Clinical impact and frequency of anatomic pathology errors in cancer diagnoses.
BACKGROUND
To the authors' knowledge, the frequency and clinical impact of errors in the anatomic pathology diagnosis of cancer have been poorly characterized to date.


METHODS
The authors examined errors in patients who underwent anatomic pathology tests to determine the presence or absence of cancer or precancerous lesions in four hospitals. They analyzed 1 year of retrospective errors detected through a standardized cytologic-histologic correlation process (in which patient same-site cytologic and histologic specimens were compared). Medical record reviews were performed to determine patient outcomes. The authors also measured the institutional frequency, cause (i.e., pathologist interpretation or sampling), and clinical impact of diagnostic cancer errors.


RESULTS
The frequency of errors in cancer diagnosis was found to be dependent on the institution (P < 0.001) and ranged from 1.79-9.42% and from 4.87-11.8% of all correlated gynecologic and nongynecologic cases, respectively. A statistically significant association was found between institution and error cause (P < 0.001); the cause of errors resulting from pathologic misinterpretation ranged from 5.0-50.7% (the remainder were due to clinical sampling). A statistically significant association was found between institution and assignment of the clinical impact of error (P < 0.001); the aggregated data demonstrated that for gynecologic and nongynecologic errors, 45% and 39%, respectively, were associated with harm. The pairwise kappa statistic for interobserver agreement on cause of error ranged from 0.118-0.737.


CONCLUSIONS
Errors in cancer diagnosis are reported to occur in up to 11.8% of all reviewed cytologic-histologic specimen pairs. To the authors' knowledge, little agreement exists regarding whether pathology errors are secondary to misinterpretation or poor clinical sampling of tissues and whether pathology errors result in serious harm.
Raab
Stephen S
SS
Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania 15232, USA. raabss@upmc.edu
Grzybicki
Dana Marie
DM
Janosky
Janine E
JE
Zarbo
Richard J
RJ
Meier
Frederick A
FA
Jensen
Chris
C
Geyer
Stanley J
SJ
D003951:Diagnostic Errors / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000175:diagnosis*; D015588:Observer Variation; D010340:Pathology, Surgical / Q000592:standards*; D011785:Quality Assurance, Health Care