PSO Membership
Building a Culture of Safety
Touching Lives. Enriching Futures.
Lisa Corbett, Peggy Binzer, and Dr. Susan Saik
Peebles
Touching Lives. Enriching Futures.
North Carolina has several statutes
that create peer review processes and provide
protection for that information.
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State facilities struggled with forming true
peer review committees, and following
procedures.
Touching Lives. Enriching Futures.
In 2009, in a Tort Claim case against
a State Facility, Plaintiff’s counsel requested
root cause analyses going back for a period of
YEARS in a document production request.
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The State objected on grounds that the
information was protected under State peer
review laws.
Touching Lives. Enriching Futures.
The Deputy Commissioner ordered
the Facility to produce the records to him for
review, and ultimately released them to
plaintiff’s counsel.
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The facility and its staff thereafter did not
want to engage in any type of peer review
activities due to the concern that they would
not be protected in litigation.
Touching Lives. Enriching Futures.
In 2007, North Carolina moved from
having an internal P & A, the Governor’s
Advocacy Council for Persons with Disabilities,
(GACPD) to having an external P & A.
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Prior to 2007, GACPD did not request peer
review or root cause analysis information.
Touching Lives. Enriching Futures.
On November 18, 2011, DRNC filed
an action in NC’s Middle District. DRNC v.
Moses Cone, 1:11-cv-812.
 Moses Cone has a behavioral health unit, and
a client of that unit died within an hour of
having been restrained.
 DRNC initiated an investigation and requested
records, including the medical record, peer
review and root cause analysis documents.
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Touching Lives. Enriching Futures.
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Moses Cone produced the medical record but
refused to produce peer review or root cause
analysis, citing the peer review protection by
law.
Moses Cone filed a motion to dismiss which
was denied.
DRNC filed a motion for judgment on the
pleadings, which was granted.
Touching Lives. Enriching Futures.
The Court followed the law from other
Circuits and ruled that DRNC was entitled to
peer review under the federal law.
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DRNC will use the information to make its
determination of whether or not abuse or
neglect occurred.
Result: a chilling effect on peer review
processes.
Touching Lives. Enriching Futures.
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The purpose of the PSQIA is to create a
culture of safety by providing legal
protection for quality information while
permitting the sharing of best practices and
other information to continuously improve
the quality of patient care.
Many states’ peer review protections have
been eroded, the protections do not cross
state lines, and are generally inadequate for
the purpose of sharing information among
unrelated entities.
Touching Lives. Enriching Futures.
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Patient Safety Organization (PSO):
A means of furthering the ability to accelerate the
identification of, understanding of, and implementation of
evidence-based solutions for preventable harm.
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Patient Safety Evaluation System (PSES):
The collection, management, or analysis of information for
reporting to or by a PSO.
◦ Clinical Prospective: Where clinicians can share information
about medical errors and how to prevent them to bring
lesson learned to the bed-side.
◦ Legal Prospective: Identifies protected information and
protected space.
Touching Lives. Enriching Futures.
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Patient Safety Work Product (PSWP):
◦ Any quality data and analysis, oral statements – assembled
or developed by a provider for reporting to a PSO and are
reported to the PSO – that could improve quality of patient
care or which constitute the deliberations or analysis of a
PSES.
◦ Patient Safety Work Product that is collected and
developed in the PSES must be reported for the protections
to attach:
 Actually reporting
 Representative reporting
 Functional Reporting
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Analysis, conversations and deliberations in PSES are
protected without reporting to the PSO.
Touching Lives. Enriching Futures.
Privilege:
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◦ Information is not subject to subpoena, discovery, or admission into evidence
◦ Federal privilege preempts state tort laws but not reporting laws
◦ Federal privilege does not preempt state laws that provide stronger peer review
protections
◦ Provides federal liability protections to providers:
 Federal privilege and confidentiality protections cross state lines
 Federal privilege preempts state tort laws but not state reporting laws (e.g., shield
for event reports)
 Establishes a federal peer review privilege for all providers (e.g., nurses, EMT,
pharmacists)
 Preempts use of protected information in federal cases (e.g., racial discrimination)
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Confidentiality –
The Act places a statutory requirement on providers not to
disclose “Patient Safety Work Product,” except under certain circumstances and imposes
penalties of up to $10,000 per violation against any person or principal who knowingly
or recklessly violates the confidentiality provisions.
Touching Lives. Enriching Futures.
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PSO cannot be compelled: A patient safety
organization shall not be compelled to disclose
information collected or developed under this part
whether or not such information is patient safety
work product unless such information is:
◦ Identified,
◦ Is not patient safety work product, and
◦ Is not reasonably available from another source.
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Providers have additional defenses: Providers must
exert the privilege and have the burden of proof
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Patient Safety Work Product is NOT:
◦ Any document required to be reported by law
◦ Information collected, maintained or developed separately, or
which exists separately, from a PSES (medical record, billing
information).
◦ Corrective Actions
◦ Information that is dropped out of the PSES
Touching Lives. Enriching Futures.
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“Disclosure is the release of information outside of the
entity for which a specific disclosure permission must be
applicable.”
May voluntarily disclose nonidentifiable information,
best practices, clinical protocols and other
nonidentifiable information.
“Use” is defined in the preamble to the regulation. “Use”
means “the sharing of PSWP for any purpose within a
legal entity (health system, hospital),
A provider may use PSWP for any purpose within its
hospital or health system with two caveats, confidential
information should be treated as being confidential; be
careful of personnel actions.
Touching Lives. Enriching Futures.
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Survey and licensure bodies are not accrediting bodies and
are not treated as such under 42 C.F.R. 3.206. Thus, such
entities are not entitled to receive patient safety work product
voluntarily from providers.
Presently working with CMS to determine what other
information can be provided to satisfy the conditions of
participation. CMS wants to see that events are being
reporting, analyzed, systematic changes are being made, and
hospital leadership is engaged.
We recommend educating your regulatory body concerning
the PSQIA.
If a facility wants to share protected information, such as an
RCA, all providers must agree via contract, the information
shared must be marked as PSWP, and the Surveyor must be
informed that the information is protected.
Touching Lives. Enriching Futures.
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Gone beyond filling gaps in state peer review
statute
Allowing providers to talk to each other about
barriers
Peer to Peer/Case Study Collaborative Programs
Health Systems and specialties creating learning
systems and “systemizing” care
Using data to be predictive and lowering
malpractice operational costs
Solving what keeps you up at night.
Touching Lives. Enriching Futures.
14 State Operated Facilities
3
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 1
 1
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Psychiatric Hospitals
Alcohol and Drug Treatment Centers
ICF/IID Centers
Skilled Nursing Facilities
PRTF
School
Adult admissions, Long-term, Forensics, Medical Unit, Child/Adolescent, Geropsychiatry, Deaf,
Psychiatric Intensive Care, Acute Substance Abuse Treatment, Rehabilitative Substance
Abuse Treatment, Pre-trial, Residential/Respite/Crisis ICF/IID, Residential SNF
Patients and Residents served have high levels of complexity
Touching Lives. Enriching Futures.
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A blame-free environment where individuals
are able to report errors or near misses without
fear of punishment
Encouragement of collaboration across ranks
and disciplines to seek solutions to
patient/resident safety problems
Organizational commitment of resources to
address safety concerns
AHRQ Patient Safety Primer http://psnet.ahrq.gov/primer.aspx?primerID=5
Touching Lives. Enriching Futures.
Hines S, Luna, K, Lofthus J, et al. Becoming a High Reliability Organization: Operational Advice for Hospital Leaders. (Prepared by the Lewin
Group under Contract No. 290-04-0011.) AHRQ Publication No. 08-0022. Rockville, MD: Agency for Healthcare Research and Quality. April 2008
Provides a safe place for honest dialogue and
discussion.
Space that allows for open and free discussion
- to speak up without fear of retaliation.
In this environment, system failures are
identified and minimized as a result of the
reporting and analysis of safety events.
Touching Lives. Enriching Futures.
• Was the first designated federally certified PSO in North
Carolina and the 25th in the nation
• Collects data on serious patient safety events as well as near
misses and unsafe practices
• Encourages participating facilities to share their serious
reportable events, learn with others about how to prevent
these events and thus improve healthcare quality
• Current participation: 99 Facilities from 3 states
• Program is designed to be applicable for the entire continuum
of care. In the NCQC PSO there are Hospitals, SNF facilities
(10), Home Health providers, Ambulatory Surgery Centers,
and Hospital Owned Physician practices.
Touching Lives. Enriching Futures.
Improvements
and Actions
PSES
Tracking
and F/U
Ad Hoc
Involved staff
Event
Review
Committee
Interfacility
Event
Reviews
RCA
PSWP
Physician
Peer
Review
Unit
Manager
Review
Mortality
Review
Undesirable
Trends
DSOHF
PSES
Committee
analyses
Ad Hoc
Involved Staff
Event Review
Committee*
(Includes ad hoc)
Root Cause Analysis
Team**
(Includes CD, CNO,
CEO as standing
members)
Clinical
Management Team
Action
Plan
Traditional process
per facility policy
Patient/resident
Safety Events
Incident Reports
Executive Leadership
Committee
Risk
Management
QA Related Hospital
Committees
•Falls
P&T
QCC
Patient Safety
Committee
Medication Safety
Video Review
Others
Corporate Clinical
Quality Council
CCQC
* If Event Review Committee or RCA Team discovers a Physician Specific Peer
Review issue, refer to Medical Staff Peer Review process.
** Includes RCA, Sentinel Events, Death Reviews, Other event reviews
 Face
to face initial meetings with each
facility
 Policies
 PSWP
and Procedures describing the PSES
– disclaimers and security Training
 Alignment
of committees and responsibility
Touching Lives. Enriching Futures.
Developed a corporate policy that would serve as a template for
individual facilities.
◦ Due to uneven staffing and org structures, developed system that
was based on functions rather than specific positions
◦ Met with each facility and produced flow chart of how protected
information and work product would flow through each
organization
◦ Tried to use existing committees/processes and modify them
◦ Patient Safety Event Review Committee
◦ Sensible access to incident reports
◦ Work closely with Attorneys
◦ Generated a “To-Do” List
Our biggest challenge and how we have addressed it –
 Developing an understanding of the difference between PI data that
does not need to be part of the PSES and Patient Safety information that
does.
 How the facility interfaces with our corporate entity
Touching Lives. Enriching Futures.