Changes to Universal Protocol released
Changes to Universal Protocol released
Do the changes make it less contentious to field?
Due to continuing reports of wrong-site surgeries and continuing concern from the field, The Joint Commission in 2009 took a look at its Universal Protocol and its No. 1 purpose — to prevent wrong-site, wrong-person, or wrong-procedure surgeries. Now, after listening to comments from the field and convening a 2007 summit on the Universal Protocol (UP) alone and with a 2008 compliance rate of 79% for the time out before surgery, The Joint Commission has released its updated UP for 2010.
Of the changes to the Universal Protocol, Maureen Carr, MBA, project director for The Joint Commission's division of standards and survey methods, says, "we did modify it a bit. We streamlined it. We took out some of the prescriptiveness." The first change deals will what the UP applies to. Before, it read "all invasive procedures that put patients at more than minimal risk," which Carr notes was vague. The new language simply reads "all surgical and non-surgical invasive procedures." She suggests reviewing the 2010 FAQs when they are available for more details on identifying the applicable procedures.
Pre-procedure verification
A significant change is the removal of the requirement to use a "checklist." Sandy Burke, RN, MPH, LHRM, consultant with The Mihalik Group, explains, "The five times that a preprocedure checklist was required was reduced by a prescribed number, and TJC removed the requirement to have a checklist. Now the organization defines the preprocedure validation process and follows a standardized list."
"We used to tell you you had to do a preprocedure verification in all these different places: at the time it was scheduled, at the time of preadmission... This might not be appropriate for every procedure; you may not have a preadmission. So what we did is we said the organization needs to identify when to do this," Carr says.
EP 1 in 2009's Universal Protocol read that pre-procedure verification should be done:
- at the time the procedure is scheduled;
- at the time of preadmission testing and assessment;
- at the time of admission or entry into the facility for a procedure, whether elective or emergent;
- before the patient leaves the pre-procedure area or enters the procedure room;
- anytime the responsibility for care of the patient is transferred to another member of the procedural care team (including the anesthesia providers) at the time of, and during, the procedure;
- with the patient involved, awake and aware, if possible.
The corresponding 2010 EP reads: "Implement a preprocedure process to verify the correct procedure, for the correct patient, at the correct site. Note: The patient is involved in the verification process when possible."
Carr says the word "checklist" in the second EP and the requirement that there be proof that one was used was not meant to denote a formal checklist in which things needed to be checked off. Documentation of what now is called a "standardized list" is not required for every patient, but the EP reads that it is expected "that the standardized list is available and is used consistently during the preprocedure verification." The list must include, at a minimum, relevant documentation, labeled diagnostic and radiology test results, any required blood products, implants, devices, and/or special equipment for the procedure. The hospital can include any items of its choice.
The removal of the checklist requirement doesn't really mean anything, says Kurt Patton, CEO of Patton Healthcare Consulting in Glendale, AZ, and former executive director of accreditation services at The Joint Commission. "It's sort of when like in marketing, when you market features about a product that don't really matter to people. Not mandating it in a checklist means there doesn't have to be a piece of paper that says, 'Yes, we have all these things.' But mandating that you have all the appropriate equipment for a procedure means somebody still has to be going through it and saying, 'For this procedure, we're going to need these screws, these clamps, this blood, this antibiotic...' So not having it on paper means somebody's got to be flipping through the chart. So again, a sort of meaningless change."
Site marking
Another change is that a site can be marked, in "limited circumstances," by a delegated, qualified individual within the hospital including residents, licensed advance practice registered nurses, and physician assistants. That individual must be familiar with the patient and involved in the entire procedure.
Patton says the change is mostly positive as many physicians do work closely with physician assistants or nurse practitioners. But, he points out, those often are used only to help the surgeon in the preparatory phase and the requirement spells out that the delegated individual must be involved in the entire procedure.
He says hospitals "probably would have liked The Joint Commission to go a little bit further and allow that physician assistant or nurse practitioner to go around the building marking the site and then having the patient come to the procedure area. So that's one I think people may overread into and get stung by it next year."
Is the UP clearer than before on time-outs?
The time-out before the provision of anesthesia, an area Carr acknowledges there had not been complete agreement on, was removed. "So what we decided to say was you've got to do a time-out before [anesthesia] if it's the final check before you do an incision," she says.
But Patton finds the wording and the explanation The Joint Commission made at its executive briefing confusing. The final time-out, EP 2, he says, requires the immediate members of the procedure team — the individual performing the procedure, the anesthesia provider, the circulating nurse, the operating room technician, and other active participants — to be in the room at the beginning. But what was deleted, he adds, was that the time-out requires active communication, though it still requires key members be in the room. To him that makes the change irrelevant.
Also, while the EP about performing the time-out prior to anesthesia was deleted, he says that is only spelled out in the rationale, which typically does not contain scored requirements. "And during The Joint Commission's verbal presentation, they made it clear that if the surgeon isn't there, you do a time-out prior to anesthesia and you do a time-out when the surgeon comes in. So that's another immaterial change."
Carr says, "The requirements allow the organization to do a time-out before anesthesia if it wishes. If the organization chooses to do a time-out prior to anesthesia and the surgeon is not present, then they would need to conduct a time-out when the surgeon was in the room. EP 2 contains the requirement that the time-out must include 'the immediate members of the procedure team, including the individual performing the procedure...' It is, therefore, incorrect to say the requirement is in the rationale only. If the organization does a time-out without the surgeon, it does meet the requirements of the UP."
The hospital must still document that a time-out was performed but "determines the amount and type of documentation," the UP reads.
Patton points out that previously there were eight specific things to check. Many organizations did use checkboxes for these elements. "For quality improvement leaders, I think it's important to the extent possible not to use checkboxes. Because then you're vulnerable that somebody forgets to check one of the boxes. And you fail on the safety goal. If you have it listed as just three bullet points that are then validated by a signature, you've accomplished the same thing," he says.
Another change Burke points to is for surgeons who want to be present during the preparation, they can leave the room after the time-out to scrub their hands, but they must do that in an adjacent area and immediately return to the surgical room.
Carr says the purpose of the changes was to bring the goal more in line with its original intent — identifying the right patient, the right procedure, and the right site. "We had something [in the UP] about administering antibiotics. They really have nothing to do with wrong-site surgery, so we moved those."
Changes to the Universal Protocol, Carr says, generally will go into effect Jan. 1, although surveyors have been told not to survey certain EPs that are deleted in the 2010 version, including the shortened pre-procedure verification process.
Due to continuing reports of wrong-site surgeries and continuing concern from the field, The Joint Commission in 2009 took a look at its Universal Protocol and its No. 1 purpose to prevent wrong-site, wrong-person, or wrong-procedure surgeries.Subscribe Now for Access
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