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Florida Supreme Court Deals Lethal Blow to Patient Safety


Allowing the use of near-miss reports in litigation not only deters an individual provider from reporting, but it also deters the institution from promoting patient safety culture through near-miss reporting. 

The Florida Supreme Court in Charles v. Southern Baptist Hospital of Florida, recently decided that all adverse event reports were discoverable in medical malpractice litigation. [1] This decision not only undermines the patient safety goals of the 2005 Patient Safety and Quality Improvement Act (PSQIA)[2], it is contrary to prevailing medical error prevention research and curtails the international trend of promoting patient safety culture in healthcare.

Medical Error Prevention Research

Largely in response to the Institute of Medicine’s To Err is Human: Building a Safer Health System report, healthcare organizations around the world began to focus risk management strategies on detecting and preventing systemic weaknesses that lead to medical errors.[3] According to the Institute of Medicine and the World Health Organization, a critical part of medical error prevention is the implementation of error reporting and learning systems.[4]

To completely understand the detrimental impact of the Charles decision, it is important to distinguish between errors that cause injury (injury-causing errors) and errors that could have caused injury (near-misses). Although there is ongoing debate regarding injury-causing error reports, safety experts unanimously recommend that near-miss error reporting be voluntary, confidential, and non-punitive.[5] Error research shows that near-misses occur at a overwhelmingly higher rate than injury-causing errors and are a rich source of information for learning and error prevention.[6] When near-misses are reported, they can be analyzed by experts and measures can be implemented to prevent the same error from causing an injury in the future.

How do we gather this goldmine of information about near-misses? We need to make sure that healthcare providers, who commit or witness near-miss errors, aren’t afraid to report them. Acceptance of and participation in near-miss error reporting and learning systems drastically improves patient safety culture.

Guess what? Patient safety culture is good for patient safety.

What’s the quickest way to destroy patient safety culture? Punishing healthcare providers who use near-miss error reporting and learning systems by allowing near-miss error reports stored in the hospital’s error-reporting and learning system to be used against it in litigation.

Federal Law

In 2005, the PSQIA sought to promote patient safety culture by protecting records “assembled or developed by a provider for reporting to a patient safety organization” from discovery in litigation.[7] While in theory, this legislation should encourage healthcare providers to implement near-miss error reporting and learning systems, the PSQIA contains a critical exception: records prepared pursuant to state mandatory reporting obligations would not be protected. (mandatory reporting exception)[8]

Until Charles v. Southern Baptist,[9] disputes regarding the application of the mandatory reporting exception centered on injury-causing error reports, usually relating to the particular plaintiff’s medical treatment.[10] In Charles, the Florida Supreme Court seized upon this exception to find that near-miss error reports concerning all patients were excluded from the Act’s protection.[11]

Florida Law

Florida’s constitution gives patients access to healthcare provider records relating to any adverse medical incident.[12] It defines an “adverse medical incident” to include any act of a healthcare provider that caused or could have caused injury or death to any patient.[13] This gives patients in Florida the right to use near-miss error reports against a healthcare provider in litigation, violating the cardinal rule against punishment for use of a near-miss error reporting system.

But wait, what about the protection in the PSQIA? Couldn’t providers protect its near-miss reporting system by sending the information to a Patient Safety Organization? Not in Florida, which brings us to the Florida statute requiring hospitals to report adverse incidents.[14] This statutory requirement mandates near-miss reporting violating another cardinal rule that near-miss error reporting be voluntary.

Remember that exception about reports prepared pursuant to mandatory obligations? Relying upon this exception and federal agency guidance related to this exception,[15] the Florida Supreme Court determined that all adverse incident reports, which under Florida’s law includes near-miss reports and reports of errors concerning third-party patients, were discoverable under Florida’s laws and not entitled to protection by the PSQIA.[16]

One critical flaw with Florida’s scheme is that there is virtually no way to enforce near-miss error reporting. Because the error doesn’t cause damage, the state, absent extraordinary circumstances, would never know if a near-miss error was reported or not. That leaves the decision to report near-misses in the hands of healthcare providers. Allowing the use of near-miss reports in litigation not only deters an individual provider from reporting, but it also deters the institution from promoting patient safety culture through near-miss reporting. As you can imagine, the patient safety culture is something that must come from the top of the healthcare institution.[17] It requires the institution to invest copious amounts of time and money in technology, education, training, communication, analysis, and feedback. It doesn’t take a genius to recognize why it is not recommended to force reporting or punish healthcare providers who report.

The Problem of Proving Organizational Liability

While I recognize that: (1) organizational/corporate liability for medical errors is a natural consequence of the shift in medical error prevention research toward a focus on systemic errors, and (2) it may be harder to prove an organizational error without access to confidential near-miss error reports, I cannot accept that mandating and penalizing near-miss error reporting, thereby decimating patient safety culture, is the solution. I intend to write extensively on this topic, but I will briefly mention that one potential solution to this problem is to shift the burden of proof to the defendant in the case of organizational errors. In this scenario, the plaintiff would not need to access confidential near-miss error reports to prove organizational error, but the organization would bear the burden of proving that its risk management standards were non-negligent.

I’ve spent most of this piece criticizing Florida’s medical malpractice and risk management laws, but some its laws are actually very progressive. For example, similar to Germany, Florida state law mandates and regulates risk management in hospitals, including a requirement for a patient complaint system and an error-reporting system.[18] Requiring hospitals to implement well-defined risk management measures is a step forward. It is the punitive aspects of Florida’s laws that hinder progress in patient safety culture. For example, a hospital should be required to implement a near-miss reporting and learning system, but individuals should not be required to report near-misses nor should there be punishment for the individual or the hospital as a consequence of reporting in the system.

What About the Injured Plaintiff?

There is no evidence that restricting access to near-miss error reporting systems will lead to the inability to compensate injured patients for medical malpractice. Patients will always have access to their medical records as well as the hospital’s risk management standards and policies for evaluation by experts. Even if you disagree, then we must, to some extent, weigh competing social values: is compensating one individual worth crippling the entire healthcare safety culture and increasing the risk of future injury for many patients? For a medical malpractice attorney, more injuries mean more cases and more money, but I wonder how that perspective would change if she ended up in a hospital with a toxic blame culture instead of a positive patient safety culture?

Conclusion

If the success of medical error prevention requires a delicate balance between transparency and protection of patient safety work product, then the State of Florida just placed a boulder on the transparency side of the scale. If Dr. Günther Jonitz is correct that we must choose between fear and safety, make no mistake about it, Florida just chose fear.

[1] See Charles v. S. Baptist Hosp. of Florida, Inc., SC15-2180, 2017 WL 411333 (Fla. Jan. 31, 2017)

[2] 42 U.S.C. 299b–21—b–26.

[3] L. T. Kohn, J. Corrigan, & M. S. Donaldson, To err is human: Building a safer health system. National Academy Press (Nov. 22, 2016, 11:34 a.m.), http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf.

[4] See Id. See also World Health Organization, World alliance for patient safety : WHO draft guidelines for adverse event reporting and learning systems : from information to action. Geneva: World Health Organization (Feb. 6, 2017, 2:29 p.m.), http://apps.who.int/iris/bitstream/10665/69797/1/WHO-EIP-SPO-QPS-05.3-eng.pdf

[5] See Kohn, et al., supra; World Health Organization, supra; Advisory Council for the Concerted Action in Health Care, Health Care Finance, User Orientation and Quality, Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen (Feb. 6, 2017, 1:22 p.m.), http://www.svr-gesundheit.de/fileadmin/user_upload/Gutachten/2003/Kurzf-engl03.pdf; Reporting and learning subgroup of the European Commission PSQCWG, Key findings and recommendations on Reporting and learning systems for patient safety incidents across Europe, European Commission, Patient Safety and Quality of Care working group (Nov. 22, 2016, 11:44 a.m.), http://ec.europa.eu/health/patient_safety/docs/guidelines_psqcwg_reporting_learningsystems_en.pdf.

[6] S. Barth, Aus Fehlern lernen –Schwachstellen im System rechtzeitig erkennen. Berliner Ärtze ((Dec. 15, 2016, 3:25 p.m.) https://www.aerztekammer-berlin.de/10arzt/40_Qualitaetssicherung/50_Patientensicherheit/Artikel_BAE_1_2009_Patientensicherheit.pdf; see also Kohn, et al., supra

[7] 42 U.S.C. 299b–21—b–26

[8] 42 U.S.C. 299b-21(7)(B)(ii); 42 CFR 3.20 (paragraph (2)(i) of the PSWP definition)

[9] Charles, 2017 WL 411333.

[10] See Tibbs v. Bunnell, 448 S.W.3d 796 (Ky.2014) (determining whether the exception applies to a report of the plaintiff’s alleged incident); Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759 (Ky.2016) (determining whether the exception applied to reports concerning the decedent).

[11] Charles, 2017 WL 411333.

[12] Art. X, § 25(a), Fla. Const.

[13] Art. X, § 25(c)(3), Fla. Const.

[14] See § 395.0197, Fla. Stat.

[15] 81 FR 32655–60, May 24, 2016

[16] Charles, 2017 WL 411333.

[17] In a learning organization, patient safety events are seen as opportunities for learning and improvement. Therefore, leaders in learning organizations adopt a transparent, nonpunitive approach to reporting so that the organization can report to learn and can collectively learn from patient safety events. In order to become a learning organization, a hospital must have a fair and just safety culture, a strong reporting system, and a commitment to put that data to work by driving improvement. Each of these require the support and encouragement of hospital leaders. JCAHO, Comprehensive Accreditation Manual for Hospitals, Chapter on Patient Safety Systems, JCAHO (2017).

[18] See generally § 395.0197, Fla. Stat; see also § 766.110(1), Fla. Stat.