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.