WSLH PT Blog

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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.

WSLH PT Blog

Clinical Laboratories Benefit from CDC OneLab

Posted on March 1, 2024 by flowerme

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

Important CLIA Changes to Proficiency Testing Requirements

Posted on February 5, 2024 by flowerme

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)

WSLH PT Blog

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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WSLH PT Blog

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.

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WSLH PT Blog

Enrolling with Multiple PT Providers: One Lab’s Personal Strategy

Posted on August 15, 2023 by flowerme

When Julie Steele stepped into her laboratory manager role a little over five years ago, she had served as the lead tech, performing proficiency testing (PT) for over 20 years. Her laboratory decided to enroll with CAP and WSLH PT as a way to optimize her laboratory’s PT process and address specific issues.

Julie Steele, Laboratory Manager at HSHS St. Nicholas Hospital in Sheboygan, Wisconsin provides her life-long career insights to help other decision-makers gauge if having a secondary PT provider is beneficial for their laboratory.

We bring some of these insights into focus through Steele’s 25+ years of experience in conducting PT. WSLH Proficiency Testing hopes the information and experience shared below will provide you with insight into the benefits of enrolling your laboratory with more than one PT provider.

Each year before enrollment, Julie Steele and her staff review and compare clinical proficiency testing product catalogs side-by-side to determine which programs are the best fit for their laboratory. Assessing testing needs and reviewing program offerings is an ongoing process to find the best fit for her laboratory. Julie explains that using two PT providers helps her find more options that meets her laboratory’s needs.

”For instance, say you’ve got all your PT results submitted, and the report shows that all of them have shifted to the low end. Then, you can use the same test from another PT provider to further investigate and compare. We certainly have ordered the same test with CAP and WSLH Proficiency Testing to compare the results from each test,” said Steele.

Enrolling with one proficiency testing provider as your primary provider for score transmission purposes and another PT provider for the same analyte or test for quality assurance or troubleshooting purposes puts your lab in a better situation should you encounter PT failures and need to quickly address them. Julie Steele’s relationship with both PT providers assures that she has quick access to ordering available samples off-schedule or for quality assurance. To prepare your laboratory, consider contacting another PT provider about ordering such samples before you encounter certain testing scenarios.

Regarding a laboratory’s cost-effectiveness goals, Julie Steele says that enrolling with two PT providers every year has helped her laboratory keep costs down as much as possible. Cost-effectiveness is crucial; so, carefully evaluate pricing models, annual processing fees, and other indirect costs such as allotting staff time for testing when budgeting for PT enrollment. Consider the overall value provided by each provider in terms of the quality of the program and the level of support offered.

“When you are spending thousands of dollars every year on proficiency testing samples, you take cost into consideration. WSLH Proficiency Testing is a lot more reasonable when evaluating cost-effectiveness,” Julie says. She adds that cost comparison is important, but also emphasizes the importance of carefully reading the PT provider’s sample handling instructions in order to avoid the unexpected costs that come with ordering any available replacement samples.

Conclusion:

This article presents some of Julie Steele’s strategies employed at her laboratory to help decision-makers who are considering enrolling in two or more PT providers. When choosing one or more PT providers, assess your laboratory’s needs, consider testing offerings and frequency, and compare pricing and cost-effectiveness. With a closer look at one lab manager’s strategies, we take into account several other reasons that having a secondary PT provider is beneficial.

Enrolling with Two PT Providers by Regulated and Non-Regulated Analytes

Enrolling in two PT providers a year can help laboratories organize their testing programs in other cost-effective ways. For instance, some laboratories choose to enroll with one PT provider for all of their regulated analytes. They then choose to enroll with a secondary PT provider for their non-regulated analytes. For some laboratories, depending on their needs, separating their regulated and non-regulated analytes by PT provider makes it easier for them to manage their proficiency testing.

Using Multiple PT Providers for Transitional Periods

Intentionally enrolling in the same challenge with two different PT providers can help during transitional periods or staff changes. Laboratories may experience a loss of PT knowledge when a staff member or manager retires or moves.

Accreditation and Accepted Analytes:

Please make sure the selected provider(s) are:

Approved by CMS.
Accepted by the College of American Pathologists (CAP) – If your lab is accredited by CAP.
- WSLH Proficiency Testing indicates which analytes are accepted by CAP or are in the process of acceptance in their clinical PT product catalog. If you are unsure if a provider meets the CMS requirements for proficiency testing, review their current program offerings on the CMS website: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Proficiency_Testing_Providers.

Additional resources:

CMS list of non-waived testing that requires PT: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/list-of-non-waived-testing-which-pt-is-required.pdf

FAQs about the Clinical Laboratory Improvement Amendments (CLIA) for Proficiency Testing:
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure8.pdf

WSLH PT’s overview of proficiency testing: https://wslhpt.org/wp-content/uploads/2023/02/WSLHPT_Handbook_rv.02.2023.pdf

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WSLH PT Blog

The Power of Support Networks

Posted on July 7, 2023 by flowerme

Strategies, Resources, and Benefits for Clinical Laboratory Professionals

In the fast-paced and demanding field of clinical laboratory medicine, building a strong support network is crucial for the success and well-being of professionals. Support networks, comprising colleagues, mentors, and industry peers, offer a multitude of strategies and resources that are beneficial to professional growth, knowledge enhancement, and overall career satisfaction.

In a previous article, WSLH Proficiency Testing has explored making connections with peers through networking events, such as attending conferences and seminars. Certainly, these recurring annual events provide us the space to engage in conversations, share experiences, and exchange contact information to cultivate meaningful connections. However, sometimes our unique role, a transitional phase, or a new laboratory setting can make it challenging to find the support we need.

In this article, we broaden our focus on building a professional support network as a clinical laboratory professional. Through an exploration of effective strategies, we highlight valuable resources and outline the significant benefits creating a professional support network brings.

Online Learning Communities: Getting connected with others through sharing knowledge and expertise is a wonderful way to build a network of support for yourself as a laboratory professional. Join professional forums, social media groups, and other online platforms dedicated to clinical laboratory professionals. Professional associations such as ASCLS and AACC have discussion forums accessible to members through login-based access on their websites. On LinkedIn, professional associations such as ASCP, ASCLS, and ACCC have listed groups as well as industry media like the Medical Laboratory Observer and Lab Manager Magazine.

Webinars can also offer a setting where you can make connections with peers and industry experts. During a webinar, when someone is asking or sharing questions that are relevant to your laboratory’s needs, consider sending them a message if a chat feature is enabled. You can request that you can reach out to them about a similar issue you are having. Sometimes finding support outside of your workplace can provide you and your laboratory with the insight needed to create needed shifts in your practices and policies. It’s also wonderful to know that you have another person who is willing to talk through issues with you, and is just one email or call away.

Mentorship Programs: Mentor-mentee relationships can also be another beneficial dimension of your overall professional support network. Mentorship relationships help professionals gain insights, receive career advice, reduce workplace stress, and expand professional networks. There are professional associations that also have mentorship programs that create an excellent structure for mentor/mentee relationships to form. For example, when you apply with the ASCP Mentorship Program or ASCLS Mentorship Program, you gain access to their Mentorship Directory based on specific skills and experience. From there, you can request meetings to explore a mentorship relationship with potential mentors/mentees.

Workplace Engagement: Getting to know your team better is an important, often overlooked practice in building a support network to reduce burnout and maintain staff engagement. According to a recent article in Forbes, organizations have cited employee experience and mental health as the difference makers in improving engagement, retention, and productivity. While mental health comes with limitations with respect to worker privacy, laboratory managers can ensure steps are taken to improve employee well-being.

While it is not crucial to be best friends with all of our coworkers, having friendships and fostering social connection in your work life is one key factor to overall employee well-being. Forming engagement committees at work to foster social connection can be beneficial to improving social well-being, a key aspect of employee well-being overall. As a division of the Wisconsin State Lab of Hygiene, WSLH Proficiency Testing participates in our laboratory’s engagement committee, hosting weekly and monthly board game meet-ups, annual picnics, and sporting event outings to name a few.

Conclusion

The challenges of the clinical laboratory profession can be overwhelming. Building a support network is an invaluable investment for clinical laboratory professionals. As clinical laboratory professionals navigate their careers, a strong support network becomes an essential pillar of success, leading to personal fulfillment and the advancement of the field as a whole.

A support network facilitates knowledge sharing, emotional support, career advancement, collaboration, and professional development. Colleagues and mentors can provide valuable advice and share experiences to help navigate professional challenges. By adopting effective strategies, leveraging available resources, and actively engaging with colleagues, mentors, and industry peers, professionals can foster collaboration, inspires new ideas, and drives professional growth to effectively meet and exceed organizational goals.