Dec 19, 2018 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, News From Dark Daily
Human microbiota is linked to many diseases but could hold the key for advanced clinical laboratory tests and targeted precision medicine therapies
Study of the human microbiome continues to provide understanding and knowledge regarding gut bacteria and its many benefits, and incites development into new clinical laboratory tests. However, a new study reveals that our bodies might also put gut bacteria under stress leading to better health.
Traditionally, scientists believe the human gut is a hospitable environment that allows bacteria to thrive. However, microbiologists may be interested in a study by Duke University School of Medicine (Duke) that suggests the relationship between humans and their microbiomes may be adversarial as well.
In fact, the study found that human hosts are starving their microbes of nutrients and forcing them to compete for food for the benefit of the host.
“There appears to be a natural pecking order to the bacteria and us,” noted Lawrence A. David, PhD, Assistant Professor, Department of Molecular Genetics and Microbiology at Duke University School of Medicine, in an article Duke posted on Phys.org. “In a way it’s not surprising that we, the host, should hold more of the cards.”
Duke researchers published the results of their study in Nature Microbiology, an online peer-reviewed scientific journal.
Could Nitrogen Impact Gut Bacteria?
The human microbiome consists of hundreds of different types of bacteria and other various tiny organisms, such as viruses and fungi. When combined, the microbes in the human gut weigh approximately three pounds or about the same as the brain.
The theory behind Duke’s study was that the human microbiome is an ecosystem comprised of various entities that compete for resources, and which are often constricted by nutrients, such as nitrogen or phosphorus.
To perform the study, Aspen Reese, PhD, a PhD candidate at Duke during the study and now a Junior Fellow researcher at Harvard University, procured stool samples from more than 30 types of mammals. She then ground the individual samples and tabulated the number of nitrogen and carbon atoms contained within those samples.
The animals used for the study included wild zebras, giraffes and elephants from Kenya, domestic sheep, cattle and horses from New Jersey, and humans from North Carolina. The graphic above shows how “carbon-to-nitrogen ratios in poop vary between animals as a result of diet and physiology. These ratios also govern the abundance of microbes in their guts.” (Image copyright: Aspen Reese/Harvard University.)
Reese discovered that the bacteria in the human gut had access to only one nitrogen atom for every 10 carbon atoms. The bacteria in other mammals’ guts had access to one nitrogen atom for every four carbon atoms. The question arose: Could nitrogen levels in the human gut impact the microbiome?
Reese performed tests on mice to determine if nitrogen levels could help regulate the microbiome. She fed the mice a diet packed with protein, which naturally contains a large amount of nitrogen. When she increased the amount of protein fed to the mice, the amount of their gut bacteria also increased. Reese then injected nitrogen directly into the bloodstream of the mice and found that some of that nitrogen ended up in their gut bacteria.
This discovery suggests the host can help save microbes in the gut by secreting nitrogen through the cells.
“Our findings support the idea that we’ve evolved a way to keep our bacteria on a leash by leaving them starving for nitrogen,” David noted on Phys.org. “It also explains why the Western diet might be bad for us. When people eat too much protein, it swamps the host’s ability to take up that nitrogen in the small intestine, and more of it ends up making its way to the large intestine, eliminating our ability to control our microbial communities.” (Photo copyright: Duke University School of Medicine.)
Antibiotics and Gut Bacteria
The team also performed a previous study regarding the effects of antibiotics on gut bacteria, which they published in June on eLife, an online open-access journal.
In that study, the researchers gave mice a five-day treatment of antibiotics. By analyzing their stool samples daily, the scientists discovered that many of the energy sources needed by microbes in the gut accumulated as bacteria was depleted. Some species of valuable gut bacteria are eliminated by antibiotics and may never return.
The researchers found that the mice had to eat each other’s stools in order for those essential microbes to return.
“People probably won’t want to do that,” David told Phys.org.
The trillions of microbes that reside in the human gut help manage almost every function of the human body. Poor gut health can contribute to a wide variety of health problems, including allergies, arthritis, dementia, diabetes, cardiovascular disease, leaky gut syndrome, and some cancers and autoimmune diseases.
Factors such as diet, sleep habits, stress levels, and the number of bacteria an individual is exposed to on a regular basis can negatively affect the microbiome.
Continuing research into the mysteries contained in the human microbiome provide valuable data about our gut bacteria. This type of information could eventually help microbiologists and clinical laboratory professionals more accurately identify diseases and health conditions and guide physicians to appropriate, and possibly targeted, precision medicine therapies for patients.
—JP Schlingman
Related Information:
Our Microbes Are Starving, and That’s a Good Thing
Scientists Reveal How Gut Microbes ‘Recover’ after Antibiotic Treatment
How and Why Our Bodies Starve Gut Bacteria
Loss of Microbial Gut Diversity a Threat to Health?
Microbial Nitrogen Limitation in the Mammalian Large Intestine
How Many Cells Are in the Human Body—And How Many Microbes?
Mayo Clinic Researchers Find Some Bacteria Derail Weight Loss, Suggest Analysis of Individuals’ Microbiomes; a Clinical Lab Test Could Help Millions Fight Obesity
University of Illinois Study Concludes Regular Physical Exercise Improves Human Microbiome; Might Be Useful Component of New Treatment Regimens for Cancer and Other Chronic Diseases
Researchers in Two Separate Studies Discover Gut Microbiome Can Affect Efficacy of Certain Cancer Drugs; Will Findings Lead to a New Clinical Laboratory Test?
Dec 17, 2018 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Cloud-based platform—IDseq—shows potential to track the causes and spread of infectious diseases worldwide using metagenomic data
Here’s the latest example of how
big data and related technologies can give physicians—as well as
microbiologists and
clinical pathologists—a new tool for understanding infectious disease and tracking outbreaks anywhere in the world. This project is being funded and organized by well-known Silicon Valley entrepreneurs.
The project is known as
IDseq. It was announced recently in a
press release issued by
Chan Zuckerberg Biohub (CZ Biohub),
Chan Zuckerberg Initiative (CZI), and the
Bill and Melinda Gates Foundation. IDseq is a platform designed to support global disease surveillance and prevention. It will make use of gene sequencing and analysis of
metagenomic data. This data will be made accessible to the global medical community.
The system leverages the power of
cloud computing to streamline the process of transmitting and analyzing metagenomic data, as well as sharing results with other platform users.
“That will be incredibly valuable. Information sharing is one of the most powerful public-health interventions in an outbreak,”
Jennifer Gardy, PhD, an epidemiologist at the
University of British Columbia, told
The Atlantic.
Designed by Engineers to Be Easily Used by Healthcare Providers and Medical Laboratory Technicians
Coverage in
The Atlantic notes that IDseq isn’t the first tool to offer similar features.
Joseph DeRisi, PhD, a biochemist at the
University of California San Francisco and co-president of
CZ Biohub, states, however, that IDseq is one of the first designed by a large team of engineers, security experts, and other tech and medical researchers.
Many tools see their origins in academic research and are less friendly to those without advanced academic expertise. The research team’s goal, according to DeRisi, is for IDseq “To enable people in under-resourced areas to do what we’ve been trying to do in San Francisco.”
“It’s easy for us to sit in our labs dreaming up tools and platforms,” Jennifer Gardy, PhD (above), an epidemiologist at the University of British Columbia, told The Atlantic. “But we need to make sure we’re designing them in a way that makes sense to the doctors, nurses, lab techs, and epidemiologists out there in an outbreak.” (Photo copyright: Michelle Thorpe/University of British Columbia.)
Two Trials Show Promise for IDseq Use
While the software is already available for free as a collection of open source tools, the IDseq platform is now in a “soft launch” phase. The Bill and Melinda Gates Foundation is funding training for clinicians at CZ Biohub’s labs in San Francisco through its
Grand Challenges Explorations Initiative.
However, the platform has already achieved success in two noted scenarios—one at
Dhaka Shishu Hospital in Dhaka, Bangladesh, and another in
Tororo District Hospital in Uganda. Both used the system to analyze the samples of children admitted for fevers for which they found no known cause.
In the Dhaka cases,
Senjuti Saha, PhD, a microbiologist from
Child Health Research Foundation, used the platform to trace unexplained cases of meningitis to an earlier
chikungunya virus outbreak. Saha explained to
The Atlantic that her colleagues previously thought chikungunya could not cause meningitis. The platform found otherwise, allowing her to analyze a further 478 samples and detect an additional 17 cases of potential chikungunya-related meningitis.
In the Uganda cases, the researchers used
metagenomic next-generation sequencing (mNGS) data and the IDseq platform to investigate unknown causes of fever in children.
“As progress is made toward elimination of malaria in sub-Saharan Africa, it will be increasingly important to understand the landscape of pathogens that account for the remaining burden of morbidity and mortality,” researchers state in their study, currently in early access at
bioRxiv. “The use of mNGS can contribute importantly to this understanding, offering unbiased identification of infecting pathogens.”
Wide-Spread Use of IDseq Not Without Challenges
While an article in
Medium by
Charles de Bourcy, PhD, Software Engineer at Chan Zuckerberg Initiative, outlines how the IDseq platform can process up to 480GB in approximately 10 minutes, it doesn’t account for the initial data input, which can be daunting.
For areas with weak infrastructure and/or slow connection speeds, this could add significant delays as medical laboratories and healthcare workers at remote sites attempt to transfer data to the nearest IDseq-enabled location. Saha told
The Atlantic, “If the transfer is too slow or the data too large, we just [ship] hard drives.”
Sequencing requirements create additional concerns. Bulky equipment and the skills required to run sequencers could limit the ability to use the IDseq platform to analyze and share results. Clinicians might also face difficulties in sourcing sequencing reagents due to customs and supply chain concerns.
Finally, the platform still requires an expert to interpret findings. “IDseq is an excellent tool, but it needs to be paired with people who have substantive knowledge to guide its use,” Saha told
The Atlantic.
Regardless of these issues, Saha believes IDseq can help remote/resource-challenged medical labs chase diseases. “It doesn’t solve all the problems, but it means that groups like ours don’t have to spend time to build up [sequencing] capacity. And anything is better than nothing.”
IDseq might offer an excellent opportunity for microbiology laboratories, clinical laboratories, and medical researchers around the world to share data surrounding outbreaks, track disease on global and community level, and better determine the strains and probable sources of infectious diseases.
—Jon Stone
Related Information:
Chan, Zuckerberg and the Gates Foundation Unveil Open-Source Global Infectious Disease Tracker
IDseq: An Open Source Platform for Infectious Disease Detectives
Chan Zuckerberg Biohub and Chan Zuckerberg Initiative Announce First-of-Its-Kind “IDseq” Platform and Service to Enable Real-Time Global Disease Surveillance and Prevention
A Simpler Way to Get to the Bottom of Mysterious Illnesses in Poor Countries
Etiology of Fever in Ugandan Children: Identification of Microbial Pathogens Using Metagenomic Next-Generation Sequencing and IDseq, a Platform for Unbiased Metagenomic Analysis
Dec 14, 2018 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Though they mostly receive medical laboratory services from their parent health networks, microhospitals may, nevertheless, need services from independent clinical laboratories as well
For years, independent clinical laboratories and anatomic pathology groups have been adapting to healthcare networks undergoing changes based on increased demand for convenient, affordable medical services. One such innovation is the growing trend and popularity of microhospitals, which Dark Daily has reported on in multiple e-briefings.
These scaled-down healthcare facilities offer most critical medical services in smaller settings. They fill gaps between traditional hospitals and urgent-care facilities, are intended to be easier for patients to get to, and usually cost less than a typical community hospital of several hundred beds.
Although these microhospitals are typically owned by existing health networks and receive lab services from their parent health networks, for independent clinical laboratories, microhospitals could represent another potential customer in need of rapid test TATs in support of the facility’s emergency department and limited inpatient beds.
One-Stop Shops for Primary and Secondary Care
Microhospitals are typically between 20,000 and 60,000 square feet in size and offer a small number of inpatient short-stay beds—usually less than 15. They are licensed as hospitals and are usually low-trauma (levels 4/5) facilities that tend to focus on low-acuity patients.
Services at microhospitals vary from location to location, but generally include:
- emergency departments;
- imaging and diagnostic services;
- surgery and procedure centers;
- inpatient nursing facilities; and,
- medical offices.
They are open 24-hours/day, seven days/week, and commonly located in small, underserved areas where there is not sufficient demand for healthcare to support a full-size hospital.
Microhospitals operate as comprehensive, one-stop shops, with both primary and secondary care available. Many microhospitals also have certified and accredited medical laboratories onsite that can provide immediate testing results.
Population Health and Precision Medicine Benefit from Microhospitals
Microhospitals have been in existence for more than 10 years and are growing in popularity among consumers as well as providers. Rising healthcare demands, lower costs, convenient locations, and more personalized care make them popular for patients.
From a business perspective, microhospitals have much lower construction and overhead costs when compared to large hospitals, making them an affordable market-growth opportunity for providers. The savings are passed on to the patients as services are offered at a lower rate than conventional hospitals.
Another advantage of microhospitals is that the services offered can be designed specifically for the demographics of their neighborhood. A guiding goal of both population health and precision medicine initiatives.
“That’s the beauty of it,” Robert Garcia, Vice President of Healthcare Advisory Services at Transwestern, told U.S. News and World Report (U.S. News). “You can tailor the hospital to the needs of the community, so if it’s an older community it may be more catheterization lab, and if it’s a younger community it may have more orthopedic procedures.”
Nineteen states now have at least one microhospital in operation with more in the works. They often offer more convenient, quicker access to healthcare than traditional full-size hospitals can deliver. Larger facilities tend to have longer wait times and typically cannot provide the same personalized care as microhospitals, due to a higher number of patients and many diverse problems.
“Our neighborhood [microhospitals] will bring to communities an innovative, patient-centered model that provides the best possible experience and outcomes for those requiring emergency care, short hospital stays, and other outpatient services,” Cynthia Hundorfean, Allegheny Health President and CEO, told Becker’s Hospital Review. Pittsburgh-based Allegheny Health is scheduled to open four new microhospitals in 2019, all located in the metropolitan Pittsburgh area. These facilities will each offer 10 inpatient beds and emergency and diagnostic services. (Photo copyright: Allegheny Health.)
Other Plans for Community Focused Microhospitals
Phoenix-based Abrazo Community Health Network, plans to open a microhospital in Mesa, AZ, in the spring of 2019. This facility will include an emergency department, an operating room, eight inpatient rooms, and will focus on lower acuity inpatient procedures.
“Medical care continues to evolve with a consumer focus, and this is a new model for bringing healthcare services into the community,” Frank Molinaro, CEO of Abrazo’s Phoenix Market, told Commercial Executive Magazine. “The Mesa microhospital will offer a patient-friendly design with emergency and acute care services in an efficient, convenient location. It’s designed to provide close integration with our other facilities for patients who may require more complex care.”
Emerus, a microhospital developer, operates more than 20 microhospitals nationwide. According to their website, the company has 24 additional microhospitals under development.
“Emerus picks locations that have a need for additional emergency room beds,” Richard Bonnin, Senior Public Relations Consultant at Emerus, told U.S. News. “Increasing access to high-quality emergency care and focusing on the patient-physician relationship has provided a strong foundation for our growth.”
Not a Replacement for Traditional Hospitals
While microhospitals are equipped to handle a large range of healthcare issues, they are not able to deal with all medical situations. There are cases where patients may have to be referred to a larger facility.
“Not every [microhospital] is a Level 1 trauma center or cardiac center of excellence. It’s up to the smaller hospitals to diagnose, stabilize, and transfer patients as appropriate,” noted Bonnin in the U.S. News article. “They will send patients to the best trauma center, the best heart hospital, the best stroke center without a lengthy emergency room wait, depending on what the most immediate needs may be.”
Although most microhospitals are owned by existing health networks and most likely receive their medical laboratory services through their parent organization, independent clinical laboratories might find themselves being contacted when faster TATs or closer proximities are required to ensure positive healthcare outcomes.
—JP Schlingman
Related Information:
What You Need to Know about Microhospitals
5 Common Questions about Microhospitals, Answered
Microhospitals Market: Global Industry Analysis 2012-2016 and Opportunity Assessment
Microhospitals Provide Health Care Closer to Home
Microhospitals Are on the Rise
2018 Trends: Microhospitals to Gain Popularity
Allegheny Health Network to Open Four Microhospitals in 2019
Abrazo Entering East Valley with New Microhospital in Mesa
Telemedicine and Microhospitals Could Make Up for Reducing Numbers of Primary Care Physicians in US Urban and Metro Suburban Areas
‘Thinking Small’ May Be Next Big Innovation in Healthcare Delivery as Microhospitals Spring Up in Metropolitan Areas Across Multiple States
Dec 12, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
By negotiating directly with healthcare systems employers garner cost savings, while creating opportunities for clinical laboratories willing to be flexible about claims and reimbursement
It’s a healthcare trend called “direct contracting” and it is the latest method that self-insuring employers are using to better manage the cost of their health benefits plan, while maintaining access and quality for their employees. The interesting thing about direct contracting is that it might be a strategy that could work for innovative regional clinical laboratories to negotiate a place for themselves in that employer’s provider network.
Healthcare costs continue to skyrocket in the United States, and in response, many large companies are providing healthcare services to their employees by working directly with health networks and other organizations, instead of using third-party administrators (TPAs) of insurance plans to create healthcare benefits packages for their employees.
This can provide clinical laboratories and anatomic pathology groups with opportunities to create revenue and further outreach into their communities. Astute lab leaders may want to consider meeting with the decision-makers at large companies in their areas and develop strategies for working together directly. Human resources managers may be interested in the benefits of working directly with medical laboratories.
Employers Already Engaged with Health Networks for Provider Services
Self-insuring is not a new concept. In a direct contracting relationship, the employer skips the TPA in hopes of achieving cost savings. Sometimes the direct contract is for specific services that employees need most often, or they can be designed to cover the entire spectrum of services available to employees.
Many companies have already engaged in direct contracting for healthcare services. Among them are: Cisco Systems, Boeing, Intel, Walmart, and Whole Foods. Amazon, JP Morgan Chase, and Berkshire Hathaway also have announced a joint agreement to self-insure their employees, which Dark Daily reported in June. (See, “Six New Jersey Hospitals and Several Major Corporations to Self-Insure Their Million+ Employees; Trend Could Impact How Local Clinical Laboratories Get Paid,” June 11, 2018.)
Cisco has negotiated a direct healthcare agreement with Stanford Health System. Stanford operates a clinic at the Cisco campus, so that the primary care doctor is a member of the community within the company.
“I’m in their space. I’m actually where they work. I’m a bit of a village doc,” Larry Kwan, MD (above), a doctor of internal medicine with Stanford Health Care, told Reuters about his role in the Stanford clinic at the Cisco campus. About 1,000 Cisco employees are enrolled in the Stanford plan. Katelyn Johnson, Integrated Health Manager at Cisco Systems, says it’s a program that requires a more active approach from companies than traditional health benefits plans. (Photo copyrights: Stanford Health Care.)
Boeing, too, has explored direct contracting in a program where the company negotiated directly with hospitals in four different states. The direct contracts have resulted in cost savings and cover some 15,000 employees plus their families. Some of those cost savings have come from things like getting doctors to prescribe generic drugs.
Intel also has a similar program, covering around 38,000 employees and their families. They have found success in managing chronic conditions like diabetes. Technology, such as video-conferencing, also has helped lower costs and improve retention.
Even health networks are getting into the game. One recent example is the Healthcare Transformation Consortium (HTC), a six-hospital healthcare systems in New Jersey that formed to self-insure and provide direct healthcare coverage for their employees.
Companies may gain some cost savings from directly negotiating, but there are gains for the health systems as well. In a deal with Whole Foods in 2016, Adventist Health System gained a new set of skills that they plan to use in negotiating similar deals with other employers.
“We have a little bit more flexibility as a health system to design around what Whole Foods defines as quality, or what Whole Foods defines as patient satisfaction, which is sometimes different than the traditional definitions,” Arby Nahapetian, MD, regional chief medical officer and SVP at Adventist-Southern California told Modern Healthcare.
Signs Point to Trend Continuing
The Healthcare Transformation Consortium in New Jersey, along with the joint agreement between Amazon, JP Morgan Chase, and Berkshire Hathaway, are examples of what the future is likely to hold. The more these kinds of collaborations and direct contracts result in both cost savings and patient satisfaction, the more companies will likely consider direct healthcare contracts.
Hospital-based and independent laboratories may want to consider meeting with the larger employers in their service regions and explain to the HR benefits managers how better utilization of selected lab tests could improve patient outcomes and contribute to better managing costs.
After all, employers tell health insurance companies what they want to cover with their health benefits plans. So, educating the employers’ HR teams about the true value of clinical laboratory tests could be a winning strategy for labs willing to take the time to do this.
—Dava Stewart
Related Information:
Fed Up with Rising Costs, Big US Firms Dig into Healthcare
Left Out of the Game: Health Systems Offer Direct-To-Employer Contracting to Eliminate Insurers
Six New Jersey Hospitals and Several Major Corporations to Self-Insure Their Million-plus Employees; Trend Could Impact How Local Clinical Laboratories Get Paid
Dec 10, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, Uncategorized
Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them.
The Centers for Medicare and Medicaid Services (CMS) and the state of Maryland expect to save $1 billion by 2023 in expanding Maryland’s existing All-Payer Model—which focused only on inpatient services since 2014—to also include primary care physicians, skilled nursing facilities, independent clinical laboratories, and more non-hospital settings, according to a CMS statement.
Healthcare Finance notes that it represents “the first time, CMS is holding a state fully at risk for the total cost of care for Medicare beneficiaries.”
Value of Precision Medicine and Coordination of Care to Clinical Labs
“If a patient receives care at a [medical] laboratory outside of a hospital, Maryland hospitals would be looking at ways to coordinate the sharing of that freestanding laboratory information, so that the hospital can coordinate the care of that patient both within and outside the hospital setting,” Erin Cunningham, Communications Manager at MHA, told Dark Daily. Such a coordinating of efforts and sharing of clinical laboratory patient data should help promote precision medicine goals for patients engaged with physicians throughout Maryland’s healthcare networks.
The test of the new program—called the Total Cost of Care (TCOC) Model—also could be an indication that Medicare officials are intent on moving both inpatient and outpatient healthcare providers away from reimbursements based on fees-for-services.
CMS and the state of Maryland said TCOC gives diverse providers incentives to coordinate, center on patients, and save Medicare per capita costs of care each year.
“What they are really doing is tracking how effective we are at managing the quality and the costs of those particular patients that are managed by the physicians and the hospitals together,” Kevin Kelbly, VP and Chief Financial Officer at Carroll Hospital in Westminster, told the Carroll County Times. “They will have set up certain parameters. If we hit those parameters, there could be a shared savings opportunity between the hospitals and the providers,” he added. (Photo copyright: LifeBridge Health.)
The TCOC runs from 2019 through 2023, when it may be extended by officials for an additional five years.
How Does it Work?
The TCOC Model, like the earlier All-Payer Model, will limit Medicare’s costs in Maryland through a per capita, population-based payment, Healthcare Finance explained.
It includes three programs, including the:
- Maryland Primary Care Program (MDPCP), designed to incentivize physician practices by giving additional per beneficiary, per month CMS payments, and incentives for physicians to reduce the number of patients hospitalize;
- Care Redesign Program (CRP), which is a way for hospitals to make incentive payments to their partners in care. In essence, rewards may be given to providers that work efficiently with the hospital to improve quality of services; and,
- Hospital Payment Program, a population-based payment model that reimburses Maryland hospitals annually for hospital services. CMS provides financial incentives to hospitals that succeed in value-based care and reducing unnecessary hospitalizations and readmissions.
CMS and Maryland officials also identified these six high-priority areas for population health improvement:
- Substance-use disorder;
- Diabetes;
- Hypertension;
- Obesity;
- Smoking; and
- Asthma.
“We are going to save about a billion dollars over the next five years, but we are also providing better quality healthcare. So it’s going to affect real people in Maryland, and it helps us keep the whole healthcare system from collapsing, quite frankly,” Maryland Gov. Larry Hogan, told the Carroll County Times.
OneCare in Vermont, Different Approach to One Payer
Maryland is not the only state to try an all-payer model. Vermont’s OneCare is a statewide accountable care organization (ACO) model involving the state’s largest payers: Medicare, Medicaid, and Blue Cross and Blue Shield of Vermont, Healthcare Dive pointed out. The program aims to increase the number of patients under risk-based contracting and, simultaneously, encourage providers to meet population health goals, a Commonwealth Fund report noted.
Both Maryland’s and Vermont’s efforts indicate that payment plans which include value-based incentives are no longer just theory. In some markets, fees-for-service payment models may be gone for good.
Clinical laboratory leaders may want to touch base with their colleagues in Maryland and Vermont to learn how labs in those states are engaging providers and performing under payment programs that, if successful, could replace existing Medicare payment models in other states.
—Donna Marie Pocius
Related Information:
Maryland’s Total Cost of Care Model
Maryland All-Payer Model Expands to Include Outpatient Services
Gov. Hogan Sees Maryland Model as Example for U.S. Healthcare
The Maryland Model
Gov. Larry Hogan, Federal Government Sign Maryland Model All-Payer Contract
CMS Expands Maryland’s All-Payer Program to Outpatient Services
Vermont’s Bold Experiment in Community Driven Healthcare Reform
Dec 7, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Experts say medical laboratories must overcome staffing challenges and develop a culture of continual inspection readiness
Clinical laboratories and anatomic pathology groups will be entering 2019 facing not only financial upheaval from Medicare Part B fee cuts and narrowing payer networks, but also an increasingly rigorous and ever-evolving regulatory environment.
Although the Clinical Laboratory Improvement Amendments (CLIA) requirements have not undergone major changes since debuting in 1992, the medical laboratory industry has become more complex and technology-laden, resulting in old rules being applied to emerging technologies.
“People can get lulled into this sense that we know what standards are and we’re meeting them, but what has happened is the rules haven’t really changed—the industry has,” says Nora L. Hess, MBA, MT(ASCP), Senior Consultant for Accumen, a lab quality improvement company in San Diego, CA. “Technology is now jumping ahead so fast that keeping up with it and understanding how the rules are going to be applied is challenging.”
Hess and Anne T. Daley, MS, Quality Officer at ARUP Laboratories in Salt Lake City, UT, will co-present a 90-minute webinar on Dec. 13th titled, “Make Your Lab Assessment Ready in 2019: Know the Most Common Deficiencies in Accreditation and Certification and What to Expect in the Future.”
The program will review the top deficiencies reported by the College of American Pathologists (CAP), the Joint Commission, A2LA, and COLA.
Anne T. Daley, MS, CMQOE, CSSBB, CLC, MT, DLM (left), and Nora L. Hess, MBA, MT(ASCP), PMP (right), are Senior Consultants with Chi Solutions, an Accumen company. Together, they have extensive first-hand experience guiding clinical laboratories through the rigid and rigorous process of achieving inspection-ready status. (Photo copyrights: Chi Solutions, Inc.)
Why being ‘Inspection Ready’ Can Improve Performance and Increase Revenue
Striving to be “inspection ready” should be the goal of every clinical laboratory and pathology group. However, Daley notes labs typically operate with staffs that are stretched thin by retirements, illnesses, staff shortages, or ancillary demands on administrators’ time, caused by system-wide initiatives that range from electronic health record (EHR) rollouts to integration and consolidation of other labs.
“Most hospital laboratories are staffed at a level where they are working hard just to meet the daily patient care needs,” Daley says. “You add in all these additional projects and something has to give.”
In today’s challenging environment, Hess says laboratories that consistently perform well during the inspection process share several characteristics, including the following:
- a culture of quality across the laboratory; and,
- an emphasis on inspection readiness.
“They make inspection readiness a consistent focus across the entire laboratory,” Hess notes. “It becomes part of the calendar. It becomes part of what they talk about all the time. It is a part of their decision-making. It is hardwired into who they are and what they do … successful laboratories are making this part of their day-to-day activities, so it doesn’t get lost in the shuffle and it doesn’t get back-burnered.”
Hess and Daley note the types of deficiencies cited by accreditation agencies tend not to vary much from year to year. Testing personnel competency and proficiency testing are common themes, annually ranking high on top-10 lists of deficiencies found. However, laboratory directors increasingly are being singled out for issues related to qualifications and performance of responsibilities.
(To register for their Dec. 13th webinar or to order a DVD, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/make-your-lab-assessment-ready-in-2019-know-the-most-common-deficiencies-in-accreditation-and-certification/).
—Andrea Downing Peck
Related Information:
Make Your Lab Assessment Ready in 2019: Know the Most Common Deficiencies in Accreditation and Certification
CLIA Inspection–What they Mean and How to Avoid Them
‘We Wanted to Be the Best we Could Possibly Be’: CAP ISO 15189-Accredited Labs on the Difference it Makes
Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”