Healthcare Consulting Services
July 7, 2015
Medical Staff Risk Issues
We haven’t done many columns on pure medical staff issues. But several recent articles have appeared that illustrate medical staff issues impacting patient safety. Disruptive physicians, aging physicians, low-volume physicians, and too-early adopters all bring issues that impact patient safety and create problems for staff morale, patient satisfaction, and hospital image.
The disruptive physician
The disruptive physician, of course, is typically the most difficult medical staff problem. You all know them. They bully and intimidate staff. The cut corners. They violate rules. They show up late for cases. They throw things. But when you try to take corrective action no one will testify against them. When confronted about their behavior they almost always blame someone else as having been incompetent or doing something wrong.
A very interesting viewpoint on the disruptive physician was recently published (Gewertz 2015). Gewertz begins by describing bad behaviors of physicians. Then he describes an episode where he, himself, flies off the handle when the attendant at his local gym tells him he cannot use his cell phone. (I chuckled when I read this because the previous day I, too, had reacted similarly when a store had double-billed me for a small electronic part and was unable to immediately reverse the error.) Gewertz’s point is that we all have the capability of reacting boorishly at times. But the disruptive physician is not a one-time offender. Despite counseling and anger management techniques the behaviors continue. Gewertz’s suggested solution is two-fold: (1) ratchet up the peer pressure and (2) treat each instance the same way you would treat a serious adverse event. He suggests that the event should be reviewed in a confidential interdisciplinary session where the nature and consequences of the interaction(s) would be discussed openly. So you are really treating this as a “near miss” and looking to prevent such events from leading to real adverse events in the future. He is really linking the bad behavior to threats to patient safety. Indeed, as most medical directors will attest to, sooner or later the disruptive physician is involved in an incident with an untoward patient outcome. And very often those who might have been able to intervene and prevent the incident failed to do so, whereas they would have intervened with physicians not exhibiting disruptive traits and behaviors. Gewertz’s suggested process gets the problem out in the open and he hopes it would increase peer pressure to stop the disruptive behaviors and also dampen the support, overt or otherwise, that some other medical staff members provide for the disruptive physician.
Since the Joint Commission’s Sentinel Event Alert #40 “Behaviors That Undermine a Culture of Safety”, issued in 2008, most hospitals have taken steps to identify egregious behaviors and deal with them appropriately.
But just as bad as the disruptive physician are those described by Lucian Leape in what he considers to be the number one problem in patient safety today: we have a culture of disrespect (see our July 2012 What’s New in the Patient Safety World column “A Culture of Disrespect”). Leape’s 2-part series on the culture of disrespect (Leape 2012a, Leape 2012b) and the video “Lucian Leape on Key Lessons in Patient Safety” describe disrespectful behavior in 6 categories. The first category is the disruptive physician as already noted. But the other categories demonstrate disrespect in more subtle ways.
The second category in part 1 of the Leape papers (Leape 2012a) is humiliating or demeaning treatment of nurses, residents and students. (This is also one of situations where people begin to “learn” disrespectful behaviors and perpetuate the problem.) A third category is passive-aggressive behavior, characterized by negative attitudes, criticizing authority, blaming others, etc. The fourth category, passive disrespect, differs from passive-aggressive behavior in that the latter is often done with with anger and intent to cause psychological harm whereas passive disrespect is not malevolent or rooted in anger. Passive disrespect is much more common. It includes things like chronically being late for meetings, responding slowly to calls, not dictating charts in a timely fashion, and generally being poor team players. Resistance to good practices like hand hygiene, timeouts and use of checklists are common examples. The fifth category is dismissive treatment of patients. They include behavior like interrupting the patient while the patient is trying to explain symptoms, talking “about” the patient on rounds rather than “to” the patient, etc. The last category, systemic disrespect, includes all the system nuances that are disrespectful of patients, physicians, nurses, and all other personnel. Making patients “wait” has become an ingrained fact of life. Productivity and time pressures abound for providers of all disciplines. And minor forms are common: failure to address patients or staff appropriately, lack of “please” and “thank you”, etc. Leape et al. go on to describe the consequences of these behaviors and the many endogenous and exogenous factors involved in producing disrespectful behaviors.
In part 2 (Leape 2012b) the authors discuss what we must do to create a culture of respect. Modeling respectful conduct and leadership are critical and this must be begun in medical school or other professional schools. In addition, they recommend that part of the evaluation process for all staff (including physicians) should include an assessment of respectful behavior (perhaps in a “360 degree” review where personnel at all levels have input into the assessment). Adopting a code of conduct is another first step. But the most important piece is responding appropriately and in a timely fashion when disrespectful behavior occurs. Developing a learning environment (eg. where everyone has equal input into root cause analyses, etc.) is another key to creating a culture of respect.
In our March 29, 2011 Patient Safety Tip of the Week “The Silent Treatment: A Dose of Reality”) we noted a study (DesRoches 2010) which showed many physicians fail to report or confront their colleagues who are either impaired or incompetent. A third of physicians who knew that a colleague was incompetent or impaired failed to report that physician. The most common reasons cited were belief that someone else would take care of reporting, belief that nothing would happen as a result of reporting, and fear of retribution. The same applies to addressing the disruptive physician. In that column we also highlighted the 2007 American College of Physician Executives (ACPE) Quality of Care Survey (Steiger 2007) which revealed numerous examples of failure of the system as a whole to deal with incompetent, impaired or disruptive physicians.
Turning a blind eye or deaf ear to such problems just continues to make the working environment worse for all parties involved. We’ve seen numerous occasions where staff had previously stepped forward to report such behaviors, only to be ignored or, worse yet, suffer retribution for their actions. So the organization as a whole needs to ensure a supportive environment is present so that staff do not feel uncomfortable in confronting such individuals or in addressing such threats to patient safety. You can have all the policies and procedures in the world but if your culture is not conducive to eliminating these hazards we will never move patient safety to that next level. You’ve often heard the phrase “culture trumps ________” (fill in the blank with words like policy, procedure, strategy, tactics, vision, etc). In fact, “Culture trumps…Everything!”
The physician with patient complaints is often a related issue. A new study developed an algorithm to predict physician risk of formal patient complaints using routinely collected administrative data (Spittal 2015). The PRONE (Predicted Risk Of New Event) score is based upon 4 variables: (1) physician specialty (2) physician gender (3) number of previous complaints (4) time since last complaint. While most patient complaints (60%) were related to clinical issues, about a fifth were related to communication issues (13% related to physician attitude or manner). The algorithm led to a possible total score of 22. Those with scores of 0-2 had a 14% risk of a complaint in the next 2 years, whereas those with scores of 15-17 had an 88% risk of a complaint in the next 2 years. The authors suggest the PRONE score could be used to flag physicians needing deeper review. They also suggest one might “tier” interventions based upon the PRONE score. This is interesting and likely to be especially of interest to risk managers. But review of patient complaint patterns should be part of the credentialing process for all healthcare providers.
In our July 2013 What’s New in the Patient Safety World column “"Bad Apples" Back In?” we noted a study by Bismark et al. (Bismark 2013) which found that 3% of Australia’s medical workforce accounted for 49% of all complaints by patients and 1% accounted for 25% of the complaints. Moreover, there was a striking dose-response relationship, i.e. the more complaints about a physician the higher the likelihood that there would be yet further complaints. A doctor with a third complaint had a 38% chance of a further complaint within a year and 57% chance of another complaint within 2 years. For one with a fifth complaint, the chance of another complaint within 1 and 2 years, respectively, was 59% and 79%. The authors point out that we are often too late to respond to physicians who have attracted multiple complaints and that we should really look at complaints as sentinel events. The hope is that early response may result in changes in physician behaviors. An accompanying editorial (Paterson 2013) noted that patient complaints are the “canaries in the coal mine” that should alert us to deeper problems and should not be ignored. Another accompanying editorial (Gallagher 2013) focuses on the need to end our silence and speak up and tell our colleagues about ways they can improve their care and communicate better. They argue we need to do a much better job acting locally (at the departmental, medical staff, academic unit, and clinical unit levels) to address these behaviors before they need to go to higher levels. They also note the need to develop better metrics for incorporating measures of patient satisfaction. And yet a third accompanying editorial (Shojania 2013) argues there is a systems problem and that we need to focus our resources on identifying such individuals and dealing with them. They also note that, in some cases, there may be multiple system problems that lead to a physician attracting multiple complaints (eg. understaffing in a clinical area).
We, of course, would point out that staff complaints about physicians are just as important as patient complaints. Sometimes the patient complaints go elsewhere (eg. to state health departments, professional disciplinary bodies, medical societies, etc.) and you may not be aware of these for some time. Staff complaints are more often available to you immediately. It would be interesting to see how the PRONE score algorithm would work using staff complaints rather than patient complaints.
The aging physician
The other big problem is the aging physician. This is often even more difficult a problem to deal with than the disruptive physician. This physician is usually a very well liked and respected physician who has practiced at the hospital and community for many years. But now his skill levels and perhaps cognitive capabilities have begun to decline. But he/she may not be aware of this decline and everyone is afraid to confront him/her about it. Most of his/her patients still love him/her and the board members are his/her friends or have long interacted with him/her in community activities.
In a few cases he/she wants to continue practicing because they need the income. More commonly they want to continue practicing because they love what they are doing and that is their whole life. They feel obligated to their patients and communities. Some don’t have outside interests and would not know how to exist without coming to the hospital.
In the “old days” these physicians would hang out in the medical staff lounge and be asked to serve as “assistant surgeons” (they didn’t have to actually be surgeons) on surgical cases. But third party payors have now largely eliminated fees for assistant surgeons in all but a few select surgical procedures. So that route for staying active in the hospital has disappeared.
You begin to hear whispers amongst staff about their concerns regarding this physician. They all know that sooner or later he/she is going to do something that might result in patient harm. But they are not willing to come forward with specific examples.
There is a good chance your hospital bylaws have not included any verbiage about physician age since they don’t want to appear discriminatory. And it is extremely difficult to specify an age at which some sort of mandatory evaluation should be done. There are many physicians well in their 70’s who practice just fine and some in their 50’s whose skills have already deteriorated. At a recent AMA meeting the AMA voted to approve a report saying it is time to have a system for assessing the competence of older physicians but there was considerable sentiment expressed that screening physicians at a certain age “is inappropriate and smacks of ageism” (Frellick 2015). However, the AMA has not yet developed criteria or processes for such assessments.
Some times it is a specific physical skill or attribute that declines. We recall one physician who most staff thought was “blind as a bat” who would every year find an ophthalmologist who would certify that his vision was good enough for him to perform surgery.
Having access to truly independent evaluations is critical. Physicians on your own hospital staff are often uncomfortable evaluating a medical staff colleague, knowing that their assessment may result in that physician losing privileges. Equally important in our litiginous society is the threat of a lawsuit by a physician who might lose his/her privileges. We’ve seen instances where such physicians have sued for restraint of trade when a colleague in the same specialty has made an adverse determination about a physician. Because of that latter threat it is often impossible to get such an assessment within the same city or geographic region.
NPR recently did a short segment on a program for evaluating aging surgeons (Whitehead 2015). They highlighted the Aging Surgeon Program at Sinai Hospital/LifeBridge Health in Baltimore and Stanford’s Late Career Practitioner Policy. It’s pointed out that there is a dearth of literature to demonstrate that patient outcomes are any worse for older physicians than younger ones.
There, of course, is precedent in other professions where the safety for others is involved (eg. airline pilots, air traffic controllers, firefighters, etc.) for either mandatory retirement or mandatory competency screening at certain ages.
So while you are waiting for the AMA to come forward with some specific guidelines (it could be a long wait!) you should probably develop general criteria, irrespective of age, that would trigger some sort of independent competency evaluation for your physicians and consider developing an arrangement with one of the programs like the Aging Surgeon Program.
Physicians returning to the workforce
Physicians returning to practice after a gap during which they did not practice is another issue. There are numerous reasons a physician may have had a gap in practice. The gap may have been to raise a family. Or it might have been due to illness. A few years ago we saw a period when the stock market crash depleted retirement resources for many retired physicians, who then sought to re-enter practice. Ensuring that such physicians re-entering practice are competent and up-to-date is therefore very important. In New York State we had a program at Albany Medical College for preparing physicians to reenter practice. A list of physician re-entry programs is also available at PhysicianReentry.org. And the AMA has physician re-entry resources (AMA Physician Re-Entry). A recent article in the southern California press (Gorman 2015) noted physician re-entry programs at Texas A&M Health Science Center and Cedars-Sinai Medical Center and an online program in San Diego that includes several months of course work followed by a written exam and evaluation during mock visits with actors playing the role of patients.
Risks associated with low-volume physicians and hospitals
For many years we have known that there is a relationship between less-than-desirable outcomes and certain procedures performed by surgeons or hospitals who are “low-volume” (i.e. they have performed a relatively low number of such procedures). The list of procedures subject to the low-volume effect keeps growing. Yet low-volume surgeons and low-volume hospitals persist at doing these cases.
Three recent articles in US News & World Report made the issue much more apparent to the general public. The first (Sternberg 2015a) highlighted the significant differences in mortality rates for Medicare patients undergoing certain procedures in hospitals in the lowest quintile of volume (for that procedure) compared to the highest volume quintile over the 3-year period 2010 to 2012. For example, at the low-volume hospitals the mortality rate for knee replacements was double that of the high-volume ones and for hip replacement surgery the mortality rate was 77% higher in the low-volume hospitals. Readmission rates for both procedures were also about 25% higher in the low-volume hospitals.
The second article (Sternberg 2015b) noted that 3 healthcare systems (Dartmouth-Hitchcock, Johns Hopkins, and University of Michigan) have adopted (or will shortly) voluntary limitations of low-volume surgery. The recommended minimum number of procedures per year for 10 procedures are list in a third article (Sternberg 2015c). For example, for knee replacement the recommended annual minimums are 25 per surgeon and 50 per hospital. For hip replacement the recommended annual minimums are also 25 per surgeon and 50 per hospital.
Quite frankly, we don’t think some of these recommendations are rigorous enough. We wouldn’t even consider having a hip replacement from a surgeon who has only done 25 cases per year or a hospital only doing 50 per year.
This issue is a dilemma particularly for rural hospitals. Rural hospitals look to surgical procedures as potential revenue sources, particularly since profit margins are low or negative on the nonsurgical patients they provide care for. The communities and hospital boards also like the idea of providing services locally so patients don’t have to travel long distances for these services. We’ve cautioned such hospitals against setting up programs that cannot be reasonably supported by the volumes coming from their “catchment” area, keeping in mind that many of the potential patients in their geographic area are going to go elsewhere for the surgery anyway. Sometimes the counter argument is using a surgeon who has substantial volume of the procedure at another hospital who will now do surgery at both (or more) hospitals. That is not enough. There is far more to surgery than the surgeon. The rest of the surgical team and those providing the postoperative care must also have extensive experience with the procedure. That is why the newly proposed voluntary standards include case numbers for both surgeons and hospitals.
The “too early adopter”
One of the subthemes related to low-volume surgeons is the “too-early adopter”. This is the physician (often entrepreneurial) who is pushing for a new piece of equipment or pursuing privileges to do a new procedure that has only been done in a few places. Often there is also a hidden conflict of interest (love how those device manufacturers know just who to approach to get their foot in the door!). This is the physician who threatens to “take my business” to your hospital’s competitors if you don’t let him/her do this new procedure at your hospital. Over the last decade we saw hospital after hospital purchase robotic surgical systems based on such threats. They’ll usually also get a patient or two to contact the hospital administration to angrily ask “why aren’t you letting Dr. X do this procedure?”
A recent viewpoint identified this issue as a potential safety “blind spot” (Pradarelli 2015). That article discusses a court case in which a patient sued multiple parties after suffering complications of a robotic-assisted prostatectomy performed by a surgeon who had performed a very low number of such procedures. While the plaintiff failed to prove that the device manufacturer was responsible for damages, the case reiterates that credentialing and privileging are responsibilities of the hospital and medical staff. And you need to be especially aware that new devices have a way of popping up in places like the OR with little advance notice to relevant parties. It is extremely important that your organization have in place policies and procedures that specify if and when a “vendor” may be present in an OR (or other patient care area). If you do allow them access you need to clarify what they may do and you also need to ensure they meet all the other criteria you require for anyone else going into the OR (eg. infection control training, health status screening, etc.) and that the patient is informed of and agrees to their presence. Similarly, when booking surgical or procedural cases you need to make sure staff are on the lookout for “red flags” when unfamiliar pieces of equipment are included or when vendor presence is requested.
Your organization needs to carefully review privilege requests for “new” procedures and determine what the appropriate training requirements are for such. And don’t rely on device manufacturers for the training recommendations. Back in the ‘90’s when laparoscopic surgery was just being developed we saw all sorts of surgeons get a few days of training on pigs by device vendors and then a few proctored cases on real patients followed by issuance of a certificate declaring their competence in the procedure. We all recall that there was then a significant “learning curve” during which patient complication rates were quite high. Better to look at training recommendations from specialty societies, though even these may have some conflicts of interest. But it is pretty clear that your organization is at risk if one of your surgeons has adverse patient outcomes during surgeries that he/she has had little experience with. And don’t forget that you need to consider what training is necessary for the rest of your surgical teams when new procedures are introduced.
Dealing with medical staff issues is always very political and often generates lots of controversy. But those issues that impact on patient safety need to be addressed and with the increased attention in both the media and the medical literature now is a good time to get started.
Gewertz BL. Disrupting Disruptive Physicians. JAMA Surg 2015; 150(5): 385-386
The Joint Commission. Sentinel Event Alert, Issue 40: Behaviors that undermine a culture of safety. July 9, 2008
Leape LL, Shore MF, Dienstag JL, et al. Perspective: a culture of respect, part 1: the nature and causes of disrespectful behavior by physicians. Acad Med. [Epub ahead of print, May 22, 2012] 2012; 87: 1-8. http://journals.lww.com/academicmedicine/Abstract/publishahead/PerspectiveACultureofRespect,Part1The.99620.aspx
Leape LL, Shore MF, Dienstag JL, et al. Perspective: a culture of respect, part 2: creating a culture of respect. [Epub ahead of print, May 22, 2012] Acad Med. 2012; 87: 1-6. http://journals.lww.com/academicmedicine/Abstract/publishahead/PerspectiveACultureofRespect,Part2.99622.aspx
"Lucian Leape on Key Lessons in Patient Safety"
DesRoches CM, Rao SR, Fromson JA, et al. Physicians' Perceptions, Preparedness for Reporting, and Experiences Related to Impaired and Incompetent Colleagues. JAMA 2010; 304(2): 187-193
Steiger B. Doctors Say Many Obstacles Block Paths to Patient Safety. The Physician Executive 2007; 6-14 May • June 2007
Spittal MJ, Bismark MM, Studdert DM. The PRONE score: an algorithm for predicting doctors’ risks of formal patient complaints using routinely collected administrative data. BMJ Qual Saf 2015; Published Online First 8 April 2015
Bismark MM, Spittal MJ, Gurrin LC, et al. Identification of doctors at risk of recurrent complaints: a national study of healthcare complaints in Australia. BMJ Qual Saf 2013; 22: 532-540 Published Online First: 10 April 2013 doi:10.1136/bmjqs-2012-001691
Paterson R. Not so random: patient complaints and ‘frequent flier’ doctors. BMJ Qual Saf 2013;22:525-527 Published Online First: 10 April 2013 doi:10.1136/bmjqs-2013-001902
Gallagher TH, Levinson W. Physicians with multiple patient complaints: ending our silence. BMJ Qual Saf 2013; 22: 521-524 Published Online First: 10 April 2013 doi:10.1136/bmjqs-2013-001880
Shojania KG, Dixon-Woods M. ‘Bad apples’: time to redefine as a type of systems problem? BMJ Qual Saf 2013; 22: 528-531 Published Online First: 6 June 2013 doi:10.1136/bmjqs-2013-002138
Frellick M. Screen Aging Physicians for Competency, Report Asks. Medscape Medical News June 15, 2015
Whitehead N. When Should Surgeons Stop Operating? NPR News June 18, 2015
LifeBridge Health. Aging Surgeon Program
Weinacher A. Medical Staff Update. Stanford to Implement a Late Career Practitioner Policy.
PhysicianReentry.org Physician Reentry Program Links
AMA. Physician Re-entry.
Gorman A. For doctors who take a break from practice, coming back can be tough. Los Angeles Daily News 2015; June 18, 2015
Sternberg S, Dougherty G. Risks Are High at Low-Volume Hospitals. Patients at thousands of hospitals face greater risks from common operations, simply because the surgical teams don't get enough practice. US News & World Report 2015; May 18, 2015
Sternberg S. Hospitals Move to Limit Low-Volume Surgeries. Three of nation's leading hospital systems say they will limit low-volume surgeries. US News & World Report 2015; May 19, 2015
Sternberg S. Low Volume Hospitals: What to Ask. Asking these questions can improve your odds of staying safe during and after surgery. US News & World Report 2015; May 18, 2015
Pradarelli JC, Campbell DA, Dimick JB. Hospital Credentialing and Privileging of Surgeons. A Potential Safety Blind Spot. JAMA 2015; 313(13): 1313-1314
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July 14, 2015
NPSF’s RCA2 Guidelines
We’ve always had a strong conviction that the RCA (root cause analysis) is probably the most important learning tool that an organization with a good culture of safety has at its disposal. We encourage organizations to do RCA’s not just on events with bad patient outcomes but on any event that had the potential to induce harm (near-misses).
In our March 27, 2012 Patient Safety Tip of the Week “Action Plan Strength in RCA’s” we emphasized the importance of tracking whether recommended action steps were implemented following an RCA, whether they were effective, and whether there were any unintended consequences. All too often action steps never get implemented at all or consist solely of “weak” action steps and organizations are then surprised when a similar adverse event occurs in the future. Moreover, even the most well intentioned and well planned action steps sometimes lead to consequences that were never anticipated.
The National Patient Safety Foundation (NPSF) has recently released a very valuable resource to help guide organizations (or even smaller units) in doing root cause analyses (NPSF 2015). NPSF has recognized the above problem with ineffective action steps and has actually coined a new term – the Root Cause Analysis and Actions or RCA2 to emphasize the importance of the action steps.
The RCA2 appropriately acknowledges that the goal of the RCA2 is to prevent the same or similar type of adverse event from occurring in the future. Its goal is to recognize system-related issues and vulnerabilities that place an organization at risk for such occurrences and then to take appropriate action steps to eliminate or mitigate those system-related issues and vulnerabilities.
One key tenet of the RCA2 is that it only addresses system issues. It should not address or focus on individual performance. In fact, NPSF recommends that all organizations should define “blameworthy” events and actions that fall outside the purview of the safety system and define how and under what circumstances they will be handled separately. Of course, we would emphasize that system issues that lead to or facilitate improper individual performance must be addressed under the RCA2 process. For example, workarounds are (often) improper individual actions that almost always have a system issue that led to their use. Another example is “normalization of deviance” where the culture of the system led to acceptance of a certain deviation from proper practice as being “normal” and allowed that deviation to be performed by many individuals.
NPSF cites important revelations from NASA when it looked at its mishap reports. NASA noted that reports on mishaps that are subject to public view typically have two significant shortcomings that compromise the more important intent of mishap investigations. First is that all important information often does not get reported or gets “spun”. Second is that investigations focusing on individual blame tend to be shortened and fail to focus on all the relevant contributing system problems that need to be fixed. Moreover, those focusing on blame tend to generate a false sense of security that the underlying “cause” of an incident has been dealt with. These same caveats often apply to the investigations done in healthcare.
Keeping individual performance out of RCA’s or RCA2’s is important in developing trust in the organization and development of a non-punitive safety culture. Equally important in fostering a good safety culture is providing feedback from the RCA2’s in a timely fashion to those who brought the event to attention, those who may have been involved in the event (directly or indirectly), and all relevant stakeholders in the organization. Identification of system vulnerabilities requires reporting by all (staff, administration, patients, public). To develop trust in the process requires that such reporting be easy and that reporters know that action will be taken and used to improve the safety of the system. Feedback is therefore crucial.
NPSF recognizes that resources are not limitless and that an organization cannot possibly investigate in detail all potential vulnerabilities. Therefore, they recommend every organization develop a risk-based prioritization system for determining which hazards should be addressed first. This emphasizes the need to address issues that are likely to lead to harm before they actually cause harm. The risk-based prioritization system should address both the potential outcome severity and the probability of occurrence. The RCA2 document includes a very useful tool, the Safety Assessment Code (SAC) Matrix, to help in such prioritization. Near-misses (aka “close calls”) also need to be prioritized. The NPSF document notes that close calls occur 10 to 300 times more frequently than actual harm events.
One of the questions we are most often asked about RCA’s is “who should be on the RCA team?”. NPSF does a good job in the RCA2 document of advising regarding this question. They recommend the core team have 4-6 members. This facilitates scheduling meetings and optimizing resource utilization. Of course, many other people will be involved from time to time as interviewees or providers of expertise. NPSF notes that many organizations set aside a specific time slot every week for RCA2 teams that can be cancelled if there are no events or issues that need to be reviewed that week. Our own experience is that even hospitals with as few as 50-100 beds can average 2-4 RCA’s per month so we agree with establishing a regular weekly time slot for RCA2’s. The NPSF document nicely describes who should be on the teams and what qualities they should bring to the team. They emphasize that staff directly involved in an event or supervisors of staff involved in an event should not participate in the RCA2. Using patients (who have not been involved in the event under review) as team members may be helpful and has pros and cons discussed in the NPSF document. Likewise, teaching institutions should consider having a housestaff member participate.
Timing of the initial RCA2 meeting is important. NPSF recommends it be held within 72 hours of the event. That helps ensure that events are accurately recalled by witnesses and should allow enough time for scheduling interviews and other activities. In our July 24, 2007 Patient Safety Tip of the Week “Serious Incident Response Checklist” we discussed the many other things that need to be done immediately after serious events. That column included a link to our Serious Event Response Checklist, which includes things like sequestering involved equipment, identification of witnesses, disclosure to patient or family, notification of regulatory bodies and Board if necessary, and others.
The NPSF document goes on to provide a graphical representation of the RCA2 process. It includes fact finding, flow diagramming, development of causal statements, identification of potential solutions and corrective actions, implementation of action steps, monitoring/measurement and feedback.
In addition to development of the timeline or chronological flow diagram of the event the RCA2 team identifies gaps in knowledge about the event and develops team-generated questions that need to be answered in further interviews, review of documents or policies, consulting experts or best practices, and site visits.
The NPSF document strongly recommends the team visit the location of the event to get a better knowledge of the workspace and environment. In one of our earliest columns (see our April 2, 2007 Patient Safety Tip of the Week “More Alarm Issues”) we noted how multiple visits to the site of an event demonstrated that, rather than a single individual being blameworthy, a fundamental design flaw in the environment consistently led to staff reducing the volumes of critical alarms.
The RCA2 document discusses triggering questions in a very useful appendix. This groups questions into logical categories such as communication, training, fatigue/scheduling, equipment/environment, rules/policies/procedures, and barriers.
The RCA2 document also has an excellent appendix providing interviewing tips. These include recommendations such as having only 1 or 2 team members interview witnesses so as not to intimidate them with a large group. They also stress the importance of steps to ensure the recall of witnesses does not get contaminated (eg. interview as soon as possible, interview only one witness at a time, tell them not to discuss with others, etc.). Perhaps the most important consideration is letting the interviewee understand that the RCA2 is looking for system issues that need to be fixed and the team is not looking for someone to blame. Interviews should be held in a comfortable environment and avoid making it look like a legal deposition or trial. That is especially true when interviewing patients or their families. We used to see meetings with families held in Board rooms. That was probably the worst possible environment. It was intimidating for families and also gave the impression they were “up against a faceless corporate enemy”.
The NPSF RCA2 document provides several other useful tools in appendices, including Cause and Effect Diagramming and the Five Rules of Causation.
Perhaps the most important section of the entire document is that regarding actions. One tool provided in the RCA2 document is the Action Hierarchy. We previously discussed strength of actions in our March 27, 2012 Patient Safety Tip of the Week “Action Plan Strength in RCA’s”. In that column we included an analogy to the effectiveness of signs and tools used to try to get drivers to slow down in construction zones on highways. We put them together in pictures with RCA action items and now incorporate them in our webinar presentations on doing good RCA’s. Click here to see them. Remember: images are more likely to be remembered than words!
Our March 27, 2012 Patient Safety Tip of the Week “Action Plan Strength in RCA’s” discussed the importance of making sure recommended actions are carried out. The NPSF document recommends that responsibility for implementing an action be assigned to one individual, not a committee, and that a date be set for implementation. It notes that at least one measure (process or outcome measure) be set for each action and monitored over time. It provides a table with example measures in an appendix.
It is amazing at how often an RCA on a new event uncovers that the action items recommended to prevent recurrence after a previous similar event were never carried out. Our March 30, 2010 Patient Safety Tip of the Week “Publicly Released RCA’s: Everyone Learns from Them” discussed an RCA done on a case where enteral feedings were inadvertently given intravenously. At that hospital there had been a similar incident several years earlier. After the first incident an extensive root cause analysis was done and multiple recommendations were made, including key recommendations that should have prevented the current incident. But all those recommendations had not yet been fully implemented. More importantly, the recommendations were communicated back to those individuals deemed to be in the “need to know” but not widely disseminated to middle or front line management nor to front line staff.
We recommend you keep a list or table of such identified action items from all your RCA’s to discuss at your monthly patient safety committee or performance improvement committee meetings. Action items should remain on that list until they have been implemented or completed. Only that sort of rigorous discipline will ensure that you did what you said you were going to do, i.e. that you “closed the loop”.
One important consideration not specifically noted in the NPSF RCA2 document is monitoring for unintended consequences. As we noted in the introduction of today’s column, even the most well intentioned and well planned action steps sometimes lead to consequences that were never anticipated. The NPSF document does note that staff and/or patients and families should be allowed to make comments during the feedback process and those could possibly identify some potential glitches. But sometimes the unintended consequence does not appear for some time after the action is implemented. For example, one ‘strong” action resulting from an RCA2 might be removal of a certain medication or piece of equipment from a certain clinical setting. Several months later you might find that there was actually an unanticipated need for that medication or equipment.
The RCA2 document emphasizes the importance of leadership. That includes both the CEO and senior administration but also the Board. Those parties must understand and support the RCA2 process and make sure that adequate resources are provided. When a recommended action is not approved by the CEO or Board there should be an explanation as to why such action was not approved. The CEO and Board probably should also have a role in the initial risk-based prioritization system. One study (Morse 2012) noted a variety of reasons for that failure of implementation of action plans but most involved lack of leadership support, usually because the resources needed did not seem commensurate with the proposed value of the action item (see our September 15, 2009 Patient Safety Tip of the Week “ETTO’s: Efficiency-Thoroughness Trade-Offs”).
The RCA2 process should also be completed in a timely fashion. The NPSF document notes that organizations like the VA, Joint Commission, and state health departments recommend or require RCA’s to be completed within 30-45 days. That is a pretty long time frame and may be necessary for some of the actions to get approval from various committees, medical executive committees, Boards, etc. But your major action items identified should start being implemented sooner in most cases. Delays in implementation of some action steps may leave other patients at risk. It might also put the institution at risk for some bad press as one hospital recently learned (Dobbs 2015, True 2015). At that facility a patient died after a 5-fold dosing error of ketamine. The dose ordered was 100 mg but the nurse drew up 500 mg from a multidose vial because he/she anticipated the physician would order more during a procedure and inadvertently gave the patient the full 500 mg dose. Though it contradicted policy, the practice of drawing up extra doses in anticipation that “it might be needed” had become commonplace in the ICU where the event occurred (“normalization of deviance”). An RCA was apparently done promptly and identified several action steps with a few days of the adverse event. However, when the state regulatory agency showed up about 45 days later to survey the facility several of the most important action steps had not yet been completed. One was removal of the 500 mg vials of ketamine from the clinical sites (a strong action) and replacing them with 200 mg vials and this had not yet been accomplished. The other, inservicing of all relevant nursing staff (ordinarily “education” is a weak action but in this particular instance was important since the abnormal practice had become widespread amongst staff in those units) also had not been completed.
There are two additional action steps we feel need to be included in most RCA’s. One is ensuring that the loop is closed regarding disclosure and apology where appropriate (see our numerous columns on disclosure and apology listed at the end of today’s column). After a serious event in which there has been patient harm one individual (often the medical director or the attending physician) should be assigned to be the liaison with the family and keep them updated regarding the status of the findings of the RCA and lessons learned and how they will be used in a constructive manner.
And the other action step has to do with the “second victim” (see our December 17, 2013 Patient Safety Tip of the Week “The Second Victim”). Even though the RCA2 document stresses that issues regarding individual responsibility should not be part of the RCA2 process, sometimes the “second victims” are simply caregivers who did nothing wrong but were deeply impacted by the events. So one action step is making sure your “second victim” program is involved where appropriate. It is also most important that the second victim receive feedback in a prompt fashion after the RCA and investigation have taken place. One study (Ullstrom 2013) found that many second victims needed to understand and learn from the event. But many of the second victims reported lack of followup after conclusion of the investigation.
Your RCA2 program should also be reviewed annually. The NPSF RCA2 document provides examples of measures that should be considered in that annual review.
You’ll find the NPSF’s RCA2 document to be very useful in helping your organization improve its RCA process and ensure that appropriate attention is given to the actions, hence truly doing Root Cause Analysis and Actions or RCA2.
Some of our prior columns on RCA’s, FMEA’s, response to serious incidents, etc:
July 24, 2007 “Serious Incident Response Checklist”
March 30, 2010 “Publicly Released RCA’s: Everyone Learns from Them”
March 27, 2012 “Action Plan Strength in RCA’s”
March 2014 “FMEA to Avoid Breastmilk Mixups”
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”
Other very valuable resources on disclosure and apology:
NPSF (National Patient Safety Foundation) RCA2. Improving Root Cause Analyses and Actions to Prevent Harm. NPSF 2015
Morse RB, Pollack MM. Root Cause Analyses Performed in a Children's Hospital: Events, Action Plan Strength, and Implementation Rates. Journal of Healthcare Quality 2012; 34(1): 55–61)
Dobbs T. Report: After Patient Death, UVM Medical Center Waited Weeks To Fix Flawed Systems. VPR (Vermont Public Radio). July 7, 2015
Vermont Division of Licensing and Protection. April 27, 2015
True M. Patient death after ketamine overdose spurs changes at UVMMC. VTDigger.org 2015; July 9, 2015
Ullström S, Sachs MA, Hansson J, et al. Suffering in silence: a qualitative study of second victims of adverse events. BMJ Qual Saf 2013; Online First 15 November 2013
Print “NPSF’s RCA2 Guidelines”
July 21, 2015
Avoiding Distractions in the OR
We’ve discussed in detail the problem of distractions and interruptions in the OR in our Patient Safety Tips of the Week for May 21, 2013 “Perioperative Distractions” and March 17, 2015 “Distractions in the OR”.
We thought we covered the most important aspects of distractions in the OR and perioperative environment in those previous columns. But Renae Battié, president of AORN, just offered some very practical recommendations for avoiding perioperative distractions in her President’s Message in the July issue of the AORN Journal (Battié 2015).
Battié reiterates three very important elements in maintaining a culture of safety: (1) discussing daily activities with all her staff, (2) recognizing normalization of deviance and (3) recognizing that many of the distractions are created by our own well-intended actions.
We’ve discussed “normalization of deviance” in several of our columns, most recently in our July 14, 2015 Patient Safety Tip of the Week “NPSF’s RCA2 Guidelines”. This is where the culture of the system has led to acceptance of a certain deviation from proper practice as being “normal” and allowed that deviation to be performed by many individuals. The deviation has been used so frequently without serious adverse consequences occurring that staff no longer consider it abnormal. Battié uses the analogy in which we all add a few MPH above the speed limit when driving because we’ve never gotten a speeding citation or had an accident.
Discussions with her staff serve multiple purposes regarding patient and staff safety. They reinforce that “most of what happens every day truly is high risk” and thus demands engagement in every step. But they also bring to light circumstances and actions that may reveal underlying safety vulnerabilities.
Some examples she gives of staff-created distractions are actions such as checking in on coworkers and asking “Do you need a break? or “Do you need any help?”. Such actions both cause unnecessary opening of OR doors (which may, for example, impact infection rates) or lead to distractions that interrupt important activities. Outside the OR these may result in interruptions during other critical activities such as preoperative assessments or medication administration.
Another common cause of distractions and interruptions is related to technology. She notes that her facilities use wireless hands-free communication devices. But sometimes a communication may go to more than just the staff who need to see that particular communication. It is important to recognize whether those alerts or requests for help should go to everyone or just a few key staff.
Battié discusses some techniques that may be useful in minimizing distractions and interruptions. She notes her facility uses red mats in medication dispensing units to signify “no interruption zone”. Her surgical scheduling unit has devised hand signals to signify when they want quiet or when they want assistance.
Here are some of her other recommendations:
Our Patient Safety Tips of the Week May 21, 2013 “Perioperative Distractions” and March 17, 2015 “Distractions in the OR” had detailed discussion about use of cell phones and other wireless devices in and around the OR with multiple examples of distractions related to such in the OR. There are a multitude of issues related to cell phones in the OR including not only interruptions and distractions but also infection control issues, security and confidentiality issues, and detrimental effects on communication in the OR. Our recommendation is for all the OR team to leave their cellphones at the main OR desk where someone can triage incoming phone calls and messages.
You’ll, of course, get the argument “I use my cellphone to access important information pertinent to the case” (like drug information, guidelines, images, reports, etc.). But most of that information can be obtained from devices that do not also send instant messages, texts and phone calls. And if the surgeon really wants to see an imaging study you want him or her looking at it on a large computer screen rather than a small smartphone screen.
Indeed there are legitimate advantages of advanced technology in the OR. The American Association of Nurse Anesthetists recently updated its position paper on use of mobile technology in the perioperative environment and nicely discusses both the pros and cons of such use, along with excellent references (AANA 2015).
Several articles in the lay press (Richtel 2011, Luthra 2015, Hawryluk 2015) have highlighted high profile cases in which distractions occurred in the OR due to personal use of smartphones. The Hawryluk article discussed in detail the issue of distractions from smartphones in the OR, highlighting some of the work by anesthesiologist Dr. Peter Papadakos (Papadakos 2011) that we discussed in our May 21, 2013 Patient Safety Tip of the Week “Perioperative Distractions”.
The logical comparison of cell phone use in the OR is texting while driving. We fully anticipate that subpoenaing cell phone records after OR incidents may become as common as it is done after vehicular accidents (automobile, airplane, railroad, etc.). Members of the Committee on Electronic Media and Information Technology of the American Society of Anesthesiologists recently addressed the issue (Klumpner 2015). To quote Klumpner and colleagues “Anything You Say or Do (Electronically) May Be Used Against You …”. They note that traces of internet browsing, texts, Facebook posts, etc. can be found long after you’d think they would be gone and that deleting such may also be illegal or a criminal activity.
Our multiple columns on interruptions and distractions are listed below but we think you’ll find our Patient Safety Tips of the Week for May 21, 2013 “Perioperative Distractions” and March 17, 2015 Patient Safety Tip of the Week “Distractions in the OR” especially helpful.
Prior Patient Safety Tips of the Week dealing with interruptions and distractions:
See our prior columns on huddles, briefings, and debriefings:
Battié RN. Thriving in the Midst of Distractions. AORN Journal 2015; 102(1): 1-3
American Association of Nurse Anesthetists (AANA). Mobile Information Technology (Position Statement). Updated 2015.
Richtel M. As doctors use more devices, potential for distraction grows. New York Times. December 14, 2011
Luthra S. Do Cell Phones Belong in the Operating Room? Kaiser Health News 2015; July 14, 2015
Hawryluk M. Is your surgeon focused on you or his smartphone? The Bulletin (Bend, OR) 2015; Published Feb 1, 2015, Updated Feb 2, 2015
Papadakos PJ. Electronic Distraction: An Unmeasured Variable in Modern Medicine. Anesthesiology News 2011; 37:11 November 2011
Klumpner TT, Biggs DA, Gottlieb O. Technology: An Uninvited Guest in the O.R.? (American Society of Anesthesiologists Article). ASA Newsletter 2015; 79(4) April 1, 2015
Print “Avoiding Distractions in the OR”
July 28, 2015
Not All Falls Are the Same
A fall is a fall is a fall… Not so! Some falls on pediatric units or rehabilitation units or behavioral health units may be much different from falls on med/surg units or long-term care settings. We’ve discussed some of these before (see our Patient Safety Tips of the Week for January 15, 2013 “Falls on Inpatient Psychiatry” and October 7, 2008 “Lessons from Falls....from Rehab Medicine”). And always keep in mind that prevention of falls is really a secondary goal, with the primary goal being to prevent injury related to falls.
So how do we classify falls? It depends on how you intend to use the data about falls. The most widely used “quality” measures for falls simply look at the rate of falls per 1000 patient days or the rate of falls with injury per 1000 patient days. These gross rates can provide very misleading impressions about quality of care and do very little to help quality improvement efforts at the individual facility or unit level.
Various schemes have been proposed to better categorize falls. Some have been based on cause, others on preventability, others on type of unit, outcome of fall, whether a fall was assisted or not, or whether a fall was “intentional”.
In 2012, the National Database of Nursing Quality Indicators launched a project to expand its falls indicator for use on pediatric, neonatal, and psychiatric units (Staggs 2015). The NDNQI is the nation's largest repository of data related to the quality of hospital nursing care.
But defining and categorizing falls on diverse unit types has proved to be quite challenging (Staggs 2015). Staggs and colleagues concede that categorizing falls by cause may be helpful in specific situations but is not beneficial in large-scale quality improvement efforts to track and prevent inpatient falls. For example, categorizing a fall by cause may be helpful in a post-fall analysis for risk management purposes. But there are significant barriers to categorizing hospital-wide falls in a way that allows for confident comparison of rates from one hospital to another.
Staggs and colleagues argue that categorization by cause has too many problems. There is sometimes too much subjectiveness and it’s difficult to separate out which falls are “accidental” and which are “intentional” (similarly there are gray areas between “assisted” falls and “unassisted” falls). Moreover, many falls are indeed multifactorial. The classic example is the visually impaired patient who slips and falls at night because of inadequate lighting. And medications can be factored into a variety of falls.
Falls on pediatric units are particularly problematic when it comes to categorizing. Toddlers may have “developmental” falls as they are learning to walk. Older children may have “intentional” falls as they play. One particular type of event that may be labeled a fall is the “baby drop”. This is where a baby is dropped while being carried, held, or transferred from person to person. It is distinct from other falls on neonatal units, such as an infant rolling off a bed or other piece of furniture. In the NDNQI categorization both falls from furniture and baby/child drops are counted in a unit's total falls count.
A recent Pennsylvania Patient Safety Authority review found a surprising number of newborn injuries related to falls (PPSA 2014). There were 272 newborn falls reported over roughly a 10-year period and suspect this may be an underestimate because parents and family sometimes do not report such falls to staff. They actually categorized 6 types of fall in newborns:
While the numbers at any one hospital are likely to be so low that they would not impact a hospitals overall fall per 1000 patient days rate, they could conceivably impact the falls with injury per 1000 patient days rate because of the high likelihood in injury to the newborn in such falls.
The PPSA review really opened our eyes to a unique population at risk for falls. Combine the unfamiliarity of new parents or relatives with infants and the fatigue or exhaustion from sometimes prolonged labor and it is not surprising that such accidents occur. 58% of the falls occurred between midnight and 7 AM, with a peak between 5 AM and 6 AM.
And parents, family and friends are not the only ones who might drop an infant. In a recent incident, a tired nurse dropped an infant (Grossman 2015). The family was told that the nurse was feeding the newborn infant and burping him, and she was drowsy and fell asleep and dropped him. Apparently there was a resultant skull fracture and intracranial bleeding.
The PPSA review provides strategies for reducing the risk of newborn falls. These include staff education, parent and family education, discussion with parents at each shift, rooming-in without bed-sharing, review of maternal medications, hourly rounding with nurses intervening when finding a sleepy mother with a newborn in her arms, protocols for transport of newborns, and environmental assessments. Parents in one facility were also encouraged to call staff before and after newborn feeding so bedrails could be raised or lowered as appropriate.
PPSA also noted a number of maternal characteristics from the literature that were associated with newborn falls, including:
The PPSA website also has a variety of tools and educational materials pertinent to preventing newborn falls, including an excellent form for post-fall huddles.
The VA has an outstanding fall prevention program and it was recently reviewed (Murphy 2015) in the July/August 2015 issue of VA TIPS (Topics in Patient Safety). The VA National Center for Patient Safety Falls Tool Kit also has many very useful resources available for download.
The VA system (Quigley 2015) uses the classification of fall types from the work of Dr. Janet Morse and colleagues:
Quigley notes that not all falls are preventable. For example, the “unanticipated physiological fall” (exemplified by a seizure or unexpected cardiac event) can’t really be prevented (but it is still included in most fall statistics!). And the intervention programs are tailored to the fall type. For example to prevent “accidental falls” attention is paid to things like reduction of slip and trip hazards, proper lighting, safe exit transfer sides from bed or chair, elevated toilet seat, grab bars on either side of the toilet seat, height adjusted beds etc. And strategies to prevent “anticipated physiological falls” include things like multifactorial fall risk screening and assessment, linking interventions for treatment to specific fall risk factors, determining medications that increase fall risk and modify if possible, examining mobility and transfer skills and deficits and individualize plans to help patients modify or compensate, evaluating for postural hypotension and educate patients to compensate if present, and educating patients and family members about fall risk factors and treatment plan of care. Scheduled toileting programs are emphasized for specific patients. Note that we have really focused on toileting activities in past columns because such a high percentage of falls occur on toileting (see our previous Patient Safety Tips of the Week for December 22, 2009 “Falls on Toileting Activities” and June 9, 2015 “Add This to Your Fall Risk Assessment”). Quigley also stresses the importance of using teach-back strategies in verifying that patients understand the risks and are able to perform the skills necessary to prevent falls.
Our own feeling is that rate of falls with injury per 1000 patient days should remain as a hospital-wide measure that can be used for comparisons. The more generic rate of falls per 1000 patient days should be continued primarily as an internal benchmark for quality improvement purposes. Again, we find determining cause(s) for falls to be valuable in identifying vulnerabilities your system may have in fall and injury prevention.
While you need general fall risk reduction strategies (eg. reducing environmental hazards) you need to do a specific fall risk assessment on every patient and focus especially on those risk factors that are modifiable. And even some non-modifiable fall risk factors may still lead to specific interventions. One example we’ve often given is that male gender has been identified in some tools as a risk factor for falls. While you obviously cannot modify that risk factor, you might look extra carefully at toileting needs of the male patient. As before, we don’t know how much of the male risk for falls is “macho” vs. “modesty”. But if that latter is a factor in raising the fall risk during toileting in males, you may need to consider having non-female staff assist the males in toileting activities.
You also need to beware that risk prediction scores may give you a false sense of confidence. Many falls occur in patients who scored low on such assessments. And you especially need to remember that the risk of falls in the hospital is ever-changing and needs to be updated not just daily but also when certain key events take place. For example, any time a new medication is prescribed the fall risk should be reassessed (a good EHR with clinical decision support might alert nursing to redo the fall risk assessment when a medication known to be associated with falls is begun).
Some of our prior columns related to falls:
Some of our previous columns on falls after correction of vision:
June 2010 “Seeing Clearly a Common Sense Intervention”
June 2014 “New Glasses and Fall Risk”
August 2014 “Cataract Surgery and Falls”
Some of our previous columns on head trauma in the anticoagulated patient:
April 16, 2007 “Falls With Injury”
July 17, 2007 “Falls in Patients on Coumadin or Heparin or Other Anticoagulants”
June 5, 2012 “Minor Head Trauma in the Anticoagulated Patient”.
July 8, 2014 “Update: Minor Head Trauma in the Anticoagulated Patient”
Staggs VS, Davidson J, Dunton N, Crosser B. Challenges in Defining and Categorizing Falls on Diverse Unit Types: Lessons from Expansion of the NDNQI Falls Indicator. Journal of Nursing Care Quality 2015; 30(2): 106-112
Pennsylvania Patient Safety Authority (PPSA). Balancing Family and Newborn Bonding with Patient Safety. Pa Patient Saf Advis 2014; 11(3): 102-108
Grossman J. Drowsy Nurse Drops Newborn Baby in Pennsylvania. Huff Post Blog
Murphy J. Understanding the VA Fall Reduction. VA TIPS (Topics in Patient Safety) 2015; 15(4): 1-3
VA National Center for Patient Safety. Falls Tool Kit
Quigley P. Types of Falls and Suggestions to Reduce Them. VA TIPS (Topics in Patient Safety) 2015; 15(4): 3
Print “Not All Falls Are the Same”
August 11, 2015
New Oxygen Guidelines: Thoracic Society of Australia and NZ
Beginning with our April 8, 2008 Patient Safety Tip of the Week “Oxygen as a Medication” we lamented the fact that oxygen is used rather cavalierly in many medical settings. Indications for oxygen use have often lacked a solid evidence base and safety issues are largely ignored. We made a plea that oxygen should be treated just like a medication. It should require a prescription with:
In our January 27, 2009 Patient Safety Tip of the Week “Oxygen Therapy: Everything You Wanted to Know and More!” we highlighted the British Thoracic Society Guideline for Emergency Oxygen Use in Adult Patients (O’Driscoll 2015). Now the Thoracic Society of Australia and New Zealand (TSANZ) has developed new guidelines for oxygen use in the acute medical setting (Beasley 2015). These share many features with the BTS guideline but there are some differences. Also, the TSANZ guidelines do not apply to perioperative patients or ICU patients, though many of the core principles would be the same.
One key difference is in the target oxygen saturation level for most patients. The BTS guideline used an oxygen saturation of 94-98% as the target whereas the TSANZ guideline uses 92-96% as the target. This “compromise” was made to discourage overoxygenation (Walters 2015) but it also allows for identification of both deterioration and improvement in patients on supplemental oxygen. So the oxygen FIO2 or flow rate can be increased if the oxygen saturation falls below the target level but, for example, if a patient’s oxygen saturation reached 97% the FIO2 or flow rate could be reduced. Walters and King (Walters 2015) note that the emphasis is on heeding changes in the levels of oxygen saturation, not for their own sake, but as a reflection of the underlying condition.
The target for those patients with COPD or others at risk for hypercarbia remains 88-92% in both guidelines. In our January 27, 2009 Patient Safety Tip of the Week “Oxygen Therapy: Everything You Wanted to Know and More!” it was also recommended that those patients with a history of previous hypercapnic respiratory failure carry an alert card that contains recommendations about the ideal oxygen dose and target saturation range for that individual patient. Pilcher and Beasley (Pilcher 2015) cite a randomized controlled trial in COPD patients (Austin 2010) that showed mortality was over two times higher in COPD patients randomized to higher concentration oxygen, with a number need to harm (death) of 14.
The TSANZ guidelines do recommend initial arterial blood gas measurements to define the true oxygen and carbon dioxide status of the patient. They note that use of only pulse oximetry tells you nothing about the patient’s CO2 status and note the inaccuracies of venous blood gases for both oxygen and CO2 status.
The indication for supplemental oxygen therapy, with rare exceptions, is hypoxemia. For years we would routinely use supplemental oxygen in patients with acute MI or stroke. But evidence has accumulated that such is not only not helpful but may actually be harmful in patients who are not hypoxemic (see list of columns below on dangers of oxygen therapy). Note that there are patients who are “short of breath” but who have normal oxygen saturations and supplemental oxygen is not indicated in such cases.
The “dose” of oxygen is the oxygen concentration or flow rate anticipated to create the desired oxygen saturation for the particular patient. As we have emphasized before, the target oxygen saturation for most patients is 92-96% but for patients at risk for hypercarbia, such as those with COPD, the target range is lower, usually 88-92%. The oxygen concentration/flow rate should be maintained at a level to keep the oxygen saturation within the target range.
The route of oxygen administration in most cases is via nasal cannula, using FIO2’s in the 24-35% range and flow rates on 1-4 L/minute. Other routes (eg. face mask, non-rebreather reservoir masks, Venturi masks, hi-flow nasal cannula) may be used under certain circumstances.
Monitoring is by pulse oximetry, plus attention to vital signs and level of arousal. However, whenever the potential for respiratory depression is present (eg. COPD, patients with neuromuscular diseases, patients on opioids, etc.) or the patient has known or possible sleep apnea the patient should also be monitored by end-tidal CO2 measurement (capnography). And since it is really almost impossible to identify all patients at risk for sleep apnea or respiratory depression, isn’t it time we make capnography universal?
Patients with sleep apnea and those on opioids or other drugs that may cause respiratory depression merit special consideration. Firstly, they should not be routinely placed on supplemental oxygen. Only if they are hypoxemic at baseline should oxygen be used. The major risk in such patients is hypercarbia and oxygen therapy may in fact mask evolving deterioration. If you are only monitoring oxygen saturation by pulse oximetry and not monitoring end-tidal CO2 the patient may be developing progressive hypercarbia without any appreciable drop in oxygen saturation and then deteriorate precipitously.
Another note of caution regarding pulse oximetry and sleep apnea: oxygenation is normal in sleep apnea patients when they are awake. So a scenario we see over and over again is the nurse responds to the pulse oximetry alarm, the patient wakens, nurse checks the pulse oximeter and it is now working normally and shows a good oxygen saturation. It is assumed that problem leading to the alarm was “false”, perhaps positional in nature, and nothing further is done. The patient now falls asleep and has his bout of sleep apnea.
Unfortunately, at almost every hospital we visit we find patients receiving supplemental oxygen long after their need for it has ceased. That is very costly and exposes the patient to potential adverse effects of oxygen therapy. Therefore, every hospital should consider ways to flag patients no longer in need of oxygen and mechanisms for stopping oxygen therapy. You should have criteria for cessation of oxygen (eg. when x consecutive oxygen saturation readings are above 96%). Most hospitals are afraid of having time-limited orders or automatic stop orders for oxygen but having a “tickler” to trigger an alert for review of oxygen orders is pretty easy to do in today’s CPOE systems.
Note also that there are many other oxygen safety considerations. A major one is ensuring safe transport of patients on supplemental oxygen. Some of our previous columns have noted that a high percentage of in-hospital transports (eg. to radiology) result in supplemental oxygen running out. In others oxygen may be disconnected during transport, sometimes by a non-clinical person who does not understand the importance. Because of this each facility should have a formal transport handoff tool like the “Ticket to Ride” program in which all key safety considerations for transport are in checklist form to be addressed before, during and after transport (see the “Ticket to Ride” columns listed below).
Another issue oxygen cylinders being empty. On our patient safety walk rounds we routinely look at storage of oxygen cylinders. We can’t tell you how many times we find used (empty) cylinders stored together with full ones. It is so easy, particularly under urgent situations, for staff to grab an empty cylinder by mistake.
Metallic oxygen cylinders may also become lethal projectiles in the MRI suite (see our February 19, 2008 Patient Safety Tip of the Week “MRI Safety” and the other columns listed below on MRI safety).
Medical gas mix-ups fortunately have become less common now that facilities use color coding and unique connectors for different gases. Perhaps the one gas mix-up we still see is hooking up a patient to compressed air instead of oxygen.
Oxygen, of course, is one of the three elements of the “fire triad”. While we’ve done numerous columns of surgical/OR fires, don’t forget that all 3 elements may be present in other situations. Patients smoking while on oxygen is the most common cause of oxygen-related fires elsewhere in the hospital but remember that almost any heat source in an oxygen-rich environment can trigger a fire since fuel is ubiquitous.
Oxygen tubing disconnections are also possible. We previously described a case (see our March 5, 2007 Patient Safety Tip of the Week “Disabled Alarms”) in which an oxygen blender alarm on a ventilator failed to alert staff to disconnection of the oxygen source because a piece of tape had been placed over the blender alarm (probably during maintenance). While most such disconnections should readily trigger an alarm from the pulse oximetry system when the O2 saturation falls, in that case there had also been a problem with a faulty pulse oximeter.
Just as you audit the use of medications in your facility, auditing the use of oxygen in your facility should be a mandatory exercise to improve patient safety. However, you are also likely to make your CFO happy because your audit will likely lead to changes that will reduce unnecessary costs associated with inappropriate oxygen use. You should also audit compliance with orders for oxygen therapy. How many times have you gone into a patient room and seen the nasal prongs hanging down on his/her neck or being worn on his/her forehead like a sweatband or bandana!
Some hospitals have a Medical Gas Committee that oversees all aspects related to oxygen (and other gas) use. Much like your Pharmacy and Therapeutics Committee this should be a multidisciplinary body with expertise from multiple departments (medical staff, nursing, respiratory therapy, central supply, biomedical engineering, etc.).
The new TSANZ guidelines essentially make it more difficult to prescribe oxygen and create more documentation (Mitchell 2015) but both are necessary “evils” that translate to good medical care. Implementing many of the other recommendations above also requires human, time and financial resources but likely pays off in the long run.
Some of our prior columns on oxygen and potential harmful effects of oxygen:
April 8, 2008 “Oxygen as a Medication”
January 27, 2009 “Oxygen Therapy: Everything You Wanted to Know and More!”
October 6, 2009 “Oxygen Safety: More Lessons from the UK”
July 2010 “Cochrane Review: Oxygen in MI”
December 6, 2011 “Why You Need to Beware of Oxygen Therapy”
February 2012 “More Evidence of Harm from Oxygen”
March 2014 “Another Strike Against Hyperoxia”
June 17, 2014 “SO2S Confirms Routine O2 of No Benefit in Stroke”
December 2014 “Oxygen Should Be AVOIDed”
Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression:
Some of our prior columns on the “Ticket to Ride” concept:
Some of our prior columns on patient safety issues related to MRI:
O’Driscoll BR, Howard LS, Davison AG and the British Thoracic Society. Emergency Oxygen Guideline Group. BTS Guideline Emergency Oxygen Use in Adult Patients. Thorax 2008; 63 (suppl. VI): 1-68
Beasley R, Chien J, Douglas J, et al. TSANZ Oxygen guidelines for acute oxygen use in adults; swimming between the flags. Respirology. In press 2015
Walters E, King G. Appropriate use of oxygen in acute medicine. Med J Aust 2015; 203(3): 125
Mitchell C. Treat oxygen like a drug. MJA Insight 2015; 27 July 2015
Pilcher J, Beasley R. Acute use of oxygen therapy. Australian Prescriber 2015; 38(3): June 2015
Austin MA, Wills KE, Blizzard L, et al. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial. BMJ 2010; 341: c5462
August 18, 2015
Missing Obstructive Sleep Apnea
Our numerous columns on obstructive sleep apnea (OSA) have focused heavily on patients undergoing surgery (see the list of columns at the end of today’s column). But we know that OSA is highly prevalent in the general population and even more so in hospital inpatients. In our July 2010 What’s New in the Patient Safety World column “Obstructive Sleep Apnea in the General Inpatient Population” we noted a study using the STOP and Berlin questionnaires found a potential 60% prevalence of obstructive sleep apnea in patients admitted to general medicine units in an urban academic hospital, most of whom had never been diagnosed with OSA. Many of the patients were obese and most had comorbidities. A high percentage of these patients received intravenous narcotics or were prescribed benzodiazepines or both and none of these received any supplemental respiratory monitoring. The study highlights the risk of using such medications in potentially high risk patients and also highlights the potential benefits of using simple tools like STOP in identifying potential OSA candidates.
Now another study in a general medical (nonsurgical) inpatient population has confirmed a very high prevalence of OSA (Sharma 2015). Sharma and colleagues evaluated 754 consecutive medical inpatients who had a BMI ≥ 30 with the STOP questionnaire and overnight pulse oximetry. Of these, 636 were deemed to be at high risk for OSA. Subsequent polysomnography was performed on 149 patients and 87% of these had confirmation of OSA. They suggest that the use of the STOP questionnaire plus the overnight pulse oximetry may be a useful strategy to identify at-risk patients, a strategy similar to one previously suggested by Chung and colleagues (see our May 22, 2012 Patient Safety Tip of the Week “Update on Preoperative Screening for Sleep Apnea”).
Another recent study in nonsurgical patients looked at sleep disordered breathing (SDB) in heart failure patients (Khayat 2015). The researchers found in over 1000 patients admitted with acute heart failure and LVEF ≤ 45% and not already diagnosed with SDB that 47% had obstructive sleep apnea (OSA) and 31% had central sleep apnea. They then followed those who survived to discharge to assess long-term mortality. They found that both central sleep apnea and obstructive sleep apnea were independently associated with post-discharge mortality. The same researchers had previously found sleep disordered breathing to be a risk factor for rehospitalization in patients with heart failure (Khayat 2012). Exploratory analysis in the 2015 study suggested that treatment of SDB leads to survival similar to those without SDB.
Litigation related to perioperative complications in patients with OSA seems to be increasing (Fouladpour 2015). Those researchers found most cases reaching verdicts in malpractice cases were relatively young (average age 41.7 years) and male (63%). Complications occurred intraoperatively in 21%, in the PACU in 33%, and on surgical floors in 46%. The most common complications were respiratory arrest in an unmonitored setting and difficulty in airway management. Opioids were felt to play a role in 38% of cases and general anesthetics in 58%. Death occurred in 71% of the cases reviewed. Most cases were elective and some were relatively “minor” procedures (eg. dental extraction, revision of a pacemaker lead). The average financial penalty was $2.5 million in cases where the plaintiff prevailed. The authors discuss the importance of postoperative monitoring in patients with OSA. They also, however, note that problems related to airway management and premature extubations were frequent. They note that ASA guidelines recommend tracheal extubation while the patient is awake and only once neuromuscular blockade has completely resolved, and in the semiupright or lateral position. They conclude that perioperative complications related to OSA are increasingly being reported as the central contention of malpractice suits. These cases can be associated with severe financial penalties.
Another recent study (Weingarten 2015) looked at patients who needed naloxone to reverse opioid-induced respiratory depression or sedation within 48 hours after discharge from anesthetic care (transfer from the postanesthesia care unit or transfer from the operating room to postoperative areas). While they found that a respiratory event in the PACU increased the risk of needing naloxone rescue 5-fold, they also found that obstructive sleep apnea (OSA) increased the risk 2.45 fold. Their findings suggest that these patients may benefit from more careful monitoring after being discharged from anesthesia care.
Long at the top of our list of hospital-based patient safety issues is opioid-induced respiratory depression (see the list below of our previous columns on opioid-related respiratory depression). Opioid use in the hospital setting is substantial and it’s not just surgical patients who are receiving opioids. In our May 6, 2014 Patient Safety Tip of the Week “Monitoring for Opioid-induced Sedation and Respiratory Depression” we noted that over half (51%) of medical inpatients receive opioids, often in high doses (Herzig 2014). And while parenteral opioids have received the most attention, opioids delivered via any route may contribute to respiratory depression, particularly in at-risk patients.
So knowing that a patient has OSA is extremely important in preventing disastrous outcomes. We keep coming back to a study by Lynn and Curry (Lynn 2011) that we discussed in our February 22, 2011 Patient Safety Tip of the Week “Rethinking Alarms”. That article cited 3 patterns of unexplained inpatient deaths, one of which is characteristic of patients with OSA.
But to complicate things even more, a new study from Frances Chung and her colleagues in Toronto shows that a substantial number of patients without preoperative sleep apnea develop moderate-to-severe sleep disordered breathing (SDB) after surgery (Chung 2015). Patients were invited to undergo sleep studies with a portable device preoperatively at home and postoperatively on the first and third night after surgery in the hospital or at home. Of 120 patients who did not have sleep apnea on the preoperative study, 31 (25.8%) were found to have AHI > 15 events/h on postoperative night 1 and/or postoperative night 3. These were mostly driven by obstructive apneas and hypopneas rather than central apneas. Age and preoperative respiratory disturbance index (RDI) were significantly associated with the occurrence of postoperative moderate-to-severe SDB.
The Chung study basically warns us that even patients who have previously tested negative for OSA may still be at risk for OSA when undergoing surgery. The authors note that fluid shifts or medications (opioids or sedatives) may increase the apnea-hypopnea index. They noted that patients in the post-op SDB group were more prone to upper airway collapse in the supine position, which is common after surgery. They note that many may have had undetected upper airway resistance syndrome. They also suggested that the preoperative respiratory disturbance index (RDI) might be of value in predicting which patients will develop post-op SDB but note that further validation is necessary.
In our May 13, 2014 Patient Safety Tip of the Week “Perioperative Sleep Apnea: Human and Financial Impact” we noted a study (Roggenbach 2014) that looked at breathing patterns in 37 patients undergoing major surgery who had not already been diagnosed with OSA. While 59% of the patients had abnormal nocturnal breathing patterns (AHI = 5 or higher) on the pre-op night, they found increases on the third through sixth nights being significant. Previous observations had demonstrated a delayed increase in OSA after surgery, usually in conjunction with the return of REM sleep on the second or third post-op day. But this appears to be the first study to monitor for a longer duration and it shows a substantial increase in the risk of OSA in the late post-op period. Those authors speculate that the surgery itself may have a modulating effect on nocturnal breathing patterns. Their patients underwent major prostate or abdominal surgeries. They note that such surgeries are regularly associated with substantial fluid accumulation and speculate that peripharyngeal soft tissue edema might contribute to reduced airway patency.
Conventional wisdom has been that about 90% of patients with OSA have not yet been diagnosed as having OSA. While the screening methods noted above to identify patients with OSA make sense, inpatients would have already spent at least one night at risk while getting their pulse oximetry. We still think doing the STOP or STOP-Bang questionnaire is advisable but it’s obvious we will still miss some cases of OSA. And, given the new findings from Chung and colleagues, we can’t even be sure that patients with a previous sleep study negative for OSA won’t have OSA while an inpatient.
The bottom line is that appropriate monitoring is needed for any inpatient you intend to treat with opioids or sedative agents. And, as per our multiple columns on opioid-induced respiratory depression (see list below), assessing the patient’s level of arousal before and after doses of such drugs is important but obviously can’t be done on a continuous basis. We’ve also noted numerous times that patients with OSA, when wakened, likely have a normal level of arousal and normal oxygen saturation. Monitoring with only pulse oximetry in inadequate and leads to a false sense of security. So you really need to monitor such patients with capnography or apnea monitoring.
Just about every hospital we’ve been to can recall a patient who died suddenly and unexpectedly (“found dead in a bed”). And when such cases are analyzed we usually find they had risk factors for OSA and were receiving opioids or sedative agents without monitoring. So don’t just consider opioid-induced respiratory depression a problem on surgical services. You probably have just as many patients on medical services that are at risk.
Some of our prior columns on obstructive sleep apnea:
June 10, 2008 “Monitoring the Postoperative COPD Patient”
August 18, 2009 “Obstructive Sleep Apnea in the Perioperative Period”
August 17, 2010 “Preoperative Consultation – Time to Change”
July 13, 2010 “Postoperative Opioid-Induced Respiratory Depression”
November 2010 “More on Preoperative Screening for Obstructive Sleep Apnea”
February 22, 2011 “Rethinking Alarms”
November 22, 2011 “Perioperative Management of Sleep Apnea Disappointing”
May 22, 2012 “Update on Preoperative Screening for Sleep Apnea”
February 12, 2013 “CDPH: Lessons Learned from PCA Incident”
February 19, 2013 “Practical Postoperative Pain Management”
March 26, 2013 “Failure to Recognize Sleep Apnea Before Surgery”
September 24, 2013 “Perioperative Use of CPAP in OSA”
May 13, 2014 “Perioperative Sleep Apnea: Human and Financial Impact”
March 3, 2015 “Factors Related to Postoperative Respiratory Depression”
Our other columns pertaining to opioid-induced respiratory depression:
Sharma S, Mather PJ, Efird JT, et al. Obstructive sleep apnea in obese hospitalized patients: a single center experience. J Clin Sleep Med 2015; 11(7): 717–723
Khayat R, Jarjoura D, Porter K, et al. Sleep disordered breathing and post-discharge mortality in patients with acute heart failure. Eur Heart J 2015; 36(23): 1463-1469 First published online: 30 January 2015
Khayat R, Abraham W, Patt B, et al. Central sleep apnea is a predictor of cardiac readmission in hospitalized patients with systolic heart failure. J Card Fail 2012; 18: 534-540
Fouladpour N, Jesudoss R, Bolden N. et al. Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. Anesthesia & Analgesia 2015; Published ahead of print June 23, 2015
Weingarten TN, Herasevich V, McGlinch MC, et al. Predictors of Delayed Postoperative Respiratory Depression Assessed from Naloxone Administration. Anesth Analg 2015; 121(2): 422-429
Herzig SJ, Rothberg MB, Chekung M, et al. Opioid utilization and opioid-related adverse events in nonsurgical patients in US hospitals. Journal of Hospital Medicine 2014; 9(2): 73-81
Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)
Chung F, Liao P, Yang Y, et al. Postoperative Sleep-Disordered Breathing in Patients Without Preoperative Sleep Apnea. Anesth Analg 2015; 120(6): 1214-1224
Roggenbach J, Saur P, Hofer S, et al. Incidence of perioperative sleep-disordered breathing in patients undergoing major surgery: a prospective cohort study. Patient Safety in Surgery 2014; 8: 13
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August 25, 2015
Checklist for Intrahospital Transport
Many of our columns have highlighted the radiology suite as a site where many patient safety issues occur (see our October 22, 2013 Patient Safety Tip of the Week for “How Safe Is Your Radiology Suite?” and the multiple columns listed below on safety issues in the radiology suite or MRI suite). Many of the same safety issues apply to transport of patients to other areas of the hospital as well (operating room, procedure suites, etc.). So it is critical that the various risks for transporting a patient be accurately addressed and conveyed to all staff when a patient is sent to radiology or other area. One way to facilitate such handoffs is to include information in a structured communication tool for transports like the “Ticket to Ride” we described in our April 8, 2008 column “Oxygen as a Medication”. Clinical researchers in the Netherlands recently developed a checklist for intrahospital transport of critically ill patients that improves upon some previous checklists (Brunsveld-Reinders 2015). We’ll get to the details of that checklist shortly but first we need to describe some of risks involved in such intrahospital transfers.
Most of the literature on the risks associated with intrahospital transport have dealt with critically-ill patients. While incidents do occur during intrahospital transport of non-ICU patients, those from ICU’s are the most vulnerable. The percentage of ICU patients needing such intrahospital transfer probably depends on a host of factors, such as nature of the patient population, imaging capabilities, etc. One study ((Van Velsen 2011) noted that about a third of ICU patients required intrahospital transports. The literature also suggests that the risk of incidents and adverse events during transports is also related to the time duration of the transport. Hence, events such as CT scanning tend to be associated with more incidents because they require more time (PPSA 2005a). We’ll also bet that the percentage of incidents related to transports to the MRI suite has been increasing in the past decade as more and more hospitals have their own MRI suites.
The overall rate of incidents during intrahospital transports is difficult to glean from the literature. In our September 16, 2008 Patient Safety Tip of the Week “More on Radiology as a High Risk Area” we noted studies from the 1980’s and 1990’s that showed rates of transport incidents as high as 70%. A paper by Smith et al (Smith 1990) noted adverse events during 34% of all ICU transports but transport of ICU patients to the CT suite was associated with a 71% incidence of adverse events. Those high rates of transport incidents have probably diminished somewhat. Some of the authors from the current Netherlands study had previously noted an incidence of 3.7% (Van Velsen 2011). But when they prospectively monitored transports in the current study (Brunsveld-Reinders 2015) they found that in 26% of 503 transports to Radiology one or more incidents occurred.
Probably the most comprehensive review of incidents related to intrahospital transport came from the Australian Incident Monitoring Study in Critical Care, reported by researchers from Australia and Johns Hopkins (Beckmann 2004). They found 191 incidents related to intrahospital transport from 37 Australian ICU’s between 1993 and 1999. Roughly a third (31%) of the incidents had serious adverse outcomes, with major physiological derangement in 15%, physical/psychological injury in 4%, death in 2%, and prolonged hospital stay in 4%. In addition, patient/family dissatisfaction occurred in 7%. The site to which the transport occurred was evenly split between the Radiology suite and the OR, with some transports to the ward, ER, or other sites.
They were able to categorize the incidents as equipment-related in 39% and related to patient/staff management issues in 61%. Overall they identified 900 contributing factors, 46% of which were system factors and 54% human-based factors.
Equipment related issues included problems with oxygen, battery/power supply, ventilators, monitors, drug delivery systems, etc. But they also included things like problems with the hospital elevators. The patient/staff management issues mostly had to do with communication issues, airway management, vascular line management, monitoring, and positioning and set-up of equipment.
They did find a number of factors that seemed to prevent or limit harm to patients in the incidents. These included “rechecking equipment”, “rechecking the patient”, “prior experience”, “use of the correct protocol”, and “skilled assistance”. These mitigating factors led the researchers to recommend potential use of checklists, protocols/guidelines for transport, and specific training for transport or use of specialized transport teams. They also stress the importance of adequate monitoring of the patient throughout. Some of the potential checklist items to include relate to oxygen supply, battery life, lines and tubes, and capability of transferring patient between bed, stretcher and table. Preparation must include not only getting the patient and equipment ready but also liaising with the staff at the destination department.
The Beckmann study also demonstrates the value of having incident reporting that allows such drill-down and tracking of intrahospital transport incidents. That, in fact, is a metric we think should be part of an ICU quality and performance improvement program.
Problems maintaining adequate oxygenation are particularly a problem during transport of patients (within or outside of facilities). The Pennsylvania Patient Safety Authority highlighted this issue in a Patient Safety Advisory in 2005 “Continuity of Oxygen Therapy During Intrahospital Transport” (PPSA 2005b). They reviewed numerous reports to the Pennsylvania Patient Safety Reporting System (PA-PSRS) and looked at failure modes in the many steps involved in maintaining adequate oxygen therapy during transport. They noted that oxygen therapy has been reported to be interrupted in as many as 55% of transports. Failure modes identified included: failure to treat with oxygen when ordered, failure to initiate flow from the oxygen source, failure to connect the oxygen tubing to the source, failure to place the oxygen delivery device on the patient, and failure to anticipate the oxygen demand and provide an adequate supply throughout the transport.
Battery power failure (see our February 4, 2014 Patient Safety Tip of the Week “But What If the Battery Runs Low?”) is a potential risk. Not only do portable ventilators run on battery power but monitors and infusion pumps and possibly other equipment may also run on batteries.
In a commentary on the Beckmann study, Shirley and Bion (Shirley 2004) note the importance of making the decision about whether to transport a patient. They note that such decision “should be made by a senior, experienced and appropriately skilled clinician who remains responsible for the conduct of the transfer”. The potential benefits of a transport must be critically weighed against the potential risks. Beckmann et al. cite studies suggesting that care plans were changed for patients after such transports in only 24-39% of cases. So one really needs to consider how likely the imaging study (or other procedure the patient may be going for) is really going to change patient management. (See also the comments below by Day regarding questions to ask in making the decision to transport.)
Shirley and Bion also note that the transport team should be freed up from other responsibilities well in advance to allow adequate time for preparation for the transfer. They also stress that education and training are key and that part of the core curriculum for intensive care medicine should be devoted to transport medicine.
So back to the “Ticket to Ride” or intrahospital transport checklist. In the current Netherlands study (Brunsveld-Reinders 2015) the researchers first searched the literature and various databases for guidelines and checklists, then analyzed incidents that had taken place at their facility during intrahospital transport, and finally interviewed physicians and nurses about their experiences with the incidents. They then developed a checklist, discussed it with experts in the field and tested feasibility and usability.
Of the 5 checklists they found in the literature, only one (Jarden 2010) covered all three phases of transport (pre-transport, during-transport, and post-transport). So they modified that checklist to include other items they found relevant to their hospital.
They were able to identify 118 incidents related to intrahospital transfer at their hospital over the prior 36 months. Of these 38% occurred pre-transport, 47% during transport, and 15% post-transport. Equipment-related issues included, as expected, problems with oxygen supply and battery power to ventilators or infusion pumps, but also included things like equipment not suitable for use with MRI. Organization-related issues included things like inappropriate preparation of the patient leading to delays in transport or inadequate communication with the destination/receiving department. However, when they then prospectively monitored transports they found that in 26% of 503 transports to Radiology one or more incidents occurred.
Post-transport phase issues have been under the radar in the past but the Netherlands group identified many issues. Dislodgement of lines or tubes are often first noticed at this time and patients are often more hypoxic or more hypotensive after transport. They found an increased need for vasopressors or inotropes in many cases and many patients had increased agitation upon return from transports.
We refer you to the Netherlands study itself (Brunsveld-Reinders 2015) to actually see the checklist they created for intrahospital transports. The article also addresses transport team composition (which may vary depending upon whether the patient is ventilated or on pressors or inotropes) and education/training needs for members of the transport team. The equipment check prior to transport includes not only status of the oxygen supply and battery/power supplies but also considerations such as hydration before studies using radiographic contrast or whether equipment is MRI-compatible (eg. non-ferromagnetic materials, long enough IV lines, etc.) if the patient is going for an MRI. Medication and fluid status must be addressed prior to transport. And it is crucial that communication take place with the receiving department to ensure they are ready to accept the patient and whether any items such as informed consent are available. One often-overlooked item is ensuring that the transport route is clear and functional. We’ve seen unsafe transports take place because no one realized an elevator was out of service. They provide considerations for during transport, such as attention to equipment, monitoring, and medications/IV’s. And post-transport they focus on ensuring proper equipment and line/tubing connections, resumption of feeding if applicable, turning on the humidifier on the ventilator, etc. They also stress the importance of reporting any incidents or events that may have happened during the transport.
The Netherlands checklist took an average of 4.5 minutes per phase (range 3 to 10 minutes). It was generally well accepted and one of the key factors in that was its integration with their electronic medical record. A criticism was that documentation of the vital signs during the transport was paper-based rather than integrated with the EMR. Urgency of the transport was noted as an occasional barrier to its use. But we’ll point out that such urgency is a factor likely to contribute to adverse events. That was actually borne out in a German study that showed critical incidents occurred in 7.8% of emergent transfers compared to 2.4% in elective transfers (Lahner 2007). There are few truly emergent situations where the 4.5 minutes to do the checklist are likely to outweigh the benefits of planning for safe transport.
In an excellent review of issues related to intrahospital transport Day describes “the 5 W’s” (Day 2010). The first “W” is “Why” or “Why does the patient need to leave the ICU for the procedure?”. Important questions to ask here are “Are there bedside alternatives for the procedure? And “Is the patient’s condition stable?”. If the patient is considered unstable, the next questions are “Is the transport for a lifesaving intervention?” and “Is the transport to a diagnostic test pivotal to decision for emergent plan?”. Day’s second “W” is “Who”. This included both who is the patient and who will be caring for the patient and, importantly, will a handoff be required? The third “W” is “What” and refers to equipment, airway, ventilator support, circulatory support, and special considerations (eg. spine stability, intracranial pressure monitors, etc.). Under the fourth “W” for “When” Day discusses considerations about coordinating with the timing of the test or procedure (eg. fasting or withholding anticoagulants for procedures), renal protective protocols for contrast-using procedures, and collaborating with other healthcare providers. The last “W” is for “Where” which includes details about the route to be taken, issues regarding MRI safety if going for MRI, etc.
While the Netherlands checklist was developed for intrahospital transport of critically-ill patients, many of the core principles apply to transport of other inpatients as well. We have a few special considerations to comment on.
One issue that probably arises more often in non-ICU patient transports is maintenance of glucose in patients with diabetes. Many of the procedures necessitating intrahospital transport (eg. imaging or OR procedures) may require the patient to be NPO. Hence, in diabetic patients, it is common to hold insulin doses as well prior to the transport. But some patients on longer-acting insulin preparations may still be prone to hypoglycemia during a transport so you may need to ensure they have some glucose source in their IV fluids. Likewise, you have to remember to address oral or enteral intake and insulin dosing once the patient returns from the transport.
The same applies to other medications. If the patient was NPO for the transport they may miss a once daily dose of a medication unless a review of medications is performed when the patient returns.
And don’t neglect the importance of a “Ticket to Ride” type checklist for intrahospital transport of non-ventilated patients or non-ICU patients. There may be some special considerations in such cases. The “Ticket to Ride” concept (see our Patient Safety Tips of the Week for April 8, 2008 “Oxygen as a Medication”, November 18, 2008 “Ticket to Ride: Checklist, Form, or Decision Scorecard?” and August 11, 2009 “The Radiology Suite…Again!”) is a tool ideally suited for the radiology suite. It was originally developed for patients on oxygen therapy needing transport to radiology since studies had shown over 50% of such transports resulted in patients running out of oxygen. However, this concept addressing handoffs has been expanded to include attention to medication management, suicide risk, wandering risk, etc. in patients transported to radiology or other sites within the hospital. A 2009 Pennsylvania Patient Safety Authority “Patient Safety Advisory” discussed development of a standardized handoff communication tool for intrahospital transports (PPSA 2009). It has an excellent discussion on the development of questions you’ll want to use in your own transport communication tool.
Suicide risk should be considered when patients are transported to Radiology (or other sites) whether the patient is on a behavioral health unit or medical unit (see our prior columns January 6, 2009 “Preventing Inpatient Suicides”, February 9, 2010 “More on Preventing Inpatient Suicides” and December 2010 “Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units”). We’ve inspected bathrooms in radiology departments in several hospitals and uniformly found that not only do those bathrooms have numerous “loopable” items that could be used for hanging but also that they can be locked from the inside and there is typically no one readily available with a key to get in. In fact, that is one of the items we added to our patient safety scavenger hunt list (see our March 16, 2010 Patient Safety Tip of the Week “A Patient Safety Scavenger Hunt”). Bathrooms and other rooms in the radiology department also have many other tools and implements that could be used for suicide. So observation protocols for potentially suicidal patients on such units should ensure that doors are not locked (or, if they can be locked, that the “observer” has keys to access the bathroom). Having observers of the same gender as the patient also is recommended.
The “wandering” patient is also a risk when transported to other areas of the hospital. So if you have identified a patient as being at risk for wandering you need to ensure there will be appropriate supervision of that patient throughout the entire transport period.
Fall risk is something you clearly need to consider during intrahospital transports. Patients are likely to transfer from a bed to a wheelchair or gurney then to a table and then back again on many such trips. That provides ample opportunity for patients at risk for falls to actually fall and injure themselves. So the fall risk must be accurately communicated to transport staff as well as staff in the receiving department.
Hypothermia is a risk not often considered in intrahospital transfers. Particularly for some longer imaging studies or other procedures the risk for hypothermia may increase. While vital sign monitoring is mandatory in critically-ill patients on such transports, the focus is usually on blood pressure, pulse, and respiratory status. Measuring the patient’s temperature is often ignored.
One piece of equipment recommended by Day (Day 2010) for transports is a cellphone. While we’ve often discussed the potential distractions caused by cellphones in places like the OR, availability of a cellphone during a transport can be crucial. We recall as a medical student (in the days before cellphones!) being stuck in an elevator on the way to the OR with a patient needing emergent evacuation of a subdural hemaoma. Since delays and unanticipated events are common in intrahospital transports we think Day’s advice about carrying a cellphone on transports is valuable.
Wow! That’s a lot of stuff to consider in a checklist! We’ve discussed design considerations for checklists in several prior columns and it is most important to keep them as simple as possible. Remember: the goal of checklists is to help staff remember important steps or considerations that are easily missed. When checklists get too complicated or contain items that are seldom forgotten, they can become unwieldy and tend to be ignored. Checklist fatigue is real (see our May 2015 What’s New in the Patient Safety World column “The Great Checklist Debate”). In an upcoming column we’ll discuss some of the recent ideas in the literature to help improve the usability of checklists and reduce the risk of checklist fatigue.
Some of our prior columns on the “Ticket to Ride” concept:
Some of our prior columns on patient safety issues in the radiology suite:
Some of our prior columns on patient safety issues related to MRI:
Brunsveld-Reinders AH, Arbous M, Kuiper SG, de Jonge E. A comprehensive method to develop a checklist to increase safety of intra-hospital transport of critically ill patients. Critical Care 2015; 19: 214 (7 May 2015)
Van Velzen C, Brunsveld-Reinders AH, Arbous MS. Incidents related to intrahospital transport of patients in the ICU. Critical Care 2011; 15(Suppl 1): P535
Pennsylvania Patient Safety Authority. Patient Safety Advisory. Is CT a High-Risk Area for Patient Transport? PA PSRS Patient Saf Advis 2005; 2(3): 11-12
Smith I, Fleming S, Cernaianu A. Mishaps during transport from the intensive care unit. Critical Care Medicine. 1990; 18(3):278-281
Beckmann U, Gillies DM, Berenholtz SM, Wu AW, Pronovost P. Incidents relating to the intra-hospital transfer of critically ill patients: An analysis of the reports submitted to the Australian Incident Monitoring Study in Intensive Care. Intensive Care Medicine 2004; 30(8): 1579-1585
Pennsylvania Patient Safety Authority. Patient Safety Advisory. Continuity of Oxygen Therapy During Intrahospital Transport. PA PSRS Patient Saf Advis 2005; 2(3): 9-10
Shirley PJ, Bion JF. Intra-hospital transport of critically ill patients: minimising risk. Intensive Care Medicine 2004; 30(8): 1508-1510
Jarden RJ, Quirke S. Improving safety and documentation in intrahospital transport: development of an intrahospital transport tool for critically ill patients. Intensive Crit Care Nurs 2010; 26: 101-107
Lahner D, Nikolic A, Marhofer P, et al. Incidence of complications in intrahospital transport of critically ill patients: experience in an Austrian university hospital. Wein Klin Wochenschr 2007; 119: 412-416
Day D. Keeping Patients Safe During Intrahospital Transport. Crit Care Nurse 2010; 30: 18-32
Pennsylvania Patient Safety Authority. Patient Safety Advisory. Safe Intrahospital Transport of the non-ICU Patient Using Standardized Handoff Communication.
Pa Patient Saf Advis 2009; 6(1): 16-9
September 1, 2015
We ended our August 25, 2015 Patient Safety Tip of the Week “Checklist for Intrahospital Transport” noting that our checklist was really chock full of items and were wary that we might contribute to a trend toward checklist fatigue that we discussed in our May 2015 What’s New in the Patient Safety World column “The Great Checklist Debate”.
Well, what if we could do something to make use of checklists easier and more manageable? A very insightful perspective by Eliot Grigg on improving use of checklists and avoiding checklist fatigue appears in the August 2015 issue of Anesthesia & Analgesia (Grigg 2015). While written from the view of an anesthesiologist, the concepts apply to almost any checklists in healthcare. We’ll discuss Grigg’s ideas in detail below. But first we need to look at some of the barriers and facilitators for checklist success.
A timely article in Nature (Anthes 2015) nicely summarizes some of the successful checklist implementations and also the failures. That article begins with some striking examples we noted in our May 2015 What’s New in the Patient Safety World column “The Great Checklist Debate”. The original introduction of the WHO Surgical Safety Checklist (Haynes 2009) was associated with striking reductions in both mortality and complication rates. But some studies, such as one done in Ontario, Canada (Urbach 2014) showed that implementation of surgical safety checklists was not associated with significant reductions in operative mortality or complications. And the stunning success of Peter Pronovost’s central line insertion checklist for preventing CLABSI’s at both Johns Hopkins and the Michigan Keystone Project (see our March 2011 What’s New in the Patient Safety World column “Michigan ICU Collaborative Wins Big”) had difficulty being replicated in the “Matching Michigan” program in the UK. So why such variable success in checklist project implementations?
One criticism of most studies on the impact of checklists is their before-after study designs. The argument is that there are often other patient safety initiatives and so many other confounding variables that might explain improvement in the “after” period. Also, the improvements in teamwork, communication, and culture that accompany such initiatives may play as important a role as the checklists themselves. Both are probably true. But in our May 2015 What’s New in the Patient Safety World column “The Great Checklist Debate” we did discuss a recent study using a different design (stepped wedge cluster randomized controlled trial) that demonstrated a significant positive impact of the WHO Surgical Safety Checklist on patient morbidity and mortality (Haugen 2015). The Haugen study even showed a “dose effect” in that larger reductions in complications were seen when all portions of the checklist were followed. And at least one other small randomized controlled trial showed a positive impact of a checklist on post-anesthesia patient handovers (Salzwedel 2013). So there is at least some evidence from better designed studies demonstrating a positive impact from checklists.
Mayer and colleagues found significant variability in use of the WHO Surgical Safety Checklist in the UK (Mayer 2015). Overall, checklist implementation was associated with reduced case-mix-adjusted complications after surgery and was most significant when all 3 components of the checklist were completed. Full, as opposed to partial, checklist completion provides a health policy opportunity to improve checklist impact on surgical safety and quality of care. You’ll also recall that in our May 2015 What’s New in the Patient Safety World column “The Great Checklist Debate” we noted a study that showed a similar “dose-response” effect as part of an overall significant positive impact of the WHO Surgical Safety Checklist on patient morbidity and mortality (Haugen 2015).
In a qualitative study of the implementation of the WHO Surgical Safety Checklist in the UK, Russ and colleagues (Russ 2015a) found 11 themes that represented barriers and 9 themes that represented facilitators. There was wide variation among English hospitals in the adoption and impact of checklist. You’ve often heard us use the saying “culture trumps ________” (fill in the blank with words like policy, procedure, strategy, tactics, vision, etc). In fact, “Culture trumps…Everything!”. Russ and colleagues found a major barrier to be general resistance to change, particularly among senior members of the staff, to be a major barrier. Hierarchical issues also were a barrier in that the person leading the checks (often a nurse) had difficulty when senior surgeons or anesthesiologists were not cooperative. Another organizational barrier was the manner in which the checklist implementation was rolled out. Where there was no planned approach or there was an “imposed” approach, there was little sense of ownership and buy-in was lacking.
But there were also barriers related to the time it took to complete the checklist and issues specific to the checklist. For example, there were design issues (eg. wording, layout, timing of items) and some of the items were not relevant to the particular type of surgery or procedure being done.
Interestingly, many providers questioned the validity of the evidence base for the success of the checklist. The pilot study showing such tremendous improvements included many developing world hospitals and many in the UK felt their systems were already better. A feeling that the checklist might also detract from other patient safety processes was also noted by some.
But Russ and colleagues also identified facilitators for use of the checklist. Having a “champion” is a success factor noted for many patient safety initiatives and the checklist is not different. Particularly having a senior clinician as a champion was seen as key. Also, having a person with strong leadership skills and an assertive presence in the OR leading the checklist process in the OR was particularly important. Organizational facilitators included provision of education and training, providing evidence of efficacy of the checklist and relevance to their local OR, training sessions on how to best use the tool, and feedback on impact of the checklist. Enforced accountability for compliance with the checklist was noted as a facilitator by some, a barrier by others. Inclusive input from the entire multidisciplinary team was a key facilitator. Integrating use of the checklist into existing workflows was an important facilitator, as was avoiding redundancy with other safety initiatives. Also important was the ability to modify the tool for the specific surgical context and to make it more user friendly. Making the checklist less of a “checking the boxes” process and more of a tool to enhance safety discussion was mentioned. Some accomplished this by displaying the checklist on the OR wall rather than using a paper checklist.
Russ and colleagues offer the following lessons for implementing change:
The issue of auditing is a sensitive one. If you implement any kind of improvement initiative in health care you need to collect data to determine whether it is producing the results you intended. But when auditing is perceived as a punitive measure you may inadvertently cause the project to fail. Clay-Williams and Colligan (Clay-Williams 2015) in their perspective on checklist in health care and aviation note that some of the intended benefits of checklists, such as enhanced teamwork and nurses speaking up, may be negated if compliance audits lead to sanctions.
Another study by Russ and colleagues (Russ 2015b) used a standardized observational tool to assess use of the WHO Surgical Safety Checklist on a sample of 5 English hospitals and found large variation across hospitals. They found that, on average, only two thirds of the items were checked, team members were absent in more than 40% of cases, and there was failure to pause or focus on the checks in more than 70% of cases.
“Matching Michigan” was a patient safety program aimed at decreasing central line infections in over 200 intensive care units (ICUs) in England, based upon the Michigan Keystone Project in the US. It largely failed to replicate the overwhelming success seen in The Michigan Keystone Project. CLABSI rates were already lower than those in the original Michigan cohort and improvements were already occurring due to other patient safety initiatives. Though the CLABSI rates did improve some, the “Matching Michigan” project was considered a failure by many. Dixon-Woods and colleagues conducted interview with staff of multiple English ICU’s participating in the program (Dixon-Woods 2013). One unit transformed its practices and culture in response to the program; five boosted existing efforts, and 11 made little change. They found that the perception of the program as a “top-down” initiative imposed on them and punitive in nature was detrimental to the potential success of the program. But individual ICUs’ histories and local context were also highly consequential: their past experience of quality improvement, the extent to which they were able to develop high quality data collection and feedback systems, and the success of local leaders in developing consensus and coalition all influenced the program’s impact on local practices.
Those researchers identified several things that needed to happen to ensure success at hospitals. One was that there had to be at least one senior physician who took a strong leadership role and worked with senior nurses. Also data collection needed to be rigorous and command credibility.
We’ll add one other critical factor that contributes to almost every patient safety or performance improvement program: size matters! By that we mean that initiatives involving smaller groups of staff are far more likely to be successful than big ones. The UK “Matching Michigan” program involved all the hospitals in the UK. The actual Michigan Keystone Project, on the other hand, involved only ICU’s at hospitals volunteering to participate. We think one of the secrets to success is the CUSP (Comprehensive Unit-Based Safety Program) approach (see our March 2011 What’s New in the Patient Safety World column “Michigan ICU Collaborative Wins Big”). In our own experience the patient safety and quality improvement projects that are most successful are those done in relatively small settings where the key participants all know each other and work closely together as affinity groups. Contrast the striking successes of the MHA Keystone ICU project to the relative lack of success of a large scale organizational intervention on patient safety at several UK hospitals. In the UK project there seemed to be a disconnect between the frontline staff and the group overseeing the project.
So what about that perspective by Eliot Grigg on improving use of checklists and avoiding checklist fatigue (Grigg 2015)? Grigg, of course, does offer many of the above-mentioned solutions like changing culture, flattening hierarchies, reducing the number of checklists, or changing the designs of checklists. But Grigg’s best argument is that we have technological capabilities to make the checklists more useable.
Grigg notes that “the goal of ‘smart checklists’ is not to threaten provider autonomy but to mentally offload the many repetitive tasks in health care that must be completed in a largely predictable sequence”. He stresses that the efficient checklist presents the right content at the right time and in the right context. He suggests “filtering” the checklists to only include those things that have yet to be done, often with the help of technology. In that regard, some of the following contextual factors need to be considered (for an OR case):
He gives as an example that a checklist item for antibiotic administration should not be needed if your Anesthesia Information System (AIS) or equivalent electronic OR management system has already documented that the antibiotic has been administered.
Grigg further discusses the aviation analogy of two types of checklist: normal and non-normal. “Normal” checklists are those that deal with the more mundane tasks that are an integral part of routine care. “Non-normal” checklists are those that deal with emergency situations (see our August 16, 2011 Patient Safety Tip of the Week “Crisis Checklists for the OR”). The latter need to be readily available when the emergency arises. An example might be a checklist for dealing with malignant hyperthermia. (Clay-Williams and Colligan (Clay-Williams 2015) refer to these “non-normal” checklists as “boldface” checklists” meaning they are items requiring immediate action.) Note also we have in several previous columns noted a guidance from the UK Civil Aviation Authority that has some excellent recommendations about the design of emergency checklists used in aviation (UK Civil Aviation Authority 2006). Many of those design recommendations could equally apply to the “crisis” checklists needed in places like the OR.
Grigg notes that a crucial component in implementing smart checklists is having devices and software systems in the OR communicate with each other. He notes that all devices should have USB ports and wireless capabilities and use a common language for communicating their current state with each other. He suggests that RFID technology could be used to identify and readily locate both equipment and providers in the OR. And the checklists then ought to be easily accessible electronically and interfaced with the AIS as well.
Let’s apply Grigg’s concepts to the “Ticket to Ride” type checklist we described in last week’s Patient Safety Tip of the Week “Checklist for Intrahospital Transport”. One of the success factors for that checklist was its availability online in their EMR. But let’s take it even further. Important flags, such as whether a patient is at risk for falls or for wandering, might be included on the checklist only if the information from the nursing assessments in the EMR indicates the patient is at risk. Items pertaining to MRI-compatibility of equipment could appear on the checklist only if the patient is being transported for an MRI. The EMR could also indicate whether an informed consent is necessary and has been completed for the particular procedure for which the transport is occurring. Presence of various pieces of equipment on the transport gurney could be indicated via RFID technology. Battery/power status indicators from the equipment could automatically appear on the checklist. Conceivably, the amount of oxygen remaining in the oxygen cylinder might be populated in the checklist automatically via Bluetooth or other wireless technology. Ideally even the availability of elevators needed for the transport might be conveyed in real time. And reminders about restarting feedings or insulin or other medications could populate the post-transport checklist only if they had been withheld prior to the transport. Having such “filtering” could obviously reduce the “Ticket to Ride” checklist to a more manageable size and free up staff to pay more attention to things like maintenance of lines and tubing and monitoring the patient during the transport.
So is there a downside to the type of system envisioned by Grigg? The obvious one is overreliance on electronic systems that might go down periodically. Should the system fail, we could be back at square one and fail to remember some key steps in various processes. However, having such electronic systems working 99+% of the time obviously would likely improve both efficiency and safety.
We remain active advocates of checklists in healthcare. But we’re also wary of checklist fatigue. The suggestions by Grigg to better use technology and filter checklist items out to make checklist more manageable are very valuable.
Some of our prior columns on checklists:
Grigg E. Smarter Clinical Checklists: How to Minimize Checklist Fatigue and Maximize Clinician Performance. Anesth Analg 215; 121(2): 57-573
Anthes E. Hospital checklists are meant to save lives - so why do they often fail? An easy method that promised to cut complications in surgery may not be so simple after all. Nature 2015; 28 July 2015
Haynes A, Weiser T, Berry W, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009; 360(5): 491-499
Urbach DR, Govindarajan A, Saskin R, et al. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med 2014; 370(11): 1029-1038
Haugen AS, Søfteland E, Almeland SK, et al. Effect of the World Health Organization Checklist on Patient Outcomes: A Stepped Wedge Cluster Randomized Controlled Trial. Annals of Surgery 2015; 261(5): 821-828
Salzwedel C, Bartz H-J, Kühnelt I, et al. The effect of a checklist on the quality of post-anaesthesia patient handover: a randomized controlled trial. Int J Qual Health Care 2013; 25(2): 176-181
Mayer EK, Sevdalis N, Rout S, et al. Surgical Checklist Implementation Project: The Impact of Variable WHO Checklist Compliance on Risk-adjusted Clinical Outcomes After National Implementation. A Longitudinal Study. Annals of Surgery 2015; Post Author Corrections: March 13, 2015 doi: 10.1097/SLA.0000000000001185
Russ SJ, Sevdalis N, Moorthy K, et al. A Qualitative Evaluation of the Barriers and Facilitators Toward Implementation of the WHO Surgical Safety Checklist Across Hospitals in England: Lessons From the “Surgical Checklist Implementation Project”. Annals of Surgery 2015; 261(1): 81-91
Clay-Williams R, Colligan L. Back to basics: checklists in aviation and healthcare. BMJ Qual Saf 2015; 24(7): 428-431 Published Online First: 12 May 2015
Russ S, Rout S, Caris J, et al. Measuring Variation in Use of the WHO Surgical Safety Checklist in the Operating Room: A Multicenter Prospective Cross-Sectional Study. J Am Coll Surg 2015; 220(1): 1-11.e4
Dixon-Woods M, Leslie M, Tarrant C, Bion J. Explaining Matching Michigan: an ethnographic study of a patient safety program. Implement Sci 2013; 8: 70
Civil Aviation Authority (UK). CAP 676: Guidance on the Design, Presentation and Use
of Emergency and Abnormal Checklists. 2006.
Print “Smarter Checklists”
September 8, 2015
TREWScore for Early Recognition of Sepsis
The Surviving Sepsis Campaign has focused for several years on reducing the morbidity and mortality from sepsis. Early recognition and aggressive treatment of sepsis are key to survival in patients with sepsis. But recognizing patients at risk for sepsis and septic shock earlier has always been challenging.
Now researchers at Johns Hopkins (Henry 2015) used 27 routinely available physiological and laboratory data from intensive care unit patients to develop the TREWScore (Targeted Real-time Early Warning Score), an early warning score that predicts which patients are at risk for septic shock. The TREWScore identified patients before the onset of septic shock with a sensitivity of 0.85 and specificity of 0.67 and identified patients a median of 28.2 hours before onset of septic shock. Of those identified, two-thirds were identified before any sepsis-related organ dysfunction. Compared to using the MEWS (modified early warning score), the TREWScore demonstrated a 58.6% increase in the number of patients identified before sepsis-related organ failure. The authors conclude that continuous sampling of data from the electronic health records and calculation of TREWScore may allow clinicians to identify patients at risk for septic shock and provide earlier interventions that would prevent or mitigate the associated morbidity and mortality.
This is not the first effort to use information technology to help identify sepsis earlier. In our March 15, 2011 Patient Safety Tip of the Week “Early Warnings for Sepsis” we noted that investigators at Barnes-Jewish Hospital in St. Louis had published preliminary results of a system of real-time computerized alerts for possible sepsis in non-ICU patients (Sawyer 2011). Through review of prior cases the same group of investigators had derived and validated a real-time computerized prediction tool (Thiel 2010). That tool contains both information from vital signs monitoring and a variety of laboratory parameters. When the prediction tool identified a patient on the medicine ward with possible sepsis, an alert was sent automatically (via text page) to the charge nurse on that ward. That nurse would then assess the patient and notify the covering physician, who would decide on any further course of action. Their results showed that patients in the intervention group were more likely to have an increased rate of interventions (such as antibiotic escalation, fluid therapy, oxygen, cultures and other diagnostic tests, etc.) within 12 hours than the nonintervention group. Though both groups had the same rate of transfer to the ICU, those in the intervention group were transferred earlier on average. However, there was no difference in mortality or total hospital length of stay between the two groups, though this pilot study was underpowered to show any such difference.
And earlier this year we noted a study by Umsheid and colleagues that demonstrated that an early warning and response system for sepsis resulted in a significant increase in early sepsis care, ICU transfer, and sepsis documentation (Umscheid 2014). There was also a trend toward decreased sepsis mortality and increased discharge to home that did not reach statistical significance. The system was based on laboratory values and vital signs from the electronic health record monitored in real time. If a patient had ≥4 predefined abnormalities at any single time, the provider, nurse, and rapid response coordinator were notified and performed an immediate bedside patient evaluation.
And two studies presented in abstract form at specialty society meetings this year also demonstrated encouraging results with IT-based systems for early sepsis detection.
One was presented at the HIMSS annual meeting in April (Terry 2015) and discussed an electronic alerting system, POC Advisor, developed by Huntsville Hospital (in Alabama) in conjunction with Wolters-Kluwer. The system collects data from the EMR, lab, nursing notes, and patient monitors and generates alerts for nurses. The nurses then contact the responsible physician and a sepsis protocol is begun. Sensitivity of the tool was 94-98% and specificity 96-99%. During use of the tool mortality fell from 9% to 4.2%. However, in addition to use of the tool, the hospital developed staff education, sepsis protocols, standardized order sets, and sepsis teams. They did note, however, that sepsis deaths did not fall on other floors involved in the study that did not use the alert tool.
The other was presented at the Society of Critical Care Medicine Critical Care Conference in January (Melville 2015) and was used to identify sepsis in trauma patients. It used 4 readily available measures to create a predictive score. Twice-daily measures of the WBC count, heart rate, respiratory rate, and temperature were each given a score of 0 to 4. A score of 4 or higher led to a nurse alerting the clinician, who subsequently identified whether infection was present and initiated therapies. The tool had a sensitivity of 92.5%, specificity of 97.4%, positive predictive value of 73.5% and negative predictive value of 99.4%. Furthermore, the researchers found that use of the tool was associated with a reduction in the 30-day ICU mortality rate (from 13% down to 8%).
It’s not clear how the latter 2 tools compare to the Hopkins-developed tool in terms of how soon at-risk patients are identified. And it is quite likely that components of the sepsis programs in addition to use of the early detection tools played a role in the sepsis mortality improvements. Nevertheless, the ability of these new sepsis prediction tools to identify likely cases earlier is very encouraging.
And there are commercially available surveillance programs. The Cerner Sepsis Biosurveillance Program was recently implemented at Dignity Health Sierra Nevada Memorial Hospital (Cooke 2015).
These sepsis early warning systems are arriving just in time. CMS (The Centers for Medicare & Medicaid Services) has notified hospitals participating in the inpatient quality reporting program that data collection of the Severe Sepsis and Septic Shock: Management Bundle measure (NQF #0500) will begin with discharges on or after Oct. 1, 2015 (QualityNet 2015). Key elements are as follows, with the timeframe for the first three elements being within 3 hours, and the latter four elements (septic shock) within 6 hours:
In our April 1, 2014 Patient Safety Tip of the Week “Expensive Aspects of Sepsis Protocol Debunked” we discussed the results of the ProCESS trial (The ProCESS Investigators 2014). The ProCESS trial involved 31 medical centers and over 1300 patients with sepsis. The patients were randomized to one of 3 treatment arms. One arm received the full early goal-directed therapy (EGDT) protocol, which included the invasive monitoring plus guidelines for vasopressors and blood transfusions. The second arm also received management by a protocol but it did not require the invasive monitoring, vasopressors/inotropes, or blood transfusions. The third arm was the “usual care” group where the clinicians basically decided how to manage the patient. The primary end-point of the trial, mortality at 60 days, did not differ across the 3 trial arms. There were also no differences in secondary outcomes such as 90-day mortality, one-year mortality, and need for organ support.
In the accompanying editorial (Lilly 2014) Craig Lilly, MD noted that guidelines such as those included in state legislation and those endorsed by the National Quality Forum (NQF) needed to be updated now to remove the requirement for central hemodynamic monitoring. It’s pretty clear now that the expense and potential unintended consequences of such monitoring are no longer necessary.
And, indeed, the Surviving Sepsis Campaign has responded “With publication of 3 trials that do not demonstrate superiority of required use of a central venous catheter (CVC) to monitor central venous pressure (CVP) and central venous oxygen saturation (ScvO2) in all patients with septic shock who have received timely antibiotics and fluid resuscitation compared with controls or in all patients with lactate >4 mmol/L, the SSC Executive Committee has revised the improvement bundles.”
Also timely was a review in the New England Journal of Medicine about what’s new in management of septic shock, what is evidence-based and what is uncertain (Seymour 2015). Seymour and Rosengart discuss in detail the studies that led to removal of the need for protocolized invasive early goal-directed therapy (EGDT) from management guidelines. They provide a good discussion on use of focused ultrasound for assessing central hemodynamics, markers of tissue injury, the types of fluids used in resuscitation, the colloid vs. crystalloid issue, and which vasopressors are recommended. They also noted that fluid overload is common in management of septic shock and note uncertainty about the best ways to handle that. They also note that, while measurement of serum lactate is universally recommended in sepsis management, questions remain regarding lactate thresholds and frequency of determination.
In our April 1, 2014 Patient Safety Tip of the Week “Expensive Aspects of Sepsis Protocol Debunked” we did get on our soapbox to express our opinion that some of the perceived improvements in sepsis morbidity and mortality over the last decade may actually have been artifacts of changes in hospital coding practices. The pneumonia patient happily walking up and down the ward hallway pushing his IV pole might now be labelled as having sepsis because he also happens to meet 2 of the 4 SIRS criteria. Hardly what we would have envisioned as a septic patient years ago!
Nevertheless, we still recognize the importance of early recognition, timely antibiotics and adequate fluid resuscitation to reduce morbidity and mortality from sepsis. Hopefully, as more hospitals develop and adopt these computerized tools to identify sepsis earlier we will further reduce the morbidity and mortality from sepsis.
Surviving Sepsis Campaign. Website.
Henry KE, Hager DN, Pronovost PJ, Saria S. A targeted real-time early warning score (TREWScore) for septic shock. Science Translational Medicine 2015; 299(7): 299ra122; 05 Aug 2015
Sawyer AM., Deal EN, Labelle AJ, et al. Implementation of a real-time computerized sepsis alert in nonintensive care unit patients. Critical Care Medicine 2011; 39(3): 469-473
Thiel SW, Rosini JM, Shannon W, et al. Early prediction of septic shock in hospitalized patients. J Hosp Med 2010; 5(1): 19-25
Umscheid CA, Betesh J, VanZandbergen C, et al. Development, implementation, and impact of an automated early warning and response system for sepsis. J Hosp Med 2014; Article first published online: 26 SEP 2014
Terry K. Clinical Decision Support May Help Reduce Sepsis Mortality. Medscape Conference News 2015; May 20, 2015
Healthcare Information and Management Systems Society (HIMSS) Annual Conference and Exhibition: Presentation 109. Presented April 14, 2015
Melville N. Sepsis Screening Tool Spots Subtle Signs, Saves Lives. Medscape Medical News January 23, 2015
Society of Critical Care Medicine (SCCM) 44th Critical Care Congress: Abstract 8. Presented January 18, 2015
Cooke G. New tool at SNMH alerts doctors to potential sepsis cases. The Union (Western Nevada County, CA) 2015; September 1, 2015
QualityNet. Specifications Manual, Version 5.0a. Discharges 10/01/2015 to 06/30/2016. Sepsis Bundle Project (Sep) National Hospital Inpatient Quality Measures (updated 5/29/2015)
The ProCESS Investigators. A Randomized Trial of Protocol-Based Care for Early Septic Shock. N Engl J Med 2014; 370(18): 1683-93 published online March 18, 2014
Lilly CM. The ProCESS Trial - A New Era of Sepsis Management. N Engl J Med 2014; 370(18): 1750-1751 published online March 18, 2014
Surviving Sepsis Campaign. SSC Six-Hour Bundle Revised.
Seymour CW, Rosengart MR. Septic Shock. Advances in Diagnosis and Treatment. JAMA 2015; 314(7): 708-717
September 15, 2015
Another Possible Good Use of a Checklist
Seems like we’ve been talking a lot about checklists lately (see our columns for May 2015 “The Great Checklist Debate”, August 25, 2015 “Checklist for Intrahospital Transport”, and September 1, 2015 “Smarter Checklists”). This week we describe a point-of-care checklist that was introduced as part of a response to a root cause analysis of a chemotherapy incident.
ISMP Canada has reported a case in which a patient intended to receive a chemotherapy infusion over a 7-day period instead received it over 2 days (ISMP Canada 2015). The infusion pump was intended to deliver a fluorouracil infusion at a rate of 1.5 mL/h but it actually delivered the medication at a rate of 5mL/h. The patient was briefly hospitalized after the error was recognized but, fortunately, was able to be discharged shortly thereafter.
Déjà vu! The above case is remarkably similar to ones described in several of our previous columns. Our September 11, 2007 Patient Safety Tip of the Week “Root Cause Analysis of Chemotherapy Overdose” described a case involving a 43 year old woman who was being treated for an advanced nasopharyngeal carcinoma with a chemotherapy protocol of high-dose fluorouracil and cisplatinum. The chemotherapy was to be given intravenously by an infusion pump over a 4-day period. However, the pump was inadvertently programmed to infuse the entire contents over a 4-hour period instead. The patient died as a result of the mishap. We refer you back to that column for details about the numerous contributory factors and root causes found in that case.
In our April 6, 2010 Patient Safety Tip of the Week “Cancer Chemotherapy Accidents” we discussed a case of a patient, being treated for a nasopharyngeal carcinoma, who was to receive the total 5-FU dose over 5 days but the IV pump had erroneously been programmed to administer the dose over 5 hours. From the patient safety perspective, the key factor was a problem programming of the pumps. In fact, there were actually two cases and it was the first case (administering several days worth of a much less toxic agent to a different patient) that alerted the pharmacists that the above patient might have inadvertently received the overdose of 5-FU. The hospital was using pumps that looked very similar but some were programmed in milliliters per hour and others in milliliters per day. Despite a double check by two pharmacists, the error was not noticed until the first patient happened to call the hospital and tell them that her infusion had gone in over several hours rather than several days. Note that in the case in our 2007 column a double check also failed to detect the programming error on the pump. Though we do advocate double checks for high-alert medications we need to remain cognizant of the fact they are not flawless (see our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?”).
The current ISMP Canada article nicely describes the elastomeric infusion pump, which is non-electronic and does not require batteries or other equipment and comes in a variety of sizes and flow rates so they have some advantages for allowing patients to receive infusions at home.
As one of several strategies to reduce the risk of a recurrence of such adverse events the RCA team, with input from human factors experts and front-line staff, developed a point-of-care checklist. This is attached to the elastomeric infusion pump at the point of care by the healthcare provider and discussed with the patient and their family and/or caregivers. This configuration is designed to provide a visual cue when checking the infusion pump. The checklist is affixed to the outer plastic wrap of the pump so that information on the pharmacy label such as the patient name, drug name, dosage, duration and rate of infusion (in mL/h) also remains clearly visible on the pump.
The checklist itself is quite simple:
□ Rate (mL/h) stamped on pump matches Dr. order and Pharmacy label
□ Clamps are OPEN
□ Patient aware of disconnection date and time ________
□ Supplies provided for spill and/or disconnect
In addition to involving the patient in the checklist process, this point-of-care label/checklist remains with the pump, so the patient, family or other caregivers, and all healthcare providers can easily refer to and confirm completion of the checklist steps.
ISMP Canada also indicated it is working with manufacturers to help develop additional safety strategies that could be incorporated into the elastomeric infusions pumps.
One thing we would like to see would be a simple sheet of paper with red lines showing where the expected markings on the pump should be on each day of the intended infusion. The patient (or family/caregiver) could then hold the paper up against the pump and see whether the “anticipated” markings lined up with the actual markings. On day 1 you’d probably also want markings to indicate where the pump markings should be at perhaps 6, 12, 18, and 24 hours so that the patient would be able to identify much sooner a rate that was too rapid.
But one key thing still really bothers us. In our two previous columns we noted no one seemed to be asking “what is the highest dose that a patient could tolerate in one day (or less) if there was inadvertent administration of the infusion?”. A safety culture would design the protocol with sublethal dosages that would protect the patient in the event of “what can go wrong will go wrong”. It also would not put the healthcare workers at the “sharp end” in a situation none of us would want to be in.
The current ISMP Canada article notes that the elastomeric pump provides “convenience” in that it allows the patient to receive the chemotherapy at home. Is it just for the patient’s convenience? Or is it really for the convenience of the healthcare “system”? Yes, it would save healthcare dollars if the patient did not need to come in daily for an infusion or have a home health nurse administer the infusion at home daily. But if someone were to tell us that “We are hanging this potentially lethal dose of medication for your convenience. Nothing will probably go wrong.” we’d be throwing convenience out the door!
So the point-of-care checklist described in the ISMP Canada article may be a good one. But when it comes to potentially lethal consequences we are better off using forcing functions or constraints to avoid those consequences even if they are rare.
We neglected to include another great recent ISMP column on fluorouracil infusion overdoses (ISMP 2015). ISMP has received 3 new reports of such incidents in 2015 and reviewed multiple old cases as well. They have excellent descriptions of the factors contributing to such errors and make recommendations regarding: (1) prescribing clearly (with orders being for single daily doses rather than total course doses) (2) review how you certify your staff for all aspects of chemotherapy management (3) use pumps with safeguards (4) provide education and validate competency (5) enhance independent double checks (6) standardize how key information is displayed on pharmacy labels (7) educate patients about the pump process and how to check to see the infusion is not too rapid. We refer you to the ISMP article for details on each of those recommendations. They have a very good discussion about how easy it may be to choose the wrong pump or enter the wrong dosing programs. They also have good recommendations about managing toxicity.
All good recommendations but, again, we still feel strongly that the biggest danger is hanging an IV containing a potentially lethal dose of fluorouracil (or any chemotherapy agent for that matter) and hoping that nothing will go wrong with that infusion. It makes much more sense, from a safety perspective, to hang smaller (sublethal) doses daily rather than hanging a whole course’s worth of fluorouracil to be infused over several days for the sake of “convenience”.
ISMP Canada. Selection of Incorrect Medication Pump Leads to Chemotherapy Overdose. ISMP Canada Safety Bulletin 2015; 15(7): 1-4 August 26, 2015
ISMP (Institute for Safe Medication Practices). ISMP Accidental overdoses involving fluorouracil infusions. ISMP Medication Safety Alert! Acute Care Edition 2015; June 18, 2015
September 22, 2015
The Cost of Being Rude
Our July 2012 What’s New in the Patient Safety World column “A Culture of Disrespect” summarized what Lucian Leape considers to be the number one problem in patient safety today: we have a culture of disrespect. Leape noted that the problem is not just that of the obvious disruptive physician who yells at people, throws things, etc. Rather, there are much more subtle behaviors that are equally disrespectful and all are threats to teamwork and patient safety.
Now researchers in Israel have done a very clever randomized controlled trial in a simulated environment that demonstrates the negative impact of rudeness on diagnostic and procedural performance (Riskin 2015). They recruited participants from 24 NICU teams at 4 hospitals in Israel and told them they would participate in a recorded simulation involving a premature infant with necrotizing enterocolitis and would be observed throughout the simulation by an expert from the US. Half were allocated to a “rude” observer and the other half to a “neutral” observer. The “rude” observer began with a comment to the effect “…I can’t say that I’m impressed with the quality of medicine in Israel” and later added other unflattering comments. A team of NICU personnel, blinded to the group allocation, then reviewed the recorded simulations and the written documentation (diagnoses, orders). Nine items each were used for evaluating diagnostic performance and procedural performance, and single items for information-sharing and help-seeking.
Rudeness negatively affected both the overall diagnostic and procedural performance and most of the individual items for each. Using multifactorial testing they found that rudeness, by itself, was responsible for about 12% of the variation in medical performance. Rudeness was also negatively associated with information-sharing and help-seeking. Information-sharing was associated with diagnostic performance but not procedural performance. On the other hand, help-seeking was associated with procedural performance but not diagnostic performance.
The authors discuss previous research showing that rudeness can interfere at the individual level with working memory. But the current study makes it clear that rudeness has a negative impact on collaborative processes. They also note that the rudeness in this scenario came from an “outside” source and speculate whether the negative impact might be even greater if the rudeness came from a medical colleague, or was directed at a specific target, or if the intensity, length or frequency were greater.
This is a very enlightening study and confirms what we and others have always observed about the importance of civility in improving a culture of safety and positively impacting outcomes. It really validates Leape’s postulate that even “mild” forms of incivility and disrespect have a detrimental impact on patient care.
But what about more severe forms of incivility? Another new study, this one from Australia and New Zealand (Royal Australasian College of Surgeons 2015), demonstrates that bullying and harassment is common among surgeons and has a detrimental impact on patients. The Expert Advisory Group used a combination of surveys and qualitative methods (personal accounts) to address the issues. Key findings were:
Especially troubling is that there were some surgeons who did not believe that these problems exist. The researchers also acknowledge an important gap – they were not able to assess the views of those who had withdrawn from surgical training. Several themes emerged. There was strong sense that “known bullies are untouchable” and consensus that the worst offenders were a few people who wielded power. That accountability was not connected to behavior led to a perception of poor performance management in the workplace. Bullying was seen as intergenerational, with surgeons modelling their behavior on bad behaviors from previous generations. Especially significant was that bullying was part of a “toxic culture” in that it often affected whole surgical or workplace teams or units rather than being limited to individual surgeons. Hierarchical issues were critical and bystanders were often silent. Fear of reprisal or concern about positions were prominent.
They also found that gender inequity and lack of cultural diversity were both causes and effects of the culture.
Many senior and supervising surgeons were felt to lack interpersonal skills and to not value “soft” clinical skills such as team leadership. They often felt that not being critical is also “soft”. In particular, they often seem to be in a conflict between being “a strong leader” and the expectations of collaboration and teamwork.
A major problem identified was fear of speaking up about the issues. Fear of reprisal, fear that those who speak up will be seen as “weak” or unsuitable for surgery, fear of career “suicide”, lack of trust in the people who would handle complaints, and feeling that there will be a lack of consequences for perpetrators were all identified as barriers to speaking up.
The report goes on to make several recommendations to the Royal Australasian College of Surgeons regarding cultural change and leadership, surgical education, and handling of complaints.
While the above study was specific to surgery in Australia and New Zealand, we have little doubt that a similar study in most countries would have similar findings. Our March 29, 2011 Patient Safety Tip of the Week “The Silent Treatment: A Dose of Reality” included many examples of failure to speak up, with similar barriers.
In an attempt to identify and improve behaviors that threaten team performance and patient safety a recent study (Nurudeen 2015) did “360 degree” evaluations of surgeons at 8 academically affiliated hospitals with a common Code of Excellence. Three hundred and eighty-five surgeons in a variety of specialties underwent 360-degree evaluations, with a median of 29 reviewers each. Beginning 6 months after evaluation, surgeons, department heads, and reviewers completed follow-up surveys evaluating accuracy of feedback, willingness to participate in repeat evaluations, and behavior change. They found that surgeons and department heads generally felt the feedback was accurate. 60% of the surgeons responding reported making changes to their practice based on the feedback. 70% of the reviewers thought the evaluation process was valuable though only 32% reported perceiving behavior change in the surgeons.
Forms of disrespect come from a variety of sources in healthcare. The most common ones arise from the hierarchical structure that still pervades our healthcare systems. But “horizontal” or “lateral” violence/bullying/harassment is also significant and nursing is a primary occupation at risk. This refers to harmful behavior demonstrated in the workplace by one employee to another who is in either an equal or lesser position. An excellent and well-referenced overview of lateral violence in nursing was done by Christie and Jones (Christie 2014). They note that lateral violence is most often directed at new nursing graduates, nurses new to the organization, and night shift nurses. While the behaviors may be overt, they are more likely “masked and subtle” and may be escalated even to the point that they become a “normal” part of culture on the unit. Victims suffer stress, sleep disturbances, negative self images, anxiety, physical disturbances and even suicidal behaviors. Ultimately they have low job satisfaction and may leave employment or even leave the nursing profession. It can lead to poor patient care and it can also become very costly for an organization due to absenteeism and increased staff turnover. Therefore, it needs to be recognized early and nipped in the bud. Approaches for organizations and individuals are discussed in the Christie article and another by Becher and Visovsky (Becher 2012).
The American Nurses Association has recently released a new position statement on incivility, bullying and workplace violence (American Nurses Association 2015), essentially calling for zero tolerance of these behaviors. That document is very well referenced and has links to a variety of useful tools. It emphasizes that incivility and bullying may not only include actions taken but also actions not taken. It emphasizes the negative impact that incivility and bullying can have not only on target individuals but the whole organization, including patients and bystanders. Adverse effects may be physical, psychological, financial and social. It notes that incivility may include rudeness, gossiping, spreading rumors, refusing to assist a coworker, name calling, condescension, public criticism, and other actions. It also specifically warns about email and social media as vehicles for incivility and bullying. Bullying is defined as repeated unwanted actions intended to humiliate, offend, or cause distress in the target individual. It also describes workplace “mobbing” as a collective form of bullying (it even notes that sometimes the target of “mobbing” is actually an exceptional employee). It also has strong sections on workplace violence, which we’ll save for a future column.
The ANA position statement goes on to outline the responsibilities of nurses and employers to establish a culture of respect, identify and track instances of incivility, bullying and workplace violence, and use evidence-based strategies to deal with the issues. For primary prevention all must be cognizant of their own actions taken and not taken and communication with others. RN’s need to participate in development of relevant policies and procedures for dealing with these undesirable behaviors. One specific recommendation is that RN’s should establish an agreed-upon code word or signal to seek support when feeling threatened. The document provides examples of actions that promote respect and professional demeanor.
Employers must ensure that employees have the opportunity to participate in development of relevant policies and procedures and must share the organization’s commitment along with those policies and procedures with everyone in the organization. Employers must have a zero-tolerance policy regarding incivility and bullying and procedures that include reporting mechanisms, policies preventing retaliation, investigation protocols, use of neutral third parties, and ways of providing support, conflict resolution, and education.
The ANA document further describes steps and actions that a targeted individual should take when bullying or threatening behavior occurs and the roles witnesses must take.
And other sources of rudeness, incivility or disrespect may include hospital administration, patients and families, news media, and others. The Riskin study suggests that rudeness or other forms of disrespect may likely impact patient care regardless of source. It’s therefore incumbent upon all of use to identify not just the overtly disruptive workers in healthcare but also those perpetrating the more subtle forms of disrespect and incivility.
Some of our prior columns on the impact of “bad behavior” of healthcare workers:
January 2011 “No Improvement in Patient Safety: Why Not?”
March 29, 2011 “The Silent Treatment: A Dose of Reality”
July 2012 “A Culture of Disrespect”
July 2013 “"Bad Apples" Back In?”
July 7, 2015 “Medical Staff Risk Issues”
Riskin A, Erez A, Foulk TA, et al. The Impact of Rudeness on Medical Team Performance: A Randomized Trial. Pediatrics 2015; 136: 487-495
Royal Australasian College of Surgeons. Expert Advisory Group on discrimination, bullying and sexual harassment. Report to RACS: DRAFT. 8 Setptember 2015
Nurudeen SM, Kwakye G, Berry WR, et al. Can 360-Degree Reviews Help Surgeons? Evaluation of Multisource Feedback for Surgeons in a Multi-Institutional Quality Improvement Project. J Amer Coll Surg 2015; 221(4): 837-844 Published online: July 22 2015
Christie W, Jones S. Lateral Violence in Nursing and the Theory of the Nurse as Wounded Healer. OJIN: The Online Journal of Issues in Nursing 2014; 19(1)
Becher J, Visovsky C. Horizontal Violence in Nursing. MedSurg Nursing 2012; 21(4): 210-213, 232
American Nurses Association. Incivility, Bullying, and Workplace Violence. New Position Statement. Effective Date: July 22, 2015
Print “The Cost of Being Rude”
September 29, 2015
More on the 12-Hour Nursing Shift
We’ve done multiple columns on the 12-hour nursing shift. While such shifts remain popular in the US and several European countries, there are downsides as well and we’ve discussed those in our prior columns. Also, research on the relationship between shift length and patient outcomes has been limited by issues such as whether the longer shifts are voluntary or mandated.
Not only is there limited data on the impact of 12-hour shifts on patient outcomes, there is also limited data on their association with nurses’ physical and mental well-being. Now a new study, using data from 12 European countries from the large RN4CAST study, provides insight into the impact of 12-hour shifts on nurse well-being (Dall’Ora 2015). Those researchers found that, while all shift lengths greater than 8 hours were associated with more nurse adverse outcomes, nurses working shifts ≥12 h were more likely to experience burnout, have emotional exhaustion, depersonalization, and low personal accomplishment. Moreover, they were more likely to have job dissatisfaction, dissatisfaction with work schedule flexibility, and report intention to leave their job due to dissatisfaction. Nurses working shifts of 12 hours or more were 40% more likely to report job dissatisfaction and 29% more likely to report their intention to leave their job due to dissatisfaction.
In our October 2014 What’s New in the Patient Safety World column “Another Rap on the 12-Hour Nursing Shift” we discussed another study from the RN4CAST Consortium (Griffiths 2014) which showed nurses working shifts of 12 hours or more were more likely to perceive poor or failing patient safety, poor or fair quality of care, and more care activities being left undone. Working overtime, regardless of shift length, was also associated with nurses’ perception of poor or failing patient safety, poor or fair quality of care, and more care activities being left undone.
Like most previous studies, the current Dall ‘Ora study was unable to differentiate whether longer shifts were due to mandatory or voluntary overtimes as opposed to formal 12-hour shifts. Their study confirmed previous studies that there is a relationship between any overtime and adverse effects on nurses. However, they were able to demonstrate that both shift length and overtime had independent effects on the variables studied.
The authors address the seeming paradox that previous studies showed nurses preferred 12-hour shifts and their finding of higher burnout rates and job dissatisfaction.
Their findings are most relevant in that they suggest current strategies of using 12-hour shifts to help retain nursing staff may, in fact, be counterproductive in the long run and lead to more nurse absenteeism and job turnover.
But there are questions left unanswered by this and all previous studies. The Dall ‘Ora study, like the Griffiths study before it, did not distinguish between nurses who chose to work 12-hour shifts vs. those for whom it was mandated. Given the correlation between overtime and nurses’ perceptions of suboptimal quality and patient safety, one might anticipate that the degree of discomfort nurses have with their shift length may be an important contributory factor.
A recent UK review of 12-hour shifts (Ball 2015) first looked at the published literature on 12-hour shifts and found many studies were plagued by small sample sizes, limited outcome measures, poor response rates, self-reporting bias, etc. Importantly, they found no randomized controlled trials. They conclude that, in general, most of the studies appear to show some degree of negativity, either for nurses, patients, or both towards 12-hour shifts and that many of the adverse outcomes studies relate to fatigue which can also jeopardize patient safety.
They also found from survey data that 66% of nurses in the UK working in care homes worked 12-hour shifts compared to 50% of NHS hospital nurses and 39% of independent hospital nurses. They also found that those working 12-hour shifts report that they are equally or more satisfied with their working hours than nurses working shorter shifts. They then included data from the RNCAST consortium. The odds of self-reported poor quality care was 1.64 times higher for nurses working a 12-hour or longer shift compared to those working eight hours or less and a similar pattern of findings was apparent for safety ratings, though the latter did not reach statistical significance. The risk of care left undone was 1.13 times higher for nurses working a 12-hour or longer shift compared to those working eight hours or less and was statistically significant. And, when taking the other predictor variables into account, the odds of being dissatisfied with their jobs were 1.51 times higher for nurses working on shifts of 12 hours or longer compared to those work eight hours or less. Somewhat paradoxically, there was no clear pattern of variation in work schedule dissatisfaction with length of shift:
Most interesting in an article about a conference that noted some negative union views about 12-hour shifts in the UK (Merrifield 2015) were the comments posted on the website that really reflect the polarized views of nurses toward these shifts. Many love them, many hate them!
If the 12-hour shift is actually worsening job satisfaction and leading to increased nursing turnover as the Dall‘Ora study would suggest, we may be exacerbating the shortage of nurses many countries already face. Because the 12-hour shift has become so popular in the US and other countries, both with nurses and hospitals, it will likely take compelling evidence to cause reversion to shorter shifts. The majority of nurses we know like the 12-hour shift because of its flexibility and that it allows them to spend more time with their families and other activities outside the hospital. But it is this very personal preference that would make it very difficult for the ultimate study on this issue – a randomized controlled trial (RCT) – to be performed. The many problems encountered in trying to do such a study were recently noted in a pilot study intended to do such a comparison of 8-hour vs. 12-hour shifts (Martin 2015).
Probably the only way to do such a quasi-RCT would be to take a sizeable hospital with multiple wards handling comparable patients and then make half the units 8-hour shift units and the others 12-hour shift units, letting nurses choose which unit they want to work on. Objective quality and patient safety outcomes would have to be measured in addition to nurses’ impressions of care and measures of nurse well-being. Such a study would probably still be subject to selection bias. Given the hospital nursing shortages in the US it would be very difficult to adjust results for the occurrence of overtime.
This is a critically important issue in quality and patient safety as well as for considerations about nurses’ well-being and the future of the nursing workforce. But conclusive answers are not yet available. In the interim see some of our prior columns regarding strategies to mitigate nurse fatigue and also our columns on the impact of fatigue in healthcare and other industries and use of strategies such as power naps.
And speaking about 12-hour shifts, if you haven’t yet done so read the book “The Shift” by Theresa Brown (Brown 2015). It’s a real-life story about a nurse’s 12-hour shift on an oncology unit. We’ll probably formally review it at some point but it’s great reading and lets you visualize so many of the issues we talk about in our columns.
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”
December 2, 2014 “ANA Position Statement on Nurse Fatigue”
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”
December 2, 2014 “ANA Position Statement on Nurse Fatigue”
August 2015 “Surgical Resident Duty Reform and Postoperative Outcomes”
September 2015 “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”
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”
January 2015 “More Data on Effect of Resident Workhour Restrictions”
August 2015 “Surgical Resident Duty Reform and Postoperative Outcomes”
September 2015 “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”
Dall’Ora C, Griffiths P, Ball J, Simon M, Aiken LH. Association of 12 h shifts and nurses’ job satisfaction, burnout and intention to leave: findings from a cross-sectional study of 12 European countries. BMJ Open 2015, 5: doi:10.1136/bmjopen-2015-008331, published 23 August 2015
Griffiths P, Dall’Ora C, Simon M, et al. Nurses' Shift Length and Overtime Working in 12 European Countries: The Association With Perceived Quality of Care and Patient Safety. Medical Care 2014; published online September 15, 2014
Ball J, Maben J, Murrells T, Day T, Griffiths P. 12‐hour shifts: Prevalence, views and impact. National Nursing Research Unit, King’s College London. June 2015
Merrifield N. Conference told that repeated 12-hour shifts are same as 'slave labour'. NursingTimes.net 2015; 16 April, 2015
Martin DM. Nurse Fatigue and Shift Length: A Pilot Study. Nurs Econ 2015; 33(2): 81-87
Brown T. The Shift: One Nurse, Twelve Hours, Four Patients' Lives. Algonquin Books 2015
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