Paige A. Lueking

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Patient Safety Organizations and Patient Safety
Work Product Federal Protection in Action

• Paige A. Lueking

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Washington D.C.
Did Congress Enact a Federal Privilege?
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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)

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Key Terminology
Patient Safety Act-PSA Patient Safety Evaluation
System-PSES Patient Safety Work
Product-PSWP Patient Safety Organization-PSO Pat
ient Safety Rule-PSR
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PSQIA - Considerations

• Fear of Discovery in Malpractice Litigation
• State Laws Afforded Inadequate Protection
• to Keep Data Confidential
• (3) No Safe Mechanisms to Share Data

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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
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Patient Safety Work Product - PSWP

• Privileged
• Shall Not Be Subject to Subpoena, includingcivil
  or administrative proceeding against aprovider
• 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

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Patient Safety Information Becomes Patient Safety
Work Product - PSWP

• Information is Developed by Provider for Purpose
  of Reporting and is Reported to PSO
• Information is Generated by PSO for Patient
  Safety Activities
• Information Deliberations and Analysis by PSES
  or Has Been Reported to PSES or PSO

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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

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How?

Data entered into reporting program and not
maintained for any other purpose
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PATIENT SAFETY DATA ENTERED INTO PATIENT SAFETY
EVALUATION SYSTEM

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Voluntary Actions Clear, Deliberate,
Intentional, Formal
? Participation of Provider ? Materials Submitted
to PSO ? Deliberations, Analysis or Facts of
Reporting to Patient Safety Evaluation System
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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
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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

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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.
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States With Peer Review Protections - Varied
At Least 46 States Have Peer Review Protections
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Florida The Sunshine State
Amendment 7 Florida Constitution X Section 25
Plaintiffs Discovery Gone Wild

• 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
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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
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• Affidavits established that quality improvement
  reports which pharmacy created under tracking and
  reporting system were privileged under PSQIA
• Trial court granted Walgreens Motion to Dismiss
• Affirmed by Appellate Court May 29, 2012

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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
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PSO DECISIONS -Sole Purpose of Document
Preparation
PennsylvaniaHospital 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
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Not Yet Tested
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Texas The Lone Star State
The Home of
Well Defined
Well Recognized
Peer Review Protections
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What Kinds of Entities Can Become a PSO?

• Public Entity
• Private Entity
• For Profit Company
• Not-for-Profit Company

If Certified By HHS
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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

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Requirements for Initial and Continued Listing

• Demonstrate Compliance with
• 15 Requirements
• 8 Mandatory Patient Activities
• 7 Additional Criteria for Certification

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PSO Activities
? Collect and Analyze Patient Safety
Data ? Assist Providers in Improving Quality and
Safety ? Divide and Assimilate Patient Safety
Information ? Encourage Culture of Safety and
Improvement of Risks ? Provide Feedback to
Participants ? Maintain Confidentiality and
Security of Data
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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

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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.
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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
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Medical Errors From the Headlines
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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.
• Arkansas
• American Data Network PSO
• California
• California Hospital Patient Safety Organization
  (CHPSO)
• Quantros Patient Safety Center
• Connecticut
• QA to QI LLC (d/b/a QA to QI Consulting)
• The Connecticut Hospital Association Federal
  Patient Safety Organization
• District of Columbia
• American College of Physicians Patient Safety
  Organization
• Open Safety Foundation
• Pascal Metrics Inc

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• Georgia
• Piedmont Clinic, Inc.
• 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
• Indiana
• QAISys, Inc.
• Kansas
• Child Health Patient Safety Organization, Inc.
  (Child Health PSO)
• Kentucky

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• Massachusetts
• Academic Medical Center (AMC) PSO
• Fresenius Medical Care PSO, LLC
• Michigan
• Emergency Consultants PSO, LLC (d/b/a ECI PSO,
  LLC)
• MHA Patient Safety Organization
• Minnesota
• Universal Safety Solution PSO
• Missouri
• Ascension Health Patient Safety Organization
• Missouri Center for Patient Safety
• Nebraska
• Nebraska Coalition for Patient Safety
• New Jersey

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• North Carolina
• Carolinas HealthCare System Patient Safety
  Organization
• Carolinas Rehabilitation - Patient Safety
  Organization
• NC Quality Center PSO
• Ohio
• EMP Patient Safety Organization
• Ohio Patient Safety Institute
• 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
• Rhode Island

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• Texas
• PSO Services Group
• Texas Patient Safety Organization, Inc.
• The Texas AM Health Science Center Rural and
  Community Health Institute (TAMHSC-RCHI)
• WiMED, Inc.
• Utah
• Independent Data Safety Monitoring, Inc.
• Virginia
• Alliance for Patient Medication Safety
• Wake up Safe (a component of the Society for
  Pediatric Anesthesia)
• Wisconsin
• GE-PSO
• Morgridge Institute for Research PSO

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Thank you
Paige Lueking 900 Jackson Street, Suite
100Dallas, Texas 75202 Tel [phone]paige.lu
eking_at_cooperscully.com