Patient Safety

1. Patient Safety Edward Crooks MD, CMQ, CLSSBB

2. Patient Safety Perspective • 1990 IOM published To Err is Human: Building a Safer Health Care System • Extrapolation from data from the Harvard Medical Practice Study (decade earlier) – suggested that 44,000 – 98000 Americans died each year from medical errors. • Death toll is equivalent to a jumbo jet crashing each and every day in the US Jumbo Jet Unit • Vivid tangible icon for the magnitude of the problem. • If a jumbo jet was crashing every day, would you consider to fly electively. • If a jumbo jet was crashing everyday – there would be no limit as to what to do to fix the problem – prior to the IOM report nothing was being done to make patient’s safer.

3. Patient Safety All Healthcare Encounters All Errors All Adverse Events Preventable Adverse Events Non-preventable Adverse Events Near Misses Negligent Adverse Events

4. Patient Safety Important Safety Issue facing Organizations: • Establishing a culture of safety that supports a safe and just culture • Identifying organizational champions • Deploying patient safety strategies • Determine key drivers for patient safety programs • Ensuring the adoption of current and future safety-related technologies

5. Patient Safety “Leadership is the critical element in a element in a successful patient safety program and is non-delegable”

6. Patient Safety Paradigm Shift “Do no harm” Safety (Individual Responsibility) (System priority)

7. Patient Safety Deming 1986 • 85% of errors are typically due to systems issues and 15% are due to human factors. IHI, 2008 • When patients are harmed, the cause can be traced mostly to flaws in the system of care. • The key to reliable safe care does not lie in exhorting individuals to be more careful and try harder instead it lies in learning about causes of error and designing systems to prevent human error whenever possible.

8. Patient Safety QP involved in identifying and acting on opportunities to improve safety must give attention to: • Planning • Development • Implementation • Evaluation • Performance Improvement

9. Patient Safety Through the work of various government, quasigovernment, and voluntary groups, different definitions, standards and approaches have emerged. • Shojania, Duncan, McDonald, & Wachter, 2001 • Farley et al., 2007 • Standards for patient safety practices include recommendations to improve accuracy in patient identification, effectiveness of communication among care givers, precautions when using high alert medications and surgery safeguards. • Joint Commission International Center for Patient Safety, 2008 • National Patient Safety Agency • World Health Professional Alliance, 2008

10. Patient Safety The first step in creating a culture of safety is to assess the readiness of the organization to implement healthcare safety practices. • AHRQ patient safety assessment tools for healthcare • Safety culture survey to help hospital, nursing homes and ambulatory outpatient medical offices evaluate how well they had established a culture of safety in their institution. (Hospital Survey on Patient Safety Culture) • Survey use to track changes in patient safety over time and evaluate the impact of safety interventions

11. Patient Safety AHRQ - Hospital Survey on Patient Safety Culture: 2008 Comparative Database Report • Data collected and provide organization with benchmark data. • Benchmarking database was created so that organizations can determine how well they are doing in establishing a culture of safety.

12. Patient Safety AHRQ benchmarking report, 2008. • Analysis of data from 400 voluntary participating hospitals. • Teamwork within units yielded the safety culture composite with the highest average percentage of positive response (79%). • “When a lot of work needs to be done quickly, we work together as a team to get the work done”, was the item with the highest percentage (85%) in this section. • 44% of staff respondents felt that their mistakes and event reports were not used against them. • The survey item with lowest average percentage of positive response 36% was “Staff worry that mistakes they make are kept in their personnel files.

13. Patient Safety University of Texas Safety Attitude Questionnaire (SAQ) • Tools that permits healthcare organizations to • measure caregiver attitudes about six patient safety-related domains, • compare themselves with other organizations, • prompt interventions to improve safety attitudes and • measure effectiveness of these intervention. • The domain scales are: • Teamwork climate • Job satisfaction • Perceptions of management • Safety climate • Working conditions • Stress recognition

14. Patient Safety PPPSA (Physician Practice Patient Safety Assessment) • Interactive self-assessment tool for evaluating medication safety, handoffs and transitions, surgery and invasive procedures, personnel qualifications and competency, practice management and culture, and patient education and communication. • Developed by the Health Research and Educational Trust in partnership with the American Hospital Association, the Institute for safe Medication Practices, the Medical Group Management Association and tis certifying body, the American College of Medical Practice Executives. • HCQP in the ambulatory settings can use the PPPSA to • Gain specific ideas to improve patient safety • Conduct data comparison to aggregate results for similar practices • Enhance organization and provider awareness of patient safety issues • Track progress

15. Patient Safety Leadership and Culture: Integrating Healthcare Safety Concepts into the Organization. • Culture change • Leaders should be asking what happened instead of who made the error, Bostwinick and colleagues (2006) • First complete the environmental scan regarding healthcare safety. • Choose and prioritize safety practice implementation • Mistake Proofing • IHI provides blueprint for leadership to use in developing comprehensive safety programs. • NQF provides leaders with consensus-driven safety practices. • 2003 NQF endorsed a set of 30 safe practices that should be universally used in applicable clinical care settings to reduce the risk of harm to consumers. • Updated in 2006 with expanded specifications, supporting literature and guidance for implementation. • Updated in 2008 • Fair and just culture (Marx 2007)

16. Patient Safety Fair and Just Culture • Everyone throughout the organization is aware that medical errors are inevitable, but all errors and unintended events are reported – even when the events may not cause patient injury. • Acknowledges that: • Competent professionals make mistakes. • Competent professionals develop unhealthy norms (shortcuts or routine rule violations) • Has zero tolerance for reckless behavior. HCO committed to a fair and just culture identify and correct the system or processes of care that contributed to the medical error or near misses, they do not assign blame.

17. Patient Safety Principles: • Not an effort to reduce personal accountability and discipline. Instead it is a way to emphasize the importance of learning from mistakes and near misses in order to reduce errors in the future. • Individuals are accountable to the system and the greatest error is to not report a mistake and thereby prevent the system and others from learning. Policies that would discourage any healthcare provider from self-reporting errors are therefore at odds with the goals of a fair and just culture. • A new culture of patient safety will have been successfully created when all serve as safety advocates regardless of their position within an organization.

18. Patient Safety Fair and Just Culture Leads to opportunities for improvement and lesson learned Non-punitive culture of medical error reporting Reporting of more errors and near misses Improve patient safety

19. Patient Safety Learning Organization Senge’s Concept A learning organization is one “where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together” (Senge, 1990)

20. Patient Safety Learning Healthcare System is designed to: • Generate and apply the best evidence for the collaborative health choices of each patient and provider. • Drive the process of discovery as a natural outgrowth of patient care • Ensure innovation, quality, safety and value in health care. IOM, ROEBM 2007

21. Patient Safety The most pressing needs for change identified by the IOM roundtable are those related to: • Adaptation to the pace of change • The stronger synchrony of efforts • A culture of shared responsibility • A new clinical research paradigm • Clinical decision support system • Universal electronic health records • Tools for database linkage, mining, and use • The notion of clinical data as a public good • Incentives aligned for practice-based evidence • Public engagement • A trusted scientific broker • Leadership (IOM,ROEBM, 2007)

22. Patient Safety Leadership • Leaders must integrate healthcare safety practices as part of the organization strategic direction, and goals must be developed to ensure adoption and measurement of safety practices. • The patient safety program should be aligned with, the mission, vision, core values and goals of the organization.

23. Patient Safety Public Reporting Groups: Leapfrog Third party Payers Consumers Accreditation Agencies: Joint Commission Government Agencies: CMS Pressure on Leadership

24. Patient Safety Governing Board: • Have distinct responsibilities for promoting quality of care and preserving safety. • Heightened attention being to given to healthcare quality measurement and report obligations increasingly affect the responsibilities of the board directors and trustees. • Oversight of quality is being recognized as a core fiduciary responsibility of healthcare organization directors.

25. Patient Safety Responsibilities of the governing board: • The organization’s mission to provide the best possible care and to avoid harm to patients. • Ensuring and improving care cannot be delegated to the medical staff and executive leadership. • Ensuring safe and harm-free care to patient’s is the board’s job, at the very core of its fiduciary responsibility. • An activated board, in partnership with executive leadership and medical staff, can set system-level expectations and accountability for high performance, high reliability, and the elimination of harm.

26. Patient Safety Quality/Safety and Finance • Quality and safety can bring benefits to a financially stable and growing healthcare organization which is a board interest and a fiduciary duty. • Bond-rating agencies have begun to stress the importance of healthcare leaders’ attention to clinical quality outcomes and safety as they make decisions about bond rating for hospitals e.g. Standard and Poor’s and Moody’s Investor Service.

27. Patient Safety IHI outlines six things that all board should consider in their effort to improve quality and reduce harm: • Setting aims: Set a specific aim to reduce harm this year: public commitment to measurable quality improvement, establishing a clear aim for the facility or system. • Getting data and hearing stories: Select and review progress toward safer care as the first agenda item at every board meeting, grounded in transparency and putting a “human face” on harm data. • Establishing and monitoring system-level measures: Identify a small group of organization-wide measures of patient safety; update the measures continually and make them transparent to the entire organization and all of its customers. • Changing the environment, policies and culture: Commit to establishing and maintaining an environment that is respectful, fair and just for all who experience pain and loss as a result of avoidable harm and adverse outcomes: the patients, their families and staff.

28. Patient Safety • Learning --- starting with the board: develop your capability as a board. Learn how the best boards work with executives and physician leaders to reduce harm. Set an expectation for similar levels of education and training for all staff. • Establishing executive accountability: oversee the effective execution of a plan to achieve your aims to reduce harm, including executive accountability for clear performance improvement targets.

29. Patient Safety Patient Safety Goals National organizations have employed consensus-driven processes to identify healthcare safety practices that could be adopted by healthcare organizations. • There is no need to develop own safety practices. • Applicability of various safety practices is dependent on many factors; • Healthcare setting • Population served • High-risk processes • Volume-driven practices • Previous performance data • Organization should use quality tools such as prioritization matrix to select safety standards that are relevant to their population.

30. Patient Safety NQF • In 2008 endorsed 48 voluntary consensus standards to measure acute care hospital performance. • These endorsed measure carry the full weight of 375 healthcare providers, consumer groups, professional associations, purchasers, federal agencies, and research and quality improvement organizations. • These standards are vetted through the NQF’s formal Consensus Development Process. • NQF • IHI Safety

31. Patient Safety Leapfrog Group • Voluntary program aimed at mobilizing employer purchasing power to guide America’s health industry in adopting “big leaps” in healthcare safety. • The organization has distributed safety practices and has provided evidence that if the first three leaps were implemented in all urban hospital in the US, we could save 65,341 lives (Birkmeyer & Dimick), prevent as many as 907,600 serious medication errors each year and save $41.5 billion (Conrad & Gardner) • CPOE • Intensive care unit physician staffing • Evidence-based hospital referral

32. Patient Safety The Leapfrog Group: 2008 Safe Practices (National Quality Forum-Endorsed) Creating and Sustaining a Culture of Safety • Element 1: Leadership Structures and Systems • Element 2: Culture Measurement for Performance • Element 3: Teamwork Training and Skill Building • Element 4: Identification and Mitigation of Risks and Hazards Informed Consent Life-Sustaining Treatment Nursing Workforce Communication of Critical Information Labeling of Diagnostic Studies Discharge System

33. Patient Safety The Leapfrog Group: 2008 Safe Practices (National Quality Forum-Endorsed) Medication Reconciliation Prevention of Aspiration and Ventilator-Associated Pneumonia Central Venous Catheter-Related Bloodstream Infection Prevention Hand Hygiene Deep Vein Thrombosis and Venous Thromboembolism Prevention Anticoagulation Therapy

34. Patient Safety Joint Commission • Established National Patient Safety Goals (NPSGs) for nearly 15,000 healthcare organizations and programs in the US that participates in its accreditation program. • Safety goals have been set for ambulatory care, assisted living, behavioral healthcare, critical access hospital, disease-specific care programs, home care, hospitals, laboratories, long-term care, network programs, and office-based surgery.

35. Patient Safety Patient Safety Program Development HCO • Needs a written plan for a PSP • Plan should integrate patient safety goals (JC, IHI or NQF) • Patient safety requires an environment in which patients, families, organizational staff and leaders, and medical staff can identify, manage actual and potential risks to safety • Consideration should be given to • Planning and designing services • Directing services • Integrating and coordinating services • Reducing and preventing errors • Following clinical practice guideline • Actively involving patients and families in care

36. Patient Safety • Human error is inevitable. • Identification and reporting of adverse events are critical to an organization’s effort to continuously improve patient safety and create a learning environment. • Leaders have a duty to recognize the inevitability of human error. They should attempt to design systems that make such error lest likely, and avoid punitive reactions to honest errors.

37. Patient Safety Scope and Oversight of PSP • Governance and leadership • Creation of a culture of safety • Creation of a learning environment • Definition of objectives • Design of safe practices • Process implementation • Measurement, monitoring, and improvement

38. Patient Safety The PSP provides a coordinated and integrated system for hospital-wide assessment and improvement of interrelated safety, support, and clinical care processes that affect patient outcomes, including standards compliance. HCP can accomplish this by: • Using comparative data • Working collaboratively to improve compliance with Joint Commission NPSGs, Leapfrog Safe Practices, NQF-endorsed measures and federal government-vetted measures (AHQR) • Assisting all services and programs across continuum of care by identifying and mitigating risks and hazards. • Working collaboratively to enhance the sentinel event and peer review processes • Promoting transparency and dissemination of results across the organization.

39. Patient Safety HCO • Determine which performance improvement methodology should be adopted. • Emphasize the improvement of systems and processes • Create a learning environment that is just (non-punitive and accountable) and flexible and that uses techniques such as RCA, FMEA, evidence based methods and the monitoring of measurements over time.

40. Patient Safety Health Information Technology • Holds a promise of making healthcare services safer. • Alternatives for clinical decision support If Health IT is going to work then the healthcare consumer must be • at the center of the healthcare system • empowered to own his or her personal healthcare data. If it is to be effective then it needs to be: • integrated with the patient and the clinical workflow • aligned with available resources and expectation of the end user

41. Patient Safety Questions to be asked. • Is it easy to use? • How quickly does it process information? • How functional it is?

42. Patient Safety • The US Department of Health and Human Services (DHHS) Office of the National Coordinator (ONC) has been charge with developing a Nationwide Health Information Network (NHIN) to provide a secure, nationwide, interoperable health information infrastructure that will connect providers, consumers, and others involved in supporting health and healthcare. • The purpose of the NHIN is to allow health information to be accessible to healthcare providers regardless of where the patient is treated.

43. Patient Safety NHIH will achieve this goal by: • Developing capabilities for standards-based, secure data exchange nationally • Improving the coordination of care information among hospitals, laboratories, physician offices, pharmacies, and other providers. • Ensuring that appropriate information is available at the time and place of care. • Ensuring that consumers’ health information is secure and confidential. • Giving consumers new capabilities for managing and controlling their personal health records as well as providing access to their health information from electronic health records (EHRs) and other sources. • Reducing risks from medical errors and supporting the delivery of appropriate evidence-based medicine • Lowering healthcare cost resulting from inefficiencies, medical errors, and incomplete patient information. • Promoting a more effective marketplace, greater competition, and increased choice through accessibility to accurate information on healthcare costs, quality, and outcomes.

44. Patient Safety Privacy Protection • Study involving 100 patients from 6 disease groups: breast cancer, colon cancer, cystic fibrosis, diabetes, HIV infection, and sickle cell anemia. • Patient was asked about their privacy protection. • The following was ranked as being most in need of privacy protection: abortion history, mental health history, HIV/AIDS infection, genetic test results, drug and alcohol history, and sexual transmitted diseases.

45. Patient Safety How do we meet the goals of a single HER? W. Edward Hammond proposed the following: • A unique identifier • Stakeholder agreement on a common terminology • All stakeholders need to use standardized data elements with a single terminology • The leaders of all types of healthcare organizations need to be totally committed to modernizing care delivery through health IT • A national leader is needed who can articulate what needs to be done at a national level to meet these goals. • Vendors need to be brought into the process of modernizing the healthcare infrastructure. • A sustainable funding model must be developed • A feasible timeline should ne developed.

46. Patient Safety Leadership has a critical role in the adoption of health IT. Major barriers to realizing the potential benefit exists. • The need for increased standardization • Funding • Regulatory relief • A single set of privacy and security laws • A uniform approach in matching patients with their records.

47. Patient Safety Various technological solution have been proposed to enhance healthcare safety programs based on the premise that if processes are standardized and if the potential for medical errors are reduced by the automation processes, errors will be mitigated. Clancy Propose four health IT goals: • Connect health records • Build smart systems • Put patient in the center of care • Put prevention at the center of treatment.

48. Patient Safety Commonly Used IT Direct Care Delivery Technology • Bar code medication administration • Automated medication cabinets • Call systems, including emergency call bell • CPOE • Clinical results available at point of care • Standardized order sets • E-prescribing

49. Patient Safety Commonly Used IT Indirect Care Delivery Technology • Robotics • Radio frequency identification • Electronic inventory system • Computerized staffing system • Automated customized patients directive and education

50. Patient Safety Commonly Used IT Communication with Members of Healthcare Team • Electronic medical records • Documentation at point of care • Electronic ordering systems • Clinical decision support • Communication devices