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Charles v. Southern Baptist Hospital of Florida Inc.

Supreme Court of Florida

January 31, 2017

JEAN CHARLES, JR., etc., et al., Appellants,


         An Appeal from the District Court of Appeal - Statutory or Constitutional Invalidity First District - Case No. 1D15-109 (Duval County)

          Bryan Scott Gowdy of Creed & Gowdy, P.A., Jacksonville, Florida, for Appellants.

          George N. Meros, Jr. and Andre Velosy Bardos of Gray Robinson, P.A., Tallahassee, Florida; William Everett Kuntz, Michael Houston Harmon, and Earl Edwin Googe, Jr. of Smith Hulsey & Busey, Jacksonville, Florida; and Jack E. Holt, III of Grower, Ketcham, Rutherford, Bronson, Eide & Telan, P.A., Orlando, Florida, for Appellee.

          George Alexander Vaka, Nancy Ann Lauten, and Richard N. Asfar of the Vaka Law Group, P.L., Tampa, Florida; and Maame Gyamfi, AARP Foundation Litigation, Washington, District of Columbia, for Amicus Curiae AARP.

          Philip Mead Burlington of Burlington & Rockenbach, P.A., West Palm Beach, Florida, for Amicus Curiae Florida Justice Association.

          Christopher Vincent Carlyle of The Carlyle Appellate Law Firm, The Villages, Florida, for Amicus Curiae Florida Consumer Action Network.

          Katherine Eastmoore Giddings and Kristen Marie Fiore of Akerman LLP, Tallahassee, Florida; Kirk Stuart Davis of Akerman LLP, Tampa, Florida; and Kathleen T. Pankau, Senior Legal Counsel, The Joint Commission, Oakbrook Terrace, Illinois, for Amicus Curiae The Joint Commission on the Accreditation of Healthcare Organizations.

          Joshua Paul Welsh of Bush Ross, P.A., Tampa, Florida; and Michael R. Callahan of Katten Muchin Rosenman LLP, Chicago, Illinois, for Amici Curiae American Medical Association and the Florida Medical Association (the “Association Amici”); Clarity PSO, Vizient PSO, California Hospital Patient Safety Organization, CHS PSO, LLC, The PSO Advisory, LLC, Society of NeuroInterventional Surgery PSO, QA to QI LLC, Pascal Metrics, Inc., MEDNAX PSO, LLC, Child Health Patient Safety Organization, Inc., Missouri Center for Patient Safety, NC Quality Center PSO, American Data Network PSO, ECRI Institute PSO, Strategic Radiology Patient Safety Organization LLC, Ascension Health Patient Safety Organization, Quantros Patient Safety Center, Quality Circle for Healthcare, Inc., PsychSafe, UHS Acute Care PSO, Midwest Alliance for Patient Safety, Alliance for Patient Medication Safety, American Medical Foundation Patient Safety Organization, Center for the Assessment of Radiological Sciences PSO, and MCIC Vermont PSO (the “PSO Amici”); and IASIS Healthcare LLC, Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital, Crestview Hospital Corporation, Lake Wales Hospital Corporation, Manatee Memorial Hospital, L.P., La Amistad Residential Treatment Center, LLC, and Adventist Health System/Sunbelt, Inc. (the “Provider Amici”).

          Andrew Steven Bolin of Beytin, McLaughlin, McLaughlin, O'Hara, Bocchino & Bolin, Tampa, Florida, for Amici Curiae The Patient Safety Organization of Florida and ECRI Institute PSO.

          Elizabeth Joy Campbell of Locke Lord LLP, West Palm Beach, Florida; and Paul E. Dwyer of Locke Lord LLP, Providence, Rhode Island, for Amicus Curiae The Alliance for Quality Improvement and Patient Safety, Inc.

          PARIENTE, J.

         The important constitutional issue at the heart of this dispute is whether the records that patients in this State have a right to access under article X, section 25, of the Florida Constitution ("Amendment 7"), specifically records relating to "adverse medical incidents, " are privileged and confidential under the Federal Patient Safety and Quality Improvement Act ("the Federal Act"), [1] such that Amendment 7 has been preempted by federal law. The First District Court of Appeal, in Southern Baptist Hospital of Florida, Inc. v. Charles, 178 So.3d 102 (Fla. 1st DCA 2015), concluded that adverse medical incident reports requested by the Appellants pursuant to Amendment 7 in the Appellants' medical malpractice action constituted privileged and confidential "patient safety work product, " pursuant to the Federal Act and that the Federal Act preempted Amendment 7. Id. at 108-10. We accepted this appeal under our mandatory jurisdiction of appeals from a decision of a district court of appeal "declaring invalid a state statute or a provision of the state constitution." See art. V, § 3(b)(1), Fla. Const.[2]

         We disagree with the First District both as to its statutory interpretation of the Federal Act and its resulting conclusion on preemption. We hold that the Federal Act was never intended as a shield to the production of documents required by Amendment 7 and other provisions of Florida law, and Amendment 7 and other provisions of Florida law are not preempted by the Federal Act, which set up a voluntary system for hospitals to improve patient safety. Moreover, the health care provider or facility, in this case Southern Baptist Hospital of Florida ("Southern Baptist"), cannot shield documents not privileged under state law or the state constitution by virtue of its unilateral decision of where to place the documents under the voluntary reporting system created by the Federal Act. Accordingly, we reverse the decision of the First District.


         Article X, section 25, of the Florida Constitution, which is generally referred to by its ballot designation, Amendment 7, was proposed by citizen initiative and adopted in 2004. It provides patients "a right to have access to any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident." Art. X, § 25(a), Fla. Const. "Adverse medical incident" is defined broadly to include "any other act, neglect, or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient . . . ." Art. X, § 25(c)(3), Fla. Const. Amendment 7 gives patients, including those who become medical malpractice plaintiffs, access to any adverse medical incident record, including incidents involving other patients, sometimes called occurrence reports, created by health care providers.

         As this Court discussed in Florida Hospital Waterman, Inc. v. Buster, 984 So.2d 478 (Fla. 2008), the purpose of Amendment 7 "was to do away with the legislative restrictions on a Florida patient's access to a medical provider's 'history of acts, neglects, or defaults' because such history 'may be important to a patient.' " Id. at 488 (quoting Advisory Op. to the Att'y Gen. re Patients' Right to Know About Adverse Med. Incidents, 880 So.2d 617, 618 (Fla. 2004)).[3]

         As the First District stated:

In 2005, Congress . . . [passed] the Patient Safety and Quality Improvement Act of 2005 (the [Federal] Act), Pub. L. No. 109-41, 119 Stat. 424, codified at 42 U.S.C. § 299b-21 et seq., . . . following a 1999 Institute of Medicine (IOM) report, To Err is Human: Building a Safer Health System, . . . estimat[ing] that at least 44, 000 people and potentially as many as 98, 000 people die in United States hospitals each year as a result of preventable medical errors. The IOM report recommended that legislation be passed to foster the development of a reporting system through which medical errors could be identified, analyzed, and utilized to prevent further medical errors. See S. Rep. No. 108-196, at 3-4 (2003); H.R. Rep. No. 109-197, at 9 (2005). Through passage of the [Federal] Act, . . . Congress sought to "facilitate an environment in which health care providers are able to discuss errors openly and learn from them." H.R. Rep. No. 109-197, at 9 (2005). See also Patient Safety and Quality Improvement, 73 Fed. Reg. 8, 112, 8, 113 (proposed Feb. 12, 2008).

S. Baptist Hosp. of Fla., 178 So.3d at 105.

         The Federal Act creates a voluntary, confidential, non-punitive system of data sharing of health care errors for the purpose of improving the quality of medical care and patient safety. The Federal Act envisions a system in which each participating health care provider or member establishes a patient safety evaluation system, [4] in which relevant information would be collected, managed, and analyzed. 42 U.S.C. § 299b-21(6). After the information is collected in the patient safety evaluation system, the provider forwards the information to its patient safety organization, which then collects and analyzes the data and provides feedback and recommendations to providers on ways to improve patient safety and quality of care. See id. § 299b-24; 73 Fed. Reg. at 70, 733. Information reported to patient safety organizations is also shared with a central clearing house, the Network of Patient Safety Databases, which aggregates the data and makes it available to providers as an "evidence-based management resource." See 42 U.S.C. § 299b-23.

         In order to encourage and incentivize participation, within the Federal Act Congress created a protected legal environment in which providers would be comfortable sharing data "both within and across state lines, without the threat that the information will be used against [them]." 73 Fed. Reg. at 70, 732. Privilege and confidentiality protections attach to the shared information, termed "patient safety work product, " "to encourage providers to share this information without fear of liability." Id.; see 42 U.S.C. § 299b-22(a)-(b). These protections are "the foundation to furthering the overall goal of the statute to develop a national system for analyzing and learning from patient safety events." 73 Fed. Reg. at 70, 741.

         The potential burden to providers of maintaining duplicate systems to separate federally protected patient safety work product from information required to fulfill state reporting obligations was addressed in the final rule documents from the Department of Health and Human Services. See id. at 70, 742-43. The solution was to allow providers to collect all information in one patient safety evaluation system where the information remains protected unless and until the provider determines it must be removed from the patient safety evaluation system and reported to the State. Id. at 70, 742; 42 C.F.R. § 3.20 (2009) (defining patient safety work product and providing that patient safety work product removed from a patient safety evaluation system is no longer protected).

         Turning to this case, Southern Baptist participates in information sharing under the Federal Act and has established a patient safety evaluation system in which it collects, manages, and analyzes such information for reporting to its patient safety organization-PSO Florida. Southern Baptist's employees enter information into the patient safety evaluation system. Southern Baptist collects and maintains reports, which it calls "occurrence reports, " of events that are not consistent with the routine operations of the hospital or the routine care of a patient or that could result in an injury.

         Jean Charles, Jr., initiated a medical malpractice action, as next friend and duly appointed guardian of his sister, Marie Charles, and her minor children. Charles claims that Marie Charles suffered a severe neurological injury due to Southern Baptist's negligence.

         Discovery commenced in the litigation between Charles and Southern Baptist, and Charles filed three requests for production pursuant to Amendment 7. Charles requested documents: 1) related to adverse medical incidents in Southern Baptist's history, and 2) either related to any physician who worked for Southern Baptist or arising from care and treatment rendered by Southern Baptist during the three-year period preceding Marie Charles' care and treatment through the time when the discovery request was filed. Southern Baptist ultimately produced certain responsive documents, which included Code 15 Reports (required by section 395.0197(7), Florida Statutes (2014)), Annual Reports (required by section 395.0197(6), Florida Statutes (2014)), and two occurrence reports specific to Marie Charles that were extracted from Southern Baptist's patient safety evaluation system before they were reported to the patient safety organization. Southern Baptist claimed that certain other documents, primarily occurrence reports, while potentially responsive because they were adverse incident reports, were not subject to production because they were privileged and confidential under the Federal Act as patient safety work product.

         Charles moved to compel production of the documents that Southern Baptist refused to produce based on its claim of privilege under the Federal Act. In response to Southern Baptist's refusal, Charles argued that the Federal Act protects only documents created solely for the purpose of submission to a patient safety organization, and such information is not privileged and confidential if it was collected and maintained for another purpose or for dual purposes, or if the information is in any way related to a health care provider's obligation to comply with federal, state, or local laws or accrediting or licensing requirements. In a series of three orders, the circuit court agreed with Charles, finding that the adverse medical incident reports requested were not patient safety work product if they were collected or maintained for a purpose other than submission to a patient safety organization or for dual purposes. The circuit court held, "All reports of adverse medical incidents, as defined by Amendment 7, which are created, or maintained pursuant to any statutory, regulatory, licensing, or accreditation requirements are not protected from discovery under [the Federal Act.]" The circuit court found that Southern Baptist was entitled to a reasonable fee for production that Charles was to pay prior to production, and upon payment, Southern Baptist "shall produce . . . all records in its possession relating to adverse medical incidents during the time period set forth in [the] third request for production."

         Southern Baptist then filed a petition for writ of certiorari in the First District, which was granted. S. Baptist Hosp. of Fla., 178 So.3d at 104, 111. On the merits, after examining what it termed "the plain language" of the Federal Act, the First District concluded that "[t]he record here shows that the documents at issue clearly meet the definition of [patient safety work product] because they were placed into [Southern Baptist's patient safety evaluation] system where they remained pending submission to a [patient safety organization]." Id. at 108. The First District further concluded that "[t]he documents at issue also do not meet the [Federal] Act's definition of what is not [patient safety work product]. That is, they are not original patient records and were not collected, maintained, or developed separately from the [patient safety evaluation] system." Id. (emphasis in original). Accordingly, the First District concluded that "[b]ecause they meet the definition of [patient safety work product], the documents are entitled to the federal protection under the [Federal] Act." Id. at 108-09. In sum, the First District held that "[t]he plain language of the [Federal Act] is clear. A document is [patient safety work product] if it is placed into a [patient safety evaluation] system for reporting to a [patient safety organization] and does not exist outside of the [patient safety evaluation] system. The documents here meet that definition and should be regarded as [patient safety work product], which is privileged, confidential, and not discoverable." Id. at 110 (citations omitted).

         The First District also held that under the Supremacy Clause of the United States Constitution, "the [Federal Act] expressly preempts any broad discovery right under Amendment 7 to documents meeting the definition of [patient safety work product, ]" and "Amendment 7 is also impliedly preempted by the [Federal] Act because compliance with both federal and state law would be impossible." Id. Thus, the First District held that Amendment 7 "has been preempted by the [Federal] Act." Id. This appeal followed.[5]


         Because the First District concluded that the documents Charles requested were entitled to protection from discovery under the plain language of the Federal Act, we first examine the language of the Federal Act. We then determine whether the Federal Act expressly or impliedly preempts Amendment 7 and other provisions of Florida law, as the First District held.

         Statutory Construction

         Because this case involves an issue of statutory construction, our review is de novo. W. Fla. Reg'l Med. Ctr., Inc. v. See, 79 So.3d 1, 8 (Fla. 2012) ("Statutory and constitutional construction are questions of law subject to a de novo review."). "The object of statutory interpretation is to determine legislative intent." Crews v. State, 183 So.3d 329, 332 (Fla. 2015). "To discern legislative intent, this Court looks first to the plain and obvious meaning of the statute's text[.]" W. Fla. Reg'l Med. Ctr., Inc., 79 So.3d at 9. "When the statute is clear and unambiguous, courts will not look behind the statute's plain language for legislative intent or resort to rules of statutory construction to ascertain intent." Daniels v. Fla. Dept. of Health, 898 So.2d 61, 64 (Fla. 2005).

         However, we have also made clear that statutes cannot be read in isolation. "Every statute must be read as a whole with meaning ascribed to every portion and due regard given to the semantic and contextual interrelationship between its parts." Fla. Dep't of Env. Pro. v. ContractPoint Fla. Parks, LLC, 986 So.2d 1260, 1265 (Fla. 2008) (quoting Fleischman v. Dep't of Prof'l Reg., 441 So.2d 1121, 1123 (Fla. 3d DCA 1983)). A "statute should be interpreted to give effect to every clause in it, and to accord meaning and harmony to all of its parts" and is not to be read in isolation, but in the context of the entire section. Jones v. ETS of New Orleans, Inc., 793 So.2d 912, 914-15 (Fla. 2001) (quoting Acosta v. Richter, 671 So.2d 149, 153-54 (Fla. 1996)).

         The Federal Act "creates a tightly crafted federal privilege for 'patient safety work product' actually reported to a 'patient safety organization.' " Lee Med., Inc. v. Beecher, 312 S.W.3d 515, 535 (Tenn. 2010) (footnotes omitted). "Such information is not subject to discovery in legal proceedings." Rasor v. Nw. Hosp., LLC, 373 P.3d 563, 573 (Ariz.Ct.App. 2016). "The Patient Safety Act 'announces a more general approval of the medical peer review process and more sweeping evidentiary protections for materials used therein.' " Dep't of Fin. & Prof'l Regulation v. Walgreen Co., 970 N.E.2d 552, 557 (Ill.App.Ct. 2012) (quoting KD ex rel. Dieffenbach v. United States, 715 F.Supp.2d 587, 595 (D. Del. 2010)). Congress enacted the Federal Act "to encourage health care providers to voluntarily associate and communicate privileged patient safety work product . . . among themselves through in-house patient safety evaluation systems . . . and with and through affiliated patient safety organizations[.]" Tibbs v. Bunnell, 448 S.W.3d 796, 800 (Ky. 2014).

         The Federal Act defines the term "provider" in relevant part as an "entity licensed or otherwise authorized under State law to provide health care services, including . . . a hospital[.]" 42 U.S.C. § 299b-21(8)(A)(i). The Federal Act defines the term "patient safety evaluation system" as "the collection, management, or analysis of information for reporting to or by a patient safety organization." Id. § 299b-21(6). A "patient safety organization" is one certified by the Secretary of the Department of Health and Human Services whose "mission and primary activity . . . [is] to conduct activities that are to improve patient safety and the quality of health care delivery." Id. §§ 299b-21(4), 299b-24(a), (b)(1)(A). Patient safety organizations engage in a number of "patient safety activities, " including "[t]he collection and analysis of patient safety work product." Id. § 299b-21(5)(B). The Federal Act defines patient safety work product as follows:

(7) Patient safety work product
(A) In general Except as provided in subparagraph (B), the term "patient safety work product" means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements-
(i) which-
(I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or
(II) are developed by a patient safety organization for the conduct of patient safety activities;
and which could result in improved patient safety, health care quality, or health care outcomes; or
(ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.

Id. ยง 299b-21(7). The Federal Act also excludes certain information from the definition of patient safety work product and addresses a provider's duties with respect to ...

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