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Saturday, November 9, 2019

Watchdog group surveys outpatient surgery facilities for quality, safety

The Leapfrog Group’s surveys collected data from more than 300 ambulatory surgery centers and more than 1,100 hospital outpatient departments.

KEY TAKEAWAYS

Only 18% of ASCs reported they had adopted antimicrobial stewardship programs.
Pediatric advanced life support was identified as a “potential gap” if complications occur during surgical procedures involving children.
Board certification of clinicians is a differentiator that patients should consider when selecting an outpatient surgery facility.
For the first time, The Leapfrog Group has collected patient safety and quality information about ambulatory surgery centers (ASCs) and hospital outpatient departments (HOPDs).
Leapfrog has been collecting patient safety and quality data about hospital inpatient facilities for years. With more than 60% of surgical procedures now possible to perform at ASCs and HOPDs, the Washington, DC-based watchdog organization decided to expand collection of data to these same-day surgery settings.
The data was reported recently in a report based on two surveys. A new survey collected data this year from 321 ASCs. In an expanded Leapfrog Hospital Survey, data was collected this year from 1,141 HOPDs. “Both surveys were developed with guidance from national experts and include standardized, evidence-based measures of care specific to places that perform ambulatory and outpatient procedures,” the report says.
The surveys generated several key data points, including the following:
  • Life support: All ASCs and HOPDs reported having a board-certified clinician for advanced cardiovascular life support present while adult patients undergo procedures and recovery. However, fewer of the facilities reported always having a board-certified clinician present for pediatric advanced life support: 89% of ASCs and 96% of HOPDs. “This displays a potential gap in ability to perform life-saving actions if complications arise for pediatric patients,” the report says.
  • Surgery board certification: Leapfrog found that 1 in 3 same-day surgery facilities do not have 100% board-certification among surgical professionals.
  • Anesthesia board certification: Nearly 30% of ASCs reported that not all providers administering anesthesia are board certified. Nearly 20% of HOPDs reported that not all providers administering anesthesia are board certified. “Though 71% of ASCs and 83% of HOPDs report that all individuals who administer anesthesia are board-certified, there is still significant room for improvement,” the report says.
  • Surgery consent materials: Relatively few ASCs and HOPDs provided surgery consent materials to patients before the day of surgery. Consent materials were provided to patients at least three days prior to surgery at 17% of ASCs and 21% of HOPDs. Consent materials were provided to patients one to three days prior to surgery at 14% of ASCs and 21% of HOPDs. Consent materials were provided to patients the same day as surgery at 65% of ASCs and 49% of HOPDs. “Providing consent materials prior to the day of the procedure gives patients the opportunity to adequately consider the risks involved,” the report says.
  • Anesthesia consent materials: ASCs and HOPDs reported similar data for provision of anesthesia consent materials to patients. Anesthesia consent materials were provided to patients at least three days prior to surgery at 8% of ASCs and 10% of HOPDs. Consent materials were provided to patients one to three days prior to surgery at 8% of ASCs and 12% of HOPDs. Consent materials were provided to patients the same day as surgery at 80% of ASCs and 71% of HOPDs.
  • Antimicrobial stewardship: Only 18% of ASCs reported they had adopted antimicrobial stewardship programs. “ASCs are encouraged to adopt a program to promote the appropriate use of antimicrobials (including antibiotics), which can in turn improve patient outcomes, reduce microbial resistance, and ultimately decrease the spread of infections,” the report says. Although data was not available for HOPDs, 93% of acute care hospitals have reported having antimicrobial stewardship programs.

INTERPRETING THE DATA

Erica Mobley, director of operations at The Leapfrog Group, told HealthLeaders that the survey result on antimicrobial stewardship at ASCs was “certainly a concern.”
“Antibiotic and antimicrobial use in ASCs is different from that administered in other healthcare environments, which is why Leapfrog chose to include this safety protocol on its survey. Many resources and toolkits have been developed to help ASCs with implementing an antimicrobial stewardship program, and we are confident this number will grow in the future,” she said.
The findings that 11% of ASCs and 4% of HOPDs do not always have a clinician present who is certified to provide advanced life support for pediatric patients is also concerning, Mobley said. “If unexpected complications arise, these facilities may not be well-equipped to care for pediatric patients. … Parents should inquire about the availability of clinicians certified in pediatric advanced life support prior to scheduling a procedure for their child.”
When selecting an ASC or HOPD for a surgical procedure, patients should consider the presence of board-certified clinicians performing procedures and administering anesthesia, she said.
“Board certification is a voluntary process separate from licensure. Medical professionals who pursue it demonstrate a desire to grow their skillset to keep pace with the latest advancements in their specialty. Consumers considering their options for surgery should inquire whether the healthcare team consists of board-certified individuals to inform their decision of where they seek treatment. In some cases, the absence of board-certified clinicians may mean that experts who have the skillset to treat true complications are not present in the facility.”
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Experts Tell FDA to Consider Relaxing Med Equipment Sterilization Standards

An FDA advisory panel recommended the agency critically evaluate sterility assurance levels for medical products in its efforts to reduce ethylene oxide (EtO) emissions.
The common sterilant is used to disinfect medical devices, everything from wound dressings to endoscopes to surgical kits, but is also a known carcinogenic. In February, a commercial sterilization facility in Illinois was ordered to close under a state order related to emissions of the gas. In response, the FDA issued a warning that such closures could lead to a shortage of medical devices. In March, another sterilization facility, this time in Michigan, announced it would close by the end of the year.
More than 50% of all sterilization in the U.S. uses EtO.
As for switching to alternative methods for device sterilization? Such a move would require significant amounts of time and investment, as well as validation of each product with a new method, experts said at the FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee.
“In almost every case the device is dictating the sterilization method,” said panelist Stephen Li, MD, who heads a consulting firm in Palm Harbor, Florida.
The panel met on Wednesday and Thursday with an agenda aimed at reducing emissions from EtO during device sterilization “without compromising assurance of sterility or effective processing of medical devices,” and to determine whether alternative sterilization methods might be considered as a replacement EtO.
Scope of the Problem
During public testimony, Chaun Powell, of the healthcare consultancy Premier, said excess capacity of EtO sterilization across the U.S. is “nearly exhausted.”
Yet in surveying 600 suppliers, his group found that just 3% of respondents believed there was a “legitimate risk of product disruption.”
Following the Illinois and Michigan sterilization plants closures, the country’s current excess capacity is about 520 million, Powell explained. The average facility sterilizes roughly 200 million units per year. He noted, as an example, that the combined volume of Medline in Illinois and BD in Georgia is 550 million units — both of these facilities are at risk of closure.
“Simple math shows that if we close those two plants we exceed the current capacity across the entire U.S. by 30 million units,” he said. “Two facilities of average size, you name them, that’s all the capacity we have today.”
To prevent or at least address this looming potential crisis, Powell urged the FDA to create greater “upstream visibility” for stakeholders, in order to reduce any potential disruptions to the supply of medical devices and products or prevent them entirely. FDA should also seek to extend the authority it already has to deal with drug shortages to include device shortages as well.
Asked whether the dire predictions cast by Powell were accurate, Suzanne Schwartz, MD, MBA, of the FDA’s Center for Devices & Radiological Health (CDRH), said the numbers were “consistent” with the FDA’s own research and analysis.
“If even one additional facility shutdown, we will start to see spot shortages. There’s no question about that,” Schwartz told reporters. “In terms of a more catastrophic national impact, with two facilities shutdown, it’s almost a certainty.”
The Environmental Protection Agency (EPA) also now has its sights on cutting EtO emissions after a new assessment showed the carcinogen to be 50 times more potent than was previously known. In August 2018, the EPA identified 20 areas in the country where EtO is the main contributor to potential cancer risk.
On Thursday, the EPA proposed cutting EtO emissions by 93% for industrial users of the chemical. Medical device sterilizers are considered commercial users and fall outside of this proposal, but plans were announced to review emissions standards for commercial sterilization operations as well.
Advice to the FDA
Asked what the agency can do to help minimize the impact of closures on healthcare delivery organizations, one panelist suggested framing the question in two time frames.
Any immediate action would fall not to the FDA, but to the HHS Secretary, said Robert Burr, MD, MSc, an endocrinologist whose expertise includes occupational and environmental medicine.
“The Secretary could declare a public health emergency and in doing that simply override the state and override the EPA and get their missing plants back online,” he said.
Burr said the technology around abatement (reducing pollutants) is “extraordinarily good” and he sees no reason why with investments in abatement technology, sites would not be able to reach the proper emission standards relatively quickly and “reassure people in the neighborhood that things are okay.”
Schwartz agreed with the idea of separating the solutions into long- and short-term strategies. The FDA recently issued two innovation challenges for stakeholders — one focused on long-term strategies, such as identifying new sterilization methods, and the other on more near-term solutions (i.e., cutting EtO emissions). Submissions from stakeholders are currently under review by the agency.
However, she noted that any abatement or structural changes to a facility would be subject to the EPA’s authority and not the FDA’s.
David Krause, PhD, deputy office director for CDRH, noted that current standards for EtO sterilization are validated at about 10-6 — meaning that the possibility that a single spore remains nonsterile is one in a million — and asked whether 10-3 might suffice for some products.
Panelist Gary Socola, CEO of HIGHPOWER Validation Testing & Lab Services in Rochester, New York, suggested that the 10-6 validation makes sense for reusable devices, but not for single-use items — which were the focus of the discussion.
Industry representative Carol Pekar, MBA, a consultant in Massachusetts, suggested that the FDA put out guidance or a communication explaining that these lower validation levels are acceptable. She also suggested the agency issue sample validation protocols and that review could be accelerated for any related 510(k) applications.
Going a step further, gastroenterologist Ashley Faulx, MD, pointed out that many products are sterile without cause.
“We use sterile water in the colon. That makes no sense,” she said.
Michael Saubolle, PhD, of the University of Arizona College of Medicine Phoenix, pointed out that while the idea conceptually makes sense, it would be a non-starter for immuno-compromised patients.
Panel chair Frank Lewis, Jr., MD, seemed confident that allowing new methods of validating EtO sterilization and potentially reducing the amount of sterilant would not impact patient safety or the efficacy of the products.
But he said increasing the patient risk profile for some devices, such as endovascular devices, would not be acceptable.
“What we heard [from industry] was that the level can be reduced and still maintain the same assurance of sterility because the actual sterility that they achieved was several orders of magnitude greater than 10-6,” said Lewis.
“Are the standards higher than they need to be?” he said. “The answer to that has already been stated — ‘yes.'”
Alternatives to EtO
Over 2 days, the panel heard presentations from experts in sterilization with hydrogen peroxide, nitrogen dioxide, chlorine dioxide, peracetic acid, gamma rays, x-ray, e-beam, and moist and dry heat.
Lewis concluded that while there were many ideas suggested as a path forward, none could be completed in “the short run.”
Most of the gas sterilization methods cannot be used with cardboard or cellulose materials, and many of the beam technologies and other processes like gamma rays could not be used for certain plastics without fear of damaging the device.
In addition, these products would need to be re-validated before any switch was made. For Class III devices, FDA reviews sterilization validation as part of its manufacturing controls to assure the products’ safety and effectiveness.
But the panelists agreed with the idea of pursuing alternative sterilization methods for “niche categories,” and one even suggested the FDA consider a new innovation challenge to determine which broad categories of devices could be sterilized by which methods.
Jason Dominitz, MD, a gastroenterologist for the Veterans Health Administration in Seattle, suggested that the FDA do whatever is in its purview to fast-track additional sterilization approvals, so that capacity for switching exists.
While experts testified that currently only 2% of medical devices have recorded another means of sterilization besides EtO, the possibility exists that some device makers could use other methods and have not, Schwartz told MedPage Today.
Defining the FDA’s Role
Asked by reporters, between sessions, whether the FDA would consider asking Department of Health and Human Services (HHS) Secretary Alex Azar to declare a public emergency and force facilities back into production, Schwartz intimated that such a step was premature.
“When we’re dealing with a national crisis that’s certainly a lever,” she said, noting that it had been used for Ebola and other types of “infectious disease events.”
But a decision regarding such an “aggressive measure” would require more discussion with HHS and the Assistant Secretary of Preparedness Response to determine its appropriateness.
Regarding the FDA’s own authorities, Schwartz told MedPage Today that the agency has proposed legislation around device shortages similar to those by the Center for Drug Evaluation and Research for its drug shortage program.
In a situation like the current one with the EtO sterilization facility closures or in the case of a natural disaster or all-hazards event, CDRH can only request this kind of information, but companies have no regulatory or legal requirement to comply, she said.
The proposed request for additional authorities, which was published in the FDA’s 2020 Budget Request, is intended to ensure the agency has “timely and accurate” information related to “likely or confirmed national shortages of essential devices.”
The request, if made law, would give the FDA the authority to “require firms to notify FDA of an anticipated significant interruption in the supply of an essential device; require all manufacturers of devices determined to be essential to periodically provide FDA with information about the manufacturing capacity of the essential device(s) they manufacture; and authorize the temporary importation of devices whose risks presented when patients and healthcare providers lack access to critically important medical devices outweigh compliance with U.S. regulatory standards.”
The FDA is currently working on the statutory language and will be seeking out sponsors for the bill.
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Copper ICU Beds Mostly Untarnished by Bacteria

Hospital beds with copper surfaces in an intensive care unit had significantly fewer bacteria than hospital beds with plastic surfaces, even after daily cleaning and disinfection, researchers found.
Active colony forming units per 100 cm2 on beds with copper rails, foot boards, and bed controls were less than 10% of those seen on conventional beds (median 42 vs 594), reported Michael Schmidt, PhD, of Medical University in South Carolina in Charleston, writing in Applied and Environmental Microbiology.
“The findings indicate that antimicrobial copper beds can assist infection control practitioners in their quest to keep healthcare surfaces hygienic between regular cleanings, thereby reducing the potential risk of transmitting bacteria associated with healthcare associated infections,” Schmidt said in a statement.
The authors explained that “metallic copper surfaces kill bacteria through a multi-modal mechanism through its ability to disrupt bacterial respiration, generate superoxide, and destroy genomic and plasmid DNA in situ.”
Studies have found that not only does environmental contamination play a role in transmitting pathogens responsible for healthcare-acquired infections, the investigators added, but copper-containing surfaces had reduced bacterial burdens.
Nevertheless, Schmidt noted, acute-care hospital beds on which all high-risk surfaces are copper have only recently become available.
“Based on the positive results of previous trials, we worked to get a fully encapsulated copper bed produced. We needed to convince manufacturers that the risk to undertake this effort was worthwhile,” he said.
This was a pragmatic cross-over study performed in a medical intensive care unit at a single medical center, which monitored the bacterial burden of control beds from April 2017 to July 2018, and interventional beds from April 2018 to March 2019 — noting a mixture of intervention and control beds from April to July 2018, as copper beds were introduced when a patient was discharged from a control bed.
Beds were thoroughly cleaned after patient discharge, and high-touch surfaces were routinely disinfected, as part of daily cleaning protocols, the authors said. Not surprisingly, they found that control beds accumulated higher concentrations of bacteria across all sampled areas, with the tops of the bed rails the most heavily soiled.
To put this into context, the authors noted that 89% of the samples collected from the control beds exceed the benchmark terminal cleaning and disinfection risk threshold compared to 9% from the copper beds, and 42% of copper beds were free of detectable bacteria.
In fact, the area with the heaviest bacterial burden on the copper bed was the internal, patient-facing surface of the foot board — though it was significantly lower than the comparative location on the control foot board, the authors noted.
One barrier to implementing this solution could be the cost of copper beds, but Schmidt and colleagues argued it would ultimately cost less than other adjunct cleaning options. Encapsulating a bed with antimicrobial copper would cost approximately $2,200 per bed, amortized over 5 years for a total of $1.20 per bed per day. The authors said that additional daily cleaning ($12-$13/room), ultraviolet radiation ($10/room), or hydrogen peroxide vapor phase deposition ($100/room) would be much more expensive.
“The copper intervention … is the only adjunct to act continuously, actively killing bacteria … and only adding a modest increase to the environmental services/infection control budget,” they wrote. “The value delivered by this intervention to the infection control bundle warrants further studies to assess its impact on HAI rates ultimately leading to consideration for its adoption.”
Bed Techs, Inc. supported the study.
LAST UPDATED 
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Friday, November 8, 2019

Warren’s Medicare-for-All plan is a disaster

Elizabeth Warren has unveiled the blueprint for her Medicare-for-All plan and it makes very clear why she avoided transparency on the matter until now.
Over the next decade — by her own estimate — WarrenCare would cost more than $52 trillion. That includes $20 trillion in new federal spending. As a benchmark, consider that the entire federal budget is currently around $4 trillion each year.
The key feature is that Warren claims she can come up with this new $20 trillion without raising taxes “one penny” on the middle-class.
So what does that leave?
Well, to start with, to even get to the $20 trillion number, Warren assumes massive increases in efficiency under Medicare for All, both by eliminating private insurers and all of their administrative costs entirely, as well as streamlining the billing process for providers.
Of course, for any American who has ever needed so much as a driver’s license, much less required actual payment from a government agency, the idea that a federal bureaucracy will improve the efficiency and lower the costs of a payment process is ludicrous in the extreme.
Warren points to the current Medicare program’s relatively low 2.3% in administrative costs, and assumes this will carry over to her entire plan. This common Medicare-for-All talking point simply doesn’t hold up to serious scrutiny given that Medicare is able to outsource tax collection to the IRS, premium collection to the SSA, and accounting, auditing and more to HHS. In addition, the low percentage is partially a function of the high cost of caring for older patients, and one 2005 study found that Medicare in fact had higher per-beneficiary administrative dollar costs than private insurance.
Moreover, Warren’s fantastical plan relies on reimbursing all doctors and hospitals at or below 110% of current Medicare rates, rates which two-thirds of providers say don’t even cover their costs to provide the care. To wave away the very real threat of mass hospital closings with promises of improved efficiency is beyond disingenuous.
Suffice it to say, the mythical creature of Warren’s hypothetical administrative savings are unlikely to emerge from the swamp of Washington, D.C. and $20 trillion in new taxes is likely nowhere close to enough to cover the cost of the program.
But where does she plan to get the $20 trillion? Taxes, taxes, taxes.
The biggest and most creative new tax comes from redirecting employer-paid insurance premiums from private companies to the federal government, generating $9 trillion in new tax revenue over the next 10 years.
It is inconceivable that these trillions and trillions in new taxes will not be passed on to the middle class, whether in higher consumer prices or in lower pay, no matter what “mathematical gymnastics,” as the Biden campaign called it, Warren uses to pretend otherwise.
Health care for all is a laudable concept. To give every American access to affordable, quality care comes from a place of human compassion, but honest people can disagree about the best way to achieve that. The American system, while high in cost, provides the best and most innovative care in the world to an enormous and diverse population, over 90% of which currently has health care coverage.
To propose to take a sledgehammer to that system on the strength of unserious revenue promises and magical thinking does a disservice to the American people.
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Many Multiple Sclerosis Patients Considering Stem Cell Transplant

Many multiple sclerosis (MS) patients are considering autologous hematopoietic stem cell transplantation (aHSCT) as a treatment option, according to a study published in the January 2020 issue of Multiple Sclerosis and Related Disorders.
Floriaan G.C.M. De Kleermaeker, from the Viecuri Medical Center in Venlo, Netherlands, and colleagues conducted a survey of 137 patients with MS to assess disease history, knowledge about aHSCT, expectations of aHSCT, information sources, and the role they assign to their neurologists.
The researchers found that 54 percent of patients are considering aHSCT either now or in the future. Consideration was higher in those who are dissatisfied with current treatment, have a shorter disease duration (≤10 years), or are more disabled (Expanded Disability Status Scale >3.5). Only one in four reported having sufficient knowledge about aHSCT. Although patients prefer receiving information from their neurologist, patients mainly use potentially unreliable information sources (e.g., the internet and television). Half of patients think aHSCT is superior to highly effective disease-modifying therapy. Among patients interested in aHSCT, expectations of efficacy are significantly higher versus patients not wanting to undergo aHSCT. Only about one in three patients can cite at least one side effect.
“Neurologists should proactively inform their patients about the potential benefits and risks of aHSCT to enable them to choose the best treatment option,” the authors write.
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New Tool Predicts Odds of Kidney Disease

 Imagine that your doctor could predict your risk of kidney disease in the next five years with a simple calculation.
Researchers from Johns Hopkins University in Baltimore report they have done just that.
“With the risk equations that we’ve developed, physicians should be able to determine with high accuracy who will or won’t develop chronic kidney disease in the next few years — and our analyses suggest that they can maintain that accuracy in a variety of clinical settings globally,” researcher Dr. Josef Coresh said in a university news release. He’s a professor in the department of epidemiology at the Bloomberg School of Public Health at Hopkins.
This new calculation uses a mix of factors that include age, high blood pressure and diabetes to predict if someone is likely to develop chronic kidney disease.
The calculator should help doctors identify patients who are most at risk for kidney disease and would benefit the most from early treatment, they said.
Although chronic kidney disease is a progressive condition, its progression can be slowed or stopped if caught early, the researchers noted.
In the study, Coresh’s team used data on more than 5 million people from 28 countries. Using that data, they developed an equation using known chronic kidney disease risk factors that doctors could use to predict which patients are likely to develop chronic kidney disease.
Analysis of the risk scores predicted by the equations were accurate enough to be used clinically, the researchers said.
The calculator was considered accurate when used with another group of more than 2 million people.
The report was published Nov. 8 in the Journal of the American Medical Association.
More information
SOURCE: Johns Hopkins Bloomberg School of Public Health, news release, Nov. 8, 2019
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Medicare patients could lose access to proton therapy cancer treatment

Three of the scariest words in the English language are “you have cancer.”
It was not long ago that these three words were a death sentence. But today, many new treatments are helping cancer patients not only survive but thrive and live long and healthy lives.
Unfortunately, the Centers for Medicare and Medicaid Services (CMS) is proposing a new rule that will make it much harder for cancer patients to receive one of these amazing life-saving treatments. At risk is a highly precise form of radiation treatment known as proton therapy.
Unlike traditional radiation, proton therapy allows doctors to target the bulk of the cancer-fighting energy on the cancerous cells while minimizing radiation exposure to healthy tissue, reducing risks to surrounding vital areas, such as organs and bones. Recognizing these benefits, top cancer centers around the country have invested in this cutting-edge technology.
Now, the government is relying on outdated studies in a proposed rule that will severely limit access to this life-saving treatment.
In its proposed rule, CMS not only fails to include the well-established guidelines from the American Society of Radiation Oncology and the National Comprehensive Cancer Network, it cites an outdated (2014) report from the Institute for Clinical and Economic Review and a flawed Medicare Patient Advisory Commission report, in which authors cited old data and ignored clinical expert opinions.

With the rulemaking process nearing completion, Congress must step in by calling on CMS Administrator Seema Verma to remove this innovative treatment from the proposed Radiation Oncology Alternative Payment Model (RO Model). If implemented as written, many cancer institutions would be in the difficult position of not being able to offer their patients proton therapy because the reimbursement rate would not adequately cover the costs for delivering this sophisticated technology. As a result, many proton centers may have to shut their doors, and new ones won’t open as planned. Access to proton therapy would decrease for all patients—especially in rural and underserved areas—not just those covered by Medicare.
It appears that CMS’ rationale for undercutting physicians’ ability to prescribe proton therapy is based solely on short-term cost-saving objectives rather than what is the best treatment option for cancer patients. The proposed rule is penny-wise and pound-foolish. Rather than saving money, this rule will increase costs to the Medicare Trust Fund over the long term.
Without proton therapy as a viable option, more patients receiving traditional radiation will need treatment for long-term side-effects and secondary cancers later in life. This rule would deny cancer care that could lessen their suffering and improve quality of life, all in the name of short-term cost savings.

We believe the most prudent option is for CMS to remove proton therapy from the RO Model. If CMS insists on including proton therapy, the only sensible way forward is to require taking into account current medical guidelines and considerations for the resource-intensive nature of the treatment and reimburse accordingly.
Congress needs to stand up for cancer patients and make sure that CMS does not implement the RO Model as written. Cancer patients deserve the right to work directly with their medical teams to determine the best care plan for them.
Letting a government agency undercut patients’ and physicians’ options—based on outdated and flawed information, no less—should not be tolerated.
Daniel E. Smith is the executive director of the Alliance for Proton Therapy Access.
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