Keys to minimizing liability in obstetrics

By Gary Ventolini, MD, Christopher S. Croom, MD, and William W. Hurd, MD

Practicing obstetrics today requires not only the latest clinical knowledge but also people-management skills that can help minimize perinatal and maternal risk and reduce your legal exposure.

Claims of medical malpractice are all too frequent in the practice of obstetrics. Even when unfounded, they have a significant psychologic and emotional impact on clinicians. According to the American College of Obstetricians and Gynecologists, 76.5% of ACOG fellows have been sued at least once, while 25% of them will be sued four or more times.¹ In a survey of United States hospitals, more than 75% had experienced at least one obstetrical malpractice suit in the past 12 years.²

Despite our best efforts at providing excellent care, poor obstetric outcome is a risk that we deal with on a daily basis. Although only one in six patient injuries results in legal actions, the presence or absence of a medical mistake is not the deciding factor in which cases result in malpractice claims.^1,2 Some insightful obstetricians and obstetrical units have developed deliberate strategies that minimize the risk of both fetal injury and malpractice claims. Here we analyze common factors associated with malpractice claims and review strategies that appear to decrease both medical and legal risks.

Obstetric problems that commonly lead to claims

MMI Company, Inc., a risk management company and liability insurer, analyzed medical malpractice claims and documented perinatal injuries at 263 US hospitals over a 12-year period.^2-4 They found that the majority of claims and perinatal injury could be traced to five common recurrent problems:

1. failure to recognize and/or appropriately respond to antepartum/intrapartum fetal distress;

2. failure to perform a timely cesarean delivery (30 minutes from decision to incision) when indicated;

3. failure to appropriately resuscitate a depressed infant;

4. inappropriate use of oxytocin leading to uterine hyperstimulation, uterine rupture, and fetal distress and/or death; and

5. inappropriate use of forceps/vacuum leading to fetal trauma and/or preventable shoulder dystocia.

While these situations appear to be straightforward and easy to recognize, it may take a complex multifactorial strategy to avoid them.

Personal approaches to minimizing risk

As is well known, improving physician communication and patient education can decrease the risk of malpractice lawsuits.⁵ In an effort to better understand the behavior patterns that lower the risk of claims, several authors have analyzed the relationship between the number of claims and a physician's personal, educational, and practice characteristics.^6-8 The following is a summary of the common principles and skills, many of which may sound sophomoric but are too easily forgotten under the pressures of modern medical practice.

Optimize communication with patient, staff, and colleagues. Be kind to patients; kindness is the basis of caring. Patients are human beings who, for the most part, are thankful to be treated kindly. Be nice on the telephone; if you smile while you are talking, the receiving person will notice and it will be appreciated. Communicate with your patients. Good communication involves clear explanation of thoughts and clinical plans in a language that's in keeping with the listener's educational level. While communicating, make sure the patient understands what you are saying and always seize the opportunity to educate. Be compassionate, ask for questions, listen for a patient's concerns, and give her updates on the medical issues that affect her.

Recognize potentially litigious patients. According to Leaman and colleagues, there are four groups of people who need special attention and are the most likely to sue their physicians.⁹ Although no research has been reported to verify that these groups are in fact the most litigious, keeping them in mind might help you spot discontented patients:

1. unhappy patients, regardless of the cause of their unhappiness;

2. patients who are litigious by nature, as evidenced by have a pending lawsuit, threatening one, or talking about lawsuits. These individuals can be identified through the office intake questionnaire or references from former physicians. When feasible, refer them to a specialist with expertise in managing difficult patients.

3. patients whose immediate family members are not interested in listening to your explanations;

4. patients who do not understand their diagnosis, treatment, or treatment plan.

The last group is by far the largest. Despite the challenge, it remains your duty to make every possible effort to help a patient understand her condition and what, why, and how you plan to treat it. Documentation of all efforts is important.

Document appropriately. Legible documentation can often prevent an adverse outcome from progressing to a malpractice claim. Document your assessments and plans, especially when changing clinical course. If circumstances change, adjust the plan of management and document. You don't have to be right, but you have to be reasonable. The law requires that you get informed consent from your patients; only your lawyer requires you to document it. From a juror's perspective, if it is not written in the chart, it did not happen.

Retrospective additions to a patient's chart deserve special attention. All notes should be dated and timed. The initial concurrent documentation carries the most weight, since later additions are viewed as being self-serving. Later additions must be dated and timed to avoid the appearance of "altering the medical record." Missing or altered records destroy credibility and make malpractice claims more difficult to defend, regardless of whether there was negligence.

A final point about nonmedical information in medical charts: Write every note as if you were going to read it to your patient. In a court of law, you might have that opportunity. Avoid editorializing, derogatory comments, nonclinical commentary, and humor. The potential negative effect on a jury is obvious.

Manage conflict effectively. Several issues can create conflict between health-care providers and patients, including controversy related to a lack of data, medical uncertainty, and poor communication. It is important to effectively manage conflict, since conflict maximizes medicolegal risk.

Controversy will always exist in the practice of obstetrics. Much of what we accept as standard care is based purely on tradition, and much of this is driven by patient preference. Because of the unique "two-patient" nature of pregnancy, randomized, controlled trials are often difficult or impossible to conduct, even about the most controversial issues. Differences of opinion regarding strongly held beliefs are a setup for conflict.

When health-care providers disagree, they have an obligation to discuss and resolve the issue as soon as practical. It is imperative that this discussion does not occur in the presence of a patient. The tools for decreasing conflict and risk are excellent communication, clear guidelines, teamwork, consensus, and constructive—as opposed to destructive—criticism.

It is crucial to identify conflict between health-care providers quickly, before it becomes emotionally charged and increases in depth and seriousness. Address the conflict just as quickly, before any damage occurs and the misunderstanding spreads. Devise a process for conflict management that everyone involved can agree upon.

Know your limitations. We all appreciate how easy it is for routine cases to become complex quickly and without warning. Do not hesitate to seek consultation when you have a doubt, a question, or a concern about a problem or a series of events that do not make sense to you. If the patient or her family requests a second opinion, get one. The tremendous number of "new and improved" technologic advances available to physicians and our patients presents an ever-changing challenge. It is a company sales rep's job to convince you that a new instrument or procedure can be of great advantage to your patients. It is your responsibility to make sure that you received appropriate training and/or credentialing before using a new device or performing a new procedure. Ego and the quest for market advantage are never appropriate reasons to prematurely use new techniques. In the event of a complication, the first thing a plaintiff's attorney will want to know is your documented level of training and experience with the particular procedure.

Institutional approaches

Understanding and emulating the basic principles and corresponding characteristics that successful perinatal units use and have is an excellent approach to minimize both patient injury and medical malpractice claims. ACOG has detailed such principles, as proposed by Simpson, and corresponding unit characteristics described by Knox.^1,4,10

Keep the patient's safety as the first priority. Ideally an obstetric unit should:

• Generate patient safety reports at each change of nursing and physician shift.

• Be willing, when indicated for maternal or fetal problems, to transfer patients to facilities with more sophisticated resources (that is, Level III Units).

• Rehearse 30-minute "decision-to-incision" cesarean section drills.

• Have available a surgical suite, surgical and anesthesia personnel, and a neonatal resuscitation team 24 hours per day, 7 days per week.

Consider fetal well-being at all times. One of the primary purposes of labor and delivery is to prevent fetal and neonatal injury. One of the best ways to ensure fetal well-being is frequent documentation of a reassuring fetal heart rate tracing, including (when possible) a reactive non-stress test (NST). A reassuring FHR can be defined as the presence of substantial accelerations (15 beats increased from the base line, lasting 15 seconds) with appropriate variability and absence of decelerations.¹¹

A reassuring FHR tracing should be documented whenever a patient is observed with electronic fetal monitoring, and particularly before monitoring is discontinued or care is altered. Specific situations include, but are not limited to:

• maternal discharge from triage and/or the emergency room;

• administration of maternal medication during labor;

• maternal (epidural) conductive anesthesia;

• use of oxytocin augmentation;

• maternal procedures such as amniocentesis for fetal lung maturity, external cephalic version; and

• induction of labor with any indicated method.

Promote teamwork. The nurses and physicians in all areas of the obstetric unit, including triage, prenatal intensive care, labor and delivery, and postpartum, should work together to form a seamless continuum of care.

A physician's presence on the unit, when requested by a nurse, is mandatory. A labor and delivery nurse spends a great deal of time continuously assessing the patient. When she has a question or concern, or requires the presence of a physician, most of the time there is an important reason for that request.

Minimize intervention. Most pregnancies are normal and intervention creates the potential for iatrogenic injury. When a patient's labor is progressing properly, avoid the use of oxytocin. If the amniotic membranes are intact and there is no indication for artificial rupture of the membranes, postpone it or avoid it.

Adhere to ACOG guidelines and clinical protocols. In each phase of labor and delivery, there are well-defined pregnancy problems that lead to the majority of fetal and maternal injuries. To avoid malpractice claims, each obstetric unit should have standardized, well-defined treatment protocols that address these common problems to minimize injury and medical malpractice liability (Table 1).^12,13

Clinical protocols are valuable for helping you follow the standard of care and avoid potential injuries. Properly used, clinical protocols can avert problems by ensuring that routine observations are made and essential management steps are systemically taken. Many physicians see clinical protocols—which represent standard of care—as restricting the practice of medicine. However, they are empowered to deviatefrom the guidelines without fear of recrimination, as long as the justification is thoroughly documented.

The policies and procedures that govern personnel employed by hospital obstetric units should reflect the protocols used by the physicians working on labor and delivery. They should be reviewed and updated on a regular basis.

Treatment protocols for obstetric care

The following is a list of standard treatment protocols, organized by phase of obstetric care, that you should follow.

Document gestational age. An accurate estimation of gestational age (that is, "dates") is the single most important piece of information required for the management of any pregnancy. The majority of the prenatal assessments, interventions, and education are based on dates. Before considering elective delivery, reasonable certainty of fetal maturity (other than by last menstrual period) must be documented. Methods for documenting fetal maturity are:

• fetal heart tones recorded for at least 20 weeks by nonelectronic fetoscope or at least 30 weeks by Doppler;

• uterine size established by pelvic examination prior to 16 weeks' gestation;

• elapse of 36 weeks since a positive serum or urine HCG pregnancy test;

• ultrasound (U/S) measurement, based on the crown-rump length obtained between 6 and 12 weeks' gestation, supporting a gestational age of 39 weeks;

• U/S verification of gestational age obtained at 13 to 20 weeks' gestation confirms at least 39 weeks currently, as determined by clinical history and physical exam.¹³ If term gestation cannot be confirmed by the preceding criteria, amniotic fluid analysis must be used to provide evidence of fetal lung maturity.

Triage labor. Triage of patients who present to labor and delivery units is an extremely important process, where well thought-out protocols can minimize the risk of inadequately addressing important problems. Protocols should comprehensively address:

• thorough assessment and documentation of maternal and fetal well-being;

• criteria that accurately detect both preterm and term labor, with comprehensive treatment plans for both. Avoid discharging patients in active labor.

• other special high-risk situations, including premature rupture of membranes and group B streptococcus prophylaxis for premature delivery;

• when and how to transfer patients to facilities with a higher level of care¹³;

• verification before discharge that all complaints have been addressed to the patient's satisfaction, especially if they are repeated complaints.

Classify patients in labor by risk level. In the absence of a catastrophic event (abruption, sudden cord compression, cord prolapse), the vast majority of patients in labor are at low risk of developing fetal acidosis. A small group of patients can be prospectively identified who are at increased risk of complications based on the presence of known risk factors.¹⁵ A process for identifying high-risk laboring patients can be an effective way for efficiently assigning limited resources. Factors that place laboring patients in the high-risk category include¹⁵:

• preterm labor;

• multiple gestation;

• pregnancy complicated by proteinuria, diabetes, preeclampsia, chronic hypertension, or anemia

• previous cesarean delivery;

• abnormalities on U/S (decreased or increased amniotic fluid, intrauterine growth restriction, fetal anomalies);

• fetal presentation other than vertex;

• nonreactive NST;

• abnormal maternal vital signs;

• inadequate progress during labor.

Assess the fetus during labor. According to ACOG clinical guidelines, documentation of ongoing fetal assessment throughout labor is mandatory.¹⁴ In the US, the vast majority of patients in labor have continuous electronic fetal monitoring (EFM) for multiple reasons, including patient and physician preference, efficient utilization of nursing personnel, and medico-legal documentation. Intermittent auscultation is a reasonable alternative in selected low-risk patients.¹⁴ Unit protocols should spell out the criteria for selecting this approach, the method of performing and documenting it, and the indications for instituting EFM.

Monitor labor progress with cervical examination. Digital cervical examinations are necessary to determine how labor is progressing. Too infrequent examinations can delay recognition and treatment of inadequate progress. Alternatively, too frequent examinations increase the risk of infection. For low-risk patients, cervical checks should be done every 2 hours during labor, as long as the patient's labor progress follows the standard labor curve. For high-risk patients, or those not making adequate progress, cervical checks should be done every hour.

Use care with oxytocin. Use oxytocin judiciously and carefully for induction or augmentation of labor. Before starting oxytocin, obtain and document the patient's informed consent. Consider using a low-dose protocol for labor augmentation because high doses can lead to avoidable hyperstimulation and abnormal FHR tracings.¹⁴ Infuse oxytocin at 1 mU per hour and increase it by 1 mU every30 minutes. Be patient and avoid increasing the dosage too quickly, as it takes 30 to 40 minutesto reach a steady state with oxytocin. In many cases, the infusion rate can be reduced to a minimum efficacious dose required to maintain a satisfactory labor pattern. Remember, the physiologic limit is 14 mU per minute. Before administering oxytocin, evaluate and document:

• reactive NST;

• inadequate uterine contractions using Montevideo units criteria;

• vertex presentation;

• reasonable estimated fetal weight;

• adequate maternal pelvic dimensions; and

• assessment of pain control.

Special high-risk situations should be addressed, includingpremature labor, premature rupture of membranes, and group B streptococcus prophylaxis for premature delivery. Protocols delineating when to transfer patients to facilities with a higher level of care are extremely helpful for smaller units.¹⁴

Use caution with amniotomy. Artificial rupture of membranes should not be considered a standard part of normal labor. Rather, it should only be performed for specific indications, including^14-16:

• inability to monitor fetal heart tones adequately without a fetal scalp electrode;

• suspected meconium in the amniotic fluid;

• induction of labor with concomitant oxytocin augmentation.

The patient should be properly informed and documentation should be placed in the chart.

Perform amnioinfusion when indicated. Amnioinfusion is transfusion of isotonic fluid (normal saline or Ringer's lactate) into the amniotic cavity transcervically during labor. The standard technique is to infuse a 500 mL bolus followed by 100 mL/min. Indications for amnioinfusion include cord compression, as evidenced by moderate-to-severe variable decelerations; dilution of thick meconium in the amniotic fluid; and avoidance of cord compression in oligohydramnios. While performing amnioinfusion, verify that the fluid infused into the uterus is coming out and not accumulating. As with all intrapartum procedures, make sure the patient gives her informed consent and you document it in the chart.

Be prepared to perform intrauterine fetal resuscitation. Nonreassuring FHR patterns (tachycardia, bradycardia, and decelerations) are not unusual during labor. Although the sensitivity of nonreassuring FHR pattern is reasonable, the specificity is low. In other words, most infants with fetal acidosis will have a nonreassuring FHR pattern, but the majority of fetuses with nonreassuring patterns will not have fetal acidosis.¹¹ Whenever you observe a nonreassuring pattern, make efforts to optimize the fetal milieu, which is sometimes referred to as "intrauterine fetal resuscitation." In order of efficacy, the following measures have been shown to improve fetal oxygenation.^11,15

Provide IV hydration to increase placental perfusion and optimize fetal circulation. Strongly consider using isotonic IV fluids (normal saline), volume expanders such as hetastarch, or 5% albumin solution. Ringer's lactate is not as effective in increasing transplacental volume or fetal blood pressure.

Change the mother's position to help minimize cord compression. Place the patient on her side or in the Trendelenburg position.

Minimize uterine contractions to give the fetus an opportunity to obtain full blood flow from theplacenta without intermittent interruption. To do this, stop oxytocin infusion and administer terbutaline 0.125 mg IV or 0.250 mg subcutaneously.

Administer oxygen through a non-rebreathing mask at 4 L/min, but realize that it may take 15 to 20 minutes before fetal PO₂ increases.

Dislodge a fetal head compressed against the cervix to relieve variable decelerations.

Be prepared for operative delivery. When labor deviates markedly from the ideal labor curve, it's necessary to consider operative or cesarean delivery. Because delivery with forceps and vacuum extraction are common causes of malpractice claims, guidelines and strategies for use of these devices are an important part of a risk management program.

Forceps should only be used for documented indications, including any condition threatening the mother or fetus that is likely to be relieved by delivery. Maternal indications include congenital or active heart disease, acute pulmonary edema, intrapartum infection, and maternal exhaustion. Fetal indications include prolapse of the umbilical cord, placental abruption, and nonreassuring fetal well-being. Relative contraindications to operative delivery include fetal macrosomia, or a history of macrosomia; maternal pelvic deformity or android pelvis; maternal diabetes; history of difficult deliveries; shoulder dystocia; and failure of the fetus to descend in the second stage.¹⁵

Misapplication of forceps increases the risk of fetal injury. In cases of dystocia, fetal head molding can make accurate determination of position and station difficult. For this reason, palpation of the fetal ear is recommended as an accurate way to precisely determine both fetal head position and station. Palpation of the ear almost always guarantees that the station of the fetal heart is at +2. As a rule, forceps should not be used unless at least one fetal ear can be palpated by the examiner. In 1989, Bachman published a mnemonic device for forceps delivery—"ABCDEFGHIJ" checks to be accomplished before performing an instrumental delivery¹⁷:

Adequate anesthesia

Bladder empty

Cervix fully dilated

Determine fetal position (think dystocia)

Equipment check

Forceps ready, position for safety, posterior fontanelle presentation, sutures confirmation

Gentle traction

Handles in J curve

Incision assessment (episiotomy needed?)

Jaw visible, remove forceps

Vacuum extraction has become increasingly common in the US, in part because it takes less technical skill, fetal and maternal injury is less common, and the amount of force applied is limited to that of the applied vacuum.¹⁵ The disadvantages are the difficulty of performing fetal head rotations and the need for the patient's cooperation in pushing while the vacuum is applied. Indications for vacuum extraction are the same as for forceps.¹⁵ Despite the relative increase in safety of vacuum delivery compared to forceps, standard guidelines should be used. Limit vacuum use to three applications for no more than 20 minutes total application time. Forceps should rarely be used after vacuum failure. Ifvacuum extraction fails to resultin vaginal delivery, immediate cesarean delivery is obligatory.

Be prepared for obstetric complications. The obstetrician should not continue in a routine manner when an unusual complication occurs during labor or during the performance of a surgical procedure, such as cardiac arrhythmia while inducing anesthesia or failure of surgical equipment that cannot be replaced or repaired in a timely fashion. Make a conscious effort to stop and reevaluate the situation. Review the original surgical plan and if the procedure was elective, postpone it until you can confirm the patient's health status. Resist the very human tendency to overlook your own errors and consult with an appropriate colleague or specialist to quickly develop an objective and appropriate plan of action.^12,18

The patient's consent is not required for emergency treatment of a life-threatening situation. However, in the face of a major complication, a new course of action should be discussed with the patient, her spouse, or next of kin whenever possible. In addition, the entire physician team should agree on the treatment plan.

Conclusions

Preventing perinatal injury and minimizing legal exposure to malpractice is a large part of the art of modern obstetrics.

Nothing can substitute for up-to-date clinical knowledge and skills. However, understanding and adhering to the principles listed in the "Key points" box will help minimize both perinatal injury and the risk of obstetric malpractice claims.

REFERENCES

1. ACOG Committee Opinion #236. Coping with the stress of malpractice litigation. 2000 June.

2. MMI Companies, Inc. Claims database 1985-1986. http://www.mmicompanies.com and http://www.icongrouponline.com (see Health Publications section).

3. MMI Companies, Inc. Transforming insights into clinical practice improvements: a 12-year data summary resource. Deerfield, IL 1998. http://www.mmicompanies.com and http://www.icongrouponline.com (see Health Publications section).

4. Knox GE, Simpson KR, Garite TJ. High reliability perinatal visits: an approach to prevention of perinatal injury and medical malpractice claims. J Healthc Risk Manag. 1999;19:24:32.

5. Lester GW, Smith SG. Listening and talking to patients: a remedy for malpractice suits? West J Med. 1998;158:268-272.

6. Anderson EG. A new malpractice defense: common sense. Postgrad Med. 1996;100:29-30.

7. Flamm BL. Cesarean section guidelines for appropriate utilization. Springer-Verlag Publishers. 1995 New York.

8. Adamson TE, Baldwin DC Jr., Sheehan TJ, et al. Characteristics of surgeons with high and low malpractice claims rates. West J Med. 1997;166:37-44.

9. Leaman TL, Saxton JW. Life in medicine. Am Fam Physician. 1996 May: 25-27.

10. Simpson KR, Knox GE. Strategies for developing an evidence-based approach to perinatal care. Am J Maternal Child Nurs. 1999;24:122-131.

11. ACOG Committee Opinions #207. Fetal heart rate patterns: monitoring, interpretation and management. July 1995.

12. ACOG. Obstetric and gynecologic quality of care program. DOH. 2000.

13. ACOG. Standards for Obstetric-Gynecologic Services. 7th ed. 1989.

14. ACOG Practice Bulletin #10. Induction of labor. November 1999.

15. ACOG Practice Bulletin #17. Operative vaginal delivery. June 2000.

16. Chez BF, Harrey CJ, Murray ML. Critical Concepts in Fetal Heart Rate Monitoring. Baltimore, Md: Williams and Wilkins; 1990.

17. Bachman JW. Forceps delivery. J Fam Pract. 1989;29:360.

18. Rubsamer D. Health Law Update, 1996.

Dr. Ventolini is Director, Division of General Obstetrics and Gynecology, Wright State University School of Medicine; Dr. Croom is Assistant Professor, Diagnostic Ultrasound & Antenatal Services, Wright State University School of Medicine; and Dr. Hurd is N.J. Thompson Professor and Chair, Department of Obstetrics and Gynecology, Wright State University School of Medicine, Dayton, Ohio. The authors wish to acknowledge the contributions of John D. Hoffman, Esq. and Sheela M. Barhan, MD, to this article.

Key points

• Keep maternal and fetal safety first.

• Maximize patient communication.

• Emphasize teamwork in labor and delivery.

• Develop and follow appropriate guidelines, protocols, and standards of care.

• Obtain and document informed consent.

• Manage labor.

• Ensure that documentation is clear, precise, and legible.

• Pay special attention to litigious patients.

Gary Ventolini, Michael Heard. Keys to minimizing liability in obstetrics.

Contemporary Ob/Gyn

Nov. 1, 2003;48:81-96.