There are reports of phlebotomists refusing to draw monkeypox blood samples and social stigma surrounding the disease can affect who gets a medical laboratory test
Cases of monkeypox are increasing in the US—14,115 as of Aug. 19, up 1,400 from the prior week—and clinical laboratories around the country are bracing for a potential increase in monkeypox testing orders.
Several factors, however, are affecting the testing. Chief among them:
Lab workers refusing to take blood draws from potential monkeypox patients, and
Community clinics in some cities having to delay other care to deal with an onslaught of monkeypox test orders.
Here are five trends clinical laboratory leaders should be aware of that are influencing the state of monkeypox testing in the country.
Trend 1: Some Phlebotomists Refuse to Draw Possible Monkeypox Specimens
CNN reported that phlebotomists at two of the largest commercial laboratories—Labcorp and Quest Diagnostics—were either refusing or being told not to draw blood samples from suspected monkeypox patients.
“Labcorp and Quest don’t dispute that, in many cases, their phlebotomists are not taking blood from possible monkeypox patients,” according to CNN. “What remains unclear, after company statements and follow-ups from CNN, is whether the phlebotomists are refusing on their own to take blood or if it is the company policy that prevents them. The two testing giants say they’re reviewing their safety policies and procedures for their employees.”
In “Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test,” Dark Daily noted that skin lesion swabbing, such as that necessary to perform the OrthopoxvirusPCR test, is the preferred method to check for monkeypox because of higher viral counts in the lesions. However, physicians may order follow-up blood tests for confirmed monkeypox patients, and suspected patients may need bloodwork as part of other routine care.
In an update posted on its website, Quest noted it has been testing swab specimens of skin lesions for monkeypox, but those swabs are performed by providers and not Quest. However, the company was also preparing to take blood draws of possible monkeypox patients in its patient service centers.
“Given that monkeypox has been declared a national public health emergency and the most recent CDC guidance, we are now implementing procedures to safely enable patients with suspected or confirmed monkeypox infection into our patient service sites for phlebotomy blood draws and other non-swab specimen collections,” Quest stated. “This approach will enable patients with suspected or confirmed monkeypox infections to receive additional testing they may need.”
Trend 2: Guidance Is Available to Help Lab Workers Avoid Monkeypox Infection
The CDC has posted guidance to maintain infection control around suspected monkeypox specimens. Among the steps noted by the agency:
Lesion specimens from patients suspected of having monkeypox will carry the highest quantity of the virus. When possible, lab workers that have a smallpox vaccination from within the last three years should handle these specimens. Smallpox vaccination also protects from monkeypox in many cases. Unvaccinated workers who test suspected monkeypox specimens need to take extra precautions, such as wearing a buttoned lab coat, gloves, and face protection, and avoiding splashes, the CDC stated.
Blood specimens draw from suspected monkeypox patients will have a low quantity of the virus. Lab workers testing these specimens do not need to be vaccinated for monkeypox, but standard precautions should be followed.
Before using automated testing platforms with suspected monkeypox specimens, labs should conduct a risk assessment to identify potential hazards.
Trend 3: Monkeypox Testing Gains an Early Social Stigma
Some people who need to be tested for monkeypox may be hesitant to seek out a medical laboratory or patient service center because of a stigma being attached to the disease.
Although it does not match the early hysteria associated with HIV infections in the 1980s—in a 1987 poll, 60% of respondents said AIDS patients should carry a card identifying them as such, Gallup noted—there have been clear instances where people and agencies have associated monkeypox infection with men having sex with other men.
“The focus for all countries must be engaging and empowering communities of men who have sex with men to reduce the risk of infection and onward transmission, to provide care for those infected, and to safeguard human rights and dignity,” Tedros Adhanom Ghebreyesus, PhD, the Director-General at the World Health Organization, said in a July 27 media briefing.
Ghebreyesus added that while 98% of monkeypox infections have been among men who have sex with men, anyone can get the disease, including children.
“Stigma and discrimination can be as dangerous as any virus, and can fuel the outbreak,” said Tedros Adhanom Ghebreyesus, PhD (above), Director-General at the World Health Organization (WHO), in a media briefing. Clinical laboratories would be wise to prepare for a marked increase in demand for monkeypox testing. (Photo Copyright: WHO/Christopher Black.)
“Men who have sex with men have been hit the hardest by monkeypox to date, but LGBTQ+ health advocates say improper messaging risks branding monkeypox as a ‘gay disease,’ eroding effective preventive measures and allowing the virus to spread,” Bloomberg Law reported.
For example, 66% of respondents either were not sure or did not believe there is a vaccine for monkeypox.
Trend 4: Workers Who Refuse to Test Patients for Monkeypox Face Possible Backlash
Some medical professionals have raised concerns about healthcare workers being unwilling to test monkeypox patients.
“This is absolutely inexcusable. It’s a grave dereliction of duty,” David Harvey, Executive Director of the National Coalition of STD Directors, told CNN. The group represents sexually transmitted disease (STD) directors at public health departments in the US.
“For every single patient that walks [through] your door, you use universal precautions because every disease doesn’t have a phenotype or outward appearance, so you have to treat everyone exactly the same,” Garfield Clunie, MD, president of the National Medical Association and Assistant Professor of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai, told Bloomberg Law. “You can’t treat someone differently because of their sexual orientation, or race, or gender, or for any other reason.”
Trend 5: Public Clinics Show Early Signs of Monkeypox Testing Pressure
A survey of 80 public health departments conducted by the National Coalition of STD Directors indicated that some sites may already be getting overwhelmed by demand for monkeypox testing.
According to the survey results, 79% of public health clinics saw an increased demand for monkeypox testing over the past four weeks. In a troubling aspect, 28% of clinics said they could not meet testing demand if it increases.
Further, 22% of clinics have reduced screenings for other STDs to prioritize monkeypox testing. Such moves likely delay patients from receiving other care they need.
Clinical laboratories may want to take note of the survey findings. The pressure public health clinics currently face could be a precursor to similar problems at labs if demand for monkeypox testing grows.
Additionally, the device also could help reduce antibiotic-resistant infections and other HAIs and HACs, though this result was not part of the study
Research findings indicate how a new system-in-a-box device that phlebotomists and clinical laboratories would use when drawing blood could reduce contamination of blood cultures and lower patients’ use of antibiotics. In a study involving 1,800 blood cultures done on 904 patients at the University of Nebraska Medical Center (UNMC), use of the device was attributed to an 88% reduction in the blood culture contamination rate.
According to a press release by researchers at UNMC who studied the device, “With traditional blood draws, about 30% to 40% of patients with contaminated blood cultures are prescribed antibiotics unnecessarily. This contributes to antibiotic resistance and undermines nationwide efforts to improve antimicrobial stewardship.” The researchers reported their findings in an article published in the Oxford Academic journal Clinical Infectious Diseases (CID).
Blood Culture Contamination Harms Patients and Increases Cost of Care
The UNMC researchers noted that, during a blood draw, a significant percentage of blood cultures become contaminated when skin fragments containing bacteria are dislodged and mix with the patient’s blood. For the thousands of patients each day who have their blood drawn, contaminated blood cultures, which lead to false positive results for sepsis, often result in unnecessary antibiotic treatment. This in turn can lead to serious and deadly antibiotic-resistant infections with various multi-drug-resistant organisms such as Clostridium difficile infection (C. diff), as well as, other hospital-acquired infections and conditions (HAIs & HACs) due to unnecessary extended length of stay, according to Mark Rupp, MD, Professor, Department of Internal Medicine, Section of Infectious Diseases, and Medical Director, Department of Healthcare Epidemiology-Infection Control at UNMC.
In the CID article, Rupp and colleagues reported on a prospective, controlled trial conducted in the emergency department (ED) at UNMC’s partner hospital Nebraska Medicine. Results of the trial showed that the SteriPath ISDD diverts and sequesters the first 1.5 to 2 mL portion of blood. The researchers presumed that these initial drops of blood would contain the contaminating skin cells and microbes.
SteriPath is a self-contained, preassembled, sterile blood collection system. It provides proprietary vein-to-bottle technology that significantly reduces blood culture contamination, according to Magnolia Medical Technologies. This could be useful for helping phlebotomists and clinical laboratories improve the quality of specimens collected for use in blood culture testing. Click on the image above to view videos on the SteriPath ISDD. (Photo copyright: Magnolia Medical Technologies.)
The researchers tested the SteriPath ISDD during standard phlebotomy procedures in patients requiring blood cultures. After drawing 1,808 blood cultures from 904 study subjects, the researchers concluded that the ISDD significantly reduced blood culture contamination compared with standard phlebotomy procedures. The blood culture contamination among phlebotomists who used the ISDD decreased by nearly 90%, compared to phlebotomy procedures conducted by nurses who did not use the ISDD.
“We were able to decrease the false positive rate significantly through use of this device—from 1.78% down to 0.2%, which represents an 88% reduction,” Rupp noted in the UNMC press release. “The 1.78% baseline rate of contamination may seem small, but we should strive to decrease adverse events to the lowest possible level, because of the impact to the patient and the burden to our healthcare system.
“The device is innovative in that it diverts the first couple of milliliters of blood into the sequestration chamber,” Rupp explained. “That’s where we think the contaminants are. The remaining blood being drawn is then diverted into the sterile pathway into the blood culture vial, thereby preventing the contamination.”
Billions of Healthcare Dollars Could Be Saved with SteriPath’s ISDD
During a conference call with reporters, Rupp admitted that cynics might scoff at such a low rate of improvement. “Many of those folks don’t understand that we do tens of millions of blood cultures in this country every year,” he explained. “Every year, we do about 30 million or so blood cultures. That many cultures means a 2% contamination rate equates to somewhere in the neighborhood of about 600,000 contamination events. And 2% is a very respectable level. Usually clinicians are satisfied anywhere below about 3%, which is about 900,000 events each year.”
For about 40% to 50% of patients whose blood is contaminated, physicians will prescribe antibiotics, order another blood test, and require patients to stay several days in the hospital, he added. “All of this results in thousands of extra dollars being spent,” he declared. If each blood contamination case costs about $4,000, then reducing such contamination in potentially 600,000 cases each year could save more than $1 billion healthcare dollars.
According to the researchers, costs associated with blood culture contamination ranged from $1,000 per patient in 1998 to $8,700 per patient in 2009. “If a midpoint cost estimate of $4,850 is used, and the added cost of the device is not taken into account, it equates to a cost avoidance of $1.8 million per year at our institution alone,” Rupp stated. “If the low rate of contamination that we observed in the study, 0.22%, was applied to all blood cultures throughout the country, billions of dollars of excess costs could be avoided.”
This clinical study offers strong evidence that the SteriPath ISDD might prove to be a useful tool that clinical laboratories could use to help prevent unnecessary exposure to antibiotics and hospital stays, lower healthcare costs, and improve patient test outcomes. If the UNMC clinical study outcomes are replicated in future studies, then it is a technology and a solution that has the potential to be adopted by phlebotomists in medical laboratories and hospitals.
Agreements to open PSCs in the nation’s largest retail grocery and pharmacy chain stores shows a willingness by clinical laboratories to attract customers through convenience
Greater use of retail stores as the location for patient services centers (PSCs) may be an important new trend for the clinical laboratory industry. That’s because, historically, medical laboratories placed most of their patient service centers in hospital campuses or near medical office buildings.
However, in recent months, both of the nation’s billion-dollar lab companies signed deals with national retailers to put patient service centers in their stores. Dark Daily believes that the motivation for a lab company to put a PSC into a grocery store or retail pharmacy is to make it easier and more convenient for a patient to get their specimen collected at a location that is closer to their home or office. In other words, it is faster for the patient to get to their nearest grocery store for a blood draw than to travel to the hospital campus in their community.
Various news reports indicate that Quest Diagnostics (Quest) may be more active than Laboratory Corporation of America (LabCorp) in opening PSCs in grocery stores and retail pharmacies. Over the last four months, Quest has announced plans to open patient services centers with several retailers, particularly in the states of Texas and Florida. Similarly, in the past four weeks, LabCorp disclosed an agreement with Walgreens Boots Alliance (Walgreens).
Ground zero for this current interest in putting PSCs into retail stories is Phoenix, Arizona. In 2014, to serve its direct-to-consumer lab testing business model, Theranos had PSCs in about 40 Walgreen’s pharmacies. Pathologists and clinical laboratories will recall that in November, 2015, Sonora Quest Laboratories of Phoenix opened a patient service center (PSC) in a Scottsdale, Ariz., supermarket owned by Safeway. It was the first PSC Sonora Quest had opened in collaboration with a grocery store chain, but it was not the last. Less than a year later, Sonora Quest and Safeway expanded their operations by opening additional PSCs in stores throughout the Grand Canyon State.
At the same time Sonora Quest was stepping into the retail blood-drawing business, Theranos of Palo Alto, Calif., was exiting it after opening 40 PSCs in Walgreens pharmacies, most of them in Arizona. However, before leaving the lab-testing business altogether, the embattled company put a lot of effort into educating consumers about the benefits of purchasing lab tests without a physician’s order. Theranos had even supported a bill (HB2645) the Arizona State Legislature passed that allowed patients to order tests without a physician’s requisition.
Now, in 2017, Quest Diagnostics (NYSE:DGX) appears interested in following a similar strategy as Theranos and Sonora Quest by developing Quest-branded PSCs in retail chain stores. On its website, Quest states that in the past several years it has opened 106 PSCs in Albertsons, Randalls, Safeway, Tom Thumb, and Vons retail stores in nine states.
This Quest patient service center operates within a Safeway store location. (Photo copyright: Quest Diagnostics.)
In June 2017, Quest announced it would open 10 additional PSCs in Tom Thumb retail stores in North Texas by the end of the month. Thom Thumb is a division of Albertsons, a food and drug retailer with stores nationwide. In the same announcement, Quest said it plans to open PSCs in 200 Albertson’s-owned stores nationwide by the end of the year.
Give Blood Then Shop
Also in June, Quest and Walmart (NYSE:WMT) announced a deal in which the two companies would open co-branded PSCs in 15 Walmart stores in Florida and Texas by the end of 2017.
In these locations, Quest encourages patients to have their blood drawn and then shop. Such locations can accommodate collecting specimens for routine blood work, such as total cholesterol and white blood cell count, as well as complex gene-based and molecular testing. Even patients with such chronic conditions as cancer, diabetes, and hepatitis, are encouraged to use these PSCs, the lab-testing company stated in the announcement.
Not to be outdone, LabCorp also announced a deal with Walgreens in June. In Forbes, Bruce Japsen reported that Walgreens (NASDAQ:WBA) announced it would collaborate with LabCorp (NYSE:LH) to develop and operate PSCs in Walgreens drugstores in Colorado, Illinois, and North Carolina.
The deal is the first for Walgreens since its troubled relationship with Theranos ended last year. Walgreens’ collaboration with LabCorp will initially begin this summer with five patient service centers in Denver and one in Morrisville, N.C. A seventh location in Deerfield, Ill., will open by the end of the year. Financial terms of the partnership were not disclosed.
Lessons Clinical Laboratories Learned with PSCs in Retail Stores
For Quest, the speed with which it is opening new PSCs is significant, because it seems to have taken lessons that Theranos and Sonora Quest learned earlier in Ariz. and applied them to markets nationwide. It’s worth noting that Safeway and Albertsons were already two of the largest retail grocery chains in the nation before they merged in 2015.
So, while Sonora Quest was working with Safeway, its parent company, Quest, was working with Albertsons.
One other point that is significant about Quest’s efforts is that not many other clinical laboratories have a presence in retail stores. It’s unknown just how much specimen volume these retail operations generate for Quest, one of the largest clinical lab companies in America. And, it is unknown if these PSCs in retail settings are breaking even or making a profit.
One result, however, is clear. That Quest is being so aggressive in opening PSCs testifies to the company’s level of interest in serving consumers directly. In other words, these PSCs are not primarily a direct-to-consumer play, but are aimed at building market share by adding regular lab testing done for patients. In this way, the direct-to-consumer business that Quest generates is a bonus.
The deals by Quest and LabCorp also imply that both clinical laboratory companies are willing to bet on the fact that consumers may prefer the convenience of using PSCs located in retail stores they currently frequent, rather than going to patient service centers in hospitals and sitting in a waiting rooms.
Noted Humorist Garrison Keillor Encounters the Truth of Inadequate Funding for Clinical Laboratory Testing Services
It is widely recognized by pathologists and clinical laboratory managers in the United States and abroad that medical laboratory testing is a “high touch” clinical service. Each day, lots of patients interact with laboratory professionals to provide specimens. Physicians know that their own successful medical practice is dependent on a smooth-functioning and high-quality pathology testing service that delivers accurate, reliable lab test results.
Another truth in today’s healthcare system is selective underfunding of certain clinical laboratory testing services in the United States. In this country, pathologists and clinical lab managers are all too familiar with this situation. What might be at the top of the list of inadequately-reimbursed laboratory procedures is venipuncture. It has been years since Medicare, Medicaid, and private payers have reimbursed the venipuncture procedure at a level that is close to the cost of providing that service to patients.
Noted Author lauds the quiet professionals working in the world’s laboratories
Seldom do laboratory professionals get the recognition they deserve each day for their role in protecting the public health from spread of disease. Now, with the specter of an influenza pandemic hanging over the world, CNN Contributor Bob Greene suggests it is time to pay homage to what he describes as our unsung “heroes in lab coats.”
Writing yesterday in a commentary on the CNN Web site, Greene observed “Right now, as the eventual path of the swine flu emergency remains uncertain, the world is beginning to turn its pleading eyes in the direction of men and women whose names and faces we don’t even know. The wider world seldom gives them a thought until suddenly we realize that we need them.”
