PC is an otherwise healthy 47-year-old gentleman who was seeing his primary doctor for controlled IDDM and HTN. On September 23rd, 2021, his primary MD recommended a “Cologuard” screening for colon cancer and a follow-up in 4 months. The test was sent to his home by mail, he provided a sample and he returned it back to “Cologuard”. The results were then sent directly from the Cologuard company to the primary doctor’s office in October of 2021. The result sheet for the colon guard is dated October 24th.
It is unknown how this report was received by the primary doctor (Certified letter? Who opens it in the office? Is there a notification sent to the MD? Is it just scanned in?). These results are not in the patient's chart that our firm received for review.
Fast forward to February 8th 2022, PC has his follow-up with annual blood work. There is no mention of the results of the Cologuard and as mentioned, the results themselves are not in the chart. PC states that he did not ask and just assumed that “no news was good news”.
Once again, fast forward to May 18th, 2023. PC had no reason to seek medical attention until this time, this was his annual exam with blood work. He was then notified at that time that the Cologuard was a positive result. This appears to be approximately 19 months after the original results were known.
He was immediately sent to GI and a colonoscopy was done. Within 6 weeks he was found to have stage 3 colon cancer w mets to his lymph node. He will be requiring chemo treatment.
Looking for a family medicine practitioner who is using Cologuard or is familiar with the Cologuard screening process with their patients.
We appreciate your opinions and thank you in advance.
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Do you believe there might have been medical error?
Failure to report/discuss positive results is a deviation from the standard of care. Practices should have processes in place to identify and locate outstanding test results.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Given the initial positive test, more likely than not, he had a lesion at the time of the first screening test.
What makes you a good expert for this case?
I have been in practice for over 25 years and regularly order colon cancer screening tests for my patients. I don’t use Cologard often but test for occult blood with stool studies for low risk patients.
How often do you encounter cases similar to this one in your practice?
I order colon cancer screening on a daily basis and manage the results effectively.
Do you believe there might have been medical error?
In 2021, the US Preventive Services Task Force (USPSTF) issued updated guidelines recommending colon cancer screening to commence at the age of 45 for eligible individuals. One of the screening options mentioned is the Cologuard test, which has a reported false positive rate of 13%, A positive result from the Cologuard test indicates the detection of potential pre-cancerous or cancerous cells in the stool sample, though it does not serve as a definitive cancer diagnosis. The standard of care for this abnormal test result would prompt further tests for a conclusive diagnosis, with a colonoscopy being a common recommendation by the ordering provider for a more in-depth evaluation. The provider appropriately referred the patient to see a Gastroenterologist and underwent a diagnosis colonoscopy with resulting Stage 3 colon cancer with metastasis. The focal point of concern in this scenario revolves around the 19 month delay in diagnosis, and the potential consequences for the patient's prognosis and treatment options,
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The delay in diagnosis and the potential implications for the patient's prognosis and treatment options suggests a concern about the impact of the delay. However, without specific details (size of mass at time of colonoscopy) as well as the patient's condition or outcomes, it's not conclusively stated whether injury has occurred. For colon cancer, the overall 5-year relative survival rate for people is 63%. If the cancer is diagnosed at a localized stage, the survival rate is 91%. If the cancer has spread to surrounding tissues or organs and/or the regional lymph nodes, the 5-year relative survival rate is 72%. If colon cancer has spread to distant parts of the body, the 5-year relative survival rate is 13%. The delay in diagnosis has potential implications for prognosis and treatment for the patient. The question arises, if the patient had underwent a diagnostic colonoscopy earlier would the treatment findings provide a different prognosis and outcome, ie improved survival rate Additionally, if the patient was not at an average risk for colorectal cancer the patient should have received a different test for colon cancer screening instead of a Cologuard test in 2021.
What makes you a good expert for this case?
As a board-certified family medicine physician with 15 years of direct clinical experience, I have honed my skills in providing comprehensive care in an ambulatory setting, with a primary focus on prevention and chronic disease management. My extensive clinical background equips me with a deep understanding of the complexities of patient care, allowing me to navigate the nuances associated with the case at hand. Throughout my career, I have consistently demonstrated a commitment to ordering and interpreting various screening tests, ensuring a thorough and accurate assessment of patients' health status. A crucial aspect of my practice has been the diligent follow-up on test results, ensuring that each patient receives the necessary attention and intervention based on their individual health needs. I take pride in my ability to analyze and interpret medical data, providing reliable insights that can be instrumental in legal proceedings. Moreover, my experience includes appropriate referrals for patients with abnormal test results, further emphasizing my commitment to delivering comprehensive and responsible medical care. This aspect of my practice reinforces my credibility as an expert witness, as it demonstrates my adherence to professional standards and ethical considerations in the field of family medicine.
How often do you encounter cases similar to this one in your practice?
I am a board certified primary care physician who has had over 50,000 patient visits when I was a practicing physician.. My scope of practice when providing full clinical care including screening, prevention and chronic disease management. On a daily basis I was asking my patient screening guideline questions, mammogram, colonoscopies, immunizations etc. and at the annual exam these are standard questions based on the appropriate age and biological sex. In my practice I had mechanisms in place which included telling patients they should always receive test results for any labs or tests ordered by me; Unintentional human and administrative errors can occur. No news does not mean good news. It was imperative they reach out to if they had not received information on their test results within 10-12 business days.
Do you believe there might have been medical error?
There could be many variables at a PCP office that could have happened that are reasonable where a physician should. Not be held accountable for reporting this result and it is the patient’s responsibility to follow up sooner than 19 months. The result may not have been available to the physician for review, the physician cannot be expected to remember every single lab ordered or to know if patient was complaint in taking a home stool test as so many patients are not compliant with these tests. If the lab result was not available to physician for review this is standard error of the clinic not of the physician. Ultimately patient needs to follow up on this result sooner if he did not hear any result from it beforehand.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Colon cancer is slow growing. Even if colonoscopy had found it 19 months before it would likely have been there and not early stage. Delayed colonoscopy did not cause cancer.
What makes you a good expert for this case?
Have sent many fecal occult blood tests over a decade of practice .
How often do you encounter cases similar to this one in your practice?
I have run into this type of case very often.
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