General PSO Update (Text Version)

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 Operation
• 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?