Tools, Technologies and Training for Healthcare Laboratories

2020: A Terrible Year with Tremendous Accomplishments

2020. A dumpster fire of a year. How did labs fare? Was this the year that broke the lab? Or the year that labs shined more than ever? Or both?

2020: Lessons Learned and Hope for a Better New Year

James O. Westgard, Sten A. Westgard
December 2020

It's that time of the year in the US when people write their "Christmas letter" describing the good and happy events of the past year (usually highlighting all the good news and acknowledging fewer failures) That is difficult to do in this year of pandemic, yet there are signs of progress and reasons to be hopeful that the new year will be the beginning of the return to normal. That new normal will likely be different from the past, hopefully better because of the lessons we have learned this past year.

Our attention span is short. The virus’ attention span is much longer. The insidious nature of the SARS-COV-2 virus is that it takes much longer than a tiktok video, or tweet, or Facebook post to rear its ugly head. In a world with a shorter and shorter media cycle, the virus thrives on our inability to think long term. The sacrifices of past generations in the face of great challenges seem heroic in comparison to our own. In the great wars, the citizenry volunteered for battle, volunteered for war industries, endured hardship and rationing, sometimes for years. In pale comparison, we are being asked to stay at home a few weeks if we test positive, to wear mask when we go outside, to forgo mass gatherings, and yet some still feel this is too much to ask. How spoiled and selfish we have become. Every time we forget, every time we become impatient, the virus thrives.

And yet for all the distraction our technologies cause us, these same tools provided us many opportunities to stay connected during our quarantines and shelters-in-place. Together, this year the Westgards have had webinars, to Australia, Bangladesh, Brazil, China, Colombia, Ecuador, Malawi, Nepal, South Africa, and of course the USA. And still other webinars we did had global reach. In some ways, in 2020 we actually reached MORE people than ever before, and more people than we could ever have possibly reached in person. But for all the Zooms, Facetimes, Teams, Webexes and GotoMeetings we had, they didn’t really every add up to the same connection we get when we see each other in person. As we speak in December, we (Sten and James) have not been able to meet in person for 11 months. We hope 2021 (mid-year?) we will be able to remedy that painful absence.

Medical laboratory testing is being recognized as a critical healthcare service. Laboratories have suffered for many years because we operate behind the front lines. This year it became crystal clear that laboratory tests are a critical part of any strategy for managing this pandemic (and the backbone of any healthcare strategy). Numerous articles in newspapers and discussions on news programs have highlighted the importance of testing. Discussions of clinical sensitivity and specificity have been widespread and we find ourselves having that discussion with our friends and family members. A year ago, your non-laboratorian friends probably thought you had a curious profession. Now they understand how vital you are. That is progress – the challenge is to remain in the public eye and ensure the laboratory continues to get better recognition and improved resources.

We need to translate this moment into a better future. We can’t go back to the laboratory world of 2019, it’s too clear now that it was inadequate to the pressures we facein good times, not to mention in times of crisis. We need better resources, better training for staff, and a place at the table when key medical decisions are being made.

New laboratory tests have become available at a breakneck pace. It is remarkable how fast new tests for COVID-19 have been developed by manufacturers and made available by laboratories. As of early December, the WHO database of the COVID19 pipeline lists nearly 1,000 new methods. In many ways, this is the equivalent of hundreds of “Manhattan Projects” being carried out across the globe. While CDC had initial difficulties with the introduction of the reference RT-PCR testing methodology, there is now widespread application of that methodology by manufacturers, as well as many improvements and adaptations for different specimen types. Antibody tests were rapidly introduced and the FDA was responsive in tightening EUA requirements to eliminate many poor performing tests. It is striking to see that for every one antibody method the FDA grants EUA state to, there are three methods that the FDA rejects. Antigen tests are now available for rapid test applications. The swift development and implementation of these different types of tests demonstrates the extraordinary capabilities of our industry and our laboratories to rapidly deliver critical testing services. It is a genuine marvel, years from now we will look back upon this and still find amazement.

Laboratory testing can become a political issue. We have relied on the CDC, FDA, and HHS for scientific guidance, but we now have learned that politics can influence that guidance. Perhaps it was naïve to think otherwise, but it’s clear now that CDC and HHS can be intimidated by the Executive Branch to limit the influence of medical science. FDA initially provided very low standards for EUA of new tests, but tightened those requirements to a more reasonable standard after laboratory concerns. It will be important to restore the scientific leadership and influence of these agencies to right the ship of state. A side effect of this pandemic will be the shift of Laboratory-Developed Test (LDT) regulation away from FDA control, placing that responsibility firmly in HHS hands. Laboratories themselves will probably have more influence and flexibility in the future on LDT tests.

Science can be sidelined by politics in guiding pandemic strategies. The US pandemic response was disastrous, with the third wave now in progress in December 2020. As of the day we write this, December 5th, 2020, there were 277,825 deaths, with 214,099 new cases a day, for a total of 14,255,535 cases. Compared to almost every other country in the world, this is a singular disaster. Almost the entire country is a hot spot and we expect many more cases resulting from the travel over the Thanksgiving holiday (which was down by 40% but not down far enough). The Christmas holiday is yet to come and may lead to further community spread. And yet the White House is still planning Christmas parties without concern for spread. Not a good example to a Nation reeling under the onslaught of a pandemic.

Alternative facts lead to an alternative realities. Perhaps the most serious issue that results from sidelining science is the emergence of an alternative reality based on alternative facts. We have witnessed the telling of many lies, so often repeated, so often re-tweeted, and so often echoed across other social media, that it has become difficult for many to distinguish between the factual reality and an alternative reality. Witness patients dying from COVID-19 who tell their nurses and doctors they can’t have COVID because it is a hoax. Witness those in our country who won’t wear face masks because they don’t believe in COVID or don’t believe face masks will limit the spread. The critical point is that we have a substantial portion of our population that can’t distinguish between truth and lies, facts and falsehoods. Trying to bring everyone to a shared, factual understanding of reality will be a herculean task that we must face together.

And now for the good news! 2021 is a new year and the beginning of widespread vaccinations will commence. We will also have a new administration who believes in science. The new President will face a very difficult situation, in the midst of a pandemic with a 3rd or possibly 4th peak occurring, but with the light at the end of the tunnel: the emergence and availability of vaccines. Many other crises loom ahead. Economic problems due to high unemployment and lack of government support. Political conflicts between the two parties will be as furious as ever. Still it is a sign of hope because we have new people who are serious about solving these problems who are now in the positions of influence. Vaccines are on their way and we anticipate that by mid-year 2021 they will provide significant relief from the pandemic. We need to have patience, minimize contacts, wear face masks and socially distance for the next several months until our environment is once again safe.

In the US, it is not hard not to be touched by the virus. Friends, colleagues, and family have been sickened. We are lucky that our closest circle has not yet felt the lethality of SARS-COV-2. But with you and all our global community, it has been a year of heartbreaking loss. A year where grieving is interrupted by griefs anew.  We mourn with you. We hope that soon we will have the time to reckon with each indvidiual loss, rather than bracing ourselves for the next death.

Stay safe, wear masks, keep your distance, keep your exposures short when possible, and get the vaccine as soon as you are offered. Respect the science.

From all the Westgards to your laboratory, your staff, your colleagues and peers, and your families, we wish you the best for 2021.