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Rochester Regional Health

July 22, 2022 - 12:20pm
posted by Press Release in Rochester Regional Health, UMMC, urgent care, batavia, news.

Press release:

Rochester Regional Health has made the decision to close the Batavia Urgent Care at the Jerome Medical Center effective August 1, as it prepares to offer reimagined urgent care services in the Batavia Medical Campus on Oak Orchard Rd. opening next year.  Our community’s health and wellbeing is extremely important to us, so while that new four-story, 115,000-square-foot state-of-the-art building is under construction, RRH continues to offer urgent care services through primary care offices, telemedicine and at United Memorial Medical Center.

Every staff member from the Batavia Urgent Care is moving into another position within the RRH system while the organization works through the Urgent Care redesign.

“Rochester Regional Health and United Memorial envision a future healthcare model with many complimentary services under one roof that provide reliable high-quality care,” said United Memorial Medical Center President Dan Ireland.  “Existing demands for staff and resources require new thoughts on how to operate services like Urgent Care. Now is the time to reflect on the future of healthcare and thoughtfully redesign the model of care that will serve our community in the years to come.”

  • Primary care offices remain open, and providers aware of the changes ahead are prepared to see any patients with urgent needs 
  • RRH ExpressCare offers patients immediate, on-demand virtual appointments with providers through patients’ MyCare accounts.  https://www.rochesterregional.org/services/telemedicine
  • UMMC’s Emergency Department as always, is ready 24/7 to see any patients with true medical emergencies

In the coming days and weeks, patients will receive letters with more information and there will be new signs at the Batavia Urgent Care site about the changes.

The new Batavia Medical Campus building is slated to open in the Spring of 2023.

July 11, 2022 - 4:48pm

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Over the last six-plus years, plans — and hopes — for a new and improved Healthy Living campus have certainly been put to the test.

A zoning change, suggestions for less cement and more green space, lighting up Wiard Street and rethinking an entry/exit from Summit Street, plus the constant push to raise money for the $33.5 million project may have given pause but never a fullstop since 2016.

Officials and community members celebrated Monday what United Memorial Medical Center CEO Dan Ireland described as making “this vision a reality.”

Ireland and about 100 others gathered at 213 East Main St., Batavia, one of the parcels between Main and Bank Street that will be the future 78,000-square-foot facility.

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“This is a pivotal and historic day in our community’s health and wellness journey,” Ireland said. “We are breaking ground on an innovative, forward-thinking model of integrated health and wellness that will transform downtown Batavia. From a healthcare perspective, this facility and model of care that it represents will exemplify how healthcare can evolve to support the healthcare needs of the community today and for the next generations.”

“The Healthy Living Campus is the future of health care, where medical and wellness programs are integrated under one roof. It’s made possible through our community partnerships, and it’s helping patients get all the care they need and deserve in one place. 

He recalled the high level of effort it has taken during the past nearly seven years of planning, collaboration and diligent work to reach this point. He credited Rochester Regional Health’s staff teams, community partners, GLOW YMCA and “most importantly you” for arriving at the day shovels were symbolically plunged into the earth.

Not only was the event about a new facility, but also about an “innovative and integrated” system of what and how care is delivered. Meal planning, building healthy habits, assessing mental and physical health, and taking preventive measures for well-being are just some of the services to be offered.

Add in state-of-the-art exercise equipment, a new pool, an indoor track, a teaching kitchen, and an adventure room play area for children.

Top it off with 22 exam rooms and two medical procedure rooms for primary care, telemedicine appointments, behavioral health and crisis intervention support, cancer prevention, chronic illness, and community education services, and the site is a one-stop-shop for many health concerns and fitness goals, officials said. There will also be a drop-in childcare center.

“Today is not just a celebration of a new building or clinic, it’s the celebration of a community coming together to reimagine health and wellness of the future and transform our downtown," Ireland said. "It’s celebrating you and your friends and neighbors who have worked tirelessly over seven years to advocate, plan and collaborate to make this vision a reality. Without your voices, your ideas, your support, we would not be here today at this milestone. We are embarking on this exciting new chapter of health and wellness in Downtown Batavia.”

The project’s birth was a few city managers ago, when talk of an expanded Healthy Living campus at times seemed pie-in-the-sky for some. Seeing it finally come to fruition is “a big load off our minds,” City Council President Eugene Jankowski said.

“I’m excited to see this project begin,” he said. “There were a lot of setbacks, and it’s really easy to call it quits.”

He thanked all involved for remaining steadfast on the journey and “moving forward to positive outcomes” in the city’s future.

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Robert Walker, CEO of GLOW YMCA, remembered picking up the phone back then and becoming engaged in the concept. Almost seven years later, this plan “has truly changed the path of both organizations,” he said.

“Your leadership and support have impacted me tremendously,” he said.

He cited the YMCA’s mission statement: To develop the spiritual, mental, and physical wellness of all people in an atmosphere of Christian fellowship and thanked individual and collective community members for their determination to come together, strive for improvement, and see this project through.

“The GLOW YMCA and Rochester Regional Health Healthy Living Campus is a place for children, adults, and families from all walks of life in our community to come together and improve their lives — spirit, mind and body,” Walker said. “The state-of-the-art campus will not only be a benefit for the health of our residents, but also for the health of our local businesses, transforming downtown Batavia.”

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Perhaps equally notable to the support for the project is the timing now, in the midst of a post-pandemic, RRH CEO Dr. Richard Davis said.

We’re all about reimagining what healthcare can and must be in the 21st Century, we’re focusing on those strategic themes and talents of literally 20,000 of our team members … delivering the right care, in the right place, at the right time, to achieve the right health outcomes for the right value,” he said. “Healthy Living is a shining example of what truly is an innovative model.”

The strengths of two organizations — RRH and YMCA — are being brought together to offer the best of each one alone as an essential service to the city of Batavia, he said.

Officials also included Rob Rodriguez, NYS secretary of state, Senator Edward Rath III, Tom Houseknecht, on behalf of him and his wife Lynn, and Paul Battaglia, chairman of the YMCA Campaign Committee.

“I know when we started this quest in 2016 … many people thought this was an impossible dream. Now … this dream is coming true,” Battaglia said. “Today we’re not just celebrating the groundbreaking of a building, but celebrating the health of our community. This is a transformational project that is going to completely change the downtown area. It’s going to bring people downtown, create excitement and vitality that we believe will have a significant domino effect on the local businesses there. We could not be prouder of this relationship.”

The Healthy Living project was made possible with state, federal and community fundraiser monies, including an NYS economic development health care grant of $11.6 million, a $4.1 million Downtown Revitalization Initiative grant, and ongoing fundraising efforts by more than 50 GLOW YMCA and RRH volunteers.

Officials expect construction to be completed in 2023.

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Top photo: Officials take shovels in hand for the symbolic gesture during the Healthy Living campus groundbreaking ceremony Monday at 16 Bank St., Batavia. United Memorial Medical Center CEO Dan Ireland, Rob Walker, CEO of GLOW YMCA and Rochester Regional Health CEO Dr. Richard Davis say a few words during the event. Photos by Howard Owens. Renderings of the project provided by RRH.

June 24, 2022 - 8:08am
posted by Joanne Beck in news, Rochester Regional Health, UMMC Foundation, notify.

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For anyone in the vicinity of Centennial Park Thursday, you may have spotted a bunch of lemonade stands, correlating yellow decor and people enjoying the warm weather with a cool cup of lemonade. 

What you may not have noticed so readily was the fundraising taking place with each cup of beverage sold. The event, hosted by Rochester Regional Health and United Memorial Medical Center, was to raise money for baby swaddles. A goal was set to purchase 500 of the infant wraps to give to local moms. 

So why baby swaddles? What are they and why are they important enough to warrant a specific fundraiser? Over at the Healthy Living stand, registered nurse and maternal health educator Jay Balduf put it succinctly with a  two-digit number: 93.

“Ninety-three babies die annually in New York State alone, either by being rolled on by another person or loose bedding,” she said. “So that's why we promote the Safe Sleep initiative on the unit. Sacks play a role in teaching new parents, and any parent, really, about the importance of safe sleep. And it just helps us also to give back a little to the community, because most of these kids were probably delivered at UMMC.”

Baby swaddles and sacks are promoted for infants as a safe way to be in a crib and for sleep time. Other embellishments — pillows, blankets, clothing — can become a hazard if the baby gets entangled or covered with such material, said Linda Stoiber, an RN and lactation consultant.

“The hospital is a Baby-Friendly Hospital and a safe sleep designated hospital where babies are placed on their back. They are swaddled with these new swaddlers,” Stoiber said. “There should never be another blanket or a pillow, or anything around the crib, nothing else that would affect the baby then cover their face and cause them to suffocate.”

Megan Boring learned early on — with two Neonatal Intensive Care Unit babies of her own — the importance of making them feel safe, helping them to grow and be warm. A coordinator of Healthy Living’s MOMS (Medicaid Obstetrics Maternal Services)  program, she supports the belief that babies don’t belong on their bellies, she said, but more safely on their backs. Swaddling them keeps their arms tucked nicely inside, and it mimics a cocoon “as if they're sleeping still inside … the mom's womb,” she said.

“So the Safe Sleep initiative is really to help keep them on their back while they're sleeping,” she said. “I think there are moms that don't understand the importance of the swaddles. They can be expensive to some moms too. They are upwards of $25 to $30 and not all moms have. So I think that this fundraiser is important because it's going to help moms get at least one to have so that they can also be educated on safe sleep for their babies. (See related story, Lemonade stands bring out supporters, creativity and lots of yellow.)

For more information about Healthy Living programs, call (585) 344-5331 or go here.

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Top photo: Healthy Living's Baby Cafe staff Linda Stoiber, left, and MOMS program coordinator Megan Boring, hand out lemonade with information for anyone interested in baby swaddling, breastfeeding and other maternal-related issues Thursday during the Lemonade Stand fundraiser at Centennial Park. Above, Jay Balduf, Megan Boring and Linda Stoiber greet a visitor at the Healthy Living stand. Photos by Howard Owens.

 

 

June 24, 2022 - 8:00am

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Jason and Ashley Mlyniec and their two sons were some of the many people — adults and kids alike — sporting sunny yellow attire Thursday at Centennial Park.

The Batavia family had set up a table with a pitcher of lemonade and glass jars of lemon suckers and lemon puffballs. They definitely fit the theme of the inaugural lemonade stand fundraiser hosted by Rochester Regional Health and United Memorial Medical Center.

“We’re on the hospital foundation board,” Mrs. Mlyniec said. “This is for a good cause. We’ll do it again next year.”

Under the umbrella of RRH, each lemonade stand was created by individual families and groups that wanted to help raise money for the Swaddle Program. While one participant blew bubbles at her table, another stood behind a Charlie Brown-themed “the doctor is in” sign, and all of them had a special twist to their decor, including plenty of lemons.

The first-time event chairman was 10-year-old Patrick Casey, chosen for his prior involvement with fundraisers.

“I had some spare money, and I gave it to a fundraiser for the hospital, because it’s for a good cause,” he said. “If you’ve got some spare money lying around, give it to a good cause.”

Last year his mom, Lauren was talking with others about how to get young kids involved in the lemonade stand idea, and she in turn told Patrick about it.

“He thought it would be pretty fun to do for the summer,” she said.

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The Caseys — including the chairman's father Peter and sisters, Madelyn and Emily, who wanted to help out — weren’t certain how many glasses of lemonade they handed out. Though Patrick did have to make a run or two for some more cups. Overall, the experience has been “cool,” he said.

“Knowing that you made all this happen, and all these people coming here to raise money,” he said.

As for the money raised, it will go for the purchase of baby swaddles, Senior Development Officer Lori Aratari said.

“Working with the maternity department, we realized that we didn't have the funds to be able to purchase the baby swaddles. So I kind of put my thinking cap on and said what can we do that would interest the community and engage families to want to support purchasing the baby swaddles for every baby that's born?” she said. “We obviously want to make sure our babies are safe when we let them leave the hospital. We're hoping that this will become an annual event. And as you can see, folks are outdoing themselves with the variety of displays that they have to sell their lemonade, so it really was open to them to be creative.”

The goal was to raise $4,000 to buy 500 baby swaddles, and $3,600 had already been raised before the 5 p.m. start time through the hospital’s Just Giving online platform, Aratari said.(For more about the Baby Swaddle initiative, see related story, Tuck 'em in, keep 'em safe.) 

Photos by Howard Owens

Top photo: Patrick Casey, 10, this year's chairman of the first-time Lemonade Stands fundraiser for Rochester Regional Health and United Memorial Medical Center Foundation.

Second photo: The Casey family -- Patrick, Madelyn, Peter, Emily and Lauren -- enjoys working its stand Thursday at Centennial Park, Batavia. 

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Emerson Warner with lactation nurse Jay Balduf

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Marigrace Cummings pours a cool cup of lemonade for Rick and Jane Scott

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Maiy, Knox and Fae work at their lemonade stand

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Mercedes Houseknecht plays in bubbles.

April 30, 2022 - 5:50pm

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Parents may have questions now that Moderna has requested the emergency use of a COVID-19 vaccine for children under six years old.

Dr. Tracy Maier, a pediatrician with Rochester Regional Health’s Penn Fair Pediatric Group, has some answers, she says. Bottom line is that it could help, Maier said during a Zoom meeting with members of the media this week.

“It would be just one more implement in our defense against COVID,” she said. “Clearly, COVID is not going to go away, and we’ve proven that the best way to prevent the spread is to get vaccinated and to wear masks.”

“Traditionally, our population under age two has not been masking, so they are exposed, and our two- to five-year-olds are masking, if they tolerate it,” she said. “This is just one more line of defense against COVID.”

As many adults have experienced, masks, in general, have been dropped in lieu of getting vaccinations, loosened mandates and/or a belief that the imminent danger is gone. Though Genesee County’s data hasn’t exactly supported that notion. Latest statistics have shown an uptick in cases, with 168 new positive COVID-19 cases from April 13 to 19, and 278 cases from April 20 to 26. There have been a total of 185 deaths reported due to the virus as of April 25. 

Ages 0 to 19 had dipped from April 6 to 13 and then began to rise again toward the end of the month, coinciding with an increase of positives from the 60+ group, according to the Genesee Orleans Department of Health website. 

So does that mean that parents should line up to get their four-year-old a shot? Don’t just take Maier’s advice, she said. Have a talk with your child’s pediatrician. Ask questions, such as what are the benefits, the risks, and if there is anything parents should consider as unique to their child’s circumstances that make a vaccine more or less important to their health. 

Other questions may be what are the long-term effects? What difference will it make to my child with the vaccine versus not getting one, Maier said. For those in-between situations where, say, a child is under five and a parent is wondering whether to get the vaccine, “it depends on the circumstances,” she said. 

“If the child is at high risk because they have an underlying medical condition, I’d say let’s go ahead with this when it’s approved for your age group,” she said. “If not, I’d say, let’s wait until the age that we know when it’s effective.” 

Moderna’s request for emergency use, if approved, would make it the first vaccine for children under five. There are 18 million such children in the United States currently not eligible to receive a vaccine, she said. 

Despite lessened vigilance about wearing a mask, getting a vaccination “is still very important at this phase,” she said. 

“COVID is a virus, and we know from looking at other viruses (influenza) that viruses mutate and it’s going to mutate quickly,” she said. “And we know that vaccine is one of the greatest things that we have in our defense of this virus … to continue with our daily lives as usual. Once you are vaccinated, once you have been exposed and don’t have any symptoms, you can go on about your lives … children can still go to school, and they can still go to daycare (if no symptoms). It allows life to continue on as it normally would.”

This week Moderna, a biotechnology company pioneering “messenger RNA” therapeutics and vaccines, announced that it submitted a request for emergency use authorization for its COVID-19 vaccine in children six months to under two years, and two years to under six years of age. The request has been submitted to the U.S. Food and Drug Administration for approval. The FDA has 30 days for the approval process.

According to the Centers for Disease Control, if the FDA does approve the vaccine, it will continue to oversee its production to "ensure continuing safety." Monitoring of the vaccine and production, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.

Dr. Tracy Maier is a Doctor of Osteopathic Medicine at Penn Fair Pediatric Group in Penfield. 
 

April 30, 2022 - 12:03am
posted by Press Release in GCEDC, Rochester Regional Health, batavia, business, Health Care.

Press release:

The Genesee County Funding Corporation (GCFC), an affiliate of the Genesee County Economic Development Center (GCEDC), approved tax-exempt bonds to support projects by Rochester Regional Health (RRH) expanding healthcare services in Genesee County and throughout New York State at its April 28th board meeting.

The tax-exempt bonds approved by the GCFC support the construction of a 105,393 square-foot healthcare facility on Oak Orchard Road in the Town of Batavia and 56,147 square feet of related ground floor parking.

In Batavia, Rochester Regional Health will offer outpatient cardiac care, women’s health services, primary care, urgent care, outpatient surgical services, gastroenterology, outpatient radiology and other outpatient services.

The Batavia project is projected to create approximately 70 full-time equivalent jobs with an average salary of $110,000, and over 200 construction jobs.

In addition to new bonding, the project also includes improvements of machinery, equipment and other tangible personal property, the refunding or refinancing of all or a portion of the outstanding principal amounts of existing bonds, and the construction of a 96,189 square-foot healthcare facility in the town of Potsdam in St. Lawrence County.

The projects will generate over $172.6 million of economic benefits to Genesee County and other communities over 10 years, including $161.4 million of payroll for temporary and ongoing jobs, and $11.2 million of tax revenues.

April 21, 2022 - 8:50am

Updated: April 21, 4:30 p.m. with additional information about Laurie Oltramari nomination:

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The Genesee County Legislature, understanding that it has zero financial liability, is expected to pass a measure to allow the Genesee County Funding Corp. to secure up to $275 million in revenue bonds to finance a wide-reaching project of the Rochester Regional Health system.

The legislature’s Ways & Means Committee on Wednesday approved a resolution that describes RRH’s plan to finance or refinance capital improvement projects at several locations, including its new medical specialties building under construction on Route 98, north of the Thruway interchange in Batavia.

About $47 million in Series 2022 Bonds will be used for the “Batavia project:”

  • Construction of an approximately 105,393 square-foot medical facility on Route 98 that will house extension sites of three RRH affiliate hospitals to be used for outpatient cardiac care, women's health services, primary care, urgent care, outpatient surgical services, gastroenterology, outpatient radiology and other outpatient services;
  • Construction of approximately 56,147 square feet of related ground floor parking, and the acquisition and installation of machinery, equipment and other personal property.

A formal vote of the full legislature likely will take place at next Wednesday’s meeting at the Old Courthouse.

Last month, representatives of the Genesee County Economic Development Center proposed the idea of using the GCFC to act as a conduit bond issuer for RRH. Subsequently, the legislature voted to change the entity’s bylaws to allow for projects outside of the county as long as the business had operations in Genesee County.

RRH fits the bill as its network of hospitals and offices stretches across the state. According to the resolution passed yesterday, other capital improvement projects to utilize this round of funding will take place in the City of Rochester, Town of Potsdam, Town of Pittsford, Town of Penfield, Town of Canton and Town of Massena.

Before supporting this action, Ways & Means Chair Marianne Clattenburg asked for assurance that Genesee County bears no fiscal responsibility in the transaction. The premise of the resolution is that RRH would be able to issue bonds at a reduced interest rate by going through the GCFC.

“I support this as Rochester Regional Health has made a commitment to the county,” Clattenburg said. “It’s hard to get doctors to work in rural communities.”

In other action, the committee approved:

  • An application for a New York State Office of Community Renewal Community Development Block Grant of up to $750,000 to support La Fermiere Inc.’s plans to develop a yogurt and dessert production facility at the Genesee Valley Agri-Business Park on East Main Street Road in the Town of Batavia.

Per the resolution, the project will create 135 new jobs and represents a private investment of more than $20 million. If received, the grant would help finance part of the costs of machinery and equipment, including furnishing and fixtures, as well as working capital expenses.

  • The appointment of Robert Sotir of Batavia, organizer for the Bricklayers and Allied Craftworkers Local 3 NY, to the GLOW Workforce Development Board for a term at the discretion of the GLOW chief executive officers.

GOVERNOR NOMINATES OLTRAMARI

It also was announced that Gov. Kathy Hochul has nominated Laurie Oltramari of Batavia to serve as a representative on the Rochester-Genesee Transportation Authority board for a term of six years.

Contacted today, Oltramari, senior library clerk at Genesee Community College, said she initially was nominated by the Genesee County Legislature and went through "a lengthy process of submitting documentation and answering questions in terms of financial disclosures, conflict of interest, background check, public officers law, and board duties."

"I received notification yesterday that I was nominated by the governor to the Senate. I am now awaiting my Senate confirmation," said Oltramari, who previously served as executive director of the Downtown Batavia Business Improvement District.

April 12, 2022 - 7:27pm
posted by Howard B. Owens in Rochester Regional Health, COVID-19, news, notify.

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While the omicron variant of SARS-CoV-2 carries with it less risk of a serious sickness, it still is a dangerous and sometimes deadly disease, and children should be protected from it, said Dr. Steven Schulz, RRH pediatrician and medical director of RRH Pediatrics in Monroe County.

The same appears to hold true, so far, for the B2 variant of omicron.

Rochester Regional Health via Zoom hosted a press conference today for reporters from throughout the region. It was pegged to a recent study published by the American Medical Association that found that the omicron variant is six to eight times more likely to lead to infections for children less than five years old but resulted, percentage-wise, in fewer hospitalizations.

Still, with nearly two percent of infected children dying as a result of an omicron-variant COVID infection, the disease remains far more deadly than the flu.

Schultz said that based on the most recent CDC numbers he's seen, 1,300 children in the U.S. have died from COVID over the past two years.  

"If we divide that in half, that's still way, way worse than any flu season we've had in recent history," Schultz said. "You hate to ever think that your child would be the one who would have the severe complication or the severe outcome, but it does happen and kids have died and do die from COVID."

Because omicron -- and so far B2 -- is more contagious, more children under age five are getting sick but because the variants do not seem to cause as many severe outcomes, area hospitals are not seeing many young children in the hospital. 

"Kids were less likely to need to go to the ER, to be hospitalized, end up in ICU, or on mechanical ventilation in this zero to five group compared to the delta," Schultz said. "That's certainly reassuring but it also doesn't mean that it's risk-free to get omicron, especially in this age group. We definitely know that we saw kids throughout that time ending up in the hospital, even though the odds might have been a little bit less compared to delta, because more kids were getting infected, we definitely still saw lots of kids in the hospitals."

It's not just immune-compromised kids, or children with other health issues, who are getting hospitalized and dying from COVID, Schultz said.  Healthy children are at risk, too.

The good news, Schultz said, is that we have a safe and effective vaccine -- the Phizer vaccine -- available to children over the age of five. 

"We know that vaccination is still the most effective way to keep children safe," Schultz said. "The COVID vaccine is safe. It's effective. It significantly reduces the chances of ending up in the hospital. So anybody who has children five years of age and up, I definitely encourage getting the COVID vaccine right now."

Since children under age five cannot be vaccinated, the best way to protect them, Schultz said, is for everybody in a household over age five to get vaccinated.

"You're protecting the younger child as well," Schultz said. "The other thing that we know, with all of this, of course, is still that masking and social distancing works. And it's not a coincidence that, since the mask mandate has been removed in early March, we're suddenly seeing increasing rates of COVID as well as influenza. There's, there's no question about it."

He noted that the positivity rate for COVID tests in the region has jumped from a recent low of three percent to 10 percent.  That's no coincidence, he said, and tied directly to the lifting of mask mandates.

Schultz has a young son who wears a mask to school every day.  Not only does it provide an extra layer of defense for him, Schultz said, it also helps other children in the school.  There are children in his class who have moderate to severe immunosuppression.  

"I completely agree that it's a greater good for the community as a whole to wear masks," Schultz said.

He disagrees with those who say masks harm children's interpersonal development.

"There have been lots of studies that actually show that it's not the case, that kids are still able to read facial expressions, that kids are still learning those interactions," Schultz said.

The other way to protect children, and others,, Schultz noted, is for parents of symptomatic young ones is to keep them home.

"There's not really any way to tell COVID from any other viral illness, based on symptoms alone," Schultz said. "A runny nose, congestion, cough, fever, even GI symptoms, they can happen with a variety of viral illnesses. Sometimes we can test to name those viruses, whether it's COVID, whether it's flu, but sometimes it's one of the other of hundreds of viruses that are out there. So if there's a suspicion or a question, especially if you have a child going to school, or daycare, or a large family gathering coming up, where there's a higher risk of transmission between people, it's really important to have your child seen and evaluated by a healthcare provider to make sure that it's not COVID In those situations."

March 16, 2022 - 7:54pm

Officials of the Genesee County Economic Development Center are asking Genesee County legislators to consider expanding the “jurisdictional reach” of a locally controlled funding unit to facilitate $218 million in bond funds for Rochester Regional Health’s expansion projects.

Speaking at the legislature’s Ways & Means Committee meeting this afternoon at the Old County Courthouse, GCEDC President Steve Hyde encouraged passage of a resolution that would permit the Genesee County Funding Corp. to act as a conduit bond issuer for a business enterprise – either for-profit or not-for-profit – located in Genesee County that has operations directly or through affiliated entities in other counties in New York State.

The resolution, which was passed by the committee and forwarded to the full legislature, calls for an expansion of the “mission and public objective” of the GCFC to promote economic development and expand the jurisdictional reach by making the GCFC eligible to issue bonds for projects outside of Genesee County.

If passed, Rochester Regional Health, which operates United Memorial Medical Center in Batavia along with health care facilities in other counties, would be the beneficiary of the amendment to the GCFC’s current certificate of incorporation.

Hyde said that RRH is planning to invest $42 million in Batavia, primarily on the construction of a 105,000-square-foot medical center off Route 98, north of the city, and another $50 million or so on an expansion in Potsdam (St. Lawrence County).

“That’s almost $100 million in new money plus they are refinancing existing debt,” he said, pointing out that the issuance of the bond through GCFC would enable RRH to get a tax-exempt corporation interest rate instead of a taxable rate. “If not, they would have to seek multiple bonds in a number of communities and the fees would be much higher.”

He said RRH leadership approached the GCEDC “to use our GCFC, which is a county affiliate that we manage on your (the legislature’s) behalf.” The GCFC board consists of five members, all appointed by the legislature.

Mark Masse, GCEDC senior vice president of operations, said Genesee County has seen tremendous growth of companies with locations in other counties.

“This won’t affect the county’s bond rating,” he said. “It is similar to a PILOT (payment in lieu of taxes) with no risk to the county.”

Hyde said RRH is focusing on the adaptive reuse of its North Street and Bank Street campuses, including expanding senior health care at the Jerome Center and possible razing a couple buildings on North Street because parking is an issue.

“And there will be more specialties at the new medical center, such as cardiac care and surgical (improvements),” he said.

Should the legislature vote in favor of the resolution, it would not change the fact that every project connected to the GCFC would have to be approved by the governing body and a public hearing would have to be held for tax exempt circumstances, Masse said.

County Attorney James Wujcik said the resolution’s wording was appropriate, adding that the expansion of the GCFC territory “makes Genesee County more attractive for investment.”

February 3, 2022 - 8:00am
posted by Joanne Beck in news, UMMC, Rochester Regional Health, batavia, COVID-19.

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For nearly two decades Sandy Lloyd had worked at a bank before getting laid off in the midst of COVID-19. 

So she reassessed her life and took note of news reports that healthcare workers were walking off the job due to vaccine mandates.

“I wasn’t enjoying my job anymore… sitting at a desk every day,” she said, turning to the news reports. “They were losing a lot of people due to that. I thought ‘I need a job, they need people, let’s try it.’ I don’t think I would have ever pursued it if there hadn’t been a pandemic.”

Lloyd, a Corfu resident, began her new career on Dec. 6 of last year. While it may be only two months later, she has already embraced her new vocation at United Memorial Medical Center in Batavia. She admits to the many hours and long shifts but has discovered that there’s more to the working world than banking. Her formal title is clinical nursing assistant, and the job duties are a catch-all for those in need: in need of a beverage or meal, new bedding, personal hygiene assistance, a delivery to the lab, and the like.

“I’m on the third floor … I wait on everybody, get them water, pass out food trays, assist the nurses. It’s on-the-job training,” she said. “I look at the patient as a customer; it’s using customer service skills. Just being there and doing what they ask is the number one priority.”

Lloyd has merely shifted her former training and experience to focus on patients that are recovering from surgery versus bank customers cashing a check. Working with many registered and licensed practical nurses, she’s been told that she’s a “natural” in her new field. That encouragement coupled with her own enthusiasm has prompted the 41-year-old to attend nursing school in the near future.

Lloyd’s sister Dustin Miller is a nurse, and she forewarned Lloyd that it’s a tough job, while her mom seemed incredulous that her other daughter was also going into the field. The only ones not taking her new passion so well are Lloyd’s sons Bryce, 7, and 10-year-old Brody, she said. 

“They were a little upset because I work a lot of hours,” she said. “They miss their mama now.”

She works every other weekend, and the boys periodically spend time with their grandparents, “Nana” Janet and “Grumpy” Chris. Lloyd’s free time is spent playing with her sons and sleeping, she said. “We balance it all out,” she said. 

She was initially hired for a 7 a.m. to 3 p.m. time slot, and that has evolved into 12- to 16-hour shifts because she volunteers to take on extra hours, she said. Despite the potential issues due to COVID-19, she took all of the possible precautions for her and her family, including being vaccinated,  getting the booster shot, wearing a mask, and, per hospital routine, doing “a lot of hand washing.”

Other than that, it was full speed ahead.

“I just ran into it,” she said. “I can’t deny these people care because of worry about COVID. Every day is humor for me; I do something stupid to make people laugh. We all try to laugh during the day.”

Lloyd is often on the job when patients go into surgery and then later when they are recovering, which makes them ask if she ever goes home. “Yes, when you were sleeping,” she tells them. She hasn’t reconsidered her former employment and encourages others to try the healthcare field if they’re looking for a change. Her co-workers are a team working toward a common goal, she said.

Rochester Regional Health took a major loss of employees after the New York State Department of Health issued a vaccine mandate for healthcare workers. The mandate went into effect on Sept. 27, 2021. Although “many were granted religious exemptions” initially, those exemptions were overturned and all employees were required to get their first dose by Nov. 22, a Rochester Regional Health spokeswoman said.

As a result, there were approximately 350 employees in the Rochester and St. Lawrence regions “who made the personal choice to decline vaccinations and leave our health system,” the spokeswoman said. “The employees represent approximately 200 full-time equivalents.”

The void left by those workers made for many vacancies and related news stories, which in turn opened a door for Lloyd.

“I actually enjoy the job. I’m constantly learning and doing something new every day,” she said. “It really does make a difference.”

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Top photo: Sandy Lloyd of Corfu works in her new job as a clinical nursing assistant at United Memorial Medical Center in Batavia. Lloyd is pictured here with her sons Brody, middle, and Bryce. Above, Lloyd works her shift helping outpatients and nurses at UMMC. Photos top and above submitted by Rochester Regional Health, and family photo submitted by Sandy Lloyd.



 

January 13, 2022 - 11:31pm
Video Sponsor

Of all the debatable data out there regarding COVID-19, one piece about local hospitalizations is irrefutable, Dan Ireland says.

United Memorial Medical Center’s occupancy rate is at 86 percent, and 100 percent of patients admitted to the Intensive Care Unit have been unvaccinated, said Ireland, Rochester Regional Health/UMMC president, during a live-streamed health discussion Thursday. 

“Seventy-five percent of COVID admissions are unvaccinated people,” he said. “The data is clear, unvaccinated folks are suffering (from COVID symptoms and illness).”

Another statistic to note is that 100 percent of people put on ventilators were also unvaccinated, he said. Though there are various other reasons for someone being admitted to the hospital, 70 percent of them went to the hospital for COVID-19 symptoms and concerns, he said.  It was a set of coronavirus symptoms that drove them to visit the hospital, he said. 

Although some vaccinated people are experiencing break-through cases, the symptoms have not been as severe, he and Genesee and Orleans County Health Director Paul Pettit said. 

“Please, please, please get your vaccine,” Ireland said. 

Not only is that step important for protecting the health of individuals and families, it helps to free up space at the hospital, he said, citing 36 percent of the entire hospital population is attributed to COVID-19. People are still seeking health care treatments for other causes, and it’s “our job to strike that balance” between the needs of those with the COVID virus and more traditional healthcare that is needed.

Those traditional healthcare services remain open at RRH hospitals, which include elective surgeries. Those surgeries held a 90 percent occupancy rate in 
December. Ireland said that, more recently, those surgeries will still occur, but on “a much more limited basis.”

“Surgery is not closed, we’re just limiting it to limit the exposure to patients,” he said. 

The whole region is focused on restricting elective surgeries to essential only, per health department guidelines, he said, however, facilities in nearby counties have taken patients when necessary. 

There will be public announcements to inform the community of changes that may occur, such as particular hospital offices needing to close due to staffing shortages or exposure concerns, and where patients may be able to go instead. Overall, hospital staff “has done an amazing job at accommodating them at other locations,” Ireland said. 

As of Tuesday, a new visitor policy restricts hours for a 9 a.m. to 1 p.m. and 3 to 7 p.m. daily visitor schedule. Everyone will be screened, information is to be captured for potential contact tracing and visitors cannot see patients with COVID-19 or other immunity compromised patients. 

“Just be aware, if you have a loved one in the hospital, if a screener advises you of a new policy, it’s because of updated responses.”

As for those colorful and rhinestone-covered cloth masks, the latest data shows, especially in the light of the recent spread of the SARS-2-CoV variant known as Omicron, that they are not as effective as medical masks. The Hospital administration has issued a “no cloth masks” order in lieu of medical, tighter-fitting masks, such as KN95. Hospital visitors without such masks will be given one by staff, he said.

“It’s very important to protect yourself; wearing that mask is a barrier. Is it full-proof? No. But we do know it’s a barrier (to the virus),” he said. 

Ireland said that, of course, people want to get out and enjoy activities away from their homes. They can do that, but there are tools in place to protect people to have fun “safely and effectively,” he said. 

“Have some self-awareness and some self-driven compliance,” he said of wearing masks, testing when necessary, and isolating and/or quarantining if positive for the virus or exposed to someone else who is positive. Journalists participating in the event asked about the safety of student-athletes, the target number for vaccinations, and the future. 

Student-athletes are being tested based on the same protocols as other students, Pettit said.

New York State set a target vaccination rate of 70 percent, and “we’re above that number now as a whole,” he said. People who are most recently getting the vaccine seem to be doing so based on external events, such as a family member getting sick or dying from COVID-19, or mandates requiring a vaccine for certain types of travel, he said. 

And for those on the fence? His department staff is working to answer questions and provide information to anyone not yet vaccinated. 

“We’re really trying to talk to those folks who are undecided,” he said. ”Based on the data, the vaccine is very effective; it does keep people from having the severity of the disease, and it keeps them out of the ICU and off ventilators. We’re hoping these folks will make the decision at some point in the very near future.”

Genesee County has experienced a “very sharp increase” in positive cases, especially in congregate settings, such as nursing homes, he said. There have been a total of 12,105 positive cases and 164 deaths from the COVID-19 virus since the onset of the pandemic. Out of that number, 1,509 cases were in the month of December compared to 2,118 in just the first 10 days of January, he said. 

He wanted to clarify case investigations, which are conducted for confirmed cases by obtaining the person’s name, address, symptoms, date of onset, close contacts and that person’s history during the prior 48 hours, versus contact tracing, which takes the process “a little bit further” by trying to identify people who were exposed to a confirmed case of the virus and establish if those people are isolating (if found to also be positive) or quarantining due to being exposed to the person found to be positive. 

Case investigations are not changing, he said. However, due to the massive numbers of positive cases multiplied each by an estimated five to 10 exposures, it’s likely the health department may not be able to follow up on all of those cases, he said.

Genesee County Legislator Rochelle Stein reminded folks that everyone can take a part in keeping the community safe.

“Vaccinate and get the booster when you are eligible, she said. “Mask when in public places, test when you feel ill, and then stay home. These are the simple ones today.”

For further information, watch the video and/or go to GOHealthNY.org

December 7, 2021 - 4:30pm
posted by Howard B. Owens in UMMC, Rochester Regional Health, news.

Press release:

Rochester Regional Health will postpone all non-essential elective inpatient, 23 hour and same-day elective hospital surgeries and procedures for at least two weeks at Rochester General Hospital and Unity Hospital, effective Thursday, December 9. This non-essential inpatient elective surgery postponement at Rochester General and Unity is in compliance with newly released guidance from the NYS DOH. Newark-Wayne Community Hospital is not on the NYS DOH “impacted facility” list; however, Rochester Regional has proactively decided to suspend inpatient elective surgeries there this week. At this time, Clifton Springs Hospital & Clinic, United Memorial Medical Center, office-based procedures, and ambulatory surgery centers are not impacted. We are actively communicating with impacted patients and hope to resume inpatient surgeries at Rochester General and Unity as soon as it’s possible. As the area enters the third wave of this pandemic, Rochester Regional remains deeply committed to caring for the community. Patients should not delay necessary care at this time.

December 2, 2021 - 7:09pm
posted by Press Release in business, Rochester Regional Health.

Press Release from Rochester Regional Health:

Rochester Regional Health announced that its Board of Directors selected Richard "Chip" Davis, Ph.D., as the next CEO. Dr. Davis will assume his new role on March 7, 2022

The Board initiated a comprehensive national search after Eric Bieber, MD, announced his retirement more than six months ago. An internal selection committee was led by David Riedman, Chair, CEO Search Committee. The committee comprised of board members, medical and dental staff, and leadership, conducted a rigorous and inclusive interview process.

"It was clear during our interview with Dr. Davis that he has an unwavering commitment to patient safety and quality. Those qualities, along with his passion for innovation and his more than 25 years of work in complex healthcare environments, make him a great fit for Rochester Regional Health," said Michael Nuccitelli, Board Chair, Rochester Regional Health. "As a seasoned executive, Dr. Davis brings not only extensive experience but a new and energizing vision to Rochester Regional."

Dr. Davis' responsibilities as a CEO at Henry Ford include providing strategic leadership and direction over the clinical operations of the market and leading new clinical, academic, and commercial partnerships. He works closely with clinical and service line leaders to enhance coordination between primary care networks and specialty services. He has oversight of more than 100 care delivery locations, including two hospitals (totaling 1,240 beds) and over $2.5 billion in net patient revenue. Henry Ford Hospital has one of the country's largest post-graduate medical education programs with over 1,000 medical students, 517 residents, 165 fellows, and 900 nursing students. 

While at Henry Ford, Dr. Davis led an initiative to create a state-of-the-art Health System Central Command Center to coordinate transfers, admissions, and discharges across all hospital facilities. He was also instrumental in helping to broker a 30-year definitive agreement for Michigan State University to become the main academic partner for the health system and worked on the team to implement the first Hospital-at-Home program in the state of Michigan. Under his leadership the market made significant improvements in key inpatient and outpatient quality indicators.

"I am very excited to become the next CEO at Rochester Regional Health and look forward to working with all team members, the provider community, and patients and family members to continue the legacy of excellence during these challenging times," said Dr. Davis.

Prior to joining Henry Ford, Dr. Davis spent more than 25 years with Johns Hopkins Medicine (JHM) in various positions, most recently as President and CEO of Sibley Memorial Hospital, a not-for-profit hospital in Washington, DC. At Sibley, he established an Innovation Hub, the first-of-its-kind healthcare improvement accelerator in a community hospital. Dr. Davis was also the Vice President of Innovation and Patient Safety for JHM, ran ambulatory operations, and led several transformational efforts for the academic medical system. He was on faculty at The Johns Hopkins School of Medicine, School of Public Health, and Business School.

Dr. Davis received his Ph.D. in Public Health from Johns Hopkins University. He also has a Master's degree in Counseling and Consulting Psychology from Harvard University and a Bachelor's degree in Psychology from the University of Michigan. Dr. Davis returns to New York with his wife, Morgan Adessa, DAc. He has three adult children - Kylie, Dana and Will.

Rochester Regional's current President and CEO, Eric Bieber, MD, will retire from the health system on December 31, 2021.

  A native of the Finger Lakes, Dr. Davis comes to Rochester Regional Health from the Henry Ford Health System in Detroit, Michigan, where he currently serves as    Senior Vice President and CEO of Henry Ford Health System's South Market and Henry Ford Hospital. With more than 33,000 employees, Henry Ford Health System is the fifth-largest employer in metro Detroit and among the most diverse.
November 29, 2021 - 12:06pm

lesho.jpgOmicron B.1.1.529 -- a new and rapidly changing variant of the coronavirus that just this month was first identified by scientists in South Africa -- probably has found its way to the United States and should be considered as highly transmissible.

That's the opinion of Dr. Emil P. Lesho (photo at right), an Infectious Disease specialist with Rochester Regional Health, who addressed the media this morning via Zoom.

When asked about Omicron's impact in the Finger Lakes Region, Lesho said it's a bit early to tell, but "the quick answer is … it's likely in the United States."

"At last count, it was reported in 13 different countries, including Canada. So, it was first detected in South Africa … that doesn't necessarily mean that's where it originated, that's where it was detected first," he said.                                                                        

Noting that the variant has been linked to travel, he said the detection process "requires advanced whole genome sequencing (and) most hospital labs in the United States can do that technology."

"Specimens have to be collected first, then they have to be prepared, then they have to be sent to a special sequencing laboratory," he said. "So, that takes time. But as we speak, Rochester Regional is looking for this variant. We have our laboratories collecting samples and preparing them in the way I just described."

In the United States, public health officials believe that early evidence indicates an increased risk of reinfection with Omicron as compared to other variants, such as Delta. In fact, the Biden administration has placed a travel ban from South Africa and seven neighboring countries duo to this variant.

Lesho, when asked what doctors and researchers know about Omicron, said there's "a lot that we don't know."

"And, some of what myself and what anybody says today can be changed tomorrow; we're learning more and more every day."

He said Omicron has been labeled "a variant of concern," which is the highest classification of variants on the books at this time. Others are variants of interest and variants of high consequence, but as of now, no variants of high consequence have been identified.

"What we know about this Omicron -- why it's labeled a variant of concern is because of the number of changes that it has undergone, and in the rate that it had accumulated these changes; the speed at which these changes occurred," he offered. "That's what kind of surprised scientists and laboratorians."

Lesho said this one appears to be more transmissible in light of nearly 50 changes in this virus compared to preceding strains.

"It’s those number of changes or those mutations, that that are of concern. Additionally, it's where those mutations occur. So, this whole genome sequencing that I mentioned looks at the entire genetic makeup of an organism. And so that enables us to look at which parts of it have these changes," he said. "Of those 50 changes, maybe 30 or so are in the area that the vaccine uses to instruct our bodies to make the protective antibodies. So that's why it's concerning."

In any event, the doctor said that getting vaccinated -- including the booster shot at least six months after the primary series -- "still, is the best way we can protect ourselves ..."

Other points addressed by Lesho today are as follows:

VACCINATION AND VARIANTS

While vaccines provide the most protection -- apart from natural immunity from having the virus plus vaccination -- Lesho said vaccination rates globally are relatively low.

"Not many countries have been as fortunate as developed countries, such as Israel, United States ... United Kingdom," he said. "Countries in Africa have vaccination rates as low as 20 percent ... and there's potentially only 70 percent of the people in the United States that are vaccinated.

"So, what they're learning is when they talk about herd immunity -- when you get through about 70 percent of the population being immune to help the epidemic or the pandemic stop spreading, maybe we're seeing with these higher transmissible variants like Delta and this one, it may be more upwards of 80 or 85 percent, Still, the way we can prevent these new mutations and these new variants from emerging is to get as many people in the population as immune as possible."

AS WINTER APPROACHES

Lesho had a sobering message as the cold and flu season arrives and as COVID-19 cases increase: "Well, what we can expect is, unfortunately, increased fatalities."

"We are already seeing increased number of patients in the hospital and also in the ICU. And on ventilators now. So we've been seeing that unfortunate uptick for a few weeks now. So, generally, two weeks after that you have more seriousness of infections, then you start to see the fatalities. So, I think in the next couple of weeks, we'll see some fatalities."

He said that eight or nine out of 10 patients with severe risk of infections were unvaccinated.

"Now, we're seeing some breakthrough (those previously vaccinated) infections there. For the most part, for the vast majority of the breakthrough infections are not as severe as the infections in the unvaccinated. So, we can also expect more cases as people go indoors, and they gather. And then as people go to holiday gatherings."

LEVEL OF OMICRON SYMPTOMS

Lesho said Omicron symptoms are similar to previous variants.

"If you're fully vaccinated or you got an infection and then you got vaccinated, you might have very minimal symptoms and you might test positive for various reasons," he said, "So, but you could have -- it starts out typically as a loss of taste plus smell and like a fever, nausea ... COVID can present in many different ways. It can present as a gastrointestinal illness or a respiratory illness. So, the typical symptoms of the prior strains are what we expect this to present as well."

Photo courtesy of WHEC-TV.

September 30, 2021 - 4:52pm

mayoexec_1.pngThe chief medical officer at Rochester Regional Health today said that due to nursing home admission limitations as many as 80 patients who are ready to be transferred to long-term care facilities or rehabilitation centers are stuck in the system’s hospitals.

“There are, on any given day, in our … hospitals, a combined 60 to 80 patients in this category,” Dr. Rob Mayo said. “So, it is a considerable number.”

RRH is an integrated health care system with nine member hospitals, including United Memorial Medical Center in Batavia.

Mayo (photo at right) took part in a video press conference with Adam Bello, Monroe County executive; Dr. Michael Mendoza, Monroe County commissioner of public health, and Dr. Michael J. Apostolakos, chief medical officer at University of Rochester Medical Center Strong Memorial and Highland Hospitals.

The session focused on the vaccine mandate imposed upon health care workers by Gov. Kathy Hochul and its effect on staffing at hospitals and nursing homes, as well as the situation in schools and delays in receiving care at hospital emergency rooms.

Mayo said RRH is working with the other health systems and community partners to alleviate the hospital-to-nursing-home logjam.

“What we do is continue to care for them, and we continue to look for options,” he said. “We work with our partner home care agencies … but, by and large, it is a challenge to do this.”

All three doctors emphasized that employee vaccination rates at their hospitals are very high – up to 99 percent at RRH and URMC locations – but acknowledged that lower levels at nursing homes are causing significant problems.

“Among nursing home staff not all staff fit into the same categories,” Mendoza offered. “When you look at the positions, the nurse practitioners who work in the nursing homes, the vaccination rate is like among other positions – upwards of 99 percent.

“What we’re seeing among other staff, particularly the nurse aides and CNAs (Certified Nursing Assistants) and so forth, their vaccination rate more appropriately parallels the demographic from which they are representing. So, if many live in the city (of Rochester), their vaccination rate as a population is roughly the same as the vaccination rate that we’re seeing in the city.”

Mendoza called it “an absolute concern … that represents a disparity in care and health access that we’ve been seeing all across this pandemic. It is a very important problem.”

He said nursing homes are limiting the number of admissions from the hospitals in order to “keep appropriate ratios in place.”

“Right now, unfortunately for the rest of the health care system, they’ve decreased their admissions, which is creating a bottleneck, if you will, across the entire system.”

Apostolakos said the nursing home issue has resulted in the inability to transfer 55 patients in the URMC system – almost 10 percent of its inpatient capacity.

“… those patients are still taking up acute care beds in our acute care hospital,” he said. “It is causing a significant percentage of our beds to be taken up and, therefore, making it more difficult to get patients through the emergency room and into our hospital, and to accept transfers into our facility.”

 HIGH PERCENTAGE ARE VACCINATED

Mayo said that as of Monday, more than 99 percent of RRH employees are vaccinated, with less than 1 percent placed on administrative leave because of their unvaccinated status. He also said that a small percentage requested religious or medical exemptions – and those were granted in compliance with New York State regulations.

Those employees who do not qualify for an exemption and refuse to get vaccinated will be terminated sometime in the morning of Oct. 3 (this Sunday), he reported.

“Despite the successes with this vaccination mandate and regulation, we do have understaffed areas,” he said. “Many people are working overtime. We have patients in our hospitals awaiting discharge and we pleased to participate in a community-wide effort to create solutions for hospitals and for nursing homes … so we can all move patients into their appropriate environments as quickly as possible.”

He also said RRH is participating in efforts to managing strains on pediatric practices and the impact of COVID in schools.

Apostolakos said that more than 96 percent of URMC employees have been vaccinated, another 3 percent received religious exemptions and less than 1 percent elected to resign their positions.

“The not so good news,” he said, is the increasing number of COVID cases.

Sixty-nine patients at Strong have COVID, with 15 of those on a ventilator, he said, and another 84 are at other URMC facilities.

“That number continues to increase,” he said, adding that most of those patients are unvaccinated.

He pleaded with the community “to get vaccinated for yourself, for your family, for your community and for our health care workers that have been under stress and strain for the past 18 months.”

Bello said 93.8 percent of workers at Monroe County Hospital are vaccinated, with 61 employees not vaccinated, seven receiving exemptions and one who has resigned.

He said the unvaccinated workers have been placed on unpaid administrative leave for three months, but would be welcomed back if fully vaccinated.

The county executive said employees are working under stressful conditions and that he was disheartened to see people protesting in front of hospitals.

“The patients inside are sick; they’re seeking care. The health care providers are working long hours, under considerable stress. Neither patients nor health care workers deserve the disdain and anger that’s being targeted towards them and where they work,” he said.

MENDOZA: STUDENT ILLNESS INCREASES

Mendoza spoke about situation in schools, noting that they are seeing an unseasonal increase in Respiratory Syncytial Virus or RSV, which causes mild symptoms in school age kids but can be serious for infants, toddlers and older adults.

Also, a growing number of school age children who have contracted COVID-19, he said.

Per state Department of Health guidelines, the only authorized tests are the NAT and PCR tests, he said, and not the rapid antigen tests due to Monroe County’s “high” transmission status.

He said health officials are working with schools to increase testing capabilities, a procedure that is also taking place in Genesee County.

“Do not send your sick children to school. Make sure they are properly masking and follow all of the other safety protocols in place … and if they are eligible, please get them vaccinated,” he said.

EXPECT DELAYS IN THE EMERGENCY ROOM

Both Apostolakos and Mayo said that for the immediate future, delays in the emergency rooms, waiting rooms and even some urgent care centers are inevitable.

The emergency department has a triage process, with priority is given to patients depending upon severity of illness or injury, Apostolakos said, “so the wait could be several hours.”

“We encourage our patients to call their primary care providers to seek health care at urgent care if their illness is less severe,” he advised.

He also said URMC is pausing temporarily some elective surgeries where hospital stays are necessary to ensure there is enough space for patients admitted with COVID and other non-COVID illnesses.

Mayo said RRH emergency rooms and urgent care facilities have been crowded over the last couple weeks.

“It’s disappointing to acknowledge … but waits in our emergency rooms can be long; they can be several hours,” he said.

Many outpatient services have been unaffected, he said, but RRH hospitals are limiting some elective surgeries, primarily at Rochester General Hospital.

September 30, 2021 - 12:11pm
posted by Mike Pettinella in news, notify, Gov. Kathy Hochul, UMMC, Rochester Regional Health.

Vaccination rates for United Memorial Medical Center employees are right around the 90 percent mark as hospitals and other facilities around the state contend with Gov. Kathy Hochul’s Sept. 27th mandate requiring health care workers to get vaccinated or risk losing their jobs.

According to statistics on the New York State COVID-19 vaccine website -- www.covid19vaccine.health.ny.gov, 94 percent of workers at UMMC’s Bank Street campus have been vaccinated compared to 89 percent at UMMC’s North Street campus.

UMMC is part of Rochester Regional Health System, which is showing a 90 percent vaccination rate for all of its employees – a percentage point less than data for Strong Memorial Hospital University of Rochester Medical Center.

(Watch for an update later today).

The percentage of hospital workers vaccinated in the Finger Lakes Region is 90 percent, with Genesee and Orleans counties at 89 and Wyoming County at 90.

These figures are calculated from the number of hospital staff eligible for vaccination and the number completing the recommended series of a given COVID-19 vaccine product (e.g. 2 doses of the 2-dose Pfizer or Moderna vaccine or 1-dose of the 1-dose Johnson & Johnson vaccine), per the state website.

Statistics for nursing homes and assisted living facilities reveal the following for Genesee County (as reported by the individual facilities as of Sept. 27):

Nursing homes:

  • Le Roy Village Green – Residents’ complete dose: 92.7 percent; Staff complete dose: 83 percent.
  • Premier Genesee – Residents’ complete dose: 90.3 percent; Staff complete dose: 92.4 percent.
  • The Grand – Residents’ complete dose: 91.4 percent; Staff complete dose: 90.7 percent.

Assisted living:

  • Genesee Adult Home – Residents’ complete dose: 94.5 percent; Staff complete dose: 72.7 percent.
  • Le Roy Manor -- Residents’ complete dose: 97.2 percent; Staff compete dose: 92.3 percent.
  • The Manor House, Batavia – Residents’ complete dose: 100 percent; Staff compete dose: 93.6 percent.

Calls seeking comment from the administrators at the nursing homes listed above were not returned at the time of the posting of this story. Samantha Vagg is the administrator at Le Roy Village Green, Sharon Zeams is the administrator at Premier Genesee and Timothy Srye is the administrator at The Grand.

All told in Genesee County, skilled nursing facilities vaccination rates as of Sept. 28 were 94 percent for residents and 90 percent for workers and adult care facilities vaccination rates as of Sept. 28 were 97 percent for residents and 87 percent for workers.

REPORT FROM GOV. HOCHUL

On Wednesday, Hochul said that 92 percent of hospital and nursing home workforce have gotten at least one dose of a Covid vaccine, and 89 percent of adult care facilities employees have received at least one dose.

Based on total number of hospital employees in the state, an 8 percent unvaccinated rate equates to more than 41,000 who have not received at least one dose. As a result, the governor’s staff is monitoring the impact of her mandate, with the possibility of bringing in health care workers from out of the state or even from other countries.

The Genesee County Legislature, along with about seven other counties in the region, has sent a letter to the governor asking for her to include a coronavirus testing option for health care workers.

“I fully support the legislature’s position … to ensure that we didn’t have any lapse in service,” County Manager Matt Landers said today. “It’s a common sense, logical approach to the situation at hand. Obviously, we’d like to see as many people vaccinated as possible, but at the end of the day, we can’t jeopardize the care of our sick and our elderly because of the mandate.”

DATA FOR GENERAL PUBLIC

Latest statistics (as of Sept. 29) also show that 56.1 percent of Genesee County residents age 12 and over are fully vaccinated, which is less than the 63.6 percent for all New York state residents.

By zip code (as of Sept. 28), these are the percentages of those fully vaccinated:

  • Batavia – 50.4
  • East Bethany – 38.8
  • Alexander – 44
  • Basom – 44.4
  • Oakfield – 45.3
  • Byron – 48
  • Corfu – 49.6
  • Darien Center – 51.1
  • Pavilion – 53.8
  • Bergen – 55.3
  • Le Roy – 56.5
  • Stafford – 65.5
  • Elba – 73.6

In the Finger Lakes Region, the total number of people with at least one vaccine dose has increased over the past week by 7,695 to 760,752, and the total number of people with the complete vaccine series has increased over the past week by 5,590 to 706,944.

BOOSTER SHOT STATUS LOCALLY

Nola Goodrich-Kresse, public health educator, reported that the Genesee Orleans Health Department has set up clinics for those eligible for booster shots, beginning next week.

“Boosters are offered during the regular clinic day with the only difference being registration is required for boosters,” she said.

The booster shot schedule, for those 65 and older who became fully vaccinated with the Pfizer vaccine at least six months ago:

  • Oct. 6 from 12:45 to 3:30 p.m., Genesee County Health Department, 3837 West Main Street Rd., Batavia;
  • Oct. 7, from 12:45 to 3:30 p.m., Orleans County Health Department, 14016 State Route 31, Suite 101, Albion.

These shots are administered by appointment only.

September 27, 2021 - 4:21pm
posted by Howard B. Owens in COVID-19, UMMC, Rochester Regional Health, news.

Press release:

“Per the New York State  COVID-19 Vaccine Mandate for Healthcare workers, Rochester Regional Health is currently nearing 99 percent compliance. This percentage includes individuals who have received at least one dose of the vaccine, or have been granted religious or medical exemptions. Rochester Regional Health is proud of all of its employees for their hard work and dedication in keeping the community safe through the pandemic and beyond. We remain committed to serving the community and taking care of all individuals who seek care. “

September 21, 2021 - 9:14pm

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Updated: 7 a.m.:

The City of Batavia Planning & Development Committee tonight approved the site plan of the Healthy Living campus, a $30 million joint venture of United Memorial Medical Center (Rochester Regional Health) and the GLOW YMCA on East Main Street.

The tally was 3-1 in favor of the layout, with Ed Flynn, Rebecca Cohen and John Ognibene casting “yes” votes and David Beatty voting “no.” The committee’s monthly meeting took place at the City Hall Council Board Room.

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Related story: Planning committee member sees Healthy Living campus site plan as 'missed opportunity'

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“We’re extremely satisfied. We listened to what the concerns were and we made adjustments. I think they were fair and we were fair,” said GLOW YMCA Chief Executive Officer Rob Walker.

Project Consultant David Ciurzynski and representatives of the Clark Patterson Lee architectural/engineering firm had appeared before the PDC two times prior to tonight’s meeting.

Over the course of lengthy deliberations, a few changes requested by the committee were made, most notably the removal of an entrance/exit on Summit Street and removal of parking spaces in the area just east of Genesee-Orleans Regional Arts Council, on a parcel where the YMCA currently sits.

Walker said developers surrendered about 30 parking spots to create more green space.

“When you’re in business, we want those spots, but out of respect for the process, we negotiated,” he said.

On the Summit Street issue, he said, “We met with the Summit Street (Neighborhood) Association and with a number of residents and we listened and we said, OK.”

“The traffic flow is going to work just fine as we have an exit on Washington (Avenue) and an exit on Bank (Street).”

Ciurzynski said the updated site plan shows the Summit Street exit removal and parking space adjustment, adding that there are no plans to build a wall or put up additional trees in the space between GO Art! and the new YMCA building.

PDC member Ed Flynn said the board received a letter from GO Art! stating its support of the Downtown Revitalization Initiative project as long as there was no wall.

Beatty then mentioned a site plan presented by Clark Patterson Lee and sent to Gregory Hallock, GO Art! executive director, was different from the final plan. He said he had hoped the PDC would have been able to see that document.

Ciurzynski said that was a previous drawing, calling it “much more elaborate than what we have and we’re not moving forward with that because of budget reasons.”

“The plan that you have (now) is the plan that we’re moving forward with,” he said, adding that the current plan has appropriate buffering on that back side (of GO Art!). “I understand that he (Hallock) may desire something more (but) technically it’s not his property. We have to be as good neighbors as possible, but we have to also manage our budget.”

The PDC reviewed the State Environmental Quality Review paperwork and determined no adverse impact. It did advise Ciurzynski, however, to make sure the GO Art! building is protected during construction as it is an historic structure. Ciurzynski said he would send the final site plan to the State Historic Preservation Office.

With the committee’s approval in hand, the timeline becomes much clearer.

Ciurzynski said construction documents should be complete by the late fall or early winter, and then bids will be solicited.

“Hopefully, by the end of the year, we’ll start seeing some (activity), with Cary Hall coming down. And start getting the site prepped and ready for construction in earnest starting in the spring,” he said, noting that the entire project will take about 20 months, including 14 to 16 months on the main two-story, 69,420-square-foot building.

“We’re trying to get everything done as quickly as possible so we can move in and take down the (existing) YMCA,” he said. “Start construction in the spring when the weather breaks, get the building up, get everything moved over into there from the existing Y to the new Y – get that operational – and then we can start looking at taking down the old Y and developing that site.”

He acknowledged the PDC’s opposition to the amount of parking on Main Street.

“They didn’t like the look of it (and) they wanted more of an urban park environment, so we sort of split the difference,” he said. “We gave up some very significant parking for our membership but we will find ways to work around that because it was important to the Planning & Development Committee.

“They’re looking out for the city; trying to make sure they can strike a balance. We’re a partner with the city, so we want to make sure that we can strike that balance that works for everybody.”

Even with the reduction of parking spots, the campus will accommodate about 200 cars. Walker said that hospital staff would be able to continue to park in the City Centre Mall parking lot.

As previously reported on The Batavian, the Healthy Living Campus will replace the current YMCA, and will feature YMCA amenities such as gymnasium, pool, locker rooms, multipurpose rooms, exercise rooms and a community living (common) area.

It also will have 10,000 square feet for the hospital’s Healthy Living (diabetes awareness and education) program as well as a medical clinic on the second floor as a teaching unit for medical residents, and space for RRH’s Baby Café, a breastfeeding program run by lactation specialists who offer education and support to any pregnant woman or breastfeeding mom in the community at no charge.

Graham to Build 'Infill' Addition

In other action, the PDC approved a site plan submitted by Graham Mfg. to construct a 2,500-square foot one-story infill addition on the south side of the industrial complex at 4-12 Howard St.

Chris Howell, facilities manager at Graham Mfg., said the company wishes to put in a metrology lab in the new space for non-destructive testing and a stockroom -- “and to do those things well we need a separate area, which is temperature controlled and where it is clean.”

Currently, the firm’s welding and grinding operations are integrated with this kind of testing, he said, and separating those processes will improve the metrology and non-destructive testing.

The plan also is subject to review by the city’s Zoning Board of Appeals due to the entire building’s coverage area on the lot being more than the permitted 40 percent.

Previously: City of Batavia Planning & Development Committee says 'no' to Summit Street access for Healthy Living Campus

August 24, 2021 - 9:14am
posted by Press Release in UMMC, Rochester Regional Health, news, COVID-19.

Press release:

Due to the rapid transmission of the Delta variant and increased positive COVID-19 cases, Rochester Regional Health will be re-implementing a stricter visitation policy effectiveWednesday, August 25 at 9 a.m. at the following locations:

  • Clifton Springs Hospital & Clinic
  • Newark-Wayne Community Hospital
  • Rochester General Hospital
  • Unity Hospital
  • United Memorial Medical Center
  • Rochester Ambulatory Surgery Center
  • Linden Oaks Ambulatory Surgery Center
  • Westfall Ambulatory Surgery Center

New York State Department of Health continues to require masks inside healthcare facilities this includes visitors and patients. Visitors must have their temperature checked and be screened for symptoms when entering any of these facilities.

No visitation allowed 

  • COVID-19 positive patients 
  • Emergency department patients
  • Cancer infusion center patients
  • Only exceptions: pediatric patients, labor and delivery patients, patients with intellectual and/or developmental disabilities, and cognitive impairments including dementia and patients at the end-of-life (see below)

Hospital visitation policy

  • Each COVID negative patient can have one visitor at a time at the bedside 
  • Different visitors can visit the patient throughout the day as long as it is limited to one at a time
  • Visitors must be 12 years of age or older
  • Labor and Delivery (Obstetrics)
    • One visitor at a time
    • One support person (in addition to a visitor) is allowed at the beside at all times
  • Pediatrics
    • Two supports persons and one visitor
    • One visitor in pediatric ED
    • If the patient is COVID positive, one support person and one visitor
  • Patients undergoing ambulatory procedures or surgeries
    • One visitor only for pre-procedure (surgery) and post-procedure (surgery)
  • Patients with intellectual and/or developmental disabilities, and cognitive impairments including dementia
    • One support person may be present on-site at a time in the emergency room or during hospitalization
    • An additional visitor may also be with the patient during hospital-designated visiting hours 
  •  Behavioral Health inpatients
    • There is no change to the current visitation rules for Behavioral Health Inpatients
      • Two visitors during site-specific hours
  • End of life patients (appropriate PPE will be required if the patient is COVID positive):

o   Up to two visitors at the bedside at a time 

o   One support person (in addition to visitors) is allowed at the bedside; clergy are not considered a visitor

o   Social distancing must be maintained

Hospital daily visitation hours 

  • Rochester General Hospital: 9 a.m. – 1 p.m. and 4 p.m. – 8 p.m.
  • Unity Hospital: 9 a.m. – 1 p.m. and 4 p.m. – 8 p.m.
  • Clifton Springs Hospital & Clinic:  12 p.m. – 8 p.m.
  • Newark-Wayne Community Hospital: 12 p.m.  – 8 p.m.
  • United Memorial Medical Center: 9 a.m. – 1 p.m. and 3 p.m. – 7 p.m. 
  • Behavioral Health Facilities – call specific site for hours
August 23, 2021 - 1:12pm

In a major announcement today, the U.S. Food and Drug Administration is reporting the approval of the first COVID-19 vaccine – the vaccine known as the Pfizer-BioNTech COVID-19 Vaccine.

It now will be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

In response to this news, Edward E. Walsh, M.D., head of Infectious Diseases at Rochester General Hospital, and Ann Falsey, M.D., professor of Infectious Diseases and co-director of the Vaccine and Treatment Evaluation Unit at URMC and RRH Infectious Disease Physician, took questions from media members via a Zoom call at noon.

Following is that question-and-answer session:

Q. How does this process work exactly to get to this decision made by the FDA? What does it take to get full approval?

A. Walsh: Essentially, it is to collect longer timeframe for safety data, as well as increased amount of data on efficacy. The EUA (Emergency Use Authorization) was approved essentially after 2 ½ months and this is with data that was submitted in June, so it includes data out to six months and it’s that kind of longer-term data that is required for full approval.

Q. Do you believe that this will change public confidence in people who are hesitant in getting the shot, and explain what Rochester Regional (Health) is really hoping that this could change for public perception … to show that vaccine really works now?

A. Walsh: I think for some people this may be important. It’s not clear at this point if it will come to pass that a significant number of people who are hesitant to get vaccinated will now do so. There have been surveys done … which suggest that there is a significant number of people who have been hesitant will step forward now that it has received full approval. But will have to wait and see if that actually happens.

The second aspect of this is that apparently this will make it a lot easier for organizations, including the healthcare organizations, to mandate vaccination as a requirement for working. Which is a very controversial and much debated in public spaces position. It apparently will allow that to move forward more easily.

Q. What do you see as the fallout to that (noting there is a small, vocal group of healthcare workers that said they won’t get the vaccine?

A. We’ve already seen that happen in certain institutions that have made it mandatory to be vaccinated, even during the period in which it was covered by the EUA. I imagine that there will be somewhat similar vocal outcry by some individuals and possibly groups. We’ll just have to see.

I can tell you that in the past, with influenza vaccine mandates this has been a struggle prior to potentially mandating flu vaccines in healthcare environments. Only about 75 percent of people would become vaccinated each year; once it was mandated, we now exceed 90 percent, often reaching 95 percent. So, it may allow us to move forward.

Q. (Could you address) the hesitancy of some folks, who say I’d like to see this get approved by the FDA, and now were at that point?

A. Falsey: “Basically the proof is in the pudding; We’ll have to wait and see what happens. I, took, have had numerous conversations with vaccine-hesitant people, and some raise very reasonable concerns that it’s a brand new vaccine (that) came along very rapidly and want to see more data and the FDA fully approved it. I, personally, might say I don’t think you’re assessing risk/benefit properly (but) those are reasonable concerns from reasonable people.

But, I do hope that this approval and this review of this safety data, will will give them the confidence to get what is a safe vaccine and get themselves protected.

Q. How does this approval help public confidence … for some of those people who were on the fence?

A. Falsey: I hope it will help a lot. There are some people who are anti-vaccine, and no matter what the FDA does they won’t trust it or believe it. But there is a group of people … who are just nervous and this is the reassurance that they will need. I hope it goes a long way.

Walsh; I would echo that hope that it does go a long way. I think people need to realize that these vaccines were scrutinized by a very large number of individuals and coming from different backgrounds to assess their safety. This discussions that take place are very long, they review an enormous amount of data. One thing that people should realize that following rollout vaccine in late November, essentially early December, the CDC (Centers for Disease Control) has been very meticulous in tracking side effects now for essentially nine months. And they have been able to uncover any of the concerns than anyone would have with these vaccines. So, … it’s including data that extends out nine months to the general public and for a year we are now seeing in our vaccine study here at RGH (Rochester General Hospital) with the Pfizer vaccine group … we’re seeing the now out at a year.

Q. Do you foresee that Moderna, Johnson & Johnson (approval) will be coming up soon?

A. Falsey: For a full licensure, you do need six months of safety data. Moderna had its EUA shortly after Pfizer, so I would think they would be next up to become fully approved … J&J will take a little bit longer.

Q. Is this a normal timeframe for vaccines to be approved or was this hastily done?

A. Falsey: It was sped up quite a bit, but no steps were not done. All the phases, all the safety were done, it’s just that it was a huge public health crises and everyone was working non-stop. Things were done rapidly,

Walsh: The preliminary scientific basis for this vaccine was developed over 10 years prior to the pandemic. That’s an enormous amount of work that normally is rolled into how long it takes to make a vaccine. That whole process was done prior to the pandemic even starting; it was a real head start here.

The process of going through Phase 1, Phase 2 and then Phase 3 trials was speeded up but iwas primarily in the Phase 1 period which normally would take from six months to perhaps even a year. Through a very safe mechanism, you can make those go faster; because of the pandemic, they had to. As far as the Phase 3 study goes, because of the pandemic, the decision was to monitor the effectiveness of this vaccine – and all of the vaccines -- in real time rather than to simply say, ‘Let’s just analyze this data at the end of the year.’ They said, ‘Let’s analyze this data week by week to see how long it would take to demonstrate efficacy.’ And when you demonstrate 95 percent efficacy against all infection and 100 percent against severe disease at 2 ½ months, you have data that says, ‘Let’s move this forward in the face of a pandemic killing .. over 500,000 people.

Q. As far as efficacy against the Delta variant, some studies show that Moderna has a stronger efficacy than the Pfizer. Is this just a timeframe thing that Pfizer is being approved before Moderna?

A. Falsey: “I’m not specifically aware of which study you are discussing. A lot of the global data that looks at real world effectiveness of these vaccines as we look through the different variants, they all look very effective against severe disease and death … The full approval process really has more to do with safety. So, Pfizer finished their study and applied for EUA, and had a little bit of a jump there, and that’s why they have six months of safety data first, and they received their full licensure. I am sure Moderna will be along quickly.

Walsh: … for six months we’ve seen the data, and the efficacy seems to be very similar. Real world data from various states in U.S., suggested that the Moderna vaccine was holding up a little bit better than the Pfizer vaccine, but not in terms of hospitalization, severe disease and mortality. It had to do with whether or not a minor or mild infection would occur. And these are relatively small studies …

One of the problems with collecting data in the real world as opposed to an actual study, where you’re monitoring every person, is that it really requires people to come forward with minor illnesses and mild illnesses, and it also requires states to report all their illnesses, for instance, hospitalizations, mortality, and that is not always done. So, it’s a little difficult at times. I think at this point, I’d argue that there’s probably not much difference between these two vaccines in terms of their benefit.

Q. Do you hear from their patients that this is something that they care about – about FDA approval?

A. Falsey: From a select few. The majority of patients either fall into the category of vaccine enthusiasts versus … those who just aren’t going to get it. But, there are a group of people that this a step that gives them confidence. They are worried that these are new vaccines and they want full approval and review by the FDA. There are people that this is meaningful.

Q. How instrumental was URMC and Rochester Regional was in the studies for Pfizer?

A. Walsh: This town – URMC (University of Rochester Medical Center) and RRH -- provided Rochester the opportunity to really participate in cutting edge of development of the Pfizer vaccine … and also work locally with the Johnson & Johnson vaccine as well as the Astrazeneca vaccine and the concept of mixing different vaccine strategies with different vaccines.

So, Rochester, the University and RRH have contributed an enormous amount of effort to push this forward. In a certain sense, I will say that among the infectious disease community, to a large extent, … it was essentially like getting drafted into the army. We had to stop doing all of the normal things that we do and focus on essentially one disease and one illness.

Q. What regulations did this vaccine exactly have to pass … to be fully approved by the FDA?

A. Walsh: I can’t give you every detail that is required … I’ve not sat through committees that go through this process. But, as I mentioned before, it requires full vetting from all of the data from study subjects – and there are 42,000 of them in Phase 3 study. If you looked at all the data from those as well as the data from the Phase 1 and Phase 2 studies, which were much smaller, I think specifically, looking at safety data. In addition, they do have access to all of the safety data that has been developed after the EUA rollout in December. That information is dependent upon individual reporting, whether it be physician or people in the community who have been vaccinated. Whereas the study subject data of 42,000 individuals, that data is very meticulously collected … very granular, very detailed and highly scrutinized.

Q. Why do you believe it wasn’t approved fully for those 12-15 (years old)?

A. Walsh: Again, this has to do with timing. The data for 16 and up, or 17-18 and up was part of that first phase of the Phase 3 studies were once that starts moving, they went into 12-16 groups, so that is somewhat behind so we don’t have the data yet … to be fully approved.

Q. What do you think this says for the future of mRNA technology?

A. Walsh: I think it opens up opportunities in many areas where we have been unsuccessful in developing vaccines. There are many diseases that we do not have effective vaccines, or have not event attempted to look into the possibility of vaccines -- especially for viruses, It also opens up the possibility of an effective strategy to improve our existing vaccines, such as influenza. In good years, we’re happy to see 50 percent effectiveness … If we could get very high degree of efficacy it could really do a lot of public health good. I think you can make the same argument for a lot of diseases for which we really haven’t pushed hard for vaccines.

This technology may be very effective. And those studies will be slowly starting … we’re obviously still mired down in the pandemic and the problems with that issue. Boost the doses, and the variants of coronavirus that may arise and have to be dealt with. At some point, this technology will be applied to other vaccines.

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Update: 4 p.m. in response to comment below:

Under the Public Readiness and Emergency Preparedness Act, companies like Pfizer and Moderna have total immunity from liability if something unintentionally goes wrong with their vaccines. And, although the vaccines have been approved by the FDA, people can't sue that government agency as it has what is known as "sovereign immunity."

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