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A Closer Look At Multiplex Panel Testing

Posted on September 23, 2024 by flowerme

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

The Psychology of Lab Management

Posted on August 13, 2024 by flowerme

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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Preparing for 2025: An Easy, 3-Part Checklist

Posted on June 26, 2024 by flowerme

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.

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.

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.

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.

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Benefits of Attending the Clinical Lab Expo

Posted on May 28, 2024 by flowerme

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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Honoring Three Medical Laboratory Professionals

Posted on April 8, 2024 by flowerme

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.

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The Evolution of Clinical Proficiency Testing: A Historical Perspective

Posted on December 18, 2023 by flowerme

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

Posted on November 27, 2023 by flowerme

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 21^st 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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WSLH PT Blog

Where Do PT Samples Come From?

Posted on October 30, 2023 by flowerme

The Journey of Proficiency Testing Samples: Sourcing, Creation, and Quality Assurance

Proficiency testing plays a crucial role in ensuring the quality and accuracy of diagnostic testing. It helps healthcare providers identify areas for improvement, maintain compliance with regulatory standards, and ultimately enhance patient care. Central to the proficiency testing process are the samples used for evaluation; but, have you ever wondered where these proficiency testing (PT) samples come from?

In this article, we will discuss how PT samples are sourced by CMS-approved, clinical PT providers under the Clinical Laboratory Improvement Amendments (CLIA). Knowing how PT samples are created, procured, and distributed sheds more light on sample handling, storage, and their overall role in maintaining quality control standards.

Understanding Proficiency Testing Samples

Proficiency testing samples, also known as PT samples, are intricately designed materials that closely resemble patient specimens. These samples cover an extensive array of medical tests, spanning specialties like chemistry, hematology, microbiology, and immunology. Specialized commercial vendors play a pivotal role in manufacturing and distributing these PT samples to clinical laboratories globally. These vendors house teams of experts dedicated to creating and packaging PT samples that accurately simulate real patient specimens.

Partnership between CMS-Approved PT Providers and Commercial Vendors

CMS-approved proficiency testing providers collaborate with commercial manufacturers to acquire the necessary samples for assessing clinical laboratories enrolled in PT programs. Since the inception of ISO standards in 1987 and the Clinical Laboratory Improvement Amendments (CLIA) of 1988, these providers have worked diligently to ensure the procurement of high-quality PT materials. They draw upon a network of national and international commercial vendors to source samples essential for their PT programs.

Manufacturing Proficiency Testing Samples

Proficiency testing samples predominantly comprise synthetic materials. However, some samples may incorporate human or animal-derived materials like blood components, urine, serum, plasma, or other biological fluids. The choice of materials hinges on the specific tests being simulated. Raw materials undergo processing and formulation to mimic the properties of real patient specimens. This involves adjusting concentrations, incorporating preservatives, stabilizing agents, and ensuring the samples possess the appropriate characteristics to closely resemble human serum.

Reference labs, often associated with academic institutions or research centers, collaborate to maintain the quality of proficiency testing samples. For instance, the WSLH Proficiency Testing sources samples from manufacturers, but their Blood Lead program uniquely produces samples in-house.

The Unique Process of Blood Lead PT Program

At the Wisconsin State Laboratory of Hygiene (WSLH), the Blood Lead PT program stands as a remarkable example of in-house sample production. Four Jersey cows reside at the Dairy Forage Research Center at the University of Wisconsin-Madison for their sole participation in our Blood Lead PT program. These cows are dosed with lead twice a year to produce units for sample development. Before the program’s commencement over a decade ago, a study validated that dosing cows with lead twice a year didn’t affect their quality of life. Karyn Blake, the Materials Program Administrator at WSLH’s Chemical Emergency Response Program, details the unique use of bovine blood in producing PT samples for lead, mercury, and cadmium analyses. This approach is crucial due to the challenges and scarcity of using human blood for sample production.

Stock photo of Jersey cows, courtesy of Adobe Stock

Once the lead doses are administered to the cows, the collected bovine blood is processed, screened for endogenous lead concentrations, frozen into units, and stored for use in PT programs. These units can be tailored to specific concentrations as requested by different laboratories participating in proficiency testing. The blood samples may vary depending on the laboratory’s testing needs, tailored either for Point-of-Care testing or spiked with higher concentrations of lead for proficiency testing via more complex methods. For the multi-element panel PT program, the units are spiked for mercury and cadmium analysis.

Karyn Blake emphasizes the impact of this process on maintaining labs’ accreditation needs and ensuring the precision and reliability of clinical testing across various facilities. This innovative approach showcases a unique method of creating PT samples for crucial analyses. To review WSLH PT’s Blood Lead program, view page 11 in our 2024 Clinical PT Product Catalog.

Ensuring Sample Quality

During the creation of PT samples, rigorous quality control measures are implemented by commercial vendors and reference laboratories. Manufacturers of PT samples verify their accuracy, precision, and stability over time. Proficiency Testing providers, when selecting vendors to supply samples for their programs will review evidence of manufacturing quality and certificates of conformance to the ISO 9001:2015 standard for manufacturers of custom proficiency and EQA products. Once formulated and validated, PT samples are meticulously packaged to preserve their integrity during transportation and storage.

Conclusion: The Essence of Proficiency Testing Samples

The journey of proficiency testing samples, from conception to evaluation, is a meticulously orchestrated process. Commercial vendors and reference laboratories, armed with expert knowledge and an unwavering commitment to quality, collaborate with CMS-approved proficiency testing providers. This collaboration ensures the availability of high-caliber PT materials. These meticulously crafted samples, designed to emulate real patient specimens, stand as a critical component in the development of quality proficiency testing programs.

CMS-approved proficiency testing providers play a pivotal role in acquiring, distributing, and evaluating these samples for the development of PT programs. Their dedication ensures that healthcare facilities uphold high standards of quality and accuracy in patient care. As the diagnostic landscape in healthcare evolves, WSLH Proficiency Testing remains dedicated to advancing its mission of innovation, quality, and safety in clinical laboratory improvement.

In conclusion, the sourcing, creation, and quality assurance of proficiency testing samples are fundamental in upholding the integrity and precision of diagnostic testing. The intricate process and dedication behind these samples play a crucial role in advancing healthcare standards and the accuracy of patient care.

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WSLH PT Blog

Elevate Your Point-of-Care Testing Expertise at the ADLM POCT Conference

Posted on October 11, 2023 by flowerme

Are you passionate about Point-of-Care Testing (POCT) and eager to take your expertise to the next level? Whether you’re a seasoned professional or just embarking on your POCT journey, we invite you to join us at the 2023 Point-of-Care Testing Conference on November 3, 2023, in St. Petersburg, Florida.

Why Attending is a Must

Practical Skills Development: The POCT Conference blends theoretical knowledge with hands-on, practical skills that you can immediately apply in your care setting. You won’t just learn; you’ll grow and evolve as a POCT professional.
Diverse Range of Topics: From building robust training and competency programs to ensuring superior quality management and managing interfaced instrument projects, you’ll find sessions that address your specific interests and challenges.
Dynamic Learning Experience: We understand that everyone has their preferred learning style. Whether you thrive in traditional presentations, interactive workshops, or hands-on demonstrations, we’ve got you covered.
Connection Opportunities: Connect with industry experts, peers, and professionals from all around. Build relationships, share insights, and collaborate on exciting projects.
Stay Ahead of the Curve: Stay informed about the latest industry trends, regulatory updates, and technological advancements that can impact your laboratories.

Explore the Conference Program

Whether you have worked in POCT for years or are just starting out, the 2023 Point-of-Care Testing Conference is for you. Join us on November 3, 2023, in St. Petersburg, Florida for a combination of presentations and interactive activities that will ensure you not only gain theoretical knowledge but also practical skills that you can apply in your laboratories. The conference program covers a diverse range of topics relevant to those in the POCT field, including building a robust training and competency program, ensuring superior quality management, and managing interfaced instrument projects. This program, hosted by the Association for Diagnostic and Laboratory Medicine (formerly AACC), is a dynamic learning experience that caters to different learning styles.

Sessions will include:

How to Involve the Care Team in Meeting Competency

Presented by Peggy Mann, MS, MT (ASCP), CPP, University of Texas Medical Branch

Everything Everywhere All at Once??? Important Focal Points for Your POCT Program

Presented by Kim Skala, MT (ASCP), Werfen

The Quality of Statistics: Where Do We See Them and What Do They Mean for Point-of-Care Testing

Presented by Erika Deaton-Mohney, MT (ASCP), CPP, Bronson Laboratory

Connecting the Dots: Utilizing Tools, Tips, and Resources to Get Your POCT Program Connected and Stay Connected

Presented by Kerstin Halverson, MS, Werfen

Managing Point-of-Care Testing Systems from New Test Requests to Quality Improvement

Presented by Jeanne Mumford, MLS (ASCP), Johns Hopkins Medical

Learn More

Don’t miss this opportunity to enhance your POCT expertise and network with professionals who share your passion. Elevate your knowledge, grow your network, and stay at the forefront of testing trends by attending the 2023 ADLM POCT Conference. For more information and to register, visit: https://www.aacc.org/meetings-and-events/poct-conference.

Join us in St. Petersburg, Florida, on November 3, 2023, and take your Point-of-Care Testing skills to new heights. We look forward to connecting with you! Stop by our exhibitor table and say hi to Rhonda Stauske. Rhonda is one of our technical experts who is ready to answer your proficiency testing and Point-of-Care questions. To learn more about WSLH Proficiency Testing, visit our website at: https://wslhpt.org/.

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WSLH PT Blog

Meeting the Growing Need for Hepatitis C Testing & the Role of Proficiency Testing

Posted on September 12, 2023 by flowerme

Hepatitis C is a global health issue affecting at least 2.7 people in the United States. In fact, because of the public’s barriers to Hepatitis C screening, it might actually be closer to 4 million. We know the Hepatitis C virus (HCV) as the “silent killer” because 75% of those with it don’t know they’re sick until it’s serious. From 2015 to 2019, more cases of Hepatitis C were found among adults of reproductive age, with over 63% of all HCV infections occurring in individuals aged 20-39.

To increase early detection of HCV in patients, the Center for Disease Control and Prevention (CDC) now advises a one-time Hepatitis C screening for all adults (18 and over), and for those who are pregnant. Thankfully, there are many life-saving therapies available today; but, without increased access to accurate testing for all, many will miss the early detection needed for these treatments to be effective. Comprehensive proficiency testing programs are a crucial tool in the battle against Hepatitis C, supporting early detection, improving staff skills, and contributing to better global health results.

Underscoring the need to increase public access to Hepatitis C screenings, the CDC has provided updated information on how to ensure screenings are complete and accurate. Historically, about one-third of all individuals tested for HCV did not receive an HCV RNA test, when the HCV antibody test was reactive. In July 2023, the CDC released updated operational guidance, emphasizing the need to standardize Hepatitis C screenings in the United States. The CDC provides data indicating that reflex testing requiring single-visit sample collection resulted in higher rates of accurate diagnosis of Hepatitis C. While guidance on the implementation of reflex testing has helped clinical laboratories make significant steps toward achieving national HCV elimination goals, there are many communities that still face barriers to obtaining accurate and complete Hepatitis C screenings. These barriers include a lack of screening protocol, dedicated full-time staffing, and staff competency requirements. The CDC does provide an alternative recommendation, for instance, when following their HCV operational guidance is not attainable:

“If HCV RNA testing is not feasible and a person tested is not immunocompromised, do follow-up testing for HCV antibody to demonstrate seroconversion. If the person tested is immunocompromised, consider testing for HCV RNA.”

The inability at this time to uniformly implement reflex testing or needed follow-up HCV RNA testing across all communities in the United States is underscored by a recent study in diagnostics. This study compares the diagnostic accuracy of Point-Of-Care (POC) HCV viral load assays to laboratory-based testing, concluding that POCT HCV viral load tests are very accurate. This study aligns itself with the World Health Organization’s (WHO) recommendations to use POC HCV viral load assays as an additional strategy to promote access to confirmatory viral load testing and treatment. Given that capacity at the local and state levels can vary widely in the United States, there may be more studies and guidance to help communities, particularly rural communities, similarly negotiate limited access to laboratory services.

As HCV screening volumes trend upward, one barrier to diagnostic testing is assuring staff competency. To address these barriers, the CDC outlines recommendations such as who to test, when to test, how to interpret results, and proper documentation. Depending on your role and protocol in your state, passing proficiency may be required before administering Hepatitis C waived antibody tests. For instance, in the state of New Mexico, nurses and other certified staff must complete training with a passing competency prior to administering a Hepatitis C waived antibody test, such as the OraQuick HCV Rapid Antibody Test. The New Mexico example illustrates the importance of setting goals and standards to assure healthcare staff receives training prior to administering a HCV-waived antibody test. Participating in proficiency testing programs that are compatible with all waived methods is one way that all healthcare professionals conducting Point-of-Care (POC) testing can assure accuracy in testing and documentation of results.

To ensure that all participating healthcare professionals maintain competency in conducting and interpreting the results of HCV POC tests, laboratories and other medical facilities enroll in HCV proficiency testing programs. WSLH Proficiency Testing is now offering the Hepatitis C waived proficiency testing program for 2024. This program is compatible with waived methods including OraQuick HCV Rapid Antibody Test, and includes three 1ml liquid serum samples shipped twice per year. The soaring demands for Hepatitis C diagnostics require a strategic and steadfast approach. Prepare your staff with our Hepatitis C waived proficiency testing program, Item PT04192. View our Clinical PT Catalog and Ordering page for more details.

With the growing need for Hepatitis C diagnostics, it is crucial to implement a well-planned and consistent strategy. As public health organizations, laboratory experts, and the broader healthcare systems come together, our progress toward reliable, precise, and early HCV detection relies on the solid foundation of clinical proficiency testing. In this dynamic landscape, WSLH Proficiency Testing’s commitment to provide quality proficiency testing services and to improve staff competency in HCV antibody testing remains unwavering. By implementing standardized procedures and continuous quality evaluations, we can pave the way for enhanced HCV management and, ultimately, contribute to better global health outcomes.