Advancing Safety and Quality: Advancing Safety and Quality: Supporting Patient Safety Supporting Patient Safety Organizations and Reducing Organizations and Reducing Risks to Patients Risks to Patients William B. Munier, MD, MBA William B. Munier, MD, MBA Amy Helwig, MD, MS Amy Helwig, MD, MS Diane Cousins, RPh Diane Cousins, RPh Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Center for Quality Improvement and Patient Safety Center for Quality Improvement and Patient Safety September 14 & 16 AHRQ Annual Conference September 14 & 16 AHRQ Annual Conference
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Advancing Safety and Quality: Supporting Patient Safety Organizations and Reducing Risks to Patients William B. Munier, MD, MBA Amy Helwig, MD, MS Diane.
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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
• 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
– 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
– 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
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 [email protected]
– 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
– 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
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
– 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)
– 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
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
– 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