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    In a recent Florida case, a patient had a PAP smear that was sent to an outside lab where the results of the test were negative. Eight months later the patient was diagnosed with cervical cancer, and as a result underwent extensive chemotherapy and radiation treatment, and eventually required a radical hysterectomy.


    The patient was diagnosed as having a significant spread of the cancer throughout her body, and according to her and her physicians, the delay greatly shortened her life. She filed suit against the clinical laboratory, alleging the lab had misread the PAP smear and that a diagnosis should have been made earlier. The plaintiff also claimed that the laboratory failed to maintain appropriate standards for the supervision of technologists who were reading the test results. A further allegation was that if the appropriate safeguards had been in place, an earlier diagnosis of the carcinoma in-situ would have resulted. The plaintiff claimed that with an earlier diagnosis, less extensive treatment would have been necessary, and successful treatment of the condition would have been more likely.


    Testimony during the depositions indicated that the laboratory had failed to follow appropriate safeguards in overseeing how the tests were performed. The plaintiff alleged that, had appropriate safeguards had been in place, the misreading of the biopsy would have been detected. Prior to trial, the case was settled for the policy limit of $1 million.


    The utilization of diagnostic tests are an important and necessary part of medical treatment. However, there should not be absolute reliance upon these tests. If the clinical indications of a particular disease are very strong, then the clinician must look with suspicion upon test results that are not consistent with clinical findings. The procedures established by the physician's office in receiving and reviewing the results of such tests are critical in these situations. Both negative and positive results should be reviewed and initialed by a clinician before they are placed in the patient's file. This is important because the clinician who saw the patient must determine whether the negative results are consistent with the clinical findings he or she made during the physical examination, as well as the history taken from the patient about her physical condition.


    This is not to say that one should not rely upon laboratory results. The obstetrician/gynecologist who had referred the patient to the laboratory was not brought into the suit. There was no indication in that suit that the gynecological symptoms should have alerted the physician to the inaccuracy of the test. In this case, only the laboratory was sued for improper performance of the test and supervision of its employees.


    In a recent Massachusetts jury trial, a premenopausal woman in her 40s told her physician that she had been experiencing chest pain for several weeks. She said this pain radiated to her back but not to her arm or jaw. Her internist examined her and had an EKG performed, which was read as normal. His primary diagnosis was that the pain probably was not cardiac related. However, he told the patient that if the pain returned she should take an antacid, which had relieved the pain in the past. If the pain persisted, he told her take the nitroglycerin he had prescribed. If the pain still continued, he told her to go to an emergency room. He also told the patient to schedule an exercise tolerance test in the next few days.


    The next day, the patient was pain free. However, on the following morning at 2:00, the patient experienced pain and took her antacid. The pain was not relieved but she did not take a nitroglycerin. At 3:45 in the morning she went to a nearby emergency room where she suffered a cardiac arrest about an hour later. She was revived but suffered damage to her heart. The physician who saw her two days earlier for complaints of chest pain was sued for failing to diagnose that her chest pain was cardiac related.


    A major issue at trial was whether the physician had told the patient to take a daily aspirin. This was not recorded in his note but he testified that it would have been his custom and practice to do so. Another major issue was that, although cardiac related symptoms was not his primary diagnosis, he also did not ignore that possibility. The EKG was normal, but the clinical symptoms were still troubling. Therefore, further steps were taken to treat if necessary and rule out, if possible, a cardiac problem.


    The jury deliberated for less than an hour and returned a verdict for the physician. While it is appropriate for physicians to rely on such test results in their diagnoses, documented care must be taken to insure that such tests are only one aspect of the diagnosis, and that all of the patient's symptoms are considered when arriving at an ultimate decision.

    Interpretation of Diagnostic Tests

    by Attorney Frank E. Reardon

    June 1998