Patient Safety Work Product and Its Limitations: A Discussion of Two Recent Cases

Where Does Med Mal Come In?

Since the passage of the Patient Safety and Quality Improvement Act, a number of health care institutions have developed and joined patient safety organizations. Two recent decisions from the supreme courts of Kentucky and Florida have discussed the important issues of patient safety work product and whether this type of information is subject to discovery in connection with medical malpractice litigation. The opinions in these two decisions are crucial to understanding the purpose of the PSQIA and its limitations with respect to patient safety work product. Both health care leaders and attorneys dealing with these issues need to understand that documents that are prepared and reported to a patient safety organization are not necessarily “patient safety work product,” and in fact may be discoverable in medical malpractice lawsuits.

Two Recent Cases

The cases of Baptist Health Richmond v. Clouse, 497 S.W.3d 759 (Ky. 2016), and Charles v. Southern Baptist Hospital of Florida, 2017 WL 411333 (Supreme Court of Florida, Jan. 31, 2017), both speak to the issue of whether the information that is collected and reported to a PSO is protected from discovery in medical malpractice litigation.

Under the federal act, 42 U.S.C.A. § 299b, et seq., the statute defines what is considered patient safety work product and, more importantly, describes what documentation constitutes patient safety work product that is not subject to discovery. The Act also sets forth what documentation is not considered patient safety work product that is exempted from the protections of the federal act. Finally, it excludes certain information from the definition of patient safety work product, including a provider's record-keeping obligation with respect to information described in the Act under federal, state or local law, as well as the reporting of information that a health care provider is required to report to a federal, state, or local government agency for public health, surveillance, investigation or other public health purposes.

Baptist Health Richmond

In the Baptist Health Richmond case, citing from its prior opinion in Tibbs v. Bunnell, 448 S.W. 3d 796 (Ky.2014), the Kentucky Supreme Court noted that the federal act does not protect information that is collected, or maintained or developed separately from a patient safety evaluation system, even if it is collected by a patient safety evaluation system and reported to a patient safety organization. The Baptist Health Richmond court further went on to make reference to a guidance memorandum issued by HHS on May 24, 2016, with respect the interpretation and implementation of the Patient Safety Act. (The federal advisory from HHS can be found at Federal Registrar, Volume 881, No. 100.) Essentially, HHS clarified that the Patient Safety Act does not relieve a provider from its external obligations under federal, state or local law. The preamble to the Advisory went on to state:

The Department does not believe that the patient safety evaluation system enables providers to avoid transparency … The Patient Safety Act and the final rule have carefully assured that information generally available today remains available, such as medical records, original provider documents and business records.

The Advisory goes on to state that HHS was concerned that patient safety organizations were being used in an effort to avoid a provider's external obligations to create and maintain documents relative to adverse patient incidents in an effort to circumvent state or federal regulatory obligations.

The Baptist Health Richmond case dealt with a discovery order from the trial court seeking production of documents dealing with incident reports, investigative reports, and so forth. Kentucky's Supreme Court ultimately ruled that documents providers are required to create and maintain under Kentucky law are not subject to the privileges from production provided by the Patient Safety Act and are thus not patient safety work product. The concurring opinion by Deputy Chief Justice Lisabeth Hughes points to the Department of Health Advisory Report of May 24, 2016, emphasizing that records required of a provider to meet “any federal, state or local public health or health oversight requirement are original provider records and are not subject to the privilege under the Patient Safety Act and Quality Improvement Act of 2005.”

Charles v. Southern Baptist Hospital of Florida

In Charles v. Southern Baptist Hospital of Florida, the Supreme Court of Florida earlier this year overturned the District Court of Appeals' decision holding that certain requested records in this medical malpractice action were immune from discovery under the PSQIA. The court held that the documents that the hospital claimed as privileged — as patient safety work product — were in fact discoverable under the Florida constitutional provisions giving patients access to these records.

In Charles, the history surrounding the PSQIA, and the limitations of patient safety work product as defined in the Act, were discussed at length. The majority in the Charles case noted that hospitals are required to create and maintain records of adverse medical incidents under the licensing provisions of Florida law, namely Chapter 395 of the Florida Statutes. The court further noted that adverse medical incident reports do not become patient safety work product merely by reporting these documents to a patient safety organization, because Florida Statutes and Administrative Rules require providers to create and maintain these records. In support of its ruling, the Florida Supreme Court noted the Kentucky Supreme Court's similar holding in the Baptist Health Richmond.

The Florida Supreme Court held that records of adverse medical incidents do not become patient safety work product merely by being reported to and placed in the patient safety evaluation system or submitted to a patient safety organization. Since health care providers have an independent obligation under Florida law to create and maintain these records, and the Florida Constitution provides patients with a constitutional right to access these records, such records are discoverable. The court also addressed the preemption issue and determined that the Florida constitutional right to access these records was not preempted by the federal act.

Discussion

These two state supreme court decisions point out important limitations on the privileges otherwise associated with the documents that might be considered as “patient safety work product” under the federal act. Health care providers, as well as administrators who are working with patient safety organizations, need to understand that documents do not become privileged and immune from discovery merely because of the labels that health care providers associate with documents which they are required to create or maintain in accordance with state or federal law. The HHS Advisory of May 24, 2016, specifically discusses the fact that the purpose of the PSQIA was not to allow health care providers to avoid transparency for medical issues that are contained in reports that they are required to prepare and maintain by law. The HHS Guidance Report in fact specifically states:

The Patient Safety Act was not intended to give providers such methods to evade their regulatory obligations. Here, we clarify HHS interpretation of how the Patient Safety Act prohibits providers from using the PSES (patient safety evaluation systems) to protect from disclosure of records subject to such external obligations.

Accordingly, it appears certain that the limitations on patient safety work product — as articulated in the two state Supreme Court cases, and the HHS Guidance Advisory — provide clear guidance as to what is to be considered “patient safety work product” under the federal act. Attorneys handling litigation in this area need to know the specific legal obligations that providers have for creating and maintaining documents concerning adverse medical incidents in order to know whether such documentation is to be considered patient safety work product under the federal act, or not.

Conclusion

The goal behind the Patient Safety and Quality Improvement Act of 2005 still remains clear, in the authors' opinions, yet it would appear that, on occasion, health care providers have tried to use the privileges under the federal act to avoid having to produce documents that they are required to create and maintain pursuant to applicable state and/or federal law. The cases from Kentucky and Florida analyze the statutory provisions under the federal act, and these two decisions appear to harmonize with the HHS Advisory Opinion of May 24, 2016.

In the context of medical malpractice litigation, it is therefore important for lawyers representing the injured patient and health care providers to understand the overall purpose of the Healthcare Quality and Improvement Act, as well as its limitations as far as patient safety work product is concerned.

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Michael A. Petruccelli and Steven A. Osher, both members of Medical Malpractice Law & Strategy's Board of Editors, are the founders of Pettruccelli & Osher, with offices in Fort Lauderdale and Naples, FL. They concentrate their practice in medical malpractice, as well as health and other aspects of civil law.

On July 29, 2005, President George W. Bush signed legislation known as the Patient Safety and Quality Improvement Act (PSQIA) of 2005, heralding the legislation as a critical step toward the goal of ensuring top-quality and patient-driven health care for United States citizens. This legislative initiative followed a 1999 Institute of Medicine (IOM) report, which estimated that at least 44,000, and potentially as many of 98,000, people die in U.S. hospitals each year as a result of preventable medical errors. The report, titled “To Err Is Human: Building a Safer Health System,” recommended that legislation be passed to develop a reporting system by which medical errors could be identified, analyzed, and used to prevent future medical errors.

Through the PSQIA, the mechanism for the receipt of this information was the formation of patient safety organizations and a national patient safety database. Patient safety organizations (PSOs) are defined as private organizations, or a component thereof, that are certified through a process developed through the Department of Health and Human Services (HHS). Under the Act, PSOs perform the activities of conducting and organizing, as their primary activity, efforts to improve patient safety and the quality of health care delivery, collecting and analyzing patient safety work product that is submitted by their providers, and other activities. The goal of a PSO is to improve patient safety by utilizing patient safety work product to carry out its activities and to minimize patient risk of health care errors.

As part of the PSQIA, Congress stated that the information provided by the patient safety organizations and collected in the National Patient Database was to be referred to as “patient safety work product.” The Act specifically states that patient safety work product is not subject to discovery in connection with a civil or administrative proceeding, and there are a host of other protections from disclosure under the Act. The goal of providing protection from disclosure was to encourage health care providers to share information without fear of liability.

Where Does Med Mal Come In?

Since the passage of the Patient Safety and Quality Improvement Act, a number of health care institutions have developed and joined patient safety organizations. Two recent decisions from the supreme courts of Kentucky and Florida have discussed the important issues of patient safety work product and whether this type of information is subject to discovery in connection with medical malpractice litigation. The opinions in these two decisions are crucial to understanding the purpose of the PSQIA and its limitations with respect to patient safety work product. Both health care leaders and attorneys dealing with these issues need to understand that documents that are prepared and reported to a patient safety organization are not necessarily “patient safety work product,” and in fact may be discoverable in medical malpractice lawsuits.

Two Recent Cases

The cases of Baptist Health Richmond v. Clouse , 497 S.W.3d 759 (Ky. 2016), and Charles v. Southern Baptist Hospital of Florida, 2017 WL 411333 (Supreme Court of Florida, Jan. 31, 2017), both speak to the issue of whether the information that is collected and reported to a PSO is protected from discovery in medical malpractice litigation.

Under the federal act, 42 U.S.C.A. § 299b, et seq., the statute defines what is considered patient safety work product and, more importantly, describes what documentation constitutes patient safety work product that is not subject to discovery. The Act also sets forth what documentation is not considered patient safety work product that is exempted from the protections of the federal act. Finally, it excludes certain information from the definition of patient safety work product, including a provider's record-keeping obligation with respect to information described in the Act under federal, state or local law, as well as the reporting of information that a health care provider is required to report to a federal, state, or local government agency for public health, surveillance, investigation or other public health purposes.

Baptist Health Richmond

In the Baptist Health Richmond case, citing from its prior opinion in Tibbs v. Bunnell , 448 S.W. 3d 796 (Ky.2014), the Kentucky Supreme Court noted that the federal act does not protect information that is collected, or maintained or developed separately from a patient safety evaluation system, even if it is collected by a patient safety evaluation system and reported to a patient safety organization. The Baptist Health Richmond court further went on to make reference to a guidance memorandum issued by HHS on May 24, 2016, with respect the interpretation and implementation of the Patient Safety Act. (The federal advisory from HHS can be found at Federal Registrar, Volume 881, No. 100.) Essentially, HHS clarified that the Patient Safety Act does not relieve a provider from its external obligations under federal, state or local law. The preamble to the Advisory went on to state:

The Department does not believe that the patient safety evaluation system enables providers to avoid transparency … The Patient Safety Act and the final rule have carefully assured that information generally available today remains available, such as medical records, original provider documents and business records.

The Advisory goes on to state that HHS was concerned that patient safety organizations were being used in an effort to avoid a provider's external obligations to create and maintain documents relative to adverse patient incidents in an effort to circumvent state or federal regulatory obligations.

The Baptist Health Richmond case dealt with a discovery order from the trial court seeking production of documents dealing with incident reports, investigative reports, and so forth. Kentucky's Supreme Court ultimately ruled that documents providers are required to create and maintain under Kentucky law are not subject to the privileges from production provided by the Patient Safety Act and are thus not patient safety work product. The concurring opinion by Deputy Chief Justice Lisabeth Hughes points to the Department of Health Advisory Report of May 24, 2016, emphasizing that records required of a provider to meet “any federal, state or local public health or health oversight requirement are original provider records and are not subject to the privilege under the Patient Safety Act and Quality Improvement Act of 2005.”

Charles v. Southern Baptist Hospital of Florida

In Charles v. Southern Baptist Hospital of Florida, the Supreme Court of Florida earlier this year overturned the District Court of Appeals' decision holding that certain requested records in this medical malpractice action were immune from discovery under the PSQIA. The court held that the documents that the hospital claimed as privileged — as patient safety work product — were in fact discoverable under the Florida constitutional provisions giving patients access to these records.

In Charles, the history surrounding the PSQIA, and the limitations of patient safety work product as defined in the Act, were discussed at length. The majority in the Charles case noted that hospitals are required to create and maintain records of adverse medical incidents under the licensing provisions of Florida law, namely Chapter 395 of the Florida Statutes. The court further noted that adverse medical incident reports do not become patient safety work product merely by reporting these documents to a patient safety organization, because Florida Statutes and Administrative Rules require providers to create and maintain these records. In support of its ruling, the Florida Supreme Court noted the Kentucky Supreme Court's similar holding in the Baptist Health Richmond.

The Florida Supreme Court held that records of adverse medical incidents do not become patient safety work product merely by being reported to and placed in the patient safety evaluation system or submitted to a patient safety organization. Since health care providers have an independent obligation under Florida law to create and maintain these records, and the Florida Constitution provides patients with a constitutional right to access these records, such records are discoverable. The court also addressed the preemption issue and determined that the Florida constitutional right to access these records was not preempted by the federal act.

Discussion

These two state supreme court decisions point out important limitations on the privileges otherwise associated with the documents that might be considered as “patient safety work product” under the federal act. Health care providers, as well as administrators who are working with patient safety organizations, need to understand that documents do not become privileged and immune from discovery merely because of the labels that health care providers associate with documents which they are required to create or maintain in accordance with state or federal law. The HHS Advisory of May 24, 2016, specifically discusses the fact that the purpose of the PSQIA was not to allow health care providers to avoid transparency for medical issues that are contained in reports that they are required to prepare and maintain by law. The HHS Guidance Report in fact specifically states:

The Patient Safety Act was not intended to give providers such methods to evade their regulatory obligations. Here, we clarify HHS interpretation of how the Patient Safety Act prohibits providers from using the PSES (patient safety evaluation systems) to protect from disclosure of records subject to such external obligations.

Accordingly, it appears certain that the limitations on patient safety work product — as articulated in the two state Supreme Court cases, and the HHS Guidance Advisory — provide clear guidance as to what is to be considered “patient safety work product” under the federal act. Attorneys handling litigation in this area need to know the specific legal obligations that providers have for creating and maintaining documents concerning adverse medical incidents in order to know whether such documentation is to be considered patient safety work product under the federal act, or not.

Conclusion

The goal behind the Patient Safety and Quality Improvement Act of 2005 still remains clear, in the authors' opinions, yet it would appear that, on occasion, health care providers have tried to use the privileges under the federal act to avoid having to produce documents that they are required to create and maintain pursuant to applicable state and/or federal law. The cases from Kentucky and Florida analyze the statutory provisions under the federal act, and these two decisions appear to harmonize with the HHS Advisory Opinion of May 24, 2016.

In the context of medical malpractice litigation, it is therefore important for lawyers representing the injured patient and health care providers to understand the overall purpose of the Healthcare Quality and Improvement Act, as well as its limitations as far as patient safety work product is concerned.

*****
Michael A. Petruccelli and Steven A. Osher, both members of Medical Malpractice Law & Strategy's Board of Editors, are the founders of Pettruccelli & Osher, with offices in Fort Lauderdale and Naples, FL. They concentrate their practice in medical malpractice, as well as health and other aspects of civil law.