LabCorp sued for negligent misread of Pap smear

(examiner.com)

(examiner.com)

A woman in West Virginia is suing LabCorp on behalf of her now-deceased family member for negligently misreading a Pap smear as negative.  The patient was later diagnosed with advanced cervical cancer and died six months after diagnosis.  The patient’s primary care physician is also named in the suit.

The patient presented to her primary care physician on December 21, 2009 with complaints of vaginal bleeding.  A Pap smear was performed and sent to LabCorp and was signed out as “Negative for intraepithelial lesion and malignancy.”

It is unclear what kind of follow-up the patient had, but a year and a half later she went back to the same primary care physician with vaginal bleeding as well as signs and symptoms of significant anemia.

The patient was referred to a gynecologist, and was eventually diagnosed with advanced cervical cancer. Due to the advanced nature of the disease, her treatment options were apparently limited, and she died six months later.

Interestingly, the patient had a personal history of cervical carcinoma, but the Pap smear was sent to LabCorp from the primary care doc’s office with the history of “postmenopausal bleeding”; the history of cervical cancer was allegedly not mentioned.

The lawsuit asks for “compensatory and punitive damages with pre- and post-judgment interest.”

Commentary

This lawsuit was first reported on about three weeks ago.  I am just now writing about it because I have been trying to get my hands on the complaint for more details, but was unable to do so.

I do not know if a pathologist ever actually saw the Pap in question or if it was signed out by a cytotechnologist.  My guess is the latter, since no pathologist is named in the article, whereas the primary care doc is.

I also do not know if the primary care doc knew about the patient’s history of cervical cancer and simply neglected to include that history on the requisition form, or if the patient never told him. Nonetheless, the complaint states the primary care doc “knew or should have known [the patient’s] history of cervical cancer, but failed to include that vital history with the pap smear test and was otherwise negligent.”

This case reminds me of something one of my attendings in residency used to tell us:  “A pathologist cannot live by glass alone.”

By this he of course meant it is not always possible to make a correct diagnosis just by looking at the slide; a pathologist also needs to know pertinent clinical history so the slide(s) can be evaluated in the context of that patient’s situation.

Now of course sometimes the diagnosis is obvious sans clinical history, but other times, just knowing an important medical fact about the patient can make all the difference in the world.

This point is discussed in a paper titled, “When is the practice of pathology malpractice?”  It was written by RWM Giard, a pathologist and tort attorney and was published by the Rotterdam Institute of Private Law in 2010.

The inter-relatedness between pathology diagnosis and the clinical circumstances is evident. Lack of adequate information may be a source of latent causes of error. What clinical information was available? What is the clinical question? A lymph node biopsy with the question ‘Metastatic disease?’ in a patient with a history of rectal cancer but now with generalised lymphadenopathy may predispose to missing malignant lymphoma. In addition, is the form adequate with regard to patient characteristics, the anatomical origin and type of specimen and history? This information is essential for guiding the pathologist in both morphological interpretation and the use of ancillary techniques.

Quite right.

I know most clinicians do not understand this, and believe they do not need to provide us with clinical information, but they are wrong.

Comments

  1. dr.cosell says:

    We have trained enormous numbers of doctors who are ignorant about how a pathologic diagnosis is achieved. Secondly, most doctors today don’t take an appropriate history. I am often told by the surgeon, “i don’t know. I was just asked to take out their (insert organ here). There is no shame in being totally ignorant of the patient’s history. “Rule out cancer” is the worthless information provided on the requisition.

  2. Robert Nicholas says:

    I guess one of the important questions is whether or not the slide, upon re-screening, showed HSIL or LSIL. History is important but were abnormal cells on that slide or were they not.

  3. runfastdieyoung says:

    It’s a shame that managed care and other factors cause pap tests to be sent all over the place. I dont know what happened in this case but it is very nice when a patient has her paps/tissues all sent to the same lab. The history would have been in the system already for someone to see. You just cant count on physician offices to fill out requisitions thoroughly.

    Post menopausal bleeding should have been a trigger for the lab to have more than person look at the case. That is a high risk indicator at my lab which makes it automatically go to at least a second set of eyes.

    At the large corporate pap mills, they want the cytotechs to screen 120-150 cases a day using those automated imaging devices. 22 fields are viewed by the tech and then the case is resulted. Assembly line medicine at its worst.

    I’d also be curious if there were any abnormal cells on the slide or not. I keep hearing a lot of complaints about the new automated pap screening devices, cells being outside the fields selected by the machine.

  4. dr. cosell says:

    There will always be pathologists-for-hire willing to testify that “abnormal” cells are present on the slide. Unless the slide in question is mixed in with other slides and given a routine “community standard” screening, the presence of abnormal cells is meaningless. If the plaintiff’s pathologist has to spend an hour screening the slide to find the “abnormal” cells, that should not be considered malpractice.

  5. Luke Landers says:

    Runfast is correct in that the pap should have been considered high risk, but should not the clinician come under more scrutiny? I’m a cytotech, not a physician, but it just seems that a woman with abnormal vaginal bleeding warrants more testing than a pap. It is a screening test, not a diagnostic one.

  6. Robert Nicholas says:

    I fear that we are moving into a legal age when there’s no distinction between a screening test and a diagnostic test. There are a lot of lab tests with varying degrees of a positive or negative predictability. Those tests with a high negative predictability but low positive predictability present legal liabilities to physicians who do not completely “work up” a patient with positive results.

  7. dr. cosell says:

    To LabCorp and others, these malpractice cases are the cost of doing business. No more. No less.

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