Results Recorded for a Test not Performed

Description

A 30-year-old woman, whose medical record indicated a normal AFP test at 18 weeks, delivered a full-term baby with Down´s syndrome.

Key Lessons

• A quality audit of medical records can reduce opportunities for misinterpretation.

• Once testing has been discussed with and offered to a patient, document the patient’s intentions, particularly when multiple providers are caring for the patient.

• Be familiar with the policies and procedures of the institutions in which you practice. are taken seriously.

• Avoid being lulled into complacency by the absence of other significant abnormal findings in a particular circumstance.

Clinical Sequence

A 30-year-old woman (G3,P1,TAB1) was followed primarily by a nurse practitioner (NP) throughout her uneventful, second pregnancy. The same NP had cared for her during her prior pregnancy. The patient was healthy with no risk factors and had no complications with her prior pregnancy and delivery. At eight weeks, she began routine prenatal care at a hospital-based clinic.

At 11 weeks, the NP counseled the patient regarding optional alpha-fetoprotein (AFP) and HIV tests. The patient was informed that the AFP, which may identify spina bifida and Down's syndrome, is usually performed between the 15th and 18th week of the pregnancy. She was further instructed that patients whose AFP is abnormal typically undergo additional testing such as ultrasound and amniocentesis to aid a more definitive diagnosis. (During her first pregnancy, this patient’s AFP test had been normal.)

At 16 weeks, the patient was seen by a third-year resident. Her examination was normal and the baby's size was appropriate for its age. The physician ordered a growth ultrasound for 18 weeks but did not order the AFP, which typically would have been done at this visit.

At her scheduled visit at 20 weeks, the patient saw the NP who reviewed her record and noted that an ultrasound performed at 18 weeks indicated a normal fetus. The NP also documented that an AFP had been performed and was normal. The patient received routine prenatal care for the remainder of her pregnancy. Following delivery, the baby was diagnosed with Down's syndrome and a cardiac anomaly which required cardiac surgery a year later.

The clinicians met with the parents and explained that the AFP results (from her first pregnancy) in her record had been errantly interpreted as being the results of a test during her second pregnancy.

Claim Sequence

The family filed suit against the nurse practitioner and two physicians for wrongful birth based on their failure to do appropriate prenatal testing.

Disposition

The case was settled in the mid-range ($100,000-$499,000) with liability assessed equally to the NP and the resident.

Analysis

1. The AFP test result from the first pregnancy was inappropriately filed in the medical record, leading the NP to assume that this was the test for the current pregnancy. (This hospital has since switched to a computerized record system.) A quality audit of medical records can reduce opportunities for misinterpretation, such as confusing test dates. Electronic medical records (EMRs) are less vulnerable to this type of error. Given the chance for errors, even with EMRs, staff training should reinforce the importance of precise reading and review of the chart, particularly when reviewing data that may have a direct impact on the treatment plan and recommendations for the patient.

2. At 11 weeks, the NP failed to document in the medical record whether or not the patient intended to have the AFP test at her next visit. The resident's note did not mention the AFP either. Even for optional testing, once it has been discussed with and offered to a patient, the clinician should document the patient’s intentions, particularly when multiple providers are caring for the patient. Such documentation will help ensure that proper testing and follow-up on the test results is done.

3. The resident, who should have ordered the AFP, was unaware that it was hospital policy for all pregnant women to be offered this test. Clinicians need to be familiar with the policies and procedures of the institutions in which they practice. Orientation should always include review of the applicable policies and procedures and where reference copies are kept. Including information re: testing options on the house staff pocket cards can also reduce missed opportunities. When a clinician deviates from a hospital policy or procedure, the clinical basis for such deviation must be documented, including the rationale for the decisions.

4. At 18 weeks, the radiologist read the ultrasound as normal. A second reading, after the delivery, identified a subtle, but clearly detectable heart defect consistent with Down's syndrome. Improper reading of a test raises concerns regarding the practitioner’s skills and the institution’s quality. Deviation from standard practice may need to be assessed in an objective manner, by a peer review committee. Clinicians may be lulled into complacency by the absence of other significant abnormal findings in a particular circumstance. Some institutions put into place systems to help prevent clinicians from missing potentially significant findings, such as double readings of certain radiological tests, in which two clinicians independently review the same films.