Error reduction and risk management in cytopathology

Currently, tort reform is not a major priority in either the Congress of the United States or in state legislatures. Thus, it is fortunate that medical negligence claims against pathologists are relatively infrequent, at 8.3% per year per 100 insured pathologists (data from the Doctors' Company, 2000-2003). However, claims for "missed" cervical cytology specimens rank third, behind those for alleged misinterpretation of breast biopsies and pigmented skin lesions. The severity of cervical cytology errors is high, at almost $700,000 per claim, surpassed only by those concerning melanoma. There are common threads that appear consistently in the analysis of slides from allegedly misdiagnosed cervical cytology cases, including small-cell variants of high-grade squamous intraepithelial neoplasia (HGSIL), present in small numbers; hyperchromatic crowded cell groups; atypical squamous cells of undetermined significance (ASCUS); smears taken during menses; other bloody smears, particularly with degenerative features or excessive inflammation; others showing atypical repair; and unsatisfactory samples. It is important for pathologists to spend time with cytotechnologists to emphasize the patterns of abnormal smears at low microscopic magnification and those backgrounds featuring blood and inflammation which require particular attention. Managing the "look-back" requirement of the Clinical Laboratory Amendments of 1988 (CLIA88) is also crucial; the need to issue amended reports as a consequence of that provision is quite rare. Procedures for administrating and reporting retrospective reviews under the CLIA88 should be clearly outlined in a peer-reviewed procedure document in each laboratory. They should be reviewed and approved by risk managers or insurance carriers, and documented in such a manner that one obtains maximal protection from legal discovery. Consumer education is particularly important in maintaining laboratory performance and reducing risk from error in cytology. Periodic feedback to clinicians on the quality of their smear preparations, the use of ancillary techniques (eg, human papillomavirus testing), and discussion of reporting terminology are important. Moreover, one should stress the need for pertinent clinical history that is often required to initiate quality control measures for evaluation and reporting of cervical cytology specimens. The incidence of cervical cancer in the United States, at only 9700 new cases per year, is low, emphasizing the need for clinical vigilance, attention to unexplained symptoms and signs, and biopsies of any cervical abnormality. These and other efforts may assist in reducing the risk of litigation attached to allegedly false-negative gynecologic and nongynecologic cytology samples.