Unique patient safety authority enables sharing of lessons learned

Pennsylvania PSA reports on serious events collected

In the past two years, three Pennsylvania hospitals have won the coveted John M. Eisenberg Patient Safety and Quality Award, given by the National Quality Forum (NQF) and the Joint Commission on Accreditation of Health Care Organizations. In addition, the latest report on the performance of Pennsylvania hospitals by the Pennsylvania Health Care Cost Containment Council (PHC4) finds a decline in patient mortality rates for all conditions reported over the last two years. The report includes risk-adjusted mortality rates, lengths of stay, and other data for patients admitted to 167 Pennsylvania hospitals from October 2002 through September 2003.

But while hospitals from other states are garnering quality and safety awards and improving outcomes, Pennsylvania also is doing something no other state has yet done: It has established a statewide Patient Safety Authority (PSA) to help health care professionals learn from events that occur, or have the potential to occur, to avoid injuries to patients in hospitals throughout the state.

No one is claiming the PSA is responsible for this spate of safety award winners — in fact, these institutions had well-established programs in place before the PSA was created two years ago — or that it is the main reason mortality rates have dropped in Pennsylvania. But the authority is unique; it does require that hospitals pay more attention to their patient safety efforts, and it enables sharing lessons learned by some of the safety leaders in the state.

How the PSA works

The PSA is part of a tradition started by PHC4, which was established in the mid-1980s, explains John Combes, MD, senior medical advisor for the Hospital & Health System Association of Pennsylvania (HAP). "PHC4 was a way for the state to avoid rate controls around health care and to create resources for businesses and consumers to look at health care costs and some outcomes," he explains, noting that for years it has been generating what is called the "Hospital Performance Report." (For more information, go to its web site at PHC4.org.)

"The Patient Safety Authority was established by our legislature two years ago as part of Act 13, or the Mcare act," he notes. "It involved establishment of the PSA. It introduced some basic tort reforms; and it addressed unfunded [insurance] liabilities."

The authority collects reports from hospitals on events that may have harmed patients or have the potential to harm patients. "The hospitals have to report them as they occur," Combes adds.

Both serious events and incidents must be reported. Serious events are events that occur in clinical care that affect patient safety and result in harm to the patient that requires treatment, he points out.

Incidents are events that could affect patient safety, did not harm the patient, but have the potential to harm the patient.

Reporting is not voluntary, Combes emphasizes. "For serious events, the fine is about $100 a day for failure to report, and the physician or licensee can be reported to the licensing board," he says. "But the idea is not to use the information against the facility — rather, it is for [gaining] knowledge." Serious events are shared with the Department of Health, which may in turn use them to develop new regulations.

The state has contracted with ECRI (Emergency Care Research Institute) in Plymouth Meeting, PA, to analyze the data. "They review all the reports, and then the authority issues recommendations to the field in the form of a newsletter — called Patient Safety Advisory," Combes notes.

An example of the kind of information shared is several recent reports about people confusing TB syringes with insulin syringes. "Both are about the same size, with orange caps to them," he explains. "It’s an easy mix-up to make, but the gradations on the TB syringes are different.

"The beauty of this is that the report actually does the analysis of these events and then gives recommendations to the field about how they can improve care," Combes continues. The newsletter is mainly distributed electronically.

"The state has created this independent authority as a resource from which hospitals can learn," he says. "It is the first of its kind in the country, and right now it is unique; it’s the only one with mandatory requirements for reporting incidents as well as serious events."

Even hospitals with well-established quality improvement programs have felt the impact of the PSA, although they also are called upon by the state to provide advice and are used to illustrate best practices.

"We’ve had a very active quality program in our organization for many years," says Zubina Mawji, MD, acting senior vice president for quality and care management for the Lehigh Valley Hospital and Health Network in Allentown, PA, a three-hospital system that is a 2003 Eisenberg winner.

"What we have done, as a result of Act 13 and the subsequent PSA and Patient Safety Councils required under Act 13, was develop our own council in 2002. Prior to that, we had numerous committees that reviewed various areas in the network — QA, multidiscipline councils reviewing cases involving multiple departments, and so forth. As a result of the PSA, our safety council is another opportunity to review patient safety events in a different framework."

Act 13 has five major safety requirements:

  • Each facility has to designate a patient safety officer.
  • Each facility has to establish a patient safety committee.
  • Each facility has to establish a system for health care workers to report serious events and incidents, and that system must be accessible 24/7.
  • The act prohibits any retaliatory action against a health care worker for reporting a serious event or incident, in accordance with the Dec. 12, 1986, whistle-blower law.
  • Facilities must provide written notification (disclosure of any serious medical error) to patients, in accordance with the act.

"The PSA does provide direction to us at a state level on what to pay attention to, and the data is sent back to us in aggregate form, so it allows us to check in and take a pulse about what’s going on at the state level — Are we on target? Are these things we need to keep working on? It tells you the things that everybody is addressing," adds Mawji.

"That information we all enter on incidents becomes aggregate data on which [the PSA] disseminates statewide," adds Fran Miranda, RN, director of risk management and patient safety officer for the network. "It may be on best practices or on areas of concern hospitals need to focus on."

While the newsletter goes out quarterly, "if there is an area of exposure that really negatively impacts patients, [an additional alert] is sent out under separate cover," she notes.

Lehigh Valley also is one of those hospitals leading the safety movement. "We have been extremely fortunate to be ahead of the curve; we have become very vocal at the state level to help move other hospitals along," Miranda explains. "People call us up and ask for best practices."

Another 2003 Eisenberg winner, Abington (PA) Memorial Hospital, also has been both benefiting from and leading efforts to improve the statewide initiative. "We’ve found it to be a relatively easy way to report centrally on the challenges to take us to the next level," says Doron Schneider, MD, associate program director of the internal medicine residency program. "The authority is really a leader in assisting hospitals in reporting errors; we’ve been involved in their web-based initiative from the beginning as one of the pilot sites for error reporting."

The ultimate goal, he continues, is for the web-based system to interface in a more "hospital- centric" manner. "Now, our incident reports have to be hand collected and entered into our internal database, and then sent to the PSA. "It’s not efficient, and it’s resource-intensive. We’ve been working with ECRI to talk about building our own program in-house to allow nurses and other staff to collect data that can be dumped right across to the PSA."

Schneider says he’s proud to be part of the pilot phase, and while "we haven’t seen any returns yet in how the system will help hospitals create a safe environment, I imagine they will be forthcoming."

Activity is promising

Combes takes up that theme from Schneider. "I think it’s been very helpful," he asserts. "Since the reporting got up and running [in July 2004], they have received 50,000 reports. The hospitals are serious about getting information to them to analyze."

And if imitation is the sincerest form of flattery, then Pennsylvania should be flattered indeed. "Other states are piloting [programs similar to the PSA] and trying to move into this area," Schneider notes. "Kansas might also be piloting an authority."

It’s not an accident, adds Miranda, that this is happening in Pennsylvania. "We do consider ourselves fortunate — not only to be in this network, but in this state," she says. "I recently reported to our board on PHC4 data, and they were very pleased with it. I then asked my staff to look at each state to see what they were doing at a state level similar to PHC4. A little more than half the states around the country do have some level of statewide reporting of outcomes, but we have clearly been more active in addressing the data and in striving to get better every year."

Need More Information?

For more information, contact:

• John Combes, MD, Senior Medical Advisor, Hospital & Healthsystem Association of Pennsylvania, 4750 Lindle Road, P.O. Box 8600, Harrisburg PA, 17105-8600. Phone: (717) 564-9200. Fax: (717) 561-5334. Web site: www.haponline.org.

• Zubina Mawji, MD, Acting Senior Vice President, Quality and Care Management, Lehigh Valley Hospital and Health Network, 1249 S. Cedar Crest Blvd., Lower Level, P.O. Box 689, Allentown, PA 18105. Phone: (610) 402-0825. Fax: (610) 402-0826.

• Fran Miranda, RN, Director of Risk Management, Patient Safety Officer, Lehigh Valley Hospital and Health Network, 1249 S. Cedar Crest Blvd., Lower Level, P.O. Box 689, Allentown, PA 18105. Phone: (610) 402-0825. Fax: (610) 402-0826.

• Doron Schneider, MD, Associate Program Director, Internal Medicine Residency, Abington Memorial Hospital, 1200 Old York Road, Abington, PA 19001. Phone: (215) 481-7312.