Disclosure: Dr. Kern reports he is a consultant and speaker for St. Jude Medical and Volcano Therapeutics, and a consultant for Boston Scientific, Opsens, ACIST Medical, and Merit Medical.
It was a simple question, but as you’ll see, not really. Dr. Jeffrey Marshall from Atlanta asked a question on what seems to be a very straightforward and uncomplicated issue. As you can see from the following “conversation in cardiology”, this question unleashed a torrent of opinion about how the cath lab should be different from the operating room. The discussion about who should scrub the groin was only the tip of an iceberg of concern about encroachment on cath lab operations from what at times appears to be blind regulations put forward by rule makers not directly involved in or with an understanding of the cath lab environment and activity. As with all of our conversations, I would like to thank my expert colleagues for their thoughtful input and courage to share them for the betterment of our professional lives.
Jeff Marshall: I have a question about who should scrub the groin or wrist before a cardiac cath or peripheral procedure. In the OR where we occasionally work in a hybrid lab, a circulating RN (not in a sterile gown) must do the prep according to Association of Operating Room Nurses (AORN). In the cath lab, we have had the scrub tech (in a sterile gown) prep the wrist or groin. Does anyone know if there is a “standard” for the cath lab?
Mort Kern: I admit I do not really know. However, I wondered, does it really does it make a difference? It seems to me it’s just a matter of local OR rules vs. cath lab rules. Is this a real problem?
Jeff Marshall: Actually, it is a TJC (The Joint Commission) and/or Det Norske Veritas Healthcare, Inc. (DNV) regulatory issue. That’s why I ask. They want us to do it the AORN way or show why we don’t. I said in the cath lab, do it my way, and done. But I’m getting pushback from administration. It seems trivial to me, too, and maybe my admin guys are anxious because accreditation folks are coming soon.
Mort Kern: Our techs prep both arms and legs. I have not heard any feedback about who scrubs for our EP/hybrid caths at this moment.
Charles Chambers: The last time this was looked at that I am aware of for the cath lab was the 2006 SCAI Guidelines for Infection Control in the Cath Lab [pdf available online at http://www.scai.org/guidelines], which was based on available data from state and federal regulating bodies, and available literature at the time. While addressing the issues of why the electric razor is better than the blade and the differing cleansing solutions to use, no mention was made of whom. The 2012 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions [ACC/AHA/SCAI) Cath Lab Standards (Bashore et al, J Am Coll Cardiol. 2012; 59(24): 2221-2305] and the SCAI Cath Lab Best Practices [pdf available online at at http://www.scai.org/guidelines], both released around the same time, did not address this.
Jeff Marshall: Thanks, Charlie. My fear is that since we don’t have a written standard, that we may be forced to adopt a standard not designed for the cath lab. So the real crux is that the accrediting agencies (TJC and DNV) are targeting this issue (at least that’s what we have been told) as a measure to “improve upon” in the current rounds of re-accreditations. I will refrain from offering my opinion as to why they would really care, but am interested in what is best for our patients, who do not undergo “open” procedures. The fact that the nursing standard from the OR could become the rule of the land without, as I see it, much scientific basis, is the most bothersome part of this situation (a mini MOC if you will – [Thanks, Paul Teirstein and SCAI]). Does anyone know of data that could essentially combat or refute another mindless “standard” to comply with from these accrediting agencies?
Charles Chambers: No data one way or the other.
The cath lab is not the operating room
Peter Ver Lee: These kinds of issues are becoming more frequent and frustrating. Administrators and the Joint Commission seem to like to put cardiac cath labs in the “OR standards” box, whether it’s the kind of caps we wear, anesthesia and airway assessment, how long a patient should be NPO, and/or how a procedure note should be written. We now have to include a “specimens removed” comment and a “post-op diagnosis” on our preliminary note. Even more amazing is this is now required in TEE [transesophageal echocardiogram] procedures. I’d like the Joint Commission to explain to me how you remove specimens in a TEE. It’s really symptomatic of how out of touch the Joint Commission and administrators are with the way a cath lab runs and what cardiologists do in the cath lab. We are concerned about acute kidney injury, vascular injury, stent coverage, antithrombotic and antiplatelet therapy, x-ray exposure, training of scrub techs, etc., etc. None of these issues is even on the Joint Commission’s radar. They are concerned that we aren’t documenting specimens removed during a percutaneous coronary intervention (PCI). We write our post-procedure notes completely differently from the way a surgeon does. Because we are concerned about different things. The Joint Commission doesn’t care. And nobody asks us. They demand that we do things exactly the same way they are done in an OR.
Another example of the “cath lab is just an OR” mentality is this story from our hospital. The hospital is building a new tower and wants to have all imaging rooms in the same location (cath, EP, vascular) and adhere to the same “red line” OR standard. I don’t think it’s appreciated how this is going to affect door-to-balloon times in acute ST-elevation myocardial infarction (STEMI) patients. You have to let the paramedics bring in the STEMI direct from the field. They can’t hand the patient off at the doorway, and the patient is going to be wearing street clothes, and certainly will not have had a full-body Hibiclens scrub.
I would not insist that the scrub nurse scrubs the wrist or groin. We rarely have infections with cath/PCI procedures. In the electrophysiology lab and transcatheter aortic valve replacement room, it makes sense to scrub like it’s done in an OR. The science bears that out. You’re implanting a big device in someone. But in the cath lab, it doesn’t matter who scrubs the groin or the wrist. [In contrast to the OR], We also don’t need to wash our hands for 10 minutes, mark the operative site with an X, give pre-procedure antibiotics, use general anesthesia for PCIs, and count needles and sponges at the end of the case. The cath lab is very different from an OR and should not be treated as if it’s just another OR.
We [or the SCAI] should come up with a consensus statement on this. We are concerned about different things than OR staff and surgeons are. Wasting time on stuff like who is scrubbing the groin and not crossing red lines takes energy away from important things such as what the best practices are in the cath lab.
William French: The cardiac cath lab is NOT an OR. We need to insist on our own standards. As time goes by and surgery changes to a more outpatient look, they will change to the new — our way — of doing business. But the transition has been slow and ‘backward’-seeking from the suits. Maybe we need to reach out to the Joint Commission directly.
Bonnie Weiner: I would agree that it doesn’t matter who does the prep, as long as it gets done correctly. What is so special about a nurse doing it anyway? Not to be critical of nurses in any way, but they probably have less formal training in sterile technique than most of the techs. Not wearing a gown to prep doesn’t make any sense to me either.
I would agree with Peter about the other issues as well. For over 30 years, I have performed procedures wearing street clothes under a lead apron, gown etc. Now I have to put on scrubs for all the same reasons described. There are no data to support this approach; cath lab infections are extraordinarily rare and usually can be traced back to a break in technique, not operator garb or who did the site scrub. It doesn’t make sense. Our lead aprons go from patient to patient, and are generally far from clean. We don¹t change scrubs between patients and wear them out in the hospital, to the ICU and ER, so why are they so much cleaner than the clothes that I have washed and cleaned at home? [Consider the white coats as well – MK]. We really do need a statement about some of these issues.
Sterility in the cath lab?
Mitchell Krucoff: The cath lab is clearly a unique environment, and while ICD [implantable cardioverter defibrillator]/CRT [cardiac resynchronization therapy]/pacers, structural, and hybrid may bring their own caveats, I think it is in patients’ best interest to keep it that way.
Over the past few decades, I remember such “major” role-related issues as:
- Can a tech push meds (and which ones? Saline? Heparin? Beta blocker? Narcotics?)
- Can a tech inject contrast into a coronary (now we have machines that power inject)?
- Can a physician assistant (PA) get access? Place a pigtail and do a V-gram [ventriculogram]? Cannulate a coronary?
In every case, the key was to develop standard operating procedure for the lab and certification of competence for the individual filling the role. That said, scrubbing the groin is different, as it could cure the most lethal disease in the cath lab. Therefore, I would recommend we start a national movement to mandate all groins should be hand-scrubbed by the attending physician, personally. [A technique] that will cure our worst disease: “septic egos….”
Jeff Marshall: Agree. We need some type of statement.
David Cohen: This discussion reminds of one of my favorite quotes from my former mentor and colleague, Don Baim. Whenever he was asked about sterility in the cath lab, he would reply “sterility in the cath lab is somewhere between the OR and the cafeteria.”
Gurpreet Sandhu: We are fortunate to have an organization where common sense prevails. Regarding the groin prep issue, you should personally review a copy of any regulations. In some instances, other people may be misinterpreting or misapplying rules. Hiring highly paid OR scrub nurses to clean groins in a cath lab is not SOC [standard of care].
For OR red lines around cath labs, it should be clarified that a cath lab is not an OR. A STEMI is a life-threatening emergency, and a patient coming in with shock and ongoing CPR cannot wait for the paramedics to change into clean scrubs. A delay of this sort would qualify as a serious sentinel event.
Lastly, the hospital-laundered scrubs is indeed a real rule, as hospitals are required by law to ensure that blood and pathogens are adequately removed from scrubs. They can’t do this with home-laundered scrubs and caps.
Lloyd Klein: In our lab, it’s the cath lab RN that preps, but of the many things in the world of medicine going on which irk me, this has never been on my radar. And it won’t unless it’s not done right. Then, I’ll get very upset, become quite undiplomatic, and makes sure it doesn’t happen again. I don’t really care who does it, as long as things are done properly. One good thing about OR nurses is that they do have a heightened sense of sterility and infection, and that’s a good thing. It just takes one bad infection to make you take notice of the question. Fortunately, we haven’t experienced it [a cath-related infection] for many years.
Malcolm Bell: On another note, as a resident, the day I saw a consultant complete a diagnostic angiogram in his street clothes with his shirt drenched in sweat (those lead aprons can be stifling), was the day I decided scrubs were for me, not to mention risk of blood spills on my trouser pant legs, etc. These days, I am more worried about what bugs I take home with me than what I might bring in.
I do think our fellows, in general, have little concept about some basic sterility issues and with placement of various devices including valves, VCDs [vascular closure devices], etc., the risk of infection, albeit small, cannot be ignored. That said, over-the-top restrictive rules that interfere with the efficient and safe running of a lab should be questioned.
Bonnie Weiner: Malcolm, you make good points, but isn’t it up to us to educate the fellows better about technique? I would agree that some of the procedures do require a different level of “sterility”, but for the day-to-day work, we don’t have an issue in the lab, so why do we have to use an extreme measure that has unintended consequences? By the way, if you have the company line your lead with a cotton material, you don¹t sweat nearly so much, and neatness in the cath lab does count.
The bottom line
The cath lab is not an OR. OR standards have been developed for patients undergoing major operations and rightly so. The cath lab is different, with some features of an operating room, but it is not an OR for the majority of common procedures and interventions. For structural heart interventions, the cath lab should transform itself into an OR.
It does not matter who scrubs the groin or performs the skin prep, as long as that person is well trained and cognizant of the critical steps in sterile preparation. However, rules are rules in your hospital.
As for putting a cath lab in an OR and then restricting emergency access for the staff working with the STEMI patient, accommodations of some kind to assist the door-to-balloon time will be needed.
The matter of wearing scrubs is now a done deal. While inconvenient and perhaps of unproven benefit, it is part of our modern rules for cath lab operations and national standards.
Finally, we should all review all new cath lab dictums with our leaders, administrators, and colleagues, and stand up for good practices supported by outcome data, rather than blindly accepting unproven and unfounded regulations which make no sense in the cath lab operations.