National Patient Safety Board Could Be Implemented
Advocates are pushing for the formation of a National Patient Safety Board. The board would be patterned after safety agencies in the transportation and aviation industries.
- A bill in Congress would create the board.
- The bill might not pass without bipartisan sponsorship.
- A board could address chronic underreporting of safety events.
A bill in Congress could create a patient safety board modeled after the successful safety efforts in transportation. The bill would create a National Patient Safety Board (NPSB) that would do for the healthcare industry what the National Transportation Safety Board (NTSB) and Commercial Aviation Safety Team (CAST) have done to improve safety for those fields for more than 25 years.
Like NTSB and CAST, the NPSB would provide expertise to study the causes of errors and create recommendations and solutions to prevent future harms, says Karen Feinstein, president and CEO of the Jewish Healthcare Foundation and Pittsburgh Regional Health Initiative, and the spokesperson for the NPSB Advocacy Coalition.
The effort to create the NPSB began in 2021 when a coalition of leading healthcare organizations and experts began advocating for it in response to growing concern over medical errors and patient safety. In December 2022, Rep. Nanette Barragán, D-CA, introduced HR 9377 to establish the NPSB.1
Feinstein says the coalition continues to grow as more organizations become aware of the need to improve patient safety. “There is a lot of recognition that the workforce shortage and the rates of error in most of the categories of patient safety are rising, and that they’re not unrelated. With a number of experienced professionals — nurses in particular — leaving, we have more opportunity for error,” she explains. “But as we have more opportunity for error, more nurses and doctors are just getting stressed and burnt out, so that’s exacerbating the workforce shortage and the loss of experienced nurses and doctors, which then increases the opportunity for harm. It’s kind of cyclical.”
HR 9377 is a big step forward, Feinstein says, but she wishes there were more vocal support from the biggest names in the healthcare community, like the American Hospital Association and the American Medical Association. So far, they have not expressed any opposition to the proposal, but they also have not been active in supporting it and lobbying legislators, Feinstein notes.
Any reluctance to push the NPSB proposal might be due to the fact many patient safety improvements would involve upgrading or altering infrastructure like electronic health records and medication dispensing systems.
“Any hesitancy to do what needs to be done is because there will be a cost. You’re not going to redesign systems and have it be free,” Feinstein says. “We’ve got to get a better response from our electronic health records and other prompts because they’re being ignored right now. People are just overwhelmed. What we hear from doctors and nurses is that if they didn’t ignore those prompts, they would go crazy, couldn’t do their jobs, and other patients would die.”
For example, a solution must be found that alleviates the pressure on clinicians while prohibiting a dispensing system to provide two drugs with potentially deadly interactions, Feinstein says. Such solutions require a commitment to invest already-scant resources. Feinstein notes that might be why leaders are not vocal in their support of a NPSB that would pressure healthcare organizations to make those changes.
Feinstein notes Finland is well regarded for its emphasis on patient safety. The country created an agency similar to the NPSB concept. That agency investigates significant medical errors and other patient safety events, submits recommendations based on those findings, and requires hospitals to report annually for 10 years on their progress in implementing the improvements. Finland also requires medical students to take courses in safety science, quality engineering, systems theory, and other subjects related to patient safety.
“My son-in-law’s a surgeon, and I think he got half an hour on infection control, and nothing on those other topics,” Feinstein says.
Bill May Not Pass
HR 9377 may not succeed, says Robert Andrews, JD, CEO of Health Transformation Alliance in Washington, DC, which oversees the strategic direction of more than 50 major corporations to fix the U.S. healthcare system. Andrews served in the U.S. House of Representatives for 24 years.
“We think the congresswoman’s bill is a step in the right direction, but in a House that’s controlled by Republicans, it’s unlikely that the bill will become law without Republican sponsorship,” Andrews says. “I don’t know if this would get 60 votes in the Senate. But I don’t think it moves out of the House without Republican sponsorship. That’s not a reflection on the merits of the bill. It’s a reflection on the realities and the way the House works.”
Andrews suspects there has not been much objection to the bill from the healthcare industry because a bill introduced by a minority member does not have much chance of succeeding. The industry is probably not paying much attention to it for that reason, even though the NPSB would create more regulatory oversight — and no industry is eager to see that happen, he says.
If such a bill ever looked like it might pass both the House and the Senate, the healthcare industry might respond by saying there already is plenty of safety oversight and requirements from CMS, The Joint Commission, the FDA, and state departments of health, Andrews notes. They might also cite the existing legal system for malpractice compensation.
Andrews says he does not necessarily agree with those counterclaims and believes the NPSB would create consumer knowledge and transparency that does not exist. He envisions the NPSB putting an emphasis on patient safety so hospitals would market by promoting their good scores and high standards, helping patients find the safest options for care.
“I’m old enough to remember when the auto industry fought airbags ferociously. They depicted airbags as the end of the American auto industry. Of course, they weren’t,” Andrews recalls. “Airbags were required, and now they market airbags in car ads. Airbags went from being what the industry saw as oppressively expensive to being a marketing tool. I’d like to see that happen with safety standards.”
Challenging Corporate Limits
An NPSB could help break through some of the corporate mindset that hinders efforts to improve patient safety, says Gary Warren, CEO of ivWatch, an IV patient safety company in Newport News, VA. Warren says perception of the issue is framed by two comments he heard in recent years from hospital executives.
In the first, a chief financial officer at a prominent hospital told him, “We generally don’t collect data on things that are going to cost us money to fix.” The second was made by the chief medical officer of a large hospital network, who said, “Our business model is to provide the least amount of healthcare for the most amount of money.”
“These comments haunt me every time I walk into a hospital. They are appalling but define the battle between patient safety initiatives and the financial model of our healthcare system,” Warren laments. “The first casualty of this battle is and has been accurate reporting and recordkeeping. The first step in solving a problem is admitting you have one, and hospitals underreport medical errors because they have a strong financial incentive to maintain the status quo.”
An NPSB would be a welcome development, but to align with the charter of the NTSB, mandatory and consistent reporting of events needs to be the foundation, Warren says.
IV access is one procedural area the newly formed NPSB should include in their focus, Warren says. More than 80% of patients admitted to hospitals undergo this seemingly simple and common procedure. However, significant complication rates lead to drug dosing errors, skin necrosis, scarring, compartment syndrome, and even amputation in severe instances.
For a specific example of why NPSB oversight is needed, Warren says one can look at the administration of radiopharmaceuticals via an IV placement. Radiopharmaceuticals contain radioactive isotopes and are used in nuclear medicine for procedures like bone scans, heart scans, and cancer treatments. They are regulated by the Nuclear Regulatory Commission (NRC). The NRC has yet to make the extravasation (accidental delivery outside the vein) of radiopharmaceuticals a required reportable medical event.2
“Instead, just this year, the NRC, ‘in working with stakeholders,’ decided that it would be up to the patient to report the missed delivery of radioactive drugs and any complications that occur in the future,” Warren notes. “To make an analogy with the NTSB, this would be like requiring the passenger of a plane to report a crash or it never happened. The healthcare reporting system is broken.”
The problem of IV infiltration and extravasation spans more areas than nuclear medicine, Warren notes. The delivery of chemotherapy agents, antibiotics, dextrose, and vasopressors all cause injuries when delivered outside the vein. Even worse, the therapeutic effect of the drug is diminished or removed because every IV infiltration and extravasation is a drug dosing error. For example, a stroke patient needing clot-busting drugs does not receive the therapeutic benefit because of a misplaced IV.
“They die. It’s never reported,” Warren notes. “Then, there are certain patient populations such as neonates that have over 50% of their IVs fail. That’s over 50% of the patients with drug dosing errors.”
Warren says he and his colleagues constantly hear hospital leaders say, “Our hospital does not track our IV infiltration rates,” or “We do not have that problem in our hospital,” or “I don’t have time to report that event; it’s just some swelling.” That is where the friction begins and why a NPSB is so important, he says. No one wants to get in trouble — no one wants to be held accountable.
The statistics do not lie, yet there is minimal reporting on this everyday problem. “When you look at the clinical research available around IV infiltrations and extravasations, the mean infiltration incidence rate is 23.9%. Our own research from 50 ivWatch hospital evaluations exposed a 24.1% infiltration rate, which matches the published literature,” Warren explains. “If a hospital was required to report its infiltration rates publicly and reported a major outlier, for example, at 3%, that should be an immediate red flag to audit that hospital because there are two scenarios here. Either they are significantly underreporting their data, or they have solved a serious healthcare crisis and it needs to be celebrated by the world so every hospital can replicate their policies.”
Warren notes that if one plane crashes, the NTSB acts. But in medicine, people say, “It’s a small percentage, so it’s OK.”
“The problem is a small percentage of a really big number is still a big number. Additionally, people are not percentages,” Warren says. “As such, I support the formation of the NPSB, but I believe the battle begins with fixing reporting issues.”
- 117th Congress. H.R. 9377 — National Patient Safety Board Act of 2022. Dec. 1, 2022.
- U.S. Nuclear Regulatory Commission. Rulemaking: Reporting nuclear medicine injection extravasations as medical events. Page last reviewed June 29, 2023.
- Robert Andrews, JD, CEO, Health Transformation Alliance, Washington, DC. Email: [email protected].
- Karen Feinstein, President and CEO, Jewish Healthcare Foundation, Pittsburgh. Phone: (412) 594-2550.
- Gary Warren, CEO, ivWatch, Newport News, VA. Phone: (855) 489-2824.
A bill in Congress could create a patient safety board modeled after the successful safety efforts in transportation. The bill would create a National Patient Safety Board that would do for the healthcare industry what the National Transportation Safety Board and Commercial Aviation Safety Team have done to improve safety for those fields for more than 25 years.
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