Building Improvement Support:
Using a PSO in the Rural Hospital
Wesley R. Butler
Wes.Butler@BBB-Law.com
Caveats
• This presentation is intended as an overview of a
complex area of law and should not be construed as, or
relied upon, as legal advice
• This area of law is developing so interpretations of the
law throughout the presentation should be understood
as opinions
• Seek competent counsel for advice on compliance
• Do not operate a vehicle or heavy machinery while
contemplating this area of law
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
2
Why?
Should I invest time and resources developing a PSO
relationship for my rural hospital?
• Do I want to know how other hospitals address safety and
quality issues?
• Do I want to protect safety and quality information from
disclosure in medical liability suits?
• Do I want to protect physicians and staff from testifying against
colleagues for comments or criticisms made during patient safety
and quality activities?
• Do I want to encourage more robust participation in safety and
quality activities by physicians and staff?
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
3
Congress Sees a Need
• To Err Is Human – Congress gets motivated
• The Problem
– Health care workers are reluctant to discuss errors or
improvements for fear of liability
• Existing state laws alone are insufficient
– Existing construct did not create incentives for data
aggregation or cooperation among providers
– No consistency among the states (e.g., KY and FL)
– Laws were often limited in the scope of protections
– Laws were not applicable in Federal court cases
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
4
Congress Responds – the PSQIA
• Creates a voluntary program through which health care
providers can share information relating to patient
safety events with PSOs, with the aim of improving
patient safety and the quality of care nationwide
• Attaches legal protections to this information to
encourage providers to share this information without
fear of liability
• Goal – Improve patient safety by limiting the
chilling effect of litigation
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
5
Authorities
• The Patient Safety and Quality Improvement Act of
2005
– 42 U.S.C. §§ 299b-21 through 299b-26 (P.L. 109-41)
– 42 C.F.R. Part 3 (73 Fed. Reg. 70732 et seq.)
• Agency for Healthcare Research and Quality (AHRQ)
• The commentary to the final rule is very helpful
• Other laws or standards to consider:
– Mandatory reporting requirements
– Federal law preempts state law
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
6
What Needs to Be Done?
Participation in the PSO Program is voluntary, but if you
do you must know the rules. Basic outline of tasks:
• Become educated on the PSQIA
• Establish a relationship with a PSO
• Develop an internal process for choosing and
overseeing the information to be submitted to a PSO
• Educate liability counsel on how to protect information
gathered and submitted to a PSO
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
7
Understanding the PSQIA
• New Terms to Learn
Patient Safety Organization (PSO)
Patient Safety Activities
Patient Safety Work Product (PSWP)
Patient Safety Evaluation System (PSES)
Disclosure – Divulging PSWP to a separate entity
Use – PSWP shared internally within a provider
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
8
Understanding the PSQIA
• The Construct
– Voluntary reporting program between health care providers
and private entities called PSOs
– Providers assemble, develop and gather patient safety
information and report it to a PSO
– The PSO aggregates and analyzes the information and reports
findings and analyses back to providers
– Information within this process qualifies for federal privilege
and confidentiality protections
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
9
Understanding the PSQIA
• Providers create an internal reporting process called a
Patient Safety Evaluation System that collects, manages
or analyzes information for reporting to a PSO
• PSOs build an external reporting framework to receive
information from providers so that the information can
be aggregated and analyzed
• The information sharing process strengthens evidencebased practices and improvements in the delivery of
health care
• The Provider-PSO Relationship is symbiotic
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
10
Understanding the PSQIA
Assembly line analogy…
Event Provider Assembly and Analysis PSO
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
11
The PSO’s Responsibility
•
•
•
•
Must be listed with AHRQ
Must have at least two (2) participating providers
Most use Common Formats for information reporting
May vary in scope
– National, regional or state
– General purpose or focused on specific topics or areas
• May have different processes for reporting information
– Actual submission or functional reporting
• May produce a variety of reporting products
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
12
The Provider’s Responsibility
• Providers must organize and analyze the information
that will be reported to a PSO
• Patient Safety Evaluation System (PSES)
– Definition: “the collection, management, or analysis of
information for reporting to or by a PSO”
– The rules tell us little else, but the Commentary gives insight
– The provider’s internal process for collecting, managing and
analyzing information to be reported to a PSO
– AHRQ describes the PSES as unique and specific to a
provider, made to be flexible and scalable
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
13
The Provider’s Responsibility
• Patient Safety Evaluation System (cont.)
• PSES – working safe harbor for patient safety activities
• Providers are not expected to overhaul existing patient
safety activities, but some changes may be needed
• Practical Challenges:
– Proving information is within the PSES
– Proving when information entered the PSES
– Managing information within the PSES
• Provider should not place information into its PSES
unless it intends to report it to a PSO
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
14
The Provider’s Responsibility
• Patient Safety Evaluation System (cont.)
• PSES need not be documented, but …
• AHRQ recommends formal documentation of a PSES
because a provider can:
– Better identify and protect Patient Safety Work Product
– Provide substantial proof to support claims of privilege and
confidentiality
– Give notice to staff and create awareness of the privileged and
confidential nature of the information within the PSES
– Limit access to privileged and confidential information
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
15
The Provider’s Responsibility
• Patient Safety Evaluation System (cont.)
• If you do formally document a PSES, consider
including information on the following:
–
–
–
–
–
Delineate how and when information is reported to a PSO
Determine what events would be submitted to a PSO
Define how deliberations and analyses are conducted
Separate protected information from unprotected information
Designate secure physical and electronic space for conducting
patient safety activities
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
16
The Provider’s Responsibility
• Patient Safety Evaluation System (cont.)
• If you do formally document a PSES, consider
including information on the following: (cont.)
– How will information enter the PSES?
– What processes or activities will be part of the PSES?
– What personnel need access to PSWP to carry out their duties
involving operation of, or interaction with, the PSES?
– Procedures for disseminating information outside the PSES
– Conditions for access to PSWP
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
17
Patient Safety Work Product
• Patient Safety Work Product (PSWP) is a designation
for information that is deemed privileged and
confidential under the PSQIA
– Manner of saying this information is protected by the PSQIA
• AHRQ recognizes that the PSQIA’s protections are the
foundation to furthering the overall goal of the statute
• What information qualifies as PSWP (and that which
does not qualify) is a significant topic of the PSQIA
• Many types of information can become PSWP and can
include information in oral or written forms
• The definition of PSWP controls the analysis
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
18
Patient Safety Work Product
The statutory definition of PATIENT SAFETY WORK PRODUCT (42 U.S.C. § 299b-21 (7))
(A)
IN GENERAL.—Except as provided in subparagraph (B), the term ‘patient safety work product’ means any data,
reports,
records, memoranda, analyses (such as root cause analyses), or written or oral statements
(i)
which
(I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient
safety organization; or
(II) are developed by a patient safety organization for the conduct of patient safety activities;
and which could result in improved patient safety, health care quality, or health care outcomes; or
(ii)
which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety
evaluation system.
(B)
CLARIFICATION
(i)
Information described in subparagraph (A) does not include a patient’s medical record, billing and
discharge information, or
any other original patient or provider record.
(ii)
Information described in subparagraph (A) does not include information that is collected, maintained, or
developed
separately, or exists separately, from a patient safety evaluation system. Such separate
information or a copy thereof
reported to a patient safety organization shall not by reason of its
reporting be considered patient safety work product.
(iii)
Nothing in this part shall be construed to limit
(I)
the discovery of or admissibility of information described in this subparagraph in a
criminal, civil, or administrative
proceeding;
(II)
the reporting of information described in this subparagraph to a Federal, State, or local
governmental agency for
public health surveillance, investigation, or other public
health purposes or health oversight purposes; or
(III)
a provider’s recordkeeping obligation with respect to information described in this
subparagraph under
5, 2013
Federal, State, or March
local law.
Copyright © 2013 Barnett Benvenuti & Butler PLLC
19
Patient Safety Work Product
The regulatory definition of PATIENT SAFETY WORK PRODUCT (42 C.F.R. § 3.20)
(1)
memoranda,
Except as provided in paragraph (2) of this definition, patient safety work product means any data, reports, records,
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 (ii) Which identify
or constitute the
deliberations or analysis of, or identify the
fact of reporting pursuant to, a patient safety evaluation system.
(2)
(i)
Patient safety work product does not include a patient’s medical record, billing and discharge
information, or any other
original patient or provider information; nor does it include information
that is collected, maintained, or developed
separately, or exists separately, from a
patient safety evaluation system. Such separate information or a copy thereof
reported to
a PSO shall not by reason of its reporting be considered patient safety work product.
(ii)
removed from a patient
Patient safety work product assembled or developed by a provider for reporting to a PSO may be
safety evaluation system and no longer considered patient safety work product if:
(A)
(B)
patient safety evaluation system.
being:
(iii)
The provider documents the act and date of removal of such information from the
Nothing in this part shall be construed to limit information that is not patient safety work product from
(A)
Copyright © 2013 Barnett Benvenuti & (B)
Butler PLLC
health oversight purposes; or
The information has not yet been reported to a PSO; and
Discovered or admitted in a criminal, civil or administrative proceeding;
March
5, 2013
Reported to a Federal,
State,
local or Tribal governmental agency for public health or
20
Patient Safety Work Product
• What does the definition of PSWP mean?
• AHRQ tries to give clarity in the Final Rule
• Information reported to a PSO may be PSWP
– Substantiating a claim of PSWP in this case is easier as proof
can be offered to show information was reported to a PSO
• Information documented as collected within a PSES for
the purpose of reporting to a PSO may be PSWP
– Substantiating a claim of PSWP in this case poses challenges:
– Proving the purpose of collection
– Documenting the date of collection
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
21
Patient Safety Work Product
• PSWP is defined not only by what it is, but also by what
it is not
• PSWP is not…
–
–
–
–
a patient’s medical record
billing and discharge information
any other original patient or provider information
information that is collected, maintained, or developed
separately, or exists separately, from a patient safety
evaluation system
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
22
Patient Safety Work Product
• A few more practical thoughts…
• What a provider wants to claim as PSWP is within its
control
• Whether information qualifies as PSWP depends on the
provider’s preparations to comply with the PSQIA
– Understand what can never be PSWP
– Create a PSES with well defined boundaries and functions
– Operate the PSES and report to a PSO in a manner that is consistent with
the PSQIA’s goals and intentions
• Overreaching to claim everything as PSWP is not a wise practice
• Labeling information as PSWP is a wise practice
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
23
PSWP is Protected
• When information qualifies as PSWP the information is
both privileged and confidential
• Distinction between Privilege and Confidential
• Privilege – The legal ability to prevent disclosure of
specific information that could otherwise be disclosed
– Its application is not limited to litigation, but is an absolute bar
to disclosure unless waived by the holder of the privilege
• Confidential – Information that is prohibited from
disclosure because it is intended to be kept secret
• The terms are often paired together, but they should not
be used interchangeably
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
24
Privilege
• Notwithstanding any other law, PSWP shall be
privileged and shall not be:
–
–
–
–
–
Subject to subpoena or order
Subject to discovery
Subject to open records
Admitted as evidence
Admitted in a professional disciplinary proceeding
• Applies at the Federal, State, local levels of government
• The privilege allows a provider to shield the PSWP
information from persons seeking it in litigation
• There are limited exceptions to the privilege
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
25
Confidentiality
• PSWP is confidential and shall not be disclosed
• Confidentiality rule is enforced by HHS Office of Civil
Rights
• HHS-OCR intends to conduct compliance reviews of
providers and PSOs
• Civil Monetary Penalties of up to $10,000 per incident
may be assessed against providers and PSOs for breach
of confidentiality
– Providers and PSOs may be assessed the penalty even if they
disclose confidential PSWP in good faith or with good reason
– Citation 42 U.S.C. § 299b-22 (f) (1)
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
26
Confidentiality
• Confidentiality may be viewed as a double-edged sword
– Benefit – Reasonable people understand that confidential
information is intended to be kept secret
– Burden – Confidential information must be treated with great
care to assure that it is not inappropriately disclosed
• PSWP information cannot be “disclosed” but it can
“used” by the provider
– AHRQ says that the Final Rule does not regulate or limit a
provider’s internal use of PSWP information
– However, PSWP information shared with a separate entity
may be a disclosure in violation of the confidentiality rule
• Legal counsel may be needed to define who is a “separate entity”
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
27
Confidentiality
Ten disclosure permissions stated in the Final Rule
1.Disclosure in criminal proceedings
2.Disclosure to permit equitable relief for reporters
3.Disclosure authorized by identified providers
4.Disclosure for patient safety activities
5.Disclosure of non-identifiable patient safety work product
6.Disclosure for research
7.Disclosure to the FDA and entities required to report to FDA
8.Voluntary disclosure to an accrediting body
9.Disclosure for business operations
10.Disclosure to law enforcement
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
28
Confidentiality
• PSWP information disclosed in compliance with a
permission, or disclosed impermissibly, continues to be
privileged and confidential
– 42 C.F.R. § 3.208
– Except in criminal proceedings or if the information is
disclosed in nonidentifiable form
– The protections cannot be unintentionally waived
– When disclosed in this manner labeling the information as
PSWP or providing a notice is a good practice
• Is there an exception to the confidentiality rule for State
regulatory agencies?
– Short answer is “no”
– There are solutions, but planning is needed
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
29
Confidentiality
• AHRQ’s Commentary to the Final Rule (73 Fed. Reg.
70732, 70743-70744)
– Providers must comply with applicable regulatory requirements
– For PSWP to be disclosed, even to a State entity, the provider
must use an applicable disclosure permission
– The PSQIA does not preempt state laws that require providers
to report information that is not PSWP, but a State may not
require that PSWP be disclosed
• In short – Providers cannot point to the PSQIA as an
excuse for failing to meet a State regulatory
requirement, but a provider cannot use PSWP
information to meet regulatory obligations unless a
disclosure permission applies
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
30
Removal from the PSES
• Provider may remove information voluntarily from its
PSES, but the removal must be documented
– Removal means the provider no longer intends to report the
information to a PSO and protections are no longer available
– Removal option is unavailable only before information is
reported to a PSO
• Questions when considering removal:
–
–
–
–
Does the information qualify as PSWP by definition?
Does the information exist separately from the PSES?
Has the PSWP information been reported to a PSO?
Is a disclosure permission available to the situation to permit
the disclosure of PSWP without violating confidentiality?
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
31
The Courts and PSWP
• Not many published cases yet, but those that are
published are favorable to recognizing and protecting
the PSWP privilege
• Fancher v. Norton Hospitals, Inc., Case No. 10-CI-4219
(Jefferson Cir. Court, Aug. 2011)
• Walgreens v. Illinois
• KD ex rel. Dieffenbach v . United States, 715 F. Supp. 2d
587 (D. Del. 2010)
• Norton Hospitals, Inc. and Tibbs/UK
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
32
The Courts and PSWP
• Fancher v. Norton Hospitals, Inc.
“The PSQIA was thus designed to encourage this ‘culture of
safety’ by ‘providing for broad confidentiality and legal
protections of information collected and reported voluntarily
for the purposes of improving the quality of medical care and
patient safety.’ Thus, there is a clear statement of a
Congressional intent that such communications be protected
in order to foster openness in the interest of improved patient
safety. The Court therefore finds that the area has been
preempted by the federal law.”
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
33
The Courts and PSWP
• Fancher v. Norton Hospitals, Inc.
“The possibility that information given regarding a sentinel
event could then be discovered in a civil proceeding, could
have a chilling effect on accurate reporting of such events.
Further, as noted, the facts themselves are discoverable and
the Plaintiff may submit them to his own expert for analysis.
The findings of a peer review board, the Joint Commission, or
a patient safety organization are not dispositive. Only the facts
found by a jury are significant herein.”
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
34
The Courts and PSWP
• Illinois Dep’t of Financial and Professional Regulation v.
Walgreen, 970 N.E. 2d 552, (Ill. App. 2012)
• Began as an administrative action by IL
• IL petitioned trial court to enforce a subpoena
• Walgreen asserted the information was PSWP
• Trial court dismissed IL’s action finding the incident
reports were PSWP and privileged
• IL appealed to the Court of Appeals
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
35
The Courts and PSWP
• Illinois Dep’t of Financial and Professional Regulation v.
Walgreen, 970 N.E. 2d 552, (Ill. App. 2012)
• The Court of Appeals found:
– Respondent established that the only documents responsive
to petitioner's subpoenas' narrow scope of "incident reports"
were STARS reports
– Walgreen proved by affidavit that the STARS reports were
transmitted to a PSO
– STARS reports are privileged as PSWP
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
36
The Courts and PSWP
• Norton Hospitals, Inc. and Tibbs/UK
• Defendants sought writ of prohibition in Court of
Appeals seeking to stop trial court’s order
• Petitions were successful
• Court of Appeals granted writs, finding that the PSQIA
preempts the trial court’s order
– “We hold that Congress explicitly intended the Act to
preempt state law.”
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
37
The Courts and PSWP
• Norton Hospitals, Inc. and Tibbs/UK
• Court of Appeals remanded with instructions to the
trial court to apply the privilege only for “selfexamining analyses”
• Court of Appeals misapplies a U.S. District Court
decision in Francis v. U.S.
– Francis involved a common law privilege, not PSQIA
• Defendants have appealed to the KY Supreme Court
Copyright © 2013 Barnett Benvenuti & Butler PLLC
March 5, 2013
38
Thank you
Wes Butler
T. 859.226.0312
Wes.Butler@BBB-Law.com
March 5, 2013
39