February 19th, 2020 is a day that I will likely remember for the rest of my career. At University of California Davis Health in Sacramento, we were preparing for a news story of what is now considered the nation’s first clear example of community spread of SARS-CoV-2, as well as one of the first known COVID-19 hospitalizations in the United States. At that time, I was serving as director of pathology and laboratory services for UC Davis Health, and the lessons we have learned during the ensuing 20 months and counting of the COVID-19 pandemic—well into my current role as the system vice president of lab services for Legacy Health in Portland, Oregon—are stark and persistent. No one was quite prepared for the challenges posed by the COVID-19 pandemic, but one thing is clear: We must be better prepared for the next one.
Facing Practical Challenges
In the last 15 years of my professional laboratory experience, we have established the purpose for performing tests as a combination of clinical need, strategic direction, and financial impact. Laboratory leaders take pride in identifying, shaping, and implementing this purpose, as we remain mindful of available resources and the need for lean operations. However, the COVID-19 pandemic has disrupted our conventional ways of thinking and distorted our policies, procedures, and practices. Instead of trimming waste, many laboratories have been forced to abandon standardization and waste saving practices. Instead of establishing medical necessity, we have been forced to simply try to keep up with demand. In many cases, urgency has overtaken quality as a driving influence, and these are not strategies that coincide with the goals of the laboratory. Moving forward, we must find ways back to our goals of gaining technological support for valuable human resources and reclaiming control over laboratory practices.
Long before COVID-19 arrived, laboratories were dealing with issues related to the recruitment and retention of numerous staff positions. The pandemic has further muddied the waters with several staff members opting for retirement or to change professions altogether. Over the course of the past two years, this trend has become particularly evident among front line workers, such as phlebotomists and other testing personnel who have experienced new levels of burnout. Further exacerbating the issue, we saw an increase in staff members calling in sick due to self or family member exposure, or due to vaccine related symptoms. Given that labs rely on the handful of existing training programs for our labor pipeline, the pandemic also disrupted the development of our next generation of laboratorians when several training programs were paused or otherwise interrupted. While these have been tremendous and ongoing challenges, laboratorians are used to novel innovation, and in many cases, we have had to tap into our creative sides.
Notwithstanding the labor shortage, we continue to face resource limitations for all things plastic and glass, blood products, and other products. Fortunately, we have been able to utilize 3D printers to produce swabs and applied GMP techniques to produce our own specimen collection material. We also held more blood drives to assist our local and national blood suppliers with their ongoing shortages. We showed flexibility by pivoting through a continuous borrowing and sharing process as allocations of COVID testing supplies fluctuated. We created contingency plans and effectively and consistently communicated with our stakeholders. If there was a venue to raise our concerns, we spoke up. This level of leadership from the laboratory will help carry us through, but we need to apply these lessons to the future.
Breaking from Standardization and New Roads to Compliance
Laboratories are known to tend toward standardization over diversification. We are taught as laboratorians that we improve quality and efficiency and reduce redundancy and errors through standardization. As health care workers, it is also driven home that standardization improves patient satisfaction, quality of care, and overall clinical efficacy. If harmony is the synonym for laboratory standardization, incongruity is what COVID-19 introduced.
Instead of consolidating to one method, we implemented multiple methodologies (eg, antigen, antibody, RT-PCR, rapid PCR, et al) and specimen types (eg, nasopharyngeal, NP, saliva, spit, nasal wash/aspirate, etc). We also duplicated the same methodologies on multiple platforms based on reagent allocation demands and available operational configurations. To borrow from an old metaphor, the COVID-19 pandemic has been like the train coming at full speed while the tracks are still being laid. Thus, we found ourselves having to move faster than ever in our efforts toward test validation and staff training.
The COVID-19 pandemic has challenged our collective notion of medical necessity. Questions of who, when, how, and how often to test for the disease have remained difficult to answer throughout. Although FDA EUAs provided guidance on utilizing certain reagents only for symptomatic patients, as a nation, utilization became rather sloppy. Furthermore, we encountered reagent formularies that included COVID-19 with other respiratory panels, such as flu, RSV, and others. This raised new questions, such why and to what end would we test for flu and RSV, off season.
As guidelines continued to evolve and new disease strains started to create further surges and more havoc, sequencing to determine the specific mutation became the latest hot trend for public health labs and researchers, and this trend continues. We also found ourselves continuously educating clinicians around intended utilization, such as the idea that antibody testing in the current market does not detect vaccine effectiveness at this time.
As compassionate health care workers and dedicated laboratorians, we will continue to push for measures that increase quality and patient safety, but we need to learn from and apply the lessons of the COVID-19 pandemic to all aspects of laboratory operations. We have been pushed, and this has driven us to reevaluate what it means to maintain constant survey readiness; to increase the number of checklists related to safety, quality, and compliance requirements. As the pandemic challenged our traditional views on how inspections are conducted, we had to learn the nuances of virtual inspections both as part of the inspecting team or the laboratory being inspected. These are all experiences from which we can learn valuable and applicable lessons. For one, this enabled us to remain committed to quality without having the burden of traveling across the country in the middle of a pandemic. As we develop best practices in this area, we will continue to adopt and adapt to innovative technology, which in turn will make inspections more thorough and engaging.
And yet there are still more lessons to learn. When the dust settles, we will need introspections for all that we purchased and consumed. We will have to recalibrate back toward standardization and in the process, regroup and stabilize. We need to invest in our current and future workforce, as well as maintain and further utilize the new technologies we have implemented. As we start contemplating the future testing needs for long-term COVID management, we must regain accountability for those areas that may have grown lax in the nearly 2-year run of this disease. Most important, we cannot grow complacent in our vigilance and preparation for future pandemics. The entirety of health care was ill-prepared for COVID-19, so the onus is on us not to repeat history.
Iyda Antony, MBA, MS, MLS(ASCP)CM, CLS, FACHE, is system vice president of lab services at Legacy Health in Portland, Oregon. She has oversight of nearly 700 staff across multiple hospital core labs, two regional reference labs, and over 20 patient service centers across Oregon and Washington. Iyda is a past recipient of the ASCP’s national student honor award and was included in their 40 under 40 list.
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