• Article
  • July 20, 2015

Commentary: Protecting Patient Safety Is Critical

Future advances in children's hospital patient safety could be jeopardized if court case is not overturned.

By Kate Conrad, FACHE, and Michael Callahan, J.D.

Findings from a 2014 Kentucky Supreme Court case (Tibbs v. Bunnell), where the court narrowly interpreted the scope of protections involving patient safety information, are threatening important advances in this area. As a result, the confidential data shared through patient safety organizations (PSOs) to improve health care quality and safety could lose its protected status. Ultimately, the United States Supreme Court could hear the case.

For PSOs across the country, the goal is to reverse the Kentucky court's ruling. The Child Health PSO, a national organization of more than 50 children's hospitals aimed at eliminating preventable harm in U.S. children's hospitals, has signed on to an amicus brief with other PSOs and medical organizations, such as the American Medical Association and The Joint Commission. In doing so, the Child Health PSO aims to preserve the privilege and confidentiality of PSO patient safety information, called patient safety work product.

What's at risk?

The Kentucky court's ruling lifts confidentiality protections in place under the federal Patient Safety and Quality Improvement Act of 2005 (PSQIA) for data collected in patient safety systems. Today, patient safety information is openly and confidentially shared by participants in a PSO without fear of liability with the goal of improving safety in health care delivery. Should the Tibbs v. Bunnell ruling prevail, this data could be released publicly for use in lawsuits. Children's hospitals and other participants in the nation's PSOs argue documents demanded by a third party in a state medical malpractice suit are protected patient safety work product. Because most of these lawsuits ultimately settle before being heard in court, there are few appellate court decisions that have analyzed the PSQIA and PSO protections. Consequently, there is little judicial guidance to PSOs and providers.

If the Supreme Court agrees to review Tibbs v. Bunnell, it would affect how state and federal courts across the country interpret the PSQIA and its protections, therefore minimizing the piecemeal state-by-state interpretations. In 2013, CMS proposed rules to implement section 1311(h) of the Affordable Care Act, requiring hospitals with more than 50 beds to participate with a PSO, contract with a qualified health plan and participate in state insurance exchanges. Provisions have been phased in with this requirement, expected by January 2017.

Building participation in a voluntary reporting system without fear of litigation is no easy feat for PSOs. However, the appetite for building safe hospital systems is huge, particularly as mandated reporting of adverse events and supporting payment models with penalties for causing harm increase. And, it's important for hospitals to model systems after industries that have worked diligently to improve safety, such as the nuclear industry, says Patti DePompei, CEO of UH Rainbow Babies & Children's Hospital and Child Health PSO board member. "PSOs should act as early warning systems to hospitals across the country," she says. This early warning system, in combination with national efforts to improve the culture of safety, has enabled children's hospitals to become safer.

Child health PSO

The Child Health PSO has grown from 12 to more than 50 members—strengthening the early warning system for children's health care. Steve Muething, M.D., vice president of safety at Cincinnati Children's Hospital Medical Center is a clinical leader of the Child Health PSO and Children's Hospitals' Solutions for Patient Safety (SPS). "The PSO and SPS monitor the serious safety event rate, a measure of preventable harm, and we have seen a 33 percent decrease over the last year," he says.

Working closely to learn from each other, children's hospital safety leaders are uncovering ways to make important system changes. Executives at Children's National Health System in Washington, D.C., have experienced the power of participating in Child Health PSO. "We're alerted to device and equipment concerns, and within 24 hours, able to confirm if the device or equipment is in our institution and notify providers," says Rahul Shah, M.D., chief quality and safety officer. Shah meets with CEO Kurt Newman, M.D., every other week to review the institution's progress in safety. "Because of the PSO, we learn about themes and improve our investigations," Newman says. "We focus on system issues rather than what previously would have been reviewed as a singular event."

Aggregating rare events validates and allows children's hospitals to focus on learning together as a peer network rather than individually from fewer events. Leaders use what they learn to obtain needed resources to identify risks and implement procedures to mitigate future risk. Fiona Levy, clinical chair of the Child Health PSO Patient Safety Team, says a preoccupation with failure is the fundamental principle of high reliability that PSOs support.

Without federal protections, children's hospitals won't be as willing to report safety issues, thereby preventing the Child Health PSO from providing notifications for safety concerns. Participation in a PSO shows high-level commitment and a leap of faith that relies on federal backing of the regulations. "We need to trust that we have federal protections. Our providers don't want to cause a child harm," Levy says. "When the system is to blame, we must take action. We all hope to see the day when preventable harm is no longer a concern."

Staying alert

The Child Health Patient Safety Organization (PSO) releases Patient Safety Action Alerts to share lessons learned and alert hospitals to possible risks. They serve as a guide for PSO hospitals and other pediatric providers to self-assess the risk of a similar event occurring in their hospital. Here are examples:

  • Potential for event related to patients receiving liquid medications through enteral route: Identifies challenges related to measurement and administration issues 
  • Sustained or extended release medication fill and administration errors: Assesses dispensing and verification procedures for high-risk medications such as sustained/extended release narcotics
  • Fingertip amputation: Repeats a known risk in pediatric scissor safety
  • Fungal outbreak associated with hospital linens: Presents actions to mitigate risk for cutaneous Mucormycosis
  • Wrong size tracheostomy selection: Outlines strategies for communicating and validating tracheostomy tube specifics
  • Blind pediatric NG tube placements: Identifies a need to consider the risks associated with blind NG tube placement
  • Pediatric medication concentration standards with retail pharmacy: Emphasizes the need for broader adoption of pediatric medication standards

Kate Conrad, FACHE, vice president, leads Child Health PSO at Children's Hospital Association. Michael Callahan, J.D., is a partner at Katten Muchin Rosenman, LLP, in Chicago.

Send questions or comments to magazine@childrenshospitals.org.