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MALDI-TOF, Rapid Molecular Testing Strategy Fuel Outreach Growth for Cayuga Medical Center Lab

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NEW YORK (360Dx) - In a major laboratory reorganization, Cayuga Medical Center in Ithaca, New York transitioned to rapid molecular testing, including implementing a MALDI-TOF mass spectrometer for bacterial and yeast identification.

That strategy is helping the lab slash test turnaround times, improve antibiotic stewardship, and nearly double its outreach trading volume by positioning it to better compete with large commercial laboratories, lab executives said.

"We understood that for the large commercial labs, their downfall is turnaround time, because they have to get specimens to their regional labs. We thought that if we could compete on turnaround time, that would make a big difference," said Toni Burger, Cayuga Medical Center's administrative director for laboratory services, who began planning the reorganization shortly after joining the hospital system in 2010.

The lab's BioMérieux Vitek MS MALDI-TOF, implemented in early 2016, is the cornerstone of a lab transformation that also includes point-of-care molecular flu testing, rapid PCR testing, an expanded lab test menu, enhanced courier services, and additional pathology staff, according to Burger.

"When I first did the management reorganization, I added $250,000 in costs to the lab, but the senior leadership team understood what we needed to do and they trusted me," she said.

The lab has nearly doubled its outreach volume from approximately 500,000 billable tests per year when Burger joined to nearly 1 million billable tests last year – a benchmark Burger expects the lab will exceed in 2019. The outreach growth has largely come from independent physician offices and medical practices in the region, according to Burger. Cayuga Medical Center does not require its physicians' offices to use its lab, so the lab also competes to win testing from hospital physicians, she noted.

The outreach business has helped the lab grow its contribution to the hospital from approximately $7.5 million to approximately $11.5 million, according to Burger.

The lab uses the BioMérieux Vitek MS MALDI-TOF to identify bacteria or yeast from a culture in minutes, according to Laurie Mras, microbiology manager. In addition, the MALDI-TOF can make an identification from a smaller amount of an organism than traditional bacterial identification methods, so for slow-growing yeasts, for example, the lab doesn't have to grow the culture for as long in order to get a positive identification. Previously some organisms required several days of growth prior to performing identification testing. Mras estimates that the MALDI-TOF technology cuts one to four days off the identification process, depending on the organism.

To maximize the impact of the MALDI-TOF's faster bacterial identification on turnaround time, the lab, at the recommendation of BioMérieux, reorganized its workflow to read cultures three times a day rather than once, Mras said. The lab changed its workshifts to ensure there would be sufficient staffing to accommodate the three readings.

"Rather than reading plates in a timeframe that most microbiology labs do at a time that is convenient to them, we are really staffing around when those plates are going to be ready to be read. It's definitely a little bit different," Mras said.

Three daily plate readings are often recommended to synchronize with the flow of when specimens arrive at labs, according to Douglas Matthews, BioMérieux senior marketing manager for ID/AST systems. For example, some labs may receive a lot of specimens in the evening and need to schedule readings to ensure they are reading plates at a time when those evening samples will be fully incubated.

"You do three different readings so that you can read the bacteria at the right growth phase. It also helps spread out the workflow throughout the day," he said.

While purchasing a MALDI-TOF is a large upfront investment, testing on the MALDI-TOF IS actually much cheaper to run than traditional bacterial identification methods, Mras noted, which is enabling the lab to recoup its investment over time.

MALDI-TOF identification costs an estimated 50 cents to run, according to Matthews. In addition, its database of more than 1,300 species expands the number of identifications that labs can perform.

For outreach clients, Cayuga Medical Center lab also optimized the faster results it received from using the MALDI-TOF by making enhancements to its courier services, adding more couriers to its team and improving tracking technology so the lab can see when specimens have been picked up and can track by GPS how far away the courier is, according to Mras.

For hospital patients, the addition of MALDI-TOF is making an impact on antibiotic stewardship, particularly related to sepsis patients, according to Elizabeth Plocharczyk, assistant medical director, laboratory services, one of two pathologists at the lab. Even though antibiotic sensitivity testing may still be required after bacterial identification, rapid bacterial identification can help the hospital quickly move patients off of broad-spectrum antibiotics, such as vancomycin, which can have negative side effects for patients, she said.

"There have been studies that show each delay of an hour to identify the organism and initiate the appropriate antibiotic increased patient mortality by 7 percent," Plocharczyk said. "When we have been able to put people in broad categories by identifying the correct organism, that takes out the broad-spectrum antibiotics that would be used. Getting people off those antibiotics and onto the right antibiotic, even though we don't have the sensitivity yet, has decreased time to the appropriate antibiotic."

Data has indicated the hospital has been able to reduce vancomycin use by 50 percent since the lab implemented the MALDI-TOF, Plocharczyk said. Other hospitals have been able to demonstrate decreased mortality since introducing the instrument, and while Cayuga Medical Center has not yet analyzed all its days, it is hoping to be able to demonstrate similar results, she said.

Rapid PCR

Along with implementing the MALDI-TOF, Cayuga Medical Center lab also implemented the Cepheid GeneXpert PCR-based platform to test for Clostridium difficile in stool samples and for methicillin-resistant Staphylococcus aureus (MRSA) in blood cultures as well as cultures from swab samples, tissue and bodily fluids.

"If a blood culture looks suspicious for Staph, we run a PCR and within an hour we can tell whether it's Staphylococcus aureus or MRSA," Mras said, noting that a similar process is used for cultures from swab samples, tissue and bodily fluids. The system is also used to test for MRSA in nasal samples for bed placement purposes at the hospital

To speed action on the rapid PCR testing results, the lab has changed its protocols related to how it reports results.

"Instead of calling a nurse, who would call a doctor, who would call the pharmacy, who would get in touch with the doctor, we now call positive results directly to the pharmacist. They assess what type of antibiotics the patient is on, if any, and they talk to the doctor and make the antibiotic switch right then and there," Mras said.

This change was suggested by Plocharczyk, who did her residency at Ohio State University Hospital, where the lab made a similar change when implementing molecular testing.

"They discovered that it was more effective to identify and notify the pharmacist rather than to notify the providers themselves, because the pharmacist was more likely to change the antibiotic or de-escalate from an antibiotic to get patients on the appropriate one," she said.

The lab also adopted the Alere i platform, now called ID Now, for rapid molecular influenza, Streptococcus and respiratory syncytial virus (RSV) testing, which is used in a point-of care setting, Mras said. The system replaces antigen-based tests that were less sensitive.

"The tests that we ran prior were not waived, so we were only running them in our main laboratory campus with licensed medical technologists. With the [ID Now], it is waived so all the nursing staff at our urgent care centers are trained to run this testing," Mras said.

The point-of-care rapid flu test has greatly increased the number of people who can perform testing. It has also contributed to improved antibiotic stewardship, Mras said. Previously, because there was a delay in receiving test results from the main lab, and because doctors didn't always trust results of the antigen-based testing, doctors would often prescribe antivirals for flu and antibiotics for strep based on symptoms presented in office visits.

The ID Now produces test results in 10 minutes, before patients leave the facility, she noted.

"There is very close to 100 percent sensitivity and specificity, and doctors know if they get positive results, they should be prescribing antibiotics or antivirals. However, if results are negative, they can have a good degree of comfort and confidence knowing that the patient does not need any medication," she said.

Antibiotic stewardship was among the factors that that the lab presented to the hospital to make the case for transitioning to molecular technology, along with improved patient care, and decreased laboratory and pharmacy costs over the long term, according to Burger. But there were other factors as well including the staffing pressures in the laboratory industry.

"In order to be a really good microbiologist in a conventional lab, you have to have five years under your belt in microbiology, and it's hard to find those people, especially in central New York," Burger said.
The efficiency of molecular testing technology can enable the lab to grow in test volume while mitigating some of those staffing needs, she noted.

Looking forward, the lab is continuing to explore ways to innovate for the future, including potentially adopting rapid susceptibility testing technology. The lab is even considering potentially getting a drone to transport slides across Cayuga Lake to a satellite lab located within Plocharczyk's home.

"This type of molecular technology is not expected here necessarily, but there is not a reason why we can't do it. We've shown that it's cost effective and it makes a major impact on community and population health," Burger said.