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

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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

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

today s presentati on
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.
value to participating in a pso
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.
the patient safety and quality improvement act of 2005
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 .
pso protections
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.

pso rulemaking
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.
final rule highlights
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.
who can be a pso
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
some of the first psos
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
psos patient safety work product
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
reporting patient safety events
Reporting Patient Safety Events
  • Statutory and regulatory reporting requirements
  • The Network of Patient Safety Databases (NPSD)
  • Common Formats for patient safety event reporting
reporting requirements
Reporting Requirements
  • 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.
patient safety event data
Patient Safety Event Data
  • 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
network of patient safety databases
Network of Patient Safety Databases
  • 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.
data flows providers psos and pswp
Data Flows: Providers, PSOs and PSWP




AHRQ National

Quality Reports















common formats
Common Formats
  • 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.
why common formats
Why Common Formats?
  • 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.
how were common formats created
How Were Common Formats Created?
  • 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.
common format development
Common Format Development
  • 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.
design goals
Design Goals
  • 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
design goals24
Design Goals
  • 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
common formats scope
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
components of initial common format event reporting
Components of Initial Common Format Event Reporting

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.

common formats future steps
Common Formats - Future Steps
  • 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)

pso technical assistance
PSO Technical Assistance
  • 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
measuring roi
Measuring ROI
  • 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?
next steps
Next Steps