Updates in Patient Safety

1. Updates in Patient Safety Helen Burstin, MD, MPH Senior Vice President, Performance Measures National Quality Forum Academy Health June 8, 2008

2. NQF Mission • To improve the quality of American healthcare by setting national priorities and goals for performance improvement, • endorsing national consensus standards for measuring and publicly reporting on performance, and • promoting the attainment of national goals through education and outreach programs.

3. NTTAA National Technology and Transfer Advancement of Act of 1995 (NTTAA) • Defines the five key attributes of a “voluntary consensus standards-setting body” (i.e., openness, balance of interest, due process, consensus, and an appeals process) • Obligates federal government to adopt voluntary consensus standards (when the government is adopting standards) • Encourages federal government to participate in setting voluntary consensus standards

4. DRAFT - Quality Alliance Steering Committee National Framework for Quality and Cost Transparency for High-Value Care AHRQ Foundations Other NQF National Priorities Partners* NCQA The Joint Commission AMA PCPI Medical Societies Medical Specialty Boards CMS AHRQ Others** Set national priorities and goals to drive improvement and affordability Continuously evaluate health and health care QIOs Regional Collaboratives Providers Oversight Organizations Employers Health Plans Improve quality and reduce waste Consumer Outcomes High Quality Equitable Affordable Patient-Centered Develop and test evidence-based measures Establish effective public policies, payment policies, and consumer incentives to reward or foster better performance Fed/State Govt Health Plans Employers Consumers Providers NQF Endorse and maintain measures and incorporate specifications into EHRs Develop coordinated and streamlined implementation strategies: prioritization, timelines, and process solutions Generate public reports on quality and cost Aggregate data and pilot test and validate standard performance information QASC Quality Alliances Joint Commission NCQA Medical Specialty Boards Regional Collaboratives Fed/State Govt. Health Plans Others QASC Regional Collaboratives RHIOs/HIEs CMS States Health Data Stewards

5. Patient Safety 2008 IOM “To Err is Human” – 44,000 to 98,000 Americans die each year from preventable medical errors Little progress to date - measures of patient safety showed an average annual improvement of just 1 percent (NHQR 2007) Unclear impact of Patient Safety and Quality Improvement Act and emerging Patient Safety Organizations (PSOs) Growing movement toward public reporting and non-payment for “never events” 5

6. Progress?

7. NQF Roles in Patient Safety • Serious reportable events (including linkage to “no pay” events) • Cross-cutting patient safety measures • Safe practices update • Common data formats for patient safety • National priorities and goal setting • EHRs and Decision Support

8. NQF Serious Reportable Events • Serious reportable events - serious, largely preventable, and of concern to both the public and healthcare providers • 28 serious reportable events: • Care management events • Surgical events • Product or device errors • Environmental events • Patient protection

9. CMS Policy on Never Events Beginning in FY 2009, cases with these conditions would not be paid at a higher rate unless they were present on admission. Medicare will no longer pay for the additional costs of certain preventable conditions (including certain infections) acquired in the hospital. The rule identifies eight conditions, including three serious preventable events (sometimes called “never events”) that meet the statutory criteria. CMS will work to add an additional 3 conditions to the list next year. 9

10. CMS Never Events Bloodstream infections from using catheters Objects left in a patient during surgery* Urinary tract infections from catheters Air embolism, an air bubble in a blood vessel* An infection after heart surgery called mediastinitis Blood incompatibility, giving a dangerously wrong blood type* Bed sores, or pressure ulcers Falls *NQF Serious Reportable Event 10

11. Proposed CMSNever Events • Surgical site infections following certain elective procedures • Legionnaires’ disease • Extreme blood sugar derangement • Iatrogenic pneumothorax • Delirium • Ventilator-associated pneumonia • DVT/PE • Staphylococcus aureus septicemia • Clostridium difficile associated disease

12. Leapfrog Policy on Never Events • Hospitals commit to four actions if any never event* occurs within their facility: • apologize to the patient • report the event • perform a root cause analysis, and • waive costs directly related to the event. * Includes all 28 NQF SREs

13. State-level Never Events • In 2003, Minnesota became the first state to pass a never-events law that required the reporting of every never-event occurrence. • New Jersey enacted a law requiring hospitals to report serious, preventable adverse events to the state and to patients’ families • Connecticut adopted a mix of 36 NQF and state-specific reportable events for hospitals and outpatient surgical facilities.  • An Illinois law passed in 2005 will require hospitals and ambulatory surgery centers to report 24 “never events” beginning in 2008.   • Five other states, California, Connecticut, Illinois, Indiana and New Jersey, also have passed similar reporting laws or policies.

14. AHRQ Patient Safety Indicators Death in low-mortality DRGs (PSI 12) Failure to rescue (PSI 4) Foreign body left in during procedure (PSI 5 and 21) * Complications of anesthesia (PSI 1) * Selected infections due to medical care (PSI 7 and 23) * latrogenic pneumothorax (PSI 6 and 22) Postoperative pulmonary embolism or DVT (PSI 12) Postoperative hemorrhage or hematoma (PSI 9 and 27) Postoperative physiologic and metabolic derangements (PSI 10) * NQF Serious Reportable Events 14

15. AHRQ Patient Safety Indicators Postoperative respiratory failure (PSI 11) Postoperative hip fracture (PSI 8) Postoperative sepsis (PSI 13) Postoperative wound dehiscence (PSI 14 and 24) Accidental puncture and laceration (PSI 15 & 25) Transfusion reaction (PSI 16 & 26) * Decubitus ulcer (PSI 3) * Obstetric trauma (PSIs 18-20) Birth trauma -- injury to neonate (PSI 17) *NQF Serious Reportable Events 15

16. Safe Practices Update • Focus on review and maintenance of existing practices based on emerging evidence base • Steering committee: chaired by Charles Denham (TMIT) and Greg Meyer (MGH) • Additional practices under consideration for high risk safety areas (including “no pay” events)

17. Criteria for Inclusion: Safe Practices • Specificity. The practice must be a clearly and precisely defined process. • Benefit. If the practice were more widely utilized, it would save lives endangered by health care delivery... or reduce the likelihood of a serious reportable event. • Evidence of effectiveness. There must be clear evidence that the practice would be effective in reducing patient safety events. • research studies • experiential data • research findings or experiential data from non-healthcare industries that should be substantially transferable • Generalizability • Readiness

18. Safe Practices with Expected Changes • SP 4: Disclosure • SP 14: Medication Reconciliation • SP 19: Prevention of Aspiration and VAP • SP 21: Surgical Site Prevention • SP 23: Influenza Prevention • SP 28: DVT/VTE Prevention • SP 29: Anticoagulation Therapy • SP 30: Contrast Media Induced Renal Failure Prevention

19. New Safe Practices under Consideration • Hand Offs – Handovers • Second Patient • Organ Donor-ship • Urinary Tract Infection • MRSA MDRO • Pediatric Imaging • Falls • Hyperglycemia • Restraints • Reliable surgical care

20. Proposed New Practice: Catheter Associated Urinary Tract Infections

21. Patient Safety Data and Improvement Act 2005 • Provides needed legal protections to specially designated Patient Safety Organizations (PSOs) to collect and analyze patient-level information • Allows PSOs to analyze patient safety data (including patient safety events and “near misses”) to discover important quality improvement strategies. • Authorizes the Secretary to create and maintain a network of patient safety databases • AHRQ has been charged with developing the common data formats needed for patient safety event reporting and utilization by the PSOs

22. Patient Safety Data • Common Data Formats: • NQF has been tasked with development of a plan for multi-stakeholder public comment and collation of comments on the common formats • NQF will convene a Common Formats Expert Panel to develop criteria for evaluating feedback on the common formats; • review the organized and triaged comments received in response to NQF’s activation of the plan for public comment; and • provide input on the proposed common formats and suggestions for improvement to AHRQ.

23. NQF Strategic Directions • We should measure what is important to achieving the best outcomes for patients and populations • NQF Measurement Framework: promote shared accountability and measurement across patient-focused episodes of care: • Outcome measures • Appropriateness measures • Cost/resource use measures coupled with quality measures.

24. Episode Framework: Acute MI • Post AMI Trajectory 1 (T1) • Relatively healthy adult • Focus on: • Quality of Life • Functional Status • 20 Prevention Strategies • Rehabilitation • Advanced care planning • Population at Risk • 10 Prevention • (no known CAD) • 20 Prevention • (CAD no prior AMI)

25. Strategic Issues (1) • Driving toward high performance • Stakeholders have expressed concern with multiple process measures too far removed from desired action that drive attention towards care of single accountable entity – rather than system-level improvement • Shifting toward composite measures • Potential advantages of composite measures: • More understandable to patients and consumers • Reflects the comprehensive nature of care and potentially more patient centric • More oriented toward outcomes improvement • Drives multi-faceted improvement strategies

26. Strategic Issues (2) • Moving toward outcomes measurement • Growing numbers of measures of morbidity and mortality for certain conditions (e.g., CHF) • Very limited set of measures that address functional status, health-related quality of life, and shared decision-making • Measure disparities in all we do • Identify measures that are disparities-sensitive and routinely stratify quality data • Outlining a framework for collecting race, ethnicity, primary language, and socioeconomic status data in an efficient, effective, patient-centered manner

28. National Priorities Partners Establish national priorities and goals for performance measurement and public reporting Focus measurement and improvement efforts on achievement of these goals Multi-stakeholder Committee with representation from 27 leadership organizations Co-chairs Don Berwick, IHI Peggy O’Kane, NCQA 28

29. Preliminary Priority Areas • Healthcare Associated Infections* • Composite measure of infection rates in high risk areas • Avoidable Harms* • Hospital-level mortality rates • Harmonization/global measurement across serious adverse events • Continuity of Care* • Care coordination • Medication reconciliation • Patient/family engagement • Patient activation & shared decision-making

30. Preliminary Priority Areas • Overuse • Identify top 10 areas of overuse in healthcare • Population health • Composites of key preventive services and healthy lifestyle behaviors • End of life/palliative care • Composite of symptom management/HRQOL • Overutilization of hospital, ED, chemotherapy • Reliable and effective care management of chronic/acute patient-focused episodes • Frameworks completed for AMI and low back pain, ongoing work on cancer and diabetes

31. Fulfilling Measurement Needs for Priorities Standards ready now Urgent to develop Specific Site of Care Across the Continuum

32. Shared Data Elements “Sweet Spot” * Including safety measures * Including e-Rx

33. How do we get there?

34. Steps on the path • American Health Information Community (AHIC) Quality Workgroup focused on how Health IT can evolve to effectively support performance measurement. • NQF convened a Health IT Expert Panel (HITEP) to identify a set of common data elements to be standardized in order to enable automation of a prioritized set of measures through EHRs • HITEP Chair: Paul Tang, MD • Final report to be released shortly

35. Steps on the path • NQF expects to reconvene HITEP in the near future: • Develop a Quality Data Set that provides the core data elements needed for quality measurement and clinical decision support built off of clinical guidelines • Identify and prioritize the needed clinical data standards needed for the Quality Data Set  HITSP • Collect and synthesize clinical workflows within and across healthcare settings • Review condition-specific examples that would demonstrate the workflow issues involved in data aggregation within a single site of care as well as across an episode of care.

36. Not everything that counts can be counted, and not everything that can be counted counts. Albert Einstein

37. Comments/questions • Helen Burstin, MD, MPH • Senior Vice President, Performance Measureshburstin@qualityforum.org