AOB and Patient Safety

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AST Whitepaper Series™
AirStrip OB™ and Patient Safety

Background
Until now, there had been no compelling evidence demonstrating the neonatal benefit of electronic fetal monitoring (EFM). It had been the medicolegal climate in the United States that required obstetricians to integrate continuous intrapartum surveillance into their care of the laboring patient.1 But at the February 2011 Society for Maternal Fetal Medicine Annual Meeting in San Francisco, Dr. Suneet Chauhan and his colleagues presented research concluding that EFM resulted in a 53% reduction in neonatal mortality based on a sample of 1,945,789 singleton infant birth and death records from the 2004 National Birth Cohort. 2 At least 85% of the live births in the United States are assessed with continuous cardiotocography (CTG), making it the most commonly performed obstetric procedure. 3 A full description of a cardiotocograph requires a qualitative and quantitative description of uterine contractions, baseline fetal heart rate, baseline CTG variability, presence of accelerations, periodic or episodic decelerations, and changes or trends of CTG patterns over time. 4 According to the National Institute of Child Health Development (NICHD), visual assessment of these data is a key requirement for accurate interpretation. 5

Use of Cardiotocography
ACOG and NICHD have promulgated definitions that assist hospitals in encouraging meaningful communication between caregivers with respect to CTG patterns, uterine activity, variability, and designations of elective versus emergency interventions. In 2008 “reassuring and non-reassuring” were abandoned in favor of the NICHD 3 tier terminology system, which includes Normal (Category I), Abnormal (Category III) and Indeterminate (Category II).4 In terms of medical management, with Category I expectant management is acceptable; Category III patterns are abnormal and demand successful correction or delivery; with Category II (indeterminate or equivocal) patterns, providers may continue to observe if there is moderate FHR variability and/or accelerations, spontaneous or induced. It remains unclear how to manage equivocal patterns with decreased variability and absence of accelerations. 4

Mitigating Workflow Risk
If CTG is to be used, then from both a risk management and patient safety perspective it may be most beneficial to mother and fetus if providers spent their time assessing the patient during Category 2 and Category 3 CTG patterns since those periods are the most likely to require intervention. There are several realities that make it difficult for this to occur. First, the demands of workflow may require a provider to be away from the patient's bedside because they must be mobile to cover multiple patients within the LDRP unit/units. For example, there are times providers are stuck in a lengthy C-Section, repairing a perineal laceration, triaging a complicated situation, managing a shoulder dystocia, admitting an emergency, or commuting to the hospital.

© 2010 Airstrip Technologies, LP Last Update: March 11, 2011

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AST Whitepaper Series™
Next, in labor and delivery many team members are involved in the care of each patient. The delivering attending, the resident, the registered nurse, the charge nurse, the OB anesthesiologist, the antenatal provider, the neonatologist - all may need to be looped into the clinical decision making process. Depending on the care model, provider availability, and duration of labor, handoffs may also be necessary. Additionally, disagreements among team members can and will occur. Best practices in teamwork have taught us to engage in clear communication and to have a chain of command procedure in effect that allows for the timely escalation of any issues, so that providers may quickly agree upon a clinically sound plan of care in the best interest of mother and fetus. Finally, at the patient's bedside, visual assessment is a fairly passive activity in that there is no way to substantiate when providers actually view and interpret CTG data unless they login to the perinatal information system on a computer somewhere to see the waveform, or make an entry regarding their evaluation of the pattern noted in the patient's medical record. This makes it difficult to know the precise moment(s) when the strips are being visually assessed. All of these factors can be readily accommodated with mobile patient monitoring technology.

Mobile Patient Monitoring
AirStrip OB™ is a remote mobile patient monitoring technology that affords providers anytime, anywhere secure access to real-time, medical waveform data via their own smart phone over even the slowest cell phone networks to support the timely visual assessment needed to inform the clinical decision making process in an efficient fashion. With AirStrip OB, it is possible to automate proof of strip review via an authorized device. Hence, it is possible to know which data were viewed, by whom, and when. Without AirStrip OB™, providers may access this information from the patient’s bedside or, in some cases a desktop or personal computer, but too frequently providers rely upon the visual assessment of a coworker. Unfortunately, providers are not always at the bedside, nor are they sitting in front of a computer, nor is there certainty regarding the accuracy of the assessment of another. Prior to AirStrip OB™, there were delays in collaborative multidisciplinary assessment of patient data and medical management. There was no way to escalate differences of opinion via the established chain of command, and teamwork breakdowns and patient safety issued ensued. With AirStrip OB, when nurses identify a concerning CTG pattern, they notify midwives and/or physicians who can immediately view the CTG pattern on their smartphone and can discuss the treatment plan in a time sensitive fashion. Disagreements can be escalated up the chain of command immediately, regardless of the location of the providers involved. Any hospital providing an obstetric service should have the capability of responding to an obstetric emergency. No data correlate the timing of intervention with outcome, and there is little likelihood that any will be obtained. However, in general, the consensus has been that hospitals should have the capability of beginning a cesarean delivery within 30 minutes of the decision to operate. In the retrospective analysis of a malpractice case, most experts allow the caregivers about a 2–3 minute window once the prolonged deceleration starts to decide that indeed it is not going to come back to
© 2010 Airstrip Technologies, LP Last Update: March 11, 2011 2 AirStrip OB™ and Patient Safety

AST Whitepaper Series™
baseline and needs emergency intervention. The clock starts at that point. The communication efficiency gained through the use of AirStrip OB™ can reduce decision to incision time and is currently being studied at several hospitals.

Supporting Data
The data show that patient safety issues arise from the way providers are currently assessing, interpreting, and intervening with laboring patients. AirStrip OB™ is designed to help overcome the most frequently observed problems. HCA studied a total of 189 perinatal claims that were closed during the calendar years 2000 to 2005. The total value of all claims was $168 million. Seventy percent of all obstetric claims involved substandard care that was causally related to the injury. These cases accounted for 79% of all costs associated with the 189 claims. Thirty four percent of all cases involved fetal monitoring in non–vaginal birth after cesarean (VBAC) patients and represented 53% of the total losses. Substandard care was noted in 94% of the non-VBAC fetal monitoring cases. In each of these cases, delayed physician evaluation of a nonreassuring fetal heart rate tracing and delayed delivery was the primary issue associated with the adverse outcome and resulting litigation. 6 Similar studies have been conducted within other health systems. At Wayne State University, failure to monitor the fetus in accordance with the accepted clinical pathway was the most frequent departure from compliance with OB clinical pathways and resulted in a nearly six-fold increase in the odds of a malpractice claim. 7 Among Harvard hospitals, failure to or delay in diagnosis and treatment of fetal distress was a factor in up to 31% of obstetrical medical malpractice cases, a problem rooted in clinical judgment failures involving selection and management of therapy in labor and delivery, and failure to note and act upon relevant findings. Misinterpretation of fetal monitoring data was a factor in 20% of meritorious cases, and most frequently involved clinical judgment failures involving lack of or inadequate assessment and patient monitoring. 8, 9, 10 Similar findings have been noted by others 11, 12, 13, 14, 15 such that the Joint Commission has called upon hospitals and providers to improve perinatal safety 16, and the use of standards has been recommended.6, 17 A recent RAND study showed a highly significant correlation between the frequency of adverse events and malpractice claims: On average, a decrease of 10 adverse events in a given year would also see a decrease of 3.7 malpractice claims. Likewise, an increase of 10 adverse events in a given year would also see, on average, an increase of 3.7 malpractice claims. According to the statistical analysis, nearly threefourths of the variation in annual malpractice claims could be accounted for by the changes in patient safety outcomes. This correlation held true when they conducted similar analyses for medical specialties—specifically, surgeons, nonsurgical physicians, and obstetrician/gynecologists (OB-GYNs). Nearly two-thirds of the variation in malpractice claiming against physicians can be explained by changes in safety. The association is weaker for OB-GYNs, but still significant. RAND researchers used a malpractice database of 27,244 claims based on alleged events that occurred during 2001–2005 as well as 365,834 patient safety events observed during the same interval. 18 Patient safety improvements work.

© 2010 Airstrip Technologies, LP Last Update: March 11, 2011

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Documentation serves as the lynchpin of defensibility in obstetrical medical malpractice cases. Through documentation, providers communicate their observations, decisions, actions and outcomes of these actions for patients. To support patient safety, documentation must be an accurate account of what occurred and when it occurred. Yet, insufficient, missing or conflicting documentation in the medical record is too frequent an occurrence, and can make the effective defense of a medical malpractice case nearly impossible. 19 A care team is only as strong as its weakest member. Cross-monitoring of clinical events by professional colleagues helps to assure sure that A) signs of clinical deterioration in health status are recognized and addressed in a timely fashion by even the most inexperienced members of a care team; B) members of the care team are sharing their concerns with each other about their patient so that problems can be addressed before they become critical; and C) any fear, embarrassment, or reluctance in asking for help is diminished.8

Effective Use of Technology
AirStrip OB™ is being used effectively to improve patient care at hundreds of hospitals nationwide in four simple ways: 1. Providers use their own device to login to the hospital network and view waveform and other clinical data for their assigned patients when called upon by nursing or other clinical staff to do so in order to make a visual interpretation and render an opinion on patient management. 2. Providers may also use AirStrip OB™ to login to the hospital network and view waveform and other clinical data for their assigned patients proactively; if that is something they choose to do. It is not expected that delivering providers will use their device to provide continuous surveillance. 3. Providers use AirStrip OB™ to facilitate timely remote consultation for non-stress test patients, to provide access to specialty consultation, to help make more timely admission/discharge decisions, to expedite decision-to-incision timelines, to enable self-service by delivering clinicians to check the routine status of their laboring patients rather than relying on inconvenient telephone calls to the nurse, and to reassure patients when clinicians must be away from the bedside temporarily. 4. AirStrip OB™ is also used to support visual assessment that may be needed for chain of command procedures when providers disagree with one another on patient assessments or treatment plans. AirStrip OB™ automates proof of visual assessment, allows for earlier collaboration among providers, and provides a way for all team members to react and respond to critical data visually, so that providers may quickly agree upon a clinically sound plan of care in the best interest of the mother and fetus.
For questions related to this document, feel free to contact: Nancy Hudecek RN, BSN, MS Senior Vice President, Clinical Research and Effectiveness AirStrip Technologies [email protected]

© 2010 Airstrip Technologies, LP Last Update: March 11, 2011

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References
1

Alfirevic Z, Devane D, Gyte GM, et al. Continuous tocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labor. Cochrane Database Syst Rev. 2006;3:CD006066.

Society for Maternal-Fetal Medicine (2011, February 14). Electronic fetal heart rate monitoring greatly reduces infant mortality, study finds. ScienceDaily. Retrieved March 11, 2011, from http://www.sciencedaily.com/releases/2011/02/110212094609.htm
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Martin JA, Hamilton BE, Sutton PD, et al. Births: final data for 2002. Natl Vital Stat Rep.2003;52(10):1-113.

Robinson, B., Nelson, L. A Review of the Proceedings from the 2008 NICHD Workshop on Standardized Nomenclature for Cardiotocography. Update on Definitions, Interpretative Systems With Management Strategies, and Research Priorities in Relation to Intrapartum Electronic Fetal Monitoring. Rev Obstet Gynecol. 2008;1(4):186192. 2008 MedReviews®, LLC. Macones GA, Hankins GD, Spong CY, et al. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008;112:661-666. Clark, S., Belfort, M., Dildy, G., Meyers, J. 2008. Reducing Obstetric Litigation Though Alterations in Practice Patterns. American Journal of Obstetrics and Gynecology Vol. 112, No. 6, December 2008. pp 1279-83. Ransom, S., Studdert, D., Dombrowski, M., Mello, M., Brennan, T. Reduced Medicolegal Risk by Compliance With Obstetric Clinical Pathways: A Case–Control Study American Journal of Obstetrics and Gynecology VOL. 101, NO. 4, APRIL 2003. Groff, H. Understanding CRICO's Perinatal Claims. FORUM. March 2001. Volume 21. No. 1. Pp. 1-3. Gardner, R. Obstetrics-related Claims. FORUM. February 2006. Volume 24. No. 1. Pp. 10-11; 18.

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Lavalley, D., Hoffman, J. Obstetrics-related Claims 1997-2007. FORUM. September 2007. Volume 25. No. 3. Pp. 2-5.
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PIAA Claim Trend Analysis. 2004. Physician Insurers Association of America.

Chandra, A. Nundy, S., Seabury, S. The Growth Of Physician Medical Malpractice Payments: Evidence From The National Practitioner Data Bank Health Affairs Web Exclusive, May 31, 2005. American College of Obstetricians and Gynecologists. Preserving patient access to women’s health care: the facts and figures behind the liability crisis. 2004. National Practitioner Data Bank 2005 Annual Report. U.S. Department of Health and Human Services Health Resources and Services Administration. Bureau of Health Professions Practitioner Data Banks Branch White AA, Pichert JW, Bledsoe SH, Irwin C, Entman SS. Cause and effect analysis of closed claims in obstetrics and gynecology. Obstet Gynecol. 2005;105(5 Pt 1):1031-1038. More than one-third of OB adverse events were associated with communication problems.
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JCAHO. Preventing infant death and injury during delivery. Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Sentinel Event Alert, Issue 30, July 21, 2004.
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Simpson KR, Knox GE. Common areas of litigation related to care during labor and birth: Recommendations to promote patient safety and decrease risk exposure. J Perinat Neonat Nurs. 2003;17:110-125.

18

Greenberg, M., Haviland, A., Ashwood, J., Main, R. 2010. Is Better Patient Safety Associated with Less Malpractice Activity? Evidence from California. Rand Institute for Clinical Justice. Available online at http://www.rand.org/pubs/technical_reports/TR824/ Brennan T., Mello, M., Patient Safety and Medical Malpractice: A Case Study. Quality Grand Rounds. Ann Intern Med. 2003;139:267-273.
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© 2010 Airstrip Technologies, LP Last Update: March 11, 2011

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