The Medicolegal Aspect of Error in Pathology: A Search of Jury Verdicts and Settlements

2007 ◽  
Vol 131 (4) ◽  
pp. 615-618
Author(s):  
Michael J. Kornstein ◽  
Sean P. Byrne
Keyword(s):  
Medical Errors ◽  
Medical Malpractice ◽  
Breast Biopsy ◽  
False Negative ◽  
Clinical Pathology ◽  
Surgical Pathology ◽  
Legal Cases ◽  
Jury Verdict ◽  
Fine Needle Aspirates ◽  
Jury Verdicts

Abstract Context.—Identifying medical errors is a topic of current attention. Among the various approaches is the study of medical malpractice cases. Objective.—To identify the most common medical errors involving the practice of pathology from a medicolegal perspective by analysis of published jury verdict and settlement reports. Design.—Search approximately 50 publications that gather jury verdict and settlement information using LexisNexis, an on-line searchable archive, for pathology-related cases. Results.—One hundred seventy-one legal cases were identified from 1988 through 2005. Nearly one-half involved surgical pathology; among the remainder, cytology cases slightly outnumbered those pertaining to clinical pathology. Among the surgical pathology cases and overall, based on this database, the most common reason for a medical malpractice lawsuit related to pathology was the alleged missed diagnosis of melanoma on a skin biopsy specimen. Less commonly, the surgical pathology cases involved breast biopsy specimens, gynecological specimens, lung, genitourinary system, technical or preanalytic errors (eg, mixed-up specimens), soft tissue, hematopathology, head and neck, gastrointestinal/hepatobiliary system, or thyroid. Among the 48 cases related to cytology, 37 involved false-negative Papanicolaou smears. Less common were cases related to fine-needle aspirates of the breast or thyroid or cytology specimens of the lung. Among the 36 cases involving clinical pathology, 32 related to the blood bank—usually transfusion-acquired human immunodeficiency virus infection. Conclusions.—These data are in agreement with other publications as to the most frequent causes of medical malpractice allegations related to pathology. As these issues are addressed, the number of errors should decrease. Studying the jury verdict and settlements data may provide additional insight into medical errors and patient safety.

Freehand 3T MR-guided vacuum-assisted breast biopsy (VAB): a five-year experience

2017 ◽  
Vol 59 (5) ◽  
pp. 540-545 ◽  
Author(s):  
Licia Gristina ◽  
Giuseppe Rescinito ◽  
Alessandro Garlaschi ◽  
Simona Tosto ◽  
Luca Cevasco ◽  
...  
Keyword(s):  
Breast Biopsy ◽  
Ductal Carcinoma ◽  
False Negative ◽  
Surgical Pathology ◽  
Benign Lesions ◽  
Imaging Results ◽  
Malignant Lesions ◽  
3T Mr

Background Magnetic resonance (MR) permits the detection of some malignant lesions that cannot be identified with mammography or ultrasonography. The characterization of these MR-only detectable lesions often requires a biopsy. Purpose To evaluate the technique, the feasibility and the accuracy of freehand 3T MR-guided VAB for the characterization of suspicious, MR-only detectable lesions and to compare VAB results with surgical pathology and follow-up imaging results. Material and Methods During 2010–2015, 118 women who were referred for MR-guided VAB were retrospectively reviewed. All BI-RADS MR 4 and 5 lesions and some BI-RADS MR 3 lesions (according to clinical context and patient anxiety) were scheduled to undergo biopsy. Results A total of 123 suspicious lesions were retrospectively selected. Technical failures occurred in only two cases (1.6%) due to the location of the lesions. Histopathological results revealed 59 benign lesions (48%), 27 high-risk lesions (22%), and 35 malignant lesions (28.4%). Surgical pathology results led to the reclassification of eight B3 lesions: one proved to be a ductal carcinoma in situ, while seven presented with invasive features. B3 underestimation also occurred in 29% of the cases. MR follow-up was achieved for all the benign lesions and no false-negative cases were observed. No complications, 3T-related artefacts, or difficulties were observed. Conclusion Freehand 3T MR-guided VAB was found to be a valid, safe, fast, and inexpensive alternative to surgical histology.

Medicolegal Aspects of Error in Pathology

2006 ◽  
Vol 130 (5) ◽  
pp. 617-619 ◽  
Author(s):  
David B. Troxel
Keyword(s):  
Breast Biopsy ◽  
Frozen Section ◽  
False Negative ◽  
Diagnostic Category ◽  
Surgical Pathology ◽  
Papanicolaou Test ◽  
Common Cause ◽  
Dysplastic Nevus ◽  
Specimen Type ◽  
Malpractice Claims

Abstract Objective.—To discuss the various ways error is defined in surgical pathology. To identify errors in pathology practice identified by an analysis of pathology malpractice claims. Design.—Three hundred seventy-eight pathology malpractice claims were reviewed. Nuisance claims and autopsy claims were excluded; 335 pathology claims remained and were analyzed to identify repetitive patterns of specimen type and diagnostic category. Setting.—All pathology malpractice claims reported to The Doctors Company of Napa, Calif, between 1998 and 2003. Results.—Fifty-seven percent of malpractice claims involved just 5 categories of specimen type and/or diagnostic error, namely, breast specimens, melanoma, cervical Papanicolaou tests, gynecologic specimens, and system (operational) errors. Sixty-three percent of claims involved failure to diagnose cancer, resulting in delay in diagnosis or inappropriate treatment. Conclusion.—A false-negative diagnosis of melanoma was the single most common reason for filing a malpractice claim against a pathologist. Nearly one third involved melanoma misdiagnosed as Spitz nevus, “dysplastic” nevus, spindle cell squamous carcinoma, atypical fibroxanthoma, and dermatofibroma. While breast biopsy claims were a close second to melanoma, when combined with breast fine-needle aspiration and breast frozen section claims, breast specimens were the most common cause of pathology malpractice claims. Cervical Papanicolaou test claims were third in frequency behind melanoma and breast; 98% involved false-negative Papanicolaou tests. Forty-two percent of gynecologic surgical pathology claims involved misdiagnosed ovarian tumors, and 85% of these were false-negative diagnoses of malignancy. The most common cause of system errors was specimen “mix-ups” involving breast or prostate needle biopsies.

Critical Values in Anatomic Pathology

2006 ◽  
Vol 130 (5) ◽  
pp. 638-640 ◽  
Author(s):  
Jan F. Silverman ◽  
Telma C. Pereira
Keyword(s):  
Patient Safety ◽  
Improve Patient Safety ◽  
Clinical Pathology ◽  
Critical Values ◽  
Surgical Pathology ◽  
Anatomic Pathology ◽  
Wide Range ◽  
Enhance Patient Safety ◽  
Pathology Reports ◽  
Improve Patient

Abstract Similar to critical values (CVs) in clinical pathology, occasional diagnoses in surgical pathology and cytology could require immediate notification of the physician to rapidly initiate treatment. However, there are no established CV guidelines in anatomic pathology. A retrospective review of surgical pathology reports was recently conducted to study the incidence of CVs in surgical pathology and to survey the perceptions of pathologists and clinicians about CVs in surgical pathology, with a similar analysis of CVs performed in cytology. The results indicated that CVs in surgical pathology and cytology are uncommon but not rare and that there is a wide range of opinion among pathologists and between pathologists and clinicians about the need for an immediate telephone call and about the degree of urgency. It was obvious from the study that there is a lack of consensus in identifying what constitutes surgical pathology and cytology CV cases. Since the Institute of Medicine's report on medical errors, there has been an increasing number of initiatives to improve patient safety. Having guidelines for anatomic pathology CVs could enhance patient safety, in contrast to the current practice in which CV cases are managed based on common sense and on personal experience. Therefore, a discussion involving the pathology community might prove useful in an attempt to establish anatomic pathology CV guidelines that could represent a practice improvement.

Interpretation of Skin Biopsies by General Pathologists: Diagnostic Discrepancy Rate Measured by Blinded Review

2003 ◽  
Vol 127 (11) ◽  
pp. 1489-1492 ◽  
Author(s):  
Martin J. Trotter ◽  
Andrea K. Bruecks
Keyword(s):  
Primary Care ◽  
Error Detection ◽  
Primary Care Physicians ◽  
False Negative ◽  
Diagnostic Error ◽  
Surgical Pathology ◽  
Total Quality ◽  
Improvement Program ◽  
Discrepancy Rate ◽  
Skin Biopsies

Abstract Context.—Slide review has been advocated as a means to reduce diagnostic error in surgical pathology and is considered an important component of a total quality assurance program. Blinded review is an unbiased method of error detection, and this approach may be used to determine the diagnostic discrepancy rates in surgical pathology. Objective.—To determine the diagnostic discrepancy rate for skin biopsies reported by general pathologists. Design.—Five hundred eighty-nine biopsies from 500 consecutive cases submitted by primary care physicians and reported by general pathologists were examined by rapid-screen, blinded review by 2 dermatopathologists, and the original diagnosis was compared with the review interpretation. Results.—Agreement was observed in 551 (93.5%) of 589 biopsies. Blinded review of these skin biopsies by experienced dermatopathologists had a sensitivity of 100% (all lesions originally reported were detected during review). False-negative errors were the most common discrepancy, but false positives, threshold discrepancies, and differences in type or grade were also observed. Only 1.4% of biopsies had discrepancies that were of potential clinical importance. Conclusions.—Blinded review demonstrates that general pathologists reporting skin biopsies submitted by primary care physicians have a low diagnostic error rate. The method detects both false-negative and false-positive cases and identifies problematic areas that may be targeted in continuing education activities. Blinded review is a useful component of a dermatopathology quality improvement program.

Comparison of next-generation sequencing and FISH/IHC for molecular classification in glioma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14021-e14021
Author(s):  
Deze Jia ◽  
Yi Lu ◽  
Xiaomin Li ◽  
Tiantian Han ◽  
Wanglong Deng ◽  
...  
Keyword(s):  
False Negative ◽  
Clinical Pathology ◽  
Molecular Classification ◽  
Braf V600e ◽  
Actual Condition ◽  
Idh1 R132h ◽  
1P Deletion ◽  
Mutation Braf ◽  
H3 K27m Mutations

e14021 Background: The updated 2016 edition of the WHO Classification of CNS tumors indicates that IDH1 R132H, H3 K27M mutations, and co-deletion of 1p19q are strong stratification and prognostic markers glioma. FISH/IHC, as the commonly detected methods, present specific false-negative rates in the actual condition. Methods: In our study, IDH1 R132H status of 158 cases was assessed by IHC and NGS, and H3 K27M statuses of 83 patients were evaluated by IHC and NGS. 22 positive cases of 1p/19q co-deletion, all confirmed by FISH, were assessed by NGS. Results: For IDH1 R132H, 2 cases were IHC negative and were positive as confirmed by NGS. Another 10 patients with weakly IHC positive results were negative in NGS. Combined with histologic hallmarks, 6 cases of these samples could be diagnosed as glioblastoma, IDH wildtype; 1 case with POLE could be diagnosed as giant cell glioblastoma; 3 cases with BRAF V600E mutation, BRAF fusion, and ATRX mutation, respectively, could be diagnosed as pilocytic astrocytoma. Towards H3 K27M, 3 cases with IHC weakly positive were negative in NGS. Among these samples, 2 cases were diagnosed as glioblastoma, IDH wildtype by molecular and histologic hallmarks, and 1 case was medulloblastoma, SHH. Using NGS, IDH1 R132H /H3 K27M statues can be distinctly distinguished in which that is unknown by IHC. The results of NGS and FISH showed a 90.9%(20/22) consistent rate for the 1p19q co-deletion. 1 case was 1p deletion and intact 19q by FISH while 1p19q co-deletion by NGS because of the 19p deletion. 1 case was 1p19q co-deletion by FISH but 1p19q wildtype by NGS, diagnosed as glioblastoma, IDH wildtype with chr7+/10-. Conclusions: In our study, the agreement between NGS results and clinical pathology diagnosis was approximately 100%. NGS may act as the primary technology of molecular classification in glioma in the future.

Abstract 241: Legal Risk of Bystander Cardiopulmonary Resuscitation

Circulation ◽  
2019 ◽  
Vol 140 (Suppl_2) ◽  
Author(s):  
Travis Murphy ◽  
Sonora Windermere ◽  
Tareyn Morris ◽  
John Slish ◽  
Liam Holtzman ◽  
...  
Keyword(s):  
Age Groups ◽  
Research Database ◽  
Legal Cases ◽  
Legal Literature ◽  
Jury Verdicts ◽  
The Usa ◽  
Bystander Cardiopulmonary Resuscitation ◽  
Bystander Cpr ◽  
Training Motivation ◽  
Wrongful Death

Background: Research has shown disparities between provision of bystander CPR among different race, gender and age groups. Reasons for this disparity have included concern of legal liability by responders. We propose that bystanders are more likely to face litigation for lack of intervention as opposed to providing bystander CPR. This review of the legal literature seeks to quantify the number of cases brought against responders in the USA over the past 30 years. Methods: The Westlaw legal research database was searched for jury verdicts, settlements, and appellate opinions from all 50 states from 1989 to 2019, in which the use or non-use of CPR gave rise to a personal injury or wrongful death lawsuit. A total of 274 cases were initially identified and manually reviewed. Outcomes recorded included case jurisdiction, location, date, plaintiff and defendant demographics, bystander training, motivation for the lawsuit, including claims of battery for performing CPR or negligence related to injuries or death following CPR or AED use. Results: Preliminary data shows that 41.1% (114 of 274) of all cases screened were directly due to the provision of bystander CPR or lack thereof. Among the relevant cases, 64% (73 of 114) were due to inadequate or untimely bystander CPR. Battery cases due to providing CPR amounted to 32% (32 of 114), but of these, 59.4% (19 of 32) were ruled in favor of the defendant. Conclusions: This represents the largest study of legal cases involving bystander CPR in the medical literature, limitations include a lack of a national repository of trial data thus underestimating the total number of cases involving bystander CPR. The likelihood of facing litigation is significantly higher in cases where bystander CPR was delayed or not provided. The authors propose the inclusion of this data and reiteration of protective statutes in all 50 states during CPR training to reassure and encourage trainees.

Analysis of the causes of false negative cytology reports on breast cancer fine needle aspirates

Cytopathology ◽  
1995 ◽  
Vol 6 (3) ◽  
pp. 156-161 ◽  
Author(s):  
M. P. CARIAGGI ◽  
P. BULGARESI ◽  
M. CONFORTINI ◽  
L. BONARDI ◽  
C. MADDAU ◽  
...  
Keyword(s):  
Breast Cancer ◽  
False Negative ◽  
Fine Needle ◽  
Fine Needle Aspirates

scholarly journals Histopathologic Review of Previously Negative Prostatic Core Needle Biopsies following a New Diagnosis of Adenocarcinoma of the Prostate by Core Needle Biopsies: Implications for Quality Assurance Programs

2008 ◽  
Vol 1 ◽  
pp. CPath.S581
Author(s):  
Jay Patel ◽  
Lester J. Layfield
Keyword(s):  
Quality Assurance ◽  
Core Biopsy ◽  
False Negative ◽  
False Negative Rate ◽  
Intraepithelial Neoplasia ◽  
Surgical Pathology ◽  
Core Needle ◽  
Prostate Needle Biopsy ◽  
Negative Results ◽  
New Diagnosis

Programs for quality assurance are increasingly important in surgical pathology. Many quality assurance (QA) techniques for surgical pathology were adopted from procedures introduced in cytopathology. Surgical pathology specimens have diminished in size such that the majority of diagnostic biopsies of prostatic lesions are now core needle biopsies. These specimens raise issues similar to those of cytology specimens, including concerns regarding adequacy and the representative nature of the biopsy. Due to sample size, some neoplasms may not be diagnosed on initial biopsy, raising concerns regarding false negative results. Cytopathologists have instituted QA procedures including review of all previously negative slides received within five years prior to the new diagnosis of high grade squamous intraepithelial lesion or gynecologic malignancy. No such requirement exists in surgical pathology for review of core biopsies. The Department of Pathology at the University of Utah instituted a QA policy requiring review of prior negative prostatic needle biopsies following a new diagnosis of prostatic adenocarcinoma. We reviewed five years of QA records of prostate needle biopsy review. During this time, nine hundred and fifty-eight core biopsy sets were performed. Two hundred and ninety-five of these contained at least one biopsy with a diagnosis of adenocarcinoma. Two hundred and eight patients had a prior set of prostatic needle biopsies with a diagnosis of adenocarcinoma. The remaining 87 had prior biopsies with either a diagnosis of prostatic intraepithelial neoplasia (23), small atypical acinar proliferation (21) or no evidence of malignancy (43). QA review of these 87 cases revealed two biopsies which revealed foci of adenocarcinoma. Both had been initially diagnosed as no evidence of malignancy. The false negative rate for core biopsy was 0.68%. In an additional twenty-one cases, microscopic foci of atypical small acinar proliferations were found in core biopsies antedating the positive core biopsy (7.1%).

scholarly journals COVID-19 Patients Encountered by a General Surgeon: Seven Unique Scenarios

2020 ◽  
Author(s):  
Sumita Jain ◽  
Deeksha Mehta ◽  
Lakshman Aggarwal ◽  
Chandra Shekhar Sharma ◽  
Ram Babu Meena ◽  
...  
Keyword(s):  
Tertiary Care ◽  
False Negative ◽  
Case Series ◽  
Surgical Pathology ◽  
Positive Patient ◽  
North India ◽  
General Surgeon ◽  
Surgical Patient ◽  
Care Hospital ◽  
Surgical Practice

With rising demand of surgical interventions post-lockdown due to Coronavirus Infectious Disease (COVID)-19, surgeons all over the country have restarted their surgical practice. To increase caution and safety, seven scenarios in which surgeons in a Tertiary Care Centre in North India encountered COVID-19 patients during lockdown are being highlighted in the present case series. The main aim was to encourage prompt recognition and isolation of positive patients along with establishment of a clear institutional protocol for surgical practice to keep our system resilient and useful for the population we serve. Clinical and radiological records of eleven patients admitted from 22.3.2020 to 31.5.2020 (period of lockdown) in a Tertiary Care Hospital in India were studied separately and concluded consensually by two surgeons and seven unique scenarios in which a surgeon may encounter a COVID-19 patient were identified. First was the COVID-19 positive patient with concurrent symptomatic surgical pathology, second was COVID-19 positive patient incidentally diagnosed with additional surgical pathology and third was a solely surgical patient mimicking COVID-19 positive symptomatology. Fourth was a COVID-19 negative surgical patient acquiring nosocomial COVID-19 infection, fifth was COVID-19 positive surgical patient with false negative COVID-19 test report, sixth was COVID-19 suspected by intraoperative unusual intestinal findings and then, getting postoperative COVID-19 test positive for the patient and last was COVID-19 patients requiring elective surgical procedures.

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