2. Quality Assurance in Breast Pathology
Lessons Learned From a Review of Amended Reports
Archives of Pathology & Laboratory Medicine
Vol 141
February 2017
Harrison, B.T., Dillon, D.A., Richardson, A.L., Brock, J.E., Guidi, A.J. and Lester, S.C., 2016. Quality
Assurance in Breast Pathology: Lessons Learned From a Review of Amended Reports. Archives of
pathology & laboratory medicine, 141(2), pp.260-266..
8. All amended pathology reports for breast surgical specimens
for a 5-year period at a large academic medical center were
retrospectively identified and classified based on an
established taxonomy.
10. Revised pathology reports
A change in the information of a
pathology report after the report
has been finalized and released
and requires unsigning the original
report.
All changes that do more than add
information
Represents additional information
added to an unchanged original
report.
Only changes that just add
information
allows editing of the report text,
including diagnostic fields, and
requires adequate documentation
of all changes and notifications to
referring clinicians.
serves as a record of errors in
specimen collection, processing,
interpretation, and reporting.
Amendments Addendum
11. Review of amended surgical pathology reports
• Identifies defects in the surgical pathology process and to
promote quality assurance and improvement.
• A ‘‘taxonomy of defects’’ was developed and validated by
Meier and colleagues to approach the review of amended
reports.
• Classified into 4 categories—
• misidentifications
• specimen defects
• misinterpretations
• report defects
13. Review of amended surgical pathology reports
• Breast was the second most common organ site for
misinterpretations (16.2%) and misidentifications
(12.6%).
• Breast was the most common organ site for
specimen defects (41.6%).
15. • All amended pathology reports for breast surgical specimens
in the Department of Pathology at Brigham and Women’s
Hospital (Boston, Massachusetts) from January 1, 2009, to
December 31 2013, were retrospectively identified from the
departmental database of cases.
• Study specimens included core needle biopsies, excisions,
re-excisions, mastectomies and excluded consultation cases.
• Addendum reports, presumed to include added information
only, were not reviewed.
16. • The classification of amended reports was modeled after
the taxonomy of defects.
• The 4 categories included :-
1. report defects
2. specimen defects
3. misidentifications
4. Misinterpretations
• An amendment was classified as a report defect (ie, a
typographical error) only after review of the case
suggested that it would not be better classified as 1 of
the other 3 types of defects.
17. • Misinterpretations were classified into
• major diagnostic changes (potential to alter patient
care)
oupgraded
odowngraded
ochanged diagnoses.
• minor diagnostic changes
• additional diagnostic information.
19. • Of 12,228 breast pathology
reports, 122 amended
reports were identified.
• Most (88 cases; 72%)
amendments were due to
noninterpretative errors,
including 58 report defects,
12 misidentifications & 3
specimen defects.
• A few (34 cases; 27.9%) were
classified as
misinterpretations, including
14 major diagnostic changes
(11.5% of all amendments).
Amendments to Breast Pathology Cases
During a 5-Year Period
20. Major Diagnostic Changes During a 5-Year Period
Among major diagnostic changes, there were cases of
•missed microinvasion or small foci of invasion
•missed micrometastasis,
•atypical ductal hyperplasia overcalled as ductal carcinoma in situ,
•ductal carcinoma in situ involving sclerosing adenosis mistaken for invasive carcinoma,
•lymphoma mistaken for invasive carcinoma
•amyloidosis misdiagnosed as fat necrosis.
21. Major Diagnostic Changes During a 5-Year Period
•9 major changes were detected at interpretation of receptor studies and were not associated
with clinical consequences.
•3 cases were associated with clinical consequences, and of note, the same pathologist
interpreted the corresponding receptor studies.
23. DCIS involving sclerosing adenosis misinterpreted as invasive
ductal carcinoma on core biopsy and surgical excision
Apocrine ductal carcinoma in situ
involving sclerosing adenosis displayed
a highly complex, pseudoinfiltrative
architecture and marked cytologic
atypia on both core biopsy and excision
(A)
Immunohistochemical workup
(p63/cytokeratin and myosin/cytokeratin)
revealed a myoepithelial layer through
the lesion (B)
(Report amended after 2 months)
24. Diffuse, large B-Cell lymphoma misinterpreted as
triple-negative breast carcinoma on core biopsy
Diffuse, large B-cell lymphoma mimicked
poorly differentiated carcinoma on core
biopsy (C) triple negative profile on
immunohistochemical studies for estrogen
receptor, progesterone receptor, and
HER2.
On excision, the tumor consisted of sheets
of dyshesive, polygonal cells with large
vesicular nuclei and prominent nucleoli (D)
worrisome for a lymphoma.
(Report amended after 3 weeks)
25. Amyloidosis misinterpreted as fat necrosis on core biopsy
Amyloidosis of the breast manifested as deposition of eosinophilic material between adipocytes
and surrounding ducts, and as scattered calcifications, which was difficult to distinguish from fat
necrosis and fibroadenomatoid change (E).
An amorphous quality to areas initially appearing hyalinized, raising concern for amyloidosis
Further workup with Congo red (F) and sulfated Alcian blue special stains confirmed the
diagnosis.
.
27. • First study to investigate amended pathology reports specific to
breast specimens at a single institution.
• The study provided further insight into specimen
misidentifications and misinterpretations.
• Laterality reporting errors were most often discovered by the
radiology team soon after release of the final pathology report.
• Major interpretive errors were detected by pathologists, most
commonly at interpretation of immunohistochemical studies for
ER, PR and HER2.
• Major interpretative errors were associated with clinical
consequences in 3 cases.
28. • The study established standardized methodology for data
collection and benchmarks for quality measures.
• The study showed misinterpretations and specimen defects
were most often discovered by pathologists, whereas
misidentifications were most often discovered by clinicians.
• Review of ancillary studies after sign out was one of the more
common mechanisms of error detection.
• A second review at the time of predictive factor reporting
could be another valuable strategy for retrospective review of
all new breast cancer.
• The study contributed to an understanding of diagnostically
challenging cases in breast pathology.
30. • A review of amended pathology reports provides
valuable insights into surgical pathology processes.
• A review of amended pathology reports suggests
strategies for error detection and reduction.
• A second review at the time of ancillary studies is a
potentially valuable approach to the detection of
interpretive errors in a timely fashion and prevention
of associated clinical consequences.
Editor's Notes
The most common organ sites with report defects were skin (18.2%), followed by breast (17.7%), lower gastrointestinal tract (10.5%), female genital tract (10.4%), and upper gastrointestinal tract (7.6%). Cases with report defects most commonly involved neoplastic disease, as original diagnoses of benign and malignant neoplasms accounted for 61.6% of defect cases.
Misinterpretations and specimen defects were more often discovered by pathologists (73.5% and 82.7%, respectively). Misidentifications were most often discovered by clinicians (44.6%). These differences were statistically significant (P , .001, v2 test) (Table 5). In Table 6 the defect fractions for the 5 most common organ sites are reported: breast, female genital tract, upper gastrointestinal tract, lower gastrointestinal tract, and skin, with all other organs grouped as ‘‘other.’’ The most common source of misinterpretation was ‘‘other’’ (38.5%), followed by skin (20%) and breast (16%). The most common source of misidentifications was skin (42.6%), the most common site for specimen defects was breast (41.6%), and the most common site for the residual category of other nondiagnostic information defects was ‘‘other’’ (40.3%). These differences also were statistically significant (P , .001, v2 test). It should be noted that participants did not collect information about the relative number of each organ type evaluated during the study period. Thus, the relative proportions of defects by specimen type may be biased by the proportion of those specimens reported in this data collection.
