Though the potential is high for false positives and false negatives, some experts believe at-home COVID-19 testing still holds promise for slowing the spread of the coronavirus
The kit includes a nasal swab for specimen collection and a shipping package for returning the sample to a designated medical laboratory. Pixel is designed to work with LabCorp’s COVID-19 RT-PCR test, a real-time reverse transcription polymerase chain reaction (rRT-PCR) test that determines if an active SARS-CoV-2 coronavirus is present. The Pixel specimen-collection kit can be purchased for $119 on LabCorp’s website.
Presently, the Pixel kit is only available to healthcare workers and first responders who are symptomatic or who believe they may have been exposed to the virus. However, in a news release LabCorp stated that it “intends to make COVID-19 self-collection kits available to consumers in the coming weeks.”
Though purchasers have to pay for the kit themselves, a notice on LabCorp’s website states that the company “will work with you to get your purchase reimbursed by your health plan,” and that LabCorp is “actively working on a more streamlined solution, so you don’t have to pay up front.” LabCorp created a COVID-19 microsite where customers can receive future updates on the Pixel at-home test kit.
In LabCorp’s news release, Adam Schechter (at podium), President and CEO, emphasized his company’s commitment to helping patients and healthcare providers fight the COVID-19 crisis through LabCorp’s “leading testing capabilities and deep scientific and research expertise,” adding, “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.” (Photo copyright: Yahoo News/Chip Somodevilla.)
Though Finger-stick At-home Tests Prove Inaccurate, Optimism Remains
As COVID-19 wreaks havoc around the globe, in vitro diagnostic (IVD) developers, clinical laboratory companies, and healthcare professionals have scrambled to find an accurate, cost effective way to definitively test individuals for the coronavirus.
Complicating matters is the fact that many people are asymptomatic carriers who show no symptoms of the illness, but who can infect others.
Earlier this year, the UK government was optimistic that an at-home serological antibodies test would enable its citizens to collect their own blood specimens via finger sticks, and that the test would provide a way for individuals to test themselves for the coronavirus.
According to CNBC, the United Kingdom (UK) ordered millions of antibody tests, but after disappointing results, returned the kits and requested a refund.
The New York Times (NYT) reported that the British government paid $20 million upfront for two million untried antibody test kits from two Chinese companies: AllTest Biotech in Hangzhou and Wondfo Biotech in Guangzhou. Then, UK government officials announced the tests would be available to citizens within weeks, and Prime Minister Boris Johnson publicly declared the tests would be “simple as a pregnancy test.”
Neither of those predictions would come to pass. In April, British researchers announced that none of the coronavirus tests they had tried were accurate enough to be of any value.
“We see many false negatives … and we also see false positives,” he wrote, adding that the UK “is now uniquely positioned to evaluate and find the optimal test for this disease, but no country has found a kit that is up to standard.” He also noted that locating such a test should be possible, but that it may take another month or more to find.
The Chinese companies defended their tests. In the Chinese newspaper Global Times, Wondfo stated its tests are “intended only as a supplement for patients who had already tested positive for the virus,” and on its website, AllTest stated its tests should “only [be] used by professionals,” not by patients at home, the New York Times reported.
Will At-home COVID-19 Testing Ever Work?
At-home testing kits for COVID-19 may seem like a great solution to the testing dilemma, but they could also prove to be problematic. “This may not be as good as it sounds,” Edo Paz, MD, a New York Presbyterian-trained cardiologist, Clinical Director at Heartbeat Health, and Vice President Medical, at K Health, a digital health company located in New York City, told CNET.
“Collecting a proper sample from the nose or mouth takes training and shipping delays of the specimen back to the lab could impact the quality of the sample,” he said, adding, “There could be a high false negative rate, leading people who are actually infected to believe they are not, potentially contributing to the crisis.”
Clinical pathologists have a unique understanding of the challenges that must be overcome for capillary blood to be of any use for testing, and of the potential for mishandling of specimens inherent in at-home test kits.
Nevertheless, with the SARS-CoV-2 coronavirus continuing to infect people around the world, the number and variety of tests will likely increase, which could create an upsurge in business for clinical laboratories and present new challenges for performing COVID-19 tests.
Privacy concerns have one tech giant suggesting alternatives to sharing potentially identifiable location tracking data
Expect an interesting debate on the use of location tracking as a way to manage this and future pandemics. It is a debate that has implications for clinical laboratories. After all, if location tracking identifies individuals who may have been exposed to an infectious disease, will health authorities want those individuals to be immediately tested?
Location tracking has been around for quite some time. Anyone who owns a smartphone knows that digital map and navigation software applications (apps) locate our position and track our movements. That’s how they work. Maps are good. But does collecting and sharing location tracking data violate personal privacy laws that some Silicon Valley tech giants want to use to help public health officials track disease? Maybe.
Google, Facebook, and other tech companies have been talking to the US federal government about ways to use location tracking data from smartphones and online software applications to combat the spread of SARS-CoV-2, the coronavirus that causes the COVID-19 illness, reported the Washington Post.
The tracking data could be used by public health officials
to spot disease outbreaks in populations and predict how it might spread. Analyzing
the data generated by smartphone tracking and reporting apps also could be used
to identify individuals who may have been exposed to the coronavirus, and who should
get clinical laboratory tests to determine if they need medical intervention.
However, Google is apparently resistant to using its collected location data to track and identify individuals. Instead, Google Health’s Head of Communications and Public Affairs, Johnny Luu, said Google was “exploring ways that aggregated anonymized location information could help in the fight against COVID-19. One example could be helping health authorities determine the impact of social distancing, similar to the way we show popular restaurant times and traffic patterns in Google Maps,” said Luu in a statement. He stressed, though, that any such arrangement “would not involve sharing data about any individual’s location, movement, or contacts,” reported the Washington Post.
Can Privacy be Maintained While Tracking Disease?
Google’s sister company, Verily, launched a screening website in March for people who believe they may have COVID-19. The pilot program is only available to some California residents. Users of the service complete a series of online questions to determine their coronavirus risk and whether or not they should seek medical attention.
To use the service, individuals must log into the site using
a Google account and sign a consent authorization form which states data
collected may be shared with public health officials, a move that has received
criticism.
Jacob Snow, JD, a technology and civil liberties attorney with the American Civil Liberties Union (ACLU) of Northern California, expressed concerns about Verily’s program. “COVID-19 testing is a vital public necessity right now—a core imperative for slowing this disease,” he told CNET. “Access to critical testing should not depend on creating an account and sharing information with what is, essentially, an advertising company.
“This is how privacy invasions have the potential to
disproportionately harm the vulnerable,” he continued. “Google should release
this tool without those limits, so testing can proceed as quickly as possible.”
Facebook, on the other hand, has had a Disease Prevention Map program in place for about a year. This program provides location information provided by individuals who choose to participate to health organizations around the globe.
“Disease prevention maps have helped organizations respond to health emergencies for nearly a year and we’ve heard from a number of governments that they’re supportive of this work,” said Laura McGorman, Policy Lead, Data for Good at Facebook, in a statement, reported CNET. “In the coronavirus context, researchers and nonprofits can use the maps, which are built with aggregated and anonymized data that people opt in to share, to understand and help combat the spread of the virus.”
Researchers at Carnegie Mellon University worked with Facebook to create the COVID-19 Symptom Map (above), which is based on aggregated data drawn from self-reported symptoms Facebook. The map, which updates regularly, is viewable by day, counties, hospital referral regions, and COVID-19 symptoms. “This is work that social networks are well-situated to do. By distributing surveys to large numbers of people whose identities we know, we can quickly generate enough signal to correct for biases and ensure sampling is done properly,” wrote Mark Zuckerberg, Facebook founder and CEO, in a Washington Post op-ed about the Carnegie Mellon’s results, reported MobiHealthNews. (Graphic copyright: Facebook/Business Insider.)
Privacy Organizations Voice Concerns
Privacy and civil liberties issues regarding the collection
and use of smartphone data to curtail the pandemic are of concern to some organizations.
There may be legal and ethical implications present when using personal data in
this manner.
Al Gidari, JD, Director of Privacy, Center for Internet and Society at Stanford University Law School, says the balance between privacy and pandemic policy is a delicate one, reported the Washington Post. “The problem here is that this is not a law school exam. Technology can save lives, but if the implementation unreasonably threatens privacy, more lives may be at risk,” he said.
In response to public privacy concerns following the Washington
Post’s report, representatives for Google and Facebook said the companies
have not shared any aggregated and anonymized data with the government
regarding contact
tracing and COVID-19, reported the Washington Post.
Google reiterated that any related projects are still in their early stages and that they are not sure what their participation level might look like. And, CEO Mark Zuckerberg stated that Facebook “isn’t prepared to turn over people’s location data en masse to any governments for tracking the coronavirus outbreak,” reported CNET.
“I don’t think it would make sense to share people’s data in a way where they didn’t have the opportunity to opt in to do that,” Zuckerberg said.
The potential use of location tracking data, when combined
with other information, is one example of how technology can leverage non-medical
information and match it with clinical data to watch population trends.
As of April 23, there were 2,637,911 confirmed cases of COVID-19 and 184,235 deaths from the coronavirus worldwide, according to www.worldometers.info/coronavirus. And, cases of coronavirus disease have been reported in 213 countries according to the World Health Organization (WHO).
As testing increases, more cases will be reported and it is
unknown how long the virus will continue to spread, so advocates of location
tracking and similar technologies that can be brought to bear to save lives during
a disease outbreak may be worth some loss of privacy.
Pathologists and medical laboratory professionals may want
to monitor the public debate over the appropriate use of location tracking.
After all, at some future point, clinical laboratory test results of
individuals might be added to location tracking programs to help public health
authorities better monitor where disease outbreaks are occurring and how they are
spreading.
Prior to the SARS-CoV-2 pandemic, large-scale collection of medical laboratory specimens from patients sitting in their cars was an untried concept. That is no longer true.
As of today, residents who meet certain criteria for exposure to SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—can now have their biological specimens collected at drive-through testing centers in New York and 29 other states.
Drive-through collection of medical laboratory specimens is just one more way that the COVID-19 pandemic has changed forever how healthcare in the United States is delivered. In actual practice, drive-through sites are proving that it is possible to collect samples from large numbers of patients without needlessly exposing phlebotomists and other healthcare professionals to this new infectious agent. Another benefit is reducing the number of infected people entering hospital emergency rooms to be tested and potentially infecting everyone there.
Using a drive-through collection site does minimize exposure for phlebotomists and other frontline healthcare workers while they collect samples for testing. That is an important benefit. Yet, experience shows that in operation these centers have had mixed results.
New York State’s First Drive-through Testing Location
New Rochelle, New York—one of the hotspots of the COVID-19
infection—opened the state’s first drive-through testing facility on March 13,
2020. At the time it opened, the center was one of only 10 in the country.
During the center’s first four days, 1,882 people were tested, reported the New York Times (NYT). Every one of those people met the following criteria to be tested at the drive-through center or at any other testing center in NY:
Patients must have qualifying symptoms, such as a fever and cough, or be a member of a high-risk population, such as the elderly or those with pre-existing conditions.
Patients must make an appointment either through a doctor’s referral addressed to the New York State Health Department, the entity that issues the appointment, or by calling the New York State Coronavirus hotline.
On the Coronavirus Frontlines
A CNBC article co-written by Vivian Velasquez-Caldera, a Northwell Health phlebotomist who volunteered to work at the New Rochelle drive-through testing center, titled, “I Work at a Coronavirus Drive-thru Testing Site in New York. Here’s What a 12-Hour Shift Looks Like,” described what it’s like for frontline healthcare workers during a two-week rotation at the testing center.
Velasquez-Caldera said that the site collects more than 1,000 specimens per day on average and that every three hours couriers from BioReference Laboratories pick up the samples. Testing and recording of the samples take place at a medical laboratory in Elmwood Park, N.J., and patients usually get their results in a few days.
When patients arrive at the site, they must remain in their car with the windows rolled up. New York State troopers direct cars using megaphones from a safe distance. When it is time for the nasopharyngeal swab samples to be collected, troopers direct the car into the testing zone and the passengers roll down the windows, but remain in their car. Healthcare workers in full hazmat suits approach the car and ask each passenger to tip his or her head back so that a series of nasal swabs can be taken.
“Prior to the pandemic, only nurses and doctors were allowed
to do the swabbing, so I had to train for the procedure,” wrote
Velasquez-Caldera. “It’s a delicate process and just one mistake could lead to
test result errors.”
Pathologists and clinical laboratory professionals should note that the medical staff doing the specimen collection at the drive-through site in Long Island, NY, shown above are in full protective gear. This is not the case at typical patient service centers operated by clinical laboratories throughout the US. (Photo copyright: Andrew Seng/The New York Times.)
Protecting Healthcare’s Finest
Phlebotomists and other frontline healthcare workers
collecting specimens at drive-through testing centers are putting themselves at
great risk for contracting the coronavirus. In Velasquez-Caldera’s case, as in
many others, these brave individuals are doing so voluntarily, so ensuring they
have protective gear is critical.
Velasquez-Caldera praises Northwell Health for its efforts in supplying workers with personal protective equipment (PPE). “I wear gloves and a jumpsuit that protect my entire body, along with a powered air-purifying respirator—a special face shield equipped with a respirator that cleans contaminated air before circulating it inside the suit,” wrote Velasquez-Caldera in her CNBC article.
Vivian Velasquez-Caldera (above), a phlebotomist with Northwell Health Labs, is shown at the drive-through COVID-19 testing site at Glen Island Park in New Rochelle, New York. “Every day, I see all kinds of expressions on people’s faces. There’s a lot of fear, yes, but mostly gratitude. They all leave and say, ‘Thank you. Thank you so much for what you’re doing,’” she said in a CNBC story she co-wrote. (Photo copyright: Northwell Health/CNBC.)
Lessons Learned at Drive-Through Centers
While the New Rochelle COVID-19 testing center has remained
opened and continues to collect thousands of specimens each week, other drive-through
testing centers haven’t fared as well. For example, Brooklyn opened a
drive-through testing center on March 20, 2020. But just two days later, the
site was closed.
Know the CDC guidelines thoroughly. The team at KSB used role-playing scenarios before opening the center. “Our staff was very intent on following CDC guidelines to best protect our patients and community,” said Linda Clemen, RN, VP/Chief Nursing Officer.
The goal is to help patients fast, not to be perfect. “We knew we were going to make mistakes—not at the cost of patient safety, but in operations—and we knew we’d figure things out as we went along,” said David Schreiner, President/CEO.
Find partners in the community who can help. In Dixon, KSB does the testing, but local health departments process the tests and follow up with patients.
Help other organizations. “We’re receiving calls from many of our colleagues around the area,” said Clemen. “We are sending each other our plans, algorithms, whatever could help them.”
Drive-through coronavirus testing is a unique approach to
collecting clinical laboratory specimens from large numbers of patients without
having them enter doctors’ offices or patient service centers operated by
clinical laboratories. If it can help minimize the exposure of phlebotomists
and other healthcare workers collecting the specimens it is worth pursuing.
Previously considered “junk,” scientists learn that parts of DNA which don’t produce proteins are more important than first thought
It turns out that the long stretches of DNA in the human genome that are commonly called “junk DNA” or “dark DNA” may be doing important work. Researchers at the Ontario Institute for Cancer Research (OICR) recently published their findings about stretches of junk DNA that may have a role in how cancers develop.
Until very recently only about 2% of the human genome was considered important. Researchers were most interested in the portion of DNA that produces proteins, known as the coding region or CDS (coding sequence). The rest of the genome, 98% of it, was considered “junk” DNA. The OICR researchers found that all that DNA might not be junk after all, but instead plays a critical role in preventing cancer.
The OICR study included samples from more than 1,800 patients
with different types of cancer. The researchers looked at more than 100,000
sections of each patient’s genome and examined mutation patterns within the
large, non-coding parts of DNA. The researchers found that those non-coding
areas can control how and when certain genes are activated.
“One of the 30 key regions discovered was predicted to have a significant role in regulating a known anti-tumor gene in cancer cells, despite being more than 250,000 base pairs away from the gene in the genome,” states the news release.
Viewing DNA in New Ways Brings Insights
Within just the last few years, researchers have begun to
consider the architecture of DNA, and have begun to study it as a three-dimensional
(3D) structure. What they’ve learned is that the twisting, turning way that DNA
is packaged tightly into the nucleus of cells serves an important purpose. The
structure of DNA allows areas of non-coding DNA to be in close proximity to
other sections, as the OICR researchers discovered with the anti-tumor gene.
This discovery has revealed patterns that weren’t obvious
when the DNA was examined as if it were stretched out in a flat line. Before
scientists considered DNA in three dimensions, they were only able to identify certain
mutations, such as BRCA,
which are rare but indicate a higher cancer risk.
In looking at DNA as a whole, including the non-coding parts, researchers were able to identify specific Single Nucleotide Polymorphisms (SNPs) that when in particular positions can impact a person’s risk of cancer.
“Cancer-driver mutations are relatively rare in these large non-coding regions that often lie far from genes, presenting major challenges for systematic data analysis,” noted Jüri Reimand, PhD (above), molecular geneticist and principal investigator at OICR, Assistant Professor at the University of Toronto, and lead author of the OICR study. “Powered by novel statistical tools and whole genome sequencing data from more than 1,800 patients, we found evidence of new molecular mechanisms that may cause cancer and give rise to more-aggressive tumors.” (Photo copyright: University of Toronto.)
Another study conducted by scientist in England at Cancer Research UK and published in the British Journal of Cancer (BJC), titled, “Nongenic Cancer-Risk SNPs Affect Oncogenes, Tumour-Suppressor Genes, and Immune Function,” reached similar conclusions. The authors of that study wrote that “cancer-risk SNPs are associated with the expression levels of oncogenes [a gene with the potential to cause cancer] and tumor suppressor genes at a far greater rate than expected by chance. This indicates not only that mutations in these cancer genes are important, but also that genetic control of these genes by regulatory variants plays an important role.”
CRISPR and AI Bring New Discoveries
All of these genetic discoveries are a long way from being useful in developing diagnostics and treatments that can be used to help patients. However, researchers are using existing gene sequencing technologies such as CRISPR, along with artificial intelligence (AI), to speed up development.
The OICR researchers used CRISPR-Cas9 genome editing to explore the cancer-driving area of DNA they identified. And the researchers who conducted the BJC study plan to develop AI models based on their work that will better predict cancer risk.
“What we found surprised us, as it had never been reported before. Our results show that small genetic variations work collectively to subtly shift the activity of genes that drive cancer. We hope that this approach could one day save lives by helping to identify people at risk of cancer as well as other complex diseases,” said John Quackenbush, PhD, Professor, Computational Biology and Chair, Department of Biostatistics, Harvard T.H. Chan School of Public Health and lead author of the Cancer Research UK study, in a news release.
Clinical pathology may be on the cusp of change, driven in
large part by the discoveries being made in the realms of omics. New cancer
biomarkers coming out of these studies would be a boon to anatomic pathologists
and clinical laboratory diagnostics. Increased development of precision
medicine treatments based on these research findings could save many lives.
Two major clinical laboratory conferences reschedule, as the SARS-CoV-2 pandemic continues to disrupt long-planned events; Many labs are losing money as fewer patients visit physicians
This week, the ongoing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic was responsible for two important developments in the clinical laboratory industry. Both involved the rescheduling of major annual conferences. In both cases, conference organizers are placing different bets on when they think the COVID-19 outbreak, the illness caused by the SARS-CoV-2 coronavirus, will have passed and when they believe some semblance of normalcy will return to both social interaction and business activities.
On Monday, the American Association of Clinical Chemistry (AACC) announced that it would reschedule its 2020 AACC annual meeting and exhibition—originally scheduled for July 26-30, 2020, at McCormick Place in Chicago—to Dec. 13-17, 2020, also at McCormick Place.
On the same day, Dark Daily’s sister publication, The Dark Report, announced it had rescheduled the 25th annual Executive War College on Laboratory and Pathology Management to new dates and to a new hotel. This conference will now take place on July 14-15, 2020, at the Hyatt Regency Hotel in New Orleans. This is a change from the originally scheduled date of April 28-29, 2020, and from the original location, the Sheraton New Orleans Hotel.
On its website, AACC stated: “Based on input from all stakeholder groups, and in close collaboration with host city officials, the organization is pleased to announce that AACC will be able to preserve the complete Annual Scientific Meeting and Clinical Lab Expo experience to which its members, exhibitors, and the entire laboratory medicine community have been looking forward. The 2020 AACC Annual Scientific Meeting and Clinical Lab Expo will now be held December 13-17, 2020, at McCormick Place in Chicago, IL, USA.”
Each conference claims to be “the largest” in some
dimension. Each year, AACC’s annual conference attracts more than 20,000
attendees, as measured by clinical chemists and other visitors to its Expo,
which features more than 750 lab companies.
While the Executive War College claims to be the largest conference serving the business, management, operations, and financial health needs of clinical laboratories and pathology groups. Each year, it hosts almost 900 attendees—generally senior administrators, lab executives, pathologist-business leaders, consultants, and in vitro diagnostics (IVD) manufacturers. The conference is supported by more than 50 corporate benefactors and sponsors.
AACC’s rescheduling of its conference from July to December
will delay two important activities:
Many lab scientists planning to attend were hoping to participate in the first assessments of the novel coronavirus pandemic, assuming that the pandemic had passed by mid-summer.
During AACC is when the nation’s major IVD manufacturers and companies that sell lab automation, instruments, test kits, reagents, and other products introduce their latest-generation solutions. Now, many of those product launches will be pushed back to December.
Meanwhile, organizers of the Executive War College are betting that the novel coronavirus pandemic will taper down, possibly synchronized with the end of the annual influenza season in North America, which is typically sometime in April or early May.
If this proves true, then conducting the conference on July 14-15, 2020, will give lab leaders the opportunity to gather and share lessons learned during this COVID-19 outbreak in time to prepare for a possible second outbreak of COVID-19 when the next influenza season arrives in the fall. It will also be an important opportunity for lab managers and pathologists to learn ways to restore revenue lost during the pandemic.
Clinical Laboratories, Pathology Groups, Hospitals, at
Brink of Financial Ruin
“What has gone unrecognized by the national news media is how the novel coronavirus pandemic is causing financial devastation to the finances of the nation’s clinical laboratories and anatomic pathology groups,” stated Robert L. Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College. “In absolute terms, the pandemic is a growing financial disaster to the medical lab industry, and it will take years for many labs to rebuild the staff that they have laid off or terminated in recent months in order to stay operational.
“Why are all labs losing money at this time?” asked Michel.
“The answer is simple—beginning early in March, patients stopped visiting their
doctors. Hospitals ceased to admit patients for elective procedures. Fewer
patients per day means fewer lab test referrals per day and loss of the revenue
generated by those claims that pays the salaries and expenses of the labs
performing those tests. Laying off or furloughing staff is one way labs lower
costs in response to lower income.
“Many clinical labs, pathology groups, and the hospitals
they serve are steadily approaching financial ruin,” he continued. “Every week
the pandemic continues, and North American citizens are advised to shelter in
place, forces labs to draw down their dwindling financial reserves to keep
their doors open.”
Robert Michel (above), Editor-in-Chief of The Dark Report and Dark Daily and Founder of The Dark Intelligence Group, will host the 25th anniversary Executive War College on Lab and Pathology Management on July 14-15, 2020, in New Orleans. Attendees from clinical laboratories and pathology groups will gain critical insights from such learning opportunities as: “Preparing Your Lab for a Second Outbreak of COVID-19,” and “Rapidly Building Cash Flow and Restoring Your Lab’s Financial Stability Post-Pandemic.” (Photo copyright: The Dark Report.)
This crisis has created three big questions that labs need
to answer:
How much longer will the COVID-19 pandemic last
before some degree of normalcy is restored (meaning patient office visits resume
and physicians begin ordering lab tests every day)?
If there is a second outbreak of SARS-CoV-2 this
fall, what does every lab need to know to be ready?
As American society and business return to
normal, how can labs quickly build up cash flow, collect more revenue, and
restore financial stability?
“Given the unknown aspects of the SARS-CoV-2 coronavirus,
the answer to the first question is a crap-shoot. But to reschedule the
Executive War College to dates that are 14 weeks away seems a reasonable bet,”
noted Michel. “The pay-off to that bet is the ability to provide the owners and
leaders of the nation’s labs answers to the second and third questions.
“The 14 weeks between now and mid-July give us the
opportunity to organize sessions and invite speakers who can provide answers
and information to help labs with their two most pressing needs: to be prepared
for another COVID-19 outbreak later this year, and to restore cash flow and
financial health as soon as possible,” said Michel. “This will be the very
first opportunity for lab managers and pathologists to assemble, learn the
COVID-19 lessons from successful labs, gain financial insights, and network
with their peers.”
The Executive War College team is inviting suggestions for
speakers and session topics for the July 14-15 conference. The original agenda
that was taking shape for the planned dates of April 28-29 will be revised so
as to include presentations now directly relevant to the state of the clinical
lab and pathology professions for mid-year 2020. Send your suggestions for
topics and speakers to info@darkreport.com.
Information on registering for the 25th annual Executive War College, and on placing reservations at the Hyatt Regency Hotel in New Orleans, is available on the EWC website (or copy and paste this URL in your browser: https://www.executivewarcollege.com.)
People already registered for Executive War College 2020
will have their registrations automatically applied to the new July 14-15
dates.
Because patient satisfaction continues to drive Medicare scoring, interest grows in technologies that reduce or remove pain from the patient’s experience, particularly when a phlebotomist draws blood for clinical laboratory testing
This is why hospital administrators are devoting more
attention—and budget dollars—to products that have the potential to reduce the
pain experienced by patients. And patient satisfaction surveys regularly
identify pain during phlebotomy procedures as an issue.
Enter PIVO,
a sterile single-use device created by San Francisco-based Velano Vascular Technologies that
attaches to an existing peripheral
intravenous (PIV) line to extract blood samples from patients through the
use of a vacuum tube or syringe, relieving the pain of additional needle
sticks.
Needle-free blood draws is not a new concept. But the fact
that hospitals are adopting such technologies indicates that the need to
improve the patient experience is motivating more hospitals to spend money on
these types of devices.
Velano Vascular’s PIVO device (above) works by pushing a small, flexible flow tube through the IV line and directly into the vein to collect as much blood as needed for medical laboratory testing. After the blood collection has been completed, PIVO is retracted and removed from the IV and discarded. As public demand for pain free healthcare increases, will the practice of phlebotomy in all healthcare settings need to adopt as well? (Photo copyright: HIT Consultant.)
Nurses Approve of No-Stick Technology
The Centura Health system in Centennial, Colo., utilizes
PIVO at all 17 of its hospitals throughout Colorado and western Kansas.
Centura’s goal is to “eliminate some of the suffering that goes along with
needlesticks for inpatients,” Rhonda Ward, MSN,
Vice President Nursing Services and Chief Nursing Officer, South Denver Group, Centura Health, told Modern
Healthcare.
“It adds no pain to the patient,” she said. “Unfortunately,
nurses, just by nature of their work, have to create discomfort in some of the
things that they have to do. So not creating more pain for the patient has been
a big satisfier.”
Velano Vascular first gained
FDA marketing clearance for its proprietary intravenous blood-draw device
in 2015. Later that same year, Intermountain
Healthcare in Salt Lake City became the first healthcare system in the
country to implement the PIVO device. Intermountain now uses PIVO in all 22 of
its hospitals.
“Blood draws are critical, common elements in modern medicine, but they cause an unnecessary amount of anxiety, pain and risk due to the use of century-old technology and practice,” said Kim Henrichsen, MSN, Senior Vice President, Clinical Operations/Chief Nursing Executive, Intermountain Healthcare, in a press release. “We are thrilled to offer a new standard of care that, over time, will help obviate the need for needles used for hospital blood collection. This commitment to standardizing draws will enhance quality for both patients and practitioners.”
According to the Velano website, there are 400 million
inpatient blood draws in the US each year, with each patient receiving 10 to 20
needlesticks per hospital stay. The site also states there are more than 1,000
practitioner needlestick injuries per day in the US and that approximately one
in five people in the country are needle phobic. The company claims the
advantages of the PIVO device include reducing patient pain and anxiety, making
blood draws easier for Difficult Venous Access (DVA) patients, and making the
blood extraction process safer for practitioners.
“It is baffling that in an era of smartphones and space
travel, clinicians draw blood by penetrating a vein with a needle—oftentimes in
the early morning hours,” said Todd
Dunn, Director of Innovation at Intermountain Healthcare Transformation Lab
in the Intermountain press release. “Through our Design for People program, we
resolved to find a better way for our phlebotomists and nurses to more humanely
and consistently draw blood. Following 15,000 PIVO draws on adults and children
with no adverse events and overwhelmingly positive feedback from patients and
caregivers alike, it is clear that we are together establishing a new standard
of care.”
According to a
survey commission by Velano Vascular and conducted by Charter Oak Research of more than 6,500
nurses from 24 hospitals regarding the blood collection process:
Eight out of ten nurses are concerned about
needle safety.
One in three patients are considered tough
sticks.
88% of the nurses felt that blood collection
sticks and re-sticks negatively impact the patient experience.
76% of the nurses would prefer to use needle-free
blood draws over venipuncture.
84% of the nurses said they would advocate for a
needle-free blood draw device.
One of the key findings in the survey found that there is a
lack of standardization in blood collection, and that there is “significant variability
in who and how blood is collected across patient floors and time of day.”
“Commercial demand for PIVO and our family of novel solutions is being driven by a move to one-stick hospitalization and a growing realization that removing needles from blood draws improves the patient experience, protects practitioners, and boosts the bottom line,” Eric Stone, Chief Executive Officer and co-founder, Velano Vascular, told FierceBiotech.
More Research versus Patient Outcomes
Though there are peer-reviewed studies and white papers
outlining positive patient outcomes surrounding the use of the PIVO device,
some professionals feel more research on the product is needed.
“All of these studies would suggest that additional study
would be warranted,” Diane Robertson,
Director Health Technology Assessment and ECRIgene Information Services at the ECRI Institute, told Modern Healthcare.
“But while the evidence is inconclusive at this point on a number of the
potential benefits, in studies and in our look at safety information, there’s
been no indication that there’s been any harm from this technology. It’s
reasonable for hospitals to consider it. It goes back to weighing the
patient-oriented outcomes.”
The need to improve the patient experience and improve
patient satisfaction scores is motivating hospital administrators to spend
money and resources on products like the PIVO device. Clinical laboratory
leaders should be aware of the rate of adoption of such products by healthcare
systems.
Continued growth in products that can collect medical
laboratory specimens without a traditional venipuncture performed by a
phlebotomist could give innovative labs a new way to add value in patient care
in both inpatient and outpatient settings.
