Malpractice: Altering a Consent Form

Hospitals and doctors alike need no reminding of the importance of properly taking informed consent. It is one of the few areas of malpractice risk management that is included in medical training, and is reinforced by hospital procedures. In Singapore there is both an ethical and a legal requirement to obtain informed consent from a patient prior to any procedure.

The principles are simple, but in practice the process is fraught with difficulty. A medical expert (the doctor) attempts to explain to a layman (the patient) the complexities of a procedure, what to expect, and what might go wrong. The decision over what to include and what to exclude from this process is the most common source of malpractice claims (along with other communication-based issues).

There are VERY few exceptions to the requirement for taking informed consent prior to a procedure. Of course, situations do arise in emergency medicine where consent cannot be taken and the patient’s welfare requires immediate action. In other circumstances, failure to obtain consent will likely be considered unacceptable. The AMA Journal of Ethics¹ summarizes the position neatly:

Outside of emergent circumstances, it is the physician’s responsibility to provide a medical recommendation, explain the nature of the recommended intervention, and discuss its risks and benefits as well as possible alternatives to treatment. Patients must have been offered an explanation of the recommended treatment and its associated risks for patients to be considered informed; they should be provided enough information to agree to or refuse a procedure. The process of obtaining informed consent should be a meaningful conversation between a physician and patient rather than simply have as its goal a signature on a document.

The completed and signed consent form is therefore a critical document in defending allegations of medical malpractice. What happens, then, in cases where a consent form is altered after the fact? Unfortunately, Singapore has seen an example of such a grievous breach of ethical standards.

In April 2006, Dr Looi Kok Poh carried out hand surgery on a patient at Gleneagles Hospital. After the operation, he instructed a staff nurse to alter the patient’s consent form in order to reflect the procedure he had actually performed. The alterations were evident; consent forms at Gleneagles were electronic documents, and changing the document created a traceable history. As soon as the facts came to light it was evident that the claim was entirely indefensible. Dr Looi pleaded guilty before the SMC, which imposed a $10,000 fine, a one-year suspension from practice, and a censure. The disciplinary panel commented that Dr Looi “betrayed the trust reposed in him by the patient individually as well as by society as a whole, and seriously undermined public confidence in the medical profession”.

Strong words and a severe penalty, but entirely in keeping with the ethical standards that the medical profession strives to uphold. Is the situation any different, then, if a patient agrees to the alteration of a consent form?

Howden has recently received reports from a number of our clients that some Singapore hospitals are asking doctors to seek patient agreement to alter consent forms after procedures have been completed. We understand that the recommendation is that where the existing consent form may not appear adequate to cover what transpired during the procedure, doctors should revisit the form with the patient and obtain retrospective consent.

From a malpractice risk management point of view, obtaining consent after a procedure is a terrible choice. Malpractice insurance policies do not contain many exclusions, but one common to all policies reads as follows:

directly or indirectly caused by, arising out of or in any way connected with any dishonest or fraudulent act or omission,

To paraphrase; even a hint of dishonesty in a doctor’s actions gives the insurer grounds to reject a claim. Now, it is by no means clear that asking a patient to provide retrospective consent amounts to dishonesty. However, it would be easy for an insurer to form the view that the doctor’s action were entirely self-serving and contrary to the patient’s interests. In such situations, insures might well refuse to provide cover; a situation that must be avoided at all costs.

So, what is the right course of action where a doctor believes that the obtained consent may be inadequate?  

There is nothing in Howden’s malpractice insurance wording that excludes cover where a doctor has been forced to make a judgement call. Where something occurs during a procedure that requires a doctor to potentially act outside the scope of the existing patient consent, the doctor in question is free to make whatever decision he or she believes is in the patient’s best interests. Obviously, a subsequent discussion with the patient to explain what took place is essential, but asking the patient to consent to something that has already taken place is not in the interests of either patient or doctor.

Authored by:

Mike Griffiths
Regional Director, Healthcare
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¹How Should Trauma Patients’ Informed Consent or Refusal Be Regarded in a Trauma Bay or Other Emergency Settings? AMA Journal of Ethics, May 2018.