If a procedure has been shifted from the physician to the nurse, can informed consent then be obtained by the nurse, or does that responsibility remain with the ordering physician? One facility, by using nurses for the insertion of peripherally inserted central catheters (PICC lines), challenged the previous way of thinking in order to enable their specialized nurses to obtain informed consent.
At St. Mary's Health Center in Jefferson City, MO, PICC lines were inserted by a small team of specially trained nurses. These nurses, who completed a special training program to become credentialed to insert the lines, were also allowed to obtain informed consent and explain to the patient what the procedure involved. This program had faded into the background for a number of years but recently returned to the forefront with the arrival of new leadership. The new leaders saw the benefits of PICC line usage and decided to aggressively pursue a full-strength re-implementation of the program.
“We had a process in place and were in the middle of bringing the program back into place,” says Lisa Randazzo, director of performance management and clinical outcomes at St. Mary's Health Center. “The question of informed consent came back up. We were getting a lot of different feedback from people doing it different ways.”
Because it had been some time since the PICC line program had been in place, the team reexamined the whole program from top to bottom. The issue of informed consent arose early on.
“We were told that informed consent is a doctor's responsibility, but we still had our nurses who had been a part of the program previously who thought [obtaining informed consent] had worked before,” says Randazzo.
So the facility began the research process.
Legal counsel
The first place it looked, of course, was the hospital's legal representation.
“The initial response was that if it's a physician ordering the procedure, they need to provide informed consent,” says Randazzo.
This was relayed back to the team, and the PICC line-credentialed nurses raised their own concerns. “They said, 'Here's why it worked before—I'm concerned, were we doing the wrong thing?' ” says Randazzo.
There was a legitimate worry that they had been following inappropriate practices in the past. “I shared the nurses' opinion—we had made a conscious decision in the past,” says Randazzo.
They addressed these concerns with legal counsel.
“For the majority of procedures out there, whoever is ordering the procedure is going to talk about it to the patient—they may not be the performing physician,” or in this case, the performing nurse, says Randazzo.
St. Mary's legal counsel kept saying that although the nurse might be performing the procedure and be trained to tell the patient what he or she is going to do, the responsibility still fell on the physician.
“We have physicians on staff who order a PICC line but may not have the experience of performing it,” says Randazzo. “But we have nurses who have gone through a very specialized program to be prepared for it. The nurse is going to be putting in the PICC line, and so we thought the best person overall to explain the procedure to the patient would be that nurse.”
The team felt so strongly they began looking into regulations—from Joint Commission standards to CMS regulations to state department of health statutes for the rules of informed consent—trying to find any and all language covering the topic.
“We found the language vague to a certain degree,” says Randazzo. “There is language that says to look at the person performing the procedure. Well, in this case, the nurse is performing the procedure.”
Randazzo went so far as to call the Standards Interpretation Group (SIG) of The Joint Commission for advice. She was pleasantly surprised when she received a callback from a representative of the SIG. “Usually you can expect a yes-or-no answer or an explanation of the standards,” says Randazzo. “A personal call was very surprising. I asked if I startled them with my question!”
What she was told, though, was that the language of the standards lagged a bit behind current technological trends and practices.
“He advised me to look at some of the national bodies covering PICC lines, like the state board of nursing,” says Randazzo. “We're in Missouri, so I also looked at the nurse practice act.”
Missouri's nurse practice act has a decision tree that is used by the state board to walk through the steps of a process and determine what a nurse can or cannot do.
“From looking at it, I found that if I entered the decision tree thinking the nurse could obtain informed consent, I would come to that conclusion at the end of the tree, or vice versa,” says Randazzo.
So she went back to the standards again to look for anything stating that a nurse could not obtain informed consent. She came up empty.
Randazzo also consulted national societies governing infusion clinics and organizations focusing on chemotherapy and blood transfusions.
“I found a little bit about PICC lines but not a lot about informed consent,” she says.
Randazzo then set up a conference call with legal counsel to walk them through the research thus far, including the response from The Joint Commission.
“I talked with them about how passionately we felt about this—that someone who has gone through this intense training who will be performing the procedure should be able to be the one to talk about it with the patient,” she says.
Randazzo explained to the counsel that the language she had encountered in the field pointed to the person with the most knowledge about the procedure as the one who should obtain informed consent. “We felt we had made something of a case for that,” she says.
The end result was something of a compromise. St. Mary's informed consent form was amended to say that the patient gave his or her consent to the nurse to insert a PICC line as ordered by the ordering physician. This allowed the nurse to handle the face-to-face communication.
“Before getting the go-ahead, I phoned the state board of nursing,” says Randazzo. “I laid it all out: 'Here's what we're trying to do, here is our research'...I told them we think this is the right thing to do, but felt a little weird about it still. But at the same time we were still seeing a lot of chatter in the field about it. To me there wasn't a clear division” on how to handle informed consent.
The hospital asked the state nursing association straight out whether there was anything in the nurse practice act that would prohibit a nurse from getting informed consent if he or she had the knowledge and expertise to perform the procedure.
Nurse reaction
The specialized nurses had two distinct reactions to the discussion about informed consent. The first was concern—if they were not allowed to obtain informed consent now, had they erred in the past when they were actively doing so? The other, however, was just the opposite—some nurses were vocal about their professional pride and were frustrated that, despite their additional training, they might have this responsibility taken
from them.
“They didn't want to be disrespectful to their physician colleagues, but these nurses were the ones actually doing the PICC lines,” says Randazzo. “I was a little frustrated myself because I'd been a part of the program before and had my own concerns.”
Next steps
Since the decision on PICC lines, St. Mary's has added one more procedure for which nurses are allowed to obtain informed consent.
Small-bore feeding tubes are now inserted by nurses without the use of thoroscopy (in the past, this procedure was traditionally done by a radiologist).
“If we were going to allow nurses to do this for PICC lines, it made sense they could also do this for small-bore feeding tubes,” says Randazzo. “We applied the same logic to the decision.”
Overall, it has been an eye-opening experience, says Randazzo. “I really appreciated the opportunity to further explore,” she says. “It would have been very easy to say, 'Legal says we can't, so we're done.' I also really appreciated the chance to talk further with someone directly from SIG. We had a really nice conversation. It was great to really be able to talk to someone in real time and bounce ideas off him. His advice was really sound.”
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This article was adapted from one that originally appeared in the September 2010 issue of HCPro's Advisor to the ANCC Magnet Recognition Program®, [http://www.hcmarketplace.com/prod-7406/HCPros-Resource-Center-for-the-ANCC-Magnet-Recognition-Program.html], an HCPro publication.