NEB Podcast #46 -
Transcript
Interviewers: Lydia Morrison, Marketing Communications Writer & Podcast Host, New England Biolabs, Inc.
Interviewees: Susan Aitken, Molecular Laboratory Assistant Manager, Harvard University CLIA Laboratory
Lydia Morrison:
Thanks for joining us for this episode of the Lessons From Lab and Life podcast brought to you by New England Biolabs. I'm your host, Lydia Morrison, and I hope this podcast offers you some new perspective. Today, I'm joined by Susan Aitken, molecular laboratory assistant manager of the HUCL lab at Harvard university, which was created to help meet the COVID testing needs of students and staff on the Harvard university campuses.
Lydia Morrison:
Hi Susan, thanks so much for taking time out of your schedule to be here with us today.
Susan Aitken:
Hey, Lydia, thanks for asking me to be here.
Lydia Morrison:
Absolutely. So, by way of an introduction, I was hoping that you could tell our audience a little bit about the focus of your work over the last couple of years.
Susan Aitken:
Yeah, sure. So, I was trained as a medical technologist and have my ASCP certification, but back in 2012, I decided to specialize in molecular diagnostics and got my MB ASCP certification. So, my work over the past 10 years has concentrated in this specialized field of molecular diagnostics.
Lydia Morrison:
So, could you explain your role at Harvard and the Harvard university clinical laboratory?
Susan Aitken:
Yeah, sure. So, I'm the assistant manager here at HUCL. I've basically overseen daily operations, including management of all the workflow, maximizing all our throughput, inventory management, staff trainings, and competencies, quality management, and reviewing testing logistics with key Harvard stakeholders. And, in addition, I work the bench when it's needed. So, if we're short staffed, I just get out there and hop on and do the testing.
Lydia Morrison:
Wow. That's amazing. You must have a lot of skills. So, during the pandemic, the laboratory became a CLIA certified laboratory. Is that right?
Susan Aitken:
Correct.
Lydia Morrison:
How long did it take to get the CLIA lab up and running?
Susan Aitken:
Yeah, so the business plan was first submitted here at Harvard in August of 2020, and it took a couple of months for them to decide to move forward with the CLIA lab. So, in December and January of 2020 and 2021, capital requests for instrumentation were made and orders were placed to secure consumables and reagents. And, the EUA application was submitted to the FDA. And, we saw also submitted for CLIA regulatory compliance. So next, the EUA application was submitted to the FDA and regulatory compliance was submitted to CLIA. So, as this was happening, staff recruitment and training was taking place in preparation to go live, which happened in April of 2021. So, all in all, it took about five months to get the lab up and running.
Lydia Morrison:
Wow, that's great. It seems like a lot of hoops to jump through in a short period of time so congratulations on that milestone. How big was the team of lab technicians that you had working there during sort of the peak of your testing?
Susan Aitken:
At the peak of testing we had 32 employees, and that was not how the lab started out. We started out with about 12, 15 employees and when the students came back and the decision to test on a regular basis happened, we had to double our staff in a very short amount of time.
Lydia Morrison:
So, who is the testing available for? Is it available for all Harvard students, graduate students, undergraduates, professors?
Susan Aitken:
Sure. It is available for all students, staff and faculty here at Harvard. And, we also did test for MIT as well.
Lydia Morrison:
Oh, wow. So, that greatly increases the workload I'm sure. So, are there specific considerations that you needed to take into account for shipping and receiving of reagents for quality control of the reagents because it was a CLIA lab.
Susan Aitken:
Yeah. So, no special consideration was made with regards to the shipping and receiving of reagents because the companies that we are involved with ship reagents according to their recommended temperatures, and we basically follow the manufacturers recommendations for storage of these reagents. Now, one thing that we do, do that is different than a research laboratory is we do, what's called lot to lot testing to make sure that every single shipment of reagents that comes into our lab performs in a way that is acceptable for the regulatory compliance for CLIA. So, every lot that comes in, we do the testing. We have stringent protocols that have to be met in order for QC to be passed. And, once it's passed, it's put into the general area for testing use.
Lydia Morrison:
Interesting. So what sorts of tests is the lab running?
Susan Aitken:
So, we only do COVID testing here.
Lydia Morrison:
And, what kind of COVID tests are you performing? Are they PCR based or?
Susan Aitken:
They are PCR based.
Lydia Morrison:
How are the students and staff submitting their samples for the testing?
Susan Aitken:
Yeah. So, Harvard is affiliated with the company called Color and basically students, staff and faculty have to register with Color. And, then when they want to submit a sample, they go onto that Color website and do what's called activate their kit. And, what they do with this is they enter their symptom information and also enter in a specialized barcode that is affixed to the collection tube. And, it's also on a card that the individual can keep with them to check on their sample once it's submitted. And, basically it's a specialized swab called a rhinostic swab that is used to get a nasal specimen, it's self-collected. And, once it's collected, it's put back into the tube. The tube goes into a biohazard bag and the biohazard bag goes into collection bins, which were located all over campus.
Susan Aitken:
And, test kits were located all over campus as well. Once it's was in the bins, the Harvard university mail services would go all across campus, picking them up and bringing them to the lab here where we would empty them and get them ready for testing. And, what I think was awesome was at the peak, we had 54 collection bins located all across campus and mail services went to these collection bin sites several times throughout the day. And, we're constantly dropping off specimens, which really made it super efficient and really helped our turnaround times be superior.
Lydia Morrison:
Amazing. So, what were those turnaround times?
Susan Aitken:
Yeah, so from time of kit activation to time of result was 8 and a half to 16 and a half hours. And, so it was less than 24 hours and that was pretty much at our peak when we were doing 18,000 a day. But, then the turnaround time from receipt in the lab to result, was three and a half to five and a half hours. So, basically less than five hours or less than six hours, you have your result.
Lydia Morrison:
Yeah. It sounds like a very efficient process that you were able to implement. At the peak of the pandemic. How many times a week were students and staff testing?
Susan Aitken:
Yeah. So, students were testing three times a week and staff that was on campus tested once per week, but many of the students and staff chose to test more often than what was required in an effort to contain the spread of Omicron.
Lydia Morrison:
Yeah. I think we can all appreciate the comfort of being able to test daily or every other day, especially when the numbers are high in your specific area.
Susan Aitken:
Yeah.
Lydia Morrison:
So, speaking of that, the numbers are quite high in Massachusetts again, right now. I feel like it's one of those times of year in the COVID pandemic era where it seems everybody you know has it, or has had it in the last month. So, I was curious, I had heard that the HUCL lab was closing. I was curious why the lab was closing now as we sort of see these increasing rates.
Susan Aitken:
Yeah. So the main reason is that we're a high throughput lab and because our testing numbers here at Harvard and MIT are falling drastically because now we're just doing optional testing. There's no required testing being done. It isn't a cost effective or sustainable investment. So, at our peak we were testing up to 18,000 tests a day, and now we're averaging around 3,000 a tests a day and it's really just not sustainable.
Lydia Morrison:
Yeah, understood. That is a big difference. And, I'm sure the number of staff that you need to keep on hand and really the cost of having all that automation running. That's interesting to learn about and congratulations on the falling numbers at Harvard and MIT. That's amazing. Any thoughts on spinning up a flu testing facility there? Anything else? Have there been talks of maybe using that technology that you've built to test for other infectious diseases?
Susan Aitken:
Sure. I've heard people talk about multiplexing for the big three, flu, RSV and COVID, but I don't know of any plans to actually perform that testing here at Harvard.
Lydia Morrison:
Yeah. I love hearing more about the multiplexing tests too. And, I'm looking forward to sort of seeing more of those options become available in the healthcare field for individuals, especially. I mean, I feel we're rolling into summer right now, so it's not such a terrible time, but as the fall comes around next year, I'm sure it'll be another point of discussion.
Susan Aitken:
Yeah. I feel now is the time to do your validations to get ready for the fall.
Lydia Morrison:
Absolutely.
Susan Aitken:
So, if it was going to happen, now's the time to do it.
Lydia Morrison:
Right. Spoken like a true molecular laboratory manager. So, how do you think that the COVID 19 pandemic has impacted preparedness for the next virus at Harvard and MIT campuses?
Susan Aitken:
Yeah, so I think we're definitely more aware of what needs to be done in terms of preparing for the next outbreak. And, I've recently read a publication from the White House that came out in September of 2021 that was titled American Pandemic Preparedness: Transforming Our Capabilities. And, this publication outlined a very high level strategic plan for what can be done in preparation. And, it listed everything at a very high level from goals, funding, and then lastly, medical defenses.
Susan Aitken:
And, here at HUCL, that's where we are. And, clinical labs all over research labs, we're in the medical defenses area of this plan. And, I really feel like our COVID assay here in the HUCL lab can help achieve that last goal of medical defense readiness because we have a simple, inexpensive, high performing diagnostic test that is available on large scale. And, they had a goal of within weeks after the recognition of an emerging pandemic threat, but I know it takes longer than that to get an assay up and running, but I really feel like it's doable, especially with this assay that HUCL was doing.
Lydia Morrison:
That's really good to hear. It's nice to hear that there has been some improvement sort of in the fore thinking of how we can prepare for the next virus that's inevitably going to affect us as a world nation. It's nice to hear that, that groundwork has really already been laid and that there are these labs CLIA labs around the United States now, at least. And, I would suspect something similar around the globe that can really adapt quickly, even if it's not in weeks that can adapt quickly to new viral strains or to new viruses entirely.
Susan Aitken:
Sure.
Lydia Morrison:
Do you have advice that you would offer someone who's interested in a career as a medical laboratory scientist or a medical laboratory technician?
Susan Aitken:
Yeah. I would tell them that a career as a laboratory scientist has a lot of different opportunities. It can work in the traditional hospital lab setting and go up the career ladder that way. Being a lead tech, supervisor, manager, director, or they can go work for a reference lab, pharmaceutical lab research lab, or even a forensics lab. And, some people choose to go on a totally different aspect of science and go into sales. Selling instrumentation for laboratory, consumables, reagents.
Susan Aitken:
Other people they like being the hands on field engineers, fixing the instruments, and then even others they become the field application specialists that help either new users or experienced users with problems that they may be having. So, the one thing that I would encourage someone interested in this career to do is to shadow someone who is a medical laboratory scientist to see if this is something that they're interested in doing.
Lydia Morrison:
Yeah, that's great advice. I'm just thinking, it sounds like that being a medical laboratory scientist or a laboratory technician is a really great jumping off point for lots of career opportunities and different areas of expertise and growth. So, I really like that you pointed that out, I think you forgot marketing in there. I think really you can take that scientific expertise that you gain with some of that training and do anything from sales to marketing, to technical work, to bench work to probably project management and some strategic planning around how some of these assays are built and developed. So, that's really great advice.
Susan Aitken:
Yeah.
Lydia Morrison:
I just wanted to thank you one more time for taking the time out of your busy schedule. I'm sure, even though the test numbers are falling there at HUCL, you are still very busy as we sort of see these COVID-19 cases sort of linger around this mid range. So, I just wanted to thank you for taking the time to talk to us, but also for your hard work and putting the CLIA lab together and getting that up and running and supporting all those students and staff and helping keep the Cambridge and Boston area numbers sort of under surveillance and under control.
Susan Aitken:
Well, it's truly my pleasure. And, I need to put a plug in there for the person who actually got this lab up and running. It was Michelle Hope. She is a superior project manager, and she is the one who really made this lab happen. So, really kudos to her. We were all hired by her. I mean, not by her, but she was instrumental in choosing the team for the HUCL lab and really has done a phenomenal job through these past 15, 18 months.
Lydia Morrison:
Awesome. Well, that's wonderful to hear. I'm glad you have such great leadership and we look forward to hearing more about potential testing from your lab in the future.
Susan Aitken:
Sounds good. Thanks.
Lydia Morrison:
Thanks for joining us today. Please tune in next time when I interview Jessie Stickgold-Sarah, lecturer at Massachusetts Institute of Technology who shares her perspective on the importance of good communication skills, especially in science.
