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Informed Refusal Documentation

This informative article is provided by ProAssurance.

Inadequate Documentation of Patient Refusal of Treatment

Appropriate, consistent, and accurate medical record documentation is a key aspect of patient safety and liability risk management. What is, and more often what is not, documented in the record can be the pivotal factor in a malpractice lawsuit. From a risk management perspective, a complete record can help prevent and minimize the potential adverse consequences of malpractice litigation. Ultimately, the record serves as the basis for the defense of a malpractice claim or lawsuit. In a courtroom setting, the medical record can be thought of as a witness whose memory is never lost. Without documentary evidence, physician credibility versus patient credibility becomes the crux of a lawsuit, since juries can often be convinced that a course of action that is not memorialized in the medical record never occurred.  

In a lawsuit involving a patient whose refusal of treatment contributed to their injury, a physician’s defense is generally supported with documentation and testimony of standard practice. It can be difficult for defendant physicians to recall the details of a patient’s refusal of treatment by the time litigation commences, and the physician’s recall and standard practice usually conflict with the patient’s testimony. Supporting documentation not only helps recall, but also supports the physician’s defense. An informed refusal form signed by the patient and a description of the content of the informed refusal discussion in the progress notes significantly reinforces the physician’s testimony and increases the defensibility of a claim. 

In the following case study, the defense team believed they could prevail if they could establish that the patient was offered endometrial biopsy (even though it was an inferior test in this case) as an alternative to the D&C and hysteroscopy, to rule out possible endometrial cancer. However, the patient denied being informed of the risks of refusal, and the medical record documentation was too sparse to prove an informed refusal occurred. Had the defendant nurse practitioner (NP) adequately documented her recommendations and an informed refusal process, she would have been in a better defense position.  

Case Study 

Allegation: Failure to adequately educate the patient about the risks of refusal resulted in delayed diagnosis of cancer.

On April 20, 2019, a menopausal woman presented to an OB/GYN group as a new patient for irregular vaginal bleeding accompanied by severe cramping for the past year. She was examined by an NP, who ordered a pelvic ultrasound. Because the ultrasound indicated endometrial abnormalities, the NP’s plan was to schedule the patient for a D&C and hysteroscopy to rule out cancer.

The complete medical record entry for April 20, 2019, stated: “Hys D&C for eval r/o CA.”  

Over the next year, the patient, NP and OB/GYN group staff exchanged messages about scheduling an appointment to discuss the patient’s options.

On June 1, 2020, the patient returned to the OB/GYN group with continued vaginal bleeding; abdominal pelvic pain; pain with intercourse; and a painful sore on the right labium majus, which had been there for the past three months. Examination revealed a raised papule. A biopsy of the papule led to an ultimate diagnosis of endometrioid adenocarcinoma with metastases to the internal and external iliac lymph nodes, abdominal wall, and lungs. The patient filed a malpractice lawsuit alleging the NP negligently failed to diagnose cancer in a timely fashion. 


At her deposition, the NP recalled the patient refused the D&C and hysteroscopy because she could not afford the co-pay. The NP testified that her custom and practice was to offer endometrial biopsy as an alternative to D&C and hysteroscopy to patients with financial concerns. However, the patient testified in deposition that she understood the D&C and hysteroscopy were elective procedures to treat her irregular bleeding, not the recommended method for ruling out cancer. She denied understanding the abnormal ultrasound and her symptoms could be signs of cancer, or any kind of informed refusal process relative to refusing a D&C and hysteroscopy.   

The defense team believed this case turned on their ability to establish the NP offered endometrial biopsy as an alternative to D&C and hysteroscopy to rule out possible endometrial cancer, and she discussed the risks of refusing the diagnostic procedures. Notably, there was no mention of an endometrial biopsy in the patient’s record, no mention of the patient’s refusal of treatment, and no mention of the risks associated with failure to undergo further studies. The NP’s defense would rely primarily on her testimony. Consequently, the likelihood of a defense verdict at trial rested almost exclusively on who the jury chose to believe between the NP and patient regarding whether an endometrial biopsy was offered and whether the patient understood the risks of refusing further testing. 

According to causation experts, the more than a year-long delay in diagnosis had a significant impact on the patient’s prognosis. Either the endometrial biopsy or hysteroscopy and D&C most likely would have diagnosed the patient’s cancer while it was Stage I or Stage II. If diagnosed at that time, she would have had a good chance for a cure with a radical hysterectomy. However, once the patient had the labial lesion in June 2020, the cancer was metastatic (likely Stage IIIB or Stage IVA), and it was unlikely the cancer would have been curable with diagnosis and treatment at that time.   

Risk Reduction Strategies—Documenting Recommended Diagnostic Testing and Informed Refusal 

In the foregoing case, if the patient declined the D&C and hysteroscopy after obtaining costs/copay information, the discussion should have been clearly documented. Additionally, the NP should have clearly documented that her recommendation remained D&C and hysteroscopy, but endometrial biopsy was offered as an alternative. If the patient refused any workup, an informed refusal process should have occurred with clear documentation of the risks of refusal. 

Especially when recommending testing to rule out cancer, it is important to document contemporaneously what the patient is advised to do, and the poor outcomes that can result by not following through. If patients do not undergo recommended testing, it is important to document observed details associated with the patient’s nonadherence, which may later help prove not only that the recommendation was made, but also that the patient refused, despite best efforts to affect adherence. An informed refusal process should accompany any failure to persuade a patient to follow through with testing recommendations. It is important to continue to encourage the patient to undergo recommended treatment at each subsequent encounter, and to document those efforts.  

Informed Refusal Process Documentation

Documentation of the informed refusal process should include: 

  • That the informed refusal discussion took place
  • Information given to the patient about the risks of refusal and/or alternatives
  • The patient-specific issues discussed and any items that received special emphasis
  • Questions and/or concerns that the patient had and how they were addressed
  • The patient’s reason for refusing treatment
  • Efforts undertaken to ensure the patient’s understanding of the risks
  • The result of the informed refusal process
  • Efforts undertaken to determine patient decision-making capacity when appropriate 

Informed Refusal Form

A signed form cannot replace the informed refusal discussion or documentation of the discussion; however, providing the patient with the informed refusal form can give the patient more time to consider the risks of refusing treatment with the input of loved ones at home. The act of receiving documentary evidence of this process can dissuade the patient from filing a lawsuit. It is important to make a notation in the file about the patient being provided with the form, in addition to scanning the signed form into the file. If this is done, and the form is appropriately detailed and personalized, the patient will have a difficult time successfully claiming lack of an informed refusal. The informed refusal form should include the same elements as the discussion and should be written in language that the patient can understand. The elements on the form should include the following:

  • Information about potential outcomes if interventions are refused
  • Acknowledgment that the patient can withdraw the refusal
  • The offer of a second opinion, if applicable
  • Space to insert factors unique to the individual patient (e.g., the patient’s comorbidities) that affect risks and alternatives, or questions/concerns expressed by the patient and how they were addressed
  • That the patient understood the ramifications of his or her decision
  • Date, time, and patient and physician signatures 

Sometimes patients will not agree to sign an informed refusal form, in which case you should include the declination in your documentation along with a copy of the form given to the patient. Consider having another healthcare provider or nurse witness the declination to sign. 


The medical record contains the best evidence of an informed refusal process should the issue ever be raised in a claim, lawsuit, or medical board complaint. One of the more difficult issues for defense attorneys to overcome in malpractice litigation is a medical record that cannot be confidently presented to a jury as evidence of appropriate medical care. Incomplete or absent medical record documentation can make an otherwise defensible liability claim insurmountably complicated.

Additional Resource  ProAssurance Refusal of Treatment Sample Form

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