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Supply shortages still inhibiting widespread testing in Alabama

Chip Brownlee

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The total number of people tested for COVID-19 in Alabama, according to the Alabama Department of Public Health, jumped by more than 18,000 on Saturday. It was the single largest increase in the total number of tests reported in a day since the state began performing tests in early March.

The total number of reported tests jumped from 52,641 (about 1.07 percent of Alabama’s population) to 71,344 (1.46 percent of the population) in a single day. The large relative increase in total tests performed gave some people, particularly online, the impression that Alabama had begun to dramatically and almost miraculously expand its testing in the course of a few days.

But many of the negative tests reported Saturday in that large batch were weeks old, according to the Alabama Department of Public Health, some dating back to the first few days of expanded testing when drive-thru centers in Jefferson County began testing hundreds of people in mid-March.

“We had some reports from a couple of big labs who had not been recording negatives and just sort of sent in these bulk reports kind of all at once,” said State Health Officer Dr. Scott Harris in an interview with APR Monday. “All those tests didn’t occur on the same day or anything like that.”

While labs are required, by law, to report positive test results for COVID-19 within a few hours, negative results are a much different matter. In the early days of the outbreak, there was more focus on the positive results, but as discussion gears up surrounding efforts to “reopen” the state’s economy by lifting or easing Gov. Kay Ivey’s stay-at-home order, the total number of tests performed has become an increasingly important metric. To get that number, the state needs to be able to capture negative tests, too, not just the positive ones.

Public health experts — including researchers at the Harvard Global Health Institute and the University of Washington Institute for Health Metrics and Evaluation — have recommended that states need to drastically increase their testing capacity before a safe reopening can happen. Testing and contact tracing are imperative to being able to find, identify and contain new cases to prevent a second spike in infections.

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Without labs reporting their negative tests in a timely manner, it’s difficult to estimate how many people are being tested on a daily or even weekly basis in the state, Harris said.

The large batch of new tests reported Saturday shows just how hard it is for state officials to get a grasp around how many tests are being performed. For the public, it’s even harder to understand. A spike in new tests reported on a single day can be misleading when, in reality, those 18,000 tests were performed over the course of a month.

“For a lot of labs, for example, the pop-up labs that were in Jefferson County, the first drive-thrus, they were just keeping track of that on paper,” Harris said of the negative test results. “They have only just now started sending us negative results. And that’s one of the reasons the test number jumped so much in one day. We just got a box of papers, and people had to go in and manually input all those lab results, and we still don’t know if we’re getting them all.”

The Alabama Department of Public Health, through an emergency order, has required labs reporting test results to include negative tests in their counts, but reporting has been sporadic from commercial labs, as evidenced by the dump of new tests on Saturday.

Harris said the state has also had trouble getting negative test results from out-of-state labs that are performing tests on samples collected in Alabama and tests on Alabama residents who had samples collected out-of-state. Other labs, including Diatherix in Huntsville, Synergy in Mobile and UAB’s pathology lab in Birmingham, have been much better about reporting tests in a timely manner.

“I say all of that to say that we don’t know how many tests are being done per day,” Harris said.

The Alabama Department of Public Health’s best estimate is that about 1,000 people a day are being tested in Alabama for COVID-19, which includes the state’s lab and dozens of other commercial and hospital labs performing tests.

That estimate makes even a five-day or seven-day rolling average look inaccurate. APR last week began providing a five-day average of new tests reported on our data dashboard page. After the new tests were reported Saturday, it caused the five-day average to jump to 5,000 tests per day, which is far too high, based on Harris’s estimate.

But Harris said there has been progress made on expanding testing. More people are getting tested now than a few weeks ago, he said. New testing sites are opening weekly in rural counties. UAB has expanded testing capacity available in the Birmingham metro area. And Harris said Alabama is aiming to get to 50,000 tests per week at some point in the near future. That would be about 1 percent of the state’s population tested per week, he said.

So far, about 1.5 percent of the state’s population has been tested since early March.

“The idea of 50,000 tests a week actually is doable, based on what people are reporting to us right now,” Harris said. “There’s enough capacity available in all of these labs to handle that volume. But practically speaking, we’re nowhere near that.”

Such an increased level of mass testing would require about 7,100 tests per day, seven days a week.

That’s about the same as the level recommended by the researchers at Harvard, who said states should get to 152 tests per 100,000 people per day by May 1.

Even more conservative recommendations, like the one from public health officials included in Rep. Terri Sewell’s advisory group report, say Alabama needs to test about 11,200 people a week to be able to safely reopen with appropriate containment and contact tracing.

“So, we’re not there yet either,” Harris said. “But that’s probably conceivable.”

What are the barriers to more testing?

The Alabama Department of Public Health’s State Bureau of Clinical Laboratories is able to perform about 350 tests on a good day, “when everything’s perfect,” Harris said. He said it’s unlikely that the state lab will be able to scale up much more given its current resources and capacity.

“I really think that one big perception issue around testing is that the feds have made it clear that state public health labs are not going to be the ones doing the bulk of testing, even when we would like to be,” Harris said. “They’ve made it very clear that we need to be augmenting the private capacity. That’s what we’re trying to do, and we’re trying to recruit people to do that.”

The state has been reaching out to private labs over the last few weeks, asking them to report their current level of capacity and how many tests they think they will actually be able to perform going forward. The numbers look good, at first glance, Harris said — maybe even enough to get to 50,000 tests per week pretty quickly.

“In theory, we have an idea that we could do what we need to do,” Harris said. But the practical reality is much different.

Testing supply shortages are still inhibiting more widespread availability of testing, Harris said.

“In some of the national news conferences, they say, there’s plenty of testing out there,” Harris said. “And that’s technically true if you add up all the available capacity in all the labs. There’s enough empty slots in the laboratory to handle millions of tests. But just practically speaking, it’s just not evenly distributed and not everybody has all the equipment they need to get that done.”

Labs have reported to the Alabama Department of Public Health that they are facing shortages of testing kits, reagents and other materials needed. A lab may be able to perform thousands of tests before reaching their capacity, but that does not mean they have the supplies they need to do so.

Jordan DeMoss, the vice president of Clinical Operations at UAB, and Dr. Rachael Lee, an epidemiologist at UAB, at a press conference Monday, echoed Harris’s comments about supply shortages affecting the availability of testing statewide and at UAB, where their lab has been able to expand testing in recent weeks.

“Jordan and his team, they’re constantly calling for more swabs and more reagents in order to test,” Lee said. “If we could test all patients regardless of their symptoms, we would. That’s what limits us the most.”

On top of supply issues, Harris said another aspect limiting the availability of testing is the geographical disparities of available testing. Reliance on commercial laboratories has made that a more difficult problem to fix.

“A lot of it is just the uneven distribution of testing around the state,” Harris said. “If you’re in Jefferson County, and you go to your doctor today, and you need a test, you can almost certainly get one. But if you’re in one of our many rural counties, that’s just not possible. … There’s just not the same availability if you’re in the Wiregrass or the Black Belt.”

The Department of Public Health is working to use community health centers and county health department offices to make up for the lack of testing in the Black Belt, the Wiregrass and other rural areas of the state.

“I think just about every clinic has done some testing, but most of them have a lot more capacity,” Harris said.

To ramp up testing, the centers need personal protective equipment and testing materials. Harris said he hopes that some of the new funding included in Congress’s latest COVID-19 bill will help expand testing at the community health centers and health department offices. But that won’t solve all of the issues, he said.

“Even though we have county health departments that are doing testing throughout the state, but especially in the Black Belt, it’s still not convenient,” Harris said, noting that people would have to drive a long way to reach a county seat where the county health department office is located.

On top of engaging county-level health departments and community health centers, Harris said the state is working with UAB to expand testing at their lab so that UAB can be tapped to handle some tests if outbreaks emerge in more rural areas — like the outbreaks in Marshall County, Chambers County and Tallapoosa County.

When will people without symptoms be able to get tested?

So far, states across the country have prioritized people most at risk of having the virus including those in long-term care facilities like nursing homes and assisted living facilities, health care workers, people with moderate to severe symptoms, hospitalized patients and people who have been around others who have tested positive.

But the evidence is clear that a sizeable portion of the people infected with COVID-19 do not show any symptoms or symptoms so mild they do not need medical treatment. While that is good news in that it lowers the virus’s mortality rate, it makes it difficult to contain the virus’s spread.

A preliminary study testing for antibodies indicated that as many as 2.7 million New Yorkers were infected without realizing it, Gov. Andrew Cuomo said last week. Another small study of pregnant women in New York found that 15 percent tested positive for the virus, and 80 percent of them had no symptoms. Of more than 800 cases aboard the U.S. Navy carrier Theodore Roosevelt, 60 percent were asymptomatic.

Yet, all of those people are still able to spread the virus, meaning that such precautions as temperature checks at workplaces and other symptom screenings may only be partially effective in limiting the virus’s spread.

Harris said the department would like to be able to test those without symptoms, but that the capacity is just not there yet. It will be a while before the health department recommends testing for those without symptoms.

“I think we would want to do that,” Harris said. “But are we in the position to do that? We’re not.”

In the few populations that have had expanded testing — like long-term care facility residents and employees, and health care workers — the number of cases is higher than the general population. That could be because they are at higher risk of exposure, but at least part of it is expanded testing. As of Monday, at least 1,793 people in those three groups had tested positive for the virus, or about 28 percent of Alabama’s confirmed cases.

Those groups, along with those who have been exposed and around other vulnerable people, will likely be the first to have access to testing for asymptomatic or pre-symptomatic people.

“And so if we start testing asymptomatic people on a large scale, I think we would want to start with those groups,” Harris said.

Chip Brownlee is a political reporter, online content manager and webmaster at the Alabama Political Reporter. You can email him at [email protected] or reach him via Twitter.

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Governor

Governor awards $48 million to Department of Education, up to $50 million for higher education

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Gov. Kay Ivey on Monday awarded $48 million of the Governor’s Emergency Education Relief Fund (GEERF) to the Alabama State Department of Education in response to challenges related to COVID-19. This allocation will enable schools to enact policies established in the Alabama State Department of Education’s Roadmap to Reopening Schools.

As schools across Alabama are navigating increased challenges related to COVID-19, this initial investment will assist by providing budget stability, enable distance learning for any student that seeks it, and get additional resources to students most in need.

The allocation will be used as follows:

  • $10 million to equip all school buses with WiFi capabilities to increase internet connectivity and help bridge the digital divide
  • $4 million to improve remote learning opportunities by providing digital textbook and library resources for all students
  • $26 million to provide additional academic support to bridge learning and achievement gaps
  • $9 million to support intensive before and after school tutoring resources for learning and remediation in schools

Additionally, Alabama institutions of higher education will be able to submit requests for a combined reimbursement of up to $50 million of the federal Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Alabama received approximately $1.9 billion of CARES Act funding to respond to and mitigate the coronavirus pandemic. Alabama Act 2020-199 designated up to $118.3 million of the Coronavirus Relief Fund for any lawful purpose as provided by the United States Congress, the United States Treasury Department, or any other federal entity of competent jurisdiction.

“I am pleased to invest in our state’s greatest asset – our students,” Governor Ivey said. “As we respond and adapt to COVID-19, we must ensure that our local school districts and institutions of higher education receive necessary support and provide our students full access to their educational opportunities. Closing school during the pandemic disproportionately impacts students who are already struggling, and it is our obligation to provide as much stability and access possible in these uncertain times.”

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Elections

Jefferson County GOP pens letter to governor complaining of Democrat appointed as probate judge

Brandon Moseley

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Gov. Kay Ivey speaks at a press conference. (via Governor's Office)

The members of Jefferson County Republican Party Steering Committee last week sent a letter to Alabama Gov. Kay Ivey bitterly complaining about her recent appointment of Jim Naftel, a Democrat, as a Jefferson County probate judge.

“We, both as elected officials and leaders of the Jefferson County Republican Party Steering Committee, on behalf of the entire Jefferson County Republican Executive Committee wish to express our displeasure in your appointment to Jefferson County Probate Judge, Place 1,” the letter reads.

“Our main objection is we had one request and that was one request only – the appointment of qualified Republican to this post,” the Jefferson County GOP continued. “In recent history, your pick for this position was given the opportunity to participate in the Republican Primary, he chose to vote as a Democrat. In 2018, when you were running for Governor in the Republican Primary, he chose to vote a Democrat ballot. Even this past March of 2020, when he had a chance to cast his vote for President Donald Trump, he again chose to vote in the Democrat primary.”

“Secondly, this position runs all elections for Jefferson County,” the Steering Committee added. “On June 30th, Secretary of State John Merrill was quoted in Alabama Today as stating, ‘The probate judge has a significant level of influence. I cannot emphasize how important it is that this person is involved, interested, and informed on all things related to elections.’ We have no knowledge of your appointee’s experience in this area. We are not aware of his previous expertise in the election process at the county level or having been involved with any level of ballot security activities in our County.”

In the letter, the members said all of the Republican legislators and commissioners recommended a specific qualified Republican to be appointed to this post.

“This Republican had been recommended and mentored by a former ALGOP General Counsel who you personally hired to be your legal counsel during your last campaign,” the letter reads. “This choice was clearly experienced in the elections area of the Probate position and was best prepared to serve as our chief elections officer. Rarely, if ever, do all of these people agree on one thing and they agreed on this. These above stated reasons are why we, both as elected leaders in Jefferson County and members of the Jefferson County Republican Party, would like you to be aware of our displeasure for your selection of Probate Judge, we request a clear explanation of why this choice was selected despite the request as outlined above, and we hope you will listen to our counsel on future appointments in Jefferson County.”

The letter was signed by Jefferson County Republican Party Chairman Paul DeMarco and the other officers and members of the steering committee.

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Naftel was appointed to fill the position previously held by Judge Alan King, who has retired after 19 years of service.

“As one of my appointees, you will be making important decisions that directly affect the citizens of Alabama,” Ivey wrote to Naftel. “I have made honesty and integrity a priority in my Administration, and I know that you will embody these two virtues while serving the people of Alabama. Please plan to be a good steward of the taxpayers’ money and work in your position to instill trust in state government. The responsibility that comes with this appointment is not to be taken lightly. I trust that you will rise to the occasion and set a standard for others to follow.”

Naftel was an attorney with Maynard, Coooper & Gale, where he has worked since 1998.

“Jim is a shareholder and member of the Firm’s Estate, Trust and Business Planning Practice, Fiduciary Advisory Services Practice, and the Fiduciary, Trust and Estate Litigation Practice groups,” the firm wrote in his bio on their website. “In his Fiduciary Litigation practice, Jim advises and represents both individuals and corporate fiduciaries in their capacity as trustees and executors, including pre-litigation, mediation, trial and appellate proceedings. Jim also represents beneficiaries of estates and trusts. In addition, Jim represents clients in proceedings related to financial abuse of the elderly, conservatorships, guardianships and other protective proceedings.”

Naftel is a Fellow of the American College of Trust and Estate Counsel, has been recognized as one of The Best Lawyers in America in the areas of Trust and Estates and Litigation: Trusts and Estates. He earned a law degree from the University of Alabama law school in 1998. He has a bachelor’s degree from the University of Mississippi in 1994.

“It is an honor to be appointed and I look forward to serving Jefferson County in this role,” Naftel told AL.com.

Republicans, including Alabama Republican Party Chairman Terry Lathan, had been urging the governor to appoint a Republican to the position.

Former Alabama Republican Party Chairman Bill Armistead wrote hours ahead of the appointment, “For the life of me, I cannot understand why we are even having a conversation about our Republican governor appointing a Democrat as the top election official in Jefferson County. If we have to lobby our Republican governor to appoint a Republican to this important position we have a real problem!”

While Republicans continue to dominate Alabama politics, the party has grown increasingly uncompetitive in Jefferson County, where Republican Sheriff Mike Hale was defeated in 2018 and the last two Republican district attorneys were both defeated in general elections.

While Hillary Clinton was trounced statewide in 2016, she carried Jefferson County, as did Barack Obama in 2012 and 2008.

The last time that a Republican presidential nominee carried Jefferson County was incumbent President George W. Bush back in 2004. Naftel’s appointment could perhaps be interpreted as meaning that the governor’s office believes that Jefferson County is a lost cause for Republicans moving forward given recent demographic changes and that the best a Republican governor can hope for is to pick the best Democrat for countywide office as a Republican would lose reelection.

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Courts

Lawsuit claims governor ignored nomination process to appoint probate judge

Micah Danney

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James "Jim" Naftel II

A lawsuit filed Wednesday is challenging Gov. Kay Ivey’s appointment of Birmingham attorney James “Jim” Naftel II as Jefferson County probate judge place 1.

The suit, filed the day Ivey announced the appointment, alleges she circumvented the Jefferson County Judicial Commission’s nominating process. She should have selected an appointee from a list of three nominees provided by the commission as the state’s Constitution requires, the suit says.

“Because Judge Naftel was not lawfully or properly appointed as Probate Judge of Jefferson County, he is currently usurping, intruding, and unlawfully holding that office,” the suit alleges.

Ivey’s office said she disagrees with the suit’s interpretation of the law. 

“The state constitution gives the governor the authority to fill this vacancy,” said Gina Maiola, Ivey’s press secretary. “Judge Naftel is highly qualified to serve as probate judge, and the governor looks forward to his many years of excellent public service to the people of Jefferson County and the state as a whole.”

Barry Ragsdale, an attorney with the firm Sirote & Permutt, P.C., said that he has no issue with who Ivey chose, only how she did it.

“I frankly have nothing but respect for Judge Naftel,” Ragsdale said. “I think he’ll make a great probate judge. I think he’s going to end up being the probate judge, but it’s about protecting a process that we’ve had in Jefferson County for 70 years.”

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Jefferson County was the first of six counties to create such a commission. It originally applied only to Jefferson County Circuit Court, but that was expanded in 1973 to include any judicial office, the suit says — including probate judges. 

Ragsdale said it is important because the process is meant to provide local input into whom potential judges are. Commissioners are local citizens who likely know the people they nominate, whereas a governor probably doesn’t. 

“That takes most of the politics out of it,” Ragsdale said. He noted that before the first commission was created in 1950, George Wallace appointed his relatives to the bench when vacancies opened. A local screening process prevents that, Ragsdale said.

“We have that, we fought for it, and we fought governors for decades to follow the process,” he said.

Ragsdale believes this is a case of a governor simply wanting to exercise power, he said.

“She’s absolutely wrong about what the law says, and we intend to prove that,” Ragsdale said.

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Economy

Ivey announces SiO2’s $163 million expansion in Auburn

Brandon Moseley

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Alabama Gov. Kay Ivey announced Wednesday that SiO2 Materials Science plans to invest $163 million in an expansion at its Auburn facility.

The announcement came just after securing a major contract to supply the federal government with vials to support the COVID-19 vaccine effort if and when an effective vaccine is developed. The project will create 220 jobs.

“It is exciting to know that SiO2 will be directly involved in providing a product essential to addressing the COVID-19 crisis, which will impact not only Alabamians but the entire country,” Ivey said. “This is a testament to the ingenuity of this great company and its growing Alabama workforce.”

Economic developer Nicole Jones told the Alabama Political Reporter, “Vials produced by SiO2 Materials Science may be the critical component needed to ensure safety in the vaccine distribution process. The breakthrough technology developed by the Auburn-based company provides a glimmer of hope amidst challenging times and showcases how Alabamians are working diligently to craft solutions that will assist our nation and the world in the fight against COVID-19. In addition, the 220 new, high-skilled jobs housed in Auburn Technology Park West will bring economic benefits to Lee County as well as the entire state of Alabama.”

The expansion will allow SiO2 to increase its production capacity so that it can meet the expected demand for vials and syringes when a coronavirus vaccine is finally approved for mass use.

In June, SiO2 announced an $143 million contract with federal government agencies for a production scale-up of the company’s state-of-the-art packaging platform for storing novel coronavirus (SARS-CoV-2) vaccines and therapeutics.

Bobby Abrams is the CEO of SiO2.

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“The pandemic presents an enormous challenge for all people,” Abrams said. “We are extremely grateful for Senator Shelby’s steadfast support and assistance, and we’re honored to collaborate with our government so a COVID-19 vaccine can be safely and quickly distributed. The State of Alabama and the City of Auburn for many years have been very supportive of SiO2 Materials Science during its research, development, commercialization, and now scale-up phases of the company.”

Over the last 10 years, SiO2 has developed its patented vial platform, which combines a plastic container with a microscopic, pure glass coating on the inside that is ideal for biological drugs and vaccines. The product, developed in Auburn with help from experts from four major U.S. research institutions, combines the benefits of both glass and plastic without drawbacks.

“There are problems with plastic, and there are problems with glass, and we resolve all of them,” Abrams said.

SiO2 will expand its existing facility at 2250 Riley Street and will invest in a new molding facility at 2425 Innovation Drive, both located in the Auburn Technology Park West.

Construction is already under way to expand the facility on Innovation Drive. The completed approximately 70,000-square-foot facility will increase the production capacity of SiO2’s injection molding operation.

“We’re proud to have some of the world’s leading scientists and product developers working in our community,” Auburn Mayor Ron Anders said. “With the presence of these companies and Auburn University’s outstanding medical and engineering programs, we believe we’ll see significant growth in the biotech industry right here in Auburn. On top of that, the well-paying jobs created through this project will result in significant economic opportunities for our local businesses.”

Greg Canfield, the secretary of the Alabama Department of Commerce, said that SiO2’s expansion project in Auburn will help ensure that the nation’s health authorities have an ample supply of vials and syringes to administer a vaccine for COVID-19 as soon as it is developed.

“Having a steady supply of SiO2’s innovative vials will represent a key strategic advantage for federal agencies wanting to act rapidly once a vaccine is available to counter the coronavirus,” Canfield said.

Robert S. Langer is a professor at the David H. Koch Institute at MIT and a company adviser.

A key element of SiO2’s product is enhanced safety for healthcare providers and for patients, who are at a lower risk of adverse side effects. A combination of plastic and a microscopic layer of glass also means vials and syringes won’t break, shatter or crack. SiO2 ships its products worldwide.

“Many drug development and drug formulation innovations can be limited due to variables associated with traditional glass vials and syringes,” Langer said. “The SiO2 vials and syringes eliminate these variables and allow drug development partners to bring their innovations to life.”

SiO2 is a privately-owned company based in Auburn, where it has around 200 employees. The Retirement Systems of Alabama provided early financial support for the company.

517,464 people have already died from the COVID-19 global pandemic, including 130,602 Americans.

 

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