Annual Report

April 30, 2015

2014 Patient Safety Authority Annual Report

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Masthead

Board of Directors

Rachel Levine, MD, Acting Chair
Stanton N. Smullens, MD, Vice Chair
Radheshyam Agrawal, MD
Jan Boswinkel, MD
John Bulger, DO, MBA
Joan M. Garzarelli, RN, MSN
Daniel Glunk, MD
Lorina L. Marshall-Blake
Gary Merica, BSc, MBA/HCM
Clifford Rieders, Esq.
Eric Weitz, Esq.

Staff
Michael Doering, MBA, Executive Director
Regina Hoffman, RN, Director of Patient Safety Liaisons
Laurene M. Baker, MA, Director of Communications
Christina Hunt, RN, MSN, MBA, Director of Collaborations
Howard Newstadt, JD, MBA, Finance Director & CIO
Joanne Adkins, RN, BSN, CIC, Infection Prevention Analyst
Teresa Plesce, Office Manager
Karen McKinnon-Lipsett, Administrative Specialist
Shelly Mixell, Executive Assistant
Denise Conder, Administrative Specialist
Megan Shetterly, RN, MS, Senior Patient Safety Liaison, Northeast Region
Michelle Bell, RN, Patient Safety Liaison, Delaware Valley North Region
Jeff Bomboy, RN, Patient Safety Liaison, Northeast Region
Richard Kundravi, Patient Safety Liaison, Northwest Region
Robert Yonash, RN, Patient Safety Liaison, Southwest Region
Patient Safety Liaison, [Vacant], Delaware Valley South Region
Patient Safety Liaison, [Vacant], South Central Region
Theresa V. Arnold, DPM, Mgr., Clinical Analysis
Michael Baccam, MFA, Associate Editor (Advisory)
Sharon Bradley, RN, CIC, Sr. Infect. Prev. Analyst
Phyllis Bray, Database Administrator
John R. Clarke, MD, Clinical Director Emeritus
James Davis, MSN, RN, CIC, Sr. Infect. Prev. Analyst
Ellen Deutsch, MD, Clinical Director, Editor (Advisory)
Michelle Feil, MSN, RN, Sr. Patient Safety Analyst
Edward Finley, Data Analyst
Lea Anne Gardner, PhD, RN, Sr. Patient Safety Analyst
Michael J. Gaunt, PharmD, Sr. Medication Safety Analyst
Matthew Grissinger, RPh, Mgr., Medication Safety Analysis
Tom Ignudo, IT Manager
Shawn Kincaid, System Developer
Ben Kramer, System Administrator
Susan Lafferty, Administrative Assistant
Donna Lockette, Business Analyst
Mary C. Magee, MSN, RN, Sr. Patient Safety Analyst
William M. Marella, MBA, Program Director
Christina Michalek, BSc Pharm, RPh, Sr. Medication Safety Analyst
Miranda R. Minetti, Program Coord./Comm. Asst.
Jesse Munn, MBA, Operations Mgr., Managing Editor (Advisory)
Carly Sterner, System Developer
Susan C. Wallace, MPH, Patient Safety Analyst

Letter from the Board Chair

Dear Fellow Pennsylvanians:

Marking its 10th year of reporting in 2014, the Patient Safety Authority (Authority) continues to work to improve patient safety in Pennsylvania’s healthcare facilities through data analysis and collaboration. By December 2014, the number of reports submitted through the Pennsylvania Patient Safety Reporting System (PA-PSRS) reached over 2.2 million. High-harm events decreased 45% since 2005. Serious Events in 2014 decreased by 6.2% per month compared with 2013. Incidents also decreased by 2.4% per month compared with 2013. Time will tell whether these decreases in Serious Events and Incidents are a trend or an anomaly for 2014.

Through its Patient Safety Liaison (PSL) Program, the Authority conducted 189 educational sessions for almost 10,000 individuals. Audiences for these sessions included hospital leadership, patient safety committees, nurses, physicians, patient safety officers, respiratory therapists, radiology staff, and many others. Topics for the sessions included falls, human factors, culture of safety in the operating room, teamwork and communication, TeamSTEPPS, root-cause analysis, MCARE reporting requirements, the value of near-miss reporting, preventing wrong-site surgeries, and others.

Collaborations with healthcare facilities, the Hospital and Healthsystem Association of Pennsylvania (HAP), and other Pennsylvania healthcare organizations continued through the federal Partnership for Patients program. The Authority’s collaborations in Pennsylvania focus on reducing falls, wrong-site surgeries, and adverse drug events statewide. All collaborations have resulted in decreased harmful patient safety events. Although the federal program has ended, the Authority will continue to collaborate with healthcare facilities on these areas as well as others.

The Authority marked its 10th anniversary in March 2014 of publishing the Pennsylvania Patient Safety Advisory (Advisory). The award-winning academic journal is the Authority’s flagship publication based on analysis of adverse events and near misses occurring in Pennsylvania’s healthcare facilities. The Authority has published more than 475 safety-focused articles, with over 4,100 changes in Pennsylvania acute care facilities and nursing homes directly attributed to the Advisory articles since 2005.

Last year, the Authority continued to educate Pennsylvania healthcare workers in hospitals, nursing homes, ambulatory surgical facilities, and professional organizations across the commonwealth in infection prevention. A long-term care best practice assessment tool was introduced, as well as new analytical tools for nursing homes in 2014.

As the new chair of the Patient Safety Authority’s Board of Directors, I look forward to working with Pennsylvania healthcare facilities and nursing homes to further improve patient safety through the new educational initiatives and programs detailed in this report.

On behalf of the board, I am pleased to submit this annual report for your review.

Rachel Levine, MD
Acting Chair, Board of Directors
Patient Safety Authority

Introduction

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 through the collection of data, identification of problems, and recommendation of solutions that promote patient safety in hospitals, ambulatory surgical facilities (ASFs), birthing centers, and abortion facilities.

The Authority initiated statewide mandatory reporting in June 2004, making Pennsylvania the only state in the nation to require reporting of Serious Events and Incidents (near misses). All reports are confidentialand nondiscoverable, and they should not include any patient or provider names. In 2007, the legislature added a chapter to the MCARE Act that addressed the reporting of healthcare-associated infections (HAIs) in Pennsylvania and required infection reporting from nursing homes.

This report provides a high-level overview of the Authority’s 2014 activities. More detail is provided in several addendums referenced in this report.

In June 2014, the Authority marked 10 years of reporting through the Pennsylvania Patient Safety Reporting System (PA-PSRS). The Authority uses the patient safety event reports in many ways to reduce and avoid patient harm to Pennsylvanians being treated at reporting facilities. See “Breadth of Authority Activities” for an illustrative look at the Authority’s activities over the last 10 years.

Data Collection and Analysis Overview

PA-PSRS is a secure, web-based system that permits medical facilities to submit reports of what the Pennsylvania MCARE Act defines as “Serious Events” and “Incidents” (see Addendum A for definitions). Statewide mandatory reporting through PA-PSRS went into effect June 28, 2004. All information submitted through PA-PSRS is confidential, and no information about individual facilities is made public.

As defined by the MCARE Act, PA-PSRS is a facility-based reporting system. It is important for Pennsylvania patients and their families to recognize there are other complaint and error reporting systems that are available for individuals. The Department of Health can issue sanctions and penalties, including fines and forfeiture of license, to healthcare facilities that fail to comply. Citizens can file complaints related to hospitals and ASFs by calling the Department of Health at (800)254-5164; for complaints related to birthing centers, they can call the Department of Health at (717) 783-1379. Complaints against licensed medical professionals can be filed with the Department of State’s Bureau of Professional and Occupational Affairs at (800) 822-2113.

All reports to PA-PSRS are submitted by facilities through a process identified in their patient safety plans, as required by the MCARE Act. However, the MCARE Act provides one exception to this facility-based reporting requirement. Under this exception, a healthcare worker who feels that his or her facility has not complied with the MCARE Act reporting requirements may submit an anonymous report directly to the Authority. Anonymous reports are specifically addressed later in this report.

To access PA-PSRS, facilities need only a computer with Internet access and to register with the Authority. There is no need for a facility to procure costly equipment or software to meet statutory reporting requirements, and only minimal self-directed training is necessary to learn how to navigate PA-PSRS. In addition, the Authority developed a subsystem in PA-PSRS that allows facilities to interface their own data collection systems with PA-PSRS for the submission of non-harm events. In 2014, over 60% of all reports submitted to the Authority came through this interface process. The use of the interface significantly reduces the resources needed by facilities to enter this important information.

Reporting facilities submitted over a quarter of a million reports through PA-PSRS in 2014. Approximately 3% of non-infection reports involved some level of patient harm. As with all reporting systems, the information collected is dependent on the degree to which facility reporting is accurate and complete. The reporting cultures and patterns in each facility, and their interpretations of the MCARE Act, do lead to reporting variation. The Authority is primarily a data collection, analysis, and education agency. The Authority does not audit the information provided by the facilities. The Pennsylvania Department of Health has primary regulatory authority for the MCARE Act. As such, the Department of Health receives all reports with patient harm, has the authority to audit facility reporting, and can fine facilities for failure to report.

The Authority has been working closely with the Department of Health and facility stakeholders to reduce this reporting variation for patient harm events. This standardization initiative resulted in a set of reporting principles. These principles will be effective in April 2015.

This section highlights select data analyses and graphics. Additional information can be found in Addendum B.

Reports by Month and Submission Type

Between January 1 and December 31, 2014, Pennsylvania acute care facilities (all reporting facilities with the exception of nursing homes) submitted 240,778 reports through PA-PSRS, bringing the number of reports submitted by these facilities since the program’s inception to 2,271,374. Table 1 shows the distribution of submitted reports by month for calendar year 2014.

Reports by Facility Type

As shown in Table 2, the total number of reports submitted through PA-PSRS in 2014 surpassed a quarter million. The vast majority of reports (87.1%) were submitted by hospitals; nursing homes, which submit only HAI reports, account for an additional 10.7% of the overall total.

Table 1. Reports Submitted through PA-PSRS in 2014 by Month, Acute-Level Facilities

Table 2. Reports Submitted through PA-PSRS in 2014 by Facility Type

High-Harm Events Decrease, Along with Patient Deaths

Approximately 2.9% of submitted reports were Serious Events, while 97.1% were Incidents. In 2014, the Authority received 20,065 reports per month on average, an average decrease of 486 (2.4%) per month from 2013, the first annualized decrease in reporting through PA-PSRS. In 2014, the Authority received 208 reports of events from acute-level facilities that may have contributed to or resulted in the patient’s death, a decrease of 13 reports (5.9%) from 2013. Additionally, reports with harm scores of G, H, and I are considered high-harm events. For example, an event that occurred and resulted in permanent harm to the patient is given a harm score of G, and an event that occurred and resulted in a near-death event is given a harm score of H. An event resulting in a patient death is given a harm score of I. Figure 1 below shows these high-harm events have been steadily decreasing annually since 2005, both in number and as a percentage of Serious Events. More about Pennsylvania healthcare facility data can be found in Addendum B.

The Pennsylvania Patient Safety Advisory Turns 10

The Advisory provides timely original scientific evidence and reviews of scientific evidence that can be used by healthcare systems and providers to improve healthcare delivery systems and educate providers about safe healthcare practices. The emphasis is on problems reported to the Authority, especially those associated with a high combination of frequency, severity, and possibility of solution; novel problems and solutions; and problems in which urgent communication and information could have a significant impact on patient outcomes. The “Readership” infographic on the following page shows the distribution of subscribers across the globe for the Advisory.

Since 2004, more than 475 safety-focused Advisory articles have been published and over 4,100 documented changes in Pennsylvania acute care facilities and nursing homes are directly attributed to Advisory articles. The Authority has provided 47 Advisory-based educational toolkits, which garnered over 100,000 website hits in 2014. More than 11,900 Advisory-based CME credits have been earned by healthcare professionals from 2006 through 2014.

Through its Advisory, the Authority will continue to help make healthcare as safe as possible for patients in Pennsylvania. As 2015 unfolds, look for enrichments in the readability of the articles and the accompanying practical resources. The content, design, and distribution methods for articles and resources will sharpen further. The goal will remain presenting information in a practical, straightforward manner while maintaining the important scientific process that provides validity. More information about the Advisory can be found in Addendum C.

Training and Education Efforts

The Patient Safety Liaison (PSL) Program continues to provide a unique resource to Pennsylvania healthcare facilities. PSLs are a facility’s personal link to the Authority. Every Pennsylvania hospital, ASF, birthing center, and abortion facility is assigned one of seven regional PSLs. Each PSL serves as an educator and consultant to their assigned facilities, providing on-site educational programs, assisting in collaborative work, analyzing patient safety events, and providing methods for improvement through Advisory articles, toolkits, and other available resources. In addition to conducting 189 educational sessions to over 9,000 healthcare professionals, PSLs made over 900 visits to individual healthcare facilities in 2014. Since 2010, the number of healthcare professionals educated by the Authority has increased significantly.

Educational programs were conducted throughout Pennsylvania at the facility, regional, and state level. Audiences included hospital leadership, patient safety committees, nurses, physicians, patient safety officers, respiratory therapists, radiology staff, therapy staff, nursing home staff, and many others. Presentations were given in person and in webinar sessions. Continuing education credits are offered for registered nurses for on-site programs at no charge to the facility.

Educational topics included the following: falls, human factors, culture of safety in the operating room, teamwork and communication, TeamSTEPPS, root-cause analysis, medication safety, Medical Care Availability and Reduction of Error (MCARE) Act reporting requirements, value of near-miss reporting, infection prevention, operating room fire safety, preventing wrong-site surgeries, just culture, failure mode and effects analysis (FMEA), and using data to improve patient safety.

Infection prevention analysts also provide educational sessions on HAIs to healthcare facilities and nursing homes.

In 2014, Authority infection prevention analysts provided educational programs to over 1,500 Pennsylvania healthcare workers in hospitals, nursing homes, ASFs, and professional organizations across the commonwealth, as well as to various advocacy groups and healthcare partners in infection prevention and patient safety.

More about the Authority’s education activities can be found in Addendum D.

Collaborations

The Authority has found that collaborating with facilities in Pennsylvania has helped facilities make improvements in specific areas where the data shows work needs to be done. In 2014, the Authority’s collaboration projects provided access to evidence-based best practices, education, tools, resources, facility networking and sharing, and published articles in the Advisory that would allow work to be shared statewide. The work with the Hospital and Healthsystem Association of Pennsylvania (HAP) Pennsylvania Hospital Engagement Network (HAP PA-HEN) utilized the majority of the Authority’s collaborative resources in 2014; however, the Authority was also able to begin a collaborative project with long-term care facilities to prevent catheter-associated urinary tract infections (CAUTIs). In addition, the Authority fostered collaborative partnerships in 2014 with the Philadelphia Department of Public Health, Quality Insights Quality Innovation Network, and the Health Research and Educational Trust national implementation of the Comprehensive Unit-based Safety Program (CUSP) for CAUTI in long-term care. Collaborations and partnership topics included falls; wrong-site surgery; harmful adverse drug events with anticoagulants, insulin, and opioids; CAUTIs; HAIs; and CUSP for CAUTI in long-term care.

Patient Safety Authority and How It Aligns with National Patient Safety Priorities

The Authority has a comprehensive patient safety mandate established under the MCARE Act. In 2014, the Authority consulted with a patient safety expert to receive feedback from field and expert patient safety advocates through several interviews to assess its alignment with national patient safety priorities. Figure 3 is the result of the consultant’s interviews and shows the Authority aligns strongly with national patient safety efforts.

The Authority’s patient safety efforts were rated particularly strong in the areas of support for the healthcare workforce to enable focus on patient care and improvement work, its focus on culture, and its promotion and spread of patient safety work, among others. This promotion of its work includes collaborations. These collaborations often involve working with national organizations and groups.

For example, the Authority works with the National Patient Safety Foundation (NPSF) in a variety of ways. The Authority’s clinical director sits on NPSF’s oversight committee. The Authority’s director of PSLs works with NPSF on its Certified Professional in Patient Safety (CPPS) exam and taught a review course in April 2015. The Authority will also speak at NPSF’s national conference about its work on falls reduction and its work with ASFs to reduce transfers to hospitals and procedure cancellations. An Authority infection prevention analyst also works with NPSF on their oversight committee that is conducting a research study on non-ventilator-associated hospital-acquired pneumonia. The Authority had previously published an Advisory article on the topic, which garnered NPSF’s interest.

The Authority has also initiated discussion on the safety of electronic health records. The Authority was one of the first organizations to publish on the topic through an Advisory article, which garnered the interest of the Office of the National Coordinator for Health Information Technology. The Authority has also contracted with Health Research and Educational Trust on a 14-month collaboration to develop and implement an infection prevention and safety program to support long-term care facilities in adopting evidence-based infection prevention practices to reduce CAUTIs and improve safety culture.

The Authority also continues to work with the HAP PA-HEN through the federal Partnership for Patients program to reduce falls, wrong-site surgeries, and adverse drug events with opioids.

The collaborative and partnership activities are detailed in Addendum E.

“I Am Patient Safety” Poster Campaign Recognizes Pennsylvania Healthcare Workers

The Authority held its annual I AM Patient Safety poster recognition contest during the last several months to recognize individuals and groups within Pennsylvania’s healthcare facilities who have demonstrated a personal commitment to patient safety. The recognition poster contest is held each year, with posters delivered to facilities in time for Patient Safety Awareness Week. The contest helps patient safety officers promote progress being made within their facilities to improve patient safety.

Several Authority board members and management staff comprised the judging panel. The panel judged submissions upon the following criteria: the person or group (1) had a discernible impact on patient safety for one or many patients, (2) demonstrated a personal commitmentto patient safety, and (3) demonstrated that a strong patient safety culture is present in the facility. Bonus points were awarded for submissions that demonstrated initiative taken by an individual.

Winners received their photos and patient safety efforts highlighted on posters that can be displayed within their facilities. They also received a certificate and an I Am Patient Safety recognition pin from the Authority. Winners were invited to attend the March 2015 Patient Safety Authority Board of Directors meeting for lunch and to meet the Authority board members and staff.

The individuals and groups recognized for the “I AM Patient Safety” poster contest are featured on the cover of the 2014 Annual Report. Their achievements and posters can be found in Addendum G. The addendum is a reprint of the 2015 March Advisory article.

The Authority’s HAI Reduction Efforts

HAIs can be devastating and even deadly. HAIs are associated with increased mortality and greater costs of care. According to the Centers for Disease Control and Prevention (CDC), approximately 1 out of every 20 patients in United States hospitals will contract an HAI. The most common types of HAIs are bloodstream infections, urinary tract infections, surgical site infections, gastrointestinal illnesses such as Clostridium difficile or norovirus, lower respiratory tract infections such as pneumonia, and skin and soft-tissue infections.

Since the inception of HAI reporting in 2009, the Authority’s HAI prevention activities have advanced from the initial articles published in the Advisory to offering webinars, conducting on-site facility visits, developing toolkits, and interfacing with local, state, and national partners focusing on HAI prevention.

Long-Term Care HAI Data Analysis

On April 1, 2014, the Authority began collecting HAI reports from long-term care facilities through PA-PSRS using updated criteria that closely follow the revised McGeer criteria published in 2012. Addendum F refers to data collected before April 1, 2014, as version 1 data; the data period of April 1, 2014, through December 31, 2014, is referred to as version 2 data.

Facilities in Pennsylvania submitted a total of 28,825 infection reports through PA-PSRS in 2014; a 6.9% decrease from the 30,958 submitted in 2013. The decrease in reporting may have resulted, in part, from the changes in criteria instituted in April 2014, when facilities modified their surveillance activities to capture reformed HAI-related data points.

Participation in Rapid Ebola Preparedness Teams

In response to the threat of Ebola-related morbidity and mortality, Authority analysts, in conjunction with the Pennsylvania Department of Health, CDC, and the Association for Professionals in Infection Control and Epidemiology, participated in site assessments to evaluate proposed Ebola treatment centers in Pennsylvania. Two sets of visits to each site occurred: one with the state-led teams and one with the CDC.

The initial visit focused on overall preparedness related to Ebola, but the assessments looked at all-hazard readiness as the overall goal that facilities should strive to achieve. The second visit, with CDC in attendance, showcased the programs that Pennsylvania facilities operationalized in a very short time frame. CDC acted in a consultative role with the state-led team and the facility representatives. The outcome of a successful joint visit was the facility’s designation as a state Ebola treatment center. Designation meant that the assessed facility could theoretically manage a patient with Ebola from admission to discharge in a coordinated and safe manner.

The Authority thanks the facilities that agreed to be assessed for designation and acknowledges the financial and operational commitment the facilities displayed in response to a potential infectious threat to Pennsylvania’s residents. The CDC list of Ebola treatment centers is available at http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/current-treatment-centers.html.

Long-Term Care Best-Practice Assessment Tool

Monitoring compliance with best practices aimed at preventing HAIs is fundamental to identifying improvement targets. Designed in 2011, the Authority’s Long-Term Care Best-Practice Assessment Tool helps facilities assess best practice strategies for HAI prevention and compliance in seven categories: hand hygiene, environmental infection control, outbreak control, and prevention of urinary tract, respiratory, skin and soft-tissue, and gastrointestinal multidrug-resistant organism infections.

New Analytical Tools for Nursing Homes

In April 2014, the Authority implemented PA-PSRS changes for nursing home users according to the 2012 McGeer criteria. Due to the recent change in reporting requirements, the Authority updated its analytical reports and tools for nursing homes. Features of the analytical tools include the following: analytics are generated to provide real-time information; individual facility infection rates can now be compared with a peer group rate or state rate; reports are exportable as Excel, Word, or PDF documents; graphs and tables have been designed with improved display features; and users can drill down through their data from a facility level through to the unit level.

More information about the Authority’s HAI activities can be found in Addendum F.

Recommendations to the Department of Health

In 2014, the Authority focused its attention on standardization of reporting. Since its inception, facilities have asked the Authority to standardize reporting for clarity of certain issues. The Authority and the Pennsylvania Department of Health (the Department), along with HAP, the Hospital Council of Western Pennsylvania, and the Pennsylvania Ambulatory Surgery Association, developed 28 guiding principles to provide more consistent and clearer standards for reporting requirements defined in section 302 of the MCARE Act. The document published in the September 27, 2014, Pennsylvania Bulletin outlines final guidance to acute healthcare facilities in Pennsylvania in making determinations about whether specific occurrences meet the statutory definitions of Serious Events, Incidents, and Infrastructure Failures. Public comments from the draft guidance published in the January 4, 2014, Pennsylvania Bulletin are included in the September 2014 document.

The guidance principles went into effect April 1, 2015. Prior to implementation, facilities were educated about what the Authority and the Department have agreed to in regard to the principles and reporting to help consistency. Questions were taken during the education sessions regarding the principles. A fact sheet with the questions and answers will be made available.

Since its inception, the Authority has had a special focus on preventing surgical procedures from being performed on the wrong patient, wrong body part, wrong side of the body, or wrong level of a correctly identified anatomic site—collectively referred to as “wrong-site surgery.” While this type of event is rare at the level of an individual hospital or ASF, the Authority has developed the largest database of reports on wrong-site surgery cases in the United States, and possibly the world. The Authority’s analysis of several hundred of these reports allowed the Authority to identify principles that, when followed, can prevent these events.

Having developed the evidence base for these principles and demonstrated that facilities adopting these principles can drastically reduce the occurrence of wrong-site surgery, the Authority took the initial steps toward issuing formal recommendations on wrong-site surgery prevention. The Authority met with the Pennsylvania Department of Health in January 2012 to discuss the process for making recommendations and obtained its agreement in principle that recommendations on this topic would benefit the commonwealth.

In March 2012, the Authority distributed draft recommendations for public comment to the patient safety officers of all acute care facilities that perform surgery, as well as to the Pennsylvania chapters of relevant clinical specialty societies and professional associations. The Authority received feedback from these stakeholders on whether they envisioned any barriers to implementation of the principles. In November 2012, the Authority published a supplementary Advisory discussing the feedback received from the Pennsylvania professional organizations.

The Authority and the Department of Health expected to address the wrong-site surgery recommendations in late 2014 but did not due to the standardization of the 28 guiding principles discussed previously. The Authority will work with Department of Health to address the wrong-site surgery recommendations, once education and implementation for the standardization guiding principles is complete.

Anonymous Reports

The MCARE Act includes an important provision that permits individual healthcare workers to submit what the MCARE Act defines as an “anonymous report.” Under this provision, a healthcare worker who has complied with section 308(a) of the act may file an anonymous report regarding a Serious Event. The MCARE Act requires facilities to make anonymous report forms available to healthcare workers. The Authority does not receive many anonymous reports.

The Authority makes the forms available on the PA-PSRS website, which is accessible without a password. The reporting form is a simple, one-page questionnaire. To ensure healthcare workers are aware of the option to submit an anonymous report, the Authority developed an anonymous report pamphlet. The pamphlet includes an anonymous report form with guidelines for filing a report so patient safety officers can make them easily accessible for hospital staff. While making their routine visits to facilities in their region, the Authority’s PSLs also ensure patient safety officers are making the anonymous report forms accessible to employees.

Healthcare workers are able to submit anonymous reports according to the protocols established through PA-PSRS. Individuals completing the form do not need to identify themselves, and the Authority assigns professional clinical staff to conduct any subsequent investigations. The Authority encourages healthcare workers to submit anonymous reports when they believe their facility is not responding appropriately to a Serious Event. The MCARE Act requires that the annual report include the number of anonymous reports filed and reviews conducted by the Authority. The Authority received one anonymous report in 2014 that complied with MCARE Act requirements. The Authority has received a total of 11 anonymous reports since reporting began in 2004.

Referrals to Licensure Boards

The MCARE Act requires the Authority to identify the number of referrals to licensure boards for failure to submit reports under the act’s reporting requirements. No such situations were identified during 2014. However, it is important to note that the Authority is unlikely to receive information related to a referral to a licensure board, as PA-PSRS reports do not include the names of individual licensed practitioners.

Fiscal Statements and Contracts

The MCARE Act establishes the Patient Safety Trust Fund as a separate account in the State Treasury. Under the MCARE Act, the Authority, which has sole discretion to determine how those funds are used to effectuate the purposes of the patient safety provisions of the act, administers funds in the Patient Safety Trust Fund. Funds for the Patient Safety Trust Fund come from assessments made by the Department of Health on certain medical facilities.

The Authority recognizes that Pennsylvania hospitals, birthing centers, ASFs, abortion facilities, and nursing homes bear financial responsibility for costs associated with complying with mandatory reporting requirements. Accordingly, the Authority has focused on two fiscal goals: to be moderate in the use of moneys contributed by the healthcare industry and to ensure that healthcare facilities paying for PA-PSRS receive direct benefits from the system and from Authority programs in return.

In this regard, within the design of PA-PSRS, the Authority included a variety of integral and analytical tools that provide immediate, real-time feedback to facilities on their own adverse event and near-miss reports and activities. Most recently, the Authority has provided nursing homes with an infection analytic system within PA-PSRS. Facilities can use these tools for their internal patient safety and quality improvement programs. The Authority also publishes the Advisory, a scholarly journal issued quarterly that includes detailed analysis and identification of trends of reports submitted through PA-PSRS.

Also, the Authority has provided numerous training and education programs, including patient safety officer basics and beyond-the-basics education, regional root-cause analysis seminars, and programs on failure mode and effects analysis, reduction of MRSA in ASFs, and evidence-based best practice in preventing wrong-site surgery, to name a few. All of these programs are offered for free. As identified elsewhere in this report, the Authority expanded its services by organizing and supporting research collaboratives with reporting facilities and other patientsafety-centric organizations. The Authority also provides continuing medical education and patient safety curriculum development. By directly offering clinical guidance, feedback, and educational programs to providers about actual events that occur in Pennsylvania, the Authority provides measurable value back to the healthcare industry that contributes to funding this program.

Funding Received from Hospitals, ASFs, Birthing Centers, and Abortion Facilities

The MCARE Act set a limit of $5,000,000 on the total aggregate assessment on acute care facilities for any one year beginning in 2002, plus an annual increase based on the Consumer Price Index (CPI) for each subsequent year.

On January 28, 2014, the Authority board authorized a recommendation to the Department of Health that the FY 2013-2014 acute care surcharge assessment total $5.5 million. This amount was equal to the surcharge assessment from the previous fiscal year and was 17% less than the maximum annual amount that could have been assessed for the year pursuant to section 305(d) of the MCARE Act. See Table 3.

At the time of this recommendation, the Authority board tookseveral points into consideration, including the following:

The Authority FY 2013-2014 budget was approximately $8.6 million, of which approximately $7.6 million was related to non-HAI expenditures.
The Authority received $0.8 million in revenue for work performed for the Centers for Medicare and Medicaid Services (CMS) Partnership for Patients initiative. HAP manages the Pennsylvania Hospital Engagement Network (HEN) that provided the framework for these activities.
The Authority budget increased by $2.0 million, or 30.8%, over the previous fiscal year. This budget included $1.6 million in strategic initiative spending.
Excluding the strategic initiative spending, the budget increased 5.6% over the previous year, which was offset by $0.8 million in HEN/CMS revenues.

Additionally, on December 9, 2014, the Authority board authorized a recommendation to the Department of Health that the FY 2014-2015 acute care surcharge assessment total $6.2 million. This amount is a $0.7 million, or 12.7%, increase over the FY 2013-2014 acute care assessment and is 8% less than the maximum annual amount that could have been assessed for the year pursuant to section 305(d) of the MCARE Act.

At the time of this recommendation, the Authority board took several points into consideration, including the following:

The Authority FY 2014-2015 budget is approximately $8.2 million, of which approximately $7.2 million is related to non-HAI expenditures.
The Authority budget decreased by $433 thousand, or -5.0%, from the previous fiscal year. This budget included $1.2 million in Strategic Initiative spending.
Since FY 2009-2010, the acute care assessment had increased by $500 thousand or 2.5% per year.
Since the FY 2007-2008 acute care assessment of $5.4 million, the acute care assessment had increased by just $100 thousand over six years, a 2% total increase through FY 2013-14, or 0.3% per year.
Also considered in authorizing this increase were staff and program growth, significant increases in Commonwealth of Pennsylvania mandated benefit pool rates and the conclusion of the HEN contract in December 2014.

Table 3. Acute Care Facility Assessments

* The number of facilities assessed by Department of Health (DOH) differs from the number of Medical Care Availability and Reduction of Error (MCARE) Act facilities cited elsewhere in this report due to the differences in the dates chosen to calculate the number of facilities for these two different purposes.
† Amounts assessed and amounts received will differ because a few facilities may have closed in the interim or are in bankruptcy. In a few cases, the DOH is pursuing action to enforce facility compliance with the MCARE Act’s assessment requirement.
‡ Total assessments received are greater than assessments made because some funds received were late payments for the previous year’s assessment.
§ DOH has not yet calculated the FY 2014-15 acute care assessments as of the production of this table.

Funding Received from Nursing Homes

Act 52 of the MCARE Act allows the Department of Health to assess the nursing homes up to $1,000,000 per year for any one year, beginning in 2008, plus an annual increase based on the CPI for each subsequent year. In 2008, following the Authority’s suggestion, the Department of Health assessed 725 nursing home facilities $1,000,000 and transferred $1,000,782 to the Patient Safety Trust Fund for FY 2008-2009. This money can only be spent on activities related to HAI and implementation and maintenance of chapter 4 of the MCARE Act.

On January 28, 2014, the Authority board authorized a recommendation to the Department of Health that the FY 2013-2014 nursing home surcharge assessment total $1.0 million. This amount was $100 thousand more the previous year’s assessment and was approximately 6.5% below the maximum assessment permitted under Act 52 based on annual CPI adjustments.

Additionally, on December 9, 2014, the Authority board authorized a recommendation to the Department of Health that the FY 2014-2015 nursing home surcharge assessment total $1.05 million. This amount is $50 thousand more than the previous year’s assessment and is approximately 3.6% below the maximum assessment permitted under Act 52 based on annual CPI adjustments. See Table 4.

Table 4. Nursing Home Assessments

* Total assessments received are greater than assessments made because, in a few cases, funds received were late payments for the previous year’s assessment.
† The Department of Health (DOH) has not yet calculated the FY 2014-15 acute care assessments as of the production of this table.

Annual Expenditures

During calendar year 2014, the Authority spent approximately $7.4 million and received HEN-related reimbursement of $842 thousand resulting in net expenditures of $6.6 million. See Table 5.

Table 5. Actual Expenditures for Calendar Year 2014

Patient Safety Authority Contracts

The MCARE Act requires the Authority to identify a list of contracts entered into pursuant to the act, including the amounts awarded to each contractor.

During calendar year 2014, the Authority received services under the following contracts (key: FC [funds commitment]; PO [purchase order]):

ECRI Institute, FC # 4000013036

Five-year contract for program administration, clinical analysis, training, and data collection and reporting infrastructure services, extended through September 2014.

November 2008 to September 30, 2014

Total contract amount: $25,977,719
over 5 years and 11 months

Total contract expenditures: $24,316,370.15

Amount invoiced for 2008: $ 496,373.04
(November and December)

Amount invoiced for 2009: $3,664,012.67
(January through December)

Amount invoiced for 2010: $3,723,832.43
(January through December)

Amount invoiced for 2011: $3,854,487.96
(January through December)

Amount invoiced for 2012: $4,253,118.44
(January through December)

Amount invoiced for 2013: $4,601,794.47
(January through December)

Amount invoiced for 2014: $3,722,751.13
(January through September)

ECRI Institute, FC # 4000018888

Four-year, nine-month contract for program administration, clinical analysis, training, and data collection and reporting infrastructure services.

October 1, 2014, through June 30, 2019

Total contract amount: $24,227,233
over 4 years and 9 months

Amount invoiced for 2014: $767,354.02
(October through November) – unaudited

December 2014 invoice not yet received.

IKON Office Solutions, PO # 4500712922

B&W Copier Lease
August 1, 2013, to June 30, 2017, @ $202.62/month

13-month lease expense (Jan-Jan) paid in CY 2014:
$2,630.31 (includes $3.75 credit)

XEROX Corporation, PO # 4500734462

Color Copier Lease
October 1, 2013, to August 31, 2017,
@ $398.39/month with no overage charge

12-month lease expense (Oct-Dec): $4,780.68

DELL Marketing LP, PO # 4300409286

SAS Visual Analytics software licenses and training
Issue date: March 31, 2014. Total PO: $62,948.30.

Amount Expended in 2014: $62,948.30

SAS Institute Inc., FC # 4000018726

Professional services agreement for installation and development of SAS Visual Analytics software

SAS contract # S4033-1. Effective July 29, 2014.

Total commitment: $36,683.52
Amount Expended in 2014: $30,433.69

Contracts under which the Authority received revenue as contractor:

HRET Subcontract Agreement – CAUTI LTC Cohort 2

Federal Fixed Price – HHSA2902010000251,
Task Order #8

2014 base period: $25,000.00
Option period: $25,000.00
(exercisable through September 18, 2015)

Amount invoiced by Authority in 2014: $25,000.00

HAP/CMS Subcontract Agreement - Hospital Engagement Network (HEN)

Option Year 1 – Contact HHSM-500-2012-022C.3
Amount invoiced by Authority in 2014: $845,480.00

Patient Safety Authority Balance Sheet

The following balance sheet (Table 6) reflects the status of the Patient Safety Trust Fund as of December 31, 2014:

Table 6. Patient Safety Trust Fund Balance Sheet (Unaudited), as of December 31, 2014*

Board of Directors and Public Meetings

Members of the board of directors are appointed by the governor and the general assembly according to certain occupational or residence requirements. As of December 31, 2014, members include:

Physician appointed by the Governor who serves as Chair:
Rachel Levine, MD, Physician General
Residence: Middletown (Dauphin County)

Appointee of the President pro tempore of the Senate:
Daniel Glunk, MD, MHCDS
Residence: Williamsport (Lycoming County)

Appointee of the Minority Leader of the Senate:
Cliff Rieders, Esq.
Residence: Williamsport (Lycoming County)

Appointee of the Speaker of the House:
Stanton N. Smullens, MD, Vice Chair
Residence: Philadelphia (Philadelphia County)

Appointee of the Minority Leader of the House:
Eric Weitz, Esq.
Residence: Carlisle (Cumberland County)

Nurse appointed by the Governor:
Joan M. Garzarelli, RN, MSN
Residence: Irwin (Westmoreland County)

Pharmacist appointed by the Governor:
Gary A. Merica, BSc, MBA/HCM
Residence: Red Lion (York County)

Hospital employee appointed by the Governor:
Radheshyam Agrawal, MD
Residence: Pittsburgh (Allegheny County)

Healthcare worker appointed by the Governor:
Jan Boswinkel, MD
Residence: Havertown (Delaware County)

Non-healthcare worker appointed by the Governor:
Lorina L. Marshall-Blake
Residence: Philadelphia (Philadelphia County)

Physician appointed by the Governor:
John Bulger, DO, MBA
Residence: Danville (Montour County)

The MCARE Act requires the board of directors to meet at least quarterly. During 2014, the board met frequently to assess and develop future patient safety educational and advocacy activities, including developing standards for more consistent reporting. Representatives of healthcare, consumer, and other stakeholder groups, including the general assembly, have attended and spoken at public meetings. Following are the dates of all public board meetings held by the Authority during 2014:

January 28, 2014
March 4, 2014
April 23, 2014
June 10, 2014
July 23, 2014 (cancelled)
September 9, 2014
October 29, 2014 (cancelled)
December 9, 2014

Summary minutes of the public meetings are available on the Authority’s website at patientsafety.pa.gov.

Addendum A: Definitions

The Medical Care Availability and Reduction of Error (MCARE) Act requires healthcare facilities to submit reports on the following three kinds of occurrences:

1. Serious Event. An adverse event resulting in patient harm. The legal definition, from the MCARE Act, reads as follows: “An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.”

2. Incident. A “near miss” in which the patient was not harmed. The MCARE Act defines this as follows: “An event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event.”

3. Infrastructure Failure. A potential patient safety issue associated with the physical plant of a healthcare facility, the availability of clinical services, or criminal activity. The MCARE Act defines this as follows: “An undesirable or unintended event, occurrence or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety.” Reports of Infrastructure Failures are not addressed in this report because these are submitted only to the Department of Health.

Reports of Serious Events and Incidents are submitted to the Authority for the purposes of learning how the healthcare system can be made safer in Pennsylvania. Reports of Serious Events and Infrastructure Failures are submitted to the Department of Health for the purposes of fulfilling its role as a regulator of Pennsylvania healthcare facilities.

The MCARE Act requires the following types of facilities to submit reports of Serious Events, Incidents, and Infrastructure Failures to the Authority through the Pennsylvania Patient Safety Reporting System (PA-PSRS):

Hospitals. The Health Care Facilities Act (35 Pa. Stat. Ann. § 448.802a) defines a hospital as “an institution having an organized medical staff established for the purpose of providing to inpatients, by or under the supervision of physicians, diagnostic and therapeutic services for the care of persons who are injured, disabled, pregnant, diseased, sick or mentally ill or rehabilitation services for the rehabilitation of persons who are injured, disabled, pregnant, diseased, sick or mentally ill. The term includes facilities for the diagnosis and treatment of disorders within the scope of specific medical specialties, but not facilities caring exclusively for the mentally ill.” For the purposes of this report, at the end of 2014, there were 239 hospitals in the Commonwealth of Pennsylvania.

Ambulatory surgical facilities. The Health Care Facilities Act defines an ambulatory surgical facility as “a facility or portion thereof not located upon the premises of a hospital which provides specialty or multispecialty outpatient surgical treatment. Ambulatory surgical facility does not include individual or group practice offices or private physicians or dentists, unless such offices have a distinct part used solely for outpatient treatment on a regular and organized basis. Outpatient surgical treatment means surgical treatment to patients who do not require hospitalization but who require constant medical supervision following the surgical procedure performed.” For the purposes of this report, at the end of 2014, there were 302 ambulatory surgical facilities in the Commonwealth of Pennsylvania.

Birthing centers. The Health Care Facilities Act defines a birthing center as “a facility not part of a hospital which provides maternity care to childbearing families not requiring hospitalization. A birthing center provides a home-like atmosphere for maternity care, including prenatal, labor, delivery, postpartum care related to medically uncomplicated pregnancies.” For the purposes of this report, at the end of 2014, there were five birthing centers in the Commonwealth of Pennsylvania.

Abortion facilities. Act 30 of 2006 extended the reporting requirements in the MCARE Act to abortion facilities that perform more than 100 procedures per year. For the purposes of this report, at the end of 2014, there were 19 qualifying abortion facilities in the Commonwealth of Pennsylvania.

Nursing homes. Act 52 of 2007 revised the MCARE Act to require nursing homes to report HAIs to the Authority. Reporting from these facilities began in June 2009. For the purposes of this report, at the end of 2014, there were 703 nursing homes in the Commonwealth of Pennsylvania. See the addendum for data received to date from nursing homes.

Other pertinent definitions used in this report include the following:

Medical error. This term is commonly used when discussing patient safety, but it is not defined in the MCARE Act. The word “error” appears in PA-PSRS and in this report. For example, one category of reports discussed is “medication errors.” In PA-PSRS, the word “error” is used in the sense intended by the Institute of Medicine Committee on Data Standards for Patient Safety, which defines an error as follows: “The failure of a planned action to be completed as intended (i.e., error of execution), and the use of a wrong plan to achieve an aim (i.e., error of planning) . . . . It also includes failure of an unplanned action that should have been completed (omission).”¹

Adverse event. This term also appears in this report, though it is not defined in the MCARE Act. The Institute of Medicine Committee on Data Standards for Patient Safety defines an adverse event as follows: “an event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.”¹ The Authority considers this term to be broader than “medical error,” as some adverse events may result from clinical care without necessarily involving an error.

Within the MCARE Act, the term “medical error” is used in section 102: “Every effort must be made to eliminate medical errors by identifying problems and implementing solutions that promote patient safety.” It is also used in defining the scope of chapter 3, “Patient Safety”: “This chapter relates to the reduction of medical errors for the purpose of ensuring patient safety.”

While PA-PSRS does include reports of events that result from errors, the program’s focus is on the broader scope of actual and potential adverse events—not only those that resulted from errors.

Patient safety officer. The MCARE Act requires each medical facility to designate a single individual to serve as that facility’s patient safety officer. Under the MCARE Act, the patient safety officer is responsible for submitting reports to the Authority. The MCARE Act also assigns other responsibilities to the patient safety officer.

Note

1. Aspden P, Corrigan JM, Wolcott J, et al., eds. Committee on Data Standards for Patient Safety. Institute of Medicine. Patient safety: achieving a new standard of care. Washington (DC): National Academies Press; 2004.