Examples of Standard of Care: Obstetrics, Gynecology, Perinatal, Neonatal Medicine

Mothers with multiple births are far more likely to be hospitalized with complications such as pre-eclampsia and pulmonary embolism. A high degree of triplets and quadruplets have at least one child with a major handicap such as cerebral palsy. Accordingly, it is extremely important for the OB/GYN to be extremely careful in monitoring the expectant mother with multiple children. Ultrasound in the first trimester is certainly recommended for diagnostic purposes and determination of amnionicity and chorionicity, ruling out monoamniotic twins and early loss of fetus. In the second trimester, it becomes important in detecting anomalies, abnormal growth or dichorionic twins, assessment of the cervix, assessment of the amniotic fluid volume and genetic testing. In the third trimester, ultrasound is important to determine abnormal fetal growth, anti-partum fetal surveillance and assessment of the cervix. It is important to diagnosis amnionicity and chroionicity, the number and position of the fetuses, the number and position placentas, the thickness of the membrane, the sex of the fetuses and to confirm monoamniotic twins. When there are twin pregnancies, a cervix shorter than 25 mm at twenty-four weeks suggests delivery before thirty-two, thirty-five and thirty-seven weeks. Digital examination is not as objective. It is clearly not easy to scan twins and it is even more difficult with triplets or quadruplets.

The general practice OB/GYN should be extremely careful following multiple births without some specialization involved. Failure to diagnosis appropriately, an inaccurate dating, lack of recognizing the implications of amnionicity and chorionicity, the failure to detect anomalies and failure to provide genetic counseling for twins can certainly lead to malpractice claims. It is also important for the OB/GYN to educate the patient about pre-term labor issue/risks. Failure or delay of diagnosis of this problem, failure to give steroids or inappropriate use of Tocolytic therapy or inappropriate use of cerclage can also lead to malpractice claims. Moreover, there needs to be close follow up of twins being treated for pre-term labor either in or out of the hospital. The OB/GYN must have experience in managing pre-term labor in twins or face the real prospect of a claim being made. Delay in transferring a patient to a higher level facility in order to prevent post-birth injury due to lack of specialized neonatal care can also lead to claims against the OB/GYN and/or hospital. Other issues involved in multiple birth situations include lack of experience in performing vaginal delivery, failure to properly advise the mother about her various options for delivery, the lack of ultrasound in labor and delivery, failure to have two OB/GYN doctors available for a twin vaginal delivery, failure to properly monitor at appropriate intervals the second twin delivered and failure to prepare for possible emergency cesarean of the second twin.

The OB/GYN can expect to be questioned about his loss of income for his failure to refer a multiple birth situation to a specialist in the event that a problem occurs. A jury certainly would not want to hear or suspect that a doctor failed to refer a patient to a specialist merely because he was concerned about a loss of income.

Unfortunately, there are significant changes in cardiac and respiratory physiology associated with the birth of an infant. These may include elimination of lung fluid, decrease in pulmonary artery pressure, increased systemic vascular resistance. These and other changes may be delayed because of prematurity. It is important for the OB/GYN to react quickly and recognize cardio-respiratory failure and the need for immediate resuscitation. Clearly, immediate intervention of an infant in cardio-respiratory trouble can have far-reaching consequences on later neonatal course.

The standard of care for an OB/GYN in this situation is, based upon the best available scientific evidence in order to properly intervene with appropriate resuscitation efforts. It is important, for example, for the OB/GYN to maintain temperature within a normal range at the time of birth, this then becomes important in neonatal resuscitation as well. Unfortunately, a premature infant can have his/her body temperature drop quickly in the delivery room. This can result in catastrophic consequences including death. The OB/GYN must understand and prepare for the infant’s core temperature decreasing rapidly because of evaporative losses from the wet body. Moreover, the cold delivery room environment can also cause radiant and convective heat losses. Studies have shown that a naked, wet, term infant loses significant skin temperature and core temperature within thirty minutes of birth. Although some degree of cooling is appropriate for initiation of breathing and stimulation of thyroid function and at times could be helpful for the term infant at risk for possible cerebral injury, maintenance of the body temperature at or near 37 degrees Centigrade has been suggested as the appropriate standard of care for neonates. A pre-term infant has more difficulty maintaining temperature than a term infant does by peripheral vasoconstriction. Therefore, it is very important for the pre-term baby’s health to reduce the chance of hypothermia and maintain appropriate body temperature immediately after birth. Accordingly, it would be important to have available external heat such as radiant warmers to provide this consistency required. For pre-term infants, it may also be advisable to have the baby wrapped in transparent polythene that has a high rate of radiant heat transmission; however, it would be important to also monitor the temperature of the baby because this technique may produce elevated temperature.

A premature infant is very vulnerable to lung injury. A pneumothorax may develop into chronic lung disease. Therefore, it is very important for the OB/GYN to manage the infant initially in a correct way to prevent chronic lung disease; however, the physician must be careful to avoid excessive lung inflation. In the event that the physician is convinced that ongoing ventilation is required, positive and expiratory pressure should be utilized quickly in order to prevent the complete deflation of the lungs at the end of expiration as well as establishing and maintaining functional residual capacity. Otherwise, subsequent hyaline membrane disease may result.

Spontaneously breathing premature infants present other issues. Often an endotracheal intubation is used for resuscitation. If an infant is not intubated, a procedure known as continuous and expiratory pressure may be applied. However, this procedure is still in the developmental stage. There is concern, for example, about other organ morbidity with the use of continuous expiratory pressure.

Many experts are concerned about adverse effects of one-hundred percent oxygen as it relates to respiratory physiology, cerebral circulation and tissue damage from oxygen free radicals. Similarly, there are concerns about tissue damage from oxygen deprivation. Therefore, careful administration of a variable concentration of oxygen appears to be the standard of care. However, it must be monitored closely so that excessive oxygen is not used especially in the premature baby. Finally, appropriate dosing and administration of medicine is important with regard to resuscitation of the pre-term infant. Epinephrine is usually provided by venous access. Although it is also known to be provided by endotracheal means, this is not the accepted procedure at the present time.

There are various risk factors involved regarding cervical cancer. Primarily, these are sexual activity, cigarette smoking and immune system alterations. The American College of Obstetricians suggests that annual cytology screening three years after the initiation of sexual activity is required but no later than twenty-one years of age. Women younger than age thirty should have the screening every year, women between age thirty and older may have screening every two to three years provided there is no prior history of problems, no HIV infection and they have three prior negative pap smears.

Treatment of stage for stage IA1 cervical cancer would suggest the need for total hysterectomy or cone biopsy; for IA2, IB1 a radical hysterectomy, radial trachelectomy or radiation therapy; for stage IB2 chemo-radiation treatment followed by total hysterectomy. Some experts, however suggest that a radical hysterectomy of stage IB2 would be appropriate followed by radiation and chemotherapy.

Complications following a radical hysterectomy could include major urinary tract injuries, blood loss, bladder dysfunction, as well as other potential problems. The treating physician must understand, however that sexual histories are often not very accurate, clearly the sexual history of the patient’s partners are almost impossible to discover. Most experts agree that conservative surgery would be appropriate for very early discovered carcinoma. Some suggest the potential use of radical trachelectomy for stage IA2 and selected IB patients. Clearly, however, multi-modality therapy is standard.

Fetal sonography can provide valuable information regarding malformations in the fetus. In addition to the anatomy, the sonographer should look for the amniotic fluid volume, the placenta, the fetal presentation, the umbilical cord, the cervix, the gestational age and growth and the maternal uterus and adnexa. After eighteen weeks, the sonographer can look much more clearly at the head and neck, the brain anatomy, the lip and palette, the heart, including the four chamber view of the heart, the outflow tracts of the heart, the abdomen including the stomach, kidneys, bladder, umbilical cord, the spine and the extremities including the presence or absence of arms or legs. Unfortunately, many medical professionals are unable to read the sonography films appropriately. They frequently do not identify various problem areas. If they are unable to read the sonography results, they should be referring the patient to a specialist when any abnormality is suspected.

The diagnosis of breast cancer is easily one of the most common reasons why physicians are sued for medical malpractice. Obviously, the patient should disclose any specific problems they have with regard to current signs or symptoms of breast cancer that may not be obvious or apparent to the examining physician. The history and physical examination needs to be a thorough, accurate and a well documented exam. If there is a suspicious finding, prompt intervention is required. If there are ambiguous or less specific findings, the management of the problem would still require a deliberate plan. Unfamiliarity with the breast evaluation would require the physician to refer the patient to a specialist. Notes documenting the exam that are illegible are virtually always deemed ambiguous. The location of any cysts discovered should be not only stated in the written record but also reflected in a drawing of the breast itself. On the other hand, if the clinical notes do not clearly suggest a separate location for a presumed benign mass, which was eventually determined to be malignant, the doctor could easily find himself in the middle of a malpractice claim. Moreover, it is the doctor’s responsibility to clearly communicate the results of the examination with the patient and document the communication. In addition, the physician should tell the patient what limitations are inherent in the examination so that further diagnostic measures may be taken if deemed appropriate. The screening mammography may also be required depending on family history or other circumstances to ensure that there is no claim or speculation that the cancer could have been determined at an earlier time.

If a physician accepts a patient on a self-referral basis, that physician has the duty to provide the physical examination and communicate the results to the patient. Moreover, a physician cannot simply rely on a normal imaging or screening study where there is a clinically suspicious mass. Rather, the discovery of a suspicious mass necessarily obligates the physician to further investigation and intervention.

Where there are alternative management strategies available and a benign finding is suggested, it would clearly be a breach the standard of care to fail to consider alternative management strategies. Therefore, if the physician observed a solid mass, a tissue diagnosis would be the appropriate standard of care. The growing mass would certainly cause more heightened suspicion than information in mammography screening. In the event a physician does recommend a biopsy, that recommendation should be clearly documented in his records. Moreover, tissue diagnosis would be necessary in order to consider surgery. Even when there is no major area of concern in an initial examination, if a breast is found to be lumpy or bumpy, this should provide enough information for the physician to do follow up exams in shorter intervals than otherwise might be required.

The mammogram interpretation is also subject to a reasonable standard of care requirement. If abnormalities are adequately determined, they must be characterized as such in the reading. The tissue samples taken for the various techniques utilized to determine biopsy results also have an effect on possible claims. Even if the test results are negative but the sampling results are from fine needle aspiration or core biopsy but are inconsistent with a clinical course or mammographic findings, continued follow up may be required.

Although cessation of the physician patient relationship after a normal breast examination may relieve the physician of further responsibility, a physician cannot simply abandon the patient and fail to follow up or refer the patient were a clinical abnormality was observed. Indeed, depending on the patient’s condition, a more heightened responsibility may result on the part of the physician. A physician who does not normally read mammograms and/or is not a specialist, still has a duty to refer a patient to a specialist, particularly in view of a test that might be positive. In addition, if a patient’s clinical condition clearly suggests a growing mass and there is a negative biopsy report, it is the responsibility of the physician to see this discrepancy in the report and re-evaluate additional management options. This is particularly true where limiting tissue sampling techniques are used.

There are various requirements of informed consent including state law, federal law, hospital standards, ACOG, American Medical Association Code of Ethics and Food and Drug Administration regulations. The common law of Maryland in several cases therein require the doctor to reveal to his patient the nature of the ailment, the nature of proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. In order to prevail in an informed consent claim, the patient must be able to prove there was no emergency need for the medical treatment, the physician did not inform the patient of the material risks of the treatment, a reasonable person in the patient’s position would not have consented to the treatment if the physician had disclosed all the risks, and the patient’s injuries were causally related to the treatment. 42 CFR, section 482.51 indicates that hospitals who participate in the Medicare program must provide informed consent to its patients. JCAHO standards and the American Hospital Association Patient’s Bill of Rights also suggest the need for informed consent. ACOG in its technical bulletin # 136 indicates the necessity of informed consent. The American Medical Association Code of Ethics E-8.08 and E-10.01 sets forth similar standards for its members. Informed consent is required for surgery, mode of delivery of a baby, anesthesia, medications, tests that carry risks, medical advice based upon tests, who will be doing the suggested procedure, clinical trials, conditions that raise the risk of a bad outcome, any suggested new technology or equipment and any change in condition or plan of treatment is indicated. Often a doctor will suggest that informed consent was not required because the treatment was of an emergency situation. Sometimes the doctor may indicate that the patient verbally consented to the treatment regimen. These conversations should always be documented. In virtually all cases, the written approval of the patient should be obtained even though many hospitals have a general consent form,

The Court of Appeals clarified the informed consent requirements for surgery and medical treatment. Heretofore, it was assumed there needed to be a physical battery in order to prevail on an informed consent case. The Court of Appeals however, stated that was not necessary. Physical invasion is not required to prevail on an informed consent claim. This essentially overrules the prior cases Reed v. Camagnolo and Arrabal v. Crew – Taylor which suggested there needed to be proof of affirmative invasive treatment. See McQuitty, a minor, et al. v. Spangler, et al., No. 137, September Term 2008.

(Courts and Judicial Proceedings Article, MD Code, § 5-109)

§ 5-109. Actions against health care providers -

1. Limitations. An action for damages for an injury arising out of the rendering of or failure to render professional services by a health care provider shall be filed within the earlier of:
   1. Five years of the time the injury was committed; or
   2. Three years of the date the injury was discovered.
2. Actions by claimants under age 11. Except as provided in subsection (c) of this section, if the claimant was under the age of 11 years at the time the injury was committed, the time limitations prescribed in subsection (a) of this section shall commence when the claimant reaches the age of 11 years.
3. Exceptions to age limitations in certain actions.
   1. The provisions of subsection (b) of this section may not be applied to an action for damages for an injury:
      1. To the reproduction system of the claimant; or
      2. Caused by a foreign object negligently left in the claimant’s body.
   2. In an action for damages for an injury described in this subsection, if the claimant was under the age of 16 years at the time the injury was committed, the time limitations prescribed in subsection (a) of this section shall commence when the claimant reaches the age of 16 years.
4. Effect of filing claim. For the purposes of this section, the filing of a claim with the Health Care Alternative Dispute Resolution Office in accordance with § 3-2A-04 of this article shall be deemed the filing of an action.
5. Effect of other provisions. The provisions of § 5-201 of the title that relate of a cause of action of a minor may not be construed as limiting the application of subsection (b) or (c) of this section. **
6. Application. Nothing contained in this section may be construed as limiting the application of the provisions of:
   1. § 5-201 of this title that relate to a cause of action of a mental incompetent; or
   2. § 5-203 of this title ***

* § 3-2A-04 is the Health Care Malpractice Claims Subtitle
** § 5-201 refers to a person under a disability such as a minor or mental incompetent. It requires a claim to be filed within the lesser of three years or the applicable period of limitations after the date of disability is removed.
*** § 5-203 refers to ignorance of any cause of action induced by fraud. If fraud is involved the cause of action is deemed to accrue at the time when the party discovered, or by the exercise of ordinary diligence should have discovered the fraud.

Special Statute of limitations issues (exceptions to normal 3 year statute under Courts and Judicial Proceedings Article, § 5-101) :

1. Breast implants – see § 5-116. There are 180 days limitations from date of completion of an opt out period in a class action or any non binding mediation in a class action that need to be considered.
2. Sexual Abuse. Refers to § 5-701 of the Family Law Article for definition. Provides for 7 year statute of limitations from the date the victim attains the age of majority. Repressed memory is not a disability unless the victim is insane and unable to manage their own affairs. Doe v. Maskell, 342 Md. 684, 679 A. 2d 1087 (1966), 519 U.S. 1093, 117 S. Ct. 770, 136 L. Ed. 2d 716 (1997); Doe v. Archdiocese of Wash., 114 Md. App. 169, 689 A. 2d 634 (1997).
3. Assault, Libel, or Slander. Must be filed within one year of the date it accrues. In a medical malpractice context, if a claimant has consented to a procedure and another procedure was performed, the statue of limitations would be as provided under § 5-101. The additional surgery was not considered an unconsented to assault. Lipscomb v. Memorial Hosp., 733 F. 2d 332 (4thCir. 1984).
4. Intentional Infliction of Emotion Distress. The three year statute applies. Robinson v. Vitro Corp., 620 F. Supp. 1066 (D. Md. 1985).
5. Product Liability Arising in a Foreign Jurisdiction. See § 5-115. If a cause of action arose in another jurisdiction and is filed by a non resident in Maryland, the non resident’s State statute of limitations will control if it is less than our Maryland statute of limitations. There are some exceptions.

Also be sure to read our Frequently Asked Questions about Medical Malpractice

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