A new biosecurity initiative at the Freeman Spogli Institute for International Studies (FSI) aims to identify and mitigate biological risks, both natural and man-made, and safeguard the future of the life sciences and associated technologies.

The initiative will be led by David A. Relman, a senior fellow at the Center for International Security and Cooperation and FSI. Relman, the Thomas C. and Joan M. Merigan Professor in the Departments of Medicine, and Microbiology & Immunology, has served as the science co-director at CISAC for the past four years. He will leave this position on Aug. 31 to lead the new initiative.

Michael McFaul, director and senior fellow at FSI, said, “With exceptional leadership skills, valuable experience and abundant energy, David Relman is ideally positioned to work with scholars from across campus who offer critical expertise in biosecurity. This is an exciting, challenging and important new initiative for FSI that is designed to protect public health from the many new risks now accelerating.”

Relman said the biosecurity initiative will seek to advance the beneficial applications of the life sciences while reducing the risks of misuse by promoting research, education and policy outreach in biological security. His CISAC leadership gives him the know-how to lead such a wide-ranging effort across diverse disciplines and communities.

Relman said, “The opportunity to serve as co-director at CISAC has been a wonderful experience, one that has afforded me the chance to get to know outstanding faculty and staff, their scholarship, and critical policy-relevant work, all of which I had not fully appreciated sitting across campus. This experience has made clear the unusual qualities of Stanford University, and the great people that work here. I am now greatly looking forward to this new opportunity at FSI.”

Biosecurity collaborations

During Relman’s term as CISAC’s science co-director from 2013-2017, he led an expansion of the transdisciplinary work in science and security to include biology, biological and other areas of engineering, medicine, and earth and environmental sciences.

The foundations for work in biological science, technology and security were established at CISAC, especially in the hiring of Megan Palmer, a senior research scholar at CISAC and FSI. Both Relman and Palmer worked together on engagements and discussions with a growing network of more than 20 faculty involved in biosecurity across Stanford.

Palmer said, “Stanford has an opportunity and imperative to advance security strategies for biological science and technology in a global age. Our faculty bring together expertise in areas including technology, policy, and ethics, and are deeply engaged in shaping future of biotechnology policy and practices.”

New insights, new risks

In his new post, Relman said he intends to build on this foundation by creating an initiative that consolidates and focuses activity in biosecurity, develops research and educational programs, attracts new resources, and looks outward at opportunities for policy impact and changing practices across the globe.

Relman said that “new capabilities and insights are reshaping important aspects of the life sciences and associated technologies, and are accompanied by a host of new risks.” If misused, whether by malice or accident, “they pose the potential for large-scale harm,” he noted.

Relman added that the initiative will bring together interest and expertise across the centers and programs of FSI in partnership with Schools and Departments across the university.

At FSI, CISAC will co-sponsor the biological security initiative, which will leverage Stanford expertise in the life sciences, engineering, law and policy.  Key partners will include Tim Stearns (biology), Drew Endy (bioengineering), Mildred Cho (bioethics), and Hank Greely (law), according to Relman. The biosecurity group will also partner with another new program at FSI in global health and conflict, which is led by Paul Wise, Frank Fukuyama, Steve Stedman, Steve Krasner, and others, he added.

Stanford’s School of Medicine and Department of Medicine will also co-sponsor the initiative, thanks to leadership from Lloyd Minor, Michele Barry and Robert Harrington. Relman looks forward to establishing similar relationships with other schools and departments, he said.

 “These partnerships are critical. I’m excited to work with a growing community both within and beyond Stanford towards the goal of a peaceful and prosperous world in the century of biology,” he said.

MEDIA CONTACTS:

David Relman, Center for International Security and Cooperation: relman@stanford.edu

Megan Palmer, Center for International Security and Cooperation:  mjpalmer@stanford.edu

Clifton B. Parker, Center for International Security and Cooperation: (650) 725-6488, cbparker@stanford.edu

Design learning and journey maps are all the rage here at Stanford University and in Silicon Valley. So why not apply it to health systems to reduce diagnostic errors?

That’s what Stanford Health Policy’s Kathryn M. McDonald is trying to do: Map the journey of worrisome scenarios that keep clinicians up at night, and then plant design seeds that might just help those clinicians get back to sleep.

One of those real-world scenarios involves a preventable diagnostic error made as a high-risk condition unfolds across multiple visits to the doctor. Missed cancer diagnoses, for example, are the leading cause for paid medical malpractice claims in the ambulatory setting, with one in 20 patients experiencing potentially preventable diagnostic errors each year.

“For example, a patient who has a positive fecal blood test, but no follow-up colonoscopy within a reasonable period may experience a missed opportunity to detect and successfully treat colon cancer,” McDonald said.

McDonald and her team worked with San Francisco public health clinics that cater to low-income patients to investigate this key problem — missed diagnosis and prevention activities during outpatient care — then came up with design seeds to plant possible solutions.

She and her co-authors published their research in the journal Implementation Science. The project was conducted at the Ambulatory Safety Center for Innovation (ASCENT), a patient safety learning laboratory led by Dr. Urmimala Sarkar at University of California San Francisco, and funded by the federal Agency for Healthcare Research and Quality.

The team used a research design approach called “journey mapping,” a tool that tells the story of a customer’s experience through his own viewpoint. They constructed maps for each pathway used by doctors to monitor patients with sinister findings, starting with the initial diagnostic assessment during an initial clinic visit and continuing through ongoing follow-up visits.

“Whenever participants in the study verbalized elements of the pathway that were particularly vulnerable to error or poor monitoring, we marked the activity with a bullseye target, also referred to by clinicians as a ‘pain point,’” the authors wrote. “To our knowledge, this technique has seldom been applied to the ambulatory setting, and has not been targeted to clinic workflow efficiency or patient safety intervention development.”

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“A design seed gives the specs for what a solution needs to do,” said McDonald, who is the executive director of Stanford Health Policy’s Center for Health Policy and Center for Primary Care and Outcomes Research. “Once you know the vulnerabilities through journey mapping, you create all the design seeds that are tied to the problem, then the implementation stage becomes much more straightforward and more likely to assure that all the key goals are met.”

To test out this theory, McDonald’s team spent the last two years working with doctors, residents, nurse practitioners and registered nurses with the San Francisco Health Network. The publicly funded integrated health network operates under the auspices of the San Francisco Department of Public Health and includes 14 primary care clinics, as well as urgent and specialty care at Zuckerberg San Francisco General hospital.

“The health system serves many of the most medically and socially vulnerable patients in San Francisco,” the authors wrote in their research paper. “Like many safety-net systems and ambulatory practices, the health system does not have a comprehensive electronic health record system and struggles with information transfer as well as fragmentation of health information across over 50 electronic platforms.”

The health system had more than half a million outpatient visits last year by people who could not afford care. Patients at the network’s main clinics and hospital are diverse: 35 percent are Latino, 21 percent are white, another 21 percent are Asians, and 17 percent are African-American.

Only 1 percent of the network population has commercial insurance; 10 percent were uninsured; 57 percent were on Medi-Cal — California’s Medicaid program — 21 percent were on Medicare and the remaining 11 percent were covered by other, mostly public sources.

This type of ambulatory health care is complex, requiring constant tracking and reconciliation of individual patient activities, patient data, and the unique evolution of each clinical case.

"Human factors and industrial design methodologies have tremendous potential to help unravel these complexities and provide fundamental insights that can drive the development of novel solutions," said co-author George Su of the University of California San Francisco School of Medicine.

McDonald said that journey mapping helped frontline clinic members see their workflow for a specific task, which in this case was monitoring this diverse population for follow-up visits after a potentially sinister finding. The system challenge is population management of an ill-defined problem.

“Lots of ambulatory care work is done one patient interaction at a time, but robust monitoring requires a view from a higher plane,” she said in an interview. “Journey mapping makes the aerial view more tangible and realistic for clinic team input.”

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McDonald’s team selected high-risk cancer situations: incidentally discovered pulmonary nodules; monitoring for breast, colorectal and prostate cancers; and ear, nose and throat cancers. These high-risk cancers require recurring and timely follow-up care to assure intervention whenever the disease takes hold.

The team interviewed clinicians from each of five specialty clinics responsible for these high-risk patients in pulmonary medicine, breast cancer, gastroenterology, urology, and otolaryngology. They asked the frontline clinicians: “What keeps you up and night? And what are your clinical hunches about who might fall through the cracks?”

While the providers talked about the types of patients who become lost to follow-up visits, the researchers found, none of the clinics had a standardized and efficient method of quantifying how many patients were lost to follow-up care and, perhaps more importantly, why.

“Many other health networks share similar struggles with incomplete documentation and measuring the real-time scope of patient safety problems,” wrote McDonald and co-authors Sarkar, Su and Sarah Lisker of the University of California San Francisco School of Medicine; and Emily S. Patterson of Ohio State University College of Medicine.

“When a patient has a warning signal for a serious condition that has yet to materialize but may in the future, the ability of a clinical team to watch the patient closely over time hinges on incredible vigilance on the part of individual clinicians — hardly an ideal solution,” McDonald said.

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This is the crux of the problem, she said, and where so-called “design seeds” are planted.

“The design seeds lay the groundwork in a very specific fashion. Journey mapping and process tracing figure out the problem, in our case, vulnerabilities, and then the design seeds are the first-stage of the solution,” McDonald said. “It’s very user-focused, learning directly from those who are on the frontlines of the work, and making sure that the problem is specified in a way that allows for the developments of solutions that can scale more flexibly during implementation.”

The team identified 45 vulnerabilities within San Francisco’s publicly funded health clinics.

“Repeatedly, we heard that clinicians worry about properly tracking these patients, and are troubled by the significant personnel time required in carrying out patient-level monitoring activities without tools and organization approaches for population-level monitoring,” they wrote.

But even then, the team did not jump straight to solutions. That’s the next step.

The team will launch a pilot project to test possible solutions that will grow from the design seeds, such as whether new digital technology, workflow arrangements, and structured data collection could help find those patients lost in the cracks of an overloaded system.

“Such focused and potentially scalable work is particularly needed for patients who may be lost to follow-up in systems that are stretched for dollars and time,” the authors concluded. “Providers will often create informal workarounds in response to the lack of comprehensive and coordinated record-keeping systems, which can result in errors as well as redundant efforts.”

The ASCENT team is already implementing a monitoring solution informed by the journey mapping activities, in subspecialty care clinics at Zuckerberg San Francisco General, by testing technical and workflow models.

“We determined the need for a registry for high-risk patients in the otolaryngology clinic to help us monitor the entire process,” said Sarkar, a primary care physician and head of the ASCENT lab at UCSF. “This means the final diagnosis, workup and treatment planning, the actual treatment itself and then surveillance and follow-up.”