HARRISBURG: The Patient Safety Authority issued its Annual Report for 2006 with survey information indicating that change is occurring as a result of guidance issued in Patient Safety Advisories, but the survey also indicated more work is needed to improve patient safety and reduce preventable medical errors in Pennsylvania’s healthcare facilities.
“The patient safety officers in Pennsylvania’s healthcare facilities, responding to a statewide survey, indicated that they implemented over 500 changes in their facilities as a result of the Advisory guidance and PSOs collectively gave marks of 97 percent or better for the Advisories’ usefulness, relevance and readability,” said Dr. Ana Pujols-McKee, chair of the Patient Safety Authority Board of Directors. “However, the survey also shows that facilities find there is room for improvement in increasing the culture of safety within their institutions and thus reducing preventable medical errors.”
McKee added that an important component of increasing patient safety in healthcare facilities is to continue developing cultures of safety which means leadership must keep encouraging full and open disclosure to patients, and the acknowledgement of mistakes while implementing procedures to prevent future errors.
Under Act 13 of 2002, all hospitals, birthing centers and ambulatory surgical facilities (certain abortion facilities were added in 2007) must submit reports of Serious Events (actual adverse events) and Incidents (near misses). In the calendar year of 2006, facilities submitted a total of 195,832 reports, an increase of nearly 26,000 reports over 2005. Approximately 96.5% of these reports were Incidents that did not result in patient harm. The remaining 3.5% were Serious Events, in which the patient received some level of harm, ranging from minor, temporary harm to death.
The Authority issues quarterly Patient Safety Advisories to provide guidance to facilities about steps they can take to promote patient safety and reduce the potential for medical error. The Advisory articles have generated considerable attention, with the Authority recognized in October 2006 with the prestigious John M. Eisenberg award in large part as a result of the Advisories’ usefulness. National medical publications, as well as The Wall Street Journal, have written articles derived from the Patient Safety Advisory and PA-PSRS data.
More than 40 articles based on specific events submitted through PA-PSRS were published in 2006. Research findings and guidance communicated through Patient Safety Advisories are highlighted below:
- In the March 2006 issue, one article raised concerns regarding the administration and monitoring of a popular sedation drug call Propofol (PRO-pa-fall). Over 100 reports cited the drug in question, including four reports involving the patient’s death. Other articles in this issue detail infection risks involving manufacturer’s representatives, contaminated surgical instruments and look-alike drug packaging.
- The June 2006 issue highlighted data showing that verbal drug orders are often misunderstood and lead to errors. Facilities were given a toolkit to implement which includes a read-back procedure to help reduce the likelihood of error. Other articles in this issue describe risks associated with hydrofluoric acid exposure, procedures to help reduce the risks of transplant tissue contamination, problems associated with the painkiller Demerol and trends in adverse event reporting among behavioral health hospitals.
- The Supplementary August issue updated facilities on the efforts made by hospitals to standardize color-coded wristbands in Pennsylvania. In 2005, a patient nearly died in a Pennsylvania hospital due to confusion caused by the color of the wristband. Since then the Authority and a group of hospitals in Pennsylvania have gained national recognition for their efforts in reducing the risks associated with color-coded wristbands.
- In the September 2006 issue, an article raised awareness about the frequency of skin tears among older patients. Older patients (age 65 and older) account for 88 percent of all skin tears reported. Clinical guidance to prevent the painful unsightly wounds was given. Other articles in this issue show risks associated with MRI-incompatible sandbags, taking a closer look at medication errors and why they happen, the dangers associated with the high-alert drug epinephrine and information on how to prevent bed sores.
- In the December 2006 issue, an article informed orthopedic surgeons about the rare but deadly hip surgery complication known as Bone Cement Implantation Syndrome (BCIS). In five out of six reports of BCIS received, the patient died from cardiac arrest associated with the implantation of the new hip prosthesis. Other articles in this issue show the dangers of hospital bed entrapment, the prevalence of perforations of the colon during colonoscopy, risks associated with feeding tube placement when outdated methods are used and the dangers associated with the high-alert drug Heparin.
In 2006, educational toolkits were added to Advisories to help healthcare facilities implement the guidance offered in the Patient Safety Advisory. The toolkits include slideshows for educating frontline caregivers, posters and other materials for raising awareness. Facilities in Pennsylvania and nationally have used the toolkits to improve patient safety in their facilities. The Authority also sponsored a two-day Root Cause Analysis conference to help facilities get to the “root cause” of events and make the necessary process changes to prevent errors from occurring again.
“In the last year, the Authority has focused more on its educational initiatives for facilities,” said Michael Doering, interim executive director of the Patient Safety Authority. “The toolkits and educational workshops sponsored by the Authority will continue, along with more initiatives all geared toward helping facilities implement strategies that will improve patient safety in Pennsylvania’s healthcare facilities.”
Doering added that while the educational efforts have increased and facilities have implemented changes, the work must continue because reports continue to increase.
“The number of reports increased by 26,000 in 2006,” said Doering. “While reported events with harm have decreased slightly, the number of near misses has increased. On the one hand, we’re pleased with these numbers because it means healthcare facilities are being more vigilant in reporting potential errors, but if
appropriate changes aren’t made, the threat still exists for harmful errors to occur.”
A total of 464 healthcare facilities were subject to Act 13 reporting requirements in 2006. Hospitals accounted for 98.7% of all reports submitted. The most frequently reported events were errors related to procedures, treatments and tests and medication errors (47%). However, complications related to procedures, treatments and tests resulted in more Serious Events or events that caused harm (42%), even though there were only
14% of them reported.
The Patient Safety Authority survey mentioned above was distributed to all Patient Safety Officers (PSOs) from Pennsylvania hospitals, ambulatory surgical facilities and birthing centers in November 2006. The Authority received responses from 186 out of 419 PSOs of record at the time of the survey, representing a response rate of 44%. For complete survey results go to pages 13-18 of the Annual Report.
An Executive Summary of the 2006 Annual Report is attached to this press release. For the complete Annual Report, go to www.patientsafetyauthority, or click on the following link http://patientsafetyauthority.org/PatientSafetyAuthority/Documents/annual_report_2007.pdf.
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Executive Summary of 2006
The Patient Safety Authority is an independent state agency established under Act 13 of 2002, the Medical Care Availability and Reduction of Error “Mcare” Act. It is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety in hospitals, ambulatory surgical facilities, birthing centers and most recently certain abortion providers. Its role is non-regulatory and nonpunitive.
The Authority initiated statewide mandatory reporting in June 2004, making Pennsylvania the first state in the nation to require the reporting of both actual adverse events and near-misses. All reports are confidential and nondiscoverable, and they do not include any patient or provider names. All submitted reports receive varying levels of review and analysis by experts in medicine, nursing, pharmacy, medical equipment, and risk management.
By many measures, the Pennsylvania Patient Safety Reporting System (PA-PSRS) system has elevated Pennsylvania to the forefront of patient safety activities around the country. At the end of 2006, PA-PSRS had collected nearly 436,000 reports, making it one of the largest databases of its kind. The Authority and PA-PSRS are featured prominently in national studies of state patient safety systems. The PA-PSRS database has generated interest not only throughout the United States but also as far as the United Kingdom, Norway and Switzerland.
During 2006, the Patient Safety Authority continued to focus on its data collection, analysis and educational outreach activities that promote its goal of reducing and eliminating medical errors. In May, the Authority offered an intensive two-day Root Cause Analysis seminar for patient safety officers and senior managers and provided educational toolkits with selected Patient Safety Advisory articles to assist facilities in educating staff. These and other educational resources helped facilities implement real change in their institutions.
2006 John M. Eisenberg Award Winner
In October, the Patient Safety Authority received the prestigious 2006 John M. Eisenberg Award for advancing patient safety and quality in the Commonwealth. Presented jointly by the Joint Commission and the National Quality Forum (NQF), the award acknowledges the Authority’s impact in patient safety on a regional and national level. The award also recognizes the Authority’s efforts to make the Pennsylvania Patient Safety Reporting System (PA-PSRS) into a nationally recognized resource for education and learning about patient safety. The award highlights the accomplishments and impact the Patient Safety Authority has in the eyes of its peers in the national patient safety community.
The accomplishments of the award recipients are linked to the principles that Dr. Eisenberg promoted throughout his career. These include a dedication to improving the quality of health care and patient safety,
leadership in advancing methods for measuring and reporting health care quality, expanding the public’s
capacity to evaluate the quality and safety of health care, and promoting health care choices based upon information about safety and quality.
This is the fifth year for the Eisenberg awards program, which recognizes major achievements of individuals and organizations in improving patient safety and quality. The annual awards include an individual lifetime achievement award and awards in the categories of system innovation (local and national) or research. In addition to the Patient Safety Authority, other Eisenberg award winners for 2006 include: Donald Berwick, MD, president, CEO and cofounder of the Institute for Healthcare Improvement (IHI) in Boston, for Individual Achievement; Jerry Gurwitz,MD, nationally recognized expert in geriatric medicine and professor at the University of Massachusetts School of Medicine, for Research; Minnesota Alliance for Patient Safety for Innovation in Patient Safety and Quality at a Regional Level; and the Wichita (KS) Citywide Heart Care Collaborative for Innovation in Patient Safety and Quality at a Local Level.
Using PA-PSRS Data to Provide Guidance and Promote Change and Safety
The Authority’s professional staff of clinical analysts reviews and analyzes all Serious Event and Incident reports. Their research is published in the Patient Safety Advisory, a quarterly publication directed primarily to healthcare professionals and facility administrators. Advisory articles provide clinical guidance about process improvements facilities can adopt to improve patient safety and reduce potential patient harm. To date, more than 100 scholarly articles about specific events submitted through PA-PSRS have been published. In 2006, generated from an Incident in PA-PSRS data, facilities in northeastern and central Pennsylvania spearheaded a grassroots effort to reduce patient harm by creating the “Colors of Safety Task Force” which implemented and standardized a number of safe practices throughout their facilities. The Advisory is distributed electronically throughout the Commonwealth and around the country. It is also accessible on the Authority website. For synopses of selected Advisory articles from 2006, refer to “Patient Safety Guidance Based on Report Analysis and Research” (page 47).
Through a survey conducted by the Authority in the fall of 2006, patient safety officers confirmed the Advisories were a valuable resource and an impetus for change. Of hospital respondents, 77% said they had implemented changes in their facility’s practices as a result of information from the Advisory. On average, each hospital had implemented approximately five significant policy/process changes based on guidance provided in the Advisory articles.
In 2006, PA-PSRS added a significant enhancement to the Advisories by introducing toolkits that help healthcare facilities implement the guidance offered in the Patient Safety Advisory. For example, In June 2006, the article “Improving the Safety of Telephone or Verbal Orders” was accompanied by a self-running, narrated online presentation appropriate for front-line clinicians; a sample policy and procedure around verbal orders; and a poster to help reinforce key messages with staff. The August 2006 Supplementary Advisory “Update on Use of Color-Coded Wristbands” was accompanied by a similar toolkit developed by the Colors of Safety Task Force, which was consistent with guidance from PA-PSRS.
Research findings highlighted through Patient Safety Advisory articles include issues that:
- Raised awareness of problems associated with the use of the sedation drug propofol by highlighting cases where the drug was not administered or monitored properly putting patients at risk and even in some cases causing death.
- Focused attention on the increased risk of medication errors when drugs are ordered verbally over the telephone instead of using a read-back procedure in which the person receiving the order writes it down, reads it back and gets confirmation that they understood the order correctly. An educational toolkit accompanied the article that included a poster, a slideshow and sample policy procedures for implementation to help further educate staff.
- Highlighted ways to avoid painful skin injuries, known as skin tears, and to treat them when they occur. Guidance to practitioners on how to avoid skin tears and provide proper techniques when treating them were included in a toolkit to educate staff and family.
- Identified rare cases of intraoperative deaths during hip replacement due to Bone Cement Implantation Syndrome (BCIS) in which five out of six of the patients died. Several risk reduction strategies in the article include evaluating and monitoring the patient’s condition before and during surgery. The six BCIS cases would most likely not have been noticed had it not been for the aggregation of the cases over the last two years through the PA-PSRS reporting system.
- Focused attention on the dangers of hospital bed rail entrapment and measures facilities can take to prevent injury and death from entrapment. A toolkit was also provided for front-line caregivers to help them implement changes within their facilities to reduce the risk of patients being trapped in their bed rails.
The Authority’s research findings are disseminated widely through the Patient Safety Advisories. The importance of distributing the Advisories to all appropriate staff cannot be emphasized enough so that the facility can benefit fully from the “lessons learned.” While several of Pennsylvania’s patient safety officers have commented on the usefulness of Patient Safety Advisories, one facility in particular encompassed the purpose of the Advisory overall:
“Your Advisory publications are extremely helpful in educating all staff as well as giving the facility a focus to prevent future occurrences.”
Patient Safety Officer
Pennsylvania healthcare facility
Education and Outreach Efforts Increase “Cultures of Safety”
The Authority continues to embark on new education and outreach initiatives to improve patient safety in Pennsylvania’s healthcare facilities.
In the three years since mandatory reporting was initiated in Pennsylvania, PA-PSRS has received almost half of a million reports, a significant database that validates the utility of mandatory reporting, especially the mandatory reporting of near-misses. The point of mandatory reporting is not merely to collect reports but to learn from past experiences in one’s own facility and from the experiences of other facilities. Hospitals have responded to clinical guidance contained in the Patient Safety Advisory by implementing new, safer procedures and protocols.
By many measures, the PA-PSRS system has elevated Pennsylvania to the forefront of patient safety activities around the country. The PA-PSRS database has generated interest from throughout the United States and as far as the United Kingdom, Norway and Switzerland.
Adverse event reporting is a first step in dealing with issues of quality and safety. The action of submitting a report is an acknowledgement that something actually or almost happened, but the next steps are important—learning why it happened and implementing steps to prevent it from happening again. The Authority recognizes this is no easy task, but it’s a challenge that everyone from hospital CEOs to the maintenance workers in every facility should accept.
The Authority understands 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.
For its part in educating facilities, 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; collaborated with other statewide organizations to develop new research projects and initiatives using PA-PSRS data; and facilitated access to continuing education credits related to patient safety for physicians and other healthcare professionals. News media around the Commonwealth, including the state’s major newspapers, carried articles about the Authority’s research and publications. In addition, several medical, clinical and professional journals, reprinted or cited articles that originally appeared in a Patient Safety Advisory. Among the publications and organizations that picked up articles from the Advisory are the Joint Commission Perspectives on Patient Safety, Contemporary Surgery, Outpatient Surgery Magazine, HealthLeaders Magazine, the Robert Wood Johnson Foundation website, Patient Safety Net (published by the U.S. Agency for Healthcare Research and Quality), MedSun (published by the Federal Drug Administration’s Medical Device Surveillance Network), Medical News Today, Patient Safety and Quality Healthcare, OR Manager, Physicians News Digest, Infection Control Today, Nursing Spectrum, and the newsletters of numerous professional associations such as DecisionHealth, HC Pro, the Association for the Advancement of Medical Instrumentation (AAMI), Towers-Perrin RX Collaborative newsletter, the American Organization of Nurse Executives and the American Association of Critical-Care Nursing. Clinical staff also published articles in the American Surgeon, American Journal of Surgery, AORN Journal and Medicare Patient Management Journal.
The Patient Safety Authority Board continues to expand its focus on educational programs, like the Root Cause Analysis Seminar held in 2006, and by sponsoring an intensive two-day workshop on Failure Mode and Effects Analysis (FMEA) in May and June 2007. The workshop will allow Pennsylvania healthcare facilities to learn how to mitigate potential risks and develop control strategies where risk is present within their own healthcare facilities.
Results from the Patient Safety Authority’s annual Fall 2006 survey suggest that Act 13 and the Patient Safety Authority have continued to help promote a culture of safety in Pennsylvania healthcare facilities. More than 87% (up from 80% in 2005) of the patient safety officers responding to the Authority’s annual survey credited Act 13 with improving the culture of safety within their facilities. Equally important, 72% 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 priorities in 2006 for the future that include promoting a culture of safety within individual healthcare facilities. The Authority met with Pennsylvania government officials to discuss plans for encouraging a culture of safety throughout the healthcare community. Those discussions continue into 2007 with plans for implementation underway. 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.
Patterns and Trends in PA-PSRS Reports
The Authority’s core mission is to collect and analyze reports of Serious Events and Incidents. The Authority accomplishes this through the Pennsylvania Patient Safety Reporting System, known as PA-PSRS—a secure, web-based, data collection and analysis system.
The Authority collected and analyzed data submitted by Pennsylvania’s 460 hospitals, ambulatory surgical facilities and birthing centers. These facilities submitted 195,832 reports: 6,937 of Serious Events (actual adverse events) and 188,895 of Incidents (often called near-misses) through PA-PSRS in 2006. Approximately 96% of the events were classified as Incidents.
Patterns and trends are evaluated in this Annual Report according to the recovery rate. The recovery rate is the percentage of reports without reported harm (Incidents) compared to all reports. The desired result is that the recovery rate increase. Increases will be due to a decrease in Serious Event reports, which is desirable, and/or an increase in reports of detected events that did not harm the patient (Incidents), which is also considered desirable by patient safety experts.
Report volume in 2006 showed an increase of almost 26,000 reports over 2005, with a decrease in Serious Events and a slight increase in the recovery rate.
When reporting an event to PA-PSRS, a facility uses a classification system or “taxonomy” to characterize the occurrence they are reporting. A facility classifies a report by identifying what PA-PSRS defines as the “Event Type.” The Event Type essentially answers the most basic question about an occurrence: “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 2006 by their Event Type.
Figure 1. Percentage of Reports by Event Type (2006)
Other highlights of data submitted through PA-PSRS during the calendar year 2006 are:
- 464 hospitals, ambulatory surgical facilities and birthing centers were subject to Act 13 reporting requirements. They submitted 195,832 reports of Serious Events and Incidents through PA-PSRS, an increase of almost 26,000 reports over 2005.
- Incidents, in which the patient was not harmed, accounted for 96.5% of all reports; 3.5% of all reports were Serious Events, which indicates that the patient received some level of harm, ranging from minor, temporary harm to death. This represents an increase in the recovery rate.
- Reports from hospitals accounted for 98.7% of all reports submitted.
- Reports by region show the largest number 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 region counties submitted a greater number of Incidents (no harm to the patient): 98.5%, compared to the statewide average of 96.8%, representing a higher recovery rate.
- Reports of healthcare associated infections (HAI) from 2005 and 2006 increased by 63% which may be the result of the Authority’s efforts at the end of 2005 to encourage facilities to regard infections as a significant patient safety issue. Reporting increased in almost every HAI subcategory, as well as in each region of Pennsylvania. Overall, HAIs are one of the top three complications most frequently reported to PA-PSRS. Despite this increase in reporting of HAI’s, this still represents a small portion of those that actually occur.
- Statewide, the most frequently reported events in hospitals involved Errors related to Procedures/Treatments/Tests (24%). However, these are not the ones most frequently associated with Serious Events (events that cause harm).
- Complications related to procedures, treatments, or tests accounted for 42% of all Serious Events.
- Patient Falls accounted for 17% of all reports, and 4% of Falls were considered Serious Events.
- Consistent with last year, 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 2006, 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.
- Reports of children and adolescents (aged 21 and younger) increased 33% in 2006. Errors related to procedures, treatments and tests were the most commonly submitted type of report, accounting for 35% of the reports for this population.
- Reports involving perinatal patients (those aged 20 days or younger) increased 14.6% from 2,885 in 2005 to 3,305 in 2006. About one-fifth (20.5%) of the perinatal reports were related to Medication Errors.
- Medication Errors accounted for 23% of all reports (down from 2005), and 1% of Medication Errors were considered Serious Events. That means that, in almost 99% of Medication Errors, the patient was not harmed. One in four (25%) medication errors involves a high alert medication—these drugs carry risk of significant harm to the patient if used incorrectly.
The complete Annual Report, as well as more information about the Authority and access to issues of the Patient Safety Advisory, is available on the Authority’s website, www.patientsafetyauthority.org.
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