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Decentralized Testing: Effect on the future of laboratories

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Laboratory professionals are seeing more and more testing moving away from the central lab. The tests might be at bedside, in the phlebotomy station, in radiology, the emergency room, ICU, and even at home. These tests are being performed by nurses, clinicians, and medical associates. Additionally, medical professionals are sending more complex testing that does not require rapid turnaround time to reference laboratories. 

What does that mean for the average hospital or clinic laboratory? What is our role as professional laboratorians in this changing environment? What are the advantages and disadvantages of this exodus of testing from the main lab?

Point-Of-Care Testing (POCT) has enabled rapid results to be obtained while remaining with or near the actual patient. The advantages of this proximity of processing tests to the patient are apparent in the ability to administer insulin 

or other life-saving medicines within moments clearly improving patient outcomes. In the case of radiology, another advantage is efficient workflow as a technician is able to evaluate the safety of administering contrast media through sampling creatinine (kidney function) levels. Obviously, these advantages are significant when it comes to patient outcomes, but there are risks as well.

POCT, from the individuals who are asked to conduct the tests to the test quality itself, comes with a number of concerns that are exacerbated by the increased proliferation of such tests. The greatest risk is the fact that you are placing testing in the hands of individuals who have not been trained in understanding the importance of quality control and in recognizing poor results. Therefore POCT is often considered the lowest element on their patient care list. My sister has lived this experience. In her 40 years as a registered nurse, she says, her focus was patient comfort. While testing was something that had to be done, there were far more immediate concerns that had to be addressed. An excellent educational foundation sets up individuals for success. Given that the education of laboratory professionals gives primary focus to the study of analytical procedures, testing done in a core laboratory lends to more reliable, quality patient testing.

There are certainly benefits and risks to weigh in medical professional settings when deciding to outsource testing from the core laboratory. This not only includes POCT but sending tests to reference laboratories. Weighing delays created by sample transport for referral testing against patient outcomes must be a consideration since test results drive the majority of medical decisions. Norman Moore, PhD, director of scientific affairs for infectious diseases at Alere Inc. says that, “the main advantage is that outsourcing usually saves cost per test. However, we are finding that the cost savings on a test level are not balanced by the cost on a patient level in most instances.” Often clinics and hospitals may decide to outsource given that a referral lab can process many tests at a time versus at the pace of the technician or technicians available to process tests one-by-one in house. The ability for referral laboratories to process large batches of testing samples is often also seen as a way to address laboratory staffing shortages. Dr. Moore adds that outsourcing for the purpose of cost-saving is not very advantageous for patient care, given that referral testing delays access to results which, in turn, delays the healthcare provider’s ability to provide a timely diagnosis for the patient.

During the winter time, when the spread of respiratory infections are at their peak, it is important to diagnose and treat early. Furthermore, this need for a quick testing response is more acute in emergency room settings to address emergent patient needs. Outsourcing, especially in context of the growing availability of more samples that can process multiple tests at once, is not sustainable in the long-run, regarding budgets and, ultimately, patient care. It seems that keeping testing in-house, while also addressing laboratory staffing shortages that put a strain on providing timely, accurate patient testing brings us back to the question of Point-Of-Care Testing to help alleviate challenges.

POCT is a proven approach for providing a faster turnaround time of laboratory results. What must be addressed now, as companies continue to improve POCT equipment, is how hospitals and clinics can assure best practices in POCT. I would encourage laboratories to actively engage in training, quality control and proficiency testing for the point of care testing areas. Last year, AACC released a guideline that can help administrators and lab leadership define POCT performance in their facilities. The key questions that they ask are:

  • What is the value of an interdisciplinary committee to oversee POCT?
  • Does education improve POCT performance?
  • What is the optimal staffing model for POCT?
  • Do proficiency testing (PT)/external quality assessment (EQA) programs improve POCT performance and patient outcomes?
  • Does data management improve POCT outcomes?
  • How should staff select POCT devices?
  • How does POCT improve process?

I would highly recommend that facilities use this guideline to not only help define their current POCT performance but to help develop best practice in POCT.

Several years ago, the AACC released an article aimed to help facilities improve POCT compliance through preparing staff for routine inspection. If nurse leadership and other medical staff responsible for POCT know what questions inspectors may ask and what staff can anticipate, the work towards the standardization of accurate POCT can start to become more integrated among all staff involved. In other words, preparing for a POCT inspection can serve as a starting point for staff to start defining POCT performance and to start implementing best practices in POCT.

In addition, testing across multiple platforms should occur to prevent discrepancies between in-lab testing and POCT. I would also caution that the laboratory evaluate testing to remain in house vs. sent out based on patient critical need. If facilities intend to rely on referral testing, the referring laboratory must ascertain and have available the credentialing of the reference laboratory such as the CLIA and/or CAP certificate.

Point-Of-Care Testing is here to stay. Outsourcing lab work is a strategy that isn’t going anywhere. These facts highlight the importance taking a closer look at our current practices outside of the core laboratory and weighing them against our patient care outcomes, especially if we are approaching our questions from a cost-benefit analytical framework. Professional organizations such as the AACC have provided the latest resources to help hospital and clinic staff to improve POCT best practices and assure POCT compliance.

Take advantage of those resources and keep an eye on helpful articles from proficiency testing providers and regulatory agencies for helpful tips and guidelines to tease out the more complex side of planning, organizing, and coordinating POCT and referral testing. Core laboratories are encouraged to partner with nursing staff and other medical personnel to create training infrastructure on POCT analysis. Laboratory staff can also help implement a routine, internal audit of POCT practices that is POCT compliant with regulatory agencies, which in turn, helps everyone involved be inspection ready.

Reference:  The Shift to Point of Care Testing: In Clinical Chemistry Q&A, lab industry leaders look at impact of technology, reimbursement, other factors in move from hospital-based settings.
Date: NOV.12.2015  // Source: CLN Stat

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Occupational Safety From A Public Health Standpoint

While much has changed in our world since the start of the pandemic, there are some positive developments and plenty of lessons learned that will help us as we move toward the future. Certainly, lessons were learned in the world of laboratory safety. Here at the Wisconsin State Lab of Hygiene, which is home to WSLH Proficiency Testing, we are constantly learning about adaptation during the COVID-19 pandemic from our colleagues and coworkers at the Wisconsin Occupational Health Laboratory Division. In particular, their free consultation program WisCon has expanded their services from assisting small businesses with chemical, noise, and air monitoring, to now providing COVID-19 consultations and respirator fit test kits to facilities, including skilled nursing facilities. As North American Occupational Safety and Health Week (May 2-8) approaches, WSLH Proficiency Testing (PT) wants to raise awareness of the importance of preventing injuries and illnesses at work. Regardless of our sector or industry of employment, WSLH PT hopes that individuals and organizations take advantage of the resources that maybe available to them to ensure a safe and healthy work environment.

Ernie Stracener (right), consultation program manager, and Dan Trocke (left), safety consultant with the Wisconsin State Laboratory of Hygiene at the University of Wisconsin–Madison, pack PPE supplies into boxes at a warehouse in Madison. Photo by Bryce Richter

Ernie Stracener from the Wisconsin State Lab of Hygiene gets to see how everything is made, from foundries pouring molten steel to veterinarian clinics conducting testing for your pets. It’s a wonderful side-perk in his efforts to help small businesses maintain safe working conditions. Ernie Stracener is the Consultation Program Manager for the Wisconsin State Laboratory of Hygiene’s WisCon project, which provides free industrial hygiene inspections and occupational safety consultations for small businesses across the state of Wisconsin. 

The WisCon project is the largest consultation agency in the state of Wisconsin, helping the private sector have on-site and virtual consultations regarding any potential work-related hazards, including noise level testing, gas monitoring and air quality sampling.

Every week, consultants from WisCon travel the state conducting on-site inspections and providing safety consultations to small businesses with under 250 employees. That adds up to a little over 450 on-site consultations with approximately 350 businesses every year. The WisCon project has been in existence for 40 plus years, and has had to get creative like so many others in response to COVID-19 in how they provide their services.

 Since the pandemic, WisCon has been providing consultations on COVID-related activities. Starting in July of last year, the Wisconsin State Lab of Hygiene partnered with the Wisconsin Department of Health Service (WDHS) to expand lab capacity in SARS-CoV-2 testing for the state. As part of that partnership, WisCon received funding to provide COVID-19 consulting, create and distribute respiratory fit tests for N-95 masks and other respirators, and develop decontamination methods for single-use PPE for small businesses and medical facilities. Such services that WisCon provides, Ernie adds, are very unique to the state of Wisconsin. “It may be happening from other sources, but this is a product of a very specific request from the Wisconsin Department of Health Services. We were glad we could be plugged into the COVID relief efforts in this way. It’s been rewarding,” said Stacener.

As WisCon continues to provide and expand occupational health and safety services to small businesses and facilities in the private sector within Wisconsin, there are other sectors that could benefit from WisCon’s free consultations, including the public sector. However, public sector employees in Wisconsin right now can take advantage of COVID-related consultations from WisCon.  Many more opportunities to expand service in workplace safety and industrial hygiene in all sectors of employment may arise as individuals become aware of the vital resource that WisCon provides. Raising awareness as part of North American Occupational Safety and Health Week presents an excellent opportunity to focus, reinforce, and strengthen commitment to occupational safety and health. For clinical laboratories in particular, WSLH Proficiency Testing encourages you to visit OSHA’s Laboratories page promoting a culture of safety and implementing standards and practices.

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The Future of the Medical Laboratory Professions

We’ve all likely heard the statistic: 70% of medical decisions are based on laboratory diagnostics. During Medical Laboratory Professionals Week, aka “Lab Week” we are reminded of this and other ways we make meaningful impact in patient care. It’s a week of celebration, but also a week to heighten the visibility of our careers, as much of the public is still not as aware of our profession and our contribution to patient care. With the onset of a global pandemic, many members of our professional community indicate Phlebotomists, Medical Technologists, and Technicians have gained significant visibility as media outlets cover the COVID-19 testing efforts. Last year, the New York Times published an article about the stresses medical laboratory professionals face, including many personal stories of long hours, sleepless nights and lack of social interaction with the demands of increased testing exacerbating pre-pandemic issues, such as staffing shortages. Never before has the public had such an in-depth look at the word of medical laboratories. In this article, educators and scientists speak to the importance of increasing meaningful visibility in the media and in classrooms in order to help attract and grow a pool of qualified talent in medical laboratories.

Michelle Schulfer, Clinical Coordinator and Senior Lecturer for Clinical Laboratory Science at the UW-Stevens Point, says while there is some increased visibility in the media due in part to the pandemic, there’s a lot of missed opportunity to give the people featured in the B-roll footage of the local news an identity. Often Michelle will be watching the nightly news report on the latest testing efforts at the local hospital and spot some of her former students in the broadcast. Occasionally, the station will air a clip of one of the reporters talking with the hospital’s lab manager, who is also a former student of Michelle’s.

“I think to myself, ‘tell the reporters who you are and what you all do!’ People know about doctors and nurses, but they do not know our name as medical laboratory professionals. People need to hear our profession name and what we do, so they can aspire to it,” said Michelle.

Such missed opportunities in the midst of ongoing staffing shortages could be alleviated by a deeper public focus in the news media. “We are doing great things. It’s important to give our work an identity,” adds Michelle. She also addressed the importance of the stories, nuances, and opportunities that exist for both Medical Laboratory Scientists and Medical Laboratory Technician. Leah Narans, Program Director of Medical Technician and Phlebotomy Programs at Madison College, agrees and discussed the importance of word-of-mouth outreach, including strategies such as inviting Medical Technologists and Technicians to talk with grade schools about what they do, whether it’s part of a science unit or career learning opportunity.

“It’s important to reach out and connect with high school counselors and give them a name for what we do,” Leah Narans says. “Again, it’s all about the name.” Before the pandemic hit last year, Leah Narans spoke with 60 high school counselors. In the meeting, Leah discussed the 2-year program at Madison College, where students are getting certified, getting 100% job placement, and then getting tuition reimbursement if they decide to go on and get their Bachelor’s Degree and their Master’s Degree to become a Medical Lab Scientist or Lab Manager. “Their eyes nearly exploded with amazement when I told them,” said Leah. “They had no idea what to expect!”

As educators work to increase enrollment in medical laboratory science education programs, they discuss the urgency of their work given other external factors that are both within and beyond the scope of the pandemic. One factor that Michelle and Leah both discuss is the possible “retirement bubble,” that may further widen during the course of the pandemic. According to the Medical Laboratory Observer’s 2020 Annual Salary Survey report, 45% of all medical laboratory professionals have a minimum of 20 years’ experience, with 31% having 25 or more years of experience.

Only 23% have 5 years or less of experience. At the same time, medical laboratory sciences can expect a lot of job market growth in the coming years.

According to the Bureau of Labor Statistics, the overall job outlook for Medical Laboratory Scientists and Technicians is solid, expecting to grow 13% between 2019 and 2029, faster than the average for all occupations. The government attributes this growth in part to the aging population, leading to additional diagnostic testing. According to a survey report in the May 2018 issue of the American Journal of Clinical Pathology, this data “strongly suggested the crucial need in the supply of qualified and certified laboratory personnel.” With a “retirement bubble” potentially on the horizon and there being a growing need for lab qualified and certified professionals, recruitment and retention of students in accredited Medical Laboratory Science programs is key.

In a recent “Inside the Lab” podcast episode produced by ASCP, three educators discussed the educational recruitment and retention strategies and resources available to them to address this issue. Strategies shared included implementing more practical lab experience for high school students and inviting Medical Laboratory Professionals to teach a special lesson to students, during a unit on blood, for example. The podcast also highlights resources that ASCP offers to assist with such strategies—ASCP’s Patient Champions curriculum that can be incorporated into lessons and ASCP’s Career Ambassador’s program, which encourages Medical Laboratory Professionals to share their passion for their careers with students, and how they can make a difference as a Medical Laboratory Scientist or Medical Laboratory Technician.

Laura Schreiber, Microbiology Proficiency Testing Coordinator for WSLH Proficiency Testing, says “I would want to show students how exciting it is to get to read about a new test that could make a great impact, and then getting to perform such a test in the lab a few years later. Being a part of a rapidly changing field where I am learning something new all of the time is very fulfilling.”

Laura worked on the bench for years (and still does part-time), before deciding to pursue her current position as a coordinator for a proficiency testing provider. She adds that while both jobs comes with its challenges, her love for her jobs both on and off the bench to improve laboratory quality outweighs the rest. She said she does not take for granted the love she has for her work as a Medical Laboratory Scientist.

Laura was a few years out of college, working in a different field, when she realized her career wasn’t fulfilling. She saw how happy her Mom seemed in her career as a Medical Laboratory Scientist, and wanted to capture that same career fulfillment. She was inspired to follow her Mom’s path, while forging her own as a Medical Laboratory Scientist specialized in Microbiology.

“I always loved Microbiology as a kid,” said Laura. “Having dedicated teachers and people in my life who supported my curiosity and interest in Microbiology made all the difference.”

Stories like Laura’s are important to tell, so that other individuals aspiring to make a difference in their careers can see what is possible. As the need for qualified medical laboratory professionals grow, educators will work to increase the number of graduates to fill vacancies in the laboratory. For those of us in the lab full-time, we can amplify such strategies by providing virtual (and eventually in-person) shadowing opportunities, classroom visits, and story sharing. Sharing our journey and our passion as medical laboratory professionals not only during Medical Professionals Lab Week but year-round will help grow the time and talent we need to maintain a happier, more sustainable workforce and laboratory quality, overall.

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On The Road Again: A Look at the World of Tradeshows

 

By Kristine Hansbery
Director of WSLH Proficiency Testing

Adapting to the new world of digital technology and virtual communication has presented both opportunities and barriers. The COVID-19 pandemic has necessarily pushed us further into the world of virtual communication which, in turn, has effected the way we do events and tradeshows. These events have always provided the ability to acquire much needed Continuing Education Units (CEUs), and wonderful opportunity to network with our peers.

 

Numerous vendors and show sponsors have recreated this important venue in a virtual setting for laboratory personnel as well as vendors promoting their product. There have been some successes and some, well, not so much. This article provides a closer look at this world of virtual events that have been rather hit or miss, and those perennial favorites of the past, and what makes them so special. We at WSLH Proficiency Testing hope this guide provides potential show attendees with the opportunity to explore new shows as well as make informed decisions regarding the expense and value of each venue.

There just is no way you can replace human contact with virtual events. Something must be said regarding the person-to-person networking that happens at each event. Capturing the attention of attendees at a virtual venue can be difficult given that the structure at in-person events encourages networking naturally. From the perspective of a vendor, the best virtual event by far for us was the Lab Director’s Summit, sponsored by MLO. This event actually created events that mimicked the real one-on-one conversations that would exist at a live event. They took it a further step by allowing vendors to present their product line as a 30-minute presentation to attendees in the following ways:

  1. Have one-on-one meetings with each and every attendee (like a dating event). The vendor has a 15-minute meeting with an attendee, a bell rings and then the next attendee arrives in the booth.
  2. Initiate meetings either set by the attendee or the vendor, in a polite nonintrusive manner.

While the best of the virtual world allows for greater connection and networking, we have all experienced the limitations with this format, technologically and socially. It’s important for our species to connect and see each other in-person. Plus, how much more eye-strain and zoom fatigue can we handle, given that much of our personal lives are online these days? While we hope we can return to real-life shows in 2021, let’s take a look at some of the top live events that we find rewarding and, let’s face it, just plain fun.

American Society of Clinical Laboratory Scientists (ASCLS) meetings
While each and every one of these ASCLS state-sponsored events are good, some stand out as particularly engaging.

ASCLS Minnesota takes place yearly at the Earle Brown Center, which captured the horse lover in me with old timey pictures of the largest horse in the world (at one time) as well as some race horse facts and other photos. The venue is very well attended by both laboratory professionals and vendors. The opportunities to network are plentiful. What a great show!

ASCLS Montana provides one of the most welcoming shows with beautiful scenery wherever you look.

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Our Lab’s Public Health Response to COVID-19

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.

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How We Cope During COVID-19

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

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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A Conversation with Dr. Kurtycz

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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Public Health: A Heroic History

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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Who’s who of laboratory regulations

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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