OBSTETRICS and GYNECOLOGY a Clinical Guide to Improving Patient Safety and Managing Risk

OBSTETRICS AND GYNECOLOGY A clinical guide to improving patient safety and managing risk

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This topic-based guide to reducing liability in obstetrics and gynecology is an essential reference for obstetricians, gynecologists, family practitioners, and advanced practice providers who are actively involved in delivering women’s healthcare.

A patient safety risk manager is always available to provide industry-leading expertise, including custom programs, practice risk assessments, and education.

Not for distribution TABLE OF CONTENTS

Noninvasive Cell-Free DNA Testing, Amniocentesis, and Chorionic Villus Sampling ...... 2

Pregnancy of Unknown Location and Ectopic Pregnancy ...... 5

Preeclampsia and Eclampsia ...... 8

Vaginal Birth After Cesarean Section ...... 12

Shoulder Dystocia ...... 15

Indications for Placental Examination and Pathology ...... 18

Postpartum Hemorrhage ...... 21

Failure to Diagnose Breast Cancer and Management of Abnormal Screening Results ...... 24

Failure to Diagnose Cervical Cancer and Management of Abnormal Pap Tests ...... 28

Dealing with Noncompliance in the Ob/Gyn Patient ...... 31

Contributors from The Doctors Company’s Department of Patient Safety and Risk Management: Annie Herlik, JD, FASHRM; David O. Hester, FASHRM, CPHRM; Cynthia Morrison, RN, CPHRM; Carol Murray, RHIA, CPHRM; Darrell Ranum, JD, CPHRM; Susan Shepard, MSN, RN; Kathleen Stillwell, MPA, RN; Amy Wasdin, RN, CPHRM; and Pamela Willis, BSN, JD. ContributorsNot from The Doctors Company’s for Obstetric Advisory distribution Board: Jay Berman, MD; Susan Mann, MD; Elisabeth Nye, MD, FACOG; Christine Pecci, MD; Marcus Tower, MD, FACOG; and Larry Veltman, MD, FACOG, CPHRM.

This guide is not a standard of care. Any guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any action or treatment must be made by each healthcare practitioner in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

OBSTETRICS AND GYNECOLOGY 3 NONINVASIVE CELL-FREE DNA TESTING, AMNIOCENTESIS, AND CHORIONIC VILLUS SAMPLING

NONINVASIVE CELL-FREE DNA TESTING ASSOCIATED RISKS Prenatal blood screening is often recommended to determine Malpractice claims in this area frequently arise from issues whether a patient may be at increased risk of fetal genetic related to the handling of screening tests or their results. disorder. There are various screening options for common Improperly interpreted results, delays in reporting results fetal aneuploidies and neural tube defects. Since 2011, to the patient, failure to follow up on indeterminate or cell-free DNA testing has been readily available in most uninterpretable results, and timing issues related to obtaining U.S. markets, but was initially recommended only for those the testing—whether it is due to patient noncompliance with at increased risk of fetal aneuploidy. Given its increase in appointment scheduling or with failure to order the testing— use by the general population of pregnant patients over the are all common areas for allegations of negligence. last few years, several risk management issues should be Providers should take care to ensure that patients fully considered if offering routine cell-free DNA testing. This understand the limitations of the selected screening tests. section discusses risk prevention strategies associated It is important for a patient to know that the fraction of fetal with the use of noninvasive prenatal testing protocols and DNA captured in the sample may affect the reliability and examines related topics of risk management considerations detection capability of the test. If the fetal fraction is not for amniocentesis and chorionic villus sampling. great enough, there may be a case for repeating the test later in pregnancy, as fetal fraction should increase with gestational age. An additional consideration to be aware of is that maternal BMI may reduce the fetal fraction in the Providers should take care to sample obtained. Finally, varying technology and detection percentages exist amongst available testing products. It ensure that patients fully understand is important to share accuracy rates with patients and to advise them that false positives and false negatives still the limitations of the selected exist with cell-free DNA testing. Abnormal screening results should always be confirmed via chorionic villus sampling or screening tests. amniocentesis prior to making irreversible decisions, such as termination of a pregnancy. The American College of Obstetricians and Gynecologists In this process of educating patients on screening test has reported that while chromosomal abnormalities occur limitations, either a signature of acknowledgment, properly in approximately one in 150 live births, Down syndrome executed in the style of informed consent, or a detailed (trisomy 21) occurs in approximately one in 800 live births. progress note on the discussion should be included in the The College also notes that, while cell-free DNA testing has medical record. the highest reported detection rate for fetal Down syndrome, An informed discussion with the patient should include other types of prenatal testing are still important to consider the risks, benefits, prognosis with and without testing, as they will screen for certain anomalies that cell-free DNA and alternatives to prenatal screening. In addition, when 1 cannot detect. considering testing, cell-free DNA screening results should A variety of options are available to screen for aneuploidy not be the sole consideration in managing pregnancy in all trimesters of pregnancy. Cell-free DNA testing is decisions. Ultrasound testing may be appropriate in cer- noninvasive and evaluates the fetal DNA found circulating tain circumstances to assist in evaluating possible fetal in maternal blood. The process screens for a variety of fetal structural abnormalities. conditions,Not such as the presence of anfor Rh-positive fetus in distributionan Additional recommendations may be found in American Not for distribution Rh-negative mother, can detect some genetic abnormalities, College of Obstetricians and Gynecologists, Committee and will also positively identify the gender of the fetus. Opinion No. 640 (September 2015).2 Screening can be done as early as nine weeks of gestation through full term. Cell-free DNA screening has the highest reported detection rate for Down syndrome.

OBSTETRICS AND GYNECOLOGY 2 AMNIOCENTESIS FOR FETAL CHROMOSOMAL ANALYSIS both of which occur most frequently if CVS is performed at less than 10 weeks estimated gestational age. Because Prenatal diagnosis of fetal chromosomal abnormality is the the CVS-obtained karyotype is taken from placental tissue, most common indication for invasive prenatal testing. Most amniocentesis may subsequently need to be performed malpractice claims involving an amniocentesis procedure when CVS results are indeterminate or inadequate. As with performed during the second trimester are attributed to amniocentesis, fetomaternal hemorrhage can occur and Rh- diagnostic error and involve timing factors rather than negative women should receive anti-D Rh immunoglobulin. performance issues. These can be avoided by implementing Other CVS complications are similar to those of amniocentesis simple, yet effective, loss prevention measures. and include, but are not limited to, infection and rupture of membranes. ASSOCIATED RISKS Mid-trimester amniocentesis is regarded as a low-risk procedure in terms of injury to the mother and fetus. Risks include a miscarriage rate of one in 300–500 cases. Other Create a high-risk follow-up tracking complications include, but are not limited to, bleeding with mixing of maternal and fetal blood in Rh-negative mothers, mechanism to monitor all office amnionitis and maternal sepsis, excessive leakage of amniotic fluid, and injury to the fetus. diagnostic test results and scheduled Although the incidence of such complications is relatively low, the injury severity levels are high and, thus, are often a repeat or serial testing. precipitating factor of malpractice claims. It is recommended that no amniocentesis be performed prior to 14 weeks of fetal PATIENT SAFETY ISSUES gestation as the risk of miscarriage is 10 times more than if Loss prevention measures for amniocentesis and CVS begin done at greater than 15 weeks of gestation. with a customized informed consent process. It is efficacious Error allegations surrounding an amniocentesis procedure to implement an educational component for the patient at can occur predicated on a failure to diagnose birth the time of the discussion and consent. Such education defects or genetic problems due to performing the test should specify the risks, benefits, and alternatives to the prematurely (prior to the 12th week) or beyond the 18th amniocentesis and CVS, as well as the procedure’s limitations week of pregnancy. Specific missed diagnoses include Down (i.e., normal results do not equal a normal baby). Check with syndrome, cystic fibrosis, and neural tube defects. your state requirements for informed consent to ensure that Other significant error allegations related to the performance you cover all of the required elements. of amniocentesis can result from the failure to recognize that Create a high-risk follow-up tracking mechanism to monitor all a complication of the procedure has occurred. Inadequate office diagnostic test results and scheduled repeat or serial informed consent is often an issue in claims arising from testing. The tracking mechanism is necessary to validate amniocentesis. A second option is to offer chorionic completion and the timely receipt by the physician of all villus sampling. test results. It should also include documentation of the physician’s response and any follow-up actions taken. CHORIONIC VILLUS SAMPLING Schedule appropriate follow-up office visits frequently Chorionic villus sampling (CVS) is an alternative to enough to provide adequate monitoring of the pregnancy amniocentesis. The major benefit of CVS over amniocentesis and of pending test results. Although patients cannot be is that this procedure can be performed between 10 and forced to keep appointments, an attempt should be made to 14 weeks gestation, which allows prenatal genetic disorder contact them when an appointment is missed and to assist diagnosis significantly earlier than amniocentesis. Chorionic with rescheduling. Your state law may be prescriptive when tissue is obtained transabdominally or transcervically and sent notifying patients. Documentation of failed appointment for genetic analysis. Direct examination of the trophoblastic follow-up efforts is essential. cells can provide a karyotype within two and 48 hours, but When indicated, promptly refer the patient for consultations concurrent cell culture is recommended (results commonly with specialists. Formalize consultation requests in writing, Not for distribution take sevenNot days) due to the risk of false-positivefor results, anddistribution and clearly define each physician’s responsibility for managing the benefit of a more accurate analysis of the fetal karyotype. the patient. Be sure the patient is made aware of who the As with amniocentesis, fetal loss or fetal injuries are the most consultant is and the reason for the consultation. serious complications. Risks associated with CVS include fetal limb-reduction defects and oromandibular hypogenesis,

OBSTETRICS AND GYNECOLOGY 3 AMNIOCENTESIS AND CVS— INFORMED REFUSAL PATIENT SAFETY RECOMMENDATIONS Patients who refuse or delay noninvasive prenatal testing, Provide patient education regarding amniocentesis CVS, or amniocentesis or who are otherwise noncompliant and CVS. should be fully informed about the potential consequences. Set realistic patient expectations. Normal results do Document your discussions with the patients, and employ not equal a normal baby. an informed refusal form. A sample “Refusal to Consent to Treatment, Medication, or Testing” form is available under

Schedule amniocentesis or CVS with specificity Miscellaneous in our Informed Consent resource center and in conjunction with gestational age. at thedoctors.com/consent. Use a customized informed consent process or, In many cases, a refusal form will prevent pursuit of a claim better yet, a shared decision-making program. or become persuasive evidence before a jury in the event Make sure that patients have the opportunity to of an unavoidable claim. To further reduce your liability ask questions during the informed consent process. exposure, contact your patient safety risk manager to Create a high-risk follow-up tracking system to discuss terminating the physician-patient relationship with monitor diagnostic test results. noncompliant patients. Time follow-up visits to facilitate adequate monitoring and result reporting. REFERENCES Document patient noncompliance and confirm in writing 1. American College of Obstetricians and Gynecologists. ACOG Practice with a certified letter requiring patient signature at Bulletin No. 163: Screening for Fetal Aneuploidy. May 2016. delivery. Follow state law patient notification requirements. 2. American College of Obstetricians and Gynecologists. Cell-Free Document patient refusal of recommended testing with DNA Screening for Fetal Aneuploidy. Committee Opinion No. 640. a signed informed refusal form. September 2015. Consider terminating the physician-patient relationship with noncompliant patients. Review state law in case ADDITIONAL RESOURCES there are patient termination requirements. PIAA Data Sharing Project. Semiannual Report, 2012 ed. Physician Refer patients for consultations with specialists promptly. Insurers Association of America. Rockville, MD; 2012. Seek legal guidance or contact The Doctors Company American College of Obstetricians and Gynecologists. Committee when you are uncertain about how to proceed from a on Patient Safety and Quality Improvement. Tracking and Reminder patient safety/risk management standpoint. Systems. Committee Opinion No. 546: Obstet Gynecol. 2012 Dec;120(6):1535-7.

American College of Obstetricians and Gynecologists, ACOG Practice Bulletin No. 162: Prenatal Diagnostic Testing for Genetic Disorders. May 2016.

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OBSTETRICS AND GYNECOLOGY 4 PREGNANCY OF UNKNOWN LOCATION AND ECTOPIC PREGNANCY

PREGNANCY OF UNKNOWN LOCATION failure to diagnose and treat in a timely manner. This section is designed to guide the physician toward early recognition A pregnancy of unknown location (PUL) is defined when and management of this high-risk condition. a pregnancy test is positive, but there are no signs of intrauterine pregnancy or of an extrauterine pregnancy. When transvaginal ultrasound cannot visualize an ectopic pregnancy, IMPLEMENT PRENATAL SYSTEMS APPROACH the initial diagnosis is classified as a PUL. These women The first step is identifying patients who are at high risk for should be followed until a definitive diagnosis can be made. ectopic pregnancy or PUL. Risk factors from the patient’s Although statistics vary, up to one-third of women referred history include previous history of ectopic pregnancy, for ultrasound may have an initial diagnosis of PUL. previous abdominal or pelvic surgery, pregnancy following There can be many causes for PUL, and it is not synonymous a sterilization failure, previous pelvic inflammatory disease, with ectopic pregnancy. Missing a PUL diagnosis is one of the and a history of infertility. most difficult to defend due to the associated morbidity and Our claims analysis identified fallopian tube rupture, mortality. Another concern includes overtreatment causing hemorrhage, and maternal death as associated risks of the demise of a potentially viable intrauterine pregnancy, thus ectopic pregnancy. Surgical risks and complications include sonographic evaluation and interval serum hCG are absolutely hemorrhage, infection, and death. Depression resulting 1,2 essential prior to any medical or surgical treatment. from the emotional consequences of unresolved grief must be recognized—just as if a full-term pregnancy has been ECTOPIC PREGNANCY lost. Depression is often one of the injuries alleged in these malpractice claims. With the advent of nonsurgical medical Ectopic pregnancy occurs once in every 50 pregnancies. treatments, allegations of unnecessary salpingo-oophorectomy In terms of malpractice claims, most allegations involving and scarring have increased. ectopic pregnancy arise from prenatal care and assessment. More specifically, allegations of malpractice often include a Claims related to ectopic pregnancy and PUL often result failure to diagnose the ectopic pregnancy and/or failure to from misdiagnosis and failure to treat in a timely manner. treat the condition in a timely manner. (See Figure 1 for top A high-risk protocol to refer the symptomatic or PUL patient allegations in ectopic pregnancy claims.) to specialized management will reduce the risk of errors attributed to a failure to supervise the patient and improper In Figure 2, patient assessment issues included the failure delegation of care. Another category of risk is unnecessary or delay in ordering a diagnostic test, failure to establish surgery due to false-positive diagnosis. Confirm a positive a differential diagnosis, and misinterpretation of diagnostic hCG blood test with a urine test to lessen this exposure. tests. Patient factors were noted to include noncompliance with a follow-up call or appointment or with the treatment Loss prevention measures must focus on early detection and plan. Communication factors are frequently cited to timely, noninvasive treatment. Notwithstanding prediagnosed include lack of follow-up instructions, poor rapport, and conditions, it is frequently not possible to predict an ectopic language barriers. pregnancy or PUL. It should, therefore, be the goal to provide early (first visit) education to each obstetrical patient. The When a diagnosis can be made early enough using serial hCG education should include the signs and symptoms of ectopic and intravaginal ultrasound, there is a heightened expectancy pregnancy or PUL and the necessity of early intervention, for nonsurgical resolution of ectopic pregnancy. Accordingly, particularly as it relates to surgical versus medical treatments. Not for distribution there is a Nothigher exposure to litigation, for based on a perceived distribution

OBSTETRICS AND GYNECOLOGY 5 REFER THE PATIENT FOR GRIEF SUPPORT Establish a telephone triage protocol that refers patients who call with complaints of first trimester bleeding or any In many instances, empathy expressed following an ectopic suspicious symptoms to immediate physician notification pregnancy or PUL can help prevent a claim. Often, the and sign-off. motivation for pursuing litigation is emotionally based, driven by the patient’s perception—or that of her partner—of the Establish high-risk protocols for first trimester vaginal degree of empathy expressed. In 1999, the American College bleeding, abdominal, pelvic, or shoulder/neck pain, or of Obstetricians and Gynecologists issued a statement: dizziness/fainting. Physician management is advised— rather than delegation to advanced practice providers. Promptly record any positive or questionable diagnostic While expressions of grief will vary among cultures, findings, and follow up with the patient immediately. a deep sense of loss and sorrow is nearly universal. Have an adequate tracking mechanism in place to ensure The depth of the sorrow is not necessarily related to that all test results are promptly completed and received the length of the pregnancy or the age of the infant. by the physician. Parents who lose a fetus to miscarriage or ectopic Promote referral for grief support for ectopic loss. pregnancy might be just as devastated as parents whose older infant died of SIDS. REFERENCES

1. Condous G, Timmerman D, Goldstein S, Valentin L, Jurkovic D, Contact your patient safety risk manager for assistance with Bourne T. Pregnancies of unknown location: consensus statement. Ultrasound in Obstet and Gynecol. 2012;28:121-122. (Statement by communicating adverse events and complications, or visit our the International Society of Ultrasound in Obstetrics and Gynecology Disclosure Resources page at thedoctors.com/disclosure. on the management of women with PUL.)

2. Barnhart D, van Mello NM, Bourne T, et al. Pregnancy of unknown ECTOPIC PREGNANCY— location: a consensus statement of nomenclature, definitions, and PATIENT SAFETY RECOMMENDATIONS outcome. Ferti Steril. 2011 Mar 1;95(3):857-866. Document all patient complaints, symptoms, and maternal ADDITIONAL RESOURCES risk factors. Thoroughly document previous pregnancy and delivery American College of Obstetricians and Gynecologists. Ectopic Pregnancy. FAQ 155. www.acog.org/~/media/For%20Patients/faq155. history, including complications and outcomes. Accessed October 30, 2013. Share pertinent risk factor information with all American College of Obstetricians and Gynecologists. ACOG Practice involved providers. Bulletin No. 94: Medical Management of Ectopic Pregnancy. June Strive for early detection/noninvasive treatment. Ultra- 2008. Reaffirmed 2014. sound and knowledge of serial hCG levels as they relate PIAA Data Sharing Project. Semiannual Report, 2012 ed. Physician to ultrasound findings are imperative. Insurers Association of America. Rockville, MD; 2012.

Ensure early (first prenatal visit) patient education MedlinePlus. Ectopic Pregnancy. www.nlm.nih.gov/medlineplus/ency/ regarding the signs, symptoms, and incidence of ectopic article/000895.htm. Accessed January 30, 2013. pregnancy and the necessity of early intervention, Parks MA, Barnhart KT, Howard DL. Is there a consensus regarding as well as surgical versus medical treatment. management of a pregnancy of unknown location? Obstet Gynecol. 2016;127(5):32S. Not for distribution Not for distribution

OBSTETRICS AND GYNECOLOGY 6 FIGURE 1 Top Allegations in Ectopic Pregnancy Claims

Diagnosis Related (failure, delay, or wrong) 85% Delay in Surgery 6% Improper Management of Pregnancy 3% Improper Performance of Surgery 3% Failure to Report Patient’s Condition % to Another Provider 3

Source: The Doctors Company Closed Claims 2007–2015

FIGURE 2 Factors That Contributed to Patient Injury in Ectopic Pregnancy Claims

Patient Assessment Issues 79% Patient Factors 21% Insufficient or Lack of Documentation 17% Communication Between Patient/ % Family and Provider 15 Communication Among Providers 12 %

Note: Some claims had more than one contributing factor.

Source: The Doctors Company Closed Claims 2007–2015

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7 PREECLAMPSIA AND ECLAMPSIA

This section reviews the risks and errors associated with Obesity. preeclampsia/eclampsia and recommends strategies to Systemic lupus erythematosus. minimize risk and prevent avoidable errors. Advanced maternal age (older than 40 years). As a high-risk obstetrical diagnosis, preeclampsia occurs in 5 to 10 percent of all pregnancies, and the incidence A prenatal record should capture the necessary data to has increased by 25 percent in the past two decades. The monitor each obstetrical patient for possible development majority of malpractice claims involving preeclampsia arise of hypertensive disorders of pregnancy. Data include, but primarily from failure to diagnose and improper management are not limited to, blood pressure, urine for protein, and rapid of pregnancy. weight gain. Special protocols for patients who fall into the high-risk IMPLEMENT A PRENATAL SYSTEMS APPROACH category as determined by early assessment will guide ongoing management throughout pregnancy. Protocols The use of uterine artery Doppler velocimetry and circulating include diagnostic testing, office monitoring, patient and urinary biomarkers has been studied. To date, however, education, and informed consent discussions between the these tests have been found to have a low positive predictive physician and the patient and her family when appropriate. value and are not recommended. In the absence of an ideal predictive test for preeclampsia, the best strategy is to strive Patient education brochures help reinforce informed consent for early detection. There are known clinical factors that and are offered by various organizations, such as the increase the risk of preeclampsia; therefore, a comprehensive American College of Obstetricians and Gynecologists. Make medical and obstetrical history is essential in identifying a sure to document your discussion of educational brochures woman who has a predisposition to the disease. with the patient. Keep a sample file of all educational brochures that includes those in current use and those outdated and no longer in use. Such materials might later need to be produced as evidence in the event of a claim. In the absence of an ideal Staff should be educated about managing high-risk patients. The Doctors Company Patient Safety and Risk Management predictive test for preeclampsia, Department offers comprehensive in-service programs to assist office staff in understanding the importance of patient the best strategy is to strive for communication and diligence in documentation. early detection. PREVENTION OF PREECLAMPSIA2 Despite extensive research, no strategy has been proven to 1 CLINICAL RISK FACTORS FOR PREECLAMPSIA be unequivocally effective. However, the American College Primiparity. of Obstetricians and Gynecologists recommends starting low- dose aspirin (60–80 mg) in the late first trimester in high-risk Previous preeclamptic pregnancy. women, such as those with a medical history of early onset Chronic hypertension, chronic renal disease, or both. preeclampsia and preterm delivery at less than 34 0/7 weeks History of thrombophilia. or those with preeclampsia in more than one prior pregnancy. Multifetal pregnancy. In vitro fertilization. DIAGNOSIS OF PREECLAMPSIA3 Family history of preeclampsia. Blood pressure greater than or equal to 140/90 mmHg Type I Notdiabetes mellitus or type IIfor diabetes mellitus. distributionon two occasions at least four hours apart after Not for distribution 20 weeks of gestation in a patient with previously normal blood pressure.

OBSTETRICS AND GYNECOLOGY 8 Blood pressure greater than or equal to 160/110 mmHg. APPROPRIATE DOCUMENTATION AND USE OF MAGNESIUM6 And Administration of magnesium sulfate is indicated for Proteinuria greater than or equal to 300 mg or more of seizure prophylaxis in women who have eclampsia or protein in a 24-hour urine collection. preeclampsia with severe features. Protocols should be in Or place for monitoring these women for magnesium toxicity. Documentation for using magnesium should be time specific Protein/creatinine ratio of at least 0.3 (each measured and should include the medical rationale, patient-physician as mg/dL). discussion of possible complications, and the plan of care In the absence of proteinuria, criteria for preeclampsia may with risks and benefits. still be met if new onset hypertension occurs in conjunction with new onset of severe features defined by the American ASSOCIATED RISKS College of Obstetricians and Gynecologists. In an analysis of medical malpractice claims pertaining to preeclampsia/eclampsia, the predominant injuries mirror the ANTEPARTUM MANAGEMENT OF PREECLAMPSIA4 most significant medical risks of the condition, including the Once the diagnosis is made, if one or more of the following occurrence of preterm labor resulting in prematurity of the circumstances exist, the woman should be hospitalized infant that can lead to fetal neurological impairment or death. and delivered: Possible injuries to the mother include maternal stroke, 37 0/7 weeks gestation or greater. paralysis, blindness, and death. Suspected abruption. 34 0/7 weeks or more gestation AND one of the following: MOST COMMON ALLEGATIONS – Progressive labor or rupture of membranes. The most prevalent allegations related to hypertension in pregnancy include claims alleging failure or delay in diagnosis, – Ultrasonographic estimated fetal weight less wrong diagnosis, improper management of pregnancy, than fifth percentile. improper management of labor or delay in delivery of the – Persistent amniotic fluid index <5 cm. infant (The Doctors Company Closed Claims 2007–2015). – Persistent biophysical profile 6/10 or less. PATIENT SAFETY ISSUES Women who have mild gestational hypertension or preeclampsia without severe features may be managed in Informed Consent Process or Shared Decision the hospital or at home with restricted activity and serial Making maternal and fetal evaluation. When it is apparent that the patient is predisposed to or may be developing preeclampsia, begin patient education TREATMENT OF SEVERE HYPERTENSION about risks and any interventional treatments that may DURING PREGNANCY5 be necessary. Clarify the patient’s level of understanding and willingness to comply with the treatment plans. The For women with sustained systolic blood pressure >160 mmHg discussion should include three major areas: outpatient or diastolic blood pressure >110 mmHg, the use of anti- care instructions, including, but not limited to, activity hypertensive medication is recommended to reduce the and diet; office appointments; and hospital admission onset of life-threatening maternal complications. Hydralazine, expectations, including induction of labor and aggressive labetalol, or oral nifedipine are all acceptable medications to use of magnesium sulfate. treat severe hypertension in pregnancy. Magnesium sulfate is not recommended as an antihypertensive but is still the Protocols for Preeclampsia Supervision drug of choice for seizure prophylaxis in severe preeclampsia and eclampsia. Model order sets are available from the Protocols for evaluation and supervision of preeclampsia American College of Obstetricians and Gynecologists. (See should include physical exam and blood tests. Creatinine the Additional Resources section.) clearance testing should be established as a standard operating procedure in the office, and should be highlighted Not for distribution Not for distributionin the patient care record to demonstrate completion.

OBSTETRICS AND GYNECOLOGY 9 A tracking mechanism is necessary to validate completion and to the next pregnancy. Women should also seek prenatal care physician receipt of all test results. The tracking mechanism early in the next pregnancy for ultrasound and assessment of should also facilitate documentation of the physician’s disease. Strong encouragement and monitoring are essential response and any follow-up orders. Continued supervision to ensuring that postpartum care occurs. The visit should throughout the pregnancy should include frequent laboratory be structured to identify and monitor all relevant conditions, test reassessment, regular nonstress tests, biophysical issues, and concerns. profiles, and periodic ultrasound assessment of fetal growth and amniotic fluid levels. Provider-Patient Communication As the patient’s clinical picture develops, talk about the previous educational components and informed consent discussions that pertain to the complication and its Medical record documentation management. Keep lines of communication open, and establish good rapport and a relationship of trust with the should include plan of care, patient and her family. This attention to good communication can prevent a lawsuit in the event of an adverse outcome. treatment rationale, and As shown in Figure 1, there are many contributing factors in preeclampsia and eclampsia claims. Patient assessment review of laboratory tests issues arise from failures to establish a differential diagnosis, and fetal assessments. consider available clinical information, address abnormal findings, and order diagnostic tests. Frequently, a provider did not communicate well about the patient’s condition. Weekend, night shift, or holiday staff affected the care of patients. Staff issues arose from lack of education Clinical Documentation and/or training. Medical record documentation should include plan of care, treatment rationale, and review of laboratory tests and fetal PREECLAMPSIA/ECLAMPSIA— assessments. This will support diligent supervision and PATIENT SAFETY RECOMMENDATIONS prompt intervention. While the primary goal is to promote excellent patient care, the documentation also serves to Document all patient complaints, symptoms, and decrease the exposure to claims, which include allegations maternal risk factors. of failure to recognize and treat complications appropriately. Thoroughly document previous pregnancy and delivery history, including complications and outcomes. Obtain Consultations Implement a prenatal systems approach—strive Appropriate consultation with specialists, both maternal and for early detection. fetal, when the need is anticipated will support the physician’s best FIGURE 1 efforts. Once requested, be sure that consults are conducted in a timely Top Seven Factors That Contributed to Patient Injury manner and formalized in writing. The in Preeclampsia and Eclampsia Claims management of the patient should be clearly defined regarding total or Patient Assessment Issues % partial responsibility of each physician. 79 Be sure that the patient is made aware Communication Among Providers 64% of the consultant’s responsibilities. Workflow/Workload 29% Postpartum Follow-Up Selection and Management of Therapy 29% Postpartum follow-up is a vital step Patient Monitoring 29% in the care of the patient with hypertensive diseaseNot in pregnancy. All for distributionStaff Issues 21% Not for distribution women with a history of preeclampsia Failure or Delay in Obtaining 21% have an elevated lifelong risk for future a Consult or Referral cardiovascular disease. They should be Note: Some claims had more than one contributing factor. instructed to seek medical care prior Source: The Doctors Company Closed Claims 2007–2015

OBSTETRICS AND GYNECOLOGY 10 Establish protocols for prevention, diagnosis, follow-up, REFERENCES and reevaluation. 1–6. American College of Obstetricians and Gynecologists, Task Force Educate patients about the signs and symptoms of on Hypertension in Pregnancy. Hypertension in Pregnancy. preeclampsia throughout pregnancy. Protocols or www.acog.org/Resources-And-Publications/Task-Force-and educational materials should be available at a level -Work-Group-Reports/Hypertension-in-Pregnancy. Accessed that patients can understand. Document the patients’ July 28, 2016. understanding of your counseling. All providers should document and share ADDITIONAL RESOURCES pertinent information. American College of Obstetricians and Gynecologists. High Blood Do not delegate to advanced practice providers. Pressure During Pregnancy. FAQ034. www.acog.org/Patients/FAQs/ Preeclampsia-and-High-Blood-Pressure-During-Pregnancy. Published Promptly record any positive or questionable diagnostic September 2014. Accessed August 2, 2016. findings and follow up with the patient immediately. Physician Insurers Association of America. Minimizing Obstetrical Risk, Obtain specific informed consent for patients Clinical Issues for Today’s Practitioner. 1996 Oct. PIAA Data Sharing predisposed to or developing preeclampsia. Project. 2012 Closed Claim Report. Physician Insurers Association of America. Rockville, MD; 2012. Institute prompt therapy for acute onset severe hypertension. PIAA. Neurological Impairment in Newborns: A Malpractice Claim Study. Physician Insurers Association of America. Rockville, MD; 1998. Promptly initiate IV magnesium for preeclampsia with severe features or eclampsia. American College of Obstetricians and Gynecologists. Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy Obtain appropriate and timely consultation and the Postpartum Period. Committee Opinion No. 692. with specialists. www.acog.org/Resources-And-Publications/Committee-Opinions/ Committee-on-Obstetric-Practice/Emergent-Therapy-for-Acute Document fetal assessment. -Onset-Severe-Hypertension-During-Pregnancy-and-the Establish practice protocols to promptly identify and -Postpartum-Period. Published April 2017. manage any intrapartum complications. American College of Obstetricians and Gynecologists. First-Trimester Establish lines of communication within the delivery Risk Assessment for Early-Onset Preeclampsia. Committee Opinion No. team to ensure immediate response and action at the 638. www.acog.org/Resources-And-Publications/Committee-Opinions/ Committee-on-Obstetric-Practice/First-Trimester-Risk-Assessment-for earliest signs of change in maternal or fetal status. -Early-Onset-Preeclampsia. Published September 2015. Accessed August 2, 2016.

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OBSTETRICS AND GYNECOLOGY 11 VAGINAL BIRTH AFTER CESAREAN SECTION

Vaginal birth after cesarean section (VBAC) is viewed as a Previous classical cesarean or inverted T uterine incision. high-risk delivery, given the inherent possibility of uterine Previous uterine rupture. rupture and the corresponding potential malpractice claim Previous transfundal surgery. severity. This section reviews the risks associated with VBAC delivery and provides strategies to minimize these risks and Contraindicated vaginal delivery, e.g., placenta previa. successfully document and defend the care rendered in the The following factors predict a decreased probability of event a claim is filed. success with VBAC:2

RISKS ASSOCIATED WITH VBAC Recurrent indication for cesarean delivery (labor dystocia). Increased maternal age. According to the American College of Obstetricians and

Gynecologists, the risk of uterine rupture with attempted Nonwhite ethnicity. VBAC delivery is significantly higher than that associated Gestational age greater than 40 weeks. with an elective repeat cesarean delivery. Uterine rupture Maternal obesity. occurs with a trial of labor after cesarean (TOLAC) 0.7 to Preeclampsia. 1.8 percent of the time. However, to date, there is not an accurate method to determine which patients undergoing Short interpregnancy interval. a TOLAC will experience a uterine rupture.1 Increased neonatal birth weight.

PRENATAL LOSS PREVENTION MEASURES Document the patient’s prior obstetrical history in Proper selection of candidates conjunction with the current prenatal assessment in order to determine and later support that a TOLAC is reasonable, for TOLAC/VBAC is vital to not recommended, or contraindicated. The American College of Obstetricians and Gynecologists provides a useful patient patient safety. safety checklist on trial of labor after cesarean delivery. (See the Additional Resources section.) A tool such as this Published studies indicate that 60 to 80 percent of trials may be helpful in guiding both prenatal and intrapartum of labor in appropriately selected patients with previous documentation on the matter. cesarean delivery result in vaginal delivery. However, Documentation in the labor and delivery progress notes rupture or dehiscence of a previous uterine scar can be should reflect that the patient’s progression of labor was life threatening for both the mother and fetus. The injuries closely monitored. Document the timing of events during alleged in claims involving uterine rupture following TOLAC progression of labor as accurately and contemporaneously have a high severity and can include massive maternal as possible. If an emergent obstetric event occurs, hold a hemorrhage with accompanying sequelae of hysterectomy, debriefing meeting with all hospital team members to review fetal demise, or permanent asphyxial injury to the infant. times and the sequence of events based on the notes that were recorded during the event. This debriefing will avoid PATIENT SELECTION FOR TOLAC any confusion in the medical record when the event is documented by multiple providers. Apply these same charting tips Proper selection of candidates for TOLAC/VBAC is vital to during the postpartum period, such as the recognition and patient safety, as well as being a fundamental loss prevention medical management of any complication. measure. Standard-of-care issues arise when patient selection is faulty. Accordingly, patient selection for TOLAC/VBAC must be consideredNot carefully. Those who havefor experienced the distributionINFORMED CONSENT AND SHARED DECISION MAKING Not for distribution following are not generally candidates: Advise the patient of the risks, benefits, and alternatives to VBAC. Discuss the risk factors individual to each patient, such as a proven or unproven pelvis. Prevent unrealistic

OBSTETRICS AND GYNECOLOGY 12 expectations by explaining that you are only able to offer a an anesthesia provider physically present and immediately trial of labor and that a vaginal birth may not be possible and available during the entire TOLAC. Management of uterine is dependent on progression of labor. It is also important to rupture, with its inherent complications, is well beyond discuss the increase in risks if a TOLAC fails and becomes the scope of advanced practice providers, such as nurse a repeat cesarean delivery. Discuss these eventualities in midwives. According to the American College of Obstetricians relation to the routine risks of a planned repeat cesarean. and Gynecologists, “Because of the risks associated with As advised by the American College of Obstetricians and TOLAC and that uterine rupture and other complications Gynecologists, it is also necessary to discuss the capabilities may be unpredictable, the College recommends that TOLAC of the planned birth facility to respond to emergency be undertaken in facilities with staff immediately available cesarean delivery needs, ensuring that the patient has to provide emergency care.”3 In the event of a claim, the all the information needed to make an informed decision. definition of “immediately available” will be decided by a Document all informed consent and teaching discussions. jury, and the term generally implies no delay. Even when the These discussions should take place throughout the defense shows correct medical treatment, a jury will focus pregnancy. This documentation will later support the deci- mainly on the obstetrician and the entire team not being sion to proceed with or abandon VBAC as the delivery of immediately available and will often presume that if the choice. Early in pregnancy, provide patients with educational entire team had been present, the immediate intervention materials that thoroughly explain VBAC and the associated would have prevented the adverse outcome. risks and complications. Require that patients sign a specific TOLAC/VBAC informed consent form, as well as a consent DOCUMENTATION form for cesarean section delivery. In general, medical record documentation should create a chronological word picture of the assessment, diagnosis, POSTPARTUM COMPLICATIONS treatment plan, and outcomes. Detail the instructions to the Malpractice claims involving TOLAC or VBAC also arise patient regarding follow-up, further testing, or referral to a as a result of the postpartum management of the patient. specialist. Document telephone instructions provided to the Postpartum complications of TOLAC/VBAC patients are patient, as well as clinical care decisions made throughout significantly higher following a uterine rupture and can include pregnancy and during labor. Obtain procedure-specific major and severe puerperal infection, signed consent forms that specify the risks, benefits, paralytic ileus, sequelae related to emergency hysterectomy, and/or other FIGURE 1 surgical complications. Allegations in such claims include delay in diagnosis Factors That Contributed to Patient Injury in VBAC Claims and treatment of the complication(s). Discussion of these possible Patient Assessment Issues 40% postpartum complications should therefore be a routine part of the Technical Performance 36% informed consent process for TOLAC. Retained Foreign Body 24% Communication Between Patient/ % CLAIM ANALYSIS Family and Provider 16

Analysis of issues arising from Note: Some claims had more than one contributing factor. attempted VBAC deliveries reveals a common factor: the lack of Source: The Doctors Company Closed Claims 2007–2015 immediately available resources in the event of uterine rupture. Inadequate response time in performing emergency cesarean delivery is a and alternatives of the anticipated care. Document prevalent factor. It is often attributed to a failure to recognize the medical rationale supporting your assessment and that the delivery center could not routinely provide the level of the treatment plan (and any subsequent alterations) support necessary to successfully manage the complications in conjunction with the patient’s clinical status. When Not for distribution inherent inNot uterine rupture. for distributiondocumenting in the chart, ask yourself: Will I be able to Another cause of malpractice claims is the failure to have defend my actions retrospectively? both an obstetrician capable of handling complications and

OBSTETRICS AND GYNECOLOGY 13 PRACTICE ENVIRONMENT REFERENCES

On-call and covering arrangements must be considered. In a 1. Grobman WA, Lai Y, Landon MB, et al. Prediction of uterine rupture group practice setting, all physicians of the practice should associated with attempted vaginal birth after cesarean delivery. Am J decide on coverage arrangements pertaining to current Obstet Gynecol. 2008;199:30.e1-30.e5. VBAC/TOLAC practice guidelines. 2. American College of Obstetricians and Gynecologists. ACOG Practice Patient assessment issues include the failure to respond to Bulletin No. 115: Vaginal Birth After Previous Cesarean Delivery. August 2010. Reaffirmed 2015. a patient’s repeated concerns/symptoms, address abnormal findings, and consider available clinical information. When 3. Ibid. there is a complication of surgery, poor technique or incorrect surgical count, technical performance is cited. ADDITIONAL RESOURCES Communication issues arise from inadequate consent or poor patient rapport, including unsympathetic responses Guise JM, Eden K, Emeis C, et al. Vaginal birth after cesarean: new to the patient. insights. Rockville, MD: Agency for Healthcare Research and Quality (U.S.); 2010 Mar. Evidence Reports/Technology Assessments, No. 191. www.ncbi.nlm.nih.gov/books/NBK44571. Accessed August 2, 2016.

American College of Obstetricians and Gynecologists. Trial of Labor After Previous Cesarean Delivery (Intrapartum Admission). Patient Safety Checklist. No. 9. November 2012. Reaffirmed 2016. www.acog.org/Resources-And-Publications/Patient-Safety-Checklists/ Trial-of-Labor-After-Previous-Cesarean-Delivery.

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OBSTETRICS AND GYNECOLOGY 14 SHOULDER DYSTOCIA

Birth injuries continue to be a major contributor to medical While the presence of risk factors cannot truly predict malpractice losses. Significant among the injuries are those shoulder dystocia, the first step toward loss prevention is an stemming from shoulder dystocia and the resulting brachial accurate prenatal assessment to identify patients who may plexus injuries. The majority of claims involving shoulder be at risk. Early identification will enable the physician to dystocia arise from deliveries in which manual maneuvers have—and document—informed consent discussions with the have been applied to relieve the dystocia. According to patient regarding vaginal versus cesarean delivery; implement The Doctors Company’s 2007–2015 claims data, manually management protocols that include tracking diagnostics; have assisted deliveries account for 63 percent of all shoulder scheduled reassessments; and monitor periodic weights and dystocia and brachial plexus injury claims. measurements closely. An assessment format that highlights Because the occurrence of shoulder dystocia is unpredictable the clinical factors indicative of shoulder dystocia will alert and can occur with even the most experienced practitioner, the provider to the presence of these risk factors. a well-orchestrated plan of action is necessary to prevent Antepartum factors that may increase the risk of shoulder complications that could lead to brachial plexus injury brain dystocia and should be part of the prenatal assessment damage, or, on rare occasions, even neonatal death. This include but are not limited to: section covers the risks and related errors involving shoulder Fetal macrosomia. dystocia and provides strategies to enhance patient safety, minimize risk, prevent error, and successfully defend a claim. Post-term gestation. The discussion will also provide suggestions to facilitate a Maternal diabetes. proactive approach and to validate the quality of care. Previous history of a macrosomic birth. Maternal obesity. Previous history of shoulder dystocia. Most injuries associated with ANTEPARTUM LOSS PREVENTION shoulder dystocia are manifested Timely ultrasound estimates of the fetal weight will help to confirm a suspected risk factor for shoulder dystocia, as brachial plexus injuries or hypoxic but ultrasonography is not always an accurate predictor of macrosomia. Additionally, most macrosomic infants do brain injuries. not experience shoulder dystocia. Effective communication between the physician and the patient and/or patient’s family Most injuries associated with shoulder dystocia are regarding the risk will serve to alert, educate, and involve manifested as brachial plexus injuries or hypoxic brain the patient in the decision-making processes. Document injuries. Data from The Doctors Company found 354 all interpretations, interventions, plans of care, and patient closed claims pertaining to shoulder dystocia injuries in informed consent discussions. Include signed informed neonates between 2007–2015. Brachial plexus injury was consent forms in the record. the most common neonatal injury representing 26 percent of all neonatal injury claims. The second most common PATIENT INVOLVEMENT neonatal injury was hypoxic ischemic encephalopathy (HIE) representing 23 percent of neonatal injury claims. Moreover, It is important to identify and teach the patient about risk these claims have traditionally been among the most difficult factors of shoulder dystocia related to obstetrical history, to successfully defend. Despite medical evidence to the the presence of diabetes, and current diagnostic or physical contrary, jurors often accept the argument that the injury findings. It is prudent to conduct an early prenatal discussion could not occur unless there was improper technique by of delivery techniques to include the nature and purpose of Not for distribution Not for distributionthe maneuvers, possible alternative methods of treatment, the provider. the risks involved, and the possibility of complications. This discussion should be repeated and well documented as the pregnancy continues and the risk factors persist.

OBSTETRICS AND GYNECOLOGY 15 Having a complete, specific, and documented informed management tool that can demonstrate the clinical course consent discussion early on and continuing through the of labor and delivery and document the measures taken to pregnancy, a review of the previously discussed and resolve the shoulder dystocia. The template should include agreed-upon decisions as labor begins, and a signed consent the precise times of the diagnosis of shoulder dystocia and form all contribute to preparing the patient for delivery. the subsequent times related to the interventions. Identify those present on the healthcare team. Clarify their roles LABOR MANAGEMENT and the outcome for both infant and mother. The American College of Obstetricians and Gynecologists provides a Identifying the at-risk patient, predicated on timely and useful patient safety checklist. (See the Additional complete prenatal assessments, should lead the physician Resources section.) to closely monitor the patient’s labor progression for If the forms are not included in the hospital chart, the indications of difficulty. As always, it is imperative that physician can use them for dictation and place them in the management of labor and any delivery complications the patient’s office chart. be documented accurately. The medical record should exhibit a chronological word picture of the labor and delivery while documenting the INTRAPARTUM RISK FACTORS following information: Associated intrapartum risk factors include induction of labor, epidural anesthesia, prolonged second stage, and operative ANTENATAL ASSESSMENT vaginal delivery. Although data are inadequate to suggest that the labor curve is a useful predictor of shoulder dystocia, Presence of risks for shoulder dystocia. suspected macrosomia, coupled with abnormal labor, can be a warning scenario for impending shoulder dystocia. Abnormal INTRAPARTUM ASSESSMENT labor can be interpreted as protracted active phase of labor, secondary arrest of labor, or prolonged second stage of labor. 1. Mode of delivery of the infant’s head: Spontaneous or operative. INTRAPARTUM LOSS PREVENTION Presenting position of head. If a combination of suspected macrosomia and abnormal Which shoulder was anterior. labor arises, avoid operative vaginal delivery when possible. Amount of traction (none, gentle, The presence of these risk factors, coupled with the inherent moderate, significant). inability to predict shoulder dystocia, may warrant prudence in avoiding aggressive facilitation of a vaginal delivery. 2. Time of diagnosis of shoulder dystocia (after delivery Moreover, delivery by forceps or vacuum extractor from of the head). a +2 or higher station may actually increase the risk of 3. Time until resolution and delivery of baby’s body. shoulder dystocia. 4. Maneuvers used and time implemented, in exact order To reinforce patient understanding of the necessary with results: interventions, the physician should involve the patient McRoberts maneuver. and her family early in decision making, and as much as possible during the labor process. Document this Suprapubic pressure. discussion, and reinforce the informed consent as the Delivery of posterior arm. need for manual manipulation techniques or cesarean Shoulder rotation (Wood’s or Rubin’s maneuver). section becomes evident. Maternal hands and knees positioning (Gaskin maneuver). LOSS REDUCTION AND DEFENSIBILITY AFTER SHOULDER DYSTOCIA Replacement of head for cesarean section (Zavanelli maneuver). Complete and accurate documentation will substantiate appropriate management of shoulder dystocia. In the event 5. Assistants, when present, and what role they played. of litigation,Not a well-documented medical for record will preclude distribution 6. Infant’s status: Not for distribution many of the allegations made in shoulder dystocia claims. Apgar scores. A customized template for documentation or a model-type Cord gases. guide for dictation is an excellent, proactive patient safety/risk

OBSTETRICS AND GYNECOLOGY 16 Moro reflex. FIGURE 1 Movement of arms. Top Six Factors That Contributed to Patient Injury Resuscitation. in Shoulder Dystocia Claims Transfer. 7. Notification of pediatrician time Selection and Management of Therapy 7961% and time of arrival of pediatrician. Insufficient or Lack of Documentation 29% 64% 8. Mother’s status. 9. Explanation given to patient and/or Technical Performance 29%29% family member(s). Communication Between Patient/ %% Family and Provider 2924 Review the delivery with the patient Patient Assessment Issues %% and family. Include the previously 2229 known risks for shoulder dystocia, Patient Factors 2118%% the sequence of events at delivery, % the actions that were taken during Note: Some claims had more than one contributing factor. 21 the delivery, and why the actions were taken. Be sure the family is aware Source: The Doctors Company Closed Claims 2007–2015 of your concern and your availability to answer questions at a later time. Whenever possible, attend NICU rounds with ADDITIONAL RESOURCES the infant’s attending physician in order to gain information American College of Obstetricians and Gynecologists. ACOG Practice on the injury and to facilitate open communication with the Bulletin No. 40: Shoulder Dystocia. 2002. Reaffirmed 2015. parents of the infant. American College of Obstetricians and Gynecologists. Documenting As seen in Figure 1, multiple factors can contribute to Shoulder Dystocia Patient Safety Checklist No. 6. August 2012. a potential shoulder dystocia injury claim. The most www.acog.org/Resources-And-Publications/Patient-Safety-Checklists/ Documenting-Shoulder-Dystocia. frequently cited issue is the “selection and management of therapy.” The contributing factor “insufficient or lack of Varga R, Repke J. Type 1 diabetes mellitus and pregnancy. Rev Obstet documentation” refers to a lack of notation in the medical Gynecol. 2010 Summer;3(3):92-100. www.ncbi.nlm.nih.gov/pmc/ record regarding the clinical findings and rationale, or it articles/PMC3046748/. Accessed August 2, 2016. refers to inadequate documentation of informed consent. Willis P. Shoulder dystocia documentation: implementing a protocol The “communication” category, encompassing 24 percent in your facility. The Doctors Company. Available at www.thedoctors of claims, refers to situations in which the patient or family .com/KnowledgeCenter/PatientSafety/articles/Shoulder-Dystocia -Documentation-Implementing-a-Protocol-in-Your-Facility. felt that unsympathetic remarks were made by the provider, a language barrier was an issue, or informed consent was not perceived by the patient. “Patient assessment issues” include failure or delay in ordering diagnostic tests or considering available clinical information, whereas the “patient factors” category includes situations of patient failure to comply with treatment plan or follow-up.

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OBSTETRICS AND GYNECOLOGY 17 INDICATIONS FOR PLACENTAL EXAMINATION AND PATHOLOGY

The likelihood of litigation is almost certain in the case of GROSS PLACENTAL EXAMINATION a neurologically impaired newborn. Allegations of negligent Gross examination of the placenta should always be management of labor and delivery commonly focus on the performed at the time of delivery in order to determine if timing of fetal injury. However, the most important evidence pathological evaluation is indicated. A common and effective for a successful causation defense is often discarded. memory device for routine placental examination is LMNOP: This section reviews loss prevention measures pertaining to placental examination and outlines strategies for Look at the entire placenta for any gross abnormalities of minimizing risk. the placenta, its membranes, or the umbilical cord. Measure the full length of the umbilical cord. Note all observations in the medical records. Injuries that appear to be birth Or Photograph the placenta. related can usually be traced to Pathological examination is indicated when there is reason to suspect an abnormal maternal condition, compromised problems that occurred early in fetus/newborn, and/or placenta/umbilical cord abnormalities. fetal life. If there is no indication for pathological examination, the placenta should be stored without preservatives at least until the mother and newborn are discharged. Some organizations PLACENTAL EXAMINATION store the placenta for a week after birth before discarding. Obtaining placental pathology, when indicated due to Examination of the placenta can provide the evidence maternal risk factors, fetal and newborn adversities, or needed to determine the biological cause of a prenatal or placental/umbilical cord abnormalities, is an essential loss developmental abnormality.1 Placental pathology can pinpoint prevention measure. problems, such as infarcts or viral infections. Injuries that appear to be birth related can usually be traced to problems Situations that suggest sending the placenta for pathological that occurred early in fetal life. Placental pathology is also a examination include those listed below. useful tool for explaining the diagnosis of failure to progress during labor due to amnionitis. MATERNAL CONDITIONS It is estimated that placental pathology is obtained in less (INCLUDE BUT ARE NOT LIMITED TO)2 than 15 percent of the cases that warrant it. It should not Diabetes mellitus. be presumed that placentas from “normal” pregnancies will always be normal. Placental examination should not be Preeclampsia/eclampsia. reserved solely for catastrophic outcomes or in what may Premature rupture of membrane. otherwise have been a normal or unremarkable pregnancy. Pre-term delivery (<36 weeks). Post-term delivery (>42 weeks). Unexplained fever. Poor previous obstetrical history. Not for distribution History of drug abuse, including cocaine. Not for distribution

OBSTETRICS AND GYNECOLOGY 18 FETUS/NEWBORN ADVERSITIES UMBILICAL CORD (INCLUDE BUT ARE NOT LIMITED TO) Length (measured in centimeters). Stillborn. Insertion point. Neonatal death. Number of vessels. Multiple gestation. True knots or twists (undercoiling or overcoiling). Prematurity. Obstructions. Intrauterine growth restriction. Infection. Congenital anomalies. Unusual appearance. Erythroblastosis fetalis. Transfer to neonatal intensive care unit. MEMBRANES Nonreassuring fetal heart rate tracing. Color. Presence of meconium. Insertion into the placenta. Apgar score <5 at one minute or <7 at five minutes. Amnion/nodosum. Presence/absence of cysts and location. PLACENTA/UMBILICAL CORD ABNORMALITIES Point of rupture (in centimeters from margin). (INCLUDE BUT ARE NOT LIMITED TO) Infarcts. PLACENTA Abruptio placenta. Color. Vasa previa. Size (width, depth, length). Placenta previa. Amnion/nodosum. Abnormal calcification. Presence/absence of cysts and location. Abnormal appearance of placental cord (too long or Evidence of hemorrhage. too short). Evidence of infarction. UMBILICAL CORD GASES Fetal surface description.

At all deliveries, a section of the umbilical cord can be Maternal surface description. double-clamped and placed on the delivery table. The section For multiple births: fused and/or vascular anastomoses. of cord will be stable for pH and blood gas analysis for up to 60 minutes. If a serious abnormality arises with the infant To ensure consistency of application, make sure a written within this period of time, blood should be drawn from the procedure also exists in the birthing center for handling the segment of cord and sent to the laboratory for analysis. placenta and umbilical cord and in the pathology department for placental examinations. CONTRIBUTIONS FROM PATHOLOGY CONTRIBUTION FROM LABORATORY It is important to establish a protocol and implement appropriate education for delivery room personnel to conduct A critical item needed for adequate defense of impaired and document gross examination of the placenta. Additionally, newborn claims is the correct handling or labeling of cord it should be ensured that delivery room nursing personnel blood. A process should be in place to ensure that the cord are trained to obtain blood gases from cord and placenta. blood is appropriately labeled and that the timing and storage Organizations should determine what resources are readily of the cord blood are appropriate. available to obtain expert pathological examination of the placenta. If a local pathologist is not trained in placental examination, consideration should be given to sending Not for distribution placenta pathologyNot specimens to an outsidefor facility that distribution can offer detailed examinations. When documenting the gross appearance of the placenta, consideration should be given to the following:3

OBSTETRICS AND GYNECOLOGY 19 REQUESTING PATHOLOGICAL EXAMINATION Red flag patients for placental pathology who report prenatal complaints, signs and symptoms, or family history The information that accompanies the request for pathological of fevers, contagious diseases, viruses, or serious illnesses examination can help ensure the integrity of the findings. during the prenatal period. When submitting a placenta for pathological examination, it is important to include the following information4 with the Implement and consistently order placental pathology for placenta and cord: all abnormalities of pregnancy, labor, delivery, or of the neonate (including unfavorable Apgar scores), and for any Gross placental examination form or narrative abnormal gross appearance of the placenta or cord. documentation. Ensure that all placentas are stored from three to seven A copy of the delivery record. days after delivery. The name of the delivering physician. Maintain communication with all providers managing the The name of the neonatologist. patient’s pregnancy. All providers should document and The reason(s) for the pathological examination. share pertinent information. Any additional information or issues. Promptly record any positive or questionable diagnostic findings, and follow up with the patient immediately. After any unfavorable obstetric outcome, hold a debriefing Provide explanations about an abnormal placenta, huddle with all participating healthcare team members to including how the abnormalities might pertain to current carefully review the sequence of events based on the notes events or outcomes, as well as affect future pregnancies. that were recorded by scribes and staff members as the event unfolded. This debriefing will decrease confusion in REFERENCES the medical record once the event is documented by the multiple participating parties and will help paint the picture 1. American College of Obstetricians and Gynecologists, American that accompanies placental pathology and cord blood Academy of Pediatrics. Neonatal encephalopathy and cerebral palsy: defining the pathogenesis and pathophysiology. Second edition. Elk result information. Grove Village, IL (AAP); Washington, DC (ACOG), 2014. (Chapter 4: The Role of Placental Pathology in Neonatal Encephalopathy and Cerebral Palsy). PLACENTAL EXAMINATION— PATIENT SAFETY RECOMMENDATIONS 2. Langston C, Kaplan C, Macpherson T, Manci E, Peevy K, Clark B, et al. Practice guideline for examination of the placenta: developed Document all patient complaints, symptoms, and by the Placental Pathology Practice Guideline Development Task maternal risk factors. Force of the College of American Pathologists. Arch Pathol Lab Med. 1997;121:449-76. Conduct a gross placental examination using the LMNOP memory device, and complete a gross placental 3. Hargitai B, Marton T, Cox PM. Best practice no. 178: examination of the human placenta. . 2004;57(8):785-92. examination form or narrative documentation. J Clin Path Provide accurate and complete information when 4. Kraus FT, Redline RW, Gersell DJ, Nelson DM, Dicke JM. Atlas of nontumor pathology: placental pathology. AFIP, 2004. requesting pathological examination.

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OBSTETRICS AND GYNECOLOGY 20 POSTPARTUM HEMORRHAGE

Postpartum hemorrhage, also called obstetric hemorrhage, cases. Assessment issues revolved around failure to establish remains a major cause of obstetric morbidity and mortality. a differential diagnosis or consider available clinical infor- The pregnancy-related maternal mortality ratios in the United mation; failure or delay in ordering diagnostic tests; and States were 17.8 and 15.9 deaths per 100,000 live births in ambiguous, incomplete, or contradictory information. Another 2011 and 2012, respectively. National statistics suggest that factor worth noting, but not included in the above listing, was 11.3 percent of these deaths during 2011 and 2012 were that the caregiver was distracted, multitasking, or interrupted. caused by obstetric hemorrhage.1 Postpartum hemorrhage is defined as blood loss greater than POSTPARTUM HEMORRHAGE— 500 mL following a vaginal delivery or greater than 1,000 mL PATIENT SAFETY RECOMMENDATIONS following cesarean delivery.2,3 A loss of these amounts within The use of a classification system for each patient regarding 24 hours of delivery is termed an early or primary postpartum her risk of postpartum hemorrhage allows for preparation prior hemorrhage, whereas such losses are described as late or to delivery, including type and screen or type and crossmatch secondary postpartum hemorrhage if they occur more than of blood products. 24 hours after delivery.4,5,6 Additionally, in a large, population-based study,7 the significant The occurrence of obstetric hemorrhage can be strongly risk factors identified using a multivariable analysis were: related to management of the third stage of labor. This section provides suggestions for documentation tools to Retained placenta. facilitate a proactive approach and validate the quality of Failure to progress during the second stage of labor. care rendered in hemorrhage situations. The discussion Placenta accreta. will cover the risks and errors related to postpartum hemorrhage and provide strategies to enhance patient Lacerations. safety and minimize risk. Instrumental delivery. According to a study done by The Doctors Company on Large-for-gestational-age (LGA) newborn. 2007–2015 closed claim data, postpartum hemorrhage Hypertensive disorders. accounts for 3.3 percent of all obstetric-related claims. Induction of labor. As seen in Figure 1, technical performance is the top Augmentation of labor with oxytocin. risk factor contributing to patient injury in postpartum hemorrhage claims. This category includes situations in which a known complication occurred or where poor technique FIGURE 1 was identified. Inappropriate selection and management of therapy is the Top Factors That Contributed to Patient Injury second, closely related category in Postpartum Hemorrhage Claims of factors contributing to patient injury. Workload was also an issue, especially during night shift or holiday Technical Performance 7935% time periods. Documentation of Selection and Management of Therapy 23%64% postpartum hemorrhage management was insufficient or lacking in regard Workflow/Workload 29% 19% to clinical findings, informed consent, Insufficient or Lack of Documentation 29% 19% and/or the date and timing in many of the claims. At times, providers Communication Among Providers 29%16% Not for distribution failed to establishNot clear lines of for distribution Patient Assessment Issues 21% % responsibility regarding the patient’s 13 condition, a factor that contributed to % Note: Some claims had more than one contributing factor. 21 16 percent of postpartum hemorrhage Source: The Doctors Company Closed Claims 2007–2015

OBSTETRICS AND GYNECOLOGY 21 Other risk factors for postpartum hemorrhage include obesity prevented. One in every 67 patients so treated would (a BMI over 40 can significantly increase the risk of atonic avoid transfusion with blood products.14,15 8,9 uterine hemorrhage) and serotonin-norepinephrine reuptake Estimating blood loss in every delivery allows providers to 10,11 inhibitor exposure in late pregnancy. remain vigilant in selection of management techniques. Prevention of postpartum hemorrhage is enhanced when Quantified blood loss (QBL) via weight of saturated materials practitioners remain cognizant and vigilant of the underlying is becoming increasingly more recommended as a standard causes and risk factors. Obstetric hemorrhage has many of care.16 The use of QBL enables the healthcare team to potential causes, but the most common, by a wide margin, is identify postpartum hemorrhage in a more objective manner. uterine atony, i.e., failure of the uterus to contract and retract In almost all cases in which failure to proceed with surgical management is chosen after medical management has failed to control a massive hemorrhage, not attempting surgery would lead to maternal death. High-quality evidence suggests that Ensure that facility obstetric committee meetings include periodic discussion on availability and location of devices active management of the third stage and resources, such as various balloon tamponade devices, supplies and instruments for B-lynch suture placement or of labor reduces the incidence and arterial ligation, or other recommended tools for postpartum hemorrhage surgical management. severity of postpartum hemorrhage. TREATMENT GUIDELINES AND DOCUMENTATION following delivery of the infant. Postpartum hemorrhage in The implementation of a systematic bundle approach has a previous pregnancy is a major risk factor, and every effort proven to be successful in the treatment of postpartum should be made to determine the severity and cause of the hemorrhage as well as in other obstetric emergencies. Several previous incident. In a recent randomized trial in the United authoritative resources are available to provide guidance in States, large birth weight, induction or augmentation of developing protocols for management of the hemorrhage as labor, chorioamnionitis, magnesium sulfate use, and previous well as documentation of the care rendered. obstetric hemorrhage were all positively associated with increased risk of postpartum hemorrhage.12 Early recognition The American College of Obstetricians and Gynecologists has and the implementation of bundle treatment strategies can produced Obstetric Hemorrhage Risk Assessment Tables, decrease morbidity and mortality. checklists for management of an active hemorrhage, and a Massive Transfusion Protocol in its Obstetric Hemorrhage Certainly, the presence of significant antepartum or Bundle available at acog.org/About-ACOG/ACOG-Districts/ intrapartum risk factors warrants delivery on a maternity District-II/SMI-OB-Hemorrhage. unit that has readily available resources to deal with massive obstetric hemorrhage. However, all medical facilities should The California Maternal Quality Care Collaborative have protocols for preventing and managing postpartum (CMQCC) has also become a nationally recognized hemorrhage emergencies. source for obstetric hemorrhage management protocols, checklists, and documentation tools. These resources High-quality evidence suggests that active management of are available for download at cmqcc.org/resources-tool-kits/ the third stage of labor reduces the incidence and severity toolkits/ob-hemorrhage-toolkit. of postpartum hemorrhage. Active management is the combination of (1) uterotonic administration (preferably Likewise, the National Partnership for Maternal Safety has oxytocin) immediately upon delivery of the infant, (2) early introduced a bundle outlining the four “Rs” of obstetric cord clamping and cutting, and (3) gentle cord traction with hemorrhage care: 13 uterine countertraction when the uterus is well contracted. Readiness. Active management can facilitate an approximate 60 percent Recognition Prevention. reduction in the occurrence of postpartum hemorrhage. An Response. 80 percent reduction in the need for therapeutic uterotonic agents was also noted. The results indicate that for every Reporting and Systems Learning. 12 patients receiving active rather than physiological Not for distributionThis bundle is available at safehealthcareforeverywoman.org. Not for distribution management, one postpartum hemorrhage could be

OBSTETRICS AND GYNECOLOGY 22 The value of a bundle approach can be immeasurable 7. Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric when combined with periodic simulation drills in which risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Maternal Fetal the full obstetric team has the opportunity to both become Neonatal Med. 2005 September;18(3):149-54. [Medline.] and remain familiar with protocols and documentation tools. The relative frequency and potential consequences 8. See note 4 above. of this postpartum emergency necessitate proactive risk 9. Blomberg M. Maternal obesity and risk of postpartum hemorrhage. management, familiarity with protocols, and the ability Obstet Gynecol. 2011 September;118(3):561-8. [Medline.] to mobilize choreographed care on a moment’s notice. 10. Hanley GE, Smolina K, Mintzes B, Oberlander TF, Morgan SG. Postpartum hemorrhage and use of serotonin reuptake inhibitor antidepressants in pregnancy. Obstet Gynecol. 2016 March; REFERENCES 127(3):553-61. [Medline.] . 1 Pregnancy-Related Deaths: Pregnancy Mortality Surveillance 11. Haelle T. Venlafaxine tied to increased postpartum hemorrhage risk. System. Centers for Disease Control and Prevention website. Medscape Medical News. www.medscape.com/viewarticle/858900. www.cdc.gov/reproductivehealth/MaternalInfantHealth/ February 15, 2016. Accessed: March 2, 2016. PMSS.html. Accessed October 20, 2016. 12. Jackson KW Jr, Albert JR, Schemmer GK, Elliot M, Humphrey A, 2. Baskett TF. Complications of the Third Stage of Labour. Essential Taylor J. A randomized controlled trial comparing oxytocin adminis- Management of Obstetrical Emergencies. 3rd ed. Bristol, England: tration before and after placental delivery in the prevention of Clinical Press; 1999:196-201. postpartum hemorrhage. Am J Obstet Gynecol. 2001 October; 3. Sentilhes L, Vayssière C, Deneux-Tharaux C, et al. Postpartum 185(4):873-7. [Medline.] hemorrhage: guidelines for clinical practice from the French College 13. See note 10 above. of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care 14. See note 11 above. (SFAR). Eur J Obstet Gynecol Reprod Biol. 2016 March;198: 12-21. [Medline.] 15. See note 12 above.

4. Obstetric Hemorrhage. American College of Obstetricians and 16. See note 5 above. Gynecologists website. www.acog.org/About-ACOG/ACOG-Districts/ District-II/SMI-OB-Hemorrhage. Accessed July 7, 2016.

5. OB Hemorrhage Toolkit V 2.0. California Maternal Quality Care ADDITIONAL RESOURCES Collaborative website. www.cmqcc.org/resources-tool-kits/toolkits/ McDonald S, Abbott JM, Higgins SP. Prophylactic ergometrine-oxytocin ob-hemorrhage-toolkit. Accessed July 7, 2016. versus oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2004. (1):CD000201. 6. AIM e-Module 2: Obstetric Hemorrhage. Council on Patient Safety in Women’s Health Care website. Elbourne DR, Prendiville WJ, Carroli G, Wood J, McDonald S. www.safehealthcareforeverywoman.org. Accessed July 7, 2016. Prophylactic use of oxytocin in the third stage of labour. Cochrane Database Syst Rev. 2001. CD001808. [Medline].

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OBSTETRICS AND GYNECOLOGY 23 FAILURE TO DIAGNOSE BREAST CANCER AND MANAGEMENT OF ABNORMAL SCREENING RESULTS

After conditions involving pregnancy and childbirth, malignant DOCUMENTATION neoplasms of the female breast are the most prevalent Document the patient’s history and all physical findings. conditions resulting in obstetric and gynecologic malpractice Use diagrams and include verbal descriptions, both positive claims. In the United States, more than 200,000 women and negative, regarding the following: palpable mass, nipple are diagnosed with breast cancer every year, and more discharge, skin dimpling, nipple retraction, and tissue than 40,000 women die from it annually. Breast cancer is thickening. Note with specificity all patient complaints and recognized as a leading cause of premature mortality among denials. A well-documented medical record is vital to quality U.S. women. Early detection of breast cancer is associated patient care and is the best loss prevention measure. with a decrease in breast cancer morbidity and mortality.1 Set the appointment for the next visit and the next mammogram before the patient leaves the office. Make all necessary consultation arrangements and verify compliance. A meticulous tracking mechanism A meticulous tracking mechanism is necessary to validate completion of—and physician’s receipt of—all test results. is necessary to validate completion It should capture the necessary documentation of the physician’s response and follow-up instructions given to of—and physician’s receipt of— the patient. If the patient does not speak English, it is recommended all test results. that the physician use a qualified translator and document in the medical record that a translator was used. Family PATIENT SAFETY AND LOSS PREVENTION members and individuals who accompany the patient to the medical office are not appropriate to serve as translators for This section outlines strategies for patient safety and loss important healthcare discussions. If a qualified translator is prevention and makes recommendations for early diagnosis not available, consider using a commercial translation service and treatment. While not intended to provide the standard available by phone. of care, the information should be a useful guideline for proactive risk management by reducing exposures to breast cancer claims. PATIENT EDUCATION AND BREAST SELF-AWARENESS A comprehensive approach to early diagnosis of female breast In October 2015, the American Cancer Society advised that cancer has traditionally included three elements: routine routine breast self-examination for screening purposes was clinical breast examination, frequent patient self-screening no longer recommended due to lack of evidence of benefit. (including breast self-examination or breast self-awareness), The American College of Obstetricians and Gynecologists, and regularly scheduled breast imaging. The patient’s clinical however, noted in its reaction to the American Cancer complaints should also be considered and documented. Society statement that patient breast self-awareness, as well as annual clinical breast exams, continue to be important preliminary screening measures. PHYSICIAN OFFICE PRACTICE POLICIES AND PROCEDURES Patients should be advised of office policies for screening SCREENING GUIDELINES FOR ASYMPTOMATIC PATIENTS mammograms, clinical examinations, and the expectation the patient will report any positive findings at the time of self- Mammograms provide substantial benefit for early detection screening to the office. Engage patients in their treatment in women 40 years of age and older, according to the Not for distributionAmerican College of Obstetricians and Gynecologists. In Not for distribution and decision making. response to the American Cancer Society revised guidelines of October 2015, the College maintained its recommendations to begin mammography and clinical breast examination at age 40.

OBSTETRICS AND GYNECOLOGY 24 The recommendations of the College are:2 SYMPTOMATIC PATIENTS Screening mammography every year for women aged Common reasons for errors in diagnosis include: 40–49 years. Failure to address positive physical examination findings. Screening mammography every year for women aged Inadequate patient follow-up. 50 years or older. Reliance on a negative or equivocal mammography report. Breast self-awareness has the potential to detect palpable breast cancer and can be recommended. Clinical breast exam every year for women aged 19 or older. Awareness of risk factors can help CLINICAL BREAST EXAM target key patient populations for The American College of Obstetricians and Gynecologists continues to recommend that clinical breast exams be done closer surveillance and education. every year for women aged 19 or older. The clinical breast exam should be conducted with the Commonly, a mammogram is ordered in response to a patient sitting and arms raised, as well as with the patient physical finding of a palpable breast or lymph node mass. supine. Examine the entire breast mound from mid-sternum However, mammography has a false-negative rate as high to posterior axillary line and from the costal margin to the as 20 percent. If the mammogram is negative in the face of clavicle. Documenting the exam is essential to ensure that suspicious clinical findings, further follow up and/or additional the patient receives all subsequent care needed for breast testing is advisable. In some cases, breast biopsy may be health, as well as providing a complete record in the defense necessary to resolve any doubt. Close attention to follow-up of a claim. history and physical examination is necessary in virtually all cases and is the best way to decrease the likelihood of a The manifestations of the various types of breast cancer call delayed diagnosis claim, should a malignancy later develop. for a thorough and complete examination in order to detect early development of the cancer. For example, several types of breast cancer are first felt as a hard lump. Among these ASSOCIATED RISKS types of cancer is the most common, invasive ductal cancer, Awareness of risk factors can help target key patient which makes up 70 percent of all newly diagnosed cases. populations for closer surveillance and education. However, Invasive Paget’s disease is a rare breast cancer in the ducts it is important to remember that the absence of risk factors beneath the nipple, which starts as an itchy, eczema-like should not provide a false sense of security that the disease rash around the nipple. will not develop. Indeed, the majority of breast cancers are diagnosed in women who do not have specific risk factors. Inflammatory carcinoma is an aggressive type of breast cancer, which is manifested by acutely inflamed and The Centers for Disease Control has identified a number swollen skin over the breast because lymph vessels are of breast cancer risk factors. These are available at blocked by cancer. cdc.gov/cancer/breast/basic_info/risk_factors.htm. Given the diverse presentations of this disease, the clinical Having a risk factor does not mean that breast cancer will breast examination should include adequate inspection and develop, and not all risk factors are equally weighted. A palpation to assess such factors as: combination of several factors presents a higher risk; however, the most prevalent risk factor by far is aging. Most breast Skin flattening or dimpling. cancers are found in women who are 50 years old or older. Skin erythema. Although the likelihood of breast cancer increases with

Skin edema. age, it is important to be diligent with diagnosis of younger Nipple retraction. patients with breast complaints or abnormal physical findings. Nipple eczema. Younger patients tend to have denser breasts—which makes examination more difficult; similarly, their mammograms Nipple discharge. Not for distribution Not for distributionare more difficult to read. It is an unfortunate fact of life Breast fixation. that invasive breast cancer may develop in younger women, Tissue thickening. and the diagnosis must not be overlooked based on age. Palpable masses.

OBSTETRICS AND GYNECOLOGY 25 Breast cancer in young women is more FIGURE 1 likely to be hereditary than breast cancer in older women, but this is still Key Factors in Breast Cancer Claims just a risk factor, and a negative family Involving Delayed Diagnosis history never rules out the diagnosis. Inadequate Patient Assessment 71% GENETICS Patient Factors 19% Approximately 5 percent to 10 percent of breast cancers are Failure/Delay in Obtaining Consult 17% thought to be hereditary. Genetic Communication Between Patient/ 16 % testing may be warranted. Additional Family and Provider information is available at Communication Among Providers 12 % breastcancer.org/risk/factors/genetics. Note: Some claims had more than one contributing factor.

BREAST CANCER FACTS Source: The Doctors Company and CRICO Strategies 2009–2014 The PIAA Breast Cancer Study stresses that the delay in diagnosis of breast FIGURE 2 cancer is the most frequent and most expensive of all malpractice claims. Top Four Allegations in Breast Cancer Claims In 38.7 percent of the cases, the patient’s presenting symptom Diagnosis Related (failure, delay, or wrong) 90% was a lump in the breast. Over 24 percent of these cases were initially Improper Management of Treatment 4% misdiagnosed as benign conditions, Delay in Treatment or Procedure % such as a cyst, fibrocystic disease, or 1 other benign processes. The patients Improper Medication Management 1% in the claims analysis averaged 40.6 years of age, which supports the need for vigilance when a younger Source: The Doctors Company Closed Claims 2007–2015 woman presents with a breast lump. It is recommended that all abnormal physical findings be to patient injury. Patient assessment issues included pursued to a definitive diagnosis within four to six weeks of misinterpretation of diagnostic studies, failure or delay in the patient’s initial presentation. The office practice should be ordering diagnostic tests, failure to establish a differential committed to following an accepted algorithm for evaluation diagnosis, and over-reliance on negative findings in patients and response to positive findings in a timely manner. with continued symptoms. Situations in which patients were not compliant with follow-up THE DOCTORS COMPANY/CRICO STRATEGIES BREAST appointments or with treatment plans, along with instances CANCER CLOSED CLAIMS STUDY in which patients interrupted care to seek other providers due to dissatisfaction, were significant issues in the Patient The Doctors Company and CRICO Strategies pooled mal- Factors category. practice claims data to study 342 breast cancer claims occurring between 2009 and 2014. Communication failures involving patients included insufficient or lack of follow-up instructions given, failure The specialties most frequently named were radiology, family or delay in scheduling or performing recommended tests, practice, and gynecology, usually because of a delay in and overall poor rapport with the patient. diagnosis. Unreliable office system issues were identified as a concern contributing to a delay, leading to misinter- Where documentation was considered to be a contributing pretation of diagnostic studies, delay or failure to order factor in the claim, allegations included inadequate description additionalNot tests, communication issues,for poor documentation, distribution of clinical findings, lack of evidence of follow-up efforts, or Not for distribution and failure to follow up on missed appointments. inadequate discussion of patient’s refusal of treatment. In the final three categories of the claims studied, providers Further details identified within each of the categories in did not communicate well to the patient or failed to read Figure 1 provide insight into specific factors contributing medical records that were available to them. There were also

OBSTETRICS AND GYNECOLOGY 26 occasions in which the physician did not receive a report, the physician’s recommendations for testing and/or treatment received the wrong report, or results were filed before and that the patient understands the potential problems or being reviewed by a physician. These issues were similarly complications that could occur. A sample “Refusal to Consent reflected in the failure of follow-up systems category for to Treatment, Medication, or Testing” form is available under both routine screenings and new findings. As shown in Miscellaneous in our Informed Consent resource center Figure 2, The Doctors Company identified factors alleged at thedoctors.com/consent. to have contributed to patient injury in our own study of 204 closed claims. GETTING SUED FOR BREAST CANCER Less frequent allegations in the study included wrong or Suits involving breast cancer are among the most common unnecessary treatment, improper performance of treat- causes of malpractice litigation in the United States. The ment or procedure, improper performance of surgery, majority of breast cancer cases allege delay in diagnosis. improper management of the surgical patient, and failure These claims may be divided into those involving diagnostic to obtain consent. error and those involving poor communication. Additional claims arise from therapeutic acts of omission or commission. ERRORS IN DIAGNOSIS For more information, access an expanded article, “Getting Sued for Breast Cancer” by Richard E. Anderson, MD, FACP, Diagnostic errors, especially those involving the inter- available at thedoctors.com/KnowledgeCenter/PatientSafety/ pretation of mammography, continue to be the most articles/Getting-Sued-for-Breast-Cancer. common allegations in breast cancer claims. Manual breast examination, when coded as the precipitating procedure in a claim, has the highest average REFERENCES indemnity payment. These are usually situations in which 1. Learn About Cancer. American Cancer Society website. www.cancer the manual exam was the only “procedure” performed or .org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics. when it was not performed at all. Accessed August 5, 2016. Diagnostic errors also have arisen from the trend to 2. ACOG Statement on Revised American Cancer Society minimize the invasiveness of biopsies by performing Recommendations on Breast Cancer Screening. American College of fine-needle and sentinel node biopsies. Results may Obstetricians and Gynecologists. www.acog.org/About-ACOG/News -Room/Statements/2015/ACOG-Statement-on-Recommendations yield suboptimal information and lead to increased -on-Breast-Cancer-Screening. Accessed August 5, 2016. claim exposure. ADDITIONAL RESOURCES DELAY IN DIAGNOSIS DUE TO PATIENT NONCOMPLIANCE American College of Obstetricians and Gynecologists. ACOG Practice In claims involving delay in diagnosis and patient non- Bulletin No. 122: Breast Cancer Screening. August 2011. compliance, the following factors were identified as the most prevalent reasons: Caplan L. Delay in breast cancer: implications for stage at diagnosis and survival. Front Public Health. 2014 July; 2:87. www.ncbi.nlm.nih.gov/ Failure to keep follow-up appointments. pmc/articles/PMC4114209/. Accessed May 2016.

Procrastination by patient. Greenberg P, Ranum D, Siegal D. Navigating risks in breast cancer Behavioral/emotional problems. diagnosis and treatment. Patient Safety and Quality Healthcare. 2015 October. www.psqh.com/analysis/navigating-risks-in-breast-cancer Socioeconomic issues. -diagnosis-and-treatment. Accessed August 9, 2016.

Fear of the diagnosis or necessary procedures. Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Refusal to have a mammogram and/or other Review, 1975–2012, National Cancer Institute. Bethesda, MD, based on November 2014 SEER data submission, posted to the SEER diagnostic study. website, April 2015. www.seer.cancer.gov/archive/csr/1975_2012/.

PIAA Data Sharing Project. Specialty Specific Series. OB/GYN Surgery. REFUSAL OF CARE January 1, 2004–December 31, 2013. 2105.

In many cases of diagnostic delay noted in the study, patients Jemal A, Simard EP, Dorell C, et al. Annual report to the nation on the did not follow their doctors’ recommendations for follow-up status of cancer, 1975–2009, featuring the burden and trends in human evaluation(s). Such cases are difficult to defend unless papillomavirus (HPV)-associated cancers and HPV vaccination coverage Not for distribution Not for distributionlevels. J Natl Cancer Inst. 2013 Feb 6:105(3); Epub 2013 Jan 7. physician documentation of follow-up efforts is adequate. If the patient does not want to follow recommendations for Centers for Disease Control and Prevention. Breast cancer rates testing and/or treatment, consider using a form. by state. www.cdc.gov/cancer/breast/statistics/state.htm. Accessed refusal of care October 30, 2013. Such a form is used to document the patient’s declination of

OBSTETRICS AND GYNECOLOGY 27 FAILURE TO DIAGNOSE CERVICAL CANCER AND MANAGEMENT OF ABNORMAL PAP TESTS

Failures to diagnose and delay in diagnosis of cervical PATIENT PROFILE cancer are among the most prevalent types of medical Risk factors for cervical cancer include, but are not limited malpractice claims encountered in obstetrics and gynecology. to, multiple full-term pregnancies, young age at the first Notwithstanding causation factors, claims alleging a delay full-term pregnancy, certain types of genital warts (specifically in diagnosis of cervical cancer are difficult to defend. the human papillomavirus [HPV]), immunosuppression In many cases, an otherwise medically defensible claim is (HIV), chlamydia infection, long-time use of oral contra- compromised by inadequate documentation. Loss prevention ceptives, cigarette smoking, poverty, family history, and strategies to reduce exposure are predicated on appropriate inadequate screening. assessment, screening, test result tracking, and timely Almost all cervical cancers are related to HPV infection, most follow-up. This section reviews the risks and the related errors commonly high-risk HPV types 16 and 18. These types are associated with cervical cancer and recommends strategies not associated with genital warts (HPV types 6 and 11).2 An to minimize risk, reduce the risk of error, and successfully adequate patient history should identify the high-risk patient, defend the unavoidable claim. who can then be closely followed. The patient’s care plan should include adequate screening for HPV and HIV, and other sexually transmitted infections as appropriate, as well as meticulous and timely Pap tests or smears and pelvic exams. Documentation of all efforts to track Pap tests use thin-layer liquid-based cytology, which is more sensitive than the conventional Pap smear and allows testing and follow up with the patient should for high-risk HPV on the same specimen collected for the Pap test. Documentation of all efforts to track and follow up with be maintained. the patient should be maintained. Comprehensive patient education increases awareness and encourages compliance. ASSOCIATED RISKS The American Cancer Society predicts that there will be SCREENING RECOMMENDATIONS about 12,820 new cases of invasive cervical cancer in the A review of claims involving misdiagnosis or failure to United States in 2017. Approximately 4,210 women will die diagnose cervical cancer indicates that, many times, the from this disease in that time. When detected at an early cancers might have been identified earlier. The American stage, the five-year survival rate is estimated at 93 percent Cancer Society, American College of Obstetricians and for women with invasive cervical cancer. In contrast, women Gynecologists, and many other professional societies with more advanced disease have a much lower five-year recommend cytologic screening (Pap tests or Pap smears) for survival rate after diagnosis. For example, women with cervical cancer on all women at age 21 and continuing every stage II cervical cancer have about a 58–63 percent five-year three years until age 29 if results have been normal. Women survival rate, and women with stage IV cervical cancer have ages 30 to 65 who have had previous normal results should a five-year survival rate of approximately 15–16 percent. have cytology combined with an HPV test (co-testing) every Routine screenings can identify precancerous lesions of the five years or in the alternative, continue with a schedule of cervix. Early in the disease process, patients are generally cytology every three years. Women over 65 may discontinue asymptomatic. Later signs and symptoms include, but are further cytology screening if they have had regular negative not limited to, abnormal vaginal bleeding, unusual discharge screenings in the previous 10 years.3,4,5 from the vagina, and pain during intercourse.1 Routine screening recommendations do not apply to certain Not for distributionhigh-risk patients or those who have had a previous diagnosis Not for distribution of cervical cancer or its precursors. This group requires

OBSTETRICS AND GYNECOLOGY 28 closer follow-up. Both the American College of Obstetricians the patient regarding follow-up, further testing, or referral and Gynecologists and the American Society for Colposcopy to a specialist. Documentation should include telephone and Cervical Pathology guidelines include recommendations instructions provided to the patient as well as clinical care for follow-up after abnormal screening test results as well decisions. Obtain signed consent forms that specify the as guidelines for return to routine screening. It is important risks, benefits, and alternatives of the diagnostic study or to remember and to remind patients that adhering to treatment, and document the informed consent conversation. recommended cytology guidelines does not preclude the need Document the medical rationale supporting your assessment, 6,7 for comprehensive yearly exams. the diagnosis established or pending, and the treatment plan (and subsequent alterations) in conjunction with the patient’s MANAGEMENT OF AN ABNORMAL PAP TEST OR SMEAR clinical status. When a patient’s cytology result is abnormal, the follow-up testing may include a repeat Pap test or smear with COMMUNICATION co-testing for high-risk HPV, colposcopy, biopsy, endo- Effective communication between all members of the cervical sampling, or endometrial sampling. The age of the healthcare team and the patient is important. A cancer patient and her history, including any prior abnormal cervical diagnosis often elicits feelings of denial. Give the information cancer screening test results, determines the appropriate clearly and simply, allowing for the news to be understood. testing and follow-up regimen. Patients with a history of Invite questions and give time for your answers to sink in. cervical intraepithelial neoplasia 2+ (CIN 2+) have an Sincere expression of compassion and empathy can soften a increased recurrence risk for up to 20 years and must be difficult blow. It may take time for the patient to be ready educated and followed accordingly. It is recommended that American College of Obstetricians and Gynecologists and American Society FIGURE 1 for Colposcopy and Cervical Pathology Top Factors That Contributed to Patient Injury guidelines be reviewed thoroughly and periodically for recommendations on the in Cervical Cancer Claims management of patients with abnormal 8 screening results. Patient Assessment Issues 78% Patient Factors 33% APPROPRIATE FOLLOW-UP Communication Between Patient/ EVALUATION AND TREATMENT Family and Provider 33% A proportion of preventable cervical Insufficient or Lack of Documentation 22% cancers are attributed to patients with abnormal Pap smears, precancerous Note: Some claims had more than one contributing factor. conditions, or those who do not receive timely follow-up treatment. A mechanism Source: The Doctors Company Closed Claims 2007–2015 to track diagnostic testing and test results will significantly reduce the exposure to claims to make informed treatment decisions. Written information asserting delay in diagnosis. about therapeutic options and support resources will be helpful as the patient begins to absorb the implications Components necessary for an effective tracking system of the diagnosis. include a method to ensure that diagnostic studies, consultations, and laboratory test results are received By facilitating early diagnosis, timely treatment, and excellent and reviewed by the physician before they are placed in rapport with the patient, the exposure to claims entailing the patient’s chart and a method to identify and address failure to diagnose and treat in a timely manner can be patients who fail to keep appointments or who fail to significantly reduced. have the diagnostic tests completed in a timely manner. As illustrated in Figure 1, the top contributing factor in cervical cancer claims involves patient assessment issues. DOCUMENTATION These included the failure or delay in ordering diagnostic Not for distribution Not for distributiontests, addressing abnormal findings, establishing a differential Medical record documentation should create a chronological diagnosis, or misinterpreting diagnostic studies. Patients word picture of the assessment, diagnosis, treatment plans, who were noncompliant with follow-up calls or appointments and outcomes. Document details of the instructions to

OBSTETRICS AND GYNECOLOGY 29 underscore the need to make sure patients understand REFERENCES their part in their healthcare. Communication between patient/family and provider included insufficient follow-up 1. Cervical Cancer-American Cancer Society. American Cancer Society website. www.cancer.org/acs/groups/cid/documents/ instructions and inadequate informed consent for treatment webcontent/003094-pdf.pdf. Published 2016. Accessed options. Clinical findings and follow-up effort documentation August 3, 2016. were lacking or insufficient. 2. HPV and Cancer. National Cancer Institute About Cancer website. www.cancer.gov/about-cancer/causes-prevention/risk/infectious CERVICAL CANCER—PATIENT SAFETY RECOMMENDATIONS -agents/hpv-fact-sheet. Accessed August 3, 2016. Identify and closely follow high-risk patients who have a 3. Cervical Cancer: Screening. U.S. Preventive Services Task Force website. www.uspreventiveservicestaskforce.org/Page/Document/ history of abnormal Pap tests or smears and/or high-risk UpdateSummaryFinal/cervical-cancer-screening. Published March HPV test results. 2012. Accessed August 3, 2016.

Provide comprehensive patient education. 4. American College of Obstetricians and Gynecologists. Summary: Adhere to recommended guidelines for Pap tests and Cervical Cancer Screening and Prevention. Practice Bulletin No. 157: . 2016;127(1):185-187. smears and pelvic examinations. Obstet Gynecol Ensure that follow-up testing of abnormal testing results 5. Cervical Cancer Screening Guidelines. American Cancer Society website. www.cancer.org/healthy/ is completed. informationforhealthcareprofessionals/acsguidelines/ Implement a mechanism to track diagnostic testing and cervicalcancerscreeningguidelines/index. Published 2012. test results. Accessed August 3, 2016. Document instructions provided to the patient and 6. American College of Obstetricians and Gynecologists. FAQs: clinical care decisions. Abnormal Cervical Cancer Screening Test Results. www.acog.org/ Patients/FAQs/Abnormal-Cervical-Cancer-Screening-Test-Results. Consider terminating the physician-patient relationship Published January 2016. Accessed August 3, 2016. when the patient refuses to follow the treatment plan 7. Massa LS, Einstein MH, Huh WK, et al. 2012 updated consensus and follow-up. guidelines for the management of abnormal cervical cancer Obtain consultation from specialists when indicated. screening tests and cancer precursors. Journal of Lower Genital Tract Disease. 2013;17(5) S1:S27. Document the patient’s understanding of the need for subsequent testing. 8. American Society for Colposcopy and Cervical Pathology. Guidelines. www.asccp.org/asccp-guidelines. Accessed August 3, 2016. Seek patient safety advice whenever uncertain about how to proceed. ADDITIONAL RESOURCES

Cervical Cancer. American Cancer Society website. www.cancer.org/ cancer/cervicalcancer/detailedguide/cervical-cancer-key-statistics. Accessed April 20, 2016.

Guidelines and Algorithms for Management of Abnormal Screening Results. American Society for Colposcopy and Cervical Pathology (ASCCP) website. www.asccp.org/asccp-guidelines. Accessed July 7, 2016.

American Cancer Society Guidelines for the Early Detection of Cancer. American Cancer Society website. www.cancer.org/healthy/ findcancerearly/cancerscreeningguidelines/american-cancer-society -guidelines-for-the-early-detection-of-cancer. Accessed April 4, 2016.

2016 Patient FAQs Cervical Cancer Screening. American College of Obstetricians and Gynecologists website. www.acog.org/Patients/FAQs/ Not for distributionCervical-Cancer-Screening. Not for distribution

OBSTETRICS AND GYNECOLOGY 30 DEALING WITH NONCOMPLIANCE IN THE OB/GYN PATIENT

Despite high-risk protocols, a noncompliant patient gestational age are often time sensitive, so follow-up efforts compromises her own prognosis and the physician’s ability and notification sent to the patient must be prompt. to render appropriate, if not urgent, care. Consequently, Inform patients of the potential risks and consequences patients who do not follow the recommended treatment of their refusal to undergo recommended diagnostic studies plan are at inherently greater risk for poor outcomes. and treatment. Document your discussion in the medical The Doctors Company evaluated 1,804 closed obstetrical/ records, and send the patients written confirmation of gynecology claims from 2007–2015 for risk issues associated their informed refusals. A sample “Refusal to Consent to with patient factors. Patient noncompliance contributed Treatment, Medication, or Testing” form is available under to patient injury in 10.9 percent of the cases. Examples Miscellaneous in our Informed Consent resource center included patient noncompliance with the following: at thedoctors.com/consent. Follow-up calls or appointments. Treatment plans. Medication plans. It is important to document each It is important to document each occasion when the patient fails to keep a scheduled appointment or does not comply occasion when the patient fails to with recommended diagnostic testing and treatment. Inform patients who refuse to undergo recommended diagnostic keep a scheduled appointment or studies and treatment of the potential risk and consequences of their refusal. Document your discussion in the medical does not comply with recommended record, and send the patient written confirmation of her informed refusal. Follow statutory requirements for patient diagnostic testing and treatment. notification. Clinicians should have a process in place that ensures the providers are aware of patients who repeatedly Case Example: A 28-year-old female presented to her cancel or are no-shows for their appointments. doctor for her first pregnancy in May. The patient’s EDC was August 16. The patient refused all blood testing and was told To help achieve patient compliance with recommended to follow up in two weeks. She followed up four weeks later. diagnostic testing and treatment and to document your She continued to be noncompliant and was advised of the efforts, consider two phone calls and a letter. A clinician’s risks, including fetal demise. The patient was a scheduled staff should make two attempts to reschedule by phone induction and failed to show for induction on August 24 and, if there is no acceptable result, send a certified letter and again on August 25 and 26. Although the husband was that requires the patient’s signature. Scanning a copy of the called and advised to bring his wife in on multiple occasions, paperwork accompanying the certified letter into the medical the calls were not documented. It was assumed that the record is also recommended. patient was seeking care elsewhere. The patient presented on In this process, it is also helpful to address patient September 6 at 42 weeks and two days gestational age. She noncompliance by including educational information on the delivered an infant with low Apgars, cord around neck, and risks of noncompliance during telephone discussions or in meconium aspiration. The infant has developmental delays a letter. Having an established process for patient follow- and seizures. This case resulted in a large verdict against up will aid in defending a claim alleging failure to treat or the provider. Not for distribution diagnose inNot a timely manner. The timefor parameters relative todistribution

OBSTETRICS AND GYNECOLOGY 31 NONCOMPLIANCE—PATIENT SAFETY RECOMMENDATIONS for induction of labor could have served as diligent effort on the physician’s part to educate the patient on the risks To increase the ability to defend this case, meticulous she was undertaking, as well as to document the education documentation of all follow-up efforts would have been ideal. and patient contact. However onerous these documentation Assuming that the patient had found another doctor to care efforts may seem at the time, taking these recommended steps make defending a case easier. To further reduce your liability exposure when caring for noncompliant patients, consider terminating the physician- Documentation of all phone calls with patient relationship. It should, however, be recognized that there is a limited window of time to terminate the relationship the patient’s husband and his refusal when dealing with an obstetrical patient. If a patient is pregnant, termination of the relationship can be safely to bring the patient in for induction accomplished only during the first trimester, only in cases of uncomplicated pregnancies, and with adequate time to would most likely have been helpful find another practitioner. Termination in the second trimester should only occur for uncomplicated pregnancies and with in the defense of this case. transfer of the patient to another obstetrical practitioner accepted prior to cessation of services. Termination of for her and ceasing follow-up efforts at the end of August the relationship during the last trimester should only occur made the case against the physician more difficult to defend. under extreme circumstances, such as practitioner illness, Documentation of all phone calls with the patient’s husband and so on. and his refusal to bring the patient in for induction would Contact your patient safety risk manager to discuss specific most likely have been helpful in the defense of this case. A guidelines for terminating the physician-patient relationship certified letter outlining the risks of noncompliance to a plan with a pregnant patient.

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