Using 5-year retrospective reviews to manage risk, improve quality
R. Marshall Austin, MD, PhD
Five-year retrospective reviews of negative or normal smears, available for patients with newly cytologically detected high-grade squamous intraepithelial lesions or cancer, is a federal regulation for all laboratories practicing gynecologic cytology under the Clinical Laboratory Improvement Amendments of 1988 (Arch Pathol Lab Med. 1997;121:296- 298). Cytology Rule 493.1257(d)(3) says: "For each patient with a current high grade or above intraepithelial lesion (moderate dysplasia or CIN2 or above) the laboratory must review all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that would affect patient care, the laboratory must notify the physician and issue an amended report." This type of educational rescreening has long been recognized as a valuable way to benefit from the lessons only hindsight and followup can sometimes provide.
Some laboratories initially interpreted this regulation incorrectly as a requirement to issue amended reports on all prior negative Pap tests harboring in retrospect even the most questionable abnormal changes. This misimpression appears to have been a significant factor in destructively increasing Pap litigation after the new regulations went into effect in 1992 and in the unfortunate decision of some laboratories thereafter to discontinue Pap testing. In time, most laboratories have come to understand the problem of hindsight bias in these reviews and that amended reports are required only when current patient care is affected, an unlikely situation in the face of a current high grade or cancer Pap interpretation (Diagn Cytopathol. 1997;17:399-400). A Health Care Financing Administration cytotechnologist official issued the following clarification in 1996: "HCFA gives broad latitude to individual laboratories to determine whether findings in retrospective rescreenings affect patient care and when and how they should be reported to the patient's physician. Each laboratory must have a written policy that defines the term significant discrepancy and reporting protocols and must have documentation that the policy is being followed" (ASCT News. 1996;17(8):95).
The most useful aspect of the retrospective reviews is their potential educational value in giving the cytotechnologist and pathologist staff the opportunity to review (with the advantage of hindsight) smears that are likely to contain only subtle or scarce cytologic clues to the significant abnormality that developed later. In these reviews, it is important to recall that a major tenant of Deming quality assurance theory is that QA procedures that have potential punitive consequences are likely to result in system defects remaining hidden. In this context, while it is important to document thorough, careful educational rescreening of the case material, it is equally important to guard against overemphasizing the documentation of questionable changes or changes recognizable only with the advantage of hindsight. The latter practices could make the reviews appear to the staff to be punitive rather than positive and educational.
One example of a useful five-year retrospective review form that follows these positive quality-improvement-oriented principles is shown on page 43. Each negative slide is first rescreened closely and marked by a senior QC cytotechnologist and then reviewed secondly by the original screening cytotechnologist. A key aspect of this approach is the laboratory manual's definition of "significant discrepancy" as any retrospective review interpretation of a negative slide that would affect current patient care. Under this clinical definition, the retrospective interpretation of slides, even after the most careful educational reviews, generally remains as "negative." Only unusual slides with changes that would affect current patient care, even after a current HSIL or cancer finding, result in "positive" interpretations. This approach appears to this viewer to be a highly meritorious option that balances lawful written CLIA requirements with Deming quality improvement principles and prudent risk management.
Dr. Austin is a member of the CAP Cytopathology Committee and medical director and director of cytopathology and gynecologic pathology services for Coastal Pathology Laboratories, Charleston, SC.