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Advancing Safety and Quality: Supporting Patient Safety Organizations (Text Version)

Slide presentation from the AHRQ 2009 conference.

On September 16, 2009, William B. Munier, Amy Helwig, and Diane Cousins made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (853 KB).

Slide 1

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

Slide 2


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

Slide 3

The Patient Safety and Quality Improvement Act of 2005

  • Creates "Patient Safety Organizations" (PSOs)
  • Establishes "Network of Patient Safety Databases" (NPSD)
  • Authorizes establishment of "Common Formats" for reporting patient safety events
  • Requires reporting of findings annually in AHRQ's National Health Quality / Disparities Reports

Slide 4

The Patient Safety Act

  • 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
    • AHRQ administers the program
    • Office for Civil Rights handles enforcement
    • Program is voluntary

Slide 5

Alignment with AHRQ's Vision

  • 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
  • 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

Slide 6

PSO Operations

Slide 7

Listing PSOs

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

Slide 8

PSOs in 26 States and the District of Columbia

Each shaded state on this map is the home of at least one PSO. All PSOs can operate nationwide regardless of their home state.

Image: An image of the United States is shown with the 26 states with PSOs highlighted.

Slide 9

Program Interest is High

  • Nearly 22,000 subscribers to AHRQ's PSO Listserv
  • 3,500 + visits to the AHRQ PSO Web site on average each month

Slide 10

PSO Status

  • 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

Slide 11

Who Can be a PSO?

  • Eligible organizations
    • Any public or private entity / component
    • Any for-profit or not-for-profit / component
  • 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

Slide 12

PSOs: Becoming a PSO

  • Entities seeking listing must complete a "Certification for Initial Listing" form
  • 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
  • Funding: no Federal funding from AHRQ, but technical assistance without charge
  • Provider Choice of PSO: voluntary, marketplace assessment

Slide 13

Some of the First PSOs

  • UHC Clinical Practice Advancement Center
  • ECRI Institute PSO
  • Florida Patient Safety Corporation
  • Institute for Safe Medication Practices (ISMP)
  • Kentucky Institute for Patient Safety and Quality
  • California Hospital Patient Safety Organization
  • Premier Patient Safety Organization

Slide 14

PSO Activities

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

Slide 15

Potential Concerns

  • 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"

Slide 16

Potential Concerns

  • 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
    • Not discrete geographically
    • Voluntary, spontaneous reporting

Slide 17

How Do Providers Benefit From Working With A PSO?

  • Receive uniform Federal confidentiality & privilege protections
  • 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
    • PSO level
    • PSO to PSO analysis & sharing
    • NPSD

Slide 18

Key Questions Providers Should Ask A PSO

  • 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?
  • 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?

Slide 19

Key Questions Providers Should Ask A PSO

  • Will the PSO help me set up a patient safety evaluation system?
  • How will my patient safety work product be protected at the PSO?
  • Does the PSO work with the NPSD?

Slide 20

AHRQ Compliance Reviews

  • Planned to begin in 2010
  • Designed so that each PSO is subject to a compliance review at least every 6 years
  • Will include:
    • A request to inspect a PSO's required documentation for patient safety activities
    • Review of documentation at AHRQ
    • A site visit

Slide 21

"Patient Safety Organizations: A Compliance Self-Assessment Guide"

1st Annual PSO Meeting

  • Intent: Assist entities in making the required attestations, & PSOs in preparing for a compliance review
  • Approach: Sample questions to encourage each PSO to take a thorough & systematic approach to compliance
  • Context: Questions illustrative, do not apply to every PSO, & do not establish new standards or requirements beyond those established by the Patient Safety Rule

Slide 22

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)
  • 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

Slide 23

Common Formats

Slide 24

Data Flow: Provider to PSO to NPSD to User

Flowchart: A flowchart of the Provider to PSO to NPSD to User is shown.

Slide 25

PSO Requirements

  • 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

Slide 26

AHRQ's Common Formats

  • 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
  • Facilitate exchange of information, learning

Image of the AHRQ Common Formats logo is shown to the right of the text.

Slide 27

Design Goals

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

Slide 28

Framework and Scope

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

Slide 29

Common Formats 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

Slide 30

Modularized Common Formats

Healthcare Event Reporting Form (HERF)

  • Identity
  • Date, Time
  • Location
  • Reporter
  • Narrative
  • Link to other forms
Patient information Form (PIF)
  • Demographics
  • Harm
  • Interventions
Event-specific forms
  • Eight types of events, e.g.,
  • Fall
  • HAI
  • Medication
Summary of Initial Report (SIR)
  • Assessment of preventability
  • Final narrative
  • Contributing factors
  • Encoding

Slide 31

Common Formats: Revising and Refining

  • 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
    • 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

Slide 32

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
  • Content simplified
  • Forms streamlined
  • Key elements added
    • Contributing factors
    • Notation of Serious Reportable Events

Slide 33

Common Formats 1.0 Highlights

  • Components
    • Available now at:
      • Event Descriptions (New)
      • Paper forms to allow immediate implementation
      • A Users Guide
      • Quick Guide (New)
    • In development
      • Patient safety population reports
      • Technical specifications

Slide 34

Common Formats 1.0 Highlights

  • Event Descriptions (New)
    • Outlines the precise information to be collected
    • Specifies the information desired for a particular event category
      • Definition, Scope, Risk Assessment / Preventive Actions, & Circumstances
      • 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

Slide 35

Common Formats 1.0: Highlights of Changes

  • 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

Slide 36

Common Formats 1.0: Support Materials

  • Users Guide
    • Common Formats background information & guidance on use of paper forms
  • Quick Guide
    • Brief directions for completing the forms
    • Graphical demonstration of module assembly for complete report

Slide 37

Feedback Process for Common Formats Evolution

  • AHRQ seeing feedback to refine Common Formats
  • The National Quality Forum
  • Process will be a continuing one, guiding periodic updates of the Common Formats

Slide 38

Next Steps

Slide 39

PSOs: Next Steps

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

Slide 40

Common Formats: Next Steps

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

Slide 41

Reporting: Next Steps

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

Slide 42

NPSD: Next Steps

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

Slide 43

The Future

  • 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
    • EHRs
    • Other reporting systems
  • Data aggregation, analysis, & learning will be markedly accelerated, potentiating ability to make & measure progress in reducing risk

Slide 44

AHRQ's Vision

  • 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

Slide 45

AHRQ's Vision

  • 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

Slide 46

AHRQ's Vision

  • 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

Slide 47

Your questions?

Current as of December 2009
Internet Citation: Advancing Safety and Quality: Supporting Patient Safety Organizations (Text Version). December 2009. Agency for Healthcare Research and Quality, Rockville, MD.


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