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.

Anaplastic carcinoma of the thyroid with chondroblastoma features mimicking papillary carcinoma: a case report.

BACKGROUND: An unusual case of anaplastic carcinoma of the thyroid arising from a metastatic focus of papillary carcinoma. CASE: The tumor affected a 69-year-old woman with a history of total thyroidectomy for papillary thyroid carcinoma 4 years previously. She presented with a rapidly enlarging neck mass that histologically simulated chondroblastoma. A small, embedded focus of residual follicular variant of papillary carcinoma was present. The patient died of disease 3 months later. CONCLUSION: This "chondroblastoma" variant of anaplastic thyroid carcinoma has not been reported to date.

Critical diagnoses (critical values) in anatomic pathology.

Similar to critical values in clinical pathology, occasional diagnoses in surgical pathology and cytology may require urgent contact of the physician to facilitate rapid intervention or treatment. However, there are no established critical value (critical diagnosis) guidelines in anatomic pathology. As discussed herein, the Association of Directors of Anatomic and Surgical Pathology (ADASP) believes that establishing anatomic pathology critical diagnosis guidelines represents a practice improvement and patient safety initiative. The ADASP also recognizes that a generic anatomic pathology critical diagnosis guideline such as this should only be used as a template because the list needs to be customized at each individual hospital after consultation with relevant clinical services. Based on surveys of the membership of the ADASP, this document provides examples of possible critical diagnoses in anatomic pathology.

MR imaging of infiltrative muscle involvement with Langerhans cell histiocytosis.

Langerhans cell histiocytosis (LCH) consists of three clinical syndromes of varying severity resulting from basic cellular defect leading to lipid deposition within histiocytes. Radiologically, bone lesions are similar in all three forms of LCH and are due to bone destruction. An eosinophilic granuloma of the bone can involve skeletal muscle by direct extension from the bone. However, skeletal muscle involvement is rare and is not reported on MR imaging previously in the English literature. Our case not only shows biopsy-proven muscle involvement by LCH but also reports the first diffuse nodular pattern of muscle involvement by LCH.

Rapid prescreen of cervical liquid-based cytology preparations: results of a study in an academic medical center.

A rapid prescreening or rapid rescreening method for quality assurance in cervical cytology has been used in Europe and in Canada but has not been accepted in the United States. The rapid prescreen method was tested in a cytology laboratory that serves an academic medical center with a high-risk population for cervical cancer. For a period of 3 months, a tray of 20 sequentially numbered Surepath™ liquid-based preparations, randomly selected from the cervical cytology daily workload, were each prescreened in a random fashion for 1 minute. Experienced cytotechnologists performed the rapid prescreen. Results were recorded as negative, further review needed, or epithelial cell abnormality, category specified. The 20 cervical cytology preparations were then replaced in their same position in the daily workload for routine screening performed by another cytotechnologist. Final interpretation was by a cytopathologist as requested or required by Clinical Laboratory Improvement Amendments of 1988. The rapid prescreen data was tabulated and compared with data for a similar time period using the laboratory's normal quality assurance program. Seven hundred and twelve cases underwent rapid prescreen. Six hundred and forty-two were interpreted as negative. Twenty-six cases were interpreted as low-grade squamous intraepithelial lesion (LGSIL) or higher. Forty-four cases were classified as needing further review. For the 642 negative cases by rapid prescreening, routine screening reported 537 as negative and 105 as either abnormal or needed cytopathologist review. The error rate for the rapid prescreen is 50 of 712 (7.0%); for LGSIL and above 19 of 712 (2.6%). Of the 105 abnormal cases or those submitted for cytopathologist review, 31 were interpreted as atypical squamous cells of undermined significance (ASCUS), 41 cases as reactive/repair, 17 as LGSIL, 4 as unsatisfactory, 1 as atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesion (ASC-H), 8 as the presence of endometrial cells in a women aged >40, 1 as malignant melanoma, and 2 as within normal limits with the presence of Actinomyces. The laboratory's routine quality assurance program selects cases, 10% of initially interpreted negative cases plus any gynecologic cytology on patients with a prior abnormal cervical cytology, or history of cervical epithelial cell abnormality. This quality assurance program averages 29% of cases, 4,045 of a total of 13,767, in 2008. Thirty-seven (0.9%) cases were detected in this rescreen (ASCUS, 16 cases; LGSIL, 13 cases; 1 high-grade squamous intraepithelial lesion; 4 ASC-H; and 3 atypical glandular cells of undetermined significance). Eliminating ASCUS cases, eight significant cases were detected, with an error rate of 0.2%. In this cytology laboratory, the rapid prescreen did not prove as reliable as routine quality assurance program for cervical cytology cases.

Premalignant and malignant cells in sputum from lung cancer patients.

BACKGROUND: The objective of this study was to assess the frequency of premalignant and malignant cells in sputum from patients with lung cancer and to measure the dependence of these cells on cancer stage, histologic type, tumor size, and tumor location. METHODS: This analysis included 444 patients with lung cancer. First, all patients were asked to produce sputum spontaneously; then, they underwent sputum induction. Slide preparations of the sputa were screened for the presence of abnormal cells. RESULTS: Of all patients with lung cancer who had produced adequate specimens, 74.6% had sputum that was positive for premalignant or worse cells, whereas 48.7% had sputum that was positive for malignant cells alone. Surprisingly, the presence of premalignant or worse cells in sputum depended only moderately on disease stage (82.9% of stage IV cancers vs 65.9% of stage I cancers), tumor size (78.6% of tumors >2 cm vs 64.7% of tumors

A multi-institutional survey of critical diagnoses (critical values) in surgical pathology and cytology.

Critical values (CVs) are well established in clinical pathology, and an analogous concept has recently been suggested in anatomic pathology, with the terminology of critical values, or, alternatively, critical diagnoses (CDs). To better identify anatomic pathology CVs, a survey was sent to 225 members of the Association of Directors of Anatomic and Surgical Pathology (ADASP) for grading 17 possible surgical pathology and 18 possible cytology CVs. There were 73 responses for surgical pathology and 57 for cytology. The majority of the respondents believed in the concept of CVs in anatomic pathology. There was good agreement concerning most of the possible CVs, although there were differences of opinion for some diagnoses. Several additional CVs were suggested, and there was discussion of the best terminology for CVs, degree of urgency, and appropriate notification documentation. A few respondents expressed concern about medicolegal implications. Based on the results of this survey, an ADASP committee has developed national guidelines for CDs (CVs) in surgical pathology and cytology.

Diagnostic terminology and morphologic criteria for cytologic diagnosis of thyroid lesions: a synopsis of the National Cancer Institute Thyroid Fine-Needle Aspiration State of the Science Conference.

The National Cancer Institute (NCI) sponsored the NCI Thyroid Fine-needle Aspiration (FNA) State of the Science Conference on October 22-23, 2007 in Bethesda, MD. The two-day meeting was accompanied by a permanent informational website and several on-line discussion periods between May 1 and December 15, 2007 (http://thyroidfna.cancer.gov). This document summarizes matters regarding diagnostic terminology/classification scheme for thyroid FNA interpretation and cytomorphologic criteria for the diagnosis of various benign and malignant thyroid lesions. (http://thyroidfna.cancer.gov/pages/info/agenda/).

Prognostic value of tumor thickness in patients with Merkel cell carcinoma.

BACKGROUND AND OBJECTIVES: Merkel cell carcinoma is an aggressive skin malignancy that often presents with tumor metastases. We hypothesized that tumor thickness might correlate with both regional and metastatic tumor spread and could, therefore, be used as an independent prognostic variable. The purpose of this study was to see if depth of tumor invasion would predict prognosis independent of tumor stage. METHODS: Data pertaining to clinical presentation, pathology, treatment, and survival were collected for patients diagnosed with Merkel cell carcinoma from 1972 to 2005. Patients were staged according to AJCC guidelines. Pathologic specimens were evaluated for tumor thickness. The relationship between tumor thickness and disease-free survival or overall survival was analyzed using Kaplan-Meier survival analyses. RESULTS: Sixty patients were identified. Five-year disease-free survivals for Stages 1, 2, and 3 patients were 20%, 33%, and 0%, respectively. Five-year overall survivals for Stages 1, 2, and 3 patients were 33.3%, 60%, and 16.7%, respectively. There was no correlation between tumor thickness and either disease-free survival or overall survival. CONCLUSIONS: This study suggests that tumor thickness is not an independent risk factor for survival. Mean tumor thickness did increase with the AJCC stages, but this most likely represents more advanced stage of disease.

Surgical pathology--second reviews, institutional reviews, audits, and correlations: what's out there? Error or diagnostic variation?

CONTEXT: A variety of methodologies have been used to report error rates in surgical pathology within the peer-reviewed medical literature. The media has selectively and superficially reported these error rates creating a climate of disinformation between physicians and the public. OBJECTIVES: To review the medical literature on diagnostic error in surgical pathology and summarize and compare these data with selected reports in the print and broadcast media. DESIGN: A search of the medical literature from the National Library of Medicine database using the heading "Error and Pathology Diagnosis." RESULTS: Three thousand nine hundred ninety-two citations were found, of which 83 directly measured in some manner errors in surgical and cytopathology. Major error rates ranged from 1.5% to 5.7% globally for institutional consults. Error rates were less, 0.26% to 1.2% for global in-house prospective review and 4.0% for in-house and retrospective blinded review. Error rates also varied by anatomic site: skin, institutional consult, 1.4%; prostate, institutional consult, 0.5%; and thyroid, institutional consult, 7.0%. Error rates reported in citations used by the Wall Street Journal were as follows: prostate, Gleason score changed by 1 point, 44% and resultant change in treatment for prostate cancer, 10%; for breast, altered lumpectomy or mastectomy plan, 8%; and diagnosis changed for thyroid lesions, 18%. Errors in second opinion on breast lesions (single pathologist author for the study) fall within the range of global reviews. Errors for second opinions on prostate cancer were principally 81% upgrades in Gleason score for prostate core needle biopsies. However, this resulted in an upgrade of patient risk category in only 10.8% of patients. Data for the article on change in diagnosis of thyroid lesions were incomplete. There appeared to be 3 significant diagnostic errors (4.5%). CONCLUSIONS: Pathology is not immune to the power of the media to create concern about accuracy of diagnosis in surgical pathology and cytopathology. Detailed analysis of the medical literature cited by the media determines that painting the big picture and hitting the highlights can be profoundly misleading.

Malignant transformation of fibrous dysplasia into chondroblastic osteosarcoma.

A case of malignant transformation of polyostotic fibrous dysplasia into maxillary chondroblastic osteosarcoma is presented. The clinical, radiographic, CT, MR imaging features and pathological findings of polyostotic fibrous dysplasia and its malignant transformation are described. Malignant transformation of fibrous dysplasia is rare and has not previously been described in the English literature in this location in McCune-Albright syndrome and in the absence of radiation treatment.

Reducing or eliminating use of the category of atypical squamous cells of undetermined significance decreases the diagnostic accuracy of the Papanicolaou smear.

BACKGROUND: The diagnosis of "atypical squamous cells of undetermined significance" (ASCUS) is controversial, not only for the clinical utility of its subcategories (favor reactive vs. favor dysplasia), but for its very existence as an expression of uncertainty. In the current study, the authors investigated the impact of reducing and eliminating this category on the sensitivity and predictive values for detecting squamous intraepithelial lesions (SILs). METHODS: One hundred cervical Papanicolaou (Pap) smears originally diagnosed as ASCUS, all of which had histologic follow-up, were reviewed blindly and reclassified as either negative (within normal limits/benign cellular changes), low-grade SIL (LSIL), or high-grade SIL (HSIL) by 1 reviewer who eliminated ASCUS as a diagnostic possibility entirely. A second reviewer reinterpreted the cases but attempted to use the ASCUS diagnosis (favor reactive or favor dysplasia) sparingly. All histologic diagnoses were reviewed, and an adjudicated final diagnosis was established. Reviewed smear interpretations were correlated with the histologic diagnosis (original, reviewed, and adjudicated). Statistical analysis was performed using the Fisher exact test. RESULTS: Thirty-eight women had histologically confirmed SIL (21 LSIL cases and 17 HSIL cases [including 1 case of endocervical adenocarcinoma]); 31 of these 38 cases originally were classified as ASCUS, not otherwise specified, 1 case was classified as ASCUS favor reactive, and 6 cases were classified as ASCUS favor dysplasia. The reviewer who used the ASCUS diagnosis sparingly reclassified the smears as negative (62 cases); ASCUS, favor reactive (3 cases); ASCUS, favor dysplasia (13 cases); LSIL (19 cases); and HSIL (3 cases). The reviewer who eliminated the ASCUS category reclassified the smears as negative (59 cases), LSIL (29 cases), and HSIL (12 cases). The rate of SIL/HSIL in those cases interpreted as abnormal was 38%/17% originally, 42%/24% with a reduced ASCUS interpretation, and 37%/17% when the ASCUS category was eliminated. In those ASCUS smears that were reclassified as negative, the SIL/HSIL rate was 35%/13% with the reduced ASCUS interpretation and 39%/17% when the ASCUS category was eliminated. The sensitivity for detecting a SIL/HSIL was reduced from 100%/100% for the original ASCUS interpretation to 42%/53% for the reduced ASCUS interpretation to 39%/41% with the elimination of the ASCUS interpretation. CONCLUSIONS: Although in the current study utilization of the ASCUS diagnosis was found to result in a 62% negative or reactive outcome on biopsy, a significant number of patients with SIL were detected (38% in the current series, 17% with HSIL). Despite the improved correlation with negative biopsies, reducing or eliminating the ASCUS diagnosis appears to decrease the sensitivity of the Pap smear significantly and appears to be no better than chance at predicting a diagnosis of SIL on biopsy, including HSIL.