Consent process was ‘demonstrably lacking’

Student involvement in a medical procedure without the patient’s consent has sparked an audit at Te Whatu Ora Southern to determine if the incident was a one-off.

The decision of health and disability commissioner Morag McDowell released yesterday detailed the 2018 insertion under general anaesthetic of a mirena intrauterine device (IUD) by a student and a registrar, while other students observed.

The patient, a woman in her twenties with a mild intellectual disability, was "distressed" that medical students had been involved, in spite of an earlier refusal of consent on a form she had completed.

The form had not been included in the patient’s file, and assumptions were made, leading Ms McDowell to describe the system for obtaining consent at what was then the Southern District Health Board (SDHB) as "demonstrably lacking".

Ms McDowell found Te Whatu Health New Zealand Ora Southern (HNZS) in breach of the code of health and disability services consumers rights for providing services involving teaching to the woman without first notifying her, and not obtaining her informed consent.

Rights contained in the code were partly informed by the 1998 Cartwright Cervical Cancer Inquiry, which criticised the practice of students, under supervision, undertaking internal vaginal examinations on anaesthetised women without their consent.

Ms McDowell recommended an audit of cases with obstetrics and gynaecology in which students had been observers or participants in sensitive procedures, "to check from the patient’s clinical records whether consent was given and recorded".

Findings should be reported back within six months, including the steps being taken to remedy any problems.

Further training on consent was also recommended.

Medical education was important, the decision said.

"However, there is a clear expectation that such examinations can be conducted only with unequivocal informed consent, given the vulnerability of the person being examined."

"Clear ethical leadership is required to embed a culture of vigilance around informed consent."

Following these events the SDHB reviewed its policies, process and forms concerning student involvement, she noted.

HNZS chief medical officer Dr David Gow said changes included the 2020 introduction of a new consent form.

"We would like to reassure the patient, their family, and our community that these changes will reduce the chances of our systems and processes failing to ensure consent was obtained and recorded," he said.

"Te Whatu Ora Southern accepts the health and disability commissioner’s decision in relation to this patient's care and we are sincerely sorry for the experience the patient had in 2018."

All the commissioner’s recommendations would be implemented, he said.

"We are currently implementing an audit to evaluate the changes to our processes and ensure compliance with our updated policy," Dr Gow said.

 

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