Update on PSO Implementation

1
Update on PSO Implementation

• Presentation to
• American Hospital Quality Association
• New Orleans, LA
• February 15, 2007

2
Todays Patient Safety Baseline

• Are patients safer now? Data from neither the
  entire US health care system nor the individual
  hospitals can yield a credible answer.
• JAMA - August 9, 2006
• Pronovost PJ, Miller MR, Wachter RM. Tracking
  Progress in Patient Safety an elusive target.
  JAMA. 2006296696-699.

3
Where have we been?

• November 1999 IOM Releases To Err is Human
• 2000 Congress begins debate on event reporting
  legislation
• 2001-2004 Congress directs AHRQ to fund reporting
  demonstration projects
• 2005 Congress passes The Patient Safety and
  Quality Act (PSIQA)
• September 2005 AHRQ begins drafting regulations

4
Where are we going

• March 2006 AHRQ holds public listing sessions for
  public input
• December 2006 AHRQ and Office of Civil Rights
  submits draft regulations to the Office of the
  Secretary of HHS
• Winter 2007 OS sends regulations out for HHS
  review
• Next stop OMB
• Release NPRM?
• Release Final Regulations ?
• Establish PSO?

5
Patient Safety Act of 2005

• Creates Patient Safety Organizations (PSOs)
• Establishes Network of Patient Safety Databases
• Requires reporting of findings annually in AHRQs
  National Health Quality/Disparities Reports
• Mandates Comptroller General to study
  effectiveness of Act (by 2010)

6
PSQIA PL 109-41

• Amends AHRQs enabling legislation
• AHRQ will administer program
• Office of Civil Rights will handle enforcement
• Program is voluntary
• Purpose of Act
• To improve patient safety
• To reduce the incidence of events that adversely
  affect patient safety

7
Problems Law Addresses

• Fear of malpractice litigation
• Inadequate protection by state laws
• Inability to aggregate data on a large scale

8
How Law Addresses Problems

• Authorizes creation of PSOs they enter into
  contracts with providers to assist them to
  analyze threats to patient safety to reduce or
  prevent them
• Requires PSOs to work with more than one provider
  so that PSOs can aggregate data across providers
• Provides Federal privilege/confidentiality
  protection for analyses reports significantly
  limits their use in criminal, civil,
  administrative proceedings

9
Patient Safety Organizations (PSOs)
10
Who Can be a PSO?

• Eligible organizations
• Public or private entities
• Profit or not-for-profit entities
• Provider entities, such as hospital chains
• Other entities that establish components
• Ineligible organizations
• Insurance companies or their affiliates

11
Types of PSOs

• PSOs may be free-standing or a component of
  another organization (such as a provider system)
• Component PSOs must meet additional criteria
• Maintain separate operations from parent
  organization
• No unauthorized disclosures to parent
  organization
• Mission does not create conflict of interest with
  parent

12
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
• Operate PS evaluation systems provide feedback
  to participants
• Maintain confidentiality security of PS data

13
In the Mean Time
Network of Patient Safety Databases (NPSD)
14
NPSD

• Simplifies task of reporting events
• Employs common formats (definitions, data
  elements, etc.) promotes interoperability
• Generates de-identified information relevant to
  preventing harm to patients
• Aggregation of data
• Analysis of events, profiles, reports
• Dissemination of results, best practices
• Provides benchmarking trend reports

15
AHRQ Inventory of Reporting Systems

• Begun in January 2005
• Establishes evidence base for development of
  common definitions formats
• Includes representation from many operating
  systems other stakeholders

16
Inventory Scope

• Federal
• State
• Collaborative entities (e.g., ECRI, JCAHO)
• Institutions (e.g., hospital chains)
• Commercial off-the-shelf software systems
• International (e.g., AIMS, NPSA)
• Standards development organizations

17
Inventory Content

• Reporting system descriptions
• Reporting items
• Data elements
• Definitions
• Encoding schemes

18
Inventory of Reporting Systems
19
AHRQ Inventory of Reporting Systems

• Preliminary findings
• Commonality found for some definitions
• Variability found for many
• Few systems collect information on complete
  improvement cycle

20
Common Format Development

• Begin with representatives of Federal agencies
  with reporting systems
• DoD, CDC, FDA, VA, others
• Codify analyze AHRQ inventory database
• Develop initial common formats, definitions for
  provision to PSOs
• Involve interested parties from the private
  sector in refinement maintenance

21
Our Next Steps

• Develop publish rules governing certification
  operation of PSOs
• Operational section AHRQ
• Enforcement section OCR
• OMB regulatory forms - AHRQ
• Review PSO applications publish list of PSOs
  whose certifications are accepted
• Provide common formats to PSOs

22

• Questions/Discussion

James B Battles, PhD Center for Quality
Improvement and Patient Safety 540 Gaither
Road Rockville, MD 20850 Phone (301)
427-1332 Email james.battles_at_ahrq.hhs.gov