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Survey of Medical Informatics CS 493 – Fall 2004 October 11, 2004 V. “Juggy” Jagannathan Adverse Event Analysis Chapter 6: Patient Safety - Achieving a New Standard of Care. IOM Report Adverse Event  Defined as “an event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient” Detecting adverse events     Voluntary and mandatory reporting Retrospective chart review Automated surveillance of EHR, discharge summaries, claims data Monitor care plans and track discrepancy between expected outcome and realized outcome Comparison of approaches   Automated better than chart review better than voluntary reporting Approaches are complementary Data requirements for ADEs  Triggers in a chart review (examples):        Unexpected need for blood transfusion Transfer to an ICU Comments about drug reaction in the chart Abnormal lab values Unexpected hypotension Mental state change Page 205, box 6-1 Automated review approach  Four different approaches:    ICD-9 codes Reports of new allergy Rule-based   Box 6-2 rules for detecting ADEs., page 207 Data mining of textual reports   Diuretic drug  fatigue could be a potential adverse event Box 6-3, page 208 Monitoring the care process  Diabetes Quality Improvement Project (DQIP) set of measures for assessing the quality of adult diabetes care [Table 6- 1 and 6-2 – pg 209-211]          Hemoglobin A1C management Lipid management Urine protein testing Eye examination Foot examination BP management Smoking cessation Influenza immunization and aspirin use Table 6-3 Physician Order Entry System – validation modules Analysis of adverse event systems     What – adverse event? Which – process caused the event to occur? When – did the event occur and in what context? Where – did the event occur? Addressing Errors of Omission    Need more data elements from the patient Eg. DQIP Requires statistical analysis Implications for data standards     Precise definition of terms Minimum datasets with coding and narrative text – page 219 Explicit Data Collection Processes Integrating data across systems and settings Future Vision     Increasing importance of automated triggers Definition of core constructs Detection of adverse events using claims data Integrated approach to detecting and preventing adverse events Near-Miss Analysis Chapter 7: Patient Safety - Achieving a New Standard of Care. IOM Report Definition of a near miss    One definition: A near miss is an occurrence with potentially important safety-related effects which, in the end, was prevented from developing into actual consequences. Alternate definition: A near miss is defined as an act of commission or omission that could have harmed the patient, but did not cause harm as a result of chance, prevention or mitigation. Synonymous to “potential adverse events” or “close calls” Near miss  Phases      Initial failures Dangerous situation Inadequate defenses Recovery Figure 7-1 pg 228 Near Miss analysis   Intrinsically, as currently organized is a lowreliability system Importance of near-miss reporting  Goals for Near-Miss systems    Modeling – to gain a qualitative insight Trending – to gain quantitative insight Mindfulness/alertness Causal Continuum Assumption   Causal factors that lead to consequential accidents  causal factors that lead to nonconsequential events or near misses Validated in transportation industry – not in healthcare. Dual Pathway  Analytical pathway   Collecting incident data; analyzing root causes and acting on it Cultural pathway  Changing the culture of identifying and reporting and addressing near misses The role of the patient   Patient can play an active role Family and friends can play a role Fundamental aspects of near-miss systems   Database of incidents Root-cause taxonomies     Failure root causes Recovery root causes Context variables Free text Functional requirements of near-miss system  General   Integration with other systems such as adverse event reporting Comprehensive coverage    Quality, environment, reliability, cost Model-based analysis Organizational learning System Characteristics  Types and levels   Table 7-1, pg 235 Implementation and operational factors      Nature of information collected Use of information Tools that assist in collection and analysis Reporting mechanisms Organizational buy-in Problems of data collection      Action oriented Event focused Consequence driven Technical myopia Variable quality General Framework  Table 7-2 pg. 241 Implications for data standards    Definitions and models Taxonomies (ontologies) Design