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ALWAYS Document Your Informed Refusal Conversations

This Case of the Month emphasizes the importance of documenting conversations with patients regarding informed refusal.


Beware: A good physician-patient relationship may not always save the day when adult children get involved.


Mr. S, a 65-year-old male patient had his initial visit with Dr. G, his new primary care physician (PCP). At this visit, Dr. G ordered routine lab work, including a prostate-specific antigen (PSA) blood test, which resulted in 2.7 (Year 1). The following year, Mr. S saw Dr. G for his annual visit. A PSA was ordered which resulted in 8.6 (Year 2) and Dr. G. contacted Mr. S to inform him of the elevated result. Mr. S was referred to a urologist who performed a prostate biopsy. The biopsy was negative for cancer. Over the following decade, Mr. S saw Dr. G annually, and sometimes semi-annually, and routine PSA levels were ordered. From Year 3 to Year 8, Mr. S's PSA levels fluctuated between 3.8 to 5.4. In Year 9, his PSA levels increased to 6.7 and a repeat level was drawn six months later, and resulted in 5.66. Six months later (Year 10), the PSA level was 6.69.


Although not documented, Dr. G recommended Mr. S see a urologist when the PSA levels remained elevated. Mr. S declined the referral, rationalizing it was not needed because when his PSA was over 8, his biopsy was negative. Dr. G reiterated the elevated PSA could be indicative of cancer that eventually metastasizes and leads to death. However, Mr. S still insisted he did not want to see a urologist and have another biopsy, even if it meant death, because the biopsy “hurt like hell.” The patient’s wife witnessed this conversation.


Mr. S returned to Dr. G the following year, and another PSA was ordered (Year 11) and resulted in 25.15. Dr. G contacted Mr. S regarding the result and need for a urology referral. Given the significant increase in the PSA level, Mr. S agreed to see a urologist. He followed up with a urologist and underwent a prostate biopsy which revealed cancer. A post-procedure bone scan showed widely disseminated osseus metastases.


Although Mr. S and his wife had a good relationship with Dr. G, they hired an attorney who filed a notice of intent (NOI) to sue at the insistence of their adult children. The significant increase in the PSA level to 25.25 in year 11 prompted the children to question the accuracy of Dr. G’s interpretation and follow up of the prior PSA levels. Unfortunately, Dr. G did not document his many conversations with Mr. S regarding: the risk of not seeing a urologist for the elevated PSA levels; not having a prostate biopsy; or the consequences of refusing treatment, including cancer, metastases, and death. Had these conversations and Mr. S's refusal to follow medical advice been documented in the medical record, an attorney may not have pursued legal action.


After the NOI was issued, Mr. S's wife visited Dr. G and apologized to him for pursuing a lawsuit. She informed him that it was not her husband’s nor her desire to sue him. Unknown to Dr. G, Mr. S's wife also made a gift to the hospital in Dr. G’s honor. The plaintiff attorney subsequently withdrew his representation of the patient, and the case was not pursued by the patient or his family.


Although justice prevailed, Dr. G could have avoided months of needless anxiety following the issuance of the NOI had he documented Mr. S's informed refusals to follow up on the elevated PSA levels. Patients have the right to refuse a proposed procedure or treatment, including a physician’s recommendation that a patient see a specialist.¹ In cases that proceed to trial, the California jury instructions given on informed refusal are: “A (physician) must explain the risks of refusing a procedure in language that a patient can understand and give the patient as much information as (they) need to make an informed decision, including any risk that a reasonable person would consider important in deciding not to have a medical procedure (treatment). The patient must be told about any risk of death, serious injury, or significant potential complications that may occur if the procedure is refused. A physician is not required to explain minor risks that are not likely to occur.”² Although documentation of this discussion is not included in the jury instructions, documentation in the medical record provides evidence of the patient’s informed refusal should the patient dispute the discussion or is no longer alive to testify.


Dona Constantine is a Senior Risk & Patient Safety Specialist. Questions or comments related to this article should be directed to DConstantine@CAPphysicians.com.


References

¹Kichler, Deborah “You Didn’t Tell Me That. Informed Refusal as a Defense”. Risk Management and Patient Safety News, p. 1. October 2020  https://www.capphysicians.com/articles/you-didnt-tell-me-informed-refus…

²Judicial Council of California Civil Jury Instructions (2023 edition), CACI No. 534. https://www.courts.ca.gov/partners/documents/Judicial_Council_of_California_Civil_Jury_Instructions.pdf

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