FINAL UNTIL TIME EXPIRES TO FILE REHEARING MOTION, AND IF
Appeal from the District Court of Appeal - Statutory or
Constitutional Invalidity First District - Case No. 1D15-109
Scott Gowdy of Creed & Gowdy, P.A., Jacksonville,
Florida, for Appellants.
N. Meros, Jr. and Andre Velosy Bardos of Gray Robinson, P.A.,
Tallahassee, Florida; William Everett Kuntz, Michael Houston
Harmon, and Earl Edwin Googe, Jr. of Smith Hulsey &
Busey, Jacksonville, Florida; and Jack E. Holt, III of
Grower, Ketcham, Rutherford, Bronson, Eide & Telan, P.A.,
Orlando, Florida, for Appellee.
Alexander Vaka, Nancy Ann Lauten, and Richard N. Asfar of the
Vaka Law Group, P.L., Tampa, Florida; and Maame Gyamfi, AARP
Foundation Litigation, Washington, District of Columbia, for
Amicus Curiae AARP.
Mead Burlington of Burlington & Rockenbach, P.A., West
Palm Beach, Florida, for Amicus Curiae Florida Justice
Christopher Vincent Carlyle of The Carlyle Appellate Law
Firm, The Villages, Florida, for Amicus Curiae Florida
Consumer Action Network.
Katherine Eastmoore Giddings and Kristen Marie Fiore of
Akerman LLP, Tallahassee, Florida; Kirk Stuart Davis of
Akerman LLP, Tampa, Florida; and Kathleen T. Pankau, Senior
Legal Counsel, The Joint Commission, Oakbrook Terrace,
Illinois, for Amicus Curiae The Joint Commission on the
Accreditation of Healthcare Organizations.
Paul Welsh of Bush Ross, P.A., Tampa, Florida; and Michael R.
Callahan of Katten Muchin Rosenman LLP, Chicago, Illinois,
for Amici Curiae American Medical Association and the Florida
Medical Association (the “Association Amici”);
Clarity PSO, Vizient PSO, California Hospital Patient Safety
Organization, CHS PSO, LLC, The PSO Advisory, LLC, Society of
NeuroInterventional Surgery PSO, QA to QI LLC, Pascal
Metrics, Inc., MEDNAX PSO, LLC, Child Health Patient Safety
Organization, Inc., Missouri Center for Patient Safety, NC
Quality Center PSO, American Data Network PSO, ECRI Institute
PSO, Strategic Radiology Patient Safety Organization LLC,
Ascension Health Patient Safety Organization, Quantros
Patient Safety Center, Quality Circle for Healthcare, Inc.,
PsychSafe, UHS Acute Care PSO, Midwest Alliance for Patient
Safety, Alliance for Patient Medication Safety, American
Medical Foundation Patient Safety Organization, Center for
the Assessment of Radiological Sciences PSO, and MCIC Vermont
PSO (the “PSO Amici”); and IASIS Healthcare LLC,
Florida Health Sciences Center, Inc. d/b/a Tampa General
Hospital, Crestview Hospital Corporation, Lake Wales Hospital
Corporation, Manatee Memorial Hospital, L.P., La Amistad
Residential Treatment Center, LLC, and Adventist Health
System/Sunbelt, Inc. (the “Provider Amici”).
Steven Bolin of Beytin, McLaughlin, McLaughlin, O'Hara,
Bocchino & Bolin, Tampa, Florida, for Amici Curiae The
Patient Safety Organization of Florida and ECRI Institute
Elizabeth Joy Campbell of Locke Lord LLP, West Palm Beach,
Florida; and Paul E. Dwyer of Locke Lord LLP, Providence,
Rhode Island, for Amicus Curiae The Alliance for Quality
Improvement and Patient Safety, Inc.
important constitutional issue at the heart of this dispute
is whether the records that patients in this State have a
right to access under article X, section 25, of the Florida
Constitution ("Amendment 7"), specifically records
relating to "adverse medical incidents, " are
privileged and confidential under the Federal Patient Safety
and Quality Improvement Act ("the Federal Act"),
such that Amendment 7 has been preempted by federal law. The
First District Court of Appeal, in Southern Baptist
Hospital of Florida, Inc. v. Charles, 178 So.3d 102
(Fla. 1st DCA 2015), concluded that adverse medical incident
reports requested by the Appellants pursuant to Amendment 7
in the Appellants' medical malpractice action constituted
privileged and confidential "patient safety work
product, " pursuant to the Federal Act and that the
Federal Act preempted Amendment 7. Id. at 108-10. We
accepted this appeal under our mandatory jurisdiction of
appeals from a decision of a district court of appeal
"declaring invalid a state statute or a provision of the
state constitution." See art. V, §
3(b)(1), Fla. Const.
disagree with the First District both as to its statutory
interpretation of the Federal Act and its resulting
conclusion on preemption. We hold that the Federal Act was
never intended as a shield to the production of documents
required by Amendment 7 and other provisions of Florida law,
and Amendment 7 and other provisions of Florida law are not
preempted by the Federal Act, which set up a voluntary system
for hospitals to improve patient safety. Moreover, the health
care provider or facility, in this case Southern Baptist
Hospital of Florida ("Southern Baptist"), cannot
shield documents not privileged under state law or the state
constitution by virtue of its unilateral decision of where to
place the documents under the voluntary reporting system
created by the Federal Act. Accordingly, we reverse the
decision of the First District.
X, section 25, of the Florida Constitution, which is
generally referred to by its ballot designation, Amendment 7,
was proposed by citizen initiative and adopted in 2004. It
provides patients "a right to have access to any records
made or received in the course of business by a health care
facility or provider relating to any adverse medical
incident." Art. X, § 25(a), Fla. Const.
"Adverse medical incident" is defined broadly to
include "any other act, neglect, or default of a health
care facility or health care provider that caused or could
have caused injury to or death of a patient . . . ."
Art. X, § 25(c)(3), Fla. Const. Amendment 7 gives
patients, including those who become medical malpractice
plaintiffs, access to any adverse medical incident record,
including incidents involving other patients, sometimes
called occurrence reports, created by health care providers.
Court discussed in Florida Hospital Waterman, Inc. v.
Buster, 984 So.2d 478 (Fla. 2008), the purpose of
Amendment 7 "was to do away with the legislative
restrictions on a Florida patient's access to a medical
provider's 'history of acts, neglects, or
defaults' because such history 'may be important to a
patient.' " Id. at 488 (quoting
Advisory Op. to the Att'y Gen. re Patients' Right
to Know About Adverse Med. Incidents, 880 So.2d 617, 618
First District stated:
In 2005, Congress . . . [passed] the Patient Safety and
Quality Improvement Act of 2005 (the [Federal] Act), Pub. L.
No. 109-41, 119 Stat. 424, codified at 42 U.S.C. §
299b-21 et seq., . . . following a 1999 Institute of
Medicine (IOM) report, To Err is Human: Building a Safer
Health System, . . . estimat[ing] that at least 44, 000
people and potentially as many as 98, 000 people die in
United States hospitals each year as a result of preventable
medical errors. The IOM report recommended that legislation
be passed to foster the development of a reporting system
through which medical errors could be identified, analyzed,
and utilized to prevent further medical errors. See
S. Rep. No. 108-196, at 3-4 (2003); H.R. Rep. No. 109-197, at
9 (2005). Through passage of the [Federal] Act, . . .
Congress sought to "facilitate an environment in which
health care providers are able to discuss errors openly and
learn from them." H.R. Rep. No. 109-197, at 9 (2005).
See also Patient Safety and Quality Improvement, 73
Fed. Reg. 8, 112, 8, 113 (proposed Feb. 12, 2008).
S. Baptist Hosp. of Fla., 178 So.3d at 105.
Federal Act creates a voluntary, confidential, non-punitive
system of data sharing of health care errors for the purpose
of improving the quality of medical care and patient safety.
The Federal Act envisions a system in which each
participating health care provider or member establishes a
patient safety evaluation system,  in which relevant
information would be collected, managed, and analyzed. 42
U.S.C. § 299b-21(6). After the information is collected
in the patient safety evaluation system, the provider
forwards the information to its patient safety organization,
which then collects and analyzes the data and provides
feedback and recommendations to providers on ways to improve
patient safety and quality of care. See id. §
299b-24; 73 Fed. Reg. at 70, 733. Information reported to
patient safety organizations is also shared with a central
clearing house, the Network of Patient Safety Databases,
which aggregates the data and makes it available to providers
as an "evidence-based management resource."
See 42 U.S.C. § 299b-23.
order to encourage and incentivize participation, within the
Federal Act Congress created a protected legal environment in
which providers would be comfortable sharing data "both
within and across state lines, without the threat that the
information will be used against [them]." 73 Fed. Reg.
at 70, 732. Privilege and confidentiality protections attach
to the shared information, termed "patient safety work
product, " "to encourage providers to share this
information without fear of liability." Id.;
see 42 U.S.C. § 299b-22(a)-(b). These
protections are "the foundation to furthering the
overall goal of the statute to develop a national system for
analyzing and learning from patient safety events." 73
Fed. Reg. at 70, 741.
potential burden to providers of maintaining duplicate
systems to separate federally protected patient safety work
product from information required to fulfill state reporting
obligations was addressed in the final rule documents from
the Department of Health and Human Services. See id.
at 70, 742-43. The solution was to allow providers to collect
all information in one patient safety evaluation system where
the information remains protected unless and until the
provider determines it must be removed from the patient
safety evaluation system and reported to the State.
Id. at 70, 742; 42 C.F.R. § 3.20 (2009)
(defining patient safety work product and providing that
patient safety work product removed from a patient safety
evaluation system is no longer protected).
to this case, Southern Baptist participates in information
sharing under the Federal Act and has established a patient
safety evaluation system in which it collects, manages, and
analyzes such information for reporting to its patient safety
organization-PSO Florida. Southern Baptist's employees
enter information into the patient safety evaluation system.
Southern Baptist collects and maintains reports, which it
calls "occurrence reports, " of events that are not
consistent with the routine operations of the hospital or the
routine care of a patient or that could result in an injury.
Charles, Jr., initiated a medical malpractice action, as next
friend and duly appointed guardian of his sister, Marie
Charles, and her minor children. Charles claims that Marie
Charles suffered a severe neurological injury due to Southern
commenced in the litigation between Charles and Southern
Baptist, and Charles filed three requests for production
pursuant to Amendment 7. Charles requested documents: 1)
related to adverse medical incidents in Southern
Baptist's history, and 2) either related to any physician
who worked for Southern Baptist or arising from care and
treatment rendered by Southern Baptist during the three-year
period preceding Marie Charles' care and treatment
through the time when the discovery request was filed.
Southern Baptist ultimately produced certain responsive
documents, which included Code 15 Reports (required by
section 395.0197(7), Florida Statutes (2014)), Annual Reports
(required by section 395.0197(6), Florida Statutes (2014)),
and two occurrence reports specific to Marie Charles that
were extracted from Southern Baptist's patient safety
evaluation system before they were reported to the patient
safety organization. Southern Baptist claimed that certain
other documents, primarily occurrence reports, while
potentially responsive because they were adverse incident
reports, were not subject to production because they were
privileged and confidential under the Federal Act as patient
safety work product.
moved to compel production of the documents that Southern
Baptist refused to produce based on its claim of privilege
under the Federal Act. In response to Southern Baptist's
refusal, Charles argued that the Federal Act protects only
documents created solely for the purpose of submission to a
patient safety organization, and such information is not
privileged and confidential if it was collected and
maintained for another purpose or for dual purposes, or if
the information is in any way related to a health care
provider's obligation to comply with federal, state, or
local laws or accrediting or licensing requirements. In a
series of three orders, the circuit court agreed with
Charles, finding that the adverse medical incident reports
requested were not patient safety work product if they were
collected or maintained for a purpose other than submission
to a patient safety organization or for dual purposes. The
circuit court held, "All reports of adverse medical
incidents, as defined by Amendment 7, which are created, or
maintained pursuant to any statutory, regulatory, licensing,
or accreditation requirements are not protected from
discovery under [the Federal Act.]" The circuit court
found that Southern Baptist was entitled to a reasonable fee
for production that Charles was to pay prior to production,
and upon payment, Southern Baptist "shall produce . . .
all records in its possession relating to adverse medical
incidents during the time period set forth in [the] third
request for production."
Baptist then filed a petition for writ of certiorari in the
First District, which was granted. S. Baptist Hosp. of
Fla., 178 So.3d at 104, 111. On the merits, after
examining what it termed "the plain language" of
the Federal Act, the First District concluded that
"[t]he record here shows that the documents at issue
clearly meet the definition of [patient safety work product]
because they were placed into [Southern Baptist's patient
safety evaluation] system where they remained pending
submission to a [patient safety organization]."
Id. at 108. The First District further concluded
that "[t]he documents at issue also do not meet the
[Federal] Act's definition of what is not
[patient safety work product]. That is, they are not original
patient records and were not collected, maintained, or
developed separately from the [patient safety evaluation]
system." Id. (emphasis in original).
Accordingly, the First District concluded that
"[b]ecause they meet the definition of [patient safety
work product], the documents are entitled to the federal
protection under the [Federal] Act." Id. at
108-09. In sum, the First District held that "[t]he
plain language of the [Federal Act] is clear. A document is
[patient safety work product] if it is placed into a [patient
safety evaluation] system for reporting to a [patient safety
organization] and does not exist outside of the [patient
safety evaluation] system. The documents here meet that
definition and should be regarded as [patient safety work
product], which is privileged, confidential, and not
discoverable." Id. at 110 (citations omitted).
First District also held that under the Supremacy Clause of
the United States Constitution, "the [Federal Act]
expressly preempts any broad discovery right under Amendment
7 to documents meeting the definition of [patient safety work
product, ]" and "Amendment 7 is also impliedly
preempted by the [Federal] Act because compliance with both
federal and state law would be impossible." Id.
Thus, the First District held that Amendment 7 "has been
preempted by the [Federal] Act." Id. This
the First District concluded that the documents Charles
requested were entitled to protection from discovery under
the plain language of the Federal Act, we first examine the
language of the Federal Act. We then determine whether the
Federal Act expressly or impliedly preempts Amendment 7 and
other provisions of Florida law, as the First District held.
this case involves an issue of statutory construction, our
review is de novo. W. Fla. Reg'l Med. Ctr., Inc. v.
See, 79 So.3d 1, 8 (Fla. 2012) ("Statutory and
constitutional construction are questions of law subject to a
de novo review."). "The object of statutory
interpretation is to determine legislative intent."
Crews v. State, 183 So.3d 329, 332 (Fla. 2015).
"To discern legislative intent, this Court looks first
to the plain and obvious meaning of the statute's
text[.]" W. Fla. Reg'l Med. Ctr., Inc., 79
So.3d at 9. "When the statute is clear and unambiguous,
courts will not look behind the statute's plain language
for legislative intent or resort to rules of statutory
construction to ascertain intent." Daniels v. Fla.
Dept. of Health, 898 So.2d 61, 64 (Fla. 2005).
we have also made clear that statutes cannot be read in
isolation. "Every statute must be read as a whole with
meaning ascribed to every portion and due regard given to the
semantic and contextual interrelationship between its
parts." Fla. Dep't of Env. Pro. v. ContractPoint
Fla. Parks, LLC, 986 So.2d 1260, 1265 (Fla. 2008)
(quoting Fleischman v. Dep't of Prof'l Reg.,
441 So.2d 1121, 1123 (Fla. 3d DCA 1983)). A "statute
should be interpreted to give effect to every clause in it,
and to accord meaning and harmony to all of its parts"
and is not to be read in isolation, but in the context of the
entire section. Jones v. ETS of New Orleans, Inc.,
793 So.2d 912, 914-15 (Fla. 2001) (quoting Acosta v.
Richter, 671 So.2d 149, 153-54 (Fla. 1996)).
Federal Act "creates a tightly crafted federal privilege
for 'patient safety work product' actually reported
to a 'patient safety organization.' " Lee
Med., Inc. v. Beecher, 312 S.W.3d 515, 535 (Tenn. 2010)
(footnotes omitted). "Such information is not subject to
discovery in legal proceedings." Rasor v. Nw. Hosp.,
LLC, 373 P.3d 563, 573 (Ariz.Ct.App. 2016). "The
Patient Safety Act 'announces a more general approval of
the medical peer review process and more sweeping evidentiary
protections for materials used therein.' "
Dep't of Fin. & Prof'l Regulation v. Walgreen
Co., 970 N.E.2d 552, 557 (Ill.App.Ct. 2012) (quoting
KD ex rel. Dieffenbach v. United States, 715
F.Supp.2d 587, 595 (D. Del. 2010)). Congress enacted the
Federal Act "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[.]" Tibbs v.
Bunnell, 448 S.W.3d 796, 800 (Ky. 2014).
Federal Act defines the term "provider" in relevant
part as an "entity licensed or otherwise authorized
under State law to provide health care services, including .
. . a hospital[.]" 42 U.S.C. § 299b-21(8)(A)(i).
The Federal Act defines the term "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). A
"patient safety organization" is one certified by
the Secretary of the Department of Health and Human Services
whose "mission and primary activity . . . [is] to
conduct activities that are to improve patient safety and the
quality of health care delivery." Id.
§§ 299b-21(4), 299b-24(a), (b)(1)(A). Patient
safety organizations engage in a number of "patient
safety activities, " including "[t]he collection
and analysis of patient safety work product."
Id. § 299b-21(5)(B). The Federal Act defines
patient safety work product as follows:
(7) Patient safety work product
(A) In general Except as provided in subparagraph (B), the
term "patient safety work product" means any data,
reports, records, memoranda, analyses (such as root cause
analyses), or written or oral statements-
(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.
Id. § 299b-21(7). The Federal Act also excludes
certain information from the definition of patient safety
work product and addresses a provider's duties with
respect to ...