General PSO Update

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General PSO Update

• AHRQ Annual Conference 2008
• Amy Helwig, MD, MS
• William B Munier, MD, MBA
• Larry Patton
• 8 September 2008

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Presentation Organization

• Moderator Amy Helwig
• PSO Status Bill Munier
• PSO Operations Larry Patton

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Overview of PSO Sessions

• Sunday
• Common Formats Workshop
• Monday
• Confidentiality, PSWP, the PSOs
• General PSO Update
• PSO Status
• PSO Operations
• Tuesday
• 8 am Common Format Mini I Brookside A B
• 10 am Common Fmt Mini II Middlebrook
• 1 pm Common Fmt Mini III Brookside A B

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Presentation Organization

• Moderator Amy Helwig
• PSO Status Bill Munier
• PSO Operations Larry Patton

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Medical Errors in History

• In my opinion, physicians kill as many people
  as we generals.
• Napoleon Bonaparte

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Progress?

• The only two wins we are sure of are
• Removal of concentrated KCl from the floors
• Introduction of infusion devices to eliminate
  free-flow IVs in hospitals.
• Dennis OLeary, CEO, Joint
• Commission June 1, 2007

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The Patient Safety and Quality Improvement Act of
2005

• Encourages formation of PSOs to improve the
  quality safety of health care
• AHRQ will administer rules for listing qualified
  PSOs
• HHS Office for Civil Rights will be responsible
  for enforcing confidentiality

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• Rather than a patchwork of state-by-state
  protections, there will now be national uniform
  protections that is, confidentiality privilege
  for clinicians entities performing patient
  safety activities

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Proposed Patient Safety Regulation

• PSOs will provide feedback to clinicians health
  care organizations on improving safety
• The Act does not relieve clinicians or health
  care organizations from meeting reporting
  requirements under Federal, state, or local laws
• The proposed rule (NPRM) was published
• in the February 12th Federal Register
• comment period ended April 14th
• 150 comments received many very
• detailed

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Regulations Process
HHS Completes Draft Regulations
OMB Reviews
NPRM Published
Comments Accepted HHS Revises
OMB Review (of revisions)
Final Rule Published
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Patient Safety Organizations (PSOs)
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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
• Statute prohibits health insurance issuer or
  component of health insurance issuer
• NPRM proposes prohibiting any public or private
  entity that regulates providers
• e.g., The Joint Commission

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Potential PSO Sponsors

• Hospital associations
• Hospital chains
• Medical societies
• Specialty societies
• Group practices
• Newly-created organizations
• Others

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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

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Network of Patient Safety Databases (NPSD)
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NPSD

• Provides benchmarks 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

• PSOs will collect, aggregate, analyze
  information on quality safety of care
• Statute authorizes collection of this information
  in a standardized manner
• Common Formats are now available
• Allow aggregation of comparable data at local,
  PSO, national level
• Facilitate the exchange of information
• Underlie the ability to compare learn

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• Common Formats can provide a common language for
  patient safety reporting across the nation

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Common FormatsDevelopment Cycle

• Formats will not be subject to
• Federal regulatory processes
• NQF formal consensus process
• Formats will
• Be updated annually as guidance
• Have tight version control
• Formats are
• Currently limited to the hospital setting
• Planned for additional settings

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Presentation Organization

• Moderator Amy Helwig
• PSO Status Bill Munier
• PSO Operations Larry Patton

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PSOs The Basics

• Providers are NOT required to work with PSOs
• Providers are NOT required to enter contracts
  with PSOs to obtain protections (but note HIPAA
  Privacy Rule requires business associate
  agreement if provider is a covered entity and
  shares PHI with a PSO)
• While AHRQ will list PSOs for the Secretary, PSOs
  will not receive funding from AHRQ AHRQ will
  provide technical assistance
• AHRQs regulatory authority only extends to PSOs
  AHRQ will not regulate providers that work with
  PSOs

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PSOs AHRQ Approach

• Streamlined process of simple attestation spot
  checks to ensure compliance with requirements and
  entities are subject to penalties for false
  statements
• Expect marketplace will assess worth of a PSO
  Proposed rule emphasizes transparency /
  disclosure to enable providers to make those
  decisions
• Proposed rule emphasizes technical assistance and
  a non-adversarial approach whenever possible to
  promoting compliance by PSOs with the criteria
  they must meet but if a PSO fails to correct
  deficiencies, the NPRM gives AHRQ the authority
  to take action

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Subpart BPSO Portion of the Rule

• 3.102 - Process and Requirements for Initial
  and Continued Listing
• 3.104 - Secretarial Actions
• 3.106 - Security Requirements
• 3.108 - Correction of Deficiencies, Revocation,
  and Voluntary Relinquishment
• 3.110 - Assessment of PSO Compliance
• 3.112 - Submissions and Forms

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PSOs Listing Requirements

• 15 Statutory Requirements
• 8 Patient Safety Activities (PSAs)
• 7 Criteria
• Initial listing policies procedures in place
  to perform 8 PSAs and will meet 7 criteria upon
  listing
• Seeking continued listing are performing/will
  continue to perform all 8 PSAs and complying
  with/will continue to comply with 7 criteria
• 18 Statutory Requirements for Component PSOs
• 3 additional requirements

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PSOs Remaining a PSO

• Listing is for 3-year renewable periods
• BUT statute includes a requirement that every 24
  months a PSO must demonstrate that it has bona
  fide contracts with more than 1 provider
• Proposed rule would require 2 contracts to meet
  that test

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Confidentiality

• The statute provides federal confidentiality and
  privilege protections to patient safety work
  product (PSWP) and specifies when disclosures are
  permitted
• Confidentiality and privilege protections
  continue after disclosure, with limited
  exceptions
• PSWP may contain protected health information
  (PHI) requiring covered providers to also comply
  with the HIPAA Privacy Rule requirements

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Patient Safety Work Product

• PSWP is any data
• Developed by a provider and reported to a PSO
• Developed by a PSO for the conduct of patient
  safety activities, or
• That identifies or constitutes deliberations of
  or the fact of reporting pursuant to a patient
  safety evaluation system
• Original provider records (e.g., medical,
  billing) are not PSWP
• Non-identifiable PSWP is not confidential or
  privileged

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Confidentiality Protections Implications for
Providers

• The Patient Safety Acts confidentiality
  protections have the potential to significantly
  expand provider-based patient safety initiatives
• The proposed rule does NOT impose specific
  requirements on providers within the framework
  of rule, providers have great flexibility on how
  to operate and develop systems to meet their
  needs
• But there are a number of issues that providers
  need to consider

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Confidentiality Implications for Providers

• External Reporting Statute does not relieve a
  provider of obligations under other laws or
  regulations that require external reporting of
  information those requirements must be met with
  information that is NOT protected (not PSWP)
• Internal Use of PSWP within the legal entity of a
  provider is NOT a disclosure but consider
• Any holder of PSWP can make disclosures
• Intersection with credentialing or disciplinary
  actions
• If provider is covered entity, disclosures must
  meet HIPAA and Patient Safety Act requirements

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Your questions?