**Transcript of Cyberseminar**

**Evidence-based Synthesis Program**

**Prevention of Wrong Site Surgery, Retained Surgical Items, and Surgical Fires, A Systematic Review**

**Presenter: Paul Shekelle, PhD, MD**

**April 9, 2014**

*This is an unedited transcript of this session. As such, it may contain omissions or errors due to sound quality or misinterpretation. For clarification or verification of any points in the transcript, please refer to the audio version posted at www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm or contact Susanne Hempel, PhD,**susanne_hempel@rand.org*

*Moderator:*We are the top of the hour here, and I want to welcome everyone to today’s HSR&D Cyberseminar.  Today’s session is a part of our spotlight on Evidence-Based Synthesis Program’s Cyberseminar series, and today’s session is Prevention of Wrong Site Surgery, Retained Surgical Items, and Surgical Fires, A Systematic Review.   Our presenters today—our first presenter is Paul Shekelle.  Paul is a staff physician at the West Los Angeles Veteran’s Affairs Medical Center and has served as director of the Southern California Evidence-Based Practice Center for the RAND Corporation since 1997.  He is also a Professor of Medicine at the University of California, Los Angeles.  

**He is joined by Susanne Hempel.  She is a Behavioral Scientist at the RAND Corporation and a Professor at the Pardee Rand Graduate School.  She works at the Southern California Evidence-Based Practice Center and for the VA Evidence-Synthesis Program carrying out systematic reviews in healthcare research.  They are joined today by Dr. William Gunnar.  He was appointed as the National Director of Surgery for Patient Care Services in November, 2008.  He is responsible for the policy and clinical oversight of the 130 Veteran's Health Administration Surgical Programs.  I would like to turn things over to our presenters today.

*Dr. Shekelle:*Okay, great.  Thanks so much.  I’m going to go ahead and get started.  I’m Paul Shekelle here at the West LA VA, and I’m going to—just to orient you to this, I’m going to talk about the first few slides.  Then we’re going to—I’ll also ask Dr. Gunnar for just a little bit of comment at the beginning about their interest in this.  Then we’ll turn it over to Susanne Hempel to go through some of the details of it, and then we’ll come back to questions at the end, which could be answered by any of the three of us.  

As you can see, the title of this is Prevention of Wrong Site Surgery, Retained Surgical Items and Surgical Fires, A Systematic Review.  Can you advance to the next slide, please?  Great, thanks so much.  Although there’s only three of us who are going to be doing the presenting here, there’s a lot of people that helped contribute to this.  I’m not going to read through all the people here, but you can see a bunch of people who participated through the VA, and through the Evidence Synthesis Program, and then a bunch of people through VA nationally who are giving us input and helping us refine and interpret some of the evidence.

Let's move on to the next slide.  This is the disclosure.  Again, I’m not going to read through this, but the important thing is that what we’re presenting to you is not necessarily official VA policy.  This is a review for which we’re responsible for the content.  It’s going to be used by VA to help inform what they do, but it is not official VA policy.  None of the people on the RAND or the VA side of this have any financial conflicts of interest with this.

Next slide, please.  Let me just—probably a lot of people on this call have been on other Evidence Synthesis Program Cyberseminars, but perhaps not everybody, so let me just spend a slide orienting people to the Evidence Synthesis Program.  This is something sponsored by the query part of central office and the idea was that it is to help provide VA policymakers with timely and relevant reviews of the literature on topics of their interest.  The way it usually happens is that there's some stakeholder or group of stakeholders within the VA system, mostly but not always from Central Office who want to know something about the evidence about a particular topic in order to help be able to make a decision.  

Then they ask one of the Evidence Synthesis Programs to do it.  There are four of us: one at Durham, ours here at GLA, one in Portland, and one in Minneapolis.  These were originally located because they were also the sites of Agency for Healthcare Research and quality-sponsored Evidence-Based Practice Centers.  Obviously, the methods of both are very similar.  They both produce systematic reviews.  The ESP ones do it just for a VA audience, and the AHRQ Program produces it for a large number of different stakeholders.

Next slide, please.  I already sort of went over this, but these are the kinds of things that—the reasons why VA stakeholders want some of this.  They’re either going to develop a clinical policy, they’re going to be doing something on implementation, or we’ve occasionally gotten requests to go through the evidence in order to help set up research agendas.  If any of you out there on the phone have a topic that you’re interested in, that’s the link that you'd use to actually submit a topic, a nomination, and then those get reviewed at some kind of regular frequency by the various powers that be who then assign us out the topics that they select to do.

Let's go to the next one.  Each of the four ESP sites are essentially meta-analysis and systemic review toolboxes.  We know how to search the literature, and assess the quality of the studies, and do meta-analysis, and all that.  For each one of these, we have to then be assisted by a Technical Expert Panel in the topic of interest.  We might get assigned a topic on health IT in which case we’re going to have health IT experts.  We might get assigned a topic on acupuncture in which case we’re going to have a couple of alternative medicine experts, or we get assigned a topic like this in which case we have surgery and related experts.  The reports are published on the VA intranet, and many of them ultimately end up being journal articles, as well.  

Next slide, please.  That was a brief run-through of the ESP program.  Now we’re going to talk about this specific topic.  Let’s go ahead and advance one additional slide here.  Let's stop right here for a second.  Dr. Gunnar is one of the stakeholders that requested this topic.  Did you just want to say a minute or two, Dr. Gunnar, about what the interest was for this from the CO perspective?

*Dr. Gunnar:*This is Bill Gunnar, National Director of Surgery, I think as the introduction stated.  I appreciate the opportunity to join this discussion.  The background on this is that prior to 2010, the National Center of Patient Safety in our National Surgery Office collected this information separately.  We found in our own—in our communication between the two program offices that we had separate rates, separate events, separate definitions.  In 2010, we got together and defined what these—what would—what the definitions are for each one of these components for both Wrong Site Surgery, Retained Surgical Items, and Surgical Fires.  

I will say that you will—if you search joint commission definition, you may note right away that wrong implant doesn’t exist.  If you look at the Association of American Society of Anesthesiology, their definitions for OR fire don’t exist the way—aren’t the same as our definitions.  We recognized that our organization, the VHA, we wanted to take—throw a broad net and capture these events but in doing so, we needed the background of what is available literature.  

The ESP program is the perfect place to be able to—as a resource and what a great resource it is to be able to ask here are the things that we define as safety issues for the operating room environment.  What is the rest of—what's the literature show?   How does it define these things?  How do we incorporate that into the results that we’re getting now going forward?  I think that frames it pretty well.  

*Dr. Shekelle:*Great, thanks so much.  I’m just going to go over this and turn it over to Dr. Hempel.  As you heard from Dr. Gunnar, the stakeholders in VA had these specific outcomes in mind.  That’s going to be these never-event outcomes, and that’s going to be important as you hear Susanne Hempel go through the evidence and that some of the multi-component interventions for surgical safety, like the WHO checklist or the universal protocol, are certainly designed to try to help reduce these.  They’re also designed to try to help reduce other things, too, like surgical operative mortality and other things like surgical site infections.  

Frequently, the studies of those kinds of multi-component interventions use a composite measure of their outcome where these things are then buried inside of an outcome that also includes 30-day mortality, re-operation, and surgical site infections.  What you’re going to be hearing today is going to be some of that material pulled back out, and that may cause you a little bit of dissonance over what you’ve read in journal articles about the composite measure.  I just want to foreshadow that right now to explain that that’s why some of what you’re going to see may look a little different than what your memory is because your memory is about the composite measures.

With that, let’s go to the next slide.  Next slide, Susanne?

*Dr. Hempel:*This is the next slide.

*Dr. Shekelle:*The next slide is also the background review?  I’m so sorry; let me turn it over to you.

*Dr. Hempel:*It’s alright.  Let me just ask our host, Heidi, do you need to reload the slides?  Can I get the slides now?

*Moderator:*I’m pulling them down quick and reloading them, and I’m hoping Dr. Gunnar will be able to see them now.  

*Dr. Gunnar:*I was sharing someone else’s screen.  Now it’s clear.  We’re on the same page.  Great, thank you.  

*Dr. Hempel:*Let me go back one slide.  I just want to say quickly for this systematic review, and we completed this last year.  We used a very broad definition of Wrong Site Surgery so it could be anything from wrong site, the wrong side, the wrong level in spine surgery, the wrong procedure, the wrong implant in eye surgery, or the wrong patient.  We have also adopted for this review a very broad definition of surgery.  We were primarily interested in studies that reported on procedures when an incision was made.  

The second topic, Retained Surgical Items, again, we adopted a very broad definition.  It could be anything from forgotten surgical sponges to device fragments that broke off and were left unnoticed.  We excluded items that were intentionally placed before wound closure; for example, stents that were placed intentionally but then not removed as scheduled.  

Regarding the third topic, fires, we also adopted a broad definition.  It was not limited to fires on the patient.  It could be fires in the operating room that were not close to the patient but in the same environment.  In general, what we would say is that all three events have potentially devastating consequences, not just for the patient but also for individual healthcare providers that can be held responsible under specific circumstances and it's, of course, damaging for the facilities.  The events, although they do happen, they are considered preventable.  They are considered never events, events that should never happen.  The preventative goal is a rate of zero.

In terms of the background for this review, we searched nine electronic databases because we were interested in capturing the prevalence.  We were interested in root causes.  We were interested in interventions but also in provider behavior interventions.  We were also interested in technological novelties.  We limited the search to 2004 because our task was to provide an overview of the current literature, not a historical overview, and 2004 was chosen.  This was when the universal protocol has been in effect.  The universal protocol had been widely disseminated.  It addresses wrong site surgery, but it has also overall a stronger emphasis on surgical safety or safety for patients in surgery.

In total, we have included 129 empirical studies and guidelines.  It was a very large review.  For this presentation, we can only go into selected aspects of the report.  The full report is available on the intranet.  While we are working on a publication, it is only available within the VA, but soon it will also be publicly available.  There has also been a management brief that went out in December.  

We had four questions, four key questions for this review.  The first question was what is the prevalence of wrong-site surgery, retained surgical items, and surgical fires?  The second, what are the identified root causes of these events?  What is the quality of current guidelines?  What is the effectiveness of interventions that try to prevent these events?

In terms of the first question, the prevalence of events, we found the most information on wrong site surgery.  We included 28 studies that reported on the event of interest and a denominator.  Not all studies reported a rate or a per procedure data but for that—for those studies that did, we should note that there was variations across estimates, and this variation we speculated had to do or we know to some extent the variation in estimates had to do with the data source.  We included self-reports and surveys as well as studies using state-wide reporting systems.  All sources have advantages and disadvantages, and we looked at the information where we could find it.  

Studies definitely also varied in what they considered an event and what was a close call.  In some cases, a reportable event had to be associated with harm to the patient.  In some studies, having prepared the wrong surgical site was considered an event, for others not if the mistake was corrected during the procedure and even when anesthesia had been prepared for the wrong side.  The observation period also makes a difference.  We only included studies that covered 2004 and later, but some others have commented on the phenomenon that event rates went up just before and after the introduction of the universal protocol because people were just more alert to the issue.

Across 7 studies, the median estimate was 0.09 events per 10,000 procedures, about 1 event in 100,000 procedures.  Estimates ranged from no events in 10,000 procedures—it was too small to show anything—to studies that found more of a rate of 1 event in 10,000 procedures.  That was even in data sets that did not concentrate on the particular type of surgical procedure.  Prevalence estimates also varied by specialty and by procedure.  For some of the estimates, some specialties’ estimates are much higher, closer to 2 events in 10,000 procedures, for example for eye surgery and dental surgery.

Most information is currently available on spine surgery, and we found two recent surveys, recent meaning published in the last six years, with 50 percent of surgeons indicating that they had performed at least one wrong level spine operation during their career.  Then again, for estimates like that, we have to keep in mind that this lifetime prevalence covers a long period of time, and some of the events would've definitely taken place before the introduction of the universal protocol.  

What can we take from this?  First of all, wrong site surgery is rare, but the rate is not zero.  The events continue to occur even after the universal protocol has been implemented, and there is variation estimates.  Using the average estimate, here is only a very rough estimate.  

Then we reviewed the prevalence of retained surgical items.  We found 20 studies that reported on prevalence.  The median estimate, again there was variation across 9 studies with general estimates rather than specialty or procedure-specific data with 1.4 events per 10,000 procedures.  Retained surgical items are much more common.  There was variation, and I’ve copied out a figure here showing point estimates and the confidence interval for those studies that actually reported events and the number of procedures for the estimate.  The range was here between 0 events up to 3 events in 10,000 procedures.  

Again, we think, to some extent, the variation had to do with defining when an item is officially retained.  Some studies use the wound closure as the cut-off; others used the patient leaving the operating room, which can be after x-rays had been interpreted, even if the wound had to be re-opened.  They had a much broader definition or a much closer, narrow definition of when items were actually considered retained or left behind.  Some of the studies that we found only reported data on specific items.  The most common item that was reported was a surgical sponge.  Several others have also highlighted that events occurred even when—or were discovered even when surgical counts had been recorded as correct.

Yeah, then the last question, the prevalence of surgical fires.  You might ask why are fires in the operating room?  Why is that an issue?  Fires are always bad anywhere.  There is some particular relevance to surgery because all three elements of the fire triangle that I’ve put here on the slide, they are routinely present.  There’s an ignition source like a laser.  There is lots of fuels around like drapes.  There’s often supplemental oxygen for the patient making the operating room an oxygen-enriched environment.  In such an environment, it is easier to start a fire, and it will burn faster and hotter.

Unfortunately, we only found three published studies, and none of these studies reported a per procedure estimate of the prevalence.  We don’t know how often fires occur in surgical practice.  We found one survey that indicated that 23 percent of ENT and head and neck surgeons had experienced at least one operating room fire.  It was unclear whether they were involved directly, and this result is obviously based on a single survey.  We also found the response rate very low, and people with a fire experience might have responded more eagerly to a survey.  Again, lifetime prevalence can cover a long period of time.

Yeah, so then our second key question, what are the identified root causes of wrong site surgery, retained surgical items, and surgical fires?  Again, we found most research on wrong site surgery events.  We included 23 either published institutional root cause analyses or detailed analyses.  We included reviews that analyzed published case studies, always more than one.  We did not review single case studies for this review.  We also included risk factor studies.  

In this literature for wrong site surgery, communication was cited most often as the root cause or as a contributing factor.  Communication was insufficient.  There were many examples from surgical team members not speaking up when they suspected that the wrong site was targeted, surgeons not listening to concerns, or critical information was just not communicated to the surgical team.  We found several analyses that indicated that events either resulted from misinformation where false information was actually obtained from other departments or there were scheduling errors.  Quite often, it was actually misperception, meaning the available information was not actually wrong; it was just misinterpreted.  

A large number of studies also identified polices as the root cause or a contributing factor.  There were different scenarios.  The simplest scenario was staff not following procedures even though its organizational policy was to perform a time-out; staff didn’t do it because they were already behind schedule.  Other cases involved technically complying with the policy but not in a meaningful way.  For example, the site was marked, but it wasn’t visible anymore after draping, or a time-out was performed, but people were not really listening.  

Some of the detailed institutional root cause analyses found that their policies were inadequate.  For example, the type of procedure was documented on consent forms but not which side, which is a major problem for all lateral structures.  Some analyses indicated that it had to do with a lack of standardization of procedures.  One example was staff noticing discrepancies in the documentation but because it wasn’t obvious who was responsible to reconcile these discrepancies, it wasn’t done at all.  

In terms of retained surgical items, the root cause was interesting to see that we found fewer analyses although the event is more frequent than wrong site surgery.  We speculated it was because events are not necessarily immediately discovered, and it’s then difficult to reconstruct the situation days, weeks, or even years later when a forgotten sponge or a device fragment is discovered that had been asymptomatic.  For retained surgical items, a number of factors were reported, and it is difficult for us to establish their relative importance.  

Here, I want to present factors that came up in different types of studies in institution root cause analysis and risk factor studies.  One of them was—one factor were case-related factors or factors that had to do with patient or procedure characteristics.  Emergency procedures appear to increase the risk.  In multi-variant analyses, unexpected intraoperative events and the procedure duration were independent predictors of events.  The patient’s BMI was also identified as an independent risk factor.  

There were several equipment-related reports.  For example, the tip of a guide wire breaking off or other device fragments that were not noticed.  Then there were several reports of staff factors contributing to events.  Incorrect or incomplete counts are predictive of retained surgical items.  Shift changes have also been shown to be a contributing factor in a couple of studies.  Several analyses found that the existing policies were either insufficient or again, they were not standardized enough to guide staff.  For example, in one detailed root cause analysis, it was highlighted that imaging techniques were available to staff if they had a suspicion, but because there were no clear rules when to request additional x-rays, it wasn’t done.  

In this literature too, communication was identified as a root cause for retained surgical items.  Within the surgical team, it had to do with not speaking up when someone was worried and also across units where, for example, in one case the radiology department said, “We wished we had known about a suspicion because then we would have looked harder for a suspected item.”

Root causes of surgical fires, despite the unclear prevalence, we found quite a few studies here.  One very interesting study was based on a survey, but it analyzed 100 fires that people described, the respondents described.  From that, the study was able to provide information on the relative frequency of elements.  The most common ignition sources were actually electrosurgical units by far; then lasers; and sometimes light cords.  Most common fuels were actually airway tubes and then drapes or towels.  Supplemental oxygen was in use in the large majority of cases.  

Several studies showed that reported fires occur often in procedures involving the face and the neck.  Overall, we should say most studies pointed to equipment.  Some studies highlighted problematic staff behavior using the equipment, like not waiting for prep solution to dry, or allowing oxygen to pool under drapes, which indicated more of a general lack of awareness of the risks.  

Communication was highlighted in an institutional root cause analysis where they reconstructed a fire incident.  One of the contributing factors was that the staff did not alert each other to problem situations.  A team member left an alcohol-soaked sponge on the patient while the others did not guess that it was alcohol-soaked.  Several publications reminded the reader that the fire triangle elements are traditionally controlled by specific members of the surgical team.  Ignition sources are controlled by surgeons, anesthesia providers control oxygen, circulating nurses control fuels.  In the event of a fire, all three need to communicate and work together effectively.  

Our third key question actually is what is the quality of current guidelines in use to prevent wrong-site surgery, retained surgical items, and surgical fires?  Although we identified literally hundreds of publications providing advice to practitioners, there are only four guidelines included in the National Guideline Clearinghouse that are relevant to our events.  One is an adaptation of the universal protocol.  It was adapted by interventional radiology.  One provides guidance on retained surgical items.  One is a peri-operative protocol that addresses wrong site surgery and retained surgical items, and one is a guideline for the prevention of operating room fires.  

To us, it was surprising to find only four official guidelines to be included in the clearinghouse.  Guidelines need to meet the Institute of Medicine Standards for guidelines, which includes systematically developed statements.  They have to be produced for a professional body.  They have to be based on a systematic literature review and the statements, or the guidelines, have to be current so they have to be developed or reviewed within the last five years.  The quality of the guideline we found varied.  We used a specific tool to assess those guidelines.  There were some common themes including the use of checklists and multiple re-checking throughout the operative process.  Overall they were very difficult to compare because some were specialty-focused while others were just generally applicable.  

Then finally, effectiveness of interventions; first most literature is available, again, on interventions aiming to prevent wrong site surgery.  First we found five studies that evaluated the effect of the universal protocol.  The results varied.  One study pointed out that reporting went up as a result of the protocol.  There were two studies with long follow-up periods.  Both were six year follow-ups, and both indicated positive results.  The largest effect here on the ratio, it was shown in an academic neurosurgical practice which they attributed entirely to complying with the universal protocol.  

We also identified studies focusing on components of the universal protocol.  What is a good—they all had to do with ensuring that pre-procedure verification process actually happens, or different ways of marking the procedure site, or reminding providers to mark the procedure site.  Most research was actually available on timeouts and how to ensure that a timeout happens.  Several studies used a checklist just to ensure that a timeout actually happens.  Not many of them reported per procedure data, and none reported a statistically significant effect.

We found some evidence for the effect of education.  Three included studies evaluating educational interventions, and all three tested a unique approach.  There were fairly complex interventions.  One of them reported pre-post per procedure data, and the study actually showed a statistically significant improvement.  It was specific to wrong site tooth extractions.  The intervention involved disseminating a new clinical guideline with a lot more guidance for staff and a training program that reviewed previous wrong site events.  In this institution, the protocol effectively eliminated wrong site tooth extractions in a three-year intervention period.  

Then we also found evidence for medical team training.  The reviewing was actually four evaluations.  All are unique interventions but with an emphasis on team training.  None of the studies reported pre-post per procedure data, but one study reported a statistically significant improvement.  That was actually a VA data set reporting on the effect of a program to improve communication and patient safety which was nationally implemented between 2006 and 2009.  This program was in addition to the VA’s directive ensuring correct surgery and invasive procedures and other regular patient safety programs.  

The study found that the number of events per month decreased significantly while the number of close calls actually increased, so people were successful in preventing wrong site surgery events.  Our second area of interest was the prevention of retained surgical items.  Although we included a number of evaluations, there was only one intervention that reported a statistically significant effect.  That was for a data matrix-coded sponge system.  We also identified a randomized control trial evaluating barcoding surgical sponges but only reported on 300 procedures.  Not surprisingly, they didn’t report any events in any of the groups.

Another study evaluated a radio frequency detection system, also for surgical sponges, and it had a positive effect, but it only reported on 2,000 patients.  It was far too small to document a statically significant effect.  The data matrix-coded sponge system means that each sponge is uniquely identifiable and has to be scanned in and out of the surgical field.  It was implemented throughout the institution at the Mayo Clinic, and it effectively eliminated retained sponges.  The effect was statistically significant.  

The study did address concerns that it takes time to scan each item in and out.  They looked at the actual count time and the total operating time, and they found that the total time did not increase.  The one-year utilization of the system added $12 per case.  They also published cost effectiveness analyses where they show that the system is cost-effective when medical legal costs are considered that would result from an adverse event.  It should be noted that the study only looked at surgical sponges and although that’s the most frequently retained item, it’s not the only one.  

Prevention of the final review question, the effectiveness of interventions to prevent surgical fires, we included eight evaluations of very diverse interventions; fire drills, more education, using fire risk assessments routinely.  The largest study that reported per-procedure data was on 1,500 patients.  At this point, we have to consider fires as the rarest event of the three events and unfortunately for this area, we did not find a lot of research, and we found very small samples only.  These were the interventions.

To summarize, we included 70 evaluations that reported on the event of interest or close calls.  Overall, there were only very few conclusive intervention evaluations.  Apart from the effect of the universal protocol, the positive effects were found in single studies only, and they weren’t yet replicated by another author group.  Many evaluations did not have a comparator, so we did not know what the prior probability of the events was and how much of an effect the intervention had.  Many evaluations did not report a denominator.  They only concentrated on the events, for example, because they found there were no events.

They did not say how many procedures they have performed since the introduction of the intervention.  Many studies that reported pre-post and per-procedure data were hopelessly underpowered to show an effect.  The sample size was too small.  There are two ways you can look at it; either you say the sample size is too small or the follow-up period was too short.  A long follow-up period would increase the number of available observations.  It is obvious that intervention evaluations in this area are very, very challenging.  

Rare events are notoriously difficult to study because it needs really large sample sizes because you are trying to show a difference in an already rare event.  Power to show an event either needs, as presented here an example, the number of procedures or the number of observations you need to look at.  This is just beyond the capacity of most single hospital studies.  It either needs large organizational data, or long periods of time, or follow-up periods.  

In terms of future research, what we took away was in terms of prevalence, several states have introduced mandatory reporting of these events.  A comprehensive analysis that would actually analyze this data would be very useful in providing just additional data that would strengthen our current estimate and make it more precise.  Joint commission and accredited hospitals are required to perform a root cause analysis when events happen.  Again, a statistical analysis of this data would probably provide us with more insight in the relative frequency and the relative importance of potential causes.  

We think more existing recommendations should try to comply with the Institute of Medicine approach to guidelines so that they would meet the standards to be included in the National Guideline Clearinghouse.  In terms of intervention data, what we take away from the existing literature is more data are needed.  This is for sure; more data and more per-procedure data have to be reported.  Future studies should also not just rely on standard statistical tests because rare events are very, very difficult to study.  One possible approach is to use near-miss data or close calls to be able to analyze the effect on a more frequent outcome.  

Other authors also have suggested using validated process measures; for example, measuring the adherence to processes that have been established in an institutional root cause analysis to be a contributing factor.  We know that it is relevant and then to test the adherence to these process measures that are grounded in empirical data.  Another option is to use run charts or statistical process control methods where not the rate of events per procedures are analyzed but other metrics like the time to events.  

Here are some more resources.  There's a link to the Directive Ensuring Correct Surgery and Invasive Procedures, and we’ve also put the webpage of the National Center for Patient Safety for VA resources if you are interested.  This was it for me.

*Dr. Shekelle:*Thank you very much, Susanne.  Now Heidi, we have what, about seven or eight minutes left, or six minutes left for questions?

*Moderator:*Something like that.  We haven’t received any questions in yet from the audience.  Please take this opportunity.  The Q&A box is in the lower right-hand corner of your screen.  Please type those questions in and we have a few minutes to get to them right now.  

*Dr. Shekelle:*Let me just give a couple of summative comments.  I think the summation would be something like the—we don’t know as much about this as we know about things that happen more commonly in medicine.  It has everything to do with the fact that they are rare.  The best available estimate of the wrong site program is probably that it is somewhere in the 1 per 100,000.  The best estimate of the retained surgical items thing is that it’s about 10 times more than that, maybe 1 in 10,000, 2 in 10,000 kind of a thing.  In terms of trying to reduce these, all of the studies that have been done essentially run into the problems of sample size if you’re going to be using traditional statistical methods.  Trying to prove that something that was 1 in 10,000 and goes to 1 in 20,000. or if it’s 1 in 100,000 and goes to 1 in 200,000, it’s just very, very difficult.  The validity of some of these kinds of things has to rest on something other than traditional TEA testing and something like that.

Alright, let’s see.  We have a few questions here.  The first one, somebody said thank you very much.  We’ll be glad to take those kinds of things.  Here’s the next one.  Was there any research and analysis related specifically to anesthesia and regional block procedures?  I’m going to give that to Susanne.  Was there anything specific about anesthesia and regional block procedures?

*Dr. Hempel:*Yes, that was targeted in a couple of intervention studies.  As for the prevalence estimates, though, there was variation in studies whether that would be considered anevent.  In some studies, they excluded anesthesia events; they said if the procedure, if the incision did not go ahead.

*Dr. Shekelle:*The next question is, and this one sounds like it’s going to be for you, Dr. Gunnar, or maybe you’ll know who to send this one to.  The next one is we have had difficulty to get the surgery count system approved for purchase due to it being manufactured in China and not US-made.  Is it possible that this can be waivered?  

*Dr. Gunnar:*The answer to that is no, but I will give you a perspective from having looked at the event rates in facilities with and without surgical count system.  Thirty percent of our VHA surgical programs have surgi-count systems of one form or another, and the event rates are the same.  

*Dr. Shekelle:*These are data that we weren’t—have you guys *[cross talk]*

*Dr. Gunnar:*No, that’s just not the question.  The question is two points.  One is from a VA—it's not a—that’s just my recent review of the events and the facilities that have the surgical count systems in relationship to their RSI and for data; you didn’t have that information.  Keep it; there it is.  I’ll publish it and then you will.  

*Dr. Shekelle:*The answer is it can’t be waivered.  How have these other sites who have these surgi-center things been able to get it?  Do you know?  Again, I’m talking about something I don’t know about and at least the question came from somebody who made it sound like the only place it comes from is China.  These other 30 sites that have it, where have they gotten it from?

*Dr. Gunnar:*This has to do with procurement policy.  The best individual to ask would be your—and they already know.  It would be your local procurements folks.

*Dr. Shekelle:*The next question is overall—and this one again sounds like it may be to you, Dr. Gunnar.  Overall, has the VA endorsed any certain type of scanner wand used in the OR for assistance in preventing retained sponges?

*Dr. Gunnar:*I think that was asked.  At least I answered it clairvoyantly, no.  We have not endorsed any particular type and for the reason stated.  What really has to happen is that the OR environment has to have a robust culture of safety that ensures that counts are done appropriately, that—and the policy that is associated with preventing retained surgical items is followed, and folks can go to that.  There are a number of lessons learned in that policy.  We modified it based on root cause analysis of cases, and some of it which was explained about—Susanne explained about if you’ve got long cases going across shift changes.  

There’s also deep pelvic cases or cases associated with a lot of blood loss.  Those are cases that even though you have a correct count, and let me asterisk that.  No one would leave the operating room with an incorrect count.  Where retained surgical items occur, they all have correct counts.  If you, in fact, follow those guidelines including a robust wound sweep before and sort of a pause in the operating room before you close, then there is a—it satisfies the communication component that Susanne was talking about.  The last is that anybody—any member of the team should never be questioned if they say I would like an x-ray at the completion of this procedure.  I’m just not comfortable that we have—this is a patient at high-risk for retained surgical items.  Get an x-ray and go with—and no one should be stopped in the operating room from making that happen.  

*Dr. Shekelle:*We are virtually out of time, but I have one more question that I’m going to take here.  Did you consider evaluation of guidelines from AORN Nursing Standards?  I can answer that one.  We considered only things that were in the National Guideline Clearinghouse, so whoever asked that question, if you want to email to Heidi what the link is to those guidelines, we can have a look at them.  There’s still a couple more questions that have come through, but I’m afraid we’re actually over time now.  I don’t think we can take any more.  I need to pass it back to you, Heidi.

*Dr. Hempel:*Paul, we actually have this seminar scheduled for 50 minutes.

*Dr. Shekelle:*Oh, we have extra time.  My entire fault.  Here’s the next question then.  It says all high risk industries such as the fire service, police, aviation, etc. face the same problem as medicine in developing team training that truly meets the ideals of the workgroups involved.  While all agree the training works in reducing traditional confrontation and error, developing the ideal process has proven very difficult in that these people in these careers are very busy and taking these people out of service is extremely costly.  My question is whether anyone has found the ideal team training that matches the personality of these high-risk professionals that we are talking about?  We are traditionally a group who are used to an intense active environment, especially simulation which can be rather expensive.  

I will let Dr. Gunnar also try and add to that one, although I would add that certainly some other industries who also have expensive people take them out of rotation to take them to Colorado to train them.  I’m thinking specifically of pilots and what they do in simulations there.  Dr. Gunnar?

*Dr. Gunnar:*It’s really great, and thank Ken Wolski for that, I’m sorry—are we supposed to be able to say where that came from?

*Dr. Shekelle:*You just broke the anonymity, but that’s okay I’m sure.

*Dr. Gunnar:*Ken just wrote a book that complements OR safety so we need to throw—I’ll give him his own advertisement, so congratulations, Ken.  This comes from a knowledgeable point of reference.  This is why in 2000—I just want to check the date because I was looking that up.  Following NCPS’s Medical Team Training which was a day event, stand-down for the OR, everybody became—that was a requirement across the nation.  It sort of went out in a wave.  We did put together a mandatory learning.  Back then, it was LMS; it's TMS now, training for all staff engaged in performing surgical procedures or actually invasive procedures in and outside the operating room.

As of March 2011, there’s a requirement that everyone at least go through a training module that ensures that they understand the policy and what’s expected of them with regard to timeouts and ensuring the correct procedure is performed.  We also put together along with—as a collaborative between the National Center for Patient Safety, National Surgery Office, and SimLEARN which is the EES’s program for simulation, a train the trainer scenario using clinical, simulated clinical scenarios.  That, I think, is a—there is—we took a team of four people from each of the divisions to sort of train the trainer.  

I believe each of the division chief surgical consultants was one of those four people, and I think there were three other leads from each of the divisions.  There should be a core group of knowledge regarding what it takes to train any environment, anyone in the operating room environment, on what the protocol is for ensuring correct surgery and the fact that scenario and that training session still exists.  You can utilize that as a way forward.  Currently, we don’t have that same—that hasn’t been applied to retained surgical items, or OR fires, or patient burns associated with chemical or fire burns.  We can take that suggestion and move it forward.  Thanks for that.

*Dr. Shekelle:*That is the last question then.  I can turn it over to you Heidi.

*Moderator:*Yes, you can.  Thank you very much.  Right now, I’m putting up a feedback form, if our audience could take just a few moments to fill that in.  There is no submit button, so once you have put your information in there, we have received it.  Don’t worry about hitting a submit button.  Drs. Shekelle, Hempel and Gunnar, I really want to thank all three of you for taking the time to prepare and present for today’s session.  This was a fantastic session.  We really, really appreciate the time that all of you put into this.  We also want to thank your audience.  Thank you so much for joining us for today’s HSR&D Cyberseminar, and we do hope to see you at a future session.  

*[End of Audio]*

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