PSO Common Formats for Patient Safety Event Reporting (Text Version)

AHRQ 2008 Annual Conference

Slides

Slide 1

Patient Safety Organization (PSO) Common Formats for Patient Safety Event Reporting

AHRQ Annual Conference 2008
Amy Helwig, MD, MS
September 7, 2008

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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 Network of Patient Safety Databases (NPSD).

Slide 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

Slide 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.

Slide 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.

Slide 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.

Slide 16

Components of Version 0.1 Beta and Supporting Materials

Complete Patient Safety Report:

• Generic Forms:
  • HERF
  • PIF
  • FAF
• HERF + PIF + FAF + Event Specific Form (Example: Anesthesia)

Slide 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.

Slide 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).

Slide 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.

Slide 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)

Note: AHRQ intends to develop additional event-specific Common Formats over time.

Slide 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.

Slide 22

Components of Version 0.1 Beta and Supporting Materials

Complete Patient Safety Report—Workflow

• HERF + PIF + Event Specific Form (Example: Anesthesia) + FAF

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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.

Slide 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)

Slide 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).

Slide 32

Questions and Answers

Slide 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.

Slide 34

Thank you!