Clinical laboratory leaders may be aware that many hospitals still do not have capabilities to make a timely diagnosis of sepsis
Despite the fact that “one in three people who dies in a hospital had sepsis during that hospitalization,” recent data from the Centers for Disease Control and Prevention (CDC) show that many hospitals in the US lack the resources to identify sepsis and begin treatment as soon as possible, CNN reported.
According to the CDC, 1.7 million Americans develop sepsis annually. And of that group, at least 350,000 adults die in hospitals or hospice care centers. Clinical laboratories tasked with performing the plethora of tests needed to diagnose sepsis will agree that it is one of the gravest healthcare dangers patients face.
To address this potentially deadly threat, the CDC developed the “Hospital Sepsis Program Core Elements: 2023” to support the implementation of sepsis protocols at all hospitals, to optimize any existing sepsis programs, and to organize staff and identify resources to lower sepsis rates and raise survivability.
“Modeled after CDC’s Core Elements of Antibiotic Stewardship, which has proven to be an impactful resource to protect patients from the harms caused by unnecessary antibiotic use and to combat antimicrobial resistance, the Sepsis Core Elements were created with the expectation that all hospitals, regardless of size and location, would benefit from this resource,” a CDC press release noted.
“CDC’s Hospital Sepsis Program Core Elements are a guide for structuring sepsis programs that put your healthcare providers in the best position to rapidly identify and provide effective care for all types of patients with sepsis,” said Raymund Dantes, MD (above), Medical Advisor, National Healthcare Safety Network, CDC, and Associate Professor, Emory University School of Medicine, in a CDC press release. Hospital medical laboratories will play a key role in the success of the CDC’s sepsis program. (Photo copyright: Emory School of Medicine.)
Seven Elements to Improve Sepsis Diagnosis
Sepsis can occur when chemicals released into the bloodstream to fight off an infection produce massive inflammation throughout the body. This potentially fatal reaction can cause a deluge of changes within the body that damage multiple organs, leading them to fail.
The CDC designed its hospital sepsis program to improve and monitor the management and outcomes of patients with sepsis. The core elements of the program include seven main points:
Hospital Leadership Commitment: Management must dedicate the necessary staff, financial, and information technology resources.
Accountability: Appoint a team responsible for program goals and outcomes.
Multi-professional Expertise: Make sure key personnel throughout the healthcare system are engaged in the program.
Action: Implement structures and processes to improve the identification of the illness and patient outcomes.
Tracking: Develop initiatives to measure sepsis epidemiology, management, overall outcomes, and progress towards established goals.
Reporting: Provide information on sepsis management and outcomes to relevant partners.
Education: Provide healthcare professionals, patients, and family/caregivers with information on sepsis.
“Sepsis is taking too many lives. One in three people who dies in a hospital has sepsis during that hospitalization. Rapid diagnosis and immediate appropriate treatment, including antibiotics, are essential to saving lives, yet the challenges of awareness about and recognition of sepsis are enormous,” said CDC Director Mandy Cohen, MD, in the CDC press release. “That’s why CDC is calling on all US hospitals to have a sepsis program and raise the bar on sepsis care by incorporating these seven core elements.”
Early Diagnosis Presents Challenges
Sepsis care is complex. The condition requires urgent medical intervention to prevent organ damage and death. But the symptoms, which include fever or low temperature, shivering, confusion, breathing difficulties, extreme body pain or discomfort, high heart rate, weak pulse or low blood pressure, and low urine output, can be general and indicative of other illnesses.
The diagnosis of sepsis usually requires the collection of a blood culture specimen that is then incubated until there is enough bacterial growth to identify the specific strains of bacteria in a particular patient. This process can take several days, which can delay the administering of the most effective treatment for the condition. Treatment usually includes antibiotics and intravenous fluids.
A recent CDC survey of 5,221 US hospitals showed that in 2022, only 73% of hospitals reported having a sepsis program, ranging from 53% among hospitals with less than 25 beds to 95% among hospitals with over 500 beds.
That survey, released in the CDC’s August Morbidity and Mortality Weekly Report (MMWR), also discovered that only 55% of all hospitals had personnel with dedicated time to manage and conduct necessary daily activities for a sepsis program.
Raymund Dantes, MD, Medical Advisor, National Healthcare Safety Network, CDC, and Associate Professor, Emory University School of Medicine, told CNN that as many as 1,400 hospitals have no sepsis program in place at all. Therefore, he added, the CDC’s Hospital Sepsis Program Core Elements documents also include a “getting started guide” to help those hospitals create the needed committees.
“For those hospitals that already have sepsis programs underway and have available resources, we have a lot more details and best practices that we’ve collected from hospitals about how to better improve your sepsis programs,” he said. “The seven elements complement clinical guidelines by describing the leadership, expertise, tracking, education, and other elements that can be implemented in a wide variety of hospitals to improve the quality of sepsis care.”
Hospital Laboratories Play a Key Role in Reducing Sepsis
According to the CDC, anyone can get an infection and almost any infection can lead to sepsis. However, some populations are more vulnerable to sepsis than others. They include:
Older persons
Pregnant or recently pregnant women
Neonates
Hospitalized Patients
Patients in Intensive Care Units
People with weakened immune systems
People with chronic medical conditions
According to the World Health Organization (WHO), there were 48.9 million sepsis cases and 11 million sepsis-related deaths worldwide in 2017. This number accounted for almost 20% of all global deaths. Almost half of all the global sepsis cases occurred in children, resulting in 2.9 million deaths in children under the age of five.
“Sepsis is complex, often difficult to identify, and takes a tremendous societal toll in the United States,” said Steven Simpson, MD, Professor of Medicine at the University of Kansas and Chair, Board of Directors, Sepsis Alliance, a non-profit organization dedicated to raising awareness and reducing suffering from sepsis, in a press release. “To tackle the number one killer in American hospitals, we need a comprehensive National Action Plan to find cures, get them in the hands of professionals, and educate the public and professionals alike.”
Hospital medical laboratories can help reduce sepsis by finding ways to support their physicians’ diagnoses of this infection that has taken so many lives.
This is another approach to the liquid biopsy that clinical laboratories and pathologists may use to detect cancer less invasively
Screening for cancer usually involves invasive, often painful, costly biopsies to provide samples for diagnostic clinical laboratory testing. But now, scientists at the University of Technology (UTS) in Sydney, Australia, have developed a novel approach to identifying tumorous cells in the bloodstream that uses imaging to cause cells with elevated lactase to fluoresce, according to a UTS news release.
The UTS researchers created a Static Droplet Microfluidic (SDM) device that detects circulating tumor cells (CTC) that have separated from the cancer source and entered the bloodstream. The isolation of CTCs is an intrinsic principle behind liquid biopsies, and microfluidic gadgets can improve the efficiency in which problematic cells are captured.
The University of Technology’s new SDM device could lead the way for very early detection of cancers and help medical professionals monitor and treat cancers.
“Managing cancer through the assessment of tumor cells in blood samples is far less invasive than taking tissue biopsies. It allows doctors to do repeat tests and monitor a patient’s response to treatment,” explained Majid E. Warkiani, PhD, Professor, School of Biomedical Engineering, UTS, and one of the authors of the study, in a news release. Clinical laboratories and pathologists may soon have a new liquid biopsy approach to detecting cancers. (Photo copyright: University of New South Wales.)
Precision Medicine a Goal of UTS Research
The University of Technology’s new SDM device differentiates tumor cells from normal cells using a unique metabolic signature of cancer that involves the waste product lactate.
“A single tumor cell can exist among billions of blood cells in just one milliliter of blood, making it very difficult to find,” explained Majid E. Warkiani, PhD, a professor in the School of Biomedical Engineering at UTS and one of the authors of the study, in the news release.
“The new [SDM] detection technology has 38,400 chambers capable of isolating and classifying the number of metabolically active tumor cells,” he added.
“In the 1920s, Otto Warburg discovered that cancer cells consume a lot of glucose and so produce more lactate. Our device monitors single cells for increased lactate using pH sensitive fluorescent dyes that detect acidification around cells,” Warkiani noted.
After the SDM device has detected the presence of questionable cells, those cells undergo further genetic testing and molecular analysis to determine the source of the cancer. Because circulating tumor cells are a precursor of metastasis, the device’s ability to identify CTCs in very small quantities can aid in the diagnosis and classification of the cancer and the establishment of personalized treatment plans, a key goal of precision medicine.
The new technology was also designed to be operated easily by medical personnel without the need for high-end equipment and tedious, lengthy training sessions. This feature should allow for easier integration into medical research, clinical laboratory diagnostics, and enable physicians to monitor cancer patients in a functional and inexpensive manner, according to the published study.
“Managing cancer through the assessment of tumor cells in blood samples is far less invasive than taking tissue biopsies. It allows doctors to do repeat tests and monitor a patient’s response to treatment,” stated Warkiani in the press release.
The team have filed for a provisional patent for the device and plan on releasing it commercially in the future.
Other Breakthroughs in MCED Testing
Scientists around the world have been working to develop a simple blood test for diagnosing cancer and creating optimal treatment protocols for a long time. There have been some notable breakthroughs in the advancement of multi-cancer early detection (MCED) tests, which Dark Daily has covered in prior ebriefings.
According to the Centers for Disease Control and Prevention (CDC), cancer ranks second in the leading causes of death in the US, just behind heart disease. There were 1,603,844 new cancer cases reported in 2020, and 602,347 people died of various cancers that year in the US.
According to the National Cancer Institute, the most common cancers diagnosed in the US annually include:
Cancer is a force in Australia as well. It’s estimated that 151,000 Australians were diagnosed with cancer in 2021, and that nearly one in two Australians will receive a diagnosis of the illness by the age of 85, according to Cancer Council South Australia.
The population of Australia in 2021 was 25.69 million, compared to the US in the same year at 331.9 million.
The development of the University of Technology’s static droplet microfluidic device is another approach in the use of liquid biopsies as a means to detect cancer less invasively.
More research and clinical studies are needed before the device can be ready for clinical use by anatomic pathology groups and medical laboratories, but its creation may lead to faster diagnosis of cancers, especially in the early stages, which could lead to improved patient outcomes.
Demand for low cost, convenient access to doctors and drugs is driving transformation to decentralized medical care, and retail pharmacy chains see opportunity in offering primary care services
Retail pharmacies and pharmacists continue to play a growing role in healthcare as consumer demand for lower cost and convenience pushes the nation’s medical landscape away from centralized healthcare systems. Clinical laboratories have seen this in the increasing trend of consumers seeking vaccinations and home-health tests at their local drug stores.
Results of a pair of surveys dubbed “Pharmacy Next” conducted by Wolters Kluwer Health revealed that 58% of people are now willing to be treated for non-emergency healthcare conditions in non-traditional medical environments, such as retail pharmacies and clinics.
This is a finding that clinical laboratory managers and pathologists should incorporate into their labs’ strategic planning. It portends a shift in care away from the traditional primary care clinic—typically located in the campus around the community hospital—and toward retail pharmacies. Labs will want to capture the test referrals originating from the primary care clinics located in retail pharmacies.
This willingness to access medical care in non-traditional environments is especially true among people in Generation Y (Millennials) and Generation Z (Zoomers)—people born between 1981-1996 (Gen Y) and 1997-2012 (Gen Z), according to Journey Matters.
“As we saw in last year’s survey, primary care decentralization is continuing—the traditional one doctor-one patient, single point of coordination is vanishing, and this is especially evident in younger generations,” said Peter Bonis, MD, Wolters Kluwer’s Chief Medical Officer, in a press release.
The online surveys of more than 2,000 US adults was weighted by age, gender, household income, and education to be representative of the entire population of the United States.
“By preparing for this shift today, providers can work in concert across care sites to deliver the best care to patients,” said Peter Bonis, MD, Wolters Kluwer Health Chief Medical Officer, in a press release. “Likewise, newer care delivery models, like retail pharmacies and clinics, can ensure they’re ready to meet the expectations of healthcare consumers, who will increasingly be turning to them for a growing range of care needs.” Clinical laboratories may find new revenue opportunities working with the primary care clinics operating within local retail pharmacists and clinicians. (Photo copyright: Wolters Kluwer.)
Key Findings of the Wolters Kluwer Pharmacy Next Studies
Some key insights of the surveys include:
Care is rapidly decentralizing with 58% stating they are likely to visit a local pharmacy for non-emergency medical care.
Younger generations are signaling lasting change within the industry as they are more open to non-traditional styles of care.
61% of respondents envision most primary care services being provided at pharmacies, retail clinics, or pharmacy clinics within the next five years. Of the respondents, 70% of Millennials, 66% of Gen Z, 65% of Gen X, and 43% of Baby Boomers believe this transition will occur.
Consumers are worried about prescription costs and availability.
92% of respondents said physicians and pharmacists should inform patients of generic options.
59% of surveyed consumers have concerns about drug tampering and theft when it involves mail order or subscription prescription services.
One in three respondents believe convenience is more important than credentials in non-emergency situations.
The survey indicates that healthcare consumers across multiple generations are open to a shift in some medical services from doctors to pharmacists. However, there were some notable differences between generations.
Respondents of the Baby Boomer (55%) and Gen X (57%) generations stated they would trust a physician assistant with medication prescriptions, while only 42% of Gen Z and 47% of Millennial respondents felt the same way.
Additionally, Boomers (57%) and Gen X (67%) said they would feel comfortable with a nurse practitioner issuing their prescriptions, while only 44% of Gen Z and 53% of Millennials said they would.
Increased Comfort with Genetic Testing at Pharmacies
The surveys also showed that younger generations are more open to the field of pharmacogenomics, which combines pharmacology and genomics to analyze how an individual’s genetic makeup (aka, heredity) affects the efficacy and reactions to certain drugs. This is a key component of precision medicine.
Overall, 68% of individuals polled believe their individual genomic data could guide prescription decisions, with Millennials (77%) and Gen Z (74%) being the primary believers. Additionally, 88% of respondents stated they see an incentive for health insurers to cover genomic testing, and 72% said they would be open to genetic testing for personalized medical care.
But pharmacists and clinicians should be aware that advancing pharmacogenomics will require addressing privacy concerns. According to the Wolters Kluwer study, 57% of Gen Z and 53% of Millennials have apprehension surrounding genetic testing due to privacy risks, with 35% of Gen X and Boomers holding that same opinion.
Healthcare Staff Shortages, Drug Cost a Concern
Survey respondents are also concerned about pharmacy staff shortages and expenditures when seeking care at a pharmacy. Half of the participants are worried they will receive the wrong medication, half worry about getting the incorrect dosage, and almost half (47%) fear receiving the wrong directions due to overburdened pharmacy employees.
More people in Gen Z (59%) and Millennials (60%) had these concerns compared to Gen X (44%) and Boomers (38%).
Sadly, a distressing 44% of those surveyed admitted to not filling a prescription due to the costs. That number jumps to a staggering 56% among individuals with no health insurance, compared to 42% for insured patients.
“From hospitals to doctors’ offices, from pharmacies to pharma and beyond, healthcare must move to more affordable and accessible primary care models, adopt innovations that help deliver more personalized care, and address persistent safety and cost concerns that consumers have about their medications,” said Bonis in the press release.
Can Pharmacies Deliver Primary Care as Well as Doctor’s Offices?
Pharmacies may be logical setting for at least some non-emergency health services. According to the Centers for Disease Control and Prevention (CDC), approximately 90% of the US population live within five miles of a pharmacy and about 72% of visits to physician’s offices involve the prescribing and monitoring of medication therapies.
“We’re not talking about complicated services. We’re talking low-acuity, very basic care,” said Anita Patel, PharmD, Vice President of Pharmacy Services Development for Walgreens, at the HIMSS conference.
Pharmacies across the country continue to add more healthcare services to their available public offerings. This trend will likely persist into the future as healthcare becomes more expensive, wait times for physician appointments increases, and medical staff shortages rise. Thus, there may be opportunities for clinical laboratories to support pharmacists and doctors working in retail settings.
Certainly every clinical laboratory in the United States has a unique story about dealing with the challenges of the SARS-CoV-2 outbreak, but only BioReference did testing for multiple professional sports leagues and the cruise ship industry
Few would challenge the assertion that the nation’s clinical laboratories (along with public health officials) were caught flat-footed when the SARS-CoV-2 coronavirus reached the United States in the winter of 2021. Even as the federal Centers for Disease Control and Prevention (CDC) and some labs rushed to develop reliable medical laboratory tests for COVID-19 in the early weeks of the outbreak, the demand for tests far outstripped supply in this country for many months.
This was the moment when the pandemic’s need meant lab testing opportunity for medical laboratories across the nation. This was particularly true for Elmwood Park, New Jersey-based BioReference Laboratories, Inc. (BRLI), a division of OPKO, Inc. BioReference found itself in the nation’s first pandemic hot zone—New York City and surrounding counties.
Not only was this lab company geographically in the center of the first overwhelming surge of COVID-19 cases, but its management team had important relationships across government and business. For that reason, its management team was pulled into the earliest planning sessions by government officials at the city, state, and federal level.
Consequently, in the earliest days of the outbreak, BioReference was one of the nation’s first labs to help organize and support drive-through COVID-19 specimen collection centers. Its management team went on to accomplish many notable firsts in the lab’s response to the pandemic. All of this is described in the recently-published book “Swab–Leadership in the Race to Provide COVID Testing to America.”
As CEO of BioReference Laboratories during the time of the COVID-19 pandemic in 2020 and 2021, physician Jon R. Cohen, MD (above), energized his clinical lab’s management team and staff to rise to a series of unique challenges, ranging from helping set up the nation’s first drive-through COVID-19 sampling sites in New York City to performing testing for professional sports leagues, such as the NBA, the NFL, and the NHL. (Photo copyright: New York Foundling, Inc.)
Harnessing the Creativity and Energy of a Clinical Lab Staff
The book’s author is Jon R. Cohen, MD, who was CEO of BioReference Laboratories throughout the course of the pandemic. Cohen is now CEO of Talkspace, a virtual behavioral health company.
“Swab” documents BioReference lab’s response to the SARS-CoV-2 pandemic and tells the tale of how the lab company harnessed the creativity of its managers and lab scientists to speedily build up daily test volumes at a time when automation, analyzers, test kits, collection supplies, and reagents were in short supply.
Clinical laboratory professionals interested in lab management will gain valuable insights from Cohen’s approach to writing “Swab.”
While describing BioReference lab’s many innovative COVID-19 testing services, Cohen also provides readers with the management lessons and insights he used to impart needed skills to the company managers, while also inspiring BioReference Lab’s staff to devote the extra effort necessary to deliver COVID-19 testing in novel ways and in unusual settings.
When New York City hospitals were overwhelmed by cases in the earliest days of the pandemic, Cohen’s personal contacts with political leaders came into play. Just a few years earlier, Cohen had run for statewide office as a Democrat. He had friendships with the New York City Mayor Bill de Blasio, with the New York State Governor Mario Cuomo, and with Senators Charles Schumer and Kirsten Gillibrand.
Cohen’s Lab Had a Seat at Government Planning Tables
As these government officials convened various task forces to address the pandemic, Cohen describes how BioReference had a seat at the table and a voice in viable ways to organize specimen collection and COVID-19 testing literally overnight and on an unprecedented scale.
The pandemic’s early days in late February, March, and April of 2020 were only the first challenges to be overcome by the management at BioReference. “Swab” describes a remarkable progression of innovative SARS-CoV-2 testing programs initiated by Cohen and his team. Each of these testing programs was tailored to the specific needs of different industries. No other clinical laboratory organization in the United States was as successful at serving this range of clients. For example:
For the last eight games of the National Basketball Association’s 2020 season and playoffs, BioReference created and managed the NBA’s “biosecure bubble” program at Disney World in Orlando. Over the course of 172 games, 150,000 SARS-CoV-2 tests were performed with zero-positivity.
The National Football League watched the NBA play in its bubble that summer. BioReference got the call and worked with NFL management to provide COVID-19 tests. For the 2020 season, in support of 268 games played across the United States, BioReference performed 1.23 million tests for 5,000 players, coaches, and staff, with an infection rate of less than 1%.
Along with the NBA and NFL, BioReference provided SARS-CoV-2 testing for professional soccer and hockey, the Winter X Games, and the US men’s and women’s Olympic soccer teams.
One of the lab company’s more complex SARS-CoV-2 testing programs involved the cruise ship industry. In 2021, BioReference established sites in 13 ports around the US and the Caribbean. The lab placed staff on as many as 24 cruise ships at one time.
Of course, testing for schools, colleges, universities, and employers was part of BRLI’s testing services over the course of the COVID-19 pandemic as well.
Creativity of Clinical Lab Managers and Staff
As the examples above illustrate, “Swab” will give readers a ringside seat in how BioReference Laboratories harnessed the creativity and skills of its management team and staff to address the unprecedented demands for timely, accurate COVID-19 testing from the very beginning of the pandemic through its waning months.
Cohen writes with an accessible style and provides readers with an easy-to-read narrative of his lab company’s journey through the pandemic. Each of the book’s 10 chapters ends with a “Leadership Reflection” that Cohen uses to describe the management methods he utilized to keep BRLI’s thousands of employees on task and on time, so that the end result month after month was “mission accomplished.”
In today’s digital age, the statement “this book is available at a bookstore near you” may not be applicable. What is true is that author Jon R. Cohen’s “Swab–Leadership in the Race to Provide COVID Testing to America” can be ordered at Amazon.com, Alibris.com, and other web-based booksellers.
Level 3 bio labs handle Ebola, smallpox and other deadly diseases, and may play a role in research into the human genome
Because of the COVID-19 pandemic, there is a concerted effort to improve public health laboratories and increase the growth of bioresearch. Clinical laboratories across the country are required by law to send specimens of certain infectious diseases to public health labs for testing and analysis. The results of those tests are then reported to the federal Centers for Disease Control and Prevention (CDC), which is working to foster robust connections and relationships between clinical labs and public health labs.
A land transaction for a 1.6-acre purchase between Dallas County and TXRE Properties closed in April. The development of the lab is expected to cost $52 million and should be completed by late 2025 with occupancy as early as January 2026.
The graphic above is an artist rendering of what the new Dallas County Health and Human Services Public Health Laboratory may look like. For some time now, Dallas County has been working to create a hub centered around infrastructure and buildings to be used for bio development and research, public health labs, and even clinical laboratories. (Graphic copyright: 5G Studio Collaborative.)
Continuing Support for HHS
“The large-scale response required for COVID-19 demonstrated the need for the acquisition that will permit the continued support of the HHS efforts in response to the ongoing safety, containment, incident response to emerging and high consequence diseases that could operate at the peak of a crisis without hindering or being hindered by other county operations,” states a Dallas County Commissioners Court Order, D Magazine reported.
“The county currently utilizes owned facilities to provide laboratory services, testing services, and other initiatives,” according to the court order. “These facilities have performance and design shortcomings and have required significant capital expenditure for their ongoing use.
“To avoid leasing space and avoid additional capital investment into deferred and ongoing maintenance, the county has been searching for a suitable location/acquisition to collocate uses/departments into a centralized, efficient, and suitable laboratory,” the court order continued.
Lab Will Conduct Research into Potentially Fatal Diseases
The facility will pursue becoming a Biological Safety Level-3 laboratory. BSL-3 labs typically conduct research or work on microbes that can cause serious and potentially fatal disease through inhalation. These labs are required to be easily decontaminated. They must also have additional safety measures, including interlocked doors, sealed windows, floors, and walls, and filtered ventilation systems.
“The core diagnostic functions are—along with safety—related to identification, containment, security, and incident response to emerging and high consequence diseases,” the court order notes.
A Georgetown University article published last year concluded there are 148 institutions with BSL-3 laboratories in the US. This number was established by identifying and totaling the number of BSL-3 facilities that published research between 2006 and 2021 using PubMed Central, a full-text archive of biomedical and life sciences journal literature at the US National Institutes of Health’s National Library of Medicine (NIH/NLM).
The creation of this new biosafety lab in Dallas is consistent with the trend of investment dollars being poured into research into the human genome. This type of research, along with the creation of new facilities, can directly lead to new biomarkers that can be utilized in clinical laboratory testing and disease prevention.
