The issue of the decision to incision, or decision to delivery interval (DDI), is perhaps one of the most misunderstood and challenging issues faced by obstetric teams today and certainly one that arises in many medical malpractice cases in obstetrics. There are primarily 2 issues that make this topic so problematic and so difficult to address. The first is the difference between organizational standards and the legal standard of care; the second is the lack of empirical evidence on what is best practice coupled with the variety of factors that can affect DDI. This column provides a brief overview of both issues and some risk management strategies for obstetric teams confronted with the challenges of DDI in today's highly litigious society.

All healthcare organizations, hospitals, and obstetric teams recognize the significance of time related to intrapartum emergencies, and many institutions have created specific designations regarding the timing of cesarean deliveries during labor, often using terms such as "urgent" versus "emergent" versus "scheduled" or categories that are somehow related to the relative urgency of the scenario. These designations range from vague (what is the real difference between urgent and emergent?) to very specific (within 15 minutes, within 30 minutes, etc), and all are the results of the good intentions of very dedicated healthcare professionals to promote patient safety and effect a rapid response to changing intrapartum conditions, including the deterioration of fetal heart rate tracings. Problems arise when, following a poor neonatal outcome and the onset of malpractice litigation, it comes to light that these institutional standards were not met.

The actual legal standard of care in medical malpractice cases is a standard based entirely upon the reasonableness of the actions and responses of the obstetric team, but the reality is such that institutional rules and standards will be cited and relied upon by all parties. The problem with addressing legal standard of care in DDI is that what is reasonable for one patient in one institution may be different from what is reasonable in another patient in another setting. And at the crux of the matter is one overriding issue, that of the 30-minute rule, the concept that the irrefutable legal standard for DDI is 30 minutes or less. The origin of this "rule" may well have been the original guidelines on perinatal care, but regardless of origin, this myth is so firmly entrenched in the collective consciousness of obstetrics, it has become gospel. As Nageotte so aptly points out, "The fact remains that the 30-minute rule is the current standard."1^(p177) This remains true even with little empirical evidence to support any one fixed number of minutes for DDI.2

Unfortunately, for both clinicians and the families they serve, this adherence to an absolute time frame is not only unrealistic but also unreasonable, which actually puts it in conflict with the legal concept of standard of care. There are so many factors influencing just the incision to delivery interval (IDI) alone (previous cesarean delivery, body mass index [BMI], neonatal birth weight),3 making setting a hard and fast rule on DDI at best challenging and at perhaps at worst unrealistic. Obesity alone is such an issue with IDI; it proves the need for a more rational approach. Pulman et al4 found that BMI affected both IDI and composite neonatal morbidity, with the average time from skin incision to delivery ranging from 9.4 minutes in women with a BMI of less than 30 to 16 minutes for women whose BMI was 50 or higher. In addition, the quality of informed consent discussions related to cesarean or operative delivery for fetal indications can be a problem, as time is of the essence in such situations.5

The ability of most institutions to meet the 30-minute rule has been shown to be a problem as well. In one study, initial data revealed only 25% adherence to the rule for cesarean deliveries performed for fetal indications during labor, prompting a quality improvement process. Following the process, the standard was met 65% of the time, with an average DDI of 27 minutes.6 Such a dramatic and significant improvement is laudable, yet the outcomes following process improvements show the likely implausibility of attaining delivery within the 30-minute window in each and every situation.

Given the number of problems and challenges clinicians face, and the lack of evidence available for setting an absolute one-size-fits-all rule, what are the best risk management strategies? Here are the author's opinions:

1. Recognize that the 30-minute rule, as unreasonable as it may be, is likely here to stay. This recognition should prompt vigorous quality improvement programs, a number of which have already been published and shown to be successful, and can serve as models.

2. Ensure that providers manage patient and family expectations. Midwives and physicians could have informed consent discussions regarding emergency cesarean or operative delivery during the antepartum period, when there is time for adequate discussion of risks, benefits, and future implications. Documentation of such antepartum discussions could streamline the intrapartum process when time really is of the essence.

3. Change institutional guidelines for DDI related to cesarean delivery to something more reasonable, such as "as quickly and efficiently as is safely possible." Then educate all clinicians on the importance of both speed and safety. Ensure clinicians are able to articulate why greater than 30 minutes was reasonable in those cases where factors such as a high BMI may have contributed to a longer DDI.

4. Consider tracking and analysis of each and every DDI as a routine part of quality assurance. When recurrent delays are seen with individual providers or certain team members, provide one-to-one counseling to determine improvement plans.

These suggestions will not stop allegations related to the 30-minute rule from occurring in obstetric malpractice cases, nor are there any proven methods to avoid litigation when unanticipated outcomes occur in perinatal care. However, clinicians who can and keep going reasonably, and can articulate such thought and action in the defense of their care, will find the entire process of litigation easier. And providing attention and review to each and every cesarean or operative delivery will allow clinicians to improve and streamline emergency processes, resulting in care that is both safe and effective.

-Lisa A. Miller, CNM, JD

Founder

Perinatal Risk Management and Education Services

Portland, Oregon

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