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But there's no need to adopt practice right away
Automated Pap smear screening is a high-tech way to reduce the exceptionally high liability risk of false-negative results, but it isn't a complete solution to the problem and is not yet a mandatory addition to your risk management program. That's the consensus of risk managers and attorneys who say automated screening can be a good backstop for the inevitable failings of manual screening.
Automated screening systems have received a great deal of attention among clinicians in recent years because they promise to provide a safety net for positive smears that slip past the cytotechnologist - a mistake made all the more fearsome by the fact that it may rob a woman of the opportunity to seek early treatment for cancer. The systems are designed to be used mostly as backup for the primary Pap smear screen.
Two automated screening systems are available. Papnet, manufactured by Suffern, NY-based Neuromedical Systems, is the better known and more heavily marketed system, but a similar system is provided by Richmond, VA-based Neopath under the name AutoPap. Papnet is approved by the Food and Drug Administration only for rescreening, but AutoPap is approved for primary screening as well.
Little information is available on the effectiveness of the AutoPap system. Recent studies of the Papnet system suggest that it works as promised for the most part, finding some Pap smears with abnormal cells that were missed by the clinicians. But there is debate over whether the system finds enough false negatives to justify the cost, and there is uncertainty over how best to incorporate automated screens to lower the potential liability risks.
Risk managers have reason to be particularly interested in whether the Papnet system is effective. Unlike many other clinical innovations, the Papnet system has the potential to directly address a serious liability risk. The typical human screening of a Pap smear - in which a technician is looking at thousands of cells and trying to find possibly just a few abnormal cells - can have a false-negative rate of 20% even when the technician is skilled, experienced, and diligent, according to a report from the National Institutes of Health.1 About half of those false negatives are due to inadequate specimen sampling, meaning the screening technician has a poor sample to look at. But the other half are simply the result of the abnormal cells being overlooked.
Strict quality standards in the laboratory can help reduce the rate of false negatives, but it is accepted that some false negatives due to human error are inevitable. Those missed Pap smears can significantly delay treatment for cancer that might be stopped if caught in time, so the human cost is enormous. Accordingly, the malpractice risk for providers also is enormous. Insurance company data show that malpractice claims involving false-negative Pap smears have caused pathology to rise in recent years from one of the specialties with the lowest malpractice risk to one of the highest.2 Data from 1994 show that cervicovaginal cytology cases made up only one-third of malpractice cases in anatomic pathology, but they accounted for 77% of paid losses.
The malpractice cases almost always involve delayed diagnosis, with the ultimate liability usually held by the pathologists and pathology laboratories. Hospitals and referring physicians usually are included in the lawsuit, of course, even if they ultimately are found not responsible for the false-negative Pap smear. Gynecologists and family practitioners often are sued for delayed diagnosis involving Pap smears, and some studies have shown that they can be among the most costly.
For pathologists, the average payout on a cervical cytology malpractice claim in 1995 was $116,560, the highest of any type of pathology claim.3 Claims usually arise when prior negative smears are examined after a woman is diagnosed with cervical cancer; it is common for patients and attorneys to request previous Pap smear slides once a woman is diagnosed. A federal regulation, Clinical Laboratory Improvement Act, even requires labs to review a patient's Pap smears it has on hand from the previous five years when the patient is diagnosed with a current high-grade intraephithelial lesion or worse. If the new review shows a previous Pap smear to be a false negative, the lab must provide an amended report to the patient's physician. The report is required only when it would affect the patient's care, but that usually is the case. Of course, handing over that report is like inviting a lawsuit.
The issue of false-negative Pap smears gained public attention in the early 1990s when news reports alleged that several laboratories encouraged cytotechnologists to read such a huge number of Pap smears that the false-negative rate rose beyond the level of unavoidable errors. Some providers settled for millions of dollars.
The Papnet system comes into play only after a cytotechnologist already has screened a Pap smear and declared it negative. Then the same slide is read by the Papnet computer, which looks for any abnormal cells. If the Papnet system detects abnormal cells, a cytotechnologist takes another look at the slide to make a final determination. (See story, p. 111, for a look at the effectiveness of the Papnet system.)
Even though many pathologists welcome an automated method for catching false negatives, the Papnet system definitely is not the standard of care, says Jack Bierig, JD, general counsel for the College of American Pathologists in Northfield, IL. The mere existence of a new technology does not create an obligation to use it, and neither does research showing that the technology can detect some false negatives, Bierig says.
That point is echoed by Neil Rosen, JD, a health care attorney in Pittsburgh who has dealt with false-negative Pap smear cases in the past. He tells Healthcare Risk Management the obligation clearly lies with the lab to perform a Pap smear screen that meets all facets of the standard of care, and other providers are obligated to make sure the lab they are referring patients to meets that standard of care. But right now, the Papnet system is not part of that standard of care.
"The bottom line is the report to the patient. Is it right or wrong?" Rosen says. "If it's wrong, I want to know why it's wrong. If it's wrong because you didn't meet the standard of care, that's a problem. But if you met the standard of care and didn't choose to use an automated screen, I'm not sure there's any liability question there."
If you decide to use the automated Pap smear screen, that creates an obligation to use it correctly, Rosen says. There is the possibility that a plaintiff's attorney could find a flaw in the way the Papnet system was used, but that is a slight risk and no more than you would encounter with the introduction of any new technology, he says.
The American College of Obstetricians and Gynecologists (ACOG) in Washington, DC, cautioned its members recently not to adopt the Papnet system or other automated Pap smear technologies without serious consideration. The group underscored the point that there is no obligation to use the new systems. (See p. 112 for more on the ACOG warning.)
Those were some of the factors discussed when officials at West Florida Medical Center Clinic in Pensacola recently considered incorporating the Papnet system to reduce false negatives and the associated risks to patients and the facility. After an extensive look at the automated system and the possible benefits, the officials decided not to use the system, says Luci Bailly, RN, CRM, director of quality and risk management.
The automated system was considered in a series of meetings in August 1997. Clinicians had suggested using the Papnet system because it promised to reduce false-negative Pap smears, and Bailly initially thought it might be a good way to reduce the liability risk.
"Liability from misread Pap smears is of high interest, definitely," she says. "Any time you're giving an inaccurate report, the consequences can be enormous. So if there's a way to reduce the liability that comes from an inaccurate report, it sounds like a good idea."
But then Bailly and her colleagues at the clinic started looking into the efficacy of the system and the potential pros and cons. When the clinic's own pathologists did not heartily endorse the idea, that was a major setback. Bailly says she and her colleagues were struck by the idea that pathologists, who certainly know more about the issue than anyone else, did not welcome a computerized safety net for the cytotechnologists.
"They didn't agree that this was an answer to the problem of false negatives, even though everyone admits they happen," she says. "I think if this method truly were the best it could be, you'd have pathologists pushing for it."
That left the clinic to decide whether the Papnet system was worth added expense as just an additional step that did no harm and might in some cases do some good. In the end, the committee decided the automated screen was not worth the $40 or so that would be charged to each patient. Insurers are unlikely to pay for a second screen, so the cost usually is passed on to the patient.
"We're more comfortable concentrating on encouraging women to come in for an annual Pap smear, and we have a pretty aggressive follow-up system," she says. "We make sure we follow up with the ones we know have a problem. We felt that was an important part of our program to concentrate on."
Since there is some evidence that the Papnet system can keep some false negatives from going unnoticed, it might be a good idea to offer the automated screen as an option to patients who want to be doubly sure their Pap smears are negative. Attorneys Bierig and Rosen say there is no added risk in taking that path, though they say you must be careful in how you present that option to the patient.
You could institute a system in which negative Pap smear results are accompanied by a written explanation that your facility and the laboratory have taken due care in ensuring that the results are accurate, but acknowledging that there is the inevitable possibility of a false-negative result. The patient can be informed that Papnet automated screening is available, though the usefulness in detecting abnormal Pap smears remains unclear. Position the Papnet option as a way for the patient to take one more step in checking for an abnormal Pap smear, not as an reason to feel that the proffered test result is suspect.
Be sure to include information for the patient on the cost of automated screening and how to obtain it. Another option is to provide all of that information upfront when the Pap smear is obtained and before any screening is performed. Then the patient can be asked whether the laboratory should proceed to an automated screen if the result is negative.
Whether provided before or after the initial screen, that information and the patient's decision should be noted in the patient's record. Once that step is taken, the provider's liability for false-negative Pap smear results will be diminished significantly, Bierig says. Since the decision was made by the patient, it would be difficult for a patient to claim damages based on the failure to have the false result checked by the Papnet system, he says.
Rosen strongly suggests that this information should be accompanied by a reminder that faithfully obtaining an annual Pap smear probably is the best way to ensure that cervical cancer does not go unnoticed, rather than focusing on the possibility of a false negative in a single screen.
"If a woman has yearly Pap smears, there is simply no reason for her to have invasive cancer of the cervix," Rosen says. "It would be a big mistake to focus on the technology instead of encouraging women to get regular exams."
1. National Institutes of Health. Consensus Statement Online 1996. April 1, 1998; 43:1-24.
2. Austin RM. College of American Pathologists Confer ence on Quality and Liability Issues with the Papanicolaou Smear: Introduction. Arch Pathol Lab Med 1997; 121:227-228.
3. Scott MD. Pap smears and melanomas continue to lead pathology malpractice losses. Doctors Advocate 1995; Fourth quarter.