Providing clear information to obtain informed consent vital before undertaking procedures

In this case, a woman visited her GP to discuss having a contraceptive intrauterine device (IUD) inserted. Several swabs and urine samples were taken prior to the procedure. When the woman arrived at her appointment to undergo the procedure the following day, a chaperone nurse noted from her computer file that the woman had a positive result for a bacterial infection, and raised it with the GP. The GP reassured the woman that the procedure would not be affected by this, and went ahead with the procedure.

During the procedure, the GP also performed a biopsy without informing the woman she was doing so. Immediately after the procedure the woman experienced discomfort and back pain, and required additional support to return home.

Another GP who saw the woman in a subsequent appointment to explain the results of the biopsy taken during the procedure became concerned by her distress at discovering she had undergone an invasive procedure without her knowledge or consent. The woman lodged a complaint with HDC, and the GP wrote to the Medical Council of New Zealand about his concerns around the services provided to the woman. The woman did not receive anything in writing from the medical centre in response to her concerns.

The Deputy Commissioner considered that the intention to take a biopsy was information that a woman in these circumstances needed in order to make an informed choice and give her consent.

Undertaking this invasive procedure without documenting the woman’s consent, and the untimely discussion with the woman about her positive bacterial infection, amounted to a failure to provide care with reasonable skill.

Although the woman did not lay a formal complaint with the medical centre, it was clear during the investigation that the medical centre was aware of the nature of her concerns and did not acknowledge or respond to the woman’s concerns in writing. This is inconsistent with the Code of Health and Disability Services Consumers’ Rights, and the medical centre’s Complaints Policy.

We recommended that the GP undertake training on communication and informed consent; arrange for an external audit of a random sample of documentation for biopsy procedures she has performed; review local guidance on IUD insertions and biopsies; and provide an apology to the woman. We also recommended that the Medical Council of New Zealand consider whether a review of the GP’s competence and/or conduct is warranted, and that the medical centre review and amend its complaints policy; provide training to staff on the amended policy; and consider creating a new general informed consent policy.

Read the full decision report here.