Improve the quality of healthcare in Pennsylvania by collecting and analyzing patient safety information, Safe healthcare for all patients developing solutions to patient safety issues, and sharing this information through education and 2016 Pennsylvania Patient Safety Authority Annual Report April 28, 2017 collaboration. •• Letter from the Board Chair Dear Fellow Pennsylvanians: The year 2016 proved to be a year of continuing improve- invoked innovation strategies that foster ideas and concepts ment and transformation for the Pennsylvania Patient Safety to address longstanding and emerging patient safety topics. Authority. Diligent efforts continued around data collec- In the Authority’s focus on innovation, it looks to strengthen tion and analysis, patient safety information dissemination, existing services provided to healthcare facilities and culti- education and outreach, and collaborative partnerships. In vate new viewpoints when facilities seek to address patient addition, the agency embraced new leadership, employed safety concerns. innovative strategies, and developed its 2017–2020 strate- gic plan, which includes expanded outreach to patients and In 2016, staff and directors developed the Authority’s third other sectors. strategic plan. The 2017–2020 plan concentrates on four strategic pathways to focus on (1) improving diagnosis, Pennsylvania healthcare facilities continued efforts to (2) the patient, (3) long-term care, and (4) evaluating the identify and report patient safety events. Acute healthcare reporting system. While foundational efforts have and will facilities reported 255,714 events, a 7% increase over remain the priority, expanding outreach and education 2015. The Authority continues to observe an increase in to patients and other sectors will prove beneficial for all the percentage of events reported as Incidents (events that patients. do not harm the patient) rather than Serious Events (events that harm the patient). Further, the Authority received 218 In its past, present, and future, the Authority has been and reports of events that may have contributed to or resulted in projects to be effective and relevant in analyzing reports a patient’s death, a 13.8% decrease from 2015. Notably about patient safety events and disseminating, educat- in 2016, the Authority observed positive signs associated ing, and collaborating about strategies to reduce patient with efforts to standardize reporting implemented during harm. Through 2016, the Authority’s Pennsylvania Patient 2015. With regard to nursing homes reporting healthcare- Safety Advisory has provided more than 540 patient-safety- associated infections (HAIs), 2016 was the second calendar focused articles, associated with nearly 50 educational year for reporting using revised criteria. Nursing homes toolkits, as well as credited with more than 4,650 process reported 27,544 HAI events, a 13% decrease from 2015. improvements by healthcare facilities. In 2016 alone, the Authority’s PSLs, infection prevention analysts, and In March 2016, the Authority bid farewell to Michael C. patient safety analysts educated nearly 10,500 attendees Doering, MBA, former executive director. We wish Mike well of Authority patient safety programs and presentations. in his retirement, and appreciate his nine years of executive And success through 2016 in the Authority’s collaborative leadership that saw implementation of the patient safety improvement projects on targeted interventions in health- liaison (PSL) program, HAI reporting, and other milestones care facilities has led to additional programs with Authority in data analysis, publication, collaboration, and education partners. and outreach initiatives. As chair of the Board of Directors, I look forward to our Following Mike’s retirement, the Board of Directors continuing work and new initiatives with Pennsylvania welcomed Regina Hoffman, MBA, BSN, RN, CPPS, as healthcare facilities and in the Authority’s vision of safe executive director. Regina joined the Authority in 2012, healthcare for all patients. most recently served as director of the PSL program, and possesses relevant and fresh perspective about the agency’s On behalf of the Board, I am pleased to submit this annual future. Under Regina’s leadership to date, the Authority has report for your review. Rachel Levine, MD Physician General, Commonwealth of Pennsylvania Chair, Board of Directors Pennsylvania Patient Safety Authority i Pennsylvania Patient Safety Authority Board of Directors Rachel Levine, MD, Chair Stanton N. Smullens, MD, Vice Chair Radheshyam Agrawal, MD Jan Boswinkel, MD John Bulger, DO, MBA Daniel Glunk, MD, MHCDS Arleen Kessler, PharmD, MBA, RPh Mary Ellen Mannix, MRPE Clifford Rieders, Esq. Linda Waddell, MSN, RN Eric Weitz, Esq. Staff Regina Hoffman, MBA, BSN, RN, CPPS Terri Roberts, BSN, RN, CIC Kelly Gipson, BSN, RN, CPPS Executive Director Infection Prevention Analyst Patient Safety Liaison Michelle Bell, BSN, RN, FISMP CPPS , Teresa Plesce Richard Kundravi, BS, CPPS Director of Outreach and Education Office Manager Patient Safety Liaison Christina Hunt, MBA, MSN, RN, HCM, Karen McKinnon-Lipsett Christopher Mamrol, BSN, RN CPPS Administrative Specialist Patient Safety Liaison Director of Collaborative Programs Shelly Mixell Melanie Motts, M.Ed, BSN, RN, CPPS Howard Newstadt, JD, MBA, CGCIO Executive Assistant Patient Safety Liaison Finance Director & CIO Megan Shetterly, MS, RN, CPPS Catherine Reynolds, DL, MJ, BSN, RN Rebecca Jones, MBA, BSN, RN, Senior Patient Safety Liaison Patient Safety Liaison CPHRM, CPPS Jeff Bomboy, BS, RN, CPPS Special Assistant to the Executive Director Robert Yonash, RN, CPPS Patient Safety Liaison Patient Safety Liaison JoAnn Adkins, BSN, RN, CIC Infection Prevention Analyst Theresa V. Arnold, DPM Edward Finley William M. Marella, MBA, MMI Mgr., Clinical Analysis Data Analyst Program Director Julia Barndt, MA Michael J. Gaunt, PharmD Christina Michalek, BSc Pharm, RPh, Associate Editor (Advisory) Sr. Medication Safety Analyst FASHP Sharon Bradley, RN, CIC Matthew Grissinger, RPh, FISMP FASCP , Sr. Medication Safety Analyst Sr. Infect. Prev. Analyst Mgr., Medication Safety Analysis Jesse Munn, MBA Phyllis Bray Shawn Kincaid Operations Mgr., Managing Editor Database Administrator System Developer (Advisory) John R. Clarke, MD Ben Kramer Badal Sanghvi, MBA Clinical Director Emeritus System Administrator IT Manager James Davis, MSN, RN, CIC Susan Lafferty Sr. Infect. Prev. Analyst Administrative Assistant Carly Sterner System Developer Eloise DeHaan, ELS Donna Lockette Copyeditor (Advisory) Business Analyst Dawn Thomas Ellen Deutsch, MD, MS, CPPS Mary C. Magee, MSN, RN, CPHQ, CPPS Communication Specialist Clinical Director, Editor (Advisory) Sr. Patient Safety / Quality Analyst Susan C. Wallace, MPH, CPHRM Michelle Feil, MSN, RN, CPPS Patient Safety Analyst Sr. Patient Safety Analyst ii Table of Contents Executive Summary1 Strategic Plan5 Definitions7 Overview of Data Reported through PA-PSRS 11 Reporting Standardization: Guidance for Acute Healthcare Reporting 39 Healthcare-Associated Infections47 The Pennsylvania Patient Safety Advisory69 Educational Programs75 Collaborative Strategies to Improve Patient Safety79 The Authority Celebrates Pennsylvania Healthcare Providers for Outstanding Patient Safety Efforts 88 Recommendations to the Department of Health 93 Anonymous Reports94 Referrals to Licensure Boards 95 Fiscal Statements and Contracts97 Board of Directors and Public Meetings 103 iii Executive Summary The Pennsylvania Patient Safety Authority recognizes the significant strides in patient safety improvement made by Pennsylvania healthcare facilities, as well as the important work that remains. In 2016, the Authority published a study of the effectiveness of data collection, data analysis, information dissemination, and statewide collaborative learning by the Authority and its partners to reduce health- care-associated patient harm in the Commonwealth. In the five measures selected for analysis, these core patient safety efforts led to an estimated 2,600 lives saved and $147 million saved since 2004. The Authority, an independent state agency established under the Medical Care Availability and Reduction of Error (MCARE) Act1 of 2002, collects and analyzes data reported through its Pennsylvania Patient Safety Reporting System (PA-PSRS) and then provides strategies and lessons learned to healthcare facilities to improve safety and help prevent patient harm. View Infographic online at www.patientsafetyauthority.org. Under the MCARE Act, healthcare facilities must report Serious Events (events that harm the patient) and Incidents A change in leadership occurred in 2016, as former ex- or “near misses” (events that do not harm the patient) to ecutive director Michael C. Doering retired. The Board of the Authority. Facilities must notify patients or their fami- Directors named Regina M. Hoffman executive director in lies when a Serious Event has occurred. The Pennsylvania March 2016. The board and staff engaged in the Author- Department of Health also receives Serious Event reports ity’s third strategic planning process, in which participants for its regulatory role. developed a mission statement, vision, and four strategic pathways of focus on (1) improving diagnosis, (2) the The Authority initiated statewide mandatory reporting in patient, (3) long-term care, and (4) evaluating the report- June 2004. All reports are confidential and non-discover- ing system. It is important to address these pathways while able. In 2007, MCARE was amended (Act No. 2007-52: continuing the foundational efforts of data collection and Reduction and Prevention of Health Care-Associated In- analysis, information dissemination, education, and col- fection and Long-Term Care Nursing Facilities2) for nursing laborative learning. homes to report healthcare-associated infections (HAIs) as Serious Events to the Authority. The aforementioned analysis about the value of patient safety improvement efforts in Pennsylvania also discusses This executive summary highlights the Authority’s 2016 the decrease in high-harm events (i.e., Serious Events that activities; specific details are included in the correspond- result in permanent harm, near death, or death), a trend ing sections of the overall annual report. that continues in events reported during 2016. Acute MISSION VISION Improve the quality of healthcare in Pennsylvania by Safe healthcare for all patients. collecting and analyzing patient safety information, developing solutions to patient safety issues, and sharing this information through education and collaboration. Pennsylvania Patient Safety Authority 2016 Annual Report 1 healthcare facilities reported 255,714 events, with an Of the Authority’s website traffic in 2016 (n = 1,563,044 increasing percentage of events reported as Incidents (n hits) Advisory articles and toolkits comprised the majority, = 248,166), rather than Serious Events (n = 7,548). This with 753,893 and 145,548 hits, respectively. brings the total number of events reported (2004 through 2016) to 2.76 million. The reporting category, Error relat- Staff—including patient safety liaisons (PSLs), patient ed to Procedure/Treatment/Test, continues to be the most safety analysts, infection prevention analysts, and phy- common category of Incident reports, and Complication sicians—as well as patient safety and subject matter of Procedure/Treatment/Test the most common category experts, use the Authority’s analysis, disseminated infor- of Serious Events. Of Serious Events, facilities reported mation, and additional research to educate healthcare 218 events that may have contributed to or resulted in a providers about patient safety strategies. In 2016, educa- patient’s death, a 13.8% decrease from 2015 as well as tional programs were associated with education of nearly an overall decrease from 2005 through 2016. 4,000 participants onsite at healthcare facilities, nearly 1,800 through regional/other presentations, nearly 4,000 Staff and board members, as well as participants from through webinars, and nearly 800 through the Authority’s other agencies and organizations in the Commonwealth, online education system. The Authority further enhanced engaged in efforts to improve consistency in acute health- its PSL outreach to reporting facilities with “Keystones” care facility event reporting with standards effected in April (i.e., targeted, topical outreach to facilities accompanied 2015. In 2016, the Authority observed positive indicators by consultative tools and resources). associated with these standardization efforts, including improvement in Serious Event reporting, a near doubling In its work to reduce HAIs, the Authority’s infection of events reported under the new and revised event types prevention staff educated participants during activi- and subtypes, and continued participation by reporting ties mentioned above. Staff researched and published facilities in education about standardization principles. educational and assessment tools (e.g., accompany- ing Advisory articles) to address reported HAI events; in Nursing homes reported 27,544 HAI events in 2016, a feedback, hospital and nursing home representatives 13% decrease from the previous year. The year 2016 rep- reported that these tools were highly useful in increasing resents the second full year of data since revised reporting staff knowledge and identifying specific areas of focus for criteria was implemented in 2014. Some highlights of prevention efforts. Furthermore, staff continued work with 2016 event data include that catheter-associated urinary the Pennsylvania Department of Health, the Hospital and tract infections (CAUTIs) continue to be the predominant Healthsystem Association of Pennsylvania (HAP), and local urinary tract infection by pooled infection rate, gastroin- health departments to help Pennsylvania acute healthcare testinal infection reports decreased (statistically significant) facilities prepare for episodic biological threats by provid- compared with such reports in 2015, and reports of influ- ing consultation associated with site visits. enza in Pennsylvania align with nationally reported data. The Authority has long recognized the value of collabora- Events reported by Pennsylvania healthcare facilities, re- tive learning and continued its focus on such improve- quests for information from Pennsylvania healthcare pro- ment efforts in 2016. Staff concluded work with HAP on viders, and review of the medical and patient safety litera- Hospital Engagement Network (HEN) 2.0 immersion ture prompts analysis of the aggregate event reports. This projects, addressing falls with harm and adverse drug leads to dissemination of analysis and guidance through events, as well as HAIs. Success in HEN 2.0 and during the Authority’s journal, the Pennsylvania Patient Safety previous contracts led to the Authority again working with Advisory. From the first issue in March 2004 through HAP which was awarded a primary federal contract for , December 2016, the Advisory has provided nearly 540 the Hospital Improvement Innovation Network (HIIN) in safety-focused articles and nearly 50 associated “toolkits” September 2016. The Authority is leading HIIN projects of assessment tools and education, available at www. addressing adverse drug events, falls, and culture of patientsafetyauthority.org. To date, Pennsylvania health- safety. The Authority is also co-leading a HIIN project with care facilities credit the Advisory with contributing to more the Health Care Improvement Foundation to reduce emer- than 4,650 structure and process improvements. Top- gency department radiologic diagnostic errors. ics addressed during 2016 include surgical procedures, medication-related events, infection prevention, maternity, Finally, healthcare facilities again had the opportunity to leadership, patient/family involvement, and teamwork. showcase commitment to patient safety and reward the 2 2016 Annual Report Pennsylvania Patient Safety Authority people involved through the annual “I Am Patient Safety” $8.5 million, with approximately $7.2 million funding contest. The Authority recognized 14 individuals or groups expenditures other than for HAI programs. from nominations from Pennsylvania facilities, all of whom are featured in this annual report. The Authority remains strongly committed to its founda- tional patient safety efforts, as evidenced by its continued The Authority recognizes that Pennsylvania healthcare fa- attention to and enhancement of its data collection and cilities bear financial responsibility for costs associated with analysis, information dissemination, education efforts, complying with mandatory reporting requirements. The and collaborative learning outputs. Innovation is key to Authority focuses on two fiscal goals: (1) to be prudent in ongoing success, a critical concept for both the Author- the use of moneys contributed by the healthcare industry, ity’s foundational efforts and its forthcoming strategic and (2) to assure that healthcare facilities paying for PA- pathways to enhance patient safety for all patients in the PSRS receive direct benefits from the system and Authority Commonwealth. programs. The Authority’s FY 2016–2017 budget totals Notes 1. Medical Care Availability and Reduction of Error (MCARE) Act of March 20, 2002, P 154, No. 13, Cl. 40. Avail- .L. able: http://www.legis.state.pa.us/cfdocs/legis/li/ucons- Check.cfm?yr=2002&sessInd=0&act=13. 2. Medical Care Availability and Reduction of Error (MCARE) Act - Reduction and Prevention of Health Care-Asso- ciated Infection and Long-Term Care Nursing Facilities Act of July 20, 2007, P 331, No. 52, Cl. 40. http:// .L. www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2007&sessInd=0&act=52. Pennsylvania Patient Safety Authority 2016 Annual Report 3 Strategic Plan During 2016, the Pennsylvania Patient Safety Authority under the Medical Care Availability and Reduction of Board of Directors and staff engaged in a third strate- Error (MCARE) Act.1 gic planning process. A contracted facilitator conducted research and stakeholder interviews. Research included The Authority continues to be committed to its key pro- summaries of current thinking in the field, the issue of grams. However, the Authority also believes that expand- patient safety in nonacute-care settings, and an overview ing its outreach to patients and other sectors will enhance of state adverse-event reporting systems. patient safety for all patients in the Commonwealth. Providing education to patients will help them become Using a creative problem-solving process, the Authority informed and engaged participants in their healthcare. conducted a daylong strategic planning meeting in Sep- Expanding education and outreach to sectors that are part tember 2016. The board and staff members participated of the circle of care will help healthcare facilities achieve in activities to develop a mission statement, vision, and their patient safety goals for the populations they serve. strategic pathways. A strategic plan was drafted with the assistance of Authority board members and a representa- More information about the Authority’s 2017–2020 tive from the HAI Advisory Panel. The Authority developed strategic plan is shown in the figure below. key strategic pathways to enhance its foundational work Note 1. Medical Care Availability and Reduction of Error (MCARE) Act of March 20, 2002, P 154, No 13 40. Available: .L. http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2002&sessInd=0&act=13 Pennsylvania Patient Safety Authority 2016 Annual Report 5 Strategic Plan 2017–2020 VISION FOCUS ON EVALUATING Safe healthcare for all patients THE REPORTING SYSTEM FOCUS ON Evaluate scope of patient LONG-TERM safety events captured CARE via PA-PSRS Identify opportunities FOCUS ON Identify key topics to improve data THE PATIENT Expand educational capture offerings FOCUS ON Expand inclusion of Lead an infection IMPROVING patient perspective prevention DIAGNOSIS Identify key topics collaborative Analyze internal and Educate patients on external data to safe healthcare identify trends Improve awareness Update PA-PSRS to of and access to improve data capture resources Lead an ED radiology We will continue to provide collaborative Expand educational these foundational services to offerings support our current and future work Include focus on ambulatory clinics Pennsylvania and practices Patient Safety Data Toolkits analysis Reporting System (PA-PSRS) Advisories/ Facility Patient Safety recommendations contact and Liaisons & Infection consultation Preventionists Online and Collaborative live education Website learning MISSION Improve the quality of healthcare in Pennsylvania by collecting and analyzing patient safety information, developing solutions to patient safety issues, and sharing this information through education and collaboration. 6 2016 Annual Report Pennsylvania Patient Safety Authority Definitions Pennsylvania healthcare facilities are required to submit Reports of Serious Events and Incidents are submitted to reports on the following four kinds of occurrences: the Pennsylvania Patient Safety Authority for the purposes of learning how the healthcare system can be made safer in 1. Serious Event. An adverse event resulting in patient Pennsylvania. Reports of Serious Events and Infrastructure harm. The legal definition from the Medical Care Failures are submitted to the Department so it can fulfill its Availability and Reduction of Error (MCARE) Act:1 role as a regulator of Pennsylvania healthcare facilities. “An event, occurrence or situation involving the clini- cal care of a patient in a medical facility that results The MCARE Act requires the following types of facilities in death or compromises patient safety and results to submit reports of Serious Events, Incidents, and Infra- in an unanticipated injury requiring the delivery of structure Failures to the Authority through the Pennsylvania additional health care services to the patient. The Patient Safety Reporting System (PA-PSRS): term does not include an incident.” Hospitals. The Health Care Facilities Act2 defines a hos- 2. Incident. A “near miss,” in which the patient was pital as “an institution having an organized medical staff not harmed. The legal definition from the MCARE established for the purpose of providing to inpatients, by Act:1 “An event, occurrence or situation involving the or under the supervision of physicians, diagnostic and clinical care of a patient in a medical facility which therapeutic services for the care of persons who are in- could have injured the patient but did not either jured, disabled, pregnant, diseased, sick or mentally ill or cause an unanticipated injury or require the delivery rehabilitation services for the rehabilitation of persons who of additional health care services to the patient. The are injured, disabled, pregnant, diseased, sick or men- term does not include a serious event.” tally ill. The term includes facilities for the diagnosis and treatment of disorders within the scope of specific medical 3. Infrastructure Failure. A potential patient safety issue specialties, but not facilities caring exclusively for the men- associated with the physical plant of a healthcare tally ill.” For this report, at the end of 2016, the Common- facility, the availability of clinical services, or criminal wealth of Pennsylvania had 238 qualifying hospitals. activity. The legal definition from the MCARE Act:1 “An undesirable or unintended event, occurrence Ambulatory surgical facilities. The Health Care Facilities or situation involving the infrastructure of a medical Act2 defines an ambulatory surgical facility as “a facil- facility or the discontinuation or significant disrup- ity or portion thereof not located upon the premises of a tion of a service which could seriously compromise hospital which provides specialty or multispecialty outpa- patient safety.” Reports of Infrastructure Failures are tient surgical treatment. Ambulatory surgical facility does submitted only to the state Department of Health not include individual or group practice offices of private and, therefore, are not addressed in this report. physicians or dentists, unless such offices have a distinct part used solely for outpatient treatment on a regular and 4. Other. The U.S. Centers for Medicare and Medicaid organized basis. …Outpatient surgical treatment means Services (CMS) requires hospitals to report to the surgical treatment to patients who do not require hospital- Department any death of patients in restraints or in ization but who require constant medical supervision fol- seclusion or in which restraints or seclusion were lowing the surgical procedure performed.” For this report, used within 24 hours of death (other than soft wrist at the end of 2016, the Commonwealth of Pennsylvania restraints). Deaths in which the restraints or seclu- had 309 qualifying ambulatory surgical facilities. sion are suspected of or confirmed as having played a role in the death should be reported as Serious Birthing centers.The Health Care Facilities Act2 defines Events. Other deaths in which the restraint or seclu- a birthing center as “a facility not part of a hospital sion use was incidental or not suspected should be which provides maternity care to childbearing families reported under this “Other” category. not requiring hospitalization. A birth[ing] center provides a home-like atmosphere for maternity care, including Pennsylvania Patient Safety Authority 2016 Annual Report 7 prenatal labor delivery and postpartum care related to events may result from clinical care without necessarily medically uncomplicated pregnancies.” For this report, at involving an error. the end of 2016, the Commonwealth of Pennsylvania had six qualifying birthing centers. Although PA-PSRS includes reports of events that result from errors, the Authority’s focus is on the broader scope Act 30 of 20063 extended the report- Abortion facilities. of actual and potential adverse events—not only those ing requirements in the MCARE Act to abortion facilities that result from errors. that perform more than 100 procedures per year. For this report, at the end of 2016, the Commonwealth of Penn- Patient safety officer. The MCARE Act requires each sylvania had 19 qualifying abortion facilities. medical facility to designate a single individual to serve as that facility’s patient safety officer. Under the MCARE Nursing homes. Act 52 of 20074 revised the MCARE Act Act, the patient safety officer is responsible for submitting to require nursing homes to report healthcare-associated reports to the Authority. The MCARE Act also assigns other infections (HAIs) to the Authority. Specifically, the act states responsibilities to the patient safety officer. that “the occurrence of a health care-associated infection Patient safety liaison. The patient safety liaison (PSL) is a in a health care facility shall be deemed a serious event as defined in section 302.”4 Reporting from these facilities be- unique resource to Pennsylvania MCARE facilities. Serv- gan in June 2009. For this report, at the end of 2016, the ing as the face of the Authority, the PSL provides educa- Commonwealth of Pennsylvania had 703 qualifying nursing tion and consultation to MCARE facilities and ensures homes. See the Healthcare-Associated Infections section of that facilities are aware of the resources available to this report for data received from nursing homes. them through the Authority, such as educational toolkits, presentations, and webinars. The program has eight PSLs Other pertinent definitions used in this report are as follows: located regionally throughout Pennsylvania. Medical error. This term is commonly used when discuss- Analyst. The patient safety analyst (analyst) is a member of ing patient safety, but it is not defined in the MCARE Act. the Authority team of clinical professionals with degrees The word “error” appears in PA-PSRS and in this report. and experience in medicine, nursing, pharmacy, health For example, one category of reports discussed is “medi- administration, risk management, product engineering, cation errors.” The Institute of Medicine’s Committee on and statistical analysis. The analyst reviews, aggregates, Data Standards for Patient Safety defines an error as the and investigates reports submitted through PA-PSRS. “failure of a planned action to be completed as intended One example of an analyst is an infection prevention (IP) (i.e., error of execution) or the use of a wrong plan to analyst, who tracks and trends reported HAIs. The IPs work achieve an aim (i.e., error of planning)…. It also includes closely with other agencies and groups (the Department, failure of an unplanned action that should have been Association for Professionals in Infection Control and Epi- completed (omission).”5 demiology [APIC]) to address HAI topics in Pennsylvania. Within the MCARE Act, the term “medical error” is used Reporting standardization. Twenty-eight guiding principles in section 102: “Every effort must be made to reduce went into effect on April 1, 2015, to improve consistency and eliminate medical errors by identifying problems and in event reporting through PA-PSRS. The guidance was implementing solutions that promote patient safety.” It developed to help provide consistent standards to acute is also used in defining the scope of chapter 3, “Patient healthcare facilities in Pennsylvania in determining whether Safety”: “This chapter relates to the reduction of medical occurrences within facilities meet the statutory definitions errors for the purpose of ensuring patient safety.”1 of Serious Events, Incidents, and Infrastructure Failures as defined in section 302 of the MCARE Act.6 The Authority, Adverse event. This term also appears in this report, al- the Department, and healthcare facility staff have worked though it is not defined in the MCARE Act. The Institute of together toward a shared understanding of the require- Medicine Committee on Data Standards for Patient Safety ments. The reporting guidelines were identified based defines an adverse event as follows: “An event that results on frequently asked questions (FAQs), controversies, and in unintended harm to the patient by an act of commission inconsistencies that were evident in the data collected by or omission rather than by the underlying disease or con- the Authority and the Department. dition of the patient.”5 The Authority considers this term to be broader than “medical error,” because some adverse 8 2016 Annual Report Pennsylvania Patient Safety Authority Notes 1. Medical Care Availability and Reduction of Error (MCARE) 5. Institute of Medicine Committee on Quality of Health Care Act of March 20, 2002, P 154, No 13 40. Available: .L. in America. Kohn LT, Corrigan JM, Donaldson MS, editors. http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. To err is human: building a safer health system. Wash- cfm?yr=2002&sessInd=0&act=13. ington (DC): National Academy Press; 1999 Nov. 223 p. Also available: http://www.nationalacademies.org/hmd/ 2. Health Care Facilities Act of Jul. 19, 1979, P 130, No. .L. Reports/1999/To-Err-is-Human-Building-A-Safer-Health- 48, Cl. 35 § 448.802a. Available: http://www.legis.state. System.aspx. pa.us/WU01/LI/LI/US/PDF/1979/0/0048..PDF. 6. Final guidance for acute healthcare facility determinations 3. Medical Care Availability And Reduction Of Error (MCARE) of reporting requirements under the Medical Care Avail- Act - Extending Patient Safety Standards To Certain Abor- ability and Reduction of Error (MCARE) Act, 44 Pa. Bull. tion Facilities Act of May 1, 2006, P 103, No.30 Cl. .L. 6178 (2014 Sep 27). Also available: http://www.pabulle- 40. Available: http://www.legis.state.pa.us/cfdocs/legis/li/ tin.com/secure/data/vol44/44-39/2041.html. uconsCheck.cfm?yr=2006&sessInd=0&act=30. 4. Medical Care Availability and Reduction of Error (MCARE) Act - Reduction and Prevention of Health Care-Associated Infection and Long-Term Care Nursing Facilities Act of July 20, 2007, P 331, No.52, Cl. 40. Available: .L. http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2007&sessInd=0&act=52. Pennsylvania Patient Safety Authority 2016 Annual Report 9 Overview of Data Reported through PA-PSRS Introduction During 2016, more than a quarter million events were estimated that more than 2,600 lives and more than reported through the Pennsylvania Patient Safety Report- $147 million were saved. ing System (PA-PSRS), with an increasing percentage of reports submitted as Incidents, rather than Serious Events. The analysis also discusses the decrease in high harm The category Error related to Procedure/ Treatment/ Test events numbers overall, including the following: continues to be the most common category of Incident Given that the number of medical interactions is in- reports, and Complication of Procedure/ Treatment/ Test creasing, a plausible hypothesis for this decline in high the most common category of Serious Events. harm events is that as improvements are realized in In 2016, the Pennsylvania Patient Safety Authority patient safety, the number and severity of harmful ad- published an analysis based on clinical outcomes and verse events is decreasing. The Authority has seen an economic estimates for patient-safety measures in which increase in the number of Incident (non-harm) events concentrated improvement efforts have occurred.1 Mea- reported through PA-PSRS, and this is consistent with sures chosen for analysis included falls with harm, central this hypothesis that there is a shift to earlier detection line-associated bloodstream infection, catheter-associated and reporting of events with fewer events reaching the urinary tract infection, wrong-site surgery, and high harm patient and causing serious harm.1 events. The intent was to estimate the value of data As noted, this decline of high harm events continues to aggregation (e.g., through PA-PSRS), analysis, dissemi- be evident through the 2016 reporting period, as well as nation, and statewide collaborative learning to reduce the increasing percentage of reports describing Incidents. healthcare-associated patient harm in the Commonwealth This annual report section explains the PA-PSRS reporting during reporting periods of 11 to 12 years (e.g., inception process and focuses on reported event data and evident of PA-PSRS reporting in 2004 through 2015). The Authority reporting trends. Pennsylvania Patient Safety Reporting System (PA-PSRS) PA-PSRS is a secure, web-based system that permits to hospitals and ambulatory surgical facilities by call- medical facilities to submit reports of “Serious Events” and ing the Department of Health at 1-800-254-5164. The “Incidents” involving patients, as defined by the Medical website to file complaints is http://www.health.pa.gov/ Care Availability and Reduction of Error (MCARE) Act.2 facilities/Consumers/Complaints/Pages/default.aspx. Statewide mandatory reporting through PA-PSRS went into Complaints against licensed medical professionals can be effect June 28, 2004. All information submitted through filed with the Department of State’s Bureau of Professional PA-PSRS is confidential, and no information about individ- and Occupational Affairs at 1-800-822-2113. ual facilities is made public. The Department of Health can issue sanctions and penalties, including fines and forfeiture Facilities submit event reports through a process identified of license, to healthcare facilities that fail to comply. in each facilities’ own patient safety plans, as required by the MCARE Act. However, the MCARE Act provides for As defined by the MCARE Act, PA-PSRS is a facility-based one exception to this facility-based reporting requirement: reporting system. Other complaint systems are available a healthcare worker who feels that his or her facility has for individual citizens. Citizens can file complaints related not complied with the MCARE Act reporting requirements Pennsylvania Patient Safety Authority 2016 Annual Report 11 may submit an Anonymous Report directly to the Authority where the event took place, the type of event, and the lev- (see Anonymous Reports). el of patient harm, if any. Patient and healthcare provider names are not solicited. Additionally, the report collects Facility users can access PA-PSRS by means of a computer considerable detail about “contributing factors,” such as with Internet access and minimal, self-directed online staffing, the workplace environment and management, the training.* Patient safety liaisons assigned to each acute impact of health information technology (HIT), and clinical healthcare facility provide additional guidance, and an protocols. Users are also asked to identify the root causes on-call Help Desk is available during business hours. of Serious Events and to suggest procedures that can be implemented to prevent a reoccurrence. To report an event, facility users respond to 22 core ques- tions (e.g., check boxes, free-text narratives); the system PA-PSRS was developed under contract with ECRI Institute, directs to follow-up questions, based on the answers to a Pennsylvania-based independent, nonprofit health ser- previous questions. The process is similar for nursing vices research agency, in partnership with Hewlett Packard homes, which began reporting healthcare-associated Enterprise (HPE), a leading international, information tech- infections (HAIs) in June 2009, with the system posing 18 nology firm, and the Institute for Safe Medication Prac- core and follow-up questions, depending on the type of tices (ISMP), also a Pennsylvania-based, nonprofit health infection reported.† research organization. Facility users provide demographic information (such as a patient’s age and gender), the location within a facility Analysis, Resources, and Feedback The Authority team that analyzes reports includes profes- individual patient-care level. More information about the sionals with degrees and experience in medicine, nursing, Advisory and the data collected through PA-PSRS is cov- pharmacy, health administration, risk and quality man- ered in The Pennsylvania Patient Safety Advisory section. agement, product engineering, and statistical analysis. Additionally, all issues of the Advisory are accessible on Additionally, through its contract staff, the Authority has the Authority’s website at www.patientsafetyauthority.org. access to a large pool of subject matter experts in virtually every medical specialty. The Authority has also developed analytical tools within PA-PSRS that are available to reporting facilities. These Based on this comprehensive analysis and augmented by tools provide patient safety professionals, quality improve- review of healthcare literature and interviews with experts, ment specialists, and risk managers with detailed reports the Authority develops and publishes articles and addi- analyzing data related to their specific facilities in a timely tional resources through the Pennsylvania Patient Safety manner. Many reports can be exported to other software Advisory. The Advisory articles are directed primarily to programs for inclusion in facility publications or reports healthcare professionals, for use by both clinical and ad- and presentations to trustees and senior management. ministrative staff to improve processes and outcomes. The Additionally, facility personnel have the ability to export articles are often supplemented by toolkits, many of which all, or any portion, of their own facility’s data. Managers are interactive, that may be used to clarify and standardize can use this information for their internal quality improve- reporting practices as well as to assess and improve pa- ment and patient safety activities. tient care practices at the organizational, microsystem, or Interpreting PA-PSRS Data Many factors influence the number of reports submitted by quality are just two. Additional factors that affect reporting any particular facility, of which each facility’s safety and include facility size, case volume, services provided, * Available to PA-PSRS users only; contact the Help Desk for more details. † HAIs from nursing homes are addressed under Healthcare-Associated Infections. 12 2016 Annual Report Pennsylvania Patient Safety Authority patient case mix, severity of illness, understanding of what “near misses”—unsafe conditions and events that did not occurrences are reportable, and success in detecting harm patients.3 After more than a dozen years of data reportable occurrences. collection, it is widely considered the most comprehensive program of this type in the United States. The following factors should be considered when review- ing PA-PSRS data: Many factors influence differences between data obtained from different facilities. The most valuable comparisons are —— Data presented in this report include only re- those made by individual healthcare facilities, as they monitor ports of Serious Events and Incidents. Although their own performance over time and in relation to specific PA-PSRS also collects reports of Infrastructure patient safety goals relevant to their healthcare setting. Failures and reports that fall outside of these categorizations (Other), these reports are sub- mitted only to the Pennsylvania Department of Figure 1. Submission of PA-PSRS Reports Health. The Authority does not receive reports of Infrastructure Failures or Other (Figure 1). Incidents —— Unless specifically noted, data presented in this report are based on reports submitted through PA-PSRS between January 1, 2016, and Decem- Serious Events ber 31, 2016. Data from acute-care facilities are presented in this section. HAI data from Healthcare nursing homes are presented in Healthcare- facilities Infrastructure Failures Associated Infections. —— Unless specifically noted, numbers of reports in different categories are actual “raw numbers” Other MS17211 and have not been adjusted for any facility- or patient-related factors that may influence differ- ences in report volume among different facilities. —— Unless specifically noted, historic data and trend Finally, overarching explanations of why certain event types predominate in aggregate data are complex, span the years 2005 through 2016. These years especially because each event type may relate to numer- are the twelve full calendar years of PA-PSRS ous and diverse clinical situations. The Authority identi- data collection. fies and approaches themes from the annual report and —— The data are not adjusted to account for specific topics from the event reports (i.e., that have the medical facility openings, closings, or changes potential for generalizable learning and improvement to of ownership. patient safety) based on their frequency, severity, interest to clinicians, or other relevance. Subsequently, the Authority Caution is advised when comparing data contained in this develops information and opportunities for improvement, report with data published by other patient safety reporting and disseminates said information to healthcare facilities systems. PA-PSRS was developed within the context of the in Pennsylvania and other consumers through its Advisory, MCARE Act, which has its own unique definitions for what education and collaboration focuses, and other outreach is and what is not reportable through PA-PSRS.2 PA-PSRS activities (see the respective sections of this report for also uses a specific taxonomy of event types that may be specific examples). different from the lists used by other systems. PA-PSRS was the first mandatory state program collecting data on Pennsylvania Patient Safety Authority 2016 Annual Report 13 Report Volume Reports by Month and Submission Type Between January 1 and December 31, 2016, Pennsyl- Of reports submitted in 2016, 3% were Serious Events, vania acute care facilities submitted 255,714 reports while 97% were Incidents. In 2016, the Authority received through PA-PSRS, bringing the total number of reports an average of 21,310 reports per month. This total breaks submitted since the program’s inception to 2,765,059. down to an average of 20,681 Incident reports and 629 Figure 2 shows the distribution of submitted reports by Serious Event reports per month. month for calendar year 2016. For the year, 7,548 Seri- ous Events and 248,166 Incidents were reported. Figure 2. Number of Reports Submitted through PA-PSRS in 2016, Acute-Care Facilities NUMBER OF REPORTS 25,000 680 645 619 670 637 584 644 649 599 661 582 20,000 578 18,825 22,830 20,290 19,286 19,918 20,989 15,000 19,166 20,405 21,804 21,411 20,767 22,375 10,000 5,000 0 Jan Feb May Jun Jul Aug Sep Oct Nov Dec Mar Apr MONTH MS17212 Serious events Incidents Reports by Facility Type As shown in Table 1, the total number of reports submitted the predominance of reports from hospitals is even more through PA-PSRS in 2016 surpassed a quarter million. The pronounced (96.9%). Nursing homes submitted 9.7% of vast majority of all reports (87.5%) were submitted by hos- the overall total number of reports in 2016. pitals. Among acute-level facilities (non-nursing homes), Table 1. Reports through PA-PSRS by Facility Type (2016) BIRTHING AMBULATORY CENTERS/ ALL ACUTE NURSING ALL FACILITIES SURGICAL ABORTION LEVEL HOMES REPORTING FACILITY TYPE HOSPITALS FACILITIES FACILITIES FACILITIES (HAI ONLY) VIA PA-PSRS Number of reports submitted 247,763 7,672 279 255,714 27,544 283,258 Number of facilities active as of December 31, 2016 238 308 25 571 703 1,274 14 2016 Annual Report Pennsylvania Patient Safety Authority Figure 3. Number and Percentages of Reports by Acute Facility Types, 2005 through 2016 NUMBER OF SUBMITTED REPORTS Ambulatory facilities Hospitals 300,000 2.1% 2.5% 2.9% 3.1% 250,000 1.6% 1.7% 2.1% 2.2% 1.3% 1.4% 1.3% 97.9% 97.5% 97.1% 96.9% 200,000 1.2% 97.9% 97.8% 98.7% 98.6% 98.4% 98.3% 150,000 98.7% 100,000 98.8% 50,000 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR NUMBER OF SUBMITTED REPORTS BY AMBULATORY FACILITIES 2,500 Common cause variation Special cause variation 1,977.8 2,000 1,804.7 1,500 1,631.6 562.3 1,000 Upper control limit 500 Center line 389.1 216 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) RANGE 250 Upper control limit 212.6 200 150 100 Center line 65.1 50 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) NUMBER OF SUBMITTED REPORTS BY HOSPITALS 80,000 72,122.5 70,000 Upper control limit 62,495.7 60,000 56,808.3 50,000 Center line 47,181.5 52,289.0 40,000 30,000 37,554.8 20,000 Lower control limit 10,000 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) RANGE 12,000 Upper control limit 11,823.6 10,000 8,000 6,000 4,000 Center line 3,619.1 2,000 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 MS17279 YEAR (BY QUARTER) Note: Control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). Pennsylvania Patient Safety Authority 2016 Annual Report 15 The remainder of this data section will focus on acute-care facilities; data from nursing homes are presented in Health- Control Charts care-Associated Infections. Evaluate Process Figure 3 shows the increasing percentage of report submis- Stability over Time sions from nonhospital acute-level facilities—ambulatory surgical facilities, birthing centers, and abortion facilities How does one know whether variation in data from a process or system is expected (ASFs/BCs/ABFs)—compared with hospital reports from or erratic? Control charts are used as a way 2005 to 2016. The figure contains trended control charts of to visually monitor a process for stability.1 quarterly report submissions from both ambulatory facilities When a process is stable, or in control, some and hospitals. Although both groups experienced increased variation is expected and is referred to as reporting in general, the percentage from ambulatory facili- common cause variation. When the process ties is increasing more quickly, by comparison. Notice that is unstable, the chart will show out-of-range both reporting patterns appear to be stable, exhibiting com- fluctuation, known as special cause or mon cause variation from quarter to quarter. nonrandom variation. Control charts contain these key elements: Report Submission Trends •• A line chart of data measuring the The trend line superimposed over the number of monthly process over time. reports in Figure 4 indicates that the volume of reports is •• A center line (CL) calculated as the growing at a modest rate and that reporting has had a average or median of the data. stable increase in recent years. •• An upper control limit (UCL) line cal- culated at 3 sigma above the center Figure 4. Number of Submitted Reports, Monthly, 2005 line. through 2016 •• A lower control limit (LCL) line calcu- NUMBER OF REPORTS lated at 3 sigma below the center line. 25,000 Throughout this report, the individual moving range (IMR) control chart is used to evaluate 20,000 stability of a single process using variable data (number of reports, rate per 1,000 15,000 patient days) . One should evaluate the range (bottom) chart first. If it is “out of control,” so 10,000 is the process. If the range chart looks okay, then evaluate the X (top) chart. 5,000 M S17213 Where appropriate, trend charts are used. 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 The CL, UCL, and LCL are sloped at the same angle to portray the incline or decline of the respective data. This allows for evaluation YEAR of the trend against normal expectations of Monthly reports Trend increase and decrease. Figure 5 supports the proposition of improved reporting. Note Depicting the volume of Serious Events and Incidents on a 1. KnowWare International, Inc. What is a relative scale (24:1) shows that the volume of Serious Events Control Chart? [online] [cited 2017 Mar 20] has increased somewhat over the long term, but not as https://www.qimacros.com/control-chart/ sharply as the volume of Incidents. However, new published guidance* that clarified interpretations of the Serious Event definition and its component terms may have been temporally * http://www.pabulletin.com/secure/data/vol44/44-39/2041.html 16 2016 Annual Report Pennsylvania Patient Safety Authority Figure 5. Number of Serious Event and Incident Reports and Trend of Serious Reports, Monthly, 2005 through 2016 INCIDENT SERIOUS EVENT REPORTS Incidents Serious Events REPORTS 25,000 1,000 20,000 800 15,000 600 10,000 400 5,000 200 0 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR NUMBER OF SERIOUS EVENT REPORTS Final Guidance released 940 Upper control limit 769.9 840 748.3 740 Center line 639.5 640 540 Lower control limit 440 530.7 482.1 340 240 140 40 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR Common cause variation Special cause variation RANGE 250 Upper control limit 193.3 200 150 133.6 100 Center line 59.2 50 40.9 Lower control limit 0 MS17214 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR Note: Control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). Pennsylvania Patient Safety Authority 2016 Annual Report 17 associated with reporting of these events. The two control gest that the timing of the guidance was associated with charts in Figure 5 have an adjustment for when the final decreased variability (possibly greater standardization) in guidance was issued in April 2015—the process change the number of Serious Events reported. point was noted and the variability recalculated. They sug- Reports by Event Type When reporting an event through PA-PSRS, a facility uses These categories are further broken down into second- a classification taxonomy to characterize the occurrence and third-level subcategories. For example, the category being reported. At the outset, a facility classifies a report “Falls” includes a series of subcategories such as: by identifying what PA-PSRS defines as the “event type.” An event type dictionary is one way the Authority classi- •• Falls while Lying in Bed fies and analysts look for patterns and trends in submitted •• Falls while Ambulating reports. The top-level event type essentially answers the most basic question about an occurrence: “What type of •• Falls in the Hallways of the Facility event happened?” The complete event-type dictionary is a three-level, hierarchical taxonomy with 222 distinct •• Other Types of Falls event types. Figure 6. Comparison of Event Types by Percentage* of Total Reports Submitted, 2016 All Serious Events 18% 14% 10% 53% 30% 3% 8% 7% 12% 11% 14% 8% 3% 2% 2% 2% 2% 1% 1% Errors related to procedure/ Skin integrity Adverse drug reactions treatment/test (not a medication error) Equipment/supplies/devices Medication errors Self harm Other/miscellaneous† Falls Transfusions All serious events‡ Complications of procedure/ MS17215 treatment/test * Event types are coordinated by color between Incidents (97%) and Serious Events (3%). At left, values are a percentage of total Incidents submitted. At right, values are percentage of total Serious Events submitted. Due to rounding, percentages may appear greater or less than 100%. † This is not a single category of completely unclassified reports but rather a category that includes specific subcategories that did not logically fit under other existing top-level headings. Examples of subcategories under Other/Miscellaneous include Inappropriate Discharge, Other Unexpected Death, and Electric Shock to the Patient. ‡ Serious Events represent 3% of overall 2016 PA-PSRS submissions. Transfusions, not pictured under Serious Events, represent less than 1% of the total Serious Events. 18 2016 Annual Report Pennsylvania Patient Safety Authority Figure 6 shows the percentage of reports submitted from Table 2. Highest Percentage Increases among acute-level facilities under each top-level event type in Report Submissions by Event Subtype, 2016 2016. The most frequently reported occurrences were ERRORS RELATED TO CHANGE IN Errors Related to Procedure/ Treatment/ Test (29%) and PROCEDURE/ NUMBER OF CHANGE TREATMENT/TEST REPORTS IN (%) Medication Errors (18%). These two event types account for 2016 VS. 2015 about 47% of all reports submitted. Although Errors Related Laboratory test problem/ to Procedure/ Treatment/ Test was the event type most fre- 6,160 83.9 Specimen quality problem quently reported through PA-PSRS, it was not the event type Laboratory test problem/ most frequently associated with patient harm. Other 2,048 34.9 Also shown in Figure 6 is a graphic comparison of the Referral/Consult problem/ 939 46.2 Delay in service percentage of submissions as Serious Events and Incidents by event type. The event type Complications of Procedure/ Surgery or invasive procedure problem/Procedure cancelled 571 20.3 Treatment/ Test accounted for more than half (53%) of or not performed the Serious Events submitted in 2016. This event type historically constitutes the largest percentage of Serious Events. For example, in calendar years 2014 and 2015, the percentage of Serious Events from this event type Table 3. Annual Decrease of Reports by Event Subtype, 2016 were 53% and 54%, respectively. DECREASING CHANGE IN CHANGE EVENT TYPES NUMBER OF (%) Analysis reveals that the number of the event type Errors REPORTS IN 2016 VS. 2015 Related to Procedure/ Treatment/ Test increased 21%, com- pared to 2015. This category’s increase equates to 76.2% Skin integrity/Pressure ulcers/ -4,644 -51.6 Admitted from other facility of the total report submission increase in 2016. Table 2 shows several subtypes within that category accounting for Other/Other -2,518 -14.5 the predominant increases by percentage. As noted previ- Skin integrity/ Pressure ulcers/ -850 -68.0 ously, the Authority identifies and approaches apparent New ulcer <24 hours after admission themes from the annual report and other analysis sources for Skin integrity/Other -561 -14.8 subsequent education and prevention strategies to health- care facilities. More in-depth analysis of these distributions may provide input in forthcoming education, if warranted. procedure complications, and orthopedic-related events. A This increase in Errors Related to Procedure/ Treatment/ decrease in Pressure Injury reports may also reflect the effect Test was offset by decreases in overall Skin Integrity reports of standardization and clarifications made in the Final Guid- (-19.1%) and the Other/Other sub-event type reports ance document.* Further information about the Standardiza- (-14.5%). The standardization effort, which included the tion effort can be found in Reporting Standardization. addition of several new reporting subtypes may have con- tributed to the decrease in the number reports submitted Table 3 lists several event subtypes that realized decreases. in the Other/Other subtype—for example, patients return- ing to the emergency department after discharge, surgical Reports by Level of Patient Harm For every report submitted through PA-PSRS, the associat- much harm it caused.† This scale4 ranges from “unsafe ed healthcare facility applies a 10-item scale to measure conditions” (e.g., look-alike medications stored next to whether an event “reached” the patient and, if so, how one another) to the death of the patient. * http://www.pabulletin.com/secure/data/vol44/44-39/2041.html † For example, an event in which a phlebotomist prepares to draw blood from the wrong patient but catches the error by checking the patient’s wristband would be an event that did not reach the patient. Pennsylvania Patient Safety Authority 2016 Annual Report 19 Figure 7 shows the reports received during 2016 catego- •• Anesthesia Event/ Aspiration reports—54.2% rized by the level of harm (as described above). For the involved harm most part, the reports at each level of harm follow a similar distribution by event type as they do in the database as a •• Complication following surgery or invasive proce- whole (e.g., Harm score C is generally the most frequently dure/ Unplanned return to operating room—48.0% submitted harm score for each event type). However, as reports involved harm seen in recent years, not all event types adhere to the These findings, similar to other data trends identified by distribution shown in Figure 7. For example, while the event Authority staff, will be queued and investigated further. If type Complication of Procedure/ Treatment / Test comprise warranted, these data distributions may be addressed in 14.8% of reports overall in 2016, as previously noted, it forthcoming education. comprises 53.0% of the reports of events involving harm, including those resulting in or contributing to the patient’s At the other end of the spectrum, although the event type death. Complication event examples include the following: Medication Errors comprises 17.9% of reports in 2016, it •• Complication following surgery or invasive proce- comprises only 2.3% of reports involving harm and 0.9% dure/ Pneumothorax reports—57.1% involved harm of reports of events contributing to or resulting in death. Figure 7. PA-PSRS Harm Scale for Acute-Level Facilities, 2016 PERCENTAGE OF REPORTS 45 42.79 40 35 32.14 30 25 20 15 12.91 10 8.02 5 MS17216 1.19 1.96 0.83 0.03 0.05 0.09 0 A B1 B2 C D E F G H I HARM SCORE HARM LEVEL HARM SCORE DEFINITION Unsafe A Circumstance that could lead to an Condition adverse event Event, No Harm B1, B2, C, D Often called a “near miss,” an event that either did not reach the patient or did reach the patient but did not cause harm Event, Harm, E, F, G, H An event that reached the patient and excluding Death caused temporary or permanent harm Event, Death I An event that resulted in or contributed to death Note: Percentage of Harm Scores given to second decimal to illustrate low percentages of higher harm. 20 2016 Annual Report Pennsylvania Patient Safety Authority Reports of the event type Error Related to Procedure/ Treat- The event type in which unsafe conditions were least fre- ment/ Test were also associated with harm or death at a fre- quently reported by percentage was Adverse Drug Reac- quency lower than their representation in the database as a tions. Of all reports of the Adverse Drug Reactions event whole. Although 7.4% of events resulted in patient harm, no type, 0.3% were reported as unsafe conditions. deaths were associated with reports related to Skin Integrity. Reports with harm scores of G, H, and I are deemed high The designation “Harm Score A” is intended to identify harm events because they are associated with permanent “unsafe conditions,” meaning that there was an observed harm or death. With the exception of high harm events situation, or hazard, in which some harm was a possibility if in 2015, the number of high harm events has decreased corrective action was not taken. Unsafe conditions were cited annually since 2005, both in number and as a percent- in 8% of the reports submitted in 2016. As shown in Figure age of Serious Events, as shown in Figure 9. Although the 8, and consistent with previous annual analysis, the event overall number of high harm events is trending downward, type in which unsafe conditions were most often reported the rate of decrease slows in the last eight quarters. was Error Related to Procedure/ Treatment/ Test (40%). Figure 8. Reports by Event Type and Level of Patient Harm, 2016 EVENT TYPES Error related to procedure/treatment/test Medication error Complication of procedure/treatment/test Fall Skin integrity Equipment/supplies/devices Adverse drug reaction Transfusion Self harm Other/miscellaneous MS17217 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 NUMBER OF REPORTS Error related Complication Equipment/ Adverse to procedure/ Medication of procedure/ Skin supplies/ drug Self Other/ treatment/test error treatment/test Fall integrity devices reaction Transfusion harm miscellaneous Unsafe condition 8,249 2,190 1,473 191 2,808 1,181 53 859 19 3,481 Event, no harm 65,102 43,380 32,428 33,363 21,296 5,637 5,398 3,457 1,478 16,113 Harmful event 596 171 3,852 937 544 74 221 27 145 763 Death event 11 2 149 3 0 2 0 1 7 43 Pennsylvania Patient Safety Authority 2016 Annual Report 21 Figure 9. Number, Percentage, and Trends of High Harm Events Reported by Acute-Level Facilities through PA-PSRS by Year, 2005-2016 NUMBER OF HIGH HARM REPORTS 500 6.0%* I 453 450 H 5.2% 5.0% 4.2% G 400 360 365 366 3.7% 4.0% 350 306 3.6% 299 287 3.2% 3.3% 300 254 2.9% 253 2.9% 2.9% 250 2.5% 2.5% 221 208 218 2.5% 2.1% 2.1% 184 176 182 1.6% 173 2.1% 1.9% 200 155 171 1.8% 1.6% 135 1.3% 1.2% 145 150 1.2% 1.2% 130 124 1.3% 106 90 95 94 100 87 0.6% 0.7% 0.7% 47 53 59 0.9% 50 0.8% 0.7% 0.6% 0.8% 1.0% 68 73 48 59 75 58 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR NUMBER OF HIGH HARM REPORTS 275 Upper control limit 225 216.4 175 Center line 137.9 125 Lower control limit 121.1 90.3 75 42.6 25 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) RANGE Common cause variation Special cause variation 70 Upper control limit 58.5 60 50 40 30 Center line 17.9 20 10 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 MS17278 YEAR (BY QUARTER) * Percent of Serious Events Note: Control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). 22 2016 Annual Report Pennsylvania Patient Safety Authority Reports Involving the Patient’s Death Reports involving events that may have contributed to or This decrease follows the general trend of the decreas- resulted in the patient’s death (harm score I) account for ing number of harm score I reports, as seen in Figure 10, fewer than 0.09% (i.e., about one tenth of one percent) over the twelve-year period starting in 2005. The total for of all submitted reports. In 2016, the Authority received 2016 is second fewest for a full year of reporting in PA- 218 reports of events that had a harm score of I, a 13.8% PSRS history. The majority of reports involving a patient’s decrease from 2015. death are associated with the event type Complications of Procedure/ Treatment/ Test. Figure 10. Trend of Death Events Reported by Acute-Level Facilities through PA-PSRS by Quarter, 2005-2016 NUMBER OF DEATH EVENT REPORTS 160 Upper control limit 140 136.9 120 Center line 100 103.4 80.7 80 Lower control limit 70 60 40 47.2 20 13.8 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) Common cause variation Special cause variation RANGE 45 Upper control limit 41.1 40 35 30 25 20 15 Center line 12.6 10 5 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 MS17280 YEAR (BY QUARTER) Note: Control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). Pennsylvania Patient Safety Authority 2016 Annual Report 23 In terms of particular event types, although 14.8% of another invasive procedure (56.4%), with the next highest all reports in 2016 were attributed to Complication of percentages reported as patients who suffered cardiopul- Procedure/ Treatment/ Test, 68.3% of all reports involv- monary arrest outside the intensive care unit (ICU) setting ing patient death were of that event type (Figure 11). Of (14.1%) and neonatal complications (7.4%). the reports involving death associated with complications, the majority describe patients who died after surgery or Figure 11. Reports Involving the Patient’s Death, by Event Type, 2005 through 2016 NUMBER OF EVENTS ASSOCIATED WITH PATIENT DEATHS 500 400 300 200 100 MS17218 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR Complication of procedure/treatment/test 277 200 214 215 181 180 169 144 128 111 144 149 Error related to 17 20 20 19 18 22 14 21 14 18 14 11 procedure/treatment/test Fall 16 24 14 11 9 17 17 11 8 14 10 3 Medication error 11 7 7 2 2 6 4 5 3 4 3 2 Adverse drug reaction 8 8 5 12 3 3 2 4 2 3 4 0 Equipment/supplies/devices 2 2 3 2 3 3 2 3 3 0 5 2 Self harm 0 0 0 0 0 0 0 0 0 0 2 7 Transfusion 3 0 0 1 1 0 0 0 0 1 1 1 Skin integrity 1 0 0 0 1 0 0 0 0 0 0 0 Other/miscellaneous 117 99 103 103 86 68 81 65 64 56 70 43 Notes: Event types listed in ascending order by total. Self-harm added as event type in 2015. 24 2016 Annual Report Pennsylvania Patient Safety Authority Patient Demographics PA-PSRS collects few demographic details about patients data are limited to gender and age. Figure 12 shows because the Authority is not authorized to collect individu- report submissions by age and gender. ally identifying information. As a result, patient disparity Figure 12. Number and Percentage of Reports Submitted by Age Cohort and Gender, 2016 NUMBER OF REPORTS 25,000 20,000 15,000 10,000 5,000 MS17219 0 0 to 4 5 to 14 15 to 24 25 to 34 35 to 44 45 to 54 55 to 64 65 to 74 75 to 84 85+ Unknown AGE COHORTS IN YEARS Female Male Patient Gender Of the 255,714 reports submitted in 2016, 132,144 of reports involving female patients classified as Serious (51.7%) involved female patients, and 123,570 (48.3%) Events, compared to 2.8% for reports involving males. involved male patients. This proportion by gender is in line with the Authority’s reported trends since 2004 and with Figure 13 shows the distribution of reports by patient evidence in the medical literature. According to Nowatzki gender and event type. Many of the patterns observed in and Grant, during childbearing years, women are more 20156 are evident this year as well. Among these ob- likely than men to have encounters with the healthcare served patterns, the proportion of reports involving female system, and because women have a longer life expectancy patients was greater than 60% among reports of Adverse than men, there are more women in the general popula- Drug Reactions and Self Harm. The three event types tion in the older age cohorts.5 involving a greater proportion of male patients in 2016 included equipment issues, falls, and skin integrity reports. The proportion of reports classified as Serious Events dif- fered slightly according to the patient’s gender, with 3.1% Pennsylvania Patient Safety Authority 2016 Annual Report 25 Figure 13. Number and Percentage of Reports Submitted by Gender and Event Type, 2016 NUMBER OF REPORTS 80,000 70,000 60,000 47.7% 50,000 40,000 48.8% 30,000 44.2% 51.6% 20,000 52.3% 52.9% 48.9% 51.2% 37.7% 55.8% 10,000 48.4% 47.7% 32.9% 52.2% 47.1% 67.1% 51.1% MS17220 62.3% 47.8% 52.3% 0 Medication Adverse Equipment/ Falls Errors Complications Transfusions Skin Self harm Other/ errors drug supplies/ related to of procedure/ integrity miscellaneous reactions devices procedure/ treatment/ treatment/ test test EVENT TYPES Male 22,337 2,136 3,601 17,804 35,305 16,750 2,076 13,035 542 9,984 Female 23,406 3,536 3,293 16,690 38,653 21,152 2,278 11,613 1,107 10,416 Patient Age Figure 14 shows the proportion of events reported through of reports) merely reflects greater representation in the PA-PSRS, from hospitals only, by gender and by patient healthcare system in terms of number of admissions and age cohort. As discussed above, this figure reflects that patient days. The PHC4 data show that patients age 65 women are more likely as are men to have encounters and older make up 39.8% of the admissions to hospitals with the healthcare system during childbearing years. in 2015. Patients age 65 or older account for 41.0% of all reports from hospitals through PA-PSRS in 2016. The fact that patient age and gender in reports submitted through PA-PSRS track so closely to distribution of age and Also shown on this figure is the proportion of hospital in- gender in the hospitalized population speaks to the overall patient admissions as reported by the Pennsylvania Health generalizability of the data healthcare facilities submitted Care Cost Containment Council (PHC4).* Reports through to the Authority. PA-PSRS roughly track admissions by age cohort. Older patients’ representation among PA-PSRS reports (41.0% * Based upon publicly available data from the website of the Pennsylvania Health Care Containment Council (www.PHC4.org). Estimates based on statewide inpatient data from 2015. 26 2016 Annual Report Pennsylvania Patient Safety Authority Patients in High and Low Age Cohorts Elderly Patients In the Authority’s previous annual reports, several patterns pressure injuries, in 2005. This figure declined steadily to of interest were identified with respect to reports involving 64.6% in 2016. The decline in the submission of reports elderly hospital patients (age 65 or older). For example, of pressure injuries may reflect the effect of standardization fewer than 50% of reported Falls have involved elderly and exclusions in reporting as outlined in the Final Guid- patients since 2014 (Figure 15). ance document.* See the Reporting Standardization section for more details about previous and ongoing efforts. In another area of interest, elderly hospital patients ac- counted for 73.2% of Skin Integrity reports, including Figure 14. Proportion of Hospital Reports Submitted by Gender and Age Cohort, 2016* PERCENTAGE BY AGE COHORT 20 Admissions (PHC4 data) 15 Female (PA-PSRS data) Male (PA-PSRS data) 10 5 MS17221 0 0 5 15 25 35 45 55 65 75 85+ to 4 to 14 to 24 to 34 to 44 to 54 to 64 to 74 to 84 AGE COHORTS IN YEARS * Based upon publicly available data from the website of the Pennsylvania Health Care Cost Containment Council (www.PHC4.org). Estimates based on statewide inpatient data from 2015. PA-PSRS, Pennsylvania Patient Safety Reporting System; PHC4, Pennsylvania Health Care Cost Containment Council. Figure 15. Percentage of Reports of Specific Event Types Involving Elderly Hospital Patients (age 65 or older) PERCENTAGE 100 90 80 73.2 73.2 73.6 73.2 70.7 70.6 69.5 68.1 68.0 66.7 70 64.0 62.4 61.2 66.0 64.6 60.1 57.4 60 56.2 54.2 52.0 51.1 49.6 49.9 49.1 50 53.0 53.2 52.8 51.9 50.0 48.3 46.9 40 46.0 43.2 42.9 43.4 41.0 30 20 MS17222 10 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR Skin integrity Falls Total * Final Guidance for Acute Healthcare Facility Determinations of Reporting Requirements under the Medical Care Availability and Reduction of Error (MCARE) Act. 44 Pa.B. 6178, September 27, 2014. Available online: http://www.pabulletin.com/secure/data/vol44/44-39/2041.html Pennsylvania Patient Safety Authority 2016 Annual Report 27 Figure 16. Percentage of Medication Errors among All Event Types Involving Perinatal Hospital Patients (20 days or younger), 2005 through 2016 PERCENTAGE 30 Upper control limit 25 26.8 24.2 Center line 20 17.9 15 Lower control limit 14.2 11.6 10 5 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) Common cause variation Special cause variation RANGE 9 Upper control limit 7.7 8 7 6 5 4 3 Center line 2.4 2 1 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) MS17281 Note: Control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). 28 2016 Annual Report Pennsylvania Patient Safety Authority Perinatal Patients In all, 8,551 reports involved perinatal hospital patients About one fifth (19.9%) of reports involving perinatal (those aged 20 days or younger), an increase of 879 re- patients were related to Medication Errors. There is a slight ports (10.3%) from 2015. Less than 2% (1.36%) of perinatal but consistent decline in the percentage of reports involving reports were classified as Serious Events, noticeably lower Medication Errors since 2005 for this age cohort (Figure than the overall Serious Event percentage of 3.0% for 2016. 16). Complication of Procedure, Treatment and Test ac- counted for 73.3% of the Serious Events in this age group, About two thirds (66.4%) of reports for perinatal patients which is somewhat higher than for this event type in 2015 were related to events of Error or Complication of Proce- (61.2%). Four out of five of these complications are neona- dure/ Treatment/ Test. Because of specialized needs based tal complications, such as birth injury or trauma (n = 35), on age and size, these patients are proportionally more other (n = 15), unplanned transfer to the neonatal inten- likely to experience errors or complications compared with sive care unit (NICU; n = 7) and neonatal death (n = 6). other event types associated with older patient age groups. Children and Adolescents A total of 46,656 reports submitted through PA-PSRS in Test, accounting for 35% of the reports of this population, 2016 involved children and adolescents (i.e., patients and Medication Errors, at 28.8%. However, the event type younger than 21 years). This number is higher this year Complication of Procedure/ Treatment/ Test made up 55.4% because of normal variation in reporting. The top two of the 540 Serious Events for this age group. Table 4 lists the report types were Error Related to Procedure/ Treatment/ three largest event subtypes by percentage in this age group. Table 4. Top Three Complication of Procedure/ Test/ Treatment Subtypes, by Percentage of Serious Events among Children and Adolescents, 2016 COMPLICATIONS OF PROCEDURES/TREATMENTS/TESTS SERIOUS EVENTS SERIOUS EVENTS (ALL SERIOUS EVENTS FOR CHILDREN AND ADOLESCENTS) (NO.) (%) Complications of Procedures/Treatments/Tests 299 55.4 Complication following surgery or invasive procedure/Unplanned 74 13.7 return to operating room Complication following surgery or invasive procedure/Other 59 10.9 Neonatal complication/Birth injury or trauma 35 6.5 Reports by Location/Department (Hospitals Only) PA-PSRS has 155 designated care areas for hospitals. These Although most hospital reports were submitted from the are the locations or departments of the hospital in which Critical Care and General Medical/ Surgical areas, the a patient receives care or is exposed to in the process of greatest number of Serious Events came from Surgical Ser- receiving care. As illustrated in Figure 17, the care areas vices, accounting for nearly one third of Serious Events from designated as Critical Care Areas and General Medical/ hospitals. However, the care areas with highest proportion Surgical Units were cited as the locations for the greatest of Serious Events per submitted report were the Diagnostic/ number of overall reports submitted in 2016, each generat- Labs Care Group and Surgical Services (Table 5). ing nearly one fifth of the total. Other hospital departments with high report rates were Pediatric Care, Surgical Services, and Intermediate Unit. Pennsylvania Patient Safety Authority 2016 Annual Report 29 Figure 17. Percentage of Submitted Reports by Location/Department (Hospitals Only), 2016 CARE AREA GROUP Critical care 18.2 General medical/Surgical units 17.3 Pediatric care 11.0 Surgical services 9.5 Intermediate unit 7.4 Ancillary departments 6.2 Specialty units 5.6 Radiology services 4.7 Inpatient psychiatry 4.5 Inpatient rehabilitation 4.5 Outpatient clinics 3.2 Obstetrical care 2.8 Physical plant 2.3 Diagnostics/Labs 1.5 Rehabilitation services 0.9 Extended care 0.3 Administration 0.2 Chemical dependency 0.1 MS17223 Other 0.0 0 5 10 15 20 PERCENTAGE Table 5. Number and Percentage of Serious Events among all Serious Events and of Submitted Reports, by Care Area Location (Hospitals Only), 2016 SERIOUS EVENTS SERIOUS EVENTS LOCATION SERIOUS EVENTS TOTAL BY GROUP (%) (% OF TOTAL) Diagnostic/Labs 299 3,686 8.1 5.1 Surgical services 1,873 23,506 8.0 32.0 Inpatient psychiatric 380 11,066 3.4 6.5 Obstetrical care 228 6,959 3.3 3.9 Physical plant 147 5,577 2.6 2.5 14 other care groups 2,922 196,969 1.5 50.0 30 2016 Annual Report Pennsylvania Patient Safety Authority Reports by Region and Submission Type For this report, the Pennsylvania Patient Safety Authority region, the number of reports from hospitals per 1,000 Board of Directors has adopted a geographic break- patient days.* This figure shows that, after accounting down of the Commonwealth into six regions, as shown in for the differences in the volume of healthcare provided Figure 18. This breakdown is based on the Department of by hospitals in each region, those in the Northwest and Health’s Public Health Districts. Southcentral regions reported the highest number of Inci- dents per 1,000 patient days. The variation in the number of reports submitted through PA-PSRS by geographic region (Figure 19) may be Figure 21 shows that the Northcentral and Northeast explained by noting proportion of reporting patterns; for regions submitted the greatest proportion of Serious example, more reports may be submitted in regions with Events, comprising 4.9% and 3.4% of their event reports, larger populations and greater numbers of healthcare respectively, as compared to the statewide pooled mean facilities. Consistent with this statement, the regions with of 2.6%. Conversely, the Southeast and Southwest regions the greatest number of reports (Southeast and Southwest) submitted the highest proportion of Incidents comprising were those with the Commonwealth’s two largest popula- 98.2% and 98.0% of their event reports, respectively. tion centers: Philadelphia and Pittsburgh, respectively. The Authority will continue to look for trends and closely moni- Many factors contribute to reporting variation. The Au- tor the data within these regions. thority continues to provide education about reporting, to refine the reporting criteria when appropriate, and to Adjusting the report volume for a measure of healthcare examine variance. It would be speculative to consider utilization paints a different picture. Figure 20 shows, by facilities in any of the regions as less or more safe than Figure 18. Regions of the Commonwealth Northwest Northcentral Northeast Erie McKean Susquehanna Warren Tioga Bradford Potter Crawford Wayne Forest Wyoming Elk Cameron Sullivan Lackawanna Venango Lycoming Pike Mercer Clinton Luzerne Clarion Jefferson Columbia Monroe Lawrence Clearfield Montour Centre Union Butler Armstrong Northumberland Carbon Snyder Northampton Beaver Schuylkill Indiana Mifflin Lehigh Juniata Allegheny Cambria Blair Bucks Perry Dauphin Berks Lebanon Westmoreland Huntingdon Cumberland Montgomery Washington Lancaster Chester Fayette Somerset Bedford Fulton Franklin Adams York MS15180 Greene Philadelphia Delaware Southwest Southcentral Southeast * Based upon publicly available data from the website of the Pennsylvania Health Care Containment Council (www.PHC4.org). Estimates based on statewide inpatient data from 2015. Pennsylvania Patient Safety Authority 2016 Annual Report 31 those in other regions based solely on this data. It may Southeast region submitted 46.9% of all Medication Errors mean that the healthcare providers in certain facilities or submitted in 2016. Meanwhile, the region accounted for regions were better at identifying and reporting potential 19.9% of all Other/Miscellaneous reports, as compared patient safety issues. The Authority does not risk adjust for to the region’s 34.3% overall share of the Common- factors (e.g., severity of illness). The Authority will further wealth’s reports. review this variation in the coming year. Another example of variability in reporting is found in Figure 22 shows that the Southwest region has the largest the Northwest region; hospitals of that region submitted number of reports submitted per hospital. 14.8% of all its reports as Other/Miscellaneous reports, the highest percentage of the state. Further analysis reveals that regional reporting by hospi- tals varies by event type. For instance, the hospitals in the Figure 19. Number of Serious Event and Incident Reports Figure 20. Reports from Hospitals* per 1,000 Estimated from Hospitals by Region, 2016 Patient Days by Region, 2016 Northwest Northcentral Northeast Northwest Northcentral Northeast ! 544 ! 1.1 ! 773 ! 905 ! 1.6 ! 0.8 18,094 35.6 14,976 26,062 31.8 23.6 ! 1,258 ! 821 ! 1,539 ! 0.6 ! 0.8 ! 0.4 62,041 37,156 83,399 29.2 34.1 22.3 MS17224 MS17282 Southwest Southcentral Southeast Southwest Southcentral Southeast ! Serious Events Incidents ! Serious Events Incidents Figure 21. Percentage of Incident and Serious Event Figure 22. Pooled Mean of Reports Submitted Per Hospital Reports from Hospitals by Region, 2016 by Region, 2016 Northwest Northcentral Northeast Northwest Northcentral Northeast ! 2.9% ! 4.9% ! 3.4% 746 97.1% 750 95.1% 96.6% 963 ! 2.0% ! 2.2% ! 1.8% 1,241 98.2% 1,187 1,103 98.0% 97.8% MS17225 MS17226 Southwest Southcentral Southeast Southwest Southcentral Southeast ! Serious Events Incidents Statewide pooled mean = 1,058 * Based upon publicly available data from the website of the Pennsylvania Health Care Containment Council (www.PHC4.org). Estimates based on statewide inpatient data from 2015. 32 2016 Annual Report Pennsylvania Patient Safety Authority Figure 23 shows the percentage of each event type percentage against the percentage of submissions by submitted by regional hospitals. Figures 24 through 29 event type. isolate each region, comparing the overall submission Figure 23. Percentage of Reports Submitted by Hospitals per Event Type by Region, 2016 REGION 2% 2% 2% 0% Southwest 14% 15% 30% 17% 11% 8% 4% 2% 1% 0% Northwest 16% 14% 25% 16% 7% 15% 2% 3% 4% 2% Southcentral 17% 12% 34% 13% 6% 8% 2% 4% 1% 1% Northcentral 17% 12% 25% 20% 7% 10% 2% 3% 1% 1% Southeast 25% 14% 30% 10% 10% 4% 3% 3% 1% 0% Northeast 13% 15% 23% 18% 16% 7% 0 10 20 30 40 50 60 70 80 90 100 PERCENTAGE Medication error Complication of procedure/ Treatment/Test Adverse drug reaction (not a medication error) Transfusion Equipment/Supplies/Devices Skin Integrity Fall Patient self-harm Error related to procedure/ MS17227 Treatment/Test Other/Miscellaneous Pennsylvania Patient Safety Authority 2016 Annual Report 33 Figure 24. Reports Submitted by Hospitals per Event Type by Northeast Region, 2016 Percentage of reports submitted by event type PERCENTAGE OF REPORTS Overall percentage of reports submitted 20 17.5% 18 16 15.1% 13.4% 10.9% 14 11.5% 12.2% 12 10.7% 10 8.7% 7.8% 7.9% 8 6.0% 6 4 2 0 vic es/ tre f pr /tes e/ Tr /tes e/ n ity rm s er tion ll en err ion ou sio Fa gr u ) es at oc t an t t r t r Eq ica g r or ha t/s or en du en u de ppli ne ica pm n ct sfu te m ed r lf- tio tm ce ui tio ea in la ed se ica trea pro el in M isc nt Sk ed ru to tie /m o m d Pa ed n a rse er th at ot ve O el (n Ad rr pl ro om MS17228 Er EVENT TYPE C Figure 25. Reports Submitted by Hospitals per Event Type by Southeast Region, 2016 Percentage of reports submitted by event type PERCENTAGE OF REPORTS Overall percentage of reports submitted 50 46.9% 45 40 35.8% 34.9% 34.9% 35.3% 34.3% 35 30 26.4% 27.5% 24.5% 23.4% 25 19.9% 20 15 10 5 0 vic es/ tre f pr /tes e/ Tr /tes e/ n ity rm s ed ru err ion ll en err ion ou sio Fa gr u ) es oc t an t t r t r Eq ica g r or ha t/s or n en du en u de ppli t ne ica pm n ct sfu te m ed lf- tio tm ce ui tio ea in la ed se ica trea pro el in M isc nt Sk at to tie /m o m d Pa ed a rse er th at ot ve O el (n Ad rr pl ro om MS17229 Er EVENT TYPE C 34 2016 Annual Report Pennsylvania Patient Safety Authority Figure 26. Reports Submitted by Hospitals per Event Type by Northcentral Region, 2016 Percentage of reports submitted by event type PERCENTAGE OF REPORTS Overall percentage of reports submitted 14 12.7% 12 10 9.5% 8.9% 8.8% 8 6.8% 5.9% 5.5% 5.4% 6 4.8% 4.6% 6.4% 4 2 0 vic es/ tre f pr /tes e/ Tr /tes e/ n ity rm s ed ru err ion ll en err ion ou sio Fa gr u ) es oc t an t t r t r Eq ica g r or ha t/s or n en du en u de ppli t ne ica pm n ct sfu te m ed lf- tio tm ce ui tio ea in la ed se ica trea pro el in M isc nt Sk at to tie /m o m d Pa ed a rse er th at ot ve O el (n Ad rr pl ro om MS17230 Er EVENT TYPE C Figure 27. Reports Submitted by Hospitals per Event Type by Southcentral Region, 2016 Percentage of reports submitted by event type PERCENTAGE OF REPORTS Overall percentage of 45 reports submitted 39.2% 40 35 31.4% 30 25 20 18.4% 17.9% 16.8% 14.0% 13.6% 12.9% 14.0% 15 9.6% 15.3% 10 5 0 vic es/ tre f pr /tes e/ Tr /tes e/ n ity rm s ed ru err ion ll en err ion ou sio Fa gr u ) es oc t an t t r t r Eq ica g r or ha t/s or n en du en u de ppli t ne ica pm n ct sfu te m ed lf- tio tm ce ui tio ea in la ed se ica trea pro el in M isc nt Sk at to tie /m o m d Pa ed a rse er th at ot ve O el (n Ad rr pl ro om MS17231 Er EVENT TYPE C Pennsylvania Patient Safety Authority 2016 Annual Report 35 Figure 28. Reports Submitted by Hospitals per Event Type by Northwest Region, 2016 Percentage of reports submitted by event type PERCENTAGE OF REPORTS Overall percentage of 18 reports submitted 15.7% 16 14 12.9% 12 10 8.4% 6.5% 7.6% 6.5% 7.5% 8 5.7% 6 4.8% 5.2% 4.4% 4 2 0 vic es/ tre f pr /tes e/ Tr /tes e/ n ity rm s ed ru err ion ll en err ion ou sio Fa gr u ) es oc t an t t r t r Eq ica g r or ha t/s or n en du en u de ppli t ne ica pm n ct sfu te m ed lf- tio tm ce ui tio ea in la ed se ica trea pro el in M isc nt Sk at to tie /m o m d Pa ed a rse er th at ot ve O el (n Ad rr pl ro om MS17232 Er EVENT TYPE C Figure 29. Reports Submitted by Hospitals per Event Type by Southwest Region, 2016 Percentage of reports submitted by event type PERCENTAGE OF REPORTS Overall percentage of 35 reports submitted 30.7% 30 26.9% 26.2% 26.8% 27.3% 28.0% 25.2% 25 20.9% 25.6% 20 18.8% 15 10.1% 10 5 0 vic es/ tre f pr /tes e/ Tr /tes e/ n ity rm s ed ru err ion ll en err ion ou sio Fa gr u ) es oc t an t t r t r Eq ica g r or ha t/s or n en du en u de ppli t ne ica pm n ct sfu te m ed lf- tio tm ce ui tio ea in la ed se ica trea pro el in M isc nt Sk at to tie /m o m d Pa ed a rse er th at ot ve O el (n Ad rr pl ro om MS17233 Er EVENT TYPE C 36 2016 Annual Report Pennsylvania Patient Safety Authority Conclusion The data presented in this section suggest that healthcare Authority completes its twelfth calendar year of collecting, facilities in the Commonwealth continue to make prog- analyzing, and providing information about medical errors ress in their efforts to identify and report patient safety and patient harm, the data trends noted reflect positively events. The average monthly number of events submitted on the efforts made by healthcare institutions in the Com- through PA-PSRS by Pennsylvania acute-level healthcare monwealth. As noted previously, the Authority estimated facilities increased 7% in 2016 over 2015. The increased that more than 2,600 lives and more than $147 million reporting of Incidents may suggest earlier recognition and were saved since 2005.1 The encouraging trends noted proactive mitigation of hazards with fewer events reach- above are starting points. The Authority looks forward ing the patient and causing serious harm.1 The number to learning whether these observations and trends are of Serious Events related to death continues to be a low repeatable. and decreasing proportion of submitted reports. As the Notes 1. Magee MC, Marella WM, Newstadt HM, Clarke JR, Doer- 4. NCC MERP index for categorizing medication errors. Na- ing MC. The value of improving patient safety in Pennsyl- tional Coordinating Council for Medication Error Reporting vania. Pa Patient Saf Advis. 2016 Dec;13(4):125-36. Also and Prevention; 2001 Feb. 1 p. Also available: http://www. available: http://patientsafetyauthority.org/ADVISORIES/ nccmerp.org/types-medication-errors. AdvisoryLibrary/2016/Dec;13(4)/Pages/125.aspx. 5. Nowatzki N, Grant KR. Sex is not enough: the need for 2. Medical Care Availability and Reduction of Error (MCARE) gender-based analysis in health research. Health Care Act of March 20, 2002, P 154, No. 13, Cl. 40. Avail- .L. Women Int. 2011 Apr;32(4):263-77. Also available: able: http://www.legis.state.pa.us/cfdocs/legis/li/ucons- http://dx.doi.org/10.1080/07399332.2010.519838. Check.cfm?yr=2002&sessInd=0&act=13. PMID: 21409661 3. Levinson DR. Adverse events in hospitals: state reporting systems. Washington (DC): Office of Inspector General (OIG), Department of Health and Human Services; 2008 Dec. 37 p. Also available: http://oig.hhs.gov/oei/reports/ oei-06-07-00471.pdf. Pennsylvania Patient Safety Authority 2016 Annual Report 37 Reporting Standardization: Guidance for Acute Healthcare Reporting Introduction Twenty-eight guiding principles went into effect on April 1, determining whether occurrences within facilities meet the 2015, to improve consistency in event reporting through statutory definitions of Serious Events, Incidents, or Infra- the Pennsylvania Patient Safety Reporting System (PA-PSRS). structure Failures as defined in section 302 of the MCARE The Pennsylvania Patient Safety Authority (Authority) and Act.2 The Authority, the Department, and healthcare facility the Pennsylvania Department of Health (Department) jointly staff have worked together toward a shared understanding developed the “Final Guidance for Acute Healthcare Facil- of these requirements. The reporting guidelines were identi- ity Determinations of Reporting Requirements under the fied based on frequently asked questions (FAQs), contro- Medical Care Availability and Reduction of Error (MCARE) versies, and inconsistencies that were evident in the data Act.”1 This guidance document provides consistent collected by the Authority and the Department. standards to acute healthcare facilities in Pennsylvania in Education An online education program was developed and made The Authority’s outreach to disseminate and educate peo- available concurrent with the April 1, 2015, release of the ple about the new reporting standards continued in 2016 Final Guidance to ensure that all Authority, Department, with more than 6,600 education modules completed by and healthcare-facility staff had a common understanding 809 (i.e., 80%) of registered online learners. of the principles. Assessing the Impact of Reporting Standardization A set of performance measures was identified to assess the end of December 2016, 80% of registered the impact standardization had on reporting practices. online learners completed all required modules. In 2016, the Authority was encouraged to see that the —— Analysis of events reported as related to health indicators it felt were important continued to move in the desired direction. For example: information technology revealed that more than half involve medication errors. —— An improvement in Serious Event reporting has been noted since the new standards went into The principles continue to have good acceptance among effect in April 2015. healthcare providers, as evidenced by the improvement in the volume and quality of the reports submitted. —— The number of reports submitted under the new and revised event types and subtypes that Table. Number of Events Submitted under the New promote more consistent reporting have nearly Event Type and Subtypes REPORTS Q1 Q2 Q3 Q4 TOTAL doubled over the total submitted in 2015 (see 2015 N/A 683 1,323 1,443 3,469 Table). 2016 1,629 1,495 1,704 1,948 6,776 —— Healthcare facilities continued to participate in Note: As reported to the Pennsylvania Patient Safety Authority, education for the standardization principles. By April 2015 through December 2016. N/A: Not applicable. Pennsylvania Patient Safety Authority 2016 Annual Report 39 Serious Events The guidance clarified interpretations of the Serious Event (see Overview of Data Reported through PA-PSRS, Figure definition and its component terms. The number of Seri- 5). Standardizing Serious Event reporting was intended to ous Event reports from acute healthcare facilities in Penn- improve the accuracy of event reporting; the number of sylvania in 2016 increased by 6.7% over 2014. The Au- Serious Event reports increased in 2015 after standardiza- thority believes standardization contributed to this increase tion, and 2016 numbers appear to remain consistent with Figure 1. Serious Event Reporting Pattern (January 2005 through December 2016) NUMBER OF SERIOUS EVENTS 2,373 Final Guidance released 2,273 Upper control limit 2,184 2,173 2,073 2,043 1,973 Center line 1,919 1,873 1,794 1,773 1,673 Lower control limit 1,653 1,573 1,473 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) Common cause variation Special cause variation RANGE 350 Upper control limit 325.7 300 250 200 153.1 150 Center line 99.7 100 50 46.9 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) MS17234 Note: As reported to the Pennsylvania Patient Safety Authority; control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). 40 2016 Annual Report Pennsylvania Patient Safety Authority patterns after standardization. The monthly mean number the Serious Event reporting pattern. Before standardiza- of Serious Event reports submitted by acute healthcare tion went into effect in April 2015, the number of reports facilities before standardization (i.e., 2014 through March trended downward. However, this trend changed when the 2015) was 595 and increased to 640 after implemen- guidance was implemented with a noted reduction in the tation (i.e., April 2015 through December 2016). The reporting pattern variation through 2016. control chart shown in Figure 1 shows the change in Figure 2. New Event Type “Patient Self-Harm” Reporting Pattern (April 2015 through December 2016) NUMBER OF REPORTS 250 229.0 200 Upper control limit 159.5 156.1 150 100 83.2 Center line 86.6 50 Lower control limit 13.7 0 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2015 2016 YEAR (BY MONTH) Common cause variation Special cause variation RANGE 100 Upper control limit 89.5 90 80 70 60 50 40 30 Center line 27.4 20 10 Lower control limit 0 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2015 2016 MS17283 YEAR (BY MONTH) Note: As reported to the Pennsylvania Patient Safety Authority; control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). Pennsylvania Patient Safety Authority 2016 Annual Report 41 New Event Type and Subtypes New and revised event types and subtypes were created in 2016, facilities submitted more than 6,700 Serious Events PA-PSRS to help facilities standardize and improve reporting and Incidents using the new event type and subtypes (see accuracy. The PA-PSRS new event type, Patient Self-Harm Table), a 95.3% increase over the total number of events and other new subtypes, appear under Complications of submitted in these categories in 2015. Procedure/Treatment/Test and Other/Miscellaneous. In Figure 3. Event Type “Other/Miscellaneous” Reporting Pattern (January 2005 through December 2016) NUMBER OF OTHER/MISCELLANEOUS REPORTS Final Guidance released 6,415 5,915 5,415 Upper control limit 5,305.2 4,996.9 4,915 4,415 Center line 4,315.4 3,845.1 3,915 3,415 Lower control limit 3,325.6 2,915 2,693.3 2,415 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) Common cause variation Special cause variation RANGE 1,600 1,414.6 1,400 Upper control limit 1,215.6 1,200 1,000 800 600 433.0 Center line 372.1 400 200 Lower control limit 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 YEAR (BY QUARTER) MS17235 Note: As reported to the Pennsylvania Patient Safety Authority; control charts generated using QIMacros® 2016 (KnowWare International, Inc., Denver, CO), based on Six Sigma principles and Healthcare IHI rules (information available at https://www.qimacros.com/pdf/qiuser.pdf). 42 2016 Annual Report Pennsylvania Patient Safety Authority Complications of Procedure/Treatment/Test As a part of the standardization effort, new and revised psychiatric evaluation). “Use of reversal agents (Not neu- event subtypes were created in the Complication of romuscular blockers)” in the subtype Anesthesia Event was Procedure, Treatment, or Test event type. “Patient in 302 revised. With the addition of these new event subtypes, the process eloped – with injury” was a new addition un- total number of Serious Events reported increased 7.2% der Emergency Department (302 process is involuntary as compared with Serious Events reporting in 2014. See commitment into a mental health institute for emergency Overview of Data Reported through PA-PSRS. Patient Self-Harm Pennsylvania healthcare facilities continued to submit and the rise in the number of reports may be attributable event reports using the patient self-harm event type and to improved awareness (e.g., online education) of the subtypes. Figure 2 illustrates a steady increase in the event type by PA-PSRS users. The Authority will continue number of reports submitted through this event type since to evaluate events reported and offer solutions to mitigate it was introduced in April 2015. The implementation of harmful patient outcomes. See Overview of Data Reported this category allowed for specific reporting of these events, through PA-PSRS. Other/Miscellaneous The number of new reports submitted by facilities using In 2016, the number of events reported as subtype the event type “Other/Miscellaneous” continued to de- “Other” in this category fell by 36% and 14.5% as cline, as expected with the development of new subtypes. compared with reporting in 2014 and 2015, respectively, The control chart shown in Figure 3 shows the change in suggesting that reporters used more specific categories the “Other/Miscellaneous” reporting pattern over time. to report events and resulting in an overall improvement With the development of the new subtypes, the num- in the specificity of the reports submitted. The greatest ber of events reported using this event type has trended increase in the number of events reported using new event downward since April 2015, with a noted reduction in the types and subtypes was submitted through the new event reporting pattern variation through 2016. subtype, Unanticipated Transfer to Higher Level of Care. More than 5,000 events were submitted using this subtype with Intrafacility Transfer comprising nearly 70% of the reported events. Health Information Technology Healthcare organizations have rapidly adopted electronic “Did HIT cause or contribute to this event?” Figure 4 health records (EHRs) over the past few years as informa- shows the progression in the number of affirmative re- tion systems increasingly become interoperable, and the sponses to this question from April 2015 through Decem- Authority has seen an increase in events that are related ber 2016. The majority of these HIT-related events involve to health information technology (HIT) as a causative or Medication Errors (54.6%) and Errors in Procedures/Treat- contributing factor. However, HIT may also help prevent ments/Tests (32.3%). other types of safety problems that are not necessarily HIT- related. To identify events in which HIT may have played After collecting and analyzing events associated with a role, several questions were added through PA-PSRS to medication errors in which HIT caused or contributed to help identify such events and the systems involved. reportable events, the Authority will publish a Pennsylvania Patient Safety Advisory analysis about this topic in 2017. The HIT measure represents the aggregate number of events submitted with “yes” responses to the question, Pennsylvania Patient Safety Authority 2016 Annual Report 43 Figure 4. Events Related to Health Information Technology (April 2015 through December 2016) NUMBER OF EVENTS 350 309 301 291 297 294 300 280 269 275 246 239 243 243 239 240 250 225 231 209 196 205 194 200 183 150 100 50 MS17236 0 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2015 2016 YEAR (BY MONTH) Note: As reported to the Pennsylvania Patient Safety Authority. Infrastructure Failures and Other Infrastructure Failures and specific “Other” events related to restraints and seclusion are reportable to the Depart- ment and are beyond the scope of this report. Facilities with Low Report Volume The events reported through PA-PSRS inform the analyses •• No Serious Events submitted through PA-PSRS for published in the Pennsylvania Patient Safety Advisory, one year and they are the basis for the educational programs and collaborative forums that allow healthcare organiza- •• No Incidents submitted through PA-PSRS for one year tions throughout the state to learn from one another. The •• Reporting of Serious Events, Incidents, or total re- Authority consistently monitors and notifies those facilities ports per 1,000 patient days is less than 10% of the that: (1) submit a low volume of reports as compared with mean of their hospital type (e.g., acute, behavioral, the volume of reports from like facility types or (2) do not children’s facilities) submit any reports through PA-PSRS. A goal of standard- ization is to increase the number and precision of reports Ambulatory surgical facilities identified with low report received through PA-PSRS from all facility types. volumes meet any of the following criteria: •• No reports submitted through PA-PSRS for one year Figure 5 shows the annual number of hospital and ambu- (4+ rooms) or two years (<4 rooms), AND latory surgical facilities with low report volumes. •• There are no extenuating circumstances identified Hospitals identified with low report volumes meet any of by the facility’s patient safety liaison the following criteria: •• Facilities of unknown room size will be treated as having fewer than 4 rooms 44 2016 Annual Report Pennsylvania Patient Safety Authority Figure 5. Number of Facilities with Low Report Volumes NUMBER OF FACILITIES 40 36 35 30 30 29 26 27 25 26 21 20 17 15 14 13 11 9 10 MS17237 5 2010 2011 2012 2013 2014 2015 YEARS Hospitals Ambulatory surgical facilities Linear trend (hospitals) Linear trend (ambulatory surgical facilities) Note: As reported to the Pennsylvania Patient Safety Authority. Failure to report as required by the MCARE Act is a Evidenced by the number of facilities identified as reporting violation of the Health Care Facilities Act.2 In addition to low event volumes, the Authority established the first pa- any penalty that may be imposed under the Health Care tient safety liaison Keystone project, The Keys to Reporting, Facilities Act, a medical facility that fails to report a Seri- in 2016 to help facilities identify opportunities to improve ous Event or an Infrastructure Failure may be subject to an and evaluate common barriers to reporting. The patient administrative penalty of $1,000 per day imposed by the safety liaisons also offer education to facilities and health- Department. The Authority actively monitors facilities with care providers at their request. See Educational Programs low report volumes and notifies senior leaders in writing. for more information. Pressure Injury Reporting Standardization To help acute healthcare facilities determine whether oc- Authority, the Department, and healthcare facility staff have currences of pressure injuries meet the statutory definitions a shared understanding of the requirements. The subjects of Incidents or Serious Events as defined in the MCARE of these requirements were identified based on inconsisten- Act, the Authority staff and its Board of Directors identified cies that were evident in the data collected by the Authority pressure injury reporting as the next priority for standard- and the Department. ization. A multi-disciplinary work group with backgrounds in medicine (including wound care), nursing (including The drafted guidance document was published in the Penn- Wound, Ostomy, and Continence nurses), administra- sylvania Bulletin 46 Pa.B. 6198 on October 1, 2016, for tion and facility operations, regulation, patient safety and public comment through October 31, 2016. The Authority, healthcare quality, and a patient representative developed the Department, and the other members of the work group recommendations for pressure injury reporting. reviewed 15 public comments and will make selected changes to the document in response to those comments. These guidance recommendations were intended to pro- A final guidance document will be issued to guide interpre- vide consistent and clear standards for the MCARE Act’s tations about whether occurrences of pressure injuries meet reporting requirements for pressure injuries so that the the statutory definitions of Incidents or Serious Events as Pennsylvania Patient Safety Authority 2016 Annual Report 45 defined under the MCARE Act and will include the agen- 2017, the agencies will need to modify PA-PSRS to support cies’ response to the correspondence received. Assuming implementation of these standards and develop an educa- the Authority’s Board of Directors and the Secretary of tion program for staff of both agencies as well as affected the Department approve the final guidance document in healthcare facilities. Notes 1. Final guidance for acute healthcare facility determinations of reporting requirements under the Medical Care Avail- ability and Reduction of Error (MCARE) Act, 44 Pa. Bull. 6178 (2014 Sep 27). Also available: http://www.pabulle- tin.com/secure/data/vol44/44-39/2041.html. 2. Medical Care Availability and Reduction of Error (MCARE) Act of March 20, 2002, P 154, No 13 40. Available: .L. http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2002&sessInd=0&act=13. 46 2016 Annual Report Pennsylvania Patient Safety Authority Healthcare-Associated Infections Introduction Healthcare-associated infections (HAIs) continue to be ance to both the Authority and Department on activities an important public health challenge. HAIs are infections to prevent HAIs. The Authority’s infection prevention patients develop while receiving treatment for other condi- analysts use data from HAI reports to prioritize prevention tions and can occur in any healthcare setting. The Centers activities. The Authority also partners with local, state, and for Disease Control and Prevention (CDC) estimates 1 in national organizations to reduce HAIs. 25 hospitalized patients will develop an HAI during their care.1 Research by Columbia University estimates 1.6 The Authority sponsors in-depth educational offerings million to 3.8 million HAIs occur among nursing home tailored to meet the needs of the audience, covering residents in the United States annually.2 These infections topics including sepsis, scabies, pneumonia, and are associated with significant morbidity and mortality and environment of care issues. Multiple modalities are used increased healthcare costs. According to CDC, pneumo- to present the education, including webinars, Pennsylvania nia, gastrointestinal illness such as Clostridium difficile Patient Safety Advisory articles, toolkits, presentations or norovirus infections, urinary tract infections, primary at conferences and symposiums, and on-site facility bloodstream infections, and surgical site infections are the consultations and presentations. most common HAIs.3 The Centers for Medicare and Medicaid Services (CMS) Working toward the elimination of HAI is a priority for the released new regulations for long-term care in Octo- Authority because many of these infections are prevent- ber 2016. Key elements of these regulations include the able. The Medical Care Availability and Reduction of establishment of a formal infection prevention and control Error (MCARE) Act was amended (Act 52)4 in 2007 to program with a comprehensive facility assessment and a encompass HAI prevention, and it mandates HAI reporting designated infection prevention and control officer to over- for hospitals and nursing homes. Pennsylvania hospitals see the program; development of an antibiotic stewardship report infections through CDC’s National Healthcare program with involvement of a pharmacist to oversee Surveillance Network (NHSN) and Pennsylvania nursing antibiotic use; standardization of information provided homes report infections through the Pennsylvania Patient during care transitions; and food and nutrition services to Safety Reporting System (PA-PSRS). comply with applicable federal, state, and local laws, reg- ulations, and codes. The Authority’s infection prevention The Authority uses knowledge gained through analysis of analysts are an available resource, providing guidance to HAI reports to detect infection trends and develop new help facilities meet the requirements of these regulations. strategies to prevent HAIs. HAI data from CDC’s NHSN are also analyzed by the Department of Health for hospi- This section summarizes the Authority’s HAI activities tal trends. The HAI Advisory Panel provides advice and guid- in 2016. Education and Outreach Programs In 2016, the Authority’s infection prevention analysts national and state partners, in a grade school district provided education to about 5,600 healthcare workers. annual event, and for each of the Authority’s ambulatory The infection prevention analysts presented information surgical facilities’ symposia. An overview of this education at healthcare facilities, on statewide webinars, for our is shown in the following graphic. Pennsylvania Patient Safety Authority 2016 Annual Report 47 Infection Prevention Education and Outreach Programs Schools: 150 students Webinars*: “Tips from the Toolbox” and teachers 981 attendees – Early Detection of Sepsis in Long-Term Care Hempfield Area School Antibiotic Stewardship District’s “3rd Annual STEAM Central Line-Associated – Preventing Non-Ventilator Academy” — Science, Bloodstream Infections Healthcare Acquired Technology, Engineering, Arts, Pneumonia and Math skills Improving Isolation Awareness PA-PSRS Analytics – Scabies Urinary Tract Infections Facility Education: ASF Symposia: 386 attendees 155 attendees Clostridium difficile Topic: Influenza “Environmental Pneumonias and Hygiene in Ambulatory Antimicrobial Therapy Surgery Facilities” Safe Injection Practices Zika 09 2 17 MS State and National Presentations: Central Pennsylvania Association for 3,200 attendees through Healthcare Quality national partners Pennsylvania Association of 813 attendees through Directors of Nursing Administration state partners Pennsylvania Coalition of Affiliated Healthcare & Living Communities Professional Organizations: Pennsylvania Health Care Association for Professionals Association in Infection Control and Epidemiology *Attendees located in PA, DE, NJ, WV, and LA. 48 2016 Annual Report Pennsylvania Patient Safety Authority “ ” I will use the Patient Safety Authority resources more frequently. “ Most of the program was new information that I can put into practice. ” Innovation “ The Authority’s infection prevention analysts attended innovation training provided by the Authority in 2016. I learned we have a good system; This training provided knowledge of the creative problem- ” just need to keep people solving framework for the analysts to use in their work informed, educated, and accountable. with education, the Advisory, PA-PSRS nursing home data, “ resources, and the Authority’s HAI Advisory Panel (see ” lightbulb). You just helped me put a new spin on an old issue. “ Thank you for all you do to help; ” I feel more connected to the Infection MS17093 prevention infection control community. HAI Advisory Panel Think Big Success Support Facility consults Brainstorming Ideas Infection Prevention and Control Annual Survey Innovation Teamwork Education In the fall, the Authority distributed an infection prevention and control–specific survey to hospital and nursing home Efficient Plan Webinars infection prevention analysts, as a subset of an annual sur- Sharing Strategy vey. It was intended to elicit information about the effective- ness of the Authority’s guidance and educational programs Tools Goals and to capture critical information about facilities’ infection prevention and control practices. The responses inform and Resources help the Authority prioritize future research, education, and collaboration programs. Inspiring Statewide The top five infection prevention and control areas of inter- est for hospitals are (in order of importance): hand hygiene, Research C. difficile infection, surveillance for HAI, antibiotic steward- Leading Creative MS17094 ship, and environmental infection control. Nursing homes listed the top five infection prevention and control topics of Analysis interest as urinary tract infection (UTI), antibiotic steward- ship, pneumonia, surveillance for HAI, and influenza. Pennsylvania Patient Safety Authority 2016 Annual Report 49 As a result of reading one or more of the 2016 infection following graphic shows samples of changes initiated by prevention and control Advisory articles, hospitals and Pennsylvania healthcare facilities as a result of reading a nursing homes made 117 changes to policies, systems, specific infection control Advisory article. education, collaboration, and communication. The Advisory: Strategies to Turn the Tide against Inappriopriate Advisory: Early Detection of Antibiotic Utilization Sepsis in Pennsylvania’s — Developed formulas for appropriate Long-Term Care Residents antibiotic choices — Added to QAPI initiative — Instituted a recheck of antibiotics and — Staff educated on early warning signs culture results — Sepsis protocol pilot to MEC for input — Antibiotic use tracked and evaluated at QAPI meetings PENNS YLVANIA PATIE NT SAFE T Y ADVISORY Advisory: A Conceptual An Independent Agency of the Commonwealth of Pennsylvania Advisory: Produced by ECRI Institute and ISMP under contract Framework for Improving to the Pennsylvania Patient Safety Authority Isolation Awareness in Scabies - Strategies for Pennsylvania Acute Management and Control Care Hospitals — Changed environmental — Standardized network HEALTHCARE FACILITY cleaning process isolation practices across CHANGES AS A — New tracking forms provide better (case) information multiple hospitals — Increased observations (use) RESULT OF READING — Revamped policy on scabies of PPE, and made isolation PENNSYLVANIA PATIENT infestation management compliance a PI measure SAFETY ADVISORY — Reevaluated signage system and patient/visitor education ARTICLES Advisory: Data Snapshot: Clostridium Difficile Infections in Long-Term Care Facilities — Reinforced C. diff contact precaution practices — Implemented new environmental cleaning products and schedules MS17095 — Improved QA and ongoing review and early identification process C. diff, Clostridium difficile infection; MEC, medical executive committee; PI, performance improvement; PPE, personal protective equipment; QA, quality assurance; QAPI, Quality assurance and performance improvement. Survey respondents who indicated that they used one or job. Most impressive was the response from multiple more of the Authority tools gave the majority of the tools respondents that a decrease in HAIs in their respective high scores for their usefulness in increasing staff knowl- facilities was attributed to use of one or more of the Au- edge about infection prevention and control, identifying thority tools. Figure 1 shows how the facilities scored the specific areas in which to direct infection control resources usefulness of 11 tools in decreasing HAIs. All of the tools and helping infection prevention analysts perform their are accompanied by an Advisory article. 50 2016 Annual Report Pennsylvania Patient Safety Authority Figure 1. The Usefulness of Authority Toolkits in Decreasing HAI Rates TOOLKIT 85% Long Term Care Best Practice Assessment 0% 51% INTERACT Stop and Watch Early Warning Tool 50% Scabies Transmission, Symptoms, 69% Diagnosis and Control Poster 25% 58% Scabies Case/Contact Investigation Line List 0% 63% Scabies Outbreak Control Checklist 50% Antibiotic Use Best Practices/ 67% Suboptimal Practices Decision Tree 67% 58% Acute Gastroenteritis Outbreak Case Log 100% Norovirus Outcome and 69% Process Measure Worksheet 60% 76% Norovirus Preparedness Checklist 16% Decision-Making Map to Improve 83% Hand Hygiene Behavior 57% 75% Patient Safety Impact Assessment Tool MS17096 63% 0 10 20 30 40 50 60 70 80 90 100 PERCENTAGE* Nursing home Hospital * Among survey respondents who used one or more Authority tools, percentage who found tool useful. Healthcare-Associated Infection Advisory Panel In response to the requirements of Act 52 of 2007,4 the criteria, adding notes to the PA-PSRS user manual with Authority’s board of directors approved a panel of infec- the UTI criteria changes, and providing facilities with the tion control experts to help implement the Act. The role of updated information through a program memorandum. the HAI Advisory panel is to provide advice and guidance to the Authority and other state agencies, such as Penn- The panel met in December 2016 to discuss an increase sylvania Department of Health, in implementing the HAI in central line–associated bloodstream infections and legislation. bloodstream infections (CLABSIs/BSIs), a decrease in catheter-associated urinary tract infections (CAUTI), new The Advisory panel met in June 2016 to review CDC baseline HAI rates from CDC, CDC‘s standardized infec- changes to UTI criteria and to discuss potential changes to tion ratio (SIR) method versus Pennsylvania’s SIR method, PA-PSRS and overall guidance from the panel. The panel and the new CMS long-term care guidelines. The Depart- suggested aligning UTI reporting in PA-PSRS with national ment, which currently calculates Pennsylvania’s baseline Pennsylvania Patient Safety Authority 2016 Annual Report 51 HAI rates, provided an overview of CDC’s revised hospital The HAI Advisory panel continues to meet to discuss baseline calculations. Feedback from the panel of experts HAI-related topics. A new HAI Advisory panel member provided guidance to the Department to facilitate align- was added and was to begin participating in activities in ment with CDC criteria for hospital data. 2017. See Figure 2. Figure 2. HAI Advisory Panel Activities New CMS LTC Aligned guidelines Acute care PA-PSRS LTC CLABSI & BSI UTI reporting increase and with national CAUTI decrease criteria Updated Acute care PA-PSRS LTC CDC vs. user’s manual PA SIR with UTI criteria discussion changes Disseminated Acute LTC program care CDC memo about re-baselining UTI criteria discussion changes MS17097 BSI, Bloodstream infection; CAUTI, catheter-associated urinary tract infection; CDC, Centers for Disease Control and Prevention; CLABSI, central line–associated bloodstream infection; CMS, Centers for Medicare and Medicaid Services; LTC, long-term care; LTCF, long-term care facility; PA-PSRS, Pennsylvania Patient Safety Reporting System; PA, Pennsylvania; SIR, standardized infection ratio; UTI, urinary tract infection. Emergency Preparedness The Authority, the Department, the Hospital and Health- • Equipment evaluation system Association of Pennsylvania (HAP), and local health departments have worked together over the past two years • Personal protective equipment use to help Pennsylvania acute-care facilities prepare for epi- • Suggestions for simulation and practice drills sodic biological threats by providing consultation before and during site visits. The Authority provides infection Although these activities fall under the auspices of Ebola prevention and control expertise for the following: disease preparedness and build on CDC’s Rapid Ebola Preparedness team visits, the Authority has supported • Employee health and worked with Pennsylvania facilities on emergency • Patient safety and holistic care preparedness since 2014. The Authority looks forward to continuing the partnerships with the Department, HAP , • System design local health departments, and the acute-care facilities that have been designated as biologic hazard preparedness • Workflow management treatment centers or that continue to strive for that status. 52 2016 Annual Report Pennsylvania Patient Safety Authority Nursing Home Data Analysis The year 2016 was the second full calendar year of data of data based on the McGeer criteria, comparison in this from nursing homes reported through PA-PSRS using the report of two data points would have no statistical signifi- revised McGeer criteria.5 Authority analysts grouped several cance in terms of realizing or predicting trends.6 The 2017 infection classifications into specific care areas because this annual report will make possible testing of these data for practice helps nursing homes concentrate their surveillance, trends, because three calendar years will be avaliable for resources, and prevalence investigations. Individual facili- statistical analysis. ties can access reports about their own HAI occurrences in specific patient care areas in the PA-PSRS nursing home However, comparison of lower respiratory tract infection HAI analytics tab. In 2016, Pennsylvania nursing homes (LRTI) events is provided (in subsequent sections) by month reported 27,544 HAI events through PA-PSRS, a 13% de- and year because they are affected by seasonal variabil- crease from the 31,672 submitted in 2015. ity and the influence of community disease pressure on the nursing home. A year-to-year comparison of device- In previous reports, analysts have provided figures and related bloodstream infections is also provided to draw tables depicting trends of nursing home HAI in Pennsylva- attention to the observation by Authority analysts that the nia. Because 2016 represents the second calendar year number of reports increased in most months. Analysis Method Of the 703 facilities active as of December 31, 2016, quotient is then divided by the number of days in basic validation criteria were met by 678 (96.4%) facili- each month. In the 2016 data, 16 nursing homes ties, spanning five care areas.* were excluded, compared to 21 in 2015. The Authority excluded 25 facilities for analysis based on •• No nursing homes were excluded at the unit level the following (where relevant, comparisons to exclusions for reporting infections without accompanying resi- in 2015 are provided): dent days in 2016 data. •• Resident days were not entered for every month of •• One nursing home was excluded from analysis 2016; 8 nursing homes were excluded, compared for CAUTIs in 2016 data because CAUTIs were with 17 in 2015. reported without accompanying catheter days. •• Nursing homes had a month during which occu- •• No nursing homes were excluded from analysis for pancy was above 100% or below 50%. Occupancy CLABSIs in 2016 data for reporting CLABSIs without is calculated by dividing the number of resident days accompanying central-line days. by the number of beds listed for each facility. The Urinary Tract Infection Table 1 shows 2016 UTIs by care area and in aggregate total. CAUTI overall has the greatest rates of the UTI category, followed by symptomatic urinary tract infection (SUTI), then both of the asymptomatic bacteremic urinary tract infection (ABUTI) types. * The following sections and associated tables and graphs include breakdowns by care area where applicable. Care areas are defined in the PA-PSRS Training Manual and Users’ Guide. Nursing Home Event Reporting.7 Pennsylvania Patient Safety Authority 2016 Annual Report 53 CAUTI Ventilator-dependent units seem to have significantly device use rate. Compared with 2015 data, SN/STR units lower CAUTI rates as compared with other units. Demen- experienced a decrease in CAUTI, albeit not statistically tia and mixed units appear to have the highest rates of significant: CAUTI (Figure 3). The dementia units have a very low rate of device use, signaling that it may be difficult to lower •• 2015: rate 0.85 (95% confidence interval [CI], their CAUTI rate further unless novel care practices are 0.77 to 0.93) developed to address prevention. The skilled nursing/ •• 2016: rate 0.82 (95% CI, 0.74 to 0.91) short-term rehabilitation (SN/STR) units have the highest SUTI SUTI (Figure 4) remains low overall; however, it is most prevalent in mixed and SN/STR units. ABUTI Both C types are depicted as having pooled rates of zero. prevention standpoint in all environments regardless ABUTI signals the transformation of an asymptomatic of rate interpretation because of its potential for life- UTI into a bloodstream infection, essentially sepsis or at theatening consequences. least bacteriemia. ABUTI should remain a focus from a Respiratory Tract Infection Pneumonia continues to be the predominant infection type ratory tract infection (LRTI) types remain fairly consistent in all care areas (Table 2). The rates of other lower respi- throughout the months, with the exception of influenza. Influenza The incidence of influenza in January 2016 as compared influenza when the incidence in the community is unusu- to January 2015 was lower in terms of LRTI rates (Fig- ally large. For example, nursing homes may consider ure 5), probably because of the influence of annual and screening visitors for respiratory illness before or during a seasonal variability. The rate of influenza has a temporal visit, then provide just-in-time education about respiratory association with the rate of pneumonia within this popula- etiquette, mask use, and hand hygiene. tion of patients. CDC FluView data (Figures 6 and 7) show the national impact of influenza by week. When data Other interventions nursing homes may wish to consider in these figures is combined to equate to calendar year include placing signage and providing materials such 2016, in terms of trends, the resulting national laboratory as masks, hand sanitizer, and tissues at entrances, which data is similar epidemiologically with Pennsylvania event could help protect residents from illness and heighten reports through PA-PSRS in 2016 (Figure 8). awareness of visitors about their impact on the health of residents. Resident education and their use of respiratory This similarity in statewide and national influenza trends etiquette, as well as appropriate use of isolation, could be reinforces the need for continued preventative measures areas of focus. that protect residents in a nursing home facility from Gastrointestinal Infection Gastrointestinal infections in 2016 were primarily C. dif- ficile and norovirus (Table 3). There were few reports of bacterial gastrointestinal infections. 54 2016 Annual Report Pennsylvania Patient Safety Authority C. difficile The rate of C. difficile infection was highest in the ventila- A statistically significant decrease in the confidence inter- tor dependent units, which may be related to the fact that val in gastrointestinal total infections occurred between the ventilator dependent units also experienced a higher 2015 and 2016: rate of pneumonia as compared with other unit types (Table 2). According to Chmielewska and co-authors, •• 2015 rate per 1,000 resident days: 0.15 (95% CI, “One of the most common gastrointestinal infections 0.15 to 0.16) after the antibiotic treatment of community or nosocomial •• 2016 rate per 1,000 resident days: 0.12 (95% CI, pneumonia is caused by the anaerobic spore Clostridium 0.12 to 0.13) difficile.”8 Given the higher acuity and nature of the constellation of patients on ventilator dependent units and •• This reduction is likely atributed to a reduction in their susceptibility to respiratory infection, these units may the rate of norovirus with a positive laboratory result be prime areas of focus for antibiotic stewardship pro- as well as norovirus by Kaplan criteria. Analysis of grams for the prevention of C. difficile infection. this difference is impossible without national trend data in order to identify external pressure and seasonality.9 Norovirus CDC’s “U.S. Trends of Norovirus-associated Outcomes external pressure. A norovirus outbreak is defined as three Figures” webpage was last reviewed on June 24, 2016, or more cases of norovirus defined within a three-day and last updated on October 30, 2013.9 To aid Pennsyl- period.10 Further, Figure 9 shows the number of reports vania nursing homes, Figure 9 provides seasonal trends to from nursing homes that did or did not meet the norovi- help nursing homes prepare for norovirus in the coming rus outbreak definition. year associated with timing and expected duration of Skin and Soft Tissue Infection Cellulitis, soft tissue, or wound infection remain constant in ventilator dependent units, as well as others, to assess throughout the defined care areas, which is consistent with infection-control practices, such as hand hygiene and iso- the 2015 annual report. The incidence of both scabies lation practices, and to conduct root-cause analysis when and conjunctivitis is present in all care areas. Units for scabies or conjunctivitis cases occur, to build knowledge ventilator-dependent patients seem to experience more and prevention strategies. See Table 4 for 2016 events. conjunctivitis in general. The Authority encourages staff Central Line–Associated Blood Stream Infection CLABSI is split into three separate categories: dialysis to say, the median rate per 1,000 central line days was 0, lines, temporary lines, and permanent lines. The definition not that there were no infections occurring. for each line type is available in Figure 11. Pennsylvania nursing homes reported more CLABSI events A rate table is not included in this analysis because the in 2016 than in 2015 (Figures 10 and 11). Because only pooled rates by care area for 2016 remain at 0.0. CLABSI two years of data are available for analysis, there are too is measured as a rate per 1,000 central line days.11 In few data points to predict whether this will become an circumstances in which CLABSI rates are very low, even ongoing trend. According to the literature, mortality rates zero, there may still be infections happening. For example, because of CLABSI are between 12% and 25% and costs Pronovost and co-authors noted that, after their interven- are between $3,700 and $36,000 per occurrence.13,14 tion aimed at CLABSI reduction, “within 3 months after CLABSI should remain a focus for all care areas that implementation the median infection rate was 0.”12 That is house residents with central lines regardless of zero or Pennsylvania Patient Safety Authority 2016 Annual Report 55 very low-pooled rates of infection. The Authority encour- cal standards. Facilities could also engage dialysis centers ages facilities to assess practices related to the care and in conversations about care and maintenance of dialysis maintenance of central lines and adhere to accepted clini- lines, to coordinate care and maintenance. Conclusion The analytics presented herein related to HAI are no lon- encourages individual facilities to use the analytics within ger static yearly reports. Upon login to PA-PSRS, nursing PA-PSRS to lead continuous performance improvement homes can access facility-specific data as well as state- interventions at the facility level. wide and peer group data through the “Analytical Data Tools Menu”; the data are updated daily. The Authority See following pages for data tables and figures. Note: Table rows indicating totals show the number of nursing homes reporting for the given type of infection with each unit name. This is not to be confused with the sum of the unit types for that infection. There may be overlap of unit types reporting at any given facility. 56 2016 Annual Report Pennsylvania Patient Safety Authority Table 1. Urinary Tract Infections, Pooled Mean Rates, by Subcategory and Care Unit, 2016 DEVICE NUMBER OF UTILIZATION POOLED INFECTION RATE UNIT NAME (N) INFECTIONS RESIDENT DAYS CATHETER DAYS RATE* (95% CI) †,‡ CAUTI—Catheter in place with localizing urinary signs or symptoms or catheter removed within the past 2 calendar days at the facility Dementia unit (25) 33 2,293,538 37,318 0.016 0.88 (0.58 - 1.19) Mixed unit (118) 335 7,739,418 372,521 0.048 0.9 (0.8 - 1) Nursing unit (107) 281 8,426,415 355,114 0.042 0.79 (0.70 - 0.88) SN/STR unit (157) 392 9,109,775 475,261 0.052 0.82 (0.74 - 0.91) Vent unit (7) 30 173,405 43,885 0.253 0.68 (0.44 - 0.93) Total (356) 1,071 27,742,551 1,284,099 0.046 0.83 (0.78 - 0.88) Device-Related ABUTI—Catheter in place without localizing urinary signs or symptoms Dementia unit (1) 1 2,293,538 37,318 0.016 0.03 (0 - 0.08) Mixed unit (10) 10 7,739,418 372,521 0.048 0.03 (0.01 - 0.04) Nursing unit (7) 10 8,426,415 355,114 0.042 0.03 (0.01 - 0.05) SN/STR unit (18) 23 9,109,775 475,261 0.052 0.05 (0.03 - 0.07) Vent unit (2) 3 173,405 43,885 0.253 0.07 (0 - 0.15) Total (37) 47 27,742,551 1,284,099 0.046 0.04 (0.03 - 0.05) SUTI—Catheter not present or catheter removed for more than 2 calendar days within the facility with localizing urinary signs or symptoms Dementia unit (84) 230 2,293,538 NA NA 0.1 (0.09 - 0.11) Mixed unit (160) 1,328 7,739,418 NA NA 0.17 (0.16 - 0.18) Nursing unit (181) 1,215 8,426,415 NA NA 0.14 (0.14 - 0.15) SN/STR unit (252) 1,649 9,109,775 NA NA 0.18 (0.17 - 0.19) Vent unit (7) 12 173,405 NA NA 0.07 (0.03 - 0.11) Total (491) 4,434 27,742,551 NA NA 0.16 (0.16 - 0.16) ABUTI—Catheter not present or catheter removed for more than 2 calendar days within the facility without localizing urinary signs or symptoms (may have fever) Dementia unit (5) 9 2,293,538 NA NA 0 (0 - 0.01) Mixed unit (31) 41 7,739,418 NA NA 0.01 (0 - 0.01) Nursing unit (26) 39 8,426,415 NA NA 0 (0 - 0.01) SN/STR unit (39) 70 9,109,775 NA NA 0.01 (0.01 - 0.01) Vent unit (2) 2 173,405 NA NA 0.01 (0 - 0.03) Total (93) 161 27,742,551 NA NA 0.01 (0 - 0.01) Note: As reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) in 2016 ABUTI, Asymptomatic bacteremic urinary tract infection; CI, confidence interval; CAUTI, catheter-associated urinary tract infection; NA, not applicable; SN/STR, skilled nursing/short-term rehabilitation; SUTI, symptomatic urinary tract infection; vent, ventilator-dependent. * Device utilization rate (DUR): number of urinary catheter days ÷ number of resident days † Basic urinary tract infection (UTI) rate calculation: number of UTI ÷ number of resident days × 1,000 ‡ CAUTI rate calculation: number of CAUTI ÷ number of catheter days × 1,000 Pennsylvania Patient Safety Authority 2016 Annual Report 57 Figure 3. CAUTI Rates, by Care Unit and Month, 2016 CAUTI RATES (PER 1,000 CATHETER DAYS) 6 5 4 3 2 1 MS17284 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec MONTH Ventilator dependent unit 0.89 1.54 0.57 0.55 1.55 0.26 0.24 0.25 0.58 0.27 0.83 0.84 Skilled nursing/short-term rehabilitation unit 0.65 0.91 1.04 0.70 0.75 0.73 0.90 0.93 0.95 0.70 0.77 0.84 Nursing unit 0.73 0.81 0.86 1.06 0.66 0.65 0.53 1.05 0.66 0.78 0.85 0.85 Mixed unit 0.84 1.39 0.67 1.01 0.63 0.97 0.93 0.85 0.72 0.75 0.96 1.11 Dementia unit 1.09 0.39 0.91 0.31 0.94 0.31 0.61 0.64 0.64 0.91 1.62 2.24 Figure 4. SUTI Rates, by Care Unit and Month, 2016 SUTI RATES (PER 1,000 RESIDENT DAYS) 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 MS17285 0.0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec MONTH Ventilator dependent unit 0.00 0.07 0.07 0.13 0.13 0.00 0.14 0.00 0.07 0.07 0.07 0.07 Skilled nursing/short-term rehabilitation unit 0.18 0.15 0.16 0.18 0.17 0.16 0.23 0.18 0.22 0.18 0.18 0.18 Nursing unit 0.14 0.11 0.15 0.17 0.16 0.12 0.12 0.17 0.15 0.15 0.17 0.11 Mixed unit 0.13 0.16 0.19 0.18 0.15 0.17 0.18 0.19 0.19 0.18 0.20 0.14 Dementia unit 0.08 0.10 0.16 0.10 0.14 0.07 0.12 0.08 0.09 0.10 0.10 0.07 58 2016 Annual Report Pennsylvania Patient Safety Authority Table 2. Respiratory Tract Infections, Pooled Mean Rates, by Subcategory and Care Unit, 2016 POOLED INFECTION RATE UNIT NAME (N) NUMBER OF INFECTIONS RESIDENT DAYS (95% CI)* Influenza—The resident has tested positive for influenza Dementia unit (18) 55 2,293,538 0.02 (0.02 - 0.03) Mixed unit (40) 131 7,739,418 0.02 (0.01 - 0.02) Nursing unit (45) 135 8,426,415 0.02 (0.01 - 0.02) SN/STR unit (62) 168 9,109,775 0.02 (0.02 - 0.02) Vent unit (1) 4 173,405 0.02 (0 - 0.05) Total (81) 493 27,742,551 0.02 (0.02 - 0.02) Influenza-like illness—The resident has fever, influenza is suspected. Testing for influenza is negative or not performed, there may be a dry cough, but no other overt signs Dementia unit (9) 10 2,293,538 0 (0 - 0.01) Mixed unit (13) 32 7,739,418 0 (0 - 0.01) Nursing unit (17) 34 8,426,415 0 (0 - 0.01) SN/STR unit (29) 37 9,109,775 0 (0 - 0.01) Vent unit (0) 0 173,405 0 (0 - 0) Total (137) 113 27,742,551 0 (0 - 0) Lower respiratory tract infection—Chest radiograph is negative for pneumonia or a new infiltrate and the resident is without fever; or no chest radiograph performed Dementia unit (81) 233 2,293,538 0.1 (0.09 - 0.11) Mixed unit (137) 823 7,739,418 0.11 (0.1 - 0.11) Nursing unit (152) 718 8,426,415 0.09 (0.08 - 0.09) SN/STR unit (198) 1,132 9,109,775 0.12 (0.12 - 0.13) Vent unit (9) 28 173,405 0.16 (0.1 - 0.22) Total (426) 2,934 27,742,551 0.11 (0.1 - 0.11) Pneumonia—Resident’s chest radiograph is positive for pneumonia or a new infiltrate Dementia unit (120) 377 2,293,538 0.16 (0.15 - 0.18) Mixed unit (186) 1,548 7,739,418 0.2 (0.19 - 0.21) Nursing unit (206) 1,451 8,426,415 0.17 (0.16 - 0.18) SN/STR unit (283) 1,958 9,109,775 0.21 (0.21 - 0.22) Vent unit (9) 99 173,405 0.57 (0.46 - 0.68) Total (198) 5,433 27,742,551 0.2 (0.19 - 0.2) Total Respiratory Tract Infections Dementia unit (136) 675 2,293,538 0.29 (0.27 - 0.32) Mixed unit (194) 2,534 7,739,418 0.33 (0.31 - 0.34) Nursing unit (217) 2,338 8,426,415 0.28 (0.27 - 0.29) SN/STR unit (303) 3,295 9,109,775 0.36 (0.35 - 0.37) Vent unit (11) 131 173,405 0.76 (0.63 - 0.88) Total (577) 8,973 27,742,551 0.32 (0.32 - 0.33) Note: As reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) in 2016 CI, Confidence interval; SN/STR, skilled nursing/short-term rehabilitation; vent, ventilator dependent. * Rate calculation: number of infections ÷ number of resident days × 1,000 Pennsylvania Patient Safety Authority 2016 Annual Report 59 Figure 5. Lower Respiratory Tract Infection (LRTI) Rates, by Criteria Definition and Month, 2015 versus 2016 LRTI RATES (PER 1,000 RESIDENT DAYS) 1.4 1.2 1.0 0.8 0.6 0.4 0.2 MS17286 0.0 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec MONTH (BY YEAR) Influenza — The resident has tested positive for influenza 0.60 0.01 0.19 0.01 0.07 0.05 0.04 0.06 0.01 0.01 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.06 The resident has fever, influenza is suspected. Testing for influenza is negative or not performed; there may be a dry cough, but no other overt signs 0.12 0.00 0.02 0.00 0.02 0.01 0.01 0.01 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.01 0.00 0.00 0.00 0.00 0.00 0.00 0.01 Chest radiograph is negative for pneumonia or a new infiltrate and the resident is without fever 0.04 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.01 0.01 0.02 0.01 0.02 0.02 0.01 0.02 0.01 0.01 0.02 0.01 0.01 0.02 0.01 0.01 No chest radiograph performed or radiograph is negative for pneumonia or new infiltrate 0.20 0.11 0.15 0.13 0.13 0.12 0.16 0.10 0.09 0.08 0.11 0.07 0.11 0.06 0.08 0.06 0.08 0.08 0.08 0.09 0.07 0.08 0.08 0.09 Resident's chest radiograph is positive for pneumonia or new infiltrate 0.29 0.22 0.23 0.27 0.24 0.22 0.24 0.22 0.18 0.16 0.22 0.17 0.22 0.17 0.18 0.16 0.18 0.19 0.17 0.18 0.18 0.19 0.17 0.20 60 2016 Annual Report Pennsylvania Patient Safety Authority Figure 6. CDC FluView by Week, 2015–2016 Source: From Centers for Disease Control and Prevention. Influenza positive tests reported to CDC by US public health laboratories, national summary, 2015–2016, week ending Oct 01, 2016 [online]. [cited 2017 Mar 26]. https://gis.cdc.gov/grasp/fluview/fluportaldashboard.html Figure 7. CDC FluView by week, 2016-2017 Source: From Centers for Disease Control and Prevention. Influenza positive tests reported to CDC by US public health laboratories, national summary, 2016–2017, week ending Mar 18, 2017 [online]. [cited 2017 Mar 26]. https://gis.cdc.gov/grasp/fluview/fluportaldashboard.html Pennsylvania Patient Safety Authority 2016 Annual Report 61 Figure 8. Influenza Reports, by Care Unit and Month, 2016 NUMBER OF REPORTS 150 120 90 60 30 MS17287 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec MONTH Ventilator dependent unit 0 4 0 0 0 0 0 0 0 0 0 0 Skilled nursing/short-term rehabilitation unit 13 22 25 54 3 1 0 0 0 0 3 47 Nursing unit 1 2 41 52 5 1 2 0 1 0 2 28 Mixed unit 1 5 45 28 6 0 1 0 2 0 1 42 Dementia unit 0 0 14 3 7 0 0 0 0 0 1 30 62 2016 Annual Report Pennsylvania Patient Safety Authority Table 3. Gastrointestinal Infections, Pooled Mean Rates, by Subcategory and Care Unit, 2016 NUMBER OF POOLED INFECTION RATE UNIT NAME (N) INFECTIONS RESIDENT DAYS (95% CI)* Clostridium difficile—The resident has diarrhea and a stool sample is positive for C. difficile toxin A or B, or a toxin-producing C. difficile organism is identified from stool culture or by molecular testing, or Pseudomembranous colitis identified through endoscopic examination, surgery, or biopsy Dementia unit (32) 53 2,293,538 0.02 (0.02 - 0.03) Mixed unit (160) 548 7,739,418 0.07 (0.06 - 0.08) Nursing unit (150) 447 8,426,415 0.05 (0.05 - 0.06) SN/STR unit (250) 1,074 9,109,775 0.12 (0.11 - 0.12) Vent unit (11) 43 173,405 0.25 (0.17 - 0.32) Total (480) 2,165 27,742,551 0.08 (0.07 - 0.08) Norovirus—The resident has diarrhea and/or vomiting and laboratory results are positive for Norovirus Dementia unit (1) 1 2,293,538 0 (0 - 0) Mixed unit (7) 15 7,739,418 0 (0 - 0) Nursing unit (4) 4 8,426,415 0 (0 - 0) SN/STR unit (13) 21 9,109,775 0 (0 - 0) Vent unit (0) 0 173,405 0 (0 - 0) Total (22) 41 27,742,551 0 (0 - 0) Bacterial gastroenteritis—The resident has diarrhea and/or vomiting and laboratory results are positive for a bacteriologic pathogen Dementia unit (1) 1 2,293,538 0 (0 - 0) Mixed unit (6) 7 7,739,418 0 (0 - 0) Nursing unit (5) 5 8,426,415 0 (0 - 0) SN/STR unit (7) 8 9,109,775 0 (0 - 0) Vent unit (0) 0 173,405 0 (0 - 0) Total (19) 21 27,742,551 0 (0 - 0) Kaplan—Norovirus is suspected based on Kaplan criteria; the resident has diarrhea and/or vomiting and C. difficile results are negative Dementia unit (17) 137 2,293,538 0.06 (0.05 - 0.07) Mixed unit (20) 294 7,739,418 0.04 (0.03 - 0.04) Nursing unit (25) 325 8,426,415 0.04 (0.03 - 0.04) SN/STR unit (30) 417 9,109,775 0.05 (0.04 - 0.05) Vent unit (0) 0 173,405 0 (0 - 0) Total (67) 1,173 27,742,551 0.04 (0.04 - 0.04) Total Gastrointestinal Infections Reported Dementia unit (32) 192 2,293,538 0.08 (0.07 - 0.1) Mixed unit (160) 864 7,739,418 0.11 (0.1 - 0.12) Nursing unit (150) 781 8,426,415 0.09 (0.09 - 0.1) SN/STR unit (250) 1,520 9,109,775 0.17 (0.16 - 0.18) Vent unit (11) 43 173,405 0.25 (0.17 - 0.32) Total (504) 3,400 27,742,551 0.12 (0.12 - 0.13) Note: As reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) in 2016 CI, Confidence interval; SN/STR, skilled nursing/short-term rehabilitation; vent, ventilator dependent. * Rate calculation: number of infections ÷ number of resident days × 1,000 Pennsylvania Patient Safety Authority 2016 Annual Report 63 Figure 9. Norovirus Outbreaks by Month, 2016 NUMBER OF NURSING HOME REPORTS 25 20 15 10 5 MS17288 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec MONTH With an outbreak 10 13 14 11 4 0 0 1 1 1 2 12 Without an outbreak 2 3 7 4 1 4 3 1 0 1 2 6 64 2016 Annual Report Pennsylvania Patient Safety Authority Table 4. Skin and Soft Tissue Infections, Pooled Mean Rates, by Subcategory and Care Unit, 2016 POOLED INFECTION RATE UNIT NAME (N) NUMBER OF INFECTIONS RESIDENT DAYS (95% CI)* Cellulitis, soft tissue, or wound infection Dementia unit (103) 317 2,293,538 0.14 (0.12 - 0.15) Mixed unit (183) 1,597 7,739,418 0.21 (0.2 - 0.22) Nursing unit (206) 1,609 8,426,415 0.19 (0.18 - 0.2) SN/STR unit (277) 1,769 9,109,775 0.19 (0.19 - 0.2) Vent unit (11) 56 173,405 0.32 (0.24 - 0.41) Total (546) 5,348 27,742,551 0.19 (0.19 - 0.2) Conjunctivitis Dementia unit (101) 365 2,293,538 0.16 (0.14 - 0.18) Mixed unit (150) 1,004 7,739,418 0.13 (0.12 - 0.14) Nursing unit (177) 1,099 8,426,415 0.13 (0.12 - 0.14) SN/STR unit (200) 975 9,109,775 0.11 (0.1 - 0.11) Vent unit (9) 28 173,405 0.16 (0.1 - 0.22) Total (455) 3,471 27,742,551 0.13 (0.12 - 0.13) Scabies Dementia unit (14) 36 2,293,538 0.02 (0.01 - 0.02) Mixed unit (27) 42 7,739,418 0.01 (0 - 0.01) Nursing unit (19) 44 8,426,415 0.01 (0 - 0.01) SN/STR unit (41) 98 9,109,775 0.01 (0.01 - 0.01) Vent unit (0) 0 173,405 0 (0 - 0) Total (91) 220 27,742,551 0.01 (0.01 - 0.01) Total Skin and Soft Tissue Infections Dementia unit (140) 718 2,293,538 0.31 (0.29 - 0.34) Mixed unit (205) 2,643 7,739,418 0.34 (0.33 - 0.35) Nursing unit (221) 2,752 8,426,415 0.33 (0.31 - 0.34) SN/STR unit (309) 2,842 9,109,775 0.31 (0.3 - 0.32) Vent unit (12) 84 173,405 0.48 (0.38 - 0.59) Total (589) 9,039 27,742,551 0.33 (0.32 - 0.33) Note: As reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) in 2016 CI, Confidence interval; SN/STR, skilled nursing/short-term rehabilitation; vent, ventilator dependent. * Rate calculation: number of infections ÷ number of resident days × 1,000 Pennsylvania Patient Safety Authority 2016 Annual Report 65 Figure 10. Device-Related Bloodstream Infections, by Care Unit NUMBER OF REPORTS 60 50 49 40 34 30 23 20 19 17 15 14 10 MS17289 0 0 0 0 Dementia unit Mixed unit Skilled nursing/ Nursing unit Ventilator short-term dependent unit rehabilitation unit UNIT 2015 2016 Figure 11. Device-Related Bloodstream Infections, by Subcategory NUMBER OF REPORTS 16 14 12 10 8 6 4 2 MS17290 0 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 2015 2016 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec MONTH (BY YEAR) Resident has a vascular catheter used for dialysis access 2 1 1 5 4 1 0 2 0 1 3 5 2 0 1 5 1 3 2 2 2 5 3 1 Resident has a central line (temporary) 4 4 3 8 2 6 4 7 1 3 2 5 2 4 6 3 3 5 1 12 0 2 4 3 Resident has a permanent line (port or tunneled line, not used for dialysis) 0 0 0 0 1 1 0 0 1 4 1 5 1 2 1 0 3 1 0 1 0 0 2 1 66 2016 Annual Report Pennsylvania Patient Safety Authority Notes 1. HAI data and statistics. [internet]. Atlanta (GA): Centers 8. Chmielewska M, Zycinska K, Lenartowicz B, Hadzik- for Disease Control and Prevention (CDC); 2016 Oct 5 Blaszcyzk M, Cieplak M, Kur Z, Wardyn KA. Clostridium [accessed 2017 Apr 07]. [4 p]. Available: https://www.cdc. difficile infection due to pneumonia treatment: mortality gov/hai/surveillance/index.html. risk models. In: Pokorski M, editor(s). Pathobiology of Pul- monary Disorders. 2016. p. 59-63. Also available: DOI: 2. Herzig C, DIck AW, Sorbero M, Pogrozelska-Maziarz M, 10.1007/5584_2016_160. Crawford Cohen C, Stone P [896] Longitudinal trends in . infection rates in US nursing homes, 2006 - 2011. IDWeek 9. U.S. trends of norovirus-associated outcomes figures. 2014. October 8-12, 2014; Philadelphia (PA). 2014 Oct [internet]. Atlanta (GA): Centers for Disease Control and 10. Also available: https://idsa.confex.com/idsa/2014/ Prevention (CDC); [accessed 2017 Mar 19]. Available: webprogram/Paper46630.html. https://www.cdc.gov/norovirus/trends-outbreaks-figure-1. html#fig1a. 3. National and state healthcare associated infections prog- ress report. Atlanta (GA): Centers for Disease Control and 10. Kaplan JE, Feldman R, Campbell DS, Lookabaugh C, Gary Prevention (CDC); 2016. 140 p. Also available: https:// GW. The frequency of a Norwalk-like pattern of illness www.cdc.gov/hai/surveillance/progress-report/index.html. in outbreaks of acute gastroenteritis. Am J Public Health. 1982 Dec;72(12):1329-32. PMID: 6291414 4. Medical Care Availability and Reduction of Error (MCARE) Act - Reduction and Prevention of Health Care-Asso- 11. Centers for Disease Control and Prevention (CDC). ciated Infection and Long-Term Care Nursing Facilities Bloodstream Infection Event (Central Line-Associated Act of July 20, 2007, P 331, No.52, Cl. 40. http:// .L. Bloodstream Infection and non-central line-associated www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. Bloodstream Infection). Atlanta (GA): Centers for Disease cfm?yr=2007&sessInd=0&act=52. Control and Prevention (CDC); 2017 Jan. 38 p. Also avail- able: https://www.cdc.gov/nhsn/pdfs/pscmanual/4psc_ 5. Stone ND, Ashraf MS, Calder J, Crnich CJ, Crossley K, clabscurrent.pdf. Drinka PJ, Gould CV, Juthani-Mehta M, Lautenbach E, Loeb M, Maccannell T, Malani PN, Mody L, Mylotte JM, 12. Pronovost P Needham D, Berenholtz S, Sinopoli D, Chu H, , Nicolle LE, Roghmann MC, Schweon SJ, Simor AE, Smith Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, PW, Stevenson KB, Bradley SF, Society for Healthcare Kepros J, Goeschel C. An intervention to decrease cath- Epidemiology Long-Term Care Special Interest Group. eter-related bloodstream infections in the ICU. N Engl J Surveillance definitions of infections in long-term care Med. 2006 Dec 28;355(26):2725-32. PMID: 17192537 facilities: revisiting the McGeer criteria. Infect Control Hosp 13. Centers for Disease Control and Prevention (CDC). Vital Epidemiol. 2012 Oct;33(10):965-77. Also available: signs: central line-associated blood stream infections--Unit- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538836/. ed States, 2001, 2008, and 2009. MMWR Morb. Mortal. PMID: 22961014 Wkly. Rep.. 2011 Mar 4;60(8):243-8. PMID: 21368740 6. Edwards RD, Magee J, Bassetti WH. Technical analysis of 14. Scott II RD. The direct medical costs of healthcare- stock trends. 10th ed. Boca Raton (FL): CRC Press; 2012. associated infections in U.S. hospitals and the benefits of 624 p. prevention. Atlanta (GA): Centers for Disease Control and 7. Pennsylvania Patient Safety Authority. Training manual and Prevention (CDC); 2009 Mar. 13 p. Also available: http:// users’ guide. Nursing home event reporting. Version 4.0. www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper.pdf. Harrisburg (PA): Pennsylvania Patient Safety Authority; 2016 Oct 13. Pennsylvania Patient Safety Authority 2016 Annual Report 67 The Pennsylvania Patient Safety Advisory Through its Pennsylvania Patient Safety Advisory, the 37 outbreaks; hospital inpatient, emergency, and Pennsylvania Patient Safety Authority continues to help outpatient settings reported 110 events associated improve patient safety in Pennsylvania. From the first issue with scabies.5 in March 2004 through December 2016, the Advisory has provided nearly 540 safety-focused articles. Patient •• In an analysis of the most recent 10 years of events safety events—including “good catches” and unsafe reported in Pennsylvania, analysts identified a conditions—reported by Pennsylvania healthcare facili- 66.4% reduction in the number of opioid wrong- ties, requests for information from Pennsylvania healthcare drug events reported, and a 79.4% reduction in providers, and review of the medical and patient safety the number of wrong-drug events involving mix-ups literature prompts analysis of the aggregate event data; between morphine and HYDROmorphone.6 specific examples from 2016 include the following: •• Healthcare personnel are responsible for removing •• A select set of patient safety measures—falls with the tourniquet after intravenous insertion, phleboto- harm, central line–associated bloodstream infec- my, and anesthesia blocks are complete. An online tions, catheter-associated urinary tract infections, video provides suggestions to help healthcare pro- wrong-site surgeries, and high harm events—was viders overcome persistent challenges in ensuring analyzed to demonstrate patient safety improve- tourniquet removal (https://youtu.be/fsc6chuPBkc).7 ments associated with the combined efforts of Overall, in responses collected through annual surveys Pennsylvania healthcare facilities, statewide qual- conducted since 2005, Commonwealth facilities credit the ity improvement entities, and the Authority. The Advisory with contributing to more than 4,650 structure Authority estimates that through 2015, for these five and process improvements; the Authority assumes these measures alone, more than 2,600 lives and more numbers represent just the tip of the iceberg. Support- than $147 million were saved.1 ing education and improvement endeavors constitute the •• Although rarely reported to the Authority in Penn- primary objective of the Advisory, as follows: sylvania, incorrect-end colostomy formation using “The Pennsylvania Patient Safety Advisory provides the distal bowl limb can potentially result in serious timely original scientific evidence and reviews of harm to patients or even death.2 scientific evidence that can be used by healthcare •• In a Pennsylvania event associated with a “good systems and providers to improve healthcare-delivery catch,” a healthcare worker noted that pads for an systems and educate providers about safe healthcare automated external defibrillator (AED) were incom- practices. The emphasis is on problems reported to patible with the accompanying AED. Beyond just en- the Pennsylvania Patient Safety Authority, especially suring that all of the parts fit together correctly on this those associated with a high combination of frequen- particular AED, this person went further, and checked cy, severity, and possibility of solution; novel problems on the other similar devices throughout the facility.3 and solutions; and problems in which urgent com- munication of information could have a significant •• Analysts estimate that an average of 1.7 newborn impact on patient outcomes.”8 misidentification events occur daily in Pennsylvania, affecting 4.6 newborns per 1,000 births.4 By introducing video presentations and heat map graph- ics, staff continued to enhance the readability and •• Through November 2015, Pennsylvania nurs- presentation of information during 2016. A graphic ing homes reported 484 cases of scabies and display of scabies transmission, symptoms, diagnosis, Pennsylvania Patient Safety Authority 2016 Annual Report 69 and control was a highlight. Articles consistently identi- improvements. Finally, as noted in Educational Programs, fied and analyzed problems and challenges, presented Advisory-based, concise webinars allowed participants to narrative stories, and offered strategies and solutions. The interact with analysts and explore the principles of patient Advisory also featured several articles addressing modern safety and methods to implement improvements. concepts and processes in patient safety and care delivery, such as using simulation to improve care, appreciating The following pages illustrate the depth and breadth of the essential human element in technology-driven care the Authority’s Advisory in 2016, as well as during its processes, and promoting the value of lessons learned 13-volume history, and its demonstrated value in the through “good catches,” which stimulated system-wide healthcare community. Notes 1. Magee MC, Marella WM, Newstadt HM, Clarke JR, Doer- 5. Bradley S. Scabies: strategies for management and control. ing MC. The value of improving patient safety in Pennsyl- Pa Patient Saf Advis. 2016 Jun;13(2):66-73. Also vania. Pa Patient Saf Advis. 2016 Dec;13(4):125-36. Also available: http://patientsafetyauthority.org/ADVISORIES/ available: http://patientsafetyauthority.org/ADVISORIES/ AdvisoryLibrary/2016/jun;13(2)/Pages/66.aspx. AdvisoryLibrary/2016/Dec;13(4)/Pages/125.aspx. 6. Grissinger M. Decline in serious events and wrong-drug 2. Feil M. Incorrect end colostomy formation using the distal reports involving opioids in Pennsylvania facilities. Pa bowel limb. Pa Patient Saf Advis. 2016 Sep;13(3):118-21. Patient Saf Advis. 2016 Mar;13(1):29-31. Also available: Also available: http://patientsafetyauthority.org/ADVISO- http://patientsafetyauthority.org/ADVISORIES/Advisory RIES/AdvisoryLibrary/2016/sep;13(3)/Pages/118.aspx. Library/2016/Mar;13(1)/Pages/29.aspx. 3. Saves, system improvements, and safety-II. Pa Patient Saf 7. Magee M. The forgotten tourniquet - an update. Pa Advis. 2016 Dec;13(4):171. Also available: http://patient- Patient Saf Advis. 2016 Mar;13(1):32-5. Also available: safetyauthority.org/ADVISORIES/AdvisoryLibrary/2016/ http://patientsafetyauthority.org/ADVISORIES/Advisory dec;13(4)/Pages/171.aspx. Library/2016/Mar;13(1)/Pages/32.aspx. 4. Wallace S. Newborns pose unique identification chal- 8. About the Pennsylvania Patient Safety Advisory. [internet]. lenges. Pa Patient Saf Advis. 2016 Jun;13(2):42-9. Also Harrisburg (PA): Pennsylvania Patient Safety Authority; available: http://patientsafetyauthority.org/ADVISORIES/ 2016 [accessed 2016 Jan 28]. [2 p]. Available: http:// AdvisoryLibrary/2016/jun;13(2)/Pages/42.aspx. patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/ Documents/editorial_info.pdf. 70 2016 Annual Report Pennsylvania Patient Safety Authority 2016 Articles Infection Prevention Clostridium difficile Infections Scabies Transmission, Early Detection Surgery of Sepsis Symptoms, Diagnosis, and Incorrect-End Colostomies Infection Control Control Preoperative Screening: and CAUTIs Collaboration Nursing Homes Ophthalmology Process Reduce CAUTIs Assessment Scabies Patient Wrong-Site Surgery: Updates and Family Involvement Medication Health Literacy Drug Interactions Identifying Patients with Incorrect Patient Weights Dementia Medication Errors Wrong-Site Surgery: involving Students Patient Engagement Prescribing Errors Opioids Simulation and Patient Safety Events Computerized Can Simulation in situ Prescriber Order Improve Patient Safety? Entry (CPOE) System Evaluation Teamwork Maternity Blood Transfusions Newborn Identification Forgotten Maternal Serious Events Tourniquets Postpartum Intraosseous Lines Hemorrhage Leadership Isolation Awareness Checklists Innovation is Key Missed Respiratory Healthcare: Complex, Saves, System Therapy Adaptive, Evolving Improvements, and That Pesky Human I Am Patient Safety II Factor Safety Awards Value of Improving Patient Safety Tourniquet Removal and Discard Process Content is grouped according to predominant patient safety foci. For more information by areas of focus, MS17104 see “Patient Safety Focus” at http://patientsafetyauthority.org. Pennsylvania Patient Safety Authority 2016 Annual Report 71 Scope 540+ articles published in 64 issues and supplements since March 2004 49 toolkits available, including myriad tools (2016 emphasized) On the Web 2016 Advisory Hits: Top Articles per Issue Toolkit: March 145,589 Medication Errors Involving Healthcare Students Family Members Advocate for Improved Identification of Patients with Dementia in the Acute Care Setting Advisory: 753,893 June Newborns Pose Unique Identification Challenges 2016 Health Literacy and Patient Safety Events Web traffic (hits): 1,563,044 September Prescribing Errors that Cause Harm Early Detection of Sepsis in Pennsylvania’s Long-Term Care Residents December Update on Wrong-Site Surgery: Reports from Remainder of website: Ambulatory Surgical Facilities (e.g., homepage, Analysis of Reported Drug Interactions: search, webinar recordings, A Recipe for Harm to Patients press releases) 0 500 1,000 1,500 2,000 2,500 3,000 663,562 Note: Hits as of December 31, 2016. Articles published earlier MS17105 have had more time to garner hits. 72 2016 Annual Report Pennsylvania Patient Safety Authority Readership 332 new subscribers in 2016 5,497 Authority program recipients* 1,837 Pennsylvania subscribers† 3,107 subscribers in the United States Subscribers in 49 states, as well as Washington, DC, and Puerto Rico Subscribers in 45 countries 3,276 subscribers worldwide (top five, other than U.S. emphasized) MS17106 * Recipients include reporting system users from acute healthcare facilities and nursing homes, as well as board and panel members in Pennsylvania. These recipients are not included in the total numbers of PA/U.S./worldwide subscribers indicated above. † Subscriber numbers reported through 2016 exclude any subscribers with email addresses that indicated lack of receipt (i.e., “bounced”) during 2016. Pennsylvania Patient Safety Authority 2016 Annual Report 73 4,650+ documented* Value changes in Pennsylvania acute- care facilities and nursing homes directly attributed to Advisory articles since 2005 2016 Ratings of the Advisory Acute-care Facilities 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 Nursing Homes 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 Weighted Average 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 Usefulness Relevance Readability Scientific Quality Educational Value Annual Survey Respondents “ The tracking forms are more helpful than what “ We have developed an antibiotic stewardship ” ” we were using. I was able to provide better and program—to be rolled out next week. more useful information to staff. “ We now ensure that someone, patient “ We have patients’ height and weight taken ” or significant other, has a complete in preoperative area so it is accurate on ” understanding of post-op discharge H&P for procedure date. instructions. “ We are in the process of changing our electronic medical record and will incorporate your points ” Through 2016, the media or medical 12,320+ literature attributed or mentioned Advisory-based CME credits, Authority-associated content in more than 2006 through 2016† 850 instances, including nearly 450 references to Advisory articles. * According to Authority user surveys (internal reports): acute-care facilities (2005-2016) and nursing homes (2009-2016). MS17107 † The Authority applies select articles for CME credit through the Pennsylvania Medical Society (http://www.pamedsoc.org). 74 2016 Annual Report Pennsylvania Patient Safety Authority Educational Programs Educating healthcare providers about risk and mitiga- programs. Education is offered through various means so tion strategies is key to improving patient safety. Without that individuals can participate in ways that are most con- knowledge and understanding of events, creating mean- venient for them. Educational programs can be provided ingful improvement is difficult. The Authority’s statewide on-site at an individual facility’s request, in large regional perspective of events allows a unique insight into the chal- meetings with opportunities to network with peers, on live lenges healthcare providers face and a unique opportunity webinars that can be accessed from any computer while to use this information to develop programs specific to allowing for interaction with the presenters, or by means these challenges. of online education that can be done at anytime from anywhere. Eighty-three individual patient safety officers Authority staff—including patient safety liaisons (PSLs), were educated via in-person just-in-time training, and patient safety analysts, infection prevention analysts, and 144 education sessions were held on-site at the request physicians—in conjunction with outside patient safety of facilities. and subject matter experts conduct these educational Hours spent educating 478.7 6 13 17 MS Pennsylvania Patient Safety Authority 2016 Annual Report 75 2016 Education Programs Webinars: Other (professional 3,964 attendees organizations and Newborn Safety schools): Errors involving Healthcare Students 1,164 attendees Improving Isolation Awareness Board’s Role Behavioral Patients in the Don’t Gamble on Patient Safety Acute Care Setting From Reporting to Prevention Safety-I and Safety-II Nurse Leaders Scabies Dementia That Pesky Human Factor Human Factors Moving Patient Safety Forward In-Person: 3,957 attendees Health Literacy Clostridium difficile MS17130 Falls Distractions in the Operating Room Online learning Failure Modes and management system Effects Analysis (LMS) and continuing From Reporting to Prevention medical eduction (CME): Root Cause Analysis 783 attendees Just Culture Regional: Final Guidance for Reporting Medication Safety 612 attendees Alarm Management Culture of Safety Health Information Technology Ambulatory Surgery Teamwork Pressure Ulcers Just Culture Wrong-Site Surgery Hand Hygiene Health Literacy Safe Injection Practices 10 Things Every Patient Safety Officer Should Know 76 2016 Annual Report Pennsylvania Patient Safety Authority ASF SYMPOSIA 2016 Annual symposia held to meet the Scranton specific requests and educational needs of Ambulatory Plymouth Meeting Surgical Facilities Lebanon Warrendale TOPICS On Becoming a QAPI Cat: Improving Quality Active Shooter Workplace 88% strongly agree that they would Violence recommend this program to a friend Wrong-Site Surgery Environmental Hygiene MS17133 Number of Pennsylvania individuals educated 10,480 in 2016 6,946 in 2015 MS17132 327 hours of CME were awarded for Authority UED CONTIN programs through our H! GROWT partnership with UPMC. MS17131 Pennsylvania Patient Safety Authority 2016 Annual Report 77 Patient Safety Liaison (PSL) Program The PSL program continues to be a unique program available to Pennsylvania hospitals, ambulatory surgical facilities, birthing centers, and abortion facilities. The PSLs serve as a resource to these facilities for reporting under the Medical Care Availability and Reduction of Error Act, patient safety education, patient safety consultative ser- The first Keystone, vices, and for ensuring facilities are knowledgeable about Authority resources. The PSL team consists of eight profes- “Keys to Reporting,” sionals who bring a wide range of skills and experience in patient safety to these facilities. started September 1 In 2016, the PSL program underwent some redesign, with a focus on creating a more cohesive team with shared vision and goals and additional resources for facilities. Periodically, the PSLs will roll out a new “Keystone.” Each 137 MS17 keystone will have a specific topic focus with consultative tools and resources to support facilities in those areas. PROGRAM USEFULNESS* 4.24 815 Mobile 0 1 2 3 4 5 consultations MS17135 *2016 acute care user survey 317 Educational 730 programs In-person visits 26 On-site consultations MS17134 78 2016 Annual Report Pennsylvania Patient Safety Authority Collaborative Strategies to Improve Patient Safety Unity is strength…when there is teamwork and collaboration, wonderful things can be achieved. —Mattie Stepanek The Pennsylvania Patient Safety Authority has formed stra- The Authority partnered with the Hospital and Healthsys- tegic partnerships with organizations and facilities in the tem Association of Pennsylvania (HAP) at the end of 2015 Commonwealth, collaborating to improve patient safety. and 2016 to work on the second Hospital Engagement All collaborations use evidence-based best practices and Network (HEN) contract* and begin work on the Hospital provide education, tools, resources, and opportunities for Improvement Innovation Network (HIIN) contract.† The facility networking and sharing. The Authority evaluates Authority will continue the success of previous HEN con- grant and other funding and partnership opportunities to tracts with the HIIN contract, which began on September support collaborative efforts. 28, 2016. Following is a summary of the collaborative and partnership activities. Hospital and Healthsystem Association of Pennsylvania Hospital Engagement Network* On September 24, 2015, HAP was awarded the primary The Authority continued to build on the success of first federal contract for Pennsylvania’s Hospital Engagement HAP PA-HEN by continuing to manage the HEN 2.0 im- Network 2.0 (HAP PA-HEN 2.0). The Authority partnered mersion projects, comprising Falls with Harm Reduction with HAP and other Pennsylvania healthcare organizations project (Falls) and the Preventing Harmful Adverse Drug to work with Pennsylvania hospitals to reduce healthcare- Events Related to Anticoagulants, Insulin, and Opioids acquired conditions. The contract ended on September project (ADE). The Authority also co-led a culture of safety 23, 2016. program in partnership with HAP and supported HAP with the PA-HEN 2.0 Healthcare Associated Infections (HAI) The goals of the national Partnership for Patients (PfP) projects. The Authority provided support by providing ac- Hospital Engagement Network (HEN) 2.0 were as follows: cess to PassKey, a secure, collaborative site that allowed each project to communicate and share information with •• Reduce all-cause preventable inpatient harm by participants. 40%. The main HAP PA-HEN 2.0 project activities for 2016 are •• Reduce 30-day all-cause readmissions by 20%. shown on “Building on Success: HEN 2.0 Collaboration.” * The analyses upon which this publication is based were performed under Contract Number HHSM- 500-2015-00300C, entitled, “Partnership for Patients Hospital Engagement 2.0 Contract.” † The analyses upon which this publication is based were performed under Contract Number HHSM-500-2016-00066C, entitled, “Partnership for Patients Hospital Improvement Innovation Network Contract, sponsored by the Centers for Medicare & Medicaid Services, Department of Health and Human Services.” Pennsylvania Patient Safety Authority 2016 Annual Report 79 Building on Success: HEN 2.0* Collaboration HAP HEN 2.0 Webinar Education Programs 11 3 Culture ADE with HAP 7 FALLS ADE FALLS TOOLS TOOLS Org. Assessment of Safe Falls Self-Assessment Tool Anticoagulant Practices Falls Self-Assessment Org. Assessment of Safe Action Plan Insulin Practices Postfall Investigation Tool Opioid Knowledge Falls Prevention Process Self-Assessment Measures Audit Tool Org. Assessment of Safe Opioid Practices Anticoagulants tools: http://patientsafetyauthority.org/Educational- Falls tools: http://patientsafetyauthority.org/EducationalTools/Pa- Tools/PatientSafetyTools/ams/Pages/Home.aspx tientSafetyTools/falls/Pages/home.aspx Insulin tools: http://patientsafetyauthority.org/EducationalTools/ PatientSafetyTools/insulin/Pages/home.aspx Opioids tools: http://patientsafetyauthority.org/EducationalTools/ PatientSafetyTools/opioids/Pages/home.aspx MS17086 ADE, Preventing Harmful Adverse Drug Events Related to Anticoagulants, Insulin, and Opioids project; Falls, Falls with Harm Reduction project; COS, culture of safety; HAP Hospital and Healthsystem Association of Pennsylvania; HEN 2.0, , Partnership for Patients Hospital Engagement 2.0 Contract. * The analyses upon which this publication is based were performed under Contract Number HHSM- 500-2015-00300C, entitled, “Partnership for Patients Hospital Engagement 2.0 Contract.” 80 2016 Annual Report Pennsylvania Patient Safety Authority Preventing Harmful Adverse Drug Events Related to Anticoagulants, Insulin, and Opioids The Authority partnered with HAP PA-HEN 2.0* to reduce practitioners’ current knowledge about the use of adverse drug events related to anticoagulants, insulin, and opioids. More than 1,700 individual practitioners opioids. The Authority’s analysis of adverse drug events completed the assessment. It has identified numer- found the following: ous, basic knowledge gaps by practitioners, which will hopefully spur organizations to address these •• Over an 18-month period ending in 2009, Pennsyl- gaps and assess staff knowledge about other high- vania healthcare facilities submitted 2,685 medica- alert medications.4 tion error reports to the Authority involving the use of insulin. More than 52% of the reported events The goals of HAP PA-HEN 2.0 were to reduce adverse led to situations in which a patient may have or ac- drug events related to anticoagulants, insulin, and opioids tually received the wrong dose of insulin (e.g., dose by 40%, help hospitals assess their practices, provide omissions, wrong dose/overdosage, wrong dose/ education on these adverse drug event topics, and help underdosage, extra dose, wrong rate errors), which hospitals improve their discharge education process for could lead to difficulties in glycemic control.1 anticoagulants and insulin. The outcome measures for the immersion project are shown in the Table. •• Analysts reviewed medication error reports submit- ted from July 2013 through June 2014 involving Fourteen hospitals focused on the immersion project. The oral anticoagulants. Of the 831 errors related to Collaborative for Effective Prescription Opioid Policies oral anticoagulants analyzed, the most common (CEPOP) recognized the work being done by the ADE event types were drug omissions (32.5%, n = 270), team through its CEPOP Salutes award (http://cepoponline. other (18.5%, n = 154), and extra doses (11.7%, org/resource/cepop-salutes-webinar-august-2016/). This n = 97).2 award recognizes HENs for their efforts to combat pre- scription opioid misuse, abuse, and diversion, beginning •• As a part of the first HAP adverse drug event col- with pain management in the inpatient setting. laboration, a 45-item organization assessment tool was developed to assess the safety of opioid The ADE project provided hospitals educational webinars, practices in hospitals. Findings from the assessment the use of PassKey, one-on-one coaching calls, and mul- revealed many opportunities to improve medica- tiple hospital coaching calls. The ADE project offered 11 tion safety and established a baseline of current educational webinars that were made available to all HAP practices regarding opioid use that can be used to PA-HEN 2.0 hospitals. Although this contract has ended, evaluate ongoing improvement.3 the work to preventing adverse drug events related to anti- coagulants, insulin, and opioids will continue with HIIN. •• In the same project, an 11-question opioid knowl- edge assessment tool was developed to assess Prevention of Falls with Harm The Authority partnered with HAP to reduce falls with HEN 2.0 Falls project was to reduce the number of falls harm, which was the second most reported Serious Event with harm by 40% from the 2010 baseline. in Pennsylvania in 2015.5 Falls can have a serious impact on a person’s ability to function, as well as their life ex- Thirty-four hospitals participated in the falls project: 28 pectancy. In 2015, Pennsylvania facilities reported 34,004 acute-care hospitals, 2 behavioral health hospitals, 3 falls events through the Pennsylvania Patient Safety Report- rehabilitation hospitals, and 1 skilled nursing and rehabili- ing System (PA-PSRS). Of these falls events, 947 had harm tation unit. Of these, 23 hospitals had participated in the sufficient to be classified as a Serious Event. The category first HEN falls project, and 11 were new enrollees for HEN Falls with Harm continues to represent a significant patient 2.0. safety challenge for hospitals. The goal of the HAP PA- * The analyses upon which this publication is based were performed under Contract Number HHSM- 500- 2015-00300C, entitled, “Partnership for Patients Hospital Engagement 2.0 Contract.” Pennsylvania Patient Safety Authority 2016 Annual Report 81 Table. HEN 2.0* Outcome and Process Measures for Anticoagulants, Insulin, Opioids, and Falls Projects IMMERSION PROJECT HEN-WIDE PROJECT TYPE OUTCOME MEASURES PROCESS MEASURES OUTCOME MEASURE Patients discharged on an anticoagulant receiving INRs >5 per the number of drug-specific information Aggregate anticoagulant Anticoagulant inpatients prescribed warfarin education per patients serious events therapy discharged on these medications Patients discharged on an insulin receiving Blood sugars <50 mg/dL drug-specific information Insulin per total number of patients Aggregate insulin serious events education per patients receiving insulin discharged on these medications Naloxone use to reverse Patients discharged on adverse effects from opioids an opioid receiving per total number of patients receiv- drug-specific information Opioid ing opioids Aggregate opioid serious events education per patients The number of rapid response team discharged on these calls related to opioids per the total medications number of rapid response calls The percentage of patients identified at risk who had a prevention protocol in place before Falls with harm per 1,000 Falls with harm per 1,000 the fall with harm Falls with harm patient days (using PA patient days (using PA definitions) The percentage of pa- definitions) tients who were assessed for risk prior to experiencing a fall with harm HEN, Hospital Engagement Network; INR, international normalized ratio; PA, Pennsylvania Safety Authority’s standardization project. * The analyses upon which this publication is based were performed under Contract Number HHSM-500-2015- 00300C, entitled, “Partnership for Patients Hospital Engagement 2.0 Contract.” Hospitals used the Pennsylvania standardized definition of complete the self-assessment survey and action plan. The falls and falls with harm to ensure consistency in reporting. evidence-based self-assessment tool was developed in The Falls project offered educational webinars, coaching the first HEN contract and revised for HEN 2.0. The other calls, hospital visits, in-person regional meetings, a col- tools were optional and provided additional resources laborative website, and falls preventions tools (see Build- to the hospitals for monitoring their falls programs. The ing on Success: HEN 2.0 Collaboration for links to tools) Authority also offered hospital visits to provide feedback as resources for the participants. to the falls team, assist with data analysis and assessment, help with action plan development and monitoring, and The Falls project offered immersion hospitals a model to identify opportunities to collaborate with other hospitals. follow using the acronym FALLS. During the HAP PA-HEN 2.0 falls project, 26 hospitals participated in hospital visits. This helped to guide the hospital project teams in de- veloping and improving their falls-prevention programs. Hospitals that participated in this project were required to 82 2016 Annual Report Pennsylvania Patient Safety Authority The falls project provided hospitals seven educational webinars and coaching calls that were made available Form a team to all the HAP PA-HEN 2.0* hospitals. Although this contract has ended, the work to prevent falls with harm Assess your falls program will continue with the HIIN subcontract (see Table). Look at your gaps Learn why falls are happening Study your data MS17159 Hospital and Healthsystem Association of Pennsylvania Hospital Improvement Innovation Network† On September 28, 2016, HAP was awarded one of the The Authority’s success in previous partnerships with HAP 16 primary federal contracts for HIIN. The Authority has has led to the leadership of the Authority on the adverse formed partnerships with HAP and other Pennsylvania drug events, prevention of falls with harm, and culture healthcare organizations to work with Pennsylvania hospi- of safety projects. The Authority is also leading a project tals to reduce healthcare-acquired conditions. with the Health Care Improvement Foundation to reduce emergency department radiologic diagnostic errors. The The goals of the HIIN are to achieve the following: Authority issued a press release in November 2016 that •• A 20% decrease in overall patient harm. can be found on the Authority’s website: http://patient- safetyauthority.org/NewsAndInformation/PressReleases/ •• A 12% reduction in 30-day readmissions as a Pages/pr_November_10_2016_Final.aspx. population-based measure from 2014 baseline. Experts Work to Prevent Wrong-Site Anesthesia Nerve Blocks in Pennsylvania Wrong-site local and regional anesthesia nerve blocks •• To evaluate current practices for preventing wrong- represent a significant portion of wrong-site operating site/side blocks, through interviews with expert panel room procedures. Between July 1, 2004, and December members and stakeholders including anesthesiolo- 31, 2016, wrong-site nerve blocks performed by anesthe- gists, surgeons, nurses, and patient representatives. siologists and surgeons comprised 25.9% of all wrong-site •• To conduct a systematic literature review that will be procedures reported through PA-PSRS. Given that only a used as a knowledge base for developing a guid- fraction of patients who are vulnerable to wrong-site sur- ance document. gery receive anesthesia in the form of blocks, the propor- tion of wrong-site anesthesia blocks is notable. •• To draft and disseminate guidance and resource document(s) to address wrong-site/side regional The Authority has partnered with the Pennsylvania Society of anesthesia block prevention for physicians, nurses, Anesthesiologists for the following: and healthcare facilities. * The analyses upon which this publication is based were performed under Contract Number HHSM- 500-2015- 00300C, entitled, “Partnership for Patients Hospital Engagement 2.0 Contract.” † The analyses upon which this publication is based were performed under Contract Number HHSM-500-2016- 00066C, entitled, “Partnership for Patients Hospital Improvement Innovation Network Contract, sponsored by the Centers for Medicare & Medicaid Services, Department of Health and Human Services.” Pennsylvania Patient Safety Authority 2016 Annual Report 83 Collaborative Feedback Annual Survey Collaborative Results The Authority seeks feedback from facilities each year through an annual survey. Some of the questions in the survey help the Authority learn about topics that facilities are interested in for collaboration. A summary of the results is shown in the following infographic: And the results are... Percentage of ACU LON facilities that G TE -TER CA responded by CARE 35.1% 24.4% M facility type RE Is your facility currently participating in any collaborative projects? ACUTE CARE LONG-TERM CARE 19.0 Yes 11.6 70.9 No 57.4 10.1 Unsure 31.0 MS17087 100 80 60 40 20 0 0 20 40 60 80 100 Percentage Percentage Acute Care Long-Term Care Topic Interests: Topic Interests: Infection prevention Preventing urinary tract (overall) infections Simulation to improve Antibiotic stewardship patient safety Modifying risk factors Standardizing for respiratory tract emergency codes infections MS17087 84 2016 Annual Report Pennsylvania Patient Safety Authority Partnerships The Authority’s partnerships help provide important relationships that complement, enhance, and expand the knowledge of the Authority. The graphic below provides information on our partnerships in 2016 (an interactive version is available online with this annual report at www.patientsafetyauthority.org). Association for Professionals in Infection Control and Epidemiology (APIC) – Active involvement in state and national chapters – Presented at APIC annual conference – On APIC research committee Health Research and Education Trust (HRET) National Patient Safety Foundation (NPSF) – Member of the national Kendal Outreach, LLC project team for CAUTI – On the research oversight committee measurement and – On the executive oversight committee – Partnered to offer the second definitions annual infection prevention – Assist in the development and education of the webinar series – Partnered to write a Certified Professional in Patient Safety credential research article on evidence base for urinary leg bags One and Only Pennsylvania Campaign Department of Health – Provide education Pennsylvania – Reduce HAIs on safe injection practices – Support facility Patient Safety reporting and Authority education Pennsylvania Association of Directors of Nursing Administration (PADONA) The Health Care Quality Insights Improvement Renal Network 4 – Authority provides infection control resources Foundation (HCIF) – Authority supports Renal – PADONA highlights the Authority’s Advisory – Health Literacy partner to Network 4 for its articles and tools in its communications provide education dialysis center project – PADONA sponsored a statewide webinar in 2016 – Member of the Pennsylvania Health Literacy Coalition MS17088 Pennsylvania Patient Safety Authority 2016 Annual Report 85 Notes 1. Medication errors with the dosing of insulin: prob- 4. Grissinger M. Results of the opioid knowledge assess- lems across the continuum. Pa Patient Saf Advis. 2010 ment from the PA hospital engagement network adverse Mar;7(1):9-17. Also available: http://www.patientsafety- drug event collaboration. Pa Patient Saf Advis. 2013 authority.org/ADVISORIES/AdvisoryLibrary/2010/Mar7(1)/ Mar;10(1):27-33. Also available: http://patientsafety Pages/09.aspx. authority.org/ADVISORIES/AdvisoryLibrary/2013/ Mar;10(1)/Pages/19.aspx. 2. Andreica I, Grissinger M. Oral anticoagulants: a review of common errors and risk reduction strategies. Pa Patient 5. Pennsylvania Patient Safety Authority 2015 annual report. Saf Advis. 2015 Jun;12(2):54-61. Also available: Harrisburg (PA): Pennsylvania Patient Safety Authority; http://patientsafetyauthority.org/ADVISORIES/Advisory 2016 Apr 29. 98 p. Also available: http://patientsafety Library/2015/Jun;12(2)/Pages/54.aspx. authority.org/PatientSafetyAuthority/Documents/annual_ report_2015.pdf. 3. Grissinger M, Lamis RL. Results of the PA-HEN organization assessment of safe practices for a class of high-alert medi- cation. Pa Patient Saf Advis. 2013 Jun;10(2):59-66. Also available: http://patientsafetyauthority.org/ADVISORIES/ AdvisoryLibrary/2013/Jun;10(2)/Pages/59.aspx. 86 2016 Annual Report Pennsylvania Patient Safety Authority Pennsylvania Patient Safety Authority 2016 Annual Report 87 The Authority Celebrates Pennsylvania Healthcare Providers for Outstanding Patient Safety Efforts Regina Hoffman, MBA, BSN, RN, CPPS Executive Director Pennsylvania Patient Safety Authority Introduction The Pennsylvania Patient Safety Authority held its annual facility representatives were also invited to attend the March I Am Patient Safety contest to recognize individuals and 2017 Authority Board of Directors meeting and a luncheon groups taking action to positively impact patient safety. The to meet Authority board members and staff. I want to thank contest provides an opportunity to showcase the great work everyone who participated in the contest. It is always a being done in Pennsylvania healthcare facilities and reward challenge to narrow such an impressive group of nomina- the people involved. We received more nominations this tions down to just a handful of winners. year than ever before. As one of the judges, I personally read all 184 submissions and was impressed by the evident The next round of nominations begins May 1, 2017. Please level of dedication and resulting impact on patient safety. take the time to acknowledge the patient safety stars in your facilities by nominating them for this contest. The Author- The judging panel, composed of an Authority board ity board members and staff appreciate the time you have member, executive and management staff, and a patient taken to tell us about your colleagues’ efforts to improve community member, evaluated submissions using the patient safety in Pennsylvania. following criteria: the person or group demonstrated (1) a discernible impact on patient safety for one or many Thank you, again, to all who participated in the I Am patients, (2) a commitment to patient safety, (3) a strong Patient Safety contest. Please join me in congratulating the patient safety culture present in the facility, and (4) initia- winners for their commitment to patient safety. tive. Winners were awarded with a plaque, certificate, The individuals and groups recognized for the I Am Patient and recognition pin from the Authority. Their photos and Safety contest and their achievements are grouped by patient safety efforts were highlighted on posters that could name of facility.¹ be displayed within their facilities. Winners and healthcare Scan this code with your mobile device’s QR reader to view videos about winners on the Authority's Facebook page. 1 Any included numbers and/or results were provided for publication by the recognized healthcare facilities. The Pennsylvania Patient Safety Authority has not independently verified, and bears no responsibility or liability for, these numbers and/or results. 88 2016 Annual Report Pennsylvania Patient Safety Authority Trisha Patel, PharmD, BCPS, BCCCP dangerous radiation. Rose Hall, supervisor of the CT Scan Critical Care and Infectious Disease Pharmacist Department, and her team made it their priority to reduce Cancer Treatment Centers of America® at Eastern the amount of radiation used in scans. They worked with Regional Medical Center radiologists to implement new protocols, and new scanning technology was introduced. A patient with cancer was ill with signs and symptoms that sug- gested a urinary tract infection. Trisha Patel, a critical care and Because of these changes, the image quality of CT scans infectious disease pharmacist, went beyond her standard inpa- improved and average radiation exposure was cut in half. tient duties to review the outpatient’s urine test results. Trisha, Einstein ranked in the top 17th percentile of participating who works to ensure that patients are on the right antibiotics providers in the American College of Radiology Dose for their particular disease, noticed the patient was infected Index Registry. with a harmful, multidrug-resistant bacterium. She called the infectious disease consultant and the patient was admitted to the hospital to receive necessary intravenous (IV) antibiotics. Andrew Klee, Infection Control Practitioner The Healthcare Acquired Infections Team Trisha’s attention to detail and quick identification of the Guthrie Robert Packer Hospital bacteria prevented the patient from developing a worsening infection. Good hand hygiene is important in protecting patients from healthcare-acquired infections (HAIs) that healthcare workers can unintentionally spread. The HAI Team, under infection preventionist Andrew Klee, convinced the hospital Melissa Hewitt, Clinical Nurse Manager, Registered to install an electronic hand-hygiene monitoring system. Nurse, Certified Neonatal Intensive Care Nursing, MSN Any employee who routinely enters patient rooms wears a Arlene Stonelake, Registered Nurse, Certified monitoring badge, and handwashing compliance is posted for all to see. The team also collaborated with the Envi- Meghan Mahoney, Registered Nurse, Certified ronmental Services Department to use an ultraviolet-light Labor & Delivery Department robot to disinfect operating and intensive care unit rooms. Einstein Medical Center Montgomery The results were favorable—the oncology unit saw a A manufacturer changed the packaging of a medication threefold decrease in patients infected in the hospital with for IV treatment, and the new bag looked very much like the harmful bacterium Clostridium difficile. another medication. As nurses in the Labor & Delivery department, Melissa Hewitt, clinical nurse manager; Ar- lene Stonelake, registered nurse; and Meghan Mahoney, Paul Karlin, DO, Medical Director of Critical Care Unit registered nurse worried that the wrong medication could (CCU) and Division Chief for Pulmonary Medicine be given to patients. After trying numerous solutions, the Jeanes Hospital group and hospital pharmacy changed procedures so that instead of using two sizes of IV bags, the medication with Jeanes Hospital performs case reviews for each patient the new packaging is prepared only in a 500 mL bag, the death, to improve patient safety and quality of care. Dr. department’s only bag of that size. Karlin performs the lion’s share of these case reviews. He looks to improve clinical care, foster respect and com- The team’s persistence led to a safer process for distin- munication among providers, provide patient dignity, and guishing IV medications. enhance family-member relations. He is frank about op- portunities for improvement but does not place blame. Rose Hall, RT (R) (CT), and her team in the His efforts, as architect of a new departmental structure CT Scan Department and captain of the ship, have prompted physician and Einstein Medical Center Philadelphia staff education, policy and process revisions, and practice changes that support better patient outcomes. Although important in evaluating patients, computed tomography (CT) scans increase patient exposure to Pennsylvania Patient Safety Authority 2016 Annual Report 89 The Pain Center of OSS Health This finding led to a hospital-wide assessment and repair OSS Health of the wheel locks on all beds in the facility, lessening patients’ risk of falling. A large team of nurses in a pain-management procedure center needed to consult about cases while still maintain- ing patients’ privacy. To achieve this, the center imple- mented among the staff use of two-way wireless com- Ashley Hartzell, Registered Nurse munications, with devices that have a microphone and a Babette Rudick, Registered Nurse single earpiece. Lisa Swenson, BSN, RN, ONC Recently, a patient in the procedure room fainted while Jacqueline Brown, Medical Assistant being helped from the procedure table to a wheelchair. Tina Frank, MHS, BSN, RN The procedure room nurse used her wireless device to call for assistance. Multiple staff members responded. Thanks Teresa Diez, Certified Registered Nurse Practitioner to the wireless system, the post-op nurses were also aware Surgery Optimization Clinic of the situation and notified the family and gathered the PinnacleHealth System supplies needed to properly care for the patient. A surgery optimization clinic was established by Tina Frank, MHS, BSN, RN, with the help of her team Teresa Wannetta Love, Registered Nurse, CCRN Diez, CRNP; Lisa Swenson, BSN, RN, ONC; Ashley Hartzell, RN; Babette Rudick, RN; and Jacqueline Brown, Intensive Care Unit MA. They collaborate with healthcare providers inside and Phoenixville Hospital outside the hospital to coordinate care, looking at “the whole person” through one-on-one education and sup- As a registered nurse in the intensive care unit (ICU), port before surgery. These programs include screenings Wannetta (Neadie) Love observed two patients who each related to pain, smoking, sleep apnea and alcohol use, had an endotracheal tube. One patient had a facial pres- weight management and dietary practices, and “prehabili- sure injury associated with the endotracheal tube, while tation” to improve mobility. the other patient did not. She investigated and found that the unaffected patient had been transferred from another facility that used a special holder to reduce pressure-injury development. Love championed the use of these holders. Endoscopy Department and Infection Prevention and Control Staff Because of her efforts, the hospital decided to purchase PinnacleHealth System the pressure-reduction devices, which are now used in the ICU. No facial pressure injuries have occurred since. Recently, gastrointestinal professionals were shocked to learn that nationally, an antibiotic-resistant organism was being spread to patients through endoscopes that were Erin Madden, Patient Care Assistant - Nursing 4S PCT contaminated, even after proper cleaning (the scopes have crevices that shelter bacteria). The PinnacleHealth Phoenixville Hospital endoscopy leadership, the endoscopy team, and the in- As a patient care assistant, Erin Madden was helping a fection control department devised a plan to mitigate the patient into bed. She had made sure the bed’s wheels risk to patients. The endoscopy team embraced the new were locked, but during the patient’s transfer, the bed disinfecting process, even though it takes more time. shifted away. Fortunately, the patient did not fall. The bed After reorientation and education, the Endoscopy De- was repaired. But Erin remained concerned and raised partment staff process endoscopes beyond professional the issue during one of the unit’s daily safety huddles. The standards. concern was relayed to hospital leadership. It was discov- ered that even with wheels locked, nearly 60% of the beds on the unit were unstable. 90 2016 Annual Report Pennsylvania Patient Safety Authority Renu Joshi, MD, Medical Director, Endocrinology Quality Based Improvement Resident Teams Endocrinology Team Department of Surgery NP Inpatient Endocrinology Service Thomas Jefferson University Hospital PinnacleHealth System Recognizing the importance of quality and safety educa- When patients with diabetes are hospitalized, controlling tion, surgical residents at Thomas Jefferson University their blood glucose levels is difficult. Hospital workers may Hospital established the Quality Based Improvement not have expertise in managing glucose levels. Addition- Resident Teams (QBIRT) initiative. Under QBIRT, residents ally, the patient is seen by multiple practitioners—each have researched, developed, and launched programs to treatment can affect a patient’s blood glucose levels. As reduce harm and improve the quality of care for surgi- medical director for endocrinology, Dr. Joshi heads a cal patients. They have led projects that have resulted in Diabetes Clinical Initiative and championed the creation reducing surgical site infections and catheter-associated of a Nurse Practitioner Inpatient Endocrinology Service. urinary tract infections and safer insertion of feeding This multidisciplinary service improves knowledge among tubes. With one hospital-wide QBIRT initiative, residents nonspecialist staff and provides education, advice, and analyzed data and created a “risk score” to help predict support to clinical staff, patients, and families. postoperative respiratory failure in an effort to intervene earlier and prevent these complications. Because of this program, diabetic patients’ hospital stays are shorter and they have fewer surgical-site infections Through advanced analytics, best practice implementa- than before. tion, team integration, and innovation, the residents of QBIRT have made a significant difference in patient care and surgical outcomes. Donna Miller, Nurse Manager Jessica Radicke, Administrative Charge Registered Nurse ICU Service Partners Marissa McMeen, Infection Control Practitioner Infectious Disease Practitioners Bone Marrow Transplant Unit UPMC Susquehanna’s Williamsport Regional Thomas Jefferson University Hospital Medical Center Concerned about the number of central line–associated A team of intensive care service partners, infectious bloodstream infections (CLABSIs) in the Bone Marrow disease practitioners, and a professional development Transplant Unit, Donna Miller, nurse manager; Jessica specialist analyzed every CLABSI in the ICU. They aimed Radicke, administrative charge registered nurse; and Ma- to reduce CLABSIs. The expectation was set that staff rissa McMeen, infection control practitioner made positive would wear a mask and use a sterile drape whenever ac- changes. Protocols were altered to limit who could change cessing a central line (to give medications or draw blood). central-line dressings, and staffing was adjusted to cover The professional development specialist conducts compe- this task. They introduced a medical manikin so nurses could tency checks and infectious disease practitioners monitor practice and demonstrate accessing the central line. Senior compliance with infection-control practices. leadership recognized and celebrated the team’s success. After achieving 572 days without a CLABSI, these partners Since the action plan was implemented, the unit experi- continue with the goal of zero CLABSI for patients in the ICU. enced just one CLABSI in 15 months. Pennsylvania Patient Safety Authority 2016 Annual Report 91 Recommendations to the Department of Health The Medical Care Availability and Reduction of Error statutory or regulatory changes. However, the Authority (MCARE) Act calls upon the Authority to suggest recom- continues to work in partnership with the Department of mendations for statutory or regulatory changes that may Health to standardize reporting requirements. Please see help improve patient safety in the Commonwealth. In Reporting Standardization: Guidance for Acute Healthcare 2016, the Board had no formal recommendations for Reporting. Pennsylvania Patient Safety Authority 2016 Annual Report 93 Anonymous Reports The Medical Care Availability and Reduction of Error review the anonymous-report process with new patient (MCARE) Act includes an important provision that permits safety officers as part of their educational and onboarding individual healthcare workers to submit what the act de- programs. See Educational Programs for more informa- fines as an “anonymous report.”1 Under this provision, a tion. Individuals completing the form do not need to healthcare worker who has complied with section 308(a) identify themselves, and the Authority assigns professional of the act may file an anonymous report regarding a Seri- clinical staff to conduct any subsequent investigations. ous Event. The MCARE Act requires facilities to make the The Authority encourages healthcare workers to submit anonymous report form available to healthcare workers. anonymous reports when they believe their facility is not appropriately reporting or responding to a Serious Event. The form is available on the Pennsylvania Patient Safety Authority’s website and through the Pennsylvania Patient The MCARE Act requires that the annual report include Safety Reporting System. The reporting form is a simple, the number of anonymous reports filed and reviews con- one-page questionnaire. To ensure healthcare workers ducted by the Authority. In 2016, the Authority received are aware of the option to submit an anonymous report, four anonymous reports that complied with MCARE Act the Authority developed an anonymous report pamphlet. requirements. The Authority has received 15 anonymous It includes an anonymous report form with guidelines for reports since reporting began in 2004 (see Figure). filing a report. The Authority’s patient safety liaisons also Figure. Anonymous Reports Received by the Authority that Complied with MCARE Act Requirements, 2004 through 2016 NUMBER OF REPORTS 5 4 4 3 3 2 1 1 1 1 1 1 1 1 1 0 0 0 0 04 05 06 07 08 09 10 11 12 13 14 15 16 20 20 20 20 20 20 20 20 20 20 20 20 20 MS17199 YEAR Note 1. Medical Care Availability and Reduction of Error (MCARE) Act of March 20, 2002, P 154, No 13 40. Available: .L. http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2002&sessInd=0&act=13. 94 2016 Annual Report Pennsylvania Patient Safety Authority Referrals to Licensure Boards The Medical Care Availability and Reduction of Error licensing board of failure to report. No such situations (MCARE) Act requires the Pennsylvania Patient Safety were reported to the Authority during 2016. However, the Authority to identify the number of referrals to licen- Authority is unlikely to receive information related to a sure boards for failure to submit reports under the Act’s referral to a licensure board because Pennsylvania Patient reporting requirements.1 MCARE specifies that it is the Safety Reporting System (PA-PSRS) reports do not include medical facility’s responsibility to notify the licensee’s the names of individual licensed practitioners. Note 1. Medical Care Availability and Reduction of Error (MCARE) Act of March 20, 2002, P 154, No 13 40. Available: .L. http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2002&sessInd=0&act=13. Pennsylvania Patient Safety Authority 2016 Annual Report 95 Fiscal Statements and Contracts The Medical Care Availability and Reduction of Error on their own adverse event and near-miss reports and (MCARE) Act1 establishes the Patient Safety Trust Fund as activities. The Authority recently provided nursing homes a separate account in the Pennsylvania Treasury. Under with an infection analytic system within PA-PSRS. Facilities the MCARE Act, the Pennsylvania Patient Safety Author- can use these tools for their internal patient safety and ity determines how those funds are used to effectuate the quality improvement programs. In 2016, the Authority patient safety provisions of the Act and administers funds began working on the PA-PSRS Application Modernization in the Patient Safety Trust Fund. Funds come primarily from (AMOD). The AMOD project entails a complete redesign assessment surcharges made by the Department of Health of the PA-PSRS application with a planned release to the on certain medical facilities. facilities in 2018. Also in 2016, the Authority’s SAS Visual Analytics Reporting System was named a national finalist The Authority recognizes that Pennsylvania hospitals, birth- in the Emerging & Innovative Technologies category of the ing centers, ambulatory surgical facilities, abortion facili- National Association of State Chief Information Officers ties, and nursing homes bear financial responsibility for (NASCIO) 2016 State IT Recognition Awards. costs associated with complying with mandatory reporting requirements. Accordingly, the Authority has focused on The Authority provides numerous training and educa- two fiscal goals: (1) to be prudent in the use of moneys tion programs, including programs related to reporting, contributed by the healthcare industry, and (2) to as- investigating, and analyzing events, risk assessment, and sure that healthcare facilities paying for the Pennsylvania patient safety topic-specific education. The Authority Patient Safety Reporting System (PA-PSRS) receive direct also publishes the Pennsylvania Patient Safety Advisory, benefits from the system and from Authority programs in a scholarly journal issued quarterly that includes detailed return. Pursuant to Section 304(A)(4) of the MCARE Act, analysis and identification of trends of reports submitted as a general rule, the Authority is authorized to receive through PA-PSRS. All these programs are offered at no funds from any source consistent with the Authority’s additional cost to the facilities. As identified elsewhere in purposes under the Act. Consistent with this mandate, the this annual report, the Authority expanded its services by Authority at times contracts with and receives funding from organizing and supporting research collaborations with other healthcare-related entities to reduce medical errors reporting facilities and other patient-safety-centric orga- and promote patient safety in the Commonwealth. These nizations. The Authority also provides continuing medical contracts in 2016 are described in the section, “Contracts education and patient safety curriculum development. By under which the Authority Received Revenue in 2016 as directly offering clinical guidance, feedback, and edu- a Contractor,” which lists contracts with the Hospital and cational programs to providers about actual events that Healthsystem Association of Pennsylvania (HAP) and the occur in Pennsylvania, the Authority provides measurable Health Care Improvement Foundation (HCIF). value back to the healthcare industry that contributes to funding this program. In this regard, within the design of PA-PSRS, the Author- ity included a variety of integral and analytical tools that provide immediate, real-time feedback to facilities Pennsylvania Patient Safety Authority 2016 Annual Report 97 Funding Received from Hospitals, Ambulatory Surgical Facilities, Birthing Centers, and Abortion Facilities The MCARE Act1 set an initial limit of $5 million on the amount that could have been assessed for the year total aggregate assessment on acute-care facilities for pursuant to Section 305(d) of the MCARE Act. Beginning any one year beginning in 2002, plus an annual increase in 2015, the Authority Board authorized the use of the based on the consumer price index (CPI) for each sub- Northeast Medical Professional Services CPI to calculate sequent year. For fiscal year 2016–2017, the maximum annual adjustments to maximum assessments. allowable acute-care assessment is $7,097,85, against the Authority Board’s approved aggregate acute-care as- At the time of this acute-care assessment recommenda- sessment of $6,675,000. tion, the Patient Safety Authority Board considered several points, including the following: On December 13, 2016, the Authority Board authorized a recommendation to the Department of Health that •• The Patient Safety Authority’s FY 2016–2017 bud- the FY 2016–2017 acute-care assessment surcharges get totals about $8.5 million, with approximately should total $6.675 million. This amount is a $175,000, $7.2 million funding expenditures other than for or 2.7%, increase over the FY 2015–2016 acute-care healthcare-associated infection (HAI). assessment and is 6.0% less than the maximum annual Table 1. Acute Care Facility Assessments A NUMBER OF FACILITIES ASSESSED BY DEPARTMENT APPROVED TOTAL ASSESSMENTS RECEIVED FISCAL YEAR OF HEALTH ASSESSMENTS BY DEPARTMENT OF HEALTH B 2002-03 356 $5,000,000 $4,663,000 2003-04 377 $2,500,000 $2,542,316 2004-05 414 $2,500,000 $2,508,787 C 2005-06 450 $2,500,000 $2,500,149 2006-07 453 $2,500,000 $2,500,034 2007-08 526 $5,400,000 $5,391,583 2008-09 524 $4,000,000 $3,972,677 2009-10 519 $5,000,000 $4,989,781 2010-11 542 $5,000,000 $4,981,443 2011-12 550 $5,100,000 $5,063,723 2012-13 545 $5,500,000 $5,504,549 2013-14 556 $5,500,000 $5,492,002 2014-15 564 $6,200,000 $6,209,459 2015-16 569 $6,500,000 $6,494,845 2016-17 D $6,675,000 $68,814,348 A The number of facilities assessed by the Department of Health differs from the number of the Medical Care Availability and Reduction of Error (MCARE) Act’s facilities cited elsewhere in this report because of differences in the dates chosen to calculate the number of facilities for these two different purposes. B Amounts assessed and amounts received differ because a few facilities may have closed in the interim or are in bankruptcy. In a few cases, the Department of Health has pursued action to enforce facility compliance with the MCARE Act’s assessment requirement C Total assessments received are greater than assessments made because some funds received were late payments for the previous year’s assessment. D 2016-17 missing figures were unavailable at the time of publication and will appear in next year’s annual report. 98 2016 Annual Report Pennsylvania Patient Safety Authority •• The Patient Safety Authority’s FY 2016–2017 ment has increased by an average of 2.62% budget increased by $249,000, or 3.0%, from the per year. previous fiscal year budget. Also considered in authorizing this increase were staff and •• The FY 2016–2017 acute-care assessment of program growth, significant increases in Commonwealth $6.675 million has increased by $1.675 million of Pennsylvania mandated burdened benefit rates, and from the Authority’s initial acute-care assessment in projected contract revenue in FY 2016–2017. FY 2002–2003 of $5.0 million, a 2.39% per year average increase. Table 1 shows the number of acute-care facilities as- sessed, approved assessments, and assessments received •• Since the Authority’s FY 2007–2008 acute-care for each fiscal year. assessment of $5.4 million, the acute-care assess- Funding Received from Nursing Homes Act 522 of the MCARE Act allows the Department of On December 13, 2016, the Authority Board autho- Health to assess Pennsylvania nursing homes up to an rized a recommendation to the Department that the FY aggregate amount of $1 million per year for any one 2016–2017 nursing home assessment surcharges should year beginning in 2008, plus an annual increase based total $1.11 million. This amount is $20,000 more than on the CPI for each subsequent year. In 2008, following the previous year’s assessment and is approximately 3.1% the Authority’s suggestion, the Department assessed 725 below the maximum assessment permitted under Act 52, nursing home facilities a total of $1,000,000 and trans- based on annual CPI adjustments. Beginning in 2015, the ferred $1,000,782 to the Patient Safety Trust Fund for FY Authority Board authorized the use of the Northeast Medi- 2008–2009. This money could be spent only on activities cal Professional Services CPI to calculate annual adjust- related to HAI and implementation and maintenance of ments to maximum assessments. Chapter 4 of the MCARE Act. For FY 2016–2017, the Act 52 maximum allowable assessment is $1,145,915, against Table 2 shows the number nursing homes assessed, ap- the Authority Board’s approved aggregate assessment of proved assessments, and assessments received for each $1,110,000. fiscal year. Table 2. Nursing Home Assessments NUMBER OF FACILITIES TOTAL ASSESSMENTS ASSESSED BY DEPARTMENT APPROVED RECEIVED BY DEPARTMENT OF FISCAL YEAR OF HEALTH ASSESSMENTS HEALTH 2008-09 725 $1,000,000 $1,000,782 2009-10 711 $800,000 $799,382 2010-11 707 $800,000 $799,829 2011-12 707 $800,000 $804,473 A 2012-13 711 $900,000 $913,315 A 2013-14 698 $1,000,000 $998,751 2014-15 703 $1,050,000 $1,049,842 2015-16 702 $1,080,000 $1,079,505 2016-17 B $1,080,000 $7,445,879 A Total assessments received are greater than assessments made because some funds received were late payments for the previous year’s assessment. B FY 2016-2017 missing figures were unavailable at the time of publication and will appear in the next year’s annual report. Pennsylvania Patient Safety Authority 2016 Annual Report 99 Annual Expenditures During calendar year 2016, the Authority spent about $7.833 million and received contract and service related receipts of $546,000, resulting in net expenditures of $7.286 million (Table 3). Table 3. Expenditures for Calendar Year 2016 CONTROL LEVEL AMOUNT 61: Personnel $2,494,304 63: Operating $5,338,706 Contract Revenue Receipts -$546,399 Net expenditures $7,286,611 Patient Safety Authority Contracts The MCARE Act requires the Authority to identify a list of During calendar year 2016, the Authority received contracts entered into pursuant to the Act, including the services under the following contracts (FC, funds commit- amounts awarded to each contractor. ment; PO, purchase order). ECRI Institute, FC # 4000018888 XEROX Corp., PO # 4500734462 Four-year, nine-month contract for program administra- Xerox color copier lease tion, clinical analysis, training and data collection, and October 1, 2013, to August 31, 2017 @ $398.39/ reporting infrastructure services. month with no overage charge October 1, 2014, through June 30, 2019 12-month lease expense (Jan-Dec) Total contract amount: $24,227,233 paid in 2016: $4,780.68 over 4 years and 9 months DELL Marketing LP PO # 4300446203 , Amount invoiced for 2014 (October through December): $1,135,983.79 SAS Visual Analytics software maintenance Amount invoiced for 2015 Valid from March 31, 2016 – March 31, 2017 (January through December): $4,824,833.20 Amount expended in 2016: $11,909.78 Amount invoiced for 2016 (January through November): $4,946,827.23 Happy Cog, Philadelphia, PA (Purchasing Card) (December 2016 invoice estimated and unaudited) Logo design contract (completed) Amount expended in 2016: $10,000.00 IKON Office Solutions, PO # 4500712922 Contract Value: $10,000.00 Ricoh B&W copier lease August 1, 2013, to June 30, 2017 @ $202.62/month 12-month lease expense (Jan-Dec) paid in 2016: $2,431.44 100 2016 Annual Report Pennsylvania Patient Safety Authority Contracts under which the Authority Received Revenue Patient Safety Authority Balance Sheet in 2016 as a Contractor: Table 4, Balance Sheet, reflects the status of the Patient Safety Trust Fund as of December 31, 2016. HCIF (Health Care Improvement Foundation) Agreements 1 (Completed) & 2 (Ongoing) – Table 4. Patient Safety Trust Fund Balance Sheet Health Literacy Projects (Unaudited), as of December 31, 2016 HCIF 1 Total Receipts in 2016: $27,198.02 ASSETS HCIF 2 Total Receipts in 2016: $1,198.99 Cash in transit $1,199 Temporary investments $5,632,604 Total Assets $5,633,803 HAP/CMS subcontract agreement – HAP–PA Hospital Engagement Network (HEN 2.0), LIABILITIES AND FUND BALANCE Completed in 2016 Liabilities Total Receipts in 2016: $518,002.00 Accounts payable and accrued liabilities $6,975 Invoices payable $420,070 Total Liabilities $427,045 Fund Balance Restricted $5,206,758 Total Fund Balance $5,206,758 Total Liabilities and Fund Balance $5,633,803 Source: Comptroller Operations, Commonwealth Bureau of Accounting and Financial Management Notes 1. Medical Care Availability and Reduction of Error (MCARE) Act of March 20, 2002, P 154, No 13 40. Available: .L. http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2002&sessInd=0&act=13. 2. Medical Care Availability and Reduction of Error (MCARE) Act - Reduction and Prevention of Health Care-Asso- ciated Infection and Long-Term Care Nursing Facilities Act of July 20, 2007, P 331, No. 52, Cl.40. http:// .L. www.legis.state.pa.us/cfdocs/legis/li/uconsCheck. cfm?yr=2007&sessInd=0&act=52. Pennsylvania Patient Safety Authority 2016 Annual Report 101 Board of Directors and Public Meetings Members of the board of directors are appointed by the Physician appointed by the Governor: governor and the general assembly according to certain John Bulger, DO, MBA occupational or residence requirements. As of December Residence: Danville (Montour County) 31, 2016, members included: The Medical Care Availability and Reduction of Error Physician appointed by the Governor who serves as Chair: (MCARE) Act requires the board of directors to meet at Rachel Levine, MD, Physician General least quarterly.1 During 2016, the board met frequently to Residence: Middletown (Dauphin County) assess and develop future patient safety educational and advocacy activities, including developing standards for Appointee of the President pro tempore of the Senate: more consistent reporting. Representatives of healthcare, Daniel Glunk, MD, MHCDS consumer, and other stakeholder groups, including the Residence: Williamsport (Lycoming County) general assembly, have attended and spoken at public Appointee of the Minority Leader of the Senate: meetings. Following are the dates of all public board Cliff Rieders, Esq. meetings held by the Authority during 2016: Residence: Williamsport (Lycoming County) •• January 26, 2016 Appointee of the Speaker of the House: •• March 8, 2016 Stanton N. Smullens, MD, Vice Chair Residence: Philadelphia (Philadelphia County) •• April 26, 2016 •• June 7, 2016 (cancelled) Appointee of the Minority Leader of the House: Eric Weitz, Esq. •• July 26, 2016 Residence: Philadelphia (Philadelphia County) •• September 13, 2016 Pharmacist appointed by the Governor: •• October 25, 2016 Arleen G. Kessler, PharmD, MBA, RPh •• December 13, 2016 Residence: Williamsport (Lycoming County) Summary minutes of the public meetings are available on the Hospital employee appointed by the Governor: Authority’s website at http://www.patientsafetyauthority.org. Radheshyam Agrawal, MD Residence: Pittsburgh (Allegheny County) Address: Healthcare worker appointed by the Governor: Pennsylvania Patient Safety Authority Jan Boswinkel, MD 333 Market Street, Lobby Level Residence: Havertown (Delaware County) Harrisburg, PA 17120 Phone: (717) 346-0469 Non-healthcare worker appointed by the Governor: Fax: (717) 346-1090 Mary Ellen Mannix, MRPE E-mail: patientsafetyauthority@pa.gov Residence: Wayne (Delaware County) Note 1. Medical Care Availability and Reduction of Error (MCARE) Act of March 20, 2002, P 154, No. 13, Cl. 40. Avail- .L. able: http://www.legis.state.pa.us/cfdocs/legis/li/ucons- Check.cfm?yr=2002&sessInd=0&act=13. Pennsylvania Patient Safety Authority 2016 Annual Report 103 Phone | (717) 346-0469 Fax | (717) 346-1090 E-mail | patientsafetyauthority@pa.gov Website | www.patientsafetyauthority.org Address 333 Market Street Lobby Level Harrisburg, PA 17120