It is often the case that a practice which is routine and customary in the health care field can be made to look like something more sinister when viewed under the scope of litigation. It is also true that health care providers sometimes engage in practices which create unnecessary problems for themselves.
It has been the common practice at most labs across the nation to have Pap smears (done as a screening test for evidence of cell changes that might indicate or lead to cervical cancer) initially read and interpreted by technicians, not routinely by physicians. Physicians (specialists in pathology or cytology) are expected to review any positive studies (those which show some possible abnormalities) to confirm the diagnosis, and often they will review a certain percentage of negative studies as a quality control measure. Most Pap smears, however, are not seen by a physician if they are "negative" -- i.e., normal. Unfortunately, it is well accepted in the field of gynecology that there is a false negative rate of approximately 4% or so when using this test. This means that some women who do have cellular changes will not have had their studies reviewed by a physician before the report is sent to their gynecologists. There is no evidence that having every study reviewed by a physician would change that rate.
That false-negative rate is why the Pap smear is characterized as a screening test and not as a definitive test.
A lawsuit has now been filed against the Magee Womens Hospital, affiliated with the University of Pittsburgh, based on the hospital laboratory's practice of electronically stamping the name of a physician on all reports, positive or negative. This practice, it is claimed, is designed to promote referrals by falsely making it appear that all tests are being reviewed by physicians. One interesting wrinkle: one plaintiff in the lawsuit is a physician who formerly worked for the lab as a pathologist, but who was reportedly fired from her position in August 2002.
The plaintiffs are seeking class action certification. Their law firm has created a web page to promote the lawsuit. There is apparently no evidence that any of the named plaintiffs have had a diagnosis of cervical cancer missed as a result of this practice.
The news reports do not mention another potential complicating factor: Under regulations promulgated by the Federal government, many of which are followed by private health insurance carriers, a Pap smear "requiring interpretation by a physician" is billed at a higher rate than a smear "by a technician under physician supervision". See this page for an example. (Note that you will have to accept a clickthrough license agreement to use this page, a point which itself could raise a number of intriguing IP-related questions.)
We have no way of knowing whether billing considerations played a part in the Magee laboratory's decision to use a physician's electronic signature on all reports. That decision, however, creates a number of unnecessary medico-legal issues now that this issue has been raised in a lawsuit, and none of them put the laboratory in a very favorable light.
In addition, this challenge to the routine use of an "electronic signature" by someone other than the person purported to certify the document could have far-reaching implications for the legal status of signatures outside of the medical field.
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