Legal Aspects Of Health Care Administration 11th Edition by George Pozgar

Exercise 9

Facts
The patient had several gynecological examinations, including Pap smears, in 1977, 1978, 1980, 1984, 1986, and 1987. The patient's physician performed the examinations. Specimens for the Pap test were submitted to a laboratory for evaluation. The laboratory procedure included a clerk assigning each specimen a number when it was received. A cytotechnologist would then screen the specimen. If the specimen was determined to be abnormal, it would be marked for review by a pathologist. Out of the Pap tests that were determined to be normal, only 1 in 10 was actually viewed by a pathologist. The pathologist made recommendations based on the classification of the Pap tests. A biopsy would be recommended if the Pap test was determined to be Class IV.
Except for the Pap test in 1987, which showed premalignant cellular changes, all of the patient's other Pap tests were determined to be negative. In 1986, the laboratory made a notation to the patient's physician that "moderate inflammation" was present. The patient's physician, who was treating her with antibiotics for a foot inflammation, thought that the medication would also treat the other inflammation. In September 1987, the patient returned to her physician complaining of pain, erratic periods, and tiredness. After completing a physical, her physician took a Pap test, which he sent to the laboratory. He also referred her to a gynecologist. The pathologist recommended a biopsy. Biopsies and further physical examinations revealed squamous cell carcinoma that had spread to her pelvic bones. Her Pap tests were reexamined by the laboratory, which reported that the 1986 smear showed that malignancy was highly likely. The patient was referred to the University of Minnesota to determine whether she was a viable candidate for radiation treatment. The cancer, however, had spread, and the patient was not considered a candidate for radiation treatment because she had no chance of survival. When the university reviewed all of the available slides, they found cellular changes back to 1984.
The patient sued in 1988, alleging that the laboratory failed to detect and report cellular changes in her Pap tests in time to prevent the spread of the cancer. Before trial, the patient died. Her husband and sister were substituted as plaintiffs, and the complaint was amended to include a wrongful death action. After trial, a jury awarded $3.7 million in damages, which were reduced to $1 million by the circuit court. The jury found against the laboratory, and the laboratory appealed.
Issue
Was it erroneous for the trial court to submit to the jury the 1988 negligence claim based on the 1984 slide?
Holding
The South Dakota Supreme Court upheld the jury verdict and restored the $3.7 million damage award.
Reason
The court determined that evidence relating to negligence claims pertaining to Pap tests taken more than 2 years before filing the action was admissible because the patient had a continuing relationship with the clinical laboratory as a result of her physician submitting her Pap tests to the laboratory over a period of time.
How might continuous quality improvement activities improve the laboratory's operations?