2010 PATIENT SAFETY AUTHORITY ANNUAL REPORT

• Implement the legal requirements of MCARE as amended by Act 52 of 2007, by establishing and maintaining the reporting system and publishing data to allow theassessment of HAI prevention efforts in this care setting.
• Provide limited validation of data quality.
• Analyze the data to support Advisory articles, educational programs and the Annual Report.
• Use the data to identify facilities that are successful with their HAI prevention efforts and those that are unsuccessful in implementing best practices and to assist with methods of implementing improvement strategies.

• Approximately 714 nursing homes reported 27,869 HAIs to the Authority in 2010. Infections reported include: Respiratory tract infections (9,929); gastrointestinal infections (8,495), skin and soft tissue infections (5,214) and urinary tract infections (3,883).
• Between 2009 and 2010, nursing homes reduced urinary tract infections by 14% in residents without a catheter and by 15% in residents with catheters.
• In 2010, preliminary rates of skin and soft tissue infections were reduced by 18% compared to 2009.

• 538 hospitals, ambulatory surgical facilities, abortion facilities and birthing centers submitted 225,624 reports of Serious Events and Incidents to the Authority, a decrease of 1,046 reports from 2009. In 2010, the Authority received 18,802 reports per month on average, a decrease of 0.5% from 2009. The total number of Serious Events and Incidents reported to the Authority since reporting began June 2004 is in excess of 1.3 million.
• Approximately 97% of all reports submitted by these facilities in 2010 were Incidents, or did not cause harm to the patient. Approximately 3% of all reports were submitted as Serious Events, meaning the patient received some level of unanticipated injury ranging from minor, temporary harm to death. Despite several months where this percentage rose to 4% or greater, there appears to be a downward trend in the percentage of Serious Events among reports submitted to the Authority during the last three years.
• The number of Incident reports averaged 18,176 per month, a decrease of 0.1% from 2009. Serious Event reports averaged 626 per month, a 9.2% decrease from the previous year. Most of the decrease of Serious Event submissions can be attributed to a 39% drop in Skin Integrity (pressure ulcers) Serious Event reports and a 13% decrease in Falls from 2009.
• Reports from hospitals accounted for 85% of all reports submitted. Nursing homes submitted 13.2% of the overall total. Among acute-level facilities (non-nursing homes), hospital’s account for 98% of all reports submitted.
• Ambulatory surgical facilities submitted 13.2 reports per facility in 2010 compared to 12.2 reports per facility in 2009 and 11.8 reports per facility in 2008. 
• Statewide, the most frequently reported events in hospitals involved Errors related to Procedures/Treatments/Tests (22%) and Medication Errors (20%) totaling 42% of all reports submitted. 
• Reports of Medication Errors decreased overall by 8% from 48,881 reports submitted in 2009 to 45,034 reports submitted in 2010. Approximately 98% of these reports were Incidents or near misses.
• While Errors related to Procedure/Treatment/Test were the event type most frequently reported through PA-PSRS, they were not the event type most frequently associated with patient harm. The event type Complications of Procedures/Treatments/Tests accounted for just 13% of all submitted reports, but totaled 46% of all Serious Event reports and 60% of all reports of events resulting in or contributing to the patient’s death; meaning this event type is significantly associated with harm to the patient. Conversely, while Medication Errors comprise 20% of reports in 2010, they only accounted for 4% of events involving harm and 2% of events contributing to or resulting in death. 
• Reports on perinatal patients (those aged 20 days or younger) increased 5.2% compared to 2009. Four percent of all perinatal reports were classified as Serious Events, higher than the overall rate of Serious Events reporting for 2010 (3.32%).
  
• Reports on patients over age 65 continued to show decreases as in previous years. In 2004 and 2005, older patients accounted for 64% of Falls. This figure declined to 56.2% in 2010. Also, Skin Integrity reports (pressure ulcers) among older patients dropped to 70.6% in 2010 from 71.2% in 2009. More than half of all reports (51.8%) in 2009 involved patients 65 and older; this figure dropped to 48.3% in 2010. 
• The Authority expects to be able to measure more effectively patient safety improvement in Pennsylvania healthcare facilities through more collaboratives. Ongoing collaborative topics include wrong-site surgery, falls, surgical site infections and central-line associated blood stream infections.
  

• In 2010, 225,624 patient safety reports were submitted to the Authority, 3.3% of which noted harm reaching the patient. Since inception of the Authority’s reporting program, more than 1.3 million reports have been submitted. 
• The ratio of harmful events to non-harmful events continues to decrease annually. 
  
• While Errors Related to Procedures, Treatments and Tests and Medication Errors account for the most overall reports, Complications of Procedures, Treatments and Tests account for almost half of the reported harmful events.
• Deaths accounted for 0.1% of all submitted reports in 2010.

• Hospital—The Health Care Facilities Act (35 P.S. §448.802a) defines a hospital as “an institution having an organized medical staff established for the purpose of providing to inpatients, by or under the supervision of physicians, diagnostic and therapeutic services for the care of persons who are injured, disabled, pregnant, diseased, sick or mentally ill, or rehabilitative services for the rehabilitation of persons who are injured, disabled, pregnant, diseased, sick or mentally ill. The term includes facilities for the diagnosis and treatment of disorders within the scope of specific medical specialties, but not facilities caring exclusively for the mentally ill.” For the purposes of this report, at the end of 2010, there were 242 Hospitals in the Commonwealth of Pennsylvania
• Ambulatory Surgical Facility—The Health Care Facilities Act defines an ambulatory surgical facility as “a facility or portion thereof not located upon the premises of a hospital which provides specialty or multispecialty outpatient surgical treatment. Ambulatory surgical facility does not include individual or group practice offices or private physicians or dentists, unless such offices have a distinct part used solely for outpatient treatment on a regular and organized basis. Outpatient surgical treatment means surgical treatment to patients who do not require hospitalization but who require constant medical supervision following the surgical procedure performed.” For the purposes of this report, at the end of 2010, there were 276 ambulatory surgical facilities in the Commonwealth of Pennsylvania.
• Birthing Center—The Health Care Facilities Act defines a birthing center as “a facility not part of a hospital which provides maternity care to childbearing families not requiring hospitalization. A birthing center provides a home-like atmosphere for maternity care, including prenatal, labor, delivery, post partum care related to medically uncomplicated pregnancies.” For the purposes of this report, at the end of 2010, there were five birthing centers in the Commonwealth of Pennsylvania. 
• Abortion Facility—Act 30 of 2006 extended the reporting requirements in Act 13 to abortion facilities that perform more than 100 procedures per year. For the purposes of this report, at the end of 2010, there were 15 qualifying abortion facilities in the Commonwealth of Pennsylvania. 
• Nursing Home—Act 52 of 2007 revised Act 13 of 2002 (MCARE) to require nursing homes to report HAIs to the Authority. Reporting from these facilities began in June 2009. See page 58 for data received to date from nursing homes. For the purposes of this report, at the end of 2010, there were 714 licensed nursing homes in the Commonwealth of Pennsylvania. 
  

• Medical Error—This term is commonly used when discussing patient safety, but it is not defined in Act 13. The word “error” appears in the PA-PSRS system and in this report. For example, one category of reports discussed is “Medication Errors.” In PA-PSRS the word “error” is used in the sense intended by the Institute of Medicine Committee on Data Standards for Patient Safety, which defined an error as:
  

Report Volume 

Reports by Month and Submission Type 

Reports by Facility Type 

Report Submission Trends 

Reports by Event Type 

• Unsafe Conditions—Circumstances that could lead to an adverse event (accounting for 12% of all reports) 
• Event, No Harm—An event that either did not reach the patient or did reach the patient but did not cause harm (often called a “near miss,” accounting for 85% of all reports) 
• Event, Harm—An event that reached the patient and caused temporary or permanent harm (3.2%)
• Event, Death—An event occurred that resulted in or contributed to death (0.1%)

• General Medical/Surgical Units 
• General Medicine Ward 
• Medical/Surgical/Oncology Unit 
• Critical Care 
• Emergency Department 
• Burn Unit 
• Medical/Surgical ICU 
• Intermediate Unit 
• Telemetry 
• Cardiac Intermediate Unit 
• Respiratory Intermediate Unit
  

• 49,888 healthcare-associated infections (HAIs) were reported to the Authority in 2010; 22,019 from hospitals and 27,869 from nursing homes. 
• Preliminary crude infection rates in hospitals dropped by about 6% overall from 2009 to 2010. 
• Between 2008 and 2010, preliminary results show that hospitals reduced CatheterAssociated Urinary Tract Infections (CAUTI) by 26%, Central-Line Associated Bloodstream Infections (CLABSI) by 44%, and Ventilator-Associated Pneumonia by 27%. 
• Between 2009 and 2010, nursing homes reported fewer urinary tract infections by 14% in residents without a catheter and by 15% in residents with catheters. Skin and soft tissue infections were reduced by 18%. The rate of respiratory tract infections was unchanged in 2010, and the rate of gastrointestinal tract infections was considerably higher in 2010; however, 2009 rates are based on the first six months of data collection and did not include several months of norovirus season. 
• The Authority published seven HAI-related articles in the Patient Safety Advisory in 2010 on such topics as norovirus preparedness, Clostridium difficile infection, skin and soft tissue infections, endoscope reprocessing, handling MRSA-positive patients in ambulatory surgery facilities, reducing CLABSIs, and others. 
• The Authority is supporting several HAI collaborative projects, including the national CUSP initiative on reducing CLABSI, and programs to reduce SSIs with the Pennsylvania NSQIP Consortium and a group of hospitals in Western Pennsylvania. 

The Authority, the DOH and PHC4 worked together in 2010 to continue meeting MCARE's HA-related requirements by: 

• Validating and analyzing the infection reports from nursing homes and hospitals. 
• Providing facilities with guidance on best practices based on this analysis. 
• Publishing the results of this work in the Patient Safety Advisory. 
• Developing educational programs and supporting multi-facility collaboratives to encourage cross-institutional learning. 
• Details of the Authority’s accomplishments in 2010 related to HAI prevention are presented in this chapter.
  

• Not providing patient days for each of the 12 months of 2010 
• Providing zero as a monthly total of patient days for any month of 2010 
• Not providing device days related to reported infections of that type for the given month 

Nursing Home Data

Analysis 

Urinary Tract Infections 

Respiratory Tract Infections 

Skin and Soft Tissue Infections 

Gastrointestinal Infections 

Other Infections

Facility response to infection 

Organisms Identified in Laboratory Studies

Nursing Home Data Integrity and Validation 

Nursing Home Feedback from the Authority’s Annual Survey 

HAI Criteria

Analytical Data Tools 

HAI Advisory Panel

Act 52 of 2007 required the Authority to establish an external advisory committee composed of experts in HAIs from throughout the state. Participants on this committee include hospital and nursing home infection preventionists, infectious disease physicians, and geriatricians. The HAI Advisory Panel assists the state agencies in:

HAI Educational Programs and Collaboratives 

Webinars/audio conferences 

Onsite Educational Presentations 

Nursing Home Visits/Coaching Program

Comprehensive Unit Based Safety Program (CUSP) Initiative 

National Surgical Quality Infection Prevention (NSQIP) Collaborative 

Western Pennsylvania SSI collaborative 

Plans for 2011 

Education, Outreach and Collaboration

The Patient Safety Liaison Program – reaching out for conversations to improve patient safety

PSL Mission: Educating Healthcare Facilities by Collaborating 

A Complete PSL Program

Strengths and Opportunities

Building Relationships to Improve Patient Safety 

Educational Sessions 

Patient Safety Knowledge Exchange (PassKey)

Collaborations

PSL Program Challenges

Some Facilities Still Resistant to Meeting with their PSL 

PSOs WEARING MULTIPLE HATS HAVE LIMITED TIME

Working as a Team to Improve Patient Safety is Difficult for Many Facilities 

Patient Safety Knowledge Exchange (PassKey) – Providing an Opportunity to Converse with Peers

Educational Courses – Educating for Process Change 

Basic Foundation Course

Beyond the Basics – Two-Day Program 

MRSA Program

Patient Safety Training for Executives and Boards of Trustees

Awareness Campaigns to Increase Patient Safety

Consumer Tips and Brochures

Help Desk Inquiries

INTERVIEWS WITH HEALTHCARE STAFF ABOUT THE PATIENT SAFETY LIAISON PROGRAM 

Anne Hast was formerly vice president of Patient Care Services of a larger organization before becoming the Chief Nursing Officer at Advanced Surgical Hospital-a 14-bed for-profit, physician owned orthopedic specialty hospital. Anne helped open the doors on the new facility as its Patient Safety Officer. In her previous position, Anne had worked on patient safety for the organization as part of a group. At Advanced Surgical Hospital she is responsible for the entire patient safety program. Anne said she knew about the MCARE Act and wrote the organization’s patient safety plan for the Department of Health (DOH), but did not know about the Authority’s Patient Safety Liaison program. The DOH surveyor for the facility suggested she give her PSL a call. She did and was advised by her PSL to sign up for two educational programs provided by the Authority called “Basics Foundation Course” and “Beyond the Basics.” Anne also brought along her second in command to learn about the Authority. 

Authority Collaborative Helps Facilities Work Together and Develop New Best Practices 

Small Facilities Look to the Authority and PSL Program for Help from the “Experts” 

The PSL Program 

The Patient Safety Advisories and Website 

Collaborations 

Authority’s Advisory Article Helps Make Culture Change and Collaborative Brings New Focus with Dramatic Results 

THE AUTHORITY’S ANNUAL SURVEY OF PATIENT SAFETY OFFICERS 

Patient Safety Advisory 

THE PATIENT SAFETY AUTHORITY ADVISORY 

Patient Safety Advisory Subscriptions Go Global Program Distribution 

General Distribution 

U.S. Locale 

General Distribution Growth 

Subscribers of Interest 

Controlling the Annual Threat of Norovirus Gastroenteritis Outbreaks 

Adverse Drug Events with HYDROmorphone: How Preventable are They? 

Diagnostic Error in Acute Care 

• Implement policy and procedures that include 
• staff accountability for implementing chain of command when patient safety is in question, 
• code of conduct (e.g., expectations of professional behaviors), 
• transparency (e.g., model of desirable behaviors) so that all staff are able to talk about vulnerabilities and failures without fear of reprisal, 
• zero tolerance for egregious disruptive behaviors, and 
• definitions of behaviors that will be referred for disciplinary action.  
• Conduct open discussions (e.g., regular patient safety rounds) about risks and barriers with the patient safety officer, other quality improvement staff, clinical leaders, and clinicians. 
• Encourage interdisciplinary dialogue to address ongoing conflicts and move beyond them. 
• Educate and coach leaders and managers in skills that address relationship building and collaborative practice. 
• Assess staff perception of the extent of unprofessional behaviors and the risk of harm to patients. 
• Implement a reporting/surveillance system for disruptive behaviors. 
• Support reporting/surveillance with follow-up interventions for involved staff that progress from informal conversations to detailed action plans to disciplinary action, when warranted. 

• Clinical staff 
• Trace lines back to points of origin to verify correct connections. 
• After patient’s arrival to new care area or as part of patient handoff, recheck connections and trace lines back to points of origin. 
• Do not force connections.
• Only use an adapter that is indicated for the specific application. 
• Label high-risk catheters according to type (e.g., epidural). 
• Route lines with different purposes in unique, standardized directions. 
• Identify and manage worker fatigue to prevent inattentiveness. 
• Nonclinical staff 
• Provide regular misconnection prevention education. 
• Assess the need for adapters and limit or restrict routine use. 
• Revise and/or establish purchasing policies that include purchasing equipment with misconnection safeguards. 
• Assess for the potential for misconnections during prepurchase evaluations and acceptance testing. 

• Clinical staff 
• Do not use standard luer syringes for oral medications or enteral feedings. 
• Prohibit modifying intravenous (IV) or enteral feeding devices. 
• Before administering solutions, ensure identification labels indicate the correct delivery route. 
• If color-coding lines and connectors, consider Joint Commission’s concerns about the unintended consequences of this approach, including user reliance on color-coding rather than assuring correct connections and confusion resulting from nonstandard color-coding systems among facilities. The Joint Commission notes that continual education and training about color-coding would be necessary. 
• Nonclinical staff 
• Purchase an adequate number of distinctly labeled enteral pumps to reduce use of infusion pumps for enteral administration to adult patients. When using syringe pumps for neonatal feedings, ensure that the pumps are distinguishable from syringe pumps used for IV administration or other purposes. 
• Purchase only enteral feeding sets that are incompatible with female luer connections. 
• Purchase only non-IV-compatible enteral feeding containers. 
• Secure enteral administration sets with enteral feeding containers or use preattached sets before sending them to patient care units. 
• Perform prepurchase evaluations of enteral feeding systems with guidance from a multidisciplinary team. 

• Of the 158 hospitals reporting CLABSI events, 21.5% indicated compliance with all three practices in every event report. 
• Hospitals with the lowest CLABSI rates reported a higher rate of compliance with daily evaluation of line necessity. 
• Hospitals with the lowest CLABSI rates were more than twice as compliant with all three practices as hospitals with the highest CLABSI rates. 
• Compliance with the practices averaged 55.8% for the 1,916 CLABSI reports. 
• An average of 38% of the CLABSI reports documented unknown compliance with the practices. 

• meeting with providers on the unit (i.e., safety rounds) to discuss barriers to improvement;
• supporting an infection prevention and control program, providing resources for education, and ensuring accountability of personnel
• selecting a physician champion to communicate with medical staff and designating nursing leaders to maintain unit awareness.

• scrubbing before every access with 70% alcohol or an alcohol/chlorhexidine preparation
• changing gauze every two days and transparent dressings at least every seven days (more frequently if soiled, damp, or loose); and
• replacing administration sets no more frequently than every 72 hours, but if used for bloods and lipids, every 24 hours
  

1. Ineffective communication among providers, between providers and patients, and between providers across healthcare settings
2. Inadequate transitions of care within hospitals and between hospitals and community settings

Medication Errors with the Dosing of Insulin: Problems across the Continuum 2010

• Develop a system for interpretation and communication of radiographic discrepancies that can be implemented during each shift.
• Implement a standardized method for timely communication at each stage of the information chain, including the following:
• Inform the radiologist of the ED physician’s interpretation.
• Communicate the radiologist’s interpretation of the ED radiograph to the ED physician.
• Develop a consistent method to reconcile the radiograph interpretation with the actual follow-up care provided to the patient.
• Communicate the radiographic readings to the referring or subsequent treating physician and the patient as appropriate.

• Pennsylvania hospitals have made significant strides in reducing the incidence of healthcare-associated infections (HAIs). For example, the catheter-related urinary tract infection rates in all unit types in Pennsylvania hospitals were lower than in comparable units nationally, ranging from 19% to 84%.^vi 
• A report on HAIs from the U.S. Centers for Disease Control and Prevention found that Pennsylvania’s rate of central line-associated bloodstream infections was nearly one-third lower than the national average.^vii
  
• A grassroots effort by Pennsylvania hospitals to implement the Authority’s guidance on the use of color-coded patient wristbands to communicate important clinical information has developed into a de facto standard endorsed by the American Hospital Association and adopted or in the process of adoption in some form in 40 U.S. states.^viii
  
• The 2011 June Advisory will feature the results of an Authority-sponsored collaborative in which participating hospitals substantially reduced errors in blood specimen labeling. The Authority is supporting other multi-facility collaboratives on such topics as wrong-site surgery, patient falls, and surgical site infections that the Authority hopes will report positive results in the near future.

1. PA-PSRS Software and Applications (Appendix A) 
2. Educational Program Presentations (Appendix B) 
3. PA-PSRS Patient Safety Advisory Subscriptions (Appendix C)

• Directs CMS to extend its policy of non-payment for certain hospital-acquired conditions (HACs) from Medicare (effective in 2007) to Medicaid (effective July 2011).
• Provides for financial penalties for hospitals in the top quartile on selected HACs by 2015 and incentive payments for hospitals that perform well.
• Financial penalties for hospitals that exceed expected benchmarks for readmissions.
• Results of patient safety and quality metrics for healthcare facilities will be published by CMS on consumer-friendly websites like HospitalCompare and NursingHomeCompare.

• The Patient Safety Trust Fund would have had a negative uncommitted balance by the end of the current fiscal year in June 2010.
• The Patient Safety Authority budget only increased by 2 percent for FY 2009-2010. Any increases in budgeted spending were focused on patient safety programs assisting facilities. Staff did not receive pay increases for this fiscal year.
  
• The Patient Safety Authority FY 2009-2010 budget was approximately $5.8 million. Staff projected expenditures for this period of approximately $5.5 million would result in savings of approximately $300,000.