Q&A with Mary M. Munchak, MBA, MT(ASCP)
Director; Laboratory Services
EvergreenHealth
Kirkland, Washington

MedicalLab Management: As one of the first hospitals to encounter patients with confirmed COVID-19 in the US, what were laboratory administration’s early impressions of the virus?

Mary Munchak: On the morning of Friday, February 28, the lab administration was participating in our standard safety huddle when we were informed that two patients in EvergreenHealth’s Critical Care Unit (CCU) met the revised CDC criteria for testing for COVID-19 and had been tested. We sent the specimens out to the Department of Health (DOH) for Seattle and King County but did not expect the results to come back positive. Even so, when we found they did, we were prepared. We knew it was serious.

MLM: When your laboratory was alerted that patients were presenting with suspected symptoms, what were the initial steps taken?

Munchak: Our technical operations manager (the laboratory administrator on call that last weekend in February) spent the entire weekend at the hospital helping to establish an Incident Command Center (ICC) and participating in regular briefings alongside hospital administrators, physicians, nurses, and other department leaders.

Our initial process for sending the specimens to the DOH for testing was manually intensive. We were filling out paper requisition forms to accompany the specimens, receiving faxed reports, and manually collecting result data on patients and exposed employees. The microbiology department was inundated with phone calls looking for information on how to properly collect specimens and inquiring if we had received results of those that had been tested. Our business operations manager quickly built a LIS order set for COVID-19 testing to enable the entering of results into the EMR system, although this process remained a manual one during the first few weeks.

We also had to make sure we had a sufficient supply chain of viral transport media (VTM) and nasopharyngeal swabs. That first weekend, we were approached by a vendor with an analyzer that would perform PCR testing for COVID-19. We connected with hospital administration, who worked with the EvergreenHealth Foundation to secure a pledge to fund the purchase of the analyzer. The vendor was able to deliver the analyzer that first week, and our microbiology team of medical laboratory scientists and laboratory assistants worked around the clock to validate the instrument.

Last, our technical operations officer quickly identified the need for a digital dashboard to monitor our testing status. He collaborated with key IT leaders to develop the first draft and both of our teams were in the room together to see it go live for the first time. Since then, the dashboard has grown in sophistication and we have continued to refine it over time. To date, the EvergreenHealth Laboratory Services COVID-19 Dashboard tracks a range of metrics, including, but not limited to:

• Total number of tests administered to both patients and employees
• Number of positive test results
• Number of negative test results
• Number of inconclusive test results
• Number of test results still pending

Beyond testing data, the dashboard also records the number of deaths of patients who tested positive for COVID-19. EvergreenHealth shares these key metrics on its public-facing dashboard, which is updated weekly and published on the health system’s website, as well.

MLM: It has been over 6 months since the New York Times presented a view inside EvergreenHealth during the early days of the pandemic. How would you describe the changes that have taken place in the lab and in the hospital in general since that time?

Munchak: In the beginning, the CDC’s requirements for PPE changed often. As an example, most employees were not required to wear masks in their normal day-to-day operations, as the focus was on conserving masks for health care workers on the front lines. However, the CDC then updated its guidelines to mandate that everyone wear a mask while around others in the hospital.

Once COVID-19 arrived in our community, EvergreenHealth began operating under enhanced safety measures, including screening all staff, patients, and visitors upon entry; increasing sanitation of surfaces across all hospital facilities; and practicing social distancing. Since then, we have continued to closely follow CDC guidelines.

MLM: Looking back, what PPE has been the most necessary in the laboratory for maintaining safe operations?

Munchak: The N95 fit-tested masks for phlebotomists working in patient rooms has turned out to be extremely important. As for the medical laboratory scientists in the main lab and in the microbiology lab, our universal precautions and routine PPE have been sufficient. Given that these laboratories work with all kinds of infectious agents on a day-to-day basis, these staff members are likewise trained in all the proper safety protocols.

MLM: What materials and technologies proved to be most necessary and beneficial to your operations during the last 3 months?

Munchak: Certainly, the ability to perform coronavirus PCR testing on site proved indispensable. In the early days of the pandemic (when the DOH lab was being inundated), we partnered with University of Washington’s laboratory in order to help expedite our testing processes. In addition to the initial PCR instrument we were using for urgent tests, we learned that an additional existing vendor of ours had a PCR test available that could increase our capacity. By this time, EvergreenHealth had set up a drive-through collection process, so testing was in high demand and we needed all the resources we could find.

MLM: What role can the laboratory play in monitoring for complications resulting from COVID-19?

Munchak: We are confident that our providers are able to ascertain the clinical picture of a patient with COVID-19 and we in the laboratory serve as their diagnostic partner. As we continue to learn more about how COVID-19 affects both short- and long-term health, the clinical response will continue to evolve as well. Our clinical providers are ordering coagulation studies and blood gas analyses along with other routine laboratory tests in the effort to not only gain control over COVID-19, but also to best serve all our patients. We see the lab’s role as taking responsibility for proper blood and body fluid specimen collection, transportation, diagnostic analysis, and communication back to the provider(s) as quickly as is safely possible. In this way, COVID-19 has changed our processes very little; it has simply redirected our emphasis.

MLM: What processes are now in place to avoid transmission within the facility for lab staff?

Munchak: I have 90 employees in the lab (35 of whom are phlebotomists) that practice excellent hand hygiene and isolation precautions every day. In addition, and I want to emphasize this, we have accountability for one another. This is part of a quality-based environment. We train our staff to not only learn and follow safe laboratory practices, but also instruct them on how to ensure the safety of their colleagues. In our case, “spotters” are designated to observe and coach the donning and doffing of isolation gowns and other PPE. We are also well trained in emergency management and are prepared to follow isolation precautions if necessary. While COVID-19 hit us early and unexpectedly, our dedication to long-standing safety and quality measures enabled us to adapt as quickly as possible.

MLM: What lessons do you hope can result in positive measures to change lab practices and improve the clinical response to a pandemic?

Munchak: I feel so fortunate to work in a high-reliability organization. We have high standards, sound procedures, and effective collaboration across all areas from nursing, to finance, to environmental services, and everything in between. I value the trust that our hospital administrators have in the lab leadership and our medical director. It seems as though providers throughout the health care industry have gained a new respect for laboratory medicine. Many now have greater clarity of what it takes to statistically and mathematically validate a new test methodology to ensure the accuracy of a patient’s lab test result, all under intense pressure.

In addition to the importance of trust and collaboration, below are some key strengths that enabled EvergreenHealth, and the lab team specifically, to respond swiftly and successfully to COVID-19:

1. Leadership planning and organization: I cannot say enough great things about our technical operations manager, Troy Harrell, and our business operations manager, Kristi Brown, and their respective teams within the laboratory. Having experts in their fields as leaders in planning, organizing, and executing has set a positive example for the entire team to follow.
2. Disaster preparedness: EvergreenHealth sends a team to Atlanta each year to participate in a week-long disaster preparedness training event. One staff member’s experience and advanced training from that event proved to be a terrific asset in managing COVID-19.
3. Delegation: On that first weekend in late February, the hospital established ICC where everyone was assigned a clear role. They had a plan even before we knew we needed a plan and the team seamlessly executed it. That process has extended and although the delegation of tasks has become more predictable, our ability to act quickly was key.
4. Communication: Strong and clear communication from facility and laboratory leaders, as well as the facility’s marketing and communications team, in providing decisive information throughout the organization is essential.
5. Pain point recognition: Like many hospitals across the country, among the major stressors have been dealing with shortages of supplies and working through bottlenecks at outside testing operations and reference labs. It is important to recognize the decrease in lab requests from the ED, our primary care clinics, and surgery clinics as a result of reductions in those patient populations due to concerns over acquiring COVID-19.
6. Regulatory oversight: In order to ease the impact of the pandemic, the US FDA and other agencies have relaxed oversight of certain laboratory testing operations (among other concessions throughout health care), and this has produced mixed results. Positively, in an effort to flood the market with testing capability, the normally strict regulations and time-consuming validation studies were waived; a benefit for established and reputable vendors. However, this also encouraged companies to exploit the pandemic for financial gain. As laboratory directors know, you cannot cut corners with science, and poor sensitivity and specificity will not pass muster for validation.

MLM: What lessons have you taken personally and how do you anticipate changing your own practice to safeguard against future outbreaks of this kind?

Munchak: Without question, this is a highly contagious and potentially virulent virus, but I did not maintain a constant fear of becoming infected. Lab personnel are exposed to all sorts of biohazards throughout their careers—mycobacterium, Brucella, even anthrax—and we are trained to treat every specimen as infectious. Lab coats, gloves, face shields, and biosafety cabinets are among the PPE we use every day, and these have continued to provide us the protection we need.

That said, as an institution, we have learned many lessons since the pandemic first began. So much so, our administration established a dedicated website to cover multiple topics and our resulting actions. FIGURE 1 shows the introduction to this document, which can be viewed in its entirety at: evergreenhealth.com/covid-19-lessons

Click here to view a larger version of this Figure

MLM: In an ideal world, if there were no budget or political constraints, how would you like to see labs respond to a threat like COVID-19?

Munchak: I believe community hospitals, if given enough testing supplies, can turn around test results much more quickly than large-scale commercial laboratories. While it has proven beneficial to have a reference lab partner for esoteric tests, when it comes to test results needed STAT to diagnose a patient presenting in an ED, it does not make sense to send out a specimen, often long distance, to an out-of-town commercial laboratory whose results are expected in days, not hours. It may be easier to manage the supply chain and send supplies in bulk to the larger labs, but in crisis, patients need to be dispositioned to the appropriate care level. I would recommend working with state hospital associations first to develop strategies at the local level for distributing needed supplies to hospitals across the state.

Mary would like to thank Troy Harrell, MHA, MLS(ASCP), Technical Operations and Quality Manager; Kristi Brown, Lab Business Operations Manager; Dr. Ken Meckler, EvergreenHealth Medical Director; Dr. Francis Riedo, Medical Director of Infectious Disease, and the entire EvergreenHealth laboratory team.

Mary Munchak, MBA, MT(ASCP), is the director of laboratory services at EvergreenHealth in Kirkland, Washington, where she is responsible for the overall operations, leadership, direction, and administration of a range of laboratory operations and procedures at multiple clinical locations. EvergreenHealth Laboratory Services is accredited by the College of American Pathologists (CAP) and is CLIA (Clinical Laboratory Improvement Act) licensed.