As other authors in this special edition of the Bulletin of the American College of Surgeons have noted, medical liability lawsuits are financially and emotionally costly. In these respects and more, they harm patients, providers, and the medical and legal systems. The pervasive tropes of “bad apple” physicians, greedy lawyers, and exploited patients do little to promote patient well-being and patient-provider trust. Nonetheless, achieving medical liability reform has proved difficult in New York and elsewhere. New York State has responded to these challenges in part through an Agency for Healthcare Research and Quality (AHRQ)-funded Patient Safety and Medical Liability Reform Demonstration Project. This article describes the processes and systems created to meet its objectives.
The AHRQ request for applications
Already looking for creative alternatives to New York’s medical liability system, a small interdisciplinary state team responded with interest to AHRQ’s request for applications to participate in the 2009 Medical Liability Reform/Patient Safety demonstration project. The AHRQ initiative offered funding to states and/or hospital systems for programs that would promote patient safety, improve patient-provider communication, ensure fair and prompt settlements for injured patients, and reduce the incidence of frivolous lawsuits and liability premiums. Although many reform efforts were under way, AHRQ’s emphasis on improving patient safety added a critical challenge.
New York State project
To meet the wide-ranging requirements of the AHRQ initiative, the New York team expanded to include additional representatives from the Department of Health and the Unified Court System, as well as five major academic medical centers in New York City. It also recruited Michelle Mello, JD, PhD, a public health researcher who would evaluate components of the project, and Richard Boothman, JD, a pioneer in disclosure and offer programs.
A central component of the project was a communication and resolution program (CRP), to be piloted in the departments of general surgery of the five participating hospitals. Its goals were to reduce preventable harm to patients and, when harm nevertheless occurred, to resolve disputes while preserving the physician-patient relationship. The New York State proposal also included an expansion of a pre-existing judicial program for disputes that resulted in lawsuits. The proposal was successful. In 2010, AHRQ awarded New York State a $3 million demonstration grant to fund the pilot program for three years. The program is currently in its third and final year.
Focus on patient safety
In keeping with the AHRQ guidelines, the New York State project focused on patient safety. The work plan identified three areas of emphasis: development of a culture of safety, enhanced adverse event reporting, and implementation of patient safety activities.
Participating institutions were responsible for assessing their safety culture by administering AHRQ’s Hospital Survey of Patient Safety Culture to general surgery department staff. Hospitals were required to identify opportunities for improvement and design initiatives to address them. The survey will be re-administered in the final months of the project.
Building upon improvements in the culture of safety, participating institutions were encouraged to enhance their systems of tracking and responding to adverse events. Hospitals expanded adverse event data sources beyond traditional clinical reporting. Known complications were included for further evaluation, with a focus on the patient’s perspective on the event.
Hospitals were expected to adopt appropriate safety measures and incorporate current initiatives into the project scope. These included the use of surgical safety checklists and “zones of silence” to reduce distraction and error. In addition, the development of an obese surgical patient practice guideline and better preoperative assessments, among other initiatives, were identified to help reduce preventable harm.
CRP elements and processes
The CRP established personnel and protocol for the identification, reporting, and resolution of study events. A CRP study event was defined as an adverse event that did or could result in serious harm to a patient while in the care of the perioperative unit. Level of harm is assessed using the AHRQ scale. Study events are reported to the “hospital designee,” who notifies other hospital staff and oversees the process. Responding to the patients’ immediate needs is the first priority.
An investigation is conducted promptly and the findings are presented to a review committee, which recommends systems improvements and determines the appropriate resolution. If monetary compensation is to be offered, an early settlement subcommittee is convened. Representatives of the review committee and the early settlement subcommittee meet with patients and families to explain the findings of the investigation and, if appropriate, to offer an apology and to discuss resolution, as well as measures to prevent recurrences. At all stages of the CRP process, the emphasis is on consistent communication with the patient and family. To facilitate CRP implementation, general surgery department staff participated in a customized training program to improve post-event communication with patients.
The New York State Patient Safety and Medical Liability Reform program included an expansion of a program that had been piloted by the New York State Unified Court System for cases filed against New York City public hospitals. The judge-directed negotiation program was intended to handle those cases that the CRP did not resolve, as well as pre-existing cases. The project team developed a new “medicine for judges” curriculum, including lectures on medical records, anatomy, specific medical injuries, settlement techniques, and legal issues related to medical liability litigation. A total of 60 judges attended a three-day training course. The materials and presentations were subsequently made available online to all New York State judges.
Under the program, all lawsuits against one of the five participating hospitals are assigned to trained judges who retain the cases for their duration or until a plaintiff opts out. The plaintiff may request a jury trial at any point. An RN/JD provides clinical assistance to the judges. The parties meet in the judge’s chambers instead of a courtroom, and they are required to appear fully prepared and with authority to settle. Case conferences are frequent and focused on the prompt achievement of a fair settlement.
The judge-directed negotiation program, which has since expanded to Erie County, has been met with enthusiasm from both the plaintiff and defense bars. Significantly, the program has provided confidence to hospitals in a high-risk liability climate like New York’s to participate in the CRP.
A formal evaluation of the CRP and judge-directed negotiation programs is forthcoming and will be performed by Ms. Mello and colleagues at the Harvard School of Public Health, Boston, MA. Meanwhile, data from the hospital sites and the court system are being gathered.
The experience of developing and implementing the program has underscored the interconnectedness of diverse approaches to medical liability reform. Above all, patient safety is at the heart of the matter: it must be the chief driver for all stakeholders, including providers, public health officials, hospital administrators, attorneys, and the judiciary. As AHRQ foresaw in creating this initiative, putting patient safety first can promote liability reform.
This project was supported by grant number R18HS019505 from the AHRQ. The content is solely the responsibility of the authors and does not necessarily represent the official views of the AHRQ.