A diagnosis of breast cancer is
devastating; however, a wrong diagnosis can be more devastating. Unfortunately,
misdiagnosis can occur; a patient with breast cancer will be told she does not
have cancer, and a patient who does not have breast cancer can be told that she
does have it. Obviously, either of these errors can cause significant harm to a
patient. Fortunately, a diagnostic service is available that can reduce
diagnostic errors: know error®. To obtain the facts regarding diagnostic
errors, I consulted with Dr. David Brousseau, director of Radiology of Los
Angeles Center for Women’s Health and Laura Beggrow, president of Strand
Diagnostics/Know Error. The accompanying slide show explains how diagnostic
errors can occur.
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| Breast Biopsies System |
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The know error system uses bar coding, forensic principles,
and DNA matching to confirm that surgical biopsy samples being evaluated belong
exclusively to the patient being diagnosed. (Forensic principles are the use of
science or technology in the investigation and establishment of facts or
evidence.) The know error system for breast biopsies is in use in medical
practices across the nation. Since the test was launched in September 2012
nearly 13,000 breast cancer patients have been tested using the know error
system. (The know error test was first launched in prostate cancer in 2010.
From 2010- September 2013- over 106,000 prostate cancer patients have been
tested)
The cost of medical services is of major importance to most
Americans. The good news is that the know error system kits are provided to
physicians practices at no charge to the patient nor practice. Ms. Beggrow told
me that the patient’s insurance company is billed for the molecular diagnostic
testing performed. Reimbursement varies and currently averages around $400 per
patient. Strand Diagnostics makes testing available to all appropriate breast
cancer patients regardless of their insurance, providing comprehensive
assistance and support for all patients throughout the reimbursement process.
The know error system is a DNA Specimen Provenance Assignment (DSPA) molecular
diagnostic test billed to governmental and commercial insurance providers.
Therefore, patients will only be responsible for the in-network deductible,
co-insurance, and co-pay amounts applied by their carriers.
Ms. Beggrow told me that they are discovering diagnostic
errors in 1.18% of the breast patients that they test. Whether or not the
patient received a false positive diagnosis is a function of the diagnosis of
the "complementary" tissue. That is, if a patient DOES have breast
cancer and her tissue is switched with someone that ALSO has breast cancer,
then by chance, neither patient will receive a false reading of cancer.
(Although the grade and volume of cancer may have been different, neither would
have received a false cancer diagnosis.) The bottom line is that know error can
reduce that approximately 1% chance of error to zero.
I asked Dr. Brousseau how often diagnostic errors occurred
and if they were increasing. He told me that Specimen Provenance Complications
(SPCs) can occur as a result of human error during any step in the complex
biopsy diagnostic testing cycle. Some examples of SPCs include mislabeling,
specimen transposition, and foreign cell contamination. Approximately 3.5% of
cases receiving a positive cancer diagnosis are subject to undetected SPCs,
which could lead to a cancer diagnosis being assigned to the wrong patient.
Conversely this could lead to a delay in women with breast cancer receiving
their diagnosis, potentially delaying life-saving treatment.
The Centers for Disease Control and Prevention (CDC)
estimates that more than 200,000 women are diagnosed with breast cancer
annually in the United States, meaning approximately 2,000 women per year could
be incorrectly diagnosed with breast cancer. Since the issue continues to be
undetected and under-reported that number will continue to increase. The error
rate provided only includes healthy patients who are diagnosed with cancer;
however, it does not include those who are told they do not have cancer but
later on do in fact receive a positive biopsy result. These mistakes can set in
motion the overtreatment of thousands of patients annually as well as delay the
potentially life-saving treatments of women with cancer.
Dr. Brousseau noted that the attention to detail,
particularly with respect to specimen labeling, varies widely among medical
institutions. At his institution, the Los Angeles Center for Women’s Health,
specimens are processed and labeled immediately. He stressed that avoiding
batch processing at the point of acquisition is important for patient safety.
Nonetheless, many if not most, institutions now utilize third party services to
process the specimens before they are reviewed for diagnosis. Since this part
of the process is beyond their direct control, they feel very comfortable with
the knowledge that the know error system helps them avoid any transposition
issues which could potentially occur in subsequent processing. Fortunately,
they have not discovered any mislabeling or transposition errors since we began
using this system about nine months ago.
Dr. Brousseau told me that issues of cross-contamination are
becoming of greater concern to the medical community as tissue specimens
undergo more frequent gene testing to predict prognosis and gene testing is
employed in decision-making about the use of chemotherapeutic agents. Although
cross-contamination itself may not lead to a cancer diagnosis in the wrong
patient, it could have a significant effect on a choice about the subsequent
treatment. In summary, he said, “Patients that hear those dreaded words - you
have breast cancer - and how many are actually getting the wrong diagnosis. Now,
with the help of a DNA test, physicians around the Country are aiming to lower
the rate at which these errors occur.”
At nearly every step of the 20-step biopsy diagnostic
process there is room for mix-ups to hide, undetected. This can be caused by
two errors: (1) the patient's sample is switched with another's and (2) the
patients sample is contaminated with one or more patient's DNA tissue. Over
200,000 woman are diagnosed with breast cancer per year. This means that
treatment recommendations (including removal of healthy breasts and prostates,
chemotherapy, radiation) are being made for cancer-free patients and
life-saving treatment is being delayed in some cases as well.
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| Breast Biopsy; Uses, Side Effects, Procedure, Results |
Now, when a patient comes into the physician’s office to
have a surgical biopsy- where the physician takes a sample of the mass in the
breast - they are also given a DNA test (know error system) via cheek swab.
When the biopsy sample comes back to the lab and tests positive for cancer, it
is then sent to the lab and the DNA from the cheek swab is matched with the DNA
from the biopsy sample. From here, it can be determined if the biopsy sample is
in fact that patients. This test is a simple, non-invasive way to reassure the
patient their diagnosis is their own and, if they do have cancer, then they are
receiving the accurate treatment.
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