Sprinting into a Marathon: Striving for Quality in the Covid19 Crisis
A few months into the Covid19 crisis, we need to stop treating it as a short-term crisis and start preparing it like it's a long-term emergency.
Sprinting into a Marathon: Striving for Quality in the Covid19 Crisis
James O. Westgard, PhD and Sten Westgard, MS
Let us begin with a bit of gallows humor. Early in the film, Up in the Air, the head of a company starts a speech to his employees with a stark declaration: ”Retailers are down 20 percent. Auto industry is in the dump. Housing market doesn’t have a heartbeat. It is one of the worst times on record for America.” Then he pauses. “This is our moment.” This company, it turns out, specializes in laying off the employees of other companies, and the worst time in America means better business for them.
As the world faces a perilous virus, laboratory testing is having its moment. Laboratories and laboratory professionals are demonstrating their vital importance to healthcare, indeed to the survival of millions. We wish there was a better time to shine, but as it happens, this is ours. We used to hint, not seriously, that the only time healthcare or the general public would recognize the importance of the laboratory was during some type of strike, a moment where testing became suddenly unavailable. We now wish a pandemic was not the way the world reached this realization.
But here we are, in a world in desperate need of our services.
First, we need to dispense with politics. Anyone who claims this is just a hoax, or a flu, or a bad flu, has probably said that from a safe distance in an untouched part of the world. There aren’t many of those left. Soon those safe zones won’t exist. China wouldn’t call what happened to them a hoax. South Korea wouldn’t describe their experience as a simple case of the flu. Italy and Spain right now are still grappling with something far worse than a bad flu. New York City is facing a death toll multiple times worse than the 9/11 attack. The numbers, the science, the data, all point to a real global pandemic.
As Laboratory professionals, you are uniquely equipped for this moment, with your competence, your professional ethics, and your demonstrated dedication. You have always known how important your results are, how critical they are for the right treatment for the right patient. This year, with covid19, the rest of the world is realizing just how vital those laboratory results are.
Because laboratories deal in facts, you are the truth tellers*, and you are the only path out of this crisis, until we have a vaccine. Without large scale testing, not just PCR but also serology, with contact tracing and isolation, we can’t sort out when and how much we can re-open and resume what will become the new normal of life. Because this virus is so insidious, hiding in people who are asymptomatic and using them as stealth shedders and spreaders, or lurking inside people for weeks before surfacing, we need tests more than ever.
Just a few words of advice as you forge ahead...
Expect to be overwhelmed. Many of you already are. For some, you are still in the calm before the storm. You may be lucky but don’t expect that. Expect to have more patients, more testing needs, more demands, than ever before. But even as you may grapple with the first wave of this crisis, you need to begin planning for the waves to come. Until we have a vaccine, testing is the critical weapon in this fight.
Expect shortages. In test swabs, in viral transport medium, in reagents. If you have a steady supply today, expect you will not have one at some point in the future. Build redundancies – consider bringing in more than one method of testing into your laboratory, from an independent supplier or company, so if your supplies for method X go down, you still have a shot with method Y. For years we have been chasing the efficiencies of what managers called LEAN**. Today you need to build a defense in depth, with stockpiles and backups. Validate alternatives for swabs, consider making your own viral transport medium if you can, improvise and develop workarounds (those old skills are going to come in handy). If you’re a high complexity lab, throw some talent into Lab-Developed Tests.
Think long-term. Plan beyond this wave, the next wave, and the wave after that. Assume at least one year of testing demands, maybe two years. This is why we used the word marathon in the title. It would be wonderful to be wrong, to see this end in a few months. But since the only victory can be achieved with vaccination, with all countries getting control over the virus spread, it's hard to see a quick fix in the future.
Don’t forget quality. Yes, the FDA in the US has essentially thrown open the doors to allow any manufacturer to get into the testing game (US regulatory agencies were first too strict, now they’re too lenient, hoping that on average they got this right). At the time of this writing, more than 70 manufacturers had jumped into the market. As of April 13, the global FIND database listed more than 250! There’s no chance that all these companies are producing perfect tests. There’s a high probability that several of these methods, rushed to market, are going to be very poor. Demand better quality. Demand data on validation studies, sensitivity, specificity. Conduct those studies in your own lab. Share them with your colleagues. You should add third-party controls to your methods as soon as possible – if the manufacturer controls are always in, that’s not a sign everything is fine, that’s probably telling you the controls are not sensitive enough. Get into a PT /EQA program for these methods. In the short run, consider round robins or “ring trials” with hospitals near you.
Don't overhype the power of a test. We shouldn’t overstate the ability of testing to diagnose a patient. Where the virus has overrun the community, testing can become secondary, you must assume everyone probably has it, and now you’re not trying to track the disease so much as differentiate the very sick from the less sick. The diagnostic test might not be as important as all the other tests that monitor the patients’ health and the clinical presentatoin. We also know there are significant pre-analytical challenges with swabs, as well as false negative issues, with rt-PCR testing methods. There will be false positives. There will be false negatives. Make sure you give right advice.
Finally, BE BOLD. Don’t be shy. For too long, the laboratory has endured cost-cutting, resource starvation, staff leaning, and other neglect. Some of our challenges in facing the virus are direct outcomes from this short-sightedness. It is tempting, particularly given our history, not to talk about this while we deal with the crisis. But we need to put down a marker. Be bold. Demand the resources that you need – that the patients need – in order not only to deal with the immediate crisis, but for the long struggle ahead. Don’t allow the executives to shunt you back into the basement of budgeting and resources once this over.
You are the vector of truth.
You are the vector of life.
You are the vector of hope that will get us through this crisis.
Thank you to all the labs and all the professionals around the world who are in this fight, who are shouldering the burden, who are going to win this war for all of us.
Jim and Sten
A few footnotes:
*Khosrow Shotorbani, president and executive director of Project Santa Fe Foundation, the Lab 2.0 movement deserve credit for first calling laboratories “truth tellers.”
**In defense of LEAN, often the approach was used as an excuse to cut staff and inventory, not adopt a true Toyota production system. Just-in-time inventory was supposed to be complemented by inventories build for emergencies. But most organizations ignored that part.