“Every human being of adult years and sound mind has a right to determine what shall be done with his own body….”, is an often quoted (in bioethics and legal literature) statement by Justice Cardozo from the well-known case Schloendorff v. Society of New York Hospital, 105 N.E. 92, 1914.
Informed consent as Wikipedia informs us “is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards”. It is interesting to note that this term was first used by Paul G. Gebhard, an attorney well educated from Yale and Harvard Law School and the senior partner in the government, health care and association group of the Chicago law firm of Jenner & Block, in a 1957 medical malpractice case in which a patient contended that a physician at a Stanford University hospital had not fully disclosed the risk in a recommended treatment.
As an informed consent grants the right to a patient to be involved in their care decision, the inform consent informs a patient of those factors related to the planned care required for an informed decision.
Informed consent can be obtained when at several points in the care process. Informed consent can thus be obtained when a patient is admitted for inpatient care before certain procedures or treatments for which the risk is high.
It is important to know the following:
- the consent process is clearly defined in the hospital’s policies and procedures incorporating relevant laws and regulations
- the role patients and families in the informed consent process – (i) they are informed as to what tests, procedures, and treatments require consent and how they can give consent (for example, given verbally, by signing a consent form, or through some other means), (ii) they understand who may, in addition to the patient, give consent
- trained designated staff members inform patients, obtain and document patient consent. Here I like to quote the Malaysian Medical Council (MMC) which “upholds that the responsibility for obtaining consent lies with the practitioner performing the procedure. He is the best person who can ensure that the necessary information is communicated and discussed”, as stated in its “A Guidebook for House Officers”, paragraph 4.12, pages 37-38, dated 23 April 2008. A statement from a booklet by the MMC, “Good Medical Practice”, paragraph 3.7, page 13 also defines and states the role of doctors in providing an informed consent.
Now that you as a HIM/MR practitioner finished reading from the above a brief overview of the basic human right of a patient to informed consent, you need to know the kind of documentation that goes into a medical record.related to informed consent which is obtained before surgery, anesthesia, use of blood and blood products, and other high-risk treatments and procedures.
A medical record will contain an informed consent for :
- surgical or invasive procedures
- anesthesia other than local including moderate (“conscious”) and deep sedation
- blood and blood products used
- high-risk procedures and treatments
When informed consent is taken, the following will also be recorded in a medical record:
- identity of the individual providing information to patient and family
- patient’s signature or a record of verbal consent
Thus, the 5 required documentation in the medical record providing information to patient and family includes numbers 1 to 4 as given above and number 5, ” identity of the individual providing information to patient and family and the patient’s signature or a record of verbal consent”
Whether or not your hospital is been accredited by the Joint Commission International(JCI), you need to play your role to ensure that an informed consent is documented in the medical record when a patient had surgery, anesthesia, used of blood and blood products, and undergone other high-risk treatments and procedures.
If you hospital is been accredited by JCI, then you must be informed that JCI Standard *PFR.6.4 applies to an informed consent documentation in a medical record. JCI Standard PFR.6.4 states that “Informed consent is obtained before surgery, anesthesia, use of blood and blood products, and other high-risk treatments and procedures”.
Still on the subject of JCI accreditation, it’s good to be aware not only of JCI Standard PFR.6.4, but also I think as an informed HIM/MR pratitioner to also know the following too:
- that a hospital has a clearly defined informed consent process described in policies and procedures
- who are trained to implement these policies and procedures
- what is clearly explained regarding any proposed treatment(s) or procedures to the patient and, when appropriate, the family
In addition, be informed that:
- designated staff members who are trained, not only to carry out the process of giving out the informed consent but also obtain and document patient consent in accordance to the JCI Standard PFR.6 which states that “Patient informed consent is obtained through a process defined by the organization and carried out by trained staff in a language the patient can understand”.
- these trained designated staff members provide information as stated the elements (a) to (h) as in the JCI Standard PFR.6.1 which states that “Patients and families receive adequate information about the illness, proposed treatment(s), and health care practitioners so that they can make care decisions”
So much more to be informed on informed consent, and I think I covered pretty much already on JCI Standards PFR.6, PFR.6.1 and PFR.6.4
*PFR stands for Patient Family Rights
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Informed consent is an important topic that generates much discussion – all agree it is required – but how and when taken elicits various views.
1. The informed consent should be obtained by the person who is going to perform the procedure ( surgery, anesthesia, invasive procedure etc.). Your view that designated staff trained to..,..and document consent implies the task can be left to a nurse or a healthcare worker. This may not be legally correct. The assigned person may omit important details or complications or have inadequate knowledge of alternate therapies.
2. Legally the consent is to be obtained when the decision to undergo the procedure or surgery ….. Is obtained. This decision is mostly taken during out-patient consultation for all planned surgery and therefore the consent should be obtained at this point after the doctor has explained the risk-benefit factors and discussed alternatives. If the patient desires to have a second opinion this may be recorded and in such a case the consent can be obtained when the patient decides to get admitted or reports to the hospital for the procedure.
3. Some consultants delegate the task of getting and documenting the consent to their juniors – registrar / houseman/ intern or the ward nurse as they are apparently too busy to do what they consider as just a formality!
4. A semi-educated, ignorant, sick patient may not be in the best position to judge if the proposed surgery or procedure is the only alternative available. Explaining all the risks and options may overwhelm him and lead him to refuse the consent at the risk of harming him self.
Dr Rajeev Kapur, thank you for kind comments, much appreciated.
It is all in my efforts to strengthen clinical information in medical records documentation through this blog, using JCI as a benchmark.
In your comment No. 1, you stated that “The informed consent should be obtained by the person who is going to perform the procedure ( surgery, anesthesia, invasive procedure etc.)”.
YES, I could not agree less, Sir.
I had actually quoted the Malaysian Medical Council (MMC) which “upholds that the responsibility for obtaining consent lies with the practitioner performing the procedure. He is the best person who can ensure that the necessary information is communicated and discussed”. In Malaysia, informed consent is always and always obtained by a doctor but of course other trained staff members do assist in the patient education of obtaining informed consent.
in the same paragraph I had also wrote “trained designated staff members inform patients, obtain and document patient consent”.
While I agree with you that doctors as the principal caregivers are the most suitable healthcare professionals to obtain the informed consent, sometimes the are exceptions and this is supported by legal and other regulations/guidelines as I have to inform below.
Sir, JCI does state under Standard PFR.6 (JCI 2011, p.68) that “Designated staff members are trained to inform patients and to obtain and to document patient consent”. This statement can be verified from a Google search when many websites listed point to such a legal provision – for example in the US, which do match this JCI statement. If there is a legal provision anywhere in the world, then I am sure designated, trained staff members can be used to inform patients and to obtain and to document patient consent.
After-all JCI is a US based entity and they prepared standards based on standard practice in the US. I think countries that are adopting JCI, rightly need to create new legal provisions to support this JCI standard PFR.6 and the Measurable Elements 2 of standard PFR.6. Alternatively, such countries could strictly limit the process of obtaining informed consent to doctors solely but but must ensure that hospital policies does contain clause(s) that restrict any other staff member from obtaining informed consent.
I agree with your views from No. 2 to No. 4. I have covered about them in the post above.
Dr Rajeev Kapur, I look forward to your views on any post from this blog, as it is all a learning process on all ends. Thank You Sir.