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WSLH Proficiency Testing

Wisconsin State Laboratory of Hygiene

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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.

Meet some of the WSLH PT team

As part of a national public health lab, we put the quality of our partnerships with clinical labs at the forefront of our work for laboratory improvement. WSLH PT is a people place, this includes the people who help make the programs and the day-to-day operations at WSLH Proficiency Testing run smoothly. We could not do what we do for laboratory quality without our dedicated team. We would like to take this moment to recognize Judy Nichols, Mike Argall, and Kristine Hansbery, three amazing individuals who bring a lot of knowledge, skills, and the camaraderie with them to the office.

Judy Nichols

Meet Judy Nichols. Judy is a Technical Coordinator for Blood Gas Chemistries, Coagulation, Environmental Reference Certification (WI), QC Standards, and Water Microbiology. Before coming to WSLH PT, Judy worked as an AACC Certified Point-of-Care (POC) consultant for 4 acute care centers in Illinois, where she oversaw their POC testing. She received her Bachelors of Science degree in Medical Technology at Marquette University in Milwaukee, Wisconsin. She says that the people and the greater flexibility in her schedule are what she likes most about working at WSLH PT. When she is not at work, Judy enjoys gardening, reading, travel, and music festivals. Most of her friends and loved ones would describe her as silly, but dependable, independent, and stubborn (in the best way possible). This summer, she’s been enjoying spending time with her kids, and helping them get ready for their second year of college. Oh, how the time flies!

 

Mike Argall

Meet Mike Argall. Mike serves as the Technical Supervisor for WSLH Proficiency Testing, where he oversees a technical staff of 7 Medical Laboratory Professionals. Before coming to WSLH PT, Mike worked as a bench tech and technical supervisor for three different clinical labs. Mike gains a lot of satisfaction at work when he and the rest of his team at WSLH PT can provide a service that really helps a client. When Mike isn’t working, he enjoys spending time with his wife and three children. If Mike had to eat one thing for the rest of her life, it would probably be burritos! Mike has lived in Wisconsin his entire life. He always looks forward to spending time on the lake with his family and friends, boating, fishing, and just enjoying the scenery.

 

Kristine Hansbery

Meet Kristine Hansbery, Director of WSLH Proficiency Testing. As Director, Kristine works to encourage all laboratories to participate in proficiency testing programs, with the understanding that proficiency performance aides laboratories in identifying issues with testing protocols that could affect patient care and safety. Kris and four sisters grew up on a dairy farm in Wisconsin. As children, they learned that their Father had cancer; so she and her sisters spent a lot of time at hospitals hoping for answers. Kris learned to appreciate the dedication and heartache that came with being a healthcare provider. In fact, she and her two younger sisters would end up working in healthcare. College was great at Michigan State, and her internship at Henry Ford in Detroit taught her a lot. Before stepping into her role as Director of WSLH Proficiency Testing, Kris worked for 30 years as a Medical Technologist in hospitals all over the United States. “My biggest take away is though we all want to do our best; sometimes we need a reminder of the link between what we do in the laboratory and how it impacts real people and their families,” she said. When Kris isn’t working, she loves to spend time with her family, her cat Voodoo, and her horse, Grace. Right now, she enjoys preparing for her new home in Mexico, where she hopes to retire in the future.

 

 

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.

Final rule from CMS & CDC on PT programs

On July 11, 2022, CMS and CDC issued a final rule [CMS-3355-F] to update proficiency testing (PT) regulations related to analytes, acceptable performance for laboratories, and administrative processes for proficiency testing programs established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The final PT rule considers improvements in accuracy and precision of testing since 1992 and new and emerging technologies.

The effective date of the revisions to PT requirements (§§ 493.2 and 493.801 through 493.959) will be July 11, 2024, two years after the publication date of this final rule in the Federal Register.  The delayed effective date reflects the timeframe PT programs will need to produce or acquire PT samples to meet the revised regulations and incorporate any updates to PT reporting requirements.  In addition, laboratories will need time to prepare and enroll in proficiency testing to meet the new requirements once the samples are available from the PT programs.  However, the regulations related to laboratories performing tests of moderate complexity and high complexity testing that also perform waived testing and proficiency testing enrollment (§§ 493.20 and 493.25) will be effective 30 days (August 10, 2022) after the publication date of this final rule.

WSLH Proficiency Testing will keep you up-to-date in our communications on how we are aligning our PT programs with the final PT rule. If you are not already receiving our monthly newsletter, please sign up here to receive relevant updates and more. You may also follow WSLH Proficiency Testing on LinkedIn to receive information directly to your newsfeed. If you have any questions, please review the fact sheet on the CLIA website, or download the fact sheet directly here

You can download the final rule from the Federal Register at: https://www.federalregister.gov/documents/2022/07/11/2022-14513/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to.   You may also go to https://www.federalregister.gov/ and search for “CMS-3355-F.”

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.

Steering Clear: Avoiding common PT errors

Words like “failure” can be scary. In the world of medical laboratory science, the word failure takes on a whole new level of serious, real-life consequences, should failures occur during any kind of testing. Thankfully, when it comes to investigating proficiency testing (PT) failures, there is an abundance of information available online to help clinical laboratories develop corrective and preventative actions.

Pre-examination, examination, and reporting checklists that are generated in root cause analysis, like this handy one from Lablogatory, can serve as a “launch pad” for the development of guidelines to take corrective action. Clinical laboratories use root cause analysis to identify, define, and resolve a core issue, so that resulting errors or failures cease in future proficiency testing efforts. This systematic process of analysis can help us ask the questions that give us the full story of why a failure occurred.

Much like journalists, we laboratory professionals ask “who, what, when, where, and why” questions to help us investigate. In the vein of root-cause analysis, WSLH Proficiency Testing has provided detailed scenarios of common PT failures exemplified throughout the proficiency testing process, from pre-examination to reporting. The review of detailed scenarios in specific proficiency testing programs, which are couched in real-world, empirical evidence can aid clinical lab staff in the development of strategies from investigation to action.

Let’s visit the world of hematology proficiency testing for our first scenario. Since hematology proficiency testing (PT) samples are manufactured material, most PT samples for hematology have to be tested in the quality control (QC) mode instead of patient mode to recover the correct values. In one particular instance, a laboratory did not use the barcode provided on the PT sample. Instead, the lab applied their own barcode which triggered the sample to be tested in patient mode, leading to failures on the differential parameters. The barcode provided by the PT provider would have triggered the sample to be tested in the correct QC mode; and, the lab would have recovered the correct values.

This is a common sample handling error seen in hematology PT and is very avoidable. Many times, labs are instructed to perform remedial action as required by their accreditation agency as a result of this handling error. Sometimes it is helpful to see an example, in order to be able to identify the causes that result in a lab testing in the wrong mode. 

Please see the snippet of a 2020 HemeReg1 report, for example.

Here are some key steps and resources to consider in avoiding this common error:

  • Always read the proficiency testing sample handling instructions that come with your PT kit. In this particular instance, there were specific handling instructions provided for each type of hematology instrument explaining how to test the PT samples in QC mode. If you do not understand the handling instructions, call your PT provider for clarification.
  • Your hematology instrument manufacturer can also be a resource to assist you with testing your PT samples in the mode specified by your PT sample handling instructions.
  • The CLIA Proficiency Testing and PT Referral booklet (pg. 7) provides some helpful guidance explaining that, although you are required to test PT samples like you would patient samples, sometimes PT samples require special treatment.

In the world of Blood Bank (Immunohematology) proficiency testing, the need for labs to seek out remedial testing most often stems from compatibility failures. The Blood Bank Comprehensive program includes a set of five samples (unknowns), plus a donor cell for compatibility testing. When reporting online, it is important to list the compatibility testing method used for each sample. Select if an immediate spin or anti-human globulin (AHG) method was used, so that the type of testing matches the situation and your lab protocol. Some labs use a combination of immediate spin (negative screen) and AHG (positive screen) testing. Others may use AHG for all compatibility testing samples regardless of the screen result. Let’s take a look at these two common errors and helpful hints we can employ to sidestep these failures in the future: 

  • If your lab performs anti-human globulin (AHG) crossmatches, you must perform them on the PT survey when warranted (i.e., when a sample has a positive antibody screen). Do not report an immediate spin crossmatch interpretation as your final result on samples that warrant an AHG crossmatch (has a positive screen) or you risk failure.
  • Labs that routinely perform both immediate spin and AHG testing on all samples should report the serologic interpretation as “Not compatible” if either test is positive.
  • Per CMS, labs using antiglobulin crossmatch methods (automated or manual) that employ a technology only designed to detect incompatibilities due to IgG antibodies, must also use an immediate spin crossmatch to detect incompatibilities due to IgM antibodies (i.e., ABO incompatibilities). 

(Please see the snippet of a 2020 BloodBank3 report, for example.)

Immunohematology proficiency testing samples have a shorter shelf life, as they are manufactured to simulate whole blood. When the PT event closes, these samples expire. Therefore, if a lab needs to troubleshoot a failure, the age or expiration of the samples should be noted with follow-up documentation.  

The oversight of any step, however small, can create major setbacks in proficiency testing. One such oversight commonly made among clinical laboratories is the failure to identify a PT sample—in other words, to treat a proficiency testing sample like a patient sample. Recently, one of our proficiency testing program coordinators received a call from a lab requesting replacement of Blood Gas proficiency testing samples. Upon receiving more context from the lab supervisor, the WSLH PT program coordinator learned that the lab had given the sample set and instructions to the selected Point-Of-Care analyst who was to run proficiency testing for the current event. The analyst ran all five samples without inputting the sample ID into the instrument (i-STAT). They then returned their printouts to the supervisor for submission to WSLH PT. When questioned, they reported that the samples had been run “in order”, but had no proof; so, those results could not be submitted for the event. Subsequently, the supervisor had to call WSLH PT to order (and pay for) a replacement sample set to retest with the sample IDs before they could complete the event.

These detailed, real-world instances that WSLH Proficiency Testing program coordinators have provided aim to assist clinical lab staff in the development of their own strategies, which are situated in root cause analysis. Investigation, planning, and communication with all participating staff can help clinical laboratories get to the root cause of common problems, and to make sure such errors do not happen again. WSLH Proficiency Testing offers a corrective action form online for clinical laboratories to use as a tool or guideline for investigating PT failures. Please refer to our Resource page where you can find this form among other helpful resources for clinical laboratories conducting PT. Utilizing resources and learning from scenarios such as these can aid laboratory professionals in initiating conversations, investigations, and trainings with staff so that common PT failures may be avoided in the future.

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WSLH PT Blog

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WSLH PT Staff Spotlight: Meet Tracy Servey

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Meet Tracy Servey! Tracy is a Medical Technologist and Proficiency Testing Coordinator for WSLH Proficiency Testing. Hailing from the Mid-Atlantic region of the United States, Tracy grew up in Meadville, Pennsylvania. Upon graduating high school, Tracy attended college at the Clarion University of Pennsylvania and at the St. Vincent School of Medical Technology, graduating with the class of 1997.

Tracy got her start as a bench generalist (MT ASCP) in northwestern Pennsylvania, where she worked for 10 years before moving to the Midwest to be with WSLH PT. She is now approaching her 15th year with WSLH Proficiency Testing!

At WSLH PT, Tracy coordinates microscopy modules, including provider-performed microscopy, hematology cell identification, as well as body fluid cell and crystal identification. She also coordinates hematology, urinalysis, and several quality assurance modules. Tracy enjoys the friendly environment and wealth of knowledge she is surrounded by every day at work. When she is not working, Tracy loves camping, hiking, exploring the outdoors, and spending time with her husband and two Norwegian Elkhound dogs, Leif and Truce. Tracy is looking forward to spending the winter months in her bunkhouse cabin in Northern Minnesota, which she and her husband finished building together in late summer.

WSLH PT Blog

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Feeling Thankful For The Lessons Learned

5 reasons we’re grateful for those teachable moments of the pandemic 

1. Assuring Laboratory Accuracy
When the pandemic hit, CMS determined that it would be business as usual. Yes, we are thankful for that. It meant more work for us creating different staffing models to do the same work. The reward was knowing that laboratory accuracy was still being measured. We are also thankful for the many lessons learned during this time too.

2. Lessons From The Supply Chain
We learned that the current method of procurement did not stand up to increased demand. In spite of the manufacturer’s ramping up production of needed items, raw materials were unavailable. Even when items could be produced, transportation bottlenecks confounded our ability to get what was needed. Distribution was sporadic; and, some facilities had much and others not enough. There was no system of sharing. We now know that we need better communication as well as a directory of alternate sources. We are thankful that these challenges are being talked about and addressed.

3. Staying Safe At Work
Offices in clinical and other healthcare settings got creative with how they worked, to allow staff and their families to shelter-in-place and quarantine safely. We put our public health values into practice, serving as models for how other workplaces across industries might implement public health measures in response to COVID-19. In particular, WSLH Proficiency Testing was able to shift to a blend of in-office and remote work, so that we could maintain proper social distancing and mitigate the possibility of transmission with less people in the office. We discovered that we could still effectively provide technical troubleshooting and responsive customer service from the safety of our homes. We continue to be grateful for this flexibility.

We learned that biosafety protocols needed review or revision. Clinical laboratories had to discover ways to stay safe, while managing a great influx of tests to process and analyze. From a biosafety standpoint, clinical laboratories had to take pause and assess biosafety challenges, such as how suspected or confirmed SARS-CoV-2 samples should be handled and transported. Clinical labs also had to practice greater care in practicing other testing procedures that are sure not to develop aerosols or droplets in unintentional or undetected ways. We are grateful for the published guidance and resources available for clinical labs to address biosafety challenges.

4. Adapting To Emergent Telecommunication Needs
We also adapted to new telecommunication needs, and to the various tools and platforms that continue to help us stay connected. Across organizations, we are now seeing a successful blending of online teleconferencing and networking platforms with in-person interaction. We hope this hybridization of communication techniques will be furthered in ways to increase inclusivity and promote public health safety in the workplace. We are thankful for the opportunity to learn how to optimize our use of the tools, platforms, and strategies to address emergent workplace needs, both in and beyond the realm of internal and external communications.

5. Everyone Plays A Part In Public Health
Sometimes our lessons learned are difficult to process, especially when we are in the midst of a challenge and might not be able to see how we might move forward. We have and continue to be challenged by disinformation and distrust as the pandemic was politicized from the start. This politicization of the pandemic also, in turn, politicized public health measures that we know work. This has made implementation of a nationwide vaccine program challenging, among other public health measures that we did not foresee would be contested in the political arena. We learned we needed to ramp up our educational outreach and hold media-based organizations accountable for how information about the pandemic was and continues to be disseminated. We learned that we needed to educate the public not just in the face of a pandemic but always in preparation for the inevitable recurrence of new and puzzling infections.

We wish we did not have to learn some of these lessons through the course of a global pandemic; but, such monumental challenges throughout history have been teachable moments for all of us clinical laboratory professionals, the broader scientific community, and champions of public health. The scientific world has pulled together their time, talents, and resources to create new testing platforms, to advance epidemiological tracking, and, through research and diligent work, to develop more than one vaccine to protect healthcare workers and the general population. We are grateful for the individuals and organizations who continue to work at all levels of society to make a changes, at the institutional level, at the individual level, and at the interactional level. We are, most of all, thankful to our customers and laboratories nationwide for not giving up and working together to find a solution. We all have a part to play, and we are grateful for your contributions.

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The Emergence of Coordinated Laboratory Networks

September 11th and the unique work of a Med Tech in public health

This year marked the 20th anniversary of the September 11th attacks in the United States. Erin Bowles remembers where she was on that day. Erin had just stepped into her supervisor role at Wheaton Franciscan Healthcare about two or three months before. She was tucked away in a room, attending a training led by a few nuns who held administrative positions at the hospital. As she was learning how the whole healthcare system came to be at Wheaton, a few of the nuns got word of what happened and rolled in a TV to watch the fateful events of September 11th, 2001 unfold. Years later, Erin Bowles would become the Wisconsin State Lab of Hygiene’s coordinator for the Wisconsin Clinical Laboratory Network, which was born out of public health’s response to 9/11.

The Wisconsin Clinical Laboratory Network (WCLN) is part of the Wisconsin State Laboratory of Hygiene’s public health response to the federal government’s anticipation of and preparation for bioterrorist attacks following 9/11. The CDC allocated federal funds to public health labs (PHLs) nationwide, indicating that PHLs should get to know the clinical labs in their state and their testing capabilities. Today, the aim of the WCLN encompasses emergency preparedness, disease surveillance, laboratory diagnostics, training and education, and communications. What ultimately drew Erin to working as the assistant WCLN coordinator at the Wisconsin State Laboratory of Hygiene (WSLH) was her passion for education, public health, and microbiology.

As a clinical lab professional, Erin participated in the WSLH’s Virology and TB Networks. She remembers the first outreach to the clinical laboratories when Pete Shult, then director of the Communicable Disease Division (CDD) at WSLH, and Carol Kirk, the original WCLN Coordinator, developed the WCLN.  When the WSLH was hiring an assistant WCLN coordinator, Erin was intrigued. Erin actually heard about the job through a fax that came across her desk; as many of us may remember, this was during a time when fax machines were more commonly used than today.

 “When I saw the announcement, I thought hmmm…,” said Erin with a laugh. “I was really impressed by Carol and Pete and what they were doing at the State Lab. The people here are so passionate about what they do. I love being in public health and thinking about the big picture.”

Now, as the coordinator of the Wisconsin Clinical Laboratory Network, Erin works with more than 130 member clinical laboratories throughout the state, visiting and connecting with labs to provide meaningful guidance and support. This has been especially important during the pandemic. 

Before the COVID-19 pandemic, Erin really enjoyed travelling around the state meeting with WCLN members in their own laboratories to build or maintain relationships and providing educational events, such as Gram stain wet workshops. These wet workshops address the fact that while many of the clinical labs these days are referring most of their microbiology testing to a central laboratory within their healthcare system, or to a reference laboratory, they still need the vital skills required to perform a good quality Gram stain.  It is important to keep practicing these more traditional microbiology methods, even as we work more and more with rapid testing methods. That is why Erin says WSLH Proficiency Testings Bioterrorism Preparedness Exercise (WSLH PT Clinical Catalog, page 35) is really important for any clinical laboratory in the United States and beyond to practice.

“It is one of the most important exercises we can provide clinical labs because laboratory professionals do not often get to see these agents, to isolate and identify them. If they are not constantly reminded of certain checkpoints, they forget and exposures occur,” Erin says.

Since microbiology has changed (and for the better) to much more rapid methods, lab professionals may not be sufficiently practiced in some of the more traditional microbiology methods necessary when dealing with some organisms. Exposures are most likely to occur when these checkpoints are missed.

“You may not routinely Gram stain an organism before you put it on a more rapid identification system. In doing this, you may emulsify the organism while working on the open bench. You’ve probably just created an aerosol which would be an exposure,” said Erin. “When you conduct a bioterrorism preparedness exercise, it makes you more aware and reminds you to think more mindfully of those checkpoints.”

Erin adds that WSLH PT’s educational bioterrorism preparedness exercise also helps laboratory professionals become more mindful of the longer 48-to-72 hour slow growth typical of hazardous pathogens, like Brucella sp. or Francisella sp. Most pathogens you encounter typically grow in about 24 hours.

“Slow growth is still a very important indicator that you’ve got a particularly nasty bug,” Erin emphasizes. “It’s a really good exercise that should be practiced a couple of times a year, and it’s a great way to train new employees.”

Whether you are a clinical laboratory in the state of Wisconsin or beyond, the WSLH aims to provide support in a variety of ways. Through her committee work for the Association of Public Health Laboratories (APHL), Erin has been able to work on projects that support clinical labs throughout the United States on topics such as emergency preparedness and biosafety. In 2017, Erin was nationally recognized by APHL as an Emerging Leader. Some of the projects she has worked on are the revision of the American Society for Microbiology (ASM) Sentinel Level Clinical Laboratory Guidelines, “Definition of Sentinel Clinical Laboratories, the creation of the APHL “Clinical Laboratory Preparedness and Response Guide”, and the development of various sections within the “Competency Guidelines for Public Health Laboratory Professionals: CDC and the Association of Public Health Laboratories”.

Erin is thankful for the opportunity to work with the sentinel hospitals and clinical laboratories in Wisconsin that are often the first to recognize unusual infections or outbreaks and alert public health officials. Erin thoroughly enjoys her work maintaining and supporting the WCLN and feels fortunate to be allowed to contribute to public health national initiatives through her work with APHL.

Erin Bowles is an amazing leader in public health and WSLH Proficiency Testing is grateful to share an office with her. Erin is a wonderful resource and wealth of knowledge for WSLH PT staff, as we share in our work for educational outreach and laboratory quality.

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Remembering Our Laboratory Leadership

As you may or may not know, WSLH Proficiency Testing is the only proficiency testing provider that is a part of a public health lab. We are particularly proud of the history of public health excellence that our colleagues at the Wisconsin State Laboratory of Hygiene (WSLH) have advanced since our inception as a clinical proficiency testing provider in 1966. In light of a colleague’s recent passing, we wanted to highlight his contributions to immunology and to public health overall. Rjurik (Rik) Golubjatnikov, PhD, emeritus chief immunologist at the Wisconsin State Laboratory of Hygiene (WSLH) and emeritus University of Wisconsin (UW) professor of preventive medicine, passed away in late July 2021 in Madison, Wisconsin. Dr. Rik was the WSLH’s Chief Immunologist from 1967 until his retirement in the late 1990s. Dr. Stan Inhorn, emeritus director and medical director of the Wisconsin State Laboratory of Hygiene and emeritus UW professor of preventive medicine wrote this obituary for Dr. Rik. Telling stories about each other and about our work as medical laboratory professionals and public health leaders remind us why we do the work that we do and keep us feeling connected as a community. Here is an excerpt of that obituary:

Rjurik (Rik) Golubjatnikov, PhD Rik Golubjatnikov was born on June 19, 1931 on Muhu island, one of many islands that lie offshore of Estonia in the Baltic Sea. His father was the island’s doctor, health official, and coroner. His mother was a singer and expert in national dresses and textiles. Because of its location in Europe, Estonia was affected by cultural and political events in Scandinavia, Russia, Germany, and other European countries. Consequently, Rik became proficient in speaking Estonian, German, Russian, and later Spanish.

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Rik’s life changed in 1939 when Germany and Russia signed the Molotov-Ribbentrop Pact that gave Estonia and Finland to the Soviet Union. […] On July 1, 1941, a mass deportation resulted in Rik’s father being sent to a gulag in Russia where he perished within a year. Rik, his older brother, and their mother were sent to a camp in northern Estonia where they worked in the fields, slept on the floor, and endured many hardships.

In August, Germany violated their pact with Russia and invaded the Baltic countries. Rik’s family was allowed to return to their home. Life under the German occupation was difficult. Their attempt to sail to Sweden in a small boat was unsuccessful, resulting in the family being sent to a labor camp near Frankfurt where Rik contracted tuberculosis.

The nightmare ended in 1945 when the U.S. Army swept into Germany. A camp for Estonian displaced persons was established in Geislingen, a town in Southern Germany, under the direction of UNRRA. Their home for the next four years was a small room in a duplex house. A school was started with enough teachers but little in the way of supplies. The curriculum included English, and Rik’s proficiency in English was bolstered by writing to pen pals in the U.S. Boy Scout leaders from England and the U.S. came to the camp and started a troop. At a Jamboree in France, Rik’s brother met a Scoutmaster from Illinois who found a sponsor for the family in Springfield, Illinois. In August, 1949 they sailed to the U.S. and to their new home, a large estate near Springfield. They bonded with the lady of the house and her two children, performing household jobs in exchange for their board.

Rik passed the high school equivalency exam and obtained a scholarship to Millikin University in Decatur, IL. […] He received his Ph.D. in Epidemiologic Studies [at the School of Public Health at the University of Michigan] in 1964 and took a job at SUNY in Buffalo as an Assistant Clinical Professor in the Department of Preventive Medicine. His research was in a virus vaccine evaluation project, which required that he build a virology and serology laboratory for the project.

In 1967, Rik accepted an offer to start a Section of Immunology at the Wisconsin State Laboratory of Hygiene (WSLH) on the University of Wisconsin campus. […] Rik was a leader in designing programs for control of syphilis and gonorrhea, and later other sexually transmitted infections. He helped design the creation of serum banks, which were crucial in documenting epidemics of infectious diseases. […]

Rik’s research interests extended to Central and South America, where he carried out serum surveys to determine the prevalence of various infectious diseases. When the AIDS epidemic started in the 1980s, he carried out serologic studies in Wisconsin and several countries in the Americas. Other studies included tests for infectious mononucleosis, HIV, maternally transmitted agents, enzyme tests for streptococcal infections and tests for other respiratory infections. […]

Rik had many friends in Madison and in the countries where he traveled. He is survived by his  nephews and their families.

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WSLH Proficiency Testing Staff Spotlights

As part of a public health lab, we put people first. That includes the people who help make the programs and the day-to-day operations at WSLH Proficiency Testing run smoothly. We could not do what we do for laboratory quality without our wonderful and dedicated team. We would like to take this moment to recognize Danielle Kratzke and Rhonda Stauske, two amazing Medical Technologists who bring a lot of knowledge, skills, and camaraderie with them to the office. Stay tuned for more staff spotlights next month!

Meet Danielle Kratzke! Danielle is a Medical Technologist and Proficiency Testing Coordinator in Chemistry and Special Chemistry programs for WSLH Proficiency Testing. Danielle grew up in Peshtigo, WI and moved to Madison, WI for college at the University of Wisconsin-Madison. Before coming to WSLH PT, she worked as a Medical Technologist in the QC Lab at the American Red Cross and in the Clinical Pathology Lab at Covance in Madison, Wisconsin.

Besides her great coworkers, Danielle’s favorite thing about working with WSLH PT is the enjoyment of analyzing the data and seeing labs perform well. “It is great to see an analyte with 100% consensus, low CV%, and all labs getting 100%,” said Danielle. When she’s not at work, Danielle enjoys playing with her cats Luna (aka Little Girl) and Felis Catus (aka Felis, Fee Fee, Buddy), hiking nature trails, relaxing with friends with a cold brew, trying new restaurants, playing board games, going to the movies, and attending neighborhood festivals. This summer, Danielle is looking forward to attending some of those neighborhood festivals, concerts, and movies again!

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Meet Rhonda Stauske! Rhonda is a Medical Technologist and Proficiency Testing Coordinator for WSLH Proficiency Testing. Thoughtful and generous, Rhonda’s golden rule is treat others how you want to be treated. That’s why, she says, her favorite thing about working at WSLH PT is the people. “Best coworkers ever,” Rhonda says. Before coming to WSLH PT, Rhonda worked as a Medical Technologist at a clinic in Madison, WI.

At WSLH PT, Rhonda coordinates PT events including Immunology, Blood Lead, Legionella, and International Shipments. When she’s not at work, she enjoys spending time with her husband, who is the funniest person she has ever met, and her teenage son, who is in high school and now learning how to drive. She also loves to read, garden, travel, and go on walks. If Rhonda had to eat one thing for the rest of her life, it would probably be tacos! Rhonda has lived in the Madison, Wisconsin area her entire life. She’s looking forward to a lot of things in her near future, including her trip to Greece later on this summer!

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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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