                                             RENDERED: SEPTEMBER 22, 2016
                                                         TO BE PUBLISHED

               $uprrntr (Court iaf eTcfi rtru
                                           t
                              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).




                                         2
                                   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.

                                          3
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.


                                         4
      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-


                                         5
            (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.]


                                        6
      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-




                                         7
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
                                           9
      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


                                         10
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


                                          11
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.




                                         12
        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


                                         13
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.




                                          14
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




                                 15
