HARRISBURG: The Pennsylvania Patient Safety Authority issued its 2008 Annual Report with survey information containing the level of adoption of some process and safety practices related to guidance published in Patient Safety Advisories and objectives established by national patient safety organizations. “While experts agree it’s difficult to measure patient safety, the Authority has attempted to establish a baseline through a survey after five years of collecting reports from Pennsylvania’s healthcare facilities,” Dr. Ana Pujols-McKee, chair of the Pennsylvania Patient Safety Authority said. “The results show facilities have adopted some practices to help improve patient safety, but in some other areas improvements can be made.”
Pujols-McKee said the methodology behind the survey included input from Patient Safety Officers (PSOs) and patient safety practices defined by national organizations including: the Centers for Medicare and Medicaid Services Hospital-Acquired Conditions, the Joint Commission’s 2009 National Patient Safety Goals and the National Quality Forum’s Serious Reportable Events and Safe Practices for Better Healthcare. The survey included practices relevant to hospitals, ambulatory surgical facilities (ASFs), birthing centers and abortion facilities.
The safe practices surveyed were organized into five domains: Safety Leadership; Medication Safety; Safe Surgery; Infection Prevention; and Device Safety.
“In regard to safety leadership, our results show hospitals are doing pretty well in implementing cultures of safety that allow individuals within those facilities to voice their concerns if they don’t like how an adverse event was handled, but there are still one-third of the hospitals that responded that have not adopted principles that provide a just culture,” Pujols-McKee said. “Similar results were found for ASFs and other facilities.”
Pujols-McKee explained that a “just culture” is one that does not punish individuals for honest mistakes or for reporting safety concerns and injuries. It also does not go to the opposite extreme by permitting repeated, intentional rule violations. A just culture seeks a middle ground that tries to find system or engineering solutions to reduce inevitable human errors, while holding individuals accountable for intentionally violating safety policies or procedures.
The majority of responding hospitals (70%) report some level of implementation of Just Culture principles, with 59% reporting full implementation hospital-wide. One-third of hospitals (30%) report that they have not yet implemented these principles. The Authority found similar results for ASFs and other facilities, with 72% reporting some level of implementation, while 28% have not adopted this approach.
Pujols-McKee said an important component of instituting a just culture is to ensure leadership in a facility shares the responsibility of providing the safest environment possible for patients. Senior leaders can demonstrate their leadership on safety by inviting PSOs to address their Board of Trustees and to make patient safety a standing item on a board agenda.
“Nearly half [47%] of participating hospital PSOs reported that they had attended four or more Board of Trustees meetings, while in one-third the PSO did not attend any,” Pujols-McKee said. “ASFs had similar responses with forty-four percent reporting PSO participation in four or more board meetings and twenty-four percent reporting none. I think we can work with facilities to improve these numbers by educating leadership on safety and its relevance to their facilities.”
All 525 Pennsylvania facility PSOs received the survey. A total of 200 facilities statewide completed the survey, including 118 hospitals (59%), 80 ambulatory surgical facilities (40%), one birthing center (0.5%) and one abortion facility (0.5%). For confidentiality reasons, the birthing centers and abortion facilities responses were combined with ASFs.
For the complete methodology behind the survey and results for all patient safety domains go to Page 11 of the 2008 Annual Report on the Authority’s website at www.patientsafetyauthority.org.
Pujols-McKee said the Authority has begun educating Boards of Trustees and other senior leadership on patient safety through a program in conjunction with the Hospital and Healthsystem Association of Pennsylvania (HAP) and the American Hospital Association (AHA). The program was designed for senior leadership and board members to engage them in patient safety issues. Four pilot sessions have been funded by the Authority with the expectation that the program will be delivered statewide once feedback from the pilot sessions is obtained.
“The boards of trustees education program is a top priority of the Authority’s mission to ensure all individuals from the top on down participate in making their facilities safer for patients,” Pujols-McKee said. Our first pilot session was successful and we anticipate the next three will garner the same positive response and action needed to make real changes to improve patient safety.”
Pujols-McKee said another educational component begun in 2008 by the Authority is the Patient Safety Liaison (PSL) program. Led by the Director of Educational Programs, the PSL program gives facilities a consultant with whom they can discuss patient safety issues and receive educational materials based upon Pennsylvania data. A PSL was hired in the northeastern part of the state August 2008 with two others on board for the northwest and south central regions by July 2009. The full complement of six PSLs is projected for FY 09-10.
“We know from our annual user survey that facilities find the information in our Patient Safety Advisories useful [98%], relevant [97%], readable [99%], high in scientific quality [97%] and high in educational value [99%],” Pujols-McKee said. “We also know that over sixty-two percent of PSOs surveyed have made or plan to make changes based upon the guidance. What our PSL program is here to do is help more facilities implement that guidance and find out what else the Authority can provide to help them make process changes in their facilities.”
Pujols-McKee added that so far facilities in the northeast have given feedback that has provided two new educational sessions for facilities on methicillin-resistant Staphylococcus aureus (MRSA) and basic patient safety principles behind Act 13 of 2002. These sessions will be available to facilities statewide once all PSLs are in their regions.
For more information on the Patient Safety Liaison program and other Authority educational activities go to Page 80 of the 2008 Annual Report.
Another important component of the Authority’s mission is to help facilities define what should or should not be reported. In the 2007 Annual Report, the Authority discussed at length variations in reporting by facilities. Potential explanations for the disparity include differences in Act 13 interpretations, facility case mix, varying levels of facility cultures of safety and potential over-reporting and under-reporting.
Pujols-McKee said the Authority’s board of directors has been working with the Department of Health to improve reporting standardization through a guiding principals document. The document has been published in the Pennsylvania Bulletin for public comment. The Authority’s board is taking the comments into account while modifying the guiding principals document. The Authority will forward the document to the Department of Health that will need to approve and implement the guidance as the regulating agency. The Authority, in turn, will provide education and training to healthcare facilities based upon the guidance.
For more information on the standardization reporting project go to Page 55 of the 2008 Annual Report.
Providing education and training for Act 52 of 2007 (healthcare-associated infection law) to Pennsylvania’s healthcare facilities and nursing homes is also a priority for the Authority, according to Pujols-McKee. Hospitals began reporting healthcare-associated infections through the Centers for Disease Control and Prevention’s National Health Surveillance Network (NHSN) in February 2008. By law, the Authority, Department of Health and Pennsylvania’s Healthcare Cost Containment Council (PHC4) receive the data to fulfill each agency’s mission.
By law, Pennsylvania nursing homes must also report healthcare-associated infections to the Authority for analysis.
“The Authority has been working with its HAI Advisory Panel made up of infection experts from across the state to develop the reporting requirements for nursing homes,” Pujols-McKee said. “We recently began a pilot reporting program for nursing homes and we expect all nursing homes to be reporting healthcare-associated infections in June.”
The Authority also unveiled a new website recently with a tagline representing its mission “Analyzing, Educating and Collaborating for Patient Safety.”
“Throughout last year, the Authority has made significant progress on the priorities outlined in its strategic plan,” Pujols-McKee said. “Through the measurement survey and the PSL program we should be able to gauge how much progress facilities are making in implementing real change in their institutions. Feedback gathered during these facility visits will also help the Authority tailor its educational activities to best support the ongoing patient safety efforts made by facilities.”
An Executive Summary of the 2008 Annual Report is attached to this press release. The complete Annual Report for 2008, as well as additional information about the Patient Safety Authority is accessible on the Authority’s website, www.patientsafetyauthority.org.
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Executive Summary
The Pennsylvania Patient Safety Authority is an independent state agency established under Act 13 of 2002, the Medical Care and Reduction of Error “MCare” Act. It is charged with taking steps to reduce and eliminate medical errors by indentifying problems and recommending solutions that promote patient safety in hospitals, ambulatory surgical facilities, birthing centers and certain abortion providers. In June 2009, the Authority will begin collecting infection reports from nursing homes. The Authority’s role is non-regulatory and non-punitive.
The Authority initiated statewide mandatory reporting in June 2004, making Pennsylvania the only state in the nation to require the reporting of Serious Events and Incidents (near misses). All reports are confidential and non-discoverable, and they do not include any patient or provider names.
The 2008 Annual Report focuses on five healthcare domains that the Authority data shows need process changes for improved patient safety and ultimately a reduction in medical errors. The five domains include: leadership and patient safety, medication safety, safe surgery, infection prevention and device safety. Much of this report is based on information derived from a survey given to Pennsylvania healthcare facilities reporting under Act 13 of 2002 and Act 30 of 2006. While measuring patient safety is difficult for any organization, the Authority attempts to establish a baseline through the survey process for future annual reports, ongoing analysis and education initiatives.
Aggregate data from 2008 facility data reports will also be given for report volume, patient demographics, patterns in reports and information on new educational initiatives, such as the Patient Safety Liaison Program, developed to improve communication with facilities, provide the Authority with feedback and develop targeted educational programs. For copies of the 2008 Annual Report go to www.patientsafetyauthority.org.
Measuring Improvement
The Authority’s most challenging question since it began educating healthcare facilities through Pennsylvania Patient Safety Advisories is whether healthcare in Pennsylvania is becoming safer. This question is not unique to Pennsylvania. It is a national concern not only for the United States but in other countries as well. Experts in patient safety are forced to admit that while we have made progress since the 1999 publication of the Institute of Medicine’s To Err Is Human, we are just at the beginning of a journey and we have a long way to go.
A number of strategies are being employed statewide to promote safety. For example, Pennsylvania’s Medical Care Availability and Reduction of Error Act of 2002 (MCare) made significant structural changes in the healthcare system, including the establishment of the Pennsylvania Patient Safety Authority, implementation of reporting requirements and the requirement for disclosing Serious Events to patients. Both public and private payers are beginning to decline reimbursement for potentially preventable adverse events. Healthcare quality information is increasingly available to the general public in an effort to promote patient selection of higher quality healthcare facilities and providers. The current national economic crisis and the continuing escalation of healthcare costs have renewed policymakers’ calls for a payment system that rewards efficiency. We have also witnessed the significant efforts of healthcare providers throughout Pennsylvania striving to solve the safety problems they identify in their own facilities.
For example, the Authority conducted a survey this year in which a total of 200 Pennsylvania healthcare facilities participated, including 118 hospitals (59%), 80 ambulatory surgical facilities (40%), one birthing center (0.5%), and one abortion facility (0.5%). For confidentiality purposes, the birthing center and abortion facility responses were included among ASFs.
One of the survey domains was safety leadership. Conducting formal patient safety walkarounds with members of the Board of Trustees provides senior leaders the opportunity to listen to the patient safety issues identified by staff. Regular walkarounds provide a forum to learn about issues related to team practice, communication, and a transparent culture in order to create improvements. The Authority asked participating healthcare facilities how often they performed patient safety walkarounds with a member of the Board of Trustees during the past year. Among hospitals, about one-third (32%) had done this at least once during the year, but the majority (68%) have not instituted this practice. This is one of the processes we will continue to monitor to ensure facilities are getting the support needed from leadership improvement.
Another question related to patient safety leadership is how often Patient Safety Officers (PSOs) participate in Board of Trustees meetings. Senior leaders can demonstrate their leadership on safety by inviting PSOs to address their Board of Trustees and to make safety a standing item on the board agenda. Doing so demonstrates that management and Trustees view safety as an important component of the Trustee’s oversight responsibility. Among participating hospitals, nearly half (47%) responded that they attended four or more Board of Trustees meetings, while in one-third (31%), the PSO did not attend any. Responses were similar among ASFs and other facilities, with 44% reporting PSO participation in four or more board meetings and 24% reporting none. Overall, 46% of participants reported that their PSO attended four or more board meetings over the past year, suggesting that this practice has gained acceptance in many facilities.
Finally when participating facilities were asked whether they have adopted a “just culture” in their institutions, the majority of hospitals (70%) reported some level of implementation. A “just culture” is one that does not punish individuals for honest mistakes or for reporting safety concerns and injuries. It also does not go to the opposite extreme by permitting repeated, intentional rule violations. Rather, a just culture seeks a middle ground that tries to find system or engineering solutions to reduce inevitable human errors, while holding individuals accountable for intentionally violating safety policies or procedures. In the Authority survey, each facility was asked if they had written instructions for staff about error reporting which include “Just Culture” principles. These principles incorporate open communication with all staff and include accountability to promote a safe environment to learn from mistakes. As mentioned, a majority of hospitals report some level of implementation of “Just Culture” principles, with 59% reporting full implementation hospital-wide. One-third of hospitals (30%) report that they have not yet implemented these principles. Similar results were found for ASFs and other facilities, with 72% reporting some level of implementation, while 28% have not adopted this approach. For the complete results of the survey, please go to Page 11.
But how do we know whether these efforts are actually making the healthcare system safer?
The ultimate measures of safety are the number of lives saved or the number of injuries prevented, but these concepts are notoriously difficult to measure in practice. Medicine is imprecise, and we don’t always know whether bad outcomes are the results of errors, or whether they would have turned out better if we had done something differently.
There are many sources of data on patient safety, all of which suffer from significant biases and flaws. The most reliable way to collect data on the number of adverse events that occur is to have independent providers observing every healthcare encounter, but obviously this is impractical. The “gold standard” used in many safety studies is retrospective chart review, in which trained clinicians review individual medical charts looking for specific complications or errors, but even this is resource-intensive and therefore too expensive to do on a routine basis. Administrative data—information on the diagnoses made and procedures performed on patients—is available from hospitals, but these data are subject to unreliable coding practices that are used primarily for billing rather than monitoring adverse events.
In this annual report, in addition to summarizing the results of the facility surveys, we also discuss the related problems identified through PA-PSRS data, and the results of the Authority’s analysis of adverse event reports and potential solutions published in the Pennsylvania Patient Safety Advisory.
For participating facilities, following publication of this annual report, the Patient Safety Authority will provide a detailed report comparing their level of adoption of these practices with that of similar facilities. We have encouraged Patient Safety Officers and CEOs to share these reports with their Patient Safety Committees, their senior leadership and their Board of Trustees. We anticipate that these reports will highlight for each institution their own successes as well as areas for further improvement.
Any set of safety practices would be, by definition, incomplete. However, as one window into the processes in place in Pennsylvania healthcare facilities, we believe they provide a useful view of the current state of safety in the healthcare system.
Standardization of Reporting Update
In its 2007 Annual Report, the Authority discussed at length variations in reporting by facilities. The Authority outlined many potential explanations for the disparity such as that Act 13 of 2002 includes several ambiguous terms that define what should be reported (e.g. ‘unanticipated’) and some facilities may have more evolved cultures of safety that encourage higher levels of Incident reporting. In a focus group of Patient Safety Officers in 2007, the PSOs also requested more guidance on what events should be reported.
In its 2007 Annual Report, the Authority outlined its plan to attempt to close the gap on the reporting variations. One of the main objectives of the plan was to work with the Department of Health to explore both organizations’ interpretations of Act 13 of 2002 requirements, with the goal of providing interpretive guidance that can be used by facility PSOs, Patient Safety Committees and Department of Health surveyors.
In the past year, the Authority has worked with the Department of Health to develop some standardization of reporting through a guiding principles document.
The Patient Safety Authority Board of Directors discussed the guiding principles at its September 2008 meeting. The board did not reach consensus on several issues and asked that the document be revised and discussed in future board meetings. In January 2009, a revised document was presented to the board and the Deputy Director of Quality Assurance from the Department of Health also gave a presentation on the standardization document.
During this time, the Authority also sent letters to 50 facilities that fell into the lowest tranches of reporting. This prompted one facility to contact the Authority for assistance with patient safety education. Another facility contacted the Authority to inquire about help in increasing Incident reports. In a recent analysis of the reporting patterns among those facilities that received the letter, we compared their reporting during the last quarter of 2008 and the first quarter of 2009. We found that the number of reports overall from this group increased by 58%. Reporting of Serious Events rose 9%, while reporting of Incidents rose 53%.
The Authority also published an editorial in the 2008 December Pennsylvania Patient Safety Advisory extolling the benefits of reporting Incidents.
In February 2009, the public comment period began on the draft standardization principles developed by the Authority and the Department of Health. A copy of the document containing draft guidance was published in the Pennsylvania Bulletin Saturday, February 28. The Authority also sent emails to PSOs with a link to the document in the Pennsylvania Bulletin. The public comments are being tabulated as of the writing of this report.
Concurrently with issuing a draft guidance document for public comment, we incorporated in our annual survey of PSOs the example scenarios used in the draft guidance document to help us understand the level of consensus that might exist around the draft interpretations.
We asked PSOs from hospitals to consider each example scenario and designate them as whether they believed their facility would classify the event as a Serious Event (harm), as an Incident (no harm) or not reportable at all. Participants could also respond that they needed more information to make a determination. Definitions of a Serious Event and Incident were not provided. The respondents had to rely on the experience of their positions in order to formulate their opinions.
Overall, the results of these questions demonstrate continued extensive variability in PSOs’ interpretations of MCare’s reporting requirements. A chart summarizing responses is presented in Figure 38 on page 57.
The Authority discussed in the 2007 Annual Report the wide variation in facilities’ rates of reporting, and the survey results support the position that this variation is the result of differences in interpretations of the reporting requirements.
The Authority believes this level of variation is unacceptable and will continue to work towards improvement. However, the Authority is not the regulating agency that monitors patient safety reporting. Only the Department of Health has the authority to ensure facilities are reporting properly. The Authority will continue to work with the department to establish a more appropriate reporting framework.
The Authority anticipates some form of final approval guidance to be drafted by the Board of Directors and forwarded to the Department of Health who would have to approve and implement guidance. Once approved by the Department of Health, the department as the regulator of Act 13 of 2002 will be responsible for ensuring the facilities are reporting according to the guidance.
The Authority will provide education and training to healthcare facilities reporting through the Pennsylvania Patient Safety Reporting System and Department of Health licensure surveyors based upon the standardization document.
Education Mission – Moving Forward
The Authority has been fulfilling its mission of educating its stakeholders not only through its Pennsylvania Patient Safety Advisory but also through its outreach and collaboration efforts. The Patient Safety Liaison (PSL) pilot program, begun in 2008, has allowed the Authority and individual facilities one-on-one visits to help tailor patient safety improvement programs. Along with the PSL program, the Authority began educating Boards of Trustees and top level management through another pilot program developed in partnership with the Hospital and Healthsystem Association of Pennsylvania (HAP) and the American Hospital Association (AHA). The Authority has also reached out to several state associations to provide continuing education credits for physicians, nurses and pharmacists.
The Patient Safety Liaison Program
Fulfilling a critical component of its mission and the 2007 strategic plan, the Authority hired a Director of Educational Programs to oversee its educational initiatives including the Patient Safety Liaison (PSL) program.
At the request of Patient Safety Officers for “more of a presence” from the Authority, the Patient Safety Liaison program was developed. The PSL acts as a consultant to Pennsylvania’s healthcare facilities to ensure they are aware of the numerous educational resources available to them from the Authority. While acting as a liaison between the Authority and healthcare facilities, the PSL also serves as a liaison between healthcare facilities within the region.
The first Patient Safety Liaison was hired in August 2008 in the northeast region of Pennsylvania. The northeast region has 71 medical facilities, hospitals, birthing centers, ambulatory surgical facilities (ASF) and certain abortion facilities. There are currently 66 PSOs overseeing these 71 medical facilities. The reception of the medical facilities to the PSL has been welcoming and forthcoming. The attendance at the first meetings is varied from leadership (CEOs), middle management, owners of facilities and PSOs. Topics discussed are varied but consistent themes related to patient safety. These themes include identified opportunities for improvement, strategies being employed, successes, barriers and sharing of information. The PSL also takes this opportunity to share with the audience resources currently available to the PSO through the Authority and other organizations. These resources include items such as toolkits, Pennsylvania Patient Safety Advisory articles, patient safety information from other entities, consumer tips and availability of continuing education credits in patient safety. The PSL also solicits feedback from Patient Safety Officers to understand what they need from the Authority to improve patient safety in their specific facility.
New education programs and sessions were developed by the Authority at the request of the northeast facilities. These programs and sessions will be instituted statewide once the other regional Patient Safety Liaisons are on board.
The Authority developed a basic patient safety program, called the “Patient Safety Officer Foundation Curriculum” to discuss the specifics behind patient safety and Act 13 of 2002. Personnel attending the program included CEOs, management staff and PSOs from hospitals and ambulatory surgical facilities. Feedback was very positive and there were numerous requests for additional educational sessions regarding patient safety leadership and insights, such as human factors, highly reliable organizations (HRO), crew management and proactive risk reduction strategies (FMEA). The Authority is developing a second program called “Beyond the Basics” to coincide with the basic program.
Through the northeast PSL’s interactions with PSOs of various care settings, educational needs regarding specific health care topics have been identified. For example, in April 2009 a half-day session on methicillin-resistant Staphylococcus aureus (MRSA) was given to ambulatory surgical facility employees in the northeast region. The session was well received. More HAI sessions are planned throughout the state once the other PSLs are on board.
The PSL and Director of Educational Programs also speak to numerous professional healthcare organizations about the PSL program to ensure it is utilized by the healthcare facilities. In February 2009, a presentation about the PSL program was given to the Council for Small Hospitals at the Hospital and Healthsystem Association of Pennsylvania (HAP). The program was embraced as a resource to help educate staff at no additional costs to their facility.
Currently it is projected that three (3) additional PSLs will be hired for the northwest, southwest and south central regions of Pennsylvania for FY 08-09. The Authority is in the first steps of the selection process and expects to have the three new hires in place in late spring (May-June 2009). The full complement of six (6) PSLs is projected for FY 09-10.
Patient Safety Training for Trustees
This year the Authority put its strategic plan initiative to educate executive management and Boards of Trustees into action. The initiative is designed to raise awareness and increase responsibility for patient safety by bringing it to the board level.
The Patient Safety Authority partnered with the Hospital and Healthsystem Association of Pennsylvania (HAP) and the American Hospital Association (AHA) to begin a pilot program. An advisory panel composed of executive leaders and trustees from hospitals and health systems assisted the Patient Safety Authority and HAP to develop a customized educational program that would help foster the kind of senior level and board engagement needed for improved patient safety. A business model was developed and the Authority provided the funding needed to host four training sessions in which a total of about 300 persons would participate.
Dr. John Combes of the American Hospital Association’s Center for Health Care Governance developed the four pilot trustee training sessions that include:
One session for a group of 3 or 4 small/rural hospitals
- One session for a group of 3 or 4 community hospitals
- One session for a stand-alone community hospital
- One session for a multi-hospital system
The first conference was held for the Board of Trustees at Susquehanna Health in Williamsport in the fall of 2008 with positive feedback.
The President and CEO of Susquehanna Health attended the conference and made several patient safety improvements to its organization as a result of the program.
“This conference provided the material and motivation necessary to complete a thorough review of our trustees’ role in quality and safety. I fully endorse the program for all hospital and health system trustees charged with or interested in quality and safety of the services their organizations provide…Susquehanna Health anticipates using a modified version of this curriculum for future programmatic evaluation and strategic planning. We are grateful that this program helped stimulate our thinking and provided us with the motivation to make these changes.”
Steven P. Johnson, FACHE
President and CEO
Susquehanna Health
Additional sessions will be scheduled by HAP limiting the size and presentation length to allow more interaction with participants. More updates of the program’s success will follow. At the conclusion of the pilot sessions, the Authority hopes to support this training for all hospitals in Pennsylvania.
Pennsylvania Healthcare Organizations to Offer Continuing Education Credits through Patient Safety Advisories
The Patient Safety Authority has collaborated with healthcare associations throughout the state to provide continuing education credits for their memberships.
The Authority and the Pennsylvania Medical Society have been working together for several years providing doctors across Pennsylvania with continuing medical education credits. This year the medical society has asked the Authority to work with them to tailor the Pennsylvania Patient Safety Advisory articles so physicians can more readily choose articles that pertain to their discipline.
The Authority also met with the Pennsylvania State Nurses Association (PSNA) to provide continuing education hours for Pennsylvania nurses through its Web site. Licensed nurses in Pennsylvania will be required to have 30 continuing education hours for renewal in 2010. The Authority will provide current and retrospective articles to the PSNA and they will be posted on the PSNA Web site. The hours can be obtained by members and non-members of the PSNA. The Authority expects members to be able to obtain the continuing education hours through its June 2009 Pennsylvania Patient Safety Advisory.
The Pennsylvania Pharmacists Association (PPA) is also interested in partnering with the Authority to provide continuing education credits for Pennsylvania pharmacists. Their current partner will no longer provide material for continuing education giving the Authority the opportunity to fill a gap for Pennsylvania pharmacists to obtain their patient safety credits that will be required for license renewal. Currently, the PPA has a year of continuing education material for their bi-monthly journal but they welcome the Authority’s partnership to provide more options for their members to obtain patient safety credits.
Healthcare-Associated Infections (HAI) - What's Next
In July 2007, legislation was signed into law as Act 52 to prevent and reduce healthcare-associated infections in hospitals and nursing homes. The Pennsylvania Patient Safety Authority has been working with the various healthcare agencies (Pennsylvania Department of Health, Pennsylvania Healthcare Cost Containment Council and the Centers for Disease Control and Prevention) since then to implement the new law and move toward eradicating all HAI in Pennsylvania. Act 52 of 2007 requires the Authority to perform a significant amount of activities to support healthcare-associated infection elimination efforts. Many of these activities are related to preparing for HAI reporting by nursing homes.
In July 2007, Act 52 was signed into law.
Key provisions of the bill include the following.
Hospitals must:
Develop infection control plans outlining the steps they will take to prevent and reduce infections.
- Educate healthcare workers as to how they can prevent infections.
- Screen high-risk populations for methicillin-resistant Staphylococcus aureus (MRSA), a type of infection that cannot be cured with many available antibiotics.
- Report infections to the Patient Safety Authority, Department of Health (DOH), and the Pennsylvania Healthcare Cost Containment Council (PHC4), through the CDC’s National Health Safety Network (NHSN).
Nursing Homes must:
- Develop infection control plans
- Submit reports of HAI events to the Authority and the Department of Health
Act 52 of 2007 also requires the Department of Health to set risk-adjusted benchmarks for the purpose of data comparison, which will be introduced in 2009.
While the Authority, PHC4 and DOH all have access to NHSN data, DOH, as the regulating agency, is working with hospitals on data integrity and fixing identifiable reporting errors. To this end, DOH sent a series of reports to the hospitals identifying HAI reports submitted from July 1, 2008 through December 31, 2008 that needed modification. This activity was completed in April 2009. At this point, DOH locked down the data. It is this data that is presented in the Authority’s annual report. As the Authority has just received this information, we are now beginning to perform more detailed analyses that will lead to additional educational opportunities. We will publish the results of some of these analyses in future issues of the Pennsylvania Patient Safety Advisory.
Hospitals entered a total of 18,307 HAI events into the NHSN database between July 1 and December 31, 2008. The DOH infections and report totals are included in Table 3 on page 35 of this annual report. This information and data in this report is not comparable to the Authority’s 2007 annual report nor is it comparable to other Pennsylvania HAI data sources. For example, PHC4’s annual HAI reports differ because facility and infection types vary between PHC4 data collection and what is currently being reported by hospitals through NHSN as a result of Act 52 of 2007.
The following hospital types are included in NHSN reporting: all acute care hospitals, children’s hospitals, long-term care hospitals, psychiatric hospitals and rehabilitation hospitals. The PHC4 data is limited to acute care hospitals.
In addition, current reporting through NHSN includes more types of HAI reporting that was collected previously by PHC4.
PHC4 HAI reports do not include the following HAI events:
– systemic infections
– eye, ear, nose, throat, or mouth infections, including upper respiratory infections
– surgical site infections identified during readmissions
The DOH in consultation with the Authority and PHC4 developed calculation/benchmarking areas which include catheter-associated urinary tract infections (CAUTIs), central line-associated blood stream infections (CLABSIs), and select surgical site infections (abdominal hysterectomy, cardiac surgery, and hip and knee replacements).
The Authority looks forward to future DOH data reports to include CAUTIs and CLABSIs rates, select cardiac surgeries and device-associated infections.
The Authority’s efforts have been focused on establishing the HAI reporting infrastructure for hospitals and nursing homes. We have also published HAI-related articles in the Pennsylvania Patient Safety Advisory and are giving presentations on reducing healthcare-associated infections. Infection prevention is also one of the domains of care included in our patient safety measurement project which is a primary focus of this annual report. A complete timeline of the tasks the Authority has undertaken to date for Act 52 of 2007 include:
September 2007 – The Authority establishes the Healthcare-Associated Infection Advisory (HAI) panel made up of infection control experts from throughout the state.
December 2007 – Draft HAI reporting requirements for hospitals were published in the Pennsylvania Bulletin. The Authority collected and distributed the public comments from facilities regarding the draft document. The HAI Advisory Panel reviewed comments and developed a final reporting document for hospitals based upon their expertise and the public comments.
February 2008 – Hospitals began mandatory reporting of HAIs using the Centers for Disease Control and Prevention’s National Health Surveillance Network (NHSN).
March 2008 – Final reporting requirements for hospitals were published. The Authority embarked upon an extensive education and outreach program to ensure that Pennsylvania healthcare facilities understood the reporting requirements. Several presentations were given by Authority staff throughout 2008 to hospitals and nursing homes regarding Act 52.
March-April 2008 – The Authority and the HAI Advisory Panel worked with the Department of Health to develop the list of reportable infection events and reporting criteria for nursing homes. These infections will be tracked by the Authority and the Department of Health through the Pennsylvania Patient Safety Reporting System (PA-PSRS).
May 2008 – The draft reporting requirements for nursing homes were published in the Pennsylvania Bulletin and open for comment. The Authority received over 60 comments from nursing home organizations from across the state.
September 2008 – The final reporting requirements and criteria for nursing home HAI reporting was published in the Pennsylvania Bulletin.
December 2008 – The Authority conducted a Web conference attended by over 600 long-term care facilities to define and outline the criteria for infections that will be tracked in nursing homes.
January – March 2009 – The Authority completed 30 training sessions for 1250 nursing home employees throughout the state to prepare them for mandatory reporting. An HAI training curriculum, including an extensive Users Guide and Training Manual, was delivered in the training sessions.
April 2009 – A pilot reporting session will be held for two weeks with volunteer nursing home facilities to test the new system and ensure any problems are addressed prior to mandatory reporting in June.
May 2009 – A Webinar training session will be held for those facilities that could not make the live training sessions.
September 2008 – May 2009 – The nursing home HAI reporting system was developed as a subset of the Pennsylvania Patient Safety Reporting System (PA-PSRS). This process was lengthy because the PA-PSRS system had to be rebuilt specifically for nursing home reporting. The addition of nursing homes expands the number of facilities reporting through PA-PSRS to two and a half times the current amount of facilities reporting to the Authority.
June 2009 – Mandatory reporting of nursing homes begins.
Since Act 52 of 2007 was signed into law, the Authority has been educating the hospitals and nursing homes through Pennsylvania Patient Safety Advisories. The Advisories are based upon data collected in PA-PSRS. Once the nursing homes begin reporting in June the Authority expects to have more information specifically geared toward nursing home infections to pass on to the facilities as guidance.
Highlights of Data Submitted to the Pennsylvania Patient Safety Authority
Other highlights regarding the data submitted to the Pennsylvania Patient Safety Authority during calendar year 2008 are listed below. For more detailed information and graphics, please see the “Data Collection and Analysis” section of the full report beginning on page 51.
525 hospitals, birthing centers, ambulatory surgical facilities, abortion facilities and birthing centers were subject to Act 13 of 2002 and Act 30 of 2006 reporting requirements. They submitted 219,874 reports of Serious Events and Incidents to the Authority, an increase of 7,891 reports from 2007.
Approximately 96% of all reports were Incidents, or did not cause harm to the patient; approximately 4% of all reports were Serious Events, which indicates that the patient received some level of harm, ranging from minor, temporary harm to death.
The number of Incident reports averaged 17,602 per month, an increase of 3% from 2007. Serious Event reports averaged 720 per month, representing a 19% increase from 2007. A significant portion of this increase can be traced to healthcare-associated infections reported by law as a Serious Event earlier in the year as a result of Act 52 of 2007.
Reports from hospitals accounted for 98.6% of all reports submitted. However, reports submitted by ambulatory surgical facilities increased from 10.7 reports per facility in 2007 to 11.8 reports per facility in 2008.
When evaluated regionally, the largest numbers of reports come from the southeastern and southwestern counties, which is consistent with the population within Pennsylvania. When report volume is adjusted for patient days, facilities in the north central counties appear to be more aggressively reporting events. Serious Events submitted in the north central region were 7.6%, significantly larger than the statewide average of Serious Events (3.5%). These higher numbers could be due to several factors including: a higher number of actual patient safety events; differences in the ability to indentify patient safety events (especially Incidents); and differences in the way facilities report patient safety events based on Mcare law interpretation.
Statewide, the most frequently reported events in hospitals involved Errors related to Procedures/Treatments/Tests (23%) and Medication Errors (22%). However, Errors related to Procedures/Treatments/Test comprise only 8% of reports involving harm or death and Medication errors comprise only 4% of events involving harm and 1% of events contributing to or resulting in death.
Conversely, while Complications related to Procedures/Treatments/Tests comprise only 13% of reports overall in 2008, they comprise 43% of the reports of events involving harm and 59% of all reports of events resulting in or contributing to the patient’s death.
Patients over age 65 were especially vulnerable to Serious Events and Incidents, representing more than half (52%) of all reports submitted to the Authority. In 2008, approximately 60% of all Falls and 73% of all reports related to Skin Integrity involved older patients. Falls reports for older patients are down by 4% since mandatory reporting began in 2004. Skin integrity reports remain the same. Skin integrity reports include pressure sores, bruises and other skin-related conditions.
In a recent survey, 218 Patient Safety Officers (PSOs) reported making 607 changes in their facilities in 2008 as a result of specific Pennsylvania Patient Safety Advisory articles. PSOs from hospitals (115) cited 484 changes, while PSOs from ASFs (103) cited 123. Please see page 89 for more information about this survey.