BALANCING PATIENT SAFETY WITH PATIENTS RIGHTS A comparative legal - PowerPoint PPT Presentation

BALANCING PATIENT SAFETY WITH PATIENTS’ RIGHTS A comparative legal perspective

What are we really balancing?

To Err is Human 1 ¨ According to the IOM’s report, most errors are caused by systemic problems, not individual providers, and blaming an individual does little to prevent errors and improve patient safety. ¨ The IOM found that the human error research of sociologist, Charles Perrow, and psychologist, James Reason, which is used in high-risk complex organizations including aviation and nuclear power, is also applicable to the healthcare industry. Reason explains that complex systems usually fail because of several weaknesses in the process chain. 1 L. T. Kohn, J. Corrigan, & M. S. Donaldson, Institute of Medicine, To err is human: Building a safer health system (1999)

Paradigm Shift in Error Prevention

Error Reporting and Learning Systems ¨ To address the problem of systemic errors, the IOM, and subsequently the World Health Organization (WHO), recommended the implementation of non- punitive error reporting and learning systems to encourage the detection and prevention of errors. 2 ¨ Central to the success of systemic learning is replacement of the traditional “blame culture” in healthcare with a “trustworthy learning and safety culture” that embraces sanction-free reporting. 3 2 World Health Organization, World Alliance for Patient Safety: WHO Draft Guidelines for Adverse Event Reporting and Learning Systems: From Information to Action (2005) 3 Sonja Barth, Aus Fehlern lernen –Schwachstellen imSystem rechtzeitig erkennen . Berliner Ärtze 1/2009 S. 14

Here is the Problem

The Law is Designed to Focus on the Individual Provider ¨ In both Germany and the United States, medical malpractice law is designed to focus primarily on the individual provider in cases of treatment error.

It’s Time to Rethink Organizational/ Corporate Liability ¨ While the concept of organizational and corporate negligence is established in both American and German jurisprudence, it has never focused on the healthcare organization’s duty to prevent systemic errors with risk management measures. ¨ When an organization is sued for direct negligence, the claims generally focus on: ¤ Supervision/guidance/credentialing ¤ Maintenance ¤ Hygiene

Establishing a Legal Duty of Non- Negligent Risk Management ¨ Germany ¤ In Germany, federal law establishes an obligation that healthcare providers develop quality assurance measures, namely, sections 135 and 136 of SGB V require that healthcare providers participate in cross- facility quality assurance measures, introduce and develop a quality management system, including a patient complaint management system, and submit annual quality reports. 4 4 §§135 - 137 SGB V.

Establishing a Legal Duty of Non- Negligent Risk Management ¨ United States ¤ In the United States, state laws differ regarding legal requirements for risk management in hospitals. n In Florida, state law requires hospitals to ensure comprehensive risk management, including the obligation to implement patient complaint and error reporting systems and disclose adverse events to patients. 5 n In New York, state law requires hospitals to report and investigate incidents involving patient deaths, fires in the hospital, equipment malfunction, poisoning, strikes by hospital staff, external disasters that affect hospital operations, and termination of services vital to hospital operation. 6 5 § 766.110(1), Fla. Stat., § 395.0197, Fla. Stat. 6 NY PBH §2805-l.

Establishing a Legal Duty of Non- Negligent Risk Management ¨ United States ¤ In the private regulatory sphere, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) has increasingly focused on patient safety standards. 7 n LD.03.01.01 - create and maintain a culture of safety and quality n LD.04.04.05 - implement integrated patient safety programs and provide and encourage the use of sanction- free reporting systems n LD.03.02.01- collect and analyse performance data 7 The Joint Commission, Comprehensive Accreditation Manual for Hospitals , ch. "Patient Safety Systems" (2017).

A Duty to Risk Management: The Need for Legal Standards ¨ The healthcare industry is seeing an explosion of internal and external regulations and policies governing risk management, all of which create new potential standards of care for healthcare organizations. ¨ Although legal, regulatory, and institutional standards should reflect the industry’s best practices and provide flexibility, holding healthcare organizations to such vast and vague standards of care in court may jeopardize the very safety culture that new risk management standards are meant to create.

A Duty to Risk Management: Evidentiary Problems ¨ The default burden of proof rules in the United States and Germany expose an area of conflict between risk management policies that promote confidential and sanction-free error reporting and policies that support a cause of action for negligent risk management against the organization. In both countries, the plaintiff bears the burden to produce evidence of alleged negligence by the healthcare provider.

A Duty to Risk Management: Preserving Confidentiality of Reporting and Learning Systems ¨ United States ¤ Historically, a combination of attorney-client privilege, medical peer-review privilege, and the evidentiary rule excluding subsequent remedial measures offered some protection for hospitals using error reporting and analysis, but there is inconsistency in the case law regarding the extension of these privileges to error reports in litigation. 8 ¤ While Congress sought to offer protection through the PSQIA, attorneys seeking access to error reports for use in medical malpractice lawsuits immediately challenged the evidentiary protection provided by the Act. 9 8 Cynthia J. Dollar, Promoting Better Healthcare: Policy Arguments for Concurrent Quality Assurance and Attorney- Client Hospital Incident Report Privileges , 3 Health Matrix 259 (1993). 9 42 U.S.C. 299b–21—b–26

A Duty to Risk Management: Preserving Confidentiality of Reporting and Learning Systems ¨ Germany ¤ There are no explicit legal protections for information and documents stored in error reporting and learning systems, aside from whistle- blower protections for reporters, but the anonymity of German error reporting and learning systems combined with conservative discovery and evidentiary rules have thus far insulated confidential reporting data from being used against German healthcare providers in litigation. ¤ A patient has no right of access to the documentation or data from clinical risk management and hospital-internal CIRS systems, because the patient’s right to access is restricted to documentation that relates to him and documentation that has been compiled pursuant to a medical or nursing obligation to provide information on the patient’s treatment course. Unlike patient treatment records, CIRS data is used to prevent dangers and protect patients against avoidable risks. 10 ¤ While anonymisation and outsourcing of error reports can reduce the probability that a patient will have access to CIRS reports, access cannot be legally prevented. 11 10 Andrea Pauli, Risikiomanagement und CIRS als Gegenstand der Krankenhaushaftung (2013). 11 Jasmine Thüß, Rechtsfragen des Critical Incident Reportings in der Medizin (2012).

Recent U.S. Example of Legal Threat to Patient Safety Culture ¨ The Florida Supreme Court in Charles v. Southern Baptist Hospital of Florida, Inc , recently decided that all adverse event reports were discoverable in medical malpractice litigation. 12 ¨ Florida’s constitution gives patients access to healthcare provider records relating to any adverse medical incident. 13 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. 14 ¨ 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. 12 Charles v. S. Baptist Hosp. of Florida, Inc ., SC15-2180, 2017 WL 411333 (Fla. Jan. 31, 2017) 13 Art. X, § 25(a), Fla. Const. 14 Art. X, § 25(c)(3), Fla. Const.

Patient Safety v. Patients’ Rights ¨ As error reporting and learning systems become commonplace in healthcare organizations, courts will be forced to negotiate competing social, legal, and political interests to develop jurisprudence that balances the transparency required to safeguard patients’ rights and the confidentiality required to safeguard patient safety culture.

Recognizing the Valid Goals ¨ Medical Negligence Law ¤ The legal system is necessary to compensate victims of medical malpractice. ¤ The legal system is also a means of generating societal change. ¨ Patient Safety Agenda ¤ Patient safety culture is necessary for the prevention of medical errors. ¤ The success of patient safety culture relies, in part, on a certain level of confidentiality and protection from the legal system.