Dr. Roberta Barnes Carey ’71, retired director of the Laboratory Quality Management Program at the Centers for Disease Control and Prevention (CDC), offers a glimpse of the preparations, response measures and essential role of the institute’s quality control processes that are critical for the nation’s healthcare system as it faces the ongoing COVID-19 outbreak.
Dr. Carey joined the CDC’s Division of Healthcare Quality Promotion as Chief of the Clinical Microbiology and Epidemiology Branch in 2004. She later served as acting director for the Division of Laboratory Systems, which provides technical and scientific oversight for the regulations that set the federal quality standards for the nation’s clinical laboratories. She served as the CLIA Director (Clinical Laboratory Improvement Amendments) for CDC’s infectious diseases laboratories in Atlanta that are certified by the CMS (Centers for Medicare and Medicaid).
“I have been retired from the CDC for almost four years so my insight is based on past experience and general knowledge and not insider secrets,” says Carey. “I am very confident that we will get through this and come out smarter on the other side.”
In a critical public health moment like responding to the COVID-19 outbreak, what role does the CDC’s laboratory quality management program play?
The Laboratory Quality Management Program works with the CDC infectious diseases laboratories to establish and follow proven quality practices that ensure the highest level of scientific, regulatory and safety measures for the tests developed and performed. A quality management system is the backbone for all laboratory functions performed in public health or clinical hospital laboratories. Now as we are testing for coronavirus, those quality practices are being exercised daily to provide accurate and reliable testing results. Having clearly written protocols, competent and well-trained personnel, and reliable laboratory information systems enable laboratories to function 24/7 under these very demanding and stressful conditions.
Setting aside initial reporting and testing failures, was an outbreak of this scale and severity inevitable? To what extent does the CDC assume that a pandemic like this is only a matter of time, and how is that attitude reflected in the CDC’s preparedness?
Although no one has a crystal ball to predict a world health crisis, CDC has always been focused on preparedness in the event of a major disaster. The CDC and other public health laboratories in the individual states have drills to simulate potential outbreaks and disruptive scenarios, such as natural disasters. After these multi-day exercises, participants analyze what went right and what could be done better in the event of a real crisis. So preparedness is a way of daily life. However, a pandemic of this magnitude is the culmination of many political, social, financial and medical circumstances that may not have been predicted.
What do you see as the primary challenges facing the quality management program — and the CDC in general — in responding to COVID-19, both today and going forward? What do the scientists there need from the government and the general public to do their work as effectively an efficiently as possible?
Although the scientists and support personnel at the CDC strive to do their very best, they are not perfect. The rapidly developed CDC test to diagnose CoVID-19 had a problem with a confirmatory step that was publicized widely and did much to harm the excellent reputation of those on the front lines developing tests to meet new and novel pathogens that arise. More communication from the CDC laboratory scientists and epidemiologists and less from politicians with no scientific background would go a long way to bring true information based on data to the world. The testing burden has moved from the CDC to the clinical arena where more tests can be performed for those who need them. Regulatory hurdles to ensure that the newly developed tests work were a double-edged sword — safeguarding our patients, but at a cost of weeks lost in releasing approved tests to allow an accurate picture of who is infected with this novel coronavirus. We will all learn from this experience and hopefully be better prepared to manage the next health crisis.
For her contributions to her professional community, Carey was honored in 2013 with the William Smith Alumnae Achievement Award. Read more about her Life of Consequence.