The opinion
J-A27022-25 2026 PA Super 53
TIFFANY GRIFFIN AND CHAD : IN THE SUPERIOR COURT OF
GREAVES : PENNSYLVANIA
:
:
v. :
:
:
THE BRYN MAWR HOSPITAL AND :
MAIN LINE HOSPITALS, INC. D/B/A : No. 3361 EDA 2024
THE BRYN MAWR HOSPITAL, JOHN :
DOE, BRENDA DEFEO, AND :
DONAHUE FUNERAL HOME OF UPPER :
DARBY, INC. :
:
:
APPEAL OF: THE BRYN MAWR :
HOSPITAL AND MAIN LINE :
HOSPITALS, INC. D/B/A THE BRYN :
MAWR HOSPITAL, BRENDA DEFEO :
Appeal from the Order Entered December 2, 2024
In the Court of Common Pleas of Montgomery County Civil Division at
No(s): 2022-06086
BEFORE: BOWES, J., MURRAY, J., and BECK, J.
OPINION BY BECK, J.: FILED MARCH 19, 2026
The Bryn Mawr Hospital and Main Line Hospitals, Inc. d/b/a The Bryn
Mawr Hospital (“the Hospital”), and Brenda DeFeo (“DeFeo”) (collectively,
“Defendants”) appeal from the order entered by the Montgomery County
Court of Common Pleas (“trial court”) compelling Defendants to produce
certain documents to Tiffany Griffin (“Griffin”) and Chad Greaves (“Greaves”)
(collectively, “Plaintiffs”). On appeal, Defendants argue that the trial court
erred in concluding that the documents were not privileged under the Medical
J-A27022-25
Care Availability and Reduction of Error Act (“MCARE”) 1 and the Patient Safety
Quality and Improvement Act (“PSQIA”)2. We conclude that the trial court
correctly determined that the documents at issue are not subject to the
evidentiary privilege under MCARE, but erred in finding that certain of the
documents were not subject to the evidentiary privilege of PSQIA. We
therefore affirm in part and reverse in part the trial court’s order.
Facts and Procedural History
In 2018, Griffin became pregnant. Greaves was the father. When she
was eighteen weeks pregnant, Griffin and Greaves learned that the fetus had
a genetic condition and would likely be stillborn or die soon after delivery.
Shortly after receiving this news, on October 1, 2018, Griffin began to bleed
heavily and sought medical attention at the Hospital. The Hospital performed
an ultrasound-guided dilation and evacuation procedure, during which Griffin
delivered the fetus intact but deceased. Plaintiffs declined to donate the fetal
remains to the Hospital for testing and instead authorized Donahue Funeral
Home of Upper Darby, Inc. (“Donahue Funeral Home”) to retrieve and cremate
the remains.
On October 13, 2018, Plaintiffs received ashes from Donahue Funeral
Home. On October 18, 2018, DeFeo, who was then Vice President of the
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1 40 P.S. §§ 1303.101-1303.910.
2 42 U.S.C. §§ 299b-21-299b-26.
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Hospital, called Griffin and informed her that there had been a “mix up” at the
Hospital, that the ashes she and Greaves had received were not that of their
unborn fetus, but likely were Griffin’s placenta, and that they had located the
fetal remains. See Complaint, 3/5/2020, ¶ 31. The Hospital then gave the
remains to Plaintiffs who sent them to another funeral home for cremation.
On March 5, 2020, Plaintiffs filed suit against Defendants in Delaware
County. In their complaint, Plaintiffs raised claims of negligent infliction of
emotional distress (“NIED”), intentional infliction of emotional distress
(“IIED”), tortious interference with a dead body, interference with the right of
sepulcher, corporate negligence, and negligence against Defendants. 3 In
support of their claims of NIED and IIED, Plaintiffs alleged that they suffered
emotional distress with physical manifestations, including “grief, rage, nausea,
hysteria, weight loss, nervousness, sleeplessness, nightmares and anxiety[.]”
Id. ¶¶ 42, 45. Plaintiffs further alleged that Griffin’s mental state worsened
to the point that she had to be admitted to the Crisis Center at Mercy
Fitzgerald Hospital for twelve hours and that her employer subsequently
terminated her employment because of her deteriorating mental state. Id.
¶¶ 44, 46-48.
In March 2020, Plaintiffs served Defendants with several discovery
requests. Of relevance to this appeal, in their request for production of
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3 They further raised claims of NIED and breach of contract against Donahue
Funeral Home.
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documents, Plaintiffs sought all documents, files, correspondence, and reports
related to Griffin, the fetal remains, and the investigation into the mishandling
of the fetal remains; any policies or procedures regarding such investigations;
and policies and procedures related to the handling of remains. According to
Plaintiffs, Defendants objected to most of Plaintiffs’ discovery requests,
including objections asserting that certain documents were protected from
discovery by attorney-client and other statutory privileges.
On September 5, 2023,4 Plaintiffs filed a motion seeking, in pertinent
part, to compel responses to their discovery requests. On February 9, 2024,
the trial court issued an order granting in part and denying in part Plaintiffs’
motion to compel discovery. Of relevance to this appeal, the trial court
permitted Defendants to object to the production of documents with the
provision of a privilege log to Plaintiffs, cautioning that Defendants would not
be permitted to make a general claim of privilege. See Trial Court Order,
2/9/2024, ¶¶ 2-3.
Defendants subsequently provided Plaintiffs with a privilege log
identifying the following documents, which are the basis of this appeal (“the
four documents”):
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4 The record reflects that there were several delays, beginning on February
24, 2021, when the Delaware County Court of Common Pleas entered an order
granting Defendants’ request to transfer the case to Montogomery County.
Plaintiffs filed a motion for reconsideration on the issue of change of venue,
which the Delaware court initially granted, but ultimately transferred the case
to Montgomery County, on February 8, 2022.
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1. Main Line Health Post Mortem Cause Analysis Report, prepared
by Patient Safety Officer, Beth Herbst on October 23, 2018;
2. Situation, Background, Assessment, and Recommendations
(“SBAR”) Report, prepared by Patient Safety Officer, Beth Herbst
on January 10, 2019;
3. Main Line SBAR Report prepared by Judy Gilbert of the Bryn
Mawr Pathology Laboratory on October 10, 2019; and
4. Pennsylvania Patient Safety Reporting System Report (“PA-
PSRS”), prepared on December 19, 2018.
See Memorandum in Support of Defendants’ Response to Plaintiffs’ Motion for
Sanctions, 6/10/2024, Ex. A (“Privilege/Non-Disclosure Log, 3/8/2024”).
Defendants claimed that each of the four documents was subject to the
evidentiary privileges of MCARE, PSQIA, and the Peer Review Protection Act 5.
See id. Defendants later provided an amended privilege log in which they
withdrew their Peer Review Protection Act claim of privilege for the four
documents and the PSQIA privilege for the PA-PSRS report only. See id., Ex.
B (“Amended Privilege/Non-Disclosure Log, 6/10/2024”).
Plaintiffs subsequently filed motions seeking to compel the production
of the four documents and for sanctions. On August 27, 2024, the trial court
held a hearing on these motions and conducted an in-camera review of the
four documents. On December 2, 2024, the trial court entered an order
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5 63 P.S. §§ 425.1-425.4.
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directing Defendants to produce the four documents to Plaintiffs. This timely
appeal followed.6 Defendants present the following issues for review:
A. Did the [trial] court err in concluding that the four documents
did not pertain to a patient safety event and were therefore not
entitled to privilege protection under MCARE or [PSQIA]?
B. Did the [trial] court err in concluding that the four documents
did not meet the requirements for privilege protection under
[s]ection 311(a) of MCARE?
C. Did the [trial] court err in concluding that the PA-PSRS report
to the Pennsylvania Patient Safety Authority was not privileged
under [s]ection 311(d) of MCARE?
D. Did the lower court err in ordering the production of patient
safety work product that is strictly and preemptively privileged
under [PSQIA]?
Defendants’ Brief at 5. Although Defendants purport to raise four separate
issues on appeal, their brief focuses on two arguments: (1) the trial court
erred in determining that the four documents were not subject to MCARE’s
evidentiary privilege, and (2) the trial court erred in concluding that each of
those documents, with the exception of the PA-PSRS report, were not subject
to PSQIA’s evidentiary privilege. We will examine each statutory privilege and
Defendants’ corresponding arguments below.
Standard of Review
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6 We note that although the appeal from a discovery order is interlocutory,
“Pennsylvania courts have held that discovery orders involving potentially
confidential and privileged materials are immediately appealable as collateral
to the principal action.” Boyle v. Main Line Health, Inc., 345 A.3d 291, 294
n.1 (Pa. Super. 2025) (citation omitted).
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We begin by setting forth our standard of review of discovery orders and
claims of evidentiary privilege.
In reviewing the propriety of a discovery order, our standard of
review is whether the trial court committed an abuse of discretion.
Abuse of discretion occurs if the trial court renders a judgment
that is manifestly unreasonable, arbitrary or capricious; that fails
to apply the law; or that is motivated by partiality, prejudice, bias
or ill-will.
Carlino E. Brandywine, L.P. v. Brandywine Vill. Assocs., 260 A.3d 179,
195-96 (Pa. Super. 2021) (citation and brackets omitted). “When the claim
of privilege requires consideration of a question of law, such as the
interpretation of a statute, our standard of review is de novo, and the scope
of our review is plenary.” Ford-Bey v. Pro. Anesthesia Servs., 302 A.3d
789, 796 (Pa. Super. 2023).
“The purpose of the discovery rules is to prevent surprise and unfairness
and to allow a fair trial on the merits.” Carlino E. Brandywine, 260 A.3d at
195 (quotation marks and citation omitted). “Generally, discovery is liberally
allowed with respect to any matter, not privileged, which is relevant to the
cause being tried.” Id. (quotation marks and citation omitted).
“Pennsylvania law imposes a shifting burden of proof in disputes when
deciding whether to compel disclosure of materials over a claim of any
privilege.” Ford-Bey, 302 A.3d at 796. “The party asserting a privilege bears
the burden of producing facts establishing proper invocation of the privilege.”
Ungurian v. Beyzman, 232 A.3d 786, 795 (Pa. Super. 2020). “Then the
burden shifts to the party seeking disclosure to set forth facts showing that
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disclosure will not violate the privilege.” Id. (brackets and citation omitted).
“If the party asserting the privilege produces insufficient facts to invoke the
privilege, then the burden will not shift to the party seeking disclosure.” Ford-
Bey, 302 A.3d at 796. “Absent a sufficient showing of facts to support a
privilege[,] the communications are not protected.” Ungurian, 232 A.3d at
795 (original brackets, quotation marks, and citation omitted).
Our review of the claims raised require us to interpret the relevant
statutory provisions. The paramount tenant of the Statutory Construction Act 7
is that “the object of all interpretation and construction of statutes is to
ascertain and effectuate the intention of the General Assembly.” Foxfield at
Naaman’s Creek Homeowner’s Assoc. v. Eventoff, 329 A.3d 1271, 1278
(Pa. Super. 2024) (citation and brackets omitted); see also 1 Pa.C.S.
§ 1921(a).
As we have often recognized, the General Assembly’s intent is best
expressed through the plain language of the statute. Therefore,
when the terms of a statute are clear and unambiguous, they will
be given effect consistent with their plain and common meaning.
This means ascribing to the particular words and phrases the
definitions which they have acquired through their common and
approved usage. It is only in instances where the words of a
statute are not explicit, or they are ambiguous, is there need to
resort to consideration of the factors in aid of construction
enumerated in 1 Pa.C.S.[] § 1921(c).
Eventoff, 329 A.3d at 1278 (quotation marks, brackets, and citations
omitted); see also 1 Pa.C.S. §§ 1903(a), 1921(b). “Moreover, when a term
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7 1 Pa.C.S. §§ 1501-1991.
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is not defined in a statute, its common and approved usage may be
ascertained by examining its dictionary definition.” Eventoff, 329 A.3d at
1278 (quotation marks and citation omitted).
MCARE
The General Assembly’s stated objective of MCARE is “to ensure that
medical care is available in this Commonwealth through a comprehensive and
high-quality health care system.” 40 P.S. § 1303.102. Chapter 3 of MCARE
“relates to the reduction of medical errors for the purpose of ensuring patient
safety.” Id. § 1303.301. It requires medical facilities to “develop,
implement[,] and comply with an internal patient safety plan that shall be
established for the purpose of improving the health and safety of patients[,]”
which, pertinent to this appeal, must establish a system for healthcare
workers to report “incidents” and “serious events.” Id. § 1303.307(a), (b)(3).
An “incident” is “[a]n event, occurrence[,] or situation involving the clinical
care of a patient in a medical facility which could have injured the patient
but did not either cause an unanticipated injury or require the delivery of
additional health care services to the patient.” Id. § 1303.302 (emphasis
added). A “serious event” is “[a]n event, occurrence or situation involving
the clinical care of a patient in a medical facility that results in death or
compromises patient safety and results in an unanticipated injury requiring
the delivery of additional health care services to the patient.” Id. (emphasis
added). As the bolded language reflects, a key component of both an
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“incident” and a “serious event” is that each must be related to the clinical
care of a specific patient. See id.
Healthcare workers that reasonably believe an incident or serious event
has occurred must report them according to the dictates of the patient safety
plan. Id. § 1303.308(a). The patient safety plan must designate a patient
safety officer and establish a patient safety committee for the taking,
investigation, and review of such reports. Id. §§ 1303.307(b), 1303.310(b).
Medical facilities must then report serious events to the Pennsylvania
Department of Health (“the Department”) and the Pennsylvania Patient Safety
Authority (“the Authority”), and incidents solely to the Authority. Id.
1303.313(a), (b).
The General Assembly included corresponding confidentiality provisions
to the reporting requirements delineated in Chapter 3. 8
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8 Section 1303.311 provides, in relevant part:
(a) Prepared materials.--Any documents, materials or
information solely prepared or created for the purpose of
compliance with section 310(b) or of reporting under section
304(a)(5) or (b), 306(a)(2) or (3), 307(b)(3), 308(a), 309(4),
310(b)(5) or 313 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
(Footnote Continued Next Page)
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Critical for our purposes is that section 311(a) protects “[a]ny documents,
materials or information solely prepared or created for the purpose of
compliance with section 310(b) or of reporting under” the listed statutory
provisions, “which arise out of matters reviewed by the patient safety
committee pursuant to section 310(b) or the governing board of a medical
____________________________________________
action or proceeding merely because they were presented to the
patient safety committee or governing board of a medical facility.
* * *
(c) Applicability.--The confidentiality protections set forth in
subsections (a) and (b) shall only apply to the documents,
materials or information prepared or created pursuant to the
responsibilities of the patient safety committee or governing board
of a medical facility set forth in section 310(b).
(d) Received materials.--Except as set forth in subsection (f),
any documents, materials or information received by the authority
or department from the medical facility, health care worker,
patient safety committee or governing board of a medical facility
solely prepared or created for the purpose of compliance with
section 310(b) or of reporting under section 304(a)(5) or (b),
306(a)(2) or (3), 307(b)(3), 308(a), 309(4), 310(b)(5) or 313
shall not be discoverable or admissible as evidence in any civil or
administrative action or proceeding. Any records received by the
authority or department from the medical facility, health care
worker, patient safety committee or governing board of a medical
facility pursuant to the requirements of this act shall not be
discoverable from the department or the authority in any civil or
administrative action or proceeding. Documents, materials,
records or information may be used by the authority or
department to comply with the reporting requirements under
subsection (f) and section 304(a)(7) or (c) or 306(b).
Id. § 1303.311(a), (c), (d).
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facility pursuant to section 310(b).” Id. § 1303.311(a). Section 311(d)
provides the same evidentiary privilege for “documents, materials or
information” involving the same statutory provisions that a medical facility
sends to the Department or the Authority. Id. § 1303.311(d). The
commonality between the listed statutory provisions in sections 311(a) and
(d) is that each provision sets forth guidelines and mandates for investigations
and reporting relating to incidents and serious events. See id. §§
1303.304(a)(5), (b), 1303.306(a)(2)-(3), 1303.307(b)(3), 1303.308(a),
1303.309(4), 1303.310(b)(5), 1303.313.
Thus, materials created or received to comply with Chapter 3’s reporting
requirements are privileged and not subject to disclosure in litigation. See
Ford-Bey, 302 A.3d at 795; see also 40 P.S. § 1303.311(a), (c), (d). As
this Court has explained, the General Assembly intended for the confidentiality
provision of section 311 to balance the MCARE requirements to report and
respond to incidents and serious events “with assurances that documents,
material, and information prepared or created to comply with MCARE will not
be used against a facility in civil litigation.” Ford-Bey, 302 A.3d at 795.
Additionally, the plain language of the statute makes clear that the General
Assembly’s intent in enacting MCARE was to promote patient safety. See 40
P.S. § 1303.301 (stating that MCARE “relates to the reduction of medical
errors for the purpose of ensuring patient safety”).
Arguments and Trial Court Rationale
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Defendants contend that the trial court erred in concluding that the four
documents were not subject to the MCARE privilege. See Defendants’ Brief
at 23-39. They assert that the trial court wrongly determined that documents
and information relating to the Hospital’s mishandling of the fetal remains
were not within the scope of MCARE’s section 311 privilege provisions because
the mishandling of the fetal remains did not occur during the direct
administration of clinical care to a patient. Id. at 23-24. According to
Defendants, the “disposition of fetal remains extracted during delivery of a
stillborn fetus is closely related and connected to the medical procedure itself;
indeed, it is a necessary consequence of the medical procedure.” Id. at 26.
They argue that by restricting the reporting and privilege provisions of MCARE
to exclude any occurrence that does not involve the direct clinical care of a
patient, the trial court’s interpretation of the terms “serious event” and
“incident” was too narrow. See id. at 24-26. “In doing so, the court brushed
aside the allegations of the [c]omplaint, which alleged not just potential, but
actual, harm to [Griffin] as a direct and foreseeable consequence of the error
in disposition of the fetal remains that had been extracted from her.” Id. at
26.
Additionally, Defendants argue that they satisfied all the “basic
requirements” for reporting under MCARE, as the Hospital has a patient safety
plan, a patient safety office, and a patient safety committee, and their affidavit
evidence demonstrates that the Hospital prepared each of the four documents
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solely for MCARE compliance. See id. at 30-35. Consequently, they assert
that under these circumstances, the four documents were privileged under
section 311(a) of MCARE. Id. at 32-35. Further, Defendants contend that
the PA-PSRS report is also subject to the privilege of section 311(d) of MCARE,
as the Hospital submitted that report to the Authority. Id. at 39.
In rejecting Defendants’ claim that the four documents are subject to
the evidentiary privilege of MCARE, the trial court explained:
The allegations of the [c]omplaint in this case do not allege liability
involving the clinical care of a patient [that] resulted in or could
have resulted in the death or serious injury to a patient. The
provisions of the MCARE Act are not applicable to the issues in this
lawsuit. There are no allegations of medical errors by any of the
[d]efendants. The alleged negligence does not meet the definition
of a “serious event” or “incident” as set forth in this act, as they
do not involve “the clinical care of a patient in a medical facility.”
There are no allegations that the “clinical care provided to the
patient,” [Griffin], was negligent or at issue in this lawsuit.
Therefore, no privilege provided by the MCARE Act prevents
discovery of the documents Plaintiffs seek.
Trial Court Opinion, 3/12/2025, at 12-13 (footnote omitted).
Analysis
The record reflects that Patricia Walsh (“Walsh”), the System Manager
for Risk and Safety at Main Line Health, averred in her affidavit that the
Hospital had a patient safety officer, a patient safety plan, and patient safety
committee. Memorandum in Support of Defendants’ Response to Plaintiffs’
Motion for Sanctions, 6/10/2024, Ex. C (“Walsh Affidavit, 6/7/2024”) ¶¶ 4-6.
Thus, the Hospital had the necessary personnel and systems in place for
investigating and reporting incidents and serious events under MCARE. See
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id.; see also 40 P.S. § 1303.307(b)(1)-(3). The record further reflects that
Beth Herbst, the Hospital’s patient safety officer, stated in her affidavit that
after receiving Judy Gilbert’s SBAR report from the pathology lab regarding
the fetal remains and her own investigation of the issue, she determined that
the mishandling of the fetal remains was reportable as an incident under
MCARE. Memorandum in Support of Defendants’ Response to Plaintiffs’ Motion
for Sanctions, 6/10/2024, Ex. D (“Herbst Affidavit, 6/7/2024”) ¶¶ 5, 9.
While Defendants may have believed that the mishandling of the fetal
remains was a reportable incident under MCARE and that they investigated
and reported it as such, nothing in the language of MCARE’s confidentiality
provisions supports a finding that a medical facility’s subjective belief as to
whether an issue is reportable as an incident or serious event controls the
applicability of the evidentiary privilege. See 40 P.S. § 1303.311. To the
contrary, section 311(a) expressly states that “[a]ny 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.”
Id. § 1303.311(a) (emphasis added).
We therefore conclude that documents, materials, records, or
information must relate to an issue that satisfies the statutory definition of an
“incident” or “serious event” to be subject to MCARE’s evidentiary privilege.
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See id. § 1303.311. To conclude otherwise, i.e., to allow a medical facility’s
subjective belief to control, would, in effect, permit a medical facility to use
the MCARE privilege as a sword instead of a shield, and make privileged any
document it wished not to disclose in litigation. With that in mind, we now
examine whether the mishandling of the fetal remains constituted an incident
or serious event under MCARE.
As stated above, for an event, situation, or occurrence to constitute an
incident or serious event, it must involve “the clinical care of a patient[.]” 40
P.S. § 1303.302. Although the statute does not define the phrase “clinical
care,” its common and approved usage reflects that it constitutes the provision
of direct medical attention to a patient. See TABER’S CYCLOPEDIC MEDICAL
DICTIONARY, 501, 390 (24th ed. 2021) (defining “clinical” as “[f]ounded on
actual observation and treatment of patients as distinguished from data or
facts obtained from other sources” and “care” as “the application of
professional skill, support, and concern to provide health benefits to a person
or a community”). This aligns with the definitions of substantially similar
phrases in other statutory provisions. See, e.g., 43 P.S. § 932.2 (defining
“clinical care services” in the Prohibition of Excessive Overtime in Health Care
Act as the “diagnostic, treatment or rehabilitative services provided in a health
care facility”); 34 Pa. Code § 123.103(b) (under the Workers’ Compensation
Act, the “the phrase ‘active in clinical practice’ means the act of providing
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preventive care and the evaluation, treatment and management of medical
conditions of patients on an ongoing basis”).
In this case, the claims Plaintiffs raised in their complaint relate to the
Hospital’s actions that occurred after the administration of direct medical care
to Griffin. See Complaint, 3/5/2020, ¶¶ 49-112. More directly, the Hospital’s
handling of the fetal remains did not have any impact on the dilation and
evacuation procedure the Hospital performed on Griffin, the patient. See id.
Following the completion of the dilation and evacuation, there was nothing
more that Griffin needed for her medical care—no testing of the fetal remains
was required (in fact, she expressly refused to allow any such testing to
occur)—and neither party contends that Defendants’ mishandling of the fetal
tissue could have in any way impacted the medical care Griffin required. See
id. The Hospital’s mishandling of the fetal remains was wholly attenuated
from Griffin’s care and therefore did not constitute “clinical care of a patient.”
Nor could the mishandling of fetal remains “have injured the patient,” as is
required for an “incident” or have resulted in her “death or compromise[d]
patient safety” as is required for it to constitute a “serious event.” See 40
P.S. § 1303.302.
Although Plaintiffs allege that Griffin ultimately suffered emotional
distress from the mishandling of the fetal remains, which required additional
treatment in the form of mental health intervention, this was entirely
unrelated to the clinical care Griffin received from Defendants—i.e., the
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dilation and evacuation procedure she received at the Hospital. See
Complaint, 3/5/2020, ¶¶ 42-48. Accordingly, based on the foregoing we
conclude that the trial court did not err in determining that the section 311
privilege does not apply to the four documents.
PSQIA
“PSQIA was enacted to establish a nationally uniform set of protections
for healthcare providers, and to encourage hospitals and other healthcare
providers to analyze and discuss patient safety and healthcare quality,
including medical errors, without fear of those evaluations being used in civil
litigation.” Boyle, 345 A.3d at 303. The privilege provision of PSQIA protects
“patient safety work product.” 42 U.S.C. § 299b-22(a). It defines “patient
safety work product” as
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.
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Id. § 299b-21(7)(A). Section 299b-22 thus provides that patient safety work
product is privileged and confidential and not subject to a discovery order in
a state civil proceeding. See id. § 299b-22(a)-(b). These privileges also
apply notwithstanding any other provision of state law. See id.
The term “patient safety activities” under PSQIA means the following:
(A) Efforts to improve patient safety and the quality of health care
delivery.
(B) The collection and analysis of patient safety work product.
(C) The development and dissemination of information with
respect to improving patient safety, such as recommendations,
protocols, or information regarding best practices.
(D) The utilization of patient safety work product for the purposes
of encouraging a culture of safety and of providing feedback and
assistance to effectively minimize patient risk.
(E) The maintenance of procedures to preserve confidentiality
with respect to patient safety work product.
(F) The provision of appropriate security measures with respect
to patient safety work product.
(G) The utilization of qualified staff.
(H) Activities related to the operation of a patient safety
evaluation system and to the provision of feedback to participants
in a patient safety evaluation system.
Id. § 299b-21(5).
Arguments and Trial Court Rationale
Defendants assert that the trial court erred in concluding the documents
at issue (those other than the PA-PSRS report) (“the three documents”) were
not subject to the PSQIA evidentiary privilege. See Defendants’ Brief at 40-
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52. Specifically, they contend that the trial court incorrectly determined that
documents or other information relating to the investigation, analysis, and
reporting of the mishandling of the fetal remains did constitute patient safety
work product under PSQIA. See id. Defendants contend that for documents
to be privileged under PSQIA, they do not need to relate to a patient, as PSQIA
does not require a nexus between the information a party is seeking and a
patient or medical care provided by a medical facility. Id. at 45-47. Rather,
they maintain that language of PSQIA is far broader than MCARE, and that
information or documentation constitutes patient safety work product so long
as “its review is geared towards improving quality.” Id. at 47-48. Pointedly,
Defendants argue that, “the tracking of tissue in the laboratory and the
whereabouts of fetal remains fall squarely within that purpose” and that “it is
unquestionable that policies and procedures regarding the storage and
tracking of specimens in the lab is of critical consequence to the health, safety
and quality of care provided by [a medical facility].” Id. at 48, 50.
Additionally, Defendants observe that PSQIA is a federal statute that
supersedes “any conflicting state law provision that otherwise render the
information discoverable.” Id. at 42.
In rejecting Defendants’ claim that the three documents are subject to
the evidentiary privilege of PSQIA, the trial court explained:
The documents sought by [Plaintiffs] do not fit the definition of
patient work safety product as defined in 42 U.S.C. [§] 229b-21.
The records sought do not involve care given to a patient by a
medical provider. This lawsuit is not about patient safety issues.
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Rather, it is about alleged negligence in [the handling of the fetal
remains]. Thus, because the alleged negligence in this case did
not involve patient safety as defined in PSQIA, the Patient Safety
and Quality Improvement Act does not provide any privilege to
[Defendants that would preclude] the disclosure of the documents
Plaintiffs seek.
Trial Court Opinion, 3/12/2025, at 13-14.
Analysis
At the outset, we agree with the trial court that the three documents in
question are not privileged under section 299b-21(7)(A)(i). See id. The
record reflects that Walsh conceded in her affidavit that the Hospital did not
report the three documents at issue to the Hospital’s patient safety
organization nor did the patient safety organization prepare the documents.
See Walsh Affidavit, 6/7/2024, ¶ 12. Additionally, Defendants make no
assertion that the patient safety organization developed the three documents.
See Defendants’ Brief at 40-52.
We disagree, however, with the trial court’s conclusion as it relates to
section 299b-21(7)(A)(ii). See Trial Court Opinion, 3/12/2025, at 13-14. In
contrast to MCARE, a medical facility’s intent in developing a document is
relevant in determining whether the document is subject to PSQIA’s privilege
provision as section 299b-21(7)(A)(ii) expressly states the privilege applies to
“deliberations or analysis of, or … reporting pursuant to, a patient safety
evaluation system.” Compare 40 P.S. §§ 1303.302, 1303.307(b),
1303.310(b), 1303.311(a), with 42 U.S.C. § 299b-21(7)(A)(ii). In this case,
Walsh stated in her affidavit that the three documents constitute “analysis”
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conducted within the Hospital’s patient safety evaluation system. Walsh
Affidavit, 6/7/2024, ¶¶ 12-14. She also frequently refers to the documents
as patient safety work product. See id. Additionally, the Hospital’s patient
safety evaluation system policy states that patient safety work product is
privileged and confidential and its definition of patient safety work product
mirrors PSQIA’s same definition and includes the clarification that information
for which privilege is asserted must be of a category that “could improve
patient safety, health care quality or health care outcomes.” Id., Ex. B at 2.
Further, we reviewed the three documents for purposes of this appeal and
confirmed that they include analysis pursuant to the Hospital’s patient safety
evaluation system, detailing the facts underlying what occurred and how, if at
all, it aligned with or violated the Hospital’s policies and processes.
Importantly, unlike MCARE, PSQIA includes no requirement that patient
safety work product bear a direct link or nexus to a particular patient or the
clinical care of a patient. See, e.g., Shands Teaching Hosp. & Clinics, Inc.
v. Beylotte, 357 So.3d 307, 309 (Fla. Dist. Ct. App. 2023) (holding that
report regarding a visitor’s slip-and-fall at a hospital was privileged even
though the visitor was not a patient because “staff, patients, and visitors alike”
could “face similar slip-and-fall risks in a hospital’s common areas”). Instead,
as the plain language of the statute makes clear, for the PSQIA privilege under
section 299b-21(7)(A)(ii) to apply, the document in question must simply
contain “deliberations or analysis of, or … reporting pursuant to, a patient
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safety evaluation system.” 42 U.S.C. § 299b-21(7)(A)(ii). PSQIA protects
“work product so long as it identifies or constitutes the deliberations or
analysis of, or identifies the fact of reporting pursuant to a patient safety
evaluation system, … regardless of whether it is reported to a patient safety
organization.” In Re: Baycare Med. Grp., 101 F.4th 1287, 1291 (11th Cir.
2024) (citation and quotation marks omitted).
Moreover, unlike MCARE, PSQIA not only addresses what happened to
a given patient, but hypothetically what could have happened to a similarly
situated patient in another circumstance. Compare 40 P.S. §§ 1303.302,
1303.307(b), 1303.310(b), 1303.311(a), with 42 U.S.C. § 299b-21(7)(A)(ii).
Thus, contrary to the trial court’s conclusion, for purposes of the PSQIA
privilege it is of no moment that the allegations in the complaint did relate to
medical care the Hospital administered to Griffin or a patient safety issue, and
instead exclusively related to the mishandling of the fetal remains. See Trial
Court Opinion, 3/12/2025, at 13-14.
The Senate Report on PSQIA confirms our interpretation that the
unambiguous language of the statute reflects the legislature’s intent for a
broad definition of patient safety work product, as it states that “the entire
health care delivery system can benefit from a systems analysis of near misses
and errors that have resulted in adverse events for systems improvement and
corrective action.” Senate Report, 108-196 (Nov. 17, 2003) at 4. This more
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expansive application of the privilege also aligns with the overall purpose of
PSQIA:
The purpose of this legislation is to encourage a “culture of safety”
and quality in the U.S. health care system 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. These protections will facilitate
an environment in which health care professionals and
organizations report and evaluate health care errors and share
their experiences with others in order to prevent similar
occurrences.
Id. at 3; see also Francis v. U.S., 2011 WL 2224509, at *6 (S.D. N.Y. 2011)
(unpublished decision) (describing the protections afforded by the PSQIA
confidentiality privilege as “broad”).
Based on the foregoing, we conclude that the mishandling of the fetal
remains that occurred here falls squarely within the stated purpose of PSQIA.
The record reflects that in response to the mishandling of the fetal remains,
the Hospital investigated the incident as a failure of its laboratory and
pathology procedures. See Herbst Affidavit, 6/7/2024, ¶¶ 4-6. Indeed, one
of the documents to which Defendants assert the PSQIA privilege attaches
was prepared by staff from the pathology lab. See Amended Privilege/Non-
Disclosure Log, 6/10/2024. Additionally, the Hospital’s uncontroverted
affidavit evidence established that the documents in question contained
analysis and that the Hospital maintained the three documents exclusively
within its patient safety evaluation system. See Herbst Affidavit, 6/7/2024,
¶¶ 5, 8; Walsh Affidavit, 6/7/2024, ¶¶ 12-14. This established the necessary
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requirements for application of PSQIA’s privilege under section 299b-
21(7)(A)(ii), as the record supports the conclusion that the three documents
were deliberations or analysis of, or reporting pursuant to, the Hospital’s
patient safety evaluation system. See id.
As we have already concluded, the failing of the Hospital’s laboratory
and pathology procedures did not harm or threaten harm to Griffin as it related
to her dilation and evacuation procedure. However, if the laboratory and
pathology procedural failing occurred in a different context—for example, the
mishandling of potentially cancerous tissue removed from a patient that
required further testing—this could have resulted in a delayed or incorrect
diagnosis, and therefore would clearly involve issues of patient safety. Cf.
Green Analytics North, LLC v. Pa. Dep’t of Health, 343 A.3d 1086, 1097
(Pa. 2025) (explaining, in a case involving the Medical Marijuana Act,
“accurate and independent test results serve the clearly expressed statutory
goals of patient safety”). It is indisputable that policies and procedures
regarding the storage and tracking of laboratory or pathology specimens that
require further testing for patient diagnosis and/or treatment are critical to
the health, safety, and quality of care provided by a hospital. 9 See id.
____________________________________________
9 Respectfully, the concurring and dissenting opinion (“CDO”) interprets
PSQIA too narrowly. See CDO at 10. Our learned colleague focuses on what
specifically may or may not have occurred with respect to the fetal remains in
this case, based upon Hospital policy, rather than more broadly considering
the implications of the Hospital’s mishandling of excised tissue. The record
(Footnote Continued Next Page)
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Conclusion
Based on the foregoing, we conclude that the trial court correctly found
that the four documents were not privileged under MCARE. It erred, however,
in determining that the three documents did not constitute patient safety work
product under PSQIA and were not subject to PSQIA’s privilege protection.
We therefore affirm the trial court’s order to the extent that it requires
Defendants to disclose the PA-PSRS report and reverse the order to the extent
that it requires Defendants to disclose the remaining three documents.
Order affirmed in part and reversed in part. Case remanded.
Jurisdiction relinquished.
Judge Bowes joins the Opinion.
Judge Murray files a Concurring and Dissenting Opinion.
Date: 3/19/2026
____________________________________________
indicates that the Hospital left the fetal remains in the morgue for an extended
period, and that the morgue expressly falls within the purview of the pathology
department. Thus, this matter directly involves the Hospital’s pathology
department mishandling or misplacing human tissue. As we explained above,
PSQIA not only addresses what happened to a specific patient in a given
situation, but hypothetically what could have happened to a similarly situated
patient in another circumstance.
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