IN THE CIRCUIT COURT, FOURTH
JUDICIAL CIRCUIT, IN AND
FOR
DUVAL COUNTY, FLORIDA
JEAN
CHARLES,
JR.,
as next friend
and
duly
appointed
Guardian
of
his sister
MARIE
CHARLES,
and
her
minor
children,
ERVIN
ALSTON,
ANGEL
ALSTON
and
JAZMIN
HOUSTON,
minors,
Plaintiffs
vs.
SOUTHERN
BAPTIST
HOSPITAL
OF
CASE NO.:
DIVISION:
FLORIDA,
INC.
d/b/a
BAPTIST
MEDICAL
CENTER-SOUTH,
KRISTIN
FERNANDEZ,
D.O.,
Gynecologist, YUVAL Z.
NAOT,
M.D., Hematologist/
Oncologist,
SAFEER
A.ASHRAF, M.D., Hematologist/
Oncologist,
INTEGRATED
COMMUNITY
ONCOLOGY
NETWORK,
LLC.,
a
Florida
limited liability
corporation,
ANDREW
NAMEN, M.D., Pulmonologist,
GREGORY
J.
SENGSTOCK,
M.D., Neurologist,
JOHN
D.
PENNINGTON,
M.D.
Internist,
EUGENE
R.
BEBEAU, M.D., Anesthesiologist,
and
ROBERT
E.
ROSEMUND,
M.D.,
Family
Practitioner,
Defendants.
----------------------------------------/
16-2012-CA-002677
CV-H
ORDER
ON
PLANTIFFS'
MOTION
TO
COMPEL
THE
PRODUCTION
OF
AMENDMENT
7
DOCUMENTS
I.
Background
and
Procedural
Posture
This is a medical malpractice case. The Plaintiffs have alleged that Marie Charles
suffered neurological injuries as the result
of
the negligence
of
the Defendants while she was a
patient at Baptist Medical Center -
South and Baptist Medical Center - Downtown. Specifically,
the Plaintiffs allege that Marie Charles was subject to an unnecessary, and contra-indicated,
surgery while under the care
of
the Defendants at Baptist Medical Center - South. They further
1
allege that, due to complicating medical factors known to the Defendants, Marie Charles suffered
a stroke while undergoing this surgery. Finally, the Plaintiffs allege that the treatment given to
Marie Charles at Baptist Medical Center -
South and Baptist Medical Center - Downtown after
suffering her stroke was untimely and negligent.
On July 24, 2013, the Plaintiff served a third set
of
requests for production on Defendant
Baptist. In
brief
, these requests asked, pursuant to Art. 10 Sec. 25
of
the Florida Constitution
(Amendment 7), for adverse incident reports (as defined
by
Amendment 7) relating to the
following:
1.
Marie Charles;
2. The defendant doctors;
3. Any physicians working at Baptist Medical Center -
South between 2007 and the present;
4.
Any
physicians working at any Baptist Medical Center facility between 2007 and the
present;
5. Emergency care at any Baptist Medical Center facility between
2007 and the present;
6.
Any care and/or treatment at any Baptist Medical Center facility between 2007 and the
present;
7.
Any care and/or treatment at Baptist Medical Center - South between 2007 and the
present;
In addition, each request contained the following explanatory language:
This request is limited to adverse incident documents (as described above) that are
created by you, or maintained by you, or provided
by
you to any state or federal
agency, pursuant to any obligation or requirement in any state
or
federal law, rule,
or regUlation. As limited, this request includes, but is not limited to, documents
created by you, or maintained by you pursuant to Fla. Stat. § 395.0197, 766.010,
and 395.0193. This request, as limited, specifically includes,
but
is not limited to,
your annual adverse incident summary report and any and all Code
15
Reports.
(Emphasis added).
On
August, 23 2013, Baptist responded to Plaintiffs' Third Request
For
Production.
Baptist stated it had no documents responsive to Requests 1 and 2, and agreed to produce
documents responsive to Requests 3 through 7. Baptist then produced Code
15
Reports and
Annual Reports. Baptist and the Plaintiffs then exchanged a
number
of
letters regarding
2
Baptist's response
to
the Plaintiffs' Third Request for Production. At the end of this exchange,
Baptist acknowledged that it had other potentially responsive documents, but claimed that these
documents were protected from discovery under the Federal
Patient Safety and Quality
Improvement Act
("PSQIA") -
42
U.S.C. § 299b-21 et. seq.
The Plaintiffs then filed a motion
to
compel the production
of
all remaining Amendment
7 documents responsive
to
their Third Request For Production. Following the filing
of
this
motion, the Court heard argument regarding the production
of
Amendment 7 documents on
several occasions, and both the Plaintiff and Baptist submitted case law and other authority for
the Court's consideration.
In
addition, the parties engaged in negotiations, attempting to work
out a compromise on this issue. During these negotiations, Baptist produced two incident reports
relating directly
to
the care
of
Marie Charles that gives rise
to
this case.
The parties have now reached an impasse. Baptist has produced Annual Reports, Code
15
Reports, and two incident reports relating to Marie Charles.
It
maintains its objection under
the
PSQIA
to
the production
of
any other documents. On June 24, 2014 the Plaintiffs brought
this issue back before the Court. The Plaintiffs seek an order granting their motion to compel the
production
of
all Amendment 7 Documents that were created or maintained by Baptist as
required by state or federal law or regulation or credentialing entity requirements, or which were
provided by Baptist
to
any state or federal agency or other credentialing entity pursuant
to
any
obligation or requirement in any state or federal law, rule, regulation, or licensing or
accreditation obligation. Baptist asks that the Court deny the Plaintiffs' motion
to
the extent it
seeks documents not already produced.
II. Analysis
The Plaintiffs' Motion
to
Compel Production
of
Amendment 7 Documents deals with the
3
interaction
of
Amendment 7 and the PSQIA. Amendment 7 gave Floridians broad access
to
adverse incident records from medical providers. The PSQIA creates a privilege protecting
documents that qualify as so called
"Patient Safety Work Product."
Passed
in 2004, Amendment 7 provides that patients have a right to any records made or
received in the course
of
business by a health care facility or provider relating to any adverse
incident.
Fla.
Canst. Art. 10 § 25. "Adverse incidents" are broadly defined to include: medical
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 the death
of
a patient.
Id.
These categories include, but are 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 repOlied 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. Id.
Since 2004, Amendment 7 has been the subject
of
extensive litigation. Florida appellate
courts have ruled on issues relating
to
Amendment 7, turning back several common law and
statutory challenges to the law.
See:
Cedars Healthcare Group
v.
Martinez, 39 Fla.
L.
Weekly,
S60 (Fla. Jan.
30,2014);
Florida Hospital Waterman
v.
Buster, 984 So.2d 478 (Fla. 2008); West
Florida Regional Medical Center
v.
Lynda See, et aI., 70 So.3d 1 (Fla. 2012); Morton Plant
Hospital Association, Inc.
v.
Shabhas, 960 So.2d 820 (Fla. 2nd DCA 2007); Columbia Hospital
Corporation
of
South Broward
v.
Fain,
16
So.3d 236 (Fla.
4th
DCA
2009); Baldwin v. Shands
Teaching Hospital and Clinics, Inc.,
45
So.3d 119 (Fla. 1 st
DCA
2010); Dania Acevedo
v.
Doctors Hospital, Inc., 68 So.3d 949 (Fla. 3rd DCA 2011); Lakeland Regional Medical Center
v.
Neely, 8 So.3d 1268 (Fla. 2nd 2009); Florida Eye Clinic
v.
Mary T. Gmash,
14
So.3d eFla 5th
DCA
2009).
4
In this case, Baptist has argued that the documents sought
by
the Plaintiffs are protected
from discovery by the PSQIA. The PSQIA authorizes the creation
of
patient safety
organizations
(PSO's). A healthcare provider may collect information through a patient safety
evaluation system (PSES) and then share that information with a PSO. The information thus
collected and shared may be classified
as
Patient Safety Work Product (PSWP), but only
if
the
information fits within the Act's definition
ofPSWP,
which is as follows:
(A) IN GENERAL -
Except as provided in subparagraph (B), the term
"patient safety work product" means
any data, reports, records, memoranda, analysis (such as root cause analyses), or written
or oral statement -
(1)
which-
(1)
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.
42
U.S.C. §299b-21 (7)(A) (2006). The PSQIA grants privilege from discovery and
confidentiality protection to
PSWP. See: 42 U.S.C. §299b-22(A) and (B) (2006).
However, the Act contains significant restrictions on the definition
of
PSWP and the
applicability
of
the privilege and confidentiality protections. These restrictions are found under
the heading
"CLARIFICATION" in § 299b-21 (7)(B) and provide in pertinent part as follows:
(B) CLARIFICATION
(i) ...
(ii) Information described
ill
subparagraph (A) does not include information that is
5
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-
(1)
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
government
agency
for
public
health
surveillance,
investigation,
or
other
public health purposes; or
(III) a
provider's
record
keeping obligation
with
respect to information
described in this
subparagraph
under
Federal,
State,
or
local law.
42
U.S.C. §299b-21 (7)(B) (emphasis added).
Under the plain language
of
the PSQIA, information collected, maintained, or developed
for purposes other than submission to a
PSO does not constitute PSWP and is not privileged or
confidential under the Act. Specifically, information collected, maintained, or developed
to
fulfill obligations under federal, state, or local law does not constitute PSWP.
The U.S. Department
of
Health and Human Services, during the rule making process
surrounding the implementation
of
the PSQIA, gave significant guidance to what is and is not
PSWP. Both Baptist and the Plaintiff cited extensively to the rule summary found in Fed. Reg.
Vol 73, No. 226, 70732 et. seq. (Nov. 21,
2008). In that Summary, HHS explains that reporting
obligations under state and federal laws must be met with non-privileged materials:
Even when laws or regulations require the reporting
of
the information regarding
the type
of
events also reported to PSOs, the Patient Safety Act does not shield
providers from their obligation to comply with such requirements. These
external
obligations
must
be
met
with
information
that
is
not
patient
safety
work
product
and
oversight entities continue to have access to this original
information
in the same
manner
as such entities have
had
access
prior
to
the
6
passage
of
the
Patient
Safety Act.
Id.
at 70742 (emphasis added). HHS goes on to explain that information collected for state or
federal record keeping or reporting requirements is not
PSWP:
The Patient Safety Act establishes a protected space or system that
is
separate,
distinct, and resides alongside but does not replace other information collecting
activities mandated by laws, regulations, and accrediting and licensing
requirements
as
well as voluntary reporting activities that occur for the purposes
of
maintaining accountability in the health care system.
Information
is
not
patient
safety
work
product
if
it
is
collected to comply
with
external
obligations, such as: state incident
reporting
requirements;
[or] ... certification
or
licensing records
for
compliance with health oversight agency
requirements
.
...
Id.
(emphasis added). HHS Further explained that PSWP
is
limited only to information obtained
by a healthcare provider's
PSES for the sole purpose
of
reporting to its PSO, and information
collected for other purposes does not become
PSWP by virtue
of
the fact that it was submitted
to
aPSO:
Providers should be cautioned
to
consider whether there are other purposes for
which an analysis may be used to determine whether protection as patient safety
work product
is
necessary or warranted.
Further,
the
definition of
patient
safety
work
product
is
clear
that
information
collected
for
a
purpose
other
than
reporting
to a
PSO
may
not
become
patient
safety
work
product
only based
upon
the
reporting
of
that
information
to a PSO.
Id.
at 70744 (Emphasis added).
The final rules promulgated by
HHS reaffirm the limitations referred
to
above. "Patient
safety work product 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
PSO shall not by reason
of
its reporting be considered
patient safety work
product." 42 C.F.
R.
§3.20, Patient safety work product (2)(i) (emphasis
7
added). Sec. 3.20 goes on
to
state that: "Nothing in this part shall be construed
to
limit
information that is not patient safety work product from being
...
reported to a Federal, State,
local or Tribal government agency for public health oversight purposes; or maintained
as
part
of
a providers' record keeping obligation under Federal, State, local or Tribal law. 42 C.F.R. §3.20,
Patient safety work product (2)(iii) (emphasis added).
Documents are not
PSWP
if
those documents were collected or maintained for a purpose
other than submission
to
a PSO or for a dual purposes. Any documents that are collected
pursuant to a healthcare provider's obligation to comply with federal, state, or local laws, or
accrediting or licensing requirements are not privileged under the
PSQIA, and such documents
do
not gain privilege by being submitted
to
the PSO.
Florida's statutes and administrative rules contain numerous requirements for record
keeping and reporting
of
adverse incidents by healthcare providers. For instance, Section
395.0197, Florida Statutes and Fla. Admin. Code 59A-I0.0055 establish a system whereby
reports
of
adverse incident are to be created, maintained and reported to ACHA. Section
395.0197(4) mandates that health care providers establish a risk management program that
includes written incident reports. Rule
59A-IO.0055 describes what information these incident
reports must contain. Both
Section 395.0197(13) and Rule 59A-1O.0055(3)(b) mandate that
ACHA shall have access to these reports and can review them upon request.
Other statutes that
trigger record keeping and/or reporting requirement include Sections 766.101 and 395.0193.
Documents created or maintained pursuant to statutory or regulatory schemes such as these are
notPSWP.
The language
of
the Plaintiffs' Third Request for Production is tailored
to
ask for only
8
those documents created or maintained pursuant to statutory, regulatory, licensing, or
accreditation requirements.
Since these documents are not PSWP, they are not privileged or
protect from discovery under the
PSQIA.
Baptist argues that, regardless
of
the purpose behind the collection
of
information in its
possession, only infOlmation actually provided
to
the government entities
is
not privileged under
the
PSQIA. However,
in
referring to non-privileged information, the terms used repeatedly by
the statutes and other authorities is
"collected" and "maintained."
It
is the collection and
maintenance
of
information and records for a regulatory purpose, not the actual provision
of
that
information to the government, that takes information out
of
the ambit
of
the PSQIA. In the
words
of
the HHS information "collected to comply with external obligations, such
as:
state
incident reporting requirements;
[or]
...
certification or licensing records for compliance with
health oversight agency requirements
...
" is not privileged. Federal Register, Part III, Vol. 73,
No. 226, at 70742 (Nov. 21,2008) (emphasis added).
Finally, there is a dispute between Baptist and the Plaintiffs on who should bear the cost
of
the production
of
the documents at issue. The Plaintiffs argue that no costs are appropriate
under the language
of
Amendment
7,
and that the costs asked for by Baptist for similar
documents in similar cases is excessive. They have expressed a desire to do discovery on the
issue
of
such costs. Baptist, for its part, claims entitlement to costs under the provisions
of
Florida Statutes. The Court is not ruling, at this point, on either entitlement to costs
of
production or the amount
of
these costs should they be ordered.
Accordingly, it is
9
ORDERED:
1.
Plaintiffs' Motion to Compel the Production
of
Amendment 7 Documents IS
GRANTED.
2.
All adverse incident reports, 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
Patient Safety and Quality Improvement Act
("PSQIA").
3.
By
subsequent Order, the Court will address the breath and scope
of
the
Amendment 7 documents to be produced, the timing
of
the production and Baptist's demand for
reimbursement
of
the cost
of
identifying and producing the Amendment 7 documents.
DONE AND ORDERED in chambers at Jacksonville, Duval County, Florida,
this_
day
of
July, 2014.
Copies fumished to all counsel
of
record.
10
ORDER
ENTERtCJ
JUL
3 0
2014
Waddell
A.
Wallace,
III
Circuit Judge
