AMENDMENT 7 “PATIENT’S RIGHT TO KNOW”: USER FRIENDLY GUIDE FOR RISK MANAGERS AND A POSSIBLE SOLUTION TO FORCED DISCLOSURE

by

Melissa E. Black, Esq.

Seiden, Alder & Matthewman, P.A.

 

           On June 20, 2005, Governor Jeb Bush signed into law Senate Bill 938 to take effect immediately. This Bill formalized the requirements of Constitutional Amendment 7, that requires disclosure of adverse medical incidents. Amendment 7, which has created controversy since its voter approval in November of 2004, allows access to records of “adverse medical incidents.” The new law however does not permit the introduction of these disclosed records into evidence in a medical malpractice action. Thus, while certain protections have been afforded by the new law, there remains challenges for the hospital risk manager to maintain patient confidentiality, peer review and compliance. This brief summary will hopefully help guide you through this new law and its impact.

The new law statutory frame-work to Amendment 7 is Section 381.028, Florida Statutes and will be referred to herein as the “Patients’ Right-To-Know Act.” According to the law, the Patient’s Right to Know Act is not intended to undermine the laws protecting peer review, but implement Amendment 7.
 

 WHEN EFFECTIVE

            Patients are entitled to copies of adverse medical incident reports that are created on or after November 2, 2004. In addition, the actual incident must have occurred on or after November 2, 2004. Therefore, patients cannot have access to adverse medical incident reports created prior to November 2, 2004. There is a retroactive provision which allows a patient , requesting records on or after November 2, 2008, the right to request records created within the four years prior to the date of the request. This means that, conceivably, on November 2, 2008 a patient may request any adverse medical incident reports created on November 2, 2004 through and including November 2, 2008.

WHAT IT COVERS

The Patient’s Right To Know Act defines “Adverse Medical Incident,” as:

medical negligence, intentional misconduct, and any other act, neglect, or default of a health care facility or health care provider which cause or could have caused injury to or the 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, incidents that are reported to or reviewed by any health care facility peer review, risk management, quality assurance, credential, or similar committee or any representative of such committee.¹ Section 381.028 (3) (b) Florida Statutes (2005).

We believe this definition in the law is problematic in that it requires the hospital risk manager to analyze an incident and decide if there was negligent or intentional misconduct on behalf of the health care provider. The hospital risk manager or other hospital personnel, through no fault of their own, may lack the ability or knowledge necessary to make that determination.

         As you know, reporting requirements under the Agency For Healthcare Administration (AHCA) rules, which are still in effect, are more straight forward as they only require a risk manager to determine whether or not an incident met the criteria as an “adverse incident” as defined in Internal Risk Management Program Section 395.1097, Florida Statute, where the criteria is clearly defined as:

For purposes of reporting to the agency pursuant to this section, the term “adverse incident” means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which:

(a) Results in one of the following injuries:

1. Death;

2. Brain or spinal damage;

3. Permanent disfigurement;

4. Fracture or dislocation of bones or joints;

5. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;

6. Any condition that required specialized medical attention or surgical intervention resulting form non-emergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or

7. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident;

(b) Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition;

(c) Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or

(d) Was a procedure to remove unplanned foreign objects remaining from a surgical procedure. Section 395.1097 Florida Statutes (2003)


Accordingly, the definition for “adverse incident” under AHCA’s Internal Risk Management provision (Florida Statute Section 395.1097) differs from the definition of “adverse medical incident” under the Patient’s Right To Know Act. The Internal Risk Management provision under AHCA specifically defines the types of incidents to report by outcome, whereas, as of June 20, 2005, the Patient’s Right To Know Act requires a legal analysis of an incident to determine what is negligent or intentional misconduct. However, notably absent from the Florida’s Right to Know Act are the definitions for negligent or intentional misconduct.

Even with this uncertainty the hospital risk manager must maintain the privacy and not disclose the identity of other patients involved in the incident. Therefore, in the event that an adverse medical incident report includes patient identifiers, the risk manager or other healthcare personnel tasked with this duty must first redact the protected information prior to producing copies of the reports to the patient requesting them.

 HOW REQUESTS MUST BE MADE

The Patient’s Right to Know Act requires that the patient requesting copies of adverse medical incident reports make their requests in writing. The health care provider must process the request in a “timely manner” and may charge the requesting patient the “reasonable and actual” cost for complying with the request. This includes a reasonable charge for the staff time necessary to search for records, redact protected patient information and make copies. The health care provider may request either full or partial payment prior to processing the adverse medical incident records request.

WHAT TO COPY OR PRODUCE

            Notwithstanding the above, there are records which are not subject to disclosure. The definition of “Records” under the Patient’s Right To Know Act provides: 

the final report of any adverse medical incident.  Medical records that are not the final report of any adverse medical incident, including drafts or other nonfinal versions; notes; and any documents or portions thereof which constitute, contain, or reflect any attorney-client communications or any attorney-client work product may not be considered “records” for purposes of s. 25, Art. X of the State Constitution and this act. Section 381.028 (3) (j) Florida Statutes (2005). 

Therefore, a Risk Manager is not obligated to produce any adverse medical incident report that has not been finalized or reflects attorney-client communications and/or work product.  One interpretation of this provision suggests that attorney-client privilege protection attaches to the adverse medical incident report once the hospital attorney confers with and directs the Risk Manager to prepare the adverse medical incident report.  Arguably, this document would then be privileged from disclosure under the attorney-client work product doctrine, and explicate provision of The Right to Know Act. 

                        NOT ADMISSIBLE IN COURT                                               

            In the event that adverse medical incident  reports are disclosed under the Patient’s Right to Know Act, the patient cannot use the information in any civil action or administrative hearing: 

This section does not repeal or otherwise alter any existing restrictions on the discoverability or admissibility of records relating to adverse medical incidents otherwise provided by law, including but not limited to, those contained in ss. 395.0191, 395.0193, 395.0197, 766.101 and 766.1016, or repeal or otherwise alter any immunity provided to, or prohibition against compelling testimony by persons providing information or participating in any peer review panel, medical review committee, hospital committee, or other hospital board otherwise provided by law, including but not limited to , ss. 395.0191, 395.0193, 395.0197, 766.101 and 766.1016. 

Section 381.028 (6) (a) Florida Statutes (2005) and: 

Except as otherwise provided by act of the Legislature, records of adverse medical incidents, including any information contained therein, obtained under s. 25, Art. X of the State Constitution, are not discoverable or admissible into evidence and may not be used for any purpose, including impeachment, in any civil or administrative action against a health care facility or health care provider.  This includes information relating to performance or quality improvement initiatives and information relating to the identity of reviewers, complainants, or any person providing information contained in or used in, or any person participating in the creation of the records of adverse medical incidents.  Section 381.028 (6) (b) Florida Statutes (2005).   

Thus, while the patient may have access to the information contained in adverse medical incident reports, they cannot use that information as evidence to prove their case whether it be a civil or administrative action against a health care facility or health care provider.  However, we believe it is clear that Plaintiff lawyers will be fishing for information on a daily basis, and will seek to use this information in focusing discovery requests and in questioning hospital witnesses.  Accordingly, as set forth below, we believe it maybe necessary to use the law’s provision of attorney-client protection to put lawyers into the loop to lessen the impact of blanket disclosure of vast numbers of incident reports. 

 MAKING RECORDS ATTORNEY CLIENT PROTECTED

             Obviously, maintaining compliance with the Patient’s Right to Know Act will be a daunting task for the health care risk manager.  Proper hospital policies and procedures will assist in providing an efficient and safe way to maintain compliance with the Patient’s Right to Know Act.  However, at this time, based upon case law and the statute as it is currently interpreted, we believe that bringing the hospital’s lawyers into the loop early maybe essential.  The hospital’s lawyer will be able to assist in the critical analysis of whether the law applies to the potential adverse medical incidents, and assist in whether or not a particular incident involves negligent or intentional misconduct.  Although determination needs to be made on a case by case basis, and upon consultation with hospital counsel after review of current case law, we believe that by sending all reports of adverse medical incidents to the hospital’s lawyers, all such reports will be made not subject to disclosure under the provisions of The Right to Know Act.  Section 381.028(3)(j).  If this manner of incorporation of the hospital’s counsel is undertaken, then care should be made to adequately set forth in any and all responses to public inquiries, under The Right to Know Act, for adverse medical incidents that the hospital’s response is subject to, and made without the inclusion of, any and all, attorney-client communications or attorney work product as set forth in Section 381.028(3)(j) Florida Statutes.

  

NOTICE: This material has been prepared for informational purposes only, and does not constitute legal advice. The information herein is not intended to create a lawyer-client relationship. You should not act upon this information without seeking professional counsel. Should you wish to retain Seiden, Alder & Matthewman, P.A., please contact us at our Boca Raton office.