The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF PENNSYLVANIA
RICHARD RUMSEY, No. 4:18-CV-01605
Plaintiff, (Judge Brann)
v.
GUTHRIE MEDICAL GROUP, P.C.,
by and through its officers, agents
and/or employees, and ROBERT
PACKER HOSPITAL, by and through
its officers, agents and/or employees,
Defendants.
MEMORANDUM OPINION
SEPTEMBER 26, 2019
Plaintiff Richard Rumsey brings this medical malpractice action against the
defendant medical entities, whom I will collectively refer to as “Guthrie.” Rumsey
alleges that Guthrie was negligent in failing to test or treat him for a MRSA infection
that escalated following an elective procedure.
In discovery, Rumsey has sought information pertaining to Guthrie’s
infection-prevention procedures. Guthrie in turn objects to three discovery requests
and previously instructed a witness—Andrew Klee, an infection-prevention
specialist for Guthrie—not to answer questions at his deposition pertaining to the
same, asserting that these are protected by the patient safety work product privilege.
The patient safety work product privilege is intended to promote candor in
patient safety evaluations from clinicians who may otherwise mince their words out
of fear of malpractice litigation.1 The hope is that enabling blunt criticism will help
to stem the staggering number of deaths from preventable medical errors each year—
which at least one study estimated was the third-leading cause of death in the United
States.2 All fifty states, the District of Columbia, and the federal government have
enacted some form of this privilege.3 Of those, Guthrie claims privilege under the
federal Patient Safety and Quality Improvement Act4 (PSQIA) and the Pennsylvania
Medical Care Availability and Reduction of Error Act5 (the “MCARE Act”), the
latter applicable here through Federal Rule of Evidence 501.
The PSQIA creates a framework through which medical care providers may
engage in privileged peer review of their patient safety practices. First, the provider
develops a process for collecting, managing, and analyzing patient safety data; this
process is called the “patient safety evaluation system.” The provider then discloses
that data to a certified third-party patient safety organization. Ultimately, privilege
attaches to the underlying patient safety work product that is prepared for the purpose
1 See S Rep No 108–196, at 2 (2003); HR Rep No 109–197, at 9 (2005).
2 Martin A. Makary & Michael Daniel, Medical Error—The Third Leading Cause of Death in the
US, 353 Brit Med J 1 (2016).
3 Charles G. Kels, Odd Man Out? The Medical Peer Review Privilege in Federal Litigation, 60
Fed Law 52, 52 (Dec. 2013).
4 42 USC §§ 299b-21–26.
of disclosing to a patient safety organization as part of a patient safety evaluation
system. The MCARE Act provides a similar structure.6
With that overview in mind, I first look to the language of the statutes.7 The
PSQIA defines “patient safety work product” as:8
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.
The PSQIA goes on to clarify:9
(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.
6 See 40 Pa CSA § 1303.311.
7 Doe v Hesketh, 828 F3d 159, 167 (3d Cir 2016).
8 42 USC § 299b-21(7)(A).
Essentially, documents generated by the evaluation process are protected, but such
information does not become privileged merely by virtue of having been reported.
“[T]he critical inquiry is the purpose of creating the information, and the information
will only be considered patient safety work product if it is created ‘for the purpose
of reporting’ to a patient safety organization.”10
As noted above, the MCARE Act operates similarly. It provides:11
(a) Prepared Materials.—Any documents, materials or information
solely prepared or created for the purpose of compliance with section
310(b) or of reporting . . . which arise out of matters reviewed by the
patient safety committee pursuant to section 310(b) or the governing
board of a medical facility pursuant to section 310(b) are confidential
and shall not be discoverable or admissible as evidence in any civil or
administrative action or proceeding. Any documents, materials, records
or information that would otherwise be available from original sources
shall not be construed as immune from discovery or use in any civil or
administrative action or proceeding merely because they were
presented to the patient safety committee or governing board of a
medical facility.
(b) Meetings.—No person who performs responsibilities for or
participates in meetings of the patient safety committee or governing
board of a medical facility pursuant to section 310(b) shall be allowed
to testify as to any matters within the knowledge gained by the person’s
responsibilities or participation on the patient safety committee or
governing board of a medical facility, provided, however, the person
shall be allowed to testify as to any matters within the person’s
knowledge which was gained outside of the persons’s [sic]
10 Crawford v Corizon Health, Inc, 2018 WL 3361147, at *2 (WD Pa July 10, 2018), quoting
Patient Safety Act Guidance, 81 Fed Reg 32655, 32656.
responsibilities or participation on the patient safety committee or
governing board of a medical facility pursuant to section 310(b).
The MCARE Act’s protection is similar to the PSQIA’s but narrower in that it must
be “solely” prepared for that purpose. Privilege under the MCARE Act has been
applied only where (1) the documents were solely prepared or created for the
purpose of compliance with the MCARE Act’s “serious events” reporting
requirements; (2) they arise out of matters reviewed by the patient safety committee
or the governing board; and (3) they are not otherwise available from original
sources.12
I now turn to Guthrie’s objections. Guthrie objected to three requests for
discovery.
i) Request No. 6: “A copy of all infection prevention and infection control
materials which Defendants received prior to May 1, 2017 from
[Vizient] and/or any other company.”
The MCARE Act privileges only documents “solely prepared or created for
the purpose of compliance with section 310(b) or of reporting . . . .”13 The patient
safety organization neither “compl[ies] with” nor “report[s]”—the provider does.
Therefore, documents generated by Vizient, a patient safety organization, are not
privileged under the MCARE Act.
12 Haines v Cherian, 2016 WL 831946, at *5 (MD Pa Feb 29, 2016), quoting Venosh v Henzes,
2013 WL 9593953, at *10 (Pa Ct Common Pleas July 17, 2013).
13 40 Pa CSA § 1303.311(a) (emphasis added).
However, the documents fall under the PSQIA’s definition—documents that
are produced by the patient safety organization for the purpose of conducting patient
safety activities.14 Vizient was a patient safety organization that Guthrie conducted
patient safety activities with. The information arising out of this relationship is
protected under the PSQIA.15
ii) Request No. 9: “A copy of Defendants’ agendas, notes and any and all
other written records of Defendants’ monthly (or other than monthly)
quality committee meetings from May 1, 2016 to May 1, 2017 insofar
as they discuss infection prevention or infection control.”
This is the quintessential example of patient safety work product privilege.
Quality committee meetings are a core aspect of Guthrie’s patient safety evaluation
system. Agendas, notes, and other written records from these meetings are squarely
work product and are “deliberations or analysis of” a patient safety evaluation
system. These are protected under the PSQIA and the MCARE Act, as well as
Pennsylvania’s Peer Review Protection Act.16
iii) Request No. 20: “A copy of any and all correspondence and
communication between Defendants and any federal, state, county or
local governmental agency within the past 5 years on the subject of
infection prevention, infection reporting, infection management and
infection rates.”
These are not “work product” within the relevant definition. Corresponding
with governmental agencies is not a part of Guthrie’s patient safety evaluation
14 42 U.S.C. § 299b-21(7)(A)(i)(II).
15 I further find that the phrase “and/or any other company” is vague and overly broad.
16 63 Pa CSA § 425.4 (“[P]roceedings and records of a review committee shall be held in
program, nor is it a part of its process of disclosing peer-review information to its
patient safety organizations. For that same reason, such correspondence would not
have been generated for the purpose of reporting. Therefore, these documents are
not privileged. However, the time frame requested is overly broad; I now limit it to
communications from May 1, 2015 to May 1, 2017.
Guthrie also objected to a series of questions at the deposition of Andrew
Klee. The patient safety work product privilege bars a witness from testifying to the
proceedings of quality committee meetings or other knowledge he gained by virtue
of participating in the patient safety evaluation system.17 However, the privilege is
not so broad as to cover Guthrie’s infection-prevention policies generally, and
information available outside of the evaluation system does not become privileged
merely by virtue of its use in the evaluation process.
Here, Rumsey’s counsel asked questions regarding subjects such as Guthrie’s
quality committee meetings, how the committee determined infection preparedness,
the data used to reach preparedness conclusions, and why they collected certain data
and not others. These questions seek information generated by the patient safety
evaluation system, and I will not order the parties to reopen the deposition to have
them answered.
* * *
The patient safety work product privilege is a quiet corner of the room, not a
private island. The statutes carve an exception to the presumption of free and open
disclosure to facilitate a specific, carefully designed process of disclosure. If they
are cautious to remain within the confines of the patient safety evaluation system,
medical professionals may provide the brutally honest feedback hospitals need to
keep their patients safe without fear of its use in litigation.
An appropriate Order follows.
BY THE COURT:
s/ Matthew W. Brann
Matthew W. Brann
United States District Judge