A 52-year-old male developed metastatic prostate cancer a year after highly elevated PSA test values were reported to the physician’s office but never followed or reported to the patient.
- Reliable systems for test result management in the office practice address receipt and review of the test results, and communication of the results to the patient.
- Patients can play a role in reducing risk if they are engaged in their care and understand the importance of screening tests.
- Immediacy and honesty in communication with a patient following an adverse event maximizes the potential of preserving the provider/patient relationship.
A 52-year-old male patient presented to his PCP’s office for his annual physical exam. The patient had been treating with this PCP for more than 20 years, and had a medical history that included type II diabetes, high cholesterol, and back pain. One month before the physical, the patient had been seen for his back pain and had undergone an MRI of the L-spine, lumbar x-rays, and steroid injections with some relief. At this time, the PCP documented a thorough physical exam, including a normal prostate. Additionally, the PCP ordered routine blood work.
The final lab report documented a Hgb A1c 6.3 (normal); cholesterol of 191 (borderline high) and a PSA of 15.78 (nml 0–4). The PCP had not documented the tests he ordered, and did not notice the PSA findings. He proceeded to send two form letters to the patient: the first one addressed only the patient's cholesterol with advice to consume a low fat diet and increase his exercise; the second letter addressed the rest of the lab results. Unfortunately this letter commented on the patient’s good blood sugar control, but failed to address the PSA. Additionally, this letter was not signed by the PCP, but appears to have been mailed to the patient, possibly by an assistant.
The patient was seen three times over the next 12 months for follow up on his diabetes and cholesterol. During this time, the patient was put on Lipitor to lower his cholesterol. No PSA tests were ordered or addressed during this time period. Several months later, however, the patient presented to the Emergency Department with right flank pain, radiating to his lower abdomen and back, and was admitted to the hospital. Rectal and prostate exams were abnormal, PSA was 557.4, and an abdominal and pelvic CT showed retroperitoneal adenopathy with diffuse bony lesions suggesting metastases. The patient went on to have a biopsy with a Gleason score of 9 and perineural invasion. He was diagnosed with stage 4 prostate cancer and is being treated with hormonal therapy; however prognosis is poor.
The patient sued the PCP, alleging that the PSA test results were neglected, and that this delayed the patient’s diagnosis of prostate cancer.
The case was settled in the mid-range ($100,000-$499,999).
- The PCP failed to follow up on an abnormal test result that he ordered.
One leading cause of claims related to prostate cancer is a mishandled test result, specifically, once a test is ordered it is not tracked or followed up. Although professional recommendations call for discussion of PSA testing by a certain age, it should not be ordered without a risk-benefit discussion and patient consent. Unfortunately, the PSA test can be easily checked off during routine blood tests. However, once PSA testing has been initiated, it is the physician’s responsibility to continue to test periodically and to track the results. If an abnormal result is received, further testing is recommended, in a timely manner. Reliable office systems ensure that the test is done once it is ordered, the result is reviewed by the ordering clinician, the patient gets a copy, and abnormal results have a documented follow-up plan.
- The patient claimed that he didn’t know that a PSA had been performed or what a PSA test result would mean.
Patients need to understand the relevance of a test that their physician recommends. In general, this will support patient compliance and help manage expectations. Initiate the discussion about PSA testing with male patients age 50, sooner for patients with risk factors (note that, in randomized trials of PSA testing, reductions in morbidity and mortality from prostate cancer have not been documented). Side effects from intervention are significant. Therefore, discuss with the patient the risks and benefits of testing—including no testing—and document the discussion and patient preferences in the medical record. Additionally, this conversation should be repeated every few years.
- The office system for reporting test results to the patient broke down, and he never received notification of his highly elevated PSA.
A breakdown in communication regarding a patient’s test result generally happens in one of two ways: 1) the result is not received or acted upon by the physician; or 2) the result is sent to the physician, but never communicated to the patient. Office practices with systems that ensure tracking and reconciliation of all test results, both normal and abnormal, reduce the risk of a delayed diagnosis. This includes confirmation of physician review and receipt of critical test results prior to filing, as well as patient notification of normal and abnormal test results. Patients can be enlisted as partners in making their care safer by advising them about the timing and what to expect regarding notification of their test results, and instructing them to contact the office when results have not been received. Setting an expectation with patients that they should receive notification of their test results promotes a sense of partnership and engagement.
- The patient argued that, if the cancer had been found a year earlier, it would have been organ-confined and curable.
When the standard of care is not met, and a diagnosis is delayed, a defensive strategy that the delay did not affect the outcome may fall on deaf ears. In the absence of clinical consensus among expert reviewers about whether negligence caused a specific outcome, a settlement may be in everyone’s interest.