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July 1, 2014
Interruptions and Radiologists
We’ve done many columns on the importance of prompt and accurate communication of test results, particularly those with significant findings, back to physicians. This applies especially to imaging and other radiology studies. But did you ever think about what impact that communication might have on a radiologist’s workflow? And what other interruptions and distractions that radiologist might have? We know that interruptions have a detrimental impact on nurses and physicians in many settings and would anticipate such interruptions would be detrimental to the radiologist’s function as well.
A recent study looked at how often a radiologist on-call gets interrupted (Yu 2014). Yu and colleagues utilized data from their central telecommunications center to determine how often radiologists on-call might have their workflow be interrupted by phone calls. They excluded calls between 8AM and 5PM Mondays thru Fridays because there is no “on-call” radiologist during those hours.
During a typical 8PM to 8AM overnight shift there was an average of 72 telephone calls, with a median call duration 57 seconds, and the average time spent on the phone was 108 minutes. The median interval from the start of one telephone call to the start of the next ranged from 3 to 10 minutes, depending on the time of day. There was also a correlation between volume of phone calls and the volume of CT scans being done (volume of other imaging studies was not measured as part of this study).
The study did not include any measure of image interpretation accuracy or disparities between interpretations by the on-call radiologist and any subsequent interpretations. But one would strongly suspect, based upon studies on the impact of interruptions in multiple other medical and non-medical settings, that all these interruptions might have a detrimental impact. Yu and colleagues noted that between 1PM and 1AM the chance of being interrupted at least once by an incoming telephone call was 37% for a study requiring 5 minutes to read and 59% for a 10-minute study (they note the average time to read a CT scan of the abdomen and pelvis is 8-10 minutes so a radiologist might be interrupted up to 2.5 times during such interpretations).
Yu and colleagues point out that while interpretation of imaging studies is the primary function of the radiologist there are numerous other activities and responsibilities for the on-call radiologist. They have to review exam protocols, do injections for contrast and nuclear studies, do ultrasound scans, and do clinical consults in addition to communicating test results to referring physicians. The Yu study did not quantify all these other “interruptions” but they are likely to also substantially impact the workflow of the on-call radiologist. We would also note that the radiologist has a whole host of other activities that are important in preventing adverse events occurring in the radiology suite that are not directly related to the radiology procedure being done (see our October 22, 2013 Patient Safety Tip of the Week “How Safe is Your Radiology Suite?”).
The overall frequency of interruptions for on-call radiologists thus is comparable to the frequency of interruptions for emergency physicians (see our March 8, 2011 Patient Safety Tip of the Week “Yes, Physicians Get Interrupted Too!”).
So how can the system be changed to reduce the frequency of interruptions for the on-call radiologist? Yu and colleagues note that posting preliminary reports on the electronic medical record has likely had a beneficial effect on frequency of calls. They have also begun having medical students assist the on-call radiologist by answering the phone and triaging imaging reports. We would add that we have seen both academic and community hospitals utilize radiology physician assistants during high activity periods. These PA’s can help with things like contrast injections, etc. Hospitals having the luxury of larger radiology staffs might have a dedicated second radiologist during high volume periods whose sole responsibility is interpreting images. Note that the latter might also be reading images off-site via teleradiology.
We certainly would not want to do anything that would interfere with the radiologist communicating significant findings to the appropriate physician (see our numerous columns list below on communicating significant findings). But while incoming calls were the majority in the Yu study, outgoing calls may also be significant. One problem we frequently encounter is difficulty tracking down the responsible physician to whom to communicate results. That is particularly problematic in academic settings where coverage responsibilities are frequently changing. Sometimes it’s even difficult to track down the service responsible for the patient. So anything you can do to facilitate identification of the responsible physician would be a positive step.
Being the on-call radiologist is no cushy job! We need to appreciate the frequent interruptions they encounter and try to help minimize those.
Prior Patient Safety Tips of the Week dealing with interruptions and distractions:
See also our other columns on communicating significant results:
Yu J-P, Kansagra AP, Morgan J. The Radiologist's Workflow Environment: Evaluation of Disruptors and Potential Implications. JACR 2014; published online April 26, 2014
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July 8, 2014
Update: Minor Head Trauma in the Anticoagulated Patient
Recently we’ve had a lot of hits on our prior columns on minor head trauma in the anticoagulated patient. In our July 17, 2007 Patient Safety Tip of the Week “Falls in Patients on Coumadin or Heparin or Other Anticoagulants” we highlighted the problem of delayed hemorrhage after falls in patients on anticoagulants. Specifically we discussed the patient who falls and has minor head trauma, has a negative CT scan of the head, and then later develops a subdural hematoma (or other intracranial hemorrhage). The example we gave was an elderly patient with a cardiac condition on full-dose heparinization while an inpatient who had an unwitnessed fall in the hospital one evening. He did not lose consciousness and was alert and fully oriented when the medical resident examined him after the fall. He had a mild ecchymosis on his right forehead but no focal neurological signs and no evidence of trauma elsewhere on the body. Because the patient was fully anticoagulated, the resident ordered an emergency head CT scan, which was normal. No changes were made in his heparin regimen. The following morning the patient was more somnolent than usual and a repeat CT scan showed a sizeable subdural hematoma that required surgical evacuation.
Our June 5, 2012 Patient Safety Tip of the Week “Minor Head Trauma in the Anticoagulated Patient” discussed some new studies on the issue. We again noted that the several good clinical decision rules on head scanning after minor head trauma, such as the Canadian CT Head Rule (Stiell 2001), and the New Orleans criteria (Haydel 2000) do not apply to patients on anticoagulants. The new studies we reviewed showed that collectively the incidence of delayed intracranial hemorrhage in anticoagulated patients with a normal initial CT scan is actually quite low. The biggest predictor of delayed intracranial hemorrhage in one study (Menditto 2012) was an INR >3.
Now a recent article in the Journal of Emergency Medicine (Cohn 2014) again asked the question “What is the risk of delayed ICH (intracranial hemorrhage) in anticoagulated patients with minor head injury and a normal initial CT scan?”. The authors did a comprehensive search of the literature to determine the evidence base for answers to this question. Though their search strategy identified 279 articles, they found that only four articles really focused on the question at hand, three of which (Menditto 2012, Nishijima 2012, Kaen 2010) we’ve already discussed in our June 5, 2012 Patient Safety Tip of the Week “Minor Head Trauma in the Anticoagulated Patient”.
The authors noted that these studies showed the incidence of delayed intracranial hemorrhage after an initially normal head CT scan ranged from 0.6% to 6%. However, they go on to appropriately note that we are not really interested in those patient having asymptomatic delayed ICH in whom no intervention is necessary. What we are really interested in is those patients in whom death or neurosurgical intervention (i.e clinically significant outcomes) occurred. The incidence of these ranged from 0 to 1.1%.
They also go on to note that not all patients are the same. Many of the studies included consisted of predominantly geriatric patients. Others were on concomitant antiplatelet therapy. And, as we noted in our June 5, 2012 Patient Safety Tip of the Week “Minor Head Trauma in the Anticoagulated Patient” the degree of anticoagulation is important.
The authors conclude that routine hospital observation for 24 hours or repeat head CT scan for all anticoagulated patients with minor head trauma and a normal CT scan is not warranted but that we need to identify subgroups at higher risk in whom those recommendations might apply. They note that patients with supratherapeutic INR’s and those on concomitant antiplatelet therapy might be such high risk patients meriting further observation or repeat CT scans.
A commentary at the end of the Cohn paper by one of the co-authors (AB Sanders) adds the issue of cost into the picture. He notes the editorial by Li (Li 2012) that estimated 24-hour observation and a repeat CT scan would add approximately $1 million per patient undergoing neurological intervention. Sanders also notes that it is not clear whether such strategy would actually impact mortality.
A second almost identical recent review of the literature (Rendell 2014) found 7 papers relevant to the question and also came to the conclusion that observation is unnecessary following a normal brain CT in warfarinized patients with head injury. Rendell notes that, though anecdotal reports have led to the practice of 24-hour observation and repeat CT in anticoagulated patients with head trauma, the experience in the larger studies would support discharge home for such patients with normal CT scan and INR <3.
Unfortunately, there is a new factor not discussed in either the Cohn or Rendell paper (or the literature they reviewed) that confounds the issue: more and more patients are now on the newer oral anticoagulants (eg. dabigatran, rivaroxaban, apixaban) in whom we can’t easily measure their degree of anticoagulation. All those TV commercials you see touting “you don’t need to go for monthly lab work anymore” with these agents may come back to bite us when trying to identify which anticoagulated patients are really at higher risk of delayed ICH.
So, as before, we emphasize the need for good instructions for the patient and, more importantly, for the caregivers when such patients are to be discharged. The major initial symptoms and signs of subdural hematomas are usually related to changes in the level of consciousness or cognition rather than “focal” neurological signs. These signs can be subtle. That’s why we previously warned in our July 17, 2007 Patient Safety Tip of the Week “Falls in Patients on Coumadin or Heparin or Other Anticoagulants” that the “neuro checks” must be carried out as ordered (whether the patient is under hospital observation or being observed by family or others at home). We’ve often seen in that past that there is a tendency for “neuro checks” to be overlooked when the patient is asleep – which is exactly when neuro checks are most important! The article by Rendell also notes that telephone follow-up the next day may be an effective strategy.
The patient with the supratherapeutic INR or concomitant antiplatelet therapy or no reliable caregiver who can observe them at home would be one you might consider for 24 hour hospital observation and repeat CT scan in 24 hours. However, as in our June 5, 2012 Patient Safety Tip of the Week “Minor Head Trauma in the Anticoagulated Patient” the optimal timing of subsequent CT scans remains unkown.
Note that our comments all pertain to anticoagulated patients in whom the initial CT scan is normal. Another recent study in head trauma patients with intracranial hemorrhage on initial CT scan (Joseph 2014) found that patients previously treated with warfarin, aspirin or clopidogrel had a threefold increase in the rate of worsening on repeat CT scan (26% vs. 9%).
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”.
Stiell IG, Wells GA, Vandemheen K, et al. for the CCC Study Group. The Canadian CT Head Rule for patients with minor head injury. Lancet 2001; 357: 1391–96
Haydel MJ, Preston CA, Mills TJ, et al. Indications for computed tomography in patients with minor head injury. N Eng J Med 2000; 343(2): 100-105
Menditto VG, Lucci M, Polonara S, Pomponio G, et al. Management of Minor Head Injury in Patients Receiving Oral Anticoagulant Therapy: A Prospective Study of a 24-Hour Observation Protocol. Ann Emerg Med 2012; 59(6): 451-455
Cohn B, Keim SM, Sanders AB. Can Anticoagulated Patients Be Discharged Home Safely From the Emergency Department After Minor Head Injury? J Emerg Med 2014; 46(3): 410-417
Nishijima DK, Offerman SR, Ballard DW, Vinson DR, et al. Immediate and Delayed Traumatic Intracranial Hemorrhage in Patients With Head Trauma and Preinjury Warfarin or Clopidogrel Use. Ann Emerg Med 2012; 59(6): 460-468
Kaen A, Jimenez-Roldan L, Arrese I, et al. The Value of Sequential Computed Tomography Scanning in Anticoagulated Patients Suffering From Minor Head Injury.
Journal of Trauma-Injury Infection & Critical Care 2012; 68(4): 895-898
Li J. Admit All Anticoagulated Head-Injured Patients? A Million Dollars Versus Your Dime. You Make the Call. Ann Emerg Med 2012; 59(6): 457-459
Rendell S. Observation is unnecessary following a normal CT brain in warfarinised head injuries: an update. BestBets (Best Evidence Topics) 2014. 30th April 2014
Joseph B, Sadoun M, Aziz H, et al. Repeat head computed tomography in anticoagulated traumatic brain injury patients: still warranted. Am Surg 2014; 80(1): 43-47
July 15, 2014
Barriers to Success of Early Warning Systems
We’ve done lots of columns on early warning scores (like MEWS, PEWS, and MEOWS) as tools to help in early recognition of patients with clinical deterioration. While the logic behind such scoring systems seems well-founded there has been a paucity of high-level evidence that such systems lead to substantial improvement in patient outcomes. Because of that and other factors, hospitals in the US have been very reluctant to adopt early warning scores into routine practice even as hospitals in the UK have been mandated to adopt such systems.
We’ve always been puzzled that something that seems so rational has failed to live up to its theoretical potential. But an excellent study just published in the nursing literature (Watson 2014) provides great insight into the barriers that impact implementation of an early warning system.
Watson and colleagues used a mixed methodology to evaluate factors related to their use of PEWS (the Pediatric Early Warning Score) at a children’s hospital. The methods included a retrospective review of VS (vital signs) and PEWS documentation, behavioral observations of RN activities related to patient assessment, and feedback from RN’s about workflow and their perception of PEWS.
Their chart review found a mean delay in charting of vital signs of 20 minutes for non-RN personnel (primarily patient care technicians) vs. 36.5 minutes for RN’s. They also found that there was poor consistency between charted vital signs (for heart rate and respiratory rate) and the numbers used in the PEWS. The behavioral observation demonstrated much multitasking by RN’s, most RN’s recorded patient assessments on paper and then used the paper when inputting assessments into the computer, and often used VS from monitors rather than from physical assessments. Bedside EMR charting occurred only 14% of the time.
The nurse feedback revealed that there were significant barriers to their concurrent charting: lack of computer availability or functionality, excess log-on times, and preferences for not charting in front of patients/family. RN’s also explained the discrepancy between charted VS and those used for PEWS in that they usually wanted to use their own assessments in the PEWS rather than the assessments done by the patient care techs. They also expressed their lack of confidence that the PEWS could detect deterioration above and beyond their own assessment skills.
Watson and colleagues suggest changes to the physical environment and improved technology interfaces to support real-time data entry as ways to improve usefulness of the PEWS. Beside computer access or use of smartphones or tablets for documentation would help. They also note that many EMR’s automatically populate VS into the early warning score tool. They also suggest examination of RN and non-RN tasks, perhaps returning VS assessment to RN’s so that data collection and documentation would be integrated. They felt it important to acknowledge the ambivalence RN’s had about the value of the PEWS and suggested adding RN concerns or family concerns to the criteria for the score.
Note that the latter (i.e. nurses felt the tool could not detect deterioration any better than they could) has been noted before. In fact, in our March 2012 What’s New in the Patient Safety World column “Value of an Expanded Early Warning System Score” we noted that the expanded MEWS in a Netherlands study (Smith 2012) also used what we consider a most valuable measure: the nurse’s bedside gestalt of the patient’s condition!
This is an outstanding practical study which provides tremendous insight into why early warning scores have so far failed to demonstrate clearcut improvement in patient outcomes. It’s also a great example of how hospital-wide or system-wide implementation of a quality improvement intervention is likely to fail if we do not understand its impact on workflows and culture. Doing a pilot project first with the types of assessments done by Watson and colleagues would likely uncover many of the barriers they eventually found.
Some of our other columns on MEWS or recognition of clinical deterioration:
Watson A, Skipper C, Steury R, et al. Inpatient Nursing Care and Early Warning Scores: A Workflow Mismatch. J Nurs Care Qual 2014; 29(3): 215-222
Smith T, Den Hartog D, Moerman T, et al. Accuracy of an expanded early warning score for patients in general and trauma surgery wards. British Journal of Surgery 2012; 99: 192-197
July 22, 2014
More on Operating Room Briefings and Debriefings
When we work on improving surgical safety and OR efficiency one of the first things we look at is whether the organization is doing briefings and debriefings. Preoperative briefings (sometimes called “huddles”) and postoperative debriefings are tools we have strongly recommended since we first began talking about the TeamSTEPPS™ training program back in 2007 (see our our May 22, 2007 Patient Safety Tip of the Week “More on TeamSTEPPS™” and our March 2009 What’s New in the Patient Safety World column “Surgical Team Training”). Briefings and debriefings are also core components of many of the crew resource management programs such as the VA’s Medical Team Training Program (see our January 11, 2011 Patient Safety Tip of the Week “NPSA (UK) ‘How to Guide’: Five Steps to Safer Surgery”).
Our April 2012 What’s New in the Patient Safety World column “Operating Room Briefings and Debriefings” focused on structuring OR briefings and debriefings and use of tools such as checklists to facilitate these. Now a new study from Johns Hopkins (Hicks 2014) provides further evidence of successful implementation of OR briefings and debriefings and emphasizes some key points that we always stress:
(1) though standardization of briefings is helpful, the briefings must be customized for the service(s) and disciplines involved in the surgery
(2) you have to have a culture of safety in order to be successful with such programs
(3) you have to demonstrate that action is taken on issues identified at the debriefings
Hicks and colleagues used their OR CUSP (Comprehensive Unit-Based Safety Program) to develop and implement OR briefings and debriefings tailored for colorectal surgery. 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. CUSP’s are prime examples of such affinity groups. We discussed CUSP’s in our March 2011 What’s New in the Patient Safety World column “Michigan ICU Collaborative Wins Big” and referred readers to Pronovost 2006 and Timmel 2010 for good descriptions of the CUSP model. The CUSP model is also nicely described in Peter Pronovost’s book “Safe Patients, Smart Hospitals” (see our July 6, 2010 Patient Safety Tip of the Week “Book Reviews: Pronovost and Gawande”).
Through their briefing and debriefings their colorectal team was able to identify and improve several aspects of patient care. They better identified which patients needed steroids prior to surgery and they developed better ways to identify and separate out tools from the “dirty” parts of procedures to help improve surgical site infection rates. Also, their CUSP identified an issue with availability of interpreter services for patients not speaking English and developed a system to ensure the interpreter appointments the day prior to surgery.
One vital thing they did was to assign a frontline nurse to spend 4 to 6 hours a week addressing defects that were revealed during the briefings and debriefings and provide feedback to all parties that those defects were fixed. Nothing can kill a debriefing program faster than failure to fix those things you found wrong at these debriefings. Fortunately at Hopkins the OR management and hospital leadership provide the resources necessary to fix such issues.
Hicks and colleagues describe another phenomenon we see all too often at hospitals when briefings and debriefings are implemented: they are often nurse-driven in the beginning and do not become fully successful until there is buy-in from surgery and anesthesiology leadership.
The Hicks article provides examples of their briefing and debriefing tools and checklists. Other examples of such checklists for the preoperative briefings may be found on either the NHS Patient Safety First website or the VA website. Video examples of preoperative briefings may also be found at the NHS website or the VA website. The online version of a study (Bandari 2012) we highlighted in our April 2012 What’s New in the Patient Safety World column “Operating Room Briefings and Debriefings” also provides copies of the tools they used.
The Hicks article also discusses the need to take into account the workflows of all the participants so they can all be freed up at the same time to convene a pre-op briefing.
Some of the issues we’ve previously pointed out that might be discussed in a pre-op briefing/huddle are:
But it’s very important not to make the process too complicated. Your pre-op briefing should probably take no more than about 2-3 minutes. Be sure to customize them. A briefing for an orthopedic surgery case is likely to be significantly different than one for a gynecological procedure.
In debriefings you are basically asking “What went well?”, “What didn’t go well?” and “What could we do better next time?”. You’ll often identify the need to fix broken equipment or ensure the availability of appropriate backup instruments. Sometimes it’s something simple like tray set-ups or equipment set-ups that interfered with the surgeon’s movements during the procedure. But, again, be sure that someone follows up on issues identified and communicates back to the group when they are fixed. Also, make sure you identify at the debriefing any problems you had with team communication during the procedure.
A structured debriefing tool may also be useful. An example of one such tool used at Florida’s Memorial Health System was published recently in the Anesthesia Patient Safety Foundation (APSF) Newsletter (Marks 2014). At Memorial the tool records action items identified at the debriefing. The circulator is the “owner” who is responsible for referring any action items identified to the appropriate person for followup. Corrective action on those identified issues usually takes place within 12-48 hours. They also recommend that a list of the action items and their resolution status be sent to hospital administration on a weekly or monthly basis. (Note that the Marks paper also has some excellent examples of issues identified at debriefings and notes how physician satisfaction improved considerably after implementation of debriefings, even among those surgeons and anesthesiologists who were originally concerned that debriefings would add too much time to procedures).
Importantly, the mere performance of the briefings and debriefings fosters a sense of belonging to teams, empowerment for all members, and better communication. These lead not only to a culture of safety but they also significantly improve job satisfaction for all involved.
Our December 9, 2008 Patient Safety Tip of the Week “Huddles in Healthcare” also discussed how huddles and briefings can be useful in a variety of healthcare situations, not just the preoperative one.
Some of our prior articles on OR briefings and debriefings:
Hicks CW, Rosen M, Hobson DB, et al. Improving Safety and Quality of Care With Enhanced Teamwork Through Operating Room Briefings. JAMA Surg 2014; Published online July 09, 2014. doi:10.1001/jamasurg.2014.172
Pronovost PJ, King J, Holzmueller CG, et al. A Web-based Tool for the Comprehensive Unit-based Safety Program (CUSP). Joint Commission Journal on Quality and Patient Safety 2006; 32(3): 119-129
Timmel J, Kent PS, Holzmueller CG, et al. Impact of the Comprehensive Unit-Based Safety Program (CUSP) on Safety Culture in a Surgical Inpatient Unit.
Joint Commission Journal on Quality and Patient Safety 2010; 36(6): 252-260
Pronovost P, Vohr E. Safe Patients, Smart Hospitals: How One Doctor's Checklist Can Help Us Change Health Care from the Inside Out. Hudson Street Press 2010
NHS Patient Safety First. video demonstrating sample pre-op briefings
NHS Patient Safety First. Quick guide to briefing and debriefing.
Veterans Health Administration. Preoperative Briefing Guide for Use in the Operating Room.
Veterans Health Administration. Postoperative Briefing Guide for Use in the Operating Room.
Veterans Health Administration. Preoperative Briefing Video.
Bandari J, Schumacher K, Simon M, et al. Surfacing Safety Hazards Using Standardized Operating Room Briefings and Debriefings at a Large Regional Medical Center. The Joint Commission Journal on Quality and Patient Safety 2012; 38(4): 154-160
Marks SW, Loskove J, Greenfield A, et al. Surgical Team Debriefing and Follow-Up: Creating an Efficient, Positive Operating Room Environment to Improve Patient Safety. Experience from the Memorial Healthcare System, Florida. APSF Newsletter 2014; 29(1): 7-12 June 2014
July 29, 2014
The 12-Hour Nursing Shift: Debate Continues
Our all-time most popular Patient Safety Tip of the Week was our November 9, 2010 Patient Safety Tip of the Week “12-Hour Nursing Shifts and Patient Safety”. In that column we discussed some of the pros and cons of these longer shifts as they related to both healthcare and other industries. We concluded that the literature to date really did not answer the question as to whether those shifts had a detrimental impact on patient safety or patient outcomes.
Then in our February 2011 What’s New in the Patient Safety World column “Update on 12-hour Nursing Shifts” and our November 13, 2012 Patient Safety Tip of the Week “The 12-Hour Nursing Shift: More Downsides” we discussed some evidence suggesting a detrimental impact of such hours on patient care and satisfaction as well as a longer term negative impact on nurses’ satisfaction (Stimpfel 2012).
There hasn’t been a whole lot on the 12-hour shift in the literature since that last column. But it did come up again in a couple articles within the past few months. The first was a Pennsylvania Patient Safety Authority review of data on incidents reported in which healthcare worker fatigue was noted to be a contributing factor (Dubeck 2014). Between 2004 and 2013 they found over 1600 such incidents involving fatigue on a variety of healthcare workers. Medication errors accounted for 62.1%, and errors related to a procedure, treatment, or test 26.4%. Dubeck discusses the 12-hour nursing work shift in addition to other factors which promote fatigue.
Another new study (Chen 2014), based on survey data, found that nurses on 12-hour shifts experienced a moderate to high level of acute fatigue and moderate levels of chronic fatigue and inter-shift recovery. Lack of regular exercise and older age were associated with higher acute fatigue. They concluded there is a need to establish fatigue intervention programs for nurses working 12-hour shifts.
There is ample evidence in the literature that fatigue has detrimental influences on attention and concentration, reaction time, cognition, communication and judgment among other things. Dubeck notes the widely quoted statistic that 17 hours of sustained wakefulness is equivalent to a blood alcohol level of 0.05% and that after 24 hours, it is equivalent to 0.10%. And we’ve done multiple columns on the impact of fatigue on healthcare workers, not only nurses but physicians, pharmacists and others (see the list at the end of today’s column). One study (Arnedt 2005) demonstrated that resident performance impairment post-call after 4 weeks of heavy call is equivalent to or worse than the impairment observed at 0.04 to 0.05 g% blood alcohol concentration on tests of sustained attention, vigilance, and simulated driving. Moreover, residents’ self-assessment of heavy call performance was limited and task-dependent. And there are numerous examples of the negative impact of fatigue on the health of nurses’ themselves (eg. higher risks of needle sticks, car accidents, etc.) that we’ve noted in previous columns listed below.
But the fundamental question we are asking here is “Is there evidence that the 12-hour nursing shift results in more patient harm or worse patient outcomes than the more traditional 8-hour shift?” And, because no studies have been done allowing direct comparison of care rendered via the two scheduling patterns and eliminating potential confounding factors, we still cannot confidently answer that question. Because the 12-hour shift has become so popular, both with nurses and hospitals, it will likely take compelling evidence to cause reversion to shorter shifts. In fact, we previously noted the most common shift length in a survey was 12-13 hours, worked by 65% of nurses responding (Stimpfel 2013). Another recent paper puts that number at 75% (Townsend 2013). 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.
There are some things we like about 12-hour shifts. The major one is the reduction in handoffs. In fact, in most industries that reduction in handoffs is touted as the most important benefit of 12-hour shift. Instead of the three handoffs seen with 8-hour shifts, you only have two handoffs with 12-hour shifts. And, just as importantly, you are typically handing off to the same individuals that you received a handoff from at the start of your shift (adding an element of “I want my handoff to be as good as the one I expect to get”). Since handoffs are very vulnerable to errors, anything that reduces the number of handoffs or improves their efficiency and efficacy is likely to improve patient care.
Another unknown variable is what we refer to as the “consecutive day phenomenon”. A study on shift workers in fields other than healthcare (Folkard 2003) showed that the risk of incidents increased each consecutive day worked. For example, on average for night shifts risk was 6% higher on the second night, 17% higher on the third night, and 36% higher on the fourth night (for morning/day shifts the corresponding risks were 2%, 7% and 17%). Extrapolating, one might suspect that we might see fewer errors if you only have to work 3 straight days rather than 4 or 5. The Folkard study demonstrated that risks are not uniform throughout the day but are greater at certain times, especially at night, and even vary based upon temporal relationship to breaks. Those authors stress that all these factors (number of successive night shifts, length of night shifts, and provision of breaks) must all be considered in combination. They note it is conceivable that a 12-hour night shift with frequent rest breaks might well prove safer than an 8-hour shift with only one mid-shift break.
Another factor in the 12-hour vs. 8-hour debate is the hours actually worked. In the old “8-hour shift world” it was very common for nurses to work back-to-back shifts (“doubles”) to fill in when scheduled nurses were unable to work. So those nurses were working at least 16 straight hours. So reversion to 8-hour shifts won’t be successful if many nurses now end up doing 16 consecutive hours.
But probably the most important point made in the Dubeck paper is that solutions focusing only on hours worked are not likely to be very successful. We agree wholeheartedly. We’re all familiar with the the work hour restrictions on residents and other physicians in training. The evidence of impact of those restrictions on patient outcomes is mixed and, overall, not very compelling. Dubeck notes that two of the major causes of fatigue (disruption of circadian rhythm sleep and sleep deprivation) are not addressed by pure work hour restriction policies.
Dubeck makes a case for more focus on FRMS’s (Fatigue Risk Management Systems) and interventions to mitigate errors that might be caused by fatigued healthcare workers. These might be modeled on similar programs recommended by the Federal Aviation Administration (FAA) for pilots and aviation personnel. She describes what an ideal FRMS would look like and cites one such FRMS being used by Queensland Health in Australia (Queensland Health 2014). Dubeck also provides a nice table of interventions and whether they do each of the following:
For example, a napping strategy might only reduce fatigue whereas fatigue-proofing task procedures would impact the latter two categories.
Multiple studies have also demonstrated that people (in any industry, not just healthcare) tend to underestimate their levels of fatigue and impairment compared to their performance on formal testing. Some day we will have the equivalent of the brief “sobriety” test that can rapidly identify healthcare workers who are impaired by fatigue. We’ll leave development and validation of such a test up to our psychology colleagues but we’d envision that at regular intervals beyond 8 hours (maybe even sooner) the healthcare worker will get buzzed on his/her smartphone and have to complete some simple test of reaction times or attention span. If the worker scores outside the established threshold the hospital will need to have resources in place to take over duties of that worker (completely or at least temporarily until fatigue is alleviated by, for example, a nap).
We recommend you read our November 9, 2010 Patient Safety Tip of the Week “12-Hour Nursing Shifts and Patient Safety” to see some of the excellent prior work that has been done by Geiger-Brown and colleagues (Geiger-Brown 2010) and Fallis and colleagues (Fallis 2011) regarding some of the strategies to mitigate nurse fatigue and also our columns listed below on the impact of fatigue in healthcare and other industries and use of strategies such as power naps.
Some of our other columns on the role of fatigue in Patient Safety:
November 9, 2010 “12-Hour Nursing Shifts and Patient Safety”
April 26, 2011 “Sleeping Air Traffic Controllers: What About Healthcare?”
February 2011 “Update on 12-hour Nursing Shifts”
September 2011 “Shiftwork and Patient Safety
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
January 3, 2012 “Unintended Consequences of Restricted Housestaff Hours”
June 2012 “June 2012 Surgeon Fatigue”
November 2012 “The Mid-Day Nap”
November 13, 2012 “The 12-Hour Nursing Shift: More Downsides”
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”
Stimpfel AW, Sloane DM, Aiken LH. The Longer The Shifts For Hospital Nurses, The Higher The Levels Of Burnout And Patient Dissatisfaction. Health Affairs 2012; 31(11): 2501-2509, November 2012
Dubeck D. Heathcare Worker Fatigue: Current Strategies for Prevention. Pa Patient Saf Advis 2014; 11(2): 53-60 June 2014
Chen J, Davis KG, Daraiseh NM, et al. Fatigue and recovery in 12-hour dayshift hospital nurses. Journal of Nursing Management 2014; 22(5) 593-603 July 2014
Arnedt JT, Owens J, Crouch M, et al. Neurobehavioral Performance of Residents After Heavy Night Call vs After Alcohol Ingestion. JAMA 2005; 294(9): 1025-1033
Stimpfel AW, Aiken LH. Hospital Staff Nurses' Shift Length Associated With Safety and Quality of Care. Journal of Nursing Care Quality 2013; 28(2): 122-129
Townsend T, Anderson P. Are extended work hours worth the risk? Am Nurs Today 2013; 8(5): 8-11 May 2013
Folkard S, Tucker P. Shift work, safety and productivity. Occupational Medicine 2003; 53: 95-101
Queensland Health. Human Resources Policy. Fatigue Risk Management. Policy # I1 (QH-OL-171). June 2014
Geiger-Brown J, Trinkoff AM. Is It Time to Pull the Plug on 12-Hour Shifts? Part 3. harm reduction strategies if keeping 12-Hour Shifts. Journal of Nursing Administration 2010; 40(9): 357-9, 2010 Sep
Fallis, WM, McMillan DE, Edwards MP. Napping During Night Shift: Practices, Preferences, and Perceptions of Critical Care and Emergency Department Nurses
Crit Care Nurse March 31, 2011 vol. 31 no. 2 e1-e11
August 12, 2014
Surgical Fires Back in the News
We’ve done many columns on surgical fires (see the list at the end of today’s column). Theoretically, such fires should never happen. Nevertheless, every year we continue to see reports of patients harmed by fires in the OR and all have contributing factors that should have been avoidable.
Last month Modern Healthcare had a cover story about surgical fires (Carlson 2014a). It was highlighted by a case in which an emergency tracheostomy was being attempted on a patient with a severe allergic reaction that had caused a swollen tongue that impaired breathing. The surgeon asked that the patient be prepped, then made an incision which bled. He then used an electric cauterizing tool that ignited the alcohol-based skin disinfectant. The patient suffered second degree burns on his neck and shoulders. There was inadequate delay for alcohol-based skin the disinfectant to dry and the patient had received 100% oxygen. Thus all the elements of the “fire triangle” (fuel, oxidizer, heat source) were present in a high-risk patient (head and neck surgical procedure). We discussed the role of alcohol-based skin preps or other volatile substances in our April 24, 2012 Patient Safety Tip of the Week “Fire Hazard of Skin Preps, Oxygen” and our June 25, 2013 Patient Safety Tip of the Week “Update on Surgical Fires”.
One post-incident step the hospital in the above case did was to ban use of alchohol-based skin disinfectants in emergency cases. We’ve actually previously briefly noted this case (Natt 2013) in our October 1, 2013 Patient Safety Tip of the Week “Fuels and Oxygen in OR Fires”. They implemented a policy prohibiting alcohol-based skin preps in any emergency surgery that does not allow sufficient drying time (usually 3 minutes or longer). Instead they have gone back to non-alcohol-based preps like Betadine for such emergency cases.
A preview of AORN's new skin prepping guidelines (Van Wicklin 2014) notes that there is not enough strong evidence to say that any one antiseptic is more effective than another for preventing SSIs. Alcohol-based antiseptics may be more effective than those that are water-based, but other than that, the evidence doesn't clearly favor one over another. She points out that a Cochrane review of 13 randomized control trials concluded that the evidence for skin antiseptics is lacking quality, and that no conclusion could be reached as to which is the most effective skin antiseptic. She also notes that evidence supports the use of colored antiseptics, both to ensure complete coverage of the surgical site and to reduce the risk of fire. So it appears we really don’t lose efficacy in preventing SSI’s when we use non-alcohol-based skin preps in cases at high risk for surgical fires.
One of the authors of the Modern Healthcare article a few days later noted that some scientists and others pointed out that oxygen is not flammable (Carlson 2014b). Yes, that is technically correct. What oxygen does is make it easier for various flammable items and substances to ignite and burn when exposed to a heat source. For example, the alcohol-based skin preps will burn faster and more intensely in higher oxygen concentrations (Eichhorn 2013).
Eichhorn points out that many anesthesiologists fail to recognize the great risks caused by open supplemental oxygen (nasal cannulae or perforated facial masks used with 2 or 3L/min oxygen flow) during monitored anesthesia care (MAC). That is certainly supported by the malpractice claims study we highlighted in our June 25, 2013 Patient Safety Tip of the Week “Update on Surgical Fires”. In that study (Mehta 2013) 99% of cases involved procedures known to be high risk for fires (head, neck, or upper chest surgery), electrocautery was the ignition source in 90%, and oxygen was the oxidizer in 95%. The vast majority of claims were for fires that occurred during monitored anesthesia care rather than general anesthesia and in the vast majority of claims involving monitored anesthesia care the oxygen was delivered by an open delivery system. There has been a trend for surgical/OR fires to be seen more often in relatively minor surgery (eg. plastic procedures, removal of skin lesions, temporal artery biopsies, etc.), done under sedation or monitored anesthesia care where there is open delivery of oxygen.
Eichhorn notes that eliminating open delivery of supplemental oxygen during upper body MAC procedures has been a focus of the Anesthesia Patient Safety Foundation. He notes that supplemental oxygen is overused and in many cases is unnecessary. Though he does discuss some less reliable strategies to mitigate the oxygen risk, he stresses that the patient who truly needs oxygen should receive it via a laryngeal mask or endotracheal tube. The recently updated ASA Practice Advisory for the Prevention and Management of Operating Room Fires (Apfelbaum 2013) also stresses that.
In our July 22, 2014 Patient Safety Tip of the Week “More on Operating Room Briefings and Debriefings” we again reiterated that one of the questions we always expect to be asked during the pre-op briefing/huddle is “Is this a high risk case for surgical fire?”. The pre-op briefing/huddle often gets overlooked in emergency cases but that is a question easily asked when you have the nurse, anesthetist and surgeon readying the patient for the procedure. Others include discussion of the surgical fire risk as part of their surgical timeout or Universal Protocol.
While we still recommend every organization perform drills on how to respond to OR fires, we concur with Culp and colleagues (Culp 2013) and Eichhorn that the focus needs to be on prevention. We’ve emphasized in the numerous columns below the need to include a fire risk assessment in your pre-procedure “huddle” and include this in your Surgical Safety Checklist. Eichhorn points out that our training in anesthesiology residency programs (and inservicing and continuing medical education for previously trained anesthesiologists) must focus on the need to avoid open delivery of oxygen in procedures done under MAC.
We’ve always praised the California Department of Public Health’s publication of root cause analyses and plans of correction for serious hospital events because they almost always have valuable lessons learned for all healthcare organizations. Last month the CDPH had two such cases that involved surgical fires, both of which include important lessons learned.
In the first case, a patient developed second degree burns of her face and lip after a fire erupted during surgery on her nose for a basal cell carcinoma (CDPH 2014a). The patient was receiving oxygen via nasal cannula when the surgeon began using a Bovie device for cautery. The surgeon apparently did not announce in advance his intent to use the Bovie. The hospital policy in existence at the time required that the surgeon announce such intent so that the anesthesiologist could stop oxygen administration for at least one minute prior to use of the elecctrocautery.
The case illustrates an important point: you can have the best policy in the world but if staff fail to follow it untoward consequences may occur. The hospital did the customary re-education of surgeons, anesthesiologists, and surgical/OR staff after the event and ensured inclusion of surgical fire prevention in its orientation and reorientation activities. It also modified its policy and procedure for surgical fire prevention and audited subsequent head and neck surgical procedures for compliance with the policy.
In their revised P&P they did include 5 steps we like:
That, of course, is a good example of the importance of using “hearback” and 2-way communication to ensure that all understand the events to be undertaken.
The revised P&P also required the anesthesiologist to document in the OR chart the time at which oxygen was stopped. That also allows for auditing by quality improvement personnel of cases for compliance with the policy.
One critical element not mentioned in the CDPH document is whether that hospital’s P&P’s include discussion of fire risk either as part of a pre-surgical briefing/huddle or as part of the surgical timeout. We think that is critical and strongly suggest all facilities actually include that as part of a checklist for either the pre-procedure briefing or the timeout (see our January 2011 What’s New in the Patient Safety World column “Surgical Fires Not Just in High-Risk Cases” for examples of how to do this).
Inservicing on prevention of rare events is simply not enough to help all remember the risks and steps involved in prevention of such events. Including the risk in the pre-op briefing/huddle or surgical timeout raises awareness in real time.
The second CDPH case (CDPH 2014b) did include in the Plan of Correction incorporation of discussion of fire risk into their Universal Protocol and creation of a “Fire Risk Assessment Tool”. That case involved planned same day surgery for wide-excision removal of a squamous cell carcinoma from the neck of a patient. The case was being done while 60% oxygen was being administered via face mask and Chloraprep had been used for skin preparation. When the surgeon began to use a cautery device a spark apparently ignited operative gauze and fire flashed up to the face mask. The patient suffered second degree burns to his eyelids, eyebrows, forehead, cheeks and anterior third of his tongue. Staff immediately removed the mask and surgical drapes and flushed the patient’s face and affected areas with saline. Because there was some tongue swelling the patient was intubated to protect the airway. A plastic surgeon and wound surgeon were immediately called in to evaluate the patient. The neck surgery was completed while the patient was put under general anesthesia and he was then transferred to the Burn Unit of another hospital where he underwent burn management, including skin grafting.
The hospital’s various policies and procedures apparently did not include stopping flow of oxygen for at least a minute prior to using electrocautery. In addition, the skin prep had utilized Chloraprep with the 26 ml applicator, which has specific labeling not to be used for head and neck surgery. Note that in our April 24, 2012 Patient Safety Tip of the Week “Fire Hazard of Skin Preps Oxygen” we noted another surgical fire in which a hospital had switched from the 10.5 ml Chloraprep applicator, which did not have the warning to avoid use in head and neck surgery, to the 26 ml applicator which did have the warning.
The hospital subsequently revised its P&P’s and did customary inservicing and education of all impacted departments. In addition to developing the fire risk assessment tool and including fire risk assessment in their Universal Protocol, they also mandated that non-alcohol-containing skin preps be used for head/neck surgery rather than Chloraprep. Their revised P&P’s included anesthesiologists securing the airway (eg. intubation) in head and neck cases where oxygen is required.
They also now require use of wet sponges in the surgical field in all cases above the xyphoid, attention to avoid accumulation of oxygen under surgical drapes, and attention to the power used in electrocautery units or laser units. They also include fire drills for surgical fires and monitor cases for compliance with policies.
Surgical fires should be 100% preventable. In addition to those measures that reduce the oxygen-enriched environment and minimize the risk of flammable substances (such as used in skin preps), improving communication between surgeons and all OR staff, doing drills and simulations, training and inservicing, and monitoring for compliance with P&P’s, probably the most important thing you can do is continuously raise awareness of surgical fire risk by incorporating such discussion into your pre-op briefing/huddle or your surgical timeout or Universal Protocol.
Our prior columns on surgical fires:
Carlson J, Rice S. Safety advocates push to curb hospital surgical fires. Modern Healthcare 2014; July 12, 2014
Natt TM. Operating-Room Fire at Hospital Burns Patient, Prompts Changes. thepilot.com August 9, 2013
Van Wicklin S. A Preview of AORN's New Skin Prepping Guidelines. Let a growing body of evidence govern your bedside practice. OutpatientSurgery.net 2014
Carlson J. Chemistry 101: Oxygen is not flammable. Modern Healthcare 2014; July 16, 2014
Eichhorn JH. A Burning Issue: Preventing Patient Fires in the Operating Room. Anesthesiology 2013; 119(4): 749-751
Mehta SP, Bhananker SM, Posner KL, Domino KB. Operating Room Fires: A Closed Claims Analysis. Anesthesiology 2013; 118(5): 1133-1139, May 2013
Apfelbaum JL, Caplan RA, Barker SJ, et al. Practice Advisory for the Prevention and Management of Operating Room Fires: An Updated Report by the American Society of Anesthesiologists Task Force on Operating Room Fires. Anesthesiology 2013; 118(2): 271-290
Culp WC, Kimbrough BA, Luna S. Flammability of Surgical Drapes and Materials in Varying Concentrations of Oxygen. Anesthesiology 2013; 119(4): 770-776
CDPH (California Department of Public Health). Complaint Intake Number CA00224633. CDPH 2014
CDPH (California Department of Public Health). Complaint Intake Number CA00256145. CDPH 2014
ECRI Institute. Surgical Fire Prevention.
AORN (Association of periOperative Registered Nurses). Fire Safety Tool Kit.
FDA. Preventing Surgical Fires.
Christiana Care Health System. Surgical Fire Risk Assessment.
APSF (Anesthesia Patient Safety Foundation). Resources. Fire Safety Video. Prevention And Management Of Operating Room Fires.
Print “Surgical Fires Back in the News”
August 19, 2014
Some More Lessons Learned on Retained Surgical Items
Just when you think you’ve learned everything about retained surgical items/retained foreign objects you get surprised by some new lessons learned.
Among the most recent CDPH (California Department of Public Health) release of RCA’s and plans of correction were another 4 cases of retained foreign objects. Three were in ob/gyn procedures. That should not be surprising since a substantial proportion of retained surgical items have been reported in Ob/Gyn procedures and vaginal deliveries (Stiller 2010). The Minnesota Hospital Association and ICSI also have focused on Ob/Gyn procedures in their efforts to prevent retained foreign objects. The fourth retained foreign object case was related to a pacemaker insertion.
(CDPH CA00180867, CA00180956) had many of the factors previously identified as contributing to retained surgical items (eg. conversion to open procedure, transitioning of OR staff during the procedure, etc.) and reinforced many of the important recommendations we’ve discussed in our prior columns. The latter include fundamentals of the “count”, use of white boards and “count bags”, ensuring attention of all and avoiding distractions during the count, good communication between staff, the methodical wound exam, and the importance of auditing to ensure all components of your policies are carried out.
Three of the cases involved surgical sponges or lap packs, which are the most commonly retained foreign objects. But what caught our eye was a case with another unusual retained surgical item and the system implications it had in its lessons learned. You’ll recall in our Patient Safety Tips of the Week for June 12, 2012 “Lessons Learned from the CDPH: Retained Foreign Bodies” and November 5, 2013 “Joint Commission Sentinel Event Alert: Unintended Retained Foreign Objects” we noted several unusual items found as retained foreign bodies (a blue towel, a cautery tip, a Kerlix bandage, a piece of labeling tape from a surgical instrument, and a fish-shaped soft flexible viscera retainer).
The case with the unusual retained surgical item (CDPH CA00268068) began as a laparoscopic supracervical hysterectomy. The surgical counts for sponges, instruments, sharps and needles were “correct” as done by the scrub person and RN circulator. The patient was discharged. Approximately a year and a half later examination because of post-intercourse bleeding and pain revealed a circular piece of metal attached to the patient’s cervix. This was removed by the physician and confirmed to be a KOH Cup™. The KOH Cup™ is a device intended to improve safety during certain procedures. Used in combination with a uterine manipulator, the KOH Cup™ enhances traction capabilities, enabling greater access and visualization of critical anatomic structures and helps prevent damage to such adjacent structures.
Though the hospital at the time of the original surgery did have a policy regarding what to do if an instrument was discovered to be missing, apparently neither the surgical team nor sterile processing department noted that the KOH Cup™ was missing and did not initiate attempts to find it. At the time the KOH Cup™ was apparently not considered separately from the uterine manipulator.
The hospital subsequently began attaching the KOH Cup™ to the uterine manipulator with a suture. It also added the KOH Cup™ to its list of surgical instruments separate from the uterine manipulator. The hospital also added a “red rule” to ensure that all foreign objects placed into the vaginal cavity have a “tail” that is visible from the outside and that all items placed into the vaginal cavity are announced by the surgeon and entered onto the instrument count white board. It also included discussion and documentation during the post-case debriefing that the surgeon has examined the patient for all items and removed them (see also our July 22, 2014 Patient Safety Tip of the Week “More on Operating Room Briefings and Debriefings”).
The hospital also developed a policy and procedure on “Missing Instruments/Parts, Procedure for Locating”. They did inservicing of all appropriate staff and initiated an audit program for surgical counts and specifically for KOH cups.
Though the KOH Cup™ was another unusual retained surgical item, we were actually most interested in the role that SPD staff and central supply might play in patient safety initiatives to prevent retained surgical items. In fact, we found one such case where they actually did just that with a missing KOH Cup™ (FDA 2014). That case was begun as a laparoscopic assisted vaginal hysterectomy, using a KOH Cup™ and uterine manipulator. When the case was converted to an open total abdominal hysterectomy the surgeon removed the uterine manipulator and the laparoscopic instruments were passed on by staff and a new instrument tray opened for the TAH. The case was completed without problems. The next day the central supply supervisor called OR staff noting that the KOH Cup™ was missing from the instrument set and another had been ordered. Staff were confident the missing KOH Cup™ had not been discarded and subsequently contacted the surgeon, who examined the patient and found and removed the missing KOH Cup™.
We suspect that many facilities likely simply consider such instances an inventory or logistical problem. We wonder how many would ask the question “Could that missing item still be inside the patient?”. It’s another great example we can use when we go department to department telling them “patient safety is everyone’s job”.
What does your facility do when an instrument or other object is missing from a tray or set after a procedure?
We’ve already done several columns on retained surgical items (listed below). We encourage you to read them because they contain a wealth of information on the topic.
Our prior columns on retained surgical items/retained foreign objects (RSI’s/RFO’s):
Stiller RJ, Ivy MJ, Thompson T. Preventing retained foreign objects in ob/gyn surgery. Contemporary OB/GYN 2010; June 1, 2010
Minnesota Hospital Association. Eliminating Retained Foreign Objects (Safe Count and Safe Account Programs).
ICSI (Institute for Clinical Systems Improvement). Prevention of Unintentionally Retained Foreign Objects During Vaginal Deliveries. Revision date: January 2012
CDPH (California Department of Public Health). Complaint Intake Number CA00268068. CDPH 2014
CDPH (California Department of Public Health). Complaint Intake Number CA0029845B. CDPH 2014
CDPH (California Department of Public Health). Complaint Intake Number CA00309249. CDPH 2014
CDPH (California Department of Public Health). Complaint Intake Number CA00180867, CA00180956. CDPH 2014
FDA. MAUDE Adverse Event Report: COOPER SURGICAL KOH CUP VAGINAL FORNICES DELINEATORS UTERINE MANIPULATOR. Page Last Updated: 07/31/2014
August 26, 2014
Surgeons' Perception of Intraoperative Time
We once overheard a conversation in which a surgeon was attempting to schedule a colorectal case into a free 2-hour opening on the OR schedule. The battle-tested OR manager responded “Dr. X, you’ve never done a case in less than 3 hours!”. The surgeon begged to differ. He was sure he only took about 2 hours, on average, for such cases. But the OR manager had data to back her up. In fact, the surgeon had never done such a case in less than 3 hours and most lasted considerably longer.
We’ve done a number of columns about the potential patient safety consequences of prolonged procedures and addressed the issue of lack of awareness of the duration of surgery. So one question to ask is “How aware are surgeons of their intraoperative time utilization?”.
One group of researchers, in fact, addressed that very question recently (Erestam 2014). That group did a pilot study in a Swedish academic center using surgeons’ perceptions of time spent in various phases of colorectal procedures compared to actually measured times. They found little difference at the group level between perceived and actual times. But at the individual level they found substantial variation. Time spent in the dissection/resection stage had the most variation (varied from 43 to 308 minutes). They also found a correlation between duration of some phases and duration of other phases. For example, a longer duration of the dissection/resection phase correlated with a longer time to close the abdomen. And a longer duration of the hand-sewn anastomosis also correlated with the time needed to close the abdomen.
The study was just a pilot study. There were 18 surgeons in a single center and actual time was only measured in 21 cases. The authors anticipate a larger study. But we don’t doubt for a minute the basic premise: surgeons typically have a poor awareness of their intraoperative time utilization. Note that in the Erestam study the surgeons were asked about their case time utilization at a time when they were not operating. Our experience is that surgeon awareness of case duration during actual surgery is even worse.
Our March 10, 2009 Patient Safety Tip of the Week “Prolonged Surgical Duration and Time Awareness” discussed time unawareness during many surgeries. In addition to the potential impact on infectious complications, we noted that there are other potential patient safety issues related to prolonged surgical duration such as DVT, decubiti, hypothermia, fluid/electrolyte shifts, nerve compression, compartment syndromes, and rhabdomyolysis. Long-duration cases also increase the likelihood of personnel changes that increase the chance of retained foreign objects or retained surgical items (see last week’s Patient Safety Tip of the Week “Some More Lessons Learned on Retained Surgical Items”). And the fatigue factor comes into play with longer cases, increasing the likelihood of a variety of other errors.
Surgical case duration is also one of the few modifiable risk factors for surgical infections. A number of studies in the past have demonstrated an association between perioperative infection and the duration of the surgical procedure. In our January 2010 What’s New in the Patient Safety World column “Operative Duration and Infection” we noted a study (Proctor et al 2010) which looked at a large database of general surgical procedures and demonstrated a linear relationship between duration of surgery and infectious complications. The infectious complication rate increased by 2.5% per half hour and hospital length of stay (LOS) also increased geometrically by 6% per half hour.
There are many factors that may lead to increased surgical durations, including case type and complexity, emergency vs. elective nature, patient-related factors, proficiency of the surgeon, lack of team familiarity, interruptions, equipment issues, presence of trainees and poor communication.
In our July 21, 2012 Patient Safety Tip of the Week “Surgical Case Duration and Miscommunications” we discussed a study (Gillespie 2012) on the various factors involved in prolonging surgery. They looked at most of the above factors plus intraoperative interruptions and whether or not pre-op huddles/briefings were done. Mean duration of surgery for all cases was 85 minutes, compared to an expected mean duration of 60 minutes. Preoperative briefings were done in only 12.5% of cases. Communication failures occurred in 57% of the cases, an average of 1.9 per case, and the only factor that independently predicted deviation from expected duration of surgery was the number of miscommunications. While interruptions were frequent (occurring in 66.9% of cases, with a mean number of interruptions per case = 2.3) they did not independently predict prolonged duration. Miscommunications were more frequent when some members of the OR team had less experience. They also had examples where insufficient or inaccurate information was conveyed but the recipient did not seek clarification.
Gillespie et al. spend a good deal of time discussing the value of preop briefings. We, of course, are big fans of the preop huddle/briefing. See our prior columns on pre-op briefings and post-op debriefings:
During a preop huddle the team will often recognize that a piece of important equipment is missing, avoiding the considerable delay that might have occurred if that had been discovered well into the case. Checklists have been utilized more often for the preoperative briefings or huddles. We previously noted a study by Lingard et al (Lingard 2008) that used a checklist to structure short team briefings and documented reduction in the number of communication failures. Our December 9, 2008 Patient Safety Tip of the Week “Huddles in Healthcare” discussed an article by Nundy and colleagues at Johns Hopkins (Nundy 2008). They used a very simple format for pre-operative briefings that led to a 31% reduction in unexpected delays in the OR and a 19% reduction in communication breakdowns that lead to delays.
We recommend that the OR team, during the presurgical huddle, should discuss issues related to prolonged cases. For example, they should discuss whether intraoperative DVT prophylaxis should begin if the procedure lasts beyond a certain duration. Or discuss at what duration a repositioning of the patient (to avoid nerve compression, compartment syndrome, or rhabdomyolysis) might be wise. And it would be very useful to have an estimate of time remaining to again trigger some discussion on the above issues. In addition to the DVT prophylaxis and repositioning issues, it might raise questions about the need to temporarily ease up on traction. It might direct attention to maintenance of the patient’s body temperature. In a very prolonged case it might raise questions about the need for further doses of prophylactic antibiotics.
So good communication begins before the patient has actually entered the OR and is necessary throughout the case to ensure more efficient and safe performance of surgery. (And don’t forget that the postop debriefing may help you save time during your next case as well!)
We also recommend that someone in the OR, usually the anesthesiologist, be tasked with calling out the running case duration at regular intervals (for example, every 30 minutes). That makes everyone aware of the issues that may need to be considered in cases that are taking longer than expected. The announcement of the duration should be accompanied by announcement of pre-agreed-upon actions (for example, a second dose of antibiotics or a change in patient positioning).
No one is happy when surgical cases take too long. There are safety issues, as noted above, for the patient. Staff dissatisfaction increases. Other patients and surgeons become disappointed if their subsequent case has to be cancelled (and that next patient’s employer becomes unhappy if he/she has to take a second day off from work). Your surgical scheduling becomes chaotic. Your hospital or facility may suffer financially due to unexpected overtime costs and lost opportunity costs (for other cases that might have been done).
So make surgical case duration an issue of importance for your organization. Make sure you keep good data on duration of all cases, major and minor, and actually utilize that data during scheduling. Do your pre-op huddles/briefings and post-op debriefings in all cases. And make intraoperative time awareness part of your regular OR routines.
Our prior columns focusing on surgical case duration:
Erestam S, Erichsen A, Derwinger K and Kodeda K. A survey of surgeons’ perception and awareness of intraoperative time utilization. Patient Safety in Surgery 2014; 8: 30 (1 July 2014)
Procter LD, Davenport DL, Bernard AC, Zwischenberger JB. General Surgical Operative Duration Is Associated with Increased Risk-Adjusted Infectious Complication Rates and Length of Hospital Stay, Journal of the Amercican College of Surgeons 2010; 210: 60-65
Gillespie BM, Chaboyer W, Fairweather N. Factors that influence the expected length of operation: results of a prospective study. BMJ Qual Saf 2012; 21(1): 3-12 Published Online First: 14 October 2011 doi:10.1136/bmjqs-2011-000169
Lingard L, Regehr G, Orser B, et al. Evaluation of a Preoperative Checklist and Team Briefing Among Surgeons, Nurses, and Anesthesiologists to Reduce Failures in Communication. Arch Surg, Jan 2008; 143: 12-17
Nundy S, Mukherjee A, Sexton JB, et al. Impact of Preoperative Briefings on Operating Room Delays: A Preliminary Report. Arch Surg 2008; 143(11): 1068-1072
September 2, 2014
Frailty and the Trauma Patient
Indicators of frailty are excellent predictors of complications in a variety of surgical settings (see list of our prior columns on frailty and surgery at the end of today’s column). In fact, we’ve often stressed that assessment for frailty is probably the most important pre-op consideration in the geriatric patient undergoing surgery.
Two studies from the University of Arizona Medical Center have now focused on use of frailty indices in geriatric trauma patients. The first (Joseph 2014a) was a 2-year prospective study at their level I trauma center of 250 trauma patients aged 65 years and older. The frailty index they used consisted of 50 variables that could be assessed for preadmission status. Frailty was present in 40% of the total geriatric trauma population. The frailty score was an independent predictor of both inhospital complications and adverse discharge disposition. Urinary tract infections and pneumonia were the most common complications among the patients with frailty.
Patients with frailty also had longer hospital lengths of stay (LOS) and ICU lengths of stay and, thus, higher hospital costs. Adverse discharge dispositions (death or discharge to a nursing home) were also significantly more common among patients with frailty (37.3% vs. 12.9%). All 5 deaths in their study occurred in patients with frailty. The frailty score was better than patient age as a predictor of complications and adverse discharge disposition. In their study the frailty score was also a better predictor of adverse discharge disposition than the Injury Severity Score.
The authors note that geriatric patients are becoming an increasing portion of the trauma population and that they have been historically underrepresented in academic studies of trauma patients.
Use of a frailty index could thus help identify trauma patients at greatest risk of complications and help us identify patients in need of additional resources. It should also help us be realistic when discussing long-term plans with patients’ families and caretakers.
And the frailty index might also be important in stratifying patient risk. From their results, it would be predictable that use of mortality rates and complication rates to compare trauma centers could be very misleading if the proportion of frail patients differs considerably across centers.
The above study utilized the frailty index developed by Searle et al (Searle 2008), also known by some as the Rockwood index (named for the senior author of that paper). That index has 50 variables, most of which can be dichotomized (i.e. yes or no response), allowing for a summated score. It does, however, utilize variables that measure a patient’s performance status before their trauma occurred. While it is unlikely that trauma surgeons would be administering this frailty index themselves on their patients, it would be very easy to train other members of the multidisciplinary trauma team to administer it.
Our regular readers know we favor simpler screening for frailty (see prior columns listed below). The Timed-Up-and-Go Test works remarkably well as a simple, easy, brief predictor of frailty and can be easily performed in a physician’s office prior to surgery. However, it’s obvious that you don’t have that opportunity in the trauma patient.
The University of Arizona Medical Center researchers (Joseph 2014b), cognizant of the challenges in using a 50-variable frailty index, have developed their own modified 15-variable Trauma-Specific Frailty Index (TSFI). They performed a 2-year prospective analysis of all geriatric trauma patients (n = 200) presenting to their Level I trauma center and showed the TSFI score was an independent predictor of unfavorable discharge disposition, whereas age was not. The authors conclude that the Trauma-Specific Frailty Index is an effective tool that can aid clinicians in planning discharge disposition of geriatric trauma patients.
It should really come as no surprise that frail patients fare worse after trauma. But the University of Arizona studies increase our awareness of the magnitude of this problem in the trauma population and provide use with some very useful tools to help manage such patients.
Some of our prior columns on preoperative assessment and frailty:
Joseph B, Pandit V, Zangbar B, et al. Superiority of Frailty Over Age in Predicting Outcomes Among Geriatric Trauma Patients: A Prospective Analysis. JAMA Surg 2014; 149(8): 766-772
Searle SD, Mitnitski A, Gahbauer EA, et al. A standard procedure for creating a frailty index. BMC Geriatr 2008; 8: 24
Joseph B, Pandit V, Zangbar B, et al. Validating Trauma-Specific Frailty Index for Geriatric Trauma Patients: A Prospective Analysis. J Amer Coll Surg 2014; 219(1): 10–17, July 2014
Print “Frailty and the Trauma Patient”
September 9, 2014
Handoffs/handovers have been our single most frequent individual topic over the years (see the list of prior columns at the end of today’s column). However, almost everything written about handoffs/handovers has been about the transfer of information (and responsibility) either to someone who will be covering patients for a specified time or to someone on another service who will be receiving the patient in transfer. Almost nothing appears in the literature about what we like to call the “handback”. This refers to the transfer of information (and responsibility) back from the covering physician to the original physician or team.
This month a great study was published on issues arising with the most common form of handback – morning rounds on an academic service (Devlin 2014). But don’t stop reading if you are not at an academic or training institution! We strongly suspect that the same issues identified by Devlin and colleagues apply equally well to non-training settings, such as a night hospitalist reporting back to the daytime hospitalists in a community hospital or physicians in a rural hospital cross-covering for a long weekend.
The authors studied the morning handovers on general internal medicine services at two academic medical centers in Toronto. A researcher was present for the morning rounds and documented how and where the handovers were conducted, what information was transferred, and whether there were interruptions or distractions during the handover process. In addition, the researchers did extensive review of those patients being “covered” the night before (reviewing the charts, progress notes, orders, nurses’ notes, lab results, etc.). The study was not focused on new patients admitted during the previous night shift but rather solely on those previously admitted patients who had been “signed out” to the covering physician and were now being reported back to the daytime medical team. Hence, these patients were being “handed back”.
Out of 453 individual medical records reviewed the researchers identified 141 clinically important overnight issues (change in patient’s clinical status 47.5%, abnormal lab test result 15.6%, review/response to a consultant’s recommendations 12.8%). Significantly, 40% of the clinically important overnight issues were not included in the verbal handover and not documented in a progress note in 85% (overall 37% were not passed on in either the verbal handover or the medical record). An internet-based written sign-out tool available at these centers was used to document only 7.8% of the clinically important overnight issues. Extrapolating, the researchers note that hundreds of clinically important issues might not be handed over every month at their institutions. And these were not trivial issues that were overlooked. They were issues like patients with chest discomfort on whom cardiac enzymes and EKG’s were ordered, or patients in whom consultants recommended holding off on anticoagulation.
Teams in the Toronto study spent the bulk of their morning rounds discussing newly admitted patients and spent only 11 minutes on average discussing overnight issues on previously admitted patients.
Devlin and colleagues also kept track of the interruptions and distractions occurring during the morning rounds handback. The teams experienced an average of 6.2 distractions per hour resulting in 2.6 interruptions per hour during the morning rounds handover. Over half the interruptions were due to pagers or overhead speakers and announcements. Interruptions by other physicians, nurses, and other members of the healthcare team were also frequent.
The researchers identified certain features that promoted appropriate discussion of clinical important overnight issues. Foremost was “running the list”, i.e. discussing every patient on the list of overnight patients (as opposed to the on-call resident just discussing patients he/she felt needed discussion or handing over to a third party who would update the rest of the team). Distractions correlated negatively with handover of overnight issues.
The researchers note that the preferred method of “running the list” is also a good interruption-handling strategy (i.e. you are more likely to return to the correct point of discussion if you are running the list of patients and less likely to skip over something because of the interruption).
Another extremely important point Devlin and colleagues make is that the handover format for morning rounds (or the handback) may need to be different from the format used for the handover that occurs from the daytime team to the covering physician. We’ve made that point in many of our prior columns, that is the format of the handoff or handover should be tailored to the type of transfer of responsibility and “one size does not fit all” (see our February 14, 2012 Patient Safety Tip of the Week “Handoffs – More Than Battle of the Mnemonics”). Specifically, Devlin and colleagues suggest that the SBAR format may be preferable to the I-PASS format in this scenario because it focuses discussion on specific situations and emphasizes the on-call physician’s assessment and response.
The authors had recommendations for improvement of these handovers at the individual, team, training program, and training environment levels. Probably the most important recommendation is to set aside enough dedicated time (while minimizing interruptions) to “run the list” of patients in the presence of the physician who had been on-call.
Though not specifically addressing the “handback”, a recent collaboration among 23 pediatric hospitals (Bigham 2014) demonstrated a significant decrease in handoff-related care failures for multiple different handoff types. The improvement project was guided by evidence-based recommendations regarding handoff intent and content, standardized handoff tools/methods, and clear transition of responsibility. Hospitals tailored handoff elements to locally important handoff types. Examples of the handoff types included shift-to-shift handoffs, emergency department to inpatient handoffs, and perioperative to inpatient handoffs. Handoff-related care failures decreased from 25.8% at baseline to 7.9% in the final intervention period.
Compliance to critical components of the handoff process improved, as did provider satisfaction. Key elements required, regardless of the handoff type, were that active participation by both the sending and receiving teams were required, discrete times
and mechanisms set aside for the receiving team to ask questions, a proscribed script of important handoff elements was available, and a “read back” summary of basic issues and next steps was accessible. One very interesting finding was that even where baseline compliance with individual elements was pretty good at baseline, relatively small incremental improvements in those individual elements collectively led to very good reductions in overall handoff failures.
Though restrictions on hours that residents may work have increased the number and complexity of handoffs/handovers, most of the same issues apply to other physician coverage arrangements. Yes, one resident just finishing a 24-hour shift may have to leave immediately after morning rounds. But a physician in a community or rural hospital who is covering for another physician also has competing requirements for his/her time (eg. office hours, scheduled surgery, etc.). And the same types of interruptions and distractions (phone calls, pages, nurses or colleagues or families requesting information, etc.) apply equally well to morning rounds or the physician cross-coverage handback.
Though neither the Toronto study nor the pediatric collaborative looked at the impact of the missed handoff issues on patient harm or actual patient outcomes, we would certainly predict that improvement in the handback process would likely prevent many adverse events and outcomes. Both are very good studies and have implications for all healthcare organizations, not just academic ones.
Read about many other handoff issues (in both healthcare and other industries) in some of our previous columns:
May 15, 2007 “Communication, Hearback and Other Lessons from Aviation”
May 22, 2007 “More on TeamSTEPPS™”
August 28, 2007 “Lessons Learned from Transportation Accidents”
December 11, 2007 “Communication…Communication…Communication”
February 26, 2008 “Nightmares….The Hospital at Night”
September 30, 2008 “Hot Topic: Handoffs”
November 18, 2008 “Ticket to Ride: Checklist, Form, or Decision Scorecard?”
December 2008 “Another Good Paper on Handoffs”.
June 30, 2009 “iSoBAR: Australian Clinical Handoffs/Handovers”
April 25, 2009 “Interruptions, Distractions, Inattention…Oops!”
April 13, 2010 “Update on Handoffs”
July 12, 2011 “Psst! Pass it on…How a kid’s game can mold good handoffs”
July 19, 2011 “Communication Across Professions”
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
December 2011 “AORN Perioperative Handoff Toolkit”
February 14, 2012 “Handoffs – More Than Battle of the Mnemonics”
March 2012 “More on Perioperative Handoffs”
June 2012 “I-PASS Results and Resources Now Available”
August 2012 “New Joint Commission Tools for Improving Handoffs”
August 2012 “Review of Postoperative Handoffs”
January 29, 2013 “A Flurry of Activity on Handoffs”
December 10, 2013 “Better Handoffs, Better Results”
February 11, 2014 “Another Perioperative Handoff Tool: SWITCH”
March 2014 “The “Reverse” Perioperative Handoff: ICU to OR”
Devlin MK, Kozij NK, Kiss A, et al. Morning Handover of On-Call IssuesOpportunities for Improvement. JAMA Intern Med 2014; 174(9): 1479-1485
Bigham MT, Logsdon TR, Manicone PE, et al. Decreasing Handoff-Related Care Failures in Children’s Hospitals. Pediatrics 2014; 134:2 e572-e579; published ahead of print July 7, 2014,
Print “The Handback”
September 16, 2014
Focus on Home Care
We know some of our readers will read no further when the see “home care” in the title. But the problems that take place in home care are the result of errors and contributing factors that occur throughout the healthcare system and usually not the result of errors by what we might traditionally think of as “home care” providers. Particularly as the bulk of medical care is being shifted to the home and ambulatory care side, we are likely to see more and more adverse events occurring outside the hospital setting.
A little over a year ago we did a column on adverse events in home care (see our August 13, 2013 Patient Safety Tip of the Week “Adverse Events in Home Care”) in which we reviewed several excellent studies done in Canada. Well, our neighbors to the north have again made another excellent contribution to our understanding of adverse events in home care. ISMP Canada has done an analysis of medication incidents in home care (ISMP Canada 2014).
ISMP Canada found 153 incidents over roughly 14 years in their database of voluntary medication safety incidents and found there were three main themes:
Two-thirds of the incidents involved problems in the transition of patients from the hospital to home. That obviously includes problems with medication reconciliation. The authors stress that a discharge medication plan must not only focus on the medications themselves. Rather there needs to be a comprehensive assessment of the patient and his family or caregivers regarding financial issues, knowledge deficits, physical challenges, etc. They note that a medication considered “appropriate” may, in fact, be “inappropriate” if the patient cannot afford, manipulate or swallow it.
But they take it a step further and point out that our communication with community partners may be suboptimal. While home care nursing is usually made aware of the discharge medication plan, the community pharmacy seldom is. That can give rise to delays in treatment (eg. a pharmacy may not have a particular drug in routine stock). We’ve previously also discussed another way the community pharmacy is often cut out of the loop. In our May 27, 2014 Patient Safety Tip of the Week “A Gap in ePrescribing: Stopping Medications” we highlighted a critical issue: stopping a medication is often much different than starting one. Starting a medication requires an active process – you either write a prescription, enter one into a computer, or call the pharmacy. But discontinuing a medication is often more passive – you may just tell the patient to stop it. You don’t call the pharmacy to stop it. And, if there was no associated office visit, you might forget to update the patient’s medication list in your office EMR (or paper records) until the patient’s next office visit. Thus, a patient may continue to get medications that you thought you had stopped. A study done in a large multispecialty group practice in Massachusetts (Allen 2012) showed that among targeted medications that were electronically discontinued (on the practice’s EMR) 1.5% were subsequently dispensed by a pharmacy at least once. We suspect those discontinued at hospital discharge are equally likely to continue to be dispensed when the community pharmacy is left out of the loop.
The second main theme in the ISMP Canada analysis, involved in 14% of their incidents, was complex communications. They point out examples where communication must take place among multiple different providers, with each communication increasing the likelihood of error. An example they provide was a patient suffering continued pain despite a plan for use of a pain pump in the home. A pain pump had been delivered to the home but no nursing visit was scheduled in advance so an undue delay in pain management occurred. ISMP Canada points out that coordination among home care providers can be very complex – involving electronic referrals, faxes, phone calls, and manual documentation. They note that any change in the care plan may affect multiple providers. The fact that our current systems are poor at intercommunicating often leads to duplication of effort and an increased likelihood of error. They note that a physician may need to write orders on a home care order sheet but then also write new prescriptions.
The third ISMP Canada theme was medication handling. This theme, which involved in 22% of their incidents, included errors in dispensing, administering, and repackaging medications. They note that many patients on multiple medications do better when their medications are repackaged into blister packs or dosettes. They stress that systematic double checks need to take place when repackaging and that the blister packs or dosettes must have the patient name and list of contents clearly labelled. They note a fatal incident where a patient’s dosette was filled with medications intended for the patient’s spouse.
Also included in this theme are cases in which patients or their caregivers misinterpret instructions for use of a medication. An example was use of the abbreviation “tsp”, which was interpreted by some as “tablespoon” rather than “teaspoon”. Also problematic is the instruction “take as directed”. In our April 12, 2011 Patient Safety Tip of the Week “Medication Issues in the Ambulatory Setting” we noted how you tell patients to take their meds (the “sig:” on your prescriptions) is also critical. A study (Wolf 2011) gave well-educated volunteers prescriptions for seven drugs and watched them try to figure out how and when to take them all. They could theoretically be consolidated to be taken in 4 dosing sets per day. Yet only 15% were able to consolidate the regimen to 4 times daily or less. Most ended up with regimens taking medications 6 or 7 times daily. Even the instructions “twice daily” and “every 12 hours” resulted in medications being taken at different times.
The drugs involved in the ISMP Canada study included high-alert medications in a quarter of the incidents (opioids, anticoagulants, hypoglycemic agents, immunosuppressants, and pediatric liquids) so it’s not surprising that over a third of the reported incidents resulted in harm to patients.
The ISMP Canada database relies on voluntary reporting. Undoubtedly, the actual prevalence of medication errors in home care is much higher. But this is an excellent article that draws attention to how care in multiple parts of our complex medical system impacts on patients in their home setting.
We also suggerst that you read a couple of our prior Patient Safety Tips of the Week that have important considerations for medication safety in the home care environment:
April 12, 2011 “Medication Issues in the Ambulatory Setting”
August 13, 2013 “Adverse Events in Home Care”
ISMP Canada. Aggregate Analysis of Medication Incidents in Home Care. ISMP Canada Safety Bulletin 2014; 14(8): 1-4
Allen AS, Sequist TD. Pharmacy Dispensing of Electronically Discontinued Medications. Ann Intern Med 2012; 157(10): 700-705
Wolf MS; Curtis LM, Waite K, et al. Helping Patients Simplify and Safely Use Complex Prescription Regimens. Arch Intern Med. 2011; 171(4): 300-305
Print “Focus on Home Care”
September 23, 2014
Stroke Thrombolysis: Need to Focus on Imaging-to-Needle Time
Patients with acute ischemic stroke who are candidates for intravenous thrombolytic therapy benefit most when thrombolytic therapy can be accomplished in a more timely fashion. We’ve done a number of columns on reducing door-to-needle (DTN) times for thrombolysis in acute stroke patients (see our Patient Safety Tips of the Week for November 6, 2012 “Using LEAN to Improve Stroke Care” and March 18, 2014 “Systems Approach Improving Stroke Care”).
Many organizations have achieved success in reducing the door-to-imaging (DTI) times. But a recent study from Michigan (Sauser 2014) shows that we may need to focus more on the imaging-to-needle (ITN) times. Sauser and colleagues assessed thrombolytic therapy at 30 Michigan hospitals and found that 68.4% of patients with acute ischemic stroke achieved DTI times within the guideline target of 25 minutes. Yet only 28.7% achieved DTN times within the guideline target of 60 minutes.
They found that neither annual stroke volume nor primary stroke center designation were significant predictors of shorter DTN time. And patient-level factors (including stroke severity among others) accounted for only about 15% of the variation in DTN times between hospitals. Once they adjusted data for patient-level factors, DTI times accounted for only 10% of the variation between hospitals whereas 65% of the variation was attributable to differences in the ITN (imaging-to-needle) times. Thus, greater focus is needed on improving processes that take place on completion of imaging studies.
Many hospitals have focused their improvement efforts on shortening the door-to-imaging (DTI) time since it has been a key component of the Get With The Guidelines®-Stroke program. Sauser and colleagues point out that many of the personnel and processes involved in the DTI and ITN intervals are different. Processes after imaging include image interpretation, decision making, ordering and preparing tPA, laboratory testing, discussion and informed consent with the patient and family, and administering the tPA. This requires coordination amongst several different physicians and communication amongst numerous healthcare personnel and other individuals.
One interesting point of discussion in the Sauser study is the observation that decisions take longer when the physician has more time available. They note prior studies have demonstrated patients with shorter onset-to-arrival (OTA) times often have longer door-to-needle (DTN) times. In our March 18, 2014 Patient Safety Tip of the Week “Systems Approach Improving Stroke Care” we noted a study that mentioned times to treatment are often paradoxically increased in patients having in-hospital strokes (Meretoja 2012).
One of the key opportunities is getting those other processes underway before or while the patient having his/her imaging studies done. In our March 18, 2014 Patient Safety Tip of the Week “Systems Approach Improving Stroke Care” we discussed several studies that had demonstrated substantial improvements in door-to-needle times. One done in the US (Binning 2014) cut its door-to-needle times by over 50% and even had several cases with door-to-needle times under 20 minutes. The other, done in Finland, achieved a median door-to-needle time of 20 minutes (Meretoja 2012). In both, door-to-imaging times were reduced considerably by having the patient taken directly by EMS personnel to the CT suite rather than to the emergency department. However, a host of other processes were set in place as soon as the EMS personnel notified the hospitals they had a likely stroke patient. Expedited registration allowed for ordering the imaging studies and the blood work. Bloods were drawn for laboratory studies as soon as the patient arrived at the CT suite. In addition, the pharmacy is alerted so that the tPA can be prepared for administration. Lab studies, a bottleneck in many hospitals, were expedited by using point-of-care (POC) testing for the only two critical studies: blood glucose levels and INR’s. A physician, adept at stroke diagnosis but not necessarily a neurologist, evaluates the patient at the CT suite and administers the tPA right in the CT suite if the patient meets criteria and the CT scan and lab results do not show any contraindication.
Another key is that the process of obtaining an accurate history (often from family) begins as soon as the EMS notification comes in. The Finnish program had one additional advantage often not available in the US: an integrated electronic health record.
Another key factor is immediate interpretation of the imaging study. If a radiologist is not available for interpretation (either on-site or remotely) the “stroke” physician interprets it. The Finnish study also emphasizes the need to keep imaging simple. They just do standard non-contrast CT and reserve advanced imaging like perfusion imaging for unclear cases only.
Meretoja and colleagues concluded “the key to success in reducing the delays is to do only the basics while the patient has arrived, and to do as much as possible before, during transport.”
Reducing the overall door-to-needle times gives the stroke patient better odds of good functional outcome. Moreover, the reduced times also increase the percentage of stroke patients that are eligible for thrombolytic therapy. In the Binning study the percentage of patients receiving tPA increased to 18% from their historical rate of 5%.
We suggest that you read our prior columns, listed below, that have good links to many of the good performance improvement studies done on thrombolytic therapy and links to resources from the American Heart Association/American Stroke Association's Target: Stroke Initiative.
Some of our previous columns on improving stroke care:
November 6, 2012 “Using LEAN to Improve Stroke Care”
March 18, 2014 “Systems Approach Improving Stroke Care”
Sauser K, Levine DA, Nickles AV, Reeve MJ. Hospital Variation in Thrombolysis Times Among Patients With Acute Ischemic StrokeThe Contributions of Door-to-Imaging Time and Imaging-to-Needle Time. JAMA Neurol. 2014; 71(9): 1155-1161
Meretoja A, Strbian D, Mustanoja S, et al. Reducing in-hospital delay to 20 minutes in stroke thrombolysis. Neurology 2012; 79: 306–313
American Heart Association. Get With The Guidelines®-Stroke program.
Binning MJ, Sanfillippo G, Rosen W et al. The Neurological Emergency Room and Prehospital Stroke Alert: The Whole Is Greater Than the Sum of Its Parts. Neurosurgery 2014; 74(3): 281–285
September 30, 2014
More on Deprescribing
It was only earlier this year that we first saw the term “deprescribing” (see our March 4, 2014 Patient Safety Tip of the Week “Evidence-Based Prescribing and Deprescribing in the Elderly”). But we’ve obviously long been big advocates of discontinuing medications which no longer have a positive benefit:harm ratio (see the list of all our previous columns on inappropriate medications at the end of today’s column).
This month the Medical Journal of Australia has several good articles on deprescribing. The first article (Scott 2014) chronicles the statistics on the consequences of polypharmacy and then describes the barriers to deprescribing.
The first barrier to deprescribing noted by Scott and colleagues is an underappreciation of the magnitude of polypharmacy-related harm. They note that many times symptoms in the elderly (such as falls, delirium, lethargy, depression) are not recognized as adverse drug events.
A second barrier is the increasing intensity of medical care. Prescription of many medications is driven by clinical guidelines, quality measures, and performance incentives. They note that this often results in “prescribing cascades” in which more drugs are added for new illness, including some that are actually adverse drug events (ADE’s) misinterpreted as new illnesses.
A very important point raised by Scott et al. is the drugs on which we focus may be wrong. Many of the potentially inappropriate medications on Beers’ List actually probably account for relatively few adverse drug events in aggregate. In our June 21, 2011 Patient Safety Tip of the Week “STOPP Using Beers’ List?” we noted that the STOPP criteria identified potentially avoidable ADE’s impacting on hospitalization over twice as often as did Beers’ criteria and that such ADE’s are extremely common. Scott et al. point out the work of Budnitz and colleagues (Budnitz 2011) that showed most emergency hospitalizations for recognized adverse drug events in older adults resulted from a few commonly used medications (eg. warfarin, antiplatelet agents, insulins, oral hypoglycemic agents) and relatively few resulted from medications typically designated as high-risk or inappropriate in such lists.
One of the barriers to deprescribing noted by Scott and colleagues is a reluctance by physicians to discontinue a medication started by another physician, especially those started by a specialist. We agree that such is a barrier. But one equally big barrier we see is reluctance to discontinue medications that they themselves started. We’ve previously described an initiative in a health system in which physicians were made aware of the potential adverse effects of amitriptyline in the elderly. The number of new prescriptions for amitriptyline decreased but almost never did the physicians discontinue amitriptyline they had already prescribed for their patients.
The patient’s fear or ambivalence is another barrier. Patients are often reluctant to stop a drug that had improved symptoms in the past or had been expected to prolong life or have other long-term benefits. They may perceive deprescribing as “abandonment” rather than as an attempt to improve their quality of life or decrease risks of adverse events.
Scott and colleagues mention, but don’t emphasize, what we consider to be a huge barrier: limited time and remuneration for deprescribing. It is very time consuming to sit down and go over all the medications, go back in history to find out why and by whom certain medications were prescribed, discuss the pros and cons of medication cessation with the patient, communicate with other physicians about discontinuation, and then monitor the patient for unwanted effects once a medication is discontinued. Most of that time is not reimbursed in our current payment systems. (But that is where exists an opportunity to fully utilize other members of the healthcare team to do some of the legwork.)
Scott et al. offer several potential solutions. One important one is reframing the issue, to make sure the patient understands deprescribing is an attempt to improve their quality of life or decrease risks of adverse events and not an act of abandonment. That’s extremely important in maintaining trust and preserving the physician-patient relationship. We need to discuss the benefit:harm tradeoffs for discontinuation of each drug and assess the patient’s willingness to try discontinuation. They suggest targeting those patients at highest risk for ADE’s. That includes not only patients on the most drugs but also those with past history of ADE’s, frailty, multiple comorbidities, multiple prescribers, and those in residential settings.
They suggest targeting drugs most likely to be non-beneficial, which they consider in 5 categories:
Giving the physician access to specific discontinuation regimens is important and Scott et al. provide links to websites and other resources in their article. Lastly, Scott et al. recommend interdisciplinary meetings with other prescribers and clinical pharmacologists or pharmacists, and stress the importance of having the same generalist clinician overseeing the process over multiple visits.
We had actually previously mentioned Dr. Scott’s approach to deprescribing (see our March 4, 2014 Patient Safety Tip of the Week “Evidence-Based Prescribing and Deprescribing in the Elderly”). Scott and colleagues (Scott 2012) had developed a 10 step conceptual framework for minimizing inappropriate medications in older populations and deprescribing:
The second MJA article (Reeve 2014), also supportive of deprescribing in general, is a bit more cautious and points out that there is actually a dearth of evidence on actual patient outcome benefits of deprescribing. Reeve and colleagues note that of the multiple studies demonstrating interventions that successfully reduce polypharmacy only half included outcome measures other than number of drugs and only one-third of the latter showed a benefit in clinical outcomes. Similarly, the effect of programs to reduce potentially inappropriate medications on clinical outcomes has not been rigorously studied.
Reeve et al. discuss several potential harms of deprescribing. One is the occurrence of withdrawal reactions. They cite previous studies that showed 26% of medication cessations in older adults resulted in adverse withdrawal reactions, sometimes resulting in ER visits or even hospitalizations. However, they note that appropriate tapering of medications prior to cessation can prevent many such reactions.
They also note that drug interactions may affect medications other than the one being discontinued. Our May 27, 2014 Patient Safety Tip of the Week “A Gap in ePrescribing: Stopping Medications” described one such example. So it is imperative that patients be monitored after medication cessation just as we would monitor patients at the start of a new medication.
Return of the medical condition for which the drug was originally prescribed is a concern for both patients and physicians. But, generally, restarting the medication in such instances is usually successful. They note particularly that the impact of cessation of preventive medications, where the benefit is many years from now, has not been well studied.
There are several good resources available that have algorithms or frameworks for discontinuing medications (Scott 2013, Bain 2008, Garfinkel 2010). The 2013 Scott (Scott 2013) and 2010 Bain (Bain 2008) articles have examples of drugs that are commonly associated with discontinuation or withdrawal symptoms and signs. The 2013 article by Scott et al. (Scott 2013) also has a table with good questions to ask about the utility of a drug.
But there is one area in which the greatest opportunity exists to help in medication cessation – when you first prescribe a drug! When you prescribe a medication for a patient you should have an exit strategy. You should be asking yourself (and discussing with your patient) the following questions:
In many ways, stopping a medication is much more complex than starting one. Deprescribing, particularly in the elderly, can be a very important process in improving patient quality of life, reducing risk of adverse consequences, and reducing morbidity. Once drugs with poor benefit:risk ratios are discontinued, patients may also become more adherent to other medications which may have high benefit:risk ratios.
Some of our past columns on Beers’ List and Inappropriate Prescribing in the Elderly:
Patient Safety Tips of the Week:
What’s New in the Patient Safety World columns:
Scott IA, Anderson K, Freeman CR, Stowasser DA. First do no harm: a real need to deprescribe in older patients. Med J Aust 2014; 201(7): 1-3
Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011; 365: 2002-2012
Scott IA, Gray LC, Martin JH, Mitchell CA. Minimizing inappropriate medications in older populations: a 10 step conceptual framework. Am J Med 2012; 125: 529–537
Reeve E, Shakib S, Hendrix I, et al. The benefits and harms of deprescribing. Med J Aust 2014; 201(7): 1-4
Scott IA, Gray LC, Martin JH, et al. Deciding when to stop: towards evidence based deprescribing of drugs in older populations. Evid Based Med 2013; 18: 121–124
Bain KT, Holmes HM, Beers MH, et al. Discontinuing medications: a novel approach for revising the prescribing stage of the medication-use process. J Am Geriatr Soc 2008; 56(10): 1946–1952
Garfinkel D, Mangin D. Feasibility study of a systematic approach for discontinuation of multiple medications in older adults. Arch Intern Med 2010; 170(18): 1648–1654
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May 6, 2014
April 29, 2014
April 22, 2014
April 15, 2014
Specimen Identification Mixups
April 8, 2014
April 1, 2014
March 25, 2014
March 18, 2014
March 11, 2014
March 4, 2014
February 25, 2014
February 18, 2014
February 11, 2014
February 4, 2014
January 28, 2014
Is Polypharmacy Always Bad?
January 21, 2014
January 14, 2014
January 7, 2014
December 24-31, 2013
Tip of the Week on Vacation
December 17, 2013
December 10, 2013
December 3, 2013
November 26, 2013
November 19, 2013
November 12, 2013
November 5, 2013
October 29, 2013
October 22, 2013
October 15, 2013
October 8, 2013
October 1, 2013
September 24, 2013
September 17, 2013
September 10, 2013
September 3, 2013
August 27 2013
August 20 2013
August 13 2013
August 6, 2013
July 9-30, 2013
Tip of the Week on Vacation
July 2, 2013
June 25, 2013
June 18, 2013
June 11, 2013
June 4, 2013
May 28, 2013
May 21, 2013
May 14, 2013
May 7, 2013
April 30, 2013
April 23, 2013
April 16, 2013
April 9, 2013
April 2, 2013
March 26, 2013
March 19, 2013
March 12, 2013
March 5, 2013
February 26, 2013
February 19, 2013
February 12, 2013
February 5, 2013
January 29, 2013
January 22, 2013
January 15, 2013
January 8, 2013
January 1, 2013
December 25, 2012
Tip of the Week on Vacation
December 18, 2012
December 11, 2012
December 4, 2012
November 27, 2012
November 20, 2012
November 13, 2012
November 6, 2012
October 30, 2012
October 23, 2012
October 16, 2012
October 9, 2012
October 2, 2012
September 25, 2012
September 18, 2012
September 11, 2012
September 4, 2012
August 28, 2012
August 21, 2012
August 14, 2012
August 7, 2012
July 31, 2012
July 24, 2012
July 17, 2012
July 10, 2012
Tip of the Week on Vacation
July 3, 2012
June 26, 2012
June 19, 2012
June 12, 2012
June 5, 2012
May 29, 2012
May 22, 2012
May 15, 2012
May 8, 2012
May 1, 2012
April 24, 2012
April 17, 2012
April 10, 2012
April 3, 2012
March 27, 2012
March 20, 2012
March 13, 2012
March 6, 2012
February 28, 2012
February 21, 2012
February 14, 2012
February 7, 2012
January 31, 2012
January 24, 2012
January 17, 2012
January 10, 2012
January 3, 2012
December 20, 2011
December 13, 2011
December 6, 2011
November 29, 2011
November 22, 2011
November 15, 2011
November 8, 2011
November 1, 2011
October 25, 2011
October 18, 2011
October 11, 2011
October 4, 2011
September 27, 2011
September 20, 2011
September 13, 2011
September 6, 2011
August 30, 2011
August 23, 2011
August 16, 2011
August 9, 2011
August 2, 2011
July 26, 2011
July 19, 2011
July 12, 2011
July 5, 2011
June 28, 2011
June 21, 2011
June 14, 2011
June 6, 2011
May 31, 2011
May 24, 2011
May 17, 2011
May 10, 2011
May 3, 2011
April 26, 2011
April 19, 2011
April 12, 2011
April 5, 2011
March 29, 2011
The Silent Treatment:A Dose of Reality
March 22, 2011
March 15, 2011
March 8, 2011
March 1, 2011
February 22, 2011
February 15, 2011
February 8, 2011
February 1, 2011
January 25, 2011
January 18, 2011
January 11, 2011
January 4, 2011
December 28, 2010
December 21, 2010
December 14, 2010
December 6, 2010
November 30, 2010
November 23, 2010
November 16, 2010
November 9, 2010
November 2, 2010
October 26, 2010
October 19, 2010
October 12, 2010
October 5, 2010
September 28, 2010
September 21, 2010
September 14, 2010
September 7, 2010
August 31, 2010
August 24, 2010
August 17, 2010
August 10, 2010
August 3, 2010
Tip of the Week on Vacation
July 27, 2010
July 20, 2010
July 13, 2010
July 6, 2010
June 29, 2010
June 22, 2010
June 15, 2010
June 8, 2010
June 1, 2010
May 25, 2010
May 18, 2010
May 11, 2010
May 4, 2010
April 27, 2010
April 20, 2010
April 13, 2010
April 6, 2010
March 30, 2010
March 23, 2010
March 16, 2010
March 9, 2010
March 2, 2010
February 23, 2010
February 16, 2010
February 9, 2010
February 2, 2010
January 26, 2010
January 19, 2010
January 12, 2010
January 5, 2010
December 29, 2009
December 22, 2009
December 15, 2009
December 8, 2009
December 1, 2009
November 24, 2009
November 17, 2009
November 10, 2009
November 3, 2009
October 27, 2009
October 20, 2009
October 13, 2009
October 6, 2009
September 29, 2009
September 22, 2009
September 15, 2009
September 8, 2009
September 1, 2009
August 25, 2009
August 18, 2009
August 11, 2009
August 4, 2009
July 28, 2009
July 21, 2009
July 14, 2009
July 7, 2009
June 30, 2009
June 23, 2009
June 16, 2009
June 9, 2009
June 2, 2009
May 26, 2009
May 19, 2009
May 12, 2009
May 5, 2009
April 28, 2009
April 21, 2009
April 14, 2009
April 7, 2009
March 31, 2009
March 24, 2009
March 17, 2009
March 10, 2009
March 3, 2009
February 24, 2009
February 17, 2009
February 10, 2009
February 3, 2009
January 27, 2009
January 20, 2009
January 13, 2009
January 6, 2009
December 30, 2008
December 23, 2008
December 16, 2008
December 9, 2008
December 2, 2008
November 25, 2008
November 18, 2008
November 11, 2008
November 4, 2008
October 28, 2008
October 21, 2008
October 14, 2008
October 7, 2008
September 30, 2008
September 23, 2008
September 16, 2008
September 9, 2008
September 2, 2008
August 26, 2008
August 19, 2008
August 12, 2008
August 5, 2008
July 29, 2008
July 22, 2008
July 15, 2008
July 8, 2008
July 1, 2008
June 24, 2008
June 17, 2008
June 10, 2008
June 3, 2008
May 6, 2008
April 29, 2008
April 22, 2008
April 15, 2008
April 8, 2008
April 1, 2008
March 25, 2008
March 18, 2008
March 11, 2008
March 4, 2008
February 26, 2008
February 19, 2008
February 12, 2008
February 5, 2008
January 29, 2008
January 22, 2008
January 15, 2008
January 8, 2008
January 1, 2008
December 25, 2007
December 18, 2007
December 11, 2007
December 4, 2007
November 20, 2007
November 13, 2007
November 6, 2007
October 30, 2007
October 23, 2007
October 16, 2007
October 9, 2007
October 2, 2007
September 25, 2007
September 18, 2007
September 11, 2007
September 4, 2007
August 28, 2007
August 21, 2007
August 14, 2007
August 7, 2007
July 31, 2007
July 24, 2007
July 17, 2007
July 10, 2007
July 3, 2007
June 26, 2007
June 19, 2007
June 12, 2007
June 5, 2007
May 29, 2007
May 22, 2007
May 15, 2007
May 8, 2007
May 1, 2007
April 23, 2007
April 16, 2007
April 9, 2007
April 2, 2007
March 26, 2007
March 19, 2007
March 12, 2007
March 5, 2007
February 26, 2007