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Just How Confidential is Information in Patient Safety Information?

by admin on March 8, 2018 No comments

patient safety informationBy: Jacqueline Bain

Not too long ago, when something would go wrong in a hospital, a patient’s medical record might note the facts of what had happened (“Mrs. Jones was found on the floor of her hospital room with a swollen wrist. An x-ray revealed a wrist fracture.”), while the hospital’s incident report would analyze why it happened in order to prevent further harm (“Orderly Green forgot to raise the guardrails on Mrs. Jones’ bed. Mrs. Jones fell out of her bed as a result of the displaced guardrail. Let’s put in place a policy that all guardrails must be raised if an orderly steps more than three feet from a patient’s bed.”). Should Mrs. Jones decide to sue the hospital, she and her attorney would have access to the medical record, but not necessarily the incident report.

Incident reports like the one mentioned above have long been meant as a learning tool for facilities to analyze unfortunate occurrences on their premises and learn from their mistakes to prevent future harm. However, these reports often contain admissions of fault, or near admissions of fault. So how can a hospital balance its need to improve on past practices without opening itself to a mountain of liability? Florida’s state laws seemingly contrast with Federal laws.

FLORIDA’S AMENDMENT 7: After a vote of the public, the Florida Constitution was amended in 2004 to provide that a patient has “a right to access any records made or received in the course of business by a health care facility or provider relating to an adverse medical incident” (“Amendment 7”). Amendment 7 defined the term “adverse medical incident” to include any act, neglect, or default of a health care facility or health care provider that caused or could have caused injury or death to a patient, including those mandating reports to governmental agencies and peer review bodies.

For instance, if Dr. McBride on an inpatient unit prescribed patient Mr. Shah with an antibiotic, but the hospital pharmacist misread the script and packaged up a powerful painkiller. Even if the pharmacist realized her mistake moments before the drug left the pharmacy, this is incident is subject to disclosure under Amendment 7. No one was harmed, but the near miss could have caused injury to Mr. Shah.

The purpose of Amendment 7 was to allow patients’ unrestricted access to their medical providers’ history of acts, neglects, or defaults “because such history may be important to a patient”. Still, Courts interpret Amendment 7 to state that the intention of Florida’s people is to “lift the shroud of privilege and confidentiality in order to foster disclosure of information that will allow patients to determine from whom they should seek health care, evaluate the quality and fitness of health care providers currently rendering service to them, and allow them access to information gathered through the self-policing processes during the discovery period of litigation filed by injured patients or the estates of deceased patients against their health care providers.” Florida Hosp. Waterman, Inc. v. Buster (Buster II) (2006). Florida State Courts have taken an expansive approach to allow disclosure of any record created as a result of an adverse medical incident. There are no statutory limitations on discovery of any type of adverse medical incident report.

In practice, hospitals and other health care facilities have stated that patients hardly ever, if ever, research hospital incident reports in their search for a medical provider. Using the examples above, what are the chances that Mrs. Green would have called the hospital and asked for its data regarding patient falls from their beds prior to going to the hospital? And what are the chances that Mr. Shah called the hospital to ask about pharmacy near-misses prior to seeking care and treatment from Dr. McBride?

FEDERAL PATIENT SAFETY ACT: In 2005, Congress passed the Patient Safety and Quality Improvement Act (“PSQIA”), establishing a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues. PSQIA promoted the sharing of information about adverse patient safety events among providers and patient safety organizations within and across state lines. That sharing of information was intended to help hospitals and facilities learn from those adverse events, thus improving patient safety and quality of care.

However, PSQIA also sought to address provider concerns about the potential for damage from these reported incidents serving as a roadmap for provider liability from negative patient outcomes. Congress created a privilege and confidentiality protection to encourage healthcare providers and facilities to make PSQIA reports and ultimately improve the delivery of patient care. Under PSQIA, patient safety work product is privileged and not subject to disclosure:

  • in any civil, criminal, or administrative subpoena or order;
  • in connection with any civil, criminal, or administrative proceeding;
  • under the Freedom of Information Act or similar law;
  • in any governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding; or
  • in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.

PSQIA’s confidentiality and privilege protections are limited to health care facilities or providers working through a Federally-listed patient safety organization. (There are currently 58 patient safety organizations serving Florida.)

After PSQIA was enacted, hospitals across Florida (and the nation) implemented patient safety evaluation systems, which collect reports of events that are not consistent with routine hospital operations or patient care. They also participated in Federally-listed patient safety organizations, which analyze the information provided through patient safety evaluation systems and present findings for future use.

INTERPRETING THE LAWS: Given that Florida’s Amendment 7 favors disclosure and the Federal PSQIA favors confidentiality in the name of preventing future harm, what would happen in the following scenario:

A patient is hurt receiving care at a Florida hospital, and the patient’s attorney requests information related to that patient’s injury, including the patient’s medical record and any information entered into the hospital’s patient safety evaluation system about similar events.

Should the hospital disclose its incident reports, as it is required to do under Amendment 7, or should it keep them confidential, as it is allowed to do under PSQIA? The Florida Supreme Court undertook to answer this question twice in 2017.

In January 2017, in Charles v. Southern Baptist Hospital of Florida, Inc., the Florida Supreme Court noted that PSQIA does not afford privilege to “a patient’s medical record, billing and discharge information, or any other original patient or provider record,” or “information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.” Using that exclusion, the Florida Supreme Court held that adverse medical incident reports are not patient safety work product. Moreover, 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, adverse medical incident reports are discoverable.

In Edwards v. Thomas, decided in October 2017, the Florida Supreme Court held that external peer review documents are also discoverable. The Court reasoned first that PSQIA was not intended to allow health care providers or facilities to avoid their regulatory obligations and unjustly claim that certain records are privileged and confidential by: (i) maintaining reports only on their patient safety evaluations systems, or (ii) developing reports outside of a patient safety evaluations system, placing a duplicate copy on the patient safety evaluations system, and then deleting the original. Second, the Court held that “[p]art of a Florida hospital’s day-to-day business is recording and addressing adverse medical incidents that might arise in daily operations, and responding to these adverse incidents in a way that will not only improve the quality of care rendered, but also prepare the hospital for any potential litigation that may arise from such an incident.”

CONCLUSION: We haven’t seen the last of the litigation in this patient safety information area, but for now, the protections afforded by PSQIA have certainly whittled the law down to a matchstick. Nevertheless, in the event that a hospital is requested to disclose its incident reports, or peer review data, or other information that isn’t necessarily maintained in a patient’s medical record, the request is worth a second look from counsel. Unfettered disclosure is certainly currently the trend of the Florida Judiciary in pursuit of Amendment 7. However, one can only guess how the Federal Courts would rule if given the opportunity.
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