Patient Safety Organization: Why You Can

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Patient Safety Organization Why You Cant
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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Todays 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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• PSO Orientation

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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 AHRQs
  National Health Quality/Disparities Reports.
• Amends AHRQs 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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How Does the Patient Safety Evaluation System Fit
with QI Activities?
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Reporting Patient Safety Events

• 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

• 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

• 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

• 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

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Data Flows Providers, PSOs and PSWP
Provider
Provider
Provider
AHRQ National Quality Reports
PSO
User PSO
PPC
NPSD
PSO
User Provider
PSO
User Researchers
Other Qualified Sources
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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.

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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.

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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.

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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.

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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

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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

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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

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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.

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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)

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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

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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?

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Next Steps

• Letter of Intent by Nov. 1
• www.tha.org/pso
• For more information, contact
• Kristen Jenkins _at_ kjenkins_at_dwfhc.org or
  469/648-5016
• Starr West _at_ swest_at_tha.org or 512/465-1042

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Your questions?