Our objectives are:
to describe to you the incidents of surgical items and outcomes in relation to pa you review the steps of the retained foreign body proactive risk analysis in our workgroup sessions, evaluating the processes used to prevent
retained su and also to discuss the surgical count process and the implications to the environment or to the staff of an incorrect count including retrospective charts, 400, review of potential high risk
of retained su and appraise an IRB research study on interruptions and distractions that we did in the operating room, in the cardiac room specifically,
during the count process and its impact on the surgical environment and patient care.
The patient safety issues that are reported by the AORN nurses are also related to the sentinel event that reported by The Joint Commission. Preventing wrong site surgery, still as you can see, it's more than 50%.
Preventing retained surgical items or foreign body. Preventing medication errors. Preventing medication errors, what we do in the operating room, it is very strict that we label our medication containers.
Recently, there was an incident where a new nurse who was supposed to be coping with being new and a surgeon who is a pain surgeon, not because he's a pain, he's a surgeon who treat pain, so he's going to the lumbar area and asking for the contrast.
But instead of contrast, he took the lidocaine. And how did they find it? There is no picture because lidocaine will not give us the contrast. So labeling is part of our job. As a clinical nurse specialist,
Louise and I are always making rounds to make sure that the scrub nurse labels the containers of every medication. Preventing failures in instrument reprocessing, this part is very, very important especially recently. Because of the outbreak of the Carbapenem
resistant to antibiotics, from the ERCP procedures, it becomes mandatory for the nurses in the room to preclean the scopes. We partnered with the manufacturers, specialists, the educators from the company to give nurses the in-service
how to clean the scope properly before it's sent to the final processing department.
These are the pictures of most commonly retained surgical items is the surgical sponge. Examples is laparotomy pads and smaller sponges.
As you can see in the picture, they comes in varieties, different sizes. But in the OR, the procedure should use all X-ray detectable items. It's a must. Because what happens here in the other side of the picture,
you can see a mark that is 4x4. It was left behind. There was a story about a surgeon who used the 4x4 in abdominal laparoscopic surgery. Laparoscopic meaning there are three holes or one hole. He asked for 4x4 to clean the end of the scope,
inserted it in the abdomen. What happened after that, the circulator at the end of the case was looking for 4x4. The surgeon put the lens again inside, asked the anesthesiologist to position the patient to Trendelenburg,
semi reverse Trendelenburg, to view from different angles. Until he declared there's no 4x4 inside. So we asked the X-ray Department, "Take the picture." The picture was negative. The abdominal part is negative.
The patient went home. What happened was he came back for difficulty of breathing. The X-ray showed the 4x4 is up in the diaphragm. Obviously, because the positioning of the patient, it migrated to the upper part of the abdomen.
So that is a case, an example of why it is important to use the X-ray detectable item. And after that, the implication to the nursing is we changed the policy that all laparoscopic surgeries should not use 4x4 at all, only the lap pads. Look at this picture.
It is so large. And how can it be? You can ask yourself, "How can it be retained, "this kind of surgical item?" But don't be surprised. When I was a new clinical nurse specialist
in the OR in 2012, this is the first problem that I encountered. There was an eventful case in open heart. Patient went and transferred to the ICU as a routine follow-up X-ray for checking the positioning of the tubes.
The resident saw it, ignored it in the X-ray, thinking, you know, "Can't be, it's so big." There was a seven-inch forcep. The follow-up X-ray was done again later on. And still the seven-inch forcep was there. So the fellow asked the resident,
"Will you please go to the bedside and remove that forcep?" So it's not on the patient, it is in the patient. So this a story of, like reverse. Patient went to the OR, the forcep was removed. It was a seven-inch forcep. It was removed.
Patient went well. Everything was done perfectly. But what happened was, in this case, was reverse. The nurse who assisted in that case, she was a seasoned, very focused, very hardworking nurse, was suspended for documenting the count was correct.
The count was correct, but obviously it's not correct. There was a forcep. She was suspended, and that scene in that event haunted her. She became aloof, she became so irritated and paranoid. Consequently, she resigned because of the torture.
The first victim is the patient. But there's a second victim here. The staff nurse. The hospital workers are always a second victim of any errors in health care. And this is specifically in the operating room.
In 5,500 cases, one item is left in a patient. And we're trying our best to improve because one is big enough to harm the patient. In a retrospective review from a level one trauma center, three cases of retained surgical items are all sponges.
This is the big case. Sponges are white, but when it mingled with the inside the body, it becomes red. So it becomes like a part of anatomy. It's so hard. So three cases
in 2,075 trauma laparotomies over an eight-year period, for an incidence of approximately one in 700. Incidence of retained surgical sponges depends upon the anatomical location of the procedure. 56%, it's in the abdomen because it is a big space.
Pelvis, 18%. And thorax, thoracic cases, like in double (mumbles) surgeries, when there is a clamp-like incision like a clamp and there's like a cave. So it's easy to lose sponges.
So we are trying to correct the count for that kind of process.
Risk factors associated with retained surgical items. When you have the awareness of what are the factors or predictors to have a retained surgical items or retained foreign body,
then you will have the knowledge how to improve yourself. In emergency surgical procedures, emergency meaning there is no time to do the standard procedure, it is between life and death of the patient. Patients could be bleeding to death.
So if I were the scrub nurse and the circulating nurse, I would be under so stressful to cope with the demand of the environment. Involvement of two or more surgical teams. Like in breast surgery. In a big cancer case, they have to remove the whole thing
and take a graph from the abdomen. Two teams are working at the same time. Incorrect surgical count in the beginning. So what do we do when there is a package of 10, supposed to be 10, and you got only nine?
You have to discard the whole thing. Discard it and not to include that in the count. So that is the proper way of doing it. Procedures involving one or more open body cavities. Prolonged surgical procedures. Good example is when we do the Ex-vivo,
like a lung is kept alive outside the body to make sure that the donor lung will be effective. That is a prolonged procedure. Unplanned change in procedure performed. When the case is ready for another case and it's changed. Because it's almost always the failure
is because there is no teamwork and communication. It is hard to change the procedure. Like the night people planned for this case and in the morning it suddenly changed, then you are supposed to do what is needed in that room,
change the whole thing. Use of an unusually large number of instruments. A good example of this kind of instruments are a surgeon who is doing a general surgery and suddenly asked for vascular instruments. So what do we do?
When we hear that this is kind of looking for vascular instruments, meaning it's an emergency, something happened that is not supposed to be. So this tray of instruments have a lot numbers of different kinds of instruments with different sizes.
So that is one we limit. We have to improve the instruments into a standard process for effective surgical counting.
I like this slide in particular. Why do I like this slide? Not that I like it, I think I find it most interesting.
The reason being is that so many times, as Nits said, there's first victims and second victims of incorrect counts and retained foreign bodies. This gives a financial attachment to a retained foreign object.
As you can see, 2002 through 2006, the average payout was 73,000 plus and the total payment was 18 million. And that's the costs for retained foreign objects. Looking at 2007 to 2011, a few years later,
the average payout went up to 104,842 and doubled. Well, not doubled. 33% about to 26.6 million in total payout of a retained foreign object. Looking at the legal defense, and we talked about second victims being the nurses,
but I think it's the whole health care team that becomes a second victim. Because no one wakes up in the morning saying, "Hey, I'm gonna hurt somebody. "I'm gonna leave something behind intentionally." And as you can see, the physician legal defense
has jumped from 12.9 million in 2002 through six to 26 million which is double. So there are definitely some financial consequences. And everyone knows pretty much the common law of torts rests (mumbles) here. The thing speaks for itself.
So, ultimately, when there's a retained foreign body, it does fall under the physician to cover that as far as financially. Yes, hospitals are involved and staffing too, but the physician takes a huge hit on that.
So I'm gonna talk about something we do at
NewYork-Presbyterian/Columbia just to give you a little background. NewYork-Presbyterian/Columbia has nine campuses now. And Nits and I work in one of the campuses. We work at the Columbia University campus. And what we did at the two main campuses,
which is Weill Cornell and Columbia campuses, we decided to do a retained foreign body proactive risk assessment. We were in the process of changing our policy with regards to when to take an X-ray in the operating room if there's an incorrect surgical count.
This project started in June of 2017. It was a proactive project that was not in relation to an RCA or anything like that. We did workgroup sessions. We broke out twice a month. It was a multidisciplinary cross-campus groups.
Again, it included Weill Cornell and Columbia. In our groups, we had physicians, surgical residents, registered nurses, surgical techs, clinical specialists, nurse managers, educators, and a quality safety nurse. So we had a good gamut of people that were involved.
And all areas where the surgical counts occurred were represented, including pediatric and adult ORs. There are two separate campuses for us, obstetrics and procedural areas.
So the problem statement is the unintentional retained foreign body
left inside a patient's body after the completion of an OR procedure are considered serious reportable events. And I think we all pretty much know that. We identify the failure modes and failure root cause analysis,
developing sustainable solutions for preventing retained foreign bodies, including false correct counts, which will help patient safety, reduce malpractice costs, government penalties, and negative media.
I think we've all heard all the negative media that occurs when something bad happens in the operating room or anywhere where there is patient care involvement. And it really gives a bad, bad vibe to all the hospitals that are involved in that.
And I don't know if anyone in this day and age can truly recover. So the goal statements for this risk assessment was prevention of retained foreign bodies. We identify the risks associated with the surgical count process,
develop mitigation strategies for the highest risk failure modes, and we completed a proactive risk assessment by developing and implementing a plan based on the failure modes and effect methodologies, the FMEA methodology.
Looking at our policy, I know policies vary from hospital to hospital, our policy, our hospital policy is really, the nine campuses follow this one policy. So we looked at surgical counts. This is taken directly from our policy I260.
Surgical counts are performed on all procedures in which sponges, instruments, needles, or any items used in the procedure could be retained. When do we do the counts? The counts are done at the beginning of the case. Ideally, it should be done
when the patient is not in the room. However, we do not do that especially with cardiac because with cardiac there is a delay of 30 to 40 minutes, anesthesias, getting the patients ready. So the circulating nurse and scrub person will do the counts with the patient in the room.
We do the counts initial. Then we do a second count if we have to do relief counts. The second count is a wound count and the third count is this final skin count. All distractions and interruptions will be kept to a minimum during the surgical counts.
That becomes important because of the IRB study that I'll discuss in a few minutes. The surgical count will be performed concurrently, audibly and visually. That's very, very important. When you're doing the counts,
it's important that the circulator and the scrub person are on the same page and actually looking at each item that's counted. And the count results will be communicated to the surgeon performing the procedure. It's then circulator nurse's responsibility
to say counts are correct or incorrect.
So looking at the consideration, and this is going back to our group study of X-ray for high risk procedures, there's been a lot of literature and we always go back to evidence-based practice as to
what are the high risk procedures that would require X-ray regardless of whether you have a correct count or an incorrect count. So the following situations would require an X-ray prior to the patient leaving the OR despite a correct count. And these are the things that
our hospital administrators toyed with, whether we should be doing these X-rays automatically. Procedures where an emergency or unexpected change in patient condition occurs, when there's a need for an additional surgical team. Procedures where permanent relief counts
could not be completed. Emergent conversion or extension of the case involving additional large numbers of countable items. And procedures in which there are three or more full-time reliefs. Looking at procedures greater than eight hours,
that's the long end of it, transfusion of four or more blood products, and a BMI of greater than 35 was initially proposed, but they had to be dropped. Because we do a lot of bariatric cases. So with that being said,
and we do transfuse a lot of blood products, and a lot of our cases are greater than eight hours, so that had to be dropped because too many patients would be having X-rays most likely unnecessarily.
So looking at a retrospective chart review,
we looked at 404 cases at the Columbia campus from the week of January 2017, and we identified 60 which would have met one or more of the proposed X-ray criteria. And that would be letter D. And that's in which procedures in which there are multiple,
three or more, full reliefs. And that is what we added to our policy. As you can see, each of the services on the left, on your right, my left, those are the types of cases that we looked at in the retrospective chart review.
This final step of our presentation was a pretty exiting one for us as nurses because we were the first nurses to do a Columbia University IRB research study. Actually, it was my idea to do something about distractions and interruptions
during the surgical count. I know the policy says it's kept to a minimum, but that's so hard to really capture. I know we have zones of silence when it comes to nurses giving out medications, but in the OR were different,
we don't give out medications per se, it's part of the procedure. So I really wanted to look at distractions and interruptions during the count process. What I did was I applied to be the principal investigator
for this research study, which was pretty unique because always had to be an MD, and just this year, in 2017, actually they changed it. It can be a nurse as long as she's masters-prepared. Columbia University, we started the process in January 2017. We received an expedited review
because there was no direct patient care involvement. What we did was we stood in the rooms and observed the count processes. We looked at distractions and interruptions. We observed 50 cardiac cases. Looked at, again, the surgical count process.
We looked at the initial, the second wound, and the third final. And we utilized a validated tool. One of the things, if you've ever done a research project, is to always use something that's already out there. It makes your life a lot easier.
So we used a validated tool. I found this surgical flow interruptions tool by a Dr. Matthias Weigl in Germany. And believe it or not, I emailed him, and the next day, asking permission to utilize his tool. And I said I wanted to modify it.
What he did was he looked at interruptions and distractions during the entire surgical procedure. I looked at it, I just wanted to modify it and look at it during the count process. Within 24 hours, this nice man wrote me back and said, "You certainly can use it," and to him keep posted as to
what our outcomes are. So we will definitely do that. Pretty interesting that I can get an email back from someone in a foreign country in less than 24 hours, but in within my department it might take a few weeks. Looking at how we went about doing it.
I think when you start doing observations and looking at things in an OR, knowing that that's a huge, huge undertaking and you need a lot of help. So in order to get people involved, and we have over 200 staff that we have in Columbia OR,
and what I wanted to do was get these nurses involved in a research project. So the criteria would be, for the nurses would be, they'd have to be CNOR, which is nationally certified in the operating room and they would have to complete the CITI/RASCAL training,
which is all your ethical and things like that, all that type of training, in which eight nurses did absolutely do that. So they were allowed to participate in our study, which was great. We established interrater reliability
by using three pilot observations. What that means is we had to get everybody on the same page. So using the tool, we made sure that everyone was using it correctly. We shot three videos of the count process. And then we had everyone sit down in a room,
use the tool for three separate cases, and then compare notes. So that's how we established interrater reliability. We had to pull in randomization. How do we do that? We used every third scheduled case on every third weekday.
And this was strictly cardiac. So there was no add-ons, there was no emergent cases, and no hybrid cases. The take-home messages, they had to be open cases. Recruitment for the study by person to person, email. We had to get the surgeons on board,
and updates were provided at monthly cardiac meetings and during the staff huddle. In particular, the cardiac staff, just tell them how we're doing. Give them a progress report so to speak. Informational consent was needed for all patients.
Again, it was an expedited review, we weren't changing anything, we weren't interfering in anything. Obviously, if something was to go wrong in the room, we would help. But we were just standing there
and observing the count process. All data was collected on hard copy, kept in a locked office in a locked drawer. And there were no identifiers on the tool. So there was no way to trace back. So the clinical question or the PICO question was,
how do distractions or interruptions during the count process influence patient safety in adult patients undergoing surgery over a six-month period? As you can tell, distractions are prevalent and potentially contribute to patient safety risks.
Phone calls, pagers, beepers, just few of the common distractions that occur during procedures, especially during the count process. Counting is an important preventive measure that's a human process,
so that's already prone to error, especially in a busy environment where multiple things are happening simultaneously. We sought to evaluate the impact of distractions during the count process on patient safety. So this is the actual tool that was used.
I know it's a little small, I'm sorry. Looking at the left-hand corner, just the date, the room number, and the observer's initials. Not any patient identifier. So what we did was line by line was look at the surgical count interruptions and distractions.
So at 7:45 a.m., there was a procedural interruption or distraction, and was from anesthesia to anesthesia, talking about the patient or case at hand. And that was done during the first count. And the procedural level,
you'll see numbers one and three on that column next to the right, second to the right. And what that means is one, the distraction level means that the count continued despite the distraction. If there was a two, that means someone else
addressed the distraction, such as a beeper. If perfusion went and answered that beeper instead of the nurse doing the count. And if you saw a three, as you would on line, I believe, 14, as you could see, again, it was procedural anesthesia. It was to the nurse
telling her that there's a bed in heart center room six. That was during the second count or the wound. That was a complete stop. The nurse had to stop the count, go make arrangements for the bed, and then go back to doing the count.
So that was a total interruption of the count. So here is a summation. We had 50 cases, this is just to sum it up. We met with neuroscientists, we met with a statistician, which is where we're at right now.
He's taking the stats and running some numbers for us. But these are the summations of what we've done on those worksheets. So as you can see, for count number one, the first count, second count, third count. The first count, people entering and exiting.
There was three for this. CIC means communication irrelevant. So that wasn't talking about the case at hand, it was about something other than the case at hand. It can be what they were doing on the weekend to the next case.
So that was considered irrelevant communication. And then there was two procedural interruptions. So they were all distraction levels of one. So the counts continued. Was the start of the wound or final count announced? That's an interesting question.
And I put that in there because our policy says the nurse is supposed to announce the start of the wound and final count. And my next slide will attest to how many times they actually do that. And I put that in there because
a lot of times the surgical team doesn't know that the count process has started. And then I added on the end total time in and out versus procedure time. I put that in there, basically, to help the statistician. Because what I wanted to see
to look at something maybe, maybe it would be a variable, I don't know right now, to look at, "Is this surgical count prolonged "based on the interruptions and distractions?" We're not there yet. Again, he has those numbers so he's looking at that as well.
Looking at national averages, I already did look at national averages for each type of case. Whether it be a (mumbles), we do fall in the range of the national average of time. So it didn't prolong it like I would have thought initially,
but, again, it's still in the statistician's hands right now. This is our final slide, and this is a summation of this interruptions and distractions. And I thought this was pretty much an eye-opener as well. If you look at the initial count,
out of the 50 cases, people entering and exiting the room was 278 times. So that means they came in, they came out. Pagers, overhead, beepers, 40 times. And this is just during their final count. All the irrelevant communication,
whether it be started by the attending, the fellow, the anesthesia, RN, or somebody else. Those numbers aren't as high, but they're still there nonetheless. Equipment failures. Looking at procedural.
Now, obviously, in the operating room, looking at that, we always have to have some type of communication about the patient, about a need of the surgeon, so that number may not be able to be improved upon. Going all the way to the right, looking at distraction level one and two (mumbles),
it was 451 times was a distraction, meant the count kept going on, but it was still there nonetheless. Level two means number seven was the count continued. Someone else took care of it other than the nurse. And then the interruption level,
as you can see the count completely stopped. That was 57 times. And that was just during the initial count. Looking at the wound count, less people entered and (mumbles). Still 165, still a huge number.
Beepers, 52 times, or pagers or overhead pages. Radio on, seven times. Just an FYI, when we were doing this observation, we did not change anything that was going on in the room dynamics.
One doc questioned me, he goes, "Oh, you're here to do the observation. "Should I shut the radio off?" I said, "Doc, you just continue doing what you always do." And he wound up leaving it on. Again, we only interjected if there was patient harm
or an adverse event in which help was needed. We were strictly there in the observation mode. Going across on the wound count, 287 procedural interruptions. What could they be? That's pretty much a surgeon request
or an anesthesia request. They could be asking for medication, anesthesia, usually protamine or heparin, or additional antibiotics, could be for the bed where the patient's going. Procedure can be also be from
the surgeon asking for something that he hadn't asked before and it came up during the second count. The level, again, going across level one, 362. The counts continued, but it still was a distraction. Level two, 16. And interruptions was 215.
So that number was real high. If you think about it, the wound count in any operating room, I think, is one of the most important counts. I'm not minimizing other counts, but this is when the patient's chest, in these instances,
is wide open. This where you really have to focus in making sure you get everything back. And you do need a few minutes to do that and do it in my opinion without interruption or distraction. I know sometimes it can't be helped
especially if it's procedural, but maybe we can get those numbers down. Looking at the final count, the final count is when you're on skin. So you're closing pretty quickly at this stage. 91 times people entering, exiting.
This is just over 50 cases. 37 times the beeper went off. Moving all the way to the right, distraction level was 189 times. Again, it was a distraction, it did not stop the count,
but, again, it was nonetheless a distraction. Level two was a seven, someone else addressed it. And 52 times the count actually stopped. So looking at the total distractions and interruptions in that little box, initial count, 515 times.
There was either a distraction or an interruption during 50 surgeries. Wound count, 593. And final count, 248. I wanted to put that in there, "Start of wound and final count announced?"
And it is our policy that the nurse should announce when the wound and final count is starting. Unfortunately, only 33%, 33 nurses did not announce it and only 17 did. So that could be a barrier that has to be looked at as well, maybe reexamined.
We are in the process now of changing our count sheets because evidence suggests that the count sheet should not have cross outs on it, addition, subtractions, anything like that. I know it's a worksheet, but at NewYork-Presbyterian, we put our count sheets on the patient chart.
So it becomes part of the medical record. We were told to by CSM, and we responded and have done that. So now we're trying very hard to get nine campuses to see the same goal of unifying and using the same count sheet,
being that we all have so many specialties. We do cardiac, vascular cases, transplant, general surgical cases, orthopedics, ENT, eye cases, ophthalmology, urology cases, GYN. We run the full gamut,
so trying to get everybody to be comfortable in using a standardized sheet is becoming, based on evidence, is quite the challenge. We're almost there, I will say that. Within the next few months we should roll out a standardized count sheet.
I wish I had it with me. In which case, we would be able to see, the numbers are preprinted on everything so it makes life a lot easier. You also have to understand that everyone writes a little different,
some (mumbles) little neater, some people have different ways of using the count sheet, so we're trying to standardized that and make that as clear as well. Also, tying up our policy into X-ray and how important radiology is.
We partner very well with Radiology Department. Especially when it comes to lost needles, our policy is based on AORN which is our standardized nursing Association of periOperative Registered Nurses. And for needles, they make sure that needles, they recommend that no X-ray be taken for a needle
10 millimeters or smaller. Because you really can't find it. And then it becomes risk versus benefit. I will share this with you with regards to retained foreign bodies, we are looking at now
disposable items which are coming up very strongly and a lot more. We see a lot more different products. And what we're finding is that a lot of these disposable products, especially the sheets, the vascular sheets,
they'll peel apart. Pieces of them, unfortunately, get lost. And we've had four instances where they've been lost in the patient. So we are looking at the different products that we use. We try to standardize the best we can,
but based on need and necessity of the patient, surgeon, and the surgery at hand, that becomes quite the challenge. Also with finance involved, too. So we are looking at that. I will say that this project that we did, and still on doing,
it's now, as I said, in the statistician hands, it was an eye-opener. Hopefully, in the future we'll have a policy that reflects the importance of doing the count and making sure that our patients are safe.
(audience applauds) We'll take any questions if anyone has questions. - [Questioner] At what time does it become a sentinel event? Does a surgeon have to be present for the final counts to happen? - [Louise] Actually, no.
Our counts, we do the preliminary count which would probably be the wound. And between the wound and the final, the cardiac surgeon walks out. If there is a discrepancy in the count, they have to be notified.
The surgeon has to be notified by telephone. If an X-ray is warranted, an X-ray is done, and an attending radiologist has to read it. And the results are discussed between the attending radiologist and the attending surgeon. So we escalate it in that way
only when there's an incorrect count. But does the surgeon have to be there for the final count? The answer is no. - [Questioner] Okay, and then my other question is, because I work in the interventional side and we kinda have a hybrid lab,
do your instruments have to be counted like say if you're putting in a Medipore or a pacemaker? - [Louise] The instrument depend on the wound, is that what the question? It depends on the wound size, if I'm answering your question correctly.
Like with hybrid you're not open, so, no, you wouldn't have to do an instrument count. It depends on the wound. I think the policy says that if there is a chance for the wound, if the chance for an instrument to be retained
based on wound, then, yes, you have to do count. But for hybrids, no. And being that you're using constant X-ray that you will visualize. But sponges, soft goods, smaller items,
yes, have to be counted. And to your point with hybrid, again, a lot of the disposable items, the sheets, the tips of those items, that's what we're finding retained foreign body. Those are not X-ray detectable.
That's gonna be the challenge to count as well. Because, you know, every kit is different, everyone opens them up and uses them, and that's what we're working on now as well, you know, looking for best practice on that. So more to come,
hopefully, soon because so many products are out there. - [Questioner] Okay. Any other questions? - Okay. - Thank you.
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