At a Glance

SUBJECT: VA Healthcare Technology Management Team, VA, National Center for Patient Safety

LOCATION: Washington, DC, and Ann Arbor, MI

SIZE: More than 1,700 medical facilities, including 153 hospitals

STAFF: More than 1,000 HTM professionals including clinical engineers and biomedical equipment technicians

The Department of Veterans Affairs (VA) operates the largest integrated healthcare system in the United States, serving 8.76 million veterans at 1,700 medical facilities, including 153 hospitals, 800 outpatient clinics, 180 veterans centers, 136 nursing homes, as well as community living centers, counseling centers, and other facilities within 21 Veterans Integrated Service Networks (VISNs).

The VA's Healthcare Technology Management team—under the leadership of Kurt Finke, BSE, since May 2011—includes more than 1,000 healthcare technology management (HTM) professionals who work with more than $6.5 billion worth of medical technology and 650,000 devices. These professionals primarily include clinical engineers (CEs) and biomedical equipment technicians (BMETs).

With such a large network, wide range of technologies, and medical devices becoming ever more complex, Finke and his team faced a challenge: How could they enhance patient safety and ensure safe operation of medical devices across all facilities? The solution turned out to be a systems-based, multidisciplinary training initiative.

A culture of safety is also the primary concern of the VA's Office of Quality, Safety and Value, said Tandi Bagian, director of human factors engineering with the VA National Center for Patient Safety (NCPS). The goal of the NCPS is the reduction and prevention of inadvertent harm to patients as a result of their care. To this end, the NCPS notes that the patient safety managers at all VA hospitals and the patient safety officers at 21 VISNs participate in the program.

Of the more than 1,000 HTM professionals at the VA, approximately 200 CEs are involved in managing a wide range of equipment and budgets, as well as overseeing multiple programs. CEs are often “consumed with evaluations, competitive bidding, buying, planning, and running the projects: managing implementation, equipment supply, integration into our electronic medical record system, safety testing, training, and sustainment,” said Finke.

The CEs have a heavy workload and an understandable tendency to focus on details and short-term goals, Finke said, so he and his team wanted to shine a spotlight on the overarching goal of patient safety. “Many of our CEs are extremely busy, so drawing their attention to the bigger picture, focusing on safety, is very important,” he said. “Most are partially aware—or only subconsciously aware—that up to 90% of their work directly contributes to a safe environment of care.”

Many organizations place responsibility primarily on managers and leaders to solve problems quickly. The result can be shortsighted, boundary-directed actions, which may have unintended and adverse consequences. Such organizations focus on short-term goals. Implementing “systems” thinking shifts responsibility to an entire team or community, fundamentally altering the way problems are viewed and solved, and placing an emphasis on the bigger picture.

Implementing “systems” thinking shifts responsibility to an entire team or community, fundamentally altering the way problems are viewed and solved, and placing an emphasis on the bigger picture.

Bagian said it is crucial that team members understand that their decisions and actions are all connected in the modern healthcare environment. “We'd like VHA to become a healthcare system where every employee is asking themselves what could go wrong, armed with an appreciation that it could happen to any one of us,” she said.

The pervasive problem of under-reporting of adverse medical device events is an example of a patient safety issue that can be addressed by promoting systems thinking, according to Finke.

“Reporting adverse events is becoming even more important as medical devices, software—such as electronic medical records, or EMRs—and IT systems are increasingly connected. Identifying connectivity failures and malware and performing integration testing are critical to ensuring patient safety.” Making sure accurate information about such incidents is passed on is vital, he notes, in order to investigate incidents, identify hazards, and if necessary, recall devices.

“Thinking ahead and assessing the potential for ‘use-issues’ is the smartest way to minimize them,” agreed Bagian. “We learn from our unfortunate experiences and close calls, and when we proactively anticipate similar issues, we can avoid having additional unfortunate experiences.”

Reporting adverse events can be achieved by coding of work orders in a computerized maintenance management system and then querying the system database. The team adds that it is important to carry out root cause analysis (RCA) of those events that score as having the highest potential for harm. An RCA report describes the problem or adverse event, the methods used to determine the causes, all probable causes, and the likelihood of each cause with supporting evidence along with actions to mitigate or eliminate each cause.

Bagian noted that “as healthcare devices become more complex … gaining a true understanding of the root causes of an event becomes more and more challenging. We can only re-engineer healthcare systems to mitigate or eliminate the causes of patient harm if we make it a priority to thoroughly investigate and analyze the harmful events and close calls we experience.”

“We now have patients with glucometers commanding their implanted drug delivery pumps, and it's not clear if misdosing is due to the external device or calibration test strips, the implanted device or meds, or the IT system through which data passes,” added Bagian. Integrating a prescription entered in the electronic medical record (EMR) for medication delivery by an infusion pump at the bedside is another medication application being developed that involves a complex system of hardware and software.

Part of the solution focuses on new hires. “Every year we bring over 20 new CEs into our team,” said Finke. These recruits are well educated; they all have engineering degrees and more than half have graduate degrees. They are, however, all new to the VA system and most go through a two-year clinical engineering development program. “We devote a conscious effort every year to what I call getting back to basics,” Finke said. “And one of the tenets of HTM at the VA is patient safety: assuring the safe operation of medical devices.”

During their training program at the VA, the newly hired CEs participate in a Patient Safety Training Boot Camp. Part of that involves learning to assess device risk prior to purchasing complex devices. The recruits could then train other CEs and eventually develop strong working relationships with their facilities' patient safety managers. They conduct their own root cause analyses of adverse medical device events.

“If we could specifically train our CEs—particularly the new ones—how to enhance medical device safety, we could instill concepts we wanted them all to be aware of,” said Finke.

The NCPS staff includes three biomedical engineers who “research device use-error via the RCA process and work with the manufacturers and chiefs of service in the VA to create a plan to remove the vulnerability from the VA system,” said Bagian. “We realized that those who purchase and maintain these complex devices would be the best suited” to work with the patient safety managers to ensure thorough investigation of adverse events.

“Thus, a partnership was born,” said Bagian, with the VA's HTM team and NCPS working together. However, the venture initially encountered some difficulties. Leadership did not immediately embrace either the idea of devoting NCPS resources to training clinical and biomedical engineers in addition to patient safety managers or that of training biomedical staff rather than nurses in patient safety, particularly given the constraints on federal spending and travel. However, plans were underway in June 2012 for the program.

“We determined that a group of twelve [CEs] was the maximum that could be approved for a given training session under the dollar limit imposed last year, and October 2012 saw the first NCPS Patient Safety Boot Camp for the Technical Career Field (TCF) Biomedical Engineer (BME) ‘Alpha Class,’” said Bagian, who was in charge of the program.

The main goals of the joint pilot project were to:

  • Train CEs in a systems approach to patient safety, so that adverse events in the field are well understood.

  • Train CEs in how to participate on an RCA team, identifying the root causes of patient safety events.

  • Disseminate this knowledge to engineering colleagues in all 153 VA facilities.

  • Strengthen the partnership between CEs and patient safety managers.

Key elements of the new training program developed by the two departments included:

  • Providing NCPS patient safety manager training with focus on HTM tools and concepts.

  • Incorporating NCPS training modules on high reliability organization structure to provide a shared vision of the VA hospital of the future.

  • Using hands-on human factors exercises for the HTM trainees to illustrate the capabilities and limitations of humans in a system, as well as illustrating how an environment or situation affects the performance of a task.

  • Emphasizing understanding of an event using the RCA process and discussing actions most likely to make a difference in removing or containing the vulnerability.

  • Providing techniques such as proactive healthcare failure mode and effect analysis (HFMEA) to assess complex new technology to be acquired by a facility.

  • Emphasizing case study analysis.

The result is not just a view of a device, but of the whole complex, interoperable system, allowing analysts to determine how the device affects patient safety across the country, and to determine system vulnerabilities that would otherwise remain hidden.

VA biomedical engineers attend a “boot camp” on patient safety.

VA biomedical engineers attend a “boot camp” on patient safety.

Members of the VA's healthcare technology management team pose for a photo at the AAMI 2012 Conference & Expo in Charlotte, NC.

Members of the VA's healthcare technology management team pose for a photo at the AAMI 2012 Conference & Expo in Charlotte, NC.

“The VA has the luxury of having a 153-facility network where any lesson discovered by a given team on a given shift at a given facility can be learned by all VA employees” said Bagian. In particular, because the VA maintains more than 1 million patient safety event reports, many of which involve devices, the unique opportunity exists for extensive analysis of the complexity of the medical device world at a national level.

“In the field, adverse events are scored, and those with a high score require a root cause analysis,” said Bagian. “In 2012, we had nearly 108,000 reports. Over 1,150 of these were investigated via RCA, and each one can be used to demonstrate national trends in specific issues.”

The result is not just a view of a device, but of the whole complex, interoperable system, allowing analysts to determine how the device impacts patient safety across the country, and to determine system vulnerabilities that would otherwise remain hidden.

The result is not just a view of a device, but of the whole complex, interoperable system, allowing analysts to determine how the device affects patient safety across the country, and to determine system vulnerabilities that would otherwise remain hidden. This holistic view also affects staff interaction, increasing collaboration, knowledge sharing, and skills, said Bagian. “NCPS analysts talk to the patient safety officers and patient safety managers, and dive into the database. There is a neat synergy to provide support for frontline engineers and technicians who might see a potential vulnerability, and work with their patient safety manager to improve healthcare systems across the entire VA.”

“I see tangible benefits that have emerged from this initiative,” said Finke. “I hear reports that RCAs are improving in quality, and that a multidisciplinary team was involved; patient safety managers comment on the talents of our HTM staff—talents that were not recognized before; and I hear people asking questions about specifications and requirements for purchasing that tie to ease of use and usability.”

The program's initial phase of training incoming CEs has been so successful that the VA is in the process of expanding it to seasoned biomedical or clinical engineers. Although the program was implemented only a year ago, data suggests that it has had an enormous impact. In 2011, according to Finke, 11,000 hours of HTM staff time were spent on RCAs. In 2013, that number jumped to 13,400 hours, a 22% increase.

Time spent in identifying and reporting issues is critical. For each adverse event, noted Bagian, “we have 45 days to make sure VA learns from the event or close call that warranted an RCA.” The team describes the device, understands the issue, and talks to manufacturers as well as clinicians who deliver the treatment to the patients. When an issue is understood to be a potential vulnerability for more than the local facility, the NCPS team determines if concrete actions can be taken at a national level to remove or reduce the potential harm, sometimes publishing a Patient Safety Advisory or Patient Safety Alert requiring VA facilities to take action. The more analysis that takes place, the more likely it is that a future adverse event can be prevented.

Trainees who have attended the program attest to the success of the initiative. “I'm more cognizant of potentially faulty medical equipment procurement and utilization processes,” said Jennifer Wong. “Patient safety is dependent on effective policies and processes rather than specific people or devices.” For Paige Armstrong, the training program was eye opening: “I didn't realize the effect I could have on patient safety within my career field as a biomedical engineer.”

Kristen Russell, a new CE at the VA, found that the Patient Safety Boot Camp “was a tremendous learning opportunity covering a wide variety of safety topics including root cause analysis, failure mode effects analysis, and human factors engineering.”

The future appears bright for the VA's ongoing partnership between patient safety managers and HTM professionals. “This is likely to create a more mission-focused, systems-focused team at every facility,” said Bagian. “We already are seeing an energized analysis in some of our RCAs involving devices—where the RCA team chooses to simulate or replicate their ideas of root causes to confirm their understanding … and an increase in proactively detecting and resolving vulnerabilities due to more involvement and detailed reporting from the field.”

The future appears bright for the VA's ongoing partnership between patient safety managers and HTM professionals.

According to Bagian, the HTM department plans to offer two core courses on patient safety to every biomedical engineer. That's not all. Based on the success of the partnership with HTM, NCPS envisions working with other departments, such as pharmacy and radiology, to better understand complex events or close calls.

About the Author

Erika Hatva, PhD, was AAMI's managing editor. She recently moved to London with her husband.