By taking early measures to combat the spread, the country had a medical laboratory test for COVID-19 available as early as Jan. 24, and was able to focus medical laboratory testing on the most at-risk individuals
With the Coronavirus disease 2019 (COVID-19) outbreak dominating headlines and medical laboratories under growing pressure to increase testing capacity, Taiwan’s rapid response to the pandemic could provide a critical model for other countries to follow.
Given its proximity to mainland China—just 81 miles—and the large number of individuals who frequently travel back and forth between the countries, Taiwan was at risk of having the second-highest number of imported COVID-19 cases, according to a model developed by researchers at Johns Hopkins University and the University of New South Wales Sydney. News reports indicate that, each year, about 60,000 flights carry 10 million passengers between Taiwan and China.
Data from Taiwan’s Centers for Disease Control (CDC) and Central Epidemic Command Center (CECC) indicate that the country has managed to contain the outbreak thanks to these aggressive actions.
As of March 19, Taiwan’s CECC reported a total of 108 laboratory-confirmed COVID-19 infections. That compares with 81,155 in China, 41,035 in Italy, and 10,755 in the US, according to data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. When the World Health Organization (WHO) reports on the number of COVID-19 cases by country, it includes the number of COVID-19 cases from Taiwan under the totals for the People’s Republic of China. WHO made this decision several years ago, under pressure by China to not recognize Taiwan as an independent nation.
The World
Population Review website says Taiwan’s population is about 23.8 million.
But its infection rate is low even on a per capita basis: Approximately 45
infections per million population, compared with 6,784 in Italy, 564 in China,
and 326 per million in the US.
The JAMA authors noted that Taiwan was prepared for
an outbreak after its experience with the severe
acute respiratory syndrome (SARS) pandemic in 2003, which also originated
in China.
Timeline of COVID-19 Outbreak at the Earliest Stages
Taiwan apparently learned a lesson about preparedness from
the SARS outbreak the rest of the world did not and that enabled the tiny
nation to respond immediately to the novel Coronavirus threat.
The country’s efforts began on Dec. 31 with inspections of
flight arrivals from Wuhan. “When there were only a very few cases [of
COVID-19] reported in China, [Taiwanese health authorities] already went onto
every airplane that came from Wuhan,” C. Jason Wang,
MD, PhD, an Associate Professor of Pediatrics and Director of the Center for Policy, Outcomes, and
Prevention at Stanford University and lead author of the JAMA
report, told Vox.
“Health officials came on the airplane and checked people for symptoms,” he
added.
Travelers who had recently visited Wuhan and displayed
symptoms of pneumonia were quarantined at home for 14 days. Taiwan’s
CDC reported that quarantined individuals were being tested for the
2019-nCoV coronavirus (later renamed to SARS-CoV-2)
soon after it was identified. The CECC, activated in January to coordinate the
government’s response, reported the first confirmed imported case on Jan. 21.
On Jan. 24, their
CDC announced that testing for the virus was being performed at the CDC and
eight designated hospitals. Testing included samples from physicians around the
country. As of Feb. 17, daily testing capacity was about 1,300 samples, the JAMA
authors reported.
Wang told Vox that aggressive measures to identify
and isolate at-risk individuals at the earliest stages reduced the volume of clinical
laboratory tests that had to be performed. “Here in the US and elsewhere, we’re
now seeing community spread,” he said. “It’s probably been here for a while.
And so now we’re trying to see, ‘Oh, how many people should we test?’ Then, you
really need to have a very large capacity in the beginning.”
More Actions by Authorities
The JAMA report supplementary materials notes a total of 124 actions taken by Taiwanese authorities between Jan. 20 and Feb. 24 to contain the outbreak. In addition to the border inspections, quarantines and testing, they included integration of data between the country’s National Health Insurance Administration and National Immigration Agency, so authorities, and later hospitals, could identify any patient who had recently traveled to China, Hong Kong, or Macau.
The steps also included:
An escalating series of travel restrictions,
eventually including suspension of most passenger flights from Taiwan to China,
as well as a suspension of tours to Hong Kong or Macau.
Use of government-issued cell phones to monitor
quarantined individuals.
Fines for individuals breaking the 14-day home
quarantine.
Fines for incoming travelers who failed to
provide accurate health information.
Fines for disseminating false information or
rumors about the epidemic.
Fines and jail sentences for profiteering on disease-prevention
products.
Designation of military camps and other
government facilities for quarantine.
Nationwide disinfection of universities,
colleges, and public spaces around schools.
The government also took aggressive action to ensure
adequate supplies of surgical masks, including stepped-up manufacturing, export
bans, price limits, and a limit of one to three masks per purchase.
The JAMA authors noted that government officials issued daily press briefings to educate the public about the outbreak. Communication efforts also included public service announcements by Taiwan Vice President Chen Chien-jen, a trained epidemiologist.
A poll taken in Taiwan on Feb. 17 and 18 indicated high approval ratings for officials’ response to the crisis.
The JAMA authors also noted some “challenges” in the
government’s response. For example, most real-time public communication was in
Mandarin Chinese and sign language, leaving out non-Taiwanese citizens in the
country. And the cruise ship Diamond Princess, later found to have infections
on board, was allowed to dock near Taipei and disembark passengers. There are
also questions about whether similar policies can be sustained through the end
of a pandemic.
Still, “well-trained and experienced teams of officials were
quick to recognize the crisis and activated emergency management structures to
address the emerging outbreak,” the JAMA authors wrote. “Taiwan is an
example of how a society can respond quickly to a crisis and protect the
interests of its citizens.”
One noteworthy difference in the speedy response to
recognition of a novel coronavirus in Taiwan, compared to recognition of the
same novel coronavirus in the United States, was the fast availability of
clinical laboratory tests for COVID-19 in Taiwan.
Pathologists and clinical laboratory professionals here in
the US are frustrated that their skills and talents at developing and
validating new assays on an accelerated timeline were not acknowledged and
leveraged by government officials as they decided how to respond to the
emergence of the novel coronavirus now called SARS-CoV-2.
In a separate study, HHS finds a 40% increase in sepsis cases, as more patients succumb to infections without effective antibiotics and antimicrobial drugs
Given the drastic steps being taken to slow the spread of the Coronavirus in America, it’s easy to forget that significant numbers of patients die each year due to antibiotic-resistant bacteria (ARB), other forms of antimicrobial resistance (AMR), and in thousands of cases the sepsis that follows the infections.
The CDC’s website states that “more than 2.8 million antibiotic-resistant infections occur in the US each year, and more than 35,000 people die as a result.” And a CDC news release states, “on average, someone in the United States gets an antibiotic-resistant infection every 11 seconds and every 15 minutes someone dies.”
Those are huge numbers.
Clinical laboratory leaders and microbiologists have learned to be vigilant as it relates to dangerously infectious antimicrobial-resistant agents that can result in severe patient harm and death. Therefore, new threats identified in the CDC’s Antibiotic Resistance Threats in the United States report will be of interest.
Drug-resistant Microbes That Pose Severe Risk
The CDC has added the fungus Candida auris (C. auris) and carbapenem-resistant Acinetobacter (a bacteria that can survive for a long time on surfaces) to its list of “urgent threats” to public health, CDC said in the news release. These drug-resistant microbes are among 18 bacteria and fungi posing a greater threat to patients’ health than CDC previously estimated, Live Science reported.
The CDC considers five threats to be urgent. Including the
latest additions, they are:
Dark Daily has regularly covered the healthcare industry’s ongoing struggle with deadly fungus and bacteria that are responsible for hospital-acquired infections (HAI) and sepsis. This latest CDC report suggests healthcare providers continue to struggle with antimicrobial-resistant agents.
Acinetobacter Threat Increases and C. auris
a New Threat since 2013
Carbapenem-resistant Acinetobacter, a bacterium that
causes pneumonia and bloodstream and urinary tract infections, escalated from
serious to urgent in 2013. About 8,500 infections and 700 deaths were noted by the
CDC in 2017.
C. auris, however, was not addressed in the 2013
report at all. “It’s a pathogen that we didn’t even know about when we wrote
our last report in 2013, and since then it’s circumvented the globe,” said Michael
Craig, Senior Adviser for the CDC’s Antibiotic Resistance Coordination and
Strategy Unit, during a news conference following the CDC announcement, Live
Science reported.
Today, C. auris is better understood. The fungus
resists emerging drugs, can result in severe infections, and can be transmitted
between patients, CDC noted.
By year-end, CDC tracking showed 988 cases in the US.
More Patients Getting Sepsis as Antibiotics Fail: HHS
Study
In a separate study published in Critical Care Medicine, a journal of the Society of Critical Care Medicine (SCCM), the US Department of Health and Human Services (HHS) found that antibiotic-resistant bacteria and fungi are resulting in more people acquiring sepsis, a life-threatening condition, according to an HHS news release.
Sepsis increased by 40% among hospitalized Medicare patients
from 2012 through 2018, HHS reported.
“These (untreatable infections) are happening here and now in the United States in large numbers. This is isn’t some developing world thing. This isn’t a threat for 2050. It’s a threat for here and now,” Cornelius “Neil” Clancy, MD, Associate Chief of Veterans Affairs Pittsburg Health System (VAPHS) and Opportunistic Pathogens, told STAT.
It is troubling to see data about so many patient deaths
related to antibiotic-resistant infections and sepsis cases when the world is
transfixed by the Coronavirus. Nevertheless, it’s important that medical laboratory
leaders and microbiologists keep track of how the US healthcare system is or is
not responding to these new infectious agents. And, to contact infection
control and environmental services colleagues to enhance surveillance, ensure
safe healthcare environments and equipment, and adopt appropriate strategies to
prevent antibiotic-resistant infections.
At present, medical laboratories are collecting blood specimens for testing by authorized public health labs. However, clinical laboratories should prepare for the likelihood they will be called on to perform the testing using the CDC test or other tests under development.
“We need to be vigilant and understand everything related to the testing and the virus,” said Bodhraj Acharya, PhD, Manager of Chemistry and Referral Testing at the Laboratory Alliance of Central New York, in an exclusive interview with Dark Daily. “If the situation comes that you have to do the testing, you have to be ready for it.”
The current criteria for determining PUIs include clinical features, such as fever or signs of lower respiratory illness, combined with epidemiological risks, such as recent travel to China or close contact with a laboratory-confirmed COVID-19 patient. The CDC notes that “criteria are subject to change as additional information becomes available” and advises healthcare providers to consult with state or local health departments if they believe a patient meets the criteria.
Test Kit Problems Delay Diagnoses
On Feb. 4, the FDA issued a Novel Coronavirus Emergency Use Authorization (EUA) allowing state and city public health laboratories, as well as Department of Defense (DoD) labs, to perform presumptive qualitative testing using the Real-Time Reverse Transcriptase PCR (RT-PCR) diagnostic panel developed by the CDC. Two days later, the CDC began distributing the test kits, a CDC statement announced. Each kit could test 700 to 800 patients, the CDC said, and could provide results from respiratory specimens in four hours.
However, on Feb. 12, the agency revealed in a telebriefing that manufacturing problems with one of the reagents had caused state laboratories to get “inconclusive laboratory results” when performing the test.
“When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories,” said Nancy Messonnier, MD, Director of the CDC National Center for Immunization and Respiratory Diseases (NCIRD), during the telebriefing. “Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct.”
During a follow-up telebriefing on Feb. 14, Messonnier said
that the CDC “is reformulating those reagents, and we are moving quickly to get
those back out to our labs at the state and local public health labs.”
Serologic Test Under Development
The current test has to be performed after a patient shows
symptoms. The “outer bound” of the virus’ incubation period is 14 days, meaning
“we expect someone who is infected to have symptoms some time during those 14
days,” Messonnier said. Testing too early could “produce a negative result,”
she continued, because “the virus hasn’t established itself sufficiently in the
system to be detected.”
Messonnier added that the agency plans to develop a serologic test that will identify people who were exposed to the virus and developed an immune response without getting sick. This will help determine how widespread it is and whether people are “seroconverting,” she said. To formulate this test, “we need to wait to draw specimens from US patients over a period of time. Once they have all of the appropriate specimens collected, I understand that it’s a matter of several weeks” before the serologic test will be ready, she concluded.
“Based on what we know now, we believe this virus spreads
mainly from person to person among close contacts, which is defined [as] about
six feet,” Messonnier said at the follow-up telebriefing. Transmission is
primarily “through respiratory droplets produced when an infected person coughs
or sneezes. People are thought to be the most contagious when they’re most
symptomatic. That’s when they’re the sickest.” However, “some spread may happen
before people show symptoms,” she said.
The virus can also spread when people touch contaminated surfaces and then touch their eyes, nose, or mouth. But it “does not last long on surfaces,” she said.
Where the Infection Began
SARS-CoV-2 was first identified during an outbreak in Wuhan, China, in December 2019. Soon thereafter, hospitals in the region “were overwhelmed” with cases of pneumonia, Dr. Acharya explained, but authorities could not trace the disease to a known pathogen. “Every time a new pathogen originates, or a current pathogen mutates into a new form, there are no molecular tests available to diagnose it,” he said.
So, genetic laboratories used next-generation sequencing, specifically unbiased nontargeted metagenomic RNA sequencing (UMERS), followed by phylogenetic analysis of nucleic acids derived from the hosts. “This approach does not require a prior knowledge of the expected pathogen,” Dr. Acharya explained. Instead, by understanding the virus’ genetic makeup, pathology laboratories could see how closely it was related to other known pathogens. They were able to identify it as a Betacoronavirus (Beta-CoVs), the family that also includes the viruses that cause SARS and Middle East Respiratory Syndrome (MERS).
This is a fast-moving story and medical laboratory leaders are advised to monitor the CDC website for continuing updates, as well as a website set up by WHO to provide technical guidance for labs.
This is an opportunity for top-producing sales reps from medical laboratories, anatomic pathology groups, and lab vendors to achieve national recognition at the upcoming Executive War College
Nominations are now open for The Dark Report’s 5th
Annual National Lab Sales Excellence Awards. This awards program recognizes
those laboratory sales professionals who exceed sales goals and successfully
help their lab organization win new clients and expand market share.
Nominating applications are available at Executive War College/5th Annual National Lab Sales Excellence Awards and should be submitted by the sales professional’s sales manager based on the sales rep’s 2019 performance. Winners will receive an all-expense paid trip to New Orleans for the 25th Annual Executive War College on Lab and Pathology Management on April 28-29.
Each winner will also receive a check for $2,000!
“This is the fifth year for this first and only national recognition program in the United States for sales professionals involved in the clinical laboratory profession,” stated Robert L. Michel, Editor-in-Chief of The Dark Report. “It’s important for our industry because it shows the leaders and pathologists in other labs that, despite negative trends in the lab marketplace, there are sales professionals who continue to generate substantial volumes of new clients, new specimens, and new revenue for the clinical labs and pathology groups they represent.
“Moreover, as the sales team in your lab learns what some of
their top-performing peers have accomplished, it raises the bar and motivates
them to achieve more and reach for stretch goals that benefit them personally
and contribute to the success of the lab that they represent,” emphasized
Michel.
“Each year, the winners of the National Lab Sales Excellence
Award tell us that this recognition was not only important for them, but that
their hospital CEO and senior administrators took notice and it raised the
profile of the lab throughout the entire hospital because of the national
recognition for the accomplishments of the lab’s top sales producer. In some
cases, the local newspapers picked up the story and reported it—another
positive benefit for the lab in the community. Some award winners report that
just the news coverage of the award led to new accounts from physicians who
wanted the top service these lab sales professionals deliver.”
Winners are selected in each of three categories that represent
the major sectors of the lab testing marketplace. The sectors are:
Hospital Laboratory Outreach;
Independent Clinical/Anatomic Pathology
Laboratory (including molecular and genetic testing); and
Nominations for National Lab Sales Excellence Awards
“We are asking that the sales managers and sales VPs of
these sales reps nominate their top candidates. Nominations of these
high-achieving medical lab industry sales professionals for the National Lab
Sales Excellence Award are being accepted now. Details and the nominating form
are available by clicking here
or by copy and pasting this URL into your web browser: https://www.executivewarcollege.com/lab-sales-excellence-award-contest/.
To be considered, nominee applications should encompass
actual sales results, feedback from nominating managers, and references from
clients. Lab sales professionals will also be judged on other variables, such
as:
The competitive environment;
Compliance with all state and federal
regulations; and
Ethical behavior.
“A panel of judges will evaluate each nomination,” noted
Michel. “These are individuals with their own impressive track record in sales
and marketing. They understand the techniques of ethical selling, the unique
aspects of marketing laboratory tests, and how much effort is required to build
the number of clients, specimen volume, and revenue from assigned territories.”
2020 Lab Sales Awards to Be Announced on April 29 in New
Orleans
Nominations for the National Lab Sales Achievement Award are
to be submitted to the offices of The Dark Report by Friday, March 20,
2020. Winners in each of the three categories will be notified by April 3 to
allow them time to make arrangements to travel to New Orleans to be at the
Executive War College for the award ceremony.
“Lab CEOs and hospital/health network lab administrators should recognize how having a winner from their sales team can turbo-charge their entire clinical laboratory sales program,” observed Michel. “By their nature, the 20% of the sales reps in your marketing program who do 80% of the business are highly competitive. We’ve had the sales vice presidents who nominated their top sales producer tell us, a year later, that having a National Lab Sales Excellence Award winner motivated the entire sales team, and that their lab saw substantial increases in specimen volume and revenue because other sales reps wanted to step up to the plate and show what they could produce.”
Michel also took the time to address the long-standing
popular wisdom in the clinical laboratory industry that every lab wants to keep
its top sales producers under wraps, because if competitors knew how much new
lab business they were generating, competitors would recruit them away.
“This is one of those clinical lab industry widely-held beliefs that
needs to disappear,” he explained. “The reality is that, in every community,
competing labs (and competing sales reps) always know who the top producers
are. Good lab leaders know how to retain their top performers and one way to do
that is to boost their reputations and recognize their sales achievements by
nominating these high-energy, result-driven producers for the unique
recognition that comes from the National Lab Sales Excellence Award.”
Lab CEOs, administrators, Sales VPs, and Sales Managers—you can click here to get the nominating form for the 5th Annual National Lab Sales Excellence Awards (or by pasting this URL into your browser: http://www.executivewarcollege.com/wp-content/uploads/National-Lab-Sales-2020-Nomination-Form_02-13-2020.pdf).
Clinical laboratory leaders are aware that reference pricing is a tool employers and health insurer can use to reduce the wide variation different providers charge for the same clinical service. In 2016 our sister publication, The Dark Report, devoted an entire issue to the subject of reference pricing. (See TDR, “The Newest Threat to Lab Revenues: Reference Pricing in Healthcare,” September 6, 2016.)
The Dark Report wrote about the reference pricing pilot conducted by Safeway, the grocery chain, in collaboration with Anthem, Inc. (NYSE:ANTM), the large health insurance company. The reference pricing program had these elements:
When Safeway employees and their beneficiaries chose a lab that priced its tests below the 60th percentile, the patient qualified for the health plan’s benefits. But if the patient chose a lab with test prices above the 60th percentile, that patient was responsible for the full cost of the test.
Safeway employees and their beneficiaries were given a real-time price checking tool that they could access by web browser and smart phone. This app, developed by Castlight Health, Inc., of San Francisco, showed the prices each lab in the Safeway/Anthem network charged for the same lab test, along with the percentile price of that test.
As reported in JAMA Internal Medicine, Safeway introduced reference pricing into its health insurance design for 15,000 employees in 2011. Three years later, the company and its employees were spending 32% less for clinical laboratory tests and saved $2.57 million during the years 2011 to 2013.
The reference pricing program at Safeway, which focused
primarily on clinical laboratory testing, succeeded because of the large
variability in how different labs price the same tests. For example, as TDR
reported:
For a basic metabolic panel, which was the most
commonly prescribed test, prices among different labs ranged from $5.75 to
$126.44; and
Prices for a lipid panel ranged from $8.85 to
$74.92.
Typically, a reference pricing arrangement is done to lower
costs, decrease disparities in pricing for similar medical services, and make
health plans more attractive to employers. This is why state health plans are
looking at implementing reference price reimbursement models as a way to reduce
healthcare costs for state employees and other beneficiaries.
North Carolina Providers Respond Negatively to State Reference
Pricing Plan
North Carolina’s State Health Plan encountered resistance
from the state’s medical community when it attempted to implement a similar
reference-price reimbursement model.
The state’s health plan covers more than 727,000
beneficiaries, including teachers, state employees, retired employees, and
their dependents. It is overseen by the State Treasurer and administered by BlueCross
BlueShield of North Carolina (Blue Cross NC).
In October 2018, North Carolina’s state health plan board of
trustees unanimously approved the Clear
Pricing Project, a reference-pricing program championed by State Treasurer Dale Folwell. A 2019 Blue
Cross NC State Health Plan Network Master Reimbursement Exhibit document
states, beginning in 2020, most hospitals would get 160% of the Medicare rate
for inpatient services and 230% for outpatient services; rural providers would
get more.
Pricing for medical lab and pathology services also was set
at 160% of the Medicare rate. The document states, “Except for services
identified by Medicare as CLIA Excluded or CLIA Waiver,
In-Office Laboratory Service fees will be limited to those services for which
you have provided Blue Cross and Blue Shield of North Carolina with evidence of
CLIA
certification.”
North Carolina’s healthcare providers had no choice but to
agree to the pricing to be included in the state’s provider network, but they
were not happy about the arrangement.
NCHA Warns Hundreds of Providers Could Be Pushed Out of
Network
Hospitals countered with a public relations and lobbying
campaign through the North Carolina Healthcare
Association (NCHA). Soon after Folwell’s announcement, the NCHA issued a
statement claiming that his plan “could force hundreds of providers out of
the State Health Plan network or out of business.” The NCHA estimated the
potential losses to hospitals and health systems at “upwards of $400 million.”
In the statement, NCHA President Steve
Lawler said, “We believe the treasurer is not being transparent about what
this proposal will do to state health plan members and their families.”
As an alternative, the NCHA proposed that the state examine
value-based approaches such as “case management, outcomes-based payment models,
and member education as ways to manage costs.”
The organization established a web page explaining its opposition
to the state’s plan and pushed for legislation that would delay its
implementation. House
Bill 184, which sought to delay implementation of the state’s healthcare
reimbursement plan, passed the state House of Representatives in April, before
stalling in the Senate in May, North
Carolina Health News reported.
Many providers simply refused to sign the necessary
contracts, Modern
Healthcare reported, even after Folwell agreed to increase the average
rate to 196%. In August, he relented and announced that for 2020, the provider
network will consist of the North Carolina State Health Plan Network—28,000
providers that had signed on to the Clear Pricing Project—plus the Blue Options
PPO Network, which includes providers that had not agreed to the new pricing.
That makes for a total of more than 68,000 providers, states
a news
release from the treasurer’s office. After the change was announced,
providers in the State Health Plan Network were permitted to revert to the Blue
Options PPO Network rates.
States may approach implementing reference pricing in
different ways, which will likely lead to a distinct disparity in outcomes. Nevertheless,
whatever approach is used, medical laboratories and pathology groups will want
to understand how reference pricing works and how it may be implemented in
their states.
Armed with that understanding, they may want to pursue a
proactive strategy of aligning the prices of their lab tests to be at the 50th percentile
or lower to avoid being the highest-priced labs in their communities and
regions.