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Laboratory Project Takes Value-Based Lab Models to Broader Health System Lab Community

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NEW YORK (360Dx) – A project launched a year ago to improve laboratory-based patient care aims to move to the next step in November by introducing health system-based laboratories to clinical initiatives intended not only to improve patient care, but to help labs begin to carve out new roles within their health systems.

The initiatives will be introduced at a workshop being held in Santa Fe, New Mexico and run by Project Santa Fe, a group formed last year by five health system-based labs that banded together to share innovations that highlight ways labs and lab data can proactively impact patient outcomes.

"Up to this point we have been a very reactive medicine," said Khosrow Shotorbani, president and CEO of TriCore Reference Laboratories, an independent lab that serves as an in-system and outpatient laboratory for multiple health systems in New Mexico. "We are of the opinion that we can actually be proactive and detect conditions even before disease manifestation is taking place. Our challenge is to create a business model around it."

For Project Santa Fe — which includes representatives of TriCore Reference Laboratories, Northwell Health Laboratories, Geisinger Health Laboratories, Henry Ford Health Laboratories, and Kaiser Permanente North Laboratories — the workshop taking place represents the start of its second phase. Initially, the group shared among themselves laboratory-led programs that had quantifiable benefits to their patient populations. Phase two involves sharing case studies with the larger heath system lab industry.

"The first year we really tried to articulate pilot programs that could be tested at one heath system site and, on the basis of evidence that might come forward, propagated to other health systems, to see how portable those ideas were," said James Crawford, executive director and senior VP for laboratory services at Northwell. "We had good progress."

The goal, Shotorbani said, was to pick projects that not only were successful at treating patients, but highlighted how lab data and other resources could be leveraged to gather new insights into issues such as care gaps, or patients who are high risk. These projects, Shotorbani said, are examples of what the group calls "lab 2.0," its term for an evidenced-based model that the group believes health system labs will have to adopt to demonstrate their value to their health system communities.

"When we started, we made a pact among the group that we were not going to focus on cost per unit. We were not going to focus on the science of the test," he said. "We were going to focus on the pre- and postanalytical side of the process that potentially reaches beyond the draw and beyond the results jurisdiction to projects that demonstrate downstream impact."

Many of the lab 2.0 projects that members of Project Santa Fe have chosen to highlight were begun before the group formed. Through Project Santa Fe, other labs within the group have been able to test and adapt the projects to the needs of their own health systems.

One example is an acute kidney injury alert developed by Northwell Health Laboratories that has more than doubled the number of patients identified with AKI. The project involves issuing an alert within the health system's electronic records to doctors when creatinine levels surpass the benchmarks that could be indicators of AKI.

"It's a very consistent finding that our alert triggers at around 21 to 22 percent of all inpatients. It takes a physician to determine whether that trigger represents acute kidney injury, because there may be other causes, starting with preexisting chronic kidney disease," Crawford said.

When the alert was first implemented in 2014, the actual identification of AKI within Northwell was around 5 percent of hospital inpatients, according to Crawford. By 2016, the number identified with AKI had risen to 13 percent.

"The way we are interpreting it, that is physician identification of acute kidney injury in patients who otherwise might not have been identified previously," he said.

TriCore has piloted the AKI program within its own service area, but because of TriCore's extensive reach, it is looking to expand the program to also include chronic kidney disease. TriCore, originally founded as a lab partnership between two New Mexico heath systems, now includes three health systems, as well as outpatient and primary care facilities. As a result, it captures close to 90 percent of regional patient data, Shotorbani said, which allows it to retain extensive histories of patients even when they visit different hospitals, outpatient facilities, or urgent care centers within New Mexico.

Having those extensive records allows TriCore to take a "longitudinal" view of a patient's health, according to Shotorbani. For example, in the case of kidney disease, a patient may have increased creatinine levels that don't meet the threshold of abnormal elevation. But the patient might have had minor incremental accumulation of creatinine levels over time that could be indicative of kidney disease, he explained.

In addition, TriCore is also doing extensive research to close gaps in prenatal care, particularly prenatal care that includes comorbidity with diabetes and hepatitis C. In New Mexico, 70 to 80 percent of prenatal care is covered by Medicaid, which is capped, and therefore can result in care gaps, Shotorbani said.

"With our algorithms we are able to detect who is at high risk and who has care gaps, so we can connect that patient to a care manager and get her onto care management early on," Shotorbani said. TriCore's research in the prenatal care area has not yet been published, he said.

At Northwell, the AKI alert came about by the hiring of a pathology informaticist, Tarush Kothari, who started with the lab in the summer of 2013. Since then, the system has added a second pathology informaticist, Tylis Chang. Kothari and Chang, as well as four pathologists within Northwell including Crawford, have taken and passed the clinical informatics board exam. The lab has also hired data scientists and data program managers.

"All the laboratory technologists, and the couriers, and the phlebotomists – there is an army of people who are generating data. Our informatics group helps maximize the value that can be derived from this information," Crawford said.

TriCore has boosted its technology capacity, too, including acquiring software company The Rhodes Group in 2015, to help create a data analytics program to support the data-driven, proactive approach to healthcare that the members of Project Santa Fe are espousing.

For Shotorbani, the organizer who first invited the participating labs to join Project Santa Fe, creating a group of like-minded labs to address improving patient care was a long-term goal. Last year, he decided the time was right to move forward with creating such a group, he said, because he felt the lab industry was reaching an inflection point where business models would have to change.

"Changing payment systems, regulatory changes, massive shrinkage of the commercial market due to the physician employment model, massive consolidation, are all basically changing the future business model of current lab medicine," he said.

Adding to the concern among health system labs who are members of the group, is the recent trend of hospital outreach labs being acquired by large lab companies. For example, in July Quest Laboratories said it would be buying the outreach laboratory services of Dignity Health Sierra Nevada Memorial Hospital. Also, Laboratory Corporation of American recently acquired the assets of Mount Sinai's Clinical Outreach Laboratories.

"To me, labs, especially with outreach, are the arteries of the system." Shotorbani said. "By selling the lab, you are basically slicing the arteries, because that's how we capture the data of the community. That data has actionability and predictive value."

The projects that Project Santa Fe has focused on are all evidence-based and quantifiable, so that labs can demonstrate results to other stakeholders within the health system, as well as to corporate executives who decide the fate of the laboratory.

"These projects have to have clinical champions. Laboratories do not do them in isolation," Crawford said. "Every single meeting I attend in this health system, I'm thinking, how can the lab help? It's amazing how frequent there is something that the lab can help with that is otherwise unrealized. We also want to flip that around so that if you are doing something in the health system, first you should think, how can we get the lab involved?"

While the labs that are members of Project Santa Fe already have a strong dialog with other stakeholders within their health systems, workshops like the one in November, which is expected to be the first in a series, are aimed at giving other labs tools to demonstrate to their health care systems the value they can provide.

"The reason that I started this is because no single institution, no single state, can do this on their own," Shortorbani said. "We need to have a critical mass in order to create enough noise and adoption toward how to best utilize the clinical lab in the future."