Patient Safety Organizations and
ACA Impact
Kelly Court
WHA Chief Quality Officer
August 23, 2013
Webinar Agenda
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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
phase
https://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 Development
Affordable Care Act
http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/html/PLAW-111publ148.htm
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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
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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
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Defines staff that have access to PSES information
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Defines how information is reported to a PSO
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Defines how information may be removed from the PSES
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Defines committees and structures supporting the PSES
– Patient safety committee, RM plan, PI plan, P&P’s
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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
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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 PSWP
a)
b)
c)
d)
e)
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.
2. Develop and disseminate information to drive
improvement
a) Best practices, protocols, recommendations on specific
topics
What a PSO Does – “Patient
Safety Activities”
4. Promote culture of safety
a)
b)
Culture of safety surveys and recommendations
Culture training
5. Preserve confidentiality of PSWP
a)
b)
Strict P/P for HIPAA compliance
Strict P/P to maintain member confidentiality
6. Preserve security of PSWP
a)
b)
c)
d)
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”
6. Efforts to improve patient safety and quality
7. Provision of feedback to participants
a) Improvement collaboratives
b) RCA reviews and critiques
c) “Safe Tables” – peer discussion of events and
actions
d) Improvement toolkits
e) 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
PSO PSES
-Conduct required activities
-Provide feedback to provider members
-Aggregate data for reporting to national
event database (if PSO chooses)
PSWP=Patient Safety Work Product
PSES=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 Timetable
What
Complete survey re: possible
interest
Hospitals
WHA
Sept 6th
X
Evaluate feedback from data
vendors
By When
X
Federal interpretation of ACA rule
Sept 6th
October?
WHA decision to proceed
X
OctoberDecember
Create policies/procedures and
seek AHRQ listing
X
4th quarter 2013
X
Begin 1st quarter
2014
Contracting to join WHA PSO
X
Question and Answer
Kelly Court
kcourt@wha.org – 608-274-1820