Florida Supreme Court Rules That Hospital "Adverse Medical Incidents" Reported to a PSO Are Not Privileged From Discovery: Impact on Participating Providers and PSOs

by Katten Muchin Rosenman LLP
Contact

Background

Southern Baptist Hospital of Florida (Hospital) was sued in a medical malpractice action in which the plaintiff sought to discover records relating to "adverse medical incidents" that occurred at the Hospital and involved any physicians who worked for the Hospital or with respect to any persons who were involved in the care of the plaintiff during the three years previous to her treatment through the date of the discovery request.

The Hospital, which participated in PSOFlorida (PSO) provided reports to the State as required under Florida's mandated reporting statutes. It also produced two occurrence reports specific to the plaintiff that had been collected in the Hospital's PSES but had not yet been reported to the PSO. Other documents which were "primarily occurrence reports" were not produced because the Hospital stated they were reported to the PSO and, therefore, were PSWP under the Patient's Safety Act and Quality Improvement Act of 2015 (Patient Safety Act) and not subject to discovery.

The Trial Court Decision

The Plaintiff moved to compel production of the documents based on the following arguments:

  • the Act only protects documents created solely for the purpose of reporting to a PSO;
  • such information is not privileged and confidential if it was collected and maintained for another purpose or for dual purposes;
  • Article 10, Section 25 of the Florida Constitution (Amendment 7) provides patients the rights to access to "any records made or received . . . relating to an adverse medical incident," and therefore the Hospital was obligated to turn over the disputed records; and
  • information cannot be protected if relating to the Hospital's obligation to comply with federal, state or local laws or accrediting or licensing requirements.

The trial court agreed with the plaintiff's arguments and held:

"All reports of adverse medical incidents, as defined by Amendment No. 7, which are created, or maintained pursuant to any statutory, regulatory, licensing, or accreditation requirements are not protected from discovery under [the Patient Safety Act]."

  • Based on this ruling, the Hospital was ordered to produce "all records in its possession relating to the adverse medical incidents" that occurred during the requested timeframes.

First District Court of Appeals

The First District Court of Appeals granted the Hospital's petition for writ of certiorari and reversed the decision of the trial court. In doing so, the Court made the following conclusions:

  • the documents at issue clearly met the definition of PSWP because they were placed into the Hospital's PSES where they remained pending submission to a PSO;
  • the documents at issue were not original patient records and were not collected, maintained or developed separately from the PSES;
  • information qualifies as PSWP if it is placed in a PSES for reporting to a PSO and does not existing outside of the PSES. For these reasons, the Court determined that the documents were PSWP and, therefore, not discoverable; and
  • the Court further held that the Patient Safety Act pre-empted the otherwise broad discovery permitted under Amendment 7 under the circumstances of this case.

Florida Supreme Court Decision

  • The plaintiff's appealed to the Florida Supreme Court, and even though the parties entered into a Stipulation of Dismissal a day before oral arguments were scheduled, the Court accepted the appeal under its mandatory jurisdiction because the Court of Appeals declared "invalid a state statute or a provision of the state constitution" when it determined that the Patient Safety Act pre-empted Amendment 7 and because it involved "an issue of statewide importance."
  • This appeal attracted national attention because it was only the second state supre"me court to review a challenge under the Patient Safety Act. Parties which filed amicus briefs in support of the Hospital, included multiple PSOs, the AMA, The Joint Commission, the Florida Medical Association and AQIPs.
  • The Court went into great length in describing various provisions of the Patient Safety Act, including the definitions of PSWP, the scope of the privilege protections, as well as information that did not qualify as PSWP. It cited to a provision of the Patient Safety Act regarding information which did not qualify as PSWP and specifically a provision of the Act which states that PSWP: "does not include information that is collected, maintained or developed separately, or exists separately, from a patient safety evaluation system." Further that the Patient Safety Act should not be interpreted in order to "limit, alter, or effect the requirements of Federal, State or local law pertaining to information that is not privileged or confidential under [the Act]."
  • Upon laying this foundation, the Court then focused on provisions of state law requiring hospitals to establish an internal risk management program, which "shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques." (§395.0197(4)-(7) Fla. Stat. (2015))
  • The statute also defines the term "adverse incident," which is an event "over which healthcare personnel could exercise control relating to medical intervention and which results in a number of listed injuries and other events." These adverse events are to be submitted as part of an annual report by the hospital. Amendment 7, but not the statute, defines the term "adverse medical incident" but does not create any reporting obligation.
  • Another statutory provision requires that hospitals establish an internal reporting system, which includes information requirements such as a "clear and concise description of the incident and the names of individuals involved directly or indirectly with the incident," which then must be analyzed to identify trends or patterns, recommendations for corrective actions and risk management prevention, and that, at least, a quarterly report be made to the Board of Directors. The last section of the Administrative Code states that the "evidence of recommended and accomplished corrective actions shall be made available for review to any authorized representative of the Agency upon request during normal working hours." (Fla. Admin. Code 59A-10.0055)
  • After identifying these state provisions, the Court then went on to cite to Amendment 7, which gives individuals the right to access any records made or received in the course of business by health care facility or provider relating to any adverse medical incident. Taken together, the Court concluded that hospitals are required to keep adverse medical incident reports, and that such reports must be made available to patients upon their request.

The Court then states:

"Simply put, adverse medical incident reports are not patient safety work product because Florida statutes and administrative rules require providers to create and maintain these records and Amendment 7 provides patients with a constitutional right to access these records. Thus, they fall within the exception of information ‘collected, maintained, or developed separately, or exists separately, from a patient safety evaluations system' (citation). In addition, their disclosure fits squarely within the provider's recordkeeping obligations under state law. (citation)."

  • To support this interpretation, the Court cites to both the recent Kentucky Supreme Court decision in Baptist Health Richmond, Inc. v. Clouse, which reached a similar conclusion involving a Kentucky statute, as well as to the HHS PSO Guidance Regarding Patient Safety Work Product and Providers' External Obligations (Guidance), which was published on May 24, 2016.
  • Essentially, the Florida Supreme Court determined that information collected within a PSES and reported to a PSO does not automatically become PSWP and, in fact, cannot qualify as PSWP if state law requires that the documents be created and maintained.

Pre-Emption

  • Although the Supreme Court could have stopped there, it decided to address the Appellate Court's holding that the Patient Safety Act pre-empted Amendment 7. It rejected the Appellate Court's analysis and ruled that because Amendment 7 was constitutionally adopted after overwhelming support by Florida voters, that the Patient Safety Act is voluntary and not required, and, furthermore, because, in its opinion, Congress recognized the importance of preserving patient rights and compensation for negligence committed against them, records which were available to patients prior to passage of the Act should remain available.

Comments

  • The decision in Charles was fully expected given the current Supreme Court's view that the "primary purpose of medical malpractice actions is not to punish the health care provider, but to compensate the victim of medical malpractice who is many times severely injured." Anyone who saw a videotape of the oral argument in Charles witnessed the hostility of the judges toward the oral arguments made by the Hospital's attorney in support of the Court of Appeals decision which, therefore, made the outcome very predictable.
  • The decision can be criticized at a number of levels, not the least of which is its failure to distinguish adverse incident reports referenced in Florida statutes, which the Hospital did report, from other documents, such as RCAs, which need not be reported. Although the Court's pre-emption analysis is faulty, no doubt plaintiff's attorneys are likely to argue that Amendment 7 effectively pre-empts the Patient Safety Act, which, if this position is adopted by lower courts, could render the Act somewhat meaningless in Florida.
  • Charles is now the second state Supreme Court decision, after Clouse, to cite to the HHS PSO Guidance in support of its interpretation that records which must be collected and maintained pursuant to state, federal, local law or accreditation standards do not qualify as PSWP.
  • Because the Court did not mention other records in dispute, such as RCAs, hospital attorneys are likely to argue that the Charles decision only applies to adverse medical incident reports and no other information that qualifies as PSWP.

Recommendations

  • Although the decisions in Charles, Clouse and Tibbs v. Bunnell are binding only on the courts in Florida and Kentucky, respectively, providers and PSOs should expect, in light of the Guidance, these decisions that plaintiff's attorneys and government agencies will attempt to broadly define what types of information must be "collected and maintained" under applicable laws and, therefore, do not qualify as PSWP.
  • It is therefore important for providers to review applicable state and federal laws and to make a good faith assessment as to whether documents are intended to be treated as PSWP fall into Bucket 1 (mandated reports); Bucket 2 (records which a provider is required to collect and maintain); or Bucket 3 (information that qualifies as PSWP and does not fall into Bucket 1 or 2 and are collected for reporting to a PSO and are reported or constitute deliberations or analysis).
  • A question to ask is whether state, federal or other authorities specify the form or content of these so-called Bucket 2 documents. As with Bucket 1 documents, a licensed provider should only include the minimal amount of information that is required, nothing more and nothing less. In other words, if no form or specific content is set forth in the statute, then create a Bucket 2 document with minimal information, mostly factual, which can then be produced to a plaintiff or an enforcement agency if requested.
  • Where a provider has Bucket 1 and/or Bucket 2 obligations, it should consider creating a third set of documents which do not reference or include the actual name of the records identified under state or federal law (i.e., "adverse incident report") but which are identified within the PSES and are being collected for the purpose of reporting and are reported or are being treated as deliberations or analysis.
  • Although this creates a degree of redundancy and additional administrative burden, which the Act supposedly was seeking to avoid, providers and PSOs must adapt to the changing legal landscape. The alternative is to be prepared to face similar challenges in light of existing court decisions and the Guidance as well as your local courts, many of which tend to support plaintiffs in malpractice actions.
  • The other method of creating PSWP is to determine whether it constitutes "deliberations or analysis". This is an alternative pathway which does not require a report to the PSO. Although D or A is not specifically defined, most PSWP arguably falls into this category if collected within the provider's PSES. Such information automatically becomes PSWP if it does not fall into Bucket 1 or Bucket 2 and does not have to be actually or functionally reported to a PSO.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Katten Muchin Rosenman LLP | Attorney Advertising

Written by:

Katten Muchin Rosenman LLP
Contact
more
less

Katten Muchin Rosenman LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.