1. Development of the Medicare Patient Safety Monitoring System Susan L. Abend, MD, FACP David R. Hunt, MD, FACS Gaston Mbateng, Ph.D. Nancy Safer, RN, MSN Janet P. Tate, MPH Nancy R. Verzier, RN, MSN, CPHQ

2. Background and Development Team DHHS Patient Safety Task Force CMS –David R. Hunt, MD, FACS Qualidigm –Connecticut Quality Improvement Organization Active Collaborators –Federal Agency Work Group AHRQ, CDC, FDA, VA –Technical Expert Panel –Computer Science Corporation (Central Data Abstraction Center)

3. Goal To determine the incidence of specific, clearly defined, hospital-acquired adverse events within the Medicare population

4. Purpose Baseline data for CMS national quality improvement initiatives –Surgical Care Improvement Project Annual data to the National Healthcare Quality Report A method for repeated assessment of events (tracking and trending) for safety improvement activities within healthcare organizations

5. Design Retrospective Cohort Study 25,000- 40,000 randomly-selected discharges/year from the Hospital Payment Monitoring Program –Data obtained from medical charts and Medicare Part A claims database HPMP cases –randomly selected cases from 50 states, D.C., Puerto Rico, U.S. Virgin Islands –sent to CDACs to check coding accuracy

6. MPSMS Definition of Adverse Event An unintended patient harm, injury, or loss more likely associated with an interaction with the health care delivery system than from an attendant disease process. Patient centered –Focuses on patient experience –Does not presume to assign severity Detects an untoward outcome Requires defined healthcare exposure Not dependent on cause –Process malfunction (error, negligence) –Imperfect technology

7. Measure Development Process Event and exposure defined Boolean algorithm developed to detect exposure-related event Alpha test Beta test Clinical review Production

8. Measure Selection Criteria Findable/FeasibleFindable/Feasible Adverse event(s) very likely to be associated with exposureAdverse event(s) very likely to be associated with exposure Common (burden on Medicare population)Common (burden on Medicare population) Responsible for serious morbidity and mortalityResponsible for serious morbidity and mortality PreventablePreventable

9. Adverse Event Rates 02 and 03 Medicare Inpatients Post-Operative Pneumonia 2.5 + 0.3 Post-Operative Venous Thromboemboli 0.6 + 0.1 Post-Operative Urinary Tract Infection 3.7 + 0.3 Knee Replacement Adverse Events 7.2 + 1.3 Hip Replacement Adverse Events 11.4 + 1.8 Rate (%) + 95%CI

10. Adverse Event Rates 02 and 03 Medicare Inpatients Ventilator Associated Pneumonia11.9 + 1.8 Hospital-Acquired Bloodstream Infection0.30 + 0.05 CVC-Associated Bloodstream Infection1.4 + 0.3 CVC-Associated Insertion Site Infection2.6 + 0.4 CVC-Associated Mechanical Adverse Events 2.3 + 0.3 Rate (%) + 95% CI

11. Average Length of Stay 02, 03 Medicare Patients With Invasive Surgical Procedures Error bars indicate 95% CI

12. Inpatient Mortality Rate 02, 03 Medicare Patients With Invasive Surgical Procedures Error bars indicate 95% CI

13. Phase II Measures One Year of Data Pending Postoperative Cardiac EventsPostoperative Cardiac Events Adverse Drug EventsAdverse Drug Events –Anticoagulant-related hemorrhagic events –Insulin/oral hypoglycemic agent-related hypoglycemic events –Antibiotic-associated C. Difficile infection Pressure UlcersPressure Ulcers

14. Phase III Measures In Development In- Hospital Falls Angiography-Related Adverse Events –Contrast nephropathy –Adverse events related to femoral artery puncture Urinary Tract Infections Associated with Bladder Catheterization

15. Reliability Agreement Rate of Reported MPSMS Variables

16. Kappa Statistic for Reported MPSMS Variables

17. Limitations Validation –No true gold standard yet defined for determining sensitivity and specificity Data source issues –Retrospective –Depends on consistent documentation of exposures and events in medical record Events are relatively infrequent Limited capability for risk adjustment

18. Policy Implications Complements reporting efforts –Able to detect denominator –No reporting bias Complements indicators derived from administrative data alone –Potential for improved sensitivity –Richer database of variables

19. Policy Implications contd Standard definitions –trackable over time Allows hospitals to use common, standard benchmarks Potential for post-discharge surveillance of events Usable in paper or electronic health records –Potential for concurrent or prospective use in error trapping or event avoidance.

20. Summary The MPSMS is a reliable tool for measuring adverse events in hospitalized patients Can measure the outcome of errors, suboptimal systems and/or technologies Uses standardized, patient-oriented definitions of adverse events Development is transparent and consensus-driven –strong collaboration between public and private stakeholders

21. Conclusion The MPSMS is a valuable tool for hospitals and health care organizations to use in making transformational changes to create a safe healthcare environment. This material was prepared by Qualidigm, the Medicare Quality Improvement Organization for Connecticut, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. Pub. # QUALCT-PSMS-200501