Jacqueline Root Publishes Article in FSHRMPS Online Journal

In a concerning reversal of the First District Court of Appeal, the Florida Supreme Court recently issued its opinion in the matter of Charles v. Southern Baptist Hospital, and settled – at least for now – the matter of Patient Safety Quality Improvement Act preemption of Florida’s Amendment 7. This opinion will have substantial impact on hospital risk management, record-keeping, and peer review, and the Patient Safety Organization (PSO) landscape.

The underlying Charles matter arose from the non-production of “occurrence reports” by Southern Baptist Hospital in response to discovery served by a medical malpractice plaintiff seeking documents “related to adverse incidents” at the hospital. Though the hospital did produce Code 15 reports, Annual Reports, and two occurrence reports specific to the patient that had not been reported to Baptist’s PSO, PSO Florida, it withheld its occurrence reports that had been entered into the patient safety evaluation system and were pending submission to Baptist’s PSO. Thus began the “dual purpose” and preemption debates.

Briefly put, the Supreme Court has now held that “dual purpose” records – those records which providers have an obligation under Florida law to create and maintain – are not patient safety work product, and thus are not protected from discovery, even if they are placed in a patient safety evaluation system. The Supreme Court also held that, at least with regard to “dual purpose” records, the PSQIA does not preempt Amendment 7. The court’s reasoning hinged on their determination that the documents in question were outside the definition of patient safety work product; because Florida statutes and administrative rules require providers to create and maintain adverse incident records and Amendment 7 provides patients with a constitutional right to access the records, they fall within the exception to the PSWP definition of information “collected, maintained, or developed separately, or exist[ing] separately from a patient safety evaluation system.” See 42 U.S.C. § 299b-21(7)(B)(ii).

If this opinion stands, the court has effectively returned healthcare providers to the Amendment 7 era, with little protection for patient safety data. While unfortunate, there are a number of ways facilities may endeavor to keep as much of this information protected as possible, which we will explore here.

1. 1. Documents not required to be created and maintained by Florida law are still protected.

First, a fair reading of the Charles decision limits those documents not protected as patient safety work product to “dual purpose” documents. Specifically, the court indicated that the documents in question were dual purpose because the hospital was required to create and maintain them pursuant to Florida statutes and administrative rules. The court refers to this as “an independent obligation under Florida law.” Thus, there is a strong argument to be made that unless a document in a facility’s patient safety evaluation system is actually required to be “created or maintained” by Florida statute and the related administrative rules, Charles does not apply, and the document remains privileged pursuant to the PSQIA. When a facility is faced with a request for documents, the best practice in a post-Charles world is to confirm that the requested documents are actually required to be maintained or created by Florida statute. If they are not, counsel for providers will have a strong argument that the documents are in fact protected from discovery by the PSQIA, despite Charles.

1. 2. Later PSO analysis is still protected.

The Department of Health and Human Services’ Guidance on Patient Safety and Quality Improvement Act published May 24, 2016 – which many suggest was instrumental in supporting the Court’s decision to reverse the First District opinion – is also informative in determining how to proceed post-Charles. Specifically, the HHS guidance discusses “pathways” by which patient safety work product is generated. The “reporting pathway” is essentially information documented for the purpose of reporting to a PSO. That pathway still exists, and still provides privileged and confidential status for the documents generated. The only carve-out under Charles is that if the document is generated for any statutory or state administrative purpose, it is excepted from the definition of PSWP, no longer considered part of the “reporting” pathway, and no longer protected. However, even though such dual purpose documents are themselves no longer protected, there is a strong argument that later analysis, which is not required by statute or regulation, is. This position is supported by the HHS guidance itself, which discusses scenarios wherein a provider maintains specific forms regarding adverse events in order to satisfy a federal or state obligation outside its patient safety evaluation system, but within the patient safety evaluation system extracts information from the form for later analysis, or a duplicate copy of the form is placed within the system for submission to the PSO so that later reporting can be conducted. See https://www.federalregister.gov/d/2016-12312/p-54. In each case, though the incident report form itself would not be protected (pursuant to the guidance and now Charles), the later separate and additional analysis would be, because such analysis is not required by any state or federal statute and fits squarely within the PSQIA definition of patient safety work product. It is this author’s opinion that this analysis extends to anything in the “analysis” path, to include root cause analyses, and peer review documentation. The analysis distinction is an important one.

1. 3. Consider a dual-track documentation system.

In light of the distinction for analysis documentation contemplated above, it may be advisable to consider once again a two-track system for patient safety data. That is, the forms mandated by state and federal law include the information that must be included pursuant to state law, but no more. For example, where a facility currently creates adverse incident reports pursuant to Florida statutory requirements, but then goes on to note the risk management handling of the situation and investigation on the same form, it will now be a better practice to use the adverse incident form solely for the minimal purpose of complying with state law. The facility could create a new investigation form, perhaps attaching a copy of the adverse incident report, or otherwise incorporating the data, for purposes of follow up risk management investigation and analysis, patient safety evaluation and submission to the facility’s PSO. While additional steps for documentation are frequently resisted by facilities, this clear distinction of purpose will likely be a major support for legal argument regarding the privileged and confidential status that should and does still exist under Charles. It is worth considering whether a two-track system is viable for your facility.

In sum, the Charles decision is unfortunate news for the PSQIA construct, but it does not have to be a death knell for protection of all analysis of patient safety events. Charles does counteract the effect of significant positive case law, but it leaves several areas untouched, and the protections of the PSQIA intact in some regards. Providers can and very much should continue to seek the privileges still available for patient safety data.

Jacqueline Root is a medical malpractice defense attorney at ROIG Lawyers in Tampa, FL, and the FSHRMPS Communication Committee Chair and Editor of FSHRMPS RiskNet. She can be reached directly at jroot@roiglawyers.com. Jacqueline would like to extend gratitude to Andrew S. Bolin, counsel for PSO Florida, for his support and input regarding this article.

The contents of this article are intended for general information and educational purposes, and should not be relied upon as advice about any particular fact situation. The distribution of this publication is not intended to create, nor does receipt of same constitute, an attorney-client relationship.