Trending
A spike in injuries and deaths of newborns at Pennsylvania hospitals has alarmed a state agency, which also says it has been unable to get the information from hospitals it needs to analyze the incidents and try to prevent them.
The Pennsylvania Patient Safety Authority says it received reports of 169 "serious events" involving neonatal care in 2022, about twice as many as in 2018.
Serious events refer to unexpected injuries or deaths suffered while receiving medical care. Some result from mistakes or are otherwise considered preventable.
The 169 serious events involve incidents such as shoulder injuries during delivery, injuries related to instruments used during delivery, and injuries due to not getting enough oxygen during delivery.
"At least 15″ of the events involved babies who died, says Regina Hoffman, the executive director of the Pennsylvania Patient Safety Authority.
The authority says it has been unable to get information from hospitals needed to analyze the events.
"We identified this topic last fall as one of critical importance. We would like to conduct this analysis as soon as possible in order to identify preventable harm and advise healthcare facilities how to avoid that harm in the future," Hoffman says.
But hospitals have resisted providing the information, saying it could cost them legal protections intended to allow the study of medical mistakes and unintended medical outcomes without fear of punishment or having the information used against them in lawsuits.
The Pennsylvania Patient Safety Authority was created by the legislature in 2002 to collect reports of serious events and near-misses at hospitals and study them to identify preventable problems and advise hospitals on improving patient safety.
Pennsylvania law requires hospitals to report such events to the authority, while also giving them confidentiality protections to alleviate fear of punishment or litigation.
At the same time, a federal law and a different Pennsylvania law encourage hospitals to review mistakes and unexpected outcomes to advance safety, while also giving legal protections as long as they follow certain rules.
Because of those rules, the Hospital and Healthsystem Association of Pennsylvania says hospitals could lose legal protections if they provide certain information sought by the patient safety authority.
Rob Shipp, HAP's vice president for population health and clinical affairs, said HAP doesn't believe the law requires hospitals to provide information related to internal investigations — one of the types of information sought by the authority.
During an April meeting of the authority, he said "hospitals cannot provide some of what you are looking for without compromising their legal protections, which none are prepared to do."
He added: "Hospitals are eager to work with you on improving the process and getting [the patient safety authority] information that you're entitled to in ways that's the most effective for everyone."
But nearly a month later, there have been no further meetings or progress toward an agreement between the authority and HAP.
After noticing the increase in neonatal incidents last year, the safety authority asked hospitals to provide results of internal investigations of the events and subsequent preventive actions, along with other medical information that might shed light on contributors to the injuries and deaths.
After hospitals objected, the safety authority dropped the request for copies of internal investigation reports, and instead proposed a form designed to gather the needed information, with some of the questions related to the investigations.
HAP continues to object to some of the questions on the grounds it could jeopardize legal protections.
At the April meeting, Hoffman voiced a sense of urgency.
"I'm sitting here with 160 events of babies who were harmed or died that I'd like more information on, so we can make more meaningful advisement and recommendations, and we could have been doing that in January and now it's almost May," she said.
A HAP spokesman said this week "we have been working with member hospitals on recommendations that we will share with the PSA for how hospitals can provide input into data collection processes so that the PSA receives the information it needs to investigate neonatal intensive care and other patient safety-related trends and hospitals' concerns related to peer-review are addressed."
The April discussion also showed tension between the authority and HAP over reporting issues separate from the neonatal events, with authority members saying some hospitals have long refused to provide any information to the authority.
Dr. Nirmal Joshi, the chair of the authority, said some lapses in reporting reflect "an honest mistake."
However, he told HAP's Shipp "you have a certain number of organizations that simply do not report the way they're supposed to report non-controversial, clean, straight answers," saying it's "one of the things we struggle with a whole lot."
Pennsylvania is the only state that requires hospitals to report mistakes and unintended medical events, according to the authority, which says it's the largest repository of patient safety data in the United States. Over the years, it has detected and advised hospitals on problems including operating on the wrong body part or patient, patients given the wrong dose of medication because their weight wasn't accurately recorded or converted from kilograms to pounds, and mistakes resulting from inconsistent patient wrist band meanings.
The authority was created two decades ago at a time when hospitals and doctors said Pennsylvania was facing a crisis of frivolous medical malpractice lawsuits and exorbitant medical malpractice insurance premiums that were causing doctors to flee the state.
There was much debate over the existence of a true "exodus" of Pennsylvania doctors, and whether the root of the problem was too many lawsuits, or too many medical mistakes. In the end, lawmakers passed a package of laws intended to weed out frivolous lawsuits and lower malpractice premiums, while also improving safety by creating the Pennsylvania Patient Safety Authority.
At the recent authority meeting, Joshi called for "a collective plan" to address the failure of some hospitals to report incidents to the authority.
"This is not about taking rigid positions. This is not about egos. This is about what is safer for all Pennsylvanians and this is about coming to the middle," he said.