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Hello and welcome to Trust and Transformations - Leaders Navigating Change. I am Geir Fuglerud the CEO of DNV Supply Chain and Product Assurance Business Area. And I'm joined today by Nancy Stratton, CEO of COLA. COLA is an organisation focussed on improving health care by accrediting laboratorians and ensuring they meet high standards of quality and safety. Under Nancy's leadership, COLA has been instrumental in providing education, advocacy and accreditation services to health care laboratories across the United States.
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Nancy, welcome to the podcast.
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Thank you, Geir. It’s quite a pleasure to be here with you today.
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So, Nancy, you've been at the forefront of pushing COLA to embrace new technologies and educational initiatives. What has been your proudest moment as CEO, and how do you keep your team inspired to continuously raise the bar in such a rapidly evolving field?
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You know, it's very difficult for me to have one proudest moment. I am continually proud of the staff. We have a team of very, very committed and dedicated surveyors, technical advisors and all the people who work on the back end. I have not worked with a team of people who have this level of dedication before in my career, so I'm always very proud of that.
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Another thing I'm very proud of is the fact that a couple of years ago we had our conference, we have an annual Laboratory Enrichment Forum Conference, and our CEO, Kathy Nucifora asked the Workforce Action panel, what can COLA do? And their response was, there are so many national organisations that have initiatives to address the laboratory workforce shortage. Why can't COLA just bring them all together? So we did the following year we hosted the Workforce Action Alliance Summit. Our planning committee consists of national laboratory organisations. We got together for the day. We laid out three initiatives that we could work on throughout the year. We got together the next year, report on what we could do, and we chose three initiatives for this year. Looking ahead to the future, knowing how much the pandemic affected the workforce, that is a very proud moment for us to know that we're trying to get the laboratory industry to work together to address this shortage that will affect health care, the future.
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So you mentioned Covid right. And leading COLA through such a dynamic time in the industry and also in healthcare at large. That must come with its challenges, what personal values or experiences have shaped your leadership style and kind of how do they influence the way you guide COLA’s mission on improving lab quality and safety?
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I like when someone's opinion is asked. you acknowledge the fact that you have received their opinion just in something as simple as a self-evaluation. We make sure that when we're doing performance evaluations, we look at what our staff is telling us. I also firmly believe in the open-door policy. If someone has ideas or concerns or suggestions, we want to know about it. I want to know about it. I like to empower our leaders to talk to their staff, to make sure that we're hearing from frontline employees. What are they hearing from our customers? Are we truly addressing what needs to be addressed? And I want to make sure that when people have a good ideas, they get the credit for it, they get acknowledged.
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So bringing both ideas and suggestions and feedback to the surface basically that's critical as part of your leadership.
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Yes, I believe in teamwork. And I also believe there are people with different perspectives, experts in different areas. And when we bring that expertise and those different perspectives together, we're able to get a better holistic view of how we should be addressing things.
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And that goes back to our board of directors. Cola has three member organisations the AMA, American Medical Association, the AAFP, American Academy of Family Physicians, and ACP, American College of Physicians. Each of those three member organisations appoint three members. So that gives us nine physicians. And those nine physicians elect three more members to the board of directors.
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So COLA is a physician led organisation, we’re led by physicians with varying specialities, varying backgrounds that strengthen the way we look at health care. And I think that that goes from the board of directors down to our frontline employees. Different perspectives, different expertise. It just makes us stronger.
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It sounds like a very collaborative way of working and also the governance of COLA. So kind of moving a little bit over to transformations happening. So when we think of words like transformation, what does that mean in the context of laboratories. What kind of change is COLA gearing up for.
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Well, I tell you, the laboratory is an area of transformation for decades, going back to using cell counters that were little haemocytometers. And when you would boil sugars with a flame and you would read electrolytes with flame photometers to the very, very advanced equipment we have today. And that just moves on into molecular and molecular used to be a speciality all within its own, and it's spreading out through more and more of the different departments within laboratories. So laboratorians are very flexible, very able to adapt and adjust to the changes that are coming. And the best thing we can do is educate, make sure people know what's out there, know why the systems are in place, why these new methodologies are coming out and how best to utilise them.
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It sounds like its been an ongoing transformation.
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So what's next when it comes to transformations?
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Well I don't think you can turn on the news or the radio without hearing about AI these days. There has got to be some guidelines where AI is used. Laboratories have had AI in some aspect for many, many years. There's automated cell counters in different areas where AI has been used.
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Generative AI is a little bit different and it will be interesting to see how clinicians may be able to use that when looking at laboratory results. Working with laboratory experts to make sure they understand it. But I think more molecular and more digital pathology and just the use of AI.
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It must be a super exciting field to work in.
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It is, and unfortunately it's not as well-known as we would like, which is where the WAA, the Workforce Action Alliance, comes into play. We make sure that we're reaching colleges, universities, high schoolers, make sure the high school science teachers know about our industry, make sure that the counsellors know about our industry because it is exciting. And even though we're getting more and more automated, you still need to possess that critical thinking skill.
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And that's what's going to help the laboratory stay extremely relevant going forward.
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So with the healthcare landscape and kind of the laboratory industry kind of evolving so rapidly, especially with new technologies. And we also see increasing pressure on health care systems. How do you ensure that laboratory quality and patient safety remain at the forefront of COLA's mission and kind of why is this focus more critical than ever?
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So recently, about two years ago, I was asked to be on the board of Project Santa Fe Foundation and PSFF, Project Santa Fe Foundation, has an initiative of Clinical Lab 2.0 and the focus of Clinical Lab 2.0 is how to go from volume based to value based. I bring this up with this question because Clinical Lab 1.0, if there's a 2.0, there has to be a 1.0. Is a very basic, high quality laboratory results. We have to ensure that the results that the clinicians and the patients are receiving are high quality. It is extremely important. Everything we learned through Covid, all of the different changes in the way testing is coming out. The FDA has their rules on laboratory developed test, LDTs. We have to make sure that we're staying abreast of all of the changes so we can educate our laboratories in the laboratory industry as a whole, continue to educate. That's key. Educate, educate, educate and make sure that the patient care is first and foremost. That's what we're here for.
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So ensuring laboratories across the country adhere to strict regulatory standards. It's a significant challenge, especially with the evolving nature of health care. How will you work to strengthen COLA's role in influencing policy and collaborating with agencies like kind of CMS, the Centres for Medicare and Medicaid, which is the chief regulatory body in the US in this case that oversees both our work, at DNV, and to ensure that labs not only meet compliance but also strive for continuous improvement.
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All accrediting organisations under CLIA, which is part of CMS, work together. They bring us together in meetings where we can have discussions. We have a liaison to CMS. We can relay our opinion on things. We can relay concerns. They've just reorganised the CLIA division and they've restructured how we have discussions, bringing more of the AOs together. And I think all AOs are focussed on quality patient results.
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And when you get all the AOs together, Accrediting Organisations together, relaying information to CLIA, part of CMS, it will only make it stronger. We also are very closely with the CDC. In fact, the CDC has asked us to make sure that when we're talking with hospitals, we are relaying information about viral haemorrhagic fever. A few years ago, Ebola hit and people were very afraid to have those samples going through equipment, handling the samples. But the CDC has guidelines, and we're trying to help the CDC get that information out there on what laboratories need to do to make sure laboratorians are safe. The equipment is fine, but the patients get the care they need. So nice collaboration with these regulatory agencies is what we've been working on very hard the last few years, and I truly think it's very beneficial for the laboratory industry. The Covid pandemic taught us we need to be prepared, and CDC has a surge testing group and COLA is part of that. And with that, we can make sure that our laboratories know what to do if unfortunately, another pandemic comes.
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Yeah. And you mentioned the pandemic of course. And, and you know all these kind of global health challenges they brought unprecedented pressures on laboratories. And I'm sure that during Covid this must have been very, very stressful times. And how did you lead COLA through that critical time and what other lessons from that experience are now shaping how you approach future potential disruptions?
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I was very proud of our staff. We were able to keep all staff on no furloughs, no layoffs, no cutbacks anywhere, we found work. We were also the first AO to receive the approval of CMS to do our virtual inspections. Now it sounds like it's a good thing you don't have to go on site, but you gain so much when you walk into a laboratory. Just the feel of the laboratory. It was a lot of work for the laboratories to upload all of the documentation they needed to, instead of sitting with one of our surveyors and discussing it with them, and our surveyors felt like they were missing out on being within the laboratory.
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Yeah, because we have the same when we go on, kind of whether that is into a hospital, when we accredit hospitals, or if we go on board a ship or an offshore platform or whatever it is, a factory. You get almost an immediate sense right, in terms of housekeeping and yeah, is this a place that is under kind of good control and governance or are there areas to improve?
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Yeah CMS is not continuing virtual surveys, which in our opinion is a good thing. And what we heard from our customers it's a good thing because they want that face-to-face interaction. We also learned that our staff was even more dedicated than what we had imagined. We were watching the positivity right in different areas of the country. And we did not send surveyors in areas where the positivity rates were really high and our surveyors were chomping at the bit to get back out there. They wanted to get in there, but we needed to keep our surveyors and their families safe.
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So we learned that we can depend on our staff. We learned that our staff will be there to help us once we get through the pandemic. And we also learned working with the CDC, that as the laboratory industry, we need to work on surge testing. We need to be prepared for massive amounts of testing that will be required if we were to have another occurrence like this in the future. So it was a nice educational process for us, very difficult in so many aspects, but we try to look at the positive side of things, and I think we took some good positive points away from that. Even as much as how often are we in the office, we learned how much we need to be in the office, how much we can work virtually. A lot of our employees are happier at home, and as long as productivity is up, as long as there are supervised well and the works getting done, you know that work life balance is important.
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Yeah and honestly, we see the same, but you know, when it comes to work life balance and people working from home, do you see that potentially long term could impact culture. You seem to be an organisation with kind of very strong culture, very passionate, engaged employees. But could it impact culture?
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I think only in a positive way. Because we have employed surveyors, unlike, a competitor of ours, we have only employed surveyors, so they have to be spread throughout the country. So we make it more cost effective to be able to go out on the surveys in different states have different regulations. So you need to be really well versed in those particular states regulations. So with more than half of our staff already virtual, allowing more people to be virtual has not had a negative impact on us. I just see it being a good thing for our organisation.
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Yeah. And of course this is a this is a big country. So you mentioned education a few times, Nancy. COLA, you have already said, you know, places a strong emphasis on education. You offer resources like webinars and tools to help laboratory professionals stay up to date with compliance and best practices. How important are these educational initiatives in contributing to long term improvements in laboratory quality?
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I think education has always been critical. We have got to make sure that people in laboratories understand what's going on, understand new developments. With our annual conference, the Laboratory Enrichment Forum, we're able to relay a lot of information to our attendees. And I think it's great. We have different keynote speakers, but we also have webinars, we have COLA Academy with courses out there. And in today's world where workforce is such an issue and people may not be able to leave the laboratory to go to conferences, or they only have a short amount of time during the day to listen to a webinar or get into a course to do some more training. It's very important for us to make sure we have relevant information out there, that we continue to respond to feedback from our courses, from our webinar, from our conference to make sure that we're providing what laboratories need. Because we can sit around in a circle and think what we think is most important. But we take the feedback, just like we do from our surveys. We always want customer feedback. Sometimes we hear things that we don't want to hear, but it's important for us to act on that feedback. And I know that's something that DNV also does well.
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We look at it as all feedback is an opportunity to improve, right. So you have to look at it positively even though sometimes it's not what you would like to hear. But you know, then you can act on it and avoid it from happening again.
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Right. That's one of the similarities between COLA and DNV. There are several similarities.
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So looking at the global health care landscape collaboration between organisation has become increasingly important and you are the result of a collaboration in itself. So but how do you, engage with more international partners and stakeholders to stay ahead of global trends and continue driving transformations in laboratory accreditation.
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CDC is one good way. There are offices throughout the world, and our relationship with CDC has only grown and improved through the years and we try and work with them, even with basic things like clean water, the importance of clean water. Our theme at our Laboratory Enrichment Forum in May of next year in Chandler, Arizona, is focusing on the health care ecosystem. One of our guest speakers is going to be a vice president from the National Kidney Foundation. Well, water is extremely important in the desert, but water is also extremely important for our kidneys.
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So us working with people like CDC, National Kidney Foundation, to get those basic concepts out, I think is good for laboratorians. I think it's good for anyone who's listening to our conferences. And I also think us working with organisations like DNV, DNV being the large global company that you are, I think we can help strengthen laboratory industry that way as well.
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So you've been instrumental in forging partnerships with healthcare organisation, clinical labs but also policymakers to expand COLA's reach and impact. How have trust and collaboration played a role in building these relationships, and how do they help advance COLA’s mission of improving health care quality through accreditation?
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Well you have to listen, you have to listen to the feedback. We have to make sure that we're getting the appropriate information out to the people and that we're delivering it in such a way that it is helpful and beneficial. We have to make sure that we do what we say. We walk the walk, we talk the talk. If we made an error, we have to admit we made an error. If we need to provide more training for our surveyors or technical advisors, then we need to do that. It's just important for us to have people understand that we are trustworthy, that we partner with people who are trustworthy, and if we need to make a change, we'll make a change.
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It sounds like kind of transparency, kind of in the client relationships is it's a tool that you use to build that trust.
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Yes. And when our business development representatives, our customer success representatives are talking with potential customers or customers who are bringing more business, we need to make sure that there's no over promising. We need to make sure that they understand what can be delivered and then we need to deliver it.
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So moving on to kind of we already touched upon it to some extent, but digitalisation. So digital health and diagnostics are transforming the way laboratories operate. How has COLA adapted to these changes and what role do you believe technology will play in the next phase of laboratory quality and safety standards?
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You know, back to AI, how is that going to be a factor, a major factor in the future? Once we hear more about guidelines, digital pathology to me is very exciting. I think it will enable the pathologists to collaborate with each other more, to be able to do their work more efficiently. Currently, if you have to transport the glass slides to pathologists to look in their microscope, instead of looking at a monitor, it takes a little bit more time and just imagining how much quicker you could get diagnoses out for patients, how much quicker they can start receiving care, I think that will be fantastic.
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We can really speed things up. Are there new risks being introduced by using these technologies?
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With AI, I think there are risks that again, I'm going to refer back to guidelines that people are working on to see how AI will be used in healthcare. Digital pathology has a lot of checks and balances in it. There's a lot of control slides that are used. There's a lot of things that pathologists can look for on the slides. I think the risk is not as great with that as it is with AI. And when you're again, when you're talking with laboratory lens, we're very, very much into documentation, checks and balances. Pathologists are the leaders of that. So when more and more pathology groups use digital pathology, it will be safe.
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Yeah. So when it comes to innovations like digital pathology and molecular diagnostics, how do you encountered any challenges, in encouraging labs to integrate these advancements without compromising on quality and safety?
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Cost, the cost of the testing, cost of the personnel. Those are challenges. Reimbursement, Medicare reimbursement, insurance reimbursement. Laboratories have to be able to do the math to know, is it something that I can bring in-house or do they need to send to a reference lab? I think a lot of laboratories want to do all they can in-house to service the patients and get the results to the physicians, clinicians as quickly as they can. But it all comes at a cost. And in the laboratory world, as it is with physician reimbursement, there have been cuts. So people need to make sure that they understand the cost of it. And make sure that they get subject matter experts in to make sure that it's being set up and validated and all done properly.
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So a little bit, in terms of the future outlook, you know, looking ahead at the healthcare industry, how do you see the role of laboratory accreditation evolving in the next decade and you know what steps are COLA taking to stay ahead of these changes and continue driving improvements in laboratory quality and patient safety?
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I'm going to have to refer back to Clinical Lab 2.0 on this, because that really is looking to the future of laboratory. It's not just payment, it's education and ensuring that other health care givers understand the importance of laboratory expertise. It's not just a bunch of numbers on paper. There's so much information that you can derive from testing from the method that was used. Longitudinal data that you can look at to see, okay, maybe a patient's BUN stayed within normal range, but was it trending up. Was their glucose trending up. Is there something we can do to prevent all of these chronic diseases getting to a bad point before patients are diagnosed. And the laboratory has these answers. The laboratory has the expertise. I see the laboratory bringing quite a lot of benefit to health care, bringing that knowledge in. And as far as laboratory accreditation, we need to keep doing what we're doing, but keep an eye on evolving technologies to make sure that our survey criteria keeps up with it, to make sure that different, different methods and different tests are validated properly, to make sure that the right results are going out.
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And developments are happening so quickly in this space. And it's very, very dynamic. So staying ahead of the curve and kind of trying to anticipate and prepare for changes, will probably kind of just continue to be important.
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They are, our surveyors have monthly training and then once a year we bring the entire company together. It's called COLA Cares. We do companywide training for non-technical staff, and then we spend a day and a half on technical training. We get subject matter experts. We get very detailed with it. And we're looking at emerging technologies. We want to make sure that we will be ready to handle these as they become more commonplace.
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So we started with leadership and I think I'll going to move towards the end also on leadership, Nancy. So you know as someone who has successfully navigated the challenges of leadership, in the healthcare and laboratory sectors, what advice would you give to future leaders looking to make a lasting impact in this rapidly evolving industry?
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Listen. Listen to people. Make sure that you know your own limitations because one person cannot know everything. Don't be in such a hurry. A lot of people want to promote up quickly, and there's a lot to be said for experience. You can learn a lot within five years. Managing people is a skill, and it's not something you can just step into and excel at right away.
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There are so many different personality things, and it takes time to learn how to work with the different personalities, the different learning styles. But to me, the ability to listen and truly hear what's being said is extremely important for people who want to become a leader.
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So to me, you know, yeah, so listen, take on the feedback. So humbleness. Would that be a good word?
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Servant leadership was a big phrase a while back. And that had a lot to do with being very humble. And that's something I agree with. And I will readily admit, if I make a mistake and then try and do something to prevent it, correct in the future. And the other thing is, don't just sit around and complain, if something needs to be addressed think about it and bring a solution, because that's how you're going to show that you are developing your leadership skills. Everyone can sit around and complain but if you can sit there and analyse it and use your critical thinking skills and come up with solutions, that's a big step in the process.
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Be a part of the solution.
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Yeah. So, Nancy, well, you truly immersed us, in your world, over the course of this episode. I can't overstate the significance of what DNV and COLA have and will do together. And obviously, while each blazing a trail in very distinct areas, we're united by our commitment to keep hospitals and labs operating at the highest standards possible. So I would like to thank you for graciously accepting, and taking the time to join me here today. Thank you Nancy.
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I have enjoyed it very much, Geir. I think this has been great. I enjoy working with DNV very much, and it's been a pleasure to get to meet you.
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You've been listening to Trust and Transformations Leaders Navigating Change. A DNV podcast. Head to DNV.com to hear more episodes of Trust and Transformations or subscribe on your favourite podcast platform so you'll never miss an episode. Thanks for listening.
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