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WSLH PT Blog

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A Closer Look At Multiplex Panel Testing

Pros, cons, and contexts of use

Multiplex panel testing, which allows for the simultaneous detection of multiple pathogens from a single sample, has become increasingly prevalent in clinical laboratories, particularly during the COVID-19 pandemic. These panels range from smaller assays targeting just a few pathogens to extensive panels that can identify 20 or more different targets. They offer significant advantages in terms of speed and efficiency when diagnosing complex infections. However, while multiplex testing brings many benefits, it also has its limitations, including high costs, the potential for overuse, and the risk of false positives. This article examines the rise of multiplex testing, its benefits and limitations, and the appropriate contexts for its use, including specific panel applications.

The Evolution of Multiplex Testing and Public Health

The foundation of multiplex testing was laid in the late 20th century with advancements in molecular diagnostics. The advent of polymerase chain reaction (PCR) technology in the 1980s revolutionized the ability to detect specific DNA and RNA sequences with high precision (Mullis, 1990). Initially, PCR was used for single-target tests, which, while effective, were limited when multiple conditions needed to be ruled out or confirmed simultaneously.

In response to outbreaks like HIV/AIDS in the 1980s and 1990s, and most recently COVID-19, the limitations of traditional testing methods became apparent. These health crises highlighted the need for more comprehensive and faster diagnostic solutions that could handle a broader range of pathogens. Public health emergencies played a crucial role in advancing the development of multiplex panel testing, demonstrating its value in both routine diagnostics and global health crises (Miller & Johnson, 2019).

Clinical laboratories also play a vital role in providing valuable data from multiplex panel testing to public health surveillance in the United States. Allen Bateman from the Communicable Disease Division at the Wisconsin State Laboratory of Hygiene (WSLH) emphasizes the importance of this contribution to the monitoring of national pathogen trends.

“When clinical laboratories provide multiplex panel results in aggregate, particularly for gastrointestinal (GI) and respiratory pathogens, it enhances our situational awareness of which pathogens are circulating nationally,” says Bateman. This data is sent each week by participating U.S. laboratories and reported in the National Respiratory and Enteric Virus Surveillance System (NREVSS). Bateman adds that this interactive dashboard is an excellent way to see how clinical laboratories are an integral part of public health surveillance, helping track the spread of viruses across regions and seasons.

Efficiency and Comprehensive Diagnosis

Modern multiplex panels are designed to detect multiple pathogens simultaneously, making them highly adaptable for various diagnostic needs. They include panels for gastrointestinal (GI) infections that identify bacteria, viruses, and parasites in patients with diarrhea, cerebrospinal fluid (CSF) panels for detecting pathogens causing meningitis or encephalitis, blood culture panels for bloodstream infections, and panels for diagnosing infections in prosthetic joints after surgery (BMC Infectious Diseases, 2022, FDA, 2020)

Respiratory multiplex panels have proven particularly valuable in diagnosing viral and bacterial infections, including influenza and respiratory syncytial virus (RSV), with studies highlighting their accuracy and rapid detection capabilities. Lower respiratory panels have shown improved specificity and sensitivity over traditional bacterial cultures, allowing for faster diagnosis of conditions like pneumonia. These advancements reduce the need for broad-spectrum antibiotics, aiding in better antibiotic stewardship (Clinical Chemistry, 2022).

 

Another benefit of multiplex panel testing is its ability to test for all targets simultaneously, rather than requiring multiple separate tests. Unlike traditional methods, which can take days to yield results, multiplex panels provide faster diagnoses, which is crucial for conditions like sepsis. Quick identification of pathogens enables timely, targeted treatment, significantly improving patient outcomes and reducing morbidity and mortality (Peeling et al., 2020). This approach enhances speed and efficiency, which are key factors driving its increased adoption in clinical microbiology laboratories.

Considerations of Panel Size, Population, and Context

To address concerns about multiplex testing, it’s crucial to consider broader healthcare factors influencing test ordering practices. A 2017 survey by the American Medical Association found that physicians believe about 20.6% of medical care is unnecessary, including a significant portion of prescriptions, tests, and procedures. This overtreatment is often driven by fears of malpractice, patient demands, and difficulties accessing comprehensive medical records, factors which also impact the use of complex and costly multiplex tests (O’Neill et al., 2017).

The Choosing Wisely® campaign, initiated by the American Board of Internal Medicine and later adopted by the American Society for Clinical Pathologists, aimed to reduce unnecessary tests and procedures by promoting evidence-based care. This initiative was particularly relevant as multiplex testing became more common, providing guidance on appropriate test utilization (ASCP, 2019).[1]

Overuse of extensive multiplex panels can strain healthcare systems and increase financial burdens. For outpatient settings, smaller panels that test for conditions like influenza, RSV, and COVID-19 are often sufficient and cost-effective, reducing unnecessary testing for rare pathogens (Wu et al., 2021). Conversely, large panels are more suitable for high-risk populations, such as hospitalized or immunocompromised patients, where the benefits of comprehensive testing justify the higher costs (Vogels et al., 2021; Schmitt et al., 2020).

False Positives and Clinical Interpretation

One notable drawback of large multiplex panels is the increased risk of false positives, particularly for rare pathogens. The positive predictive value (PPV) of a test decreases as the prevalence of the condition being tested for decreases. This means that a positive result for a rarely encountered pathogen is more likely to be false (Schmitt et al., 2020). False positives can lead to unnecessary treatments, such as antibiotics or antiviral medications, and additional follow-up testing, which complicates care and increases costs.

Interpreting results from large multiplex panels can also be challenging. A positive result for a rare pathogen may not be clinically relevant if the patient does not show corresponding symptoms. Distinguishing between true infections and cases of colonization or contamination requires careful consideration (Morens & Fauci, 2013). The potential for false positives underscores the importance of using multiplex tests judiciously, particularly in lower-risk patient populations.

Conclusion

Multiplex panel testing has significantly advanced clinical diagnostics by enabling rapid and comprehensive detection of multiple pathogens from a single sample. This technology is particularly valuable for high-risk patients or in cases of severe infections where broad diagnostic capabilities are crucial. However, it also presents challenges, including high costs, potential overuse, and the risk of false positives. Laboratories offer a variety of panel options, while clinicians are responsible for selecting the appropriate panels. This collaboration ensures that testing is both effective and cost-efficient, minimizing unnecessary procedures and managing financial impacts effectively.

For further information on multiplex panel testing and its applications, laboratory professionals can consult reputable sources such as the Communicable Disease Division (CDD) at the Wisconsin State Laboratory of Hygiene (WSLH). The Wisconsin Clinical Laboratory Network (WCLN) has also collaborated with CDD to provide informational sessions on multiplex panel testing, laboratory automation and other best practices in clinical diagnostic testing. You can find these resources and trainings archived here: Training Events | Wisconsin State Laboratory of Hygiene.

Clinical laboratories may choose from a range of CMS-approved proficiency testing (PT) providers, who can assist them with purchasing multiplex PT products. Inside our proficiency testing catalog, you will find a detailed chart of our multiplex products, which cater to various microbiology organisms and include options that are CLIA-regulated, educational, or both. For information on other specialties, take a look at WSLH PT’s 2025 Clinical Product Catalog.

References

American Society for Clinical Pathology. (2024, February 6). ASCP transitions Choosing Wisely program, continues commitment to effective test utilization. Retrieved from https://academic.oup.com/labmed/article/50/4/331/5584946

BMC Infectious Diseases. (2022). Diagnostic accuracy of multiplex respiratory pathogen panels for influenza or respiratory syncytial virus infections: Systematic review and meta-analysis. BMC Infectious Diseases. https://bmcinfectdis.biomedcentral.com

Clinical Chemistry. (2022). Next-generation diagnostics: The evolution of multiplex panels for infection detection. Clinical Chemistry, 68(1), 59-64. https://academic.oup.com/clinchem/article/68/1/59/6490236

Food and Drug Administration (FDA). (2020). FDA approves first multiplex assay. *FDA Website*. Retrieved from [https://www.fda.gov](https://www.fda.gov)

Miller, R. J., & Johnson, S. K. (2019). The role of multiplex testing in modern diagnostics. Lab Medicine, 50(4), 331-339. https://doi.org/10.1093/labmed/lmz013

Peeling, R. W., Heymann, D. L., Teo, Y. Y., & Garcia, P. J. (2020). Diagnostics for COVID-19: Moving from pandemic response to control. *The Lancet Infectious Diseases, 20*(11), 1335-1344. [https://doi.org/10.1016/S1473-3099(20)30573-5](https://doi.org/10.1016/S1473-3099(20)30573-5)

Schmitt, B., Heyn, B., Munz, M., Schultheiß, B., & Lang, T. (2020). Integration of artificial intelligence in laboratory diagnostics: A historical perspective. *Diagnostics, 10*(12), 1040. [https://doi.org/10.3390/diagnostics10121040](https://doi.org/10.3390/diagnostics10121040)

Vogels, C. B., Brito, A. F., Wyllie, A. L., et al. (2021). Multiplex qRT-PCR to distinguish SARS-CoV-2 variants of concern in clinical samples. *Journal of Clinical Microbiology, 59*(6), e00977-21. [https://doi.org/10.1128/JCM.00977-21](https://doi.org/10.1128/JCM.00977-21)

Wu, A. H., Smith, A., & Sandoval, J. (2021). Respiratory virus detection: Advances in multiplex testing. *Clinical Microbiology Reviews, 34*(4), e00061-21. [https://doi.org/10.1128/CMR.00061-21](https://doi.org/10.1128/CMR.00061-21)

 

[1] In 2024, ABIM closed the Choose Wisely® program, prompting ASCP to shift its focus to integrate effective test utilization initiatives into its Quality and Patient Safety Steering Committee, continuing its commitment to improving test use through a new best practices campaign. ASCP will keep developing guidelines and tools for laboratories, drawing on its extensive experience and member engagement from the Choosing Wisely® era (ASCP, 2024).

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

The Psychology of Lab Management

How Our Minds Influence Results, Outcomes, and Decision-Making

In the realm of clinical laboratory management, understanding the psychological factors that influence decision-making is crucial for optimizing outcomes and ensuring accurate results. Cognitive biases, which are systematic patterns of deviation from norm or rationality in judgment, play a significant role in how lab managers make decisions. In the context of lab management, these biases can significantly influence decision-making, leading to suboptimal outcomes and impacting the accuracy of results. Recognizing and mitigating these biases can lead to more effective lab management and better patient outcomes.

Examples of Cognitive Bias

Understanding the types of cognitive biases that can impact decision-making is crucial for laboratory professionals to ensure accurate and effective lab management. As discussed in an article by Today’s Clinical Lab, various cognitive biases can affect decision-making in clinical laboratories, such as confirmation bias, anchoring bias, and overconfidence bias, among others. These biases can lead to systematic errors and skewed interpretations of lab results, ultimately affecting the quality of patient care. The article elaborates on how these biases manifest in the lab setting and offers strategies for mitigating their impact.

To illustrate an example, confirmation bias refers to the tendency to search for, interpret, and remember information in a way that confirms one’s preconceptions. For lab managers, this could mean giving undue weight to test results that align with expected outcomes while disregarding those that don’t. According to a review by Vincent Berthet in “Frontiers in Psychology,” this bias can lead to the reinforcement of incorrect hypotheses, impacting the overall quality of lab results​(Frontiers)​.

Another example of cognitive bias is anchoring bias, which occurs when individuals rely too heavily on the first piece of information they receive (the “anchor”) when making decisions. In a lab setting, initial test results or preliminary diagnoses can unduly influence subsequent decisions, even when new, contradictory information emerges. The American Medical Association (AMA) highlights this bias as particularly prevalent among medical professionals, including those in laboratory settings, affecting the objectivity of subsequent evaluations​ (American Medical Association)​.

Mitigating Cognitive Biases

To mitigate the impact of cognitive biases in lab management, several strategies can be implemented. Educating lab personnel about cognitive biases is the first step toward mitigating their effects. Awareness can help individuals recognize their own biases and take corrective measures. According to a review in “Evidence-Based Nursing,” ongoing training and workshops focused on cognitive biases and their impact on decision-making are essential in creating a culture of critical thinking and self-reflection​ (Evidence-Based Nursing)​.

Implementing structured decision-making processes, such as standardized checklists and protocols, can help reduce the influence of biases. These tools ensure that all relevant information is considered and that decisions are based on objective criteria. The American Medical Association offers guidelines and frameworks that can be adapted for lab management settings​ (American Medical Association)​.

Conducting regular audits of decision-making processes and providing feedback can help identify patterns of bias and areas for improvement. Constructive feedback mechanisms foster a learning environment where biases are acknowledged and addressed. The CDC offers extensive resources on conducting audits and implementing feedback mechanisms in healthcare settings. They highlight the role of these practices in improving patient safety and laboratory quality.

Conclusion: Incorporating these principles into your lab management practices can lead to substantial improvements. At WSLH Proficiency Testing, we understand the importance and appreciate what it takes to maintain quality decision-making practices. We are committed to supporting laboratories in achieving the highest standards of accuracy and reliability in their test results. Understanding the psychological factors that influence lab management can lead to improved decision-making, enhanced performance, and better outcomes. By addressing cognitive biases through effective communication and the development policies and procedures, clinical laboratory managers can create a more efficient and positive work environment. Embrace these strategies to not only enhance lab operations but also to contribute to the overall mission of delivering high-quality patient care.  

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WSLH PT Blog

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Preparing for 2025: An Easy, 3-Part Checklist

As the 2025 proficiency testing (PT) enrollment period approaches, it’s time to ensure your clinical laboratory is not just ready but ahead of the game. Navigating the new CLIA proficiency testing rule and optimizing your lab’s procedures can seem daunting, but it is also an opportunity to optimize your laboratory’s standards and performance. Below you will find an overview of information to help your laboratory prepare for the new CLIA PT requirements as you enroll in clinical proficiency testing for 2025.

  1. Understand the New CLIA PT Requirements

In July 2022, CMS unveiled significant updates to the CLIA PT requirements, effective January 1, 2025. These changes, including new regulated analytes and revised grading criteria, are designed to enhance laboratory accuracy and reliability. For a deep dive into these updates, refer to WSLH Proficiency Testing’s CLIA PT Requirements page. On our webpage, you will find detailed tables that list the new CMS-regulated analytes with their corresponding modules and revised scoring criteria.

Further changes will be communicated closer to the implementation date of January 1, 2025.
If you have any questions about the new requirements, please contact WSLH PT at 800-462-5261 or ptservice@slh.wisc.edu.

  1. Evaluate Your Current PT Providers

Assess the capabilities of your current PT providers in light of the new requirements. Ensure they are accredited and able to support your laboratory in meeting the updated standards. Consider enrolling with multiple providers to enhance quality assurance.

Diversifying your PT providers can offer substantial benefits. Lab manager Julie Steele successfully utilizes both CAP and WSLH PT to achieve a balance between quality assurance and cost-effectiveness. Annually comparing PT catalogs and verifying provider accreditation can ensure your lab remains adaptable and resilient to transitions and staff changes. Discover more about this approach here.

  1. Review and Update Laboratory Procedures

Conduct a thorough review of current procedures and update them to align with the new CLIA requirements. This includes revising testing protocols, documentation practices, and compliance checklists. In particular, creating and optimizing your documentation protocol is key. Learn about best practices in PT documentation in this MLO article. Laboratory Manager Vicky Norrish can attest to the importance of creating excellent policies and procedures to better empower her staff. You can read about her experience and more at Grinnell Regional Medical Center on our blog. Detailed workflows, procedures, and checklists for every PT process stage, from enrollment to post-analysis, help laboratories maintain compliance with greater ease.

Conclusion

Successfully managing transitional periods can be a challenge, especially when it comes to updates to regulatory compliance. Clinical laboratories will need a robust plan for handling changes, including staff training and updating your PT provider enrollments. WSLH Proficiency Testing is here to assist your laboratory with the transition. If you have any questions about the CLIA PT requirements or would like a one-on-one consultation, please do not hesitate to contact our team of technical experts at ptservice@slh.wisc.edu, or by calling our toll-free number (800) 462-5261.

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up to receive your digest of clinical lab news, memes, and more:

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

Benefits of Attending the Clinical Lab Expo

As clinical laboratory professionals navigate the rapidly evolving landscape of healthcare, staying updated with the latest advancements and trends is crucial. The Annual Scientific Meeting & Clinical Lab Expo organized by the Association for Diagnostics & Laboratory Medicine (ADLM), formerly known as the American Association for Clinical Chemistry (AACC), offers an unparalleled opportunity to do just that. While the Scientific Meeting is indispensable for acquiring cutting-edge scientific knowledge, the Clinical Lab Expo presents unique benefits that make it equally essential for professionals in the field.

Hands-On Exposure to Innovative Technologies

One of the primary reasons to attend the Clinical Lab Expo is the hands-on exposure to the latest technologies, instruments, and other medical laboratory products. The Clinical Lab Expo is a huge interactive environment of over 900 exhibitors. This direct interaction allows laboratory professionals to assess the functionality and practicality of new tools and programs, which is crucial for making informed purchasing decisions and enhancing lab operations. By staying informed about the latest advancements and understanding the full capabilities of new products, laboratory professionals can make more cost-effective and strategic decisions regarding technology investments.

With so many vendors to visit, ADLM is adding a fun, new scavenger hunt this year. This interactive experience helps attendees explore the conference, visit exhibitor booths, and engage in meaningful interactions with industry professionals. You can get yourself prepared by familiarizing yourself with ADLM’s interactive floor plan for the Clinical Lab Expo. Along the main hallway on the Clinical Lab Expo floor, you will find WSLH Proficiency Testing and many other groups. Click here to download the Expo floor plan, and visit WSLH Proficiency Testing at Booth #2822.

In-Depth Learning Opportunities

While the Scientific Meeting provides in-depth educational sessions, the Expo complements this by offering additional learning opportunities through workshops and presentations conducted by industry experts. Gain insights into 60-minute presentations loaded with information on new technologies and solutions. These industry workshops will be held in the Exhibit Hall Theatre on the Exhibit show floor during the day on Tuesday, July 30 through Thursday, August 1.

Exhibitors often present case studies and success stories that highlight how their products have resolved specific issues in various lab settings. This practical approach enables attendees to visualize how they can implement similar solutions in their labs, improving efficiency, accuracy, and overall performance. Engaging with exhibitors and seeing live demonstrations can spark new ideas and innovative approaches to problem-solving that may not emerge from theoretical discussions alone.

Conclusion

While the ADLM Scientific Meeting is invaluable for gaining theoretical insights and understanding the latest research, the Clinical Lab Expo provides a complementary and equally critical experience. By attending the Expo, clinical laboratory professionals can engage with cutting-edge technologies, network with industry leaders, stay abreast of market trends, and find practical solutions to enhance their lab operations. The combination of these experiences ensures that attendees are not only well-informed but also well-equipped to lead their laboratories into the future. Therefore, for those looking to maximize their professional development and operational efficiency, the ADLM Clinical Lab Expo is an event that should not be missed. To register for the Expo only, click on this link: Clinical Lab Expo Registration | myADLM.org. The cost to register for the Expo only is just $40 until June 7, 2024. Registration is open now through July 27.

 

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WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

Automate Your PT Workflow

In the fast-paced realm of laboratory testing, efficiency and accuracy are paramount. Yet, amidst the daily whirlwind of processing patient samples, managing data, and ensuring quality assurance, there’s often a persistent bottleneck: managing proficiency testing (PT) workflows.

Why automate PT workflows, you might ask? The answer lies in the seamless integration of PT processes with existing LIS platforms. By eliminating the need for manual data entry, laboratories can ensure that PT results mirror the patient test order and result workflow, thus reflecting real-world scenarios accurately.

Do you or your laboratory staff type out your PT results? You may want to join us for our joint live webinar all about automating your PT workflow into your existing Laboratory Information System (LIS). Scheduled for May 13th, 2024, at 11:00 AM (CDT), this free, 30-minute webinar will provide insights into the streamlining process, and will provide a moderated Q&A session for registered participants.

Hosted by WSLH Proficiency Testing and Labgnostic PT, our guest speaker Steve Box, the Global Business Development Director at X-Lab, will invite laboratory professionals to discover how embracing automation can not only save valuable time but also mitigate risks associated with manual data entry. X-Lab’s vision is to be the leader in connecting the world’s diagnostic systems to improve healthcare for all. Their products, Labgnostic and LabReach, solve the challenges of referring and reporting diagnostic tests in and out of labs and other care organizations across Europe, the US, and Australia.

In this 30-minute webinar, you will learn about how automating your process can also remove the monotony and risk of error that comes from keying in results. Beyond the benefit of convenience, automating PT workflows enhances efficiency, reduces errors, and enhances overall laboratory quality. Moreover, it frees up valuable resources that can be redirected toward other critical tasks, ultimately improving patient care.

The launch of our joint live webinar with Labgnostic PT serves also as the start of our new partnership with Labnogistic PT, a global project of UK-based X-Lab. This new partnership between WSLH Proficiency Testing and Labgnostic PT marks a significant milestone in the advancement of streamlined laboratory operations.

“We envision a future where laboratories operate seamlessly, powered by digital healthcare solutions and connectivity,” says Steve Box. “By empowering laboratories to automate PT data submission into their existing LIS, our partnership aims to revolutionize PT workflows nationwide.”

In conclusion, the convergence of automation and collaboration promises to redefine laboratory workflows for many clinical laboratories across the United States. From simplifying PT processes to fostering partnerships that drive innovation, the future of laboratory medicine is brighter than ever. As we bid farewell to manual data entry, we welcome a new era of efficiency, accuracy, and excellence in patient care. WSLH Proficiency Testing hopes you will join us for the live webinar launch on May 13.

 

WSLH PT Blog

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Honoring Three Medical Laboratory Professionals

As we celebrate Medical Laboratory Professionals Week, WSLH Proficiency Testing shines a spotlight on dedicated individuals who work tirelessly behind the scenes to ensure the accuracy and reliability of medical testing results. Our experiences as laboratory professionals are uniquely crucial to our healthcare system, contributing significantly to patient outcomes and the broader understanding of public health.

This year, we bring you the inspiring stories of three remarkable individuals, Barb Goodson, Caitlin Miranda, and Shirely Keenan, who have dedicated their lives to the field of medical laboratory science. Each journey is unique, yet they all share a common passion for their profession and a commitment to making a difference in the lives of others.

Barb Goodson, MSW: Building a Lab from the Ground Up

Barb Goodson’s journey into the world of medical laboratory science began unexpectedly. After working for 23 years in various positions at her local public health department in Hancock, Michigan, Barb found herself thrust into the frontline response at the start of the COVID-19 pandemic in 2020. She recounts how she took on so many more roles in response and “kind of did everything,” from working in the call center to contact tracing.

However, it was in September 2020 that Barb received a unique opportunity—to build a public health testing lab in the Western Upper Peninsula of Michigan from scratch. This laboratory would serve as one of the 6 regional public health laboratories in Michigan’s Public Health Laboratory network. Armed with determination and a love for challenges, Barb took on the task with gusto. Despite not having any prior experience in a laboratory since high school, Barb embraced the project wholeheartedly.

While she initially pursued a career as a social worker specializing in geriatrics, her transition to the laboratory field was marked by her ability to identify and address community needs creatively. Over the course of a year, Barb and her team worked tirelessly to construct the laboratory and navigate through verifications and policy procedures. Finally, in September 2021, the laboratory now known as the Western UP Regional Public Health Laboratory, began testing for COVID-19 and other infectious diseases.

“My vision was for the lab to be there for COVID, but I really looked at this as an opportunity to bring on a variety of communicable disease testing in our community,” said Barb.

With her team and the support of the Michigan Bureau of Laboratories, Barb aims to provide a range of communicable disease testing to the community, bridging gaps in healthcare accessibility and ensuring faster turnaround times for critical tests. Having specialized infectious disease testing available in the local community is a significant asset, enabling healthcare providers to diagnose and treat patients more effectively.

Caitlin Miranda, M (ASCP): A Journey of Discovery and Dedication

Caitlin Miranda’s journey into the laboratory field was sparked by her exploration as a Biology major in her college years. Initially unsure of her career path upon graduation in 2008, Caitlin was encouraged to apply for an internship in a small-town hospital laboratory in Owosso, Michigan. It was here that she discovered her passion for medical laboratory science.

As an intern, Caitlin had the opportunity to immerse herself in various aspects of laboratory work, from performing routine tests to gaining insights into the intricacies of microbiology. Inspired by her experiences and supported by mentors who believed in her potential, Caitlin pursued further education in medical laboratory science.

“Once I entered the world of laboratory medicine, I knew that this was where I was exactly supposed to be,” said Caitlin. “That sense of belonging drives my passion to keep doing what I am doing.”

Throughout her career, Caitlin has held various roles at Oregon State Public Health Laboratory, from bench technologist to Microbiology lead, and now as Quality Assurance and Safety Manager. For Caitlin, the most rewarding aspect of her work as the Microbiology bench lead was knowing that her work directly impacted patient outcomes, particularly in the context of community-acquired diseases like syphilis and HIV. Today, she remarks how her experience on the bench informs her role as a decision-maker to enact meaningful changes in policy and practice for laboratory quality improvement.

As Caitlin reflects on her journey, she encourages others in the field, who may be curious about other opportunities or who are feeling burnout, to explore different career avenues connected to medical laboratories. Our unique knowledge and experience as laboratory professionals, she says, can provide crucial contributions to the broader healthcare landscape. From clinical work to administrative roles, each of us plays a vital role.

Shirley Keenan, MS, BS, MT (ASCP): From Medical Assistant to Chief Microbiologist

Shirley Keenan’s journey into medical laboratory science began in the late 1970s, when she worked as a medical assistant for a physician in a growing practice. It was here that Shirley first encountered and learned basic laboratory skills, sparking her interest in the field. However, it wasn’t until the physician hired a medical laboratory professional that Shirley considered pursuing a career in laboratory science herself. It was her colleague who encouraged her to go to school to pursue a degree in Medical Laboratory Science at the University of Buffalo in New York.

“She actually drove me to the University of Buffalo to learn more about the program and to enroll in classes,” said Shirley. “I am not sure if I would have pursued an education in laboratory medicine if it had not been for her encouragement.”

Throughout her education, she was captivated by the structured nature of laboratory work and the critical role it plays in patient care. After completing her degree, Shirley continued her education, eventually becoming Chief Microbiologist for the Public Health Department of Erie County in New York.

In her current role, Shirley oversees laboratory operations, ensuring the accuracy and reliability of test results. She emphasizes the importance of attention to detail and adherence to standard operating procedures in maintaining the quality of testing. Shirley takes pride in her team’s dedication to delivering accurate results, particularly in the context of public health initiatives like infectious disease surveillance.

Shirley acknowledges the challenges and rewards of working in the laboratory field. From her early days as a medical assistant to her current role as a chief microbiologist, Shirley’s commitment to excellence remains unwavering, driving her dedication to the profession.

 Celebrating Excellence in Medical Laboratory Science

As we honor Medical Laboratory Professionals Week, WSLH Proficiency Testing expresses gratitude to countless individuals like Barbara, Caitlin, and Shirley who work diligently behind the scenes to safeguard public health and improve patient outcomes. Their unwavering dedication and commitment to excellence exemplify the vital role of medical laboratory professionals in the healthcare system. WSLH PT celebrates all the invaluable work and individual contributions to healthcare.

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

Clinical Laboratories Benefit from CDC OneLab

Clinical Laboratories Benefit from CDC OneLab

Clinical laboratories serve as the backbone of healthcare, pivotal in diagnosing diseases and monitoring public health. Amidst evolving health challenges, the Centers for Disease Control and Prevention (CDC) introduced CDC OneLab in 2020—to empower clinical laboratories and strengthen public health infrastructure. Through centralized access to essential information, laboratories can streamline operations, reduce errors, and ensure adherence to best practices. The initiative fosters collaboration among laboratory professionals, facilitating knowledge exchange and collective problem-solving in the face of complex health threats.

As part of a national public health laboratory, WSLH Proficiency Testing understands the importance of developing and maintaining quality diagnostic testing as well as building public health infrastructure in the United States. Here are some of the key benefits of participating in the CDC’s OneLab REACH network and information hub:

Unified Access to Resources: OneLab serves as a centralized hub where laboratories can access a wealth of resources, including training modules, protocols, proficiency testing, and quality assurance guidelines. By consolidating essential information in one accessible platform, laboratories can streamline their operations, mitigate errors, and ensure compliance with best practices.

Enhanced Collaboration and Networking: In an interconnected world, collaboration is key to combating infectious diseases and advancing scientific knowledge. The OneLab Network fosters a vibrant community of laboratory professionals, enabling them to share insights, exchange ideas, and collaborate on research projects. By leveraging collective expertise and experiences, laboratories can focus more intently on problem-solving and the development of innovative strategies.

Real-time Data Sharing and Surveillance: Timely and accurate data are indispensable assets in the battle against outbreaks and epidemics. OneLab facilitates seamless data sharing and surveillance, enabling laboratories to report findings, track trends, and identify emerging threats in real time. By harnessing the power of data analytics and predictive modeling, public health agencies can swiftly respond to potential crises and implement targeted interventions.

Adoption of Best Practices and Standards: Standardization lies at the heart of laboratory medicine, ensuring consistency, reliability, and reproducibility across diverse settings. OneLab promotes the adoption of standardized protocols, methodologies, and quality control measures, fostering a culture of excellence and accountability within the laboratory community. By adhering to recognized standards, laboratories can enhance the reliability of their results and instill confidence in their stakeholders.

Capacity Building and Professional Development: Continuous learning is essential for staying abreast of advancements in laboratory science and technology. OneLab offers a comprehensive suite of training programs, workshops, and webinars, equipping laboratory professionals with the knowledge and skills needed to excel in their roles. Topics range from routine diagnostic testing to strengthening resilience against biological threats. Additionally, OneLab Test (Timely Education and Support of Testers) provides more connections and training between the testing community and the CDC to expand access to diagnostic testing. By investing in professional development, laboratories can cultivate a skilled workforce capable of meeting the evolving demands of modern healthcare.

The CDC’s OneLab initiative elevates laboratory practices, fostering collaboration, and enhancing public health preparedness. Consider joining the CDC’s OneLab by creating a free OneLab REACH account at reach.cdc.gov. Through its centralized access to resources, promotion of collaboration, real-time data sharing, adoption of best practices, emphasis on professional development, and focus on resilience, CDC OneLab offers laboratories invaluable tools to navigate the complexities of modern healthcare. As part of a national public health laboratory, the Wisconsin State Lab of Hygiene (WSLH), WSLH Proficiency Testing recognizes the importance of quality diagnostic testing and the development of robust public health infrastructure in the United States.

CDC OneLab and the Wisconsin Clinical Laboratory Network:
“The value of networking and building relationships and trust through providing educational training is definitely something that CDC OneLab is working hard to do,” says Erin Bowles, BS MLS (ASCP), who is the Wisconsin Clinical Laboratory Network (WCLN) Outreach Coordinator for WSLH. As Outreach Coordinator, Erin coordinates the WCLN, a network of clinical laboratories in the state to ensure a timely and effective response to clinical laboratory and public health needs. The WCLN purpose encompasses emergency preparedness, disease surveillance, laboratory diagnostics, training and education, and communications.

“There is nothing more wonderful than being able to connect with laboratory partners and colleagues to share our knowledge and resources,” said Erin Bowles. We’ve been doing that locally in WI for about 20 years now.”

Erin Bowles adds, “I’m thankful for the support that CDC OneLab is providing to clinical laboratories across the nation to grow and develop a strong, well-informed network of laboratory professionals. This raises the bar for all labs and encourages us all to become stronger and better able to respond to any clinical or public health challenge.”

Participating in the CDC’s OneLab REACH network and information hub offers laboratories invaluable opportunities to enhance their proficiency testing and diagnostic testing knowledge, and contribute to the broader public health effort. When laboratories engage with this transformative platform, they contribute to the collective effort to enhance diagnostic precision, disease surveillance, and outbreak response. In doing so, they play a crucial role in safeguarding public health and shaping the future of laboratory medicine.

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WSLH PT Blog

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Important CLIA Changes to Proficiency Testing Requirements

The Centers for Medicare & Medicaid Services (CMS) published their final rule on July 2022 including Proficiency Testing (PT) revisions. PT revisions will go into effect January 1, 2025 and will include analytes that will be CMS regulated along with revised grading criteria for existing analytes. Please refer to this 2025 CLIA changes document for more information, including the effective date, and also the implementation date of the CMS final rule. 

Most of the modules WSLH PT offers already meet these requirements. Where possible, WSLH PT will reassign laboratories using a non-waived method enrolled in a 3-sample PT module to a 5-sample PT module. Reassignments will be reflected on 2025 Enrollment Quotes sent out in September 2024. The tables below list new CMS regulated analytes with their corresponding modules and revised scoring criteria.

Further changes will be communicated closer to the implementation date of January 1, 2025. If you have any questions about the new requirements, please contact WSLH PT at 800-462-5261 or ptservice@slh.wisc.edu.

To view the new CMS-regulated analytes, revised scoring criteria for currently regulated analytes,
and microbiology changes, please visit our webpage: 
CLIA and Proficiency Testing Changes – WSLH Proficiency Testing (wslhpt.org)

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The Evolution of Clinical Proficiency Testing: A Historical Perspective

Early Days of Clinical Proficiency Testing

After the end of World War II, a well-known clinical laboratory scientist by the name of F. William Sunderman detailed his return from wartime to reassume his position as the director of the Hospital of the University of Pennsylvania. Having all experienced the shared realities of wartime, he and his other colleagues across Pennsylvania saw a need to convene and discuss mutual problems in their laboratories. Finding recurring inaccuracies in test results, that year in 1945, Sunderman and a group of laboratory professionals in Pennsylvania met and decided to distribute unevaluated serum specimens among their members and to report the results of analyses. The results revealed inadequacies so surprising that the Committee on Laboratories of the Pennsylvania Medical Society requested the members to check upon the accuracy of the more common chemical measurements made in hospital laboratories throughout the state.

The results were published in a survey, which were some of the papers used in Senate subcommittee hearings for the passage of the Clinical Laboratory Improvement Act (CLIA). This and other surveys were used to illustrate the historical need for federally regulated proficiency testing for laboratories in response to the passage of Medicare. Throughout much of the mid-century leading up to the passage of CLIA, about 2,000 clinical laboratories subscribed to participate in self-auditing proficiency testing programs coordinated largely by the Virginia Pathology Society, with endorsements by the American Society of Clinical Pathologists (ASCP) in 1952.

The early days of proficiency testing in the United States can be traced back to stories like this when medical laboratories began recognizing the need for standardization and quality control. Clinical proficiency testing, an essential component of healthcare quality assurance, has undergone significant evolution throughout history. From its rudimentary beginnings to the sophisticated systems in place today, the journey of clinical proficiency testing reflects advancements in medical science, technology, and the growing emphasis on patient safety.

The 1960s and the Rise of External Quality Assurance

The 1960s marked a turning point in clinical proficiency testing with the introduction of external quality assurance programs. Before then, there were no standardized regulations on laboratories across the United States. From its inception in 1967 to today, the Clinical Laboratory Improvement Amendments (CLIA) in the United States assure that lab tests are standardized and comparable between different labs. The first passage of CLIA in 1967 came upon the heels of the passage of Medicare in 1966, which was the first time the government was paying for health services for the elderly.

“If the government was going to pay for health services, they determined they had to have standards,” said Dr. Stanley Inhorn about the importance of Medicare in standardizing proficiency testing in the United States.

In an interview with the University of Wisconsin-Madison Oral History Program, Dr. Inhorn details his time as Director of the Wisconsin State Laboratory of Hygiene during the passage of Medicare and the creation of regulatory standards. During that same year Medicare passed in 1966, Dr. Inhorn and the rest of the leadership at WSLH established the Laboratory Improvement Division, known today as WSLH Proficiency Testing. In 1968, Dr. Inhorn was asked to come down to CDC to develop standards for laboratories that would be licensed and approved under Medicare. Along with other committee members, he developed standards for personnel and divided the tests into complex tests, intermediate tests, and tests that were called “waivered”, now known as “waived.” These early programs primarily focused on basic chemistry and hematology testing, paving the way for a more comprehensive approach to quality assurance in clinical laboratories. Dr. Inhorn has since served on the Clinical Laboratory Improvement Advisory Committee after the 1988 updates to the Clinical Laboratory Improvement Amendments that included regulatory updates to clinical proficiency testing.

Technological Advancements in the Late 20th Century

As technology advanced, clinical laboratories transitioned from manual techniques to automated instrumentation. This shift necessitated the development of proficiency testing programs that could keep pace with the evolving diagnostic landscape. The late 20th century saw the integration of molecular biology techniques, immunoassays, and advanced imaging technologies into clinical laboratories, prompting proficiency testing programs to expand their scope accordingly.

The advent of the internet in the late 20th century revolutionized the way proficiency testing was administered and managed. Online platforms emerged, allowing laboratories to participate in proficiency testing remotely. This not only increased accessibility but also facilitated real-time data analysis and feedback, enabling laboratories to address issues promptly and improve their testing processes.

The 21st Century: Personalized Medicine and Specialized Proficiency Testing

With the rise of personalized medicine and the increasing use of genomics, clinical proficiency testing has become more specialized. Laboratories are now required to demonstrate proficiency in molecular diagnostics, next-generation sequencing, and other cutting-edge technologies. Proficiency testing programs have adapted to include these specialized areas, ensuring that laboratories can provide accurate and reliable results in the rapidly advancing field of medical genetics. Looking to the future, advancements in artificial intelligence and machine learning are poised to play a significant role in shaping proficiency testing. These technologies have the potential to enhance data analysis, identify patterns, and further improve the accuracy and reliability of clinical testing.

Conclusion

While clinical proficiency testing has come a long way, challenges persist. The increasing complexity of diagnostic technologies, the need for global standardization, and the continuous emergence of new testing methodologies present ongoing challenges for proficiency testing programs.

The evolution of clinical proficiency testing reflects the dynamic nature of the healthcare industry. From its humble beginnings as a tool for basic quality assurance to its current status as a comprehensive and specialized system, proficiency testing has played a vital role in ensuring the accuracy and reliability of diagnostic testing. As technology continues to advance, proficiency testing programs will adapt to meet the challenges of an ever-changing healthcare landscape.

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Unwrapping the Science of Winter Traditions

The Phenomenon of Seasonal Joy

Winter brings a rich and varied tapestry of traditions that highlight the beauty of cultural differences. As we adorn our homes with festive lights and celebrate the season with loved ones, we are also reminded that woven through this tapestry of winter traditions is also the thread of our common humanity. In this article, we explore the commonality within our customs through the lens of science, and scientific foundations. From the astronomical rhythms of the winter solstice to the alchemy of warming spices, the science behind winter traditions is as fascinating as the traditions themselves.

The Biological and Astronomical Basis of Winter Traditions

At the heart of winter traditions lies the Winter Solstice, the shortest day and longest night of the year. Scientifically, this phenomenon occurs due to the axial tilt of the Earth as it orbits the sun. In a PBS News Hour article, William Teets, an astronomer at Vanderbilt University, adds, “Believe it or not, we [the Earth] is closest to the sun in January,” a reminder that the Earth’s tilt is responsible for the changing seasons, not the Earth’s distance from the sun. On the 21st of December, the winter solstice in the Northern Hemisphere marks a pivotal point where daylight hours reach their minimum. At the same time, the Southern Hemisphere is celebrating the summer solstice, marking the longest day of the year. The celestial event has long been associated with celebrations, symbolizing the triumph of light over darkness.

On a biological level, winter’s shorter days and reduced sunlight can influence our internal clock or circadian rhythm. The decrease in natural light exposure can lead to an uptick in melatonin production, the hormone responsible for regulating sleep. This shift in our biological patterns is also linked to Seasonal Affective Disorder (SAD), a form of depression that typically occurs during the winter months. Understanding these biological rhythms adds a layer of appreciation for the significance of winter traditions, as a means of slowing down, finding rest, and combating the seasonal blues.

The Psychology and Chemistry of Hot Beverages

Winter cuisine is a testament to the chemistry of comfort and celebration. Many cultures drink hot, spiced beverages such as wassail, sujeonggwa, and champurrado, especially during winter, for a calming effect on the mind and body. On a strictly biological level, when humans experience a sudden change in bodily temperature from holding a warm beverage, cortisol is released in the body, which is a chemical that helps regulate stress. According to John Hopkins Medicine, the regular consumption of certain spices was also linked to decreased rates of depression and mitigating the pain caused by arthritis. As discussed, colder weather, decreased daylight, and very busy holiday schedules can further intensify a person’s genetic or environmental influence to have depression or arthritis.

There is also a psychological and cultural dimension to consuming warm beverages which humans may employ to find a more joyful connection with others and their environment. According to several studies outlined in the Guardian, holding and consuming hot drinks has a psychological effect on human perception and behavior. One study conducted in the United Kingdom indicated that strangers holding hot drinks, such as a cup of coffee, were more likely to be perceived as trustworthy and to exhibit generous behavior. In other words, the interaction between heat and ingredients like cinnamon, cloves, and citrus creates a sensory experience that goes beyond taste. There are social, psychological, and biological benefits to our sensory connection to warm, spiced beverages, or food, for that matter.  

The Neuroscience of Holiday Gifts

Gift-giving is a practice all cultures share; and, our practices of giving and receiving during winter certainly are varied and diverse. A variety of winter traditions globally exemplify the significance of gift-giving in fostering social bonds and spreading joy. Diwali, Hanukkah, Christmas, Kwanzaa, New Year celebrations, and Lunar New Year festivities all involve the exchange of gifts, symbolizing unity and goodwill within communities. Gift-giving isn’t just a nice gesture for humans; it’s a neuroscientific marvel. When we engage in the act of giving and receiving gifts, our brains release neurotransmitters such as dopamine and oxytocin. These chemicals play a crucial role in shaping our emotional experiences.

Dopamine, often referred to as the “reward neurotransmitter,” contributes to feelings of pleasure and reinforcement. Oxytocin, known as the “love hormone,” enhances social connections and fosters a sense of trust and closeness. The importance of this neurological response lies in its ability to promote positive emotions and strengthen social bonds. When these neurotransmitters are not released or are imbalanced, it can lead to a range of emotional and social challenges. Lack of dopamine is associated with feelings of apathy and reduced motivation, while a deficiency in oxytocin may contribute to difficulties in forming and maintaining social relationships. The neurochemistry of gift-giving unveils its profound impact on human well-being, providing insights into the role of neurotransmitters in shaping our emotional landscapes and strengthening social connections.

Conclusion

Winter traditions are more than festive rituals; they are a celebration of the natural world, a dance between the scientific wonders of our planet and the cultural expressions of humanity. By delving into the science behind these traditions, we gain a deeper appreciation of winter a season of wonder and joy. From the celestial beauty of the winter solstice to the intricate dance of neurotransmitters in response to gift-giving, each tradition provides insights into the intricate interplay between environment, biology, and culture. As we move through the winter season, these traditions are expressions not only of our cultural identity, but of the brilliance of our humanity: the ingenious ways we humans adapt our senses, elevate our mood, and foster the emotional connections essential for human well-being.

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