Healthcare Consulting Services
October 7, 2014
Our Take on Patient Safety Walk Rounds
We think that Patient Safety Walk Rounds are one of the most important tools you should have in your patient safety programs. You’ve often heard us in our Patient Safety Tips of the Week say “…another good thing to add to your Patient Safety Walk Rounds”.
This month’s BMJ Quality & Safety issue has an excellent article on Patient Safety Walk Rounds (Singer & Tucker 2014). It’s a review of the literature on patient safety walk rounds and provides concise summaries of the published studies in tabular form. It emphasizes that there are actually many limitations to studies previously done, including selection bias, lack of controls, and lack of objective measures. In addition, most studies come from single sites so the generalizability is questionable. They do note that a small subset of studies have reported positive outcomes on both quality/safety metrics and safety climate measures.
One of the most important points in their review is that Patient Safety Walk Rounds can be counterproductive. That is, if the issues raised fail to be resolved, frontline staff become frustrated and the safety climate may actually deteriorate. They note studies show a negative impact when rounds are done “as a form of surveillance and control” rather than “inquiry and support”.
The authors do note that there appears to be a dose-response relationship in that involving as many staff as possible is important in successful implementation.
Singer and Tucker also discuss variations of safety rounds. One is the “adopt-a-work-unit” program or the CUSP program (Comprehensive Unit-Based Safety Program). We discussed CUSP’s in our March 2011 What’s New in the Patient Safety World column “Michigan ICU Collaborative Wins Big” and our July 22, 2014 Patient Safety Tip of the Week “More on Operating Room Briefings and Debriefings”. We’ve also referred readers to Pronovost 2006 and Timmel 2010 for good descriptions of the CUSP model. The CUSP model is also nicely described in Peter Pronovost’s book “Safe Patients, Smart Hospitals” (see our July 6, 2010 Patient Safety Tip of the Week “Book Reviews: Pronovost and Gawande”). In such models senior management work with a unit on a continuous basis rather than rotating.
Singer and Tucker also note that safety rounds can be successfully used to identify safety issues when done by people other than senior management, such as frontline staff themselves or departmental managers. Also, in our December 23, 2008 Patient Safety Tip of the Week “Why Safety Alerts Often Fail” we discussed a unique “safety coach” program that utilizes frontline staff and includes elements similar to those used in walk rounds (Lindberg 2008).
Our own take on Patient Safety Walk Rounds is less scientific and based on our own experience. But we think our observations, nevertheless, provide some good insights.
How often should you do Walk Rounds? Unfortunately there are no hard and fast guidelines. We usually recommend that each unit be visited at least every two months, perhaps supplemented by monthly rounds done by other staff.
One bad habit organizations have is only doing Patient Safety Walk Rounds on the day shift. It is extremely important that you do them on all shifts. That takes planning and commitment. Why is it important? Because two-thirds of the staff you want to include in your safety culture work on those other shifts! Not only do you need to convey to them your commitment to improving patient safety but you will also better see and hear about some of the barriers to patient safety on the evening and night shifts.
Who should be there on Patient Safety Walk Rounds? Your core team should include your CEO, COO, CMO, CNO, and head of Quality and Patient Safety. But there are others that should also participate. You’ll want a pharmacist for rounds on almost all units. Bringing your CFO on such rounds is a good way of giving him/her a better understanding of how patient safety issues can impact the bottom line. Your CIO may also gain valuable insights into how staff interact with technology and many of the safety issues resulting from complex IT issues or ones that could use an IT solution. Including representatives from other departments (eg. engineering, housekeeping, SPD, etc.) can also bring unique perspectives. We also recommend that you include your Board members in Patient Safety Walk Rounds. Not every rounds, but mandate that each Board member attend at least one walk rounds session annually. Not only will that help educate them about patient safety but you’ll be pleasantly surprised by the insights they bring to your rounds, either by their perspective as a “consumer” or patient or the perspective of whatever industry they happen to come from. For example, a banker might cringe looking at patients in line in your antiquated patient registration system and have good ideas for improving efficiency and patient flow. Note also that the current Singer & Tucker review mentions the importance of including physicians in such rounds. We wholeheartedly agree. Almost every study done on culture of safety shows disparities between the impressions of frontline staff and physicians (and administrators). However, equally important is not having the physician presence stifle open discussion of issues with staff. We’ve all too often seen situations in which behavior of a physician is the critical safety issue and staff are unwilling to speak about it in front of another physician, even the CMO. Lastly, some include a patient or patient family member. A Board member might fulfill that role but Board members may have an “insider” bias. Having an “outsider” pair of eyes and ears may be important.
Should all those individuals be on every Walk Rounds? Definitely not. Having too many upper management people on rounds can be very intimidating to staff. So split them up. Have 2-3 team members do walk rounds on one unit and others do them on another unit or another shift. You really want to be able to interact with your frontline staff and make them feel comfortable in speaking up.
What units should get Walk Rounds? Answer: all of them. But some may need particular attention, particularly those that are “melting pots” like the Radiology suite. In our October 22, 2013 Patient Safety Tip of the Week “How Safe Is Your Radiology Suite” we discussed the multitude of safety issues seen in Radiology suites that have little to do with radiology per se.
Remember, you are not just doing walk rounds for show. The most important thing you can do is identify issues and follow up. One member of each team should keep a formal issues log that includes action items and dates for expected actions. Timely feedback to frontline staff on actions taken for each item is extremely important. And beware of simply telling staff “that’s been referred to Committee X” because that often conveys the message “nothing is going to be done”. You will encounter some items that cannot be fixed simply or expediently. In such cases you need to be honest with your staff and tell them, for example, that a current budgetary or technical restraint won’t allow a quick fix (eg. “that is in the software version update to be installed in 3 months”). But at least they will know that it is still on your list. Singer & Tucker also stress that frontline staff become frustrated when senior management spends too much time prioritizing issues rather than taking actions.
Body language on Walk Rounds is extremely important. Not theirs, yours!!! The old adage that 90% of communication is nonverbal holds true. If your body language conveys disinterest or “let’s just get this over” it won’t matter what you are saying with your staff. They will recognize that such rounds are perfunctory.
We agree with Singer & Tucker that “surveillance” on walk rounds can be counterproductive but that applies mainly to surveillance of people. That doesn’t mean you shouldn’t look for some unsafe conditions when doing your safety rounds. For example, if your facility handles behavioral health patients (even if it is only in your ER) you should be looking for things like “loopable” items in the bathrooms in your radiology suite that might be used for suicide. Or you might check floor stock to make sure you don’t have vials of concentrated heparin that might mistakenly be given to patients during a heparin “flush”. Or some of the battery charging/recharging issues we raised in our February 4, 2014 Patient Safety Tip of the Week “But What If the Battery Runs Low?”. And we always recommend vigilance to alarm safety issues during Walk Rounds (see our July 2, 2013 Patient Safety Tip of the Week “Issues in Alarm Management”).
The most important thing on Walk Rounds is encouraging staff to speak up about potential safety issues. To do this you need a comfortable, nonpunative culture in which staff understand that they will be praised, not vilified, for their openness. For example, we all know that workarounds are usually potentially dangerous yet they are ubiquitous. Workarounds are almost always a sign of an underlying root cause that needs to be fixed so identifying workarounds is important. When you ask staff about workarounds you need to let them know you are looking to fix whatever problem makes them do a workaround and that you are not going to punish them for doing a workaround.
Walk Rounds are also a good way to get a feel for safety culture on each unit. We feel you get a much better understanding of “local (unit)” culture on such rounds than you get on the many formal safety culture assessment tools used by many organizations.
Lastly, how do you measure the impact of your Walk Rounds? That, of course, is difficult because it’s hard to separate out the results from Walk Rounds from all the other patient safety activities your organization is doing. Nevertheless, you should at least be able to look at your issues log and be able to report the percentage of safety issues identified and resolved. You can also elicit feedback from staff on how they perceive such rounds.
Admittedly, the evidence base for Patient Safety Walk Rounds is less robust than many of our other patient safety interventions. Nevertheless, such rounds make a lot of common sense. Just beware of potential downsides of such rounds if they are done poorly and without conviction.
Singer SJ, Tucker AL. The evolving literature on safety WalkRounds: emerging themes and practical messages. BMJ Qual Saf 2014; 23: 789-800
Pronovost PJ, King J, Holzmueller CG, et al. A Web-based Tool for the Comprehensive Unit-based Safety Program (CUSP). Joint Commission Journal on Quality and Patient Safety 2006; 32(3): 119-129
Timmel J, Kent PS, Holzmueller CG, et al. Impact of the Comprehensive Unit-Based Safety Program (CUSP) on Safety Culture in a Surgical Inpatient Unit.
Joint Commission Journal on Quality and Patient Safety 2010; 36(6): 252-260
Pronovost P, Vohr E. Safe Patients, Smart Hospitals: How One Doctor's Checklist Can Help Us Change Health Care from the Inside Out. Hudson Street Press 2010
Lindberg L, Judd K, Snyder J. Developing a Safety Culture with Front-line Staff. Health & Hospital Networks. September 2008
October 14, 2014
Articles on antibiotic misuse have been popping up all over the place recently. Half of all hospital inpatients receive at least one antibiotic (Magill 2014). Antibiotic misuse, of course, contributes to the development of antibiotic resistance and predisposes to opportunistic infections such as fungal infections and those with C. difficile. In addition, antimicrobials are frequently related to adverse drug events.
Antibiotic stewardship programs have evolved to deal with the problem of increasing antibiotic resistance and have also been shown to reduce C. difficile infections, reduce adverse events related to antibiotics, and achieve considerable cost savings. CDC now recommends that all hospitals have antibiotic stewardship programs and there are also Joint Commission standards dealing with antibiotic stewardship.
Excellent resources on antibiotic stewardship are available for free from The Joint Commission, the CDC, and Johns Hopkins Hospital. The CDC core elements document has a nice checklist for you to see if your organization is meeting the core elements of a good antibiotic stewardship program.
Probably the three most widely used strategies for antibiotic stewardship are prior authorization, antibiotic “timeouts” and audit with feedback. Prior authorization means that the antibiotic must be approved by a designated individual, such as an Infectious Disease consultant, before it will be administered. Years ago many hospitals implemented prior authorization for expensive antibiotics so it was really a cost-saving strategy. Now it has become more important as a strategy to reduce unnecessary use of certain drugs as a quality and patient safety issue. While cost savings may no longer be the primary motivation for such programs it remains important to emphasize to hospital administration that there is a positive ROI (return on investment) for antibiotic stewardship programs that justifies provision of adequate resources for such programs.
Antibiotic “timeouts” are used to force a reassessment of antibiotic treatment. They are usually done 48 hours after the initial prescription of antibiotics, a time at which culture and sensitivities should be available to guide further therapy. Often antibiotics are begun empirically for a suspected bacterial infection so it’s always necessary to ask whether such an infection treatable with antibiotics is confirmed and whether any antibiotic or the specific antibiotic, dose, and route are still appropriate.
While almost all guidelines recommend audit and feedback to ordering physicians, such activities done after the fact don’t have nearly the impact that real time interventions do. Nevertheless, it’s very useful to have such reports available at departmental meetings so that constructive discussion and peer pressure can help change behavior when there are “outlier” antibiotic prescribers. (See also below regarding retrospective audit and feedback in the outpatient setting.) But even prospective audit and feedback may be problematic (Mehta 2014). One hospital had a successful antibiotic stewardship program for several years that was based on prior authorization of several antibiotics by Infectious Disease personnel or clinical pharmacists trained in infectious diseases. In mid-2009 they decided to take several antibiotics off the prior authorization requirement and instead did daily audit and feedback for these. The researchers found that use of the latter antibiotics increased after the change, while use of those that still required prior authorization did not change. Overall use of antibiotics also increased after the change. In addition, total hospital length of stay and length of stay after the first dose of antibiotic both increased after the change was made.
We recommend that a clinical pharmacist round with the multidisciplinary team daily. In preparation for rounds the pharmacist can check to see which patients are receiving antibiotics and check the microbiology reports to see if cultures and sensitivities are done. As each patient is discussed, at least 5 questions should be asked if the patient is on antibiotics:
1) Is there an indication for antibiotics? A continued indication?
2) Is the organism grown in the lab sensitive to the antibiotic(s)?
3) Is the antibiotic dose appropriate? (some may need to be adjusted for patient weight, renal function, drug interactions, etc.)
4) Is the route of administration appropriate? (eg. can the patient now be switched to an antibiotic via the oral rather than parenteral route?)
5) Should the antibiotic be discontinued? (what is the recommended duration of therapy?)
One common error is continuation of antibiotics that were meant for prophylaxis. The quality and pay-for-performance metric that requires cessation of surgical prophylactic antibiotics by 24 hours (for most surgeries) probably has had a beneficial effect on reducing inappropriate antibiotic therapy.
Some useful tools may be protocol-based and either written or computerized. One useful tool is the automatic stop order. These should be part of protocols approved by the medical staff and mandate that the antibiotic be discontinued after a specified time interval. The physician would have to reorder the antibiotic if he/she feels further treatment is indicated. Similarly, your medical staff may approve automatic switch protocols in which a switch from parenteral to oral antibiotics may take place once certain criteria are met. Keep in mind that standardized order sets for various conditions may be very important in ensuring correct use of antibiotics but these must be kept up to date so that you do not inadvertently encourage inappropriate use of antibiotics.
Note that we like computerized physician order entry (CPOE) to require an indication for any antibiotic ordered. This helps clarify whether an antibiotic is for prophylaxis or for treatment of an infection. It is also useful to know which type of infection the antibiotic is for (eg. UTI vs. lower respiratory infection, etc.), especially since a patient may have potentially more than one site of infection.
There should be a physician leader responsible for ensuring desirable outcomes of your antibiotic stewardship programs. The CDC core elements include that one individual be responsible for outcomes of antibiotic stewardship programs and note that those that have been most successful have a physician leader. Hospitals often have their head of Infectious Diseases in this role. However, not all hospitals have an ID physician on staff and sometimes another highly visible physician (eg. a hospitalist) may be more appropriate in this role. It’s important to ensure that this physician leader have adequate time (and remuneration, if necessary) to function in this role. The CDC core elements also recommend someone with drug expertise be a co-leader of the antibiotic stewardship program and recommend that a single pharmacy leader be charged with this responsibility. Note that the CDC recommends that the hospital’s Pharmacy and Therapeutics Committee not be the body responsible for operating the antibiotic stewardship program, though it obviously needs to be kept abreast of its activities.
Many organizations have a nurse leading many of their infection control programs. But we’ve also seen others function very well in this role. For example we have seen a laboratory director, with additional training in infection control, nicely integrate the microbiology and IT aspects of infection control with the pharmacy and clinical aspects. Either person can be very valuable in assembling the reports that are needed for your program and overseeing multiple aspects of the program but you will likely get more medical staff buy-in to the antibiotic stewardship program if there is a physician leader.
Having hospital leadership ensure adequate support for antibiotic stewardship programs is much easier when you can demonstrate that such have a positive ROI (return on investment) both in terms of savings on medications, savings from fewer complications and reduced lengths of stay, meeting pay-for-performance measures, and avoiding penalties for unnecessary readmissions. The Joint Commission antibiotic stewardship toolkit provides guidelines for you to develop the business case for antibiotic stewardship customized for your organization or facility.
Education is a key component of all antibiotic stewardship programs. While most educational efforts are aimed toward the medical staff, it is also important that all nursing and pharmacy staff have a thorough understanding of the needs and principles of antibiotic stewardship programs. Our own interactions with physicians regarding antibiotic use have led us to the conclusion that focusing on cost issues will get you nowhere. Similarly, while physicians understand the problem of antibiotic resistance, most do not think their antibiotic decisions in a single case have any substantial impact on overall resistance issues. Therefore, we recommend you focus more on issues like prevention of C. difficile infections and adverse drug reactions. Again, a recurring theme for us is “stories, not statistics”. You can much more easily get staff buy-in when you tell them real-life stories about individual cases and patients than you can by spewing off a host of statistics.
Other hospital staff also have important roles in promoting antibiotic stewardship. For example, your IT staff can help ensure that clinical decision support be available to those who prescribe antibiotics. This would also include easy access to antibiotic prescribing aids and charts with the most up-to-date microbiology antibiotic sensitivity patterns at the facility. IT staff may also work with clinicians to develop computer-generated alerts that might notify a clinician of a drug interaction or alert the clinician to other conditions. For instance, an order for an anti-diarrheal in a patient on antibiotics could prompt for testing for C. difficile. Clinical decision support tools can also alert to the need for dosage adjustment when, for example, renal function is deteriorating.
Antibiotic stewardship programs should be used in healthcare facilities of all types. The benefit of an antibiotic stewardship program in pediatric patients was recently demonstrated (Newland 2014). Those researchers found that no children whose physicians followed the recommendations of the antibiotic stewardship team were readmitted to the hospital (within 30 days) compared to a 3.5% readmission rate in those for whom the physicians did not follow the team’s recommendations. Moreover, length of stay was not longer in those in whom the recommendations were followed.
Antibiotic misuse, of course, is not just a hospital problem. Antibiotics are also often prescribed during outpatient visits. A recent study from China showed found that antibiotics were included in 52.9% of outpatient visit prescription records and, of these, only 39.4% were prescribed properly (Wang 2014). The numbers in China may be inflated because of a perverse incentive to sell antibiotics to help finance the outpatient sites. But we have little doubt that antibiotics are likely overprescribed in US outpatient settings as well.
An outpatient antibiotic stewardship program in a pediatric network (Gerber 2014), consisting of provider education and audit and feedback, reduced prescribing rates for broad-spectrum antibiotics for acute respiratory infections by about 50%. However, once the audit and feedback component was discontinued, prescription of the broad-spectrum antibiotics returned almost to baseline levels.
One very interesting recent study in the US showed that antibiotic prescriptions are more frequent during later hours of primary care sessions (Linder 2014). The researchers looked at antibiotic prescriptions for acute respiratory infections (ARI’s) in primary care clinics that held 4-hour sessions in either the morning or afternoon. They found that prescriptions for “antibiotics sometimes indicated” and “antibiotics never indicated” ARI’s increased throughout both the morning and afternoon sessions. The odds ratios increased with each hour of clinic (compared to the first hour the odds ratios were 1.01, 1.14, and 1.26 respectively for the second, third and fourth hours of clinic.
We are not surprised by the above results. This sort of “fatigue” that may affect decision making is probably quite common. We’ve previously discussed that colonoscopies done later in a session are less likely to be complete and less likely to discover adenomas (see our May 3, 2011 Patient Safety Tip of the Week “It’s All in the Timing”).
Dr. Michael Bell (Bell 2014), commenting on the Chinese study by Wang et al., also mentioned that easy access to antibiotics, including over-the-counter availability of antibiotics, is a problem in global misuse of drugs. We were surprised to hear that antibiotics were available over-the-counter so we did an internet search and found at least one site (InternetDrugNews.com) that described how antibiotics can be obtained without a prescription. They sent investigators, some undercover, to try to obtain antibiotics without a prescription. It turns out your local pet store(!) probably sells many antibiotics intended for fish and these don’t require a prescription. The article also describes how antibiotics may be obtained on the internet and from various other sources without prescriptions. The article goes on to describe why some people would try to get antibiotics these ways and describes the reasons why such practices may be dangerous.
And, of course, we have the old adage “you can’t improve anything that you can’t measure”. So what metrics should you be following? Obviously you want to monitor total antibiotic prescribing in some fashion (DOT, or days of therapy, is a popular measure) but you also want to track trends in antibiotic resistance, trends in length of stay (LOS), adverse drug reactions related to antibiotics, incidence of C. difficile infections, etc. And your CFO will want to see some measures of cost savings (compare to the business case you made for the antibiotic stewardship program).
Antibiotic stewardship program make a lot of sense from both a patient safety and financial perspective. Is your organization using such programs to their fullest capabilities?
Magill SS, Edwards JR, Beldavs ZG, et al. Prevalence of Antimicrobial Use in US Acute Care Hospitals, May-September 2011. JAMA 2014; 312(14): 1438-1446
The Joint Commission. Antimicrobial Stewardship Toolkit.
CDC. Core Elements of Hospital Antibiotic Stewardship Programs.
Johns Hopkins Medicine. JHH Antibiotic Management Guidelines (updated annually).
Mehta JM, Haynes K, Wileyto EP, et al. Comparison of Prior Authorization and Prospective Audit With Feedback for Antimicrobial Stewardship. Infect Control Hosp Epidemiol 2014; 35(9): 1092-1099
Newland JG, Hersh AL, Gerber FS, et al. "Impact of a pediatric antimicrobial stewardship program on length of stay and readmissions" IDWeek 2014; Abstract 1217 as reported by Susman E. Antibiotics Control Cuts Kids' Hospital Readmission. MedPage Today. Oct 9, 2014 | Updated: Oct 10, 2014
Wang J, Wang P, Wang X, et al. Use and Prescription of Antibiotics in Primary Health Care Settings in China. JAMA Intern Med 2014; online first October 6, 2014
Gerber JS, Prasad PA, Fiks AG, et al. Durability of Benefits of an Outpatient Antimicrobial Stewardship Intervention After Discontinuation of Audit and Feedback. JAMA 2014; Published online October 10, 2014
Linder JA, Doctor JN, Friedberg MW, et al. Time of Day and the Decision to Prescribe Antibiotics. JAMA Intern Med 2014; online first October 6, 2014
Bell M. Antibiotic Misuse. A Global Crisis. JAMA Intern Med 2014; online first October 6, 2014
InternetDrugNews.com. Antibiotics Without A Prescription? InternetDrugNews.com
Print “Antibiotic Stewardship”
October 21, 2014
The Fire Department and Your Hospital
Preparation for dealing with fires in hospitals goes well beyond the RACE and PASS acronyms that all hospital staff are familiar with. A recent article on firefighting in hospitals (Stiene 2014) got our attention for its excellent recommendations and also piqued our interest in the need for special attention to certain areas. All hospitals regularly have fire drills and the local fire department responds to all these drills. And, yes, local fire and police departments do participate in joint planning for fires and other disasters with hospital staff.
Stiene discusses life safety codes relating to fires from the perspectives of the National Fire Protection Association (NFPA), CMS, and The Joint Commission. He notes striking progress made in hospital fire safety, noting that from 1980 to 1984 fire departments responded to 7100 hospital fires annually on average (with 5 deaths per year) compared to only 1400 hospital fires and one death per year from 2006 to 2010). Two of the biggest factors for the decrease have been smoking bans and installation (at original construction or by retrofitting) of automatic sprinkler systems.
Stiene discusses how hospitals evacuate patients, visitors and staff that are capable of evacuating safely and also how hospitals manage those patients not capable of evacuating on their own. He discusses the horizontal and vertical evacuation modes (moving patients to an adjacent compartment safe from smoke) and “defend-in-place” strategies for patients that must remain in place. All require responding firefighters to have an intricate understanding of the hospital’s life safety plan, its smoke compartments, sprinkler coverage and ratings, alarm detection and localization systems, medical gas systems, electrical systems and backup generators, HVAC and air handling systems, connections between various buildings, location of various shutdown devices, and many others. They also need a detailed understanding of how disruption of power will impact various areas of the hospital. Many of these resources need to be available in real time at the hospital fire command center but pre-incident planning between the hospital staff and fire department is critical. We’ll add that we often see changes made in hospitals, particularly those that do not require certificates of need or approval of state or local regulatory bodies, that don’t get promptly communicated to local fire departments.
Fire departments also need to understand the roles of the house supervisor and the administrator-on-call, the latter often not being on-site initially when the fire company responds.
Stiene notes that having a predetermined fire command center and communication protocols are very important factors that need to be part of the pre-incident planning between hospitals and fire departments. Such pre-incident planning meetings need not just the hospital fire liaison but also key staff from clinical (medical and nursing) departments and also representatives from safety, security, and engineering departments. Because of issues we’ll note later we also recommend the importance of including representatives from the lab, pharmacy and radiology. Stiene notes it is important for the fire department to train all its firefighters on these plans. He notes that may need to include mutual-aid fire companies as well. We’ll comment that it must be difficult for smaller and volunteer fire companies to always ensure their new members are fully up-to-date on the plans. The latter is a bit like hospitals ensuring that any new and/or temporary nursing staff are fully up-to-date on the most critical protocols and related issues.
There are a couple other recent resources on hospital fires. The Pan American Health Organization and WHO have published an excellent fire prevention and evacuation guide “Hospitals Don’t Burn!” (Pan American Health Organization 2014). And Gregory Bierster from the FDNY (Bierster 2011) published a study on hospital fires in the New York City area.
Bierster had some good lessons learned from the NYC hospital fires. It is important to keep track of patients not just during a fire but also being prepared before a fire. He notes that many hospitals can’t easily tell the fire department which patients are ambulatory and which are not. Obviously, keeping an up-to-date roster of all patients’ ambulation capabilities would be important. He also found that evacuation devices for those patient who are not ambulatory were often not readily available or their locations were not readily apparent. He also recommends wearing of vest by critical hospital personnel so the incident command can easily recognize them.
When a fire occurs in a hospital, certain staff members are responsible for assisting with the evacuation, closing the doors, searching, and shutting down medical gases. Bierster provides a survey of staff assignments for these functions.
Bierster notes the vaious types of hospital evacuation that have taken place in NYC hospitals: vertical (5%), horizontal (12%), and sheltered in place (17%) and that nationally, 31% of hospitals had a situation in which patients were evacuated horizontally, 21% had patients moved to another floor, had 42% had a situation where patients had to be partially evacuated outside the building.
The Pan American Health Organization and WHO (Pan American Health Organization 2014) emphasize that the initial steps to protect hospitals against fires are prevention and suppression and that complete evacuation of patients should be avoided unless absolutely necessary. They note that evacuation maps should be posted at the hospital’s main access points to clearly identify egress routes and that egress routes and exits should be clearly identified using internationally accepted identifying signs. They provide good examples of a Hospital Incident Command System Structure and tables with how to prioritize patients for evacuation.
They stress that there should be designated “patient tracking” staff who are responsible for tracking and reporting on the location of patients throughout the evacuation process, including:
They also discuss having an assembly point/holding area, which is a place or set of places where patient care units gather (outside the main clinical buildings of the hospital) to receive basic care and await transfer or reentry back into the hospital. Generally, only essential care resources are available in these areas.
The Pan American guide also has several useful tools, including:
But there are several areas only briefly mentioned by these 3 resources and several other scenarios that merit special discussion and drills with your local fire (and police) departments.
The MRI Suite
First and foremost is the MRI suite. And keep in mind that the MRI suite may also be: 1) owned and operated under a third party arrangement (eg. group of physicians, university, etc.) even though it is physically based in your hospital and 2) sited in a trailer or truck outside the hospital per se but on the hospital grounds.
There are some excellent resources available on the issue of fires in the MRI suite, including some from MRI safety guru Tobias Gilk (Gilk 2012). Gilk describes two fires affecting MRI units. One, in England, resulted in disruption of the circuits that would allow activation of the remote “quench” buttons that would allow the unit to be shut off. Hence the fire raged for days and the MRI active magnetic field persisted for 10 days amidst the rubble of an otherwise totally destroyed facility. The second, in Pennsylvania, had a much more successful outcome when the MRI staff evacuated the patient, extinguished the fire with an “MR Conditional” fire extinguisher before the fire department arrived, and successfully quenched the magnet. Gilk discusses multiple issues related to the construction of the MRI units, availability of appropriate fire extinguishing gear and training of staff on how to use the gear. But he also discusses the need for fire emergency policies and procedures specific to MRI and the need to do preplanning for such events with hospital staff and the fire departments who will respond.
Probably the biggest issue for firefighters responding to a fire (or other incident) in an MRI suite is an understanding that ferromagnetic materials may turn into projectiles or missiles on exposure to the intense magnetic field of the MRI. There are a number of tools and equipment used by firefighters and law enforcement personnel that may become projectiles in the MRI suite (SUNY Stony Brook 2011). Firefighters may carry fire extinguishers, self-breathing apparatus and oxygen tanks, axes, pics and “pike” poles that may become projectiles in the MRI unit. In addition the fire hose nozzles and hose couplings may become projectiles. Law enforcement personnel may carry guns, knives, handcuffs, flashlights, and clipboards that have similar potential to become deadly missiles. Gill, in commenting elsewhere on the Pennsylvania MRI fire, noted a case where a firefighter lost his axe to the pull of an MRI when he was ventilating the roof of a building (Darragh 2011).
An article on the fire department response to MRI emergencies (Concordnc.gov) discusses both the ferromagnetic/projectile risk and the hazards of the “quench” (release of the cryogenic gases when the MRI is shut down). It discusses many of the construction and equipment issues, including the need for a non-metallic fire extinguisher. It also describes the importance of signage warning about metallic objects and avoiding entry to the critical areas (see our prior columns on MRI safety listed at the end of today’s column). The article goes on to discuss how to fight large fires from a safe distance and what to do after the fire is extinguished, including considerations for the fire investigators. An article for a continuing education course for firefighters provides a comprehensive review of MRI-related firefighting issues and a list of questions to ask during a pre-incident planning session (Jones 2014). Good examples of MRI Safety Policies with recommendations about fires are provided below (University of Louisville, SUNY Stony Brook 2011). The SUNY Stony Brook slides nicely describe multiple other facets of MRI safety as well.
In our February 1, 2011 Patient Safety Tip of the Week “MRI Safety Audit” we mentioned that an extensive audit found fire drills were conducted in only 64% of MRI facilities in the VA system (VA 2011). Fire drills clearly need to take place in MRI facilities, whether in-hospital or stand-alone. Moreover, pre-incident planning for fires (and other emergencies) needs to take place between your organizations and your local fire (and law enforcement) departments.
Behavioral health is another major area with special concern. Also many fires occur in behavioral health units. Check just about any such unit and you will find “contraband” smuggled in by patients and/or their friends or family. Some of the more popular “contraband” items are cigarettes and matches or lighters.
And there may be patients on behavioral health units that are potentially violent. Many of the fire and police tools and equipment we mentioned under the MRI section are also potentially dangerous on behavioral health units. We have seen firefighers’ axes laid down on the floors and fire extinguishers (which could also be potentially used as weapons) left unattended during response to fires on such units.
We’ve seen cases where patients on behavioral health services have started fires with the intention of absconding during the subsequent evacuation. Also, in our December 2010 What’s New in the Patient Safety World column “Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units” we mentioned a case where locked doors automatically opened when the fire alarm went off and a patient then got access to a rooftop for a suicide jump.
Another consideration is the patient who, because of their mental health issues, refuses to leave the unit. Staff has a priority to get patients out of harm’s way. They must attend to getting as many patients away from the danger as quickly as possible. This is where head counts are extremely important and where the staff assigned with tracking patients must be able to tell the responding firefighters that someone is still on the unit.
Firefighters are probably much more aware of hazardous materials and better trained to deal with them than your average healthcare worker. Bierster noted that the hazardous material which caused the fire most frequently was flammable gas (23%), combustible gas (15%), chemical leak or spill (15%), flammable liquid (8%), bio hazard (8%) or other types of chemicals not listed on the survey (30%) (Bierster 2011). But keep in mind that hazardous materials may be encountered that were not involved in causing the fire. One may encounter hazardous chemotherapy agents if a fire involves pharmacy or hazardous radiation if a fire involves a radiology or nuclear medicine suite.
The recent Ebola “crisis” also raises special concerns regarding response to fires when hazardous materials or transmissible diseases are present. As above firefighters are probably much more aware of hazardous materials and are better trained to deal with them than your average healthcare worker. But it still takes a coordinated effort by both to safely deal with a fire when a patient in contact isolation is located in an area where there is a fire. How many hospitals that have such units have a similar place on an adjacent unit to which patients would be evacuated in the event of a fire? Your pre-incident planning should take such scenarios into account.
Lastly, we’ve previously discussed some scenarios when fire alarms have or have potentially occurred in conjunction with other events, hence our term “dual scenarios”. In the section above on behavioral health we noted how fires or fire alarms on such units have been associated with patients absconding or committing suicide.
Another possible dual scenario has to do with infant abductions. In our September 4, 2012 Patient Safety Tip of the Week “More Infant Abductions” we noted that the usually locked doors on the maternity unit may automatically unlock during a fire alert and that potential abductors may be aware of that. We suggested you might even consider doing a “Code Pink” (abduction) drill immediately following a fire alert drill.
Clearly, there are important issues to consider when you meet with your local fire department to pre-plan for potential fires and other emergency situations. Also, you should meet with them to debrief after every event they respond to, whether it is a real fire or not.
Some of our prior columns on patient safety issues related to MRI:
Steine M. Firefighting in Hospitals. Fireengineering.com 10/7/2014
Bierster G (Fire Department, City of New York, New York). Improving Fire and Life Safety in Hospitals. United States Fire Administration. 2011.
Hospitals Don’t Burn! Pan American Health Organization, 2014.
Gilk T. MRI Fire Safety. The Radiant 2012; Mar/Apr 2012
SUNY Stony Brook. MRI Safety, Policies and Procedures. SUNY Stony Brook. Social Cognitive, and Affective Neuroscience (SCAN) Center. Updated: September 2011
Darragh T. MRI fire underscores need for education and oversight. St. Luke's incident was handled deftly, but experts say such events can be disastrous. Morning Call (Lehigh Valley, PA) December 30, 2011
ConcordNC.gov. Fire Department Response to Emergencies Involving Magnetic
Resonance Imaging (MRI) . Magnetic fields can severely hamper firefighter efforts
Jones C. Magnetic Resonance Imaging Safety for Firefighters. Fireengineering.com 2014; 6/16/2014
University of Louisville. MRI/NMR Safety.
Department of Veterans Affairs Office of Inspector General. Evaluation of Magnetic Resonance Imaging Safety in Veterans Health Administration Facilities. Report No. 09-01038-77. January 26, 2011
October 28, 2014
RF Systems for Retained Surgical Items
In our multiple prior columns (see list at the end of today’s column) on retained surgical items (RSI’s) we’ve talked about the various human factors that come into play and some potential technological solutions. The manual surgical count is helpful at identifying potential retained items but is a system prone to errors. Using radiographs to detect retained surgical items can be costly and also prone to error. So just about everyone agrees that technological solutions are needed.
Two logical technologies showing promise are those used in grocery stores or in organizations where inventory may be mobile and in need of tracking. We, of course, are referring to barcode technologies and radiofrequency technologies. In the barcoding system, a scanner reads a barcode from each sponge as it is introduced to the sterile field and then again as it is removed and disposed of. This primarily helps with the counting process (it cannot locate sponges or other items that are still inside the patient). The radiofrequency (RF) technologies detect sponges with an RF chip sewn in (with the newer ones having chips with unique identification codes sewn in). These have the advantage that scanning with a “wand” or a “mat” can help locate missing items, even those still inside the patient. Also, in our November 5, 2013 Patient Safety Tip of the Week “Joint Commission Sentinel Event Alert: Unintended Retained Foreign Objects” we discussed that a group applying engineering problem-solving methodology to address the issue (Anderson and Watts 2013) concluded that the only way to eliminate the dangers is to alter the sponge itself! Hence their solution was to pursue development of a bioresorbable surgical sponge.
But while we’re waiting for those bioresorbable sponges we need to look at the existing technologies. A new study (Williams 2014) reports a greater reduction of rates of retained surgical sponges at hospitals using RF technology compared to those not using it. Williams and colleagues analyzed data from a large university consortium database that had information on incorrect counts and retained surgical items. They found that five organizations that implemented RF technology collectively demonstrated a 93% reduction in the rate of reported retained surgical sponges, compared to a 77% reduction at 5 comparable organizations that do not use RF technology.
They also showed that average OR time over a 2-year period was, on average, 16 minutes shorter in hospitals that had implemented RF technology.
They went on to do a cost analysis and estimate the cost savings (based on costs of intraoperative x-rays and extra OR time involved) and costs avoided (projected medical costs and litigation costs). They estimated that using RF technology to prevent retained surgical sponges could result in almost $600,000 savings annually compared to the cost of the RF technology at $191,000.
So their conclusion is that RF technology was effective at reducing retained surgical sponges and was very cost-effective.
But how robust are those conclusions? There may be certain biases and methodological flaws that lead to questioning those conclusions.
The rate of reported retained surgical sponges in the pre-intervention period was higher at the 5 organizations that implemented RF technology. They, thus, had an opportunity to demonstrate a greater percent improvement even if they simply “regressed to the mean”. The authors do not note why the 5 organizations that implemented RF technology did so. Was it because they had higher rates of RSS’s to start with?
The authors do state that their analysis “demonstrates that heightened national efforts aimed at preventing RSI’s have had a positive effect on reducing the number of retained sponges”. Yet in another section because of more quarter-to-quarter variability in the RSS rates at those hospitals not using RF technology they state “this variability indicates the results will not likely be sustained”.
The disparity in OR time between users and non-users of RF technology cannot be conclusively attributed to the RF technology since they did not have such OR time data prior to the implementation and did not case mix adjust. However, they cited work we’ve previously discussed by Greenberg et al. (Greenberg 2008) that showed the average time to resolve count discrepancies is 13 minutes and an unpublished study that showed a time reduction of 23 minutes. So that the 16 minute difference in the Williams study might be attributable to the RF technology is very feasible.
Also, cost savings analyses such as these, even when “conservative”, probably overestimate actual savings. For example, the statistic “one minute of OR time costs $62” came from the literature and may not be applicable to your OR. That number was likely based on hospital charges rather than costs. So if you have to take an extra 16 minutes to reconcile a count and you pay your staff a salary and don’t have to pay overtime and you don’t have another case ready to fill that 16 minutes, your actual costs are very low (you pay for continued anesthesia and your anesthesiologist might bill for another “unit”). And the cost of getting an x-ray is not $286 since your x-ray technician is likely salaried and the incremental cost (variable cost) of an x-ray is really only a few dollars at most. So be wary when you see an analysis that suggests you’re going to have a net benefit of over $400,000!
But there are other excellent contributions from the study by Williams and colleagues. They did both an aggregate analysis of either surgical count issues or RSI events in their database and a more detailed review of narrative descriptions in a subset of records within that database. Interestingly, the most commonly retained surgical items were instrument fragments (eg. drill bits, broken or missing pieces of instruments), accounting for 58% of RSI’s. Sponges were the second most frequent retained surgical item, with sponges and towels accounting for 32% of RSI’s. Note that needles were the items most frequently involved in incorrect counts but not in cases of actual retained items (presumably because most of these were picked up by radiographs done before the wound was closed).
The most common issue they identified was that the surgeon continued to close despite noting the counts were incorrect. Subsequent imaging studies led to identification of the RSI in those cases, leading to reopening the patient either before or after the patient left the OR.
Factors contributing to the events were similar to those in the literature, including emergency procedures, trauma cases, unplanned changes in procedure, multiple procedures, staffing changes during cases, lengthy procedures, communication failures, and failure to follow protocols. They also noted use of large numbers of sponges as a contributing factor. In addition, sponges that were cut or sponges that were left in a bucket or room from a prior case contributed in some cases, as did “inappropriate” use of sponges for laboratory specimen handling or dressings.
Note that a recent meta-analysis of studies on factors contributing to RSI’s (Moffatt-Bruce 2014) demonstrated that seven risk factors are significantly associated with increased RSI risk:
Interestingly, changes in nursing staff, emergency surgery, body-mass index, and operation "afterhours" were not significantly associated with increased RSI risk. The researchers proposed a risk stratification system based on these variables.
The problem of retained surgical items has persisted. We strongly back investigation of technological solutions to the problem. But we need to be very careful that we do not let biases and other methodological flaws lead us to premature conclusions about any of the technological solutions. Unfortunately, we don’t yet know what the best technological solution is to the retained surgical item problem. None is yet perfect and each has its own set of problems. So for the time being you are stuck with well-done manual counts and perhaps using one of the other technologies as an adjunct. But you can certainly expect refinements to these technologies going forward that may improve our ability to better prevent RSI’s.
Our prior columns on retained surgical items/retained foreign objects (RSI’s/RFO’s):
Anderson DE, Watts BV. Application of an Engineering Problem-Solving Methodology to Address Persistent Problems in Patient Safety: A Case Study on Retained Surgical Sponges After Surgery. Journal of Patient Safety 2013; 9(3): 134–139
Williams TL, Tung DK, Steelman VM, et al. Retained Surgical Sponges: Findings from Incident Reports and a Cost-Benefit Analysis of Radiofrequency Technology. Journal of the American College of Surgeons 2014; 219(3): 354-364
Greenberg CC, Regenbogen SE, Lipsitz SR, et al. The Frequency and Significance of Discrepancies in the Surgical Count. Ann Surg 2008; 248(2): 337-341
Moffatt-Bruce SD, Cook CH, Steinberg SM, Stawicki SP. Risk factors for retained surgical items: a meta-analysis and proposed risk stratification system. J Surg Res 2014; 190(2): 429-36
November 4, 2014
Progress on Fall Prevention
Identification of patients at risk for falls and fall-related injuries is important not only for hospital inpatients but also for patients in multiple other settings, including long-term care and community-based settings. For inpatients we look at a list of risk factors for falls to identify which patients should have fall precautions instituted. But in our August 4, 2009 Patient Safety Tip of the Week “Faulty Fall Risk Assessments?” we cautioned that simply labeling a patient as low-, moderate-, or high-risk for falls often fails to match them to specific interventions needed to prevent falls for that individual patient.
Many of the risk factors for falls are not modifiable. Therefore, a focus on potentially modifiable risk factors is needed. Wouldn’t it be great if we had a tool that easily identified such patients at risk and identified some specifically modifiable risk factors? Well, researchers in Boston have come up with such a system that stratifies risk for hospital admissions for fall-related injury based upon data readily available from the electronic medical record (Castro 2014). Moreover, since the tool weighs heavily the adverse effect burden of medications, it points to modification of a patient’s medication regimen as a potential intervention to reduce the risk of fall-related injuries.
Castro and colleagues looked at patients aged 40 and older who were admitted to 2 academic hospitals (that also serve as community hospitals) for reasons other than fall-related injuries. They collected variables readily available in the EMR at discharge, including the reconciled medication list, and looked for subsequent emergency department visits or hospital admissions over the next two years. After derivation of the risk stratification tool at one hospital they validated it at the second hospital. The unique feature of their tool is their way of estimating the burden of medications on the fall risk. Not only is the number of medications important but they also used the frequencies of adverse effects (from the literature) of medications, taking into account that drugs may have more than one risk factor for falls (eg. sedation, dizziness, gait instability, etc.). They make the tool available online at http://clearer.mghcedd.org/.
The authors suggest that using the tool to identify the highest risk group could lead to fall prevention interventions being applied in the most resource-effective manner. And, since the medication adverse effect burden is one of the most modifiable factors, re-examination and modification of a patient’s medications is a logical intervention.
We like the concept here and expect that further evaluation of the tool in multiple populations and settings will lead to more widespread adoption of the tool.
There has also been a renewed interest in identification of fall risk for patients presenting to the emergency department. Over a decade ago the PROFET study (Close 1999) showed that for community-dwelling patients aged 65 years and older who presented to an emergency department with a fall a detailed medical and occupational-therapy assessment with referral to relevant services resulted in a marked reduction of falls and recurrent falls. A new systematic review looked at risk stratification tools for geriatric patients presenting to the ED with falls (Carpenter 2014). The authors noted a paucity of validated screening tools for identifying fall risk in ED patients. An Australian study on patients 70 years and older presenting to the ED with a fall or a history of 2+ falls in the past year showed that a simple 2-question screening tool predicted subsequent falls as well as that used in the PROFET study (Tiedemann 2013). The 2 screening items were: (1) 2+ falls in the past year and (2) taking 6+ medications. On the other hand, Carpenter et al. (Carpenter 2009) looked at fall risk in elderly patients presenting to the ED with conditions other than falls. They identified 4 risk factors independently associated with future falls: non-healing foot ulcers, self-reported depression, falls in the preceding year, and inability to cut one’s own toenails (a measure of self-sufficiency or functional ability). The risk of falling was directly related to the number of these risk factors present. But in the meta-analysis by Carpenter et al. (Carpenter 2014) neither tool accurately identified increased fall risk, though the Carpenter tool accurately identified those geriatric patients at low risk for falls.
It would be most interesting to see how well the tool developed by Castro above might perform on ED patients. The same variables present on inpatient discharges should be available for ED patients and if good medication reconciliation is done of the ED patients one might expect the Castro tool to work well.
While in theory we should be most successful by implementing risk reduction strategies in those patients we identify as being at highest risk for falls, sometimes risk reduction strategies applied across the board may also be successful. A recent study from New Zealand has demonstrated that relatively low-cost home modifications and repairs can lead to a substantial reduction in the rate of injuries related to falls (Keall 2014). They randomly assigned households for home modifications to be done immediately or delayed for 3 years. They found a 26% reduction in the rate of injuries caused by falls at home per year in the group receiving the home modifications compared to those waiting for them. Injuries specific to the home-modification program were cut 39% per year exposed. The modifications were all considered to be relatively low cost and consisted of handrails for outside steps and internal stairs, bathroom grab rails, outside lighting, edging for outside steps and slip-resistant surfacing for outside areas such as decks and porches.
Particularly as we embark more on population-based management, fall reduction strategies need to be considered not just during inpatient hospitalizations but each time the patient interacts with the healthcare system.
Some of our prior columns related to falls:
Castro VM, McCoy TH, Cagan A, et al. Stratification of risk for hospital admissions for injury related to fall: cohort study. BMJ 2014; 349: g5863 (Published 24 October 2014)
Clearer: Estimate adverse effect burden of a list of medications
Close J, Ellis M, Hooper R, et al. Prevention of falls in the elderly trial (PROFET): a randomised controlled trial. The Lancet 1999; 353: 93-97
Carpenter CR, Avidan MS, Wildes T, et al. Predicting Geriatric Falls Following an Episode of Emergency Department Care: A Systematic Review. Acad Emerg Med 2014; 21(10): 1069–1082
Carpenter CR, Scheatzle MD, D’Antonio JA, et al. Identification of Fall Risk Factors in Older Adult Emergency Department Patients. Acad Emerg Med 2009; 16: 211–219
Tiedemann A, Sherrington C, Orr T, et al. Identifying older people at high risk of future falls: development and validation of a screening tool for use in emergency departments.
Emerg Med J 2013; 30: 918-92
Keall MD, Pierse N, Howden-Chapman P, et al. Home modifications to reduce injuries from falls in the Home Injury Prevention Intervention (HIPI) study: a cluster-randomised controlled trial. The Lancet 2014; Early Online Publication 23 September 2014
Print “Progress on Fall Prevention”
November 11, 2014
Early Detection of Clinical Deterioration
In our July 15, 2014 Patient Safety Tip of the Week “Barriers to Success of Early Warning Systems” we again lamented the fact that early warning systems (EWS) to detect clinical deterioration of patients earlier have yet largely failed to live up to their promise. While the logic behind such scoring systems seems well-founded there has been a paucity of high-level evidence that such systems lead to substantial improvement in patient outcomes. Because of that and other factors, hospitals in the US have been very reluctant to adopt early warning scores into routine practice even as hospitals in the UK have been mandated to adopt such systems.
In that column we discussed an excellent study in the nursing literature (Watson 2014) that provided great insight into the barriers that impact implementation of an early warning system. Some of those barriers included:
1) Delays in charting vital signs
2) Poor consistency between charted vital signs and those used in the early warning systems (EWS)
3) Multi-tasking by RN’s
4) Recording vital signs first on paper, later entering into the computer
5) Lack of computer availability or functionality
6) Excess log-on times
7) Preference for not charting in front of patient/family
8) Lack of incorporating the RN’s impression of the patient status into the EWS
9) General perception by RN’s that the EWS was no better at predicting deterioration than their own clinical impression
Watson and colleagues suggested changes to the physical environment and improved technology interfaces to support real-time data entry as ways to improve usefulness of the EWS:
1) Bedside computer access or use of smartphones or tablets for documentation
2) Have EMR’s automatically populate VS into the early warning score tool
3) Re-examination of RN and non-RN tasks, perhaps returning VS assessment to RN’s so that data collection and documentation would be integrated
4) Add RN concerns or family concerns to the criteria for the score
Now a new study that included many of those recommended practices into an EWS implementation has documented substantial improvement in mortality (Schmidt 2014). They implemented at two general hospitals in England an electronic physiological surveillance system (EPSS) which uses wireless handheld computing devices to replace a paper-based vital sign charting and clinical escalation system. After implementation of the system crude mortality for 56 diagnostic groups fell from 7.75% to 6.42% in one hospital and from 7.57% to 6.15% at the second hospital. They conclude that using technology specifically designed to improve the accuracy, reliability and availability of patients’ vital signs and early warning scores allows early recognition of and response to patient deterioration, resulting in improved mortality rates
In our February 22, 2011 Patient Safety Tip of the Week “Rethinking Alarms” we highlighted a paper by Lynn and Curry (Lynn 2011) that described 3 patterns of unexpected in-hospital deaths and discussed the problems with threshold-based alarms (almost all currently used alarm systems use threshold-based principles) in detecting early deterioration. Indeed, they posit that threshold-based alarms themselves often cause us to miss signs of early deterioration and make a case for implementation of “smart” alarms that integrate clinical data from multiple sources. The core concept of early warning systems, of course, is that using multiple factors should facilitate identification of clinical deterioration rather than just using a single factor.
In a very thoughtful commentary on the Schmidt study, David Bates and Eyal Zimlichman (Bates 2014) note the confluence of four major trends that should help overcome the barriers noted above. They note that the near-universal use of electronic medical records, better physiological sensors, background analytics, and mobile technology should facilitate earlier detection of clinical deterioration. They note that the Schmidt study still relied on intermittent vital sign measurement rather than using more continuous physiological measurements. So the potential to further improve this system is even greater. They do, however, note that the danger of alert fatigue might raise its ugly head and recommend caution and the need to address the false positive issue. They also acknowledge the importance of recognizing sociotechnical factors that might undermine such systems.
Hospitals have more and more adopted use of “middleware” and alerts delivered via mobile technologies to direct conditions needing attention to the healthcare workers who should provide that attention. That obviously is the wave of the future. It minimizes the “noise” of alerts and alarms going to everybody and gets them to the staff accountable for responses. But even then issues may arise. In our February 4, 2014 Patient Safety Tip of the Week “But What If the Battery Runs Low?” we noted a scenario where a patient event triggers an alarm that is sent to the primary nurse expected to respond but the battery in her cell phone has failed and she never receives the alert. Fortunately, the escalation procedure built into your system sends the alert to a secondary nurse who responds to the patient and no harm comes to the patient. Technological advances solve multiple problems but may introduce new potential problems as well.
In a related issue, early warning systems (EWS), of course, are intimately tied to rapid response teams (RRT’s) and rapid response systems (RRS’s). Like the evidence base for EWS, the evidence base for the success of RRT’s and RRS’s in improving patient outcomes has been mixed at best. The Medical Journal of Australia has just indicated it will be doing a series of articles exploring how RRS’s have changed approaches to patient safety, influenced end-of-life care, and the changing nature of cardiopulmonary arrest teams (Hillman 2014). One issue that has always popped up regarding both RRT’s and cardiopulmonary arrest teams is whether adverse events occur in other locations when team members have to abandon those locations to respond to the emergencies elsewhere. A new study answers that question (Concord MET Study 2014). The bad news is that disruptions of normal care routines and inconvenience to staff do occur in such situations. The good news is that it is very rare for adverse events or patient harm to come about because of those events.
Hopefully the new work by Schmidt and colleagues will rekindle interest in both early warning systems (EWS) and rapid response systems (RRS). As we have mentioned in several of our own columns on rapid response teams, the problem is not with the response teams. Rather it is with our poor recognition of early clinical deterioration.
Some of our other columns on MEWS or recognition of clinical deterioration:
Our other columns on rapid response teams:
Watson A, Skipper C, Steury R, et al. Inpatient Nursing Care and Early Warning Scores: A Workflow Mismatch. J Nurs Care Qual 2014; 29(3): 215-222
Schmidt PE, Meredith P, Prytherch DR, et al. Impact of introducing an electronic physiological surveillance system on hospital mortality. BMJ Qual Saf 2014; Published Online First: 23 September 2014
Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)
Bates DW, Zimlichman E. Finding patients before they crash: the next major opportunity to improve patient safety. BMJ Qual Saf 2014; Published Online First: 23 September 201
Hillman KM, Chen J, Jones D. Rapid response systems. Med J Aust 2014; 201 (9): 519-521
The Concord Medical Emergency Team (MET) Incidents Study Investigators. Incidents resulting from staff leaving normal duties to attend medical emergency team calls. Med J Australia 2014; 201: 528-531
November 18, 2014
Handwashing Fades at End of Shift
?Smartwatch to the Rescue
We’ve done a lot of columns on procedures done less well at the end of the day or end of the shift. Now a new study shows that compliance with handwashing also fades late in the day or toward the end of a shift. Dai and colleagues (Dai 2014) monitored handwashing by using RFID technology to determine how often and how soon healthcare workers washed their hands after entering or leaving patient rooms. Analyzing data over a 3-year period, they found that handwashing rates dropped 8.7% from the beginning to the end of a 12-hour shift. The decline was also magnified by increased work intensity and increased as individuals accumulated more total work hours the preceding week.
So are there solutions to the handwashing problem? Intermountain Healthcare may have a technological solution to this problem: the smartwatch (Terry 2014). The watch has a color-based alarm that triggers as the healthcare worker changes rooms. If the worker moves to another room it changes from green to either red or yellow to alert the worker he/she needs to wash his/her hands. Use of the watch has been associated with a reduction in infections. Commentaries from representatives of The Advisory Board and the Institute for Healthcare Improvement note that there are multiple other technological devices doing similar alerts but that there still is a need for accountability. The smartwatch and other technologies also send data back to managers so not only are there real-time reminders to wash hands but managers and medical directors can use the aggregate data for discussion with each individual healthcare worker.
Poor performance later in the day has now been noted for many procedures. In October 2014 we noted problems with laparoscopic cholecystectomies done after hours (“What Time of Day Do You Want Your Surgery?”) and in September 2009 we noted many orthopedic procedures that were problematic after-hours (September 2009 “After-Hours Surgery – Is There a Downside?”). In an upcoming column (“Another Procedure to Avoid Late in the Day or on Weekends”) we note that implantable cardioverter-defibrillator (ICD) recipients implanted in the afternoon/evening and on weekends or holidays more often experienced adverse events. We’ve also previously noted that the rate of incomplete colonoscopies increases late in the day and fewer adeomas are detected with colonoscopies later in the day (see our May 3, 2011 Patient Safety Tip of the Week “It’s All in the Timing”). And in our July 31, 2012 Patient Safety Tip of the Week “Surgical Case Duration and Miscommunications” we noted in a study of simulated surgery (Feuerbacher 2012) that residents made more errors when distracted or interrupted but all the errors occurred after 1 PM. A similar phenomenon has been reported in radiology. One study (Krupinski 2010) showed a significant reduction in diagnostic accuracy of radiologists after a day of clinical reading (average 8 hours), as measured by reduced ability to detect fractures.
So should it really come as a surprise to you that handwashing rates fall off later in the shift?
Is it fatigue that is responsible for deterioration in performance later in the day? That’s the most obvious factor. Fatigue clearly impairs cognitive processes and may lead to errors (see all our previous columns on the impact of fatigue listed at the end of today’s column). But there are other issues that might be involved. In fact, in the study by Feuerbacher (Feuerbacher 2012) fatigue was measured by several parameters and did not appear to be the primary issue.
Trying to get everything done in a condensed time period is probably one of the biggest contributing factors. When tasks are compressed into a shortened time period we have to prioritize them. While we like to think we always prioritize the most important ones first, that’s not always the case. In our November 26, 2013 Patient Safety Tip of the Week “Missed Care Opportunities” we noted that tasks which have the most immediate consequences tend to get top priority and ones that have delayed consequences are often deferred or omitted. Handwashing is an activity in which the adverse consequences (infection, etc.) are typically delayed so it’s not surprising it may get lower priorities.
Think about yourself near the end of a day or shift at work. You may be quite alert and not fatigued but lots of other things begin to pop into your consciousness and compete with your tasks at hand. You may be thinking about all the things you still need to do today before you leave. Or getting ready for tomorrow morning’s meeting. Or what you are going to do once you get home tonight. Or packing for your weekend trip.
Hunger also can be distracting. Watch your audience the next time you give an 11AM lecture!
And though it’s unlikely to contribute to the handwashing issue, monotony may contribute to some of the late-in-the-day or end-of-shift errors. In our May 3, 2011 Patient Safety Tip of the Week “It’s All in the Timing” we noted that fewer abnormalities are found by pathologists or cytology techs looking at slides for long periods (hence the interest in automated procedures to screen specimens for abnormalities). Nurses or technicians monitoring telemetry screens are also less likely to detect abnormalities when watching monitors for long periods. Errors related to monotony have been seen in other industries such as trucking, banking, inspecting goods, measuring parts, lifeguard surveillance, railway transportation, etc.
So what are the take-home lessons from all this? First, there is obvious utility in looking at various outcome measures not just in the aggregate but also by time of day (and maybe day of the week as well). Developing flexible scheduling for surgeries and procedures may reduce the late-in-the-day add-on cases. Limiting the workload in some circumstances may make sense. The colonoscopy issue was addressed by imposing a cap of 3-hours per session for individual colonoscopists. Breaking up routines can address the issue of monotony in a whole variety of processes.
Unfortunately, none of these really help the handwashing issue. Maybe that smartwatch really is the one thing that will make me take 15 seconds to wash my hands. Uh-oh! That smart sink the hospital installed just let me know that 15 seconds is not long enough for handwashing!
Some of our previous columns on the “weekend” and “after hours” effects:
Some of our other columns on the role of fatigue in Patient Safety:
Dai H, Milkman KL, Hoffman DA, Staats, BR. The Impact of Time at Work and Time Off From Work on Rule Compliance: The Case of Hand Hygiene in Health Care. Journal of Applied Psychology 2014; Published online Nov. 3, 2014
Terry K. New Smart Watch May Improve Hand Hygiene in Hospitals. Medscape 2014; Nov 10, 2014
Feuerbacher RL, Funk KH, Spight DH, et al. Realistic Distractions and Interruptions That Impair Simulated Surgical Performance by Novice Surgeons. Arch Surg 2012; 147(11): 1026-1030 published online first July 2012
Krupinski EA, Berbaum KS, Caldwell RT, et al. Long Radiology Workdays Reduce Detection and Accommodation Accuracy. Journal of the American College of Radiology 2010; 7(9): 698-704
November 25, 2014
Misdiagnosis Due to Lab Error
We’ve done lots of columns on serious test results falling through the cracks and leading to delays in diagnosis. Sometimes, however, patients may be given an incorrect diagnosis based on specimen mixups or other issues related to lab specimens.
A recent case in Ontario, Canada illustrates the latter (Carville 2014a). A 46 y.o. man with a chronic cough had a CT scan that suggested sarcoidosis. However, he underwent lung biopsy that was interpreted as showing Stage 4 lung cancer. Chemotherapy was recommended and he was under the impression he had less than 12 months to live, a prognosis tearfully relayed to his wife and young children. But the patient did not feel like he was dying and sought further opinions. He declined chemotherapy while undergoing those outside evaluations. Several outside consultants felt he did not have cancer and ultimately a second biopsy showed no sign of cancer and he was diagnosed as having sarcoidosis.
The hospital where the original biopsy was done subsequently reanalyzed the specimen and concluded it was cross-contaminated with that of another patient who did have advanced lung cancer (Carville 2014b). DNA analysis apparently showed three specimen fragments on the slide, 2 from the patient and one from the other patient (whose specimen apparently was processed on the same day).
You’ll recall from our prior columns that 2 patients are typically impacted by specimen mixups (eg. one may be erroneously given a cancer diagnosis and the other erroneously told he/she does not have cancer). However, in the current case the other patient had been given a correct diagnosis and was not impacted by the lab issue.
A physician executive was quoted as saying this was a “one in a million kind of occurrence” (Carville 2014b). But is that really true? In our January 22, 2013 Patient Safety Tip of the Week “You Don’t Know What You Don’t Know” we discussed occult specimen provenance complications (SPC’s). It’s a scary concept because it is occult, i.e. the error is not recognized because it is not identified by standard laboratory procedures. There are actually 2 types of such errors:
So I could have a prostate biopsy that either gets mixed up with someone else’s biopsy or that gets contaminated by tissue from another patient and my specimen gets reported as showing cancer. I might end up getting a treatment for prostate cancer and all the side effects even though I don’t have cancer. Or I actually could have cancer and my specimen gets interpreted as normal and I don’t get any treatment. Such errors usually only come to attention when a patient undergoes, for example, a mastectomy or prostatectomy after a biopsy was interpreted as showing cancer and the full surgical specimen removed shows no cancer.
In that column we noted a study providing an estimate of how often such SPC’s occur (Pfeifer 2013). The authors examined about 13,000 prostate biopsy specimens from a wide variety of urology practices and pathology laboratories using a DNA identification technology. They found the frequency of occult type 1 errors (a complete transposition between patients) was 0.26% and type 2 errors (contamination of the patient’s tissue with 1 or more unrelated patients) was 0.67%. Overall, the mean frequency of SPCs across practice settings was 0.22% for type 1 errors and 1.69% for type 2 errors.
Basically, it means that just under 1% of patients might be given an incorrect diagnosis that no one even suspects is incorrect!
Perhaps just as striking is the fact that virtually every lab or clinical setting they studied had at least one SPC identified. So it’s not simply that one lab is making errors. Rather this is a problem that can and does occur in every lab.
In one of our earliest columns on lab errors (see our October 9, 2007 Patient Safety Tip of the Week “Errors in the Laboratory“) we noted a paper (Suba 2007) that suggested we consider the “DNA timeout” akin to the surgical timeout where we ask the question “Is this the correct diagnosis for the correct patient?” before doing an invasive procedure. Particularly when all the pieces of evidence do not completely mesh that may not be a bad idea.
Unlike the process improvements and technological solutions to prevent specimen mixups noted in our prior columns, we know of no current means of otherwise identifying such cross-contamination. Therefore, the astute clinician must always be thinking “is this the correct diagnosis for this patient?” particularly before embarking on an invasive procedure or recommending treatment with potentially severe side effects.
The current case thus also has lessons learned about diagnostic error. The patient apparently was angered that a physician and nurse walked out of a meeting with him when he challenged the diagnosis of cancer (Carville 2014b). Not only did the patient feel relatively healthy for someone said to have advanced cancer but he also had not lost any weight even 6 months after the original diagnosis of advanced cancer. In our many prior columns on diagnostic error (see the full list below) we’ve discussed some of the cognitive biases that may have been in play here: anchoring, early closure, and confirmation bias (actually its corollary: ignoring disconfirming evidence).
Fortunately in the current case there was a happy ending and the patient never underwent unnecessary chemotherapy. Nevertheless, he and his family undoubtedly suffered unimaginable stress during the ordeal. Let’s hope everyone can learn from this case and recognize the problematic scenario early.
Some of our other columns on errors related to laboratory studies:
Some of our prior columns on diagnostic error:
Carville O. Hamilton father misdiagnosed with lung cancer demands answers. Thestar.com (Hamilton, Ontario) Published on Fri Nov 14 2014
Carville O. Hospitals ‘deeply sorry’ for lung cancer misdiagnosis. Thestar.com (Hamilton, Ontario) Published on Fri Nov 14 2014
Pfeifer JD, Liu J. Rate of Occult Specimen Provenance Complications in Routine Clinical Practice. Am J Clin Path 2013; 139: 93-100
Suba EJ, Pfeifer JD, Raab SS. Patient Identification Error Among Prostate Needle Core Biopsy Specimens—Are We Ready for a DNA Time-Out? J Urol 2007; 178(4): 1245-1248
Print “Misdiagnosis Due to Lab Error”
December 2, 2014
ANA Position Statement on Nurse Fatigue
Fatigue in health care workers as a contributing factor to many patient safety issues has been a central theme of many of our columns (see the list at the end of today’s column). Fatigue impacts everyone involved in the health care team and that even includes patients and their families. However, most of the literature on fatigue has focused on nurses and housestaff. And it shows adverse effects of fatigue not only on patient care but also on personal health.
Now the American Nurses Association has issued a position statement on nurse fatigue (ANA 2014) that calls upon nurses and employers to work together and take steps to minimize the impact of fatigue on patients and staff. It relies heavily on evidence-based strategies and outlines responsibilities for nurses individually and collectively and responsibilities for employers.
The position statement stresses that nurses must practice healthy behaviors to reduce the risk of working while fatigued and to recognize when they or a colleague are fatigued and potentially putting patient care at risk. It notes nurses should come to work well-rested and alert, take appropriate rest and meal breaks, and implement fatigue countermeasures as needed. The latter may include naps, caffeine, or both as appropriate. Note that we’ve stressed the value of naps and “power naps” as important but underutilized strategies to minimize the effects of healthcare worker fatigue in those working long shifts or night shifts (see our columns for November 9, 2010 “12-Hour Nursing Shifts and Patient Safety”, April 26, 2011 “Sleeping Air Traffic Controllers: What About Healthcare?”, January 2012 “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety” and November 2012 “The Mid-Day Nap”). Employers must provide appropriate environments for such naps. It also often takes a change in culture to make naps acceptable (many nurses still fear the potential stigma a sleeping nurse might have in the perspective of a patient or family). One VA medical center implemented many good features to mitigate fatigue but did not attempt to introduce the at-work nap because of space and culture concerns (Fuller 2014).
The ANA position statement does focus on work hours, with recommendations for both nurses and employers. It recommends limiting work weeks to 40 or fewer hours per week and limiting shifts to 12 hours or less. It recommends one or two full days off to rest after 5 consecutive 8-hour shifts or 2 days off for rest after 3 consecutive 12-hour shifts. Note also that it stresses those hour limits should include not only paid hours but any time spent on unpaid activities (conferences, meetings, mandatory training, etc.) and on-call hours should be factored in as well.
The statement calls on employers to eliminate the use of mandatory overtime. It stresses that any nurse can and should refuse overtime or additional hours when fatigued and such refusal should be free of the risk of retaliation or other penalty.
Columns we’ve done that have attracted the most attention have been those looking at the 12-hour nursing shift (see the full list below). The new ANA position statement does not specifically comment on the 12-hour nursing shift. However, it does recommend for employers “Examine work demands with respect to shift length. Shifts longer than 8 hours may be unsafe when work is physically and cognitively demanding.” We’ve pointed out that because the 12-hour shift has become so popular in the US, both with nurses and hospitals, it will likely take compelling evidence to cause reversion to shorter shifts. While several pieces of information have pointed to the downsides of 12-hour shifts, conclusive evidence that adverse patient outcomes result from such shifts has been elusive, largely due to confounding variables in all studies.
The statement urges employers to involve nurses in development of staffing plans and design work schedules that limit overtime and take into account unanticipated events, like weather- or disaster-related situations. In addition, the organization should have in place policies and procedures for what to do if a worker is too fatigued to work.
Importantly, the ANA position statement urges nurses to consider the length of any commute before applying for positions. This is important because the literature demonstrates the impact of health care worker fatigue on motor vehicle accidents following work shifts. The ANA position statement also recommends that employers provide transportation home when a nurse is too tired to drive safely or provide sleep facilities at or near the facility as an alternative.
General health issues are important in avoiding fatigue. These include adequate diet and nutrition, adequate fluid intake, exercise, and stress management. In addition it is important to understand the potential effects of prescription and over-the-counter drugs and the signs and symptoms of sleep disorders. The statement also has recommendations about appropriate sleep hygiene.
Fatigue management training and education should also be provided not only for nurses and other employees but also managers. This should include education about sleep disorders as well.
Auditing adherence to work hour guidelines is an important responsibility of employers. But your typical hospital just looks at time card data. That does not include the additional hours noted above. And most hospitals don’t audit to see if nurses actually take their recommended rest and meal breaks.
Lastly, it is important that organizations have an anonymous reporting system so that information about fatigue can be conveyed in reports about accidents, errors and near-misses.
In our July 29, 2014 Patient Safety Tip of the Week “The 12-Hour Nursing Shift: Debate Continues” we predicted that someday we will have the equivalent of the brief “sobriety” or “breathalyzer” test that can rapidly identify healthcare workers who are impaired by fatigue. We envision that at regular intervals beyond 8 hours (maybe even sooner) the healthcare worker will get buzzed on his/her smartphone and have to complete some simple test of reaction times or attention span. If the worker scores outside the established threshold the hospital will need to have resources in place to take over duties of that worker (completely or at least temporarily until fatigue is alleviated by, for example, a nap). We are actually not that far away from such a test. Studies have demonstrated alteration of saccadic eye movement metrics correlate with fatigue in several settings and recently studies in surgical residents confirmed such a correlation (Di Stasi 2014). Such a test could probably be easily adapted to most of today’s smartphones.
We’d be remiss if we failed to point out that in the Di Stasi study surgical residents who were fatigued (by both the saccadic eye movement metrics and subjective measures of fatigue) did not have their performance on simulated laparoscopic procedures affected. That, of course, demonstrates that fatigue and prolonged work hours do not always result in errors. The interaction among multiple factors is much more complicated. The literature on management of fatigue in healthcare has overwhelmingly focused on hours of work. We know that the work hour reductions for housestaff have not produced convincing evidence that patient outcomes are improved (see our many columns on work hours and housestaff listed below).
A very interesting contribution from the psychology/sociology literature looked at strategies healthcare workers use to combat fatigue (Ferguson 2013). Though the research was based upon focus groups and semi-structured interviews and not correlated with actual patient or staff outcomes (hence not considered “evidence-based”), it offers a unique look at the additional layers of defense to prevent fatigue-related errors. And, not surprisingly, it turns out that most of these strategies involve informal processes rather than formalized processes and are strongly related to non-technical skills. Yes, use of caffeine and taking breaks were strategies used by individuals. But they also found keeping busy to be a useful strategy. They also used informal error-proofing practices such as focusing on one task at a time, switching temporarily to another task, double checking oneself or asking a colleague to double check, and deferring decisions to later or to another colleague. Teams also had work practice strategies such as prioritizing finishing times for colleagues who had the shortest break between shifts, facilitating napping by “batching” tasks on the night shift, and rotating night-shift naps.
Barriers to fatigue management in the Ferguson study were individual (eg. personal responsibility for work and non-work time), organizational (eg. staffing, workload, financial, cultural), and community-based (eg. expectations for service delivery and availability).
One theme that echoes a point included in the ANA position statement is the importance of incident reporting (for fatigue-related incidents and near-misses). Though the Ferguson study was qualitative rather than quantitative, the general feeling was that such incidents are currently underreported.
We also found some interesting comments in both the ANA and Ferguson papers about individual safety in driving home after long shifts. In the Ferguson study taxi vouchers offered by some hospitals were seldom used. The ANA paper notes that things we all do when struggling with drowsy driving (such as putting windows down, turning up the radio, pinching ourselves) don’t work! Maybe that smartphone app we talked about above will also mount on our rear view mirror!
We again recommend you read our November 9, 2010 Patient Safety Tip of the Week “12-Hour Nursing Shifts and Patient Safety” to see some of the excellent prior work that has been done by Geiger-Brown and colleagues (Geiger-Brown 2010) and Fallis and colleagues (Fallis 2011) regarding some of the strategies to mitigate nurse fatigue and also our columns listed below on the impact of fatigue in healthcare and other industries and use of strategies such as power naps.
Some of our other columns on the role of fatigue in Patient Safety:
November 9, 2010 “12-Hour Nursing Shifts and Patient Safety”
April 26, 2011 “Sleeping Air Traffic Controllers: What About Healthcare?”
February 2011 “Update on 12-hour Nursing Shifts”
September 2011 “Shiftwork and Patient Safety
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
January 3, 2012 “Unintended Consequences of Restricted Housestaff Hours”
June 2012 “June 2012 Surgeon Fatigue”
November 2012 “The Mid-Day Nap”
November 13, 2012 “The 12-Hour Nursing Shift: More Downsides”
July 29, 2014 “The 12-Hour Nursing Shift: Debate Continues”
October 2014 “Another Rap on the 12-Hour Nursing Shift”
Our previous columns on the 12-hour nursing shift:
November 9, 2010 “12-Hour Nursing Shifts and Patient Safety”
February 2011 “Update on 12-hour Nursing Shifts”
November 13, 2012 “The 12-Hour Nursing Shift: More Downsides”
July 29, 2014 “The 12-Hour Nursing Shift: Debate Continues”
October 2014 “Another Rap on the 12-Hour Nursing Shift”
Some of our other columns on housestaff workhour restrictions:
December 2008 “IOM Report on Resident Work Hours”
February 26, 2008 “Nightmares: The Hospital at Night”
January 2011 “No Improvement in Patient Safety: Why Not?”
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
January 3, 2012 “Unintended Consequences of Restricted Housestaff Hours”
June 2012 “Surgeon Fatigue”
November 2012 “The Mid-Day Nap”
December 10, 2013 “Better Handoffs, Better Results”
April 22, 2014 “Impact of Resident Workhour Restrictions”
American Nurses Association. Position Statement. Addressing Nurse Fatigue to Promote Safety and Health: Joint Responsibilities of Registered Nurses and Employers to Reduce Risks. September 10, 2014
Fuller HJA, Haubert M-K. Managing Fatigue. VA National Center for Patient Safety. Topics in Patient Safety TIPS 2014; 14(5): 2
Di Stasi LL, McCamy MB, Macknik, SL, et al. Saccadic Eye Movement Metrics Reflect Surgical Residents' Fatigue. Annals of Surgery 2014; 259(4): 824-829
Ferguson SA, Neall A, Dorrian J. Strategies used by healthcare practitioners to manage fatigue-related risk: beyond work hours. Medical Sociology Online 2013; 7(2): 24-33
Geiger-Brown J. Trinkoff AM. Is It Time to Pull the Plug on 12-Hour Shifts? Part 3. harm reduction strategies if keeping 12-Hour Shifts. Journal of Nursing Administration 2010; 40(9): 357-9, 2010 Sep
Fallis, WM, McMillan DE, Edwards MP. Napping During Night Shift: Practices, Preferences, and Perceptions of Critical Care and Emergency Department Nurses
Crit Care Nurse March 31, 2011 vol. 31 no. 2 e1-e11
December 9, 2014
More Trouble with NMBA's
A 65 y.o. woman with a history of recent brain surgery suffered respiratory and cardiac arrest after inadvertently being given intravenously the neuromuscular blocking agent (NMBA) rocuronium instead of the anti-seizure medication fosphenytoin at an Oregon hospital recently (Bannow 2014). She suffered irreversible brain damage and was subsequently removed from life support and died.
Neuromuscular blocking agents (NMBA’s) are high-alert medications that cause paralysis and respiratory arrest when given to non-intubated, non-ventilated patients. As a result, inadvertent administration of NMBA’s often results in fatal outcomes. We first wrote about NMBA incidents back in 2007 and tragic NMBA incidents have continued to occur. Our February 7, 2012 Patient Safety Tip of the Week “Another Neuromuscular Blocking Agent Incident” described several unfortunate incidents involving NMBA’s and had numerous recommendations, relying heavily on excellent resources from ISMP (ISMP 2005), ISMP Canada (Koczmara 2007), and the Pennsylvania Patient Safety Authority (PPSA 2009).
The hospital in the current incident openly admitted the mistake and apologized to the patient’s family and said it would be transparent in explaining what it finds in its root cause analysis. We hope they will disseminate that RCA publicly because the lessons learned will be valuable to many healthcare organizations. That RCA, like almost all related to serious events with untoward patient outcomes, will undoubtedly show a cascade of events that came together to allow the tragic outcome. System-related factors likely put frontline healthcare workers at the sharp end of this incident and those same system-related factors are likely in play at many other organizations.
We actually know very few details about this case at present. But below are the questions we’d be asking in the RCA. Many of them are obvious and are part of every RCA done on an event (eg. Were staffing levels adequate? Were there distractions? etc.). But others may be overlooked. For example, though the focus is on the NMBA and the mixup with the anti-seizure medication what about the decision to use this particular anti-seizure medication in the first place? That decision started the cascade. So let’s start there.
Were the indications for fosphenytoin appropriate?
Fosphenytoin is a drug with very limited indications. It is most commonly used for treatment of generalized tonic-clonic status epilepticus or for treating seizures during neurosurgery. It sometimes may also be substituted, short-term, for oral phenytoin but it should be used only when oral phenytoin administration is not possible. We really don’t know from the current published reports what the indication for fosphenytoin was. Those reports simply say she went to the ER because of anxiety and concerns about her anticonvulsant medications.
Where and how were the fosphenytoin and rocuronium stored?
Were they in floor stock? Or in the pharmacy? Were they in refrigerators? Were they in automated dispensing machines? Limiting access to NMBA’s is arguably the most important intervention to prevent incidents. Many hospitals restrict them to the OR and pharmacy. In those areas where they might be needed emergently (eg. in the ER or ICU where they may be needed for emergent intubations) the drugs can be “sequestered” or sealed in the intubation kits so that they are available only at the time of intubation.
Both drugs are usually refrigerated but may be stored at room temperatures for certain periods. Fosphenytoin should not be stored at room temperature for more than 48 hours. Rocuronium may be removed from refrigerator and stored at controlled room temperature but must be used within 60 days or within 30 days once vial has been opened. Were they stored in similar locations? It is recommended that NMBA’s be segregated from all other medications in all areas where they are stored (Koczmara 2007).
In our February 7, 2012 Patient Safety Tip of the Week “Another Neuromuscular Blocking Agent Incident” we noted that storage of NMBA’s in automated dispensing machines can be especially problematic. Probably most important is only storing them in areas where they are clearly needed. Where needed, they should be kept in single access drawers. But there needs to be a special warning that the NMBA should not be used in patients who are not intubated/mechanically ventilated. Such a message could be delivered in those automated systems having the capability of messaging when an NMBA is selected for removal from a drawer. Similarly, the type of CPOE error noted in the February 7, 2012 column might be avoided by programming in an alert ensuring the patient is intubated/ventilated when the physician enters an order for an NMBA.
Were sound-alike look-alike issues a factor?
It’s pretty unlikely that sound-alike issues occurred with this drug pair (though we previously discussed sound-alike issues for several other NMBA’s). The generic names here do not sound alike and even the brand names (Zemuron and Cerebyx, respectively, for rocuronium and fosphenytoin) do not sound alike. But look-alike issues certainly are a consideration. In many of the prior incidents vials of NMBA’s have been confused with vials of other medications and vaccines. A recent ISMP Canada article (ISMP Canada 2014) has an excellent discussion of improvements made in the packaging and labeling of NMBA’s in both Canada and the US.
Were there warnings on the NMBA vials that were salient and not obscured?
Most important are warning labels for vials, syringes, bags, or storage boxes containing NMBA’s. Both ISMP and the PPSA recommend using fluorescent red labels that state “Warning: Paralyzing Agent – Causes Respiratory Arrest”. The recent ISMP Canada article (ISMP Canada 2014) noted above describes the various ways that caps, labels, etc. have been redesigned to draw attention to the warnings and notes some differences between Canada and the US.
But regardless of the warnings it is still possible they may not be heeded. The 2007 ISMP Canada review (Koczmara 2007) notes that a form of confirmation bias often is a contributing factor. Specifically, because the vials and labels may look similar to those of the “expected” medication, we tend to see what we expect to see rather than what we actually see. The phenomenon is also sometimes known as “inattentional blindness” (ISMP 2009).
Had any drug shortage led to use of different formulations of rocuronium?
Could a drug shortage have played a role? There has been a recent shortage of at least one rocuronium preparation (ASHP 2014). So one would want to investigate whether rocuronium preparations from other manufacturers or suppliers might conceivably have had different packaging or labeling that confused the local healthcare workers(s). Particularly when manufacturers or suppliers change for high-alert medications it is important that all potentially affected staff are made aware of the changes.
Who prepared the drug?
That is important as it pertains to communication, if any, between the person preparing the drug and the person administering it.
Were any syringes used appropriately labeled?
If the medication were drawn up from the vial into a syringe by someone other than the person administering the drug, was the syringe appropriately labeled? If so, did it also have a salient warning like discussed above? There have been cases also where unused syringes have been (inappropriately) returned to storage and sometimes mixed up with syringes containing other medications. We would actually recommend labeling that syringe even if the same nurse is going to immediately administer the drug to the patient and that label should have the same sort of salient warning described above. That is because interruptions and distractions (eg. a fire alert?) can occur that might lead to an unlabeled syringe with a potentially fatal medication being left lying somewhere.
Was there a change of staff or any other handoff during the key timeframe?
For example, did a second nurse administer the drug after a shift change from a syringe prepared by a previous nurse?
Was a double check done?
See our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?” and ISMP’s excellent review on independent double checks (ISMP 2013) for discussions on double checks. NMBA’s should be on your list of high-alert medications (see the ISMP List of High-Alert Medications in Acute Care Settings for examples) and should require independent double checks prior to administration. But remember that in this case it is unlikely that the person administering the drug thought it was an NMBA. They apparently thought they were administering fosphenytoin. The latter drug is not likely on a hospital’s formal list of drugs requiring independent double checks. However, fosphenytoin is a seldom-used drug and, hence, is likely unfamiliar to many healthcare workers. But even ISMP recommends against requiring independent double checks on too many drugs (ISMP 2013). That said, with unfamiliar drugs it still makes sense to do some sort of double check, such as consulting a drug reference. But there are always barriers to doing double checks (inconvenience, lack of easy access to drug reference materials, second staff not readily available, fear of appearing uninformed, etc.). But even a “mental” double check could have been important here. The dosing on a mg basis is quite different for the two drugs (that for fosphenytoin being on the order of 10 times higher than that for rocuronium). That could have alerted staff to a problem.
Was barcoding available and used?
Barcoding for bedside medication verification would be very useful in preventing this sort of error. However, many hospitals that have barcoding and bedside medication verification in place have not yet implemented it in the ER.
Were there any significant distractions?
This certainly is a possibility here. Apparently there was a “code red” (fire alert) around the time of the incident and apparently the door to the patient room closed automatically. She was said to have been found in arrest when the door was reentered. Since details of the timing of that “code red” were not specified in the early press coverage, it would be important to know if that fire alert interrupted the administration of the drug or led to a problem monitoring the patient after the administration. Note that in several of our columns (most recently in our October 21, 2014 Patient Safety Tip of the Week “The Fire Department and Your Hospital”) we’ve mentioned “dual scenarios” in which one event (such as a patient elopement or infant abduction) may occur in conjunction with a fire drill or fire alert. Sometimes it’s valuable to add a second nuance to one of your fire drills.
How was the drug administered?
If the staff thought they were administering fosphenytoin how did they administer it? Was it administered by slow IV push? Or was it administered by an unobserved infusion? The dose of IV fosphenytoin (15 to 20 mg phenytoin equivalents/kg) that is used to treat status epilepticus is administered at a maximum rate of 150 mg phenytoin equivalents/min. The typical fosphenytoin infusion administered to a 50 kg patient would take between 5 and 7 minutes, considerably shorter than it would take to administer a comparable dose of IV phenytoin to a patient (a theoretical advantage of fosphenytoin when rapid dosing is needed). Remember, we don’t yet know how much fosphenytoin was thought to be being given or how long the administration process took here. But since fosphenytoin may have similar cardiovascular side effects to phenytoin (eg. hypotension and dysrhythmias) it is prudent to observe the patient while the drug is being infused. One would anticipate that paralysis would likely have been observed by someone administering the recuronium if they were present during the administration.
How was the patient monitored?
As above it is prudent to observe the patient while the drug (presumed to be fosphenytoin) is being infused. So one would anticipate that monitoring (by direct observation, EKG) one would have been alerted that the patient had been paralyzed by an NMBA. However, respiratory depression would not be immediately detected unless the patient had capnography or apnea monitoring ongoing. Eventually, however, one should have been alerted by arrhythmias as the patient became hypoxic. If the patient was being monitored by EKG, were the alarm volumes and limits appropriate? Was pulse oximetry being used? Might the fire alert have interfered with audibility of any alarms?
Was staffing adequate at the time of the event? Were any gaps caused by factors such as change of shift? Did staff fatigue come into play? Were there issues with education and training of staff? Were any of the staff involved new to the organization or to the unit where the event occurred?
Is rocuronium or any other NMBA accessible in floor stock anywhere else it shouldn’t be?
This should be an opportunity to audit stocks of NMBA’s and ensure that they are not accessible in any sites other than where there is an absolute necessity.
The hospital already did several positive things we would also include in our checklist for investigation of any serious event (see our July 24, 2007 Patient Safety Tip of the Week“Serious Incident Response Checklist”):
What did the hospital do once it recognized the mistake that had occurred?
The hospital openly admitted the mistake and apologized to the patient’s family and said it would be transparent in explaining what it finds in its root cause analysis. Oregon did pass legislation this year encouraging disclosure and apology but this hospital had been advocates of that policy long before that. They need to keep the family in the loop as they complete their RCA and take steps to ensure similar events don’t occur again, not just at their hospital but elsewhere too. See the list below of all our columns on disclosure and apology.
Did they recognize the second victims in this unfortunate event?
Yes, they noted that staff directly involved in the event are on administrative leave and receiving counseling through the hospital’s caregiver assistance program. As we discussed in our December 17, 2013 Patient Safety Tip of the Week “The Second Victim” as far back as the early 1990’s we’ve always had an item on our serious incident response checklist to ensure that we provide appropriate attention to staff directly or indirectly involved in such incidents. Staff at the hospital in the current incident have been described as being “devastated” and are true “second victims”. Importantly, just ensuring they get counseling is not enough. We need to make sure all staff understand what they are going through and be wary that their own communication with those staff members, whether verbal or through body language, will play a big role in determining how they will cope with what happened.
In addition to describing several other incidents with accidental administration of NMBA’s to patients, our February 7, 2012 Patient Safety Tip of the Week “Another Neuromuscular Blocking Agent Incident” had several other recommendations worth repeating here:
Obviously, the biggest risk of NMBA’s is in patients who are not being mechanically ventilated. There are a couple circumstances where NMBA’s may be inadvertently ordered and given in non-ventilated patients. We previously mentioned a case (see our June 19, 2007 Patient Safety Tip of the Week “Unintended Consequences of Technological Solutions”) where an unintended consequence of CPOE led to inadvertent administration of a neuromuscular blocking agent to a patient who was not being mechanically ventilated (ISMP 2007). In that case the physician was ordering from a remote site and inadvertently entered orders on the wrong patient. The other circumstance is when a patient in an ICU is extubated and weaned from a respirator and transferred to a regular floor and someone writes “continue all previous orders” not recognizing that such might include orders for NMBA’s in a now unventilated patient.
Look-alike/sound-alike (LASA) issues are root causes in many NMBA incidents. Very often the vials closely resemble vials of other more common medications and solutions. How and where drugs are stored is an important contributing factor in many of the adverse NMBA incidents. Many of the reported incidents involving NMBA’s being confused with another intended drug have involved NMBA’s that were stored in refrigerators, especially in refrigerators where such are not usually stored. The vials have been confused with vials of other substances like normal saline, heparin, and vaccines. The 2005 ISMP alert (ISMP 2005) had several examples. In one instance an anesthesiologist put a vial of an NMBA in a refrigerator on a different unit that does not usually stock NMBA’s and the vial was mistaken for hepatitis B vaccine and was inadvertently given to seven infants. In others, vials of NMBA’s looked similar to vials of either vaccines or the diluents used with those vaccines, resulting in multiple patients being exposed to the NMBA’s.
The sound-alike issues are also problematic. Norcuron (vecuronium) has been mistaken for Narcan, vecuronium for vancomycin, atracurium for Ativan, etc. In other cases, look-alike packaging has been a major contributing factor.
Limiting access to NMBA’s is arguably the most import intervention to prevent incidents. Many hospitals restrict them to the OR and pharmacy. In those areas where they might be needed emergently (eg. in the ER or ICU where they may be needed for emergent intubations) the drugs can be “sequestered” or sealed in the intubation kits so that they are available only at the time of intubation. But while restricting access is important, keep in mind those incidents above where NMBA’s popped up in areas where they were not supposed to be. So there clearly must be other safety measures taken and you need to be ever vigilant to items showing up where they are not supposed to be.
Storage of NMBA’s in automated dispensing machines can be especially problematic. Probably most important is only storing them in areas where they are clearly needed. Where needed, they should be kept in single access drawers. But there needs to be a special warning that the NMBA should not be used in patients who are not intubated/mechanically ventilated. Such a message could be delivered in those automated systems having the capability of messaging when an NMBA is selected for removal from a drawer. Similarly, the type of CPOE error noted earlier might be avoided by programming in an alert ensuring the patient is intubated/ventilated when the physician enters an order for an NMBA.
Most important are warning labels for vials, syringes, bags, or storage boxes containing NMBA’s. Both ISMP and the PPSA recommend using fluorescent red labels that state “Warning: Paralyzing Agent – Causes Respiratory Arrest”.
The ISMP Canada review (Koczmara 2007) notes that a form of confirmation bias often is a contributing factor. Specifically, because the vials and labels may look similar to those of the “expected” medication, we tend to see what we expect to see rather than what we actually see. The phenomenon is also sometimes known as “inattentional blindness” (ISMP 2009).
Part of your medication safety program should include education and communication about NMBA’s. They should never be referred to as “muscle relaxants” and should never be allowed to be ordered on a “prn” basis (PPSA 2009). Similarly, the phrase “renew all previous orders” should never be allowed. Rather, when patients are transferred from one unit to another, the physician should write out each of the orders as if they were brand new orders. The same applies when the physician is using CPOE. While some CPOE systems have functions (or workarounds) that facilitate renewal of a large number of orders, beware that such can give rise to unintended consequences.
Prompt disposal of unused NMBA’s is also essential. Several of the previously mentioned incidents involved use of NMBA preparations that had been poorly labeled and left behind from use with one patient, then were inadvertently administered to other patients. ISMP recommends that unused NMBA’s (whether in vials, bags, or syringes) be placed in a sequestered bin for immediate pickup by pharmacy
Obviously, use of traditional medication safety measures, such as barcoding, are important and NMBA’s, being high-alert drugs, should require independent double checks before being dispensed and before being administered.
Lastly, you may find 2 other resources on NMBA’s helpful. In our July 31, 2007 Patient Safety Tip of the Week “Dangers of Neuromuscular Blocking Agents” we recommended this is a good issue to address in FMEA (Failure Mode and Effects Analysis) in your organization. Susan Paparella (Paparella 2007), from ISMP, did exactly that in the Journal of Emergency Nursing (see our November 2007 What’s New in the Patient Safety World column “FMEA Related to Neuromuscular Blocking Agents”). The ED staff had recognized NMBA’s as high-alert drugs and were contemplating their removal from ED stores, to be replaced in kits prepared for rapid-sequence intubation. FMEA is especially useful in such situations where change is to take place, because it helps identify potential unintended consequences. The article nicely describes how you do a FMEA exercise and provides examples for scoring probability and severity and use of a hazard scoring matrix. Lastly, one of the AHRQ M&M Conference cases (Weinger 2003) on an NMBA incident had 2 terrific downloadable videos addressing some of the communications issues in that case. It is well worth reading and watching the videos.
As above, we hope the Oregon hospital will disseminate their RCA publicly because the lessons learned undoubtedly will be valuable to many healthcare organizations. It is important that you use the narrative of this unfortunate case and the others mentioned in our February 7, 2012 Patient Safety Tip of the Week “Another Neuromuscular Blocking Agent Incident” to help everyone in your organization understand the vulnerabilities you might have to an NMBA incident. Telling stories that your staff can relate to is the best way to promote patient safety vigilance and interventions. Again, also consider formal audits or add NMBA Safety to your list of things you look for in your Patient Safety Walk Rounds and consider doing a FMEA on NMBA use in your organization.
Some of our prior columns on neuromuscular blocking agents (NMBA’s):
June 19, 2007 “Unintended Consequences of Technological Solutions”
July 31, 2007 “Dangers of Neuromuscular Blocking Agents”
November 2007 “FMEA Related to Neuromuscular Blocking Agents”
January 31, 2012 “Medication Safety in the OR”
February 7, 2012 “Another Neuromuscular Blocking Agent Incident”
October 22, 2013 “How Safe Is Your Radiology Suite?”
Some of our prior columns on Disclosure & Apology:
July 24, 2007 “Serious Incident Response Checklist”
June 16, 2009 “Disclosing Errors That Affect Multiple Patients”
June 22, 2010 “Disclosure and Apology: How to Do It”
September 2010 “Followup to Our Disclosure and Apology Tip of the Week”
November 2010 “IHI: Respectful Management of Serious Clinical Adverse Events”
April 2012 “Error Disclosure by Surgeons”
June 2012 “Oregon Adverse Event Disclosure Guide”
December 17, 2013 “The Second Victim”
Other very valuable resources on disclosure and apology:
Bannow T. St. Charles Bend admits mistake led to patient death. The Bulletin (Bend, Oregon) 2014; Dec. 5, 2014
ISMP (Institute for Safe Medication Practices). Paralyzed by mistakes. Preventing errors with neuromuscular blocking agents. ISMP Medication Safety Alert Acute Care Edition 2005; September 22, 2005 issue
Koczmara C, Jelincic V. Neuromuscular blocking agents: Enhancing safety by reducing the risk of accidental administration. ISMP Canada 2007 in the Spring 2007 publication of the Canadian Association of Critical Care Nurses (CACCN).
PPSA (Pennsylvania Patient Safety Authority). Patient Safety Advisory.
Neuromuscular Blocking Agents: Reducing Associated Wrong-Drug Errors
Pa Patient Saf Advis 2009; 6(4): 109-14.
ISMP Canada. Neuromuscular Blocking Agents: Sustaining Packaging Improvements over Time. ISMP Canada Safety Bulletin 2014; 14(7): 1-5
ISMP (Institute for Safe Medication Practices). Inattentional blindness: What captures your attention? ISMP Medication Safety Alert Acute Care Edition 2009; February 26, 2009
ASHP (American Society of Health-System Pharmacists). Drug Shortages. Rocuronium Injection. 29 October 2014
ISMP. Independent Double Checks: Undervalued and Misused: Selective use of this strategy can play an important role in medication safety. Acute Care ISMP Medication Safety Alert! June 13, 2013
ISMP. ISMP List of High-Alert Medications in Acute Care Settings. ISMP 2014.
Drugs.com for Professionals.Fosphenytoin Sodium Injection, USP.
ISMP (Institute for Safe Medication Practices). Remote CPOE error-a situation that's more than remotely possible. ISMP Medication Safety Alert Acute Care Edition 2007; May 31, 2007
Paparella, Susan RN, MSN Failure Mode and Effects Analysis: A Useful Tool for Risk Identification and Injury Prevention. Journal of Emergency Nursing. 33(4):367-371, August 2007
Weinger MB, Blike GT. Intubation Mishap. AHRQ Web M&M. September 2003
Print “More Trouble with NMBA’s”
December 16, 2014
More on Each Element of the Surgical Fire Triad
In our many columns on surgical fires (see the list at the end of today’s column) we’ve discussed contributions of each of the elements of the “fire triangle” (fuel, oxidizer, heat source).
First, the “fuel” side of the fire triangle. The Anesthesia Patient Safety Foundation (APSF) has their lead article about flammable surgical preps in the October 2014 issue of the APSF Newsletter (Cowles 2014). We discussed the role of alcohol-based skin preps or other volatile substances in our Patient Safety Tips of the Week for April 24, 2012 “Fire Hazard of Skin Preps, Oxygen”, June 25, 2013 “Update on Surgical Fires” and October 1, 2013 “Fuels and Oxygen in OR Fires”. But the new APSF article has some nice tables listing the alcohol content of commonly used skin preps and alcohol-based hand rubs. It has good advice about the importance of communication in the OR as it pertains to ensuring adequate drying time for surgical preps and assessment for alcohol pooling near the surgical field. It emphasizes that adequate drying time is still important in emergency cases. Our August 12, 2014 Patient Safety Tip of the Week “Surgical Fires Back in the News” described a fire in an emergency case in which there was an inadequate delay for an alcohol-based skin disinfectant to dry and the patient had received 100% oxygen. Subsequently the hospital implemented a policy prohibiting alcohol-based skin preps in any emergency surgery that does not allow sufficient drying time (usually 3 minutes or longer). Instead they have gone back to non-alcohol-based preps like Betadine for such emergency cases.
Another key point in the recent APSF article: “read the fine print”. The package inserts on the surgical preps often have warnings about fire risk. In several of our prior articles we noted another surgical fire in which a hospital had switched from the 10.5 ml Chloraprep applicator, which did not have the warning to avoid use in head and neck surgery, to the 26 ml applicator which did have the warning. It is actually quite predictable that staff wouldassume the new supplies were the same as the old and not “read the fine print”.
The other “pearl” in the APSF article about alcohol-based surgical preps is that, whereas the drying time for most such preps is typically at least 3 minutes, drying time of up to 1 hour may be needed when applied to hairy areas, body folds, or body creases.
On to the “oxidizer” side of the fire triangle. The December 2014 issue of Outpatient Surgery Magazine has a Q&A session with ECRI Institute’s Mark Bruley, considered by many to be the leading authority on OR fires (Burger 2014). Bruley stresses that oxygen is the most important element in most OR fires, noting that only about 5% of OR fires involve alcohol-based surgical preps that are still wet. He notes that the real fire hazards happen when oxygen concentrations get up above 40-50% and that anesthesia providers often gave oxygen freely from open sources in many minor procedures, using 100% regardless of patient needs. He points out that in the rare case where a patient does require oxygen from an open source you should start at 30%. He stresses, however, that the current recommendation is that when a patient does need supplemental oxygen, particularly in high-risk areas (head, neck, face, airway, chest) the patient should have a tracheostomy tube or laryngeal mask to prevent buildup of oxygen around the surgical site.
And lastly, the “heat source” side of the fire triangle (though this new information is actually about oxygen). Far and away the two most frequent contributing factors to the majority of OR fires are the oxygen-enriched environment and use of an electrocautery device (see below). So William Culp and colleagues have come up with a unique approach to address both (Culp 2014). Using the rationale that we use carbon dioxide (CO2) to extinguish fires by displacing oxygen, they designed a prototype electrocautery pencil that expresses a cone of CO2 from its tip when activated so that oxygen is displaced. They tested the device in the lab by seeing how long it took for the device to ignite a laparotomy sponge at different oxygen concentrations with the CO2 on or off. With it off the sponge ignited in 15/15 trials (all O2 concentrations) but in 0/15 trials with the CO2 on. What a great concept!
But the device is not yet ready for prime time. It appears to need some design work to make the device easier to use by surgeons. And we need to be concerned about unexpected or unintended consequences. Perhaps the biggest potential unintended consequence is a phenomena we’ve pointed out several times, described by Charles Perrow in his classic book “Normal Accidents” (Perrow 1999) where he talks about how new technologies often simply “push the envelope”. He cites as an example how the introduction of maritime radar simply encouraged boats to travel faster and did little to reduce the occurrence of maritime accidents. Indeed, the editorial (Feldman 2014) accompanying the Culp study warns about exactly that – the risk that surgeons and anesthesiologists might now consider the fire risk so low that they use oxygen indiscriminately. Feldman et al. also raise the possibility that use of the device could result in hypercarbia when used around the face or airway. And we’ll even throw in the possibility the CO2 source could be expended or malfunction without awareness of the surgeon.
But, given that OR fires continue to occur despite widespread attention, training, inservicing, posters, pre-op huddles, and other efforts, a solution that minimizes the risk of human error would be a most welcome addition. The prototype by Culp and colleagues is thus very exciting.
In our June 25, 2013 Patient Safety Tip of the Week “Update on Surgical Fires” we cited an analysis of closed malpractice claims involving surgical fires (Mehta 2013). That analysis showed that 99% involved procedures known to be high risk for fires (head, neck, or upper chest surgery), electrocautery was the ignition source in 90% of claims, and oxygen was the oxidizer in 95% of claims. Alchohol-containing prep solutions and volatile compounds were identified in only 15% of OR fires during monitored anesthesia care. Importantly, the vast majority of claims were for fires that occurred during monitored anesthesia care rather than general anesthesia. That highlights the importance of oxygen. In the vast majority of claims involving monitored anesthesia care the oxygen was delivered by an open delivery system. It really highlights that there has been a trend for surgical/OR fires to be seen more often in relatively minor surgery (eg. plastic procedures removal of skin lesions, temporal artery biopsies, etc.), done under sedation or monitored anesthesia care where there is open delivery of oxygen.
The October 2014 APSF Newsletter also had an update on claims payouts for OR fires (Sanford 2014). It notes that a malpractice insurance company for about 5000 anesthesia providers has handled 42 cases of intraoperative fire since 1990, 31 of which involved the high-risk areas of face, head and neck. Almost every case involved oxygen and electrocautery or laser instruments. It highlights a case in which the victim of an OR fire was awarded an $18 million judgment. In addition to the cognitive aids noted previously, the authors note some facilities are using “smart anesthesia messages (SAM’s)” via computer to remind the OR staff about high-risk cases. They also mention the APSF fire prevention algorithm that may be quite useful in helping the OR team identify and prepare for appropriate precautions and procedures in those identified at-risk.
We have long advocated that the surgical fire risk be discussed as part of the pre-op huddle (or pre-op briefing) and, if the case is considered high-risk, respective roles of all OR participants are called out during the surgical timeout. We’ve always liked the checklist “The Surgical Fire Assessment Protocol” developed at the San Francisco VA as part of an effort to promote fire safety in the OR (Murphy 2010). The Christiana Care Health System also has some good examples of incorporating the fire risk into Universal Protocol plus many other great tools in their Surgical Fire Risk Assessment resources.
We also can’t overemphasize the importance of doing drills for OR fires. Even if we identify high-risk cases there will be others we did not consider to be at high risk. While head, neck and upper chest surgeries have been considered to be at greatest risk for surgical fires, don’t forget that they can occur in almost any surgery (see our January 2011 What’s New in the Patient Safety World column “Surgical Fires Not Just in High-Risk Cases” and April 24, 2012 Patient Safety Tip of the Week “Fire Hazard of Skin Preps Oxygen” for examples of fires during procedures on other areas of the body). Therefore, doing drills is important so each member of the OR team know his/her role in responding to an OR fire.
We hope you’ll look at the many useful recommendations in our previous columns (listed below). And, of course, we again refer you to the valuable resources on surgical fires provided by ECRI Institute, AORN, the FDA, Christiana Care Health System and the APSF.
Our prior columns on surgical fires:
Burger J. Surgical Fire Q & A. Outpatient Surgery Magazine Online 2014; 102-109 December 2014
Cowles CE, Chang JL. Flammable Surgical Preps Require Vigilance. APSF Newsletter 2014; 29(2): 25-28 October 2014
Sanford SR, Thomas BJ, Lee LA. Medicolegal Data Implicate Oxygen as Common Factor in OR Fires. APSF Newsletter 2014; 29(2): 25, 29 October 2014
Culp WC, Kimbrough BA, Luna S, Maguddayao AJ. Mitigating Operating Room Fires: Development of a Carbon Dioxide Fire Prevention Device. Anesthesia & Analgesia 2014; 118(4): 772-775
Perrow C. Normal Accidents: Living with high-risk technologies. Princeton, New Jersey: Princeton University Press, 1999
Feldman JM, Ehrenwerth J, Dutton RP. Thinking Outside the Triangle: A New Approach to Preventing Surgical Fires. Anesthesia & Analgesia 2014; 118(4): 704-705
APSF (Anesthesia Patient Safety Foundation). Fire Prevention Algorithm.
Mehta SP, Bhananker SM, Posner KL, Domino KB. Operating Room Fires: A Closed Claims Analysis. Anesthesiology 2013; 118(5): 1133-1139, May 2013
SF VAMC Surgical Fire Risk Assessment Protocol
Murphy J. A New Effort to Promote Fire Safety in the OR. Topics In Patient Safety (TIPS) 2010; 10(6): 3
Christiana Care Health System. Surgical Fire Risk Assessment.
ECRI Institute. Surgical Fire Prevention.
AORN (Association of periOperative Registered Nurses). Fire Safety Tool Kit.
FDA. Preventing Surgical Fires.
APSF (Anesthesia Patient Safety Foundation). Resources. Fire Safety Video. Prevention And Management Of Operating Room Fires.
December 23, 2014
Iatrogenic Burns in the News Again
Just as we were publishing last week’s update on OR fires a story out of the UK reminded us that OR fires are not the only cause of burns in the OR. A 58 y.o. man underwent surgery for a renal cyst and ended up with third degree burns on his buttock and hip that ultimately required skin grafting (The Guardian 2014). The cause - a warming blanket. We’ve briefly noted burns from warming blankets in our previous columns on iatrogenic burns (see our Patient Safety Tips of the Week for June 1, 2010 “Iatrogenic Burns” and October 5, 2010 “More Iatrogenic Burns”). But this one had a unique twist. During the surgery a cold saline bag was in contact with a sensor, leading the system to perceive that the patient was hypothermic and thus increase the temperature. Investigation and a subsequent court case revealed that two other patients had received minor burns in similar circumstances at that hospital and that staff had been inadequately trained in use of the devices (Pilkington 2014).
Avoiding perioperative hypothermia improves patient outcomes by reducing the risks of infections and coagulopathy, facilitating recovery, etc. Avoiding perioperative hypothermia has become a quality focus for SCIP, Joint Commission, CMS, and other pay-for-performance programs. Warming blankets and related devices are extremely important tools used to help maintain perioperative normothermia. When used correctly they are effective, efficient and safe. We found cases of thermal injuries related to warming blankets going back as far as the 1960’s. Almost every reported case of thermal injury related to such devices had unusual additional factors or circumstances that contributed to the occurrence of thermal injury.
Poor tissue perfusion has long been recognized as a risk factor for thermal injuries with warming devices. Hence such devices typically have a warning to avoid use in patients with peripheral vascular disease, low cardiac output, aortic cross-clamping, or other causes of poor perfusion. Sometimes poor tissue perfusion may be aggravated by perioperative events. In a 3-year old having surgery for transposition of the great arteries, second- and third-degree burns developed and corresponded anatomically to the warm air exit holes of the warming blanket (Truell 2000). In addition to poor tissue perfusion related to the chronic cyanotic heart disease, the patient had significant intraoperative bleeding treated with controlled hypotension and blood product replacement and received low-dose pressor agents.
Probably the best known factor reported in burns related to warming blankets has been the practice of “hosing” or “free-hosing”. This refers to simply using the hose of the warming device without the blanket attachment and allowing the hot air to blow directly onto the patient, forcing the hot air onto one focused area of the body (Marders 2002). In an analysis of the ASA Closed Claims Project, 13 of 15 burns related to warming blankets were due to “hosing” (Mehta 2013). The occurrence of “hosing” even prompted one manufacturer of warming blankets to initiate a campaign www.stophosing.com to provide anti-hosing materials for healthcare facilities and practitioners (Augustine 2002). Mehta recommended that if you anticipate your patient might need active warming during surgery you should apply the disposable warming blanket before surgical draping (since the cost of the disposable blanket is far less than the cost of a burn injury).
And burns may develop from “hosing” in relatively short periods. A case was described in which a patient complained of feeling cold after surgery so 43o C hot air was blown directly on the patient for 30 minutes via the hose of a warming device that was not connected to a blanket (Chung 2012). The patient developed a burn in the left lower abdomen. The patient had also had epidural anesthesia with a blocking level of T10 so it is unclear whether residual loss of sensation in the area might have been an additional contributory factor.
A case that nicely describes how extrinsic factors may contribute to the risk of burns from warming devices was described by Hansen and colleagues (Hansen 2014). They described a case in which a 44-year-old man undergoing ambulatory ENT surgery sustained a 5% total body surface first-degree burn on his lower and lateral torso and upper thigh related to use of a new forced-air warming “gown” system. Because the table on which the patient lay would be rotated to facilitate access to the mouth, special straps were applied to the patient to prevent him from falling off the table. The warming device was set to a “high” setting (43o C) for almost a 4-hour surgical procedure. In addition, during the procedure several instruments, retractors, and other operative devices had been placed on top of the warming device over the patient’s abdomen. On completion of the surgery it was noted the patient had thermal injuries to his flank, lateral torso and upper thigh. The skin abnormalities corresponded to areas underneath the warming device inflow hose and the small airflow perforations in the warming gown. The authors did a root cause analysis and simulated reconstruction that found several very valuable lessons learned. Basically, rather than dispersing the heat over the whole “gown” the heat was confined to a small area bounded by the special straps, the instruments on the abdomen, and the table. The rest of the “gown” was underinflated.
The other key finding was that despite the temperature setting being on “high” for the duration of surgery, the patient’s temperature never rose above 35.7o C during the procedure. The authors retrospectively note that should have been a flag that something was not right. The patient’s temperature was being monitored via the axilla and staff may have attributed some of the problem to the fact that axillary temperatures are less reliable than oral, rectal or bladder temperatures.
Their conclusions and recommendations, plus those in the accompanying editorial (Rohr 2014), would be:
Note: We have a special comment about instruments placed on top of the patient. In our previous two columns on iatrogenic burns we noted instances where flash-sterilized tools or instruments that were “too hot to handle” were placed on drapes overlying the patient, resulting in burns to the patient.
Another paper highlighting multiple contributory factors described burns in two infants that were just opposite the exit vents of their warming blankets (Azzam 1995). In both cases the high setting (45o C) was used initially and converted to the medium setting once the infant’s temperature reached 37o C. They felt that the combination of a warming cover, plastic drape, and surgical sheets may have created a microenvironment which prevented dissipation of the heat. They note the FDA had previously mentioned contact of heated plastic with skin as a contributing factor to some warming blanket-related thermal injuries. Azzam and Krock’s recommendations were:
The role of sensory loss may also be significant. Warnings about risks of using warming blankets in diabetic patients go way back. While many of those warnings were lumped together with other warnings about using such devices in patients with poor tissue perfusion, the other significant factor in diabetics is neuropathy and loss of sensation. One report (Uzun 2010) described a 64-year-old man with type 2 diabetes of 12 years’ duration who developed a third-degree burn on his ankle after coronary bypass surgery. He had begun complaining of cold after surgery so was heated with a forced-air warming system. The nozzle of the device was not connected to the blanket and hot air at 40–43°C was blown directly onto his legs for nearly 2 hours. In addition to absent pedal pulses the 10-g-Semmes–Weinstein monofilament test revealed reduced sensation suggestive of diabetic peripheral neuropathy. In the case we noted earlier (Chung 2012) we speculated that loss of sensation related to epidural anesthesia might have been an additional factor contributing to a burn. And in a case noted below (Khan 2011), due to a hot pack rather than a warming blanket, loss of sensation in a paraplegic patient likely contributed to the burn.
The role of pressure, particularly over bony prominences, has also contributed in some cases. In one of the earliest reports of injuries related to thermal blankets in the OR, Scott reported 3 cases of skin and tissue necrosis in direct relationship to thermal blankets (Scott 1967). Each patient had prolonged exposure to warming blankets during cardiac surgery, often first at room temperature then at 40-42o C. The analysis focuses as much on the role of pressure over bony protruberances as on thermal injury. However, in one case a metal plate overlying the skin might have acted as a heat conductor. Crino and Nagel also found burns overlying bony prominences in two patients with burns related to warming blankets (Crino 1968). In describing a sacral thermal burn due to use of a “hot pack” in a paraplegic patient who had lost sensation in the area being treated Khan et al. (Khan 2011) noted multiple factors played a role in the tissue damage. In addition to the patient being insensate to the heat, the duration of the treatment was longer than usual and the hot pack was encased in its synthetic case, lacking the usual padding or towel wraps used with such treatments. That additional pressure likely played a role. Note that the risk equation for burns has usually been described as “temperature x duration”. Perhaps it should be “temperature x duration x pressure”. In fact, in view of the “hosing” injuries and the cases described with very focused exposure to hot air (Hansen 2014, Uzun 2010, Chung 2012) the role of surface area exposed to heat needs to be considered as well. Perhaps the risk equation should be “temperature x duration x pressure x area of exposure”.
Crino and Nagel (Crino 1968) also called attention to the need to consider duration of the procedure. Note that we have always recommended an issue to be discussed during the pre-op huddle/briefing (see, for example, our July 22, 2014 Patient Safety Tip of the Week “More on Operating Room Briefings and Debriefings”) is the expected duration of the procedure and what contingencies need to be considered if that duration is exceeded. The usual considerations would be things like additional doses of prophylactic antibiotics, repositioning of patients to avoid nerve injuries or decubiti, and consideration for DVT prophylaxis. It would probably be wise to add consideration of factors related to warming blankets or related devices (eg. skin examination, temperature settings, etc.) to your pre-op huddle/briefing.
And, lest one get the impression that burns suffered from misuse of or malfunction of warming blankets and related devices, a case of a fatal 30% full-thickness total body surface area burn has been reported (Sadove 1992).
Note also that, though we have focused on warming blankets and related devices in today’s column, many of the same contributory factors and considerations also apply to use of hot packs, hot water bottles and similar devices. In Massachusetts (Massachusetts DPH 2014) there were 16 serious reportable events related to serious injury or death from burns in 2013, up from 6 in 2011 (though the definition of such events was expanded in 2012). Though some of these were due to operating room fires or hot beverage spills, others were due to heating packs applied without protective cover, for too long a period of time, or not meeting safe standards (e.g. improvised heating pads). Factors such as insensitivity to pain and pressure over bony prominences may contribute to these injuries as well. In describing a thermal burn due to use of a “hot pack” in a paraplegic patient who had lost sensation in the area being treated Khan et al. (Khan 2011) noted multiple factors played a role in the tissue damage. In addition to the patient being insensate to the heat, the duration of the treatment was longer than usual and the hot pack was encased in its synthetic case, lacking the usual padding or towel wraps used with such treatments.
To reiterate recommendations to avoid thermal injuries from warming blankets and related devices:
While today’s focus is on warming blankets and related devices you’ll find many valuable lessons about other iatrogenic burns and OR fires in our prior columns.
Our prior columns on iatrogenic burns:
Our prior columns on surgical fires:
Press Association. Hospital trust faces fine after surgery patient is burned by warming blanket. The Guardian 2014; Friday 12 December 2014
Pilkington D. The hi-tech hospital mattress that left this man with third-degree burns: Equipment similar to an electric blanket overheated during surgery. The Daily Mail 2014; 14 October 2014
Truell KD, Bakerman PR, Teodori MF, Maze A. Third-degree burns due to intraoperative use of a Bair Hugger warming device. Annals of Thoracic Surgery 2000; 69(6): 1933-1934
Marders J. FDA Encourages the Reporting of Medical Device Adverse Events: Free-Hosing Hazards. APSF Newsletter 2002; 17(3): Fall 2002
Mehta SP. Burn Injuries From Warming Devices in the Operating Room. American Society of Anesthesiologists Newsletter 2013; 77(2): 16-17
Stop Hosing website.
Augustine S. Misuse of Forced-Air Warming Devices Causes Burns. APSF Newsletter 2002; 17(1): Spring 2002
Chung, K., Lee, S., Oh, S.-C., Choi, J., & Cho, H.-S. (2012). Thermal burn injury associated with a forced-air warming device. Korean Journal of Anesthesiology 2012; 62(4): 391-392
Hansen EK, Apostolidou I, Layton H, et al. Thermal Burn Associated with Intraoperative Convective Forced-Air Warming Blanket (Bair Paws™ Flex Gown System). A&A Case Reports 2014; 3(7): 81-83
Rohr JM. Editorial Comment: Manufacturer’s Response to Thermal Burn Associated with Intraoperative Convective Forced-Air Warming Blanket (Bair Paws™ Flex Gown System). A&A Case Reports 2014; 3(7): 84
Azzam FJ, Krock JL. Thermal Burns in Two Infants Associated with a Forced Air Warming System. Anesth Analg 1995; 81(3): 861
Uzun G, Mutluoglu M, Evinc R, Ozdemir Y, Sen H. Severe burn injury associated with misuse of forced-air warming device. J Anesth 2010; 24: 980-981
Khan MA, Jamnadas-Khoda B, Gorman M, et al. Iatrogenic burns from the use of hot packs in paraplegic insensate patients. Injury Extra 2011; 42(6): 64-65
Scott SM. Thermal blanket injury in the operating room. Arch Surg 1967; 94(2): 181
Crino MH, Nagel el. Thermal Burns Caused by Warming Blankets in the Operating Room. Anesthesiology 1968; 29(1): 149-150
Sadove RC, Furgasen TG. Major thermal burn as a result of intraoperative heating blanket use. J Burn Care Rehabil 1992; 13(4): 443-445
Massachusetts Department of Public Health. Public Health Council Presentation on Serious Reportable Events in Massachusetts Hospitals – August 2014
December 30, 2014
Data Accumulates on Impact of Long Surgical Duration
You’ve seen it at your facilities: surgeons blame late OR starts and long cases on the anesthesiologists taking too much time and anesthesiologists blame the surgeons for showing up late for cases and taking too long to operate. And those perceptions actually confound each other because the assumption that one or the other will be late may actually cause surgeons and anesthesiologists to delay! And neither are very good at predicting how long a case will actually take.
Yet another study has demonstrated a disparity between the ability of surgeons and anesthesia personnel to predict procedure duration and the actual duration of the procedures (Travis 2014). The researchers found that general surgeons in a New Zealand hospital underestimated the time required for the procedure by 31 minutes. Plastic surgeons underestimated by 5 minutes but orthopedic surgeons actually overestimated by 1 minute. Interestingly, anesthetists underestimated by 35 minutes. The authors conclude that the inability of clinicians to predict the necessary time for a procedure is a significant cause of delay in the operating room but there are potential differences between specialties.
Yes, such misperceptions of procedure times do wreak havoc with efficient operating room scheduling and throughput. They probably also lead to problems in teamwork and communication and morale. But we are most concerned about the potential impact for this time disparity from a patient safety perspective.
We’ve already discussed the issue in several prior columns (see our Patient Safety Tips of the Week for August 26, 2014 “Surgeons’ Perception of Intraoperative Time” and March 10, 2009 “Prolonged Surgical Duration and Time Awareness” and our January 2010 What’s New in the Patient Safety World column “Operative Duration and Infection”). There are a variety of adverse events that can potentially occur when surgical cases go past their anticipated times.
One such potential adverse event is the occurrence of venous thrombembolism (VTE). Most of us have assumed over the years that longer surgical procedures were associated with increased risk of deep venous thrombosis (DVT) and pulmonary embolism (PE). In fact, we have long recommended that the operative team discuss either during the pre-op huddle/briefing or the surgical “timeout” the expected duration of the procedure and what contingencies should be considered if a certain duration is exceeded. But, much to our surprise, there really had never been a high quality study looking quantitatively at the relationship between surgery duration and VTE risk. Now a new study has done just that (Kim 2014). The researchers, using data from the American College of Surgeons National Surgical Quality Improvement Program on over 1.4 million patients undergoing surgery with general anesthesia, found an association between surgical duration and VTE that increased in a stepwise fashion. Compared with a procedure of average duration, patients undergoing the longest procedures experienced a 1.27-fold increase in the odds of developing a VTE event.
Another recent study looked at duration of surgery as a possible risk factor for complications in neurosurgery (Golebiowski 2014). The authors did a review of 1,000 consecutive patients who underwent planned surgery for intracranial tumors at a single institution. They found that duration of surgery together with comorbidity and acquired neurological deficits is an independent risk factor for extracranial complications after brain tumor surgery. Duration of surgery was also associated with surgical site infections. The odds ratio for extracranial complications with duration of surgery per hour was 1.14. The authors note that awareness of the harms of prolonged surgery may help neurosurgeons in planning approaches and equipment and should be considered in regards to training aspects. They also note that, in view of this association between case duration and complications, any potential prolongation of cases for research purposes should be discussed as part of informed consent.
Another study used American College of Surgeons National Surgical Quality Improvement Program data to evaluate the impact or surgical duration in patients who underwent lumbar fusion procedures (Kim, BD et al 2014). They demonstrated that increasing operative time was associated with step-wise increase in risk for overall complications, medical complications, surgical complications, superficial surgical site infection, and postoperative transfusions. Operative duration of 5 hours or more was also associated with increased risk of reoperation, organ/space surgical site infection, sepsis/septic shock, wound dehiscence, and deep vein thrombosis. The editorial accompanying this study, however, urges caution in attributing too much to surgical duration (Pearson 2014). It notes that the reasons for longer cases, including patient-related factors and technical factors, may not have been adequately accounted for in the analysis even though Kim et al. had used multivariate risk-adjusted regression models.
A previous study on risk for postoperative pulmonary complications found that surgical duration of at least 2 hours was one of seven independent risk factors for such complications (Canet 2010). The authors developed a risk index based on these seven objective, easily assessed factors and suggest the index can be used to assess individual risk of postoperative pulmonary complications and focus further research on measures to improve patient care.
Our March 10, 2009 Patient Safety Tip of the Week “Prolonged Surgical Duration and Time Awareness” discussed time unawareness during many surgeries. In addition to the potential impact on infectious complications, we noted that there are other potential patient safety issues related to prolonged surgical duration such as DVT, decubiti, hypothermia, fluid/electrolyte shifts, nerve compression, compartment syndromes, and rhabdomyolysis. Long-duration cases also increase the likelihood of personnel changes that increase the chance of retained foreign objects or retained surgical items (see our August 19, 2014 Patient Safety Tip of the Week “Some More Lessons Learned on Retained Surgical Items”). And the fatigue factor comes into play with longer cases, increasing the likelihood of a variety of other errors.
Surgical case duration is also one of the few modifiable risk factors for surgical infections. A number of studies in the past have demonstrated an association between perioperative infection and the duration of the surgical procedure. In our January 2010 What’s New in the Patient Safety World column “Operative Duration and Infection” we noted a study (Proctor et al 2010) which found the infectious complication rate increased by 2.5% per half hour and hospital length of stay (LOS) also increased geometrically by 6% per half hour.
In our September 29, 2009 Patient Safety Tip of the Week “Perioperative Peripheral Nerve Injuries” and our May 2011 What’s New in the Patient Safety World column “ASA Updates Advisory for Prevention of Perioperative Peripheral Neuropathies” we discussed duration of procedures and position in causing compressive nerve injuries. A recent study (Delaney 2014) noted that total operative time was one of two predictors of postoperative brachial plexus deficits after the Latarjet shoulder procedure.
And remember – it is not just human factors that lead to long surgical cases. There may be system issues as well. In our August 26, 2014 Patient Safety Tip of the Week “Surgeons’ Perception of Intraoperative Time” we noted many factors that may lead to increased surgical durations, including case type and complexity, emergency vs. elective nature, patient-related factors, proficiency of the surgeon, lack of team familiarity, interruptions, equipment issues, presence of trainees and poor communication. Obviously patient-related issues are important. For example, a recent study (Bradley 2014) showed that for total joint replacement each 5-point increase in patient BMI increased operative time by 7 minutes. Unanticipated complications (bleeding, anomalous anatomy, etc.) may occur as well. Even if you do a great job planning in your pre-op huddle/briefing there are always potential contingencies that arise. A key piece of equipment might break or get contaminated, necessitating a delay to get a replacement.
Some have advocated for estimates of and discussions about anticipated surgical duration during the surgical “timeout”. We think that is too late and not the best opportunity for that discussion. Rather, we recommend that the OR team, during the presurgical huddle/briefing, should discuss issues related to prolonged cases. For example, they should discuss whether intraoperative DVT prophylaxis should begin if the procedure lasts beyond a certain duration. Or discuss at what duration a repositioning of the patient might be wise to avoid nerve compression, compartment syndrome, or rhabdomyolysis. And it would be very useful to have an estimate of time remaining to again trigger some discussion on the above issues. In addition to the DVT prophylaxis and repositioning issues, it might raise questions about the need to temporarily ease up on traction. It might direct attention to maintenance of the patient’s body temperature. In a very prolonged case it might raise questions about the need for further doses of prophylactic antibiotics. So good communication begins before the patient has actually entered the OR and is necessary throughout the case to ensure more efficient and safe performance of surgery. (And don’t forget that the postop debriefing may help you save time during your next case as well!)
In our July 22, 2014 Patient Safety Tip of the Week “More on Operating Room Briefings and Debriefings” (and other columns) we noted some of the issues that might be discussed in a pre-op briefing/huddle (plus we’ve added some questions that came from last week’s column “Iatrogenic Burns in the News Again” on iatrogenic burns related to warming devices):
But beware you don’t make the process too complicated. Your pre-op briefing should probably take no more than about 2-3 minutes. Be sure to customize them. A briefing for an orthopedic surgery case is likely to be significantly different than one for a gynecological procedure.
We also recommend that someone in the OR, usually the anesthesiologist, be tasked with calling out the running case duration at regular intervals (for example, every 30 minutes and more often as the case approaches the average duration for similar cases). That makes everyone aware of the issues that may need to be considered in cases that are taking longer than expected. The announcement of the duration should be accompanied by announcement of pre-agreed-upon actions (for example, a second dose of antibiotics or a change in patient positioning).
In our August 26, 2014 Patient Safety Tip of the Week “Surgeons’ Perception of Intraoperative Time” we noted no one is happy when surgical cases take too long. There are safety issues, as noted above, for the patient. Staff dissatisfaction increases. Other patients and surgeons become disappointed if their subsequent case has to be cancelled (and that next patient’s employer becomes unhappy if he/she has to take a second day off from work). Your surgical scheduling becomes chaotic. Your hospital or facility may suffer financially due to unexpected overtime costs and lost opportunity costs (for other cases that might have been done).
So make surgical case duration an issue of importance for your organization. Make sure you keep good data on duration of all cases, major and minor, and actually utilize that data during scheduling. Do your pre-op huddles/briefings and post-op debriefings in all cases. And make intraoperative time awareness part of your regular OR routines.
Our prior columns focusing on surgical case duration:
See our prior columns on huddles, briefings, and debriefings:
Travis E, Woodhouse S, Tan R, et al. Operating theatre time, where does it all go? A prospective observational study. BMJ 2014; 349: g7182
Kim JYS, Khavanin N, Rambachan A, et al. Surgical Duration and Risk of Venous Thromboembolism. JAMA Surg 2014; Published online December 03, 2014
Golebiowski A, Drewes C, Gulati S, et al. Is duration of surgery a risk factor for extracranial complications and surgical site infections after intracranial tumor operations?
Acta Neurochirurgica 2014; Date: 02 Dec 2014
Kim BD, Hsu WK, De Oliveira GS, et al. Operative Duration as an Independent Risk Factor for Postoperative Complications in Single-Level Lumbar Fusion: An Analysis of 4588 Surgical Cases. Spine 2014; 39(6): 510-520
Pearson A. Duration of Surgery: Independent Risk Factor for Complications? The Spine Blog March 28, 2014
Canet J, Gallart L, Gomar C, et al. Prediction of Postoperative Pulmonary Complications in a Population-based Surgical Cohort. Anesthesiology 2010; 113(6): 1338-1350
Procter LD, Davenport DL, Bernard AC, Zwischenberger JB. General Surgical Operative Duration Is Associated with Increased Risk-Adjusted Infectious Complication Rates and Length of Hospital Stay, Journal of the American College of Surgeons 2010; 210: 60-65
Delaney RA, Freehill MT, Janfaza DR, et al. Neuromonitoring the Latarjet Procedure. Journal of Shoulder and Elbow Surgery 2014; 23(9): e229–e230 Published in issue: September, 2014
Bradley BM, Griffiths SN, Stewart KJ, et al. The Effect of Obesity and Increasing Age on Operative Time and Length of Stay in Primary Hip and Knee Arthroplasty. J Arthroplasty 2014; 29(10) 1906–1910
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