This question is becoming more common as many facilities try to manage the expanding role of nursing in the field of vascular access. But first, let’s examine the basic principles of consent and informed consent.

Consent can be given in two ways  expressed or implied - however both must be voluntary.

1. 1)Expressed consent is given by oral or written words. Generally speaking, more invasive and risky procedures require written consent. Blood transfusions and chemotherapy fall in the risky category requiring a written consent.
   
   

2. 2)Admission to a hospital requires the patient to sign a general consent form that covers routine IV infusions and blood sampling for lab work. For alternative care sites, where general consent forms may not be used, some clinicians feel that a separate consent form must be signed for these minimally invasive procedures. PICC line insertion is an invasive procedure that should also require written consent.
   
   

Implied consent is inferred when the patient’s actions make it obvious that they accept the procedure. For example, when the patient rolls up her sleeve to have a blood sample drawn, you can conclude that she is consenting to the procedure. Implied consent also is presumed in most emergency situations; however, a PICC insertion usually is not an emergency situation.

Even when implied or expressed consents are obtained, the patient still may not understand the procedure. The term “informed consent” was first used in a lawsuit in 1957.(1 )In the ensuing years, we have seen a greater emphasis on patient’s rights and a rising number of medical malpractice claims. In 1972, the Patient’s Bill of Rights, introduced by the American Hospital Association, affirmed patients rights to obtain complete and current information about their diagnosis, planned treatments, prognosis, risk and benefits of that treatment, and alternative treatments. The patient also has the right to receive this information in understandable terms, including with the use of an interpreter if needed.

While some may consider the process of informed consent to be an administrative burden, it is actually the basis for a relationship between the patient and the healthcare provider. This relationship requires good communication and negotiation. The process may also improve outcomes and patient satisfaction.

In the past, physicians have exclusively prescribed medical treatments and performed surgical procedures. Therefore, the responsibility for obtaining informed consent fell to them. This is a legal duty that can not be transferred to other professionals. As nurses at all levels of practice  assume the task of prescribing or performing treatments, they become responsible for obtaining informed consent also. In Problems in Healthcare Law, Miller clearly states that Other independent practitioners who order or perform procedures have the same responsibility concerning these procedures.( 2) He also states that the physician performing the procedure has the responsibility for obtaining informed consent, not the referring physician. When a medical oncologist calls a surgeon to insert an implanted port, the surgeon has the responsibility for obtaining informed consent.

The same principles can be applied when nurses receive a referral to place a PICC. The physician would have the responsibility for obtaining informed consent about the treatment plan; however, the nurse performing the PICC insertion procedure is responsible for gaining informed consent for this component of the treatment plan. Based upon this information, the name of the nurse performing the procedure should be on the form. She also should provide complete information to the patient and ascertain that the patient truly understands the reason for the PICC insertion, the risks and benefits of the PICC, and the alternative methods for vascular access.

The consent form for PICC insertion should include:

1. *The patient's name and identification number;
   

2. *The name of the person performing the procedure;
   

3. *A description of the procedure in lay terms;
   

4. *The patient’s acknowledgement that the provider (doctor or nurse practitioner) has explained the expected benefits and potential risks, complications, and serious or common adverse reactions and that the patient or their agent understands this information;
   

5. *The signature of the patient or their authorized agent with the date. If an authorized agent signs the form, you must also include the person’s name, their relationship to the patient and their reason for signing the form;
   

6. *The name and title of the translator, if one was required; and
   

7. *The witnesses’s signatures, with the date.
   

Other members of the nursing staff may be asked to obtain the patient’s signature and/or be a witness to the signature. The role of these nurses is a patient advocate to protect the patient’s rights, preserve dignity, identify fears, and assess the level of understanding and approval of the procedure. Ask the patient to state what he has been told about the procedure in his own words. If you have any question about his understanding or his decision-making capacity, you must notify the person inserting the PICC to provide more education or clarify information.

The witness should be someone who is not related to the patient and not involved in caring for the patient during the procedure. This person should encourage the patient to ask questions or express any concerns about the procedure. If the patient has questions, the witness must notify the provider. Attempts to answer the questions may put the witness in the position of interfering with the relationship between the patient and provider. We also must remember that patients have the right to refuse medical and nursing treatments and to change their minds after consent forms have been signed. In these situations, the primary care nurse must notify the provider performing the procedure.

In my opinion, the process of informed consent will drive better assessment of the patient’s vascular access needs, leading to greater patient involvement in the process. When the provider alone decides that the patient needs a vascular access device, he violates the principles of informed consent if an explanation of the alternatives available is not provided. This paternalistic approach denies the patient the right of autonomy and self-determination. Consent means to agree to do something. This requires that the patient and all healthcare providers have an equal part in the process.

References

1. 1.Dunn D. Exploring the gray areas of informed consent. Nursing99 1999; 29: 41-44.
   

2. 2.Miller R D. Problems in Health Care Law. 7th ed. Gaithersburg, MD: Aspen Publishers, Inc; 1996: 383-383.
   

3. 3.NAVAN, Position paper: Tip location of peripherally inserted central catheters. Journal of Vascular Access Devices, 1998. 3(2).
   

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