Are you getting patient consent forms?
If not, you’re a lawsuit waiting to happen
Patient consent forms can be a sticky situation for home infusion providers inserting peripherally inserted central catheters (PICCs). When are they necessary? When are they not? Who exactly do they protect? Depending on who you listen to and your own situation, the answers vary.
When it comes to liability, Elizabeth Hogue, JD, a health care attorney in Burtonsville, MD, says you should have a patient sign a consent form for every PICC line you place.
"Court cases basically say that you have to get informed consent for all invasive therapies. I don’t see any change in that standard, and never would I regard the insertion of a PICC line as routine," she says. "I’m not aware of [a court case] that specifically addresses the PICC line issue, but it’s irrelevant because the general principle laid down by court cases all over the country is that any non-routine invasive treatment requires informed consent in advance."
Darnell Roth, CRNI, president of D/R Intravenous Therapy Consulting, of St. Louis, agrees that consent forms are not an option with PICC placement based on certain factors.
"There should be no doubt that the placement of the PICC is more traumatic than the insertion of a traditional peripheral cannula," she says. "Even when the placement of an indwelling PICC is performed by a competent, PICC-knowledgeable nurse, there are inherent PICC-associated complications."
Roth points out complications associated with peripheral vascular access, such as phlebitis, thrombophlebitis, ecchymosis, hematoma, insertion site infection and sepsis are all distinct possibilities, as well as compartment syndrome, antecubital nerve trauma, catheter tip malposition, catheter emboli consequential to catheter failure, and catheter tip migration.
"Considering this menu,’ one should readily recognize the importance of having obtained specific consent for PICC placement," says Roth.
While consents may not be required for all infusions, when it comes to PICCs, Roth says there is nothing to consider: get a signed consent.
"From a risk management standpoint, in my opinion potential PICC placement candidates should be given a clear explanation of what the insertion procedure entails, potential insertion-related and post insertion-related complications including signs/symptoms heralding the development of same, restrictions in life style secondary to the presence of an indwelling PICC, and other options for treatment," says Roth. "Only then can the individual intelligently provide consent for PICC placement." (For Roth’s sample consent form, obtained from the late Joe Brown, CRNI, see p. 54.)
However, what is the situation if the patient has already signed a general consent form that does not specifically mention PICCs or any other non-routine invasive treatment by name?
"It comes back to policies, procedures and protocols within a system," says Kay Coulter, CRNI, owner of Coulter Consulting, in Clearwater, FL.
For example, one provider Coulter is aware of has a policy requiring an additional patient consent if a catheter longer than 2¼ inches is placed. Some oncology centers require a consent form if a chemotherapy agent is given, while others require only the initial consent to treatment and any chemotherapy agent can be given under that umbrella consent.
"A patient always signs a general consent form any time they come into a health care system, so we have what is more or less considered blanket consent for treatment up to a point," notes Coulter. "That is why the example of chemotherapy consent will be the same for vascular access."
Accordingly, Coulter notes you need to look at your general consent form and see what is covered.
"The responsibility for legal protection is on the nurse to know the system’s policies and procedures and requirements," she says. "There is too much variation and not enough standardization at this point for a statement to be made that anything is the norm."
So Coulter’s word to the wise is to protect yourself. "Err on the side of consent," she says. "If I could not resource the protocols within my system, or if there is nothing specific in the policies and procedures, I would get patient consent verifying that they have received information about the procedure."
If you don’t have a formal PICC consent form, Coulter says at the very least you should document in the narrative notes that the PICC placement and all potential complications resulting from a PICC placement were explained to the patient, as well as making a note as to the patient’s understanding, comprehension and consent for placement of the PICC.
"I would also suggest that home infusion providers realize that the consumers are increasing their scrutiny of IV-related care," says Coulter. "Obtaining consents prior to any non-routine invasive treatment,’ as stated by Ms. Hogue, is the best practice choice."
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