“Fast is fine; but accuracy is everything.”
The quote is attributed to the famous Wyatt Earp, a sharpshooter and lawman who, with help from his two brothers, sent three outlaws to their graves in the Gunfight at the O.K. Corral in Tombstone, Arizona in 1881.
One hundred and twenty five years later, Dr. Rob Fitzgerald of the University of California, San Diego, (UC San Diego) School of Medicine borrowed the quote to help explain the advantages that mass spectrometry has had for UC San Diego’s Center for Advanced Laboratory Medicine (CALM). His talk, and those of others at the recent Symposium on Mass Spectrometry for the Modern Clinical Laboratory, made one point perfectly clear: in their laboratories, liquid chromatography-mass spectrometry is dramatically changing clinical practice.
On March 17, Waters Corporation announced the selection of the UC San Diego’s Center for Advanced Laboratory Medicine (CALM) to its Centers of Innovation Program.
Keynoting the Symposium on Mass Spectrometry for the Modern Clinical Laboratory, organized by UC San Diego, was Ronald McLawhon, M.D., Ph.D., Vice Chair of Pathology and Head of the Division of Laboratory and Genomic Medicine at the UC San Diego School of Medicine and Director of Clinical Laboratories and the CALM for UC San Diego Health.
Dr. McLawhon explained CALM’s mission is to “redefine laboratory medicine for the current era.” Opened in 2011, CALM is UC San Diego Health’s flagship clinical laboratory and is processing 7.1 million reportable tests per year and grossing in the vicinity of $400 million annually. With 90,000 ft2 of space, CALM is the center of UC San Diego Health’s laboratory services offering hundreds of routine medical tests as well as genomic and molecular services and clinical mass spectrometry.
Anyone who has ever set foot inside the laboratory can see that it is a model of cleanliness, efficiency and sophistication. Dominated by an automated track system, in which bar-coded vials, containing blood, plasma and serum samples sent to the laboratory from UC San Diego Health’s clinical integration network of affiliated hospitals, clinics and long-term care facilities, shuttle in and out of a connected system of individual, automated clinical analyzers for testing. In one corner of the laboratory is an array of mass spectrometers, from a variety of vendors, where the toxicology tests are performed using validated test methods developed by the laboratory.
“We wouldn’t have invested in mass spectrometry without a business case,” Dr. McLawhon said. “We had to show to health system executive leadership, the clinical value LC-MS brings to the operation by demonstrating improved quality of results in terms of accuracy and precision, improved turnaround times and improved service delivery. And, of course, we had to show a compelling return on investment from savings in labor and supplies.”
McLawhon pointed out to the symposium audience that the state of California is an anti-markup state; in other words his laboratory cannot add to their costs, the costs of tests sent to reference laboratories. “Our insurance company reimbursement rate averages 30% – for example, we may bill an insurance company $100 for a test but only get reimbursed $30 – so for every $100 we spend on send-out tests, we lose $70.”
“So with every test we bring in house, we generate new revenue and reduce our costs. And, with the new services we offer, we become an outreach referral center, getting work from other facilities,” McLawhon added.
In terms of LC- tandem-quadrupole mass spectrometry, the CALM has chosen to offer services for clinical toxicology focusing on vitamin D analysis and drug confirmations – THC, cocaine,benzodiazepines, amphetamines, opiates. These validated analyses account for the bulk of the tests they perform with LC-MS.
“In terms of the clinical value of LC-MS, vitamin D is a good case in point. Our vitamin D accuracy by mass spec is on the order of +/- 5%, as compared to +/-25% with immunoassays. We can identify the different forms of vitamin D, which is very important to be able to do, and we have reduced turnaround time significantly compared to what we had been doing. Our volume has now grown to 26,000 tests per year and our contribution-to-margin* at UC San Diego Health is expected to grow 20% in 2016 to $630,000. And a lot of that revenue comes from in-sourced tests that we previously sent to reference laboratories at a significant cost to us,” Dr. McLawhon said.
With the addition of LC-MS tests, Dr. McLawhon says the laboratory has seen a dramatic increase in the number of drug confirmations CALM bills for. “Pain management physicians demand a tight turnaround time. It used to take 7 to 10 days for test results to come back from the reference laboratory we used to use. Now we can run the tests ourselves and have the results to physicians in one to four days max.
“This has led to much greater satisfaction from our clinicians and eliminates false positive results that come with certain immunoassays for drugs, like amphetamines. So our test volume now is up to around 42,000 tests per year. By reducing our operating expenditures and mitigating the loss from send-outs, that business grew by more than $800,000 per year.”
Dr. McLawhon says mass spec systems do cost more, but with the increase in the number of tests his lab performs, he’s seen returns on investment for LC-MS typically within two to three years.
As Dr. McLawhon told his audience, “Welcome to the future of diagnostic and therapeutic medicine. I don’t think it’s just laboratory medicine anymore – we’re in a whole different world, and technologies like mass spectrometry are allowing us to be very different in changing health outcomes.”
*Calculated as net revenue less direct costs.