general pso update

General PSO UpdateGeneral PSO Update

AHRQ Annual Conference 2008AHRQ Annual Conference 2008Amy Helwig, MD, MSAmy Helwig, MD, MS

William B Munier, MD, MBAWilliam B Munier, MD, MBALarry PattonLarry Patton

8 September 20088 September 2008

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Presentation OrganizationPresentation Organization

Moderator – Amy HelwigModerator – Amy Helwig

PSO Status – Bill MunierPSO Status – Bill Munier

PSO Operations – Larry PattonPSO Operations – Larry Patton

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Overview of PSO SessionsOverview of PSO Sessions SundaySunday

– Common Formats WorkshopCommon Formats Workshop

MondayMonday– Confidentiality, PSWP, & the PSOsConfidentiality, PSWP, & the PSOs– General PSO UpdateGeneral PSO Update

PSO StatusPSO Status PSO OperationsPSO Operations

TuesdayTuesday– 8 am – Common Format Mini I – Brookside A & B8 am – Common Format Mini I – Brookside A & B– 10 am – Common Fmt Mini II – Middlebrook10 am – Common Fmt Mini II – Middlebrook– 1 pm – Common Fmt Mini III – Brookside A & B1 pm – Common Fmt Mini III – Brookside A & B

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Medical Errors in HistoryMedical Errors in History

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

Napoleon BonaparteNapoleon Bonaparte

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Progress?Progress?

The only two “wins” we are sure of are:The only two “wins” we are sure of are:

– Removal of concentrated KCl from the floorsRemoval of concentrated KCl from the floors

– Introduction of infusion devices to eliminate free-flow IVs in hospitals.Introduction of infusion devices to eliminate free-flow IVs in hospitals.

Dennis O’Leary, CEO, JointDennis O’Leary, CEO, JointCommission – June 1, 2007Commission – June 1, 2007

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The Patient Safety and Quality The Patient Safety and Quality Improvement Act of 2005Improvement Act of 2005

Encourages formation of PSOs to Encourages formation of PSOs to improve the quality & safety of improve the quality & safety of health carehealth care

AHRQ will administer rules for AHRQ will administer rules for listing qualified PSOslisting qualified PSOs

HHS Office for Civil Rights will be HHS Office for Civil Rights will be responsible for enforcing responsible for enforcing confidentialityconfidentiality

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Rather than a patchwork of state-by-state protections, Rather than a patchwork of state-by-state protections,

there will now be national uniform protections; that is, there will now be national uniform protections; that is,

confidentiality & privilege for clinicians & entities confidentiality & privilege for clinicians & entities

performing patient safety activitiesperforming patient safety activities

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Proposed Patient Safety Proposed Patient Safety RegulationRegulation

PSOs will provide feedback to clinicians & health care organizations on PSOs will provide feedback to clinicians & health care organizations on improving safetyimproving safety

The Act does not relieve clinicians or health care organizations from The Act does not relieve clinicians or health care organizations from meeting reporting requirements under Federal, state, or local lawsmeeting reporting requirements under Federal, state, or local laws

The proposed rule (NPRM) was publishedThe proposed rule (NPRM) was publishedin the February 12in the February 12thth Federal Register; Federal Register;comment period ended April 14thcomment period ended April 14th

150 comments received – many very150 comments received – many verydetaileddetailed

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Regulations ProcessRegulations Process

HHS Completes Draft

Regulations

OMB Reviews

NPRM Published

Comments AcceptedHHS Revises

OMB Review (of revisions)

Final Rule Published

2007

2008

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Patient Safety Organizations

(PSOs)

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Who Can be a PSO?Who Can be a PSO?

Eligible organizations:Eligible organizations:

– Any public or private entity / componentAny public or private entity / component

– Any for-profit or not-for-profit / componentAny for-profit or not-for-profit / component

Ineligible organizations:Ineligible organizations:

– Statute prohibits health insurance issuer or component of health insurance Statute prohibits health insurance issuer or component of health insurance issuerissuer

– NPRM proposes prohibiting any public or private entity that regulates providersNPRM proposes prohibiting any public or private entity that regulates providers

e.g., The Joint Commissione.g., The Joint Commission

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Potential PSO SponsorsPotential PSO Sponsors

Hospital associationsHospital associations

Hospital chainsHospital chains

Medical societiesMedical societies

Specialty societiesSpecialty societies

Group practicesGroup practices

Newly-created organizationsNewly-created organizations

OthersOthers

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PSO ActivitiesPSO Activities

Collect, analyze patient safety (PS) dataCollect, analyze patient safety (PS) data

Assist providers to improve quality & safetyAssist providers to improve quality & safety

Develop & disseminate PS informationDevelop & disseminate PS information

Encourage culture of safety & minimize patient riskEncourage culture of safety & minimize patient risk

Provide feedback to participantsProvide feedback to participants

Maintain confidentiality & security of dataMaintain confidentiality & security of data

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Network of Patient Safety Databases

(NPSD)

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NPSDNPSD

Provides benchmarks & baselines for measurementProvides benchmarks & baselines for measurement

Disseminates results, best practicesDisseminates results, best practices

Conducts analyses for the National Healthcare Quality Conducts analyses for the National Healthcare Quality ReportsReports

Develops a web-based evidence-based management Develops a web-based evidence-based management resource to support researchresource to support research

Provides technical assistance as neededProvides technical assistance as needed

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Common FormatsCommon Formats

PSOs will collect, aggregate, & analyze information on quality & PSOs will collect, aggregate, & analyze information on quality & safety of caresafety of care

Statute authorizes collection of this information in a standardized Statute authorizes collection of this information in a standardized mannermanner

Common Formats are now availableCommon Formats are now available– Allow aggregation of comparable data at local, PSO, & national levelAllow aggregation of comparable data at local, PSO, & national level

– Facilitate the exchange of informationFacilitate the exchange of information

– Underlie the ability to compare & learnUnderlie the ability to compare & learn

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Common Formats can provide a Common Formats can provide a

common language for patient safety common language for patient safety

reporting across the nationreporting across the nation

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Common FormatsCommon FormatsDevelopment CycleDevelopment Cycle

Formats will not be subject toFormats will not be subject to– Federal regulatory processesFederal regulatory processes

– NQF formal consensus processNQF formal consensus process

Formats willFormats will– Be updated annually as guidanceBe updated annually as guidance

– Have tight version controlHave tight version control

Formats areFormats are– Currently limited to the hospital settingCurrently limited to the hospital setting

– Planned for additional settingsPlanned for additional settings

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PSOs: The BasicsPSOs: The Basics

Providers are NOT required to work with PSOsProviders are NOT required to work with PSOs

Providers are NOT required to enter contracts with PSOs to obtain Providers are NOT required to enter contracts with PSOs to obtain protections (but note HIPAA Privacy Rule requires business associate protections (but note HIPAA Privacy Rule requires business associate agreement if provider is a “covered entity” and shares PHI with a PSO)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 While AHRQ will list PSOs for the Secretary, PSOs will not receive funding from AHRQ; AHRQ will provide technical assistancefrom AHRQ; AHRQ will provide technical assistance

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

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PSOs: AHRQ ApproachPSOs: AHRQ Approach

Streamlined process of simple attestation; spot checks to ensure Streamlined process of simple attestation; spot checks to ensure compliance with requirements and entities are subject to penalties for false compliance with requirements and entities are subject to penalties for false statementsstatements

Expect marketplace will assess worth of a PSO; Proposed rule emphasizes Expect marketplace will assess worth of a PSO; Proposed rule emphasizes transparency / disclosure to enable providers to make those decisionstransparency / disclosure to enable providers to make those decisions

Proposed rule emphasizes technical assistance and a non-adversarial Proposed rule emphasizes technical assistance and a non-adversarial approach whenever possible to promoting compliance by PSOs with the approach whenever possible to promoting compliance by PSOs with the criteria they must meet; but if a PSO fails to correct deficiencies, the NPRM criteria they must meet; but if a PSO fails to correct deficiencies, the NPRM gives AHRQ the authority to take actiongives AHRQ the authority to take action

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Subpart B:Subpart B:PSO Portion of the RulePSO Portion of the Rule

3.102 - Process and Requirements for Initial 3.102 - Process and Requirements for Initial and and Continued ListingContinued Listing

3.104 - Secretarial Actions3.104 - Secretarial Actions

3.106 - Security Requirements3.106 - Security Requirements

3.108 - Correction of Deficiencies, Revocation, 3.108 - Correction of Deficiencies, Revocation, and and Voluntary RelinquishmentVoluntary Relinquishment

3.110 - Assessment of PSO Compliance3.110 - Assessment of PSO Compliance

3.112 - Submissions and Forms 3.112 - Submissions and Forms

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PSOs: Listing RequirementsPSOs: Listing Requirements

15 Statutory Requirements:15 Statutory Requirements:

8 Patient Safety Activities (PSAs) 8 Patient Safety Activities (PSAs)

7 Criteria 7 Criteria

Initial listing – policies & procedures in place to perform 8 PSAs and will meet 7 Initial listing – policies & procedures in place to perform 8 PSAs and will meet 7 criteria upon listingcriteria upon listing

Seeking continued listing – are performing/will continue to perform all 8 PSAs Seeking continued listing – are performing/will continue to perform all 8 PSAs and complying with/will continue to comply with 7 criteriaand complying with/will continue to comply with 7 criteria

18 Statutory Requirements for Component PSOs18 Statutory Requirements for Component PSOs 3 additional requirements 3 additional requirements

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PSOs: Remaining a PSOPSOs: Remaining a PSO

Listing is for 3-year renewable periodsListing is for 3-year renewable periods

BUT statute includes a requirement that every BUT statute includes a requirement that every 24 months a PSO must demonstrate that it has 24 months a PSO must demonstrate that it has bona fide contracts with more than 1 provider bona fide contracts with more than 1 provider

Proposed rule would require 2 contracts to Proposed rule would require 2 contracts to meet that testmeet that test

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ConfidentialityConfidentiality

The statute provides federal confidentiality and privilege protections to The statute provides federal confidentiality and privilege protections to patient safety work product (PSWP) and specifies when disclosures are patient safety work product (PSWP) and specifies when disclosures are permittedpermitted

Confidentiality and privilege protections continue after disclosure, with Confidentiality and privilege protections continue after disclosure, with limited exceptionslimited exceptions

PSWP may contain protected health information (PHI) requiring PSWP may contain protected health information (PHI) requiring covered providers to also comply with the HIPAA Privacy Rule covered providers to also comply with the HIPAA Privacy Rule requirementsrequirements

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Patient Safety Work ProductPatient Safety Work Product

PSWP is any data:PSWP is any data:1.1. Developed by a provider and reported to a PSODeveloped by a provider and reported to a PSO

2.2. Developed by a PSO for the conduct of patient safety activities, orDeveloped by a PSO for the conduct of patient safety activities, or

3.3. That identifies or constitutes deliberations of or the fact of reporting That identifies or constitutes deliberations of or the fact of reporting pursuant to a patient safety evaluation systempursuant to a patient safety evaluation system

Original provider records (e.g., medical, billing) are not Original provider records (e.g., medical, billing) are not PSWPPSWP

Non-identifiable PSWP is not confidential or privilegedNon-identifiable PSWP is not confidential or privileged

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Confidentiality Protections: Confidentiality Protections: Implications for ProvidersImplications for Providers

The Patient Safety Act’s confidentiality protections have the potential The Patient Safety Act’s confidentiality protections have the potential to significantly expand provider-based patient safety initiativesto significantly expand provider-based patient safety initiatives

The proposed rule does NOT impose specific requirements on The proposed rule does NOT impose specific requirements on providers; within the framework of rule, providers have great providers; within the framework of rule, providers have great flexibility on how to operate and develop systems to meet their flexibility on how to operate and develop systems to meet their needsneeds

But there are a number of issues that providers need to considerBut there are a number of issues that providers need to consider

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Confidentiality:Confidentiality: Implications for Providers Implications for Providers

External Reporting – Statute does not relieve a provider of obligations under External Reporting – Statute does not relieve a provider of obligations under other laws or regulations that require external reporting of information; those other laws or regulations that require external reporting of information; those requirements must be met with information that is NOT protected (not PSWP)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 Internal Use of PSWP within the legal entity of a provider is NOT a disclosure but consider:but consider:

– Any holder of PSWP can make disclosuresAny holder of PSWP can make disclosures

– Intersection with credentialing or disciplinary actionsIntersection with credentialing or disciplinary actions

– If provider is covered entity, disclosures must meet HIPAA and Patient Safety If provider is covered entity, disclosures must meet HIPAA and Patient Safety Act requirementsAct requirements

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general pso update

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