United States: Amendment 7 Stands Its Ground Against The Federal Patient Safety And Quality Improvement Act

It is well known in Florida that Article X, Section 25 of the Florida Constitution (Amendment 7) provides patients with access to any adverse medical incident report (even involving other patients) created by healthcare providers. This has been an ongoing issue for providers in the state, given that the Federal Patient Safety and Quality Improvement Act (PSQIA) establishes a work product privilege that would otherwise protect access to such reports. Understanding that the PSQIA will not offer the same protections in Florida as elsewhere is particularly critical for healthcare providers acquiring facilities in Florida or those doing business in the state. To that end, healthcare providers should consider seeking legal counsel to address how to properly protect this information in Florida. While Amendment 7 continues to be challenged in the courts it is still being strongly enforced by the state. As discussed below, the Florida Supreme Court recently held that the PSQIA was not created to be a shield for healthcare providers to prevent individuals' access to information afforded under Amendment 7.

In Charles v. Southern Baptist Hosp. of Fla., Inc., No. SC15-2180, 2017 WL 411333 (Fla. Jan. 31, 2017), plaintiff Jean Charles, Jr. (Charles) initiated a medical malpractice action, as next friend and duly appointed guardian of his sister, Marie Charles, and her minor children. Charles requested from Southern Baptist Hospital of Florida (Hospital) documents related to adverse medical incidents in the Hospital's history and any physician who worked for the Hospital or arising from care and treatment rendered by the Hospital during the three-year period preceding Marie Charles' care and treatment through the time of the discovery request. The Hospital produced certain responsive documents including, but not limited to, Code 15 Reports, Annual Reports, and two occurrence reports specific to Marie Charles that were extracted from the Hospital's patient safety evaluation system before they were reported to the patient safety organization (PSO). However, the Hospital participates in information sharing under the PSQIA and has an established patient safety evaluation system in which it collects, manages, and analyzes such information for reporting to the Hospital's PSO. As a result, the Hospital (even though responsive) claimed the occurrence reports were not subject to production because they were privileged and confidential under the PSQIA as patient safety work product.

Charles filed a motion in the Circuit Court in Duval County to compel documents the Hospital refused to produce based on the Hospital's claim of privilege under the PSQIA. Charles argued that the PSQIA protects only documents created solely for the purpose of submission to a PSO, and if it was collected and maintained for another purpose (or a dual purpose), or if the documentation is related to an obligation for the healthcare provider to comply with the law or accrediting or licensing requirements, such documents would not be protected. The circuit court granted Charles' motion to compel and held that the adverse medical incident reports were not patient safety work product because they are maintained pursuant to the law and/or accrediting or licensing requirements.

On appeal, the First District Court of Appeal, after examining what it termed "the plain language of the PSQIA, concluded that the documents at issue were clearly entitled to protection because such documents met the definition of the patient safety work product under the law. The appeals court further concluded that the PSQIA preempts any discovery right under Amendment 7, because compliance with both federal and state law would be impossible. Charles appealed this decision, and the issue made its way to the Florida Supreme Court. The state's highest court was tasked with determining (1) whether the records are entitled to protection from discovery under the plain language of the PSQIA and (2) whether the PSQIA preempts Amendment 7 and other provisions of Florida law, as determined by the First District Court of Appeal.

The Florida Supreme Court first looked at whether the plain language of the PSQIA would protect the adverse medical incident records from being produced and concluded that the appeals court incorrectly read the PSQIA and failed to take into account the law's numerous exceptions and limitations. According to the court, the PSQIA requires providers to create and maintain medical incident reports and Amendment 7 establishes a patient's constitutional right to access these records. In concluding that the records were ineligible for patient safety work product protection because adverse medical incident reports are maintained separately from the patient safety evaluation system, the Florida Supreme Court held that the records were excepted from the patient safety work definition. Thus, adverse medical incident reports cannot be classified as confidential and privileged patient safety work product under the PSQIA if requested by patients under Amendment 7.

The Florida Supreme Court next addressed whether the First District Court of Appeals had correctly decided the preemption issue and concluded that the records in question did not expressly preempt Amendment 7 because they failed to meet the PSQIA definition of patient safety work product. However, the court stated that implied preemption can still exist even if there is no express preemption. In determining that Congress did not intend to preempt Amendment 7 through the passage of the PSQIA, which creates a voluntary reporting system, the Florida high court held that Amendment 7 did not create implied preemption of the PSQIA. The decision of the First District Court of Appeals was reversed, and the Hospital was required to turn over the adverse medical incident reports to Charles.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.