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One standard by which obstetrical practice is measured is the ability to achieve a time line of ≤30 minutes from decision for surgery to time of surgical incision for women in labor for whom a cesarean delivery is indicated due to fetal intolerance to labor. We reviewed our institution's performance regarding this standard and identified an initial rate of 25% of cases actually meeting this standard. Using a program of continuous quality improvement, various systematic and individual barriers were identified and overcome resulting in a significant change in performance. This is a report of the various processes and identified areas of challenge encountered to improve on the ability to achieve this important standard of care.
For better or worse, one of the benchmarks for the quality of care provided in obstetrics is the so-called “30-minute rule.” This rule specifically relates to the allowable time from surgical decision for delivery to surgical incision in cases in which delivery is indicated for fetal intolerance to labor. Supported by many national organizations including the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Royal College of Obstetricians and Gynecologists, clear establishment of the value, biological plausibility, and clinical achievability of this commonly referenced legal standard has remained elusive as reported.
Despite these factors and daunting clinical challenges, every modern obstetrical care unit is held to this standard and, when associated with adverse perinatal outcome, it has become a benchmark for adequacy of obstetric care in the medical-legal arena.
In an effort to assess the ability to achieve this 30-minute standard in such indicated cases at our institution, a continuous performance improvement project was initiated. The hospital is a level III community health care center with >5500 births annually to both private and public patients. The hospital has a medical staff of some 40 board-certified obstetrical and gynecological practitioners and is closely affiliated with an academic teaching institution. Medical students, residents, and fellows in obstetrics and gynecology are in attendance at the hospital as part of their academic training and work closely with the clinicians in providing care to all the patients. There are designated obstetrical anesthesiologists and maternal-fetal medicine subspecialists in the labor and delivery unit at all times. Over a 3-year period we initially reviewed and then prospectively tracked our performance and implemented various changes in practice in an effort to measure and attempt improvement in our achievement of this 30-minute standard. These interdisciplinary efforts included the participation of all caregivers, a prospective collection of data for all cesarean births arising from laboring patients, and an attempt to identify medical, physician, nursing, space, logistical, and patient-related barriers and delays. Specific endpoints including indication for surgery, time line, surgeon, nurse, and anesthesiologist were collected and shared among all caregivers. In addition, discussion of the process on several occasions with the medical and nursing staff occurred and recommendations for change received consensus. Institutional review board approval was obtained as part of a data analysis study and performance improvement project. This is a report on that effort and its outcomes.
Materials and methods
We initially obtained data for a 6-month period of time for cesarean births arising from the labor and delivery unit for all indications (phase I). In this group there were 68 women delivered specifically for fetal indications of intolerance to labor related to concerning fetal heart rate monitoring. For these patients with fetal intolerance to labor, the time from clinical decision to surgical incision occurred in ≤30 minutes in only 17 (25%) of the cases. We shared this surprising finding with our physicians and nurses and held an instructional conference on this obstetrical standard and the various challenges identified in meeting the standard. Then for a 6-month period, data were prospectively collected on all cesarean births in laboring patients with open dialogue between nurses and physicians on each case regarding indications and time lines (phase II). A worksheet was completed and collected on all cases with both the physician and nurse signatures. During this time, efforts were made to have a second operating room made available for cases of emergency arising in laboring patients. Ongoing education with emphasis on the importance of achieving the standard of ≤30 minutes occurred. The third phase of this project occurred following the specific implementation of a new work flow for our center including specific changes. The new work flow simplified communication and emphasized teamwork to promptly transport the patient to the operating room where preoperative preparations were completed. Two anesthesiologists were made available at all times as well as 2 operating rooms designated specifically for cesarean deliveries arising from the labor and delivery unit. Following another 6 months of data collection, without acceptable progress, we elected to intensify data collection and reporting. We began tracking the time from decision to transport to the operating room in addition to decision to incision time and began posting monthly results in the physician and nurses lounges (phase IV). We graphically displayed progress and listed all cases with a fetal indication that met the 30-minute standard, including the names of the obstetrician, nurse, and anesthesiologist, and time required from decision to transport and decision to incision. For cases with a decision to incision time >30 minutes, the cases were listed along with the reasons for delay, but the medical personnel were not identified. In addition, every physician and nurse received a monthly summary electronically that included the posted information. For cases not meeting the 30-minute standard, each responsible obstetrician and nurse received individual notification along with reinforcement of the work flow and suggestions for improvement. The final phase of this process involved the institution of a “code green” identifier for cesarean deliveries with a fetal indication (phase V). Specifically, when a case of fetal intolerance to labor requiring cesarean birth occurred, an overhead announcement in the labor and delivery unit of “code green” with room identification was made. This provided for immediate attention and prioritization of the case, rapid communication with anesthesia and operating room staff, and the arrival of additional nursing personnel to transport the patient. The expectation was reinforced that the physician would remain with the patient and assist the nurses in facilitating transport to the operating room within 5 minutes of the decision for cesarean delivery. In the months following the implementation of the code green process, monthly tracking and posting of outcomes continued and ongoing reinforcement, clarification, and feedback was provided to physician and nursing staff based on daily review of individual cases. At the time of the decision for cesarean delivery, emphasis was placed on deliberate communication between the physician and nurse regarding the indication and the expected time line.
As noted, the initial data suggested a performance of only 25% for such cases with an average time for decision to incision of 39 minutes and this was agreed to be unacceptable (phase I). Several problem areas were suspected including those specific to physician availability (both obstetrics and anesthesia); availability of a surgical suite; patient-specific issues such as admission procedures; preparation for surgery (eg, laboratory test results, intravenous lines, Foley catheter, compression stockings, consents); and nursing support. Following the educational effort and discussion of these various areas of concern, agreement was reached with the hospital to have a second designated operating room and nursing reorganized to be available for emergencies arising from labor and delivery. In this phase of performance improvement (phase II), the initiation of data collection was announced to all caregivers with the hope that there would be a significant change in performance. Over the next 6-month period of time, the 30-minute standard was achieved in only 45% of cases with a fetal indication for delivery with the average time from decision to incision being 37 minutes (Figure). Despite the availability of a second operating room, the results in this second phase of performance improvement were not considered to be acceptable.
Several meetings with anesthesia, operating room staff, and labor and delivery nursing staff were held to address these findings and to develop and implement a new work flow that streamlined communication and delineated the roles and responsibilities of all team members (phase III). In addition, a second anesthesiologist was made available at all times for obstetrical patients and the second operating room was fully staffed with nursing personnel. There were several issues that required attention including physician response time, willingness to initiate surgery without an assistant, availability and the placement of conduction anesthesia when indicated, access to laboratory results, and in all cases appreciation for the urgency of moving the patient to the surgical area. It was decided that the nurse and physician would attempt to move the patient within 5-10 minutes and not delay for reasons of consenting, placement of intravenous lines, Foley catheter, or compression devices but to accomplish these preparations in the operating room. The physician would immediately meet the patient in the operating room and not await communication from the nurse. Following these changes achievement of the standard rose to 56% with the average time from decision to incision decreased to 33 minutes. However, this too was considered unacceptable. Monthly communication with all physicians and nurses was accomplished and every case was shared in a spreadsheet format listing the surgeon, anesthesiologist, nursing personnel, and time line for cases achieving the standard (phase IV). Cases not achieving the standard were also listed with reason for delay, but without the physician or nurse names. However, each of these caregivers was individually contacted with the specific case in which they were involved and the standard was not met. The standard was met in 65% of the cases identified as fetal intolerance to labor and the average time from decision to incision was 27 minutes. It was also determined that for cases in which the time from decision to moving the patient to the operating room was <10 minutes, the standard was reached in almost every case. While this was considered an improvement and this finding appeared to be clinically significant, further revision of process and systems was agreed to be necessary. It should be added that during this period of performance improvement, a subanalysis of all cases of sudden fetal compromise (including cases of umbilical cord prolapse, abruptio placenta, placenta previa with acute hemorrhage, and uterine rupture) revealed that surgical birth was accomplished in a rapid fashion well within the 30-minute standard.
A code green was then initiated in an effort to highlight the importance of prioritizing these cases and making every effort to move the patient as soon as possible to the operating room even without a signed consent, Foley catheter, intravenous line, sequential compression devices, or anesthesia evaluation (phase V). Anesthesia met the patient in the operating room and addressed their specific needs in preparation for surgery. Surgery commenced as soon as all parties were in attendance and the case could be started without an assistant if so elected by the operating surgeon. This change resulted in a significant further improvement in the frequency of such cases achieving the standard of ≤30 minutes from decision to incision. Over 90% of cases met the standard with a mean time of <25 minutes and 100% of cases initiated within 40 minutes.
The ability to achieve the standard of ≤30 minutes from decision to incision for all cases of fetal intolerance to labor is very challenging. Even in a busy unit staffed continuously with 2 anesthesiologists, a maternal-fetal medicine subspecialist, and an obstetrical resident, meeting this standard appears to be a daunting task. In fact, most obstetrical units in this country do not have such professional or logistical resources. While cases of acute fetal compromise were delivered in a very rapid manner immediately following the identified emergency, the more common cases of fetal intolerance to labor as the indication for surgical birth were commonly not delivered within the established time standard. Specific areas identified that facilitated improvement in achieving this goal included the need for complete physician and nursing participation and understanding of the standard and its importance. Changes needed to be made in the logistics of getting a patient to the surgical suite from the labor room with reassignment of nursing responsibilities of critical importance. Patient-specific barriers included the admission processes, obtaining an informed consent, family and support dynamics, the actual preparation for surgery, and adequacy of anesthesia for cesarean birth. Additional issues included patient habitus often posing a challenge to anesthesia, particularly in an emergent situation. Most importantly, moving the patient to the operating room within 5-10 minutes of the decision for surgery appears to be a critical factor in achieving this standard. With intensive effort and continual reinforcement of expected process, we were able to achieve a significant improvement in our cesarean birth efficiency, but having this occur in all cases at all times is likely a standard that will never be achieved. Others have similarly reported difficulty in approaching this goal.
There are too many variables that cannot be controlled in any systematic fashion. One of the most obvious variables that needs emphasis as a limitation of the applicability of these factors to the individual patient or hospital is the broad spectrum of fetal heart rate abnormalities included in the diagnosis of fetal intolerance to labor. The diagnosis was entirely the responsibility of the managing physician and there is a great degree of variability among clinicians in their tolerance of different fetal heart rate patterns in labor. This should not, however, detract from the importance of assessing the hospital performance and making efforts to achieve meaningful improvement in achieving this standard of 30 minutes. Indeed, such efforts could be applied to all cesarean births arising from laboring women to mitigate the risk for fetal or maternal deterioration while preparing for and awaiting surgery.
It is of interest to note that this national obstetrical standard does not have a robust amount of evidence-based support. While it is certainly biologically plausible that efforts to limit the amount of time a fetus is suffering true acute stress should result in improved outcomes, studies have actually demonstrated worse outcomes among patients with the shortest of time intervals or longer delivery interval not necessarily correlating with an adverse perinatal outcome.
Perhaps some clinical circumstances inevitably have a compromised outcome regardless of the length of time of the apparent distress. In a recent report, it was suggested that the deterioration of cord arterial pH correlates with the interval from onset of fetal heart rate bradycardia to delivery when the cause of the fetal bradycardia is irreversible but not when it is reversible.
Potentially reversible causes of distress were iatrogenic uterine hyperstimulation, hypotension after epidural anesthesia, aortocaval compression and after external cephalic version without abruption. Irreversible conditions included placental abruption, cord prolapse, uterine rupture, preeclampsia, and failed instrumental delivery. Further investigation of this issue is certainly warranted as is consideration by our obstetric leadership of both the achievability and medical value of this current national standard of care.
In summary, it would appear that the standard of a 30-minute rule from surgical decision to incision for cases of fetal intolerance to labor remains and is not effected by hospital location, size, delivery volume, physician and nursing staff resources, operating room availability, patient-specific issues, or other concerns and it is a standard to which all hospitals providing obstetrical services are held. While circumstances will vary in every clinical setting and unavoidable events occur making it at times not possible to achieve this standard, it is important for all obstetrical caregivers to be aware of the standard and the challenges in achieving it. Consequently, every effort should be made to improve the ability of each labor and delivery unit to reach this goal. We suggest that this can only occur with continuous collaboration of all caregivers, ongoing data collection and analysis, peer review, and a willingness to change systems to achieve the critical goal of providing quality care and safety for all of our patients.
American College of Obstetricians and Gynecologists Committee on Professional Standards for Obstetric-Gynecologic Services