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Filing # 125089369 E-Filed 04/16/2021 03:20:25 PM
IN THE CIRCUIT COURT OF THE
EIGHTH JUDICIAL CIRCUIT IN AND
FOR ALACHUA COUNTY, FLORIDA
BRENDA SNOW,
Plaintiff, Case No. 2020-CA-001350
Vv.
SHANDS TEACHING HOSPITAL AND
CLINICS, INC. d/b/a UF HEALTH SHANDS
HOSPITAL, a Florida non-profit corporation;
and UNIVERSITY OF FLORIDA BOARD
OF TRUSTEES d/b/a UF HEALTH EYE
CENTER, a Florida Public Body Corporate,
Defendants.
/
DEFENDANTS’ RESPONSE TO PLAINTIFF’S MOTIONS AND
SUPPLEMENTAL MOTIONS TO COMPEL BETTER ANSWERS TO
FIRST SET OF INTERROGATORIES AND BETTER RESPONSES
TO FIRST REQUEST TO PRODUCE
Defendants Shands Teaching Hospital and Clinics, Inc. d/b/a UF Health Shands Hospital
and University of Florida Board of Trustees d/b/a UF Health Eye Center (collectively
“Defendants”) respond in opposition to Plaintiff's Motion and Supplemental Motion to Compel
Better Answers to her First Sets of Interrogatories and Better Responses to her First Requests to
Produce. For the reasons set forth below, Plaintiff's motion should be denied because the
information Plaintiff seeks is privileged and Defendants are prohibited by federal law from
providing such information.
BACKGROUND
Defendants have produced all of Plaintiff's medical records, charts, reports, documents,
handwritten notes, progress notes, audit trails associated with Plaintiffs medical records, and other
materials that it has pertaining to Plaintiff. See generally UFBOT Resp. To Plaintiff's 1st RFP
"2020 CA 001350" 125089369 Filed at Alachua County Clerk 04/16/2021 03:20:28 PM EDT(July 17, 2020); Shands Resp. to Plaintiff's Ist RFP (July 17, 2020). With respect to certain
interrogatories and requests for production, however, Defendants objected because the
interrogatory or request sought information that is confidential and privileged under the federal
Patient Safety and Quality Improvement Act (“PSQIA”), and Defendants are accordingly
prohibited by federal law from responding to them.
A. Discovery Directed To UFBOT
Specifically, UFBOT objected to interrogatories 12, 16, 17, and 27 on these grounds. The
interrogatories asked:
12. “Were any adverse incident reports, Code 15 reports, or root cause analysis made
which in any way pertained to the care and treatment of the plaintiff at [UFBOT]?”
16. “At any time during this Defendant’s treatment of the Plaintiff, was an incident
report filled out pertaining to Plaintiff? If so, provide full name and address of the individual(s)
who filled out the form(s). Identify by name, address and official title or employment position,
each and every individual involved in the investigation of the incident; and/or any “adverse
medical incident” review board; and/or any peer review committee regarding the incident which
is the subject of this litigation.”
17. “Please identify any and all parties to whom reports and/or investigations were
submitted regarding the incident that is the subject of the instant litigation. This includes, but is
not limited to Dr. Ames, Dr. Khurshid, Dr. Blake, Jaime Griffin and/or Dr. Gonzalez.”
27. “Please identify all complaints, warnings, discipline, and reprimands that Phillip
Ames received on or after May 11, 2018 that were in any way related to Ms. Snow, the retrobulbar
alcohol injection, his conduct in this case, and the events described in the Complaint. In your
answer, please state whether an investigation into Ms. Snow’s treatment/injuries, theadministration of the retrobulbar alcohol injection, or any of the events described in the Complaint
and, if so, who performed the investigation.”
UFBOT objected to these interrogatories, stating: To “the extent the request may be
understood to seek information protected from disclosure as confidential and privileged Patient
Safety Work Product, pursuant to the Patient Safety Quality and Improvement Act of 2005
(PSQIA, see 42 U.S.C. §§ 299b-21 — 299b-26) and its implementing regulations (see 42 C.F.R.
Par 3).” UFBOT explained that, “[a]s participants in a listed Patient Safety Organization regulated
by the Federal Agency for Health Care Research and Quality, Patient Safety Work Product is
prohibited from disclosure except in connection with Patient Safety Activities or as otherwise
provided by PSQIA. See 42 U.S.C. § 299b-22.” UFBOT further explained that the “[a]pplicability
and scope of these federal precedents, to the extent irreconcilable with Florida’s Constitution, art.
X, § 25, are the subjects of ongoing federal civil litigation.”
UFBOT also objected to Requests to Produce 14, 15, and 17, which requested:
14. “Copies of all incident reports, investigative reports, and peer review documents
pertaining to the condition, care, treatment, diagnoses, interpretation, reviews, medical opinions,
and other services rendered to or relating to Plaintiff . . . regardless of whether or not they pertain
to any internal risk management or peer review program.”
15. “Copies of all statements obtained from anyone pertaining to the condition, care,
treatment, diagnoses, interpretation, reviews, medical opinions, and other services rendered to or
relating to Plaintiff . . . regardless of whether or not they pertain to any internal risk management
or peer review program.”
17. “Any and all adverse incidents reports and root cause analysis which in any way
pertained to the care and treatment of Plaintiff... .”As with its objection to Plaintiff's interrogatory requests above, UFBOT objected to these
requests to the extent they may be understood to seek information protected from disclosure and
confidential and privileged patient safety work product, as defined under PSQIA.
B. Discovery Directed To Shands
Shands objected to interrogatories 13, 16, 17, and 18 on the same grounds as UFBOT.
Those interrogatories asked:
13. “Were any adverse incident reports, Code 15 reports, or root cause analysis made
which in any way pertained to the care and treatment of the plaintiff at SHANDS TEACHING
HOSPITAL AND CLINICS, INC. d/b/a UF HEALTH SHANDS HOSPITAL or UFBOT d/b/a
UF HEALTH EYE CENTER?”
16. “Does defendant hospital have any records, reports, notes, correspondence, test
results, logs, studies, slides, photographs, documents or any other materials which pertain to the
Plaintiff which are not contained in the patient’s hospital chart? If so, identify any such documents
or materials and set forth the name and address of the person in custody of each such item.”
17. “At the time during the subject hospitalizations of the Plaintiff, was an incident
report filled out pertaining to the Plaintiff? If so, provide full name and address of the individual(s)
who filled out the form(s). Identify by name, address and official title or employment position,
each and every individual involved in the investigation of the incident; and/or any “adverse
medical incident review board; and/or any peer review committee regarding the incident which is
the subject of this litigation.”
18. “Please identify any and all parties to whom reports and/or investigations were
submitted regarding the incident that is the subject of the instant litigation.”
Shands objected to these interrogatories to the extent they may be understood to seekinformation protected from disclosure and confidential and privileged patient safety work product,
as defined under PSQIA, raising the same objection as UFBOT, set forth above, supra, at 3.
Shands also objected to requests to produce 14, 15, 17, which requested the same
information requested of UFBOT set forth above, supra, at 3. As with its objection to Plaintiff’s
interrogatory requests, Shands objected to these requests to the extent they may be understood to
seek information protected from disclosure and confidential and privileged patient safety work
product, as defined under PSQIA.
Cc. Plaintiff's Motions To Compel.
Plaintiff initially moved to compel better answers and responses to her Interrogatories and
Requests for Production, asserting that Defendants’ responses to the above interrogatories and
tequests were insufficient or inadequate. Plaintiff later filed a Supplement to her Motion to
Compel, asserting that Amendment 7 provides her with the right to access “any records”
Defendants made or received in the course of business relating to any adverse medical incident.”
(Supp. Resp. at 2) (citing Art. X, § 25, Fla. Const.).
Plaintiff contends that “[t]he Florida Supreme Court has held, in no uncertain terms, that
Amendment 7 trumps all legal barriers, restrictions, or privileges, legislative or otherwise, that
may otherwise prevent discovery of records under Amendment 7.” (Supp. Resp. at 2) (emphasis
in original) (citing, among other cases, Edwards v. Thomas, 229 So. 3d 177, 287 (Fla. 2017)).
Plaintiff asserts she has an “absolute right” to discover records relating to any adverse medical
incident, which is broadly defined to include an event that “caused or could have caused injury to
or death of a patient.” (Supp. Resp. at 3) (emphasis added). According to Plaintiff, the
circumstances of her case “clearly” constitute an adverse medical incident and she
“unquestionably” seeks records made or received in the course of Defendants’ businesses. (Supp.Resp. at 3-4).
Citing a passage from the opinion that discusses how PSQIA works in general, Plaintiff
further contends that the Florida Supreme Court’s decision in Charles v. Southern Baptist Hospital
of Florida, Inc., 209 So. 3d 1199 (Fla. 2017), renders Defendants’ objections legally insufficient.
(Supp. Resp. at 4-5).
APPLICABLE LAW AND ARGUMENT,
The issue before the Court involves the interplay between Amendment 7 and PSQIA, and
the Florida Supreme Court’s interpretation of both laws. Consequently, this Memo first sets forth
the parameters of these laws and then explains why the documents at issue are privileged,
precluding Defendants from producing them in response to Plaintiff’s request.!
A. Patient’s Right To Access Records Of Adverse Medical Incidents Under Article X,
Section 25 Of The Florida Constitution (commonly _referred_to_by_ its ballot
designation, Amendment 7).
In 2004, Florida voters approved Amendment 7, which established a state constitutional
tight for patients “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. (emphasis added). That provision broadly defines an “adverse medical incident” as:
[M]edical negligence, intentional misconduct, and 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, including, but not limited to, those incidents that are
required by state or federal law to be reported to any governmental agency or body,
and incidents that are reported to or reviewed by any health care facility peer
review, tisk management, quality assurance, credentials, or similar committee, or
any representative of any such committees.
' This issue also is the subject of ongoing litigation in the federal courts. In Shands Teaching
Hospitals & Clinics, Inc. v. Morgan, Shands brought a declaratory judgment action seeking a
ruling from the federal district court that PSQIA preempts Amendment 7 and precludes disclosure
of patient safety work product. Whether the federal court has subject matter jurisdiction to decide
this issue is pending on appeal in the Eleventh Circuit Court of Appeals. See Shands Teaching
Hosp. & Clinics, Inc. v. Morgan, Case No. 20-11555.Id. at § 25(c)(3).
Importantly, Amendment 7 does not impose a mandatory requirement for health care
providers to create or maintain certain records. By its express terms, it is purely an access
provision: “patients have a 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. (emphasis added).
B. The Federal Patient Safety And Quality Improvement Act.
In 1999, the Institute of Medicine reported that many Americans die each year from
preventable medical errors, most of which are not caused by isolated mistakes but by “system
failures.” S. Rep. No. 108-196, at 1 (2003). Explaining that “society’s long-standing reliance on
the threat of malpractice litigation discourages health care professionals and organizations from
disclosing, sharing, and discussing information about medical errors,” it recommended the creation
of a protected system in which information might be shared and errors might be identified and
evaluated without fear of blame and litigation. /d. at 1-2.
In response, Congress passed the Patient Safety and Quality Improvement Act (“PSQIA”
or “the Act”) in 2005, codified at 42 U.S.C. § 299b-21, ef seg. The purpose of the Act is 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). The Act was intended to proactively replace
a “culture of blame” with a “culture of safety” that emphasizes communication and cooperation.
S. Rep. No. 108-196, at 2.
To that end, the Act, passed by Congress after Florida’s Amendment 7, creates a voluntary,
confidential, non-punitive system of data sharing of healthcare errors. 42 U.S.C. § 299b-22(a), (b).
Healthcare providers who choose to participate in this system begin by establishing a patient safetyevaluation system in which relevant information is collected, managed, and analyzed. /d. at §
299b-21(6). After the information is collected in the patient safety evaluation system, the provider
forwards it to a federally-approved patient safety organization, which assesses the information and
presents “feedback and assistance to effectively minimize patient risk.” Jd. at § 299b-21(5)(D); see
also id. at § 299b-24(b)(1)(G). That organization may then remove any identifying patient and
provider information and share the data with a central clearing house, called the National Patient
Safety Database, which in turn aggregates the data and makes it available to providers as an
“evidence-based management resource.” /d. at § 299b-23(a).
Information collected for submission to a patient safety organization is called “patient
safety work product.” The type of patient safety work product relevant here was created through
the “reporting pathway” authorized by the Act. This type of patient safety work product consists
of “any data, reports, records, memoranda, analyses (such as root cause analyses), or written or
oral statements,” (1) which “are assembled or developed by a provider for reporting to a patient
safety organization and are reported to a patient safety organization,” and which could result in
improved patient safety, health care quality, or health care outcomes. /d. at § 299b-21(7)(A)(i).
Because the goal of PSQIA is to encourage providers to voluntarily report patient safety
events, it provides “substantial and broad” protections to patient safety work product so providers
can participate “without fear of liability or harm reputation.” 73 Fed. Reg. 70,732-01, 70,741 (Nov.
21, 2008). These protections are “the foundation to furthering the goal of the statute to develop a
national system for analyzing and learning from patient safety events.” Jd.
Consequently, PSQIA provides that “[n]otwithstanding any other provision of Federal,
state, or local law,” patient safety work product shall be privileged, confidential, and not subject
to disclosure. 42 U.S.C. § 299b-22(a), (b) (emphasis added). Providers who violate PSQIA byknowingly disclosing confidential patient safety work product are subject to mandatory penalties.
Id. at § 299b-22(f)(1); see also 45 C.F.R. § 102.3 (updating penalty amount).
Not all information is patient safety work product. Such work product does not include (1)
“a patient’s medical record, billing and discharge information, or any other original patient or
provider record,” or (2) “information that is collected, maintained, or developed separately, or
exists separately,” from the provider’s patient safety evaluation system. 42 U.S.C. § 299b-
21(7)(B)(i), (ii). “Separate” information that is ultimately reported to a PSO, but was not created
for reporting to a PSO, does not become protected patient safety work product. /d. at § 299b-
21(7)(B)(ii).
PSQIA thus does not replace, but rather resides alongside, external collection activities
mandated by state and federal laws and regulations. 81 Fed. Reg. 32,655-01, 32,657 (May 24,
2016). To balance the potential need for using the same information for external state reporting
requirements, the United States Department of Health & Human Services (“HHS”) adopted a rule
that permitted providers to document their voluntary removal of information from their patient
safety evaluation systems before it is reported to a patient safety organization. /d. at 32,655.
HHS reasoned this rule would decrease “the need to maintain duplicate information for
different needs,” but it cautioned providers to place only information actually intended for
reporting to a patient safety organization into their evaluation systems:
[P]roviders need not maintain duplicate systems to separate information to be
teported to a [patient safety organization] from information that may be required to
fulfill state reporting obligations. All of this information, collected in one patient
safety evaluation system, is protected as patient safety work product unless the
provider determines that certain information must be removed . . . for
reporting to the state. Once removed from the patient safety evaluation system,
this information is no longer patient safety work product.
73 Fed. Reg. at 70,741-70,742 (emphases added). The rule gives healthcare providers flexibilityto determine “what information is to become patient safety work product and, thus, protected from
disclosure” and what information must be removed from a patient safety evaluation system for
state reporting obligations. Jd. at 70,773.
Cc. The Florida Supreme Court Considers The Privilege And Confidentiality Protections
Of PSQIA And Their Relationship To Amendment 7 In Charles.
Since Amendment 7’s enactment, the Florida Supreme Court has broadly construed its
provisions, declaring that it requires disclosure of a wide spectrum of records, not just those records
that were previously protected by statute. See, e.g., Fla. Hosp. Waterman, Inc. v. Buster, 984 So.
2d 478, 487-89 (Fla. 2008); Edwards v. Thomas, 229 So. 3d 277, 285 (Fla. 2017). The court
specifically considered the interplay between PSQIA and Amendment 7 in Charles v. Southern
Baptist Hospital of Florida, Inc., 209 So. 3d 1199 (Fla. 2017).
In Charles, the plaintiff initiated a medical malpractice action against a hospital and sought
records under Amendment 7. The hospital produced certain responsive documents, which included
Code 15 reports (created under section 395.0197(7), Florida Statutes), Annual Reports (created
under section 395.0197(6)), and two occurrence reports that were extracted from the hospital’s
patient safety evaluation system before they had been reported to the hospital’s patient safety
organization. The hospital claimed that other documents, which primarily consisted of occurrence
reports, were not subject to production. The hospital asserted that, although these reports were
potentially responsive because they fell under the broad definition of “adverse medical incidents”
contained in Amendment 7, they could not be produced because they were privileged and
confidential under PSQIA as patient safety work product. 209 So. 3d at 1205-06.
The plaintiff moved to compel production of the documents the hospital claimed were
privileged, asserting that PSQIA only protected documents that were created “solely” for the
purpose of submission to a patient safety organization and that such information was not privileged
10if it was collected and maintained for another purpose or for a dual purpose, or if the information
is in any way related to a healthcare provider’s obligation to comply with federal, state, or local
laws. Id. at 1206. The trial court ordered production of the documents, finding they 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. Jd.
On a petition for writ of certiorari, the First District quashed the trial court’s order.
According to that court, the plain language of PSQIA showed that the records at issue clearly met
the definition of patient safety work product because they were placed into the hospital’s patient
safety evaluation system where they remained pending submission to a patient safety organization.
Id. (discussing S. Baptist Hosp. of Fla. v. Charles, 178 So. 3d 102, 104, 111 (Fla. Ist DCA 2015)).
As that court explained:
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 (cleaned up).
The First District further held that PSQIA expressly preempts any broad discovery right
under Amendment 7 for documents that meet the definition of patient safety work product and also
impliedly preempts Amendment 7 because compliance with both state and federal law would be
impossible. /d.
On review of the First District’s opinion, the Florida Supreme Court disagreed, holding
that a document created or maintained pursuant to a state-law requirement was not developed
“solely” for submission to a federal patient safety organization. Specifically, the court held that
adverse medical incident reports are required to be created by section 395.0197(4)-(7), Florida
llStatutes, and Florida Administrative Code rule 59A-10.0055, and are, consequently, created
pursuant to an independent obligation under Florida law. This independent obligation causes the
records to fall within the exception to patient safety work product carved out by PSQIA for
information “collected, maintained, or developed separately, or exists separately, from a patient
safety evaluation system.”” 209 So. 3d at 1211 (quoting § 299b-21(7)(B)(ii)). Consequently, the
court concluded, 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.” /d. at 1212.
The court then addressed the hospital’s argument that PSQIA preempted Amendment 7.
Because the court concluded that the documents at issue in that case did not constitute patient
safety work product in the first instance, this discussion in the opinion is dicta.
According to the court, PSQIA does not expressly preempt Amendment 7 because the
documents do not constitute patient safety work product. The court further explained that PSQIA
does not impliedly preempt Amendment 7 because PSQIA is a voluntary program: “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.” /d. at 1214 (emphasis in original).
Later that same year, the court said that additional programs such as PSQIA “cannot
logically be excluded from Amendment 7’s application simply because they are in addition to the
base-level, statutorily-required risk management committees.” Edwards, 229 So. 3d at 289.
12D. The Records Plaintiff Seeks Through Her Motion To Compel Are Privileged Patient
Safety Work Product, And Defendants Are Prohibited By PSQIA From Producin:
Them.
Defendants have produced all non-patient safety work product documents that are
responsive to Plaintiff's requests, including Plaintiff's medical records, charts, reports,
handwritten reports, progress notes, audit trails associated with Plaintiff's medical records, and
other materials it has pertaining to Plaintiff. See generally UFBOT Resp. to Pl. 1st RFP (July 17,
2020); Shands Resp. to Pl. Ist RFP (July 17, 2020). The remaining documents potentially
tesponsive to Plaintiff's request fall squarely within the definition of patient safety work product
set forth in PSQIA.
Based on the plain language of PSQIA and its corresponding regulations, there are three
requirements necessary for information to constitute patient safety work product under the
“reporting pathway”:
qd) The information must be developed for the purpose of reporting to a Patient Safety
Organization;
(2) The information must have the ability to improve patient safety and the quality of
health care; and
(3) The information must be reported to the patient safety organization;
42 US.C. § 299b-21(7)(A)(i).
The information at issue here satisfies these criteria. It was created pursuant to Defendants’
internal policies relating to its participation in and compliance with PSQIA, it was submitted to
Defendants’ patient safety organization, and it was created to improve patient safety and the quality
of healthcare.
The information also does not fall within the exception to patient safety work product
13because it does not encompass an original medical record, billing or discharge information, or any
other patient record, and it was not collected, maintained, or developed separately from
Defendants’ patient safety evaluation system. /d. at (B)(ii). It also was not created pursuant to a
separate reporting requirement of state law.
The information is thus privileged as patient safety work product under the express
provisions of PSQIA.
E. Charles Does Not Apply Here Because The Information At Issue Is Not The Same As
That At Issue In Charles.
The documents at issue in Charles were occurrence reports created as contemplated by
section 395.0197, Florida Statutes, and were entered into the hospital’s patient safety evaluation
system but not reported to the hospital’s patient safety organization. Because Florida statutes
and administrative rules describe how providers may create and maintain the records, the Charles
court held that Amendment 7 authorized access to them.
Here, in contrast, the information at issue was not created pursuant to any separate state
law obligation, and it was reported to a Defendants’ patient safety organization. The Florida
Supreme Court thus did not directly consider whether this type of information constituted patient
safety work product, and Charles should not control here. Instead, the information, as patient
safety work product, is subject to the requirement of PSQIA that such records remain privileged
and confidential. Ensuring that patient safety work product remains confidential and privileged is
“the foundation” to furthering the reason the Act was created in the first instance. 73 Fed. Reg.
70,732-01, 70,741 (Nov. 21, 2008) (emphasis added).
F. To The Extent Charles Applies Here, It Was Wrongfully Decided.
To the extent the Court believes that Charles governs Defendants’ obligation to produce
the documents at issue, Defendants submit that Charles was wrongfully decided. Defendants
14understand that the Court is bound by decisions of the Florida Supreme Court, but raises this issue
here to preserve its position.
1. The Court Incorrectly Construed Amendment 7 As Imposing A Mandatory
Requirement To Create And Maintain Certain Records.
By holding that records requested under Amendment 7 could never constitute patient safety
work product because PSQIA purportedly excludes from the definition of “patient safety work
product” all records required to be created under state law, the court in Charles improperly
conflated the requirement to produce records under Amendment 7 with the requirement to create
tecords under separate statutes and regulations.
Amendment 7 does not impose a mandatory requirement to create or maintain certain
tecords. By its express terms, it is purely an access provision: “patients have a 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. (emphasis added). Indeed, the Florida
Supreme Court has expressly agreed that Amendment 7 “has but one purpose—providing access
to records on adverse medical incidents . . . .” Advisory Op. to Att'y Gen. re Patients’ Right to
Know About Adverse Med. Incidents, 880 So. 2d 617, 620 (Fla. 2004) (emphasis added).
Consequently, unlike some Florida statutes that do require certain records to be created and
copies of those records to be reported to the state (see, e.g., § 395.0197, Fla. Stat.), Amendment 7
simply authorizes a patient to access records that healthcare providers keep in the ordinary course
of business. Not all of those are created to meet state reporting requirements. Even under the
framework established by Charles, then, there are records created by hospitals that fall outside of
any mandatory reporting or recordkeeping purpose that, absent the PSQIA privilege, would not be
created because they would be encompassed by an Amendment 7 request.
Amendment 7’s definition of “adverse medical incident” bears this out still further. Under
15that provision, an “adverse medical incident” is expressly “not limited to” incidents “that are
required by state or federal law to be reported to any governmental agency or body, and incidents
that are reported to or reviewed by any health care facility peer review, risk management, quality
assurance, credentials, or similar committee, or any representative of any such committees.” Art.
X, § 25(c)(3), Fla. Const. (emphasis added).
Thus, in the absence of the preemptive federal privilege protection afforded by PSQIA,
records created for reporting to a patient safety organization under PSQIA thus would fall within
Amendment 7’s broad definition of records that patients are entitled to access. There is no
independent obligation under Florida law to create and maintain those documents, but they
nonetheless may be required to be produced under Amendment 7 because they would be kept in
the ordinary course of business, and Amendment 7 includes such records even though they are not
tequired by state law to be created. Of course, requiring the production of these documents would
defeat the protections that allow providers to fully participate in PSQIA’s patient safety reporting
activities. See 73 Fed. Reg. at 70,741. This incorrect reasoning should not stand.
2. The “Sole Purpose” Test Created In Charles Is Contrary To PSQIA.
The Florida Supreme Court held in Charles that records do not qualify as protected patient
safety work product unless they are created solely for submission to a PSO. 209 So. 3d at 1211,
1216. PSQIA, however, makes clear that records do not have to be created solely for submission
toa patient safety organization to be privileged. Providers may disclose patient safety work product
for a variety of purposes and, even if disclosed, the work product remains confidential and
privileged. H.R. Rep. No. 109-197, at 14; see also 42 U.S.C. § 299b-22(c). For example, patient
safety work product may be disclosed to “carry out patient safety activities”; for “research” and
“demonstration projects” authorized by HHS; “to an accrediting body”; “if necessary for business
16operations”; and to law enforcement. /d. at § 299b-22(c)(2)(A)-(G). Disclosures for these purposes
do not destroy the privilege. As the Act provides, “[p]atient safety work product that is disclosed
under [these exceptions] shall continue to be privileged and confidential .. . .” /d. at § 299b-
22(d)(1). Charles’s sole purpose test renders Congress’s list of permissible disclosures
meaningless.
As set forth above, the definition of patient safety work product under PSQIA is much
simpler and asks whether the information was developed by a provider for the purpose of reporting
it to a patient safety organization and was reported to a patient safety organization and whether the
information could result in improved patient safety, health quality, or health outcomes. Jd. at
§ 299b-21(7)(A)(i). The sole purpose test created by Charles thus is inconsistent with the language
of the Act. The Act nowhere says that information can only constitute patient safety work product
if it is created solely for submission to a patient safety organization.
3. The Court’s Discussion Of Preemption Is Contrary To PSQIA.
Charles concluded that PSQIA does not preempt Amendment 7 because it “does not
contain any express statement of preemption relating to Amendment 7” and that, even where
PSQIA and Amendment 7 overlapped, PSQIA would give way based on the voluntary nature of
the federal program. 209 So. 3d at 1213, 1217. This is incorrect.
First, PSQIA expressly provides that its privilege and confidentiality provisions governing
patient safety work product are effective “[n]otwithstanding any other provision of Federal, State,
or local law.” § 299b-22(a), (b). Congress therefore expressly intended to preempt Federal, State,
and local laws that conflict with the Act. This includes Amendment 7. By concluding to the
contrary, Charles nullifies the protections that Congress placed into the federal statutory scheme.
If every learning event must be disclosed, then the Act as a whole is rendered ineffective
17throughout the state.
Moreover, it is no answer that the Act does not preempt state law simply because a
provider’s decision to participate in PSQIA is voluntary. The Act makes clear that, once the
provider participates, it is subject to the mandatory requirements of the Act to maintain the
privileged and confidential nature of patient safety work product. 42 U.S.C. § 299b-22(a), (b), (f).
As Congress determined, that is the only way for providers to effectively reach across state lines
and learn from each other to help future patients. Charles’s preemption discussion thwarts
Congress’s authority and express intent in enacting PSQIA by rendering healthcare providers in
Florida incapable of learning with other states and complying with their obligations under federal
law.
4, Charles Is Contrary To Decisions From Other States On The Same Issue,
Eliminating PSQIA Protections For Florida Healthcare Providers That Other
Similarly Situated Providers In Other States Have.
Charles further undermines and nullifies PSQIA’s protections for Florida healthcare
providers, healthcare facilities, and patients because Florida providers participating in PSQIA, as
sought by Congress’s creation of the Act, will be compelled to produce privileged documents while
hospitals in other states participating in PSQIA will be entitled to protect those documents and
openly learn from each other to improve patient care for their citizens.
While states (along with the federal government) regulate and license healthcare facilities
and providers, they cannot create the comprehensive, nationwide exchange of information,
analysis, and feedback contemplated by Congress in enacting PSQIA. PSQIA creates the only
system that enables interstate access to, and analysis of, information—standardized across similar
cases and providers—to obtain the extensive patient safety and quality improvement outcomes
intended by Congress because it is founded on the absolute protections of confidentiality and
18privilege that only the federal government can provide. Any state law to the contrary adversely
affects PSQIA’s grant of confidentiality and privilege and ultimately eviscerates the bedrock
foundation of this national program.
The effect of Charles thus violates Defendants’ rights to equal protection under the law
because Florida healthcare providers, healthcare facilities, and patients are at a disadvantage to
which those in other states are not subjected.
Decisions from other states on the applicability of PSQIA bear this out even further. For
example, the court in Daley v. Teruel, 107 N.E.3d 1028, 1046-47 (Ill. App. Ct. 2018), held that
PSQIA expressly preempted state law requiring the production of patient safety work product. In
so holding, the court pointed to PSQIA’s specific provision that its privilege and protections apply
“(njotwithstanding any other provision of Federal, State, or local law . . .” and to its provisions
that nothing in the Act should be construed as preempting or otherwise affecting any state law
tequiring a provider to report information that is not patient safety work product. As the court
explained: “In other words, when information is patient safety work product, the PSQIA should
be construed as preempting any state action requiring a provider to disclose such work product.”
Id. at 1046.
Daley expressly rejected Charles’s conclusion that PSQIA does not contain an express
preemption provision with respect to documents that are patient safety work product, explaining
that PSQIA contains an unambiguous express preemption clause, which clearly demonstrates
Congress’s intent to supersede any state court order requiring the production of documents that
constitute patient safety work product. /d. at 1046-47; see also Dep’t of Fin. & Prof’l Reg. v.
Walgreen Co., 970 N.E.2d 552, 557-58 (Ill. App. Ct. 2012) (PSQIA preempted state law
authorizing regulators to compel production of documents in connection with any hearing or
19investigation carried out by state regulators; inquiry is whether reports were created within a
patient safety evaluation system and remained sequestered there).
Similarly, in University of Kentucky v. Bunnell, 532 S.W.3d 658 (Ky. Ct. App. 2017), the
court issued a writ prohibiting a circuit judge from enforcing an order compelling a state court
defendant from producing documents that constituted patient safety work product. That court
rejected the contention that the incident information was not entitled to protection under PSQIA
because it was collected and maintained by the state as part of its regulatory oversight. Instead, the
court reasoned, information found within the evaluation system could meet both the state
requirement and be patient safety work product without creating an unmet external reporting
requirement. /d. at 678. Because the report did not exist separately from the patient safety
evaluation system, it remained protected. Id.
Courts in other states have held the same. See Taylor v. Hy-Vee, Inc., No. 15-9718, 2016
WL 7405669, at *4 (D. Kan. Dec. 22, 2016) (unreported) (holding, contrary to Charles, that
regardless of whether information is used to meet internal and state-mandated quality improvement
systems, data is privileged patient safety work product if it was developed for reporting to a PSO);
Quimbey v. Cmty. Health Sys. Prof’! Servs. Corp. , 222 F. Supp. 3d 1038, 1043-44 (D.N.M. 2016)
(peer review documents qualifying under both state law and PSQIA were protected by PSQIA
even though state law would have permitted discovery).
Finally, the Middle District of Florida decided, contrary to Charles, that PSQIA preempts
Amendment 7. Fla. Health Sci. Ctr., Inc. v. Azar, 420 F. Supp. 3d 1300 (M.D. Fla. 2019), appeal
docketed, No. 19-14383 (11th Cir. Nov. 1, 2019). There, Tampa General Hospital was asked to
produce records of adverse medical incidents under Amendment 7 and believed some of the
documents responsive to that request were privileged under PSQIA. /d. at 1304-05. It sought a
20declaration from the district court enjoining HHS from imposing mandatory penalties under
PSQIA because PSQIA preempts Amendment 7. Jd.
The district court agreed, explaining that the protections provided by PSQIA are “the
foundation to furthering the overall goal of the statute to develop a national system for analyzing
and learning from patient safety events.” /d. at 1304 (citing 73 Fed. Reg. at 70,741). The court held
that PSQIA expressly preempted Amendment 7 when it provided that “[n]otwithstanding any other
provision of Federal, State, or local law, and subject to subsection (c), patient safety work product
shall be privileged . . . .” /d. at 1306 (citing 42 U.S.C. § 299b-22(a)(1), (2)). The court concluded
that this express preemption clause demonstrated Congress’s intent to supersede any court order
requiring the production of documents that are patient safety work product. /d. Because it was
undisputed that the requested documents at issue constituted patient safety work product, the court
held PSQIA preempted Amendment 7 with respect to those documents. /d. The court further
concluded that Charles did not convince it otherwise because the issue of preemption was not
directly at issue in Charles since the documents at issue in that case had not been submitted to a
patient safety organization. /d. at 1306-07.
The Eleventh Circuit thereafter issued an unpublished decision, vacating the district
court’s order on other grounds. See Fla. Health Scis. Ctr., Inc. v. Sec’y, U.S. Dep’t of Health &
Human Servs., No. 19-14383, 2021 WL 508155 (11th Cir. Feb. 11, 2021). Because, among other
reasons, the state court plaintiff’s medical negligence suit had been dismissed in state court on the
merits and the hospital was therefore no longer required to disclose patient safety work product in
that case, the Court vacated the district court’s order enjoining production of the documents and
dismissed the case for lack of jurisdiction because the hospital was not subject to an “imminent
injury.” Jd. at *3. The Court did, however, acknowledge in its general discussion of PSQIA that
21the Act “forbids participating entities, including [the hospital], from disclosing certain records that
qualify as ‘patient safety work product.”” Jd. at *1.
Consequently, to the extent Charles governs this case, it should be overturned because it
undermines Congress’s intent in creating a national, uniform system of improving patient safety.
A healthcare provider’s duties and the safety improvement opportunities for Florida patients under
an important federal law are abolished in Florida in favor of a state constitutional provision. As
Congress determined, that is the only way to effectively reach across state lines and learn from
each other to help future patients. Charles thwarts Congress’s authority and express intent in
enacting PSQIA by rendering healthcare providers in Florida incapable of learning with other
states and complying with their obligations under federal law.
CONCLUSION
Because the information Plaintiff seeks here constitutes patient safety work product, it is
absolutely privileged from disclosure under PSQIA, and this Court should deny Plaintiff’s motions
to compel. To the extent the court believes that Charles requires production of the information,
however, that decision was wrongfully decided. Florida, as the nation’s third most populous state,
should not treat its healthcare providers and patients differently from other states by effectively
prohibiting providers from complying with this important federal law.
Respectfully submitted,
s/ Christine R. Davis
Christine R. Davis (FBN 569372)
CARLTON FIELDS, P.A.
215 S. Monroe St., Suite 500
Tallahassee, FL 32301
Telephone: (850) 224-1585
Email: cdavis@carltonfields.com
Co-Counsel for Defendants
22CERTIFICATE OF SERVICE
I HEREBY CERTIFY that a true and correct coping of the foregoing has been served by
e-mail to the following on this 16th day of April, 2021.
Andrea A. Lewis
Searcy Denney Scarola Barnhart & Shipley, P.A.
2139 Palm Beach Lakes Blvd.
West Palm Beach, FL 33409
lewisteam@searcylaw.com
mweschrek @searcylaw.com
Counsel for Plaintiff
Francis E. Pierce
Mateer Harbert, P.A.
225 E. Robinson St., Suite 600
Orlando, FL 32801
mdavis@mateerharbert.com
litpleadings@mateerharbert.com
ckozimor@mateerharbert.com
Counsel for Defendant Shands Teaching Hosp. & Clinics, Inc.
Rafael E. Martinez
Wilbert R. Vancol
McEwan, Martinez, Dukes & Hall, P.A.
P.O. Box 753
Orlando, FL 32802
NOS@mmdorl.com
wvancol@mmdorl.com
mearter@mmdorl.com
rmartinez@mmdorl.com
glichtenberger@mmdorl.com
dmealpin@mmdorl.com
Counsel for Defendant Univ. of Fla. Bd. of Trustees
s/ Christine R. Davis
Christine R. Davis (FBN 569372)
23
Preview
Filing # 125089369 E-Filed 04/16/2021 03:20:25 PM IN THE CIRCUIT COURT OF THE EIGHTH JUDICIAL CIRCUIT IN AND FOR ALACHUA COUNTY, FLORIDA BRENDA SNOW, Plaintiff, Case No. 2020-CA-001350 Vv. SHANDS TEACHING HOSPITAL AND CLINICS, INC. d/b/a UF HEALTH SHANDS HOSPITAL, a Florida non-profit corporation; and UNIVERSITY OF FLORIDA BOARD OF TRUSTEES d/b/a UF HEALTH EYE CENTER, a Florida Public Body Corporate, Defendants. / DEFENDANTS’ RESPONSE TO PLAINTIFF’S MOTIONS AND SUPPLEMENTAL MOTIONS TO COMPEL BETTER ANSWERS TO FIRST SET OF INTERROGATORIES AND BETTER RESPONSES TO FIRST REQUEST TO PRODUCE Defendants Shands Teaching Hospital and Clinics, Inc. d/b/a UF Health Shands Hospital and University of Florida Board of Trustees d/b/a UF Health Eye Center (collectively “Defendants”) respond in opposition to Plaintiff's Motion and Supplemental Motion to Compel Better Answers to her First Sets of Interrogatories and Better Responses to her First Requests to Produce. For the reasons set forth below, Plaintiff's motion should be denied because the information Plaintiff seeks is privileged and Defendants are prohibited by federal law from providing such information. BACKGROUND Defendants have produced all of Plaintiff's medical records, charts, reports, documents, handwritten notes, progress notes, audit trails associated with Plaintiffs medical records, and other materials that it has pertaining to Plaintiff. See generally UFBOT Resp. To Plaintiff's 1st RFP "2020 CA 001350" 125089369 Filed at Alachua County Clerk 04/16/2021 03:20:28 PM EDT(July 17, 2020); Shands Resp. to Plaintiff's Ist RFP (July 17, 2020). With respect to certain interrogatories and requests for production, however, Defendants objected because the interrogatory or request sought information that is confidential and privileged under the federal Patient Safety and Quality Improvement Act (“PSQIA”), and Defendants are accordingly prohibited by federal law from responding to them. A. Discovery Directed To UFBOT Specifically, UFBOT objected to interrogatories 12, 16, 17, and 27 on these grounds. The interrogatories asked: 12. “Were any adverse incident reports, Code 15 reports, or root cause analysis made which in any way pertained to the care and treatment of the plaintiff at [UFBOT]?” 16. “At any time during this Defendant’s treatment of the Plaintiff, was an incident report filled out pertaining to Plaintiff? If so, provide full name and address of the individual(s) who filled out the form(s). Identify by name, address and official title or employment position, each and every individual involved in the investigation of the incident; and/or any “adverse medical incident” review board; and/or any peer review committee regarding the incident which is the subject of this litigation.” 17. “Please identify any and all parties to whom reports and/or investigations were submitted regarding the incident that is the subject of the instant litigation. This includes, but is not limited to Dr. Ames, Dr. Khurshid, Dr. Blake, Jaime Griffin and/or Dr. Gonzalez.” 27. “Please identify all complaints, warnings, discipline, and reprimands that Phillip Ames received on or after May 11, 2018 that were in any way related to Ms. Snow, the retrobulbar alcohol injection, his conduct in this case, and the events described in the Complaint. In your answer, please state whether an investigation into Ms. Snow’s treatment/injuries, theadministration of the retrobulbar alcohol injection, or any of the events described in the Complaint and, if so, who performed the investigation.” UFBOT objected to these interrogatories, stating: To “the extent the request may be understood to seek information protected from disclosure as confidential and privileged Patient Safety Work Product, pursuant to the Patient Safety Quality and Improvement Act of 2005 (PSQIA, see 42 U.S.C. §§ 299b-21 — 299b-26) and its implementing regulations (see 42 C.F.R. Par 3).” UFBOT explained that, “[a]s participants in a listed Patient Safety Organization regulated by the Federal Agency for Health Care Research and Quality, Patient Safety Work Product is prohibited from disclosure except in connection with Patient Safety Activities or as otherwise provided by PSQIA. See 42 U.S.C. § 299b-22.” UFBOT further explained that the “[a]pplicability and scope of these federal precedents, to the extent irreconcilable with Florida’s Constitution, art. X, § 25, are the subjects of ongoing federal civil litigation.” UFBOT also objected to Requests to Produce 14, 15, and 17, which requested: 14. “Copies of all incident reports, investigative reports, and peer review documents pertaining to the condition, care, treatment, diagnoses, interpretation, reviews, medical opinions, and other services rendered to or relating to Plaintiff . . . regardless of whether or not they pertain to any internal risk management or peer review program.” 15. “Copies of all statements obtained from anyone pertaining to the condition, care, treatment, diagnoses, interpretation, reviews, medical opinions, and other services rendered to or relating to Plaintiff . . . regardless of whether or not they pertain to any internal risk management or peer review program.” 17. “Any and all adverse incidents reports and root cause analysis which in any way pertained to the care and treatment of Plaintiff... .”As with its objection to Plaintiff's interrogatory requests above, UFBOT objected to these requests to the extent they may be understood to seek information protected from disclosure and confidential and privileged patient safety work product, as defined under PSQIA. B. Discovery Directed To Shands Shands objected to interrogatories 13, 16, 17, and 18 on the same grounds as UFBOT. Those interrogatories asked: 13. “Were any adverse incident reports, Code 15 reports, or root cause analysis made which in any way pertained to the care and treatment of the plaintiff at SHANDS TEACHING HOSPITAL AND CLINICS, INC. d/b/a UF HEALTH SHANDS HOSPITAL or UFBOT d/b/a UF HEALTH EYE CENTER?” 16. “Does defendant hospital have any records, reports, notes, correspondence, test results, logs, studies, slides, photographs, documents or any other materials which pertain to the Plaintiff which are not contained in the patient’s hospital chart? If so, identify any such documents or materials and set forth the name and address of the person in custody of each such item.” 17. “At the time during the subject hospitalizations of the Plaintiff, was an incident report filled out pertaining to the Plaintiff? If so, provide full name and address of the individual(s) who filled out the form(s). Identify by name, address and official title or employment position, each and every individual involved in the investigation of the incident; and/or any “adverse medical incident review board; and/or any peer review committee regarding the incident which is the subject of this litigation.” 18. “Please identify any and all parties to whom reports and/or investigations were submitted regarding the incident that is the subject of the instant litigation.” Shands objected to these interrogatories to the extent they may be understood to seekinformation protected from disclosure and confidential and privileged patient safety work product, as defined under PSQIA, raising the same objection as UFBOT, set forth above, supra, at 3. Shands also objected to requests to produce 14, 15, 17, which requested the same information requested of UFBOT set forth above, supra, at 3. As with its objection to Plaintiff’s interrogatory requests, Shands objected to these requests to the extent they may be understood to seek information protected from disclosure and confidential and privileged patient safety work product, as defined under PSQIA. Cc. Plaintiff's Motions To Compel. Plaintiff initially moved to compel better answers and responses to her Interrogatories and Requests for Production, asserting that Defendants’ responses to the above interrogatories and tequests were insufficient or inadequate. Plaintiff later filed a Supplement to her Motion to Compel, asserting that Amendment 7 provides her with the right to access “any records” Defendants made or received in the course of business relating to any adverse medical incident.” (Supp. Resp. at 2) (citing Art. X, § 25, Fla. Const.). Plaintiff contends that “[t]he Florida Supreme Court has held, in no uncertain terms, that Amendment 7 trumps all legal barriers, restrictions, or privileges, legislative or otherwise, that may otherwise prevent discovery of records under Amendment 7.” (Supp. Resp. at 2) (emphasis in original) (citing, among other cases, Edwards v. Thomas, 229 So. 3d 177, 287 (Fla. 2017)). Plaintiff asserts she has an “absolute right” to discover records relating to any adverse medical incident, which is broadly defined to include an event that “caused or could have caused injury to or death of a patient.” (Supp. Resp. at 3) (emphasis added). According to Plaintiff, the circumstances of her case “clearly” constitute an adverse medical incident and she “unquestionably” seeks records made or received in the course of Defendants’ businesses. (Supp.Resp. at 3-4). Citing a passage from the opinion that discusses how PSQIA works in general, Plaintiff further contends that the Florida Supreme Court’s decision in Charles v. Southern Baptist Hospital of Florida, Inc., 209 So. 3d 1199 (Fla. 2017), renders Defendants’ objections legally insufficient. (Supp. Resp. at 4-5). APPLICABLE LAW AND ARGUMENT, The issue before the Court involves the interplay between Amendment 7 and PSQIA, and the Florida Supreme Court’s interpretation of both laws. Consequently, this Memo first sets forth the parameters of these laws and then explains why the documents at issue are privileged, precluding Defendants from producing them in response to Plaintiff’s request.! A. Patient’s Right To Access Records Of Adverse Medical Incidents Under Article X, Section 25 Of The Florida Constitution (commonly _referred_to_by_ its ballot designation, Amendment 7). In 2004, Florida voters approved Amendment 7, which established a state constitutional tight for patients “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. (emphasis added). That provision broadly defines an “adverse medical incident” as: [M]edical negligence, intentional misconduct, and 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, including, but not limited to, those incidents that are required by state or federal law to be reported to any governmental agency or body, and incidents that are reported to or reviewed by any health care facility peer review, tisk management, quality assurance, credentials, or similar committee, or any representative of any such committees. ' This issue also is the subject of ongoing litigation in the federal courts. In Shands Teaching Hospitals & Clinics, Inc. v. Morgan, Shands brought a declaratory judgment action seeking a ruling from the federal district court that PSQIA preempts Amendment 7 and precludes disclosure of patient safety work product. Whether the federal court has subject matter jurisdiction to decide this issue is pending on appeal in the Eleventh Circuit Court of Appeals. See Shands Teaching Hosp. & Clinics, Inc. v. Morgan, Case No. 20-11555.Id. at § 25(c)(3). Importantly, Amendment 7 does not impose a mandatory requirement for health care providers to create or maintain certain records. By its express terms, it is purely an access provision: “patients have a 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. (emphasis added). B. The Federal Patient Safety And Quality Improvement Act. In 1999, the Institute of Medicine reported that many Americans die each year from preventable medical errors, most of which are not caused by isolated mistakes but by “system failures.” S. Rep. No. 108-196, at 1 (2003). Explaining that “society’s long-standing reliance on the threat of malpractice litigation discourages health care professionals and organizations from disclosing, sharing, and discussing information about medical errors,” it recommended the creation of a protected system in which information might be shared and errors might be identified and evaluated without fear of blame and litigation. /d. at 1-2. In response, Congress passed the Patient Safety and Quality Improvement Act (“PSQIA” or “the Act”) in 2005, codified at 42 U.S.C. § 299b-21, ef seg. The purpose of the Act is 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). The Act was intended to proactively replace a “culture of blame” with a “culture of safety” that emphasizes communication and cooperation. S. Rep. No. 108-196, at 2. To that end, the Act, passed by Congress after Florida’s Amendment 7, creates a voluntary, confidential, non-punitive system of data sharing of healthcare errors. 42 U.S.C. § 299b-22(a), (b). Healthcare providers who choose to participate in this system begin by establishing a patient safetyevaluation system in which relevant information is collected, managed, and analyzed. /d. at § 299b-21(6). After the information is collected in the patient safety evaluation system, the provider forwards it to a federally-approved patient safety organization, which assesses the information and presents “feedback and assistance to effectively minimize patient risk.” Jd. at § 299b-21(5)(D); see also id. at § 299b-24(b)(1)(G). That organization may then remove any identifying patient and provider information and share the data with a central clearing house, called the National Patient Safety Database, which in turn aggregates the data and makes it available to providers as an “evidence-based management resource.” /d. at § 299b-23(a). Information collected for submission to a patient safety organization is called “patient safety work product.” The type of patient safety work product relevant here was created through the “reporting pathway” authorized by the Act. This type of patient safety work product consists of “any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements,” (1) which “are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization,” and which could result in improved patient safety, health care quality, or health care outcomes. /d. at § 299b-21(7)(A)(i). Because the goal of PSQIA is to encourage providers to voluntarily report patient safety events, it provides “substantial and broad” protections to patient safety work product so providers can participate “without fear of liability or harm reputation.” 73 Fed. Reg. 70,732-01, 70,741 (Nov. 21, 2008). These protections are “the foundation to furthering the goal of the statute to develop a national system for analyzing and learning from patient safety events.” Jd. Consequently, PSQIA provides that “[n]otwithstanding any other provision of Federal, state, or local law,” patient safety work product shall be privileged, confidential, and not subject to disclosure. 42 U.S.C. § 299b-22(a), (b) (emphasis added). Providers who violate PSQIA byknowingly disclosing confidential patient safety work product are subject to mandatory penalties. Id. at § 299b-22(f)(1); see also 45 C.F.R. § 102.3 (updating penalty amount). Not all information is patient safety work product. Such work product does not include (1) “a patient’s medical record, billing and discharge information, or any other original patient or provider record,” or (2) “information that is collected, maintained, or developed separately, or exists separately,” from the provider’s patient safety evaluation system. 42 U.S.C. § 299b- 21(7)(B)(i), (ii). “Separate” information that is ultimately reported to a PSO, but was not created for reporting to a PSO, does not become protected patient safety work product. /d. at § 299b- 21(7)(B)(ii). PSQIA thus does not replace, but rather resides alongside, external collection activities mandated by state and federal laws and regulations. 81 Fed. Reg. 32,655-01, 32,657 (May 24, 2016). To balance the potential need for using the same information for external state reporting requirements, the United States Department of Health & Human Services (“HHS”) adopted a rule that permitted providers to document their voluntary removal of information from their patient safety evaluation systems before it is reported to a patient safety organization. /d. at 32,655. HHS reasoned this rule would decrease “the need to maintain duplicate information for different needs,” but it cautioned providers to place only information actually intended for reporting to a patient safety organization into their evaluation systems: [P]roviders need not maintain duplicate systems to separate information to be teported to a [patient safety organization] from information that may be required to fulfill state reporting obligations. All of this information, collected in one patient safety evaluation system, is protected as patient safety work product unless the provider determines that certain information must be removed . . . for reporting to the state. Once removed from the patient safety evaluation system, this information is no longer patient safety work product. 73 Fed. Reg. at 70,741-70,742 (emphases added). The rule gives healthcare providers flexibilityto determine “what information is to become patient safety work product and, thus, protected from disclosure” and what information must be removed from a patient safety evaluation system for state reporting obligations. Jd. at 70,773. Cc. The Florida Supreme Court Considers The Privilege And Confidentiality Protections Of PSQIA And Their Relationship To Amendment 7 In Charles. Since Amendment 7’s enactment, the Florida Supreme Court has broadly construed its provisions, declaring that it requires disclosure of a wide spectrum of records, not just those records that were previously protected by statute. See, e.g., Fla. Hosp. Waterman, Inc. v. Buster, 984 So. 2d 478, 487-89 (Fla. 2008); Edwards v. Thomas, 229 So. 3d 277, 285 (Fla. 2017). The court specifically considered the interplay between PSQIA and Amendment 7 in Charles v. Southern Baptist Hospital of Florida, Inc., 209 So. 3d 1199 (Fla. 2017). In Charles, the plaintiff initiated a medical malpractice action against a hospital and sought records under Amendment 7. The hospital produced certain responsive documents, which included Code 15 reports (created under section 395.0197(7), Florida Statutes), Annual Reports (created under section 395.0197(6)), and two occurrence reports that were extracted from the hospital’s patient safety evaluation system before they had been reported to the hospital’s patient safety organization. The hospital claimed that other documents, which primarily consisted of occurrence reports, were not subject to production. The hospital asserted that, although these reports were potentially responsive because they fell under the broad definition of “adverse medical incidents” contained in Amendment 7, they could not be produced because they were privileged and confidential under PSQIA as patient safety work product. 209 So. 3d at 1205-06. The plaintiff moved to compel production of the documents the hospital claimed were privileged, asserting that PSQIA only protected documents that were created “solely” for the purpose of submission to a patient safety organization and that such information was not privileged 10if it was collected and maintained for another purpose or for a dual purpose, or if the information is in any way related to a healthcare provider’s obligation to comply with federal, state, or local laws. Id. at 1206. The trial court ordered production of the documents, finding they 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. Jd. On a petition for writ of certiorari, the First District quashed the trial court’s order. According to that court, the plain language of PSQIA showed that the records at issue clearly met the definition of patient safety work product because they were placed into the hospital’s patient safety evaluation system where they remained pending submission to a patient safety organization. Id. (discussing S. Baptist Hosp. of Fla. v. Charles, 178 So. 3d 102, 104, 111 (Fla. Ist DCA 2015)). As that court explained: 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 (cleaned up). The First District further held that PSQIA expressly preempts any broad discovery right under Amendment 7 for documents that meet the definition of patient safety work product and also impliedly preempts Amendment 7 because compliance with both state and federal law would be impossible. /d. On review of the First District’s opinion, the Florida Supreme Court disagreed, holding that a document created or maintained pursuant to a state-law requirement was not developed “solely” for submission to a federal patient safety organization. Specifically, the court held that adverse medical incident reports are required to be created by section 395.0197(4)-(7), Florida llStatutes, and Florida Administrative Code rule 59A-10.0055, and are, consequently, created pursuant to an independent obligation under Florida law. This independent obligation causes the records to fall within the exception to patient safety work product carved out by PSQIA for information “collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.”” 209 So. 3d at 1211 (quoting § 299b-21(7)(B)(ii)). Consequently, the court concluded, 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.” /d. at 1212. The court then addressed the hospital’s argument that PSQIA preempted Amendment 7. Because the court concluded that the documents at issue in that case did not constitute patient safety work product in the first instance, this discussion in the opinion is dicta. According to the court, PSQIA does not expressly preempt Amendment 7 because the documents do not constitute patient safety work product. The court further explained that PSQIA does not impliedly preempt Amendment 7 because PSQIA is a voluntary program: “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.” /d. at 1214 (emphasis in original). Later that same year, the court said that additional programs such as PSQIA “cannot logically be excluded from Amendment 7’s application simply because they are in addition to the base-level, statutorily-required risk management committees.” Edwards, 229 So. 3d at 289. 12D. The Records Plaintiff Seeks Through Her Motion To Compel Are Privileged Patient Safety Work Product, And Defendants Are Prohibited By PSQIA From Producin: Them. Defendants have produced all non-patient safety work product documents that are responsive to Plaintiff's requests, including Plaintiff's medical records, charts, reports, handwritten reports, progress notes, audit trails associated with Plaintiff's medical records, and other materials it has pertaining to Plaintiff. See generally UFBOT Resp. to Pl. 1st RFP (July 17, 2020); Shands Resp. to Pl. Ist RFP (July 17, 2020). The remaining documents potentially tesponsive to Plaintiff's request fall squarely within the definition of patient safety work product set forth in PSQIA. Based on the plain language of PSQIA and its corresponding regulations, there are three requirements necessary for information to constitute patient safety work product under the “reporting pathway”: qd) The information must be developed for the purpose of reporting to a Patient Safety Organization; (2) The information must have the ability to improve patient safety and the quality of health care; and (3) The information must be reported to the patient safety organization; 42 US.C. § 299b-21(7)(A)(i). The information at issue here satisfies these criteria. It was created pursuant to Defendants’ internal policies relating to its participation in and compliance with PSQIA, it was submitted to Defendants’ patient safety organization, and it was created to improve patient safety and the quality of healthcare. The information also does not fall within the exception to patient safety work product 13because it does not encompass an original medical record, billing or discharge information, or any other patient record, and it was not collected, maintained, or developed separately from Defendants’ patient safety evaluation system. /d. at (B)(ii). It also was not created pursuant to a separate reporting requirement of state law. The information is thus privileged as patient safety work product under the express provisions of PSQIA. E. Charles Does Not Apply Here Because The Information At Issue Is Not The Same As That At Issue In Charles. The documents at issue in Charles were occurrence reports created as contemplated by section 395.0197, Florida Statutes, and were entered into the hospital’s patient safety evaluation system but not reported to the hospital’s patient safety organization. Because Florida statutes and administrative rules describe how providers may create and maintain the records, the Charles court held that Amendment 7 authorized access to them. Here, in contrast, the information at issue was not created pursuant to any separate state law obligation, and it was reported to a Defendants’ patient safety organization. The Florida Supreme Court thus did not directly consider whether this type of information constituted patient safety work product, and Charles should not control here. Instead, the information, as patient safety work product, is subject to the requirement of PSQIA that such records remain privileged and confidential. Ensuring that patient safety work product remains confidential and privileged is “the foundation” to furthering the reason the Act was created in the first instance. 73 Fed. Reg. 70,732-01, 70,741 (Nov. 21, 2008) (emphasis added). F. To The Extent Charles Applies Here, It Was Wrongfully Decided. To the extent the Court believes that Charles governs Defendants’ obligation to produce the documents at issue, Defendants submit that Charles was wrongfully decided. Defendants 14understand that the Court is bound by decisions of the Florida Supreme Court, but raises this issue here to preserve its position. 1. The Court Incorrectly Construed Amendment 7 As Imposing A Mandatory Requirement To Create And Maintain Certain Records. By holding that records requested under Amendment 7 could never constitute patient safety work product because PSQIA purportedly excludes from the definition of “patient safety work product” all records required to be created under state law, the court in Charles improperly conflated the requirement to produce records under Amendment 7 with the requirement to create tecords under separate statutes and regulations. Amendment 7 does not impose a mandatory requirement to create or maintain certain tecords. By its express terms, it is purely an access provision: “patients have a 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. (emphasis added). Indeed, the Florida Supreme Court has expressly agreed that Amendment 7 “has but one purpose—providing access to records on adverse medical incidents . . . .” Advisory Op. to Att'y Gen. re Patients’ Right to Know About Adverse Med. Incidents, 880 So. 2d 617, 620 (Fla. 2004) (emphasis added). Consequently, unlike some Florida statutes that do require certain records to be created and copies of those records to be reported to the state (see, e.g., § 395.0197, Fla. Stat.), Amendment 7 simply authorizes a patient to access records that healthcare providers keep in the ordinary course of business. Not all of those are created to meet state reporting requirements. Even under the framework established by Charles, then, there are records created by hospitals that fall outside of any mandatory reporting or recordkeeping purpose that, absent the PSQIA privilege, would not be created because they would be encompassed by an Amendment 7 request. Amendment 7’s definition of “adverse medical incident” bears this out still further. Under 15that provision, an “adverse medical incident” is expressly “not limited to” incidents “that are required by state or federal law to be reported to any governmental agency or body, and incidents that are reported to or reviewed by any health care facility peer review, risk management, quality assurance, credentials, or similar committee, or any representative of any such committees.” Art. X, § 25(c)(3), Fla. Const. (emphasis added). Thus, in the absence of the preemptive federal privilege protection afforded by PSQIA, records created for reporting to a patient safety organization under PSQIA thus would fall within Amendment 7’s broad definition of records that patients are entitled to access. There is no independent obligation under Florida law to create and maintain those documents, but they nonetheless may be required to be produced under Amendment 7 because they would be kept in the ordinary course of business, and Amendment 7 includes such records even though they are not tequired by state law to be created. Of course, requiring the production of these documents would defeat the protections that allow providers to fully participate in PSQIA’s patient safety reporting activities. See 73 Fed. Reg. at 70,741. This incorrect reasoning should not stand. 2. The “Sole Purpose” Test Created In Charles Is Contrary To PSQIA. The Florida Supreme Court held in Charles that records do not qualify as protected patient safety work product unless they are created solely for submission to a PSO. 209 So. 3d at 1211, 1216. PSQIA, however, makes clear that records do not have to be created solely for submission toa patient safety organization to be privileged. Providers may disclose patient safety work product for a variety of purposes and, even if disclosed, the work product remains confidential and privileged. H.R. Rep. No. 109-197, at 14; see also 42 U.S.C. § 299b-22(c). For example, patient safety work product may be disclosed to “carry out patient safety activities”; for “research” and “demonstration projects” authorized by HHS; “to an accrediting body”; “if necessary for business 16operations”; and to law enforcement. /d. at § 299b-22(c)(2)(A)-(G). Disclosures for these purposes do not destroy the privilege. As the Act provides, “[p]atient safety work product that is disclosed under [these exceptions] shall continue to be privileged and confidential .. . .” /d. at § 299b- 22(d)(1). Charles’s sole purpose test renders Congress’s list of permissible disclosures meaningless. As set forth above, the definition of patient safety work product under PSQIA is much simpler and asks whether the information was developed by a provider for the purpose of reporting it to a patient safety organization and was reported to a patient safety organization and whether the information could result in improved patient safety, health quality, or health outcomes. Jd. at § 299b-21(7)(A)(i). The sole purpose test created by Charles thus is inconsistent with the language of the Act. The Act nowhere says that information can only constitute patient safety work product if it is created solely for submission to a patient safety organization. 3. The Court’s Discussion Of Preemption Is Contrary To PSQIA. Charles concluded that PSQIA does not preempt Amendment 7 because it “does not contain any express statement of preemption relating to Amendment 7” and that, even where PSQIA and Amendment 7 overlapped, PSQIA would give way based on the voluntary nature of the federal program. 209 So. 3d at 1213, 1217. This is incorrect. First, PSQIA expressly provides that its privilege and confidentiality provisions governing patient safety work product are effective “[n]otwithstanding any other provision of Federal, State, or local law.” § 299b-22(a), (b). Congress therefore expressly intended to preempt Federal, State, and local laws that conflict with the Act. This includes Amendment 7. By concluding to the contrary, Charles nullifies the protections that Congress placed into the federal statutory scheme. If every learning event must be disclosed, then the Act as a whole is rendered ineffective 17throughout the state. Moreover, it is no answer that the Act does not preempt state law simply because a provider’s decision to participate in PSQIA is voluntary. The Act makes clear that, once the provider participates, it is subject to the mandatory requirements of the Act to maintain the privileged and confidential nature of patient safety work product. 42 U.S.C. § 299b-22(a), (b), (f). As Congress determined, that is the only way for providers to effectively reach across state lines and learn from each other to help future patients. Charles’s preemption discussion thwarts Congress’s authority and express intent in enacting PSQIA by rendering healthcare providers in Florida incapable of learning with other states and complying with their obligations under federal law. 4, Charles Is Contrary To Decisions From Other States On The Same Issue, Eliminating PSQIA Protections For Florida Healthcare Providers That Other Similarly Situated Providers In Other States Have. Charles further undermines and nullifies PSQIA’s protections for Florida healthcare providers, healthcare facilities, and patients because Florida providers participating in PSQIA, as sought by Congress’s creation of the Act, will be compelled to produce privileged documents while hospitals in other states participating in PSQIA will be entitled to protect those documents and openly learn from each other to improve patient care for their citizens. While states (along with the federal government) regulate and license healthcare facilities and providers, they cannot create the comprehensive, nationwide exchange of information, analysis, and feedback contemplated by Congress in enacting PSQIA. PSQIA creates the only system that enables interstate access to, and analysis of, information—standardized across similar cases and providers—to obtain the extensive patient safety and quality improvement outcomes intended by Congress because it is founded on the absolute protections of confidentiality and 18privilege that only the federal government can provide. Any state law to the contrary adversely affects PSQIA’s grant of confidentiality and privilege and ultimately eviscerates the bedrock foundation of this national program. The effect of Charles thus violates Defendants’ rights to equal protection under the law because Florida healthcare providers, healthcare facilities, and patients are at a disadvantage to which those in other states are not subjected. Decisions from other states on the applicability of PSQIA bear this out even further. For example, the court in Daley v. Teruel, 107 N.E.3d 1028, 1046-47 (Ill. App. Ct. 2018), held that PSQIA expressly preempted state law requiring the production of patient safety work product. In so holding, the court pointed to PSQIA’s specific provision that its privilege and protections apply “(njotwithstanding any other provision of Federal, State, or local law . . .” and to its provisions that nothing in the Act should be construed as preempting or otherwise affecting any state law tequiring a provider to report information that is not patient safety work product. As the court explained: “In other words, when information is patient safety work product, the PSQIA should be construed as preempting any state action requiring a provider to disclose such work product.” Id. at 1046. Daley expressly rejected Charles’s conclusion that PSQIA does not contain an express preemption provision with respect to documents that are patient safety work product, explaining that PSQIA contains an unambiguous express preemption clause, which clearly demonstrates Congress’s intent to supersede any state court order requiring the production of documents that constitute patient safety work product. /d. at 1046-47; see also Dep’t of Fin. & Prof’l Reg. v. Walgreen Co., 970 N.E.2d 552, 557-58 (Ill. App. Ct. 2012) (PSQIA preempted state law authorizing regulators to compel production of documents in connection with any hearing or 19investigation carried out by state regulators; inquiry is whether reports were created within a patient safety evaluation system and remained sequestered there). Similarly, in University of Kentucky v. Bunnell, 532 S.W.3d 658 (Ky. Ct. App. 2017), the court issued a writ prohibiting a circuit judge from enforcing an order compelling a state court defendant from producing documents that constituted patient safety work product. That court rejected the contention that the incident information was not entitled to protection under PSQIA because it was collected and maintained by the state as part of its regulatory oversight. Instead, the court reasoned, information found within the evaluation system could meet both the state requirement and be patient safety work product without creating an unmet external reporting requirement. /d. at 678. Because the report did not exist separately from the patient safety evaluation system, it remained protected. Id. Courts in other states have held the same. See Taylor v. Hy-Vee, Inc., No. 15-9718, 2016 WL 7405669, at *4 (D. Kan. Dec. 22, 2016) (unreported) (holding, contrary to Charles, that regardless of whether information is used to meet internal and state-mandated quality improvement systems, data is privileged patient safety work product if it was developed for reporting to a PSO); Quimbey v. Cmty. Health Sys. Prof’! Servs. Corp. , 222 F. Supp. 3d 1038, 1043-44 (D.N.M. 2016) (peer review documents qualifying under both state law and PSQIA were protected by PSQIA even though state law would have permitted discovery). Finally, the Middle District of Florida decided, contrary to Charles, that PSQIA preempts Amendment 7. Fla. Health Sci. Ctr., Inc. v. Azar, 420 F. Supp. 3d 1300 (M.D. Fla. 2019), appeal docketed, No. 19-14383 (11th Cir. Nov. 1, 2019). There, Tampa General Hospital was asked to produce records of adverse medical incidents under Amendment 7 and believed some of the documents responsive to that request were privileged under PSQIA. /d. at 1304-05. It sought a 20declaration from the district court enjoining HHS from imposing mandatory penalties under PSQIA because PSQIA preempts Amendment 7. Jd. The district court agreed, explaining that the protections provided by PSQIA are “the foundation to furthering the overall goal of the statute to develop a national system for analyzing and learning from patient safety events.” /d. at 1304 (citing 73 Fed. Reg. at 70,741). The court held that PSQIA expressly preempted Amendment 7 when it provided that “[n]otwithstanding any other provision of Federal, State, or local law, and subject to subsection (c), patient safety work product shall be privileged . . . .” /d. at 1306 (citing 42 U.S.C. § 299b-22(a)(1), (2)). The court concluded that this express preemption clause demonstrated Congress’s intent to supersede any court order requiring the production of documents that are patient safety work product. /d. Because it was undisputed that the requested documents at issue constituted patient safety work product, the court held PSQIA preempted Amendment 7 with respect to those documents. /d. The court further concluded that Charles did not convince it otherwise because the issue of preemption was not directly at issue in Charles since the documents at issue in that case had not been submitted to a patient safety organization. /d. at 1306-07. The Eleventh Circuit thereafter issued an unpublished decision, vacating the district court’s order on other grounds. See Fla. Health Scis. Ctr., Inc. v. Sec’y, U.S. Dep’t of Health & Human Servs., No. 19-14383, 2021 WL 508155 (11th Cir. Feb. 11, 2021). Because, among other reasons, the state court plaintiff’s medical negligence suit had been dismissed in state court on the merits and the hospital was therefore no longer required to disclose patient safety work product in that case, the Court vacated the district court’s order enjoining production of the documents and dismissed the case for lack of jurisdiction because the hospital was not subject to an “imminent injury.” Jd. at *3. The Court did, however, acknowledge in its general discussion of PSQIA that 21the Act “forbids participating entities, including [the hospital], from disclosing certain records that qualify as ‘patient safety work product.”” Jd. at *1. Consequently, to the extent Charles governs this case, it should be overturned because it undermines Congress’s intent in creating a national, uniform system of improving patient safety. A healthcare provider’s duties and the safety improvement opportunities for Florida patients under an important federal law are abolished in Florida in favor of a state constitutional provision. As Congress determined, that is the only way to effectively reach across state lines and learn from each other to help future patients. Charles thwarts Congress’s authority and express intent in enacting PSQIA by rendering healthcare providers in Florida incapable of learning with other states and complying with their obligations under federal law. CONCLUSION Because the information Plaintiff seeks here constitutes patient safety work product, it is absolutely privileged from disclosure under PSQIA, and this Court should deny Plaintiff’s motions to compel. To the extent the court believes that Charles requires production of the information, however, that decision was wrongfully decided. Florida, as the nation’s third most populous state, should not treat its healthcare providers and patients differently from other states by effectively prohibiting providers from complying with this important federal law. Respectfully submitted, s/ Christine R. Davis Christine R. Davis (FBN 569372) CARLTON FIELDS, P.A. 215 S. Monroe St., Suite 500 Tallahassee, FL 32301 Telephone: (850) 224-1585 Email: cdavis@carltonfields.com Co-Counsel for Defendants 22CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct coping of the foregoing has been served by e-mail to the following on this 16th day of April, 2021. Andrea A. Lewis Searcy Denney Scarola Barnhart & Shipley, P.A. 2139 Palm Beach Lakes Blvd. West Palm Beach, FL 33409 lewisteam@searcylaw.com mweschrek @searcylaw.com Counsel for Plaintiff Francis E. Pierce Mateer Harbert, P.A. 225 E. Robinson St., Suite 600 Orlando, FL 32801 mdavis@mateerharbert.com litpleadings@mateerharbert.com ckozimor@mateerharbert.com Counsel for Defendant Shands Teaching Hosp. & Clinics, Inc. Rafael E. Martinez Wilbert R. Vancol McEwan, Martinez, Dukes & Hall, P.A. P.O. Box 753 Orlando, FL 32802 NOS@mmdorl.com wvancol@mmdorl.com mearter@mmdorl.com rmartinez@mmdorl.com glichtenberger@mmdorl.com dmealpin@mmdorl.com Counsel for Defendant Univ. of Fla. Bd. of Trustees s/ Christine R. Davis Christine R. Davis (FBN 569372) 23