General PSO Update

Slide Presentation from the AHRQ 2008 Annual Conference

On September 8, 2008, Amy Helwig, MD, MS; William B. Munier, MD, MBA; and Larry Patton, made this presentation at the 2008 Annual Conference. Select to access the PowerPoint® presentation (265 KB).

Slide 1

General Patient Safety Organization (PSO) Update

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

Slide 2

Presentation Organization

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

Slide 3

Overview of PSO Sessions

• Sunday:
  • Common Formats Workshop
• Monday
  • Confidentiality, Patient Safety Work Product (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

  Slide 4

  Presentation Organization

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

  Slide 5

  Medical Errors in History

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

  Slide 6

  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 O'Leary, CEO, Joint Commission—June 1, 2007

  Slide 7

  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.

  Slide 8

  The Patient Safety and Quality Improvement Act of 2005 (continued)

  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

  Slide 9

  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.

  Slide 10

  Regulations Process

  • In 2007:
    • Department of Health and Human Services (HHS) Completes Draft Regulations
    • Office of Management and Budget (OMB) Reviews
    • Notice of Proposed Rulemaking (NPRM) Published
    • Comments Accepted
    • HHS Revises
  • In 2008:
    • OMB Review (of revisions)
    • Final Rule Published

  Slide 11

  Patient Safety Organizations (PSOs)

  Slide 12

  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

  Slide 13

  Potential PSO Sponsors

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

  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

  Network of Patient Safety Databases (NPSD)

  Slide 16

  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.

  Slide 17

  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.

  Slide 18

  Common Formats (continued)

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

  Slide 19

  Common Formats Development 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

  Slide 20

  Presentation Organization

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

  Slide 21

  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 Health Insurance Portability and Accountability Act [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.
  • AHRQ's regulatory authority only extends to PSOs; AHRQ will not regulate providers that work with PSOs.

  Slide 22

  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.

  Slide 23

  Subpart B: PSO 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

  Slide 24

  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

  Slide 25

  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.

  Slide 26

  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.

  Slide 27

  Patient Safety Work Product

  • PSWP is any data:
    1. Developed by a provider and reported to a PSO.
    2. Developed by a PSO for the conduct of patient safety activities, or
    3. 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

  Slide 28

  Confidentiality Protections: Implications for Providers

  • The Patient Safety Act's 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.

  Slide 29

  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

  Slide 30

  Your questions?

  Current as of December 2008

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  Internet Citation:

  General PSO Update. Slide Presentation from the AHRQ 2008 Annual Conference (Text Version). January 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualmtg08/090808slides/Helwig.htm]

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