Dogs’ acute sense of smell can even surpass effectiveness of some clinical laboratory testing in detecting certain diseases in humans
When it comes to COVID-19 testing, a recent Italian study demonstrates that trained dogs can detect SARS-CoV-2 with accuracy comparable to rapid molecular tests used in clinical laboratories. The researchers wanted to determine if dogs could be more effective at screening people for COVID-19 at airports, schools, and other high-traffic environments as a way to detect the coronavirus and reduce the spread of this infectious disease.
Scientists at the State University of Milan in Italy conducted a study that shows dogs can be trained to accurately identify the presence of the COVID-19 infection from both biological samples and by simply smelling an individual.
For their validation study, the Italian team trained three dogs named Nala, Otto, and Helix, “to detect the presence of SARS-CoV-2 in sweat samples from infected people. At the end of the training, the dogs achieved an average sensitivity of 93% and a specificity of 99%, showing a level of accuracy highly consistent with that of the RT-PCR [reverse transcription polymerase chain reaction] used in molecular tests and a moderate to strong reproducibility over time,” Nature reported.
RT-PCR tests are the current gold-standard for SARS-CoV-2 detection. This is yet another example of scientists training dogs to smell a disease with “acceptable” accuracy. This time for COVID-19.
“We only recruited dogs that showed themselves predisposed and positively motivated to carry out this type of activity. One of the fundamental aspects was not to cause stress or anxiety in the subjects used,” Federica Pirrone, PhD (above), Associate Professor, Department of Veterinary Medicine and Animal Sciences, University of Milan, and one of the authors of the study told Lifegate. “Training always takes place using positive reinforcement of a food nature: whether it’s a particularly appetizing morsel, a biscuit, or something that associates the dog’s search with a rewarding prize.” In some instances, dogs have been shown to be as good or more effective at detecting certain diseases than clinical laboratory testing. (Photo copyright: Facebook.)
Dogs More Accurate than Rapid Antigen Testing
Nala and four other dogs (Nim, Hope, Iris and Chaos) were later trained by canine technicians from Medical Detection Dogs Italy (MDDI) to identify the existence of the SARS-CoV-2 virus by directly smelling people waiting in line in pharmacies to get a nasal swab to test for the coronavirus.
Working with their handlers, the five dogs accurately signaled the presence or absence of the virus with 89% sensitivity and 95% specificity. That rate is “well above the minimum required by the WHO [World Health Organization] for rapid swabs for SARS-CoV-2,” according to Nature.
“The results of studies published so far on the accuracy of canine smell in detecting the presence of SARS-CoV-2 in biological samples (e.g., saliva, sweat, urine, trachea-bronchial secretions) from infected people suggest that sniffer dogs might reach percentages of sensitivity and specificity comparable to, or perhaps even higher, than those of RT-PCR,” the scientists wrote in Scientific Reports.
“However, although most of these studies are of good quality, none of them provided scientific validation of canine scent detection, despite this being an important requirement in the chemical analysis practice. Therefore, further applied research in this field is absolutely justified to provide definitive validation of this biodetection method,” the researchers concluded.
Other Studies into Using Dogs for Detecting Disease
Scientists from the Division of Biological and Health Sciences, Department of Agriculture and Livestock at the University of Sonora; and the Canine Training Center Obi-K19, both in Hermosillo, Mexico, conducted the study “as part of a Frontiers of Science Project of the National Council of Science and Technology (CONACYT), in which in addition to analyzing sweat compounds, trained dogs are put to sniff the samples and make detections in people who show symptoms or could be positive for coronavirus,” Mexico Daily Post reported.
The researchers trained four dogs with sweat samples and three dogs with saliva samples of COVID-19 positive patients. The samples were obtained from a health center located in Hermosillo, Sonora, in Mexico. The dogs were restricted to spend five minutes per patient and the researchers calculated the performance of the dogs by measuring sensitivity, specificity, and their 95% confidence intervals (CI).
The researchers concluded that all four of the dogs could detect COVID-19 from either sweat or saliva samples “with sensitivity and specificity rates significantly different from random [sampling] in the field.” According to the Frontiers in Medicine study, the researchers found their results promising because, they said, it is reasonable to expect the detection rate would improve with longer exposure to the samples.
The objective of the Mexican researchers is for the dogs to ultimately reach the sensitivity range requested by WHO for the performance of an antigen test, which is at least 80% sensitivity and 97% specificity. If that goal is achieved, dogs could become important partners in the control of the COVID-19 pandemic, the scientists wrote.
Data obtained so far from these studies indicate that biosensing dogs may represent an effective method of screening for COVID-19 as well as other diseases. More studies and clinical trials are needed before the widespread use of dogs might become feasible. Nevertheless, scientists all over the world are finding that Man’s best friend can be a powerful ally in the fight against the spread of deadly diseases.
In the meantime, the gold standard in COVID-19 testing will continue to be the FDA-cleared assays used by clinical laboratories throughout the United States.
It is more than a shortage of nurses, as most clinical laboratories report the same shortages of medical technologists and increased labor costs
Just as hospital-based clinical laboratories are unable to hire and retain adequate numbers of medical technologists (MTs) and clinical laboratory scientists (CLSs), the nursing shortage is also acute. Compounding the challenge of staffing nurses is the rapid rise in the salaries of nurses because hospitals need nurses to keep their emergency departments, operating rooms, and other services open and treating patients while also generating revenue.
The nursing shortage has been blamed on burnout due to the COVID-19 pandemic, but nurses also report consistently deteriorating conditions and say they feel undervalued and under-appreciated, according to Michigan Advance, which recently covered an averted strike by nurses at 118-bed acute care McLaren Central Hospital in Mt. Pleasant and 97-bed teaching hospital MyMichigan Medical Center Alma, both in Central Michigan.
“Nurses are leaving the bedside because the conditions that hospital corporations are creating are unbearable. The more nurses leave, the worse it becomes. This was a problem before the pandemic, and the situation has only deteriorated over the last three years,” said Jamie Brown, RN, President of the Michigan Nurses Association (MNA) and a critical care nurse at Ascension Borgess Hospital in Kalamazoo, Michigan Advance reported.
“The staffing crisis will never be adequately addressed until working conditions at hospitals are improved,” said Jamie Brown, RN (above), President of the Michigan Nurses Association in a press release. Brown’s statement correlates with claims by laboratory technicians about working conditions in clinical laboratories all over the country that are experiencing similar shortages of critical staff. (Photo copyright: Michigan Nurses Association.)
Nurse Understaffing Dangerous to Patients
In the lead up to the Michigan nurses’ strike, NPR reported on a poll conducted by market research firm Emma White Research LLC on behalf of the MNA that found 42% of nurses surveyed claimed “they know of a patient death due to nurses being assigned too many patients.” The same poll in 2016 found only 22% of nurses making the same claim.
And yet, according to an MNA news release, “There is no law that sets safe RN-to-patient ratios in hospitals, leading to RNs having too many patients at one time too often. This puts patients in danger and drives nurses out of the profession.”
Seven in 10 RNs working in direct care say they are assigned an unsafe patient load in half or more of their shifts.
Over nine in 10 RNs say requiring nurses to care for too many patients at once is affecting the quality of patient care.
Requiring set nurse-to-patient ratios could also make a difference in retention and in returning qualified nurses to the field.
According to NPR, “Nurses across the state say dangerous levels of understaffing are becoming the norm, even though hospitals are no longer overwhelmed by COVID-19 patients.”
Thus, nursing organizations in Michigan, and the legislators who support change, have proposed the Safe Patient Care Act which sets out to “to increase patient safety in Michigan hospitals by establishing minimum nurse staffing levels, limiting mandatory overtime for RNs, and adding transparency,” according to an MNA news release.
Huge Increase in Nursing Costs
Another pressure on hospitals is the rise in the cost of replacing nurses with temporary or travel nurses to maintain adequate staffing levels.
In “Hospital Temporary Labor Costs: a Staggering $1.52 Billion in FY2022,” the Massachusetts Health and Hospital Association noted that “To fill gaps in staffing, hospitals hire registered nurses and other staff through ‘traveler’ agencies. Traveler workers, especially RNs in high demand, command higher hourly wages—at least two or three times more than what an on-staff clinician would earn. Many often receive signing bonuses. In Fiscal Year 2019, [Massachusetts] hospitals spent $204 million on temporary staff. In FY2022, they spent $1.52 billion—a 610% increase. According to the MHA survey, approximately 77% of the $1.52 billion went to hiring temporary RNs.”
It’s likely this same scenario is playing out in hospitals all across America.
Are Nursing Strikes a Symptom of a Larger Healthcare Problem?
“But the problem is much bigger,” Fortune wrote. “Care workers—physicians, home health aides, early childhood care workers, physician assistants, and more—face critical challenges as a result of America’s immense care gap that may soon touch every corner of the American economy.”
Clinical laboratories are experiencing the same shortages of critical staff due in large part to the same workplace issues affecting nurses. Dark Daily covered this growing crisis in several ebriefings.
We also covered in that ebrief how the so-called “Great Resignation” caused by the COVID-19 pandemic has had a severe impact on clinical laboratory staffs, creating shortages of pathologists as well as of medical technologists, medical laboratory technicians, and other lab scientists who are vital to the nation’s network of clinical laboratories.
Hospitals across the United States—and in the UK, according to Reuters—are facing worker strikes, staff shortages, rising costs, and uncertainty about the future. Just like clinical laboratories and other segments of the healthcare industry, worker burnout and exhaustion in the wake of the COVID-19 pandemic are being cited as culprits for these woes.
But was it predictable and could it have been avoided?
“One of the big things to clear up for the public is that … we saw the writing on the wall that vacancies were going to be a problem for us, before the pandemic hit our shores,” Christopher Friese, PhD, professor of Nursing and Health Management Policy at the University of Michigan (UM), told NPR. Friese is also Director of the Center for Improving Patient and Population Health at UM.
Effects of the COVID-19 pandemic, and staffing shortages exasperated by it, will be felt by clinical laboratories, pathology groups, and the healthcare industry in general for years to come. Creative solutions must be employed to avoid more staff shortages and increase employee retention and recruitment.
Expect there to be more clinical laboratory testing at pharmacies as retail pharmacy chains expand their primary care offerings
Walgreens Boots Alliance (NASDAQ:WBA) of Deerfield, Illinois, continues to expand its primary care footprint with VillageMD’s latest acquisition of Starling Physicians, a multi-specialty physicians group with 30 locations in Connecticut, according to a VillageMD news release. Walgreens is the majority owner of VillageMD, which now has more than 700 medical centers, Healthcare Dive noted.
This deal continues the trend of corporations acquiring physician practices. Already, the majority of physicians are employees, not partners in a private practice physician group. Under corporate ownership, these physician groups often decide to change their clinical laboratory providers. For that reason, managers and pathologists at local medical laboratories will want to explore how they might provide daily lab testing services to the corporate owners of these primary care clinics.
The Hartford Business Journal called VillageMD’s acquisition of Starling Physicians—which is subject to a state investigation for possible certificate-of-need requirement—one of Connecticut’s “more high-profile healthcare merger and acquisition deals in Connecticut in recent years.”
The Starling Physicians group acquisition comes just a few months after
VillageMD paid $8.9 billion for Summit Health-CityMD of Berkeley Heights, New Jersey, with primary care services in the Northeast and Oregon. Walgreens invested $3.5 billion in that transaction, a Summit Health news release noted.
These acquisitions by Walgreens/VillageMD provide opportunities for local clinical laboratories to serve the physicians in these practices, though the operations may have a different patient flow and work process than traditional family practice clinics located in medical offices around community hospitals.
“Starling shares our vision of being a physician-led model and they provide care in a compassionate and exceptional way to all the patients they serve. By integrating primary care with specialty care, we are able to optimize access to high-quality care for our patients,” said Tim Barry (above), CEO and Chair of VillageMD in the news release. “This is a natural extension of our growth in the Northeast, including our recent acquisition of Summit Health-CityMD. Together, we are transforming the way healthcare is delivered in the United States.” Clinical laboratories in these areas will want to develop a strategy for serving the physicians practicing at these non-traditional locations. (Photo copyright: The Business Journals.)
Primary Care at Retail Locations a Growing Trend
Dark Daily and its sister publication The Dark Report have reported extensively on the growing trend by pharmacy chains and other retail superstores to add primary care services to their footprint.
In “By 2027, Walgreens Wants 1,000 Primary Care Clinics,” The Dark Report covered how Walgreens had disclosed that it would spend $5.2 billion to acquire a 63% interest to become the majority owner of VillageMD. Fierce Healthcare reported that “[Walgreens] planned to open at least 600 Village Medical at Walgreens primary-care practices across the country by 2025 and 1,000 by 2027.”
VillageMD is a primary care provider with same-day appointments, telehealth virtual visits, in-home care, and clinical laboratory diagnostic testing such as blood tests and urinalysis. Many VillageMD practices are located in buildings next door to Walgreens sites throughout the United States. (Photo copyright: Walgreens.)
Other Retailers Investing in Primary Care
Other retailers have recently taken deeper dives into healthcare as well.
According to Forbes, “The acquisition comes amid a flurry of acquisitions across the US for doctor practices, which are being purchased at an unprecedented pace by large retailers like Walgreens Boots Alliance, CVS Health, Amazon, and Walmart. Meanwhile, medical care providers owned by health insurers like UnitedHealth Group’s Optum and Cigna’s Evernorth are also in the doctor practice bidding war.”
And in February, CVS announced plans to acquire for $10.6 billion Oak Street Health, a Chicago-based primary care company with 169 medical centers across 21 states that plans to have more than 300 centers by 2026.
Do Clinical Laboratories Want Retail Customers?
The question of whether clinical laboratories should pursue retail customers is at this point academic. Consumer demand is driving the change and labs that don’t keep up may be left behind.
“The trend of putting full-service primary care clinics in retail pharmacies is a significant development for the clinical laboratory industry,” wrote Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “These clinics will need clinical lab tests and can be expected to shift patients away from traditional medical clinic sites for two reasons—lower price and convenience—since this new generation of primary care clinics will be located around the corner from where people live and work.”
Thus, healthcare system laboratories or large reference labs may want to reach out to Walgreens, CVS, Amazon, and Walmart for test referrals. These and other large retailers are investing heavily in the belief that consumers will continue to seek convenience in their healthcare.
New federal funds likely to spark additional growth in hospital-at-home programs across the US while creating need for clinical laboratories to serve these homebound patients
In one of the latest examples of health systems’ providing acute care to patients outside of traditional hospital settings, Orlando Health announced its launch of the Orlando Health Hospital Care at Home program serving central Florida.
According to an Orlando Health press release, “The Orlando Health program is the first in Central Florida to be approved for Medicare and Medicaid patients, with future plans to expand the service for patients with private insurance and at other Orlando Health locations. It is an extension of a federal initiative created during the height of the COVID-19 pandemic to increase hospital capacity and maximize resources.”
Orlando Health is a not-for-profit healthcare system with 3,200 beds at 23 hospitals and emergency departments. It is the fourth largest employer in Central Florida with 4,500 physicians and 23,000 employees. Its Hospital Care at Home program serves patients who meet clinical criteria with 24/7 telehealth remote monitoring and virtual care from the Orlando Health Patient Care Hub. In-person nursing visits are also offered daily, according to Orlando Health.
“Orlando Health wanted to be able to provide a different level of care for its patients and give them a different opportunity to be cared for other than the brick-and-mortar of the hospital,” Linda Fitzpatrick (above), Assistant Vice President for Advanced Care at Orlando Health told Health News Florida. “We’ll have decreased infectious rates in their homes, decreased exposures. It is a healthier and happier place to be in order to heal.” Clinical laboratories in the Orlando area will have the opportunity to serve healthcare providers diagnosing patients in non-traditional healthcare settings. (Photo copyright: Orlando Sentinel.)
Lowering Costs and Avoiding In-hospital Infections, Medical Errors
Treating patients at home, even after inpatient visits, can save them money. At the same time, patients are more comfortable in their own homes and that contributes to faster recoveries.
“[We’ll be able to measure] heart rate, respiration, temperature, and blood pressure. We’ll also do video conferencing from that location with the patient. We’ll have nurses going to the patient’s home at least twice a day,” interventional cardiologist Rajesh Arvind Shah, MD, Senior Medical Director of Hospital Care at Home, Orlando Health, told Health News Florida.
Orlando Health patients can be safely treated in their homes for many conditions including:
According to the American Hospital Association (AHA), “many are seeing the hospital-at-home model as a promising approach to improve value. … This care delivery model has been shown to reduce costs, improve outcomes, and enhance the patient experience. In November 2020, the Centers for Medicare and Medicaid Services launched the Acute Hospital Care at Home program to provide hospitals expanded flexibility to care for patients in their homes.”
Hospital-in-the-Home (HITH) is considered by many experts to be safer for patients, as they are not exposed to nosocomial (hospital-acquired) infections, falls, and medical errors. In its landmark “To Err is Human” report of 1999, the Institute of Medicine (IOM) estimated that medical errors killed as many as 98,000 patients in hospitals annually.
And in “Australia’s Hospital-in-the-Home Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes,” we predicted that wider adoption of that country’s HITH model of patient care would directly affect pathologists and clinical laboratory managers who worked in Australia’s hospital laboratories. Having more HITH patients would increase the need to collect specimens in patient’s homes and transport them to a local clinical laboratory for testing, and, because they are central to the communities they serve, hospital-based medical laboratories would be well-positioned to provide this diagnostic testing.
New Federal Funds for HITH Programs
One recent impetus to create new HITH programs was the passing of the Consolidated Appropriations Act, 2023 (HR 2617). The federal bill includes two-year extensions of the telehealth waivers and Acute Hospital Care at Home (AHCaH) individual waiver that got started during the COVID-19 pandemic.
As of March 20, the federal Centers for Medicare and Medicaid Services (CMS) listed 123 healthcare systems and 277 hospitals in 37 states that had been approved to use the AHCaH wavier.
Now that federal funding for AHCaH waivers has been extended, more healthcare providers will likely start or expand existing HITH programs.
“I think [the renewed funding] is going to allow for additional programs to come online,” Stephen Parodi, MD, Executive Vice President External Affairs, Communications, and Brand, Permanente Federation; and Associate Executive Director, Permanente Medical Group, told Home Health Care News.
“For the next two years, there’s going to be a regulatory framework and approval for being able to move forward. It allows for the collection of more data, more information on quality, safety, and efficiency of these existing programs,” he added. Parodi also oversees Kaiser Permanente’s Care at Home program.
Labs without Walls
Clinical laboratories can play a major role in supporting HITH patients who require timely medical test results to manage health conditions and hospital recovery. Lab leaders may want to reach out to colleagues who are planning or expanding HITH programs now that federal funding has been renewed.
Even US military clinical laboratories strive to cut costs, protect quality, and improve outcomes
Defense Health Agency (DHA), a part of the federal Department of Defense (DOD), recently launched a plan to consolidate healthcare facilities within certain geographical regions and to unify and integrate the military’s clinical laboratory operations in those areas. The goal is to streamline efficiencies and lower costs while maintaining quality lab testing services.
The DOD operates a nationwide network of medical treatment facilities (MTFs) that include state-of-the-art clinical and anatomic pathology laboratories serving military personnel and their families. These military labs face the same issues of cost, efficiency, and outcomes as do civilian clinical laboratories throughout the United States.
To address those challenges and bring together clinical laboratory services in specific regions, the DHA established the Tidewater Market in April of 2021 to serve select US Air Force, Army, and Navy MTFs in the Washington DC metro area, central North Carolina, Jacksonville, and coastal Mississippi.
Tidewater is the fifth Military Health System (MHS) market created to manage MTFs as they transition into the DHA.
Health.mil—a website maintained by the MHS as an informational resource for those it serves—describes the MHS as “one of America’s largest and most complex healthcare institutions, and the world’s preeminent military healthcare delivery operation.
“Our MHS saves lives on the battlefield, combats infectious disease around the world, and is responsible for providing health services through both direct care [at military hospitals and clinics known as ‘military treatment facilities’] and private sector care to approximately 9.6 million beneficiaries, composed of uniformed service members, military retirees, and family members,” Health.mil notes.
With 9.6 million beneficiaries, MHS is one of the largest healthcare service organizations operating in the United States.
“The establishment of this market provides a true opportunity to optimize healthcare for our beneficiaries by focusing on outcomes and access across the Tidewater market,” said Navy Rear Admiral Darin Via, MD, Tidewater market manager, in an MHS/DHA news release. “It also allows us to work towards standardization of processes, creating an easier environment for our patients to navigate within.” (Photo copyright: US Navy.)
Finding Efficiencies, Optimizing Clinical Laboratory Processes and Services
In an article outlining the Tidewater Market clinical laboratory initiative, Health.mil noted that “A market is a group of MTFs in one geographic area working together with its TRICARE partners, Veterans Affairs hospitals, other federal healthcare organizations, private sector teaching hospitals and medical universities, as well as other healthcare partners. Markets operate as a system to support the sharing of patients, staff, budget, and other functions across facilities to improve readiness and the delivery and coordination of health services.”
The Tidewater Market provides integrated, affordable, high-quality healthcare services to active-duty service members, military retirees, reservists and national guardsmen, and their families. The market currently serves more than 390,000 beneficiaries.
In 2022, the Tidewater Market Laboratory/Pathology Integration Working Group was created to optimize services while reducing costs within the market. The group was created by US Navy Captain Stacie Milavec, who has more than 23 years of experience in military medicine.
“One of DHA’s goals with setting up a market structure is to find efficiencies and optimize and standardize processes and services wherever possible,” Milavec said in an MHS/DHA news release. “We’ve been able to do exactly that by collaborating within our working group.”
Resource Sharing between Military Clinical Laboratories
The MTFs that are geographically close to each other helped expedite turnaround times for testing results. By working together, they saved the Tidewater Market an estimated $80,000 during fiscal year 2022.
One of the methods they used to streamline testing and lower costs was to allow resource sharing between facilities within the market. For example, the full-service clinical laboratory located at the Naval Medical Center Portsmouth (NMCP) began performing head and neck pathology cases, breast biopsies, and PAP testing for some of the other facilities within the Tidewater Market. These services were previously performed by other means and in some cases were sent to commercially-contracted clinical laboratories for analysis at a high cost.
The NMCP also took on Human Papilloma Virus (HPV) testing for all MTFs within the market.
In February of 2023, NMCP began taking on additional clinical chemistry tests from the 633rd Medical Group at Joint Base Langley-Eustis located in Hampton, Virginia. Prior to that collaboration, those tests were sent out to contracted labs off-base for analysis.
“[Through collaboration between the MTFs] we’ve been able to successfully transition civilian marketplace send-out testing back into the military market by utilizing market resources,” said pathologist US Air Force Captain Dianna Chormanski, MD, Laboratory Medical Director with the 633rd Medical Group at Joint Base Langley-Eustis, in the press release. “I’m a big fan of cooperation and working together, and that’s what a market should be.”
The DHA established the market-based structure as part of the National Defense Authorization Act for Fiscal Year 2017. It’s an example of regional laboratory consolidation within one region of the US where a common effort brought together clinical laboratories operating on military bases of different services. The military’s goal was a unified, integrated medical laboratory operation that could deliver targeted cost savings while maintaining quality lab testing services. It appears to be successful.
