The Program in Question
In February of this year, amid much fanfare and publicity, the Department of Obstetrics and Gynecology at New York Presbyterian Hospital-Weill Cornell Medical Center published the results of their comprehensive obstetric patient safety program in the American Journal of Obstetrics and Gynecology. Titled, 'Effect of a Comprehensive Obstetric Patient Safety Program on Compensation Payments and Sentinel Events' the article was immediately embraced by the media, politicians, legislators, obstetrician groups, and even many patient advocates as proof-positive that sentinel events and compensation payments could be drastically reduced through implementation of the Weill Cornell obstetric patient safety program (full citation: Grunebaum, A., Chervenak, F., Skupski, D.: Effect of a comprehensive obstetric patient safety program on compensation payments and sentinel events. Am J Obstet Gynecol 204. 97-105). A bill was quickly introduced to the State Senate mandating that the Weill Cornell program be replicated in every hospital across the state. With Governor Cuomo backing controversial legislation to cap non-economic jury damages, the article also became highly politicized, with both sides evidencing it for and against malpractice tort reform.

In the barrage of press releases and political commentary that followed the article's release, much attention was given to, and yet little critical analysis was made of, the authors' staggering claims. In the article, Drs. Grunebaum, Chervenak, and Skupski reported that, with implementation of a 'comprehensive obstetric patient safety program' over a six-year period from 2003-2009:

• Obstetric compensation payments dropped more than 99%, from an average of $27.69 million between 2003-2006 to $250,000 in 2009;
• Sentinel events were eliminated entirely, with none reported in 2008 and 2009.

Sounds great, doesn't it? Not so fast. Before we rush to insure the obstetricians, apply for a job, refer our expectant patients, or deliver babies ourselves at Weill Cornell, there are a few additional questions worth asking here. Shortly after the article was published, Kathleen Clark, a collaborative health care attorney and CEO of Servant Lawyership, Bob Latino, professional root cause analyst and CEO of Reliability Center, Inc., and I met to review the paper and offer feedback, not as clinicians, but as passionate advocates of patient safety and consumer engagement in the health care dialogue. Our analysis, 'The Weill Cornell Patient Safety Program Study: Feedback from Patient Safety Advocates in Medicine, Law, and Root Cause Analysis,' was published this week in an AJOG letter-to-the-editor. The link to the full letter can be found here, however, with AJOG's permission, I would like to share with you some of the questions we raised in response to Grunebaum, et al's article:

What were the criteria used to classify an incident as a 'sentinel event' in the study?The Joint Commission defines 'sentinel event' as 'an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof,' however, the authors' definition was much more narrowly defined: 'at our institution, sentinel events included maternal deaths, and serious newborn injuries, including birth asphyxia and hypoxic, ischemic encephalopathy.' Such self-imposed restrictive criteria account for only the rarest and most extreme outcomes. Since sentinel events are the 'tip of the iceberg,' a decrease in the number of sentinel events, small to begin with, may not indicate an appreciable improvement in the overall safety or quality of patient care.

How might a broader definition of 'sentinel event' to include nonfatal adverse outcomes and near misses have changed the study results and implications?
The credibility and appeal of the Weill Cornell patient safety program to a consumer-oriented audience might have been greater had results shown a decrease, not just in sentinel events but in other more frequent and often preventable adverse obstetrical outcomes such as unnecessary major surgical procedures (Weill Cornell has an extraordinarily high, 40 percent cesarean section rate), severe perineal tears, postpartum hemorrhage, neonatal ICU admissions for sepsis and jaundice, and postpartum post-traumatic stress disorder.

How did the criteria for identifying sentinel events change at the hospital over the study period?
Despite systems to track errors, adverse events, and near misses, internal and external underreporting remains a significant problem in hospitals and health care facilities everywhere (citation: Drake-Land B. CMS never events: exploring the connection between tracking near misses, organizational learning and the potential to reduce the occurrence of never events in healthcare organizations. rL Solutions. Toronto. 2008). Was it only coincidence that 2008, the first year of the CMS 'Never Event' policy prohibiting hospitals from billing for serious reportable events, just happened to be the same year that Weill Cornell's sentinel event count dropped to zero?

What organizational system-level changes have occurred to prevent the recurrence of adverse outcomes?
As we've discussed in other S&S patient safety blog posts, most adverse events are not the result of freak accidents or individual fault - they are usually the end result of a chain of chronic, repeatable, low-consequence deficiencies. The Weill Cornell program included 20 changes ranging from 'labor and delivery team training' to 'Internet-based required reading assignments and testing,' but included no data that measured understanding, use, or effectiveness of any of these changes. Proactive, statistically rigorous approaches like failure modes and effects analysis and root cause analysis - none of which were performed here - would have helped determine the relevance, reliability, sustainability, and cost-effectiveness of the safety interventions.

Were there other events or changes during this time period, aside from implementation of the patient safety program, which could have contributed to the drop in compensation payments and number of reported sentinel events?
Although the authors imply that implementation of the obstetric patient safety program was the sole driver for the drastic reduction in legal costs and adverse events, there are other contributing factors and possibilities as well. Hypothetically, an aggressive legal defense strategy and a professional culture that discourages reporting could have yielded the same results. Correlation does not imply causation.

The article focused on reducing economic losses and lawsuits as a result of catastrophic events, such as infant brain damage. A comprehensive analysis of total liability claims and costs, including cases in which a patient does not die yet still experiences significant harm, may have yielded different results. As discussed in a previous S&S blog post, the open disclosure-with-offer program at the University of Michigan (full citation: Kachalia A, Kaufman S, Boothman JD, et al. Liability claims and costs before and after implementation of a medical error disclosure program.Ann Int Med 2010; 153:213-21) demonstrated compensation payment reduction without compromising ethics, transparency, or safety culture.

The Weill Cornell article is not without merit, and the authors and the institution are to be commended for what was clearly an enormous commitment of time, energy, and money to the obstetric patient safety program during the study period. Hopefully, future continuous improvement cycles will sustain these early results, spur the gathering of additional measures, lead to more refined data analysis, and ultimately yield clear and convincing patient safety outcomes.

[Editor's note: As is typical when pertaining to a pointed Letter to the Editor, AJOG has also published the Weill Cornell study authors' responses to Dr. Pil's and her colleagues' letter, including their dismissal of the concern over the Weill Cornell cesarean section rate. To read the full response, go here.]

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