Dean Guernsey / The BulletinAirLink lead mechanic John Bentley checks the rotor on a EC145 Airbus in Bend. Both Airlink and Lifeflight, which serve Central Oregon, are accredited through the Commission on Accreditation of Air Medical Transport Systems, a voluntary program that has stricter safety requirements than the regulations required by Oregon.

In May 2010, Megan Gilbreath, an 18-year-old college student from Abilene, Texas, missed a turn, overcorrected, and rolled her pickup truck on a Texas highway. Extricated from the vehicle with a broken leg and a head injury, she was confused and lethargic, but her injuries didn’t appear life-threatening.

When the air ambulance arrived, an emergency medical technician decided to sedate and temporarily paralyze her, in order to intubate her and transport her safely. But instead of placing the breathing tube into her windpipe, the EMT inserted it into her esophagus. A ground paramedic warned the crew of the mistake but the helicopter lifted off anyway with Gilbreath unable to breathe on her own and air being pumped into her stomach instead of her lungs.

By the time the helicopter landed at the hospital 33 minutes later, Gilbreath was brain dead. Doctors were able to restore her breathing and circulation so her organs could be donated to save other lives.

While helicopter EMS crashes are hard to miss, the lack of oversight of the medical care provided onboard has largely flown under the radar. Unlike the aviation side of the service, which is subject to federal flight and safety rules, neither federal nor state health officials have been able to adequately regulate the medical side.

As a result, the medical care provided by HEMS programs depends largely on the internal standards and commitment to quality from the operators themselves, with little oversight or accountability built into the system.

“The public believes that all (medical helicopters) are well-staffed by similarly trained medical crews with the latest technology to provide the critical care needed to keep them alive,” the Association for Critical Care Transport, an advocacy group of HEMS professionals, said in a recent statement. “There is no such guarantee.”

Legal barriers

HEMS programs have fallen through the regulatory cracks in part because of the Airline Deregulation Act of 1978. The helicopter EMS sector was just getting off the ground in the 1970s, and it’s unlikely Congress gave much thought to air ambulances when crafting the new aviation law. The act pre-empts states from regulating the “prices, routes and services” of air carriers. In theory, states can still regulate the medical side of air ambulances as long as they don’t significantly impact the economics of flying the aircraft.

But that has proved to be a key loophole. Over the years, HEMS operators who haven’t wanted to comply with state laws have used court decisions or opinions from the Department of Transportation to invalidate them.

“A number of organizations have really used that provision to strike down state regulation for health care,” said Tom Judge, executive director of LifeFlight of Maine, a nonprofit hospital-based helicopter critical care system serving the entire state of Maine. “We really ought to carve air medicine out of that, because that was never intended to apply to health care regulations.”

Perhaps the most impactful case was a U.S. District Court ruling that struck down a North Carolina law requiring new HEMS programs to show there was a need for their services. MedTrans, a for-profit HEMS provider based in South Carolina, sued the state of North Carolina, claiming the certificate-of-need law as well as requirements for the company to be affiliated with an EMS provider and to have an EMS peer-review committee were preempted by the ADA.

The court reluctantly sided with MedTrans, ruling the challenged regulation provided local governments with a mechanism by which they could prevent an air carrier from operating within the state.

“The court is loath to disturb the carefully coordinated state and local EMS systems,” the court wrote in its ruling, “and it does not do so lightly.”

The decision had far-reaching implications, providing a precedent for HEMS laws to be challenged in other states and emboldening HEMS operators to fight state or local regulations that might affect their bottom line.

“It literally gutted all of the states’ emergency health services laws as much as they dealt with helicopters,” Judge said.

Other operators have sought rulings from the Department of Transportation on whether a particular state regulation was preempted by the ADA. The DOT, for example, told the state of Hawaii it could establish requirements for medical equipment as long as it was not so expensive as to constitute economic regulation.

According to the National Association of State EMS Officials, as states have attempted to regulate HEMS programs and ensure their integration with state and local EMS systems, operators have responded with lawsuits, asserting the state laws violate the ADA.

As a result, states can tightly regulate the provision of ground ambulance services but not air ambulances.

“The state of Oregon has some minimum equipment standards,” said Justin Dillingham, senior director of strategic planning and technology for LifeFlight Network. “They can get into regulating the medical supplies we carry, but what they can’t regulate is, for example, how long your tail rotor blade is.”

Oregon’s air ambulance regulations consist mainly of lists of required survival equipment in case of a crash (everything from canned smoked signals to beef jerky or granola bars) and medical equipment (including a stethoscope, male and female urinals and at least one bed pan).

Both LifeFlight and AirLink are accredited through the Commission on Accreditation of Air Medical Transport Systems, which has more extensive requirements but is a voluntary program. And unlike in other sectors of health care, Medicare puts few standards or accreditation requirements in place beyond the limited state regulations.

“For hospitals and doctors, if you want to bill the federal government for services to a patient, on behalf of the patients Medicare is going to say you have to meet these kinds of standards. Well, they don’t exist in the air medical industry,” Judge said. “HEMS is the only place that something like that doesn’t exist.”

CMS officials did not respond to requests for comment, but Judge said it’s likely the agency would need Congressional action to put such conditions of participation in place. In 2010, Sens. Maria Cantwell (D-Wash.) and Olympia Snowe (R-Maine) introduced legislation to address HEMS safety, including directing Medicare to set up an accreditation process. The bill died in committee.

After holding hearings on HEMS safety in 2009, the National Transportation Safety Board also called on CMS to establish safety standards for the industry and to not pay helicopter companies that don’t meet these standards.

NTSB also recommended national guidelines for HEMS and EMS system planning, and the National Highway Traffic Safety Administration tasked the Centers for Disease Control and Prevention to come up with those guidelines. CDC held national stakeholder meetings in 2012 and submitted a draft to DOT that year, but the DOT has yet to release the guidelines.

Self-regulation

That has left medical quality and safety concerns largely to the discretion of individual programs. Some operators — both for-profit and not-for-profit — have a strong commitment to quality and invest in medical equipment, staffing and training. But others have bowed to financial pressures and opted to cut costs.

“That doesn’t mean that everyone ignores medical treatment because there is no regulation, but it’s really highly led by the physicians, and the physician involvement (determines) how much focus and energy is put into patient care and quality management,” said Dr. David Stuhlmiller, chairman-elect of the Air Medical Transport section of the American College of Emergency Physicians. “I don’t think any service actively tries not to take good care of people, I think they’re just maybe not able to spend as much money as other services.”

Some states have established staffing regulations for HEMS, but in most parts of the country it’s up to the operators to determine what medical staff to put in the back of the helicopter. Oregon regulations require a pilot and at least one crew member, either a physician, physician assistant, nurse or basic-level EMT. And the trend nationwide has moved quickly toward hiring lower-level medical staff.

From 2008 to 2014, despite the addition of some 230 helicopters nationwide, the number of physicians flying with HEMS programs dropped from 600 doctors to 563. The number of basic-level or intermediate-level EMTs, meanwhile, increased from 557 to 846, and the number of paramedics rose from 4,476 to 5,356.

“You can hire some brand-new paramedics a lot cheaper than you can hire a very experienced one,” said Dr. Michael Abernethy, chief flight surgeon for University of Wisconsin’s Health Med Flight. “We fly physicians, which is the standard in the rest of the developed world. In the United States, we have dumbed down helicopter EMS so badly.”

Industry officials counter that the HEMS industry is already highly regulated.

“We sit at the junction of two of the more heavily regulated industries in the United States,” said Rick Sherlock, president and CEO of the Association of Air Medical Services. “I don’t think the premise is correct that there are no standards for air medical safety. There are a number of different standards out there, and we review our safety as an industry everywhere we can.”

Sherlock said that in an effort to reduce regional variations, AAMS has crafted model state guidelines for HEMS in 2012 and turned those over to the National Association of State EMS Officials for review.

“We’re certainly open to continuous improvement in operational, aviation and clinical safety in patient care,” he said. “What we want is an industry-wide review of those things so that the industry can move those issues forward.”

Accountable care

The AACTS group, on the other hand, believes the industry has had the opportunity to put in place voluntary quality improvements but has failed in its efforts to self-regulate.

“The system has become less accountable to health care and the needs of the health care system,” Judge said, “and is mostly accountable only to itself.”

He points to the government response when a Maryland State Police helicopter crashed in 2008, killing a patient and three crew members. The state launched an investigation, bringing in a panel of independent experts, including Judge, to review the incident and make safety recommendations.

“The people of Maryland got something better from that tragedy,” Judge said. “If you don’t have an accountable system, we have tragedies but we don’t necessarily learn how to make that better the next time.”

Survivor’s lament

Krista Haugen had been a flight nurse for five years when she survived a 2005 helicopter crash in Olympia, Washington. Her crew had been called to airlift a patient with a leaking abdominal aortic aneurysm from South Bend, Washington, a small town on the coast with limited access to medical care. Shortly after take-off, the weather took a turn for the worse, and the pilot decided he could not fly the mission safely. Instead, they would meet the patient in Olympia where conditions were better.

With the patient onboard, the helicopter lifted from the landing pad and Haugen immediately heard the engines slow down. The aircraft lost its lift and began to fall. Haugen was in utter disbelief. She had just attended a memorial service for three colleagues who died in a helicopter crash a month earlier. Now, strapped into the rear-facing seat in a brand new, state-of-the-art helicopter, going down in what felt like slow motion, she pictured family and friends attending her memorial service.

“I was saying to myself as we’re falling and the aircraft is coming apart, ‘You’re OK. You’re OK. You’re OK,’” she recalls. “And we came to the point where I realized this might not end well.”

The tail rotor hit the building, followed by the main rotors, which exploded into shrapnel as they impacted the cement wall. But the helicopter crashed onto dirt ground instead of pavement, and all three crew members and the patient survived.

“Oddly enough, I felt extremely prepared for this kind of accident,” Haugen said.

The crew had been outfitted with proper safety gear and strapped in with a four-point restraint system. They had undergone training on how to evacuate the aircraft after an accident, and so knew that if they survived the impact, they needed to wait until the rotors stopped spinning before bailing out. Haughen says not all HEMS programs devote the same amount of time and resources to safety and training.

“We call it an industry, but I think it’s really quite fragmented,” she said. “Certainly there’s a minimum standard required by the FAA and the accrediting bodies, but just not a lot of consistency.”

But Haugen said she was not prepared for what would come next: how difficult it would be to fly again, and how little help and support was available to her. She did a test flight with colleagues a few weeks later, and while she felt like she could function and do her job, the joy of flying was gone. She transferred to a nursing job on the ground.

“I was not prepared for the aftermath at all,” she said. “I think the common misconception at the time was that most people get killed in helicopter crashes, and so the industry is fair at honoring their fallen. But the industry has no idea what to do with survivors.”

Haugen had begun to reach out to other survivors of HEMS crashes and soon realized many were struggling with the same issues that she was. She would later co-found the Survivors Network for Air & Surface Medical Transport, primarily focused on providing support to other survivors. Haugen and the other co-founders also felt that survivors had a unique perspective and a valuable message to share.

“Until you’ve been there, you have no idea how devastating it is,” she said. “And by the time the dust settles, to muster up the energy to go back, to look at the accident closely and to look at the true root causes, for the people who were directly involved it takes a tremendous amount of energy and fortitude. I think life just sort of moves forward and those lessons are often lost.”

She eventually learned the crash was attributed to pilot error. The pilot had taken off with one engine in idle. She wanted other programs to learn from the mistake.

“This talk right now about technology and what airframe is used and different tools to help pilots complete the mission safely, we had all that. We had all the technology, we had all the bells and whistles, and still we had an accident,” she said. “I’m not downplaying the value of technology because I think it’s important but it’s not a cure-all.”

Haugen believes the industry is quick to discount accidents as pilot error and not investigate all the other factors that contribute to the crash. The HEMS industry, both for-profit and not-for-profit, has been slow to share information and collaborate on standards that would protect patients and crew.

“The irony of that is the general public doesn’t distinguish which program is which. They only know a medical helicopter crashed and it shines a disparaging light on the entire industry,” Haugen said. “The whole notion of competition, I understand it from a business perspective, but safety and survivorship should not be proprietary.”

Shawn Pruchnicki, who lectures on aviation safety at Ohio State University, said when aviation accidents occur, investigators and the industry tend to focus on a single cause, most often pilot error. But that misses the true complexity of the events, and as a result, potentially life-saving lessons are often lost.

The HEMS industry, he said, is in many ways experiencing the same growing pains as the commercial aviation industry did following deregulation.

“We have, in a capitalistic society, all these start-ups who are resource-constrained, not only with hardware but the finances involved. It’s the trade-off we make,” he said. “The problem is how far do you push it? And quite frankly in this industry as with other high-risk, safety-demand type of industries, we are borrowing from safety, and it’s not always that obvious how close we are to the edge of having an accident.”

There are attempts within the industry to develop more of a safety culture. The National EMS Pilots Association recently launched a safety culture survey that HEMS programs can use to compare themselves to other organizations.

Pruchnicki says such safety management tools can give a false sense of security, suggesting that as long as the survey results are good, that safety isn’t an ongoing concern. High-performing organizations, he says, never rest on safety and are constantly vigilant for potential problems and improvements. But that requires significant buy-in from management and the entire organization.

“What is going to happen, dare I say, is we’re going to be left standing in the rubble scratching our heads saying, ‘How did this happen?’” he said. “We’ve implemented a safety culture, why are we still standing among the wreckage?”

— Reporter: 541-617-7814, mhawryluk@bendbulletin.com