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Patient Safety Organizations and ACA Impact. Kelly Court WHA Chief Quality Officer August 23, 2013. Webinar Agenda. Patient Safety Organizations Background Recent Developments Participation Requirements Next Steps Q&A. PSO Background.

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Patient Safety Organizations and ACA Impact

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Patient Safety Organizations and ACA Impact

Kelly Court

WHA Chief Quality Officer

August 23, 2013

Webinar Agenda

  • Patient Safety Organizations Background

  • Recent Developments

  • Participation Requirements

  • Next Steps

  • Q&A

PSO Background

  • Patient Safety and Quality Improvement Act (PSQIA) of 2005 and final regulations issued November, 2008 established Patient Safety Organizations (PSO’s) and the process by which they are governed.

  • A PSO must be “listed” by DHHS and commit to:

    • Undertake efforts to improve patient safety and quality of health care

    • Develop and implement processes for voluntary and confidential reporting of adverse events and providing feedback to members

PSO Background

  • Providesfederal, state, and local protection from discovery of Patient Safety Work Product; if collected for and reported to or by a PSO

    • Reported events and trend analysis

    • Root cause analyses and peer review of events

    • Recommendations regarding analyses

    • Culture surveys

  • PSO are subject to strict confidentiality requirements which includes fines for breaches

  • PSO are subject to HIPAA privacy requirements

PSO Background

  • AHRQ manages the listing process for PSO’s:

  • Currently 70 PSO’s listed by AHRQ

  • Typical PSOs

    • State hospital associations

    • Technology vendors

    • Large health systems

    • Specialty societies/organizations

AHRQ Common Formats

  • AHRQ developed a common data dictionary, paper forms and technical requirements to submit data to PSO’s

    • Hospitals (Acute Care) – v1.2

    • Skilled Nursing – beta

    • Readmissions – beta

    • Outpatient Services – research phase

    • Surveillance module (IT “trigger tool”) – research phase

AHRQ Common Formats

  • Hospitals (Acute Care) – v1.2

    • Blood or Blood Product

    • Device or Medical/Surgical Supply, including HIT

    • Fall

    • Healthcare-associated Infection

    • Medication or Other Substance

    • Perinatal

    • Pressure Ulcer

    • Surgery or Anesthesia

    • Venous Thromboembolism

Recent Development

Affordable Care Act

  • Section 1311(h) Quality Improvement (1) Enhancing patient safety

    “Beginning on January 1, 2015, a qualified health plan may contract with

    (A) a hospital with greater than 50 beds only if such hospital (i) utilizes a patient safety evaluation system as described in part C of Title IX of the Public Health Service Act; …. or

    (B) a healthcare provider only if such provider implements such mechanisms to improve healthcare quality as the Secretary may by regulation require.“

Recent Development

Affordable Care Act

  • Jan. 1, 2015, qualified health plans in insurance exchanges may not contract with a hospital of >50 beds unless that hospital has a patient safety evaluation system (PSES)

  • PSES Definition:

    –“Patient safety evaluation system means the collection, management, or analysis of information for reporting to or by a PSO.”

    Patient Safety and Quality Improvement Act, Final Rule, Section 3.20.

  • Final rule pending- we do not know all the details

Patient Safety Evaluation System (PSES) – What a Hospital Would Need to Do

  • Defines (in writing) what information is included and excluded:

    • Common inclusions: Safety event reports, root cause, meeting minutes, quality analysis, HAC’s, investigative materials (Patient Safety Work Product)

    • Common exclusions: disciplinary action, just culture, state reporting mandates

  • Defines staff that have access to PSES information

  • Defines how information is reported to a PSO

  • Defines how information may be removed from the PSES

  • Defines committees and structures supporting the PSES

    • Patient safety committee, RM plan, PI plan, P&P’s

  • Defines how information is identified as Patient Safety Work Product (PSWP)

Submitting Information to PSO

Examples of Patient Safety Work Product that could be submitted to the PSO

  • Patient safety events (“incident/occurrence reports”) – using AHRQ Common Formats

    • Manual entry

    • Electronic upload from an existing system

  • Analyses and reports related to patient safety events

  • Investigative documents (root cause analyses)

  • Committee materials – minutes, findings, etc.

What a PSO Does – “Patient Safety Activities”

  • Collection and analysis of PSWP

    • Web-based event reporting system

    • Aggregate analysis and benchmarks

    • May report event data to national database

    • Alerts based on aggregate findings

    • Secure collection of documents – RCAs, committee materials, etc.

  • Develop and disseminate information to drive improvement

    • Best practices, protocols, recommendations on specific topics

What a PSO Does – “Patient Safety Activities”

  • Promote culture of safety

    • Culture of safety surveys and recommendations

    • Culture training

  • Preserve confidentiality of PSWP

    • Strict P/P for HIPAA compliance

    • Strict P/P to maintain member confidentiality

  • Preserve security of PSWP

    • Secure website

    • Encrypted data transfer

    • P/P to not mix PSWP with other projects

    • P/P related to staff training and physical security

What a PSO Does – “Patient Safety Activities”

  • Efforts to improve patient safety and quality

  • Provision of feedback to participants

    • Improvement collaboratives

    • RCA reviews and critiques

    • “Safe Tables” – peer discussion of events and actions

    • Improvement toolkits

    • Recommendations based on data submitted

Working with a PSO - Sample

Patient Safety and Quality Information

Information Triaged by Provider

Information Eligible to Become PSWP

-Could improve safety, quality or outcomes of care

-Assembled/developed solely for reporting to PSO

Information Not Eligible to Become PSWP

-Collected/developed for purpose other than for reporting to PSO

-Claims, medical records

-Accreditation/regulatory survey info.

-Other record keeping requirements

Provider PSES

-Date and document incoming information

-Internal analysis and collaboration

-Prepare for reporting to PSO

PSWP=Patient Safety Work Product

PSES=Patient Safety Evaluation System


-Conduct required activities

-Provide feedback to provider members

-Aggregate data for reporting to national event database (if PSO chooses)

Benefits to PSO Membership

  • Compliance with ACA requirement if >50 beds (tentative)

  • Legal protection of patient safety material

  • Broader aggregation of events that can be relatively rare

  • Access to national and state improvement content

  • Peer sharing and learning

  • Access to online event reporting if still on paper

Downsides to PSO Membership

  • Time to catalog and document your Patient Safety Evaluation System (PSES)

  • Adherence to your PSES

  • If information is entered into the PSO it cannot be removed for other purposes

  • Time to create data feeds if already using an electronic reporting system

  • Cost associated with membership (not yet determined)

  • Similar peer-to-peer sharing is protected under the state statute (WI 146.38)

Be Cautious

  • Don’t feel pressured to join a PSO until your legal counsel has a good understanding of the benefits and limitations

  • Don’t feel pressured by an existing PSO to “join quickly before the end of 2014”

Next Steps and Timetable

Question and Answer

Kelly Court – 608-274-1820

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