi:10.1038/256495a0.
3. Engvall E, Perlmann P. Enzyme-linked immunosorbent assay (ELISA). Quantitative assay of immunoglobulin G. Immunochemistry 1971;8(9):871-874. doi:10.1016/0019-2791(71)90454-X.
4. Richardson J, Hawkins P, Luxton R. The use of coated paramagnetic particles as a physical label in a magneto-immunoassay. Biosens Bioelectron. 2001;16(9-12):989-93. doi:10.1016/s0956-5663(01)00201-9.
5. Velan B, Halmann M. Chemiluminescence immunoassay; A new sensitive method for determination of antigens. Immunochemistry. 1978;15(5):331-333. doi:10.1016/0161-589 0(78)90094-9.
6. Kunert R, Reinhart D. Advances in recombinant antibody manufacturing. Appl Microbiol Biotechnol. 2016;100(8):3451-3461. doi:10.1007/s00253-016-7388-9.
7. Lua W-H, Ling W-L, Yeo JY, et al. The effects of Antibody Engineering CH and CL in Trastuzumab and Pertuzumab recombinant models: Impact on antibody production and antigen-binding. Sci Rep. 2018;8(1):718. doi:10.1038/s41598-017-18892-9.
8. Neuberger MS, Williams GT, Fox RO. Recombinant antibodies possessing novel effector functions. Nature. 1984;312(5995):604-608. doi:10.1038/312604a0.
9. Morrison SL, Johnson MJ, Herzenberg LA, Oi VT. Chimeric human antibody molecules: mouse antigen-binding domains with human constant region domains. Proc Natl Acad Sci USA. 1984;81(21):6851-6855. doi:10.1073/pnas.81.21.685.
10. Kavungal D, Magalhães P, Kumar ST, Kolla R, Lashuel HA, Altug H. Artificial intelligence-coupled plasmonic infrared sensor for detection of structural protein biomarkers in neurodegenerative diseases. Sci Adv. 2023;9(28):eadg9644. doi:10.1126/ sciadv.adg9644.
11. Bakkar N, Kovalik T, Lorenzini I, et al. Artificial intelligence in neurodegenerative disease research: use of IBM Watson to identify additional RNA-binding proteins altered in amyotrophic lateral sclerosis. Acta Neuropathol. 2018;135(2):227-247. doi:10.1007/s00401-017-1785-8.
12. T u an A-M, Ionescu B, Santarnecchi E. Artificial intelligence in neurodegenerative diseases: A review of available tools with a focus on machine learning techniques. Artif Intell Med. 2021;117:102081. doi:10.1016/j. artmed.2021.102081.
13. Gallo E. Revolutionizing synthetic antibody design: harnessing artificial intelligence and deep sequencing big data for unprecedented advances. Mol Biotechnol. February 3, 2024. doi:10.1007/s12033-024-01064-2.
14. Kim DN, McNaughton AD, Kumar N. Leveraging Artificial Intelligence to Expedite Antibody Design and Enhance Antibody-Antigen Interactions. Bioengineering (Basel). 2024;11(2). doi:10.3390/ bioengineering11020185.
Michael Salvati, MS is a Principal Scientist for Beckman Coulter Diagnostics Division in Chaska, MN. He evaluates technologies and designs/develops both reagents and assays. Jason Owens, PhD is a Senior Staff Development Scientist for Beckman Coulter Diagnostics Division in Chaska, MN. He evaluates technologies and designs/develops both reagents and assays.
Haptoglobin
Anti-Streptolysin O
Apolipoprotein AI, B, E
Apolipoprotein AII, CII, CIII b-2 Microglobulin
Hemoglobin A1c
IgA, IgG, IgM
Insulin
Krebs von den Lungen-6
Lipoprotein(a)
Microalbumin
Prealbumin
Remnant Lipoprotein Cholesterol
Preparing your lab’s automation infrastructure for the inclusion of digital pathology and AI
By Lisa-Jean Clifford
Incorporating digital pathology and AI solutions and workflows into your organization is an exciting opportunity to enhance your operational efficiency, positively impact your diagnostic accuracy, and increase the overall automation of your laboratory practice. It is essential for maintaining your competitive position in the industry with adoption of leading technology occurring at an ever-increasing rate. It is also important to understand your current technology infrastructure and workflows and to work closely with your digital pathology solution
provider to ensure that you are taking full advantage of the benefits of deploying these technologies —both today and setting the foundation for further adoption of new technologies into the future.
Things to consider
1. Understand your initial goals and your long-term goals. These two may be the same or very different, depending upon your adoption strategy and reasons. The most common goals for digital pathology solution adoption in the clinical setting today are:
• Reduce the need for transportation of glass between labs
• Access to geographically distributed facilities and pathologists
• The ability to recruit and retain pathologists
• Support the technical component (TC), professional component (PC), and global workflows for outreach clients
• Instant access to consultations for subspecialties and/or complex cases
• Tumor boards
• The ability to use artificial intelligence
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When considering the above, you may have one or more initial reasons or objectives in adoption with the understanding that you would like to achieve more of these goals, or additional ones, moving forward.
2. The implementation of digital pathology needs to be an organizational goal and not just one of the lab’s. The process starts with the technical side of the workflow — from the understanding of what the scanner(s) you choose to deploy require for ‘clean’ slides. This is something that can have a significant impact on the usability, speed, and value of digital. You must start with proper identification of your lab process for creating slides and know that things like misaligned slipcovers, smudges, fingerprints, substances on the glass, folds in tissue, bubbles, and other artifacts are going to cause scanned images (WSI’s) to be unusable. This will create inefficiencies and increased time by having to redo and rescan slides in order to get usable images to the pathologists. This is the first step in quality in, quality out.
3. Understand that your vendors are also your coaches, guides, and mentors in this process. If you have selected the right vendors — from scanner to digital solution (IMS) and AI — they are the experts on their products and services, not to mention this new fundamental workflow. Utilize them and take their input into the recommendations for how to deploy their solutions in the most effective way possible. Remember, you don’t simply want to automate a manual process. That negates the underlying value of deploying digital solutions.
4. Not all vendors and solutions are created equal. There are several ways to say you are using or deploying digital pathology. From simply looking in a viewer (monitor) to view scanned images — literally just replacing the microscope — to fully interoperable solutions that include the image management system (IMS), viewer, automated workflows, pathologist cockpit or working environment, reporting, AI, collaboration, consults, TC, PC and global workflows, etc. in a single solution.You need to consider that if your long-term goal is to be fully digital and interoperable, having less technological solutions will not get you there.
Involve stakeholders
This step is key to having a clear understanding of all facets of your current environment and infrastructure and the touchpoints for integration and workflow definition for your digital
deployment. This not only includes your Medical Director, Lab Director and representative pathologist(s), but also your IT and functional areas of the laboratory (histology, cytology, molecular, etc.). But remember that too many people can simply cause analysis paralysis. And a strong project manager on your side will be required and responsible for ensuring that the project stays on track for your organization’s goals.
Monitoring implementation
Most vendors will set a kick-off meeting to determine the steps, goals, timelines, etc. for your deployment. It is imperative that you have a good relationship with your vendors and that they work with you as partners in this initiative and don’t just see you as a customer. The difference is in taking a true interest in understanding your workflows, test types, and current configurations and ensuring that your implementation plan will meet your needs for your initial go-live or rollout but also be set up as a foundation that can pivot and scale to achieve your long-term goals.
Vendors that see you as a partner will take the time to work with you and not just have a checklist to get you to point A — meaning they get paid and can say you are live. This is something that you can determine during your evaluation of vendors and be sure they have experience in laboratory healthcare and understand this industry and your daily working environment. Square pegs and round holes don’t make for successful adoption and use.
Each step or milestone of the implementation process should be clearly defined with roles and deliverables for each party laid out. Updates and status reports should be shared, and smaller groups may meet between the larger group meeting to ensure that the project stays on track. Vendors should also work closely with each other and ‘play’ nicely with each other without you having to be in the middle. The overall goal for all involved is for you to be successful in using your solutions the way that you intend to. Any course corrections should be identified and acted upon immediately to prevent having to undo or reverse work later.
Ample testing
Testing is key to a successful go-live experience. This is very much like an LIS go-live. There are many moving parts that can be tested throughout the implementation process, allowing for faster
deployment. If you are doing testing in tandem with your configuration and integration builds, then you can do them in buckets or silos and each workflow or stage is fully vetted and verified for flow. Once you are fully configured and all applications are integrated, then full, round-trip testing of each workflow is imperative. I would recommend a testing scenario that also includes a representation of your organization. For example, if you have multiple locations, remote pathologists, multiple case types, a variety of scanner formats, and high volumes, make sure that you are testing a percentage of these simultaneously. This will ensure that your configurations, performance, and load balancing are optimized prior to roll out.
Ensure proper training and rollout
Setting expectations is a core requirement for successful adoption and use within your organization. You can determine if you are doing a phased rollout, i.e., a certain case type across your entire organization, or a representative group of pathologists for all case types, or a single location, etc. Or, depending upon your size, it might be an all-atonce scenario.
Whatever you determine, you need to work with your vendor to determine the best time for training — you want it to be close enough to go-live that people are comfortable and remember how to use the solution(s) but out far enough to allow for any questions or support that may be necessary.
It also needs to be clearly explained that while digital pathology is a natural extension of what pathologists are doing manually and historically, there is still a slight ramp time. When a pathologist first started diagnosing cases on glass, they were not as fast as they are today. It took some time (usually only a few months) for them to be able to fly through their glass cases. The same is to be expected when adopting a new workflow — it may start slower, but once they are up to speed, digital shows exponentially faster workflows, overall efficiency gains, and improved pathologist experience.
Lisa-Jean Clifford is COO and Chief Strategy Officer of Gestalt Diagnostics . Clifford
has more than 20 years of experience in high-tech industries, with over 15 of them specifically in high-tech healthcare.
API DataDirect
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!
The process is simple
Facilitating antibiotic stewardship in the laboratory
By Rajasri Chandra, MS, MBA
According to the Centers for Disease Control and Prevention (CDC), 30% of all antibiotics prescribed in the United States’ acute care hospitals are either unnecessary or suboptimal.1 Misuse or overuse of antibiotics can cause unintended adverse reactions in patients and lead to emergence of antimicrobial resistant strains. The CDC estimates that annually, more than 2.8 million patients are infected by antibiotic-resistant (AR) organisms and more than 35,000 of these patients die in the United States. 2 Additionally, antibiotic misuse is also responsible for causing deadly diarrhea in more than 500,000 patients and 15,000 deaths annually due to Clostridium difficile , a bacterium that is not typically resistant. 2 Antibiotic resistance (AR) or antimicrobial resistance (AMR) also makes an antibiotic useless in delivering life-saving medical care to surgery or cancer patients. 2
The estimated national cost is more than $4.6 billion annually to treat infections caused by a few commonly encountered antimicrobial-resistant organisms in healthcare settings, e.g., multidrug resistant Staphylococcus aureus (MRSA); vancomycin-resistant Enterococci (VRE); carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Acitenobacter
Clarion17
Sentri718
Antibiokos19
MEG20
Helps labs and hospitals to provide critical infectious disease data and insights to support antimicrobial stewardship programs.
Helps clinicians to improve antibiotic use by prioritizing patients, standardizing workflows, and turning data into insights.
Helps to select antibiotics, intercept prescriptions, and fight antimicrobial resistance.
Helps clinicians to make data-informed decisions in real time to reduce resistance, adverse drug events, and costs.
Firstline21 Makes clinical guidance on infectious diseases easily accessible at the point of care.
Identifies suboptimal antimicrobial use; detects situations where a pathogen is resistant to the antimicrobial received or when an untreated pathogen could be; determines suboptimal dosage regimens in specific populations; targets significant drug interactions and spectrum redundancies with antimicrobials and suggests alternatives; provides pharmacokinetics calculator (e.g., Colistin, Vancomycin).
Table 1. Sample software solutions.
baumannii (CRAB), Multidrug resistant Pseudomonas aeruginosa; and extended-spectrum beta-lactamases (ESBLs).3 According to the World Health Organization (WHO), antibiotic resistance was directly responsible for 1.27 million global deaths in 2019 and was a contributing factor to an estimated 4.95 million deaths.4 If corrective measures are not taken, this could rise to 10 million deaths by 2050 and be the leading cause of deaths.5 Following antimicrobial stewardship (AMS) programs is essential to fighting the growing crisis posed by antimicrobial resistance (AMR). The term “antimicrobial stewardship (AMS)” was first used by John McGowan and Dale Gerding in an article in New Horizon in 1996 where they commented on the causal association between antimicrobial use and increasing emergence of antimicrobial resistance (AMR) in hospitals.6 According to the authors, efforts to educate and follow quality management or clinical guidelines are not sufficient to control AMR, a series of additional measures are needed to be taken urgently to control this menace. They suggested conducting large-scale, well-controlled trials of antimicrobial-use regulation using sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis to determine the best methods to prevent and control AMR problems and thereby ensure the optimal antimicrobial use, e.g., “stewardship.” Additionally, consideration of the long-term effects of antimicrobial selection, dosage, and duration of treatment on resistance development for every antimicrobial treatment decision should be a part of AMS.7
Goals and guidelines
The goals of AMS programs are as follows:8
• To prevent overuse, misuse, and abuse of antibiotics when prescribing antimicrobial therapy, prescribing doctors should follow the following guidelines:
• Right drug: Is the drug effective against the present organism?
• Correct dose: Is the recommended dose within the correct range?
• Right drug-route: Is the route by which the drug is given appropriate for the patient?
• Suitable duration: Is the recommended duration of therapy appropriate?
• Timely de-escalation: From broad spectrum to pathogen directed therapy or higher to lower dose.
• To prevent antimicrobial overuse, misuse, and abuse in inpatient, outpatient, and community settings, including the agriculture industry.
• To reduce antibiotic-related adverse effects, for example, C.difficile.
• To minimize antimicrobial resistance.
• To reduce healthcare-associated costs.
In 1997, the Society for Healthcare Epidemiology of America (SHEA) and Infectious Diseases Society of America (IDSA) first published guidelines for the prevention of antimicrobial resistance in hospitals.9 The guidelines set out for the first
Software system Role in antimicrobial stewardship program
APSS22
time the criteria for applied infection control programs in hospitals. The recommended criteria were as follows:
1. Having a system for monitoring bacterial resistance and antibiotic usage;
2. Developing practice guidelines for the control and use of antibiotics;
3. Adopting the Centers for Disease Control and Prevention (CDC) Guidelines for Isolation Precautions in Hospitals;
4. Utilizing hospital committees to develop local policies;
5. Making hospital administration accountable for the implementation and enforcement of policies adopted by the hospital committees; and
6. Measuring outcomes to evaluate the effectiveness of policies put in place.
They emphasized having a multidisciplinary team approach and the role of pharmacists and administrators in the development of an optimal “antibiotic control program.” The stewardship guidelines were based on a two-pronged approach: preventing transmission of infection through infection prevention and control (IP&C) and the optimization of antibiotic use. From then on, antibiotic stewardship was increasingly used, which included education and training, decision support systems, restriction, and audit and feedback, which were incorporated into the strategic agenda of organizations seeking to optimize antibiotic use. The effectiveness of these interventions was assessed through peer-reviewed publications and several systematic reviews.10-12
In 2014, the CDC released the “Core Elements of Hospital Antibiotic Stewardship Programs” to set guidelines on antimicrobial stewardship for hospitals.1 In 2015, the United States National Action Plan for Combating Antibiotic Resistant Bacteria (CARB) received federal funding for this purpose. Since 2014, the CDC has used the National Healthcare Safety Network (NHSN) annual hospital survey to determine the extent to which hospitals have implemented the core elements. In 2015, more than 50% of hospitals with more than 50 beds reported meeting all seven core elements compared to 26% of hospitals with 25 or fewer beds.1
In November 2019, the CDC released an updated version of “The Core Elements of Hospital Antibiotic Stewardship Programs.”13 The seven core elements of hospital antibiotic stewardship are listed in Figure 1. Along with “The Core Elements of Antibiotic Stewardship,” the CDC also developed the antibiotic stewardship program assessment tool14 that provides examples of ways to implement the Core Elements. The Core Elements and the tool are an adaptable framework to guide hospitals in their efforts to optimize antibiotic prescribing. The assessment tool can be used on a periodic basis (e.g., annually) to document the current program infrastructure and activities and to help identify items that could improve the effectiveness of the stewardship program. In addition, the CDC in collaboration with the American Hospital Association, Federal Office of Rural Health Policy, and Pew Charitable Trusts prepared a document, “Implementation of Antibiotic Stewardship Core Elements Hospitals Small and Critical Access Hospitals” to provide small and critical access hospitals implementation strategies based on the seven elements of an antibiotic stewardship program.15
Role of clinical laboratories in AMS
The clinical microbiology and molecular biology laboratories play a critical role in the success of antimicrobial stewardship programs both for individual patients as well as the whole population in the following ways:
• Identification and drug susceptibility testing for patients — labs provide diagnostic testing results to identify the infectious agent, determine its antibiotic susceptibility, and help prescribing doctors in choosing the appropriate drug for treatment.
• Surveillance and outbreak investigation reporting — labs can monitor local trends in antimicrobial resistance among pathogens, create antibiograms, and share reports regarding susceptibility with prescribing physicians. Labs can also detect and report outbreaks of hospital-acquired infections to concerned authorities.
• Educating clinicians about the various tests and technologies that facilitate antibiotic stewardship.
Hospital Leadership Commitment
Dedicate necessary human, financial, and information technology resources.
Accountability
Appoint a leader or co-leaders, such as a physician and pharmacist, responsible for program management and outcomes.
Pharmacy Expertise
Appoint a pharmacist, ideally as the co-leader of the stewardship program, to help lead implementation efforts to improve antibiotic use.
Action
Implement interventions, such as prospective audit and feedback or preauthorization, to improve antibiotic use.
Tracking
Monitor antibiotic prescribing, impact of interventions, and other important outcomes, like C. difficile infections and resistance patterns.
Reporting
Regularly report information on antibiotic use and resistance to prescribers, pharmacists, nurses, and hospital leadership.
Education
Educate prescribers, pharmacists, nurses, and patients about adverse reactions from antibiotics, antibiotic resistance, and optimal
Figure 1. Core elements of hospital antibiotic stewardship programs.
Role of rapid diagnostic testing (RDT) in facilitating antimicrobial stewardship
A successful antimicrobial stewardship program needs rapid and accurate identification of pathogens, antimicrobial susceptibility testing (AST), and resistance detection. The traditional method of microbiology is slow and takes 24 to 48 hours for culture and identification and another 24 to 48 hours to generate antibiotic susceptibility results. Because of that, physicians managing patients with suspected infectious diseases started empirical treatment with broad spectrum antibiotics without waiting for laboratory results. Now, rapid diagnostic tests (RDT) are available and can provide rapid and accurate results in a matter of hours and are playing a significant role in diagnostic and antimicrobial stewardship.16
RDTs use different techniques, such as polymerase chain reaction (PCR), magnetic resonance, mass spectrometry, microarray technology, next-generation sequencing, and can rapidly identify different kinds of microorganisms — bacterial, fungi, and viral. RDTs are available for identifying respiratory tract infections and blood stream infections, antimicrobial resistance genes for determining antimicrobial resistance in organisms, and surveillance screening for MRSA.
Use of information technology in facilitating antimicrobial stewardship
Since antimicrobial stewardship requires a collaboration and flow of information among different teams in the healthcare organization, including the laboratory, information technology plays an important role in implementing a successful antimicrobial stewardship program. Table 1 lists a sample of software solutions that facilitate antimicrobial stewardship.
Conclusion
Even though antimicrobial stewardship was introduced in 1996, antimicrobial resistance still remains a global crisis. However, during the COVID-19 pandemic, antibiotic stewardship program efforts slowed tremendously due to the changes in patient care, testing, treatment, and staff availability. As a result, there was an increase in combined antimicrobial resistance by 20%.23 Antimicrobial stewardship is necessary for better patient outcomes and reduced healthcare costs. So, actions mentioned
in the guidance documents for antimicrobial stewardship need to be made a habitual practice in every healthcare setting so that even if there are pandemic situations in the future there is no rise in antimicrobial resistance. The emergence of newer technologies enabling rapid, accurate diagnosis and the increased incorporation of big data, artificial intelligence (AI), and internet of things (IoT) in healthcare is making personalized medicine possible. Personalized medicine will make antimicrobial stewardship programs a success.
REFERENCES
1. CDC. Core elements of Hospital Antibiotic Stewardship Programs. Antibiotic Prescribing and Use. Published May 20, 2024. Accessed July 26, 2024. https://www. cdc.gov/antibiotic-use/hcp/core-elements/ hospital.html?.
2. Antimicrobial resistance facts and stats. Antimicrobial Resistance. Published July 16, 2024. Accessed July 26, 2024. https:// www.cdc.gov/antimicrobial-resistance/ data-research/facts-stats/index.html.
3. Nelson RE, Hatfield KM, Wolford H, et al. National estimates of healthcare costs associated with multidrug-resistant bacterial infections among hospitalized patients in the United States. Clin Infect Dis. 2021;72(Supplement_1):S17-S26. doi:10.1093/cid/ciaa1581.
4. Antimicrobial resistance. Who.int. Accessed July 26, 2024. https://www. who.int/news-room/fact-sheets/detail/ antimicrobial-resistance.
5. O’Neill J. Review on Antimicrobial Resistance. Tackling Drug-Resistant Infections Globally (2016). Available from: https:// amr-review.org/sites/default/files/160525_ Final%20paper_with%20cover.pdf. Accessed July 26, 2024.
6. McGowan J.E., Jr., Gerding D.N. Does antibiotic restriction prevent resistance? New Horiz. 1996;4:370–376.
7. Shlaes D.M., Gerding D.N., John J.J.F., et al. Society for Healthcare Epidemiology of America and Infectious Diseases Society of America Joint Committee on the Prevention of Antimicrobial Resistance: Guidelines for the prevention of antimicrobial resistance in hospitals. Clin. Infect. Dis. 1997;25:584–599. doi:10.1086/513766.
8. Shrestha J, Zahra F, Cannady P Jr. Antimicrobial Stewardship in Non-Traditional Settings: A Practical Guide. 1st ed. (Doron S, Campion M, eds.). Springer International Publishing; 2023.
9. Shlaes DM, Gerding DN, John JF Jr, et al. Society for healthcare epidemiology of America and infectious diseases society of America joint committee on the prevention of antimicrobial resistance guidelines for the prevention of antimicrobial resistance in hospitals. Infect Control Hosp Epidemiol 1997;18(4):275-291. doi:10.1086/647610.
10. Davey P, Brown E, Hartman G. Interventions to improve antibiotic prescribing practices for hospital inpatients. In: The Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd; 2002.
11. Davey P, Brown E, Fenelon L, et al. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane
Database Syst Rev. 2005;(4):CD003543. doi:10.1002/14651858.CD003543.pub2.
12. Davey P, Peden C, Charani E, Marwick C, Michie S. Time for action—Improving the design and reporting of behaviour change interventions for antimicrobial stewardship in hospitals: Early findings from a systematic review. Int J Antimicrob Agents. 2015;45(3):203-212. doi:10.1016/j. ijantimicag.2014.11.014.
13. CDC. U.S. actions & events to combat. Antimicrobial Resistance. Published May 20, 2024. Accessed July 26, 2024. https://www. cdc.gov/antimicrobial-resistance/programs/ AR-actions-events.html.
14. Centers for Disease Control and Prevention. The Core Elements of Hospital Antibiotic Stewardship Program Tools. Accessed July 26, 2024. https://www.cdc.gov/antibiotic-use/ media/pdfs/assessment-tool-P.pdf.
15. CDC. Implementation of antibiotic stewardship Core Elements at Small and Critical Access Hospitals. Antibiotic Prescribing and Use. Published May 20, 2024. Accessed July 26, 2024. https://www.cdc.gov/antibiotic-use/ hcp/core-elements/small-and-critical-accesshospitals.html.
16. Althubyani A, Holger D. Rapid Diagnostic Testing: Changing the Game for Antimicrobial Stewardship. IDSE Infectious Disease Special Edition. Published October 20, 2023. Accessed July 26, 2024. https://www. idse.net/Review-Articles/Article/10-23/ Rapid-Diagnostic-Testing-Changingthe-Game-for-Antimicrobial-Stewardship/71647.
17. Data-driven infectious disease management. Biomerieux-usa.com. Accessed August 1, 2024. https://microsite.biomerieux-usa.com/ clarion/.
18. Wolters Kluwer. Antimicrobial Stewardship. Sentri7 Clinical Surveillance. Accessed July 26, 2024. https://www.wolterskluwer. com/en/solutions/sentri7-clinicalsurveillance/medication-management/ antimicrobial-stewardship.
19. Antibiokos-Software for antimicrobial stewardship. Nosotech. Published March 1, 2022. Accessed July 26, 2024. https://nosotech. com/en/solutions/antibiokos/.
20. Antimicrobial stewardship. MEG. Accessed July 26, 2024. https://megit.com/ antimicrobial-stewardship.
21. Firstline. Firstline - clinical decision support platform. Firstline.org. Accessed July 26, 2024. https://firstline.org/.
22. APSS - antimicrobial stewardship software & resistance surveillance. Lumed.ca. Accessed July 26, 2024. https://lumed.ca/ en/apss/.
23. CDC. COVID-19 &. Antimicrobial Resistance. Published July 16, 2024. Accessed July 26, 2024. https://www.cdc.gov/ antimicrobial-resistance/data-research/ threats/COVID-19.html.
Rajasri Chandra, MS, MBA is a global marketing leader with expertise in managing upstream, downstream, strategic, tactical, traditional, and digital marketing in biotech, in vitro diagnostics, life sciences, and pharmaceutical industries. Raj is an orchestrator of go-to-market strategies driving complete product life cycle from ideation to commercialization.
HardyCHROM
Candida + auris
Recommended for the selective isolation and differential identification of Candida species. Colonies of C. auris will appear white with a characteristic teal to teal-green “bullseye” center and show a unique fluorogenic reaction under UV light at 48-72 hours. C. auris is unique amongst other Candida species because it causes outbreaks and is resistant to nearly all antifungal drugs. This pathogen is also difficult to identify and thus can be misidentified as other species of yeasts. This medium also allows for the differentiation of C. tropicalis, C. albicans and C. krusei, and can aid in the identification of C. glabrata when used in conjunction with Rapid Trehalose Broth or GlabrataQuick™. All colonies suspected of C. auris should be subjected to confirmatory methods such as MALDI. Cat. no. G343
C. auris under UV light on HardyCHROM™ Candida + auris
MLO ’s 2024 survey of laboratory professionals
By Kara Nadeau
The results of Medical Laboratory Observer’s 2024 annual survey of laboratory professionals reveal salaries have increased for most individuals surveyed (73%), more than one-third (33%) received bonuses as part of their 2023 compensation, and employer benefits offerings remain robust in major categories (health/dental/vision insurance, 401k/pension plan, etc.).
Regarding challenges facing the profession, staffing shortages persist, although reported not to be as severe as last year. Automation is a growing area of opportunity, with more lab professionals reporting their labs having automated or further automated new procedures.
For this article, MLO also reached out to the medical laboratory community to gather commentary on the state of the field and what is needed to better support lab professionals, which we present alongside the quantitative survey results data.
A look at the respondents
Most of the 220 lab professionals taking part in the survey this year are female (72%), 46–65 years old (60%) and work in hospital laboratories (64%).
We will make comparisons between the 2024 and 2023 survey results, but it is interesting to note there were some distinct changes in respondents’ demographics compared with last year.
Workplaces and job titles
Laboratory professionals who took part in this year’s survey are more diverse in their workplaces compared with those who
participated in 2023, with one-third fewer working in hospitals (64% in 2024, down from 94% in 2023), and more employed by independent labs, government/public health labs, medical schools, MedTech/CLS education programs, and “other” facilities.
This year’s respondents were also more varied in their job titles, with fewer in lab director, manager, administrator and supervisor positions (41% in 2024, down from 73% in 2023), and more serving in medical laboratory scientists (MLS/MS) and medical laboratory technicians (MLT) roles (19% in 2024, up from 4% in 2023).
Age and experience
As with last year’s survey results, most lab professionals this year fell into the age range of 46–65 years old (60%), but there was an increase in respondents aged 45 or younger (25% in 2024, up from 18% in 2023), including those aged 26–35 (9% in 2024, up from 4% in 2023).
There were slight fluctuations in other age groups as well, with a slight decrease in individuals aged 55–65 (36% in 2024, down from 40% in 2023) and a slight increase in respondents in the 71+ age range (7% in 2024, up from 4% in 2023).
Regarding experience, nearly half of those surveyed (46%) reported having more than 30 years in the lab industry.Years of experience among the other respondents:
• 25-30 years: 15%
• 20-24 years: 10%
• 15-19 years: 7%
• 10-14 years: 11%
• 6-9 years: 6%
• 3-5 years: 2%
• Less than 3 years: 4%
Lab size
Those surveyed varied in the number of employees working in their labs:
• 1-10 employees: 22%
• 11-20 employees: 11%
• 21-50 employees: 21%
• 51-100 employees: 18%
• More than 100 employees: 22%
Lab professionals in supervisory positions also varied in how many employees they oversee:
• 1-5: 17%
• 6-10: 15%
• 11-15: 9%
• 16-20: 6%
• 21-30: 6%
• More than 30: 12%
• None: 36%
Looking at test volumes, 40% of survey respondents work for labs with annual testing volumes above 1M, with 17% reporting more than 2M tests annually. Respondents with labs across other annual testing volumes are as follows:
• 500,001 – 1M: 11%
• 100,001 – 500,000: 19%
• 50,001 – 100,000: 8%
• 25,001 – 50,000: 4%
• Less than 25,000: 7%
• N/A: 11%
Compensation and benefits
More than half (54%) of those surveyed report being salaried (down from 72% in 2023) and 46% hourly (up from 28% in 2023). Looking at annual base salary ranges, most respondents fell in the range of $50,000 and $150,000 (81%), with the highest percentage reporting salaries between $75,000 and $99,999 (37%).
The full range of responses are as follows:
• Over $151,000: 9%
• Between $100,000 and $150,000: 24%
• Between $75,000 and $99,999: 37%
• Between $50,000 and $74,999: 20%
• Between $20,000 and $49,999: 6%
• Less than $20,000: 2%
When asked if their salary changed in 2023, 73% said it increased (down from 76% in 2023), 4% said it decreased (up from 2% in 2023), and 23% said it stayed the same (up from 22% in 2023). Looking ahead to salary increases in 2024, more than half (53%) said they expect a 2–4% pay raise, which was a similar percentage rate to last year (54% in 2023).
Among the remaining respondents:
• Expect greater than 10% increase: 3%
• Expect an 8-10% increase: 3%
• Expect a 5-7% increase: 10%
• Expect less than a 2% increase: 13%
• Expect no increase: 7%
• Do not know: 10%
The percentage of lab professionals receiving bonuses as part of their 2023 compensation was 33%, while 67% said they did not receive a bonus last year.
Angela Tomei Robinson, MS, MLS ASCP cm, Laboratory Advocate, commented on the importance of compensation in the medical lab field, stating:
“Qualified professionally recognized board-certified Medical Laboratory Professionals perform quality standards of laboratory testing for patient care and deserve compensation commensurate with education and experience — similar to other healthcare professionals such as nursing and radiology and pharmacy etc. Besides compensation of salaries, the total package of supportive leadership and resourceful environments need to include benefits and flexibility of scheduling and promotion opportunities.”
Employer benefit offerings remain robust, changing little compared with last year’s survey responses. The most reported benefits among 2024 respondents were health insurance (95%), dental insurance (91%), vision insurance (87%), 401k or pension plan (86%), PTO (81%), life insurance (79%), and disability insurance (77%).
in Douglasville, GA., stressed how organizations must be willing to provide excellent benefits/incentives along with an adequate salary, stating:
“These benefits/incentives must go beyond medical/dental/vision insurance. Organizations will need to consider providing sign-on bonuses, performance-based rewards, and many opportunities for professional development (paid conferences, CEUs, and tuition reimbursement for furthering their educational endeavors).”
Other reported employer benefits include:
• Paid holidays: 64%
• Employee assistance program: 62%
• Tuition reimbursement: 58%
• Overtime pay: 47%
• Bonuses: 27%
• Flextime: 19%
• Childcare: 7%
Dr. Michael D. Todd, DHSc, MS, MT (ASCP), Director of Laboratory Services, WellStar Douglas Hospital
Regarding satisfaction with their lab’s education and training programs, one-quarter of survey respondents (25%) reported being “very satisfied,” 48% “somewhat satisfied,” 17% “somewhat dissatisfied,” and 10% “very dissatisfied.”
Job security, satisfaction, and tenure
More than half of respondents (53%) reported feeling “very secure” (down from 57% in 2023), 39% “somewhat secure” (up from 38% in 2023), 6% “somewhat insecure” (up from 3% in 2023) and 2% “very insecure” (down from 3% in 2023) in their jobs.
Turning to job satisfaction, 14% more lab professionals said they are “very satisfied” with their jobs compared with last year (44% in 2024, up from 30% in 2023). Among the remaining respondents, 44% said they are “somewhat satisfied” (down from 53% in 2023), 9% “somewhat dissatisfied” (down from 14% in 2023), and 3% “very dissatisfied” (same as last year).
Did your salary change in 2023?
This year, more lab professionals surveyed reported less than 3 years with their current employer compared with last year (22% in 2024, up from 9% in 2023), and fewer respondents reported more than 30+ years tenure (13% in 2024, down from 20% in 2023).
The remaining lab professionals reported time with current employer as follows:
• 3-5 years: 13%
• 6-9 years: 11%
• 10-14 years: 13%
• 15-19 years: 10%
• 20-24 years: 9%
• 25-30 years: 8%
Degrees, certifications, and continuing education
Looking at level of education, half of those surveyed (50%) reported holding bachelor’s degrees, 39% post-graduate degrees, 10% associate’s degrees, and 1% said high school was their highest level of education.
When asked what certifications they hold, there were some ups and downs in the percentages compared with the 2023 survey results.
While more than half of survey respondents (63%) reported certification by the American Society for Clinical Pathology, this was down from 78% in 2023. There were also fewer Medical Technology/MT (28% in 2024, down from 44% in 2023) and Clinical Laboratory Scientist/CLS certifications (14% in 2024, down from 21% in 2023). Conversely, more lab professionals reported Medical Laboratory Scientist/MLS/MS certifications (30% in 2024, up from 20% in 2023). The percentages of other certifications remained relatively unchanged year over year.
When asked from which organizations they had received professional certifications, the majority of respondents (75%) selected the American Society for Clinical Pathology (ASCP), which was only slightly lower than last year (78% in 2023). Reported certification from other organizations were similar to last year’s responses.
Turning to continuing education, nearly half of lab professionals surveyed (46%) said they took more than 11 classes last year, with 19% taking more than 20.
Challenges and opportunities
Dr. Todd commented on what seems like a snowball effect in the medical lab field, with one issue compounding the next, stating:
“Laboratory professionals, depending on where they practice their profession, can face a multitude of challenges related to staffing and job satisfaction.
Dr. Michael D. Todd, DHSc, MS, MT (ASCP)
Angela Tomei Robinson, MS, MLS ASCP cm
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The first and most obvious challenge is a shortage of trained, highly skilled lab personnel.”
He noted how many state-funded and private universities “either struggle to maintain high quality medical/clinical laboratory science programs or choose to divert funding to other programs.”
“Several two-year technical and community colleges around the country offer Medical Laboratory Technician (MLT) training programs; however, the four-year, bachelor’s degree level Medical/Clinical Lab Science (MLS) programs are few and very far between,” said Dr. Todd. “Additionally, with an expected major exodus of the current workforce due to aging and retirement
over the next 5 to 10 years, there won’t be enough training programs to keep up with the expected needed number of laboratory professionals to fill these open positions.”
According to Dr. Todd, this leads to the next challenge, which is a high rate of attrition/turnover because the job market is so competitive due to the current staffing shortage. He said with that staffing shortage comes heavier workloads (increased units of service [test volume] per FTE) leading to burn-out and more attrition.
“Couple this with the fact that salaries for laboratory professionals may not be adequate for the level of education and responsibility required for the job and the attrition rate then
The benefits your employer offers you.
climbs even higher as staff leave to find higher paying positions at their current level or look to other healthcare systems who have opportunities available for advancement to higher levels of responsibility or leadership as well as increased pay,” he added.
Dr. Todd said many professionals are choosing to leave the field all together and pursue an alternative career unrelated to the medical lab due to the “perceived and actual lack of recognition for the crucial role lab professionals play in patient care.”
This year’s survey results are in alignment with Dr. Todd’s insights, with 65% of respondents reporting how the shortage of medical personnel is having an impact on lab operational efficiency. The good news — this is down from 83% of respondents in 2023. An additional 26% of lab professionals say the shortage is having a low impact (up from 15% in 2023), and 10% said it has no impact (up from 2% in 2023).
Robinson co-authored an article for the February 2024 issue of the Biomedical Journal of Scientific & Technical Research on the shortage of medical laboratory professionals. In it, she and co-author Rodney E Rohde, PhD SM(ASCP)CM, SVCM, MBCM, FACSC, stated:
“While we all hear about physician and nursing shortages, the issue goes far deeper into dozens of healthcare professions. In particular, is the medical laboratory and public health workforce.”
Robinson and Rohde highlight the need for quality long-term solutions to the problem: “The challenges for an out-of -sight/out-of-view medical profession must not continue the path of short-term band-aids being offered.”1
When asked whether a shortage of medical personnel caused their labs to outsource more tests, 13% said “yes” compared with 26% in 2023, and 66% said “no” compared with 74% in 2023.
The changes in some of these responses are likely attributable to new answer choices offered to survey respondents this year that were not offered last year. In response to the current personnel shortage, lab professionals report taking the following steps:
• Reorganized and evaluated supply usage and storage: 6%
• Reviewed test and utilization costs and reimbursement levels: 7%
• Increased testing: 4%
• Other: 5%
When asked how many hours they work in a normal shift, more than half of respondents (56%) said they work 8 hours.
The remaining lab professionals reported normal shift hours as follows:
• 12 hours: 6%
• 10 hours: 16%
• 9 hours: 9%
• 7 hours: 1%
• 6 hours: 1%
• Hours fluctuate: 11%
Looking at automation, more lab professionals report their labs having automated or further automating new procedures in 2023 (48% in 2024, up from 42% in 2023), fewer said they did not increase automation last year (45% in 2024, down from 56% in 2023), and 7% said they did not know.
“Reports continue to claim over 70% of diagnosis relies on laboratory testing,” noted Robinson.“And medical laboratory professionals perform and manage the regulatory compliance of quality standards of laboratory testing via complicated methodologies and sophisticated instrumentation interfaced with computers. Automation is a tool to assist the independent judgment and cognitive expertise of medical laboratory professionals in all phases from pre to analytical to post. Keep in mind the fact that most variables of errors occur prior to reaching the laboratory for analytical testing — medical laboratory professionals assure accurate and precise results via total quality management.”
Dr. Todd commented on how lab process automation “can reduce the number of manual tasks and streamline various processes within the lab space, allowing lab professionals to focus on higher-level tasks that require their expertise and critical thinking skills.” He stated:
“Many repetitive tasks in the lab, such as sample handling, testing, and data analysis, can and should be automated. By doing so, labs can increase their specimen throughput without necessarily having to increase staffing levels, leading to higher productivity and the ability to manage increased workload pressure more efficiently and effectively. This often equates to substantially decreased turnaround times (TATs) as well as improved accuracy and test quality.”
“With that being said, while technology can enhance efficiency, it also requires continuous training and adaptation to change from lab professionals,” Dr. Todd added. “Keeping up with technological advancements can be very challenging with an aging workforce who is nearing retirement, and it can ultimately negatively impact job satisfaction if adequate training and support are not provided.”
Looking ahead
The laboratory leaders interviewed for this article commented on the profession moving forward and their thoughts on what is needed to advance the field.
Robinson offered her insights on raising the bar on compensation, stating:
“Salaries are finally increasing where there are mandates for entry-level personnel standards and competition for supply and demand for qualified board-certified medical laboratory professionals, but medical laboratory professionals also need to advocate and negotiate. And together we must bring media attention and public awareness and industry respect and legislative
Which lab superpower resonates with you the most?
support to Medical Laboratory Science to attract, recruit, and retain qualified board-certified — and where applicable the right to practice profession licensed — medical laboratory scientists (technologists) and technicians.”
“And together as a professional community we must oppose misguided short-term band aids lowering personnel standards and support quality long-term SOLUTIONS to shortages,” she added. “Patient care deserves no less than quality standards of laboratory testing.”
Dr. Todd offered his advice on improving staff recruitment, satisfaction, and long-term retention, stating:
“You have to take into account not only the expected practical factors but also those that will motivate employees to stay with your organization. Organizations must be willing to consistently perform market surveys and ensure that their salary ranges are a true reflection of the market/region they serve relative to other healthcare systems. One health system shouldn’t dominate in this space as it will negatively affect other health system’s ability to provide adequate lab results to their patients due to staff shortages.”
“Organizations will also need to provide an environment where staff feel that they can thrive and grow, i.e., positive work culture that emphasizes open communication, respect for your peers, and teamwork,” Dr. Todd continued.“Staff should know that they can be involved in decision-making processes and that their input is valuable to the overall decisions being made (deference to expertise).
“Lastly, organizations must understand the importance of work/life balance by offering an array of flexible scheduling options as well as provide adequate time-off from work to relax, reset, and recharge,” he added. “Overtime and on-call duties should be kept to a bare minimum so that work-life balance can be better achieved.”
REFERENCES
1. Tomei Robinson A, Mlsascpcm MS, Svcm Mbcm RERPS. Workforce in the Shadow of Healthcare -An Update on the Survival Status of Laboratory Medicine and Public Health. Biomed J Sci & Tech Res. 54(5).
Kara Nadeau has 20+ years of experience as a healthcare/ medical/technology writer, having served medical device and pharmaceutical manufacturers, healthcare facilities, software and service providers, non-profit organizations and industry associations.
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Every needlestick is one too many Progress made and still to come for sharps injury prevention
By Tammy Oppy, BS, MLS(ASCP)
Needlestick injuries are not new to the world of healthcare. In the United States, awareness around prevention began gaining momentum in the early 1990s — more than 30 years ago — with the rise of the human immunodeficiency virus (HIV) and hepatitis B and C epidemics. The Occupational Safety and Health Administration (OSHA) published the Occupational Exposure to Bloodborne Pathogens Standard in 1991 to help protect healthcare workers from the risks of needlestick injuries and subsequent exposure to bloodborne pathogens.
In 2000, the Needlestick Safety and Prevention Act (NSPA) was signed into law, effectively amending OSHA’s Bloodborne Pathogens Standard to more specifically define the types of engineering controls and devices required to improve safety, require employers to maintain a sharps injury log, and require employers to consider the input of frontline staff in the evaluation and selection of safety-engineered devices.
Both of those early milestones were significant in highlighting the risk of needlestick injuries and establishing
best practices for prevention, and data shows progress toward reducing the instances of needlesticks. However, data also shows that progress has slowed or even reversed in recent years.1 Today, the Centers for Disease Control and Prevention (CDC) estimate there are approximately 385,000 needlesticks and other sharps-related injuries to hospital-based healthcare personnel each year.2
Renewing safety focus amidst a rapidly changing healthcare landscape
Most sharps injuries involve physicians and nurses, but anyone who encounters needles in the course of their work is at risk. This includes roles from laboratory staff, nurse assistants, and medical technicians to environmental services. With a workforce already stressed by understaffing and turnover — exasperated by the COVID-19 pandemic — it is critical to consider that workers with varying levels of experience and training handling sharps may encounter them. That is why OSHA’s Bloodborne Pathogens standard stresses the creation of exposure prevention plans and regular training.
Five ways to prevent sharps and needlestick injuries, according to OSHA:3
1. Plan safe handling and disposal of sharps before any procedure.
2. Use safe and effective needle alternatives when available.
3. Activate the device’s safety features immediately after use.
4. Immediately dispose of contaminated needles in OSHA-compliant sharps containers.
5. Complete bloodborne pathogens training.
These steps may seem simple, but they are also easy to take for granted. For instance, device disposal into an appropriate sharps container. While 50.4% of sharps injuries in 2023 occurred during device use, before any safety mechanisms were activated, it is also worth noting that approximately 3% of sharps injuries occurred during disposal — the majority of which came from devices protruding from sharps containers.1
That was the case for Karen Daley, PhD, RN, MPH, FAAN. Dr. Daley, a past president of the American Nurses Association, spent more than 25 years in clinical practice at Brigham and Women’s Hospital in Boston until July 1998, when she was stuck by a needle protruding from a sharps container while disposing of a device. Needlesticks were not uncommon, and she did not think much of the incident at first.
“I never expected I would get infected with HIV and hepatitis C from a needlestick injury at work,” said Dr. Daley. “I almost did not report my exposure, but I’m grateful I was encouraged to. If I could change the circumstances contributing to my injury and infection, there are things I would have done differently. I would have made sure the needle disposal box was not overfull. I would have agreed to take the recommended post-exposure prophylaxis. All healthcare workers need to take advantage of the tools and information available to keep ourselves safe.”
Dr. Daley shares her story now to raise awareness of the risks surrounding needlestick injuries. Since her departure from clinical practice, she has been actively engaged on state, national, and
international levels as an advocate for the use of safer needle devices in healthcare practice settings. She was present when then-President Bill Clinton signed the NSPA into law in 2000.
“Seeing the power of coalition building, telling my story, and being part of the effort to get safety reform legislation passed have all been incredibly rewarding parts of my experience,” she said.
Another example of injury during device disposal comes from Annette Estrada, Greiner Bio-One Product Specialist for Preanalytics.
“In my 45 years of working in the clinical lab, I witnessed several coworkers sustain needlestick injuries,” Estrada said. “When it happened to me, I could not believe it — until I saw the punctured glove and blood.”
“My injury occurred with a butterfly device that did not have a safety mechanism. Upon completing the venipuncture, when trying to discard the device, one of the wings caught the edge of the sharps disposal box opening. The device slipped, sticking the palm of my hand.”
“I can’t help but think,” she said, “’If that butterfly had a safety device, I would have never sustained that needlestick.”
Stories like those from Dr. Daley and Estrada highlight a simple truth: Every needlestick is one too many. Even in best-case scenarios where there is no subsequent infection, the stress of an injury, risk of exposure to bloodborne pathogens and rigor of follow-up care place an incredible burden on healthcare workers who sustain needlesticks.
Engineering the future of needlestick injury prevention
When considering what measures may help prevent future needlesticks, engineering controls are a key focus. Data shows that needles and sharp devices without safety mechanisms accounted for 66.9% of sharps injuries in 2023.4 The CDC estimates that 62% to 88% of sharps injuries can be prevented simply by using safer medical devices.5 The Clinical & Laboratory Standards Institute (CLSI) standard for collecting venous blood specimens strongly encourages the use of safety-engineered blood collection devices.6 OSHA’s Bloodborne Pathogens standard requires their consideration, stating: “Engineering and work practice controls shall be used to eliminate or minimize employee exposure.”7 This means that if an effective and clinically appropriate safety-engineered sharp exists, an employer must evaluate and implement it.
Figure 1. Safety blood collection set designed for in-vein activation. Upon completion of specimen collection, the safety mechanism is activated by pressing release buttons. The needle is then automatically retracted and, at the same time, safely and irreversibly enclosed in the safety shield. A clearly audible click confirms that the safety mechanism is successfully activated.
The decades since OSHA’s original standard publication in 1991 and NSPA’s passing in 2001 have been marked by innovation in the design of safer sharps devices. Clinical laboratory practitioners see the fruits of this effort in improved blood collection devices, ranging from basic, manually assembled and activated needle shields to more advanced pre-assembled and semi-automatic devices.
Devices that enable in-vein activation – meaning the needle is completely and irreversibly sheathed as it is retracted from the patient’s vein, as illustrated in Figure 1 – offer some of the most advanced safety mechanisms among blood collection needles.
Taking responsibility for needlestick safety and prevention
Even with safety-engineered devices, proper training and education are essential to successfully reducing the rate of needlestick injuries. According to EPINet data, 27.3% of sharps injuries in 2023 were sustained while using safety-engineered devices.4 One study conducted in the Netherlands in 2018 even suggested the incidence of needlestick injuries may have increased since the wide adoption of safety- engineered devices. That study went on to identify two primary causes that may be improved with additional training: difficulty operating the devices and continued improper disposal.8
The Bloodborne Pathogens standard explicitly requires employers to provide bloodborne pathogen training to employees at the time of initial assignment and at least annually thereafter. CLSI GP41 stipulates using all safety-engineered devices according to the manufacturer’s instructions for use. Both standards call for immediate, safe disposal of used devices into appropriate sharps disposal containers.
As Dr. Daley suggested, protecting healthcare workers from needlesticks and sharps injuries requires a coalition approach. Manufacturers are responsible for continually improving and enhancing devices for safe, simple use; facility leadership is responsible for providing safe work environments, training, and tools to help protect healthcare workers; the device users themselves are responsible for taking ownership of their personal safety and following best practices to protect themselves and others.
Conclusion
Significant progress has been made in the past three decades as a result of combined focus and attention on needlestick safety and prevention. However, recent data shows the work is far from completed. As a recent consensus statement from the International Safety Center says, “Healthcare workers represent a critical national resource that must be protected from harm while they care for others. Healthcare worker safety is a crucial component of patient safety, and of the overall safety and quality of the healthcare environment.”1 Because every needlestick is one too many, progress must continue to ensure safer devices and safe practice.
Tammy Oppy, BS, MLS(ASCP) serves as Product Manager for Preanalytics at Greiner Bio-One, a global company specialized in the development, production, and distribution of high-quality laboratory products. Tammy focuses on Greiner Bio-One’s blood collection safety products, transfer devices and holders, and products for the collection and analysis of urine.
References are available online at mlo-online.com/55129622.
Genetic disease testing
By Bipin Chandra Dash, PhD
Genetic diseases or disorders are caused due to abnormality or mutations in the genetic makeup. As of July 2024, Online Mendelian Inheritance in Man (OMIM) listed 7,528 single locus (Mendelian) diseases that are associated with 4913 genes,1 and new genetic disorders are constantly being described in medical journals. 2 Around 80 percent of rare diseases are of genetic origin. 3 Currently, around 300 million people live with rare diseases. 3 Genetic disorders are broadly categorized into three types: singlegene defects, chromosomal abnormalities, and multifactorial conditions.4 Genetic diseases can be caused due to mutations in a single gene or multiple genes. 5
Single gene disorders
• Autosomal disorders are caused by a mutation in one of the 22 autosomal chromosomal pairs. These can be autosomal dominant or autosomal recessive. Autosomal dominant disorders happen when a gene mutation or abnormality from one of the parents passes on the disorder to the child. A few examples of autosomal dominant disorders are Huntington’s disease, Marfan syndrome, and achondroplasia.6 Autosomal recessive disorders happen when a gene mutation of abnormality is passed on to the child from both parents. A few examples of autosomal recessive disorders are cystic fibrosis, Tay-Sachs disease, sickle cell disease, and thalassemia.7
• X-linked disorders occur when a mutation in X-chromosome is passed on to the child. There are at least 533 disorders due to the involvement of the genes on the X chromosome. A few examples of the x-linked chromosomes are: Red-green color blindness, hemophilia, and Duchene muscular dystrophy. 8
• Y-linked disorders occur when a mutation in the Y-chromosome is passed on by a father to his son. A few exam-
ples of Y-linked chromosomes are Y chromosome infertility and some cases of Swyer syndrome.9
• Trinucleotide repeat disorders, also called triplet repeat disorders, are a set of over 30 genetic disorders caused by a mutation in which repeats of three nucleotides (trinucleotide repeats) increase in copy numbers until they cross a threshold above which they cause developmental, neurological, or neuromuscular disorders. Depending on its location, the unstable trinucleotide repeat may cause defects in a protein encoded by a gene; change the regulation of gene expression; produce a toxic RNA; or lead to production of a toxic protein.10,11,12 A few examples of trinucleotide repeat disorders are myotonic dystrophy (DM), Huntington disease, spinocerebellar ataxia, Friedreich ataxia, and fragile X syndrome.13
• Mitochondrial mutation disorders can affect one part of the body or many parts, including the brain, muscles, kidneys, heart, eyes, and ears, as mitochondria are the powerhouse of energy. Examples of mitochondria diseases are Barth syndrome, chronic progressive external ophthalmoplegia, Kearns-Sayre syndrome, Leigh syndrome, mitochondrial DNA depletion syndromes, mitochondrial encephalomyopathy, lactic acidosis, mitochondrial neurogastrointestinal encephalomyopathy, myoclonic epilepsy with ragged red fibers, neuropathy, ataxia, retinitis pigmentosa, and Pearson syndrome.14
• Imprinting disorders are congenital conditions that are due to disturbances of genomic imprinting. Genomic imprinting is the process by which only one copy of a gene in an individual (either from their mother or father) is expressed, while the other copy is suppressed. A few examples of imprinting disorders are Prader–Willi syndrome, Angelman syndrome, and Beckwith–Wiedemann syndrome.15
Photo
Chromosomal disorders
Chromosomal disorders are characterized by a morphological or numerical alteration in single or multiple chromosomes, affecting autosomes, sex chromosomes, or both.4 Chromosome abnormalities occur due to an error in cell division (mitosis or meiosis), which may occur in the prenatal, postnatal, or preimplantation periods. Chromosomal disorders are classified as numerical or structural and constitutional or acquired. A few examples of chromosomal disorder are:
• Down’s syndrome or trisomy 21
• Edward’s syndrome or trisomy 18
• Patau syndrome or trisomy 13
• Klinefelter’s syndrome or presence of additional X chromosome in males
• Turner syndrome or presence of only a single X chromosome in females
Multifactorial disorders
Multifactorial disorders, also called complex disorders, occur due to the influence of multiple genes acting in concert with environmental factors.5 This class of disorders probably represents the single largest class of inherited disorders affecting the human population. Heart disease, diabetes, cancer, asthma, schizophrenia, osteoporosis are all examples of multifactorial disorders.
Testing for genetic diseases
Genetic testing involves analysis of DNA, chromosomes, or proteins from an individual’s blood, skin, hair, or
other tissue specimens for a change, or mutation, which is associated with a genetic condition. When a mutation occurs, it may affect all or part of a gene and can result in an abnormal function leading to disease.16 Three major types of genetic testing are available in laboratories: cytogenetics examine structure and number of chromosomes under the microscope, biochemical tests measure proteins produced by genes, and molecular tests look for DNA mutations 16
Cytogenetics: This testing involves the analysis of cells in a sample of blood, tissue, amniotic fluid, bone marrow, or cerebrovascular fluid to identify any changes in an individual’s chromosomes. There are three major methods of cytogenetic testing:
Disorders of amino acid metabolism (amino acid disorders)
Disorders of organic acid metabolism (organic acidemias and acidurias)
Disorders of fatty acid oxidation
Disorders of urea cycle metabolism (urea cycle disorders
Disorders of cholesterol synthesis
Lysosomal storage disorder
Disorders of mitochondrial function (mitochondrial diseases)
Disorders of carbohydrate metabolism (carbohydrate metabolism disorders)
Disorders of connective tissue (e.g., collagen and fibrillin)
• Phenylketonuria
• Maple syrup urine disease
• Methylmalonic aciduria
• Propionic aciduria
• Glutaric acidemia type 1
• Medium-chain acyl-CoA dehydrogenase deficiency
• Citrullinemia
• Argininemia
• Ornithine transcarbamylase deficiency
• Smith-Lemli-Opitz syndrome
• Gaucher disease
• Fabry disease
• Hurler syndrome
• Niemann-Pick disease
• Leber’s hereditary optic neuropathy (LHON)
• Mitochondrial myopathy, encephalopathy, lactic acidosis,
• and stroke-like episodes (MELAS)
• Myoclonic epilepsy with ragged-red fibers (MERRF)
• Galactosemia
• Fructose intolerance
• Marfan syndrome
• Osteogenesis imperfecta
Table 1. Metabolic disorders for which biochemical genetic tests are performed.
Standard karyotyping: The first cytogenetics method used in the 1950s to visualize human chromosomes and their differences linked to conditions such as Down syndrome. In this method, chromosomes are paired and arranged in a standardized format known as karyotype or karyogram to provide a genome-wide snapshot of an individual’s chromosomes. Karyotypes are prepared using standardized staining procedures to reveal characteristic structural features for each chromosome. The stain most commonly used is Giemsa stain and produces G-banding at the site of the condensed chromosomes.17
Karyotyping is one of the most preferred methods to detect structural and numerical abnormalities and diagnose specific birth defects, genetic disorders, and even cancers. Clinical cytogeneticists analyze human karyotypes to detect gross genetic changes—anomalies involving several megabases or more of DNA. Karyotypes can indicate changes in chromosome number associated with aneuploid conditions, such as trisomy 21 (Down syndrome), as well as more subtle structural changes, such as chromosomal deletions, duplications, translocations, or inversions.
Fluorescent in situ hybridization (FISH): A molecular cytogegenetic technique developed in the early 1980s that uses fluorescent probes to bind to particular parts of a nucleic acid sequence (DNA or RNA) with a high degree of sequence complementarity. In this technique, the full set of chromosomes from an individual is affixed to a glass slide and then exposed to a fluorescently labeled probe. The fluorescently labeled probe finds and then binds to its matching sequence within the set of chromosomes. With the use of
Disease category
Metabolic disease
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a fluorescent microscope, the chromosome and sub-chromosomal location where the fluorescent probe bound can be seen.18 It is utilized to diagnose genetic diseases, gene mapping, and identification of chromosomal abnormalities, and may also be used to study comparisons among the chromosomes’ arrangements of genes of related species.
Comparative genomic hybridization (CGH) and array comparative genomic hybridization (aCGH): Comparative genomic hybridization (CGH) is a molecular cytogenetic method to analyze copy number variations (CNVs) without the need for culturing cells. This technique aims to quickly and efficiently compare two genomic DNA samples — a test and a reference arising from two sources — that are most often closely related, because it is suspected that they contain differences in terms of either gains or losses of either whole chromosomes or subchromosomal regions. This technique was originally developed to evaluate the differences between the
chromosomal complements of solid tumor and normal tissue.19
CGH has an improved resolution of 5–10 megabases compared to giemsa banding karyotyping and fluorescence in situ hybridization (FISH) that are limited by the resolution of the microscope utilized.20, 21
Array comparative genomic hybridization (aCGH): Also called as microarray-based comparative genomic hybridization, matrix CGH, array CGH is a molecular cytogenetic technique for the detection of chromosomal copy number changes on a genome-wide and high-resolution scale.22 Array CGH compares the patient’s genome against a reference genome and identifies differences between the two genomes, and thereby locates regions of genomic imbalances in the patient, utilizing the same principles of competitive fluorescence in situ hybridization as traditional CGH.
With the introduction of array CGH, the main limitation of conventional
CGH, a low resolution, is overcome. In array CGH, instead of using metaphase chromosomes as in traditional CGH, cloned DNA fragments (+100–200 kb) are used of which the exact chromosomal location is known. This allows the detection of aberrations in more detail - makes it possible to map the changes directly onto the genomic sequence with much higher resolution compared to traditional CGH.23 Using this method, copy number changes at a level of 5–10 kilobases of DNA sequences can be detected. This method allows one to identify new recurrent chromosome changes such as microdeletions and duplications in human conditions such as cancer and birth defects due to chromosome aberrations.24
Biochemical genetic testing: Some individuals exhibit “inborn errors of metabolism,” a genetic abnormality from birth that affects their body’s metabolism. Biochemical genetic tests are highly complex tests that are used to evaluate enzyme activity; functional Technology
Polymerase chain reaction (PCR)27 and real-time PCR
Multiplex ligationdependent probe amplification (MLPA)28
DNA microarray29
Sanger sequencing30
Simple, rapid, highsensitivity, high-specificity
Detects small rearrangements; up to 40 targets; high throughput; low cost
High throughput, accurate, rapid, high sensitivity
High accuracy, relatively long-read lengths, widely available, single-nucleotide resolution
Nextgeneration sequencing (NGS)31
High throughput, compared to Sanger sequencing, cost effective, high speed, better data resolution, accuracy
Possibility of false-positive results due to contamination and amplification bias; prior sequence data is required for primer design
Cannot detect copy neutral loss of heterozygosity. May have problems with mosaicism, tumor heterogeneity, or contamination with normal cells.
Costly, complex data analysis
Low throughput, relatively expensive, labor-intensive, inherent sequencing bias, inability to detect structural variants
Sequencing errors can occur in every process. Can exhibit GC bias, result influenced by quality and purity of DNA or RNA used. Storage and management of huge data generated is challenging
Genotyping, gene expression analysis, mutation detection
Detects copy number variations in complete chromosomes or single exons. Detects DNA methylation changes.
Genotyping, copy number variation, detection
Genotyping, mutation detection, validating results from nextgeneration sequencing
Whole genome sequencing, whole exome sequencing, targeted gene sequencing, RNA sequencing, enables detection of rare genetic variants
Table 2. Molecular tests for genetic diseases.
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status of proteins; and levels of metabolites such as amino acids, organic acids, and fatty acids from a wide variety of specimen types such as urine, whole blood, plasma, serum, cerebrospinal fluid, muscle biopsy, and other tissues. These tests are used to evaluate and diagnose, monitor treatment, and clinically manage such individuals.25 Table 1 provides a few examples of metabolic disorders for which biochemical genetic tests are performed.25
Molecular tests: These techniques have greatly advanced over the years and act as powerful tools for diagnosis, genetic consultation, and prevention of genetic diseases. 26 These are also used as follows:
• Determine presymptomatic individuals’ illness risk
• Detect asymptomatic recessive trait carriers
• Diagnose prenatal conditions not yet evident in pregnancy
Several factors are considered when selecting the appropriate test, including suspected conditions and their possible genetic variations. 26 A broad genetic test — whole genome sequencing or whole exome sequencing — is employed when a diagnosis is uncertain. A targeted test is preferred for suspected specific conditions. A targeted test could be for a single gene or a panel of genes and could be to detect point mutations, deletions, insertions, or copy number variations. Gene expression tests are performed to detect whether genes are active (producing mRNA and protein) or inactive. Too much activity (overexpression) or too little activity (underexpression) of specific genes may suggest particular genetic disorders, including various cancer types. Some of the commonly used methods used in molecular testing and their specific applications are provided in Table 2 .
Conclusion
To date there are 7,000 types of rare diseases and 300 million people live with rare diseases.3 80% of rare diseases are due to genetic causes, which means around 240 million people live with genetic disease. Hence genetic disease is a huge burden to the world. However, due to the complexity and variability, many genetic diseases are still not diagnosed and do not have proper treatment. That said, we can be hopeful that with the advancement of science and technology that is happening at such a rapid pace we would be
successful in offering precise solutions to patients with genetic diseases in the near future.
The advancements are taking place in various areas; for example, CRISPR/ Cas systems and small interfering ribonucleic acid (RNA) are helping to expand our understanding of genetics at the molecular level and various omics technology along with artificial intelligence are enabling better diagnosis and monitoring of genetic diseases and cell and gene therapy, which help to better manage patients having genetic diseases.
REFERENCES
1. Gene map statistics - OMIM. Omim.org. Updated August 1, 2024. Accessed August 2, 2024. https://www.omim.org/statistics/ geneMap.
2. Orphanet: Quality charter About rare diseases. Orpha.net. Accessed August 2, 2024. https://www.orpha.net/en/ other-information/about-rare-diseases.
3. The Lancet Global Health. The landscape for rare diseases in 2024. Lancet Glob Health. 2024;12(3):e341. doi:10.1016/ s2214-109x(24)00056-1.
4. Queremel Milani DA, Tadi P. Genetics, Chromosome Abnormalities. StatPearls Publishing; 2023.
5. CDC. Genetic disorders. Genomics and Your Health. Published May 17, 2024. Accessed August 2, 2024. https://www. cdc.gov/genomics-and-health/about/ genetic-disorders.html.
6. Autosomal dominant. Medlineplus.gov. Accessed August 2, 2024. https://medlineplus.gov/ency/article/002049.htm.
7. Gulani A, Weiler T. Genetics, Autosomal Recessive. StatPearls Publishing; 2023.
8. Basta M, Pandya AM. Genetics, X-Linked Inheritance. StatPearls Publishing; 2023.
9. What are the different ways a genetic condition can be inherited? Medlineplus. gov. Accessed August 2, 2024. https:// medlineplus.gov/genetics/understanding/ inheritance/inheritancepatterns/.
10. Orr HT, Zoghbi HY. Trinucleotide repeat disorders. Annu Rev Neurosci. 2007;30:575-621. doi:10.1146/annurev.neuro.29.051605.113042.
11. Boivin M, Charlet-Berguerand N. Trinucleotide CGG Repeat Diseases: An Expanding Field of Polyglycine Proteins? Front Genet. 2022;28;13:843014. doi:10.3389/ fgene.2022.843014.
12. Depienne C, Mandel JL. 30 years of repeat expansion disorders: What have we learned and what are the remaining challenges? Am J Hum Genet. 2021;6;108(5):764-785. doi:10.1016/j.ajhg.2021.03.011.
13. Paulson H. Repeat expansion diseases. Handb Clin Neurol. 2018;147:105-123. doi:10.1016/B978-0-444-63233-3.00009-9.
14. Mitochondrial disorders. National Institute of Neurological Disorders and Stroke. Accessed August 2, 2024. https://www. ninds.nih.gov/health-information/disorders/ mitochondrial-disorders.
15. Eggermann T, Monk D, de Nanclares GP, et al. Imprinting disorders. Nat Rev Dis Primers. 2023;29;9(1):33. doi:10.1038/ s41572-023-00443-4.
16. Genetic Alliance, The New York-Mid-Atlantic Consortium for Genetic and Newborn Screening Services. Genetic Testing Genetic Alliance; 2009.
17. O’connor C. Karyotyping for chromosomal abnormalities. Nature Education. 2008;1(1).
18. Fluorescence in situ hybridization (FISH). Genome.gov. Accessed August 2, 2024. https://www.genome.gov/genetics-glossary/ Fluorescence-In-Situ-Hybridization.
19. Kallioniemi A, Kallioniemi OP, Sudar D, et al. Comparative genomic hybridization for molecular cytogenetic analysis of solid tumors. Science. 1992;30;258(5083):818-21. doi:10.1126/science.1359641.
20. Strachan T, Read A. Human Molecular Genetics. Garland Science; 2010.
21. Weiss MM, Hermsen MA, Meijer GA, et al. Comparative genomic hybridisation. Mol Pathol. 1999;52(5):243-51. doi:10.1136/ mp.52.5.243.
22. Pinkel D, Albertson DG. Array comparative genomic hybridization and its applications in cancer. Nat Genet. 2005;37 Suppl:S11-7. doi:10.1038/ng1569.
23. Oostlander AE, Meijer GA, Ylstra B. Microarray-based comparative genomic hybridization and its applications in human genetics. Clin Genet. 2004;66(6):488-95. doi:10.1111/j.1399-0004.2004.00322.x.
24. Ren H, Francis W, Boys A, et al. BAC-based PCR fragment microarray: high-resolution detection of chromosomal deletion and duplication breakpoints. Hum Mutat 2005;25(5):476-82. doi:10.1002/humu.20164.
25. Centers for Disease Control and Prevention (CDC). Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders. MMWR Recomm Rep. 2012;61(RR-2):1-44.
26. Ishida C, Zubair M, Gupta V. Molecular Genetics Testing. StatPearls Publishing; 2024.
27. Garibyan L, Avashia N. Polymerase chain reaction. J Invest Dermatol. 2013;133(3):1-4. doi:10.1038/jid.2013.1.
28. Stuppia L, Antonucci I, Palka G, Gatta V. Use of the MLPA assay in the molecular diagnosis of gene copy number alterations in human genetic diseases. Int J Mol Sci. 2012;13(3):3245-3276. doi:10.3390/ ijms13033245.
29. Bumgarner R. Overview of DNA microarrays: types, applications, and their future. Curr Protoc Mol Biol. 2013 Jan;Chapter 22:Unit 22.1. doi:10.1002/0471142727. mb2201s101.
30. Frost A, van Campen J. Sanger sequencing. GeNotes. Accessed August 2, 2024. https://www.genomicseducation. hee.nhs.uk/genotes/knowledge-hub/ sanger-sequencing/.
31. Lohmann K, Klein C. Next generation sequencing and the future of genetic diagnosis. Neurotherapeutics 2014;11(4):699-707. doi:10.1007/ s13311-014-0288-8.
Bipin Chandra Dash, PhD has his doctorate in Life Science with major in Genetics and Masters in Business Administration (MBA) with major in Marketing. His areas of research are Biochemistry & Molecular Biology, Genetics, Immunology, Oncology, Virology, Tissue Culture, Vaccine R&D, etc.
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Easy-to-use analyzer prioritizing HbA1c
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A marker for long-term glucose control
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Simultaneous detection of autoantibodies
The KRONUS 3-Screen Islet Cell Autoantibody ELISA Assay Kit is for the simultaneous detection of autoantibodies to GAD and/or IA-2 and/or ZnT8 in human serum. Absorbance is measured and is proportional to the total amount of autoantibodies present. For Research Use Only. Not For Use in Diagnostic Procedures. KRONUS
Diabetes control
Dropper A1c is ideal for central laboratory and point-of-care hemoglobin A1c (HbA1c) methods, featuring 3-years frozen, 6-months refrigerated open-vial-stability, 21-days open-vial RT stability, and lot specific barcode card for Siemens DCA Vantage and DCA 2000 users. Compatible with most immunoassay analyzers. (Catalog #1510-02 – 4 x 0.9 mL 2-Level Set.) Quantimetrix
HbA1c Analyzer
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Compact HPLC analyzer for A1c testing
The Tosoh G8 Analyzer utilizes the Ion-Exchange HPLC method of HbA1c measurement with less than 2% CVs. Tosoh G8 is suitable for high throughput HbA1c testing in the laboratory or clinic environment. The compact analyzer detects and presumptively identifies commonly occurring hemoglobin variants. Tosoh Bioscience
Glucose reference materials for calibration verification
The liquid stable MATRIX PLUS Chemistry Reference Kitis available for calibration verification testing of Glucose. Verichem Laboratories
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Dedicated laboratory automation for hemostasis testing
By Anthony M. Barresi
Now more than ever, laboratories are tasked with the combined aim of maximizing test volume and reliability, while minimizing turnaround time (TAT) and cost. Automation is an essential tool to meet the challenges of rising labor costs and a shrinking laboratory professional work force. Table 1 provides examples of the potential benefits of laboratory automation. Laboratories can use a variety of key performance indicators (KPIs) to monitor the effects of automation, such as those shown in Table 2 .
Although hemostasis testing accounts for approximately 20% of the total test volume in many laboratories, it represents a significant opportunity for improved efficiency due to variables such as the relatively poor stability of coagulation factors, the high potential for assay interferences, and the time-sensitive role hemostasis testing plays in the management of critically ill patients.
Automation for hemostasis testing may be implemented as part of a total laboratory automation (TLA) system, which is typically designed to support multiple areas of the laboratory (e.g., chemistry, hematology).
• Decreased lifetime costs
• Improved efficiency and productivity
• Decreased hands-on time
• Improved use of space
• Faster and more consistent STAT and routine TAT
• Decreased rerun, reflex, and add-on testing
• Enhanced quality, standardization, and traceability
• Decreased opportunity for human errors in testing and sample handling
• Improved results integration
• Improved operator safety
• Decreased sample volume
Table 1. Potential benefits of laboratory automation.1-5
Benefits of a dedicated, specialized hemostasis automation system
Alternatively, hemostasis-dedicated automation solutions are available, which may provide increased connectivity with hemostasis instruments, allowing for a higher degree of customization and potential optimization. These dedicated hemostasis automation systems are physically smaller and less complex than TLAs and therefore can be delivered and installed faster and more easily than a full TLA system. Furthermore, the cost of a dedicated, specialized hemostasis automation system is relatively low, typically in the range of 10–20% of the cost of automating an entire laboratory. Finally, hemostasis automation systems also may benefit from specialized service and support staff who are trained to address the challenges unique to hemostasis instruments and assays.
Patient care
• Redraw rate
• Turnaround time (TAT)
• Clinician/patient complaint rate
Laboratory staff
• Injury rate
• Biohazard exposure rate
• Job satisfaction rate
• Staff retention rate
Productivity Cost
• Laboratory staff hands-on time/test
• Number of manual steps/tests
• Labor productivity (tests/ laboratory FTE)
• STAT test TAT (e.g., PT/INR, APTT)
• Autovalidation rate
• Analyzer, reagent, and consumable use
• Maintenance time/ instrument down-time
• Laboratory space utilization rate (test/ square feet)
• Volume of sendout tests
Table 2. Examples of KPIs potentially useful in monitoring the value of laboratory automation.
A. Dedicated hemostasis automation system
B. Typical TLA system with a hemostasis analyzer added
B. Typical TLA system with a hemostasis analyzer added
Figure 1. Track architecture and travel distance for hemostasis samples, comparing dedicated hemostasis automation system versus TLA system.
Centrifugation
Conclusion
Most hemostasis testing is performed using platelet-poor plasma (PPP). Producing PPP requires more intense centrifugation (higher force and/or longer time) than standard centrifugation protocols used to separate plasma or serum for typical clinical chemistry tests. Some dedicated, specialized hemostasis automation systems have been specifically designed to address this issue, with hemostasis-specific centrifugation protocols to achieve PPP in less than five minutes of spin time.1 For TLA systems to incorporate hemostasis testing, labs often employ one of three strategies: 1) centrifuge all samples at high enough intensity to achieve PPP; 2) spin hemostasis samples twice, typically with a manual centrifuge for STAT testing; or 3) provide a dedicated centrifuge for hemostasis testing.
Sample transport
After centrifugation and prior to separation of the PPP supernatant, PPP must not be agitated, or platelets will become resuspended, potentially impacting hemostasis test performance.1 Dedicated, specialized hemostasis automation systems achieve this using short, smooth, stable, and carefully leveled tracks. In contrast, more effort may be required to ensure that TLA systems do not result in significant sample agitation (See Figure 1).
System integration
For a laboratory to take full advantage of hemostasis automation, hemostasis analyzers must be closely integrated with the automation system, allowing bidirectional communication relative to test priority, system status, resource availability, and process details.
A dedicated, specialized automation system that incorporates a deep understanding of hemostasis testing and automation needs provides these connections, allowing data exchange that delivers intelligent routing and efficient workflow while providing laboratory personnel with the in-depth operational information essential for process improvement. Based on these capabilities, state-of-the-art, dedicated hemostasis automation systems provide dynamically updated sample routing with customizable rerun/reflex testing and sample sorting/banking. As of 2024, few TLA providers manufacture both hemostasis analyzers and assays. Furthermore, most current on-market TLA solutions do not offer the same degree of data connectivity with analyzers as a dedicated hemostasis automation workcell. Table 3 compares the level of connectivity and data exchange for dedicated hemostasis automation versus typical TLA systems.
Laboratories wishing to automate their hemostasis testing should carefully consider use of a dedicated, specialized hemostasis automation workcell. A dedicated system can provide capabilities not currently available from non-specialized TLA systems, which may allow laboratories to more fully realize the potential benefits of automation.
REFERENCES
1. Lippi G, Da Rin G. Advantages and limitations of total laboratory automation: a personal overview. Clin Chem Lab Med 2019;57(6):802-811. doi:10.1515/cclm-2018-1323.
2. Armbruster DA, Overcash DR, Reyes J. Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation). Clin Biochem Rev. 2014;35(3):143-153.
3. Yu HE, Lanzoni H, Steffen T, et al. Improving Laboratory Processes with Total Laboratory Automation. Lab Med. 2019;50(1):96-102. doi:10.1093/ labmed/lmy031.
4. Da Rin G, Lippi G. Total Laboratory Automation of Routine Hemostasis Testing. J Lab Autom. 2014;19(4):419-422. doi:10.1177/2211068213511246.
5. Tanasijevic MJ, Melanson SEF, Tolan NV, et al. Significant Operational Improvements with Implementation of Next Generation Laboratory Automation. Lab Med. 2021;52(4):329-337. doi:10.1093/labmed/lmaa108.
Anthony M. Barresi Senior Product Manager, Specialized Automation North America, Werfen,has decades of experience in Automation and Informatics with leading diagnostics companies, in marketing, sales, and engineering roles. He has a master’s degree in business administration from the University of Virginia, Darden Graduate School, and a bachelor of science degree in Mechanical Engineering from Virgina Tech.
Casts Priority Status Availability Details
Table 3. Data exchanged for different levels of integration with hemostasis analyzers.
Jamie Acero, MHA, CPP Manager, Point of Care Testing UPMC Clinical Lab
James R. Adams, MSHS, MLS(ASCP) Regional Medical Laboratory Scientist U.S. Department of State
Aimee Beth Angus Lead Molecular Microbiology Lifespan Academic Medical Centers
Kayla Bishop, MHA, MLS(ASCP) Laboratory Director Cleveland Area Hospital
Stephen Bishop, MBA, MS, MLS(ASCP)CM, CPHQ Director of Laboratory Services
California Hospital Medical Center U.S. Navy Reserve, Medical Service Corps Officer Laboratory Department Head for Expeditionary Medical Facility Camp Pendleton
Ida Blake Lead CLS-Chem ER at Spanish Springs
Alicia Branch, PhD Acting Lead, Outreach and Engagement Team CDC Training and Workforce Development Branch Centers for Disease Control and Prevention
Cecil James Buguis Administrative Laboratory Director Winkler County Hospital District
Celine Cang International Medical Laboratory Scientist Conexus MedStaff
Kylie Jean Caraway, MM, MLS(ASCP)CM Clinical Laboratory Director/ Manager, Wyoming Family Practice Educational Health Center of Wyoming
Lainie E. Chalk Laboratory Compliance Supervisor/ CLS Eisenhower Health
Robina Colclough-Davy, M.S., MLS(ASCP)CM Assistant Professor/Program Director Clinical Laboratory Sciences Program St. Johns University
Carlo Cornacchione, M.S.H.A., B.S., C (ASCP)CM, MLT (ASCP) Senior Medical Technologist Akron Children’s Hospital
Introducing the 2024 Award Winners
Charlie P. Cruz, PhD, SM (ASCP), MLS (ASCP), CLS Associate Lecturer and Specialist in Microbiology, Medical Laboratory Sciences University of Wyoming
Angela Dodd MLT(ASCP) Labcorp
Jeanna Donkle Microbiology Supervisor Milwaukee VAMC
Marianne T. Downes PhD MLS (ASCP)CM Program Director Geisinger School of Medical Laboratory Science
Allison Eck Laboratory Director Doylestown Hospital
Kaja Edwards, MLS (ASCP)CM Point of Care Coordinator/MLS Ozarks Community Hospital
Nicole M. Ferguson, Maj, USAF, BSC Branch Chief, AF Blood Program Air Force Medical Command
Ashley S. Frost, MHA, MLS (ASCP)CM Laboratory Director Commander, United States Public Health Service Kodiak Area Native Association
Michelle Gagan Department Chair York Technical College
Courtney Getz, MBA, BS MLS (ASCP) Laboratory Site Manager St. Luke’s University Health Network
Carolyn Hager, MLS (ASCP)CM Lab Clinical Trainer Wisconsin Diagnostic Laboratories
Hoda Hagrass, MD, PhD, FCAP, FADLM Assistant Professor Medical Director of Clinical Chemistry and Immunology Laboratories, Department of Pathology University of Arkansas for Medical Sciences
Kathleen Hainsworth MBA, MLS (ASCP) Manager, Salem Health Laboratories-Dallas Salem Health Hospitals & Clinics
Pam Hale, MLS(ASCP) M, MS General Laboratory Manager Hendrick Regional Laboratory
Nikki Heidemann Clinic Laboratory Director Boone County Health Center
Ericka Hendrix, PhD, MB(ASCP)CM Associate Professor/ Program Director of Molecular Pathology
M.S. Texas Tech University Health Sciences Center
Nicholas Hoo-Fatt, PhD(c), MS, HTL(ASCP), DP Histology Program Education Coordinator Inova Laboratories
Heather L. Hurley Executive Director, Laboratory Accreditation & Health Systems Strategic Accounts The Joint Commission
Anna Inman Anatomic Pathology Manager/ Laboratory Services
Intermountain Health-St. Mary’s Medical Center
Kathryn Jacoby, MBA, MLT (ASCP) Manager, Quality Wisconsin Diagnostic Laboratories
Dr. Meenakshi Jain Lab Director Unilabs Middle East
Rebecca A. James, MS, MLS(ASCP)CM Medical Laboratory Technology Program Director/Instructor Southeastern Technical College
Karl Kamper, MBA, MT(ASCP), FACHE System Director, Clinical Support Operations Salem Health Hospitals & Clinics
Jason Key Assistant Online Program Director/ Assistant Professor UAMS
Dwane A. Klostermann, MSTM, MLS(ASCP)SBB Medical Laboratory Technician Program Director Moraine Park Technical College
Emilia Marrero-Greene, M Ed, MT(AAB), M(ASCP) Supervisor, Microbiology Lakeland Regional Health
Max Mauch, MLS (ASCP)CM, POCT Specialist (AACC) Point of Care Coordinator Benefits Health System
Paola P. Pagan Assistant Vice President, Laboratory Operations University of Miami Health System
Fragerson Paguirigan, MLS, CLS Clinical Laboratory Scientist Christus St. Vincent Regional Medical Center
Daniel Rios Laboratory Manager Martin County Hospital District
Maridaliz Rodriguez Rosado, PhD Educator Coordinator/MLS Director Lakeland Regional Medical Center
Elisha Sirois, MSM, MLS(ASCP)CM Laboratory Manager Maine General Health
Steffini Stalos, DO, MS, FCAP Medical Laboratory Director Blood Associates LLC
Nicole Sutherland, MLS (ASCP)CM Laboratory Manager – Outreach and Support Services Avera McKennan Hospital & University Health Center
Jason Taylor Supervisor, Laboratory Services Southwest Transplant Alliance
Brittany Teeter, M.S CLS MLS(ASCP)CM Assistant Professor UT Health San Antonio
Karen Updegraff, MLS (ASCP), CPP (ADLM) Manager, Point of Care Testing Service Guthrie Medical Group/Guthrie Clinic
Megan Waldoch DL Hematology Supervisor Versiti Blood Center of WI
Ian Wallace, MLS(ASCP)CM Medical Laboratory Scientist, Laboratory Supervisor Intermountain Health Hematology Best Practice Team Lead Platte Valley Medical Center
Selena Warden, MSc, C(ASCP)CM Director, Laboratory Services Southwest Transplant Alliance
Stephanie Whitehead Executive Director, Pathology Services University Health
Kelly Winter, PhD, MPH Chief, Training and Workforce Development Branch Centers for Disease Control and Prevention
Celine Cang International Medical Laboratory Scientist
Conexus Medstaff
Age: 27 years old
Hometown: Butuan City, Philippines (currently lives in Silver Spring, Maryland)
Alma mater: Centro Escolar University in Manila, Philippines
Number of years of experience: 5 years
Someone you look up to in the industry: There are many people I admire and am grateful for, but I will always look up to my sister, who is a nurse. She introduced me to this profession before I pursued my degree in it. She encourages me to become better every day and has always pushed me to aim higher in terms of dreams and goals.
Favorite hobby: Right now, I’m deeply immersed in learning a new language, particularly French.
Favorite movie of all time: I love the movie Forrest Gump, so I could say this is my all-time favorite. It’s because the movie talks about love, resilience, and how one person can make a big difference in the world, regardless of their situation.
Favorite band or musician: I enjoy music a lot; there are many artists I like. Right now, Sza is my favorite.
Favorite thing about working in a lab: There’s always something new to discover, and the process of learning is endless. I find hematology and microbiology fascinating and rewarding. There’s so much to learn just by observing through the microscope. I take pride in my job because we assist doctors in diagnosing patients. Collaborating with my peers is another aspect of my work that I greatly enjoy.
Karen Updegraff, MLS (ASCP), CPP (ADLM)
Manager, Point of Care Testing Service
Guthrie Medical Group/ Guthrie Clinic
Age: 55
Hometown: Elmira, NY
Alma mater: Elmira College, B.S. Clinical Laboratory Science. Certified Point of Care Professional by the ADLM (formerly AACC)
Number of years of experience: 18 years as a clinical laboratory scientist. 28 years total having worked as a phlebotomist and laboratory assistant.
Someone you look up to in the industry: Anthony Fauci
Favorite hobby: Jewelry making
Favorite movie of all time: I have many favorites — it is hard to pick one — but 2004’s “Something The Lord Made,”
which highlights Laboratory Technologist Vivien Thomas and his work with Dr. Alfred Blalock in pioneering pediatric cardiac surgery in correcting Tetralogy of Fallot, is relevant to the importance of laboratory professionals in advancing medicine.
Favorite band or musician: Foo Fighters
Favorite thing about working in a lab: My favorite thing about working in the lab is the opportunity to teach non-laboratory professionals how to perform waived laboratory testing and the ability to bring the laboratory out to the point of patient care at primary and specialty offices.
Max Mauch, MLS (ASCP)CM, POCT Specialist (AACC) Point of Care Coordinator Benefits Health System
China and The Goonies
Favorite band or musician: Prince and Reel Big Fish
Age: 42
Hometown: Great Falls, Montana
Alma mater: University of Montana
Number of years of experience: 19
Someone you look up to in the industry: Rick Import
Favorite hobby: Playing/ coaching soccer, paddleboarding, kayaking
Favorite movie of all time: Big Trouble in Little
Favorite thing about working in a lab: Guiding new professionals and being the link between the main laboratory and all point-of-care users (Flight Crew, OR, RN, RT, Pharmacy, CMA, Specialties).
Jason Taylor Supervisor, Laboratory Services Southwest Transplant Alliance
Favorite Hobby: Tinkering
Hometown: Clinton, Louisiana
Alma mater: University of Louisiana at Monroe (ULM)
Number of years of experience: 17 years of experience currently
Someone you look up to the industry: Selena Warden because she’s the 1st director/manger I’ve ever dealt with that’s kept her word (I’m serious, not joking).
Favorite movie of all time: IT (the old mini-series with Tim Curry as Pennywise the Clown). The book is better than the movie!
Favorite band or musician: Musician–Marvin Gaye; Band–Arctic Monkeys
Favorite thing about working in the lab: It’s an odd intersection of technology and humanity (blood, tissue, organs, etc.) that’s often overlooked but is an absolute necessity for saving lives in the medical field. I feel we’re the unsung heroes of it all, and I love it.
MEDICAL LABORATORY OBSERVER’S
“55 Under 55”
Winner
Congratulations to Karen Updegraff, MLS (ASCP), CPP (ADLM), Manager of the Guthrie Medical Group Point of Care Testing Service, for being named one of Medical Laboratory Observer’s “55 Under 55” honorees.
Karen has made significant contributions to Guthrie’s success and patient care by upgrading inpatient and outpatient point-of-care laboratory testing. Her initiatives include automating urinalysis and urine pregnancy testing, as well as incorporating molecular Strep A testing into the test menu.
Well done, Karen!
Thank you for your dedication to continuously improving patient care at Guthrie.
Selena Warden, MSc, C(ASCP)cm Director, Laboratory Services
Southwest Transplant Alliance
Age: 47
Hometown: Bloomington, IN
Alma mater: USMC, Indiana University (Bachelor’s), University of Florida (Master’s), University of Miami (Ph.D. in progress)
Number of years of experience: 29
Someone you look up to in the industry: The Westgards; Douglas Poser Jr., MD, ABP-AP, CP, FP & TM; Ashraf Mozayani, PhD, F-ABFT; Gary L. Milburn, PhD; William D. DePond, MD; Dexter Holland, PhD
Favorite Hobby: Hiking with Veterans and anything involving Ted, my English Bulldog
Favorite movie of all time: The Last of the Mohicans Favorite band or musician: Smashing Pumpkins
Favorite thing about working in a lab: The most rewarding aspect of working in a clinical laboratory is the direct contribution to patient care and the pivotal role in saving lives.
Kayla Bishop, MHA, MLS(ASCP) Laboratory Director Cleveland Area Hospital
Age: 28
Hometown:
Alma, Arkansas
Alma mater: Oklahoma State University
Number of years of experience: 6
Someone you look up to in the industry: Katrina Billingsley, MSTM, MLS(ASCP)SBB
Favorite hobby: Drawing
Favorite movie of all time: Interstellar
Favorite band or musician: Sleep Token
Favorite thing about working in a lab: Problem solving! Every day brings new and unique scenarios where I have the opportunity to use my education and experience to creatively solve problems to lead and improve the laboratory.
INDEX OF ADVERTISERS
Ionized or Total Magnesium Levels, What Should We Measure in Critically Ill Patients?
Monitoring and measuring magnesium (Mg) values is essential to prevent the development of numerous complications in critically ill patients. This webinar will describe why Ionized Mg (iMg) may offer a more reliable indicator of Mg status during acute illness than total Mg (tMg) concentrations. Dr. Abdullah M. Al Alawi, Sr. Consultant, UMC, Muscat, Oman will discuss the incidence of dysmagnesemia and the relationship between iMg and tMg. The clinical and biochemical characteristics as well as health outcomes and their association with iMg and tMg will be addressed. Dr. Alawi will also describe the use of point-of-care devices for rapid assessment of iMg in critical situations.
Primary Presenter
Dr. Abdullah M. Al Alawi, MD, BSc, MSc, FRACP, FACP
Sr. Consultant, UMC, Muscat, Oman
Program Director, Internal Medicine Residency Program, Sultan Qaboos University Department of Medicine
Ionized Magnesium Assessment in Critically Ill Patients
Ionized magnesium disorders are common in critically ill patients and are associated with increased morbidity and mortality. Dennis Begos, MD, will discuss the advantages of measuring whole blood ionized magnesium (iMg), the physiologically and chemically active form of magnesium, for more effective management of dysmagnesemia in critically ill patients.
Presenter
Dennis Begos, MD, FACS, FACRS
Senior Director
Medical and Scientific Affairs
Nova Biomedical
Webinar Dates: Thursday, October 10, 1:00 PM ET Thursday, October 17, 3:00 PM ET
Register Now at: novabiomedical.com/img-critical-mlo
Educational Credits
This program offers 1 hour of P.A.C.E. continuing education credits. Nova Biomedical is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.
This program has been approved by the American Association of Critical-Care Nurses (AACN), for 1.00 CERPs, Synergy CERP Category A, File Number 25182. Approval refers to recognition of continuing education only and does not imply AACN approval or endorsement of the content of this educational activity, or the products mentioned.
Hemostasis automation that works on
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Make your lab a HemoCell lab.
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