Will Humble Disease Control, Prevention, Wills Blog

Contingency v. Crisis Standards of Care

As we press through contingency standards of care toward crisis standards of care, I thought it would be good to provide a little summary in plain language about what those words mean.

Hospitals generally operate under conventional standards of care. That just really means that they’re providing patient care without any change in daily practice.  Every cold and flu season hospitals face surges in demand (like the week after Christmas and off and on during January and February in Arizona). But hospitals are still operating under conventional care standards.

They will juggle space and staffing and may temporarily ask ambulances to go to alternate facilities or accelerate the discharge of healthy patients.  Staff may be asked to work in a different part of the hospital than they’re used to (for example a surgeon might be asked to work in the ER) but everyone is still working in their bounds of expertise and they’re following standard protocols.

As hospitals transition to contingency standards of care (where AZ is operating right now) hospitals change their practices and do everything they can to maintain the standard level of care.  For example, under contingency care they will use rooms of the hospital for different kinds of clinical care than usual, like converting surgical rooms for emergency services or using recovery rooms as a makeshift intensive care unit. Doctors, nurses, and respiratory therapists make different decisions about what therapies to use because of resource shortages too.  For example, they may not provide oxygen to a patient that would normally receive it because it’s in short supply.

Under contingency standards of care they also change admitting and discharge protocols.  Patients that arrive in the ER who might normally be admitted will be observed for awhile and then sent home with a prescription for example.

Practitioners may start conserving supplies by, for example, not providing precautionary oxygen to patients who under normal circumstances would receive it, but who can survive and recover without it.

Patients are transferred between hospitals as they try to level out patient loads when they have periods of time. Some hospital systems like Banner are large enough to do interfacility transfers using their own resources and data. Others will need to contact the ADHS Surge Line, where transfers can be facilitated. I’ve been told that in recent days the Surge Line has been activated to facilitate patient transfers.

Hospitals restrict non emergency procedures. This isn’t something hospitals like to do because patients really need these important procedures and because general surgery and elective procedures contribute much to the financial bottom-line. Nevertheless, these procedures will begin to be postponed or canceled. This is probably already happening.

Hospitals change their admission decisions. For example, persons presenting in the emergency department may be sent home when, under normal circumstances, they would be admitted. Likewise, a patient that would normally be admitted to an Intensive Care Unit (with robust staffing rations) might instead be placed on a general ward bed.

Hospitals change their discharge decisions. People that have been admitted and who would normally stay for a couple more days will be discharged rather than observed. In some cases, persons that are in the ICU may be discharged directly to home rather than admitted to a general ward bed. Others will be discharged to a skilled nursing facility rather than a general ward hospital bed.

When the system becomes totally saturated, as will be the case in the next 2 weeks, hospitals will ask the ADHS to allow them to operate under Crisis Standards of Care. 

“Crisis Standards of Care” is basically a protocol for making healthcare decisions when the system can’t provide all of the care that everybody needs because the needs outstrip the resources. Ethics panel discussions will be held to make difficult decisions regarding who will get care and who will not.

Under Crisis standards hospitals need to make even more substantial changes to the way they provide care. For example, staff are asked to practice outside of the scope of their usual expertise. Supplies are reused and recycled. In some circumstances, resources may become completely exhausted.

Core strategies that get used under Crisis standards include substitution, adaptation, conservation, reuse, and reallocation in the areas of for oxygen, medication administration, IV fluids, mechanical ventilation, nutrition, and staffing.

The Crisis Standards of Care also provides a protocol to help healthcare providers objectively decide who gets care when resources don’t allow everyone to get treatment.  This blog post fleshes it out How Will Patients Be Prioritized Under the New “Crisis Standards of Care”. 

Here’s a link to the ADHS Crisis Standards of Care Planning Document. It’s 141 pages, but the real heady stuff is on pages 29 through 38 where it discusses the scoring system to prioritize which patients will get treatment and which will not and how to ration care to all patients when resources are outstripped by demand.

The ADHS also has an Addendum to the report called Allocation of Scarce Resources in Acute Care Facilities Recommended for Approval by State Disaster Medical Advisory Committee.

Will Humble Disease Control, Wills Blog

This Week’s Grim Epidemiology and Hospital Capacity Report

Below is an excerpt from Joe Gerald’s Weekly Arizona Epidemiology and Hospital Capacity Report. Far more detailed charts and graphs are available in the full report.

The SARS-CoV-2 virus is mowing through Arizona like a sharpened scythe. Fatalities are stacking up like cordwood in advance of a long winter. Barring intervention, daily cases and fatalities will double or perhaps quadruple before the outbreak collapses under the weight of natural, not vaccine-induced, immunity later this spring.

While Arizonans’ poor individual decisions are undoubtedly contributing to viral spread, the Governor’s inaction in the face of a clear and present danger is of greater concern. Most recently, he has performed more poorly than other governors, but more importantly, he has performed more poorly compared to his prior success this summer. This latter point highlights the calculated indifference of his current response.

As of January 3rd, new cases were being diagnosed at a rate of 780 cases per 100,000 residents per week (Figure 11 below). This rate is increasing by approximately 220 cases per 100,000 residents per week although this brisk pace is partly an artifact of last week’s under-counting. According to the CDC, no other state is experiencing faster spread transmission.

Arizona is now reporting >700 Covid-19 deaths per week (>100 per day) and this count may underestimate true fatalities by half (see Woolf, Woolf, or Weinberger). Many of these deaths were preventable if the state had more aggressively adopted evidenced-based public health practices. Arizona weekly tally of deaths ranks second behind that of Rhode Island.

Emerging evidence from New Zealand suggests that strict Covid-19 control measures are not associated with excess mortality from other causes. In fact, New Zealand experienced an 11% reduction in all-cause mortality while only experiencing 25 Covid deaths. This should begin to debunk the false narrative about our response being worse than the virus itself. New Zealand’s economic performance also belies the false narrative surrounding the choice between saving ourselves and saving our economy.

With >10,000 Covid-19 deaths reported to date, Covid-19 will almost certainly be recognized as Arizona’s third leading cause of death in 2020. This will be 10 times the number of influenza and pneumonia deaths typically reported. If Covid-19’s true toll was accurately captured, it would likely rank as Arizona’s leading cause of death. Given the outbreak’s current severity, these numbers could be repeated in 2021.

Hospital Covid-19 occupancy continues to increase with each week setting new records for ward and ICU occupancy. If viral transmission continues to increase, hospitals’ coping mechanisms could be exhausted before the end of January. Because many of these coping mechanisms are hidden from view, it is likely that hospitals will appear to fail abruptly and with little “seeming” warning.

Hospitals continue to postpone scheduled procedures to create additional capacity for Covid-19 patients at the expense of others with serious medical conditions. However, patients who would have been previously hospitalized are undoubtedly being treated in an outpatient setting.

Health professionals are being asked to work additional hours and assume duties outside their traditional scope of practice. Shortages and burn-out will degrade our capacity to provide critical care services over the coming weeks.

The test positivity rate for traditional nasopharyngeal PCR testing set another record this week at 35% positivity. This indicates a substantial mismatch between testing capacity and demand and supports the notion that viral transmission is growing faster than case counts alone would suggest, that our viral control measures are wholly inadequate, and our testing capacity compared to other regions is poor.

Will Humble Climate Change, Wills Blog

Webinar: Arizona Corporation Commission Energy Rules

Jan 13, 2021 06:00 PM AZ Time

Register Here

A couple of months ago the Arizona Corporation Commission passed new regulations that will require state-regulated utilities to get 100% of their power from carbon-free sources by 2050. The regulation doesn’t have a specific mandate that the energy be from a renewable source like solar and wind (the regulation counts power from APS’s Palo Verde nuclear plant as a carbon-free “clean energy” source).

The regulation passed by the Commission still requires a formal Rulemaking to flesh out and finalize the requirements. That final Rulemaking will formally set the new requirements for energy storage and energy efficiency gains for power-generating utilities.

Our hope is that the final Rules will bring Arizona more in line with other states that have significantly beefed up their clean-energy mandate.

Oral public comment sessions are being held on January 19th & 20th and written comments are due on January 22nd AzPHA will be submitting comments on the final Rule before the deadline.

Interested in learning more?  A group called Solar United Neighbors is putting on a free webinar that will help you understand the new 100% carbon-free energy rules and how to make a comment with the Arizona Corporation Commission (ACC) during the public comment period.

Webinar: Arizona Corporation Commission Energy Rules
Jan 13, 2021 06:00 PM AZ Time

Register Here

Will Humble Disease Control, Vaccination, Wills Blog

UK Temporarily Authorizes Use of the Oxford/AstraZeneca Vaccine

Last Wednesday the UK’s Department of Health & Social Care and their Medicines and Healthcare Products Regulatory Agency temporarily authorized the AstraZeneca/Oxford vaccine. Here is their clinician information packet with some of the particulars

Here’s the short summary of the safety profile:

“The most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia, nausea (>20%). The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. By day 7 the incidence of subjects with at least one local or systemic reaction was 4% and 13% respectively. When compared with the first dose, adverse reactions reported after the second dose were milder and reported less frequently.  Adverse reactions were generally milder and reported less frequently in older adults (≥65 years old).”

Here’s the short summary of the efficacy profile:

“In this population, vaccine efficacy from 22 days post dose 1 was 73.00% (95% CI: 48.79; 85.76 [COVID-19 Vaccine AstraZeneca 12/7,998 vs control 44/7,982]).  Following vaccination with COVID-19 Vaccine AstraZeneca, in participants who were seronegative at baseline, seroconversion (as measured by a ≥4 fold increase from baseline in S binding antibodies) was demonstrated in ≥98% of participants at 28 days after the first dose and >99% at 28 days after the second.” 

This is a more traditional vaccine when compared to the Pfizer and Moderna vaccines. This one uses an adenovirus vector to develop the immune response, while Pfizer and Moderna use a new mRNA technology.

Importantly, this vaccine is supposed to be stored at regular refrigerator temperatures, has a 6-month shelf-life, and can be stored between 2°C and 25°C during the in-use period. These characteristics make the vaccine far more flexible and easier to use in a much wider range of settings.  It will be particularly valuable for developing nations with limited infrastructure.

Back in May,  HHS announced that they had contracted with AstraZeneca providing $1.2B to support the development of their candidate vaccine (which has been developed in conjunction with the University of Oxford). The agreement is to make available at least 300 million doses of the vaccine for the United States. 

I couldn’t find info on how many doses have already been manufactured that may be available in the U.S. when the vaccine is ultimately given Emergency Use Authorization (most likely in January).

Will Humble Disease Control, Wills Blog

ADHS Director Scraps COVID-19 Spread Metrics for Business Operations

Substantial Spread Effectively No Longer Exists as a Category for Informing Interventions

Over the summer a host of stakeholders including the business community developed COVID-19 metrics to inform policy decisions like when it’s time to impose additional operational restrictions on bars and restaurants. Shortly after the ideas were presented to the Governor’s Office, the ADHS adopted the metrics and highlighted them as a key tool for driving future intervention decisions.

The metrics were then used when the state decided to lift the limitations put on bars, restaurants and gyms during the summer “pause”.

The protocol was scrapped in mid-December to ensure that the state metrics never suggest additional operational restrictions are needed at bars and restaurants no matter how bad community spread gets.

Here’s a story from the Health Arizona Daily Star that describes the decision by Dr. Christ to scrap the business metrics and her rationale for doing so.

Under the former criteria, bars and in-person dining are not allowed to operate when a county is in the ‘Substantial’ category.

As community spread began to increase in late October and into November & December, county after county moved into the Substantial spread category. When asked why the ADHS was not advocating for enhanced interventions because of the substantial spread, Dr. Christ (the agency director) said that while the metrics and protocol were valuable for deciding when to open businesses, they weren’t useful for deciding when to close them or to impose additional operational restrictions.

As that argument became increasingly untenable, the agency changed the standards governing business operations such that it’s impossible to reach a threshold in which community spread is high enough to warrant enhanced interventions on bars and restaurants no matter how serious the infection rate gets. Basically, Substantial Spread has been eliminated as a category.

Will Humble Disease Control, Vaccination, Wills Blog

Initial Vaccination Efforts Complicated by Glitchy ADHS Computer System

Less than 18% of the COVID19 vaccines that have been delivered in Arizona had been used as of 12/31. Clearly something is amiss, but what?

It turns out that one of the core reasons for the slow use of vaccines had to do with an ADHS computer software system. It was supposed to efficiently make vaccination appointments and provide billing information among other things. It’s built into the ADHS’ Vaccine Management System (VMS).

It’s a long story, but glitches in the ADHS’ VMS scheduling software failed to make appointments for thousands of healthcare workers that had pre-registered for vaccination. Many received no information at all back from the ADHS system. Others were instructed to go to Show Low, Globe or Snowflake for their vaccine even though they live in Maricopa County.

As a result, two of the five mass vaccination sites in Maricopa County were largely empty for many days in December. The glitches have apparently been corrected as of this weekend.

It’s a long story, but if you want to read more, check out this story by Ray Stern in the Phoenix New Times:  Arizona Vaccine Rollout Delayed by Computer Glitches, County Says.

New COVID Vaccine Executive Order Issued

Last week the Governor issued an Executive Order that he said is designed to make vaccination efforts more streamlined. The Executive Order says that the ADHS is supposed to use a statewide “vaccine allocation model”, can reallocate vaccine, and must approve all private vaccination sites. It also requires counties to post their vaccination progress and vaccination sites on their websites.

The Order doesn’t give the ADHS any authority that it doesn’t already have, but it does provide some direction and expectations to the Department.

Here’s where you can look it over. Honestly, it doesn’t look substantive to me.

Will Humble Uncategorized, Wills Blog

Arizona Continues Our Hospital Capacity and Capability Crisis March

Dr. Joe Gerald just finished his weekly COVID epidemiology and hospital capability report.  As always, there are many informative charts and graphs that depict the profound trajectory of COVID-19 cases and the resulting hospital capacity and capability crisis. It’s now clear that as a system, our hospitals are operating under Contingency Standards of Care approaching the “Crisis Standards of Care” threshold.

I probably sound like a broken record- but I feel compelled to say again that the situation we now find ourselves in is not because of fate as the Governor and state health director suggest. It is largely because they have been unwilling to implement evidence-based interventions this fall including authentic enforcement of the existing “required” mitigation measures for bars, restaurants and nightclubs. A requirement without enforcement is merely a suggestion.

Below are some excerpts from this week’s report from Dr. Gerald:

Arizona hospitals’ safety margin continues to erode in the ward and ICU. Most hospitals have cancelled scheduled procedures to ensure adequate capacity for patients with Covid-19 care. We are now undergoing the great “displacement” such that hospital services are now being rationed so that patients with severe Covid-19 illness are displacing others who have slightly less severe non-Covid medical conditions.

Hospital Covid-19 occupancy continues to increase with each day setting new records for ward and ICU occupancy. By early-to-mid January hospital capacity could be overwhelmed by new Covid-19 cases. Hospitals continue to postpone scheduled procedures to create additional capacity for Covid-19 patients at the expense of others with serious medical conditions. This coping mechanism could be exhausted soon if admissions continue to increase.

Health professionals are being asked to work additional hours and assume new duties. Shortages and burn-out will degrade our capacity to provide critical care services over the coming weeks.

The test positivity rate for traditional PCR testing remains at record levels, 26% this week. The mismatch between testing capacity and demand indicates viral transmission is growing faster than estimated.

As Covid-19 illness continues to increase, delaying others’ care will become ever more difficult. At some point, hospitals will have to expand their physical capacity. Make no mistake, the Covid-19 crisis is now placing a greater share of Arizonans’ at-risk, not just those unfortunate enough to contract Covid-19.

It is also important to recognize that hospital admission and discharge practices are changing in concert with management of nonCovid-19 patients. Covid-19 patients are likely being discharged home sooner and must have higher average severity to be admitted to the hospital and ICU. Furthermore, many who would have been transferred to a tertiary care facility are being managed at smaller, more rural hospitals.

The week ending December 13th has now seen 525 recorded deaths (Figure 7). This number will rise further over the coming weeks as more deaths are made known. Covid-19 deaths are expected to exceed 500 per week for the foreseeable future and may reach a new record by late December. Recall that deaths lag new cases by 14-days and are often only known weeks later. As a rule of thumb, multiplying the number of weekly cases by 1.5%, the case fatality rate, will approximate the number of Covid-19 deaths in 2 – 3 weeks’ time.

Will Humble Disease Control, Vaccination, Wills Blog

UK Temporarily Authorizes Use of the Oxford/AstraZeneca Vaccine

The UK’s Department of Health & Social Care and their Medicines and Healthcare Products Regulatory Agency (MHRA) temporarily authorized the AstraZeneca/Oxford vaccine for use in the UK. This is a “temporary authorization” which is somewhat like our Emergency Use Authorization .

Here’s their clinician information packet with some of the particulars about the vaccine. The MHRA doesn’t appear to post as much of the Phase III data as the FDA does.

Here’s the short summary of the safety profile from the clinical information packet:

“The most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia, nausea (>20%). The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. By day 7 the incidence of subjects with at least one local or systemic reaction was 4% and 13% respectively. When compared with the first dose, adverse reactions reported after the second dose were milder and reported less frequently.  Adverse reactions were generally milder and reported less frequently in older adults (≥65 years old).”

Here’s the short summary of the efficacy profile from the packet:

“In this population, vaccine efficacy from 22 days post dose 1 was 73.00% (95% CI: 48.79; 85.76 [COVID-19 Vaccine AstraZeneca 12/7,998 vs control 44/7,982]).  Following vaccination with COVID-19 Vaccine AstraZeneca, in participants who were seronegative at baseline, seroconversion (as measured by a ≥4 fold increase from baseline in S binding antibodies) was demonstrated in ≥98% of participants at 28 days after the first dose and >99% at 28 days after the second.” 

This is a more traditional vaccine when compared to the Pfizer and Moderna vaccines. AstraZeneca uses an adenovirus vector to develop the immune response, while Pfizer and Moderna use a new mRNA technology.

Importantly, this vaccine is supposed to be stored at regular refrigerator temperatures, has a 6-month shelf-life, and can be stored between 2°C and 25°C during the in-use period. These characteristics make the vaccine far more flexible and easier to use in a much wider range of settings.  It will be particularly valuable for developing nations with limited infrastructure.

Back in May,  HHS announced that they had contracted with AstraZeneca, providing $1.2B to support the development of their candidate vaccine (which has been developed in conjunction with the University of Oxford). The agreement is to make available at least 300 million doses of the vaccine for the United States. 

I couldn’t find info on how many doses have already been manufactured that may be available in the U.S. when the vaccine is ultimately given Emergency Use Authorization (most likely in January).

Will Humble Disease Control, Vaccination, Wills Blog

ACIP Issues Second Set of Recommendations for Vaccine Priority Allocation Categories – Adding Folks 75+ to Category 1b

Arizona Vaccine Prioritization Advisory Committee Approves the New ACIP Recommendations

Last week the Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 to flesh out the priority population recommendations a bit more.  This article provides additional details. The new recommendations make the following changes:

Phase 1b: persons aged ≥75 years are moved to category 1b (previously 1c)

Phase 1c: persons aged 65–74 years, persons aged 16–64 years with high-risk medical conditions

Elevating folks 75+ to AZ’s next (1b) vaccination phase is meaningful and ethical. Thanks to AZ’s independent Vaccine Prioritization Committee for this evidence-based decision. Here’s the updated decision by the AZ Committee: https://bit.ly/38IJnlZ

There are more than 1M persons in 1b now, so outreach to seniors will be key. Because the decision to add 75+ to 1b was made yesterday (and there are 500K + people in that category) the county health departments are still working out the details. There aren’t anywhere close to 500K doses available in AZ right now. Could they focus on 85+ first? We’ll see. That would be an evidence-based decision.

Will Humble Disease Control, Wills Blog

New SARS CoV2 Variant Emerges in England

Last week we heard a lot in the media about a new genetic variant of the SARS CoV2 virus in southern England. Several countries have imposed travel limitations in response to the reports. Here’s some background about what’s going on.

Public Health England wrote last week about a cluster of genetically similar cases in mid-November. They found that the cluster is genetically distinct from the rest of cases in the UK.

An investigation of the cluster found that the virus causing the cluster appears to be transmitted more easily than other variants (the reproduction rate is higher). The virus doesn’t appear to be more lethal.

The variant has mutations in the genetic code that effect the receptor binding site on the viral coat. The authors hypothesize that the changes in the receptor binding affinity of the spike protein enhances the transmissibility of the virus.  They think it’s possible that the changes in this strain make antibodies less effective at neutralizing the virus.

So far, there’s no evidence that this particular variant (and there are thousands of variants) poses a risk to vaccine effectiveness. Vaccines are made such that they can accommodate genetic changes. The influenza virus is completely different in that it’s prone to major antigenic shifts- which is a big reason why we have new influenza vaccines each year.

Also, this virus was identified in mid-November, more than a month ago. That means it has been circulating far more widely in Europe than is currently known and possibly in the US as well.  Implementing travel restrictions as is happening in Europe is unlikely to make a meaningful difference and diverts attention from the core public health measures that we do know slow the spread of the virus. Here’s CDC’s brief and factsheet about the emerging variant.

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