“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 :

1. surgical or invasive procedures
2. anesthesia other than local including moderate (“conscious”) and deep sedation
3. blood and blood products used
4. high-risk procedures and treatments

When informed consent is taken, the following will also be recorded in a medical record:

1. identity of the individual providing information to patient and family
2. 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:

1. that a hospital has a clearly defined informed consent process described in policies and procedures
2. who are trained to implement these policies and procedures
3. what is clearly explained regarding any proposed treatment(s) or procedures to the patient and, when appropriate, the family

In addition, be informed that:

1. 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”.
2. 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