L-R: Steven Jolly, Fausto Bustamante, Larry Hughes, and Eric Afana discuss security features on a computer used for infant hearing screenings.

At Scripps Health in San Diego, more equipment has found its way onto the network. Applications and monitors have been networked for years; now, newer wireless monitors are getting networked. More devices are being linked to the electronic medical record system, and software can be just as important as hardware, such as with ultrasound. With an eye to the future, Marcia Wylie, MBA, senior director of biomedical engineering for Scripps says, “We saw the way it was going.”

Where it is going, according to team member Scot Copeland, a clinical systems specialist lead, is into a neutral zone: the nebulous area that lies between the clinical engineering and information systems (IS) departments. “It’s been a neutral zone because nobody wants to go there, and in our case, we’re going there,” Copeland says.

Team members have been acquiring IT knowledge, both on their own and through coursework supported by Scripps, and the department has taken on many more IT-related responsibilities. It even created a new position, making the neutral zone a little less neutral.

“We want to maintain our position at the bedside because we are best qualified to be there with the clinicians,” Wylie says. This meant accepting changes, acquiring new skills, and being open to new tasks.

Similarly, Scripps as a whole has been going through an analogous transition, restructuring the organization from a vertical management framework to a horizontal configuration. “There was not enough collaboration across the hospitals in the various service lines,” Wylie says. The organization had been growing (and continues to do so), but its architecture limited its ability to take advantage of its resources.

For instance, the administration wanted to centralize scheduling for radiology across the entire institution to provide patients immediate options. “We wanted to eliminate silos so, for example, if a patient could not get into one radiology facility quickly, they could have the option of traveling farther but being seen the next day,” Wylie says. For the president and chief executive officer, Chris Van Gorder, FACHE, the solution was obvious—accept the need for change, acquire a smarter structure, and be open to new responsibilities. This meant “turning the enterprise on its side.”

Though the organization was committed, the transition to a horizontal configuration was not without some upheaval for many departments. For biomedical engineering, however, it was nearly seamless. The department has long been organized horizontally and practiced standardization—for 15 years, Wylie notes—so the new initiatives were not new to the biomed department, a bonus since it was undergoing transitions of its own.

“The pace of activities increased, but the types of activities were the kind of things we had promoted and participated in to that point,” Wylie says. What was once obvious to the biomed team had become obvious to all.

Turning an Organization on its Side

Job descriptions and procedures in the biomedical engineering department were standardized long ago. The department has one centralized database (with the entire 35,000-piece inventory) across all shops that has been in use for years, and customers know who to call when they need help or have an issue.

Organized into five smaller teams—one at each of four hospitals and a mobile group that services the clinics—the department utilizes a lead for each unit who directs the work. The largest site has a team of seven, the smallest has three members, and one person is on-call 24/7, a role that rotates among team members.

Most of the technicians operate as generalists rather than specialists. There are two specialists, one of whom handles ultrasound; the rest of imaging is under contract with some first-call responsibilities.

“We try to make sure we’re multifaceted and can provide some response so the customer does not have to call back,” says Chris James, lead biomed at Scripps Green Hospital. “The customer is our first responsibility—and it gives us the opportunity to learn something new.”

Standardizing equipment helps to facilitate service and maintenance, since the department can employ cross-training and the centralized database. The department now has a list of equipment it has been able to standardize throughout the enterprise, including anesthesia machines and ICU monitors.

Many times, the same problems are encountered with a specific device, and being able to share that information across shops improves customer service. The alignment of the organizational and clinical engineering department philosophies has therefore made it easier for biomedical engineering to achieve its goals regarding standardization.

All for One, and One for All

Scot Copeland, a clinical systems specialist lead, works on a ventilator.

The biomed department sometimes encountered resistance to standardization because clinicians tend to have strong opinions regarding equipment and may not respond well to change. However, the biomedical engineering department at Scripps gets involved with acquisitions from the beginning and has learned how to guide the process of consensus. When a device is going to be installed systemwide, the team tries to assemble a related committee that is also systemwide.

Scripps encompasses four hospitals, roughly 35 clinics, and a home health program. “We meet with department managers and some of the users so that we can have consensus throughout [the organization] on the equipment of choice,” says Fausto Bustamante, corporate biomedical director at Scripps.

Of course, standardization does not mean inflexibility. “We may have variation here and there because of size or importance of certain devices,” Bustamante says. “Or we may have a device in one of the regional clinics that is not used elsewhere.”

Most requests for equipment run through the clinical engineering department. “As the second reviewer in the approval process, we have the authority to accept or reject a medical device that is being purchased,” Bustamante says. Devices standardized within the database are readily approved; others may require evaluation. Equipment can be flagged within the database throughout the year for assessment.

The department reviews the information annually when it compiles a list of recommended acquisitions for administration, approximately 4 to 5 months before the start of the fiscal year. “Our criteria is based on whether a device is no longer supported, or whether we are able to maintain it, or if there is a great advance in a patient safety feature,” Wylie says.

The biomed department’s opinion is highly valued because it is completely unbiased. “Most of the equipment is not a glorious device like an MRI, but items like the vital signs monitors, the ICU system, or older x-ray systems—basically, the workhorses that have been in use for 20 years,” Bustamante says.

The biggest challenge, as in so many health care institutions, is economic resources. It is not always possible to replace an entire inventory of a device at once, so the process takes place over a few years. Since advances leapfrog, the best device may change, but purchases made within the same product families still meet standardization requirements.

“We try to standardize where it makes sense,” Copeland says, citing the organization’s wireless monitoring system as a strong example. “We’ve selected one vendor, installed it throughout the enterprise, and standardized the way it is used. It’s increased patient safety and effectiveness of care in a way that has been measurable.”

Safe, Not Sorry

L-R: Steve Rubino and Allan MacGregor troubleshoot a patient monitor.

Another important criteria in the evaluation of products is security. The department approaches this aspect in the same way, with standardized procedures and products, where possible. “When new equipment is proposed, we’re part of a team that looks at security and what mitigation may need to be done to improve that security,” Wylie says. “A lot of medical devices are not quite up to speed yet as far as password protection and other elements that enhance security.”

If a device will not be connected to the network, there are few security-related problems, but with the number of connected devices increasing, it is a more common issue. “It’s getting to the point where everything is connected to the network, and there are a lot more capabilities and backups required of the system,” says Steven Jolly, a biomed technician at Scripps Mercy Hospital.

It is important for the team to know what vulnerabilities may exist and to fix them. Noncompliance with HIPAA standards can have serious consequences. To maximize security, the team uses a network risk score that is recorded in the database, similar to a clinical risk score. Factors in the assessment include criticality, whether the equipment contains protected electronic health information (EHI), and the probability of failures, such as a release of protected EHI, corruption of data, and/or the unavailability of data, according to Copeland.

Compatibility is analyzed, and solutions to potential risks are determined. “We want to address the vulnerabilities before equipment goes into service and make it part of the capital project,” Copeland says. The team then continues to work with the vendor after implementation to ensure that all of the latest security patches are installed and documented.

The evaluation process is completed in conjunction with Scripps’ audit and compliance group, which focuses on patient safety with a proactive drive. For instance, if a device that stores patient or drug information is lost for a certain period of time, the clinical engineering department must inform the audit and compliance group.

“We’re having to learn how to work together, and we’re finding that we need to learn more about network security,” Jolly says. It can be a delicate balance between maintaining security and maximizing function.

Offering an example, Bustamante recalls how the audit and compliance group was having IS encrypt all desktops connecting to the network; but biomed had discovered that once encrypted, devices connected to that encrypted computer no longer worked. “We had to go back to audit and compliance and reassess. It’s been a learning curve for everybody,” Bustamante says.

Neutralizing the Neutral Zone

L-R: Fausto Bustamante and Larry Hughes review test results on an infant hearing screening system.

Similarly, clinical engineering has had to learn to work with IS/IT as well. The new role of clinical systems specialist was designed to serve a dual purpose: liaise between the two departments and provide a promotion path for biomedical technicians. “We wanted to recognize that biomeds are gaining additional training and knowledge,” Wylie says.

The position was created about 3 to 4 years ago, and seven individuals on the 35-member team have earned the title. Clinical system specialists handle IT-related tasks that include security assessments and updates, integration interoperability, and project management.

“We get involved as representatives for biomedical engineering from the beginning in a lot of corporate projects that incorporate systems, and we often end up supporting them after implementation even though they originated with IS,” Copeland says.

IS has traditionally had larger budgets, administrative staff, and planning capability. “They can plan and implement the systems, but they can’t maintain them because they have no idea what the clinical environment is like,” Copeland says. “That is our specialty, so there is a hand-off in the middle.”

To be able to ensure the success of an implementation and subsequent hand-off, the clinical lead specialists must be able to understand the issues—hence, the requirement for additional training and IT knowledge. Clinical lead specialist Steven Rubino has found his experience, which includes a degree in IS and a Net+ certification, invaluable. He recalls an instance when the radiology department wanted to run a new, portable, wireless x-ray unit on a frequency that would conflict with the central house monitoring and command center. Rubino was able to explain why that would not work—talk the talk, if you will—and they moved to another frequency.

“The unit monitors 200 patients throughout the ER,” Rubino explains. “If I didn’t have my knowledge, they would have launched it on the same frequency, and we would have dropped critical heart signals—and who knows what could have happened? We are a level one trauma center.”

Empowered and Innovative

Standing, L-R: Steven Jolly, Fausto Bustamante, Scot Copeland, Marcia Wylie, Eric Afana. Kneeling, L-R: Chris James and Steve Rubino.

The central monitoring initiative—the result of an effort led by the biomedical engineering department—has become a critical component to operations in the ER. Instigated by a critical event that occurred in a hallway in 2005, a lengthy discussion ensued regarding possible solutions. “A year later, we installed a central wireless monitoring system that covered 80 patients in hallways and elevators via a unit on the eleventh floor,” Rubino says.

That number has since risen to cover 200 patients and is expected to climb to 250 in response to the success. “We’ve had more than 400 patient saves since the system was initiated,” Rubino says.

A portion of the success is due to the use of telemetry technicians on the ER floor, who handle patient movement and manage alarms. “In most ERs, there are a lot of alarms going off. Here, the telemetry technicians configure them so that the ER is quieter and there are fewer issues with false alarms,” Rubino says.

The telemetry techs are also able to better assess patients’ measurements, catching those who are spiraling down and notifying staff long before a code blue. At first, there was resistance to the use of techs; some felt the expense would offer no return. Three months and several patient saves later, it was decided they were indispensable.

“Biomed designed this system, which wouldn’t have been possible without the knowledge of the clinical systems specialists, and we are now rolling it out to other Scripps hospitals,” Rubino says.

He feels the system can provide a model for other hospitals and has the potential to become a standard of care. The FDA found it impressive when the system was presented to them. The Scripps team is now working on interoperability and a nonspecific vendor interface to connect additional instrumentation as it expands the system enterprisewide.

The effort is a perfect example of the benefit in entering the neutral zone. By embracing change, the Scripps Health biomedical engineering department is improving not only its service, but that of the organization as a whole. And, it is even more directly saving lives. There is no more obvious benefit than that.

The Scripps biomed team celebrated Biomed Week with a department picnic.

The Scripps biomedical engineering team on board the USNS Mercy. Since Scripps is located in San Diego, the team collaborates with the Navy biomeds. The department was able to arrange a tour of the hospital ship when it was docked in San Diego.

Renee Diiulio is a contributing writer for 24×7. For more information, contact .