PSO Common Formats for Patient Safety Event Reporting

1. PSO Common Formats for Patient Safety Event Reporting AHRQ Annual Conference 2008 Amy Helwig, MD, MS September 7, 2008

2. PSO Common Formats Agenda • Overview of Common Formats Version 0.1 Beta • Definition and Scope • Components of Version 0.1 Beta and Supporting Materials • Feedback Process For Common Formats Evolution • Common Formats Technical Assistance • Future Steps • Questions and Answers

3. Overview of Common Formats Version 0.1 Beta • Common Formats Goals: • Consistent with Common Formats conceptual framework • Functional • Flexible • Facility setting • Size of facility • Useable with existing workflows • Comprehensive in capturing all event types • Adaptable to work with current systems • Processes in place to enhance and expand

4. What are Common Formats? Common Formats describe the definitions, technical requirements, and reporting formats that allow healthcare providers to collect and submit standardized information regarding patient safety events.

5. Common Formats Definition and Scope Common Formats describe the technical requirements and reporting specifications for the collection and reporting of patient safety data, including all supporting material: • Paper forms to allow immediate implementation • A Users Guide • Descriptions of patient safety events and unsafe conditions to be reported • Examples of patient safety population reports • A metadata registry with data element attributes and technical specifications

6. Common Formats Definition and Scope Scope – Settings of Care • Patient Safety Act applies to all settings of care • Common Formats Version 0.1 Beta developed for the hospital setting • Future versions of the Common Formats to include: • Nursing homes and other bedded facilities • Ambulatory surgery centers • Community health centers • Physician and practitioner offices • Retail establishments, such as pharmacies • Other ambulatory care settings

7. Common Formats Definition and Scope • Common Formats apply to all patient safety concerns: • Incidents – patient safety events that reached the patient, whether or not there was harm • Near misses (or close calls) – patient safety events that did not reach the patient • Unsafe conditions – any circumstance that increases the probability of a patient safety event

8. Common Formats Definition and Scope • Scope Limits of Version 0.1 Beta • Limited to issues of patient safety • Numerator data only • Voluntary, spontaneous reporting data • Variability in rate and consistency of reporting • Goal to reduce risk • Available as paper forms • Technical specifications for vendors to follow

9. Common Formats Definition and Scope • Scope Limits of Version 0.1 Beta • Represent the initial reporting and problem identification phase of the 4 phase quality improvement cycle • Other future phases to be developed • Root cause analysis – process examination • Implementation of improvement action • Evaluation of effectiveness

10. Common Formats Definition and Scope • Limits of Version 0.1 Beta data elements • Structured data elements • Permit sorting of data for event analysis, pattern analysis and trending at all levels of the healthcare system • Allow for aggregation of data within and across provider organizations • Narrative information • Provides richness of detail about an individual event or condition needed to understand patient safety concerns at the provider and/or PSO levels • Not amenable to aggregation

11. Common Formats Definition and Scope • Limits of Version 0.1 Beta • The Common Formats are not an attempt to replace any current mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or other reporting/recording system. • Information that is identifiable to the patient, reporter, provider, and facility: • May be transmitted to a PSO as patient safety work product • Confidential and prohibited from disclosure as delineated in the Statute and Regulations • May not be transmitted to the NPSD

12. Using the Common Formats • Common Formats are designed to be used at the point of care • Ideally, initial information should be collected as soon after an event as possible • Data can be reviewed and analyzed at: • Healthcare provider organizations (e.g., headquarters of a multi-facility organization) • PSOs • NPSD (after de-identification) • Aggregate, de-identified data on patient safety sent to the NPSD in AHRQ’s annual NHQR

13. Components of Version 0.1 Beta and Supporting Materials Common Format Components - Version 0.1 Beta • Paper forms to allow immediate implementation and collection of event information • A Users Guide • Common Format event descriptions • Examples of patient safety population reports • A metadata registry with data element attributes and technical specifications

14. Components of Version 0.1 Beta and Supporting Materials Paper forms • Allow immediate implementation and collection of event information • Modular construction • Flexible • Facility setting • Size of facility • Useable with existing workflows • Comprehensive in capturing all event types

15. Components of Version 0.1 Beta and Supporting Materials Two categories of paper forms • Generic Reporting Forms • Structured elements pertaining to all types of events • Narrative section provided • Three generic forms (HERF, PIF, and FAF) • Event Specific Forms • Forms available for the most commonly-occurring types of events • Event-specific forms gather more granular structured information to supplement the generic forms. • Nine event-specific forms available

16. Components of Version 0.1 Beta and Supporting Materials Complete Patient Safety Report Generic Forms + + +

17. Components of Version 0.1 Beta and Supporting Materials HERF - Healthcare Event Reporting Form • Designed to be completed by the individual who witnessed, first discovered, or is most familiar with the details of the event • Captures information on incidents, near misses, and unsafe conditions • Structured questions and narrative • Analogous to incident reports commonly used in hospitals today • Initiates the patient safety event reporting process

18. Components of Version 0.1 Beta and Supporting Materials PIF - Patient Information Form • Supplements the HERF • Demographic information as well as additional information about the impact of the event on a patient (e.g., level of harm, unplanned interventions)

19. Components of Version 0.1 Beta and Supporting Materials Event specific forms: • Address the most commonly-occurring types of patient safety events • Supplement the information collected on the HERF, PIF, and FAF • Additional structured information • Outline the use or employment of measures designed to prevent the occurrence of the event

20. Components of Version 0.1 Beta and Supporting Materials Currently-available event-specific forms include: • Anesthesia • Blood, Tissue, Organ Transplantation or Gene Therapy • Device and Medical or Surgical Supply • Fall • Healthcare-Associated Infection • Medication & Other Substances • Perinatal • Pressure Ulcer • Surgical and Other Invasive Procedure (except Perinatal) AHRQ intends to develop additional event-specific Common Formats over time

21. Components of Version 0.1 Beta and Supporting Materials FAF - Final Assessment Form • Completed for all incidents, near misses, and unsafe conditions reported on a HERF • Assessment on preventability and recovery actions • Broad coding of location and reporter information obtained from HERF • Opportunity to add any missing information • Structured and narrative • Workflow – likely completed by supervisor or patient safety manager

22. Components of Version 0.1 Beta and Supporting Materials Complete Patient Safety Report - Workflow + + +

23. Components of Version 0.1 Beta and Supporting Materials Common Formats Users Guide • Common Formats background information and guidance on use of paper forms • Glossary of terms used with the Common Formats • Standard value sets • Facility, location of patient safety event, and provider standard value sets under development

24. Components of Version 0.1 Beta and Supporting Materials Common Format event descriptions • Plain language descriptions of the Common Formats objectives • Define the types of information to be gathered for all events • Definition of event • Scope of event • Preventive actions • Circumstances of event • Version 0.1 Beta event descriptions are currently under development

25. Components of Version 0.1 Beta and Supporting Materials • Common Format sample population reports • Can be used by PSOs, providers, and the NPSD • Allow for reports on identification of occurrence of events and patterns • Provide the foundation for learning why patient safety events occur • Version 0.1 Beta event sample reports currently under development

26. Components of Version 0.1 Beta and Supporting Materials USHIK- United States Health Information Knowledgebase • Meta data registry • Supports browsing, comparison, and synchronization of Common Format data elements with standards development organizations (such as HL7) and other healthcare organizations. • Technical specifications for the Common Formats • Allows vendors to write software programs to operationalize the formats • Currently under development

27. Common Formats Version 0.1 Beta Goals • Common Formats Goals • Consistent with Common Formats conceptual framework • Functional • Flexible • Useable with existing workflows • Comprehensive in capturing all event types • Processes for continued refinement and enhanced releases

28. Feedback Process For Common Formats Evolution • AHRQ committed to continued refinement of the Common Formats • Feedback desired from: • Private sector organizations • Non-Federal public organizations • Individual users of the Common Formats

29. Feedback process for Common Formats Evolution • The National Quality Forum will: • Assist with gathering and analyzing comments • Convene expert panel • Furnish reports to AHRQ on recommended enhancements to the Common Formats • This process will be a continuing one, guiding periodic updates of the Common Formats

30. Common Formats Technical Assistance • PSO PPC – Patient Safety Organization Privacy Protection Center • Technical Assistance available for using the Common Formats • Paper forms and user reference documentation are available for download at the PSOPPC Web-site (www.psoppc.org)

31. Future Steps • Develop expanded and enhanced versions based on user feedback • AHRQ plans to release a second version of the formats in six to nine months • Annual updates and revisions (2009 and beyond)

32. Questions and Answers

33. Common Formats Pilot Test • Provided guidance to refine and revise the Common Formats • AHRQ received feedback on the Common Formats • Style/ Formatting • Ease of use • Length of time to complete • Navigation • Wording • Clarity of instructions • Overall • Skip patterns • Consistency • Two pilot tests conducted in the Federal health centers • Department of Defense, Indian Health Services, and Veterans Health Administration

34. Thank you!