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WSLH Proficiency Testing

Wisconsin State Laboratory of Hygiene

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

Our Lab’s Public Health Response to COVID-19

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Public Health Laboratories have played a vital role in the response to the COVID-19 pandemic, not only by improving patient testing but also monitoring performance of various methods, training personnel, tracking response, and more. The WSLH in WSLH Proficiency Testing stands for the Wisconsin State Lab of Hygiene, a national public health lab, where our team of Medical Technologists provide proficiency testing (PT) services every day.  As part of a public health lab, WSLH Proficiency Testing’s suite of SARS-CoV-2 proficiency testing products is just one facet of the multi-faceted response that the Wisconsin State Lab of Hygiene (WSLH) is providing to improve accuracy of testing in an attempt to minimize the spread of COVID-19.

WSLH’s response is not only the leading response for the state of Wisconsin, but also nationwide since WSLH is a national reference center for the Centers for Disease Control (CDC). This article is a 50,000 foot view of WSLH’s response to COVID-19, and suggests by labs supporting WSLH Proficiency Testing, they are in turn giving back to WSLH’s public health response efforts.

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WSLH Proficiency Testing provides SARS-CoV-2 proficiency testing products for serology, molecular, and antigen testing; and also offers the SARS-CoV-2 analyte as part of Respiratory Multiplex product. Although helping improve patient testing by participating in proficiency testing is an important aspect of WSLH’s response to the pandemic, the full scope of the WSLH’s public health laboratory response is astounding. Creating new wastewater surveillance methodologies specifically for Covid19, increasing the volume of COVID-19 patient testing and monitoring, and implementing PPE decontamination procedures to be used in the workplace are just some of the many ways the Wisconsin State Lab of Hygiene has responded to the COVID-19 pandemic.

The emergence of Public Health as we know it began with wastewater surveillance methodologies. The work led by our lab’s water microbiology team and state partners builds upon this work as a means to limit the spread of COVID-19. Last September, surveillance sampling began in all but 5 of the 72 counties in Wisconsin. The lab’s wastewater surveillance program includes high frequency sampling for heavily populated areas and lower frequency sampling for rural areas throughout the state.  The process itself includes taking water samples at treatment facilities that represent a 24-hour’s worth of sewage that feeds into a given facility. The samples are then “combed,” so-to-speak, for the RNA genetic material that the SARS-CoV-2 virus leaves behind. These measured concentrations of the virus’s RNA can then tell our scientists how COVID-19 is impacting populations over time. In December, a dashboard was created for the public to view these changes in SARS-CoV-2 concentrations in any of the sewer sheds under surveillance.

To learn more about WSLH’s wastewater surveillance program, read this article on the University of Wisconsin-Madison’s news page.

Throughout the pandemic, laboratory workers and other healthcare professionals in the U.S. have been dealing with shortages of Personal Protective Equipment (PPE). This shortage has forced facilities to re-use or extend single-use PPE, such as gloves and N95 respirator masks. In order to re-use them, the masks need to be decontaminated. WSLH’s Occupational Health Laboratory (WOHL) have brought a critical service to the state of Wisconsin, using UV light decontamination methods, developed by Nebraska Medicine and the University of Nebraska Medical Center. Occupational health and safety consultants at WSLH have created online training videos, conduct live virtual trainings (as onsite trainings have been suspended during the pandemic), and implement PPE decontamination units at facilities. Activities like these under WSLH’s Onsite Safety and Health Consultation Program, known as WisCon, are unique among public health labs, as few conduct occupational safety consultations. To learn more about this program and more from WOHL, visit their page here.

At WSLH, the Communicable Disease Division (CDD) provides reference and specialized testing services in support of public health and ensures statewide access to laboratory expertise and capabilities in the disciplines of bacteriology, mycobacteriology, virology, parasitology, molecular microbiology, and serology. In regards to other statewide COVID-19 surveillance programs conducted at the lab, CDD is also performing antibody testing for the Past Antibody COVID-19 Community Survey (PACCS).  This study is being led by the Survey of the Health of Wisconsin (SHOW) in the UW School of Medicine and Public Health and “…will determine the prevalence of COVID-19 antibodies throughout the state.” Currently, CDD is also managing a multi-faceted suite of grants to build the lab’s response in regards to COVID-19 clinical testing. To learn more about Clinical Testing at WSLH, visit their webpage here.

From the implementation of wastewater surveillance to occupational PPE decontamination, WSLH Proficiency Testing’s SARS-CoV-2 products and technical expertise are just one of the many ways that the Wisconsin State Lab of Hygiene is responding to the COVID-19 pandemic. Thanks to the support of clinical laboratories as well as public grants, the scope of Wisconsin State Lab of Hygiene’s response to the pandemic is ever-growing.  When clinical laboratories enroll in proficiency testing with WSLH, it is wonderful to know that they are supporting many other vital services that build up the capacity of laboratory professionals to respond in their communities.

WSLH PT Blog

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

How We Cope During COVID-19

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As we ring in the New Year, with hopes, goals, and challenges in mind, medical laboratory professionals continue to respond and adapt with inspiring tenacity to assure quality patient testing. Self-care has never been so important to minimize burnout and promote a more sustainable workplace. We hope what we share below encourages you to share with us how you and your team cope with stress through adaptive strategies like resource-sharing, self-care, and storytelling. Please share with us by replying by email at ptservice@slh.wisc.edu.

As we challenged assumptions about our own ability to adapt and learn new ways of working, we forged through some of the most difficult realities of our working life during the COVID-19 pandemic. Our individual and collective journeys as laboratory professionals have taught us lessons to help us adapt to difficult situations and conditions, or have taught us that a different career trajectory is possible, and needed, for our own well-being.

Should we decide that we might survive and thrive better in healthcare settings than in other workplace settings, finding healthy coping mechanisms has been integral to minimizing burnout and compassion fatigue, beyond the other immediate health problems that have come with the job throughout this pandemic.

According to an article published in July 2020 in the American Journal for Infectious Control, the primary ways that healthcare professionals managed best to cope with the stresses of their jobs included:

limiting their own exposure to media coverage and social media; limiting sharing their COVID-19 duty details with loved ones and community members; coping through religious practices and spiritual communities; and building capacity for altruism and empathy. Based on studies like these, the Centers for Disease Control and Prevention also recommends and provides some tips for adapting healthy coping strategies to manage stress, avoid physical or mental fatigue, and build resilience.

It is important to validate your feelings and experiences first in order to be able to recognize the need for self-care, indicates The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) in an article they released in July 2020. In their article, SAMHSA points out the signs of disaster-related distress and compassion fatigue; and offers tips and resources for getting help. They offer a downloadable pdf on their website; and it is suggested to print out the last page regarding resources and post it somewhere in your facility.

Regardless of our job titles, we all have important contributions to make to the stream of life and the web of humanity. As medical laboratory professionals and healthcare professionals, dealing with the unsustainability of work conditions present challenges that no human should be asked to overcome, and yet you have. How have you and your team promoted a more sustainable workplace through adaptive strategies like resource-sharing, self-care, and storytelling? Please share with us by replying by email at ptservice@slh.wisc.edu.

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Influenza Surveillance at WSLH during the COVID-19 pandemic

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No season this 2020 has been untouched by the COVID-19 pandemic. As we’ve come to find ways to enjoy the turning of the seasons despite, many residents are dreading winter as SARS-CoV-2 cases spike across the United States. Be it holidays without in-person family and friend gatherings or learning new ways to cope with the coming cold weather, everyone has some personal difficulty they are experiencing. Clinical labs have been bracing for the difficult realities from another major wave of diagnostic testing for COVID-19 that, as experts indicate, has not yet peaked as influenza season also approaches.

Laboratory professionals are doing their best to prepare their response, as the Center for Disease Control (CDC) and public health laboratories likewise roll out their responses to aid and serve clinical laboratories as a resource. To learn more about what the Wisconsin State Laboratory of Hygiene (WSLH) is doing as a national public health lab to support clinical labs during influenza this year, I sat down virtually with Erik Reisdorf, Surveillance & Virology Team Lead for the Communicable Disease Division. 

WSLH, which is home to WSLH Proficiency Testing, is doing a lot, I learned, to provide outreach and support to clinical laboratories not only within the state of Wisconsin but across the United States.

 

Everyday behind the doors of WSLH, the Communicable Disease Division (CDD) processes hundreds of tests, not only for SARS-CoV-2 but also for other upper respiratory pathogens. WSLH processes tests to monitor activity of SARS-CoV-2, influenza and other pathogens that may be present in the 5 public health districts of Wisconsin. As WSLH’s Surveillance & Virology team Lead since 1993, Erik Reisdorf and the rest of the CDD team have played a big role in developing WSLH as one of the country’s three National Influenza Reference Centers (NIRCs), which serves to support and strengthen national surveillance activities in collaboration with the Influenza Division of the CDC.

Every week, Reisdorf’s team collaborates with clinical laboratories to receive their testing data and samples, spanning the state of Wisconsin’s 5 public health districts, including rural areas. WSLH further characterizes these surveillance samples by subtyping and full genomic sequencing in addition to culturing the virus and sending the virus isolates to CDC for further analysis. WSLH uses this data from clinical labs to provide situational awareness and monitor the genetic drift of pathogens over time. Beyond WSLH’s role of providing surveillance reports, WSLH also sends data to CDC which is critical to inform vaccine strain selection.

“Everyone plays a big role, all labs,” says Reisdorf. “Our role here at WSLH is to coordinate this surveillance work. The samples that we ask clinical labs to send us helps inform vaccine strain selection and monitor for influenza antiviral resistance.”

Reisdorf also takes time to share with us how WSLH is strategizing their testing plan and how clinical labs might negotiate their own facility and region-specific hurdles to managing diagnostic testing as other respiratory pathogens are on the rise with the coming colder winter months.

Q. With more SARS-CoV-2 cases on the rise in Wisconsin and in the United States overall, how does WSLH’s response to influenza testing look differently this year? 

A. We are dealing with a surge as SARS-CoV-2 samples in support of the pandemic response efforts. Every lab is feeling the crush this year as well. Even as the number of SARS-CoV-2 tests far exceed what we have ever done in the past for influenza, we do have to maintain resources for influenza testing, which is a priority at national level too.

We have a new test, Influenza SARS-CoV-2 Multiplex PCR, which the CDC developed so that public health labs could manage their resources better and maintain this critical public health program. This allows us to not run two separate tests for SARS COV-2 and Influenza. Clinical labs are likely looking at similar multiplex PCR tests as well; and, companies are just starting to roll out those now.

Q. What advice would you give to clinics and hospital laboratories on navigating the kinds of tests available for testing SARS-CoV-2 and influenza? 

A. What sort of test kits and what sort of volumes that clinical labs can get to stay on top of timely testing are everyone’s main pressure points this year. We are hearing of shortages of test kits and labs being on allocation. Regarding allocation, labs may want 1,000 tests a week, but can only receive 100 tests a week, for example. There have been a lot of issues with other testing supplies such as pipette tips too. It has been difficult for us with managing the surge of samples to 1,000 samples per day while also managing reagents and consumables.

How we have best been able to deal with these challenges at WSLH was to diversify our tests and instruments. We now have three PCR tests for SARS-CoV-2 and that has really helped us manage our resources to ensure that we can continue to provide testing.  If we run out of reagents on one test we can use reagents for another test to stay on top of navigating resource challenges.

Q. Any advice or words of encouragement for clinical labs regarding staying on top of patient testing and their own work-related fatigues?

A. Everyone is dealing with stressed staff, shortages of Personal Protective Equipment (PPE) and test reagents and still are doing a great job to maintain as best they can. The testing that clinical labs has done is absolutely critical for public health contact tracing efforts to help limit community spread. Timely testing is also very important, in this regard. Every clinical lab is doing the best they can do with the resources they have and their efforts are greatly appreciated by public health. They couldn’t do their jobs effectively without the timely testing performed by clinical labs.

Also, for updated information on virus activity I would also encourage clinical labs in other regions of the country to look to their states public health lab or department of public health for surveillance reports on pathogens in their state. Every state has their own surveillance program in place. If they are interested in garnering situational awareness for influenza or non-influenza  respiratory pathogens, they can connect with the right people to give them that information for their community.

Given the myriad of upper respiratory infections present during the fall/winter, a big question for many labs is how to ensure they have the right test at the right time in order to have the clearest picture for patient testing success. Clinical labs can look to surveillance programs in their state and nation-wide to help keep the knowledge gap as narrow as possible in diagnostic testing for SARS-CoV-2 and influenza amongst other emergent respiratory pathogens.

Beyond the role of providing situational awareness, public health labs in your state or region can also be a great resource for thinking through testing strategies to help with timely, accurate testing. WSLH Proficiency Testing, and WSLH overall, is a resource to clinical laboratories, state-wide and beyond. We hope that you have found this article informative and want to also take this moment to thank all of our laboratory professionals for the work that they do to everyday to help treat and heal their communities.

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WSLH PT Blog

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A Conversation with Dr. Kurtycz

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Recently, our outreach coordinator, Megan Flowers had an opportunity to sit down with Dr. Dan Kurtycz, who has served as medical director for the Wisconsin State Lab of Hygiene (WSLH) since 1998. Dr. Kurtycz or, “DK” as his students call him, will be retiring at the end of this year. Before he sets sail for his retirement years, we wanted to gather his reflections on his time in the medical community and in the world of proficiency testing through his eyes as medical director for WSLH, the public health lab which is the home of WSLH Proficiency Testing. Below you’ll find an excerpt of the interview Megan had with DK and some of the fascinating conversations shared.

Megan Flowers: How have you seen the world of proficiency testing change since you began your career?

Dan Kurtycz: It’s really come a long way since I started out as a junior pathologist. There were about a dozen proficiency testing providers during the time of my residency where they would start sending samples out of known concentrations and got to see if laboratories would get the same answers. People began complaining, well, you weren’t testing properly and my method is better; so, you began to start seeing controversies.
When I finished residency, there was a program run by the College of American Pathologists called QAS today, where you would send samples out to people and you would test them and give them an answer in their peer group. I was involved in this program as a junior pathologist, and had signed up with CAP to help them. We were in charge of a region where we reviewed everyone’s numbers and notified them when they failed or when they were too far out.

What constitutes being too far out? Dr. Jim Westgard was really important in all of this.  I actually did a fellowship with Dr. Westgard around 1983. Dr. Westgard had involved these things called control rules. If you are running a series of controls with relatively good tolerance limits there is a bell-shaped curve of results that people are going to get. Within this bell-shaped curve, you want everyone to be within at least your results within at least 95% acceptance limits, which by the way is a much higher success rate than what clinicians do when they are diagnosing patients. Westgard evolved a series of rules based in part on 95% confidence limits, 2 standard deviations out from a mean. Westgard’s control rules became very important in the literature and then became built into the machines.  For example, if you have one error in which everything is on one side of the mean then that is likely a systemic error and something is likely wrong with your machine’s calibration or the reagents you are using. Westgard’s series of rules became very important and was promulgated across the nation and around the world from right here in Wisconsin. Everyone was building his methods into their day-to-day practice. I really learned a lot from Dr. Westgard and the whole bevy of people who got involved in Westgard rules and helping refine them.

MF: In the case of the Wisconsin State Lab of Hygiene, what is the significance of having a public health lab also operate as a proficiency testing provider, that entity being  WSLH Proficiency Testing?

DK: Having a division of our lab focused on providing proficiency testing programs was from my predecessor’s efforts, Dr. Ronald Laessig, who was the Medical Director of WSLH at the time. It was important for WSLH as a national public health lab to outreach and provide support to clinical labs on all fronts, including helping labs improve their patient testing through proficiency testing. This was at the same time Laessig was working with Westgard to expand improved methodology and machines. Historically I’ve been more involved with CAP, since I work with CAP as the Medical Director of WSLH. However, what makes WSLH Proficiency Testing stand out in the world of proficiency testing is the ability to provide personable, one-on-one consultations when the laboratory professional needs it. That means a lot.

MF: What advice would you give clinical laboratories regarding their approach to proficiency testing today?

DK: Well, it’s not only about getting the numbers right. It has to be a part of a whole quality assurance program. They have to pay attention to everything from the pre-analytics through the actual testing, running the controls, and to the post-analytics. Quality isn’t only just about making sure your controls are in nowadays. The biggest errors in the laboratory are clerical, where we mess up, don’t track the specimens, and don’t get the right answers to the right people. Also, as laboratory professionals, we need to make it as easy as possible for the clinician to get what they need to take care of people. We tend to run our laboratories as factories and we forget sometimes about the patient at the end of every sample, including those proficiency testing samples that, in the end, help us better alleviate a patient’s suffering. We are not isolated in this work. We are part of the medical community. Let’s not forget the important work we do.

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WSLH PT Blog

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Public Health: A Heroic History

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L0025222 Plague doctor
Credit: Wellcome Library, London. Wellcome Images
images@wellcome.ac.uk
http://wellcomeimages.org
Plague doctor: ein Kleydung under den Todt.
Aesculape
Published: 1932
Copyrighted work available under Creative Commons Attribution only licence CC BY 4.0 http://creativecommons.org/licenses/by/4.0/

By Kristine Hansbery
Director of WSLH Proficiency Testing

With the recent Covid-19 outbreak our nation is realizing the importance of having a strong public health presence both to avert disaster and protect the wellbeing of our public. During these tumultuous times I am reminded of the words of Jon Snow from Game of Thrones, not to be confused with the “father” of epidemiology, John Snow. However, the John Snow of public health would probably agree with the Game of Thrones Jon Snow, that “There is only one war that matters. The Great War. And it is here.” Yes, the fight against the Coronavirus has become our great war and it is indeed here.

So, why is public health such an important part of this war against the pandemic? Using a historical lens, we can better understand the important role public health labs play in supporting clinical labs in this fight.

Tracing the conceptualization of “public health” and how it has translated into actions in the United Kingdom and the United States can illuminate the important role public health labs play in supporting clinical labs. In particular, the role of public health labs today in providing statistical analysis and reporting to prevent and respond to epidemics is salient to elucidate historically.

John Snow, the father of epidemiology, first made his mark on disease prevention with the “Broad Street pump.” In late August of 1853, cholera broke out in the Broad Street area of London. Snow believed the outbreak was linked to the communal pump located there. To prove his theory, he tracked and recorded incidences of cholera in and around the pump. This was the beginning of using statistics to define disease patterns so interventions could be performed.

The rise of epidemiology and subsequent interventions to stop the spread of disease, gave rise to the creation of government entities who could implement and enforce such mediations for the overall health of the public. The first public agency for health in the United States was the New York City Health Department, which was founded in 1866. This event in history marked the very beginning of the concept of “public health” in the United States. At the end of the 19th century, newly established state and local health departments in the United States began to establish laboratories to develop and apply the new scientific knowledge. (Winslow, 1923)

The early part of the 20th century in the United States saw the creation of federal programs of disease control, research and epidemiology, including the establishment of the Communicable Disease Center in 1946, now known as the Center for Disease Control and prevention (CDC). During this time, state and federal passed regulations to incorporate the concepts of sanitation and disease control using the scientific findings of public health labs.

Today, public health labs all over the U.S. work together under the CDC’s Laboratory Response Network (LRN) in order to quickly and efficiently respond to emerging infections and other public health emergencies. The Wisconsin State Lab of Hygiene (WSLH), which is the home of my organization WSLH Proficiency Testing, works closely with the CDC to provide reference and specialized testing services. Currently the Communicable Disease Division of WSLH is providing validations to help prepare clinical laboratories for Covid-19 testing.

What this dive into the history of public health has taught us is that the rise of epidemiology may have provided the foundation for public health, but social values, including community intervention and health goals, have brought about its system as we know it today. Collaborative partnerships and networks between public health labs and clinical labs will need to continue to grow to adapt and respond to today’s challenges in maintaining the health of our communities.

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WSLH PT Blog

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

Who’s who of laboratory regulations

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By Kristine Hansbery
Director of WSLH Proficiency Testing

I am perpetually surprised at how confusing the world of laboratory regulations can be; so, I decided to write a brief summary that gets down to the basics.

All laboratories at minimum must meet CMS requirements as stated in CLIA 88 and can be inspected by their state agency.

If laboratory chooses to do more the agencies listed above are the most common alternates selected.

Proficiency testing is separate from the regulatory agencies. CLIA mandates which laboratory tests require proficiency testing; however, your regulatory agent may require more.

Proficiency testing providers provide unknown samples and score performance of laboratories testing those samples. The scores are reported to CMS and any other regulatory agent the laboratory is signed up with.

A list of proficiency testing providers can be found here.

In summary:

  • Laboratories must comply with CLIA 88 regulations. Laboratories can be inspected by their state agency (CLIA office) or sign up with an alternate regulatory agent approved by CMS/CLIA
  • Laboratories performing testing that is not waived must sign up for proficiency testing and there are several choices.

For further information, visit our Resource page.

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