# Presentation: 910090

## General PSO Update

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

**Notes:**
Go immediately to the second slide.

## Presentation Organization

**Presentation Organization**

- Moderator – Amy Helwig
- PSO Status – Bill Munier
- PSO Operations – Larry Patton

## 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

## Presentation Organization

**Presentation Organization**

- Moderator – Amy Helwig
- PSO Status – Bill Munier
- PSO Operations – Larry Patton

## Medical Errors in History

- 	“In my opinion, physicians kill as many people as we generals.”
- 	Napoleon Bonaparte

## 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

## 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

## 	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

## 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

## Regulations Process

**HHS **
**Completes Draft **
**Regulations**

**OMB**
** ****Reviews**

**NPRM **
**Published**

**Comments Accepted**
**HHS Revises**

**OMB Review**
**(of revisions)**

**Final Rule **
**Published**

## (PSOs)

## 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

## Potential PSO Sponsors

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

## 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

## (NPSD)

## 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

## 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

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

## 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

## Presentation Organization

**Presentation Organization**

- Moderator – Amy Helwig
- PSO Status – Bill Munier
- PSO Operations – Larry Patton

## PSOs: The  Basics

**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
- AHRQ’s regulatory authority only extends to PSOs; AHRQ will not regulate providers that work with PSOs

## PSOs: AHRQ Approach

**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

## 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

## 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

## 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

## Confidentiality

**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

## Patient Safety Work Product

**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

## Confidentiality Protections: Implications for Providers

**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

## 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

## Your questions?