Jean Charles, Jr., etc. v. Southern Baptist Hospital of Florida, Inc., etc.

Supreme Court of Florida
____________
No. SC15-2180
____________
JEAN CHARLES, JR., etc., et al.,
Appellants,
vs.
SOUTHERN BAPTIST HOSPITAL OF FLORIDA, INC., etc., et al.,
Appellees.
[January 31, 2017]
PARIENTE, J.
The 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”),1 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
1. 42 U.S.C. § 299b-22 (2005).
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.2
We 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
2. After briefing in this case was complete and the day before Oral
Argument, the parties filed a stipulation of dismissal, which we rejected because
this case not only involves an issue of statewide importance, but also involves a
decision of the First District holding that article X, section 25, of the Florida
Constitution has been preempted by federal law and is therefore invalid. Absent an
opinion from this Court, all trial courts in this State would be bound by the opinion
of the First District, until there is a contrary decision from the appellate court in
their own district. See Pardo v. State, 596 So. 2d 665, 667 (Fla. 1992). Our
decision not to accept the stipulation of dismissal in this case is even more
compelling when not only has briefing been completed, but when the stipulation
was also filed on the eve of Oral Argument and the briefing includes several amici
on both sides of the controversy who have important interests in the outcome of
this case. See Pino v. Bank of N.Y., 76 So. 3d 927, 927 (Fla. 2011) (“It cannot be
questioned that our well-established precedent authorizes this Court to exercise its
discretion to deny the requested dismissal of a review proceeding, even where both
parties to the action agree to the dismissal in light of an agreed-upon settlement.”);
see also State v. Schopp, 653 So. 2d 1016, 1018 (Fla. 1995) (“Even where a notice
of voluntary dismissal is timely filed, a reviewing court has discretion to retain
jurisdiction and proceed with the appeal.”); Holly v. Auld, 450 So. 2d 217, 218 n.1
(Fla. 1984) (“It is well settled that mootness does not destroy an appellate court’s
jurisdiction . . . when the questions raised are of great public importance or are
likely to recur.”).
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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.
BACKGROUND
Article 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
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adverse medical incident record, including incidents involving other patients,
sometimes called occurrence reports, created by health care providers.
As this 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 (Fla. 2004)).3
As the 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).
3. The Amendment’s appearance in the November 2004 election came
after decades of frustration because citizens could not access information they
needed in order to make informed decisions about their health care. Fla. Hosp.
Waterman, 984 So. 2d at 480. Out of 7.2 million Florida voters, more than 5.8
million people (or over 80%) voted in favor of this state constitutional right. See
Fla. Dep’t of State, Division of Elections, Patient’s Right to Know About Adverse
Medical Incidents,
http://dos.elections.myflorida.com/initiatives/initdetail.asp?account=
35169&seqnum=3 (last visited on Jan. 23, 2017).
-4-
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.
The 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,4 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
4. The terms used throughout this opinion are sometimes referred to by
other sources through the use of acronyms: PSES for “patient safety evaluation
system,” PSO for “patient safety organization,” and PSWP for “patient safety work
product.” For clarity, we will refer to the terms by their full names and not the
acronyms used by other courts.
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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.
In 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.
The 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
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safety work product and providing that patient safety work product removed from
a patient safety evaluation system is no longer protected).
Turning 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.
Jean 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 Baptist’s negligence.
Discovery 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
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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.
Charles 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
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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.”
Southern 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
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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).
The 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 appeal followed.5
5. The Florida Consumer Action Network, the Association for the
Advancement of Retired Persons, and the Florida Justice Association filed amicus
briefs on behalf of the Appellants, and the Patient Safety Organization of Florida
joined by the ECRI Institute PSO, the Alliance for Quality Improvement and
Patient Safety, the Joint Commission, the American Medical Association joined by
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ANALYSIS
Because 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.
Statutory Construction
Because 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).
the Florida Medical Association and the Clarity PSO and others, filed amicus
briefs in support of the Appellees.
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However, 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)).
The 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
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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).
The 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) which—
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(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 non-patient safety work product, as follows:
(B) Clarification
(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—
(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.
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Id. § 299b-21(7)(B) (emphasis added). After describing what constitutes patient
safety work product and what does not, the Federal Act then explains that, in
general, patient safety work product is privileged and confidential:
(a) Privilege
Notwithstanding any other provision of Federal, State, or local
law, and subject to subsection (c) of this section, patient safety work
product shall be privileged and shall not be—
(1) subject to a Federal, State, or local civil, criminal, or
administrative subpoena or order, including in a Federal, State, or
local civil or administrative disciplinary proceeding against a
provider;
(2) subject to discovery in connection with a Federal, State, or
local civil, criminal, or administrative proceeding, including in a
Federal, State, or local civil or administrative disciplinary proceeding
against a provider;
...
(b) Confidentiality of patient safety work product
Notwithstanding any other provision of Federal, State, or local
law, and subject to subsection (c) of this section, patient safety work
product shall be confidential and shall not be disclosed.
Id. § 299b-22(a)-(b). Patient safety work product may only be disclosed under
certain circumstances:
(c) Exceptions
Except as provided in subsection (g)(3) of this section-
(1) Exceptions from privilege and confidentiality
Subsections (a) and (b) of this section shall not apply to (and shall not
be construed to prohibit) one or more of the following disclosures:
(A) Disclosure of relevant patient safety work product for use
in a criminal proceeding, but only after a court makes an in camera
determination that such patient safety work product contains evidence
of a criminal act and that such patient safety work product is material
to the proceeding and not reasonably available from any other source.
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(B) Disclosure of patient safety work product to the extent
required to carry out subsection (f)(4)(A) of this section.
(C) Disclosure of identifiable patient safety work product if
authorized by each provider identified in such work product.
(2) Exceptions from confidentiality
Subsection (b) of this section shall not apply to (and shall not be
construed to prohibit) one or more of the following disclosures:
(A) Disclosure of patient safety work product to carry out
patient safety activities.
(B) Disclosure of nonidentifiable patient safety work product.
(C) Disclosure of patient safety work product to grantees,
contractors, or other entities carrying out research, evaluation, or
demonstration projects authorized, funded, certified, or otherwise
sanctioned by rule or other means by the Secretary, for the purpose of
conducting research to the extent that disclosure of protected health
information would be allowed for such purpose under the HIPAA
confidentiality regulations.
(D) Disclosure by a provider to the Food and Drug
Administration with respect to a product or activity regulated by the
Food and Drug Administration.
(E) Voluntary disclosure of patient safety work product by a
provider to an accrediting body that accredits that provider.
(F) Disclosures that the Secretary may determine, by rule or
other means, are necessary for business operations and are consistent
with the goals of this part.
(G) Disclosure of patient safety work product to law
enforcement authorities relating to the commission of a crime (or to
an event reasonably believed to be a crime) if the person making the
disclosure believes, reasonably under the circumstances, that the
patient safety work product that is disclosed is necessary for criminal
law enforcement purposes.
(H) With respect to a person other than a patient safety
organization, the disclosure of patient safety work product that does
not include materials that—
(i) assess the quality of care of an identifiable provider; or
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(ii) describe or pertain to one or more actions or failures to act
by an identifiable provider.
Id. § 299b-22(c). However, unless an “exception” exists under 42 U.S.C. § 299b-
22(d)(2), “[p]atient safety work product that is disclosed under subsection (c) of
this section shall continue to be privileged and confidential as provided for in
subsections (a) and (b) of this section, and such disclosure shall not be treated as a
waiver of privilege or confidentiality[.]” Id. § 299b-22(d)(1). Finally the Federal
Act provides the following rules of construction:
(g) Rule of construction
Nothing in this section shall be construed—
(1) to limit the application of other Federal, State, or local laws
that provide greater privilege or confidentiality protections than the
privilege and confidentiality protections provided for in this section;
(2) to limit, alter, or affect the requirements of Federal, State,
or local law pertaining to information that is not privileged or
confidential under this section;
(3) except as provided in subsection (i) of this section, to alter
or affect the implementation of any provision of the HIPAA
confidentiality regulations or section 1320d-5 of this title (or
regulations promulgated under such section);
(4) to limit the authority of any provider, patient safety
organization, or other entity to enter into a contract requiring greater
confidentiality or delegating authority to make a disclosure or use in
accordance with this section;
(5) as preempting or otherwise affecting any State law
requiring a provider to report information that is not patient safety
work product; or
(6) to limit, alter, or affect any requirement for reporting to the
Food and Drug Administration information regarding the safety of a
product or activity regulated by the Food and Drug Administration.
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Id. § 299b-22(g) (emphasis added).
Charles asserts that the Federal Act expressly preserves and incorporates,
rather than preempts, a provider’s reporting and recordkeeping obligations under
state law. See id. §§ 299b-21(7)(B)(iii)(II)-(III), 299b-22(g)(2)&(5). We agree.
Congress carved out broad exceptions to the Federal Act’s definition of
patient safety work product. For example, patient safety work product “does not
include a patient’s medical record, billing and discharge information, or any other
original patient or provider record.” Id. § 299b-21(7)(B)(i). Significantly, patient
safety work product also “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.” Id. § 299b-21(7)(B)(ii). Moreover, the Federal Act clearly
states that it should not be construed to “limit, alter, or affect the requirements of
Federal, State, or local law pertaining to information that is not privileged or
confidential under [the Federal Act].” Id. § 299b-22(g)(2).
Consistent with these provisions of the Federal Act, Florida has various
statutes and rules, many of which pre-date the Federal Act, that require a health
care provider to create and maintain adverse medical incident reports. See
§ 395.0197(4)-(7), Fla. Stat. (2015) (requiring risk program that includes adverse
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incident reports); see also Fla. Admin. Code r. 59A-10.0055 (establishing risk
management system to report adverse incidents to the Florida Agency for Health
Care Administration). Amendment 7 provides individuals the right to access “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. In
other words, health care providers are required by state law to keep adverse
medical incident reports, and the right of patients to access those adverse medical
incident reports is enshrined in Florida’s Constitution.
Despite the above, the First District concluded 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.” S. Baptist
Hosp. of Fla., 178 So. 3d at 110. However, the First District’s reading of the
Federal Act was in error because it failed to consider the statute as a whole. There
are numerous exceptions and limitations placed on the Federal Act. Though the
Federal Act generally states that documents placed into a patient safety evaluation
system that do not exist outside the system are privileged and confidential work
product, it also makes clear that the provisions of the Federal Act shall not be
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construed to limit “the discovery of or admissibility of information described in
this subparagraph in a criminal, civil, or administrative proceeding,” or “a
provider’s recordkeeping obligation with respect to information described in this
subparagraph under Federal, State, or local law.” 42 U.S.C. § 299b-21(7)(B)(iii).
Simply put, adverse medical incident reports are not patient safety work
product because Florida statutes and administrative rules require providers to
create and maintain these records and Amendment 7 provides patients with a
constitutional right to access these records. Thus, they fall within the exception of
information “collected, maintained, or developed separately, or exists separately,
from a patient safety evaluation system.” See id. § 299b-21(7)(B)(ii). In addition,
their disclosure fits squarely within the providers’ recordkeeping obligations under
state law. Id. § 299b-21(7)(B)(iii)
The Kentucky Supreme Court reached the same conclusion when deciding
whether records required to be reported to the State by local laws were privileged
and confidential patient safety work product in the case of Baptist Health
Richmond, Inc. v. Clouse, 497 S.W.3d 759 (Ky. 2016). There, the Kentucky
Supreme Court stated:
[A] provider who participates in the [Federal] Act may collect
information within its patient safety evaluation system that complies
with the [Federal] 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 patient safety
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evaluation system is needed to comply with those state requirements,
it is not privileged.
....
The information that is usually contained in state-mandated
reports is not protected by the patient safety work product privilege
provided in the [Federal] Act and will be discoverable.
Id. at 766.
In conclusion, the records do not become patient safety work product simply
because they were placed in a patient safety evaluation system or submitted to a
patient safety organization because providers have an independent obligation under
Florida law to create and maintain them, and Amendment 7 provides patients with
a constitutional right to access them. See 42 U.S.C. § 299b-21(7)(B)(ii).
Consequently, adverse medical incident reports produced in conformity with state
law and requested by patients under Amendment 7 cannot be classified as
confidential and privileged patient safety work product under the Federal Act.
Preemption
The next issue addressed is whether Amendment 7 and other Florida statutes
are preempted by the Federal Act. This Court’s review is de novo. W. Fla. Reg’l
Med. Ctr., 79 So. 3d at 8. “Under the Supremacy Clause of the U.S. Constitution,
a federal law may preempt state law.” Id. at 15. “Preemption occurs when
Congress intentionally enacts legislation that is intended to supersede state law on
the same subject.” Id. The United States Supreme Court has recognized three
forms of preemption: express preemption, implied field preemption, and implied
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conflict preemption. Id. “Express preemption exists where a federal statute
explicitly preempts state law.” Id.
“The ultimate touchstone in every preemption case is the purpose of
Congress.” Id. at 16. This Court “begin[s] with a presumption against preemption,
unless preemption has been expressed in the clear and manifest purpose of
Congress.” Id. When express preemption exists, courts “focus on the plain
wording of the clause, which necessarily contains the best evidence of Congress’
preemptive intent.” Chamber of Commerce of U.S. v. Whiting, 563 U.S. 582, 594
(2011) (quoting CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993)). But
even when “a federal law contains an express pre-emption clause, it does not
immediately end the inquiry because the question of the substance and scope of
Congress’ displacement of state law still remains.” Altria Grp., Inc. v. Good, 555
U.S. 70, 76 (2008).
Moreover, for nearly seventy years, the United States Supreme Court has
applied the “assumption” that States’ historic police powers “were not to be
superseded by the Federal Act unless that was the clear and manifest purpose of
Congress.” Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). Because
States have historically regulated health and welfare, the Federal Act cannot
preempt Florida’s constitutional amendment and laws related to the disclosure of
adverse medical incidents in the absence of Congress’ clear intent to do so.
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Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (“In all pre-emption cases, and
particularly in those in which Congress has legislated . . . in a field which the
States have traditionally occupied, we start with the assumption that the historic
police powers of the States were not to be superseded by the Federal Act unless
that was the clear and manifest purpose of Congress.” (internal citations and
quotation omitted)); see U.S. Const. amend. X.
First we address whether the Federal Act preempts Amendment 7 through
express preemption. To that end, the First District stated:
As to express preemption, the Act specifically provides,
“Notwithstanding any other provision of Federal, State, or local law
. . . [patient safety work product] shall be privileged,” and goes on to
state that [patient safety work product] is not subject to disclosure in
various ways including discovery in connection with a Federal, State,
or local civil, criminal, or administrative proceeding, among other
ways. 42 U.S.C. § 299b–22. The Act also mandates a civil monetary
penalty for improper disclosure of [patient safety work product]. 42
U.S.C. § 299b–22(f)(1). Thus, the Act expressly preempts any broad
discovery right under Amendment 7 to documents meeting the
definition of [patient safety work product].
S. Baptist Hosp. of Fla., 178 So. 3d at 110. It is clear that the First District based
its conclusion on an erroneous interpretation of the definition of patient safety
work product. As stated above, the documents to which citizens have a right to
access pursuant to Amendment 7 are not patient safety work product under the
Federal Act’s definition. Accordingly, the Federal Act does not contain any
express statement of preemption relating to Amendment 7.
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However, in its opinion, the First District went on to state: “Amendment 7 is
also impliedly preempted by the [Federal] Act because compliance with both
federal and state law would be impossible[,]” and “we find [that Amendment 7]
has been preempted by the [Federal] Act.” Id. This conclusion is also based on
the First District’s erroneous interpretation of the statute, as described above.
Absent an express statement of preemption, preemption may still be implied
if a state law “interferes with the methods by which the federal statute was
designed to reach [its] goal.” Int’l Paper Co. v. Ouellette, 479 U.S. 481, 494
(1987). To this end, the United States Supreme Court has stated:
We begin the analysis by noting that it is not necessary for a federal
statute to provide explicitly that particular state laws are pre-empted.
Hillsborough [Cty.] v. Automated Medical [Labs.], Inc., 471 U.S. 707,
713 (1985). Although courts should not lightly infer pre-emption, it
may be presumed when the federal legislation is “sufficiently
comprehensive to make reasonable the inference that Congress ‘left
no room’ for supplementary state regulation.” [Id. at 713] (quoting
Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)). In
addition to express or implied pre-emption, a state law also is invalid
to the extent that it “actually conflicts with a . . . federal statute.” Ray
v. Atlantic Richfield Co., 435 U.S. 151, 158 (1978). Such a conflict
will be found when the state law “ ‘stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of
Congress.’ ” [Hillsborough Cty.,] 471 U.S. at 713 (quoting Hines v.
Davidowitz, 312 U.S. 52, 67, 61 (1941)).
Ouellette, 479 U.S. at 491-92 (footnotes omitted).
Amendment 7, which was enacted before the Federal Act, gives patients a
constitutional right to broad access to adverse medical incident records. Art. X, §
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25(a), Fla. Const. This citizen-initiated constitutional amendment provides critical
information for injured parties who have filed a medical malpractice suit as a result
of negligent care, and it also allows individuals to make informed decisions when
choosing future health care providers. Thus, this area of regulation is directly
within the states’ traditional role of regulating the health, safety, and welfare of its
citizens. See U.S. Const. amend. X.
It is antithetical to the idea of preemption, which requires a clear expression
of Congressional intent, that the Federal Act, which permits, but does not require
provider participation, would preempt a state constitutional amendment. In the
context of the Federal Act’s scheme allowing for voluntary participation, it is clear
that a mandatory disclosure law in our state constitution is not preempted by a
health care provider’s choice to participate in the Federal Act, coupled with its
choice to place documents into a patient safety evaluation system.
The legislative history of the Federal Act reveals that Congress did not
intend to strip citizens of their pre-existing state right to information through the
passage of the act. The House Report on the Federal Act highlights this fact in
describing how documents that were created and maintained separately from a
patient safety evaluation system would not become patient safety work product and
confidential simply because a health care provider, in its discretion, decided to
send those documents to a patient safety organization:
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[T]here may be documents or communications that are part of
traditional health care operations or record keeping (including but not
limited to . . . primary information at the time of events). Such
information may be in communications or copies of documents sent to
a patient safety organization. Originals or copies of such documents
are both original provider records and separate information that is
developed, collected, maintained or exist separately from any patient
safety evaluation system. Both these original documents and ordinary
information about health care operations may be relevant to a patient
safety evaluation system but are not themselves patient safety work
product.
H.R. Rep. No. 109-197, 14 (2005).
Several Senators also echoed that Congress never intended to take away
patients’ rights to hold negligent providers accountable. For example, Senator Ted
Kennedy conveyed Congress’ intent that the Federal Act should not be used to
protect providers who have harmed patients:
The legislation also creates a legal privilege for information reported
to the safety organizations, but still guaranteeing that original records,
such as patients’ charts will remain accessible to patients.
Drawing the boundaries of this privilege requires a careful
balance, and I believe the legislation has found that balance. The bill
is intended to make medical professionals feel secure in reporting
errors without fear of punishment, and it is right to do so. But the bill
tries to do so carefully, so that it does not accidentally shield persons
who have negligently or intentionally caused harm to patients. The
legislation also upholds existing state laws on reporting patient safety
information.
151 Cong. Rec. S8713-02 (daily ed. July 21, 2005) (statement of Sen. Kennedy)
In a recent report, the Department of Health and Human Services explained
that the Federal Act did not replace or destroy existing state laws and requirements:
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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 care system.
73 Fed. Reg. at 70,742.
Recently, the Department of Health and Human Services further explained
in a guidance document:
As such, the Patient Safety Act recognizes the goal of accountability
and transparency, and it attempts to balance this goal with that of
improving patient safety and reducing medical errors. While
Congress was aware of the chilling effect the fear of being sued had
on providers, the Patient Safety Act was not designed to prevent
patients who believed they were harmed from obtaining the records
about their care that they were able to obtain prior to the enactment of
the Patient Safety Act. Nor was the Patient Safety Act intended to
insulate providers from demonstrating accountability through
fulfilling their external obligations. Therefore, when interpreting the
Patient Safety Act and Patient Safety Rule, [the Department of Health
and Human Services] does so with the objective of maintaining
balance between these two policy goals, consistent with the intent of
the Patient Safety Act.
Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding
Patient Safety Work Product and Providers’ External Obligations, 81 Fed. Reg.
32,655, 32,655-56 (May 24, 2016) (footnotes omitted).
Clearly, Congress did not intend to deprive Florida citizens of such an
important constitutional measure. Rather, a review of the plain meaning of the
Federal Act, coupled with the statements of Congress and the Department of
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Health and Human Services, which is in charge of implementing the Federal Act,
in light of Florida’s Amendment 7, shows that the two systems can coexist
harmoniously. Both support the ultimate congressional goal of improving this
country’s health care system, albeit through different means. One does not
necessarily make the other unworkable. Indeed, if the First District’s view were to
become law, then medical providers would be free to determine for themselves
what information was available in litigation through their own strategic use of the
benefits in the Federal Act by placing all of their reports, regardless of any other
state requirements, in the patient safety evaluation system and therefore making
them confidential patient safety work product. Allowing such action would be
antithetical not only to the purpose of Amendment 7, but also to the Congressional
purpose of improving the health care system.
Moreover, the First District’s opinion reflects a view that somehow the
Federal Act is inconsistent with medical malpractice actions and that often medical
malpractice actions are punitive, stating:
Amendment 7 has become an important discovery tool for medical
malpractice plaintiffs as it gives broad access to adverse medical
incident records from medical providers. Amendment 7 provides a
means, albeit often a punitive one, to improve the quality of
healthcare by bringing medical errors to light.
While medical malpractice litigation is one tool to address
medical errors, other tools have emerged that seek to proactively
prevent, rather than punish, medical errors.
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S. Baptist Hosp. of Fla., 178 So. 3d at 105. We reject the two premises of the First
District’s opinion. First, the primary purpose of medical malpractice actions is not
to punish the health care provider, but to compensate the victim of medical
malpractice who is many times severely injured. Second, the creation of a Federal
Act to provide a voluntary system for health care providers is not at all inconsistent
with Amendment 7 or Florida law, and medical malpractice actions can and should
coexist with the Federal Act. The Department of Health and Human Services
explained how providers have been attempting to use the confidentiality and
privilege provisions in the Federal Act to their advantage:
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 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.
81 Fed. Reg. 32,655-01, 32,657-58.
This Case
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The documents at issue in this case were primarily adverse medical incident
reports requested by Charles. Southern Baptist acknowledged that some of its
occurrence reports would have been discoverable pursuant to that request, but for
the Federal Act. The documents were placed in Southern Baptist’s patient safety
evaluation system, likely by an employee of the hospital. However, they were
never submitted to the patient safety organization by Southern Baptist. Under this
Court’s interpretation of the Federal Act, the reports are not privileged and
confidential patient safety work product because Florida statutes and
administrative rules require providers to create and maintain them, and thus, they
were not created solely for the purpose of submission to a patient safety evaluation
system. See § 395.0197(4)-(7), Fla. Stat. (2015) (requiring risk management
program that includes adverse incident reports); see also Fla. Admin. Code r. 59A-
10.0055. The records fall squarely within the exception of information “collected,
maintained, or developed separately, or exists separately, from a patient safety
evaluation system.” See 42 U.S.C. § 299b-21(7)(B)(ii). Thus, the trial court was
correct to conclude that the documents in this case were discoverable pursuant to
Amendment 7. Accordingly, we reject the First District’s conclusion that “the
documents at issue clearly meet the definition of [patient safety work product]
because they were placed into Baptist’s [patient safety evaluation] system where
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they remained pending submission to a [patient safety organization].” S. Baptist
Hosp. of Fla., 178 So. 3d at 108.
CONCLUSION
In conclusion, we hold that Congress did not intend to preempt state laws or
Amendment 7 through the passage of the Federal Act creating a voluntary
reporting system. Rather, the clear intent of the Federal Act, as set forth in the
actual language of the Federal Act, was for the voluntary reporting system to
function harmoniously within existing state reporting and discovery laws. The
Federal Act was intended by Congress to improve the overall health care in this
system, not to act as a shield to providers, thereby dismantling an important right
afforded to Florida citizens through Amendment 7. Moreover, health care
providers should not be able to unilaterally decide which documents will be
discoverable and which will not in medical malpractice cases. Accordingly, we
reverse the decision of the First District below.
It is so ordered.
LABARGA, C.J., and LEWIS, and QUINCE, JJ., and PERRY, Senior Justice,
concur.
CANADY, J., dissents with an opinion, in which POLSTON, J., concurs.
NOT FINAL UNTIL TIME EXPIRES TO FILE REHEARING MOTION, AND
IF FILED, DETERMINED.
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CANADY, J., dissenting.
I dissent from the majority’s disapproval of the stipulation for dismissal.
The parties are entitled to a dismissal because they filed a stipulation for dismissal
under Florida Rule of Appellate Procedure 9.350(a) before this Court issued a
decision on the merits. I adhere to my view that a stipulation for dismissal filed
under rule 9.350(a) before a decision on the merits is not subject to disapproval:
Florida Rule of Appellate Procedure 9.350(a) provides that
“[w]hen any cause pending in the court is settled before a decision on
the merits, the parties shall immediately notify the court by filing a
signed stipulation for dismissal.” The rule does not appear to
contemplate that such a stipulation for dismissal is subject to
disapproval by the Court. The very designation “stipulation for
dismissal”—as opposed to “motion for dismissal”—suggests that the
act of the parties is dispositive. The committee note to the rule
recognizes that dismissal of the case is the clerk’s ministerial duty:
“On the filing of a stipulation of dismissal, the clerk of the court will
dismiss the case as to the parties signing the stipulation.”
Pino v. Bank of New York, 76 So. 3d 927, 931 (Fla. 2011) (Canady, C.J.,
dissenting) (alteration in original).
The decision of the majority here, which can have no impact on this settled
case, is a purely advisory opinion. Our job is to decide live controversies
presented by the parties to a case that is before us. It is not to opine on the issues
in a case that has been settled and that the parties have agreed should be dismissed.
POLSTON, J., concurs.
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An Appeal from the District Court of Appeal – Statutory or Constitutional
Invalidity
First District - Case No. 1D15-109
(Duval County)
Bryan Scott Gowdy of Creed & Gowdy, P.A., Jacksonville, Florida,
for Appellants
George 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
George 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
Philip Mead Burlington of Burlington & Rockenbach, P.A., West Palm Beach,
Florida,
for Amicus Curiae Florida Justice Association
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,
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for Amicus Curiae The Joint Commission on the Accreditation of Healthcare
Organizations
Joshua 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”)
Andrew Steven Bolin of Beytin, McLaughlin, McLaughlin, O’Hara, Bocchino &
Bolin, Tampa, Florida,
for Amici Curiae The Patient Safety Organization of Florida and ECRI
Institute PSO
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.
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