Mayo Clinic Laboratories: Quality testing from start to finish
Mayo Clinic’s Department of Laboratory Medicine and Pathology (DLMP) has more than 60 specialty labs that provide diagnostic testing for complex conditions to Mayo Clinic Laboratories clients around the world. To do this, all of these labs model their quality management protocols on the Quality System Essentials, a comprisal of standards and guidelines from the Clinical and Laboratory Standards Institute (CLSI). But according to Deborah Wells, director of Quality Management Services in DLMP, such quality essentials are merely a jumping off point.
“At Mayo Clinic, we absolutely follow regulations that, in our opinion, represent the minimum of what’s required,” says Wells. “But we also have our own higher level of quality that we instill in our laboratories. We go above and beyond what is required.”
This is no small doing, given that these laboratories, taken together, make up one of the largest clinical laboratories in the world, performing more than 27 million tests every year.
So how does Mayo Clinic go “above and beyond” the usual standards of quality laboratory testing? For starters, there is a unique internal structure of quality specialists, coordinators, and engineers who constantly evaluate and improve laboratory operations. This structure supports a host of quality assurance activities.
“All of our tests will have quality controls run with them to demonstrate that a particular run of testing is accurate,” says Shannon Bennett, director of Regulatory Affairs, who is heavily involved in quality practices within the laboratories.
“We also have activities like calibrating our instruments and performing instrument maintenance on routine schedules and through routine processes. Then we have proficiency testing, where we get samples with values that are unknown to us. We’ll perform appropriate testing, and the results are graded by the organization that sent us the proficiency samples.”
Wells adds, “There are regulations on how frequently you have to run quality controls. But we have found that, over the years, it may make more sense for our labs to run them more frequently, because we can prevent errors from occurring just by having that additional control value in place.”
On the odd occasion when a test doesn’t perform optimally, Mayo Clinic’s guiding principle is, What is going to be best for the patient? Bennett offers an example: “Let’s say we notice one of our test runs doesn’t look quite right. It doesn’t fail, but it’s not quite where we want it. The easy thing would be to just report the results and move on. Instead, we will step in and say, ‘Hold on, what is the patient impact on this?’ And if there’s any sort of negative impact to a patient, we’re going to do the right thing by digging deeper, even though it means more time and more expense on our part.”
Mayo Clinic Laboratories, like Mayo Clinic, is guided by a patient-centric philosophy. For more than 150 years, the Mayo Clinic Model of Care – the gold standard in comprehensive patient care – has put patients at the center of everything we do. Through partnerships with clinicians at Mayo Clinic and health care providers around the world, Mayo Clinic Laboratories can offer the most sophisticated test catalog in the world. It is because of daily collaborations that our subspecialized laboratories continue to be a critical component for patient care – turning test results into clinical answers, fast.
For a test to be as accurate as possible, quality measures must be in place well before a particular test is performed. This especially includes specimen quality. R. Ross Reichard, M.D., medical director of the Mayo Clinic Quality Academy, which offers quality improvement products and educational services to individuals and organizations, explains, “Before we’ll even do the test, our requirements ask things like, ‘How was the specimen collected? How long ago was it collected? What type of specimen is it? What temperature has this specimen been at? Some of them need to be frozen, others should not be frozen.’ So before we even do the testing, we’re making sure we have a specimen that will provide a reliable, accurate result.”
Specimen quality is something that even health care providers don’t always think about until a specimen is rejected, or a test is canceled by the lab because it doesn’t meet those requirements.
Dr. Reichard continues: “Even then, clients will ask us, ‘Why can’t you just run the test?’ And we have to explain that the test is validated based on certain parameters, and doing something just for the sake of doing it can be potentially more harmful than beneficial for the patient. So we will work with our clients to help them improve their specimen preparation and shipping process so that we get better samples to test.” (For a deeper look at pre-analytic quality measures, see our prequal article.)
Quality measures can be as simple as deciding where to best locate garbage cans in a laboratory or installing a raised lip on all work surfaces, so test tubes won’t roll off a tabletop.
They can also be as cutting edge as using handheld metal detectors in the Histology Laboratory to keep track of the more than 400,000 paraffin-embedded specimen blocks processed every year. Each block is embedded with a tiny metal sticker that the metal detector can pick up in the event a specimen goes missing (it happens to less than one-half of 1% of blocks). Every specimen is precious, representing a patient on the other end waiting for answers. So, for example, at the end of every shift, a laboratory tech will wave a metal detector over every garbage can to make certain a specimen hasn’t ended up there.
Keeping wayward specimens in check has fostered other lab innovations as well.
“We upgraded our RFID (radio frequency identification) labels for specimens coming from our GI, dermatology, and radiology departments,” says Dr. Reichard. “That upgrade was through direct collaboration with our clinical colleagues. One cool thing that came out of that was that they built in a notification system on specimen labels. So, for example, once a clinician takes a GI biopsy sample, they know how long that sample should take to reach the next reader in a lab. And if it doesn’t get there, a notification gets sent to the supervisors and managers, alerting them that this specimen is not where it’s supposed to be. This allows them to go look for that specimen in a timely manner.”
Thus, instead of not knowing an irreplaceable specimen is missing until a day or two later, when a test result was supposed to come in, the right people are notified in real time, before the lab coats have been hung up for the day, before the garbage gets taken out or the rooms have been cleaned.
Mayo Clinic leaders like Dr. Reichard are so proud of DLMP’s quality standards they not only don’t mind annual inspections by entities like the College of American Pathologists (CAP), they welcome them.
“When people come in to conduct inspections or audits, we really thrive on that because we enjoy sharing what we do while learning from outside perspectives,” he says. “We are really proud of the work we’re doing. We’re not wiping our brow and going ‘Whew’ after we pass an inspection. The beauty of a CAP inspection is they’re peer-to-peer, so it’s a time for us to talk shop with other pathologists. It’s also a time for an outside person to critique what we’re doing. It’s a chance to learn, to get better, and have a fresh set of eyes look at your workflows and your processes. It’s part of our continuous improvement mindset.”
Perhaps the most impressive reason Mayo Clinic’s test quality measures are so high is because DLMP’s pathologists and other laboratory professionals work directly with Mayo’s world-renowned clinical experts. “They are in a very real situation, daily, when it comes to patient care,” says Wells. “They’re on the cutting edge of new thoughts, and they’re getting feedback all the time, which helps us improve our tests. It’s not a warehouse situation, where we’re isolated from medical practice. Our pathologists and consultants and their test results are part of the patient’s care team, and we extend that robust care to our Mayo Clinic Laboratories clients as well.”
Mayo Clinic Laboratories grants direct access to Mayo Clinic physicians and scientists to review patient test orders and interpret results together. This collaboration extends care teams, helps optimize test orders and helps introduce physicians to new tests and new analytics technologies.
This is what makes Mayo Clinic a rare institution. The pathology labs, specimen testing process, and the clinical practice are all part of the patient’s care team. Dr. Reichard adds, “Because we are one practice, I think it’s much easier for us as pathologists to reach out to clinical colleagues, and vice versa. There are fewer barriers between divisions and departments, or between clinical practice and laboratory medicine and pathology. So I think that allows us to provide better patient care.”
While the accelerated innovation and increased access to testing that’s occurred because of the COVID-19 pandemic has been critically important to worldwide health care, so too has the crash course in laboratory testing and pathology the general public has received throughout the entirety of the pandemic.
As part of Mayo Clinic’s Neuro-Oncology practice, the Division of Laboratory Genetics and Genomics tests about 50 brain tumors a week, and upwards of 1,500 brain tumors a year from all over the world.
Lisa Brown, quality specialist for Mayo Clinic Laboratories customer service, explains working "behind the scenes" when a client calls Mayo Clinic Laboratories with an inquiry, that call is typically picked up within 20 seconds by an agent from Mayo Laboratory Inquiry (MLI). There are no phone trees or automated menus to wade through before they reach an agent. Agents mind the phones 24/7, 365 days a year.