HARRISBURG: The Patient Safety Authority issued its Annual Report for 2004, which includes information garnered from the first six months of statewide mandatory reporting through the Pennsylvania Patient Safety Reporting System (PA-PSRS).

“Pennsylvania is the first state in the country to require the reporting of both adverse events and near-misses,” noted Lorina Marshall-Blake, acting chair of the Authority’s Board of Directors. “This accomplishment has earned national recognition, and Pennsylvanians can be proud of these initial steps to reduce medical errors and enhance patient safety.”

Under Act 13 of 2002, all hospitals, birthing centers and ambulatory surgical facilities must submit reports of what the Act defines as Serious Events (actual adverse events) and Incidents (so-called “near-misses”). In the six months between the start of mandatory reporting in June 2004 and December 31, 2004, facilities submitted a total of 70,851 reports. Approximately 95% of these reports were Incidents that did not result in patient harm. The remaining 5% were Serious Events, in which the patient received some level of harm, ranging from minor, temporary harm to death.

Based on analysis of these reports by the PA-PSRS clinical staff, the Authority issues periodic Patient Safety Advisories to provide guidance to facilities about steps they can take to promote patient safety and reduce the potential for medical error. To date, the Authority has issued five quarterly and two supplementary Advisories containing scholarly research and clinical guidance on more than 40 specific healthcare situations that did or could have resulted in patient harm.

PA-PSRS, which is a confidential, web-based data collection and analysis 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.

“We encourage facilities, as well as individual providers, to use Advisory articles and the PA-PSRS system’s analytical tools as learning resources for patient safety and continuous quality improvement,” said Alan Rabinowitz, Authority administrator.

“Because the Authority is a ‘learning,’ rather than a regulatory, organization, we will facilitate the exchange of information related to patient safety, but it is the responsibility of each facility to take appropriate action to provide safe care to their patients,” Rabinowitz continued. “Individual facilities should make every effort to assess
the quality of care they provide and implement appropriate changes that enhance patient safety.”

Rabinowitz noted that one-third of hospitals responding to a survey indicated that they have already implemented new procedures as a result of Advisory articles.

For the timeframe covered by the Annual Report for 2004, a total of 427 healthcare facilities were subject to Act 13 reporting requirements. Hospitals accounted for 98.7% 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.

An Executive Summary of the Annual Report is attached to this press release. The complete Annual Report for 2004, as well as additional information about the Patient Safety Authority, the PA-PSRS system or the Patient Safety Advisories, are accessible on the Authority’s website, www.patientsafetyauthority.org.

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Annual Report 2004

 Executive Summary

During 2004, the Authority finalized the development and implementation of the Pennsylvania Patient Safety Reporting System (PA-PSRS), a confidential, web-based data collection and analysis system for Serious Events (often called adverse medical events) and Incidents (often called near-misses).

Consistent with Act 13 of 2002 (the “Mcare” Act), the Authority initiated statewide mandatory reporting among all hospitals, birthing centers and ambulatory surgical facilities in June 2004, making Pennsylvania the first state in the nation to require the reporting of both near-misses and actual adverse events. As of December 31, 2004, there were 427 healthcare facilities subject to PA-PSRS reporting requirements, and through the end of the calendar year they submitted 70,851 reports of Serious Events and Incidents. All reports are de-identified, and they do not include any patient or provider names.

The PA-PSRS program includes a professional team of clinical analysts that reviews, prioritizes and analyzes all Serious Event and Incident reports. Their role is to identify and advise facilities of situations of immediate jeopardy and to identify trends or system improvements that can be implemented to improve patient safety.

During 2004, the Authority initiated the publication of Patient Safety Advisories, quarterly journals detailing clinical analysis of reports submitted through PA-PSRS. Advisory articles are directed primarily to healthcare professionals and facility administrators, and provide clinical guidance, supplemented by a scholarly search of medical literature, about process improvements facilities can adopt to improve patient safety and reduce potential patient harm. Patient Safety Advisories are distributed electronically throughout the Commonwealth and around the country and are accessible on the Authority website.

The Authority is funded through the Patient Safety Trust Fund, a separate account in the State Treasury funded through assessments on facilities subject to Act 13 reporting requirements. Although Act 13 permits a total facility assessment of $5 million in any one year, plus an increase for cost of living adjustment, for the second year in a row the Authority requested a partial assessment of 50%, reducing the potential financial burden on Pennsylvania’s healthcare facilities.

Toward the end of 2004, the Authority initiated steps toward implementing the Patient Safety Discount provision of Act 13. Under this provision, facilities may be eligible for a reduction in their medical liability malpractice insurance premiums if they comply with certain protocols defined under the Act. In this regard, the Authority recommended two specific programs which may help facilities comply with this legislative option.

Also during 2004, the Authority continued to garner attention from other states and numerous federal government agencies, national healthcare organizations and patient safety advocacy groups and foundations. Healthcare Informatics, a monthly magazine, website and weekly e-newsletter published by the McGraw-Hill Companies, recognized the Authority by presenting the Board chair with a 2004 Healthcare IT Innovator Award for the development and implementation of the PA-PSRS system.

Highlights of data submitted through PA-PSRS during calendar year 2004 are:

• 427 hospitals, birthing centers and ambulatory surgical facilities are subject to Act 13 reporting requirements. They submitted 70,851 reports of Serious Events and Incidents through PA-PSRS.

• 95% of all reports were Incidents, in which the patient was not harmed; 5% 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 98.7% of all reports submitted.

• In hospitals, the most frequently reported events involved medication errors and falls. However, complications and errors from procedures, treatments or tests represent the most frequently reported events from ambulatory surgical facilities and birthing centers.

• Falls accounted for 21% of all reports. However, 6% of all Serious Events involved patient falls.

• Complications related to procedures, treatments or tests accounted for 31% of all Serious Events.

• In 2004, 207 Serious Events reported a patient death, representing 0.3% of all reports and 5.5% of all Serious Events. In some cases, the death was the result of the patient’s underlying clinical condition. In other cases, the death was a result of a “systems” issue, a series of events involving multiple, complex processes. In a few cases, the reports indicate that the facility penalized or sanctioned a provider—for example, by revoking medical privileges at the facility.

• Patients over age 65 are especially vulnerable to adverse events and near-misses. While those patients represent 41.2% of all inpatient hospitalizations, patients over age 65 were involved in 51.2% of all reports submitted to PA-PSRS from hospitals and represented 59% of all Serious Events. Falls were the most commonly reported occurrence among older patients, accounting for 64% of all patient falls. Older patients were also more likely to suffer from pressure sores, bruises and other skin-related conditions.

• Medication Errors accounted for 25% of all reports, 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 or adolescents were more likely to result in patient harm.

• Reports submitted to PA-PSRS validate steps that patients and their families can take to reduce their chance of being harmed. For example, patients or their loved ones should keep an up-to-date written personal health record that includes their medical condition and medications. They should also ask as many questions as necessary to understand the purpose of any procedure, test or medication prescribed for them, and they should advise their doctor or nurse whenever something “doesn’t feel right.”

• The Authority provides direct feedback to facilities through regularly published Patient Safety Advisories. More than 30% of all hospitals responding to a survey indicated that they have implemented patient safety protocols as a result of specific articles in the Advisories.

The complete Annual Report, click here. For more information about the Authority and access to Patient Safety Advisories, go to the Authority’s website, www.patientsafetyauthority.org.

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