Supply chain experts can explain ways clinical laboratories should evaluate their suppliers and sources
Suddenly, supply chain management has become a critical success factor as hospitals, health systems, and clinical laboratories throughout the United States respond to the COVID-19 pandemic. Demand for essential supplies has left many health network medical laboratories vulnerable and understocked.
One supply chain expert has several recommendations on how hospitals and clinical laboratories can respond to improve their access to needed supplies. Brent Bolton is Director of Supply Chain at Accumen, a developer of healthcare resource and performance solutions, including products specific to clinical laboratories. He says that expanding medical supply shortages—coupled with recently-issued federal regulatory guidelines—point to a potential “red-alert” disruption that will affect laboratories that want to maintain clinical testing services during this pandemic.
“There are important lessons to be learned from how the COVID-19 pandemic is disrupting the healthcare supply chain,” said Bolton. “It’s important to recognize that this is not a regional disruption for providers, such as what happens after a hurricane or a severe earthquake. It’s not even a national disruption. Rather, it is a global event where hospitals, physicians, and clinical laboratories in nearly every country are competing to redirect essential supplies to their organizations.”
Bolton said that, going forward, clinical laboratories would benefit from implementing Lean and Six Sigma process improvement techniques into inventory management and purchasing procedures when contracting for instruments, reagents, consumables, specimen collection supplies, and personal protective equipment (PPE), etc. These policies work well during periods of minimal supply/demand variability. But in the wake of COVID-19 it is imperative for supply chain professionals to be flexible and cautious. He described three useful steps:
“Many of the large medical laboratory distributors are partnering with American manufacturers that generally don’t create lab supplies—like Hewlett Packard, 3M, and Ford. Health systems can do the same. For instance, Accumen has created a distribution network of 3D printer manufacturers that have started creating 3D printed swabs to alleviate some of the supply issues.”
“Brokers who claim to have product are popping up everywhere, and some of them are scams. Most of the viable supply sources for swabs or masks, for example, require large purchases and payment in advance and generally health systems are not willing to take that risk. But these are unprecedented times and supply chains must be flexible and innovative to secure the products they need.”
“Unfortunately, this is just the first wave of shortages. The demand for testing reagents, nasopharyngeal swabs, and transport media will normalize. But, resuming elective surgeries will create blood shortages, serological testing will create shortages in consumables and blood collection devices, and increased COVID-19 testing along with population surveillance will continue to stress PPE supplies. Supply chain teams must be proactive.”
Thus, the importance of strategic planning and awareness of alternative supply sources is key to the survival of clinical laboratories moving forward, especially during times of unpredictable upheaval.
“One big issue is having enough of the supplies needed to protect the health and safety of the laboratory’s staff,” stated Bolton. “For example, in the US, a nationwide shortage of nasopharyngeal swabs and personal protective equipment, among others, increased the chance of exposure among our critical frontline clinical laboratory workers fighting the current SARS-CoV-2 coronavirus outbreak.”
“The price for C-diff testing was a loss leader, it should have been a red flag to do an assessment on their financial status,” said Bolton. “If Abbott or Roche did that strategy it’s no big deal—for them it’s a loss leader. But, with GBS, they had nothing else to fall back onto, so they were out of the market as quickly as they jumped in.”
Situations like these are visible clues that can warn clinical labs that a vendor may not be able to sustain its supply chain. When lab leaders see a growing company having financial problems that may cause difficulties in how it can keep its customers supplied with kits and reagents, they can consider that a useful warning that the possibility of a supply chain disruption may soon happen.
Most medical laboratories, Bolton explained, pick vendors based on the technology they are interested in buying for use in their labs. But at the moment that purchasing decision is made, there is seldom a strategic sourcing plan, nor have pre-approved and validated alternative sources been identified as backups should an emergency arise and the supply chain from that vendor is interrupted.
“The supply chain team and the clinical lab management team should initiate a long-term strategic sourcing roadmap together, which includes risk management and emergency preparedness plans. It is just another piece of managing the lab’s supply chain and having a robust supplier management program. Everything needs to be done holistically,” he advised.
How Clinical Laboratories Can Remain a Health System Asset During Times of Crisis
During a recent Dark Daily webinar, Bolton said that the medical laboratory supply chain is constantly evolving and involves a myriad of sourcing variables that inevitably present challenges and opportunities.
For example, he said that in other industries, it’s common practice for vendors to receive performance reviews on a quarterly basis, measured by the facility. Companies score each supplier on quality, service response time, price changes, and on-time delivery. Other factors such as flexibility, customer service, effective e-commerce, and inventory management also can be monitored.
“Clinical laboratories should consider selecting supply vendors based on similar criteria,” suggested Bolton. “The current disruptions in lab supply chains because of the pandemic are a reminder to all labs that supply chain risk reduction and cost efficiency are two ways to think strategically about the clinical laboratory as an asset (instead of a liability) for hospitals and health systems.”
In today’s healthcare environment, hospital executives think differently about ancillary services within their health networks. Clinical laboratories, in particular, have the attention of leadership—often as a cost center. That is why lab managers should help health system leaders think more strategically and position their lab as an asset for the system and a service line to drive integration.
To help clinical laboratory leaders increase their lab’s value by preparing for potential disruption to critical supply chains, Dark Daily offers a free on-demand webinar that explains:
Prevailing trends and challenges of lab operations prior to COVID-19;
Long-term strategic supply roadmapping for lab initiatives;
Utilizing capital planning to improve supply costs;
And more.
COOs, VPs of ancillary services, laboratory leaders, and supply chain leaders will gain critical insights from this crucial resource.
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.
The software applications (apps) and hardware monitoring devices involved in digital therapeutics enable physicians and patients to target and alter specific behaviors that affect certain medical conditions, such as substance abuse or depression. Combined with or without drugs, digital therapeutics are achieving positive results, according to the United Kingdom’s PwC (PricewaterhouseCoopers) Health Research Institute (PwC HRI).
The report goes on to state that digital therapeutics “is
reshaping the landscape for new medicines, product reimbursement and regulatory
oversight … [and that] new data sharing processes and payment models will be
established to integrate these products into the broader treatment arsenal and
regulatory structure for drug and device approvals.
“Connected health services,” the report continues, “enabled by devices that transmit data or connect to the Internet, give additional visibility into care delivery and new ways to improve patient outcomes.”
Digital therapeutics combine apps and monitoring devices for
the management and treatment of medical conditions. While similar to customer
wellness apps, digital therapeutics focus on specific clinical outcomes.
The non-profit Digital Therapeutics Alliance says that, unlike common “wellness” apps, digital therapeutics “possess the unique ability to incorporate additional functionalities into a comprehensive portfolio of synchronous products and services. This includes potential integration with mobile health platforms; the provision of complementary diagnostic or adherence interventions; the ability to pair with devices, sensors, or wearables; the delivery of interventions remotely; and integration into electronic prescribing, dispensing, and medical record platforms.”
“Digital therapeutics are the next frontier,” Sai Jasti, Chief Data and Analytics Officer, GlaxoSmithKline (NYSE:GSK), told PwC HRI. “I think we will see a lot more collaboration between pharmaceutical and technology companies to drive this forward, ultimately to the benefit of patients.”
Digital Therapeutics That Already Have FDA Approval
Digital therapeutics and their connected devices are subject
to the approval process of the federal Food and Drug Administration (FDA), and
some have already received that coveted clearance:
reSET from Pear Therapeutics is a 90-day prescription digital therapeutic (PDT) for substance use disorder (SUD). The Boston-based company also worked with Sandoz Inc., a division of Novartis, to receive FDA approval for reSET-O, a PDT for treating individuals with Opioid Use Disorder (OUD).
“Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way,” said Richard Francis, Division Head and CEO, Sandoz, in a press release. “New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes.”
Both reSET and reSET-O are software mobile apps that use cognitive behavioral therapy (CBT) to help individuals struggling with addictions.
“Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,” said Corey McCann, MD, PhD, President and CEO of Pear Therapeutics, in the press release following receiving FDA approval. “There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.”
Natural
Cycles is a birth control app created by a Sweden-based company of the same
name. It was approved by the FDA in 2018. This mobile app helps women track
their fertility to prevent unwanted pregnancies via the rhythm method. The app
analyzes data from past menstrual cycles and body temperature readings to
determine when the user is most fertile. On the days the user is most likely to
be ovulating, the app displays “Use Protection” on the mobile device’s screen.
“We know that women are more likely to use contraceptive methods when they have a variety of methods available to them, and the reality is that not every method is going to work for every woman,” Rebecca Simmons, PhD, Research Assistant Professor, Department of Obstetrics and Gynecology, University of Utah, told Health. “This is really exciting, in the sense that the more methods we have, the more likely it is that people can find something that works for them—and then can avoid unwanted pregnancy.”
Apple, headquartered in Cupertino, Calif., received FDA clearance in 2018 for an electrocardiogram (ECG) app for its Apple Watch Series 4 that allows users to take an ECG from their wrist to detect irregular heart rhythms and atrial fibrillation (AFIB).
“The role that technology plays in allowing patients to capture meaningful data about what’s happening with their heart—at the moment when it’s happening, like the functionality of an on-demand ECG—could be significant in new clinical care models and shared decision-making between people and their healthcare providers,” said Nancy Brown, CEO of the American Heart Association, in a press release.
Patients, Providers, and Big Pharma All Like Digital
Therapeutics
There is some evidence that patients and healthcare
providers are intrigued and willing to try digital therapeutics. In a PwC HRI survey,
more than 50% of respondents said they “would be somewhat or very likely to try
an FDA-approved app or online tool for treatment of a medical condition.”
Pharmaceutical companies also are interested in digital therapeutics. A 2018 PwC HRI survey found that 80% of pharmaceutical executives had plans to invest in digital therapeutics in the near future.
With precision medicine and pharmacogenetics, clinical laboratories
could play an essential role in supporting digital therapeutics in the future. But
to truly be competitive in this space and take advantage of the opportunity, medical
laboratories will need to increase their information technology and digital
capabilities.
Proven success at providing quality care to patients at home while lowering costs has both investors and health insurance companies intrigued
Some call it “hospital in the home.” Whatever name it is given, the high cost of keeping a patient overnight in a hospital is motivating a range of healthcare players to develop innovative ways to provide care to patients—even patients with acute conditions—in their home. This is a trend that clinical laboratories will want to watch.
With hospital beds costing $1,000 to $2,000 per night, the
economics of being treated in the comfort of their homes can be attractive to
patients. But it’s also popular with caregivers, investors, and payers, as well.
That’s why in-home healthcare services are becoming increasingly common
nationwide, and why clinical laboratories may be supplying services to more in-home
healthcare companies in the future.
One such company is DispatchHealth of Denver, Colo., which recently brought its “ER-at-Home” in-home healthcare model to cities in Texas, Massachusetts, and Washington State.
Focused primarily on seniors with high-acuity medical conditions, “Patients or caregivers contact DispatchHealth through their smartphone app, website, or phone call line and the company sends over a home care team consisting of a physician assistant or nurse practitioner, along with an [emergency] medical technician. The team has the ability to perform clinical laboratory studies, infusion, EKGs, and some higher-level procedures, such as the repair of complex lacerations,” MedCity News reported.
The DispatchHealth team arrives prepared to treat Influenza
(Flu), fever, joint or back pain, sprains, strains, eye infections, urinary
tract infections, skin rashes, and lacerations. The team also can treat more
severe conditions that cause nausea, vomiting, and diarrhea, as well as asthma
and other respiratory conditions, and illnesses of the ear, nose, and throat.
In addition, the DispatchHealth team can perform certain
clinical laboratory tests onsite, including:
High-acuity home care is a development that clinical
laboratory leaders will want to monitor because these services save people
trips to medical laboratories, urgent care centers, primary care doctors’
offices, and even emergency rooms.
“We strive to treat conditions between the ER and true emergencies—so COPD (chronic obstructive pulmonary disease) exacerbation, pneumonia, severe migraines, and other issues we can treat with IV (intravenous therapy) medication … and laboratory studies,” Mark Prather, MD, DispatchHealth Chief Executive Officer, told MedCity News, which noted the company’s partnership with Centura Health, Colorado Springs, Colo., among others.
Established in 2013 in Denver, DispatchHealth provides both
mobile and virtual healthcare, is in-network with healthcare insurance
companies, and has relationships with healthcare systems.
The company expanded this year into new markets and added
partnerships with more healthcare systems, including:
a “major nonprofit health system” in North Texas, according to a news release.
In the Spokane market, the company’s six teams and two vehicles can see about seven patients per day for an average of 45 minutes to an hour per visit, reported the Spokesman-Review. DispatchHealth employs more than 200 people and has raised more than $33 million in growth capital financing, according to a company statement.
The project involved and recognized medical practices that
effectively and efficiently cared for Medicare beneficiaries with chronic
conditions at home.
More recently, Northwell Health Labs, a division of Northwell Health, launched LabFly, a smartphone app that enables patients to schedule blood draws at home or at work, according to a news release.
“The app is a new way to give our patients access to the quality experience they would receive at one of our patient service centers, but in their living room or place of work,” said Dwayne Breining, MD, Executive Director, Northwell Health Labs, in the news release.
Investors Are Intrigued with In-Home Care
The business of treating people in their homes or offices
has some investors excited at the opportunity.
“To us, this feels like we’re investing in Uber in 2010. This is going to revolutionize and change the entire healthcare industry,” Samir Patel, Principal and co-founder of IRA Capital told the New York Times. Patel was commenting on his firm’s investment in Heal, a Los Angeles-based in-home healthcare company that launched in 2014.
In response to being contacted by smartphone app, computer, or phone, Heal sends primary care doctors and medical assistants to treat people in their homes, workplace, or at hotels.
Heal estimates completion of more than 100,000 house calls in 2019 and savings in healthcare expenses of more than $53 million due to treating people in lower cost ways, a news release stated. The company said it has experienced a 310% growth rate over 12 months and now operates in Atlanta, Georgia, California, New York, North Virginia, and the District of Columbia.
“Ten years from now, we will think of going to the doctor’s office as dated and arbitrary as going to the store to buy diapers compared to buying diapers on Amazon,” Nick Desai, co-founder of Heal, told FierceHealthcare, which reported Heal had raised $71 million from investors.
Payers Are Onboard as Well
High-acuity home care services also seem to align with health insurance company benefits and new federal payment models. Heal’s website states their services are in-network with most Medicare Advantage plans. Heal’s smartphone app also can verify insurance coverage.
DispatchHealth explains on its website that it contracts
with major payers, including Medicare and Medicaid, and charges self-pay
customers $275.
Medical laboratory leaders should consider developing
relationships with high-acuity home healthcare companies and other care
providers that deliver care to people in unconventional ways and in
non-traditional locations.
These virtual office visits use artificial intelligence and text messaging to allow real physicians to diagnose patients, write prescriptions, and order clinical laboratory tests
Clinical laboratories may soon be receiving test orders from physicians who never see their patients in person, instead evaluating and diagnosing them through a smartphone app. In response to major changes in the primary care industry—mostly driven by consumer demand—mobile app developers are introducing new methods for delivering primary care involving smartphones and artificial intelligence (AI).
Medical laboratories and pathology groups should prepare for consumers who expect their healthcare to be delivered in ways that don’t require a visit to a traditional medical office. One question is how patients using virtual primary care services will provide the specimens required for clinical laboratory tests that their primary care providers want performed?
Two companies on the forefront of such advances are 98point6 and K Health, and they provide a glimpse of primary care’s future. The two companies have developed smartphone apps that incorporate AI and the ability to interact with real physicians via text messaging.
Virtual Primary Care 24/7 Nationwide
Dark Daily has repeatedly reported that primary care in America is undergoing major changes driven by many factors including increasingly busy schedules, the popularity of rapid retail and urgent care clinics, consumer use of smartphones and the Internet to self-diagnose, and decreasing numbers of new doctors choosing primary care as a career path.
Writing in Stat, two physicians who had just completed internal medicine residencies, explained their own decisions to leave primary care. In their article, titled, “We were inspired to become primary care physicians. Now we’re reconsidering a field in crisis,” Richard Joseph, MD, and Sohan Japa, MD, cited factors that include long hours, low compensation in comparison with specialty care, and deficiencies in primary care training. At the time of their writing they were senior residents in primary care-internal medicine at Brigham and Women’s Hospital in Boston.
They also pointed to a decline in office visits to primary care doctors. “Patients are increasingly choosing urgent care centers, smartphone apps, telemedicine, and workplace and retail clinics that are often staffed by nurse practitioners and physician assistants for their immediate health needs,” they wrote.
One solution to declining populations of primary care physicians is a smartphone app created by Seattle-based 98point6. The service involves “providing virtual text-based primary care across the entire country, 24/7 of everyday,” explained Brad Younggren, MD, an emergency physician and Chief Medical Officer at 98point6, in a YouTube interview. “It’s text-based delivery of care overlaid with an AI platform on top of it.”
The service launched on May 1, 2018, in 10 states and is now available nationwide, according to press releases. 98point6 offers the service through individual subscriptions or through deals with employers, health plans, health systems, and other provider organizations. The personal plan costs $20 for the first year and $120 for the second, plus $1 per “visit.”
Subscribers use text messaging to interact with
an “automated assistant” that incorporates artificial intelligence. While
messaging, they can describe symptoms or ask questions about medical topics.
“After the automated assistant has gathered as many
questions as it deems necessary, it hands [the information] off to a
physician,” Younggren said. In most cases, all communication is via text
messaging. However, the doctor may ask the subscriber to send a photo or participate
in a video meeting.
The doctor then makes a diagnosis and treatment plan. Prescriptions can be sent to a local pharmacy and the subscriber can be referred to a clinical laboratory for tests. LabCorp or Quest Diagnostics are preferred providers, but subscribers can choose to have orders sent to independent labs as well, states the company’s website.
Younggren claims the company’s physicians can resolve more
than 90% of the cases they encounter. If, however, they can’t resolve a case, they
can refer the patient to a local physician. And because most of 98point6’s
interactions with subscribers are text-based, that messaging serves as reference
documentation for other doctors, he said.
The 98point6 physicians are full-time employees and work with the company’s technologists to improve the AI’s capabilities, Younggren said. The company claims its doctors can diagnose and treat more than 400 conditions, including: allergies, asthma, skin problems, coughs, flu, diabetes, high blood pressure, and infections. For medical emergencies, subscribers are advised to seek emergency help locally.
98point6 also can function as a front end for interacting
with patients in health systems that have their own primary-care doctors,
Younggren said. The company’s health system clients “don’t actually have a good
digital primary care front end to deliver care,” he said. “So, we can
essentially give them that, and then we can also get some detailed
understanding of how to coordinate care within the health system to drive
patients to the care that they need.” For example, this can include directing the
patient to an appropriate sub-specialist.
Leveraging Patient Data to Answer Health Questions
K Health in New York City offers a similar service based on its own AI-enabled smartphone app. The app incorporates data gleaned from the records of more than two million anonymous patients in Israel over the past 20 years, explained company co-founder Ran Shaul, co-founder and Chief Product Officer, in a blog post.
The software asks users about their “chief complaint” and
then compares the answers with data from similar cases. “We call this group
your ‘People Like Me’ cohort,” Shaul wrote. “It shows you how doctors diagnosed
those people and all the ways they were treated.”
The K Health app is free, but for a fee ranging from $14 for a one-time visit to $39 for an annual subscription, users can text with doctors, the company’s website states.
Unlike 98point6, K Health’s doctors are employed by “affiliated physician-owned professional corporations,” the company says, not K Health itself.
“The doctor you chat with will discuss a recommended treatment plan that may include a physical exam, lab tests, or radiology scans,” states K Health’s website. “They may send you directly for some of these tests, but others will require you to visit a local doctor.”
These are just the latest examples of new technologies and
services devised to help patients receive primary care. How a patient who uses
a smartphone app gets the necessary clinical laboratory tests performed is a
question yet to be answered.
Clinical laboratory leaders will want to watch this shift in
the delivery of primary care and look for opportunities to serve consumers who
are getting primary care from nontraditional sources.