By Greg Freeman
New initiatives from the Biden administration could result in improvements to patient safety, but they also may create new compliance burdens and change the standard of care used in malpractices cases. The efforts were announced at a White House Patient Safety Forum that took place on World Patient Safety Day.
The main component is a public-private National Action Alliance for Patient and Workforce Safety headed by the Agency for Healthcare Research and Quality (AHRQ). It is tasked with developing a National Healthcare Safety Dashboard to monitor progress on the prevention of patient and workforce harm. Initially the dashboard will focus only on hospitals but later will include all healthcare settings. (More information on the alliance is available online at https://www.ahrq.gov/action-alliance/index.html)
In addition, the Centers for Disease Control and Prevention (CDC) will release new guidance for hospitals on reducing diagnostic testing errors, and it will work with the Centers for Medicare & Medicaid Services (CMS) to create new measures for sepsis, the administration announced recently. CMS also will incorporate patient safety into its public reporting and quality programs, aiming to eventually use those scores to reduce payments for facilities showing poor patient safety.
Private groups also announced new patient safety plans. The Association of American Medical Colleges also announced it will release a revised set of educational competencies focused on patient safety and quality improvement. The Ambulatory Surgery Center Association is working with the Ambulatory Surgery Center Quality Collaboration to disseminate a new quality measurement tool for surgery centers.
The initiatives will have great impact and will add to the burden of compliance, says Robert Andrews, JD, CEO of Health Transformation Alliance in Scottsdale, AZ, which oversees the strategic direction of more than 50 major corporations to fix the U.S. healthcare system. Andrews served as a member of the United States House of Representatives for nearly 24 years.
On the whole, Andrews expects the initiatives to be a net win for providers because the increase in compliance costs will be more than offset by the decrease in accidents and injuries that result. The nonpartisan nature of the efforts is encouraging, he says, and so is the fact that they are data-driven.
“I was impressed by the fact that the list that came out of it wasn’t a lot of bureaucratic language. It was specific things you should watch and do,” Andrews says. “I think it will have a great impact and it will become the standard of care in some civil litigation situations. In tort law, the question is ‘were you negligent because you didn’t meet the standard of care,’ and the standard of care usually is evolved from common law lawsuits. But when there are authoritative federal agencies and public agencies that establish standards, that’s going to find its way into the civil losses.”
A healthcare provider or organization that does not follow those practices is going to have exposed civil liability, which means higher premiums and payoffs, he says.
The focus on sepsis should yield positive results for both patients and health systems, Andrews says. The standards that are emerging are to use blood tests earlier in the care regime, to use them more accurately, and to figure out who is at risk or who has sepsis so you can treat them faster, he notes.
“You’ll have to spend a little more in the blood test, that’s for sure. That will slow the process down a little bit in the lab, but discovering two hours after someone hobbled into the ER [emergency room] that they have sepsis is a lot better than discovering it two days later when they’re in ICU [intensive care unit] bed,” Andrews says. “That’s the kind of thing that I think will become the standard of care. It will require compliance experts at health systems to make sure they’re ordering those tests and using them correctly, but I think what will happen is a lot fewer sepsis lawsuits will get filed and a lot fewer people will die of sepsis.”
Healthcare leaders should be looking to translate the safety standards promulgated into specific, practical do’s and don’ts for their teams in the hospital, Andrews says. The hospital may find that it is already meeting many of the expectations but others should identify the gap as early as possible to improve quickly.
“It’s going to raise compliance obligations,” Andrews says, “and I think that your readers are going to have a whole lot more to do as a result of something like this.”
Money Still an Issue
The initiatives look good on paper but could be challenging to implement, says John D. Fanburg, JD, managing member of the Brach Eichler law firm in Roseland, NJ. Human error plays a role in most of the safety issues and that is notoriously difficult to address, he notes.
Economic concerns also will affect compliance, Fanburg says. If best practices require increased staffing in the ICU, for example, some hospitals already facing a money crunch will be hard pressed to meet them, he says.
“Where is that money coming from? You have to take into consideration that reimbursement is creating the funds to pay salaries and if that doesn’t change they can’t just hire more people,” Fanburg says. “With increased technology, virtual or otherwise, it may be easier to reduce staff at some level, but at the end of the day, technology and AI [artificial intelligence] do not solve a lot of these problems.”
The measures are likely to improve safety, but those improvements will not arrive without some administrative and compliance burdens for hospitals, says Paul F. Schmeltzer, JD, member with the Clark Hill law firm in Los Angeles.
By addressing diagnostic testing errors, the CDC’s guidance could improve the accuracy and timeliness of diagnoses, he says. This is particularly relevant in areas like infectious diseases, cancers, and chronic conditions where early and accurate diagnosis is critical to achieving favorable patient outcomes.
“I am especially looking forward to CMS’ new measures concerning sepsis, as it is a leading cause of hospital deaths. Early treatment of sepsis improves chances for survival,” he says. “The new CMS measures aimed at reducing sepsis rates should improve early detection, treatment protocols, and potentially reduce patient mortality.”
The new CDC and CMS guidance likely will present significant administrative and compliance burdens for hospitals, Schmeltzer says. Hospitals may have to deal with new requirements related to documenting the accuracy of diagnostic testing, and the CMS and CDC new guidance on sepsis protocols is likely to exceed the CDC’s current hospital sepsis program requirements. Compliance monitoring and reporting mechanisms likely will become stricter, adding to the administrative workload.
Hospitals will need to provide training for clinical and administrative staff to implement the new protocols effectively. This could add to a hospital’s operational burden because scheduling another training for already harried staff could be daunting. Hospitals might need to update their existing electronic health records systems and workflow adjustments, which would necessitate hospitals working closely with electronic health records vendors and their internal IT staff to effectuate these changes, Schmeltzer says.
In their efforts to improve diagnostic testing and sepsis outcomes, hospitals may face more frequent audits and performance evaluations from CMS or third-party entities, he says. This could cause hospitals to devote more resources to achieve compliance with these measures.
To prepare for the impact of these initiatives, hospitals should assess their current clinical workflows and strengthen their compliance systems, Schmeltzer advises. Hospitals also should assess their current diagnostic testing procedures and sepsis management protocols to identify gaps and areas for improvement, he says.
“They can start by auditing their diagnostic error rates, focusing on common errors, and implementing training programs to minimize them,” Schmeltzer says. “Hospitals may want to proactively review their sepsis protocols and ensure that they align with the latest evidence-based guidelines. Hospitals should prioritize quality improvement initiatives because CMS is likely to tie the new sepsis and diagnostic error measures to reimbursement.”
Any new patient safety efforts should help healthcare organizations address the common problem of data interoperability, says Don Woodlock, head of global healthcare solutions at InterSystems, a Boston company that supervises data management for healthcare providers.
“When you visit one hospital, the next hospital that you visit doesn’t really know about the first hospital’s care. As you move around the community, you’re sort of building siloed patient records in these different places, and even in a hospital environment, a big enterprise environment, they may have hundreds of different applications that all have little bits of information about you,” he says. “That creates safety risks where you don’t have a complete picture of the patient’s allergies or the medications that they’re on, or their chronic conditions. That was one area that I didn’t quite see addressed too much in the announcement.”
The patient safety initiatives are encouraging, says Leah Binder, CEO of The Leapfrog Group in Washington, DC.
“What’s important about the White House Patient Safety Forum is that it took place. World Patient Safety Day has been recognized at the highest levels of our federal government — both in the White House and in Congress,” Binder says. “Any hospital that doesn’t put patient safety at the top of their agenda — including their board agenda — should start now. One place to begin is the new patient safety structural measure CMS will use to monitor hospital progress. Use it as a checklist of steps to take to advance patient safety.”
Sources
- Robert Andrews, JD, CEO, Health Transformation Alliance, Scottsdale, AZ.
- Leah Binder, CEO, The Leapfrog Group, Washington, DC. Telephone: (202) 292-6713.
- John D. Fanburg, JD, Managing Member, Brach Eichler, Roseland, NJ. Telephone: (973) 403-3107. Email: [email protected]
- Paul F. Schmeltzer, JD, Member, Clark Hill, Los Angeles. Telephone: (213) 417-5163. Email: [email protected]
- Don Woodlock, Head of Global Healthcare Solutions, InterSystems, Boston, MA. Email: [email protected]
New initiatives from the Biden administration could result in improvements to patient safety, but they also may create new compliance burdens and change the standard of care used in malpractices cases.
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