Millions of cancelled healthcare appointments and lengthy waits for care abound in UK, New Zealand, and in the US
Strikes continue on multiple continents as thousands of healthcare workers walk off the job. Doctors, medical laboratory scientists, nurses, phlebotomists and others around the world have taken to the picket lines complaining about low wages, inadequate staffing, and dangerous working conditions.
In England, junior doctors (the general equivalent of medical interns in the US) continue their uphill battle to have their complaints heard by the UK government. As a result, at hospitals and clinics throughout the United Kingdom, more than one million appointments have been cancelled due to strikes, according to the BBC.
“The true scale of the disruption is likely to be higher—many hospitals reduce bookings on strike days to minimize last-minute cancellations,” the BBC reported. “A total of one million hospital appointments have had to be rescheduled along with more than 60,000 community and mental health appointments since December [2022], when industrial action started in the National Health Service (NHS).”
According to The Standard, “Consultants in England are to be re-balloted over the prospect of further strike action as doctors and the government remain in talks with a view to end the dispute. The British Medical Association (BMA) said that specialist, associate specialist, and specialty (SAS) doctors will also be balloted over potential strike action.”
“We must be prepared to take the next step and ballot for industrial action if we absolutely have to—and we will do this … if upcoming negotiations fail to achieve anything for our profession,” Ujjwala Anand Mohite, DRCPath, FEBPath (above), a histopathologist at the NHS, Dudley Group of Hospitals, and the first female Chair of the SAS committee UK, told The Guardian.
New Zealand Doctors, Clinical Laboratory Workers Strike
In September, the first-ever nationwide senior doctor strike occurred in New Zealand and was then followed by another strike of about 5,000 doctors and 100 dentists from New Zealand’s public hospitals, the World Socialist Web Site reported.
Similar to the UK, the strikes reflect mounting frustration over pay not keeping up with inflation and “decades of deteriorating conditions in the public health system,” the WSWS noted.
This follows months of strikes by the island nation’s medical laboratory workers, which are ongoing.
“Our pay scales, if you compare them internationally, are not competitive. About half of our specialists come from abroad, so it’s quite important for the country’s health system to be able to attract and keep people,” Andy Davies, a lung specialist who joined the picket outside 484-bed Wellington Hospital, told the WSWS.
“We’re not asking for the world, we’re asking for an inflationary pay rise, and we haven’t had an inflationary pay rise year-on-year, and it’s beginning to show,” he added.
“What type of health system do they want?” he continued. “Do we want one that treats all people and manages what they need, or do we want a hacked down system that does less?”
The conflicts over pay and working conditions have caused many healthcare workers in New Zealand to leave the field entirely. This has led to severe shortages of qualified workers.
“Patient waiting times—for cancer, hip replacements, cardiac problems, and many other conditions—have exploded due to understaffed and overwhelmed hospitals,” the WSWS reported.
US Healthcare Workers also Striking
The US has its share of striking healthcare workers as well. Healthcare Dive tracked 23 ongoing or anticipated strikes throughout the nation’s healthcare industry since January 1, 2023. In 2022, there were 15 strikes of healthcare workers at the nation’s hospitals and health systems.
These walkouts include doctors, nurses, pharmacy workers, imaging specialists, and thousands of frontline healthcare workers striking over dangerously low staffing levels, unsafe working conditions, and low pay.
In October, 75,000 nurses, support staff, and medical technicians from Kaiser Permanente participated in a 72-hour strike comprised of hundreds of hospitals and clinics throughout California, Washington state, Oregon, Virginia, and the District of Columbia, Reuters reported.
The three-day strike, “Marked the largest work stoppage to date in the healthcare sector,” Reuters noted. Doctors, managers, and contingency workers were employed to keep hospitals and emergency departments functioning.
“The dispute is focused on workers’ demands for better pay and measures to ease chronic staff shortages and high turnover that union officials say has undermined patient care at Kaiser,” Reuters stated.
Staffing shortages following the COVID-19 pandemic are partly to blame for current struggles, but contract staffing to fill critical positions has exacerbated the problem.
“Kaiser’s outsourcing of healthcare duties to third-party vendors and subcontractors has also emerged as a major sticking point in talks that have dragged on for six months. … The clash has put Kaiser Permanente at the forefront of growing labor unrest in the healthcare industry—and across the US economy—driven by the erosion of workers’ earning power from inflation and pandemic-related disruptions in the workforce,” Reuters noted.
Across the globe, many healthcare workers—including clinical laboratory scientists in countries like New Zealand—are feeling burnt out from working in understaffed departments for inadequate pay. Hopefully, in response to these strikes, governments and healthcare leaders can come to resolutions that bring critical medical specialists back to work.
It is more than a shortage of nurses, as most clinical laboratories report the same shortages of medical technologists and increased labor costs
Just as hospital-based clinical laboratories are unable to hire and retain adequate numbers of medical technologists (MTs) and clinical laboratory scientists (CLSs), the nursing shortage is also acute. Compounding the challenge of staffing nurses is the rapid rise in the salaries of nurses because hospitals need nurses to keep their emergency departments, operating rooms, and other services open and treating patients while also generating revenue.
The nursing shortage has been blamed on burnout due to the COVID-19 pandemic, but nurses also report consistently deteriorating conditions and say they feel undervalued and under-appreciated, according to Michigan Advance, which recently covered an averted strike by nurses at 118-bed acute care McLaren Central Hospital in Mt. Pleasant and 97-bed teaching hospital MyMichigan Medical Center Alma, both in Central Michigan.
“Nurses are leaving the bedside because the conditions that hospital corporations are creating are unbearable. The more nurses leave, the worse it becomes. This was a problem before the pandemic, and the situation has only deteriorated over the last three years,” said Jamie Brown, RN, President of the Michigan Nurses Association (MNA) and a critical care nurse at Ascension Borgess Hospital in Kalamazoo, Michigan Advance reported.
“The staffing crisis will never be adequately addressed until working conditions at hospitals are improved,” said Jamie Brown, RN (above), President of the Michigan Nurses Association in a press release. Brown’s statement correlates with claims by laboratory technicians about working conditions in clinical laboratories all over the country that are experiencing similar shortages of critical staff. (Photo copyright: Michigan Nurses Association.)
Nurse Understaffing Dangerous to Patients
In the lead up to the Michigan nurses’ strike, NPR reported on a poll conducted by market research firm Emma White Research LLC on behalf of the MNA that found 42% of nurses surveyed claimed “they know of a patient death due to nurses being assigned too many patients.” The same poll in 2016 found only 22% of nurses making the same claim.
And yet, according to an MNA news release, “There is no law that sets safe RN-to-patient ratios in hospitals, leading to RNs having too many patients at one time too often. This puts patients in danger and drives nurses out of the profession.”
Seven in 10 RNs working in direct care say they are assigned an unsafe patient load in half or more of their shifts.
Over nine in 10 RNs say requiring nurses to care for too many patients at once is affecting the quality of patient care.
Requiring set nurse-to-patient ratios could also make a difference in retention and in returning qualified nurses to the field.
According to NPR, “Nurses across the state say dangerous levels of understaffing are becoming the norm, even though hospitals are no longer overwhelmed by COVID-19 patients.”
Thus, nursing organizations in Michigan, and the legislators who support change, have proposed the Safe Patient Care Act which sets out to “to increase patient safety in Michigan hospitals by establishing minimum nurse staffing levels, limiting mandatory overtime for RNs, and adding transparency,” according to an MNA news release.
Huge Increase in Nursing Costs
Another pressure on hospitals is the rise in the cost of replacing nurses with temporary or travel nurses to maintain adequate staffing levels.
In “Hospital Temporary Labor Costs: a Staggering $1.52 Billion in FY2022,” the Massachusetts Health and Hospital Association noted that “To fill gaps in staffing, hospitals hire registered nurses and other staff through ‘traveler’ agencies. Traveler workers, especially RNs in high demand, command higher hourly wages—at least two or three times more than what an on-staff clinician would earn. Many often receive signing bonuses. In Fiscal Year 2019, [Massachusetts] hospitals spent $204 million on temporary staff. In FY2022, they spent $1.52 billion—a 610% increase. According to the MHA survey, approximately 77% of the $1.52 billion went to hiring temporary RNs.”
It’s likely this same scenario is playing out in hospitals all across America.
Are Nursing Strikes a Symptom of a Larger Healthcare Problem?
“But the problem is much bigger,” Fortune wrote. “Care workers—physicians, home health aides, early childhood care workers, physician assistants, and more—face critical challenges as a result of America’s immense care gap that may soon touch every corner of the American economy.”
Clinical laboratories are experiencing the same shortages of critical staff due in large part to the same workplace issues affecting nurses. Dark Daily covered this growing crisis in several ebriefings.
We also covered in that ebrief how the so-called “Great Resignation” caused by the COVID-19 pandemic has had a severe impact on clinical laboratory staffs, creating shortages of pathologists as well as of medical technologists, medical laboratory technicians, and other lab scientists who are vital to the nation’s network of clinical laboratories.
Hospitals across the United States—and in the UK, according to Reuters—are facing worker strikes, staff shortages, rising costs, and uncertainty about the future. Just like clinical laboratories and other segments of the healthcare industry, worker burnout and exhaustion in the wake of the COVID-19 pandemic are being cited as culprits for these woes.
But was it predictable and could it have been avoided?
“One of the big things to clear up for the public is that … we saw the writing on the wall that vacancies were going to be a problem for us, before the pandemic hit our shores,” Christopher Friese, PhD, professor of Nursing and Health Management Policy at the University of Michigan (UM), told NPR. Friese is also Director of the Center for Improving Patient and Population Health at UM.
Effects of the COVID-19 pandemic, and staffing shortages exasperated by it, will be felt by clinical laboratories, pathology groups, and the healthcare industry in general for years to come. Creative solutions must be employed to avoid more staff shortages and increase employee retention and recruitment.
Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’
Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through.
As Dark Daily’s sister publication The Dark Report, noted in “VALID and SALSA Acts Still Pending in Congress,” a standalone vote on either bill is unlikely this year. Instead, they would need to be attached to the larger spending bill. (If you’re not a subscriber to The Dark Report, check out our free trial.)
In an article for STAT, former FDA Commissioners Scott Gottlieb, MD (left), and Mark McClellan, MD, PhD (right), wrote, “The FDA is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations. The [VALID Act] would strengthen protections for consumers and patients for both diagnostic tests and cosmetics and make it easier for manufacturers to introduce better products.” (Photo copyrights: FDA/American Well.)
Political Parties Negotiating
At press time, a draft spending bill had not yet been introduced to Congress as lawmakers from both political parties negotiate funding levels.
A source told The Dark Report that until legislators hammer out those details, add-ons such as the VALID Act or SALSA are stalled. There is no guarantee either lab measure will be added to the spending bill.
“We don’t have agreements to do virtually anything,” said Senate Minority Leader Mitch McConnell (R-KY) to reporters on Dec. 6, according to Reuters. “We don’t even have an overall agreement on how much we want to spend,” he added. Reuters reported that Democrats and Republicans in the Senate were $25 billion apart in their proposals.
Congress could also pass a continuing resolution to keep the government open for a short time, which would allow lawmakers more opportunity to negotiate.
Former FDA Chiefs Weigh In
Meanwhile, proponents of the VALID Act have publicly turned the heat up for the bill. For example, STAT recently ran two commentaries—including a joint piece from a pair of former FDA commissioners—in support of the VALID Act.
Currently, LDTs are regulated through the Clinical Laboratory Improvement Amendments of 1988 (CLIA). However, supporters of the VALID Act argue that the complexity of modern LDTs deserves more scrutiny.
“The VALID Act would create a consistent standard for all tests, regardless of the kind of facility they were developed in or made in, as well as a modern regulatory framework that’s uniquely designed for the recent and emerging technologies being used to develop tests,” wrote Scott Gottlieb, MD, and Mark McClellan, MD, PhD, in STAT on Dec. 5.
Gottlieb and McClellan served as FDA commissioners from 2017-2019 and 2002-2004 respectively. They both currently serve on various boards for biotech and healthcare companies.
Pathologists, Clinical Lab Directors Express Concerns about VALID Act
Opponents of the VALID Act contend that LDT innovation will be stifled if clinical laboratories, particularly those at academic medical centers, need to spend the time and money to go through formal FDA approval. There is evidence that working pathologists in academic settings have legitimate concerns about the negative consequences that might result if the VALID Act was passed as currently written.
In “Might Valid Act Support Be Waning in Congress?” The Dark Report covered how on June 1 more than 290 pathologists and clinical laboratory directors sent a grassroots letter to a Senate committee asking for a series of concessions to be made for academic medical center labs under the VALID Act.
It is reasonable to assert that the majority of clinical laboratory professionals and pathologists are supportive of the SALSA bill, which would stop the next round of scheduled price cuts—as much as a 15% price reduction to many tests—to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). That is not true of support for the VALID Act, as currently written. Sizeable segments of the diagnostics industry have taken opposing positions regarding passage of that legislation.
For these reasons, both bills will be closely watched in coming weeks as Congress works to fund the federal government while, at the same time, incorporating a variety of other bills under the omnibus bill, which is a considered a “must pass” by many senators and representatives.
Clinical laboratory scientists should also know experts warn that ‘herd resistance’ is more likely than ‘herd immunity’ due to low vaccination rates in many parts of the world
Scientists estimate 73% of the US population may be immune to the SARS-CoV-2 omicron variant. Whether the nation is approaching “herd immunity” against the disease, however, remains open to debate, the Associated Press (AP) reported. These estimates are relevant to medical laboratories doing serology tests for COVID-19, as different individuals will have different immune system responses to COVID-19 infections and vaccines.
More than two years into the COVID-19 pandemic in the United States, the CDC’s COVID Data Tracker shows the number of daily cases dropped to fewer than 50,000 as of March 4, 2022, after reaching a high of 928,125 on January 3, 2022.
Meanwhile, the seven-day death rate per 100,000 people stands at 2.78. That’s significantly above the seven-day death rate reached last July of .45, but well below the 7.21 mark recorded on January 13, 2021.
“We’re clearly entering a new phase of the pandemic,” William Morice, II, MD, PhD, Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minn., told KARE11, an NBC affiliate.
Is Herd Immunity Achievable?
According to the AP, an estimated 73% of the US population is likely to be immune to the Omicron variant due to vaccination or natural immunity from contracting the disease. That calculation was done for the media outlet by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle. The IHME anticipates immunity to Omicron could rise to 80% this month, as more people receive vaccination booster shots or become vaccinated.
“Herd immunity is an elusive concept and doesn’t apply to coronavirus,” he told the Associated Press (AP).
Milton maintains populations are moving toward “herd resistance,” rather than “herd immunity.” This will transform COVID-19 into a permanent fixture with seasonal outbreaks similar to influenza.
Herd Immunity Varies, according to the WHO
Because antibodies that developed from vaccines—or natural immunity from a previous infection—diminish over time, waning protection means even those boosted or recently recovered from COVID-19 could be reinfected. In addition, vaccination rates vary widely around the world. Our World in Data estimates only 13.6% of people in low-income countries had received one dose of the COVID-19 vaccine as of March 7, 2022.
The World Health Organization (WHO) points out that herd immunity levels vary with different diseases. Herd immunity against measles requires about 95% of a population to be vaccinated, while the threshold for polio is about 80%.
“The proportion of the population that must be vaccinated against COVID-19 to begin inducing herd immunity is not known. This is an important area of research and will likely vary according to the community, the vaccine, the populations prioritized for vaccination, and other factors,” the WHO website states.
Living with COVID-19
Nonetheless, the US appears to be moving into a new “normal” phase of living with the disease.
In an interview with Reuters, US infectious disease expert Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases (NIAID) acknowledged a need for returning to normal living even though portions of the population—immunocompromised individuals and the unvaccinated, including children under age five who are not eligible for vaccination—remain vulnerable to more severe COVID-19.
“The fact that the world and the United States—and particularly certain parts of the United States—are just up to here with COVID, they just really need to somehow get their life back,” Fauci said. “You don’t want to be reckless and throw everything aside, but you’ve got to start inching towards that. There’s no perfect solution to this.”
Most states have lifted coronavirus-related restrictions, including masking requirements. As COVID-19 cases drop in California, Gov. Gavin Newsom put in motion a plan called SMARTER (Shots, Masks, Awareness, Readiness, Testing, Education, and Rx) that no longer responds to COVID-19 as a crisis, but instead emphasizes prevention, surveillance, and rapid response to future variant-based surges in cases.
“We have all come to understand what was not understood at the beginning of this crisis, that there’s no ending, that there’s not a moment where we declare victory,” Newsom told USA Today.
Mayo Clinic’s Morice agrees. “It can’t be out of sight, out of mind, per se, but it at least gives us hope that we can get back to some level of normalcy here over the course of the year,” he said.
Since clinical laboratories played a critical role in assay development and COVID-19 testing, medical laboratory leaders should continue monitoring COVID-19 as it moves from pandemic to endemic status due to high vaccination rates and advances in treatment options.
The COVID-19 pandemic has raised awareness among healthcare consumers as well, about the critical role laboratory medicine plays in modern medicine and healthcare. Medical laboratory leaders and pathologists would be wise to amplify this message and stress the importance of clinical laboratory testing for many diseases and healthcare conditions.
Japanese scientists who developed the detection method hope to use it to create ‘easy testing kits that anyone can use’
What do ostriches and humans have in common during the current COVID-19 pandemic? The unexpected answer is that ostrich antibodies can be used to identify humans infected with COVID-19. If proven viable in healthcare settings, the possibility exists that new clinical laboratory tests could be developed based on wearable diagnostics technologies that pathologists would interpret for doctors and patients.
The KPU scientists conducted a small study with 32 COVID-19 patients over a 10-day span. The surgical-style masks they wore later glowed around the nose and mouth areas but became dimmer over time as their viral load decreased.
“The ostrich antibody for corona placed on the mouth filter of the mask captures the coronavirus in coughing, sneezing, and water,” the researchers explained in Study Finds.
Tsukamoto himself learned he had contracted COVID-19 after wearing a prototype mask and noticing it glowed under UV light. A PCR test later confirmed his diagnosis, Kyodo News reported.
The KPU team “hopes to further develop the masks so they will glow automatically, without special lighting, if the [COVID-19] virus is detected.” Reuters noted in its coverage of the ostrich-antibody masks.
Making Medicine from Ostrich Antibodies
A profile in Audubon noted that Tsukamoto, who also serves as a veterinary medicine professor at Kyoto Prefectural University, made ostriches the focus of his research since the 1990s as he looked for ways to harness the dinosaur-like bird’s properties to fight human infections. He maintains a flock of 500 captive ostriches. Each female ostrich can produce 50 to 100 eggs/year over a 50-year life span.
Tsukamoto’s research focuses on customizing the antibodies in ostrich eggs by injecting females with inactive viruses, allergens, and bacteria, and then extracting the antibodies to develop medicines for humans. Antibodies form in the egg yolks in about six weeks and can be collected without harming the parent or young.
“The idea of using ostrich antibodies for therapeutics in general is a very interesting concept, particularly because of the advantages of producing the antibodies from eggs,” Ashley St. John, PhD, an Associate Professor in Immunology, at Duke-NUS Medical School in Singapore, told Audubon.
While more clinical studies will be needed before ostrich-antibody masks reach the commercial marketplace, Tsukamoto’s team is planning to expand their experiment to 150 participants with a goal of receiving Japanese government approval to begin selling the glowing COVID-detection masks as early as 2022. But they believe the ostrich-antibody technique ultimately may lead to development of an inexpensive COVID-19 testing kit.
“We can mass-produce antibodies from ostriches at a low cost. In the future, I want to make this into an easy testing kit that anyone can use,” Tsukamoto told Kyodo News.
Harvard, MIT Also Working on COVID-19 Detecting Facemask
According to Fast Company, the MIT/Harvard COVID-19-detecting masks use the same core technology as previous paper tests for Ebola and Zika that utilize proteins and nucleic acids embedded in paper that react to target molecules.
“They would especially be useful in situations where local variant outbreaks are occurring, allowing people to conveniently test themselves at home multiple times a day,” he told Fast Company.
“It’s on par specificity and sensitivity that you will get in a state-of-the-art [medical] laboratory, but with no one there,” Luis Ruben Soenksen, PhD, Venture Builder in Artificial Intelligence and Healthcare at MIT and one of the co-authors of the Nature Biotechnology study, told Fast Company.
As the definition of “wearable diagnostic technology” broadens, pathologists and clinical laboratory scientists may see their roles expand to include helping consumers interpret data collected by point-of-care testing technology as well as performing, evaluating, and interpreting laboratory test results that come from non-traditional sources.