1. Overview: Common Formats Overview: Common Formats Event Reporting vs. Surveillance Future of Automation Prepared for the HL-7 CQI Meeting CDR A. Gretchen Buckler, MD, MPH, USPHS February 5, 2016

2. Event Reporting Systems Surveillance via chart audit Surveillance via EHR export Current Common Formats Hospital version 1.2 Quality and Safety Review System Updates / replaces MPSMS Future development Certification criteria; vendors code Common Formats into their products; automation Order of Common Formats Development

3. Status of Common Formats Common Formats – event reporting ► v1.2 for hospitals ► v0.1 beta for nursing homes ► v2.0 will update Formats and introduce tiering concept: o Tier I - essential for national reporting o Tier II - focused on data captured for local use ► Retail Pharmacy completed; EMS and Dx Error in development Common Formats – surveillance ► Quality and Safety Review System (QSRS) for hospitals ► QSRS in use at CMS CDAC and being pilot tested in community; revisions will be necessary before release current

4. Event Reporting vs. Surveillance The Common Formats for event reporting are designed to be used during hospitalization ► Contain information in the medical record and more ► Include near misses and unsafe conditions ► Do not include denominators The Common Formats for surveillance are designed to be used after discharge ► Will include denominators; will generate rates ► Will not address near misses and unsafe conditions ► Based on audit of charts

5. Event Reporting vs. Surveillance Event reporting systems are used by patient safety professionals during a patient stay ► Individuals can be interviewed; sources other than the medical record can be reviewed ► Professionals can interpret what happened Medical record-based surveillance systems must rely on coders/abstractors ► Judgment of coders/abstractors is undesirable outside very narrow boundaries; inter-rater reliability depends on objective answers to standard, structured questions ► Human coders/abstractors do provide critical intelligence by being able to find required information in different places and in different media and successfully answer the standard questions

6. Value of Surveillance Surveillance Formats will allow collection of comparable performance data over time and across settings ► Nationally can be used for: o Generating adverse event rates / national means o Trending performance over time ► At the PSO level could be used for: o Establishing hospital and PSO means (averages) o Trending and benchmarking within and between PSOs

7. QSRS Design QSRS is modular – by clinical content area – as opposed to being a collection of individual, isolated measures Modules apply to all patients experiencing an incident and contain clinical categories and subcategories to accomplish two goals: ► Standardize information that should be standardized ► Maximize structured data collection on all adverse events, no matter how rare

8. Event Type Patient Information Harm For all events, QSRS assesses general information. QSRS Design

9. If the event is covered by an Event-Specific Format, additional information will be requested. Medication Event Type Patient Information Harm QSRS Design

10. If the event involves more than one type of adverse action, e.g., a malfunctioning device that administers too much drug, then more than one event-specific Format will be invoked. MedicationDevice Event Type Patient Information Harm QSRS Design

11. “Abstractor Narrative” can be collected for all adverse events. This information is of value for local hospital use and for refining the system. It will not appear in population reports. MedicationDevice Abstractor Narrative Event Type Patient Information Harm QSRS Design

12. QSRS Development “Event Descriptions” (EDs) are created for all adverse events of interest ► An ED is the definition of an adverse event expressed in English and written in logical form Population Reports are created next, specifying exactly what information will be presented to the user regarding the specific event type (e.g., fall) Algorithms are constructed incorporating both abstracting questions and associated logic A second set of algorithms is constructed linking answers to questions with specified reports

13. QSRS Objectives QSRS’ goal is to identify adverse events in patient charts as efficiently and accurately as possible Definition of the event is virtually all that is required Minimizing false negatives must be balanced with minimizing false positives and with abstracting times QSRS is an operational tool designed to get as close to the truth as possible, recognizing the constraints of an abstracting process and the need for cost-effective data collection

14. Future State ► Pilot testing of QSRS with JHU in four hospitals o Evaluating usability, ease of abstraction, abstraction times, inter-rater reliability, and expert panel validation of incidents ► Feasibility of automated population of fields in QSRS from EHR ► Collaboration with OptumLabs to evaluate automatic data abstraction from their extensive dataset of linked EHR and claims data ► Structured Data Capture

15. Feasibility Project Used QSRS fields, algorithms and dependencies and grouped them by the type of data and ease of extraction from an EHR o Ranged from discrete data to text fields o Even those which seemed like they might be easy to extract, were not found to be simple based on time dependencies, etc. o Some fields aren’t as accurate as they had hoped o Items that appear to be entered into discrete fields (templated notes) are not actually being stored in discrete fields in the database Will be interviewing EHR vendors and hospital systems to see what data they are currently abstracting or able to abstract

16. Standard Data Capture (SDC) Project AHRQ is an active member of the SDC project, which is an S&I Framework initiative. A subset of the AHRQ Common Format’s Medication and Device data definitions have been codified as LOINC values. We’re hoping to pilot the use of these definitions in the near future using a Patient Safety Organization (PSO) along with EHR and event reporting software vendors.

17. QUESTIONS? Contact information: Gretchen Buckler aileen.buckler@ahrq.hhs.gov