After nearly a year of dealing with an ever-present threat of COVID-19, state officials and care home administrators are eager to get vaccines out to Hawaii seniors.

But first they must get legal consent. And failing to get it could delay vaccines for thousands of seniors who are unable to make medical decisions on their own.

“It’s going to be the biggest limiting factor, other than supply of vaccine,” said Dr. Albert Yazawa, a geriatrician who serves on one of the vaccination distribution planning teams convened by the Hawaii Emergency Management Agency. “For the folks who cannot sign their own consent forms, that has to be done ahead of time. What we’re trying to do is give everybody as much time and heads up as possible even before we have clinic dates set.”

The longer it takes to get consent, the longer those seniors will be at significant risk for COVID-19, said Dr. Curtis Toma, medical director of Med-QUEST, Hawaii’s Medicaid program. The Department of Human Services held a series of webinars this week for caregivers to tell them what to expect.

The elderly are one of the groups most vulnerable to the virus.

“It’s much more devastating, so we really want to find a way to make sure they get it timely,” Toma said.

Last year, the state partnered with pharmacies to distribute flu vaccines, which Toma said served as a trial run of sorts for the COVID-19 vaccine rollout.

“What we hope is that when pharmacies get to the homes there won’t be a lot of bottlenecks, like ‘Oh I forgot to do aunty’s form,’” he said. “When we did the trial run with the flu shot earlier, one of the bottlenecks was incomplete forms.”

Obtaining consent is a regular part of the process for any vaccine, but the COVID-19 vaccine is different  — it is still under emergency use authorization from the federal government and requires extra paperwork.

“The challenge is it takes a little longer to get informed consent for a COVID-19 vaccine than it does for the flu shot,” said James Pietsch, a University of Hawaii law professor and director of the UH Elder Care Law Program.

If a senior has not completed paperwork that indicates medical preferences, or has not used a power of attorney to designate someone else to make medical decisions for them when they can no longer do so themselves, their loved ones would have to start the process of assigning a medical surrogate.

Pietsch says some states specify a hierarchy of family members who can step in to make such a decision, but in Hawaii, it’s not as simple. A medical surrogate must be selected with a consensus of all interested parties — which could include family and friends. That process must be led by the person’s physician.

There is still sometimes lingering confusion even among the medical community about who is the legally authorized representative, Pietsch says.

“It’s one of the most confusing pieces in our legislation,” he said. “Many people were trained under the concept of family members being able to make decisions for incapacitated family members. But we don’t have that statute in Hawaii. You can’t automatically go to the eldest child or something of that nature.”

When no family members or friends are able to step in, the Office of the Public Guardian assumes responsibility for the patient, triggering a process that could take months.

“I would say maybe 50% of the community don’t have these documents and have not gone through the process, so it could be a lot of individuals,” Pietsch said.

Informed consent has always been an issue, especially in nursing homes, but now it’s more pressing, said John McDermott, the state’s long-term care ombudsman. According to McDermott, the “vast majority” of nursing facility residents have dementia and therefore are not capable of making decisions about medical care.

“Many facilities have ignored this problem because of the cost of hiring an attorney to initiate guardianship. I suspect they now regret this,” he said.

It’s important for paperwork to be filled out correctly, because each injection appointment is allotted only about 15 minutes, he said.

Caregivers like Maribel Tan, the president of The Adult Foster Homecare Association of Hawaii, said she expects it to be a significant hurdle for caregivers to track down the right paperwork and people.

Tan cares for three elderly clients in her Waipahu home as part of the state Community Care Foster Family Home program. She estimated as many as one-fifth of kupuna, or elders, who live in adult foster care lack the capacity to decide whether to get vaccinated.

Even for those who have appointed someone to make such a decision, Tan has seen first-hand how difficult it can be to reach them. Sometimes they’re on vacation or live out of state. Some are elderly themselves and may not have resources to complete legal paperwork remotely.

“That would be the hard part — if they cannot come to the home or they’re not able to use email,” she said. “Then we have to really go out and go to their houses and track them down where they are.”

Two of her clients are able to decide on their own and the third did have a medical power of attorney lined up, though she has not yet received the paperwork or registration information.

Big Island Adult Foster Home Operators President Cora Cariaga signed up this week with KTA Pharmacy for vaccine appointments for her three clients and herself. She is currently counseling her colleagues on how to navigate the pre-registration process and schedule appointments. It took a couple of hours for her, she said.

Suzie Schulberg, president and CEO of The Arcadia Family of Companies, says assisted living facilities and nursing homes usually require residents to identify a legal authority to make decisions for them upon admission, so she doesn’t expect consent to be a major issue.

But oversight on the issue is fuzzy: Pietsch, the lawyer, said it’s unclear what agency is supposed to check a surrogate’s legal standing.

Pietsch is concerned that in the rush to get everyone vaccinated, facilities could try to cut corners. If a staff member were to falsely state that residents are able to give consent when they’re not, it could result in a medical malpractice claim.

Beyond the question of informed consent are language barriers, according to Yazawa.

A fact sheet that outlines the vaccine’s risks and benefits must be provided to the patient before the injection, and the patient must acknowledge it to complete the process of informed consent. The U.S. Food and Drug Administration provides various translations of the Moderna COVID-19 vaccine fact sheet.

Patients in the U.S. have the legal right to access medical care in their own language. Some might need a third-party interpreter on site.

“That’s an added dynamic,” Pietsch said, “and when you’re talking about a guardian, that makes it even more complicated.”

For kupuna able to make their own medical decisions, the process should go fairly smoothly. Pharmacies prefer written consent but in some cases will accept consent by phone or email or even verbally.

Campaigns are already underway to reach an estimated 10,000 kupuna in Hawaii long-term care facilities as part of the state’s tiered vaccine rollout plan. Another 109,000 people 75 and older who do not live in facilities are next in line. The rollout has been slower than officials had hoped and federal officials projected.

So far, approximately 35,000 doses have been administered to mostly medical workers, first responders and kupuna across the islands, according to the Hawaii Department of Health. The health department has yet to share details about who has received the vaccine as part of its goal to vaccinate hundreds of thousands of people by this summer.

Locally, more than 80% of the 315 COVID-19 related deaths in Hawaii have been among people older than 65.  Nationally, 40% of all COVID-19 related deaths in the U.S. occurred in nursing homes.

Due to the high-risk nature of congregate living settings, all of Hawaii’s nursing facilities have signed up to participate in vaccination clinics, with Walgreens and CVS taking on the bulk of logistics as federal partners, according to Patrick Harrison, the director of post-acute care at the Healthcare Association of Hawaii, a nonprofit trade association that represents local hospitals, skilled nursing facilities, assisted living facilities and home health agencies, among others.

At a retirement and assisted living facility called 15 Craigside earlier this month, staff from Walgreens helped to inoculate 375 people in two days. Another clinic will be held in February to dole out second doses.

But smaller care homes and other adult residential care homes are not included in the Walgreens/CVS federal rollout, so the state is partnering with other local pharmacies, including 5 Minute Pharmacy, Pharmacare, Times, Foodland, The Queen’s Medical Center and ELIX Rx pharmacies on Oahu. KTA Pharmacy will offer COVID-19 vaccines on the Big Island.

Some pharmacists will make home visits on Oahu and the Big Island, especially to bed-bound patients.

On other neighbor islands, kupuna will likely need to go to a vaccine site in person, Toma said.

No dates have been set yet for home visits on Oahu, but Big Island drive-thru clinics are set to begin next week, he said.

“With the hospital counts rising we do feel time pressure to get going,” he said.