WSLH PT Blog

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Important CLIA Changes to Proficiency Testing Requirements

Posted on February 5, 2024 by flowerme

The Centers for Medicare & Medicaid Services (CMS) published their final rule on July 2022 including Proficiency Testing (PT) revisions. PT revisions will go into effect January 1, 2025 and will include analytes that will be CMS regulated along with revised grading criteria for existing analytes. Please refer to this 2025 CLIA changes document for more information, including the effective date, and also the implementation date of the CMS final rule.

Most of the modules WSLH PT offers already meet these requirements. Where possible, WSLH PT will reassign laboratories using a non-waived method enrolled in a 3-sample PT module to a 5-sample PT module. Reassignments will be reflected on 2025 Enrollment Quotes sent out in September 2024. The tables below list new CMS regulated analytes with their corresponding modules and revised scoring criteria.

Further changes will be communicated closer to the implementation date of January 1, 2025. If you have any questions about the new requirements, please contact WSLH PT at 800-462-5261 or ptservice@slh.wisc.edu.

To view the new CMS-regulated analytes, revised scoring criteria for currently regulated analytes,
and microbiology changes, please visit our webpage:
CLIA and Proficiency Testing Changes – WSLH Proficiency Testing (wslhpt.org)

WSLH PT Blog

Enhancing The Role of Lab Professionals In Patient Care

Posted on April 4, 2022 by flowerme

Every year during Medical Laboratory Professionals Week, we are reminded that 70 percent of “today’s medical decisions depend on laboratory test results.” Medical Laboratory Professionals get the results that make an impact on patient care. How lab test results are interpreted is another story that does not often appear in discussions surrounding this statistic. Having more discussions on the interpretations of lab test results is an issue occupying the foremost concern and attention for many laboratory professionals. Such an issue has certainly received more focus with the release of key reports in professional journals and their coverage by industry media within the past 7 years. In response to the Institute of Medicine’s 2015 report Improving Diagnosis in Health Care, everything from doctoral programs to informational, on-the-job handouts, have been produced to address the interpretation of results with the following solution: enhance the role of the clinical laboratorian on the patient care team. Enhancing the role of clinical laboratorians, with the knowledge, skills, and abilities that they bring, is vital in providing the most informed diagnosis. The kind of problem-solving strategies developed to enhance our role demonstrates that education is at the core of the solution, educating ourselves and educating our colleagues outside of the lab. The solutions that manifest always result in a more highly collaborative team of healthcare professionals.

In 2015, the Institute of Medicine released a report, Improving Diagnosis in Health Care, stating that diagnostic errors affect 5% of US adults seeking outpatient care each year, and contribute to approximately 10% of patient deaths and 6% to 17% of hospital adverse events. The report indicated that diagnostic errors cause patient harm, and attributed the statistical occurrences to a gap in communication between physicians and laboratory professionals. Increasing intentional collaboration is required in order to close the gap, and, ultimately improve the diagnostic process, the report concluded. Not long before the release of this report, the Center for Disease Control and Prevention (CDC)’s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) conducted a survey to determine the strategies necessary to address this gap in communication. In the survey, family and general internal medicine physicians reported uncertainty in ordering diagnostic tests in 14.7% of patient encounters and 8.3% uncertainty in interpreting results. The survey also found that only 6% of the physicians surveyed consult laboratory professionals at least once a week or daily. In fact, this was the least frequently reported approach to discerning what test to order and how to interpret the test results. Those 6% who did contact laboratory professionals indicated that it was in response to “confusing ordering options on the computer/electronic medical record” or, “when the lab results do not match the patient symptoms.” It is clear from these statistics that uniting the laboratory with direct patient care is a key component in improving the diagnostic process.

How do we work together to minimize the occurrence of misdiagnosis? Researchers, educators, and others in the field know that the role of the laboratory professional and the knowledge of laboratory science is a vital component on healthcare teams to improve diagnosis. According to the February 2017 issue of Laboratory Medicine, “Some laboratory professionals have become an important member of the clinical team by providing interpretive comments, developing reflex testing programs, and participating on multidisciplinary and diagnostic management teams.” Certainly the creation of the Doctorate in Clinical Laboratory Science (DCLS) program within the past decade has enhanced the role of clinical laboratory scientists on diagnostic management teams (DMTs) today.

Brandy Gunsolus, DCLS, MLS (ASCP)CM, was the first graduate of a DCLS program, graduating from Rutgers University in May 2018. Gunsolus documented her training and her thoughts from the field as a DMT leader in her blog, The Road To DCLS. Here she frequently writes about what many laboratory professionals wonder: what kinds of questions do physicians ask her? She answers that some of those questions may be highly complex, requiring more training on the part of lab staff. However, she says she also answers many questions that “virtually every medical laboratory professional should be able to answer.” Regardless of your official job title in the lab, Gunsolus emphasizes the importance of obtaining CEUs, as they are “essential to us staying current in our profession.” There are excellent online CEUs as well as those offered in-person conferences, like those offered at the ASCLS Joint Annual Meeting. Regarding online resources, WSLH Proficiency Testing, in partnership with the University of Washington’s Medical Training Solutions (MTS), offers customizable online training and competency courses to help labs achieve professional development goals.

“Education is always the key!” Gunsolus says on the importance of including laboratory professionals on healthcare teams. “We must educate ourselves and educate our other healthcare professionals if we are ever going to improve our profession and our patient’s care and safety.”

A brief and compelling look at a few key statistics give us a helpful snapshot of the current climate of laboratory and patient care staff relations. A deeper look at what is being done today will further demonstrate that healthcare teams must work with and include laboratory professionals in order to improve and maintain accurate and reliable patient diagnoses. Stories of today’s clinical lab trailblazers like provide a unique vantage point regarding what is required to develop mutually-informed, highly collaborative diagnostic teams. Education is required, and takes a two-pronged approach: 1) Educate Others: Include laboratory staff as knowledge-sharers and team members in patient care delivery, and 2) Educate Yourself: Strive to obtain CEUs regularly, and find other professional development opportunities to stay current. Enhancing the role of the clinical laboratorian in the diagnostic process and on patient care teams will, in turn, greatly impact our visibility to the public as a healthcare professional and as a viable career choice. Laboratory professionals get results each and every day. In honor of your important contributions to healthcare, WSLH Proficiency Testing would like to take this moment to thank each and every one of you for all you do to make a difference.

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WSLH PT Blog

Feeling Thankful For The Lessons Learned

Posted on October 26, 2021 by flowerme

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.

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up to receive your digest of clinical lab news, memes, and more:

WSLH PT Blog

WSLH Proficiency Testing Staff Spotlights

Posted on July 28, 2021 by flowerme

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!

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up to receive clinical lab news, memes, and more.

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!

WSLH PT Blog

Decentralized Testing: Effect on the future of laboratories

Posted on May 25, 2021 by flowerme

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up to receive your digest of clinical lab news, memes, and more:

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

WSLH PT Blog

The Future of the Medical Laboratory Professions

Posted on March 30, 2021 by flowerme

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.