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

2 Agenda Patient Safety Act Patient Safety Act PSO Operations PSO Operations Common Formats Common Formats Next Steps Next Steps Q & A Q & A

3 The Patient Safety and Quality Improvement Act of 2005 Creates “Patient Safety Organizations” (PSOs) Creates “Patient Safety Organizations” (PSOs) Establishes “Network of Patient Safety Databases” (NPSD) Establishes “Network of Patient Safety Databases” (NPSD) Authorizes establishment of “Common Formats” for reporting patient safety events Authorizes establishment of “Common Formats” for reporting patient safety events Requires reporting of findings annually in AHRQ’s National Health Quality / Disparities Reports Requires reporting of findings annually in AHRQ’s National Health Quality / Disparities Reports

4 The Patient Safety Act Aims to improve safety by addressing Aims to improve safety by addressing – Fear of malpractice litigation – Inadequate protection by state laws – Inability to aggregate data on a large scale Amends AHRQ’s enabling legislation Amends AHRQ’s enabling legislation – AHRQ administers the program – Office for Civil Rights handles enforcement – Program is voluntary

5 Alignment with AHRQ’s Vision The PSO program is integrated with other AHRQ responsibilities The PSO program is integrated with other AHRQ responsibilities PSO operations align with the spectrum of AHRQ’s patient safety / quality improvement research, tools, & initiatives PSO operations align with the spectrum of AHRQ’s patient safety / quality improvement research, tools, & initiatives PSOs represent a unique opportunity for both “real world” input into AHRQ’s work & a potentially significant “effector” arm for AHRQ’s tools, training programs, & research findings PSOs represent a unique opportunity for both “real world” input into AHRQ’s work & a potentially significant “effector” arm for AHRQ’s tools, training programs, & research findings

6 PSO Operations

7 Listing PSOs AHRQ began listing PSOs under Interim Guidance - Oct 2008 AHRQ began listing PSOs under Interim Guidance - Oct 2008 Final rule published in the Nov 21 st, 2008 Federal Register; effective Jan 19 th, 2009 Final rule published in the Nov 21 st, 2008 Federal Register; effective Jan 19 th, PSOs “listed” by AHRQ as of Sept 16 th ; complete list at 68 PSOs “listed” by AHRQ as of Sept 16 th ; complete list at

8 PSOs in 26 States and the District of Columbia

9 Program Interest is High Nearly 22,000 subscribers to AHRQ’s PSO Listserv Nearly 22,000 subscribers to AHRQ’s PSO Listserv 3,500 + visits to the AHRQ PSO Web site on average each month 3,500 + visits to the AHRQ PSO Web site on average each month

10 PSO Status Because of provisions in the statute, reflected in the final rule, PSOs develop spontaneously; no master plan can be required Because of provisions in the statute, reflected in the final rule, PSOs develop spontaneously; no master plan can be required – PSOs are voluntary – Provider participation is voluntary – Subject matter covered is voluntary – Reporting to the NPSD is voluntary These conditions limit what AHRQ can expect in terms of PSO coverage & utility of data These conditions limit what AHRQ can expect in terms of PSO coverage & utility of data

11 Who Can be a PSO? Eligible organizations Eligible organizations – Any public or private entity / component – Any for-profit or not-for-profit / component Ineligible organizations Ineligible organizations – Health insurance issuers or their components – Accrediting & licensing bodies – Entities that regulate providers, including their agents (e.g., QIOs) – Mandatory public reporting systems

12 PSOs: Becoming a PSO Entities seeking listing must complete a “Certification for Initial Listing” form Entities seeking listing must complete a “Certification for Initial Listing” form – Available on AHRQ’s PSO Web site Application: a simple process of attestation Application: a simple process of attestation – Compliance with requirements ensured by spot checks – Entities 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 assistance without charge Funding: no Federal funding from AHRQ, but technical assistance without charge Provider Choice of PSO: voluntary, marketplace assessment Provider Choice of PSO: voluntary, marketplace assessment

13 Some of the First PSOs UHC Clinical Practice Advancement Center UHC Clinical Practice Advancement Center ECRI Institute PSO ECRI Institute PSO Florida Patient Safety Corporation Florida Patient Safety Corporation Institute for Safe Medication Practices (ISMP) Institute for Safe Medication Practices (ISMP) Kentucky Institute for Patient Safety and Quality Kentucky Institute for Patient Safety and Quality California Hospital Patient Safety Organization California Hospital Patient Safety Organization Premier Patient Safety Organization Premier Patient Safety Organization

14 PSO Activities Collect, analyze patient safety (PS) data Collect, analyze patient safety (PS) data Assist providers to improve quality & safety Assist providers to improve quality & safety Develop & disseminate PS information Develop & disseminate PS information Encourage culture of safety & minimize patient risk Encourage culture of safety & minimize patient risk Provide feedback to participants Provide feedback to participants Maintain confidentiality & security of data Maintain confidentiality & security of data

15 Potential Concerns Relationship to other reporting requirements Relationship to other reporting requirements – Mandatory state reporting – CDC’s NHSN for healthcare-associated infections – FDA reporting – Other systems Desire for one-time reporting & the elusive “interoperability” Desire for one-time reporting & the elusive “interoperability”

16 Potential Concerns Challenges inherent in patient safety reporting Challenges inherent in patient safety reporting – Uneven detection / surveillance – Lack of defined populations: denominators – Different cultures / styles of operation – Different definitions, scope, formats Challenges with PSO framework Challenges with PSO framework – Not discrete geographically – Voluntary, spontaneous reporting

17 How Do Providers Benefit From Working With A PSO? Receive uniform Federal confidentiality & privilege protections Receive uniform Federal confidentiality & privilege protections Gain protection for analysis beyond the initial report (e.g., root cause analysis) Gain protection for analysis beyond the initial report (e.g., root cause analysis) – In provider’s patient safety evaluation system or the PSO’s – Shared learning within the provider’s system Benefit from aggregation Benefit from aggregation – PSO level – PSO to PSO analysis & sharing – NPSD

18 Key Questions Providers Should Ask A PSO Does the PSO specialize or limit to a specific content area? Does the PSO specialize or limit to a specific content area? – Topic specialization (e.g., medical devices, medications, pediatric anesthesia, etc.) – Geographical focus What types of analysis & service does the PSO provide? What types of analysis & service does the PSO provide? Does the PSO use consultants or services of another PSO? Does the PSO use consultants or services of another PSO? – Will I be consulted before the PSO shares my patient safety data with external consultants?

19 Key Questions Providers Should Ask A PSO Will the PSO help me set up a patient safety evaluation system? Will the PSO help me set up a patient safety evaluation system? How will my patient safety work product be protected at the PSO? How will my patient safety work product be protected at the PSO? Does the PSO work with the NPSD? Does the PSO work with the NPSD?

20 Provider Notification of PSO Change in Status AHRQ has established a process to notify health care providers when the status of a listed PSO changes (e.g., delisting) AHRQ has established a process to notify health care providers when the status of a listed PSO changes (e.g., delisting) To request notification about a change in status of a specific PSO, please send an e- mail to To request notification about a change in status of a specific PSO, please send an e- mail to – Specify the PSO(s) about which you would like to be notified

21 Common Formats

22 PSO Data Flow: Provider to PSO to NPSD to User PPC PSO NPSD Other Qualified Sources AHRQ National Quality Reports User: Researchers User: PSO User: Provider

23 PSO Requirements PSOs & providers analyze patient safety data PSOs & providers analyze patient safety data – PSOs are required to collect information that allows comparison of “similar events among similar providers” – “Common Formats” have been made available by AHRQ, acting for the Secretary of HHS, to assist PSOs to meet this requirement – At recertification, PSOs will be required to state how they meet the requirement

24 AHRQ’s Common Formats Standardize the patient safety event information collected Standardize the patient safety event information collected – Common language & definitions – Standardized rules for data collection Allow aggregation of comparable data at local, PSO, regional, & national levels Allow aggregation of comparable data at local, PSO, regional, & national levels Facilitate exchange of information, learning Facilitate exchange of information, learning

25 Design Goals Be driven by envisioned uses Be driven by envisioned uses – First use at point-of-care – Roll up to PSO, regional, national levels Based on evidence; scientifically supportable Based on evidence; scientifically supportable Practical, intuitive, & useful Practical, intuitive, & useful As short & simple as possible As short & simple as possible Permit controlled expansion / revision Permit controlled expansion / revision Conform, where possible, with accepted wisdom (e.g., CDC for HAIs, WHO-ICPS) Conform, where possible, with accepted wisdom (e.g., CDC for HAIs, WHO-ICPS)

26 Framework and Scope Limit initial scope to safety: preventing harm to patients from the delivery of health care Limit initial scope to safety: preventing harm to patients from the delivery of health care Develop for specific delivery settings; begin with hospitals Develop for specific delivery settings; begin with hospitals Start with first phase of improvement cycle – the initial report Start with first phase of improvement cycle – the initial report Construct in modules Construct in modules

27 Common Formats Scope Common Formats apply to all patient safety concerns 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

28 Modularized 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 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

29 Common Formats: Revising and Refining Common Formats 0.1 Beta released August 2008 (prior to listing of first PSOs) Common Formats 0.1 Beta released August 2008 (prior to listing of first PSOs) National Quality Forum (NQF) process established to solicit comments & provide advice National Quality Forum (NQF) process established to solicit comments & provide advice – Over 900 comments received by NQF – NQF Expert Panel analyzed comments, provided advice to AHRQ during 2009 AHRQ revised & refined Common Formats based upon advice from NQF & DHHS agencies; Version 1.0 released on September 2, 2009 AHRQ revised & refined Common Formats based upon advice from NQF & DHHS agencies; Version 1.0 released on September 2, 2009

30 Common Formats 1.0 Highlights Refinement of 0.1 Beta based upon feedback Event Descriptions added to clarify content & enable consistent approach to future revisions Event Descriptions added to clarify content & enable consistent approach to future revisions Content simplified Content simplified Forms streamlined Forms streamlined Key elements added Key elements added – Contributing factors – Notation of Serious Reportable Events

31 Common Formats 1.0 Highlights Components Components – Available now at: Event Descriptions Event Descriptions Paper forms to allow immediate implementation Paper forms to allow immediate implementation A Users Guide A Users Guide Quick Guide Quick Guide – In development Patient safety population reports Patient safety population reports Technical specifications Technical specifications New

32 Common Formats 1.0 Highlights Event Descriptions Event Descriptions – Outlines the precise information to be collected – Specifies the information desired for a particular event category Definition, Scope, Risk Assessment / Preventive Actions, & Circumstances Definition, Scope, Risk Assessment / Preventive Actions, & Circumstances Allows for easy location of content & comparison across different event specific categories Allows for easy location of content & comparison across different event specific categories – Facilitates the comment process for consideration of content for future versions – Supports multiple types of Common Formats implementations New

33 Common Formats 1.0: Highlights of Changes Event Specific Categories Event Specific Categories – Blood or Blood Product – Device or Medical / Surgical Supply – Fall – Healthcare-Associated Infection – Medication or Other Substance – Perinatal – Pressure Ulcer – Surgery or Anesthesia

34 Common Formats 1.0: Support Materials Users Guide Users Guide – Common Formats background information & guidance on use of paper forms Quick Guide Quick Guide – Brief directions for completing the forms – Graphical demonstration of module assembly for complete report

35 Feedback Process for Common Formats Evolution AHRQ seeing feedback to refine Common Formats AHRQ seeing feedback to refine Common Formats The National Quality Forum The National Quality Forum – Online tool to gather comments – Expert panel to provide advice Process will be a continuing one, guiding periodic updates of the Common Formats Process will be a continuing one, guiding periodic updates of the Common Formats

36 Next Steps

37 PSOs: Next Steps Continue to list new PSOs Continue to list new PSOs Provide technical assistance Provide technical assistance Hold 1 st Annual Meeting of PSOs Hold 1 st Annual Meeting of PSOs – Scheduled for September 16-18, 2009 Rockville, MD

38 Common Formats: Next Steps Version 1.0 technical specifications Version 1.0 technical specifications Future expansion to other settings (e.g., long term care) Future expansion to other settings (e.g., long term care) Future extension to other improvement cycle phases (e.g., root cause analysis) Future extension to other improvement cycle phases (e.g., root cause analysis) Continuing NQF assistance Continuing NQF assistance

39 Reporting: Next Steps First-level reports First-level reports – Standard population reports; can be used at local, PSO, regional, & national level Second-level reports Second-level reports – Analysis of aggregated data Standard reports Standard reports Ad hoc reports Ad hoc reports – Useful for safety experts, researchers

40 NPSD: Next Steps Information will be submitted using the Common Formats (PSOs & other sources) Information will be submitted using the Common Formats (PSOs & other sources) Non-identifiable PSWP scheduled to be accepted in 2010 Non-identifiable PSWP scheduled to be accepted in 2010 Findings from NPSD will be published in AHRQ’s annual National Healthcare Quality & Disparities Reports Findings from NPSD will be published in AHRQ’s annual National Healthcare Quality & Disparities Reports

41 The Future Based on experience to date, Common Formats are likely to be widely adopted in the US (& in some other countries) Based on experience to date, Common Formats are likely to be widely adopted in the US (& in some other countries) Feedback to improve Formats will ensure that they are cutting-edge & provide both clinical & electronic interoperability Feedback to improve Formats will ensure that they are cutting-edge & provide both clinical & electronic interoperability – EHRs – Other reporting systems Data aggregation, analysis, & learning will be markedly accelerated, potentiating ability to make & measure progress in reducing risk Data aggregation, analysis, & learning will be markedly accelerated, potentiating ability to make & measure progress in reducing risk

42 AHRQ’s Vision A clear parallel exists between AHRQ’s patient safety activities & those that characterize PSOs’ long-term relationships with their providers A clear parallel exists between AHRQ’s patient safety activities & those that characterize PSOs’ long-term relationships with their providers – Identify risks & hazards – Design, test new safe practices / create new knowledge – Implement safe practices – Maintain vigilance

43 AHRQ’s Vision Findings will be analyzed at PSO & Network of Patient Safety Databases levels to Findings will be analyzed at PSO & Network of Patient Safety Databases levels to – Establish patient safety priorities – Stimulate research in needed areas – Publish results Results will be disseminated & implemented actively through the PSO network Results will be disseminated & implemented actively through the PSO network

44 AHRQ’s Vision PSO data can contribute significantly to understanding the nature of risks & successful risk-reduction strategies PSO data can contribute significantly to understanding the nature of risks & successful risk-reduction strategies – Won’t support establishment of rates, true benchmarking, or trending – But experience gained from providers & PSOs is interoperable & can be generalized PSOs & their providers can enhance the culture of safety, accelerate learning, & support safer, higher quality care PSOs & their providers can enhance the culture of safety, accelerate learning, & support safer, higher quality care

45 Your questions?