RENDERED: SEPTEMBER 22, 2016
TO BE PUBLISHED
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2015-SC-000657-MR 1-1 u
DATEI°113/ 14 1,44, aftwori,toc
BAPTIST HEALTH RICHMOND, INC. APPELLANT
ON REVIEW FROM COURT OF APPEALS
CASE NO. 2015-CA-001175-OA
MADISON CIRCUIT COURT NO. 14-CI-00455
V.
APPELLEE
HON. WILLIAM G. CLOUSE, JR.,
JUDGE MADISON CIRCUIT COURT,
DIVISION I
AND
TIM AGEE, INDIVIDUALLY AND AS REAL PARTY IN INTEREST
ADMINISTRATOR OF THE ESTATE OF
EVA LOUISE NALL (AGEE), DECEASED
OPINION OF THE COURT BY JUSTICE KELLER
VACATING AND REMANDING
Baptist Health Richmond, Inc. petitioned the Court of Appeals for a writ
prohibiting the Madison Circuit Court from enforcing its order requiring Baptist
Health to produce certain documents that had been requested in discovery by
the real party in interest. The Court of Appeals denied the petition, and Baptist
Health appeals from that denial. The issue on appeal is whether the requested
documents are protected from disclosure by the Patient Safety and Quality
Improvement Act of 2005 (the Act), 42 U.S.C.A. § 299b-21 et. seq. Having
reviewed the record and the arguments of the parties, we vacate the trial
court's discovery order and remand for further proceedings consistent with this
opinion.
I. BACKGROUND.
Eva Louise Nall (Agee) underwent laproscopic surgery and subsequently
died. Her husband, Tim Agee, individually and on behalf of her estate, sued
Baptist Health and a number of medical care providers alleging that her death
was the result of medical negligence. During discovery, Mr. Agee propounded a
request for production of documents to Baptist Health. The request at issue
sought: "any and all incident reports, investigation reports, sentinel event
reports, root cause analysis reports, Joint Commission reports, Medicare
reports, Medicaid reports, peer review reports and reports of any nature
relating to Eva Louise Nall (Agee)." Baptist Health designated which documents
it believed fell within the request but refused to produce them claiming that
they were protected from disclosure by the Act. Mr. Agee filed a motion to
compel, which the trial court granted in part, holding that only those
documents that had been "collected; maintained, or developed for the sole
purpose of disclosure to a Patient Safety Organization pursuant to the [Act]"
are protected. As set forth above, Baptist Health then filed an original action in
the Court of Appeals seeking a writ of prohibition. The Court of Appeals denied
Baptist's request, holding that the "sole purpose" standard applied by the trial
court is consistent with this Court's opinion in Tibbs v. Bunnell, 448 S.W.3d
796 (Ky. 2014).
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H. ANALYSIS.
We begin our analysis with a review of Tibbs, a plurality opinion.'
Although a majority of the Court agreed with the outcome in Tibbs, less than a
majority agreed on the reasoning; therefore, Tibbs has no stare decisis effect.
See Ware v. Commonwealth, Ky., 47 S.W.3d 333, 335 (2001). However, Tibbs is
certainly persuasive, and we find much with which we can agree in both the
plurality and the dissenting opinions.
The trial court in Tibbs ordered the hospital to produce an "incident" or
"event" report that had been generated by a hospital surgical nurse after the
death of a patient. 448 S.W.3d at 798. Several physicians sought to prevent
disclosure of that report, arguing that it was protected by the Act. Id. The trial
court ordered the hospital to produce the report, and the physicians sought
protection from the Court of Appeals via a writ of prohibition. Id. The Court of
Appeals issued the requested writ, but found that the Act's protection only
extended to "documents that contain a self-examining analysis." Id. at 799. In
doing so, the Court of Appeals relied, in large part, on Francis v. United States,
No. 09 Civ. 4004 (GBD)(KNF), 2011 WL 2224509 (S.D.N.Y. May 31, 2011)
which indicated that the scope of the Act's privilege extended only to the
analysis and corrective actions related to an adverse event of medical error.
Tibbs, 448 S.W.3d at 802. Thus, the Court of Appeals remanded the matter to
1 Justice Scott wrote the plurality opinion, in which Justices Venters and
Cunningham fully concurred. Justice Noble concurred in result only without separate
opinion and Justice Hughes wrote a dissenting opinion which Chief Justice Minton
joined. Justice Keller did not sit because she had presided over the Court of Appeals
panel that granted the requested writ.
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the trial court for an in camera review to determine if the requested document
contained that type of self-examining analysis. Id.
In analyzing the Court of Appeals's opinion, the plurality opinion in Tibbs
pointed out that Congress enacted the Act:
[I]n order to encourage health care providers to voluntarily
associate and communicate privileged patient safety work product
. . . among themselves through in-house patient safety evaluation
systems . . . and with and through affiliated patient safety
organizations . . . in order to hopefully create an enduring national
system capable of studying, analyzing, disseminating, and acting
on events, solutions, and recommendations for the betterment of
national patient safety, healthcare quality, and healthcare
outcomes.
Tibbs, 448 S.W.3d at 800. To incentivize participation, the Act provides
protection from disclosure to "certain categories of documents and
communications termed 'patient safety work product' that are developed in
connection with newly created patient safety organizations. This patient safety
work product is considered privileged.and, therefore, cannot be subject to
disclosure." Id. at 801 (quoting H.R. Rep. No. 109-197, 9 (2005)).
The plurality opinion then noted that the Court of Appeals's reliance on
Francis was misplaced because the language cited by the Court was dicta. Id.
at 802. Furthermore, the plurality opinion noted that "the Court of Appeals
relied on commentary from Francis regarding a prior version of the Act that
never became law, rather than on the Act itself." Id. Therefore, the plurality
opinion determined that the Court of Appeals erred by limiting the scope of
review by the trial court to "documents employing a self-critical analysis." Id.
at 802.
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The plurality opinion then undertook its own analysis of the Act and set
forth what it believed to be the proper scope of the Act's privilege and the
resultant scope of the trial court's review. As cited by the plurality opinion, the
Act defines patient safety work product as:
any data, reports, records, memoranda, and 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 healthcare 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.
Tibbs, 448 S.W.3d at 803 (quoting 42 U.S.C.A. § 299b-21 (7)(A)). However, as
the plurality opinion noted, Section (B) of 42 U.S.C.A. § 299b-21 (7) excepts
certain material from being considered patient safety work product. Id.
(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-
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(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
Federal, State, or local law.
Id. Thus, the plurality opinion determined that the Act does not "protect
information 'collected, maintained or developed separately, or existing
separately from a patient safety evaluation system' even if collected by a Patient
Safety Evaluation System and reported to a Patient Safety Organization."
Tibbs, 448 S.W.3d at 803-04. As the plurality opinion noted,
[T]he [Act] did not intend to supplant, or invalidate, traditional
state monitoring or regulation of health providers. See 42 U.S.C.A.
§ 299b-21(7)(B)(i)-(iii). . . . [T]he United States Department of
Health and Human Services' own final rules negate any such
intent: "The Patient Safety Act establishes 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 caresystem."
Id. at 807 (quoting Patient Safety and Quality Improvement, 73 FR 70732-01 at
70742) (emphasis added in opinion). Thus, the Act recognizes that providers
who participate in the Act may be subject to "dual reporting obligations." Id.
The plurality opinion noted that Kentucky mandates that:
Administrative reports shall be established, maintained and utilized
as necessary to guide the operation . . . of [health care facilities.]
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902 KAR 20:016 § 3(3)(a) (emphasis added). Such reports shall
include, among others, "incident investigation reports . . . and .. .
[o]ther pertinent reports made in the regular course of business."
Id. And such facilities shall "have written policies and procedures
governing all aspects of the operation of the facility and the
services provided, including: . . . (g) [a]n effective procedure for
recording accidents involving a patient . . . , including incidents of
transfusion reactions, drug reactions, medication errors, and
similar events . : . ." 902. KAR 20:016 § 3(4).
Id. at 808.
Based on the preceding, the plurality opinion determined that the
information in the incident report in question "would be found in an incident
report which is required by Kentucky regulations to be 'established, maintained
and utilized as necessary to guide the operation . . . of the facility.' 902 KAR
20:016 § 3(3)(a)." Id. at 809. The plurality opinion noted that the physicians
claimed the privilege applied because the information was not kept separately
but "was filed and stored in a database ostensibly dedicated to the Hospital's
Patient Safety Evaluation System operated by its Risk Management
Department and to which the hospital's [patient safety organization] has
access." Tibbs, 448 S.W.3d at 809. However, the plurality opinion concluded
that, while the information might "be relevant to [the hospital's] endeavors
under the Act, it is not, nor can it be, patient safety work product, since its
collection, creation, maintenance, and utilization is mandated by the
Commonwealth of Kentucky as part of its regulatory oversight of its healthcare
facilities." Id. Thus, the plurality opinion concluded that the trial court
should, on remand, separate the information "normally contained in . . . state-
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mandated incident reports" from "material properly privileged under the Act,"
and permit discovery of the non-privileged information. Id.
The dissent agreed with much of what the plurality opinion said about
the Act and that "patients or their estates are entitled to" information contained
in state mandated reports. Id. at 810. As the dissent noted, the Act does not
displace state law because:
[W]hen laws or regulations require the reporting of the information
regarding the type of events also reported to [patient safety
organizations], the Patient Safety Act does not shield providers from
their obligation to comply with such requirements. These external
obligations must be met with information that is not patient safety
work product and oversight entities continue to have access to this
original information in the same manner as such entities have had
access prior to the passage of the Patient Safety Act.
Id., at 814 (quoting Patient Safety and Quality Improvement, 73 FR 70732-01 at
70742)(emphasis added in opinion).
However, the dissent also noted that:
[The Senate Committee found] that broad protections are essential
to encourage reporting. Currently, there are few incentives and
many barriers for providers to collect and report information
regarding patient safety. The primary barrier relates to concerns
that information shared to promote patient safety would expose
providers to liability. Unless this information can be freely shared,
errors will continue to be hidden and errors will be repeated. A
more open, nonpunitive learning environment is needed to
encourage health care professionals and organizations to identify,
analyze, and report errors without facing the threat of litigation
and, at the same time, without compromising plaintiffs' legal rights
or affecting existing and future public reporting initiatives with
respect to the underlying data.
Tibbs, at 813-14.
8
According to the dissent, permitting judges "to sift through federally
protected patient safety data for otherwise discoverable material under state
law . . . [would] frustrate the Act's intent." Id. 810. Thus, the dissent
concluded that material, once included in the patient safety evaluation system
or submitted to a patient safety organization, is protected until removed from
that system or organization. Therefore, the only questions for a trial court to
answer in a discovery dispute would be: was the requested information ever .
includethpavionsytemd,fwaclu sit
removed. If the answer to the first question is, "Yes," and the answer to the
second question is, "No," then the information would be protected from
discovery.
While this matter has been pending, the Department of Health and
Human Services (HHS) issued additional guidance regarding interpretation and
implementation of the Act. In pertinent part, HHS stated that "the Patient
Safety Act does not permit providers to use the privilege and confidentiality
protections for [patient safety work product] to shield records required by
external recordkeeping or reporting requirements." Patient Safety and Quality
Improvement Act of 2005—HHS Guidance Regarding Patient Safety Work
Product and Providers' External Obligations, 81 FR 32655-01 at 32657. HHS
went on to note that providers have been misusing the Act in two ways to
shield from discovery otherwise discoverable documents.
First, some providers with recordkeeping or record maintenance
requirements appear to be maintaining the required records only
in their [patient safety evaluation system] and then refusing to
disclose the records, asserting that the records in their [patient
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safety evaluation system] fulfill the applicable regulatory
requirements while at the same time maintaining that the records
are privileged and confidential [patient safety work product].
Second, some providers appear to develop records to meet external
obligations outside of the [patient safety evaluation system], place
a duplicate copy of the required record into the [patient safety
evaluation system], then destroy the original outside of the [patient
safety evaluation system] and refuse to disclose the remaining copy
of the information, asserting that the copy is confidential and
privileged [patient safety work product]. The Patient Safety Act was
not intended to give providers such methods to evade their
regulatory obligations.
Id. at 32657-58. Therefore,
HHS interprets "original provider records" to include: (1) Original
records (e.g., reports or documents) that are required of a provider
to meet any Federal, state, or local public health or health
oversight requirement regardless of whether such records are
maintained inside or outside of the provider's patient safety
evaluation system; and (2) copies of records residing within the
provider's [patient safety evaluation system] that were prepared to
satisfy a Federal, state, or local public health or health oversight
record maintenance requirement, if while the provider is obligated
to maintain such information, the information is only maintained
by the provider within the [patient safety evaluation system] (e.g., if
the records or documents that were being maintained outside the
[patient safety evaluation system] to fulfill the external obligation
were lost or destroyed).
Id. at 32658 (footnote omitted). Thus, reports that are required by the
Commonwealth do not become privileged because the provider puts them in its
patient safety evaluation system.
The dissent noted that there might be times when a hospital would not
"generate a state-mandated record or report" thus frustrating a civil plaintiff s
legitimate request for information. Tibbs, 448 at 815-16. The dissent's
solution to this dilemma is for "an interested party to demand that a required
record or report be generated." Id. at 816. However, as HHS states, the
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solution is "for providers . . . to satisfy their external obligations outside of a
[patient safety evaluation system]." 81 FR 32655-01 at 32658. Providers who
satisfy those obligations should then have no fear that trial courts will be
meddling in federally protected documentation.
Having reviewed Tibbs, the arguments of the parties, the amicus curiae
herein, and the new HHS guidance, we believe that the correct result in this
case lies in middle ground between the plurality and the dissenting opinions in
Tibbs. We agree with the dissent that mandating invasion of "the hospital's
patient safety evaluation system" by trial courts every time there is a discovery
dispute would "discourage participation in the patient safety system by
Kentucky's healthcare providers." Id. at 816. However, permitting hospitals to
place and leave otherwise discoverable information in the patient safety
evaluation system in order to shield it from discovery is equally unacceptable
and, as noted by HHS, is not in keeping with the Act. Furthermore, the dissent
in Tibbs did not state how an interested party would make a demand that a
provider generate a report; to whom that demand would be made; or what
mechanism exists to enforce any order granting such a demand. Thus, we
believe that the solution offered by the dissent in Tibbs is not viable.
In summary, a provider who participates in the Act may collect
information within its patient safety evaluation system that complies with the
Act and that also complies with state statutory and regulatory requirements.
However, doing so does not relieve the provider from complying with those state
requirements and, to the extent information collected in the provider's internal
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patient safety evaluation system is needed to comply with those state
requirements, it is not privileged.
The existence of the Act does not relieve providers from fulfilling their
statutory and regulatory reporting obligations. As long as a provider fulfills
those obligations, the trial court has no reason to review the information in the
provider's patient safety evaluation system. However, if a provider fails to fulfill
those obligations, the court can conduct an in camera review of the documents
in the provider's patient safety evaluation system. In conducting that review,
the court should separate the information that is usually contained in state-
mandated reports from information that is not usually contained in those
reports. The information that is usually contained in state-mandated reports is
not protected by the patient safety work product privilege provided in the Act
and will be discoverable. Because the provider is claiming the privilege, it
bears the burden of proving that it complied with the statutory and regulatory
reporting requirements. If the provider fails to meet that burden, the party
seeking the information then bears the burden of establishing what
information is generally contained in state-mandated reports.
III. CONCLUSION.
For the foregoing reasons, we vacate the trial court's order requiring
Baptist Health Richmond, Inc. to produce documents, and we remand with
instructions for the court to undertake the review as set forth herein.
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All sitting. Keller, Cunningham, Noble and Venters, JJ., concur.
Hughes, J., concurs by separate opinion in which Minton, C.J. and Wright, J.,
join.
HUGHES, J., CONCURRING: I concur. After this Court's issuance of
Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014) and the Court of Appeals' denial of
a writ in this case, as Justice Keller notes, the Department of Health and
Human Services (HHS) issued a much-needed "Guidance Regarding Patient
Safety Work Product and Providers' External Obligations" (Guidance). In that
May 24, 2016 document, HHS clarified that records, or copies of records,
required of a provider "to meet any Federal, state, or local public health or
health oversight requirement," regardless of where maintained, are "original
provider records" not subject to the privilege arising under the Patient Safety
and Quality Improvement Act of 2005 (PSQIA). The Guidance answers the
thorny question of what happens if a provider objects to production on the
grounds that certain documents reside only in their patient safety evaluation
system created pursuant to PSQIA. I write separately simply to clarify my
understanding as to how a document request should be handled in cases
where the PSQIA is raised as a defense to production.
First, the trial court should determine whether any of the documents and
reports requested (and, obviously, relevant to the case before it) qualify as
"original provider records" under the above-cited Guidance definition regarding
Federal, state, or local public health or health oversight requirements. Notably,
HHS actually referenced a Kentucky administrative regulation as an example of
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a state mandating that a provider maintain a particular record, i.e., an incident
investigation report: "In Kentucky, hospitals are required to 'establish[],
maintain[], and utilize[]' administrative reports, including incident investigation
reports, `to guide the operation, measure productivity, and reflect the programs
of the facility.' 902 KAR 20:016 Section 3(3)(a)." Guidance at n.3. To the
extent any document or record is state-mandated or otherwise fits within the
"original provider record" definition from the Guidance, the court should order
its production. While there was some ambiguity prior to May 24, 2016, it is
now clear that even if that record is maintained solely in a patient safety
evaluation system, an order of production is proper and the PSQIA poses no
obstacle. Providers such as Baptist Health Richmond, Inc., undoubtedly
recognize their so-called "external obligations," as explained in the Guidance,
and should have such records available for prompt production. Only if they
have failed to fulfill those obligations, as Justice Keller notes, should the trial
court proceed to an in camera review of the contents of the provider's patient
safety evaluation system.
Minton, C.J. and Wright, J., join.
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COUNSEL FOR APPELLANT:
Melanie S. Marrs
Wesley Reed Butler
Chelsea Hayes
Benjamin M. Fiechter
Benjamin Beaton
Tobias Loss-Eaton
COUNSEL FOR APPELLEE:
William G. Clouse, Jr., pro se
COUNSEL FOR REAL PARTY IN INTEREST:
Gary C. Johnson
Angela Pergrem Owens
Gerald James Pierson
COUNSEL FOR AMICUS CURIAE: THE JOINT COMMISSION:
Jay Edward Ingle
COUNSEL FOR AMICUS CURIAE: PSYCHSAFE, CHS PSO, LLC; LINCOLN
TRAIL BEHAVIORAL HEALTH SYSTEM; RIVENDELL BEHAVIORAL HEALTH
SERVICES; THE RIDGE BEHAVIORAL HEALTH SYSTEM; CUMBERLAND HALL
HOSPITAL; THE BROOK HOSPITAL-DUPONT; THE BROOK HOSPITAL-KMI;
KENTUCKY RIVER MEDICAL CENTER; PAUL B. HALL REGIONAL MEDICAL
CENTER; THREE RIVERS MEDICAL CENTER; BLUEGRASS COMMUNITY
HOSPITAL; BOURBON COMMUNITY HOSPITAL; CLARK REGIONAL MEDICAL
CENTER; GEORGETOWN COMMUNITY HOSPITAL; JACKSON PURCHASE
MEDICAL CENTER; LAKE CUMBERLAND REGIONAL HOSPITAL; LOGAN
MEMORIAL HOSPITAL; MEADOWVIEW REGIONAL MEDICAL CENTER;
SPRING VIEW HOSPITAL; AND FLEMING COUNTY HOSPITAL:
David Sean Ragland
Michael R. Callahan
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