Transcript Slide 1

Patient Safety Organizations and Patient Safety
Work Product – Federal Protection in Action
Paige A. Lueking
Washington D.C.
Did Congress Enact a
Federal Privilege?
The Patient Safety and Quality Improvement Act of 2005:
PSQIA:
• Creates Patient Safety
Organization (PSO)
• Establishes Network of Patient
Safety Databases
• Authorizes Establishment of
Common Formats for Reporting
Important Safety Events
• Facilitates Reporting of Findings
in Agency for Healthcare
Research and Quality (AHRQ)
Key Terminology
Patient Safety Act-PSA
Patient Safety Evaluation System-PSES
Patient Safety Work Product-PSWP
Patient Safety Organization-PSO
Patient Safety Rule-PSR
PSQIA - Considerations
(1) Fear of Discovery in Malpractice Litigation
(2) State Laws Afforded Inadequate Protection
to Keep Data Confidential
(3) No Safe Mechanisms to Share Data
Patient Safety Work Product - PSWP
PSWP is any data: Developed by a provider and reported to a
PSO
Developed by a PSO for the collection into
patient safety evaluation system
PSWP is NOT:
Original provider records
Information that exists separately
PSWP removed from PSES
Patient Safety Work Product - PSWP
Privileged
Shall Not Be Subject to Subpoena, including
civil or administrative proceeding against a
provider
Shall Not Be Offered Into Evidence
Shall Not Be Used in Disciplinary Proceedings
Exempt From Freedom of Information Act
Exempt From Similar Federal or State
Public Records Laws
Patient Safety Information Becomes Patient Safety Work
Product - PSWP
1. Information is Developed by Provider for
Purpose of Reporting and is Reported to PSO
2. Information is Generated by PSO for Patient
Safety Activities
3. Information = Deliberations and Analysis by
PSES or Has Been Reported to PSES or
PSO
Who, What, When, Where, and Why
Patient Safety Event
Risk Management /
Quality Improvement Committee
•Enters data into system
•RCA
•Action Plan
•Decision if event should
be reported to PSO
•Report to PSO
•Collects facts from
patient and providers
•Reviews Records
•State requires mandatory
reporting
•Subsequent Legal Case
How?
Data entered into reporting program
and not maintained for any other
purpose
PATIENT SAFETY DATA ENTERED INTO PATIENT SAFETY EVALUATION SYSTEM
Voluntary Actions – Clear, Deliberate, Intentional, Formal
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Participation of Provider
Materials Submitted to PSO
Deliberations, Analysis or Facts of Reporting
to Patient Safety Evaluation System
Disclosure of PSWP – Provider – PSO- Affiliated Provider
Written Permission From All Named
in PSWP
PSWP Contains No Identifying
Information
Intersects With Credentialing or
Disciplinary Actions
If Provider Covered Entity,
Disclosures Must Meet
Requirements of HIPAA Patient
Safety Act
PSO OPERATIONS
http://www.pso.ahrq.gov
PSO News and Information
Special Interests
Clinical Information
Consumers and Patients
Funding Opportunities
Data and Surveys
Research Findings
PSOs in the United States
***30 States and the District of Columbia are the home of at least one
Patient Safety Organization. All PSOs can operate nationwide regardless
of their home state.
States With Peer Review Protections - Varied
At Least 46 States Have Peer Review Protections
Florida – The Sunshine State
Amendment 7
Florida Constitution X Section 25
 Florida Hospital Waterman, Inc. v. Buster, 932 So.2d 344 (Fla. 1st DCA
2006)
 Columbia Hospital Corp. of South Broward v. Fain, 16 So.3d 236 (Fla. 4th
Dist. 2009)
 West Florida Regional Medical Center, Inc. v. See, 2012 WL 87282 (Fla.
2012)
 Holly v. Auld, 450 So.2d 217 (Fla. 4th Dist. 1984).
Constitution and the Courts Allow Extensive Discovery
Illinois – Land of Lincoln
Key Case:
Department of Financial and Professional
Regulation v. Walgreen Co., 2012 WL 1951106 (Ill.
App. 2nd Dist., 2012)
• Subpoenas issued for incident reports of
medication errors by 3 pharmacists under
investigation
• Affidavits established that quality improvement
reports which pharmacy created under tracking and
reporting system were privileged under PSQIA
•Trial court granted Walgreen’s Motion to Dismiss
•Affirmed by Appellate Court – May 29, 2012
California – The Golden State
Schlegel v. Kaiser Found. Health Plan,
Inc., (E.D. Cal. Sep. 11, 2008)
No PSQIA Protection Because Internal
Reports Describing Kidney Transplant
Program not Created as PSWP nor
Reported to PSO
PSO DECISIONS -“Sole Purpose” of Document Preparation
Pennsylvania
Hospital had to produce incident report as burden not met
to show document was prepared solely for reporting to a
Patient Safety Organization and not for another purpose
Morgan v. Community Medical Center, June 2011
Kentucky
Trial court granted protective order as to RCA and Sentinel
Event documents which were reported to the PSO
Court discussion of Congressional intent excellent
rationale for confidentiality of documentation
Fancher v. Shields, August 2011
Not Yet Tested
Texas – The Lone Star State
The Home of
Well Defined
Well Recognized
Peer Review Protections
What Kinds of Entities Can Become a PSO?
 Public Entity
 Private Entity
 For Profit Company
 Not-for-Profit Company
If Certified By HHS
Entities Excluded from Becoming PSO
Health Insurer
Health Care Accreditation or Licensing Entity
Agent of Entity that Oversees or Enforces Health
Care Statues or Regulations
Entity that Operates a Mandatory Patient Safety
Reporting System
Requirements for Initial and Continued Listing
Demonstrate Compliance with
15 Requirements
8 Mandatory Patient Activities
7 Additional Criteria for Certification
PSO Activities
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Collect and Analyze Patient Safety Data
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Assist Providers in Improving Quality and Safety
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Divide and Assimilate Patient Safety Information
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Encourage Culture of Safety and Improvement of
Risks
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Provide Feedback to Participants
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Maintain Confidentiality and Security of Data
Exceptions to Confidentiality of PSWP
Criminal Proceedings / Investigation
Adverse Employment Action
Authorized Disclosure
Patient Safety Activities - HCA
Research, If Permitted by HIPAA
FDA
Accrediting Body
State Agencies
Business Operations
CDC
Information Flow
PATIENT SAFETY WORK PRODUCT. This information is compiled for the Happy
Health System Patient Safety Evaluation System and is privileged, confidential and not subject to discovery.
Medical Errors
To Err is Human
– Institute of Medicine
To err is human;
to forgive, divine
– Alexander Pope
To err is human.
To blame someone else is politics.
- Hubert Humphrey
Medical Errors From the Headlines
Benefits
Federal Confidentiality
Protection for Analysis and Data
Aggregated Data in “Common Format” Identifies Trends
Encourages Self Examination
Near Misses Do Not Become Sentinel Events
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Alabama
Healthcare Improvement Patient Safety Organization of Alabama, Inc.
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Arkansas
American Data Network PSO
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California
California Hospital Patient Safety Organization (CHPSO)
Quantros Patient Safety Center
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Connecticut
QA to QI LLC (d/b/a QA to QI Consulting)
The Connecticut Hospital Association Federal Patient Safety Organization
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District of Columbia
American College of Physicians Patient Safety Organization
Open Safety Foundation
Pascal Metrics Inc
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Florida
Baptist Health Patient Safety Partnership
Medical Peer Review Resource, LLC
MEDNAX PSO, LLC
Patient Safety Organization of Florida (PSOFlorida)
Quality Circle for Healthcare, Inc.
Ryder Trauma Center
UM-JMH Center for Patient Safety
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Georgia
Piedmont Clinic, Inc.
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Illinois
Anesthesia Quality Institute
Chicago Breast Cancer Quality Consortium
Clarity PSO
Society for Vascular Surgery Patient Safety Organization, LLC
The Midwest Alliance for Patient Safety
The Patient Safety Research Foundation, Inc.
UHC Performance Improvement PSO
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Indiana
QAISys, Inc.
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Kansas
Child Health Patient Safety Organization, Inc. (Child Health PSO)
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Kentucky
Kentucky Institute for Patient Safety & Quality
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Louisiana
Schumacher Group Patient Safety Organization, Inc.
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Maine
ABG Anesthesia Data Group, LLC
Specialty Benchmarks PSO
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Maryland
AABB's Patient and Donor Safety Center
Maryland Patient Safety Center, Inc.
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Massachusetts
Academic Medical Center (AMC) PSO
Fresenius Medical Care PSO, LLC
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Michigan
Emergency Consultants PSO, LLC (d/b/a ECI PSO, LLC)
MHA Patient Safety Organization
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Minnesota
Universal Safety Solution PSO
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Missouri
Ascension Health Patient Safety Organization
Missouri Center for Patient Safety
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Nebraska
Nebraska Coalition for Patient Safety
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New Jersey
New Jersey Hospital Association Health, Research & Educational Trust Institute for Quality & Patient Safety
PDR Secure LLC
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New York
MCIC Vermont, Inc. PSO
Medication Management Research Network
Northern Metropolitan Patient Safety Institute
Somnia Patient Safety Organization, Inc.
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North Carolina
Carolinas HealthCare System Patient Safety Organization
Carolinas Rehabilitation - Patient Safety Organization
NC Quality Center PSO
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Ohio
EMP Patient Safety Organization
Ohio Patient Safety Institute
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Pennsylvania
BREF PSO
Chart Institute LLC
ECRI Institute PSO
Institute for Safe Medication Practices (ISMP)
McGuckin Methods International, Inc.
PsychSafe (Component PSO of Psychiatric Solutions, Inc.)
Society of Hospital Medicine PSO
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Rhode Island
Leadership Triad
The PSO Advisory
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South Carolina
Verge Patient Safety Organization
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Tennessee
CHS PSO, LLC
Cogent Patient Safety Organization, Inc.
Premerus PSO, LLC
TeamHealth Patient Safety Organization
Tennessee Center for Patient Safety
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Texas
PSO Services Group
Texas Patient Safety Organization, Inc.
The Texas A&M Health Science Center Rural and Community Health Institute (TAMHSC-RCHI)
WiMED, Inc.
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Utah
Independent Data Safety Monitoring, Inc.
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Virginia
Alliance for Patient Medication Safety
Wake up Safe (a component of the Society for Pediatric Anesthesia)
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Wisconsin
GE-PSO
Morgridge Institute for Research PSO
Thank you
Paige Lueking
900 Jackson Street, Suite 100
Dallas, Texas 75202
Tel: 214-712-9510
[email protected]