As demand rises, Canadian clinical laboratories must learn to juggle test systems automation, funding challenges, and staffing shortages
Canada’s clinical laboratories are deeply affected by many of the trends impacting the Canadian healthcare system overall. Deployment of new technologies, such as test automation and artificial intelligence (AI) for example, are forcing Canadian labs to adapt during times of changing demographics and funding pressures.
Thus, the Canadian Diagnostic Executive Forum (CDEF), which takes place October 24-25 at the Westin Harbour Castle Hotel in Toronto, will provide an opportunity for clinical laboratory leaders to learn how to leverage technology and create positive change in their medical laboratory operations.
Change Management and Clinical Laboratory Leaders
The development of disruptive new technologies is becoming the norm and the laboratory’s role in healthcare delivery is growing. That’s why change management has become a focus of clinical laboratory leaders.
Sheila Woodcock, Convenor, WG 1 Quality and Competence in the Medical Laboratory at ISO/TC 212, and President and Principal Consultant at QSE Consulting Inc., Nova Scotia, Canada, says “allocation of resources” is a challenge for senior diagnostic executives juggling financial, technology, and staffing decisions.
In an exclusive interview with Dark Daily, Woodcock
said, “The number one lab challenge today is not having enough money; second is
not having enough people. Because if you don’t have enough money, even if there
are people out there, you can’t hire them. Money, people, and trying to keep up
with all the technological innovations bombarding us nowadays are the main
reasons to make changes.”
From deployment of digital pathology services and point-of-care (POC) testing to the introduction of automation and AI, innovation is happening at a rapid pace. It may or may not increase medical laboratory efficiency or support precision medicine, but it definitely alters laboratory infrastructure.
“Change is nearly constant in the clinical laboratory and
the healthcare network worlds, and there are many complexities that go with
that,” Woodcock said. “With the implementation of new technologies, and the
rapidly advancing world of automation in clinical laboratories that have never before
been automated, how do we ensure that when we automate new technology it
doesn’t negatively impact the quality of the testing process?”
Disruptive Changes are Redefining Clinical Laboratories
As Clinical Lab Products (CLP) points out, medical laboratories have become a reservoir of data that can “guide fact-based decisions to improve operational, financial, and clinical performance throughout their institutions.” As a result, clinical laboratories are increasingly shedding their “traditional and narrowly defined roles” in which “physicians order tests and labs report results.”
Emerging technologies also are ushering change outside of the medical laboratory. Drones soon may routinely transport patient specimens across healthcare networks. Dark Daily has reported on several new drone transport systems under development around the globe. One such system in the US involves UPS, the FAA, and WakeMed. Such high-tech specimen tracking and delivery systems could lead to fewer spoiled samples and possibly save lives, and clinical laboratories are at the heart of these innovations.
Kevin D. Orr (above), Senior Director, Hospital Business at In-Common Laboratories, told Dark Daily that laboratory leaders need to keep up with technology breakthroughs. However, knowing which tools and strategies are worth implementing is not so easy. Orr says diagnostic executives should take advantage of opportunities to “network to understand what is going on in everybody’s backyard, and to leverage some of the strategies, tools, and technologies innovators have used elsewhere.” (Photo copyright: LinkedIn.)
Kevin D. Orr, Senior Director, Hospital Business at In-Common Laboratories, believes technology may help laboratories overcome one major issue—a growing demand for testing services at a time when the laboratory workforce is shrinking, and provincial and territorial global funding is not keeping pace with diagnostic utilization rates. Orr points to digital pathology as an example of a technology that may enable labs to “do more with less” in terms of both funding and staffing.
“As people get older, there’s more demand for healthcare
services and because of that more clinical laboratory testing has to be done,”
Orr told Dark Daily. “The peak of the Baby Boomers is starting to get
sick now. We need to focus on innovations and technologies clinical
laboratories are employing to address the overarching issue of doing more with
less.”
How Clinical Laboratories Should Demonstrate Value
Woodcock, however, maintains that clinical laboratories also
need to do a better job of lobbying for funding, so they have the money needed
to implement new technologies.
“Traditionally, when labs are told they have cutbacks, they
do their utmost to work within what they have been assigned. But other
departments might be jumping up and down, getting more attention, and getting
more funding,” she said. “One of the things lab people have to learn—and are
getting better at as time goes on—is giving the lab a voice and making known
the contributions the lab makes to diagnosis and treatment of patients in a
facility.”
The Canadian Diagnostic Executive Forum on October 24-25 at
the Westin Harbour Castle Hotel in Toronto provides such an opportunity for
laboratory leaders to learn how to leverage technology to create positive
change in lab operations.
“We want to inspire people,” Orr told Dark Daily. “We
want people to leave this conference excited about what diagnostics is doing
and where it’s headed and what other people are doing. We want to show them the
bright light at the end of the tunnel, because sometimes when you’re dealing
with the negative aspects of no money or no staff or no this or that, it gets
pretty awful. We want to breathe some life and show them the rainbow and that the
light at the end of the tunnel could be just around the corner.”
The CDEF conference will be hosted by In-Common Laboratories, in conjunction with The Dark Report, Dark Daily’s sister publication. This two-day event will be packed with thought-provoking sessions on digital pathology, next-generation technology, precision medicine, blockchain, sample tracking, and artificial intelligence, as well as updates from across Canada on the latest innovations and technologies being implemented in medical laboratories.
Clinical laboratory leaders interested in positioning their labs to be paid for added-value services will get knowledge, insights, and more at upcoming third annual Clinical Lab 2.0 Workshop in November
It’s a critical time for medical laboratories. Healthcare is transitioning from a fee-for-service payment system to new value-based payment models, creating disruption and instability in the clinical lab test market. In addition, payers are cutting reimbursement for many lab tests.
These are among the market factors leading some pathologists
and clinical lab leaders to seek new or alternative sources of revenue to keep
the lights on and the machines running in their laboratories. Some might say,
it’s a dark time for the lab industry.
“This is not the time to be shy or timid,” he declared. “The
quantitative value of medical laboratory domain is significant and will be lost
if not exploited or leveraged.”
Shotorbani has reason to be positive. In recent years the Project Santa Fe Foundation (PSFF) has emerged to advocate for, and teach, the Clinical Lab 2.0 model. Clinical Lab 2.0 is an approach which focuses on longitudinal clinical laboratory data to augment population health in new payment arrangements.
Earlier this year, PSFF filed for 501(c) status, according to a news release. It is now positioned as a nonprofit organization, guided by a board of directors whose mission is “to create a disruptive value paradigm and alternative payment model that defines placement of diagnostic services in healthcare.”
Progressing Toward Clinical Lab 2.0
At the 24th Annual Executive War College on Lab and Pathology Management held in New Orleans last May, the nation’s first ever Clinical Lab 2.0 “Shark Tank” competition was won by Aspenti Health, a full-service diagnostic laboratory specializing in toxicology screening.
“This project, as well as all of the other cases that were presented, were quite strong and all were aligned with the mission of the Clinical Lab 2.0 movement,” said Shotorbani, in a news release. “This movement transforms the analytic results from a laboratory into actionable intelligence at the patient visit in partnership with front-liners and clinicians—allowing for identification of patient risks—and arming providers with insights to guide therapeutic interventions.
“Further, it reduces the administrative burden on providers by collecting SDH [social determinants of health] predictors in advance and tying them to outcomes of interest,” he continued. “By bringing SDH predictors to the office visit, it enables providers to engage in SDH without relying on their own data collection—a current care gap in many practices. The lab becomes a catalyst helping to manage the population we serve.”
Aspenti Health’s Shark Tank entry, “Integration of the Clinical Laboratory and Social Determinants of Health in the Management of Substance Use,” focused on the social factors tied to the co-use of opioids and benzodiazepines, a combination that puts patients at higher risk of drug-related overdose or death.
The project revealed that the top-two predictors of co-use
were the prescribing provider practice and the patient’s age.
“They did an interesting thing—what clinical laboratories
alone cannot do—the predictive value of lab test data mapped by zip code for
patients admitted in partnership with social determinants of health. This helps
to create delivery models to potentially help prevent opioid overdose,” said
Shotorbani, who sees economic implications for chronic conditions.
“If clinical laboratories have that ability to do that in
acute conditions such as opioid overdose, what is our opportunity to use lab test
data in chronic conditions, such as diabetes? The cost of healthcare is in
chronic conditions, and that is where clinical lab data has an essential role—to
support early detection and early prevention,” he added.
“This is often described as the transition from volume to value because this trend will fundamentally change how all clinical laboratories and anatomic pathology groups are paid,” said Khosrow Shotorbani (above), MBA, MT(ASCP), Executive Director of the Project Santa Fe Foundation (PSFF), during his presentation at the 22nd annual Executive War College in New Orleans. “This shift from volume to value also will create new winners and losers in the clinical lab industry,” he declared. “Not every lab organization will take the timely action required to introduce the value-based laboratory testing services that hospitals, physicians, and payers will need. (Photo copyright: Albuquerque Business First.)
Clinical Laboratory Data is Health Business Data
One clinical laboratory working toward that opportunity is TriCore Reference Laboratories in Albuquerque, N.M. It recently launched Diagnostic Optimization with the goal of improving the health of their communities.
“TriCore turned to this business model,” Shotorbani
explained. “It is actively pursuing the strategy of intervention, prevention,
and cost avoidance. TriCore is in conversation with health plans on how its lab
test data and other data sets can be combined and analyzed to risk-stratify a
population and to identify care gaps and assist in closing gaps.
“Further, TriCore is identifying high-risk patients early
before they are admitted to hospitals and ERs—the whole notion of facilitating
intervention between the healthcare provider and the potential person who may
get sick,” he added. “These are no longer theoretical goals. They are
realizations. Now the challenge is for Project Santa Fe to help other lab
organizations develop similar value-added collaborations in their communities.”
Renee Ennis, TriCore’s Chief Financial Officer, told American Healthcare Leader, “Women go in (to an ER) for some condition, and the lab finds out they are pregnant before anyone else,” she said, adding that TriCore reaches out to insurers who can offer care coordinators for prenatal services.
“There is definitely a movement within the industry in this
direction [of Clinical Lab 2.0],” she added. “But others might not be moving as
quickly as we are. As a leader in this transition, I think a lot of eyes are on
what we are doing and how we are doing it.”
Why Don’t More Lab Leaders Move Their Labs to Clinical
Lab 2.0?
So, what holds labs back from pursing Clinical Lab 2.0?
Shotorbani pointed to a couple of possibilities:
A lab’s traditional focus on volume while not
developing partnerships (such as with pharmacy colleagues) inside the
organization; and
Limited longitudinal data due to a provider’s
sale of lab outreach services or outsourcing the lab.
“The whole notion of Clinical Lab 2.0 is basically connecting the longitudinal data—the Holy Grail of lab medicine. That is the business model. Without the longitudinal view, the ability to become a Clinical Lab 2.0 is extremely limited,” added Shotorbani.
New Clinical Lab 2.0 Workshop Focuses on Critical ‘Pillars’
Project Santa Fe Foundation will host the Third Annual Clinical Lab. 2.0 Workshop in Chicago on November 3-5. New this year are sessions aligned with Clinical Lab 2.0 “pillars” of leadership, standards, and evidence. The conference will feature panels addressing:
C-suite Drivers: moderated by Mark Dixon, President of The Mark Dixon Group;
November workshop to teach Clinical Lab 2.0 to forward-thinkers among clinical laboratories, IVD manufacturers, and lab IT vendors offered many examples where clinical laboratory diagnostics can add value and improve patient outcomes
DATELINE: ALBUQUERQUE, New Mexico—Here in this mile-high city, a special Project Santa Fe Workshop devoted to teaching the principles of Clinical Lab 2.0 attracted an impressive roster of innovators and forward-thinkers in clinical laboratory medicine. In attendance were leaders from a select number of the nation’s first-rank health systems and hospitals, along with executives from In Vitro diagnostics (IVD) manufacturers, lab IT companies, other lab service companies, attendees from the Centers for Disease Control and Prevention, and from institutions in Canada, Germany, Israel, India, and the UK.
Their common goal was to learn more about the emerging clinical and business model for medical laboratories known as “Clinical Lab 2.0.” A key objective of the workshop was to help those lab leaders in attendance develop strategic action plans for their own lab organizations, so as to take advantage of the insights coming from the vast information streams generated by their clinical laboratories. These services would be in support the evolving needs of health systems, hospitals physicians, and health insurers to more effectively provide integrated patient-centered clinical care.
Medical Laboratories Can Use Clinical Lab 2.0 as a Path to Adding Value
Clinical Lab 2.0 is the clinical and business model of the future for medical laboratories, assert the developers of this concept. “Clinical Lab 2.0 describes the attributes needed by all medical laboratories that want to succeed in a healthcare system organized to provide precision medicine, keep people out of hospitals, and where providers—including labs—are reimbursed based on the value they provide,” stated Khosrow Shotorbani, CEO of TriCore Reference Laboratories, one of the organizers of the Project Santa Fe Clinical Lab 2.0 Workshop.
“Clinical Lab 2.0 is the path medical labs will need to follow if they are to continue providing relevant lab testing services and generate the reimbursement necessary for them to maintain a high level of clinical excellence and financial stability going forward,” he added. “This is the next generation of medical laboratory organization and operation.”
Lab 1.0 Was Lab Clinical/Business Model for 50 Years
For more than 50 years, Clinical Lab 1.0 was the model for labs,” noted James Crawford, MD, PhD, Executive Director and Senior Vice President of Laboratory Services at Northwell Health Laboratories and an organizer of the Project Santa Fe Clinical Lab 2.0 Workshop. “Lab 1.0 is transactional, focusing on generating high quality analytical data on specimens received, but without assembling these data into integrative clinical care programs. In the simplest sense, Clinical Lab 1.0 focused on generating ever-greater numbers of specimens to drive down average cost-per-test, while maximizing revenue in a fee-for-service system.
This chart shows the attributes of Clinical Lab 1.0 and compares those to the attributes of Clinical Lab 2.0. Lab 1.0 is transactional and based on increasing test volume to lower costs and maximize fee-for-service revenue. Clinical Lab 2.0 is integrative in ways that add value to lab testing services. (Graphic copyright Project Santa Fe.)
“But fee-for-service payment is going away,” he said. “Increasingly, clinical laboratories will be paid based on the value they provide. This payment can be in the form of bundled reimbursement, as a per-member-per-month payment, or as a share of the budgeted payment made to a health system, an accountable care organization (ACO), or a multispecialty provider network. As these alternative forms of provider payment become dominant, to earn a fair share of reimbursement, all medical laboratories will need a clinical strategy to deliver lab testing services that measurably contribute to improved patient outcomes while reducing the overall cost of care. This requires looking at medical laboratories’ contribution to effective delivery of the full dollar of the healthcare spend, not just the three-cents-on-the-dollar representing laboratory testing.”
Innovators in Clinical Laboratory Industry Identify New Ways to Add Value
There are already a handful of innovative clinical laboratory organizations that have clinical experience in moving past the Lab 1.0 paradigm of reporting an accurate test result within the accepted turnaround time. Leaders within these labs are collaborating with physicians and frontline care givers specifically to help them better utilize lab tests in ways that directly improve the speed and accuracy of the overall diagnostic sequence, as well as achieving therapeutic optimization as rapidly as possible. These collaborations are tracking the improvement in patient outcomes while demonstrating how better use of lab tests can lower the total cost per episode of care.
During the Clinical Lab 2.0 workshop, case studies were presented demonstrating how clinical laboratory leaders are taking the first steps to practice Clinical Lab 2.0 so as to achieve added value with medical laboratory tests. The case studies included:
· A project at Henry Ford Health to collaborate with physicians to more appropriately utilize lab tests and build consensus in support of a new lab test formulary.
· A multi-hospital initiative at Northwell Health to collaborate with physicians and nurses in the use of creating testing to make earlier, more accurate diagnoses of acute kidney injury during inpatient admissions, and better guide decisions to treat.
· A partnership involving TriCore Reference Laboratory and certain health insurers in New Mexico where the laboratory—using lab test data (some generated by emergency room testing) and other clinical data—alerts the insurers to women who are pregnant, thus allowing the insurers to provide timely guidance to the women’s care teams with the goal of improving prenatal care.
The Project Santa Fe Clinical Lab 2.0 Workshop convened on November 13-14 in Albuquerque, N.M. A broad spectrum of innovative professionals from the five Project Santa Fe member laboratories (above) were there to teach the lessons learned from their first successful efforts to collaborate with physicians and create added value from medical laboratory diagnostics. Other attendees included progressive lab leaders from several of the nation’s most prominent health systems, along with thought leaders from the IVD, lab software, and lab association sectors. (Photo copyright Project Santa Fe.)
Project Santa Fe Workshop: A Well-Attended Lab ‘Think Tank’
Participants attending the Clinical Lab 2.0 workshop included hospital lab administrators, pathologists, and clinical laboratory industry executives. The importance of this workshop is reflected in the educational grants and financial support provided by leading in vitro diagnostics manufacturers, lab IT companies, and other lab industry vendors. The lab industry vendors included:
Described as a think-tank venture, the organizers are committed to implementing projects that demonstrate how lab tests can be used in ways that add value, and then publish the resulting projects, along with data about improved patient outcomes and reductions in healthcare costs, in peer-reviewed journals. Multi-institutional studies will be required to validate the findings and outcomes from the added-value clinical collaborations initiated at the different medical laboratory organizations participating in Project Santa Fe.
Another primary goal is to share the lessons learned from these innovative projects with other like-minded pathologists, lab administrators, and lab managers. In May, Project Santa Fe organizers led a one-day workshop to teach Clinical Lab 2.0 at the Executive War College on Laboratory and Pathology Management. The workshop in Albuquerque on November 13-14 was the second learning opportunity available to medical laboratory professionals. A November 2018 workshop is planned.
Failing finances at technical pathology laboratories may be the most immediate concern for many pathology group practices
Many clinical laboratories and anatomic pathology groups now recognize the new reality of the American healthcare system: less reimbursement for laboratory testing. On one hand, the fee-for-service prices for lab tests paid by government and private payers have been aggressively slashed.
On the other hand, all payers have become stubbornly resistant to issuing coverage guidelines and setting adequate prices for the flood of new molecular assays and gene tests coming to market.
These trends have already brought a handful of medical laboratories and pathology practices to the point of bankruptcy, sale, or closure. This is definitely true for the technical laboratories owned by many local pathology groups, which have become unprofitable due to fee cuts. (See below.) (more…)
As happened on day one, yesterday it was a sizable group that included medical technologists (MT), in vitro diagnostics (IVD) manufacturers, pathologists and lab entrepreneurs. (more…)
