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Patient Safety Organization: Why You Can’t Afford NOT to Participate!. Steve Love, president/CEO, Dallas-Fort Worth Hospital Council Kristin Jenkins, president, DFWHC Education and Research Foundation Starr West, senior director, policy analysis, Texas Hospital Association Oct. 8, 2009 .

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Patient Safety Organization: Why You Can’t Afford NOT to Participate!

Steve Love, president/CEO, Dallas-Fort Worth Hospital Council

Kristin Jenkins, president, DFWHC Education and Research Foundation

Starr West, senior director, policy analysis, Texas Hospital Association

Oct. 8, 2009

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Today’s Presentation

  • Educate on the purposes and functions of a PSO.

  • Introduce the opportunity to join a statewide PSO created as a partnership of the Texas Hospital Association and the Dallas Fort Worth Hospital Council Education and Research Foundation.

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Value to Participating in a PSO

  • Obtain federal protections for sharing of patient safety information outside your organization.

  • Benchmark your events with like hospitals.

  • Standardize and automate your incident reporting system.

  • Get assistance with preventing medical errors.

  • As a “charter” member help select executive director and vendor, establish bylaws and policies and procedures.

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The Patient Safety and Quality Improvement Act of 2005

  • Creates “Patient Safety Organizations” (PSOs).

  • Establishes “Network of Patient Safety Databases.”

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

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

  • Amends AHRQ’s enabling legislation.

    • AHRQ will administer program.

    • Office of Civil Rights will handle enforcement.

    • Program is voluntary.

  • Aims to improve safety by addressing:

    • Fear of malpractice litigation.

    • Inadequate protection by state laws.

    • Inability to aggregate data on a large scale for improvement analysis and information sharing in a protected environment .

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PSO Protections

Rather than a patchwork of state-by-state protections, there now will be national uniform confidentiality and privilege protections for clinicians and entities performing quality and safety activities.

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PSO Rulemaking

  • Final rule published in the Nov. 2, 2008, Federal Register; effective Jan. 19, 2009.

  • Entities seeking certification and listing as a PSO must complete a “Certification for Initial Listing” form.

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Final Rule Highlights

  • All PSOs

    • Expands on types of entity excluded from becoming PSOs.

    • Adds requirement that PSOs must notify affected providers of improper disclosure of “patient safety work product” and/or security breaches.

  • Component PSOs

    • Eliminates proposal for separate IT system from parent organization.

    • Eliminates general restriction on shared staff with parent for most PSOs.

    • Establishes new restrictions for component PSO whose parent is excluded from listing (e.g., no shared staff with parent).

  • Patient Safety Work Product

    • Permits a provider and PSO to establish a functional reporting system.

    • Provides protection when information is documented as collected within a “patient safety evaluation system” for reporting to a PSO.

    • Allows provider to document that information is being removed voluntarily from PSES and no longer is PSWP; provider then can use for other purposes.

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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 and licensing bodies

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

    • Mandatory public reporting systems

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Some of the First PSOs

  • California Hospital Patient Safety Organization

  • ECRI Institute PSO

  • Florida Patient Safety Corporation

  • Institute for Safe Medication Practices

  • Kentucky Institute for Patient Safety and Quality

  • Quantros Patient Safety Center

  • University Healthsystem Consortium

  • PSOs currently exist in 26 states and the District of Columbia

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PSOs: Patient Safety Work Product

  • PSWP is any data:

    • Developed by a provider and reported to a PSO

    • That identifies or constitutes deliberations of or the fact of reporting pursuant to a patient safety evaluation system, or

    • Developed by a PSO for the conduct of patient safety activities

    • Protected when information is documented as collected within a “patient safety evaluation system” for reporting to a PSO

  • Original provider records (e.g., medical record, billing information) are not PSWP

  • Non-identifiable PSWP is not confidential or privileged

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Reporting Patient Safety Events Activities?

  • Statutory and regulatory reporting requirements

  • The Network of Patient Safety Databases (NPSD)

  • Common Formats for patient safety event reporting

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Reporting Requirements Activities?

  • PSO participation is voluntary, but for participating PSOs and providers:

    • 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.

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Patient Safety Event Data Activities?

  • Collection of standardized information is essential to allow:

    • “Reporting for learning” on a large scale, one of the primary objectives of the legislation

    • Comparisons

    • Trending

  • Aggregation will occur at several levels

    • Provider (e.g., hospital)

    • PSO

    • NPSD

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Network of Patient Safety Databases Activities?

  • Provides benchmarks and baselines for measurement.

  • Disseminates results, best practices.

  • Conducts analyses for the National Healthcare Quality Reports.

  • Develops a Web-based evidence-based management resource to support research.

  • Provides technical assistance as needed.

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Common Formats Activities?

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Data Flows: Activities?Providers, PSOs and PSWP




AHRQ National

Quality Reports















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Common Formats Activities?

  • PSOs will collect, aggregate and analyze information on quality and safety of care.

  • Statute authorizes collection of this information in a standardized manner.

    • Common Formats

  • Common Formats apply at the “point of care,” which is essential for assuring collection of the specified information at the time it is available.

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Why Common Formats? Activities?

  • Standardize the patient safety event information collected.

    • Common language and definitions

    • Common style/format for data elements

  • Facilitate shared learning.

  • Allow for trend and pattern comparisons – local, regional and national.

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How Were Common Formats Created? Activities?

  • AHRQ built an inventory of 66 current patient safety event reporting systems

    • Reporting forms, data elements and definitions

    • Public and private systems included

  • Inventory findings:

    • Variability across different systems

      • Different representation of same patient safety events, e.g., surgical adverse event

      • Variability in recording common elements:

        • Location, facility, etc.

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Common Format Development Activities?

  • Developed initial common formats with federal agencies with reporting systems (CDC, FDA, DoD, IHS, NIH, VA).

    • Federal subject matter experts

    • Iterative process

  • Conducted two pilot tests in hospitals.

  • Published notice of availability of Common Formats, Version 0.1 Beta, in Federal Register on Aug. 29.

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Design Goals Activities?

  • Be as short and simple as possible

    • Functional

    • Flexible

    • Usable with existing workflows

  • Comprehensive in capturing all event types

  • Use existing definitions and data elements to the extent consistent with conceptual requirements

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Design Goals Activities?

  • Construct in modules

    • Those concerns that apply to all events being reported, e.g., who, what, when, where

    • Those concerns that pertain to specific types of events, e.g., falls, medication errors

  • Specify requirements adequately to support software system development

  • Put processes in place to enhance and expand

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Common Formats Scope Activities?

  • 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

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Components of Initial Common Format Event Reporting Activities?

Currently available event-specific forms include:

  • Anesthesia

  • Blood, Tissue, Organ Transplantation or Gene Therapy

  • Device & Medical or Surgical Supply

  • Fall

  • Health Care-Associated Infection

  • Medication and Other Substances

  • Perinatal

  • Pressure Ulcer

  • Surgical and Other Invasive Procedure (except Perinatal)

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

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Common Formats - Future Steps Activities?

  • Expanded and enhanced versions based on user feedback

    • Expansion to other settings

    • Expansion to other topic areas of patient safety events

    • Complete remaining phases of quality cycle (e.g., root cause analysis)

  • Annual updates and revisions

    (2010 & beyond)

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PSO Technical Assistance Activities?

  • PSO Privacy Protection Center

    • Technical assistance for PSOs

  • Two major areas of activity

    • De-identification of Patient Safety Work Product

    • Technical assistance with use of the Common Formats

  • PPC contract awarded to the Iowa Foundation for Medical Care

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Measuring ROI Activities?

  • Benchmark your events with like hospitals. How much are quality/patient safety issues costing your hospital? How much can you save by improving?

  • What would it cost to standardize and automate your incident reporting system? How much do you save through the PSO?

  • What cost savings have been achieved by avoiding potential medical errors associated with procedures, medications, equipment, etc? How much do you save by reducing length-of-stay?

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Next Steps Activities?

  • Letter of Intent by Nov. 1


  • For more information, contact:

    • Kristen Jenkins @ or 469/648-5016

    • Starr West @ or 512/465-1042

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Your questions? Activities?