Advancing Safety and Quality:Advancing Safety and Quality:Supporting Patient Safety Organizations Supporting Patient Safety Organizations

and Reducing Risks to Patientsand Reducing Risks to Patients

William B. Munier, MD, MBAWilliam B. Munier, MD, MBAAmy Helwig, MD, MSAmy Helwig, MD, MSDiane Cousins, RPhDiane Cousins, RPh

Agency for Healthcare Research and QualityAgency for Healthcare Research and QualityCenter for Quality Improvement and Patient SafetyCenter for Quality Improvement and Patient Safety

September 14 & 16 AHRQ Annual ConferenceSeptember 14 & 16 AHRQ Annual Conference

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AgendaAgenda

Patient Safety ActPatient Safety Act

PSO OperationsPSO Operations

Common FormatsCommon Formats

Next StepsNext Steps

Q & AQ & A

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The Patient Safety and Quality The Patient Safety and Quality Improvement Act of 2005Improvement Act of 2005

• Creates “Patient Safety Organizations” Creates “Patient Safety Organizations” (PSOs)(PSOs)

• Establishes “Network of Patient Safety Establishes “Network of Patient Safety Databases” (NPSD)Databases” (NPSD)

• Authorizes establishment of “Common Authorizes establishment of “Common Formats” for reporting patient safety Formats” for reporting patient safety eventsevents

• Requires reporting of findings annually in Requires reporting of findings annually in AHRQ’s National Health Quality / AHRQ’s National Health Quality / Disparities ReportsDisparities Reports

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The Patient Safety ActThe Patient Safety Act

Aims to improve safety by addressingAims to improve safety by addressing

– Fear of malpractice litigationFear of malpractice litigation

– Inadequate protection by state lawsInadequate protection by state laws

– Inability to aggregate data on a large scaleInability to aggregate data on a large scale

Amends AHRQ’s enabling legislationAmends AHRQ’s enabling legislation

– AHRQ administers the programAHRQ administers the program

– Office for Civil Rights handles enforcementOffice for Civil Rights handles enforcement

– Program is voluntaryProgram is voluntary

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Alignment with AHRQ’s VisionAlignment with AHRQ’s Vision

The PSO program is integrated with other The PSO program is integrated with other AHRQ responsibilitiesAHRQ responsibilities

PSO operations align with the spectrum of PSO operations align with the spectrum of AHRQ’s patient safety / quality improvement AHRQ’s patient safety / quality improvement research, tools, & initiatives research, tools, & initiatives

PSOs represent a unique opportunity for both PSOs represent a unique opportunity for both “real world” input into AHRQ’s work & a “real world” input into AHRQ’s work & a potentially significant “effector” arm for AHRQ’s potentially significant “effector” arm for AHRQ’s tools, training programs, & research findingstools, training programs, & research findings

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PSO OperationsPSO Operations

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Listing PSOsListing PSOs

AHRQ began listing AHRQ began listing PSOs under Interim PSOs under Interim Guidance - Oct 2008Guidance - Oct 2008

Final rule published in Final rule published in the Nov 21the Nov 21stst, 2008 , 2008 Federal Register; Federal Register; effective Jan 19effective Jan 19thth, 2009, 2009

68 PSOs “listed” by 68 PSOs “listed” by AHRQ as of Sept 16AHRQ as of Sept 16thth; ; complete list atcomplete list at

http://www.pso.ahrq.gov

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PSOs in 26 States and the PSOs in 26 States and the District of ColumbiaDistrict of Columbia

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Program Interest is HighProgram Interest is High

Nearly 22,000 subscribers to AHRQ’s PSO Nearly 22,000 subscribers to AHRQ’s PSO ListservListserv

3,500 + visits to the AHRQ PSO Web site on 3,500 + visits to the AHRQ PSO Web site on average each monthaverage each month

http://www.pso.ahrq.gov

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PSO StatusPSO Status

Because of provisions in the statute, reflected in the final rule, PSOs Because of provisions in the statute, reflected in the final rule, PSOs develop spontaneously; no master plan can be requireddevelop spontaneously; no master plan can be required

– PSOs are voluntaryPSOs are voluntary

– Provider participation is voluntaryProvider participation is voluntary

– Subject matter covered is voluntarySubject matter covered is voluntary

– Reporting to the NPSD is voluntaryReporting to the NPSD is voluntary

These conditions limit what AHRQ can expect in terms of PSO coverage These conditions limit what AHRQ can expect in terms of PSO coverage & utility of data& utility of data

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Who Can be a PSO?Who Can be a PSO?

Eligible organizationsEligible organizations

– Any public or private entity / componentAny public or private entity / component

– Any for-profit or not-for-profit / componentAny for-profit or not-for-profit / component

Ineligible organizationsIneligible organizations– Health insurance issuers or their componentsHealth insurance issuers or their components

– Accrediting & licensing bodiesAccrediting & licensing bodies

– Entities that regulate providers, including their Entities that regulate providers, including their agents (e.g., QIOs)agents (e.g., QIOs)

– Mandatory public reporting systemsMandatory public reporting systems

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PSOs: Becoming a PSOPSOs: Becoming a PSO

Entities seeking listing must complete a “Certification for Initial Entities seeking listing must complete a “Certification for Initial Listing” formListing” form– Available on AHRQ’s PSO Web siteAvailable on AHRQ’s PSO Web site

http://www.pso.ahrq.gov/index.html

Application: a simple process of attestationApplication: a simple process of attestation– Compliance with requirements ensured by spot checksCompliance with requirements ensured by spot checks

– Entities subject to penalties for false statementsEntities subject to penalties for false statements

Listing: for 3-year renewable periods Listing: for 3-year renewable periods

Funding: no Federal funding from AHRQ, but technical Funding: no Federal funding from AHRQ, but technical assistance without chargeassistance without charge

Provider Choice of PSO: voluntary, marketplace assessmentProvider Choice of PSO: voluntary, marketplace assessment

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Some of the First PSOsSome of the First PSOs

UHC Clinical Practice Advancement CenterUHC Clinical Practice Advancement Center

ECRI Institute PSOECRI Institute PSO

Florida Patient Safety CorporationFlorida Patient Safety Corporation

Institute for Safe Medication Practices (ISMP)Institute for Safe Medication Practices (ISMP)

Kentucky Institute for Patient Safety and QualityKentucky Institute for Patient Safety and Quality

California Hospital Patient Safety OrganizationCalifornia Hospital Patient Safety Organization

Premier Patient Safety OrganizationPremier Patient Safety Organization

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PSO ActivitiesPSO Activities

Collect, analyze patient safety (PS) dataCollect, analyze patient safety (PS) data

Assist providers to improve quality & safetyAssist providers to improve quality & safety

Develop & disseminate PS informationDevelop & disseminate PS information

Encourage culture of safety & minimize Encourage culture of safety & minimize patient riskpatient risk

Provide feedback to participantsProvide feedback to participants

Maintain confidentiality & security of dataMaintain confidentiality & security of data

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Potential ConcernsPotential Concerns

Relationship to other reporting requirementsRelationship to other reporting requirements

– Mandatory state reportingMandatory state reporting

– CDC’s NHSN for healthcare-associated CDC’s NHSN for healthcare-associated infectionsinfections

– FDA reportingFDA reporting

– Other systemsOther systems

Desire for one-time reporting & the elusive Desire for one-time reporting & the elusive “interoperability”“interoperability”

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Potential ConcernsPotential Concerns

Challenges inherent in patient safety reportingChallenges inherent in patient safety reporting

– Uneven detection / surveillanceUneven detection / surveillance

– Lack of defined populations: denominatorsLack of defined populations: denominators

– Different cultures / styles of operationDifferent cultures / styles of operation

– Different definitions, scope, formatsDifferent definitions, scope, formats

Challenges with PSO frameworkChallenges with PSO framework

– Not discrete geographicallyNot discrete geographically

– Voluntary, spontaneous reportingVoluntary, spontaneous reporting

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How Do Providers BenefitHow Do Providers BenefitFrom Working With A PSO?From Working With A PSO?

Receive uniform Federal confidentiality & privilege Receive uniform Federal confidentiality & privilege protectionsprotections

Gain protection for analysis beyond the initial report Gain protection for analysis beyond the initial report (e.g., root cause analysis)(e.g., root cause analysis)– In provider’s patient safety evaluation system or the PSO’sIn provider’s patient safety evaluation system or the PSO’s– Shared learning within the provider’s systemShared learning within the provider’s system

Benefit from aggregationBenefit from aggregation– PSO levelPSO level– PSO to PSO analysis & sharingPSO to PSO analysis & sharing– NPSDNPSD

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Key Questions ProvidersKey Questions ProvidersShould Ask A PSOShould Ask A PSO

Does the PSO specialize or limit to a specific content Does the PSO specialize or limit to a specific content area? area?

– Topic specialization (e.g., medical devices, Topic specialization (e.g., medical devices, medications, pediatric anesthesia, etc.) medications, pediatric anesthesia, etc.)

– Geographical focus Geographical focus

What types of analysis & service does the PSO What types of analysis & service does the PSO provide? provide?

Does the PSO use consultants or services of Does the PSO use consultants or services of another PSO? another PSO?

– Will I be consulted before the PSO shares my patient Will I be consulted before the PSO shares my patient safety data with external consultants? safety data with external consultants?

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Key Questions ProvidersKey Questions ProvidersShould Ask A PSOShould Ask A PSO

Will the PSO help me set up a patient safety Will the PSO help me set up a patient safety evaluation system? evaluation system?

How will my patient safety work product be How will my patient safety work product be protected at the PSO? protected at the PSO?

Does the PSO work with the NPSD? Does the PSO work with the NPSD?

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Provider Notification ofProvider Notification ofPSO Change in StatusPSO Change in Status

AHRQ has established a process to notify AHRQ has established a process to notify health care providers when the status of a health care providers when the status of a listed PSO changes (e.g., delisting)listed PSO changes (e.g., delisting)

To request notification about a change in To request notification about a change in status of a specific PSO, please send an e-status of a specific PSO, please send an e-mail to mail to ProviderNotification@ahrq.hhs.gov

– Specify the PSO(s) about which you would Specify the PSO(s) about which you would like to be notifiedlike to be notified

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Common FormatsCommon Formats

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PSO

Data Flow: Provider to PSO to NPSD to UserData Flow: Provider to PSO to NPSD to User

PPC

PSO

PSO

NPSD

Other Qualified

Sources

AHRQ National Quality Reports

User:Researchers

User:PSO

User:Provider

Provider Provider Provider

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PSO RequirementsPSO Requirements

PSOs & providers analyze patient safety dataPSOs & providers analyze patient safety data

– PSOs are required to collect information that PSOs are required to collect information that allows comparison of “similar events among allows comparison of “similar events among similar providers”similar providers”

– ““Common Formats” have been made available Common Formats” have been made available by AHRQ, acting for the Secretary of HHS, to by AHRQ, acting for the Secretary of HHS, to assist PSOs to meet this requirementassist PSOs to meet this requirement

– At recertification, PSOs will be required to state At recertification, PSOs will be required to state how they meet the requirement how they meet the requirement

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AHRQ’s Common FormatsAHRQ’s Common Formats

Standardize the patient safety Standardize the patient safety event information collectedevent information collected

– Common language & definitionsCommon language & definitions

– Standardized rules for data collectionStandardized rules for data collection

Allow aggregation of comparable Allow aggregation of comparable data at local, PSO, regional, & data at local, PSO, regional, & national levelsnational levels

Facilitate exchange of information, Facilitate exchange of information, learninglearning

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Design GoalsDesign Goals

Be driven by envisioned usesBe driven by envisioned uses– First use at point-of-careFirst use at point-of-care

– Roll up to PSO, regional, national levelsRoll up to PSO, regional, national levels

Based on evidence; scientifically supportableBased on evidence; scientifically supportable

Practical, intuitive, & usefulPractical, intuitive, & useful

As short & simple as possibleAs short & simple as possible

Permit controlled expansion / revisionPermit controlled expansion / revision

Conform, where possible, with accepted wisdom Conform, where possible, with accepted wisdom (e.g., CDC for HAIs, WHO-ICPS)(e.g., CDC for HAIs, WHO-ICPS)

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Framework and ScopeFramework and Scope

Limit initial scope to safety: preventing harm Limit initial scope to safety: preventing harm to patients from the delivery of health careto patients from the delivery of health care

Develop for specific delivery settings; begin Develop for specific delivery settings; begin with hospitalswith hospitals

Start with first phase of improvement cycle – Start with first phase of improvement cycle – the initial reportthe initial report

Construct in modulesConstruct in modules

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Common Formats ScopeCommon Formats Scope

Common Formats apply to all patient safety Common Formats apply to all patient safety concernsconcerns

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

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

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

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Modularized Common FormatsModularized Common Formats

Summary of Initial Report (SIR)• Assessment of preventability• Final narrative• Contributing factors• Encoding

Event-specific forms• Eight types of events, e.g.,• Fall• HAI• Medication

Patient information Form (PIF)• Demographics• Harm• Interventions

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Healthcare Event Reporting Form (HERF)• Identity• Date, Time• Location• Reporter• Narrative• Link to other forms

Healthcare Event Reporting Form (HERF)• Identity• Date, Time• Location• Reporter• Narrative• Link to other forms

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Common Formats:Common Formats:Revising and RefiningRevising and Refining

Common Formats 0.1 Beta released August 2008 Common Formats 0.1 Beta released August 2008 (prior to listing of first PSOs)(prior to listing of first PSOs)

National Quality Forum (NQF) process established to National Quality Forum (NQF) process established to solicit comments & provide advicesolicit comments & provide advice

– Over 900 comments received by NQFOver 900 comments received by NQF

– NQF Expert Panel analyzed comments, provided advice to NQF Expert Panel analyzed comments, provided advice to AHRQ during 2009AHRQ during 2009

AHRQ revised & refined Common Formats based AHRQ revised & refined Common Formats based upon advice from NQF & DHHS agencies; Version upon advice from NQF & DHHS agencies; Version 1.0 released on September 2, 20091.0 released on September 2, 2009

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Common Formats 1.0 HighlightsCommon Formats 1.0 Highlights

Refinement of 0.1 Beta based upon feedbackRefinement of 0.1 Beta based upon feedback

Event Descriptions added to clarify content & Event Descriptions added to clarify content & enable consistent approach to future revisionsenable consistent approach to future revisions

Content simplifiedContent simplified

Forms streamlinedForms streamlined

Key elements addedKey elements added

– Contributing factorsContributing factors

– Notation of Serious Reportable EventsNotation of Serious Reportable Events

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Common Formats 1.0 HighlightsCommon Formats 1.0 Highlights

ComponentsComponents

– Available now at: Available now at: http://www.psoppc.org Event Descriptions Event Descriptions

Paper forms to allow immediate implementationPaper forms to allow immediate implementation

A Users GuideA Users Guide

Quick Guide Quick Guide

– In developmentIn development Patient safety population reportsPatient safety population reports

Technical specificationsTechnical specifications

New

New

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Common Formats 1.0 HighlightsCommon Formats 1.0 Highlights

Event DescriptionsEvent Descriptions

– Outlines the precise information to be collectedOutlines the precise information to be collected

– Specifies the information desired for a particular event Specifies the information desired for a particular event categorycategory Definition, Scope, Risk Assessment / Preventive Actions, & Definition, Scope, Risk Assessment / Preventive Actions, &

CircumstancesCircumstances

Allows for easy location of content & comparison across different Allows for easy location of content & comparison across different event specific categoriesevent specific categories

– Facilitates the comment process for consideration of content Facilitates the comment process for consideration of content for future versions for future versions

– Supports multiple types of Common Formats implementationsSupports multiple types of Common Formats implementations

New

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Common Formats 1.0:Common Formats 1.0:Highlights of ChangesHighlights of Changes

Event Specific CategoriesEvent Specific Categories

– Blood or Blood ProductBlood or Blood Product

– Device or Medical / Surgical SupplyDevice or Medical / Surgical Supply

– FallFall

– Healthcare-Associated InfectionHealthcare-Associated Infection

– Medication or Other SubstanceMedication or Other Substance

– PerinatalPerinatal

– Pressure UlcerPressure Ulcer

– Surgery or AnesthesiaSurgery or Anesthesia

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Common Formats 1.0:Common Formats 1.0:Support MaterialsSupport Materials

Users Guide Users Guide

– Common Formats background information & Common Formats background information & guidance on use of paper formsguidance on use of paper forms

Quick GuideQuick Guide

– Brief directions for completing the formsBrief directions for completing the forms

– Graphical demonstration of module assembly Graphical demonstration of module assembly for complete reportfor complete report

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Feedback Process forFeedback Process forCommon Formats Evolution Common Formats Evolution

AHRQ seeing feedback to refine Common AHRQ seeing feedback to refine Common FormatsFormats

The National Quality ForumThe National Quality Forum

– Online tool to gather commentsOnline tool to gather comments

http://www.qualityforum.org

– Expert panel to provide adviceExpert panel to provide advice

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

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Next StepsNext Steps

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PSOs: Next StepsPSOs: Next Steps

Continue to list new PSOsContinue to list new PSOs

Provide technical assistanceProvide technical assistance

Hold 1Hold 1stst Annual Meeting of Annual Meeting of PSOsPSOs

– Scheduled for Scheduled for September 16-18, 2009 September 16-18, 2009 Rockville, MDRockville, MD

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Common Formats: Next StepsCommon Formats: Next Steps

Version 1.0 technical Version 1.0 technical specificationsspecifications

Future expansion to other Future expansion to other settings (e.g., long term settings (e.g., long term care)care)

Future extension to other Future extension to other improvement cycle phases improvement cycle phases (e.g., root cause analysis)(e.g., root cause analysis)

Continuing NQF assistanceContinuing NQF assistance

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Reporting: Next StepsReporting: Next Steps

First-level reportsFirst-level reports

– Standard population reports; can be used at Standard population reports; can be used at local, PSO, regional, & national levellocal, PSO, regional, & national level

Second-level reportsSecond-level reports

– Analysis of aggregated dataAnalysis of aggregated data Standard reportsStandard reports

Ad hoc reportsAd hoc reports

– Useful for safety experts, researchersUseful for safety experts, researchers

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NPSD: Next StepsNPSD: Next Steps

Information will be submitted using the Information will be submitted using the Common Formats (PSOs & other sources)Common Formats (PSOs & other sources)

Non-identifiable PSWP scheduled to be Non-identifiable PSWP scheduled to be accepted in 2010accepted in 2010

Findings from NPSD will be published in Findings from NPSD will be published in AHRQ’s annual National Healthcare Quality & AHRQ’s annual National Healthcare Quality & Disparities ReportsDisparities Reports

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The FutureThe Future

Based on experience to date, Common Formats are Based on experience to date, Common Formats are likely to be widely adopted in the US (& in some other likely to be widely adopted in the US (& in some other countries)countries)

Feedback to improve Formats will ensure that they are Feedback to improve Formats will ensure that they are cutting-edge & provide both clinical & electronic cutting-edge & provide both clinical & electronic interoperabilityinteroperability– EHRsEHRs

– Other reporting systemsOther reporting systems

Data aggregation, analysis, & learning will be markedly Data aggregation, analysis, & learning will be markedly accelerated, potentiating ability to make & measure accelerated, potentiating ability to make & measure progress in reducing riskprogress in reducing risk

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AHRQ’s VisionAHRQ’s Vision

A clear parallel exists between AHRQ’s patient A clear parallel exists between AHRQ’s patient safety activities & those that characterize PSOs’ safety activities & those that characterize PSOs’ long-term relationships with their providerslong-term relationships with their providers

– Identify risks & hazardsIdentify risks & hazards

– Design, test new safe practices / create new Design, test new safe practices / create new knowledgeknowledge

– Implement safe practicesImplement safe practices

– Maintain vigilance Maintain vigilance

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AHRQ’s VisionAHRQ’s Vision

Findings will be analyzed at PSO & Network Findings will be analyzed at PSO & Network of Patient Safety Databases levels toof Patient Safety Databases levels to

– Establish patient safety prioritiesEstablish patient safety priorities

– Stimulate research in needed areasStimulate research in needed areas

– Publish resultsPublish results

Results will be disseminated & implemented Results will be disseminated & implemented actively through the PSO networkactively through the PSO network

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AHRQ’s VisionAHRQ’s Vision

PSO data can contribute significantly to PSO data can contribute significantly to understanding the nature of risks & successful risk-understanding the nature of risks & successful risk-reduction strategiesreduction strategies

– Won’t support establishment of rates, true Won’t support establishment of rates, true benchmarking, or trendingbenchmarking, or trending

– But experience gained from providers & PSOs is But experience gained from providers & PSOs is interoperable & can be generalizedinteroperable & can be generalized

PSOs & their providers can enhance the culture of PSOs & their providers can enhance the culture of safety, accelerate learning, & support safer, higher safety, accelerate learning, & support safer, higher quality carequality care

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Your questions?Your questions?