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Reducing Malpractice Risk From False-Negative Pap Smear Tests

Reducing Malpractice Risk From False-Negative Pap Smear Tests

Automated screening of Pap smears provides greater accuracy than traditional manual readings, as discussed in part 2 of this article . As this technology comes into greater use, the standard of care regarding Pap smears may shift, such that a physician’s failure to recommend automated screening could be held against him in a malpractice lawsuit.

Use of automated screening, however, is only one factor that could potentially reduce a physician’s risk of being sued successfully for malpractice. By following the recommendations listed below, physicians can further protect themselves from malpractice claims resulting from inaccurate Pap smear results.

Recommend annual screening. Recommend annual Pap smears to your patients, especially if they fall into one of the at-risk groups. If the patient’s insurer only covers Pap smears once every 2 or 3 years, you should still recommend annual screening and inform patients that they might have to pay for the test themselves. That way, the patient can decide for herself whether she wants the test yearly.

 Educate the patient. Educate your patients about false-negative Pap smears and why they occur. Prior to performing a Pap smear, you may want to have the patient sign a document that states that she has been informed about the potential for Pap smear errors and understands that the test, while an indicator for precancerous or cancerous conditions, is not a guarantee that the patient is free of cancer.

Avoid medical jargon as much as possible when preparing such a document and when communicating to your patients. The legal standard is usually based on what a “reasonable person” can understand.

Investigate the laboratories. If you are in private practice, investigate the laboratories you use to determine their accuracy rate for Pap smears. Inquire about the number of slides each cytotech-nologist reviews on a daily basis, the experience of the staff, and the quality control methods employed. Most laboratories will welcome the chance to present their qualifications and experience to an interested physician. Talk to your peers about the laboratories they use and any potential problems they might have had.

If you are part of a managed care or provider network that contracts out to a particular laboratory, talk with the director of medical services to find out what factors were considered when selecting a laboratory.

Determine which labs in your network (if any) use automated screening, either for primary screening or as quality control. Find out if the technology is used on all slides or only on request.

 Inform the patient of screening options. If your laboratory does not use automated screening, you should still inform your patients that automated screening methods are available. Tell them about the potential benefits and drawbacks, including the fact that automated screening is more expensive than traditional Pap smear screening, and that the patient may have to bear the additional cost.

Too often physicians assume that a patient is not willing to pay more for enhanced care. It is neither your position nor in your best interest to decide what a patient can or cannot afford. If a patient chooses not to use enhanced screening and then has one or more false-negative results, it will be very hard to argue medical negligence, since the patient was fully informed of her options.

Document results. Document Pap smear results and all information provided to the patient. Many physicians only contact patients if there is an abnormal Pap smear. It is in your best interest to send a letter to all your patients informing them of their Pap smear results. Document the date that the letter was sent. In addition, document all information that you have provided to the patient regarding Pap smears and cervical cancer during her office visits. Some physicians even record patient follow-up calls.

Best Line of Defense

Keep in mind that these are simply recommended guidelines. If you are concerned about whether you or your practice is at risk, consult with an experienced malpractice attorney who can offer you more personalized advice.

There is little doubt that most physicians today spend far more time on record keeping and paperwork than physicians did 20, or even 10, years ago. While some physicians may find following the above guidelines an imposition, such thoroughness could prove to be the best line of defense in the event that a malpractice claim is filed.


No matter how experienced and conscientious physicians are, medicine is not a perfect science. Unintentional errors or misdiagnoses do occasionally occur, and in most cases the error is caught and the patient treated without any negative effects. However, even one malpractice claim against a physician or his/her practice can have a lasting impact.

Physicians who provide obstetric and gynecologic care tend to be in the higher risk categories when it comes to malpractice claims, especially regarding Pap smear litigation. Many factors, including the subjectivity involved in diagnosing difficult cases and sampling problems with specimen collection, prevent zero-error performance. Yet new technologies such as automated screening have been clinically proven to significantly reduce the rate of false-negative results.

Incorporating the recommendations presented in this article into current practice should go a long way toward protecting a physician from malpractice suits.

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