PAP/NGC Program Review
Jack R. Bierig
A question has arisen regarding the liability
implications of removing dots or other markings (collectively, “dots”) that pathologists or cytotechnologists have placed on cytology slides to indicate cells that may be suspicious or otherwise noteworthy. Specifically, the question is this: Does it pose a greater risk to a pathologist (a) to remove dots on a slide that may suggest negligence or (b) to allow the dots to remain on the slide for the five years that the slide must be kept under CLIA? This article examines this question.
In essence, the article concludes that, with the possible exception of a temporary removal in connection with a blinded rescreening, removal of dots or other markings poses a significant risk to the pathologist. It therefore recommends against such removal. At the same time, the article suggests procedures that a laboratory might want to consider to reduce the risk of liability that might arise in connection with the practice of dotting.
It is standard practice in cytology laboratories for pathologists and cytotechnologists to place dots, circles, or other marks to highlight cells that may be of interest or that may raise concerns. Some laboratories also dot endocervical cells to justify classification of a slide as having an endocervical/transformation zone for purposes of the Bethesda system. In addition, a pathologist or cytotechnologist may dot cells to assist in fulfilling the CLIA requirement to rescreen at least 10 percent of cases originally screened as negative. [See 42 C.F.R. §493.1274(c)(1).]
What all of these situations have in common is that the dots are made in connection with the initial evaluation of a slide. Significantly, however, dots may also be placed when a slide is reviewed well after the initial evaluation. For example, a slide that has initially been reported may be reviewed if the pathologist is subsequently called upon to look at tissue and wants to correlate the tissue review with the original Pap findings. The pathologist may place dots on the slide at this later date.
Dots may also be placed on a slide after the initial reporting in connection with the CLIA requirement to rescreen negative Pap tests from the previous five years whenever a patient has a current "high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasm." [See 42 C.F.R. §493.1274 (c)(3).] Even in the best of labs, a small percentage of slides in these situations will be found to have a few high-grade premalignant cells. More commonly, nonspecific atypical cells such as "atypical squamous cells of undetermined significance," or ASCUS, will also be identified. Depending on the policy of the laboratory, dots may be placed on the slide to indicate the premalignant or ASCUS cells—particularly if the rescreening is used in the training of pathologists or technologists.
Slides reviewed in connection with tissue that reveals a malignancy or in connection with a rescreening after identification of a subsequent high-grade premalignant or malignant diagnosis are, of course, the slides most likely to become the focus of litigation. When those slides are scrutinized in litigation, it may not be clear whether particular dots were made in the course of the initial evaluation or whether they were made subsequently. Likewise, it may not be clear whether it was a pathologist or a cytotechnologist who made the dots—or why the dots were made.
A regulation implementing CLIA, 42 C.F.R. §493.1105(a)(7), provides that, with an exception for use in proficiency testing, cytology slide preparations must be retained "for at least 5 years from the date of examination." The regulation is silent with respect to how the slides must be retained. Thus, it does not seem to require retention of any dots that were placed on the slide.
The real issue, therefore, is whether removal of any dots increases or decreases any malpractice exposure a pathologist might have. A pathologist tempted to remove the dots may believe that this practice will avoid the highlighting of cells that were identified as suspicious, and may thereby reduce the likelihood of an adverse judgment. On balance, however, the consequences of dot removal are far more likely to be negative than positive.
Initially, removal of dots, no matter how benign the motive, may well cause the jury to be suspicious of the pathologist. A sophisticated plaintiffs' malpractice lawyer in the field of cytology will know about the practice of dotting and will inquire whether any dots were removed. If they were, the lawyer will argue or insinuate that the removal of the dots bespeaks a coverup by the pathologist, that is, that the pathologist removed the dots out of concern that they would expose the laboratory's negligence. Although there might well be good responses, the pathologist and laboratory will immediately be placed on the defensive.
Quite apart from the possible impact that removal of dots might have on the jury, to the extent that dot removal is seen as alteration of medical records, other negative consequences can ensue. To begin, alteration of medical records can expose the pathologist to punitive damages. In Moskovitz v. Mt. Sinai Med. Ctr., 635 N.E.2d 331 (Ohio 1994), for example, the Supreme Court of Ohio upheld an award of $1 million in punitive damages based on a physician's alteration of records. These punitive damages were imposed over and above the amount awarded for the defendants' malpractice.
Possibly even worse, alteration of medical records could lead to loss of malpractice coverage for the pathologist. Thus, in Eastern Dentists Ins. Co. v. Lindsay, 2004 WL 2004778 (Mass. Super. 2004), a trial court in Massachusetts relieved an insurer of an obligation to defend an insured dentist where the dentist allegedly altered the plaintiff-patient's medical records. In this connection, the court noted that the insurance policy included a standard provision to the effect that the insured "shall not alter any medical records. . . ." The court ruled that "the alteration of the medical records . . . frustrates the purpose of the contract provision because evidence of the alterations substantially increases the likelihood of a jury verdict . . . in favor of the patient."
Finally, serious issues can arise if the pathologist removes dots that were placed by other laboratory personnel. For example, a cytotechnologist who has been named as a defendant in malpractice litigation may want to argue that by dotting a slide, he or she called suspicious cells to the attention of the pathologist and thereby fulfilled any duty to the patient. If the pathologist has removed dots, that cytotechnologist may take the position that the pathologist is trying to hide his or her own negligence. Finger-pointing between the pathologist and cytotechnologist will be devastating to the defense.
On the other hand, properly marked dots can demonstrate that due care was exercised in the review of a cytology slide. Dots can show that the laboratory identified problem cells, marked them, and followed up. Indeed, in many ways, dotting indicates the opposite of negligence—as long as the laboratory follows up appropriately on any markings that are made and documents the followup.
Of course, one drawback of retaining dots is that the practice may make it more difficult to conduct a blinded rescreening, which is a critical aspect of a reasonable medical review. There are, however, two potential approaches to this problem. First, if the slide in question is included in a tray of slides that have also been dotted, then it would seem that the rescreening could still be blinded. Alternatively, the slides could be photographed before the blinded rescreening, the dots could then be removed, and then they could be recopied after the rescreening.
In short, balancing the potential risks and benefits of removing dots on cytology slides, the risks of removal—other than perhaps in a controlled, blinded rescreening situation—appear to outweigh the benefits significantly. The next section of this article discusses steps that pathologists might want to consider to reduce the malpractice risks associated with dotting.
Suggestions for pathologists
There seem to be two reasons that a pathologist might be tempted to remove
the dots made on a cytology slide:
- The dots can be confusing if it is unclear whether they were made at the
time of the initial review or subsequently, by whom they were made, or for
- The dots can produce liability if they highlight malignant or premalignant
cells that were not followed up on at the time of identification.
The proper way to address these problems is to implement laboratory policies that deal with them—not to remove the dots retrospectively.
With respect to uncertainty about when dots were placed, it is not difficult to see how the dots could be problematic. If dots that appear to have been placed at the time of initial review were not in fact placed at the time of the initial review, the judge or jury could easily be misled into thinking that the pathologist did not act appropriately at the time. The plaintiff's lawyer will point out the existence of the dots, establish that no followup occurred in connection with the initial diagnosis, and insinuate that the absence of followup constitutes negligence. Unless it is clear that the dots were placed after the initial review, the trier of fact may well infer negligence from the lack of followup.
This suggests that dots should be coded in a manner that identifies whether they were made initially or in connection with a subsequent review. This result could be effectuated through some form of color coding or other notation. Thus, for example, dots made during the initial screening could be one color; dots made by the pathologist upon review of the initial screen could be another color; and dots made in connection with retrospective review could be yet a third color. A system of color or other coding would explain why there was no followup on dots marked to show retrospective placement.
In this connection, it should be noted that removal of dots that are placed retrospectively for a limited time for teaching or quality assurance purposes would seem quite different from removal of dots placed in connection with the initial screening and review. Apparently, some pathologists use a pen with water-based ink when they are doing a retrospective review for teaching or QA purposes. Upon completion of this review, they routinely remove dots made during that review. While even this practice could cause problems if the review identified suspicious cells that might warrant followup, it is not the same as routine removal of dots made before the initial report.
Finally, if the lab has a policy of marking cytology slides to identify suspicious-looking cells at the time of screening or initial review, it should also have, and adhere to, a policy that requires followup on slides so marked. The worst thing a laboratory can do in this context is to permit dotting of noteworthy cells and then to undertake no further review of those cells. Indeed, the lab should require explicit confirmation before a case is signed out as negative that all marked cells have been scrutinized. In this manner, the laboratory will demonstrate its non-negligence in the review of cytology slides.
Removal from cytology slides of dots or other markings made during the screening or initial review, no matter how well intentioned, raises serious liability risks. Accordingly, this article recommends against routine removal of such dots or markings. Instead, pathologists should give consideration to implementing a system that indicates when, why, and by whom the dots were placed. They should also have procedures in place to ensure that any markings of suspicious or otherwise notable cells receive appropriate followup.
Jack Bierig, of Sidley Austin Brown & Wood, LLP, is CAP general counsel.