Singapore: Taking And Documenting Informed Consent: When Is It Not Enough?

Last Updated: 15 January 2018
Article by Vanessa Lim

Introduction

Maintaining adequate medical documentation is a challenge for many doctors working in a busy practice or healthcare institution. However, when it comes to informed consent, doctors should place high priority on ensuring that consent is appropriately taken and comprehensively documented in order to avoid potential civil liability or disciplinary proceedings.  

Below, we discuss the recent Court of Three Judges decision on Dr Jen Shek Wei's failure to obtain informed consent prior to removing a patient's ovary, the applicable standard of conduct for obtaining and documenting informed consent, and finally, tips on taking and documenting informed consent.

Case summary

Dr Jen Shek Wei, an Obstetrician and Gynaecologist in private practice, faced two charges before the SMC Disciplinary Tribunal (SMC DT), for:

  1. Advising the Patient to undergo surgery to remove a pelvic mass without conducting further evaluation and investigation of her condition, when further assessment was warranted. His failure amounted to serious negligence which objectively portrayed an abuse of the privileges which accompany registration as a medical practitioner (i.e. the first limb of professional misconduct as per Low Cze Hong v Singapore Medical Council [2008] 3 SLR(R) 612 (Low Cze Hong); and
  2. Performing a left oophorectomy on the Patient without having obtained her informed consent, in breach of Guideline 4.2.2 of the SMC's Ethical Code and Ethical Guidelines (ECEG), and that such conduct was an intentional, deliberate departure from standards observed or approved by members of the profession of good repute and competence (i.e. the second limb of professional misconduct as per Low Cze Hong).

The SMC DT convicted Dr Jen on both charges, and ordered that he (a) be suspended for a period of eight months, (b) pay a fine of $10,000, (c) be censured, (d) give a written undertaking to the SMC that he would not engage in the conduct complained of or other similar conduct, and (e) pay the costs and expenses of the disciplinary proceedings, including the costs of the SMC's solicitors.

Dr Jen appealed against the DT's decision to the Court of Three Judges, which upheld the DT's decision on both conviction and sentence.

This article will focus only on the second charge against Dr Jen for failing to obtain informed consent in breach of Guideline 4.2.2 of the SMC ECEG 2002 Edition, and the standard of conduct applicable in the context of SMC disciplinary proceedings.1

Brief background facts

The Patient consulted an Orthopaedic surgeon for a "very bad backache". After conducting investigations, the Orthopaedic surgeon referred the Patient to Dr Jen, whom she had previously consulted for fertility treatment. 

Dr Jen performed a transvaginal scan on the Patient and found that there was a lump in each of her ovaries. (As the disciplinary proceedings against Dr Jen only concerned the lump on the left ovary, the following references to "the mass" only refer to the lump on the left ovary.)

According to the Patient (which the Court of 3 Judges accepted), Dr Jen had advised her to remove the lumps as the mass was "quite huge" and there "may be cancer". Dr Jen's own account of his diagnosis was similar: he believed that the mass might be malignant, and that it should be removed for histological examination.

Dr Jen offered the Patient a choice of two surgical procedures: (a) laparoscopy or (b) open laparotomy. After Dr Jen explained that there was a risk of the cancerous cells spreading to other areas with the laparoscopy, the Patient and her husband decided to go with the open laparotomy. They also opted to have the mass sent to the laboratory for testing after surgery, and depending on the test results, the Patient could decide whether or not to go for further treatment.

On the day of the operation, the Patient signed the consent form in the hospital's admission office. According to the Patient, the name of the procedure (i.e. open left oopherectomy) was not filled in at the time of signing. (The DT did not make a finding on this.) Dr Jen was absent when the Patient signed the consent form. He only signed it before the operation when he saw the Patient in the operating theatre. During the operation, Dr Jen decided to remove the Patient's left ovary due to "suspicious" features observed. As the left fallopian tube was, in his view, badly damaged, it was removed as well together with the left ovary. The subsequent histopathological report stated that the ovarian tissues were benign.

The Patient only found out that her left ovary was removed some eight months later, when she consulted another Obstetrician and Gynaecologist for her pregnancy. She subsequently filed a complaint to the SMC against Dr Jen.

The DT's decision and appeal to the Court of Three Judges

The DT convicted Dr Jen based on the following findings:

  1. There was no contemporaneous evidence that Dr Jen had obtained informed consent through a process of explaining the risks, benefits and possible complications of the left oophorectomy apart from the hospital's consent form;
  2. Based on Dr Jen's documentation, it was not clear what clinical procedure he had advised the Patient to undergo;
  3. Dr Jen's oral evidence during the inquiry was "somewhat evasive and repetitive";
  4. Little weight was given to the evidence of Dr Jen's four witnesses; and
  5. Dr Jen failed to ensure that the Patient was adequately informed about her medical condition and options for treatment so that she was able to participate and make informed decisions about her treatment. Significantly, Dr Jen did not document the details of the surgery advised and his taking of informed consent.

On appeal, the Court of Three Judges affirmed the DT's decision and findings. We highlight some of the Court's observations in the present case which is of general applicability:

  1. A signed consent form alone may not be sufficient to raise a reasonable doubt in the Prosecution's case. It is at best an indicator that the obligation has been discharged, but it is not a conclusive defence. The key is whether the doctor had explained and the patient understood the nature of the operation and the required matters (such as the risks and complications) relating to the operation.
  2. The obligation to obtain informed consent is rooted in process and not a mere signed piece of paper. The process requires the doctor to explain the required matters.
  3. Informed consent must be documented in "sufficient detail so that any other doctor reading them would be able to take over the management of a case"; mere documentation of the name of the procedure or "explained risks" is inadequate and insufficient.
  4. It is too late to obtain informed consent in the waiting area of the operating theatre. In reality, patients who turn up at the hospital would not be in the proper frame of mind to receive and evaluate any advice on risks and treatment options.

The applicable standard of conduct of obtaining and documenting informed consent

The current applicable standard of conduct for obtaining informed consent is set out in Guideline C6 of the SMC ECEG 2016 Edition. Notably, the ethical obligation to document consent from patients for "tests, treatments, or procedures that are considered complex, invasive or have significant potential for adverse effects" is expressly set out in the same Guideline. 

The importance of documenting informed consent is further underscored by the separate and distinct duty to maintain clear and accurate medical records as set out in Guideline B3 of the SMC ECEG 2016 Edition, where the doctor's ethical duty to include all clinical details about discussions of investigation and treatment options, informed consents, results of tests and treatments and other material information is set out.

There is a strong presumption that doctors have knowledge of the applicable standard of conduct in the SMC ECEG, which is in fact the minimum standard required of all doctors. Any non-compliance with the applicable standard of conduct is automatically an intentional and deliberate departure from the applicable standard, thereby constituting professional misconduct under the first limb of Low Cze Hong.

Crucially, the Court of Three Judges had in another recent case (Judgment of Lam Kwok Tai Leslie v Singapore Medical Council [2017] SGHC 260) noted that in light of the requirement of the SMC ECEG 2016 Edition, it would "expect that the SMC, moving forward, will consider preferring charges for failure to keep proper records". In these situations, a doctor may be found guilty of professional misconduct notwithstanding that the process of obtaining informed consent was carried out, but proper documentation was not kept.

Tips on taking and documenting informed consent

While doctors do face time constraints in a busy practice, it is nevertheless important for doctors to maintain "accurate and contemporaneous documentation of each and every consultation" especially those where discussions relate to obtaining informed consent.

We set out below some tips on taking and documenting informed consent:

  1. Take the time to comprehensively document discussions with patients on the treatment plan, including the benefits, risks, complications and alternatives that were explained to the patient. Where appropriate, use tools such as anatomical models, drawings, online videos and document how these tools were used. Where drawings are made and given to the patient, the doctor should keep a copy in his patient records.
  2. Note that e-mail correspondence or instant messages (such as WhatsApp or WeChat) with a patient on a procedure or course of treatment can form part of the informed consent process. The doctor should be careful to preserve all such records.
  3. Prepare standard form addendums, patient information leaflets or checklists for commonly performed treatments and procedures, detailing the benefits, risks and complications, and alternatives to each procedure. These can be used as an aid in explaining treatment options to patients, and can be filed with the relevant consent forms or patient records as evidence of the discussion. The doctor should also make a note of any patient education materials given to the patient.

    (Do note that these may not be sufficient for every patient, as doctors will have to constantly apply their minds to the issue of whether any additional information needs to be conveyed to a particular patient given his individual circumstances.)2 If additional information is discussed, this should also be documented in the doctor's case notes.

  4. As far as possible, ensure that the completed consent form is signed and witnessed in the doctors' clinic prior to the patient's admission to the hospital.
  5. As far as possible, give the patient sufficient time to consider the benefits, risks and complications, and alternatives to the procedure offered, especially if the procedure carries significant risk of mortality or morbidity. If there are repeated discussions with the patient where risks, options or complications have been reinforced, the doctor should still take care to document each discussion in detail.

In light of the recent the judicial observations, doctors may wish to take the opportunity to re-evaluate the manner in which they currently take consent from their patients and decide whether any changes need to be made to reinforce their existing consent-taking processes.

Doctors and healthcare institutions may also seek the assistance of their medical defence organisations or legal advisors to update their consent forms and patient education materials to reduce the risk of civil liability or professional disciplinary proceedings.

Dentons Rodyk acknowledges and thanks Senior Associate Audrey Sim for her contribution to the article.

Footnotes

1 For an exposition of the appropriate standard of care of a medical practitioner in the provision of medical advice, please refer to Dentons Rodyk Reporter article on Hii Chii Kok v Ooi Peng Jin London Lucien and another [2017] SGCA 38 (Issue 3 2017)

2 See Dentons Rodyk Reporter article on Hii Chii Kok (Issue 3 2017)

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