Patient Safety Organizations and ACA Impact

Kelly CourtWHA 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• Provides federal, 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: http://www.pso.ahrq.gov/listing/psolist.htm

• 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

phasehttps://www.psoppc.org/web/patientsafety/commonformats

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 DevelopmentAffordable Care Acthttp://www.gpo.gov/fdsys/pkg/PLAW-111publ148/html/PLAW-111publ148.htm

• 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 DevelopmentAffordable 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 PSOExamples 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”

1. Collection and analysis of PSWPa) Web-based event reporting systemb) Aggregate analysis and benchmarksc) May report event data to national databased) Alerts based on aggregate findingse) Secure collection of documents – RCAs, committee

materials, etc.2. Develop and disseminate information to drive

improvementa) Best practices, protocols, recommendations on specific

topics

What a PSO Does – “Patient Safety Activities”

4. Promote culture of safetya) Culture of safety surveys and recommendationsb) Culture training

5. Preserve confidentiality of PSWPa) Strict P/P for HIPAA complianceb) Strict P/P to maintain member confidentiality

6. Preserve security of PSWPa) Secure websiteb) Encrypted data transferc) P/P to not mix PSWP with other projectsd) P/P related to staff training and physical security

What a PSO Does – “Patient Safety Activities”

6. Efforts to improve patient safety and quality7. Provision of feedback to participants

a) Improvement collaborativesb) RCA reviews and critiquesc) “Safe Tables” – peer discussion of events and

actionsd) Improvement toolkitse) Recommendations based on data submitted

Working with a PSO - SamplePatient Safety and Quality Information

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

Information Eligible to Become PSWP-Could improve safety, quality or outcomes of care-Assembled/developed solely for reporting to PSO

Provider PSES-Date and document incoming information-Internal analysis and collaboration-Prepare for reporting to PSO

PSO PSES-Conduct required activities-Provide feedback to provider members-Aggregate data for reporting to national event database (if PSO chooses)

Information Triaged by Provider

PSWP=Patient Safety Work ProductPSES=Patient Safety Evaluation System

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 TimetableWhat Hospitals WHA By When

Complete survey re: possible interest

X Sept 6th

Evaluate feedback from data vendors

X Sept 6th

Federal interpretation of ACA rule October?

WHA decision to proceed X October-December

Create policies/procedures and seek AHRQ listing

X 4th quarter 2013

Contracting to join WHA PSO X X Begin 1st quarter 2014

Question and Answer

Kelly Courtkcourt@wha.org – 608-274-1820