College of American Pathologists
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Rolling out a statewide system for patient safety

What the reports say

April 2004
Karen L. Wagner

Come summer, all of the 400 or so hospitals and ambulatory surgical and birthing centers in Pennsylvania will be reporting medical errors using a new Web-based, state-mandated reporting system. The Pennsylvania Patient Safety Reporting System is the first such statewide mandatory system in the country.

The system is a product of Act 13, state legislation passed in 2002 that created a Patient Safety Authority charged with identifying patient safety issues and recommending solutions.

Because Pennsylvania’s Department of Health remains the regulatory agency, the Patient Safety Authority has no power to sanction or fine hospitals or centers. The authority’s goal is to gather information to improve patient safety. "So, for example, if we learn that multiple facilities are confusing medicine A with medicine B because of its size, shape, or color, we can issue an advisory," says Robert Muscalus, DO, the state’s physician general and chairman of the authority’s board of directors.

The state’s hospitals and ambulatory surgical and birthing centers will be required to report all serious events, which are events in the clinical care of a patient that lead to death or unanticipated injury; incidents, which are considered close calls or near misses; and infrastructure failures, such as power failures, for example, which affect or have the potential to affect patient safety. Once the system is implemented statewide, it will replace Department of Health regulations for reporting medical errors.

"The legislation was drafted in response to several factors, including the Institute of Medicine report ’To Err is Human,’" says Dr. Muscalus. The report showed that medical errors kill between 44,000 and 98,000 people each year. Rising medical malpractice premiums were another factor, Dr. Muscalus says, and reducing medical errors may slow the increases.

The patient safety reporting system will allow users to generate reports that can be used to compare the data from one hospital or center to the statewide aggregate, and a facility can use its data to glean details about its own safety issues.

The Web-based system was developed for the authority by ECRI, a nonprofit health services research agency in Plymouth Meeting, Pa., in conjunction with the Camp Hill, Pa., office of EDS, an international information technology firm based in Plano, Tex.

According to ECRI’s director of patient safety reporting systems, Jonathan Gaev, the software used in the reporting system is based on the system developed by the University HealthSystem Consortium, a nationwide network of about 90 academic health centers. Pennsylvania’s reporting system is accessed via the Internet and does not require the use of special software. "It is password protected and extremely user friendly," Gaev says. "If you’ve ever ordered a book online from, you will be able to use this system."

The reporting system was implemented last November under a test phase. A cross-section of 22 health care facilities in Pennsylvania volunteered to participate in phase one of the project.

The volunteer facilities primarily have been entering data to test whether the system is working. So far, report Dr. Muscalus and Gaev, there have been no major glitches, and users say the system is easy to use.

Joanna Lucas, RN, BSN, director of quality and risk for Lancaster (Pa.) Regional Medical Center, a 261-bed community hospital, hopes to eventually use the reporting system database to compare data from Lancaster Regional to statewide benchmarks. "So I can go in and run a report for medication errors or other types of errors and see how we compare to the state average," she says.

While the reporting system itself is proving easy to use, categorizing and coding what’s to be reported has presented problems. For example, the system uses a harm scale to code errors as serious events or incidents, explains Jane Trombetta, senior risk manager and patient safety officer for UPMC Passavant, a 270-bed community hospital associated with the University of Pittsburgh Medical Center. But categorizing an error is not so black and white, she says. "It’s a very subjective decision whether you code something as an incident, serious event, or infrastructure failure."

In addition, because the safety authority requires detailed information in the reports, there’s more work for the facility, says Sue Brown, patient safety officer for Geisinger Medical Center, Danville. For example, Brown explains, the authority may require that the report include the outcome of the patient, or, in the case of a medication error, the specific type of error—information that a facility may not require with its internal reporting system. "We’re trying to develop a Web-based reporting system internally, and what we would do is build [information] fields to match what the safety authority’s fields are," she says.

Geisinger will most likely have to add a full-time employee to handle the extra data input. "I don’t think there’s a way around it," Brown says. "And I think most facilities have expressed that they’re going to need additional staff."

While the system will not bring vast changes to the laboratory, pathologists will have to be more aware of reportable events, says UPMC’s Trombetta. Certain errors, such as instrument problems—for example, a machine that wasn’t calibrated correctly and produces erroneous results—would be deemed an infrastructure failure, Trombetta says. It would be up to the patient safety officer, not the pathologist, to categorize that error, but the pathologist would have to be aware that the error has to be reported, she explains. In the past, such an equipment failure would most likely not have been reported, she adds.

"So basically what the PA-PSRS [safety reporting system] program has done is kind of re-categorize things a little bit," Trombetta says. "It’s going to make some of our process problems that we identify, such as instrument failures, a more reportable incident now."

The ECRI’s Gaev adds that the patient safety officer in each hospital and center will determine who can access the reporting system. "Pathologists seeking data would, therefore, contact their patient safety officer," he says. Patient safety officers can use the data they collect "to produce interesting reports for their clinical staffs."

Karen L. Wagner is a freelance writer in Forest Lake, Ill.