Lack of PSA Follow-up Leads to Litigation
When his PCP sold his practice, a 68-year-old male patient had been his patient for approximately four years. During the four years that he saw this PCP, the patient's PSA results had risen from 2.2 to 5.0. His PCP expressed concern over the rising PSA and asked the patient to undergo another PSA test.
When Dr. D took over the practice, his first appointment with the patient was in January of year 1. Dr. D reviewed the patient's previous lab results and documented that the patient's last PSA was 5.0, which was within the expected range (0.0 – 5.0). He performed a digital rectal exam (DRE), noting an enlarged, non-nodular symmetrical prostate. Dr. D documented, "Slight BPH w/borderline PSA. Re-check in November before he goes to Florida. Declined urologic consult at this time." The patient chose to be tested the day after his appointment with Dr. D rather than having the test performed in November of that year. The results came back outside the reference range, at 7.0. Dr. D initialed the lab report, but he did not date it, and the staff did not document their attempts to reach the patient.
The patient did not return to the office until year 2 when he again presented for an annual examination. Dr. D performed another DRE, which was unremarkable. He recorded a note stating a PSA test was "pending," but he did not record anything about the 7.0 PSA result from the previous year. He asked the patient to follow up in 3-6 months or sooner if needed. Dr. D received another PSA result four days after the office visit, this time reported as 8.0. He initialed and dated the report, but neither he nor the staff documented efforts to contact the patient. The patient canceled his annual physical in year 3.
The patient saw a physician in Florida who ordered another PSA test in March of year 3, reported as 8.5. The patient saw the Florida physician again in December of year 3. A repeat PSA test showed the results had risen to 12.5, prompting a referral to a urologist in Florida.
The patient saw the urologist in Florida in the spring of year 4. The urologist expressed concern over the rapid rise in PSA in nine months from 8.5 to 12.5. He ordered another PSA test which by now had risen to 18.4. Prostate biopsies were positive for Gleason-8 prostate cancer involving 50% of the tissue, representing at least a stage T2b cancer. A CT scan of the pelvis and a total bone scan was negative, and based on these results, the patient chose to have a radical prostatectomy which was attempted in April of year 4. During surgery, metastatic disease was found in the pelvic nodes, and the surgery was aborted.
The patient brought a malpractice suit against Dr. D. The parties settled the case before trial.
Discussion
Dr. D received the 7.0 PSA result and initialed the report but did not date it. There was no indication in the patient's medical record of any attempts to notify the patient of the test results. The doctor received another PSA result of 8.0. While he did initial and date this report, there was again no documentation in the patient's medical record of the practice's attempts to contact the patient. The patient was not advised of the risks associated with a high PSA result and the need for a biopsy or a referral to a urologist.
Risk Management Takeaways
Failure to diagnose is one of the most frequent allegations in malpractice claims. A direct relationship exists between this allegation and the lack of a comprehensive, reliable test/consult tracking system. The following key risk management takeaways will help you establish an effective test tracking process in your practice.
- Assure that critical values are promptly reported to a provider.
- Establish a process to identify ordered tests/referrals that have not been returned to the office.
- Follow up with patients when results are not returned to the office.
- Review all results promptly.
- Monitor providers' inboxes to assure that results are reviewed and acted upon in a timely fashion.
- Notify patients of all normal and abnormal test results with follow-up instructions.
- Document follow-up instructions in the patient's medical record.
- Instruct patients to call if they have not received their test results.