PSO Common Formats for Patient Safety Event Reporting

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PSO Common Formats for Patient Safety Event
Reporting

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

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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 AHRQs annual NHQR

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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

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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

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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

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Components of Version 0.1 Beta and Supporting
Materials

• Complete Patient Safety Report

Generic Forms



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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

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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)

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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

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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
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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

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Components of Version 0.1 Beta and Supporting
Materials

• Complete Patient Safety Report - Workflow

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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

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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

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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

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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

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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

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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

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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

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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)

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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)

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Questions and Answers
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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

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Thank you!