The University of Rochester Medical Center's Department of Pathology & Laboratory Medicine is proud to again participate in this year's annual meeting of the U.S. and Canadian Academy of Pathology (USCAP). View the list of URMC's poster and platform presentations that will take place virtually March 15-18, 2021.
Showing “remarkable resilience,” the University of Rochester Medical Center’s Clinical Microbiology team has won a Board Excellence Award for its ongoing contributions during the COVID-19 pandemic.
The annual awards recognize teams and individuals whose contributions exemplify excellence. Microbiology was one of eight URMC teams to be recognized at a virtual ceremony on Jan. 25.
Bruce Smoller, M.D., chair of Pathology & Laboratory Medicine, praised the efforts Microbiology made to carry out critical testing to help patients across the region when COVID hit.
“In spite of many obstacles, this team developed and validated all available platform options to ensure capacity could meet the growing need for testing,” he said.
Lab Director, Dwight Hardy, Ph.D., said none of this would have been possible without collaboration from many UR Medicine Labs.
“In addition to congratulating staff in Micro for a job well done, I also want to thank staff from other areas, such as, Blood Bank, Chemistry, Hematology, Toxicology, Phlebotomy, and SMS, who have worked with Micro in an overall team effort to meet the needs of our hospitals and community.”
How do you move large testing equipment from one end of a hospital to the other without delaying patient care? The answer is, very carefully. After many months of meticulous planning and preparation, four clinical labs successfully relocated to newly renovated homes at Strong Memorial Hospital. For most, this was the first major workspace upgrade they have seen in 45 years.
“Little did we know that you would be moving in the middle of one of the worst pandemics of the century, and you did that without disrupting a single test for any of our inpatients or outpatients that depend on you,” said Kathy Parrinello, hospital COO, in a video message to staff recorded in lieu of a ribbon cutting. The thank-you video also features footage from the moves and greetings from Pathology & Laboratory Medicine faculty and leadership.
The moves brought these groups into hospital space in G-2100 and 1-2100, a construction project that continued through the height of the pandemic. Automated Chemistry, Specimen Management (SMS), and a new Microbiology STAT lab moved into a shared workspace in 1-2100 and, below them, Blood Bank moved into G-2100.
Each move had its own unique set of challenges, from maintaining operations through long periods of equipment downtime to rethinking how to establish daily workflow in a brand new setting. Moving SMS and Automated Chemistry required careful coordination. Starting in May, the whole front-end SMS system went manual for the next four months, which meant big changes to workflow, said Kristi VanDeWalle, chief SMS supervisor at SMH.
“The staff were willing to try anything to make us successful and that attitude and effort translated really well in the new space,” she said. “There was a really dynamic sense of teamwork through the whole process.”
The last time any of these laboratories got “new” space was 1975. Debbie Masel, chief supervisor of Blood Bank and Transfusion Medicine, has spent the last few decades watching the lab grow, in terms of staff and services that it provides to the hospital.
“We never really went through a major renovation in all that time,” said Masel. “Even though the Blood Bank changed a lot in 45 years, our space remained the same.”
One thing remains clear – having efficient inpatient testing onsite will be part of inpatient care for many years to come. And, having a permanent home for the onsite labs will allow our clinical labs to grow to meet the day-to-day needs of patient care behind the scenes.
“You were able to keep everything running smoothly and most everyone in the hospital did not even know it was happening,” said Parrinello. “It was an enormous feat for all of you, and thank you for everything you do for our organization.”
Necessity is the mother of invention, and in the case COVID-19, grit and innovation. One great necessity in this fight has been the push to make more testing available. Like clinical laboratories across the nation, UR Medicine’s Clinical Microbiology Laboratory has overcome a series of setbacks to establish testing for SARS-CoV-2, the virus that causes COVID-19.
Thanks to a dedicated team of scientists and collaborators, the lab successfully went from having zero testing in place to providing results for 1,000 people a day in just two months.
Answering the Call
Flu season is one of the busiest for the lab, and it was just beginning to wind down in early March. But then, “COVID-19 didn’t give us much warning or time to prepare,” said Dwight Hardy, Ph.D., director of Clinical Microbiology (right).
At the onset of the pandemic, the Micro team was asked to develop a molecular test for detecting the virus. The effort was led by Nicole Pecora, M.D., Ph.D., the lab’s associate director, along with postdoctoral fellows, Andrew Cameron, Ph.D. and Jessica Bohrhunter, Ph.D., Hardy, and a group of medical technologists.
The team faced some immediate obstacles, like shortages in chemical reagents needed for testing, and lack of equipment. But after many days of long hours, they created a manual laboratory developed test (LDT) modeled after the CDC’s emergency use authorization (EUA). On March 16, the lab started testing and reporting its first patient results.
Due to instrument and reagent shortages and the manual nature of the LDT, the lab was only able to provide results for about 200 patient specimens per day. This limited testing capacity presented a stark dilemma: Who would get a test?
To address that challenge, URMC leadership brought together the Micro team and a host of other groups including Infection Prevention, Intensive Care, Emergency Medicine and others to develop testing criteria. They decided that testing would be prioritized for symptomatic inpatients and health care workers (whether or not they showed symptoms).
The goal? To help stop the spread of the disease a by identifying the COVID status of patients at the hospital for care, as well as any workers who were potentially exposed.
In about two weeks, the lab gradually increased the number of specimens it could test. Then good news came in the first week of April as the FDA gave approval to have SARS-CoV-2 testing run on an automated instrument, Roche Cobas 8800. “The Roche” is a state-of-the-art machine that was already being used to test for other infectious diseases. Because of its ability to run batches of tests at a time, this proved to be a game changer.
Instead of being forced to send specimens to commercial reference labs, all testing for SMH and its affiliates could now be performed in-house within 24 hours. This meant more patients could be tested to determine whether they were positive for COVID-19.
Compassion Behind the Scenes
The lab now performs over 1,000 tests per day and hopes to more than double that number. Shortages of test kits, reagents and specimen collection kits continue to limit the lab’s ability to increase testing volumes.
While each day is a new day when it comes to availability of resources, Hardy said supply chains appear to be slowly stabilizing. He added that in spite of the ongoing hurdles his team has faced so far, and potentially more on the horizon, he’s extremely proud of the Micro team for coming together to meet the challenges head on.
“All of us in the laboratory feel compassion for patients, their families and their loved ones and want to do the best we can as quickly as we can, to do our part in either the diagnosis or management of this particular disease,” he said. “I think that’s why people were so willing to step up to the plate, to be flexible and work long hours without being asked. They were dedicated to patient care and wanted to do their part in this unusual circumstance.”
Strong Memorial Hospital now requires all asymptomatic inpatients to be tested for COVID-19. It’s one thing to keep up with heavy clinical volumes as specimens for testing continue to increase. Lab teams are accustomed to this, even in non-pandemic times. But it’s another thing to do this work while under pressure to develop new and effective testing for the general public.
Since April, the Micro team has undertaken a second wave of test development – this time for a serological blood test to detect SARS-CoV-2 antibody, which would determine whether someone has had COVID-19 in the past.
Much like earlier discussions about who should be tested for the virus, Medical Center leaders are now finalizing the logistics of a what widespread serological testing would look like. Meanwhile, the Microbiology team is working hard to validate the test so it is more than 99 percent accurate.
While health leaders and scientists are eager to provide antibody testing as quickly as possible, they want to get it right. And since the virus is so new, it’s not yet possible to know from an antibody test whether a patient is immune to COVID-19 or how long immunity might last.
Antibody tests will be very useful in determining past infections in our community. The next chapter of the pandemic remains unknown, but Hardy says the lab is equipped and ready for what’s ahead.
“Our team has risen to unprecedented challenges that were un-predicted just a few months ago,” he said. “We realize that the challenges are not over, but we continue to do our part day-by-day to provide the best diagnostic testing possible for our patients and community.”
March 12: First positive COVID-19 case confirmed in Rochester
March 16: UR Medicine’s Clinical Microbiology Lab issues first patient test results. Due to manual nature of the test and limited testing resources, strict criteria is put in place for who can be tested.
April 3: Following FDA approval, UR Medicine Labs starts running automated testing on Roche 8800, which greatly increases test volume.
Mid-April: Testing becomes available for some asymptomatic patients, including nursing home residents, those with respiratory symptoms, and those coming for elective procedures.
May 13: Strong Memorial Hospital requires universal testing for patients that are admitted.
June 1: UR Medicine to begin antibody testing.
A watershed moment in life: A springboard to academic success. That is what pathologist, Dr. Mukesh Agarwal, calls the University of Rochester Medical Center, where he was a resident in the 1980s.
Today, Mukesh is a professor of pathology and medical education at California University of Science and Medicine’s (CUSM) School of Medicine in San Bernardino. We caught up with him recently to find learn more about what he’s been up to since his time in Rochester.
He did residency at URMC (AP/CP) from 1982-85. Subsequently, a chemical pathology fellowship at Cleveland Clinic Foundation.
After training, he spent over two decades at a newly opened Johns Hopkins Hospital affiliated to a new University medical school in the United Arab Emirates, where he held clinical and academic positions. He rose up the ranks to become Professor and Chair of Pathology. In 2017, he returned to the U.S. to take on his current role at CUSM.
His research focuses on diabetes, with more than 90 peer-reviewed publications. He has been on international panels to formulate the latest guidelines for gestational diabetes mellitus for the World Health Organization, WHO and the International Federation of Gynecology and Obstetrics, FIGO.
What are some things you remember when you look back at your time living Rochester?
Rochester helped me in more ways than I can count. I met some of the finest teachers, mentors, and colleagues there. I learned a panoply of life lessons. I have too many moments at Rochester that I treasure. It is – and will always be – a part of me. Rochester also taught me to bicycle along the canal and cook (being alone, I had to).
Were there any specific people who made an impact on you?
My mentor is Dr. Neil Blumberg, who I am still in touch with regularly. He unlocked my academic gene. Our work on transfusion immunomodulation changed medical practice. His great advice was, “Do not second guess what you have done.” I learned how to temper great academic success with humility from Drs. Dan Ryan and Anthony DiSantagnese. I learned from Dr. Thomas Bonfiglio how to relax despite being super busy and always looked up to Dr. Stanley Patton, my former chair.
Amongst the residents, Mark Mitchell’s brilliance bowled me over. His wisdom and aphorisms are beyond compare and I am honored to be regularly in touch with him. Bill Rodgers treated me like family when I was alone in Rochester. I cannot quantify my gratitude for his goodness. Each sumptuous dinner at his home was memorable. Steve Spitalnik and Glenn Ramsey were residents worth emulating. A quick story: When I was looking for external referees to evaluate my credentials for promotion, I emailed Mark Stoler after over a decade. He responded five minutes later. John Laczin visited me two times during my stint overseas. All in all, besides academia, I learned many lessons in goodness, tolerance, and ethics.
What’s it like being back in the U.S. after living and working overseas for so long?
Against all our plans, we moved back to California three years ago. It was ordained by The Fates, I suppose. Johns Hopkins overseas turned out an eclectic mix of cultures, from over 100 countries. It made us understand them better, become less judgmental, and more forgiving.
After two decades, much has changed in the U.S. Americans have become less trusting and more money oriented. Also, it is hard to decipher this new crop of millennials, students and otherwise. Growing up, we believed our professors, we did not question them. There seems to be little leap of faith in this generation.
When did you realize you wanted to become a pathologist? Was there any one experience or person who pointed you in that direction?
Like most things in my life, it was sheer serendipity. A strange trick of fate. For learning research, I tried pathology for a year. I discovered all the advantages: the happy personalities, the good mix of life balance, the teaching, the research. I was smitten – and there was no going back. The rest, as they say, is history.
What advice would you give young people looking to pursue a career like yours?
Do not overthink your life. Make lemonade when life gives you lemons. At the new Johns Hopkins overseas, there was a paucity of expertise, e.g., statistics. The ethos was different from my background. But diabetes prevalence was the second highest in the world. And pregnancy was rampant. So, I started working on gestational diabetes, which turned out to be a great hunting ground for research.
Do you have any hobbies you spend time doing outside of work?
Today, I believe I am quite a chef. I own more than 300 cookbooks. Overseas, we learned from different cultures, from Japanese to Italian to Serbian. I was always and am still passionate about English language and literature. I remain an avid cyclist. Ironically, we live in Redlands, CA. When I cycle to the nearby University of Redlands, I see huge posters with the initialism: U of R – a metaphor that the University of Rochester will always be a part of me. It is a de ja vu.
Tell us about your family.
My wife has a master’s in economics but was a home maker by choice. We have two adult daughters. Priya has a master’s in clinical therapy treating childhood trauma through play therapy. A niche field coming into its own. She went to Colgate University-a stones’ throw from U of R. Neha is starting college waiting for life to unfold. We live together, an un-American concept, but normal by Asian standards. It is a blessing to be so close together.
I am close to Upstate N.Y. My brother has been living in Binghamton for four decades. My daughter misses her alma mater, Colgate University at Hamilton, N.Y. So, I shall visit soon.
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