HARRISBURG: The Patient Safety Authority issued its Annual Report for 2005 with information indicating that meaningful improvements are being implemented in Pennsylvania healthcare facilities as a result of Act 13 (the “Mcare” Act) and the data received through the Pennsylvania Patient Safety Reporting System (PA-PSRS).

“The Authority continues working to help reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety,” said Lorina Marshall-Blake, acting chair of the Authority’s Board of Directors. “By disseminating information and clinical best practices, the Authority provides valuable feedback to healthcare professionals to help improve patient care.”

Under Act 13 of 2002, all hospitals, birthing centers and ambulatory surgical facilities must submit reports of Serious Events (actual adverse events) and Incidents (“near-misses”). During the 2005 calendar year, facilities submitted a total of 169,072 reports, an increase of nearly 26% over 2004. Approximately 96% of these reports were Incidents that did not result in patient harm. The remaining 4% were Serious Events, in which the patient received some level of harm, ranging from minor, temporary harm to death.

Based on these reports, the Authority publishes the Patient Safety Advisory, a quarterly journal that provides clinical guidance to facilities about steps they can take to promote patient safety and reduce the potential for medical error. More than 60 scholarly articles about specific events submitted through PA-PSRS were published in 2005.

Nearly 75% of hospitals who responded to a recent statewide survey said they implemented changes as a result of information contained in the Patient Safety Advisory. This statistic is consistent with other findings that credit Act 13 with enhancing patient safety within Pennsylvania’s healthcare facilities. At least 80% of healthcare executives surveyed said they believe the culture of safety has improved in their facility since the implementation of Act 13.

 “Although this is only the first full year of statewide mandatory reporting, it appears that the Authority’s work is having an impact on the delivery of care in Pennsylvania,” said Alan B.K. Rabinowitz, administrator of the Patient Safety Authority. He noted the ultimate goal of the Authority is to develop a “culture of safety” in Pennsylvania where people and institutions encourage full and open disclosure to patients, acknowledging mistakes while implementing procedures to prevent future errors.

“Real improvement does not occur unless facilities are willing to take the necessary steps to change routines that may be compromising patient safety,” said Rabinowitz.

Examples of the kinds of changes being implemented in hospitals and ambulatory surgical facilities as a result of Advisory articles include:

• reducing the number of color-coded patient wristbands in use in their facility.
• minimizing the risk of alcohol-based fires by using towels to catch alcohol runoff in the operating room.
• educating surgeons about the importance of “time out” before surgery, in which the patient’s identity and other critical elements of the procedure are reviewed.
• adding to their list of prohibited abbreviations based on potentially confusing abbreviations identified in the Advisory.
• educating staff on how to minimize the risk of anesthesia awareness.

A total of 440 healthcare facilities were subject to Act 13 reporting requirements in 2005. Hospitals accounted for 98.8% of all reports submitted. The most frequently reported events reported by hospitals involved medication errors and falls, while complications and errors from procedures, treatments or tests represented the most frequently reported events from ambulatory surgical facilities.

The average monthly number of reports submitted in 2005 showed an increase of almost 26% over reports submitted in 2004. Rabinowitz said that staff analysts attributed this increase to an improved adherence by healthcare facilities to Pennsylvania’s mandatory reporting requirements, rather than to an increase of events occurring in those facilities.

“While these numbers and the survey responses document the effectiveness of mandatory reporting, they also demonstrate that there are real risks when any of us undergoes medical care,” Rabinowitz said. “Certainly there is a lot more to do, and both facilities and individual providers must be vigilant in implementing all possible steps to assure quality outcomes and prevent patient harm.”

An Executive Summary of the Annual Report is attached to this press release. To view the complete 2005 Annual Report, click here.

BACKGROUND

The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act, as amended by Act 88 of 2005. More than 450 hospitals, birthing centers and ambulatory surgical facilities are currently subject to Act 13 reporting requirements.

Facilities submit reports of serious events and incidents through the Pennsylvania Patient Safety Reporting System (PA-PSRS), a confidential web-based system that was developed for the Authority under a contract with ECRI, a Pennsylvania-based independent, non-profit health services research agency, in partnership with EDS, a leading international, information technology firm, and the Institute for Safe Medication Practices (ISMP), also a Pennsylvania-based, non-profit health research organization.

More than 300,000 reports have been submitted through PA-PSRS since the program was initiated in June 2004. Based on those reports, the Authority issues quarterly and supplementary Patient Safety Advisories to advise hospitals, other healthcare facilities and individual providers about steps they can take to reduce and prevent patient harm. The PA-PSRS system also provides facility managers with sophisticated analytical tools that enable them to evaluate data about their own facilities. They can use this information for internal patient safety, risk management and quality improvement activities.

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Because the Authority’s research findings are disseminated widely through the Patient Safety Advisories, the “lessons learned” benefit not only Pennsylvania-based healthcare providers and facilities, but also healthcare professionals throughout the country and abroad. As Francis V. Dono, DO, medical director for an eight-hospital health system in a nearby state, wrote:

"The Patient Safety Advisory has been an outstanding resource for me and our health system. The articles are timely and address the important aspects of patient safety. As Medical Director of Patient Safety and Quality at OhioHealth, I share the Advisory with senior leadership, patient safety councils and medical staff leadership, including the house staff. The “lessons learned” are excellent examples for our staff. More states should embark upon this safety journey."

The Authority Increased Education and Outreach Efforts to Promote a “Culture of Safety”

Following implementation of the reporting system, and with report collection and analysis ongoing, the Authority has embarked on new education and outreach initiatives to improve patient safety in Pennsylvania’s healthcare facilities.

Patient safety remains a concern for both healthcare professionals and the general public. In a Fall 2005 statewide survey of adult Pennsylvania residents sponsored by the Authority and conducted by the Penn State Center for Survey Research, more than half of respondents said that they were “very” or “somewhat” worried about the safety of their medical care, and one-third of respondents reported that they or a family member had been personally involved in a preventable medical error. Only 23% of those who experienced a medical error said the healthcare worker involved had disclosed the error to them. These findings validate the need for the Authority to promote patient safety through education and training programs for healthcare professionals and administrators.

The Authority gave frequent patient safety lectures to physicians, nurses, pharmacists, hospital administrators and other healthcare workers; participated in statewide patient safety training sessions and conferences; participated in the establishment of new statewide collaborative organizations such as the PA eHealth Initiative and the Patient Safety Forum; and facilitated access to continuing education credits for physicians and other healthcare professionals.

The Patient Safety Authority Board plans to continue and expand its focus on educational programs by sponsoring an intensive two-day seminar on Root Cause Analysis. The seminar will help facilities get to the “root causes” of events that happen in their facilities, allowing them to learn from those events and prevent them from happening again.

The Authority believes an integral part of making facilities safer involves reaching out to facilities and encouraging them to develop a “culture of safety” within their institutions that includes: 1) full and open disclosure of events; 2) investigations into “why” an event occurred; and 3) improvements and prevention measures to ensure an event does not occur again.

Results from the Patient Safety Authority’s Fall 2005 survey suggest that Act 13 and the Patient Safety Authority have helped to promote a culture of safety in Pennsylvania hospitals and Ambulatory Surgical Facilities. More than 80% of the Patient Safety Officers responding to the survey credited Act 13 with improving the culture of safety within their facilities. Equally important, almost 70% of survey respondents indicated that the PA-PSRS system improved their ability to monitor patient safety within their facilities.

Consistent with these efforts, the Board established several goals in 2005 for the future that include promoting a “culture of safety” within individual healthcare facilities. Three groups targeted for these education and outreach efforts include: patient safety officers and risk managers; clinicians representing the spectrum of healthcare professionals from physicians and nurses to pharmacists, laboratory workers and technicians; and healthcare executives, with a focus on CEOs and trustees.

Improving the PA-PSRS System to Facilitate Reporting

Consistent with its core mission, the Authority collected and analyzed data submitted by Pennsylvania’s 440 hospitals, ambulatory surgical facilities and birthing centers. These facilities submitted 169,072 reports of Serious Events (actual adverse events) and Incidents (often called near-misses) through PA-PSRS in 2005, with approximately 96% of the events classified as Incidents.

Monthly report volume in 2005 showed an increase of almost 26% over 2004. Analysts attribute this increase to improved adherence by healthcare facilities to Pennsylvania’s mandatory reporting requirements, rather than to an increase in the number of actual events that occurred. Also, as Incidents increased at a greater rate than Serious Events, PA-PSRS analysts attribute this to an increased acknowledgement by healthcare workers that a near-miss had occurred.

Because facilities are required to submit reports of all Serious Events and Incidents, the Authority is committed to improving the PA-PSRS operational software to make reporting easier for facilities. Numerous system changes were implemented during the year.

A few examples of these enhancements include:

1. Providing PSA funding and staff time in order to facilitate an electronic interface to PA-PSRS for those facilities with existing electronic reporting systems, which will allow them to submit reports only once while still meeting their obligations under Act 13.

2. Augmenting the reporting system with a 6,000-item list of drug names to reduce input errors when submitting reports of medication errors and adverse drug reactions.

3. Offering PA-PSRS basic training for all new Patient Safety Officers and others who are assigned to input event reports to ensure they understand how to use the system.

The Authority also promotes reporting by conducting meaningful research to give valuable “lessons learned” back to Pennsylvania facilities; educating facilities about the importance of creating a learning culture instead of a punitive one; and ensuring the PA-PSRS system is collecting data as efficiently as possible and providing the necessary tools for facilities to study their own data and make the necessary improvements in-house.

Patterns and Trends in PA-PSRS Reports

When reporting an event to PAPSRS, a facility uses a classification system or “taxonomy” to characterize the occurrence they are reporting. At the outset, a facility classifies  a report by indentifying what PA-PSRS defines as the "Event Type." The Event Type essentially answers the most basic question about an occurence: "What happened?" While there is considerable detail within the taxonomy, at its most basic level, the PA-PSRS classification contains nine Event Types.

Figure 1 presents the percentage of reports submitted in 2005 by their Event Type.

Other highlights of data submitted through PA-PSRS during calendar year 2005 are:

• 440 hospitals, birthing centers and ambulatory surgical facilities were subject to Act 13 reporting requirements. They submitted 169,072 reports of Serious Events and Incidents through PA-PSRS, an increase of 26% over 2004.

• Ninety-six percent of all reports were Incidents, in which the patient was not harmed; 4% of all reports were Serious Events, which indicates that the patient received some level of harm, ranging from minor, temporary harm to death.

• Reports from hospitals accounted for 98.8% of all reports submitted.

• When evaluated regionally, the largest numbers of reports come from the southeastern and southwestern counties, which is consistent with the centers of population within Pennsylvania. When report volume is adjusted for population, facilities in the Northcentral counties submitted the largest number of reports. This does not necessarily suggest that facilities in that region were less safe than facilities elsewhere in the Commonwealth, but that those facilities may be more aggressive in identifying reportable events. This interpretation is supported by the observation that the difference in the number of reports submitted from the Northcentral counties involves Incidents, not Serious Events.

• Other regional variations are apparent with reports related to healthcare-associated infections (HAIs). The largest number of these reports comes from Southwestern Pennsylvania, where facilities submitted nine HAI-related reports per 10,000 patient days, a much higher volume than represented by other regions of the state. This volume can be attributed to a major regional initiative in the Southwest, sponsored by the
  Pittsburgh Regional Healthcare Initiative, to reduce incidence of HAIs within area hospitals.

• Statewide, the most frequently reported events in hospitals involved Medication Errors and Falls. However, Complications and Errors from procedures, treatments or tests represented the most frequently reported events from ambulatory surgical facilities and birthing centers.

• While patient Falls accounted for 21% of all reports, they only accounted for 4% of all Serious Events.

• Complications related to procedures, treatments or tests accounted for 38% of all Serious Events, up from 31% in 2004.

• Patients over age 65 were especially vulnerable to Serious Events and Incidents, representing more than half (53%) of all reports submitted through PA-PSRS. In 2005, 64% of all Falls and 73% of all reports related to Skin Integrity involved older patients. Skin integrity reports include pressure sores, bruises and other skin-related conditions.

• Medication Errors accounted for 25% of all reports (unchanged from 2004), but they represented only 1% of all Serious Events. That means that, in almost 99% of the cases, no patient was harmed by a medication error. Although most medication errors involve adults, medication errors involving children and adolescents were more likely to result in patient harm.

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