PSO Common Formats for Patient Safety Event Reporting

PSO Common Formats for Patient PSO Common Formats for Patient Safety Event ReportingSafety Event Reporting

AHRQ Annual Conference 2008AHRQ Annual Conference 2008

Amy Helwig, MD, MSAmy Helwig, MD, MS

September 7, 2008September 7, 2008

PSO Common FormatsPSO Common Formats

AgendaAgenda Overview of Common Formats Version 0.1 BetaOverview of Common Formats Version 0.1 Beta

Definition and ScopeDefinition and Scope

Components of Version 0.1 Beta and Supporting Components of Version 0.1 Beta and Supporting MaterialsMaterials

Feedback Process For Common Formats EvolutionFeedback Process For Common Formats Evolution

Common Formats Technical AssistanceCommon Formats Technical Assistance

Future StepsFuture Steps Questions and AnswersQuestions and Answers

OOverview of Common Formats verview of Common Formats Version 0.1 BetaVersion 0.1 Beta

Common Formats Goals:Common Formats Goals:

– Consistent with Common Formats conceptual frameworkConsistent with Common Formats conceptual framework

– FunctionalFunctional

– FlexibleFlexible Facility settingFacility setting

Size of facilitySize of facility

– Useable with existing workflowsUseable with existing workflows

– Comprehensive in capturing all event typesComprehensive in capturing all event types

– Adaptable to work with current systemsAdaptable to work with current systems

– Processes in place to enhance and expandProcesses in place to enhance and expand

What are Common Formats? What are Common Formats?

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

Common Formats Definition and ScopeCommon Formats Definition and Scope

Common Formats describe the technical requirements and Common Formats describe the technical requirements and reporting specifications for the collection and reporting of reporting specifications for the collection and reporting of patient safety data, including all supporting material:patient safety data, including all supporting material:

Paper forms to allow immediate implementationPaper forms to allow immediate implementation

A Users GuideA Users Guide

Descriptions of patient safety events and unsafe conditions to be Descriptions of patient safety events and unsafe conditions to be reportedreported

Examples of patient safety population reportsExamples of patient safety population reports

A metadata registry with data element attributes and technical A metadata registry with data element attributes and technical specificationsspecifications

Scope – Settings of CareScope – Settings of Care

– Patient Safety Act applies to all settings of carePatient Safety Act applies to all settings of care

– Common Formats Version 0.1 Beta developed for the hospital settingCommon Formats Version 0.1 Beta developed for the hospital setting

– Future versions of the Common Formats to include:Future versions of the Common Formats to include: Nursing homes and other bedded facilitiesNursing homes and other bedded facilities Ambulatory surgery centersAmbulatory surgery centers Community health centersCommunity health centers Physician and practitioner officesPhysician and practitioner offices Retail establishments, such as pharmaciesRetail establishments, such as pharmacies Other ambulatory care settings Other ambulatory care settings



Common Formats apply to all patient safety concerns:Common Formats apply to all patient safety concerns:

– Incidents – patient safety events that reached the patient, Incidents – patient safety events that reached the patient, whether or not there was harmwhether or not there was harm

– Near misses (or close calls) – patient safety events that did Near misses (or close calls) – patient safety events that did not reach the patientnot reach the patient

– Unsafe conditions – any circumstance that increases the Unsafe conditions – any circumstance that increases the probability of a patient safety eventprobability of a patient safety event


Scope Limits of Version 0.1 BetaScope Limits of Version 0.1 Beta– Limited to issues of patient safetyLimited to issues of patient safety

– Numerator data onlyNumerator data only

– Voluntary, spontaneous reporting dataVoluntary, spontaneous reporting data Variability in rate and consistency of reportingVariability in rate and consistency of reporting Goal to reduce riskGoal to reduce risk

– Available as paper forms Available as paper forms Technical specifications for vendors to followTechnical specifications for vendors to follow


Scope Limits of Version 0.1 BetaScope Limits of Version 0.1 Beta– Represent the initial reporting and problem identification Represent the initial reporting and problem identification

phase of the 4 phase quality improvement cyclephase of the 4 phase quality improvement cycle

– Other future phases to be developedOther future phases to be developed Root cause analysis – process examinationRoot cause analysis – process examination Implementation of improvement actionImplementation of improvement action Evaluation of effectivenessEvaluation of effectiveness


Limits of Version 0.1 Beta data elementsLimits of Version 0.1 Beta data elements

– StructuredStructured data elements data elements Permit sorting of data for event analysis, pattern analysis and trending Permit sorting of data for event analysis, pattern analysis and trending

at all levels of the healthcare systemat all levels of the healthcare system Allow for aggregation of data within and across provider organizationsAllow for aggregation of data within and across provider organizations

– NarrativeNarrative information information Provides richness of detail about an individual event or condition Provides richness of detail about an individual event or condition

needed to understand patient safety concerns at the provider and/or needed to understand patient safety concerns at the provider and/or PSO levels PSO levels

Not amenable to aggregationNot amenable to aggregation


Limits of Version 0.1 BetaLimits of Version 0.1 Beta– The Common Formats are not an attempt to replace any current The Common Formats are not an attempt to replace any current

mandatory reporting system, collaborative/voluntary reporting mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or other system, research-related reporting system, or other reporting/recording system. reporting/recording system.

– Information that is identifiable to the patient, reporter, provider, Information that is identifiable to the patient, reporter, provider, and facility:and facility: May be transmitted to a PSO as patient safety work productMay be transmitted to a PSO as patient safety work product Confidential and prohibited from disclosure as delineated in the Statute Confidential and prohibited from disclosure as delineated in the Statute

and Regulationsand Regulations May not be transmitted to the NPSDMay not be transmitted to the NPSD

Using the Common Formats Using the Common Formats

Common Formats are designed to be used at the point of careCommon Formats are designed to be used at the point of care

– Ideally, initial information should be collected as soon after Ideally, initial information should be collected as soon after an event as possiblean event as possible

Data can be reviewed and analyzed at:Data can be reviewed and analyzed at:

– Healthcare provider organizations (e.g., headquarters of a Healthcare provider organizations (e.g., headquarters of a multi-facility organization)multi-facility organization)

– PSOsPSOs

– NPSD (after de-identification)NPSD (after de-identification)

Aggregate, de-identified data on patient safety sent to the NPSD Aggregate, de-identified data on patient safety sent to the NPSD in AHRQ’s annual NHQRin AHRQ’s annual NHQR

Components of Version 0.1 Components of Version 0.1 Beta and Supporting MaterialsBeta and Supporting Materials

Common Format Components - Version 0.1 BetaCommon Format Components - Version 0.1 Beta

Paper forms to allow immediate implementation and Paper forms to allow immediate implementation and collection of event informationcollection of event information

A Users GuideA Users Guide

Common Format event descriptions Common Format event descriptions

Examples of patient safety population reportsExamples of patient safety population reports

A metadata registry with data element attributes and A metadata registry with data element attributes and technical specificationstechnical specifications


Paper formsPaper forms Allow immediate implementation and collection of event Allow immediate implementation and collection of event

informationinformation

Modular construction Modular construction – FlexibleFlexible

Facility settingFacility setting Size of facilitySize of facility

Useable with existing workflowsUseable with existing workflows

Comprehensive in capturing all event typesComprehensive in capturing all event types


Two categories of paper formsTwo categories of paper forms Generic Reporting FormsGeneric Reporting Forms

– Structured elements pertaining to all types of eventsStructured elements pertaining to all types of events

– Narrative section providedNarrative section provided

– Three generic forms (HERF, PIF, and FAF)Three generic forms (HERF, PIF, and FAF)

Event Specific FormsEvent Specific Forms

– Forms available for the most commonly-occurring types of Forms available for the most commonly-occurring types of eventsevents

– Event-specific forms gather more granular structured Event-specific forms gather more granular structured information to supplement the generic forms.information to supplement the generic forms.

– Nine event-specific forms availableNine event-specific forms available

Complete Patient Safety ReportComplete Patient Safety Report

Components of Version 0.1 Beta Components of Version 0.1 Beta and Supporting Materialsand Supporting Materials

+ + +

Generic Forms

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


PIF - Patient Information FormPIF - Patient Information Form Supplements the HERF Supplements the HERF

Demographic information as well as additional Demographic information as well as additional information about the impact of the event on a patient information about the impact of the event on a patient (e.g., level of harm, unplanned interventions)(e.g., level of harm, unplanned interventions)



Event specific forms:Event specific forms:

Address the most commonly-occurring types of patient Address the most commonly-occurring types of patient safety eventssafety events

Supplement the information collected on the HERF, PIF, Supplement the information collected on the HERF, PIF, and FAFand FAF

– Additional structured information Additional structured information

– Outline the use or employment of measures designed Outline the use or employment of measures designed to prevent the occurrence of the eventto prevent the occurrence of the event


Currently-available event-specific forms include:Currently-available event-specific forms include: AnesthesiaAnesthesia Blood, Tissue, Organ Transplantation or Gene TherapyBlood, Tissue, Organ Transplantation or Gene Therapy Device and Medical or Surgical SupplyDevice and Medical or Surgical Supply FallFall Healthcare-Associated InfectionHealthcare-Associated Infection Medication & Other SubstancesMedication & Other Substances PerinatalPerinatal Pressure UlcerPressure Ulcer Surgical and Other Invasive Procedure (except Surgical and Other Invasive Procedure (except

Perinatal)Perinatal)

AHRQ intends to develop additional event-specific Common Formats over timeAHRQ intends to develop additional event-specific Common Formats over time

FAF - Final Assessment FormFAF - Final Assessment Form Completed for all incidents, near misses, and unsafe Completed for all incidents, near misses, and unsafe

conditions reported on a HERFconditions reported on a HERF– Assessment on preventability and recovery actionsAssessment on preventability and recovery actions– Broad coding of location and reporter information obtained from Broad coding of location and reporter information obtained from

HERFHERF

Opportunity to add any missing informationOpportunity to add any missing information– Structured and narrativeStructured and narrative

Workflow – likely completed by supervisor or patient safety Workflow – likely completed by supervisor or patient safety managermanager


Complete Patient Safety Report - Complete Patient Safety Report - WorkflowWorkflow


+ + +


Common Formats Users GuideCommon Formats Users Guide Common Formats background information and guidance on use of Common Formats background information and guidance on use of

paper formspaper forms

Glossary of terms used with the Common FormatsGlossary of terms used with the Common Formats

Standard value setsStandard value sets– Facility, location of patient safety event, and provider standard value sets under Facility, location of patient safety event, and provider standard value sets under

developmentdevelopment


Common Format event descriptionsCommon Format event descriptions

– Plain language descriptions of the Common Formats objectives Plain language descriptions of the Common Formats objectives

– Define the types of information to be gathered for all eventsDefine the types of information to be gathered for all events Definition of eventDefinition of event

Scope of eventScope of event

Preventive actionsPreventive actions

Circumstances of eventCircumstances of event

– Version 0.1 Beta event descriptions are currently under development Version 0.1 Beta event descriptions are currently under development


Common Format sample population reportsCommon Format sample population reports

– Can be used by PSOs, providers, and the NPSDCan be used by PSOs, providers, and the NPSD Allow for reports on identification of occurrence of events and Allow for reports on identification of occurrence of events and

patternspatterns Provide the foundation for learning why patient safety events occurProvide the foundation for learning why patient safety events occur

– Version 0.1 Beta event sample reports currently under Version 0.1 Beta event sample reports currently under developmentdevelopment


USHIK- United States Health Information KnowledgebaseUSHIK- United States Health Information Knowledgebase Meta data registryMeta data registry

– Supports browsing, comparison, and synchronization of Supports browsing, comparison, and synchronization of Common Format data elements with standards development Common Format data elements with standards development organizations (such as HL7) and other healthcare organizations (such as HL7) and other healthcare organizations.organizations.

Technical specifications for the Common Formats Technical specifications for the Common Formats

Allows vendors to write software programs to operationalize the Allows vendors to write software programs to operationalize the formatsformats

Currently under developmentCurrently under development

Common Formats Common Formats Version 0.1 Beta GoalsVersion 0.1 Beta Goals

Common Formats GoalsCommon Formats Goals– Consistent with Common Formats conceptual frameworkConsistent with Common Formats conceptual framework

– FunctionalFunctional

– FlexibleFlexible

– Useable with existing workflowsUseable with existing workflows

– Comprehensive in capturing all event typesComprehensive in capturing all event types

– Processes for continued refinement and enhanced releasesProcesses for continued refinement and enhanced releases

Feedback Process For Feedback Process For Common Formats Evolution Common Formats Evolution

AHRQ committed to continued refinement AHRQ committed to continued refinement of the Common Formatsof the Common Formats

Feedback desired from:Feedback desired from:

– Private sector organizationsPrivate sector organizations

– Non-Federal public organizationsNon-Federal public organizations

– Individual users of the Common FormatsIndividual users of the Common Formats

Feedback process for Feedback process for Common Formats Evolution Common Formats Evolution

The National Quality Forum will:The National Quality Forum will:

– Assist with gathering and analyzing comments Assist with gathering and analyzing comments

– Convene expert panel Convene expert panel

– Furnish reports to AHRQ on recommended Furnish reports to AHRQ on recommended enhancements to the Common Formatsenhancements to the Common Formats

This process will be a continuing one, guiding This process will be a continuing one, guiding periodic updates of the Common Formatsperiodic updates of the Common Formats

Common Formats Technical AssistanceCommon Formats Technical Assistance

PSO PPC – Patient Safety Organization Privacy PSO PPC – Patient Safety Organization Privacy Protection CenterProtection Center

– Technical Assistance available for using the Common Technical Assistance available for using the Common FormatsFormats

– Paper forms and user reference documentation are available Paper forms and user reference documentation are available for download at the PSOPPC Web-site (for download at the PSOPPC Web-site (www.psoppc.orgwww.psoppc.org))

http://www.psoppc.org/

Future StepsFuture Steps

Develop expanded and enhanced versions based on Develop expanded and enhanced versions based on user feedbackuser feedback

AHRQ plans to release a second version of the AHRQ plans to release a second version of the formats in six to nine monthsformats in six to nine months

Annual updates and revisions Annual updates and revisions (2009 and beyond)(2009 and beyond)

Questions and AnswersQuestions and Answers

Common Formats Pilot TestCommon Formats Pilot Test

Provided guidance to refine and revise the Common FormatsProvided guidance to refine and revise the Common Formats AHRQ received feedback on the Common Formats AHRQ received feedback on the Common Formats

– Style/ FormattingStyle/ Formatting– Ease of useEase of use– Length of time to completeLength of time to complete– NavigationNavigation– WordingWording– Clarity of instructionsClarity of instructions

OverallOverall Skip patternsSkip patterns ConsistencyConsistency

Two pilot tests conducted in the Federal health centersTwo pilot tests conducted in the Federal health centers– Department of Defense, Indian Health Services, and Veterans Health Department of Defense, Indian Health Services, and Veterans Health

AdministrationAdministration

Thank you!Thank you!

PSO Common Formats for Patient Safety Event Reporting

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