The opinion
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[PUBLISH]
In the
United States Court of Appeals
For the Eleventh Circuit
____________________
No. 23-12571
____________________
In re: BAYCARE MEDICAL GROUP, INC.,
ST. JOSEPH’S HOSPITAL, INC.,
Petitioners.
____________________
On Petition for Writ of Mandamus to the
United States District Court for the
Middle District of Florida
D.C. Docket No. 8:21-cv-01891-WFJ-TGW
____________________
Before BRANCH, BRASHER, and ABUDU, Circuit Judges.
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2 Opinion of the Court 23-12571
BRASHER, Circuit Judge:
This petition for a writ of mandamus raises an issue of first
impression under the Patient Safety and Quality Improvement Act
of 2005, 42 U.S.C. § 299b-22(a). Dr. Tara Loux filed an employment
discrimination suit against her former employers BayCare Medical
Group and St. Joseph’s Hospital, which we will refer to collectively
as “BayCare.” The district court ordered BayCare to produce its
quality files and referral logs to Loux in discovery. BayCare argues
that those documents are “patient safety work product” that are
“privileged and . . . [not] subject to discovery in connection with a
Federal . . . civil . . . proceeding” under the Act. Id. § 299b-22(a)(2).
We agree that BayCare is entitled to mandamus. The district
court required BayCare to establish, as part of its privilege claim,
that the disputed documents were created or maintained for the
“sole purpose” of making reports to a patient safety organization.
We see no support for that requirement in the text of the statute.
Because the district court applied the wrong legal standard to assess
BayCare’s privilege claim, and because BayCare has no adequate
legal remedy, we GRANT the petition and direct the district court
to VACATE its orders compelling the disclosure of the privileged
documents and RECONSIDER BayCare’s assertion of privilege
consistent with this opinion.
I.
Dr. Loux sued her former employer BayCare for terminat-
ing her after she committed surgical errors. She sought to discover
BayCare’s internal documents about the performance of other
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doctors who were not fired despite also committing errors. In re-
sponse, BayCare argued that some of these files were privileged
under the Patient Safety and Quality Improvement Act of 2005.
Specifically, BayCare objected to disclosing documents, such as its
“quality files” and “referral logs,” that are stored in the secure elec-
tronic database rlDatix.
The Act creates a statutory privilege for work product pre-
pared for or reported to patient safety organizations. See 42 U.S.C.
§ 299b-22(a)(2). Patient safety organizations analyze patient safety
trends and propose new methods to providers to mitigate medical
risks in the care process. The Act tasks the Secretary of the Depart-
ment of Health & Human Services with certifying and listing enti-
ties as patient safety organizations. See id. § 299b-24. Congress cre-
ated the privilege “to encourage the reporting and analysis of med-
ical errors and health care systems by providing peer review pro-
tection of information reported to patient safety organizations for
the purposes of quality improvement and patient safety” so “an en-
vironment [exists] in which health care providers are able to discuss
errors openly and learn from them.” H.R. Rep. No. 109–197, at 9
(2005).
The privilege operates by defining three terms: patient
safety work product, patient safety organization, and patient safety
evaluation system. The Act provides that “patient safety work
product” cannot be “subject to discovery in connection with a Fed-
eral, State, or local civil . . . proceeding . . . .” 42 U.S.C. § 299b-
22(a)(2). The Act defines “patient safety work product” as, in
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4 Opinion of the Court 23-12571
relevant part, “any data, reports, records, memoranda, anal-
yses, . . . or written or oral statements” that (1) “are assembled or
developed by a provider for reporting to a patient safety organiza-
tion and are reported” or (2) otherwise “identify or constitute the
deliberations or analysis of, or identify the fact of reporting pursu-
ant to, a patient safety evaluation system.” Id. § 299b–21(7)(A). The
Act defines a “patient safety organization” as “a private or public
entity or component thereof that is listed by the Secretary” of HHS
as a qualifying entity. Id. § 299b–21(4). And the Act defines a “pa-
tient safety evaluation system” as “the collection, management, or
analysis of information for reporting to or by a patient safety or-
ganization.” Id. § 299b–21(6). The Act excludes from its protection,
among other things, “information that is collected, maintained, or
developed separately, or exists separately, from a patient safety
evaluation system.” Id. § 299b–21(7)(B)(ii).
BayCare introduced evidence about how it decides whether
to make reports to a patient safety organization. When the hospital
receives a complaint about a doctor, its Customer Experience De-
partment refers any complaint involving safety concerns to a qual-
ity care coordinator. Those patient safety referrals are tracked in
BayCare’s referral logs, which are stored in rlDatix, a “secure elec-
tronic database.” After the quality care coordinator receives the re-
ferral, the system generates a new document called a quality file.
The quality file contains descriptions of the event and records the
coordinator’s analysis, including informal “peer review” such as in-
put from department heads about whether there was a deviation
in the standard of care. The coordinator then records any rectifying
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23-12571 Opinion of the Court 5
steps performed by BayCare. He or she will also analyze whether
the concern was significant enough to forward to the Clinical Risk
Department, the final step in BayCare’s complaint evaluation pro-
cess, which sends reports to a patient safety organization and then
works with the organization to develop new safety protocols.
BayCare’s elaborate patient safety evaluation process does
not relieve it from state law recordkeeping and reporting obliga-
tions. As relevant here, the State of Florida requires BayCare to
maintain agendas and minutes of formal peer review meetings, see
Fla. Stat. § 395.0193(2), and report certain serious adverse patient
outcomes to the state within fifteen days, see id. § 395.0197(7),
which are commonly referred to as “Code-15 reports.” To comply
with these requirements, BayCare creates additional documents
using separate systems. For example, BayCare does not use docu-
ments from rlDatix as its Code-15 reports to Florida; instead, it cre-
ates the reports using the state’s reporting portal. BayCare then re-
tains its copy of the completed form outside the rlDatix database.
Similarly, when it discloses the agendas and minutes for peer re-
view meetings to the State, BayCare creates separate documents
outside rlDatix that are never placed in the database.
As a consequence, BayCare “has never used any of the [files]
kept in rlDatix to meet any external reporting obligation.” But it
concedes that it uses information stored in rlDatix for more than
just reporting to a patient safety organization. Multiple BayCare
teams can access the stored information internally for risk manage-
ment, quality assurance, peer review, or root cause analysis.
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After reviewing the contested documents and conducting a
hearing, the magistrate judge recommended that the district court
treat the documents as privileged under the Act. The magistrate
judge classified the quality files as materials that were used to assess
patient safety and quality of care. The magistrate judge determined
that the referral logs, like the quality files, were patient safety work
product that “identif[ied] the fact of reporting pursuant to, a patient
safety evaluation system.” 42 U.S.C. § 299b-21(7)(A)(ii).
The district court disagreed and ordered BayCare to provide
Loux the disputed documents. It concluded that the Act does not
privilege documents if they have a “dual purpose,” only one of
which relates to making reports to a patient safety organization.
Based on that legal conclusion, the district court held that these
documents were not privileged. The district court explained that,
to the extent Florida law required BayCare to create any infor-
mation, BayCare’s documents reflecting that information were not
solely to report to a patient safety organization and, therefore, are
not privileged. The district court likewise held that, because
BayCare used information in rlDatix for other purposes, such as
internal safety analysis and peer review, the information was not
privileged. The district court also expressed concern that Loux
would be “unable to have proper litigation discovery” without the
documents. Accordingly, the court ordered BayCare to produce
the quality files and referral logs.
This petition followed.
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II.
BayCare is entitled to a writ of mandamus if the district
court clearly abused its discretion and if there are “no other ade-
quate means” to remedy the district court’s clear abuse of discre-
tion. Jackson v. Motel 6 Multipurpose, Inc., 130 F.3d 999, 1004 (11th
Cir. 1997) (quoting In re Temple, 851 F.2d 1269, 1271 (11th Cir.
1988)). An error of law is a per se abuse of discretion. Managed Care
Advisory Grp., LLC v. CIGNA Healthcare, Inc., 939 F.3d 1145, 1153
(11th Cir. 2019). A petitioner’s right to issuance of the writ must be
clear and indisputable, and we must be satisfied that the writ is ap-
propriate under the circumstances. United States v. Shalhoub, 855
F.3d 1255, 1262–63 (11th Cir. 2017).
III.
We believe BayCare is entitled to a writ of mandamus.
There’s no dispute that mandamus is BayCare’s only possible rem-
edy. Should it have to produce the quality files and referral logs,
the disclosure of that information cannot be undone—regardless of
what protective measures the court may order. Because of the im-
portance of privileged information, the seriousness of the injury
when disclosed during discovery, and the lack of effective review
after disclosure, we have found that mandamus is the appropriate
remedy for immediate review in comparable cases. In re Fink, 876
F.2d 84, 84 (11th Cir. 1989).
The only disputed question is whether the district court
erred when it ordered BayCare to produce the quality files and
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8 Opinion of the Court 23-12571
referral logs at issue. We believe it did. BayCare argues, and we
agree, that the district court clearly abused its discretion by apply-
ing the incorrect standard to assess whether BayCare’s quality files
and referral logs fell under the privilege. Specifically, the district
court applied a “dual” or “sole” purpose test that is not supported
by the text of the Act. Rather than satisfy any atextual “sole pur-
pose” requirement, the statute requires BayCare to establish that
the files (1) “identify or constitute the deliberations or analysis of”
a patient safety evaluation system, 42 U.S.C. § 299b–21(7)(A)(ii),
and (2) are not “collected, maintained, or developed separately, or
exist[] separately, from a patient safety evaluation system,” id.
§ 299b–21(7)(B)(ii).
We can start, and end, with the text of the statute. As we’ve
already explained, the Act operates by defining—and then protect-
ing from disclosure—“patient safety work product.” It defines “pa-
tient safety work product” in three ways: (1) “data, reports, records,
memoranda, analysis . . . or written or oral statements . . . assem-
bled or developed . . . for reporting to a patient safety organiza-
tion,” id. § 299b–21(7)(A)(i)(I); (2) such things developed by a pa-
tient safety organization, id. § 299b–21(7)(A)(i)(II); and (3) such
things that “identify or constitute the deliberations or analysis of,
or identify the fact of reporting pursuant to, a patient safety evalu-
ation system,” id. § 299b–21(7)(A)(ii).
BayCare’s privilege claim arises under the third paragraph.
It argues that the quality files and referral logs reflect “the deliber-
ations or analysis of . . . a patient safety evaluation system.” Id. The
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Act defines a “patient safety evaluation system” as “the collection,
management, or analysis of information for reporting to or by a
patient safety organization.” Id. § 299b–21(6). So, reading the oper-
ative language together, BayCare must establish that the disputed
documents “identify or constitute the deliberations or analysis of”
BayCare’s process of “collect[ing], manag[ing], or analy[zing] infor-
mation for reporting to or by a patient safety organization.”
The parties do not dispute that BayCare’s rlDatix database
contains its “patient safety evaluation system” within the meaning
of the statute. Instead, the dispute is about a question of law:
BayCare argues that there is no “sole purpose” requirement in the
statute; Loux argues that there is.
We agree with BayCare. Under the plain text of this statute,
it does not matter whether BayCare created, used, or maintained
the disputed documents for multiple purposes. Contrary to the dis-
trict court’s order, nowhere does the statute require that privileged
information be “kept solely for provision to a Patient Safety Organ-
ization.” Instead, the Act privileges work product so long as it
“identif[ies] or constitute[s] the deliberations or analysis of, or iden-
tif[ies] the fact of reporting pursuant to” a patient safety evaluation
system, id. § 299b–21(7)(A), regardless of whether it is reported to
a patient safety organization. The relevant administrative rule con-
firms as much: BayCare “may use patient safety work product for
any purpose within [its] legal entity.” Patient Safety and Quality
Improvement, 73 Fed. Reg. 70732-01 at 70779 (Nov. 21, 2008).
Nothing “prohibit[s] the disclosure of patient safety work product
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among physicians and other health care professionals, particularly
for education purposes or for preventing or ameliorating harm.”
Id. at 70778.
As far as we are aware, the only basis for imposing a “sole
purpose” test is a brief reference in HHS’s supplemental guidance
from 2016. See HHS Guidance Regarding Patient Safety Work
Product and Providers’ External Obligations, 81 Fed. Reg. 32655-
01 (May 24, 2016). It includes a small chart of information that
“[c]ould be” patient safety work product if it is “prepared solely for
reporting to” a patient safety organization. Id. at 32656. But that
supplemental guidance, by definition, isn’t law. See Kisor v. Wilkie,
139 S. Ct. 2400, 2420 (2019). And that portion of the 2016 guidance
contradicts HHS’s final rule—which does have legal effect. See id.
The regulation is clear—“[U]ses of patient safety work product
within a legal entity are not regulated and thus, patient safety work
product may be used within an entity for any purpose, includ-
ing” “credentialing, disciplinary, and peer review purposes.” Pa-
tient Safety and Quality Improvement, 73 Fed. Reg. 70732-01 at
70779.
There are some statutory exceptions to the privilege, of
course. The privilege does not protect from disclosure “a patient’s
medical record, billing and discharge information, or any other
original patient or provider record.” 42 U.S.C. § 299b–21(7)(B)(i). It
also does not apply to “information that is collected, maintained,
or developed separately, or exists separately, from a patient safety
evaluation system.” Id. § 299b–21(7)(B)(ii). That kind of separately
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23-12571 Opinion of the Court 11
developed or maintained information “shall not by reason of its re-
porting be considered patient safety work product.” Id. Finally, the
privilege doesn’t affect obligations to make reports to governmen-
tal agencies or any recordkeeping obligations tied to those reports.
Id. § 299b–21(7)(B)(iii)(II)–(III).
None of these exceptions even arguably support a “sole pur-
pose” requirement. The first exception applies to a category of in-
formation exempt from privilege no matter where it is found or
why it was created. The second exception turns on where and how
information is developed, stored, or located; it states that the mere
fact that information may be privileged if it is developed in one set-
ting does not mean it is privileged in any setting. The third excep-
tion to the privilege means that states may continue to impose
recordkeeping and reporting requirements in hospital systems like
BayCare. But nothing in the statute says that documents are privi-
leged only if they are created or maintained for a single purpose.
Applying these exceptions, the district court found that
BayCare’s documents were not privileged because the quality files
and referral logs “are dual-purpose records that [BayCare was] re-
quired to make by Florida Statutes, § 395.0193(2).” That state law
requires that providers “develop written, binding procedures” for
peer review and provide agendas and minutes to the state. There
are two problems with this conclusion. First, BayCare submitted
undisputed evidence that it satisfied state reporting requirements
by creating new documents outside its patient safety evaluation sys-
tem. See id. § 299b-21(7)(B)(iii). Second, although this state law
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requires certain licensed facilities to develop procedures for peer
review, it does not require the disclosure of the peer review pro-
cess. On the contrary, state law provides that “[t]he proceedings
and records of peer review panels, committees, and governing
boards . . . are not subject to inspection under s. 119.07(1),” “are
not open to the public under the provisions of chapter 286,” and
“shall not be subject to discovery or introduction into evidence in
any civil or administrative action against a provider of professional
health services arising out of the matters which are the subject of
evaluation and review by such group or its agent . . . .” Fla. Stat.
§ 395.0193(7) & (8). Accordingly, there is no evidence in the record
that the quality files or referral logs at issue in this mandamus ac-
tion were created or maintained separately to meet any external
obligations or that they were reported to the state.
Again, administrative guidance amplifies this plain-text
point. HHS has explained that the statute allows providers to main-
tain separate systems for patient safety work product and records
necessary for external record keeping and reporting obligations.
Patient Safety Work Product, 81 Fed. Reg. 32655-01 at 32659–60.
Documents reported to a state are not privileged. Id. at 32659. So,
to avoid removing documents from a patient safety evaluation sys-
tem to meet external obligations, providers can “maintain at least
two systems or spaces: A [patient safety evaluation system] for [pa-
tient safety work product] and a separate place where it maintains
records for external obligations.” Id. at 32659. With two systems in
place, providers can ensure that they will not need to “drop out”
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information from their evaluation systems to satisfy state law re-
quirements.
In the face of this straightforward statutory analysis, Loux
makes three arguments to support the “sole purpose” test. None is
persuasive.
First, Loux argues that reading the Act according to its text
conflicts with our decision in Adkins v. Christie, 488 F.3d 1324 (11th
Cir. 2007). We disagree. In Adkins, we decided whether to recog-
nize an evidentiary privilege known as the “medical peer review
privilege” in federal civil rights cases. We ultimately declined to
recognize the privilege. Id. at 1326, 1327–30. But that medical peer
review privilege was a common law privilege our circuit had not
yet recognized. We therefore decided the question in Adkins under
Federal Rule of Evidence 501, which explained that “[e]xcept as
otherwise . . . provided by Act of Congress,” privileges “shall be
governed by the principles of the common law as they may be in-
terpreted by the courts of the United States in the light of reason
and experience.” Id. at 1328 (quoting Fed. R. Evid. 501 (1975)). And
in declining to adopt this common law privilege, we recognized
that common law privileges “remain disfavored and should not be
lightly created.” Id. But this action involves a privilege created by a
federal statute, not the common law. We are bound by what the
statute says, not our own view of whether the privilege “achieve[s]
a public good . . . .” Id. (quotation marks and citation omitted). Our
reasoning in Adkins is therefore inapplicable.
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Second, Loux relies on persuasive authority from other
courts. Although neither we nor our sister circuits have addressed
the federal privilege in similar situations, we believe our reading of
the text is consistent with most other courts that have confronted
the issue. That is, many other courts have also rejected a reading
of the statute that limits the privilege to documents created for a
“sole purpose.” See, e.g., Taylor v. Hy-Vee, Inc., No. 15-9718-JTM,
2016 WL 7405669, at *1, 3 (D. Kan. Dec. 22, 2016) (finding docu-
ments to be privileged even though the data was also used for the
provider’s “internal and state-mandated quality improvement sys-
tem”); Thompson by Willis v. United States, No. 18-CV-1520-NJR,
2020 WL 3962270, at *1, 4 (S.D. Ill. July 13, 2020) (“The privilege is
not waived for a document generated specifically for reporting to
a [patient safety organization] merely because it references infor-
mation generated elsewhere for other purposes.”); Baptist Health
Richmond, Inc. v. Clouse, 497 S.W.3d 759, 766 (Ky. 2016) (holding
that if a provider fulfills state reporting obligations with separate
documents, then courts have “no reason to review the information
in the provider’s patient safety evaluation system”).
Loux cites one precedent that requires a more extensive dis-
cussion: the Florida Supreme Court’s decision in Charles v. Southern
Baptist Hospital of Florida, Inc., 209 So.3d 1199 (Fla. 2017). In Charles,
a patient—who was also a medical malpractice plaintiff—sought
access to “adverse medical incident reports” over a provider’s ob-
jection that the reports were privileged as patient safety work prod-
uct. Id. at 1211. The Florida Supreme Court held that the reports
were not patient safety work product because they had to be
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disclosed to “patients” under a state constitutional provision. See id.
at 1204 (citing Fla. Const. art. X, § 25, amend. VII). The court anal-
ogized this state constitutional amendment to the kind of state law
recordkeeping and reporting requirement that the Act expressly
does not affect. Id. at 1214 (“[A] mandatory disclosure law in our
state constitution is not preempted by a health care provider’s
choice to” participate in patient safety activities under the Federal
Act). Because state law required that these reports be disclosed to
any patient, the Florida Supreme Court held that the “disclosure
[of these documents] fits squarely within the providers’ record-
keeping obligations under state law.” Id. at 1211. In other words,
the court held that, if state law requires records be maintained and
disclosed, then those records are not patient safety work product
just because they are in a particular database.
We believe Charles is distinguishable. The court’s bottom-
line conclusion turned on the plaintiff’s state law right to access the
documents. Unlike the plaintiff in Charles, Loux does not argue that
she has a state law right to access the information that she is seek-
ing. And, as we have already explained, both the statute and HHS
regulations provide an avenue for providers to meet their state law
reporting requirements without forfeiting the privilege that applies
to patient safety work product. See Patient Safety and Quality Im-
provement, 73 Fed. Reg. 70731-01 at 70,742; Patient Safety Work
Product, 81 Fed. Reg. 32655-01 at 32656, 32659.
Finally, Loux argues, and the district court agreed, that with-
out access to documents like these, litigants like Loux would have
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16 Opinion of the Court 23-12571
a difficult time locating comparators for their employment-related
claims. But we cannot decline to apply a statutorily created privi-
lege because of concerns about good policy. Obviously, any privi-
lege can make it more difficult for a certain litigant to prove his or
her claims. But courts are still bound to apply privileges even when
it makes a litigant’s position more difficult. See Cox v. Adm’r U.S.
Steel & Carnegie, 17 F.3d 1386, 1419 (11th Cir. 1994). Congress
weighed these policy implications when it drafted, debated, and
passed the Act.
We also note that Loux still has other discovery options to
find this information, such as deposing decisionmakers and re-
questing non-privileged records. Although certain documents may
be privileged, the fact of adverse incidents is not. And, if BayCare
cites to portions of the quality files or referral logs to argue that it
treated comparators differently because of their different patient
safety records, it may end up waiving its privilege as to those rec-
ords. See Johnson v. 27th Ave. Caraf, Inc., 9 F.4th 1300, 1313 (11th Cir.
2021) (explaining that privileges are “a shield, not a sword,” and
that parties cannot selectively disclose privileged information to
prejudice their opponent’s case).
The upshot is that the district court abused its discretion
when it applied the wrong legal standard to assess BayCare’s asser-
tion of privilege. Because the district court applied a “sole purpose”
exception to the plain text of the Act, we direct the district court to
vacate its order and reconsider BayCare’s assertion of privilege.
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Nonetheless, we emphasize the limited nature of our order.
We do not conclude that everything in BayCare’s rlDatix database
is privileged. Nor do we direct the district court to treat any partic-
ular document as privileged. We direct only that, rather than apply
a “sole purpose” test, the district court ask whether each document
reflects “identif[ication],” “deliberations,” or “analysis” about “the
collection, management, or analysis of information for reporting to
or by a patient safety organization.” And, if it does, whether the
document fits any particular exception to the definition of patient
safety work product provided in the statute.
IV.
The petition for writ of mandamus is GRANTED. We direct
the district court to VACATE its two orders (Doc. 103 and Doc.
112) and RECONSIDER BayCare’s assertion of privilege con-
sistent with this opinion.