- Email: [email protected]
Translating Patient Safety Legislation into Health Care Practice
John M. Eisenberg Patient Safety and Quality Awards
photo courtesy of Tony Brown; www.imijphoto.com
Translating Patient Safety Legislation into Health Care Practice
Left to right: Janet M. Corrigan; John R. Clarke; Edward Finley (PA-PSRS staff ); Laurie Baker; Thomas Ignudo (PA-PSRS staff ); Sharon Hutton (PSA staff ); Stanton Smullens (PSA board member); Alan B.K. Rabinowitz; Janet Johnston; Arthur Augustine and Miranda Minetti (PA-PSRS staff ); Dennis S. O' Leary he Institute of Medicine’s 1999 To Err is Human generated considerable public attention to the issue of medical errors throughout Pennsylvania, as in many other states.1 In addition to the occasional outcry over the issue of medical liability, litigation, and the seemingly high costs of professional insurance was the real or perceived threat of the departure from Pennsylvania of physicians, particularly those in a few critical specialties—such as obstetrics, orthopedics, and neurosurgery—and therefore the potential for hospitals to eliminate or curtail certain services. The issue was seen as grave in late 2001. During the next few months, representatives of the General Assembly, the Governor’s Office, physicians, hospitals, lawyers, health policy advocates and other stakeholders
T
676
December 2006
Alan B.K. Rabinowitz, M.A. John R. Clarke, M.D. William Marella, M.B.A. Janet Johnston, M.S.N., J.D. Laurie Baker, M.A. Michael Doering, M.B.A.
Article-at-a-Glance Background: An independent state agency, the Authority is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety. Pennsylvania Patient Safety Reporting System (PA-PSRS): The Authority implemented PA-PSRS, a mandatory reporting and analysis system for both adverse events and near-misses, among 450 hospitals, birthing centers, and ambulatory surgical facilities. Pennsylvania is the only state to require the reporting of both adverse events and near-misses. The Patient Safety Advisory: The Patient Safety Advisory is a quarterly publication containing articles about trends in reports submitted to PA-PSRS. The peerreviewed articles include analysis of and lessons learned from PA-PSRS reports and evidence-based risk reduction strategies based on research in the clinical literature. To complement and reinforce the effectiveness of certain Advisory articles, the Authority has introduced electronic, educational tool kits on its Web site that can be downloaded. They include posters, draft policies, audio-slide presentations for staff training, and other materials related to clinical implementation of patient safety interventions and protocols. Summary and Conclusion: In just over two years, the Authority has developed a program that turns reports into actionable items through the analysis and research of adverse events and near-misses.
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Table 1. A Summary of Act 13’s Reporting Requirements Who Reports ■ Hospitals ■ Ambulatory surgical facilities ■ Birthing centers ■ Certain abortion facilities
Types of Events ■ Near misses (“Incidents”) ■ Adverse events (“Serious Events”)
Other Provisions ■ Mandatory reporting by facilities ■ Provisions for anonymous reporting by health care workers ■ Confidential ■ No individual-identifying data ■ Nondiscoverable ■ Whistleblower protections ■ Written patient notification of serious events ■ Funded by facility assessment
negotiated comprehensive legislation incorporating medical professional liability issues, insurance provisions, tort reform, continuing medical education requirements, other licensing board matters, and patient safety. The bill was signed into law in March as Act 13—the Medical Care Availability and Reduction of Error (MCARE) Act—of 2002.2 This article focuses on the specific patient safety provisions that established the Pennsylvania Patient Safety Authority (PSA) and their subsequent implementation.
Act 13 of 2002: The Legislative Mandate Act 13 established the PSA as an independent state agency under an 11-member board of directors and funded entirely by an assessment on those facilities subject to the statute’s mandatory reporting provisions. Under the enabling legislation, all hospitals, ambulatory surgical facilities, and birthing centers are required to submit reports of adverse events and near-misses (called “Serious Events” and “Incidents,” respectively, in the statute) to the Authority. Act 30 of 2006 extended reporting requirements to certain abortion facilities.3 A summary of Act 13’s reporting requirements is shown in Table 1 (above). Act 13 also requires the Authority to contract with one or more outside organizations to collect and analyze the reports and to provide advice to the facilities about steps they could take to reduce future adverse events. In spring 2003, the Authority issued a formal Request for Proposals soliciting potential vendors to perform the data collection and analysis functions. As a result of the Commonwealth’s open bid process, the contract was awarded to ECRI, in partnership with the Institute for
December 2006
Safe Medication Practices—two well-regarded, nonprofit, research organizations—and EDS, the international business consulting and information technology (IT) services firm. Through fall 2003 and spring 2004, the Authority staff worked closely with this partnership in developing the Pennsylvania Patient Safety Reporting System (PA-PSRS, pronounced “PAY-sirs”). Statewide mandatory reporting was implemented in June 2004—on time, on budget, and without any technical glitches. Equally important, the Authority achieved buy-in from more than 420 health care facilities then subject to mandatory reporting by strategically rolling out the PAPSRS system during 19 all-day, small-group training sessions in 11 locations around the state.* Training included not only a hands-on introduction to the technical process of submitting a report but also concepts of patient safety, including the importance of teamwork, empowerment, and transparency in building a culture of safety within each institution. A positive, if unexpected, outcome of these small group training sessions was the solid working relationship the Authority developed with the patient safety officers (PSOs) and other key managers in almost every health care facility around the state—a relationship that has been strengthened through ongoing communication and collaboration since then.
PA-PSRS PA-PSRS is an interactive, Web-based system that receives reports from user-facilities and provides real-time feedback * The number of facilities fluctuates because of closures, mergers, and new facilities. Currently (September 2006) nearly 460 facilities are subject to the mandatory reporting requirements.
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
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to those users about their own data and, in some cases, statewide aggregates. Through its contractors, the Authority entered into a license agreement with the University HealthSystem Consortium (UHC) to acquire rights to the base software for Patient Safety Net (PSN), an incident reporting system owned by UHC. PA-PSRS was built on the PSN platform. The resulting PA-PSRS system is a user-friendly reporting instrument containing 21 core questions with check boxes, drop-down menus, and free-text fields. By statute, all information submitted through PA-PSRS is confidential and nondiscoverable, and there are no identifying patient or provider names. Information collected includes limited demographic patient information, the location within a facility where the event took place, the type of event, and the level of patient harm, if any. In addition, the report collects considerable detail about “contributing factors” and details related to staffing, the workplace environment, management, and clinical protocols. The user is also asked to identify the root cause of a serious event and to suggest procedures that can be implemented to prevent a recurrence. In all, there are some 400 questions within the reporting form. However, the system’s logic selects only appropriate questions on the basis of answers to previous questions. As a result, a single report contains only a portion of the data fields. Completion of a report takes only several minutes. Since initiating mandatory statewide reporting in June 2004, the Authority has received more than 385,000 reports of actual adverse events and near misses, with monthly volume as high as 18,000. About 96% of all reports are near misses. Pennsylvania is the only state to require the reporting of both adverse events and near misses.4 The PA-PSRS workflow system electronically receives and prioritizes each report, facilitating review by the PA-PSRS analytical team, as shown in Figure 1 (page 679). Headed by a trauma surgeon (J.R.C.), the analytical team includes a professional staff with academic degrees and experience in such fields as pharmacy, nursing, medicine, health administration, risk management, statistical analysis, biomedical engineering, and law. Through our contractors, the team members also have access to a large pool of subject matter experts in virtually every medical specialty.
678
December 2006
In addition to electronic triage, so far every report submitted through PA-PSRS has been manually reviewed by at least one member of the analytical team. In reviewing reports, staff identify significant trends and look for situations of immediate jeopardy. When appropriate, they contact PSOs to obtain additional information or alert the facility to potential problems. On the basis of reports submitted to PA-PSRS, the analytical staff also researches the clinical literature to identify system improvements that can improve patient safety. The results of the analyses and research are published in the Patient Safety Advisory and, on occasion, in professional journals.
The Patient Safety Advisory The Patient Safety Advisory is a quarterly publication containing articles about trends in reports submitted to PA-PSRS. It is the program’s primary analytical product. The peer-reviewed articles include analysis of and lessons learned from PA-PSRS reports and evidence-based risk reduction strategies based on research in the clinical literature. Selected topics are shown in Appendix 1 (page 681). Topics for articles are selected on the basis of the following factors: ■ Frequently reported occurrences ■ Real or potential serious patient outcomes, regardless of volume ■ Unusual or emerging trends with statewide ramifications ■ Recurring underlying themes, typically based on root causes or other contributing factors that cut across report types ■ Previously unrecognized problems related to the manufacture or packaging of equipment, medications, or other supplies ■ Reported patient safety issues that generate widespread interest within and outside the health care industry The Advisory is sent to clinicians and managers in all Pennsylvania hospitals, ambulatory surgical facilities, and birthing centers and to thousands of other providers, advocates, and health industry personnel throughout the state and the rest of the United States. The Advisory is also disseminated electronically through numerous national and international news services and listservs and is accessible on the Authority’s Web site.5
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Pennsylvania Patient Safety Reporting System (PA-PSRS) Analytical Process
Figure 1. The PA-PSRS workflow system automatically triages incoming reports according to frequency, severity, and other factors and assigns them to individual analysts. Selected reports are discussed at a weekly meeting. Analysts may contact individual facilities for follow-up or to provide guidance. The primary program output is the Patient Safety Advisory, a quarterly journal that highlights significant safety issues and provides risk mitigation strategies. PSA’s Annual Report provides information on trends at the state level.
In a recent survey of Pennsylvania patient safety officers, more than 96% of respondents rated the Advisory as useful, relevant, readable, and of good quality, 6 and a comparable percentage (97%) of PSOs reported that they distribute or forward the Advisory to other staff in their health care facility. In addition, 75% of responding hospital PSOs stated that they had made changes in their facilities on the basis of articles in the Advisory, as listed in Table 2 (page 680). To complement and reinforce the effectiveness of certain Advisory articles, the Authority has introduced electronic, educational tool kits on its Web site that can be downloaded. They include posters, draft policies, audioslide presentations for staff training, and other materials related to clinical implementation of patient safety interventions and protocols.
December 2006
One Event Drives Change: Why Near-Miss Reporting Matters The value of mandatory near-miss reporting is apparent in the following example. A near-miss was reported in which health care workers nearly failed to rescue a patient who had a cardiopulmonary arrest because the patient was thought to be designated DNR (do not resuscitate). A nurse had placed a yellow wristband on the patient, thinking that the color yellow signified “restricted extremity,” as was the practice at a nearby hospital where she also worked. However, at the current hospital yellow signified DNR. Fortunately, hospital staff recognized the error and resuscitated the patient. Although the patient was not harmed, the incident raised concerns about the risk of harm in the future if a color-coded wristband was incorrectly applied.
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Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
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Table 2. Examples of Changes Instituted by Facilities as a Result of Patient Safety Advisory Articles ■ ■
■ ■ ■ ■ ■ ■
Reducing the number of color-coded patient wristbands in use and purchasing wristbands with embossed text (e.g., “allergy”) on the wristbands to avoid confusion Convening a conference of traditionally competing health care facilities in their region to achieve consensus on the use of color-coded wristbands in their organizations. The resulting protocol policies were agreed to by each facility’s chief executive officer or other senior leadership Minimizing the risk of alcohol-based fires by using towels to catch alcohol runoff in the operating room and eliminating use of alcohol-based hair products by patients Holding an educational program for clinical staff on how to minimize the risk of anesthesia awareness and respond to it when it occurs Educating surgeons about and getting their buy-in for a preoperative “time out” before surgery, in which the patient’s identity and other critical elements of the procedure are reviewed Changing the color of tourniquets used throughout the facility so they are clearly differentiated from the patient’s skin color, reducing the likelihood that they will be left on the patient longer than intended Revising protocols related to specimen handling and extravasation of radiologic contrast Purchasing syringes from different manufacturers, so that tuberculin and insulin syringes do not have look-alike packaging
In response to that one report, PA-PSRS staff conducted a survey and concluded that color-coded wristbands were widely used throughout the state and that there were no standard meanings regarding patient characteristics or clinical requirements for different colors, even within the same health system. Given the potential for serious patient harm, the Authority issued a Supplementary Advisory7 alerting providers to the risks associated with local color codes. The response to the Advisory from facilities throughout Pennsylvania and elsewhere was overwhelming. Agencies, health systems, hospital and professional associations, and health policy makers from around the United States expressed alarm and interest in resolving this potentially risky practice. The Authority initiated conversations with neighboring state agencies and leading national organizations to assess how the health industry might achieve consensus on this issue on a regional, if not a national, level. Concurrently, a group of facilities in northeastern and central Pennsylvania formed the Color of Safety Task Force to deal with this issue head on. The task force reached consensus on the use of color-coded wristbands and developed detailed protocols, including a policy manual and training resources. All the organizations adopted a common protocol governing the use of colorcoded wristbands. Numerous hospital associations and
680
December 2006
health systems in other states have expressed intent to adopt or adapt these protocols for use within their own member organizations.8 Significantly, a single PA-PSRS report, representing one near miss in a small facility, was able to generate meaningful change. Conventional wisdom calls for investigating any unintended event that results in patient harm, but the risk of harm demonstrated by this incident validates the value of reporting and investigating nearmiss events to prevent future harmful events.
Facilitating Continuous Quality Improvement and a Culture of Safety The PA-PSRS software includes analytical tools that individual providers and health care managers can use for internal self-assessment and patient safety and quality improvement activities. These tools generate tables and charts summarizing data from an individual facility and, in some cases, aggregate statewide data. In the survey of PSOs previously cited,6 68% of responding PSOs reported that PA-PSRS had improved their ability to monitor patient safety in their facility. These respondents indicated that they use the embedded analytical tools to support their patient safety committee, advise risk and quality managers, analyze trends, and create reports for corporate management and trustees.
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
In addition to publishing the Patient Safety Advisory, the Authority sponsors educational sessions and participates in numerous hospital-based meetings of medical and nursing staffs. Although many of these activities point to the lessons learned through statewide mandatory reporting, the underlying focus is on promoting a culture of safety within the health care industry, encouraging full and open disclosure by providers and managers, and facilitating consistent event reporting in support of both a “just culture” and a culture of learning.
Summary and Conclusion In just over two years, the Authority has developed a program that turns reports into actionable items through the analysis and research of adverse events and near
misses. It is demonstrating the validity of mandatory near-miss reporting and its benefit in disseminating lessons learned to a wide audience, both within Pennsylvania and outside. J
Alan B.K. Rabinowitz, M.A., is administrator of the Pennsylvania Patient Safety Authority (PSA), Harrisburg, Pennsylvania. John R. Clarke, M.D., is clinical director of the Pennsylvania Patient Safety Reporting System (PAPSRS), PSA, and editor of the Patient Safety Advisory. William Marella, M.B.A., is PA-PSRS project manager at ECRI, Plymouth Meeting, Pennsylvania. Janet Johnston, M.S.N., J.D., is a PA-PSRS clinical analyst, PSA; Laurie Baker, M.A., is communication director; and Michael Doering, M.B.A., is PA-PSRS project manager. Please address reprint requests to Alan B.K. Rabinowitz, [email protected].
References 1. Institute of Medicine: To Err Is Human: Building a Safer Health System. Washington, D.C.: National Academy Press, 2000. 2. Commonwealth of Pennsylvania. Act 13 of 2002: Medical Care Availability and Reduction of Error (MCARE) Act (40 Pa.C.S. §1303.101 et seq.). 3. Commonwealth of Pennsylvania: Act 30 of 2006 (40 Pa.C.S. §1303.315). 4. Rosenthal J., Booth M.: Maximizing the Use of State Adverse Event Data to Improve Patient Safety. Portland, ME: National Academy for State Health Policy, 2005. 5. Patient Safety Authority: Patient Safety Advisories. http://www.psa.state.pa.us/psa/cwp/view.asp?a=1293&q=445966& psaNav=| (last accessed Oct. 4, 2006).
6. Patient Safety Authority: 2005 Annual Report, p. 9. http://www.psa.state.pa.us/psa/cwp/view.asp?a=1275&q=446267 (last accessed Oct. 3, 2006). 7. Pennsylvania Patient Safety Reporting System (PA-PSRS): Supplementary Advisory: Use of Color-Coded Patient Wristbands Creates Unnecessary Risk. Patient Safety Advisory 2 (Suppl 2), Dec. 14, 2005. http://www.psa.state.pa.us/psa/lib/psa/advisories/ v2_s2_sup_advisory_dec_14_2005.pdf (last accessed Oct. 3, 2006). 8. Pennsylvania Patient Safety Reporting System (PA-PSRS). Update on Use of Color-Coded Wristbands. Patient Safety Advisory 3 (Suppl 1), Aug. 9, 2006. http://www.psa.state.pa.us/psa/lib/psa/advisories/v3_s1_ sup_advisory_8-9-06.pdf (last accessed Oct. 3, 2006).
Appendix 1. Selected Patient Safety Advisory Articles* ■ ■ ■ ■ ■ ■
Skin Tears: The Clinical Challenge Improving the Safety of Telephone and Verbal Orders Confusion between Insulin and Tuberculin Syringes Who Administers Propofol in your Organization? Use of Color-Coded Wristbands Creates Unnecessary Risk Looking Beyond the Obvious Causes of Error
■ ■ ■ ■ ■ ■ ■
Unanticipated Care after Discharge from ASFs The Beers Criteria: Medication Screening in the Elderly Hidden Sources of Latex in Healthcare Products Use of X-Rays for Incorrect Needle Counts Bed Exit Alarms to Reduce Falls Anesthesia Awareness Changing Catheters Over a Wire
■ ■ ■ ■ ■ ■
The Role of Empowerment in Patient Safety Abbreviations: A Shortcut to Medication Errors When Patients Speak— Collaboration in Patient Safety Medication Errors Linked to Name Confusion Focus on High Alert Medications Pressure Ulcers: A Look at Reports to PA-PSRS
* ASFs, ambulatory surgical facilities; PA-PSRS, Pennsylvania Patient Safety Authority Reporting System.
December 2006
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
681
photo courtesy of Tony Brown; www.imijphoto.com
Translating Patient Safety Legislation into Health Care Practice
Left to right: Janet M. Corrigan; John R. Clarke; Edward Finley (PA-PSRS staff ); Laurie Baker; Thomas Ignudo (PA-PSRS staff ); Sharon Hutton (PSA staff ); Stanton Smullens (PSA board member); Alan B.K. Rabinowitz; Janet Johnston; Arthur Augustine and Miranda Minetti (PA-PSRS staff ); Dennis S. O' Leary he Institute of Medicine’s 1999 To Err is Human generated considerable public attention to the issue of medical errors throughout Pennsylvania, as in many other states.1 In addition to the occasional outcry over the issue of medical liability, litigation, and the seemingly high costs of professional insurance was the real or perceived threat of the departure from Pennsylvania of physicians, particularly those in a few critical specialties—such as obstetrics, orthopedics, and neurosurgery—and therefore the potential for hospitals to eliminate or curtail certain services. The issue was seen as grave in late 2001. During the next few months, representatives of the General Assembly, the Governor’s Office, physicians, hospitals, lawyers, health policy advocates and other stakeholders
T
676
December 2006
Alan B.K. Rabinowitz, M.A. John R. Clarke, M.D. William Marella, M.B.A. Janet Johnston, M.S.N., J.D. Laurie Baker, M.A. Michael Doering, M.B.A.
Article-at-a-Glance Background: An independent state agency, the Authority is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety. Pennsylvania Patient Safety Reporting System (PA-PSRS): The Authority implemented PA-PSRS, a mandatory reporting and analysis system for both adverse events and near-misses, among 450 hospitals, birthing centers, and ambulatory surgical facilities. Pennsylvania is the only state to require the reporting of both adverse events and near-misses. The Patient Safety Advisory: The Patient Safety Advisory is a quarterly publication containing articles about trends in reports submitted to PA-PSRS. The peerreviewed articles include analysis of and lessons learned from PA-PSRS reports and evidence-based risk reduction strategies based on research in the clinical literature. To complement and reinforce the effectiveness of certain Advisory articles, the Authority has introduced electronic, educational tool kits on its Web site that can be downloaded. They include posters, draft policies, audio-slide presentations for staff training, and other materials related to clinical implementation of patient safety interventions and protocols. Summary and Conclusion: In just over two years, the Authority has developed a program that turns reports into actionable items through the analysis and research of adverse events and near-misses.
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Table 1. A Summary of Act 13’s Reporting Requirements Who Reports ■ Hospitals ■ Ambulatory surgical facilities ■ Birthing centers ■ Certain abortion facilities
Types of Events ■ Near misses (“Incidents”) ■ Adverse events (“Serious Events”)
Other Provisions ■ Mandatory reporting by facilities ■ Provisions for anonymous reporting by health care workers ■ Confidential ■ No individual-identifying data ■ Nondiscoverable ■ Whistleblower protections ■ Written patient notification of serious events ■ Funded by facility assessment
negotiated comprehensive legislation incorporating medical professional liability issues, insurance provisions, tort reform, continuing medical education requirements, other licensing board matters, and patient safety. The bill was signed into law in March as Act 13—the Medical Care Availability and Reduction of Error (MCARE) Act—of 2002.2 This article focuses on the specific patient safety provisions that established the Pennsylvania Patient Safety Authority (PSA) and their subsequent implementation.
Act 13 of 2002: The Legislative Mandate Act 13 established the PSA as an independent state agency under an 11-member board of directors and funded entirely by an assessment on those facilities subject to the statute’s mandatory reporting provisions. Under the enabling legislation, all hospitals, ambulatory surgical facilities, and birthing centers are required to submit reports of adverse events and near-misses (called “Serious Events” and “Incidents,” respectively, in the statute) to the Authority. Act 30 of 2006 extended reporting requirements to certain abortion facilities.3 A summary of Act 13’s reporting requirements is shown in Table 1 (above). Act 13 also requires the Authority to contract with one or more outside organizations to collect and analyze the reports and to provide advice to the facilities about steps they could take to reduce future adverse events. In spring 2003, the Authority issued a formal Request for Proposals soliciting potential vendors to perform the data collection and analysis functions. As a result of the Commonwealth’s open bid process, the contract was awarded to ECRI, in partnership with the Institute for
December 2006
Safe Medication Practices—two well-regarded, nonprofit, research organizations—and EDS, the international business consulting and information technology (IT) services firm. Through fall 2003 and spring 2004, the Authority staff worked closely with this partnership in developing the Pennsylvania Patient Safety Reporting System (PA-PSRS, pronounced “PAY-sirs”). Statewide mandatory reporting was implemented in June 2004—on time, on budget, and without any technical glitches. Equally important, the Authority achieved buy-in from more than 420 health care facilities then subject to mandatory reporting by strategically rolling out the PAPSRS system during 19 all-day, small-group training sessions in 11 locations around the state.* Training included not only a hands-on introduction to the technical process of submitting a report but also concepts of patient safety, including the importance of teamwork, empowerment, and transparency in building a culture of safety within each institution. A positive, if unexpected, outcome of these small group training sessions was the solid working relationship the Authority developed with the patient safety officers (PSOs) and other key managers in almost every health care facility around the state—a relationship that has been strengthened through ongoing communication and collaboration since then.
PA-PSRS PA-PSRS is an interactive, Web-based system that receives reports from user-facilities and provides real-time feedback * The number of facilities fluctuates because of closures, mergers, and new facilities. Currently (September 2006) nearly 460 facilities are subject to the mandatory reporting requirements.
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
677
to those users about their own data and, in some cases, statewide aggregates. Through its contractors, the Authority entered into a license agreement with the University HealthSystem Consortium (UHC) to acquire rights to the base software for Patient Safety Net (PSN), an incident reporting system owned by UHC. PA-PSRS was built on the PSN platform. The resulting PA-PSRS system is a user-friendly reporting instrument containing 21 core questions with check boxes, drop-down menus, and free-text fields. By statute, all information submitted through PA-PSRS is confidential and nondiscoverable, and there are no identifying patient or provider names. Information collected includes limited demographic patient information, the location within a facility where the event took place, the type of event, and the level of patient harm, if any. In addition, the report collects considerable detail about “contributing factors” and details related to staffing, the workplace environment, management, and clinical protocols. The user is also asked to identify the root cause of a serious event and to suggest procedures that can be implemented to prevent a recurrence. In all, there are some 400 questions within the reporting form. However, the system’s logic selects only appropriate questions on the basis of answers to previous questions. As a result, a single report contains only a portion of the data fields. Completion of a report takes only several minutes. Since initiating mandatory statewide reporting in June 2004, the Authority has received more than 385,000 reports of actual adverse events and near misses, with monthly volume as high as 18,000. About 96% of all reports are near misses. Pennsylvania is the only state to require the reporting of both adverse events and near misses.4 The PA-PSRS workflow system electronically receives and prioritizes each report, facilitating review by the PA-PSRS analytical team, as shown in Figure 1 (page 679). Headed by a trauma surgeon (J.R.C.), the analytical team includes a professional staff with academic degrees and experience in such fields as pharmacy, nursing, medicine, health administration, risk management, statistical analysis, biomedical engineering, and law. Through our contractors, the team members also have access to a large pool of subject matter experts in virtually every medical specialty.
678
December 2006
In addition to electronic triage, so far every report submitted through PA-PSRS has been manually reviewed by at least one member of the analytical team. In reviewing reports, staff identify significant trends and look for situations of immediate jeopardy. When appropriate, they contact PSOs to obtain additional information or alert the facility to potential problems. On the basis of reports submitted to PA-PSRS, the analytical staff also researches the clinical literature to identify system improvements that can improve patient safety. The results of the analyses and research are published in the Patient Safety Advisory and, on occasion, in professional journals.
The Patient Safety Advisory The Patient Safety Advisory is a quarterly publication containing articles about trends in reports submitted to PA-PSRS. It is the program’s primary analytical product. The peer-reviewed articles include analysis of and lessons learned from PA-PSRS reports and evidence-based risk reduction strategies based on research in the clinical literature. Selected topics are shown in Appendix 1 (page 681). Topics for articles are selected on the basis of the following factors: ■ Frequently reported occurrences ■ Real or potential serious patient outcomes, regardless of volume ■ Unusual or emerging trends with statewide ramifications ■ Recurring underlying themes, typically based on root causes or other contributing factors that cut across report types ■ Previously unrecognized problems related to the manufacture or packaging of equipment, medications, or other supplies ■ Reported patient safety issues that generate widespread interest within and outside the health care industry The Advisory is sent to clinicians and managers in all Pennsylvania hospitals, ambulatory surgical facilities, and birthing centers and to thousands of other providers, advocates, and health industry personnel throughout the state and the rest of the United States. The Advisory is also disseminated electronically through numerous national and international news services and listservs and is accessible on the Authority’s Web site.5
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Pennsylvania Patient Safety Reporting System (PA-PSRS) Analytical Process
Figure 1. The PA-PSRS workflow system automatically triages incoming reports according to frequency, severity, and other factors and assigns them to individual analysts. Selected reports are discussed at a weekly meeting. Analysts may contact individual facilities for follow-up or to provide guidance. The primary program output is the Patient Safety Advisory, a quarterly journal that highlights significant safety issues and provides risk mitigation strategies. PSA’s Annual Report provides information on trends at the state level.
In a recent survey of Pennsylvania patient safety officers, more than 96% of respondents rated the Advisory as useful, relevant, readable, and of good quality, 6 and a comparable percentage (97%) of PSOs reported that they distribute or forward the Advisory to other staff in their health care facility. In addition, 75% of responding hospital PSOs stated that they had made changes in their facilities on the basis of articles in the Advisory, as listed in Table 2 (page 680). To complement and reinforce the effectiveness of certain Advisory articles, the Authority has introduced electronic, educational tool kits on its Web site that can be downloaded. They include posters, draft policies, audioslide presentations for staff training, and other materials related to clinical implementation of patient safety interventions and protocols.
December 2006
One Event Drives Change: Why Near-Miss Reporting Matters The value of mandatory near-miss reporting is apparent in the following example. A near-miss was reported in which health care workers nearly failed to rescue a patient who had a cardiopulmonary arrest because the patient was thought to be designated DNR (do not resuscitate). A nurse had placed a yellow wristband on the patient, thinking that the color yellow signified “restricted extremity,” as was the practice at a nearby hospital where she also worked. However, at the current hospital yellow signified DNR. Fortunately, hospital staff recognized the error and resuscitated the patient. Although the patient was not harmed, the incident raised concerns about the risk of harm in the future if a color-coded wristband was incorrectly applied.
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
679
Table 2. Examples of Changes Instituted by Facilities as a Result of Patient Safety Advisory Articles ■ ■
■ ■ ■ ■ ■ ■
Reducing the number of color-coded patient wristbands in use and purchasing wristbands with embossed text (e.g., “allergy”) on the wristbands to avoid confusion Convening a conference of traditionally competing health care facilities in their region to achieve consensus on the use of color-coded wristbands in their organizations. The resulting protocol policies were agreed to by each facility’s chief executive officer or other senior leadership Minimizing the risk of alcohol-based fires by using towels to catch alcohol runoff in the operating room and eliminating use of alcohol-based hair products by patients Holding an educational program for clinical staff on how to minimize the risk of anesthesia awareness and respond to it when it occurs Educating surgeons about and getting their buy-in for a preoperative “time out” before surgery, in which the patient’s identity and other critical elements of the procedure are reviewed Changing the color of tourniquets used throughout the facility so they are clearly differentiated from the patient’s skin color, reducing the likelihood that they will be left on the patient longer than intended Revising protocols related to specimen handling and extravasation of radiologic contrast Purchasing syringes from different manufacturers, so that tuberculin and insulin syringes do not have look-alike packaging
In response to that one report, PA-PSRS staff conducted a survey and concluded that color-coded wristbands were widely used throughout the state and that there were no standard meanings regarding patient characteristics or clinical requirements for different colors, even within the same health system. Given the potential for serious patient harm, the Authority issued a Supplementary Advisory7 alerting providers to the risks associated with local color codes. The response to the Advisory from facilities throughout Pennsylvania and elsewhere was overwhelming. Agencies, health systems, hospital and professional associations, and health policy makers from around the United States expressed alarm and interest in resolving this potentially risky practice. The Authority initiated conversations with neighboring state agencies and leading national organizations to assess how the health industry might achieve consensus on this issue on a regional, if not a national, level. Concurrently, a group of facilities in northeastern and central Pennsylvania formed the Color of Safety Task Force to deal with this issue head on. The task force reached consensus on the use of color-coded wristbands and developed detailed protocols, including a policy manual and training resources. All the organizations adopted a common protocol governing the use of colorcoded wristbands. Numerous hospital associations and
680
December 2006
health systems in other states have expressed intent to adopt or adapt these protocols for use within their own member organizations.8 Significantly, a single PA-PSRS report, representing one near miss in a small facility, was able to generate meaningful change. Conventional wisdom calls for investigating any unintended event that results in patient harm, but the risk of harm demonstrated by this incident validates the value of reporting and investigating nearmiss events to prevent future harmful events.
Facilitating Continuous Quality Improvement and a Culture of Safety The PA-PSRS software includes analytical tools that individual providers and health care managers can use for internal self-assessment and patient safety and quality improvement activities. These tools generate tables and charts summarizing data from an individual facility and, in some cases, aggregate statewide data. In the survey of PSOs previously cited,6 68% of responding PSOs reported that PA-PSRS had improved their ability to monitor patient safety in their facility. These respondents indicated that they use the embedded analytical tools to support their patient safety committee, advise risk and quality managers, analyze trends, and create reports for corporate management and trustees.
Volume 32 Number 12
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
In addition to publishing the Patient Safety Advisory, the Authority sponsors educational sessions and participates in numerous hospital-based meetings of medical and nursing staffs. Although many of these activities point to the lessons learned through statewide mandatory reporting, the underlying focus is on promoting a culture of safety within the health care industry, encouraging full and open disclosure by providers and managers, and facilitating consistent event reporting in support of both a “just culture” and a culture of learning.
Summary and Conclusion In just over two years, the Authority has developed a program that turns reports into actionable items through the analysis and research of adverse events and near
misses. It is demonstrating the validity of mandatory near-miss reporting and its benefit in disseminating lessons learned to a wide audience, both within Pennsylvania and outside. J
Alan B.K. Rabinowitz, M.A., is administrator of the Pennsylvania Patient Safety Authority (PSA), Harrisburg, Pennsylvania. John R. Clarke, M.D., is clinical director of the Pennsylvania Patient Safety Reporting System (PAPSRS), PSA, and editor of the Patient Safety Advisory. William Marella, M.B.A., is PA-PSRS project manager at ECRI, Plymouth Meeting, Pennsylvania. Janet Johnston, M.S.N., J.D., is a PA-PSRS clinical analyst, PSA; Laurie Baker, M.A., is communication director; and Michael Doering, M.B.A., is PA-PSRS project manager. Please address reprint requests to Alan B.K. Rabinowitz, [email protected].
References 1. Institute of Medicine: To Err Is Human: Building a Safer Health System. Washington, D.C.: National Academy Press, 2000. 2. Commonwealth of Pennsylvania. Act 13 of 2002: Medical Care Availability and Reduction of Error (MCARE) Act (40 Pa.C.S. §1303.101 et seq.). 3. Commonwealth of Pennsylvania: Act 30 of 2006 (40 Pa.C.S. §1303.315). 4. Rosenthal J., Booth M.: Maximizing the Use of State Adverse Event Data to Improve Patient Safety. Portland, ME: National Academy for State Health Policy, 2005. 5. Patient Safety Authority: Patient Safety Advisories. http://www.psa.state.pa.us/psa/cwp/view.asp?a=1293&q=445966& psaNav=| (last accessed Oct. 4, 2006).
6. Patient Safety Authority: 2005 Annual Report, p. 9. http://www.psa.state.pa.us/psa/cwp/view.asp?a=1275&q=446267 (last accessed Oct. 3, 2006). 7. Pennsylvania Patient Safety Reporting System (PA-PSRS): Supplementary Advisory: Use of Color-Coded Patient Wristbands Creates Unnecessary Risk. Patient Safety Advisory 2 (Suppl 2), Dec. 14, 2005. http://www.psa.state.pa.us/psa/lib/psa/advisories/ v2_s2_sup_advisory_dec_14_2005.pdf (last accessed Oct. 3, 2006). 8. Pennsylvania Patient Safety Reporting System (PA-PSRS). Update on Use of Color-Coded Wristbands. Patient Safety Advisory 3 (Suppl 1), Aug. 9, 2006. http://www.psa.state.pa.us/psa/lib/psa/advisories/v3_s1_ sup_advisory_8-9-06.pdf (last accessed Oct. 3, 2006).
Appendix 1. Selected Patient Safety Advisory Articles* ■ ■ ■ ■ ■ ■
Skin Tears: The Clinical Challenge Improving the Safety of Telephone and Verbal Orders Confusion between Insulin and Tuberculin Syringes Who Administers Propofol in your Organization? Use of Color-Coded Wristbands Creates Unnecessary Risk Looking Beyond the Obvious Causes of Error
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Unanticipated Care after Discharge from ASFs The Beers Criteria: Medication Screening in the Elderly Hidden Sources of Latex in Healthcare Products Use of X-Rays for Incorrect Needle Counts Bed Exit Alarms to Reduce Falls Anesthesia Awareness Changing Catheters Over a Wire
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The Role of Empowerment in Patient Safety Abbreviations: A Shortcut to Medication Errors When Patients Speak— Collaboration in Patient Safety Medication Errors Linked to Name Confusion Focus on High Alert Medications Pressure Ulcers: A Look at Reports to PA-PSRS
* ASFs, ambulatory surgical facilities; PA-PSRS, Pennsylvania Patient Safety Authority Reporting System.
December 2006
Volume 32 Number 12
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