Investigation Highlights The Importance Of Clear Information And Consent Before Undertaking Procedures

Deputy Health and Disability Commissioner, Dr Vanessa Caldwell, today released a report finding a GP in breach of the Code of Health and Disability Services Consumers’ Rights (the Code) for failing to obtain informed consent and provide care with reasonable care and skill.

A woman visited her GP to discuss having a contraceptive uterine device (IUD) inserted. Several swabs and urine samples were taken prior to the procedure. The woman was booked in to have the procedure the following day.

The woman arrived at her appointment to undergo the procedure to insert the IUD. A chaperone nurse noted from her computer file that the woman had a positive result for a bacterial infection of the vagina, and raised it with the GP. The GP reassured the woman that insertion of an IUD would not be impacted 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.

When the woman returned for a follow-up appointment, the GP was away overseas, so she was seen by another GP. The second GP explained the results of the biopsy taken during the procedure. The GP became concerned by the woman’s distress at discovering she had undergone an invasive procedure without prior knowledge or consent. The woman told the second GP that she wanted to lay a complaint and he referred her to HDC.

Communication issues between the doctors were reported to HDC and the second 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.

Dr Vanessa Caldwell 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.

"The principle of informed consent is at the heart of the Code of Health and Disability Services Consumers’ Rights (the Code), […which] provides that, apart from exceptional circumstances, health services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent," said Dr Caldwell.

Dr Caldwell was critical that 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.

"In my opinion the timing of this discussion was less than ideal. It would have been more appropriate for the GP to have discussed the BV result, and any implications that it may have had on the IUD insertion, and obtained the woman’s written consent for the procedure before the woman physically began to prepare for the procedure," said Dr Caldwell.

Although the woman did not lay a formal complaint with the medical centre, Dr Caldwell made adverse comment about the medical centre, saying:

"It was clear from her appointment with the second doctor that the woman was upset and concerned about what had happened, and that the medical centre was aware of the nature of those concerns. […] However, the medical centre did not acknowledge or respond to the woman’s concerns in writing, which is inconsistent with the Code, and that medical centre’s Complaints Policy."

Dr Caldwell 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. Dr Caldwell also recommended the Medical Council of New Zealand consider whether a review of the GP’s competence and/or conduct is warranted.

Dr Caldwell also recommended 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.

The full report on this case is available on the HDC website.

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