As of this writing, over 450,000 COVID-19 tests are administered each day around the country. My lab at a Federally Qualified Health Center (FQHQ) is running one rapid COVID-19 viral test roughly every 10 minutes, 6 days a week. In addition, every day we send out hundreds of COVID-19 viral and antibody tests to partner labs.
Whether it’s a COVID-19 test, a cholesterol level test, or a breast tissue biopsy, when our samples are whisked away by healthcare workers, we don’t often think much about what happens next. A laboratory test feels technical, reliable, and definitive; what’s invisible to the patient is just how much an accurate diagnosis depends on humans. As a lab director, my responsibility is to ensure that every test done at the lab is accurate.
News reports show a steadily rising tally of tests performed by labs such as mine across the country. This increase in testing capacity is key to containing the pandemic. Any doubt in testing accuracy erodes public confidence in the nation’s response strategy and handling of the crisis.
Since April, it has been suggested that Abbott’s ID NOW rapid COVID-19 tests might be less accurate than traditional RT-PCR tests. While the study that questioned the test’s accuracy was not peer-reviewed, it raised questions among the public, and even among my physician and nursing colleagues, who found themselves asking, “Are COVID-19 tests truly accurate?”
Though most concerns around COVID-19 test accuracy have focused around faulty machinery and companies rushing to bring their offerings to market, nearly three decades of experience have taught me that what matters most in any lab is the people. The testing professionals behind the scenes are conducting hundreds of manual actions every day that determine the validity of a test. Human beings perform the very checks that ensure a machine is giving accurate results.
Now, when stakes are higher than ever, we must recognize that accurate testing goes beyond sophisticated equipment; it also requires qualified leaders at the helm, well-trained workers, and well-funded health centers.
Without a highly dedicated professional team, sound operating protocols, proper training, supervision, and investment in the people administering and analyzing tests, the whole integrity of our testing system is compromised. One misguided collection technique, or one mislabeled specimen, can ripple outwards in catastrophic ways during a pandemic.
I learned this lesson before, when I was tasked with leading the team that was testing 1,500 children for lead poisoning in 2003. Right off the bat, I discovered three test discrepancies due to poor operational processes. After implementing new training, collection, and verification processes, we were able to deliver accurate test results for patients. We were even able to outperform big commercial labs with more expensive equipment.
Despite less specialized personnel using a rapid, portable device, our new test results proved to be more accurate. This was because of a well-trained, well-managed staff. Otherwise, without the diligent lab work by my team, the children of Newark would have been given erroneous lead poisoning diagnoses. People, process, and teamwork made a far bigger difference in accuracy than the devices alone.
Along with a dedicated group of individual professionals, a well-functioning testing process depends on other factors. Here are a few I think are integral.
Increased leadership from the top
Ensuring accurate test results goes beyond the lab—federal and state leadership is crucial during this continued public health crisis. For us to get testing accuracy right, it takes public leadership, interlaboratory collaboration, and investment in a high quality of patient care.
Since 2016, critical public health infrastructure has been systematically dismantled as a result of funding cuts at the CDC. The recent debacle in which contamination at CDC labs led to ineffective coronavirus tests has shed a harsh light on problems brewing in the public health sphere.
It is critical to establish processes across all parts of the testing ecosystem that improve accuracy, such as interlaboratory quality assurance programs. A great example is Beckman Coulter’s IQAP (interlaboratory quality assurance program), which uses daily quality control data from participating laboratories across the world to allow each lab to see where it is in comparison to a large number of peers on tests using the same analytical instruments.
Properly trained communities
We also need to ensure proper training and investment in community and public health laboratories such as mine, by ensuring that labs have the funding they need. As the COVID-19 crisis persists, CDC and states change testing guidelines on a daily basis. This is understandable as we learn more about the virus, day by day.
On top of this, manufacturers are making new recommendations specific to their tests. Healthcare professionals struggle to keep up with the training required to scale their operations while meeting these whiplash demands. Community labs, seeing cuts to their budget, often lack the guidance and training they need as a result of an underresourced and underpaid staff. In partnership with device manufacturers, we must fortify training for people who operate testing devices.
Commitment to funding
In order to serve populations, FQHCs need a bolster to direct funding. Today, in contrast to half a decade ago, there is little public funding allocated to support lab operations at FQHCs. When an FQHC wants to provide a high quality of care, it has to foot its own bills for the lab—from personnel, to facility, to capital investment and consumables.
Investing in talent
If community labs don’t attract talented people and pay them decent salaries, we risk an understaffed, undertrained workforce providing inaccurate testing information to the most vulnerable communities. Labs such as mine, which serve large parts of America, are on the precipice of losing our funding. As a community lab, we are very in tune with the communities and individual patients we serve. My patients know me, and I know many of them by name, as well as their medical needs.
Even so, health centers across the country have been forced to lay off staff and reduce hours. More than a million healthcare workers have lost their jobs.
As I write, my lab does not have the funding required to continue operations more than one month from now. We are dependent on a divided Congress passing emergency funding bills for public health facilities. If they don’t, we lose our ability to operate. Even private labs are at risk of toppling over as their revenue has dropped steeply since the onset of the pandemic as a result of increased demand for one type of test, thereby dramatically reducing the volume of other test types.
Testing is more than feeding a test tube into a machine and getting a printout. It is a highly choreographed process that requires funding, effective protocols, and hardworking, dedicated people who recognize all patients deserve a higher quality of care.
Li Jin, MD, PhD, is the laboratory director at Refuah Health Center, New Square, New York. He served as the director of the Newark public health laboratory from 2003 to 2010 in Newark, New Jersey.