Lessons from a Review of Amended Reports for Quality Assurance in Breast Pathology
The literature on quality assurance and peer-review
processes in surgical pathology is extensive, however, the majority of these
papers apply to general surgical pathology. We focused on the peer-review
reporting system of a women’s health pathology clinic that specialized in
breast and gynecologic pathology, with the explicit goal of discovering
diagnostic differences that impacted patient treatment.
Quality metrics are tracked in this specialized
practice, and any amended/corrected reports are reviewed by the Medical
Director. Error kinds are qualitative and are classified based on their
influence on patient care. As a measure of error kind and frequency, QA data
from all revised reports in breast and gynecologic pathology from 2012 to 2014
were analyzed.
Results:
343 specimens (0.54% of all reports) required revision
due to a QA metric-discovered
disparity during this time period. Breast specimens had a higher rate of
amendment than GYN specimens (1.14% of breast specimens versus 0.27% of GYN
specimens). Type A, or Minor Disagreement, was the most common mistake type
necessitating an amendment for both breast and GYN specimens (reports altered
for type A discrepancy: 78.7% of the total; 81.9% of the breast; 72.6% of GYN).
Type B, or Moderate Disagreement inconsistencies, accounted for 21.3% of all
revised instances (18.1% of the breast; 27.3% of GYN). There were no cases classified
as type C, or Major Disagreements, among all breast and GYN, reports analyzed
during the QA study.
When surgical pathology is performed in a laboratory
under strict quality assurance standards, major diagnostic interpretation
errors are unlikely. The technique reduces mistakes, improves patient safety,
and offers pathologists real-time instructional opportunities.
Patient therapy is guided by surgical pathology
diagnoses, hence accurate diagnostic interpretation is crucial for optimal
patient management. The public was taken aback when recently released
information on diagnostic disputes among pathologists examining breast biopsy
specimens revealed a roughly 25% discordance rate among pathologists
participating in the study, particularly in atypia diagnosis.
Unfortunately, in a non-CLIA lab research environment, this study was not
representative of true pathology practice and provided deceptive statistics. As
a result of this research, we decided to examine our own QA data to establish
the prevalence of diagnostic discrepancies (as determined by the review of revised
reports) in breast and GYN pathology at our institution. Comprehensive quality
assurance processes are used at our university Women’s Hospital to detect and
correct serious diagnostic issues.
Laboratory
medicine is a highly structured profession in which accuracy and safety have
been regularly assessed and regulated for decades. Pathologists use a variety
of diagnostic tools and consultations in forming a diagnostic judgment to
provide diagnostic information to other clinicians, such as access to the
patient’s electronic medical record, access to radiographic images, submission
of additional tissue levels, specialized immunohistochemical stains, access to
prior related specimen slides, and, in some cases, submission of additional
tissue. Importantly, after a diagnosis is made using these methods,
the case material is routinely re-evaluated using multiple QA measurements.
These QA procedures are used by practicing laboratories for more than only
reducing diagnostic errors.
In this study, we reviewed QA data on intradepartmental
reports that required an amendment to analyse the frequency and severity of
errors in breast and gynecologic (GYN) pathology specimens.
At our institution, quality assurance/peer review
protocols include 10% intradepartmental random case review, frozen
section/permanent section diagnosis correlation, intradepartmental consensus
conference review, review of cases presented at multidisciplinary tumor boards,
double independent reads of all breast core biopsies
and all new malignancies prior to signing out, and review of prior biopsy
materials.
Concurrently
with surgical resections, and real-time Cytohistologic correlations. In
addition, all cases that are sent to outside institutions by patient request
have incoming reports that are reviewed by the Chief of service, and
pathologists are required to issue addendum reports that state their report was
reviewed by an outside institution and diagnosis was in agreement. If a
diagnosis is not in agreement with an outside institution, the case is then
reviewed by the Chief of service to adjudicate the diagnosis with further
exterior consultation
if necessary.
The peer review processes are all monitored by the
Chief of service, who also serves as the head of the departmental quality
assurance committee. The Chief, in concert with the QA manager, initiates the
production of an amended report if the criteria for an amended report are met
as described below, and the Chief assigns an error severity based on the
reported defect and how it impacts patient care. Impact on patient care is
determined individually for each case, taking into account the pathology report
result, clinical information supplied electronic
medical record information, and clinician input.
The degree of errors in modified reports is denoted as
follows: A — Minor disagreement, such as a typo or a formatting problem that
had no influence on medical treatment; B — Moderate Disagreement, including
diagnostic flaws/omissions that would not result in a change in patient care,
Type B errors are report deficiencies that may include erroneous information,
such as omission errors, missed lymphovascular invasion, or wrong grading of
breast cancer. Such errors would not demand a change in patient care at our
facility. Type C errors represent a significant disagreement, which includes
severe diagnostic inconsistencies that would be deemed a critical event
warranting a modification
in a patient’s treatment plan.
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· 10th World Breast Pathology and Breast Cancer Conference |
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