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Copyright 2009.ECRI InstituteCopyright 2009.ECRI Institute
Working With Patient Safety Organizations (PSOs)Ronni P. Solomon
ECRI Institute
Copyright 2009.ECRI Institute
P2 Policies and Procedures for Institutions
Working with PSOs
Ronni P. Solomon, Executive Vice President and General Counsel, ECRI Institute
Agenda
� Background of Patient Safety Act
� Key concepts
�Reporting to a PSO
� Setting up your PSES
�Questions & Discussion
Copyright 2009.ECRI Institute
About ECRI Institute
� Independent, not-for-profit applied research institute, 40-year history
�Helping the healthcare community to determine the best ways of
delivering care� Patient Safety, Quality and Risk Management
� Technology Assessment, Effectiveness
� Medical Product Evaluation, Planning, Procurement
� Strict conflict of interest rules
�Qualified PSO staff; 300 person interdisciplinary staff� Clinical, safety, risk management, healthcare quality, engineering, life sciences,
information technology, statisticians, data analysts
� Federally-certified PSO
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Why ECRI Institute is a PSO
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Annual Accidental Deaths(from Lucian Leape)
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What Should We Do?
• Implement known best practices
• Redesign faulty systems
• Change the culture - from a culture of
blame to a culture of safety
• Congress should pass legislation to protect the
development and analysis of information related to
improving safety and quality.
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Why Federal Protection is Needed
• Providers fear that patient safety reports could be
used against them
• State protections vary – may offer no or inadequate
protections (e.g., no protection if data is shared
outside the hospital)
• For improvement, we need robust reporting and
aggregation of data; by analyzing more events,
patterns of failures could be more rapidly identified
Copyright 2009.ECRI Institute
Near-miss data for the health care domain
should be analyzed more extensively than is
currently the case. The data provide two types
of information relevant to patient safety – on
weaknesses in the health care system and,
equally important, on recovery processes.
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Stories from Pennsylvania
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�Near failure to
rescue patient
who arrested
Near Miss – Color Coded Wristbands
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Look-Alike Packaging
�Confusingly similar
packaging for insulin
and tuberculin
syringes
�Potential tenfold
overdose of insulin
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Discovering the Unexpected
� Medication errors involving incorrect patient weights
� 40% from the ED. Many don’t have scales capable of weighing immobilized or
unconscious patients without removing them from a gurney or stretcher.
� The not-so unusual…
� Patients scheduled for gall bladder removal only to find that the gall bladder
was already removed. Failure to obtain a proper history (patients had
dementia), and all the patients were diagnosed with ultrasound (a non-specific
test) with no further confirmation.
� 200 reports of staff who misunderstood the distinctions between
living wills and DNR orders.
� Many cases involved inappropriate withholding of treatment, failure to rescue.
Copyright 2009.ECRI Institute
Frequency, Severity
�Medication Errors
� 22% of overall
� 4% of events involving harm and
1% of events contributing to or
resulting in death.
�Complications related to
Procedures/Treatments/Tests
� 13% of overall
� 43% of events involving harm and
59% of events resulting in or
contributing to the patient’s death.
Copyright 2009.ECRI Institute
Share, Learn, Change
• 218 Patient Safety Officers
reported 607 changes in 2008
• Hand hygiene practices
• Wrong site surgery prevention
• Anticoagulation management
• Medication assessment and fall
risk
• Many more…
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Collaboratives, Analysis, Tools
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The Patient Safety Act
Many Benefits; Know the Details
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PSOs and providers are
mutually responsible
Federal Patient Safety Act
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Federal Patient Safety Act
�To improve healthcare quality and
patient safety
�To share data within a protected
legal environment
�To identify and reduce the
potential risks associated with
patient care
The Act is voluntary and does not provide
federal funding of PSOs
Copyright 2009.ECRI Institute
Legal Protections
�Not subject to subpoena in civil, criminal, administrative
proceedings
�Not subject to discovery
�Not admissible into evidence
�Not subject to FOIA
�Goes beyond state law for some
�Participation with a PSO is voluntary—legal protections
only kick-in if provider participates
Copyright 2009.ECRI Institute
What Does It Mean?
�Patient Safety Organizations (PSOs)• Entities that meet the requirements of the Patient Safety Act and Rule
�Patient Safety Work Product (PSWP)• Information that is privileged and confidential
�Patient Safety Evaluation System (PSES) • The protected space in which PSWP is assembled or developed for reporting to or from a PSO
• A provider’s deliberations and analyses within a PSES are confidential and privileged
Copyright 2009.ECRI Institute
Collaborative Model
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Patient Safety Organizations (PSO)
�Federally designated by
AHRQ
�PSO must comply with a
host of requirements
�Information reported to or
developed by a PSO for the
purpose of conducting
patient safety activities is
protected
Copyright 2009.ECRI Institute
Patient Safety Work Product (PSWP)
1. PSWP means any data, reports, records, memoranda, analyses (such as root cause
analyses), or written or oral statements (or copies of any of this material)
i. Which could improve patient safety, health care quality, or health care
outcomes; and
A. Which are assembled or developed by a provider for reporting to a PSO
and are reported to a PSO, which includes information that is
documented as within a patient safety evaluation system for reporting to
a PSO, and such documentation includes the date the information
entered the patient safety evaluation system; or
B. Are developed by a PSO for the conduct of patient safety activities; or
2. Which identify or constitute the deliberations or analysis of, or identify the fact of
reporting pursuant to, a patient safety evaluation system.
H
O
W
Copyright 2009.ECRI Institute
What is not PSWP
�Patient medical records, billing and discharge
information, other original patient or provider information
�Information that is collected, maintained, or developed
separately, or exists separately, from a PSES.
�Information collected to comply with external obligations:
e.g., state reporting requirements; FDA Medwatch;
NPDB.
Copyright 2009.ECRI Institute
When is PSWP protected?
�Upon collection
�Provider documents that the information was collected
for reporting to a PSO and the date of collection
�Query: How long is too long before submission to the
PSO?
Copyright 2009.ECRI Institute
Documenting PSWP
• Label PSWP
• Helps to prevent inappropriate disclosure.
− “CONFIDENTIAL PATIENT SAFETY WORK PRODUCT.
Protected under the Patient Safety and Quality
Improvement Act. Do not disclose unless authorized by
[name of governing document, office, or body].”
• P & Ps
Copyright 2009.ECRI InstituteCopyright 2009.ECRI Institute
Patient Safety Evaluation System (PSES)
� Defined as: the collection, management, or analysis of information for
reporting to or by a PSO
� Meant to be flexible and scalable to individual operations
� Best practice is to document the PSES
Copyright 2009.ECRI Institute
PSES…The regulations say
A protected space or system that is separate, distinct,
and resides alongside but does not replace other
information collection activities mandated by laws,
regulations, and accrediting and licensing requirements
as well as voluntary reporting activities that occur for the
purpose of maintaining accountability in the health care
system.
Copyright 2009.ECRI Institute
Keep in Mind…..
PSWP submitted to the PSO is
forever privileged and
confidential and cannot be
disclosed except in limited
circumstances – called
“permissible disclosures”.
Copyright 2009.ECRI Institute
Facility may remove PSWP
from PSES before submitting;
no longer PSWP; a virtual
copy can be sent to the PSO;
PSO still treats it as
confidential.
You Can Remove PSWP from the PSES
Copyright 2009.ECRI Institute
Internal Use of PSWP
�Is NOT regulated
�“Affiliated providers” may share identifiable PSWP
�May share with practitioners having privileges
�May share de-identified data with non-affiliated
providers
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Establishing the PSES
�Take inventory
�Committees, Departments
�Set goals
�Develop recommendation,
Obtain agreement
�Document the PSES
�Implement
�Monitor
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Questions to Consider
�Where to start…what types of data?
�How to use existing structures,
processes?
�Centralize the PSES?
�Multi-hospital systems?
�Access to PSES data?
�How long data can stay in the PSES
before reporting to a PSO?
Patient Safety Officer
PSO
Copyright 2009.ECRI Institute
Prioritizing Reportable Data
�Prioritize based on criteria:
• Promotes a culture of safety/improves care
• Impressions/subjective data that is not available in the
medical record
• Not required to be reported elsewhere (although there are
permissible disclosures)
• Data will not be used to make adverse employment
decisions
Copyright 2009.ECRI Institute
Documenting the PSES
�Some ideas….• Processes, activities, the physical space, computer systems, and
equipment that compose the PSES
• Procedures for entering data and information into the PSES
• Personnel who have access to the PSES and how they carry out their
duties and the system's operations
• Conditions for accessing PSWP that is part of the PSES
• Procedures for reporting information to the PSO and receiving feedback
form the PSO
• Procedures for disseminating information outside the PSES
Copyright 2009.ECRI Institute
P&Ps
�Purposes and Scope
�Definitions
�Describe your PSES
�Reporting to PSO
�Confidentiality, Security
�Permissible Disclosures