Healthcare Consulting Services
January 3, 2012
Unintended Consequences of Restricted Housestaff Hours
This months Whats New in the Patient Safety World column Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety highlights the serious impact of provider fatigue on patient safety. Weve done numerous columns focusing on the impact of fatigue in both nurses and physicians, not only on patient care but on their personal health. (See our Patient Safety Tips of the Week for November 9, 2010 12-Hour Nursing Shifts and Patient Safety, April 26, 2011 Sleeping Air Traffic Controllers: What About Healthcare? and our Whats New in the Patient Safety World columns for February 2011 Update on 12-hour Nursing Shifts, September 2011 Shiftwork and Patient Safety, and November 2011 Restricted Housestaff Work Hours and Patient Handoffs.)
There is absolutely no doubt about the negative impact that fatigue has on patient safety and quality outcomes. However, equally disturbing is the fact that some of our interventions to minimize fatigue in healthcare workers may introduce unintended consequences that do not remedy the underlying threats to patient safety.
In our November 2011 Whats New in the Patient Safety World column Restricted Housestaff Work Hours and Patient Handoffs we discussed the mixed results of studies looking at the impact on patients of restrictions on housestaff work hours. And weve discussed the fact that our efforts to minimize errors due to fatigue of long working hours (for not only physicians but also nurses and others) must always be balanced against the errors that occur due to fumbled handoffs that increase when work hours are restricted.
In response to the ACGME duty-hour restrictions for housestaff a variety of schedules have been tried. At Childrens Hospital in Boston they moved from a night float system to one in which housestaff worked one straight week of nights during their 28-day rotations (compared to previously working every fourth night). Christopher Landrigan, director of the Sleep and Patient Safety Program at Harvard, and colleagues (Chua 2011) looked at the impact of this change and found some surprising results. Though mean shift length was reduced by almost 2 hours, the residents nightly sleep actually was reduced from 6.72 to 4.77 hours and total sleep reduced from 7.50 to 5.47 hours! The study did not assess impact on patient care.
Childrens Hospital of Boston subsequently reverted temporarily to a more traditional overnight call schedule and now has redesigned a night team schedule taking into account the results of this study. The article is a stark reminder that sometimes in our haste to correct one problem we inadvertently develop a solution that aggravates the original problem or creates new problems. And unless you actually measure the outcomes of the changes you make you may incorrectly assume that your changes created a desirable effect.
We had previously discussed some of Landrigans work in our September 2011 Whats New in the Patient Safety World column Shiftwork and Patient Safety. An audio interview (Henkel 2011a) with him in the August issue of The Hospitalist had some really good points about the effects of shiftwork on mistakes and patient safety. He stresses that you dont want to schedule someone to work too many nights in a row, citing literature from multiple industries that shows error rates go up with consecutive nights worked. Our November 9, 2010 Patient Safety Tip of the Week 12-Hour Nursing Shifts and Patient Safety cited a study on shift workers in fields other than healthcare (Folkard 2003) which 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%). So Landrigan says that it is probably better to schedule hospitalists for only 3-4 days of night shifts rather than the more popular 7days on/7 days off pattern.
In the above interview Landrigan also discusses the biology of circadian rhythms and notes the importance of taking a 1.5-2.0 hour nap on the afternoon prior to working the first night shift and that working a day shift immediately after a night shift is not a good idea. He discusses how working consecutive night shifts adds to the burden of sleep deprivation, which ultimately has a role in the occurrence of mistakes and errors. When asked about nocturnists, he does note that some people have been able to alter their circadian rhythms to accommodate chronic night shift work. But he cautions that when such people take vacations their bodies return to a day circadian rhythm and there may be problems when they return to the night shift pattern.
Not only are too many consecutive night shifts potentially dangerous to patients, they are dangerous to the healthcare workers themselves. In the second article (Henkel 2011b) Landrigan notes We know that if hospitalists are driving home after night shifts, particularly multiple night shifts, that theyre at risk for motor vehicle crashes and at risk of sticking themselves with needles and scalpels toward the tail end of their shifts. None of us want that.
And the Journal of Neurosurgery has a series of articles on the impact of duty-hour restrictions on neurosurgery residents. Neurosurgery has been one discipline in which sentiment against the work hour restrictions has run heavy, both from attendings, educators and residents. One study (Dumont 2011) demonstrated an increase in complication rates for neurosurgical procedures after implementation of restricted work-hour rules. They postulate that the increased number of handoffs required probably plays a major role in the increase in morbidity and complications.
Another study (Ganju 2011) performed pre- and post-call simulation tests on neurosurgical residents and concluded there was a marginal decline in proficiency post-call. However, they noted that the decline was much less significant than the decline seen in general surgery residents post-call. That article and the accompanying editorial (Dacey 2011) seem to be touting neurosurgery residents are different were tougher and make a case that the same ACGME duty-hours restrictions should not apply equally to all specialties.
We dont buy that. Thats the same sort of Top Gun attitude that got many early fighter pilots killed. Fatigue is real and impairs our ability to respond no matter what professional or lifestyle activity we are engaged in. What we need to do is develop better ways to recognize when fatigue is occurring (because we ourselves are not good judges of our abilities when fatigued) and develop better systems to care for our patients when we need to excuse ourselves from patient care because we are fatigued.
But Landrigans message is clear - be careful that the solution you try is not worse than the problem itself!
Chua K-P, Gordon MB, Sectish T, Landrigan CP. Effects of a Night-Team System on Resident Sleep and Work Hours. Pediatrics 2011; 128:6 1142-1147
Henkel G. ONLINE EXCLUSIVE: How to minimize the adverse affects of working night shifts. The Hospitalist. August 2011
Henkel G. ONLINE EXCLUSIVE: Scheduling Rules of Thumb. Safety, equality should factor into HM groups coverage plans. The Hospitalist. August 2011
Folkard S, Tucker P. Shift work, safety and productivity. Occupational Medicine 2003; 53: 95-101
Dumont TM, Rughani AI, Penar PL, Horgan MA, Tranmer BI, Jewell RP. Increased rate of complications on a neurological surgery service after implementation of the Accreditation Council for Graduate Medical Education work-hour restriction: Clinical article. Journal of Neurosurgery, epub ahead of print, December 2, 2011; DOI: 10.3171/2011.9.JNS116
Ganju A, Kahol K, Lee P, Simonian N, Quinn SJ, Ferrara JJ, Batjer HH. The effect of call on neurosurgery residents skills: implication for policy regarding resident call periods. Clinical article. Journal of Neurosurgery, epub ahead of print, December 2, 2011; DOI: 10.3171/2011.9.JNS101406
Dacey RG. Resident Work Hours (editorial). Journal of Neurosurgery, epub ahead of print, December 2, 2011
Responses Batjer HH, Ganju A. and Dumont TM, Rughani AI.
January 10, 2012
Problems related to verbal orders (including both orders given verbally in face-to-face encounters and those given via telephone) have received much attention from the Joint Commission, ISMP (ISMP 2001), and the Pennsylvania Patient Safety Authority (PPSA 2006) among others. A timely article surveying hospital policies on verbal orders appears in this months issue of The Joint Commission Journal on Quality and Patient Safety (Wakefield 2012). The Wakefield article highlights the extreme variability of verbal order policies across hospitals and even some inconsistencies within hospitals.
While we all have numerous anecdotal examples of adverse events related to verbal orders, there is actually almost no literature looking at verbal order related errors from a larger perspective (Wakefield 2009). We all assume, based on common sense and our own anecdotal experiences, that verbal and telephone orders are more error-prone than written or computerized orders. Yet one of the only systematic studies addressing the issue (West 1994) failed to demonstrate that. In fact, in their study verbal orders were actually less error-prone than written or computerized orders!! They did note, however, that verbal orders became more prone to error as the orders became more complex.
Could the prior study showing that verbal orders are actually less error-prone (West 1994) have been true? There are at least some theoretical and practical reasons that verbal orders might, in fact, be less error-prone. A nurse transcribing orders does not have to decipher the handwriting of a physician on written orders. Similarly, the artifacts often seen with faxed orders (eg. missing decimal points, etc.) dont come into play with verbal orders. And the nurse (or pharmacist) taking the verbal order has the opportunity to clarify the order more easily than with written orders. And the types of orders given verbally tend to be less complex. So maybe, despite our suspicions to the contrary, they could be less error-prone. That, of course, does not mean we should not have policies, procedures and practices for dealing with verbal/telephone orders to make sure that verbal/telephone orders are as safe as possible. Wed all like to think that with the widespread implementation of computerized physician order entry (CPOE) the need for verbal or telephone orders will be eliminated. That, however, is extremely unlikely. There are always likely to be situations in settings such as the OR, ER, ICU, sterile procedure rooms, etc. where a provider is tied up attending to one patients needs and an urgent order is needed on another patient. And even where we make CPOE available remotely to physicians not on site, there will be times when the systems are unavailable.
We all have our own examples of adverse patient events related to errors in the verbal/telephone order process. And the literature is replete with more examples: vitamin K being confused with potassium (Lesar 2003), morphine 2 mg IV misinterpreted as 10 mg IV (Koczmara 2006), 15 mg of hydralazine vs 50 mg IV (Koczmara 2006), Orgaran misinterpreted as argatroban (Koczmara 2006), azithromycin misinterpreted as erythromycin (PPSA 2006), Klonopin misinterpreted for clonidine (PPSA 2006), and multiple other examples.
There are lots of common sense reasons that verbal or telephone orders are vulnerable to error and misinterpretation. Accents and pronunciation are highly variable. There may be static on telephone lines. There may be considerable background noise on either end of a phone conversation (or even face-to-face verbal communication) that impedes communication.
Covering physicians may be relatively unfamiliar with the patient and not have access to the full medical information needed to prescribe medications (or order tests or procedures) safely. And weve previously talked about the chance of patient misidentification when orders are done remotely (see our Patient Safety Tips of the Week June 19, 2007 Unintended Consequences of Technological Solutions and May 20, 2008 CPOE Unintended Consequences - Are Wrong Patient Erors More Common?).
In many cases of verbal orders the ordering provider may be otherwise distracted (eg. they are busy attending to the urgent needs of another patient) or multi-tasking. Worse yet, in some of those scenarios the provider relays the verbal order via yet a third party (Lesar 2003).
And verbal or telephone orders are vulnerable to the same errors we see with look-alike sound-alike (LASA) drugs and dangerous abbreviations in written orders.
An especially vulnerable scenario occurs when a verbal or telephone order is taken by a nurse who not only transcribes the order but must then obtain the medication (eg. from an automated dispensing machine) and administer it to the patient without any other intervening safety steps. That is likely to happen at night in many hospitals when the physician is not in the hospital and pharmacists are unavailable.
About a year ago we were at a small hospital and observed a nurse taking a telephone order. We asked How do you know who that was on the phone?. The response was Were a small hospital. We know all the doctors voices. But during our stay we noted numerous new nurses working, who obviously did not know all the doctors on staff. And it turned out that there was a continuous turnover of both ER physicians and hospitalists, so new voices appeared regularly. Imagine how this issue could be more complex in our larger teaching hospitals and academic medical centers where there is a constant turnover of housestaff. It turns out that very few hospitals have any formal mechanism in their verbal order policies for verification of the prescriber on telephone orders. In the recent Wakefield article (Wakefield 2012) only around 10% of the smaller and community hospitals had any such mechanism, whereas about 64% of academic medical centers had some sort of mechanism to verify the identity of the caller. The latter usually included callbacks to physician offices or use of physician identification numbers.
There have been reports (ISMP 2008) of several instances of fraudulent orders. In one a teenager who worked at the hospital who began answering pages to on-call residents. He issued orders for 6 patients (lab tests, oxygen orders, heparin orders) that were not caught right away because the orders were medically appropriate. Another case involved a friend of a patient with AIDS calling in a verbal order for insulin in apparent attempt to end that patients life. And another case where someone posing as a physician ordered enemas on six different patients.
The ISMP article suggests several things you can do to avoid such fraudulent telephone orders. If you don't recognize the caller, request his or her telephone number, verify it in the medical staff directory, and call the prescriber back to take the order. You can also verify a cell phone number with the prescriber's office staff or answering service. Another identification method is asking for a doctor-specific number such as medical records dictation number, but you'd need a list of these numbers to verify the caller's identity. If the caller doesn't provide a telephone number or you can't verify it, ask the individual to call back to speak to a nursing supervisor.
One key factor in errors related to verbal/telephone orders is the situation in which the orders are given. Frequently they are given in response to a request from nursing. The physician (or other provider to whom the request goes) is often busy with other activities when the request comes in so he/she is multitasking and may be distracted by the other activities. Moreover, he/she typically does not have full access to the patients medical record when the request comes in. So orders are often given without full consideration of the patients other medications, allergies, comorbidities, renal function, lab values, etc. The 2006 Pennsylvania Patient Safety Authority article (PPSA 2006) has very good descriptions of the contextual errors encountered in incidents reported to the Pennsylvania Patient Safety Reporting System.
And any time you are ordering remotely, even if you have access to the electronic medical record, you have the potential to make mistakes (see our Patient Safety Tips of the Week June 19, 2007 Unintended Consequences of Technological Solutions and May 20, 2008 CPOE Unintended Consequences - Are Wrong Patient Erors More Common?). Moreover, the 2-item patient identification rule we use throughout our systems is frequently violated with verbal/telephone orders. How often have you heard a nurse call a physician and say Im calling about Doris Jones, DOB 03/11/56. Well bet never! The call is usually goes Im calling about Mrs. Jones in Room 712B. That, of course, would be unacceptable if we were planning to do a procedure on that patient. But is it any less safe to order medications on that patient? Not really.
The excellent paper from ISMP Canada (Koczmara 2006) also includes a description of how communication is handled in other high risk industries, such as conversations between railroad engineers and railway traffic controllers.
Often the verbal/telephone order is initiated by a request from nursing staff to the provider. In such cases, nurses should use a structured format like SBAR when initiating the request and provide the appropriate context for the request. If the provider is not onsite or does not have access to the patients medical record, it is important that the nurse provide as much information about the patient as is relevant to the request. That may include information about the patients current medications, allergies, medical conditions, lab values, etc.
Read back is the most critical communication technique to be used in the verbal/telephone order process, just as it is in aviation or other high risk industries. In read back the recipient reads back the message as he/she has heard it and interpreted it. The person giving the order then confirms that such recording and interpretation of the order is correct. Because drug names and doses may be prone to misinterpretation, often special techniques must be used. The drug name should be spelled out, for example using military-like terms such as C as in Charlie, A as in Alpha, etc. Certain doses, particularly those including a -teen (such as 16) may be misunderstood as having a -ty (such as 60). So spelling out the dose may be appropriate (for example, one-six).
So here are the important things pertinent to verbal and telephone orders you need to ensure take place via your policies, procedures and practices:
BTW, texted orders are not acceptable under any circumstance (Joint Commission 2011)!
In addition to the questions addressed in the recent Wakefield article (Wakefield 2012) about verbal order policies, the 2006 PPSA article (PPSA 2006) has a Verbal Orders Toolkit, a checklist for assessing verbal orders policies, a sample policy for verbal/telephone orders, and an audit tool to use in your quality improvement activities.
And dont just use some of these techniques for verbal/telephone orders. Some types of orders we often fail to consider being verbal are really in the same category. A very interesting study (Doyle 2006) on an academic pediatric unit assessed mediation errors. Typically orders were discussed on morning rounds and the interns later entered the orders. They found over 9% of all orders had errors (most often with doses but sometimes with other errors). So they changed their process so that the orders were input while the team was still rounding in the patient rooms and read back was used. The error rate after implementation of the new process dropped to zero!
Institute for Safe Medication Practices (ISMP). Instilling a measure of safety into those whispering down the lane verbal orders. Medication Safety Alert! Acute Care Edition 2001; 6(2): 1-2
Pennsylvania Patient Safety Authority (PPSA). Improving the Safety of Telephone or Verbal Orders. PA PSRS Patient Saf Advis 2006; 3(2): 1,3-7
Wakefield DS, Wakefield BJ, Despins L, et al. A Review of Verbal Orders Policies in Acute Care Hospitals. The Joint Commission Journal on Quality and Patient Safety 2012; 38(1): 24-33
Wakefield DS, Wakefield BJ. Are verbal orders a threat to patient safety? BMJ Qual Saf Health Care 2009; 18: 165-168
West DW, Levine S, Magram G, et al. Pediatric Medication Order Error Rates Related to the Mode of Order Transmission. Arch Pediatr Adolesc Med. 1994; 148(12): 1322-1326
Lessar TS. 40 of K. AHRQ Web M&M 2003; November 2003
Koczmara C, Jelincic V, Perri D. Communication of medication orders by telephone Writing it right. CACCN 2006; 17(1): 20-24 Spring 2006
Institute for Safe Medication Practices (ISMP). Telephone orders. How do you know the caller is for real? ISMP Nurse Advise-ERR 2008; 6(7): 2 (July 2008)
The Joint Commission. Standards FAQ Details. Texting Orders. November 10, 2011.
Doyle E. To prevent ordering errors, one hospital is bringing read backs to the bedside. Cincinnati Childrens Hospital Medical Center found that the technique cut down on communication problems during rounds. Todays Hospitalist 2006; October 2006
Print Verbal Orders
January 17, 2012
Delirium and Contact Isolation
In our March 25, 2008 Patient Safety Tip of the Week More on MRSA we noted that there are unintended consequences of contact isolation. Kirkland and Weinstein (Kirkland 1999) found that healthcare workers who treated patients in contact isolation entered their rooms less frequently and had significantly less direct contact with them. Saint et al. (2003) found that attending physicians in two teaching hospitals were about half as likely to examine patients in contact isolation. Another study (Stelfox et al. 2003) showed that isolated patients are twice as the likely as control patients to suffer an adverse event during hospitalization. The difference was primarily due to preventable adverse events and included event such as falls, decubiti, and fluid/electrolyte disorders. In fact, the latter events were 8 times more likely in isolated patients. They also had a cohort of congestive heart failure patients in isolation and these patients were much less likely to have certain interventions and evidence-based care than a control group of congestive heart failure patients. And we have all seen that patients in contact isolation often do not get services such as active rehabilitation that they might get were they not in isolation. A review of the literature (Morgan 2009) found 15 studies relating to adverse outcomes of contact isolation and identified these in four main themes: less patient-healthcare worker contact, changes in systems of care that produce delays and more noninfectious adverse events, increased symptoms of depression and anxiety, and decreased patient satisfaction with care.
The University of Maryland group (Morgan 2011) had previously looked at the impact of contact isolation on quality core measures. They found that performance on several core measures for pneumonia (typically those measures that take place after the emergency room) had lower adherence though those for CHF, AMI and SCIP were not impacted. Of note, some of the measures that typically require spending more time with the patient (smoking cessation counseling, flu and pneumonia vaccination) were the measures that had lower adherence. Smoking cessation counseling was also less frequent in the CHF and AMI cohorts that were in contact isolation. A good slide presentation by Daniel Morgan, M.D., author of several of the University of Maryland studies noted above, is also available online (Morgan 2011 slides).
Now a new study from the University of Maryland (Day 2012) found that delirium was 75% more common in patients who are put into contact isolation during admission (as opposed to those placed in contact isolation at the time of admission). Though the study was retrospective and utilized administrative data, from which accurate diagnosis of delirium is difficult, the results are nevertheless impressive. Because delirium is typically undercoded in administrative data the authors used a proxy that also included unexplained use of antipsychotic drugs or use of physical restraints, measures that have been validated as better than ICD-9 coding for delirium alone. Logically, wed say that patients put in isolation after admission likely had developed a hospital-acquired infection and are likely sicker so it is not surprising that delirium occurs more frequently in this population. To take that into consideration, the authors adjusted for comorbid conditions, ICU status, length of hospitalization, age, sex, etc. but there may still have been other confounding variables. Nevertheless, it certainly appears that we can add delirium as one of the untoward events associated with contact isolation.
Whether there is a causal relationship between contact isolation and delirium or not, the implications are clear. We must be extremely vigilant for delirium in patients we put in contact isolation and put in place the multimodality measures we use to prevent delirium or to help manage it once it has occurred. In many of our prior columns on delirium we have mentioned multimodality intervention programs that were promising in reducing the incidence or severity of delirium in hospitalized patients (see our Patient Safety Tips of the Week for October 21, 2008 Preventing Delirium, October 14, 2009 Managing Delirium, February 10, 2009 Sedation in the ICU: The Dexmedetomidine Study, March 31, 2009 Screening Patients for Risk of Delirium, January 26, 2010 Preventing Postoperative Delirium, August 31, 2010 Postoperative Delirium and our September 2011 Whats New in the Patient Safety World column Modified HELP Helps Outcomes in Elderly Undergoing Abdominal Surgery).
One of those interventions is HELP, the Hospital Elder Life Program (see our October 21, 2008 Patient Safety Tip of the Week Preventing Delirium). Inouye et al (Inouye 1999) had shown in a landmark study of 852 medical patients aged 70 and older that management of 6 risk factors was able to reduce the incidence of delirium from 15% to 9.9%. The number of days with delirium and the number of episodes of delirium was also reduced by the intervention. The intervention targeted cognitive impairment, sleep deprivation, immobility, visual impairment, hearing impairment, and dehydration. This was strong evidence that a multicomponent intervention could be of benefit in reducing delirium.
Our August 31, 2010 Patient Safety Tip of the Week Postoperative Delirium had extensive recommendations from the 662-page guidance from NICE DELIRIUM: diagnosis, prevention and management that is probably the most comprehensive single-source document available on all aspects of delirium.
Some of those interventions are particularly difficult to implement when patients are in contact isolation. Those include things that promote familiarity and consistency, reassurance, reorientation, and others. Frequent assessment of hydration status and looking for potential sources of pain are often overlooked when patients are in contact isolation. Having family and friends have frequent contact with delirious patients is severely limited with contact precautions. Spending time using verbal or non-verbal de-escalation techniques with an agitated patient may be difficult when the patient is in contact isolation. And having a bunch of masked men sticking their heads into the room can be very distressing for such patients! This situation probably calls for interventions such as recording reassuring messages from loved ones for audio playback in the patients room.
And dont forget another risk seen in the delirious patient that is potentially more dangerous when in contact isolation the risk of suicide (see our Patient Safety Tips of the Week January 6, 2009 Preventing Inpatient Suicides and February 9, 2010 More on Preventing Inpatient Suicides and our December 2010 Whats New in the Patient Safety World column Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units). There have been multiple cases of patients with delirium jumping from windows on med/surg inpatient units and ICUs. So make sure your contact isolation rooms have tamper-proof windows even if you have video surveillance into those rooms. Similarly, make sure there are no chemicals or other toxic substances that a delirious patient might get into while in a contact isolation room.
All the potential unintended consequences of contact isolation need to be closely monitored for and every attempt should be made to ensure they do not happen. But now we need to add assessment, prevention and management of delirium to the list of things we must consider when we put a patient in contact isolation.
Kirkland KB, Weinstein JM. Adverse effects of contact isolation. The Lancet 1999; 354: 1177-1178 http://www.thelancet.com/journals/lancet/article/PIIS0140673699041963/abstract
Saint S, Higgins LA, Nallamothu BK, Chenoweth C. Do physicians examine patients in contact isolation less frequently? A brief report. Am J Infect Control 2003; 31: 354-356 http://www.ajicjournal.org/article/S0196-6553(02)48250-8/abstract
Stelfox HT, Bates DW, Redelmeier DA. Safety of Patients Isolated for Infection Control. JAMA. 2003;290:1899-1905
Morgan DJ, Diekema DJ, Sepkowitz K, Perencevich EN. Adverse outcomes associated with contact precautions: A review of the literature. Am J Infect Control 2009; 37(2): 8593
Morgan DJ, Day HR, Harris AD, et al. The Impact of Contact Isolation on the Quality of Inpatient Hospital Care. PLoS One. 2011; 6(7): e22190
Morgan D. Adverse Outcomes and Contact Precautions (slide presentation). 6/8/2011
Day HR, Perencevich EN, Harris AD, et al. Association Between Contact Precautions and Delirium at a Tertiary Care Center. Infection Control and Hospital Epidemiology 2012; 33(1): 34-39
Inouye SK, Bogardus ST, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM. A Multicomponent Intervention to Prevent Delirium in Hospitalized Older Patients. NEJM 1999; 340: 669-676
NICE (National Institute for Clinical Excellence). National National Clinical Guideline Centre. DELIRIUM: diagnosis, prevention and management. Clinical Guideline 103. July 2010
NICE (National Institute for Clinical Excellence). National National Clinical Guideline Centre. DELIRIUM: diagnosis, prevention and management. Clinical Guideline 103. July 2010
January 24, 2012
Patient Safety in Ambulatory Care
Were always looking for studies on patient safety in the office or ambulatory setting but weve always been bothered by the relative paucity of high quality studies in the literature on patient safety issues and interventions in those settings. Now a special committee brought together by the AMA Center for Patient Safety has basically come to the same conclusion: research and initiatives in ambulatory safety have been remarkably limited over the past decade. That committee has summarized all the patient safety research done over the past decade in the ambulatory setting in a 192-page monograph (Lorincz 2011).
The new monograph begins with a good description of how features of care in the ambulatory setting differ significantly from that in the inpatient setting. That includes more diversity of patient population, wider range of conditions and severity of illness, more logistical and information challenges, more temporally and spatially dispersed care, and different infrastructures in the ambulatory setting. But importantly the role of the patient differs considerably. Patients themselves have a much greater role in their own care than they typically do while an inpatient.
They go on to discuss various definitions and taxonomies of errors, adverse events, harm, injury, etc., classifications of severity and potential preventability. They conclude that the taxonomies are not consistent or standardized. In particular, they noted that most studies on errors in ambulatory care do not distinguish between those that cause harm and those that do not. Also, most studies have been done in primary care settings and there is little data on other settings or across settings. And, while they note the potential of electronic medical records to improve safety, they acknowledge that EHRs may introduce errors of their own and that their net effect on patient safety is not yet known. It notes that current EHRs often encourage cutting and pasting and automatic behavior like filling out checklists and templates that tend to take away from the more thoughtful reasoning process that should be part of the history taking and physical examination. They also discuss clumsy user interfaces and fact that computers sometimes fail to fit into the usual flow of work and may also cause information overload and alert fatigue.
The best-studied area of patient safety in ambulatory care is medication safety. They note that there remains a need for large-scale studies on the incidence and types of ambulatory medication errors, adverse drug events (ADEs), potential ADEs, ameliorable ADEs, and the harms they cause. They cite studies on high-risk medications and patient risk factors for ADEs and errors (eg. advanced age, impaired renal function, polypharmacy, etc.) and the importance of medication reconciliation. They note that some medication errors are under control of the ambulatory practice but others may be only indirectly under their control (eg. dispensing errors, nonadherence, etc.).
Diagnostic error is the next major category. They discuss the difficulties in even identifying diagnostic errors and note that much of the research has utilized malpractice claims, which certainly underrepresent the scope of the problem. Their section on the risk factors for diagnostic error is excellent and covers most of the factors we discussed in our Patient Safety Tips of the Week for September 28, 2010 Diagnostic Error and November 29, 2011 More on Diagnostic Error plus our multiple columns on failure to follow up on tests ordered. They note a dearth of research on interventions to prevent diagnostic error and note that approaches taken, including using IT and decision support tools or cognition-focused approaches, have yet to demonstrate significant evidence of effectiveness. Note that another paper just published (Singh 2012) reviewed 6 tested interventions and 37 suggestions for possible interventions to reduce diagnostic error and found that empirical studies, while somewhat positive, lacked rigorous methodology. They also highlighted the need for improved research on interventions to reduce diagnostic error.
A section in the monograph on office-based surgery and anesthesia notes that adverse events tend to occur in elective cosmetic procedures more often than in medically indicated procedures and that a disproportionate number of cases with patient harm involved general anesthesia. Much of the research in this area comes from Florida, which has had more oversight of office-based surgery than other states. Since this publication, there has been another review of complications of office-based surgery reported in Florida and Alabama (Starling 2011). It confirms that cosmetic procedures and those done under general anesthesia tend to be more problematic but that certification by independent accrediting bodies and surgeon board certification did not seem to make a difference.
There is a whole section on the patients role in patient safety. This includes patient adherence to advice or directions, follow up with appointments, health literacy, and communication issues.
Just as we see in RCAs of hospital adverse events, communication errors are involved in a great many adverse events on the ambulatory side. Problems at transitions of care, including issues with discharge summaries and test results pending at the time of discharge, have had a fair amount of research. Highlighted are problems in communication between primary care physicians and specialists and discontinuity that takes place at discharge or other transitions of care. The problem of communication of abnormal tests results is again stressed. Included under communication errors is the phenomenon of alert fatigue that we see with EHRs and decision support systems.
While the overall conclusions of this monograph may seem discouraging, this is a very well-researched document and incredibly well-referenced. It contains a great annotated bibliography of published research on patient safety in the ambulatory setting. It certainly highlights the need for us to focus our energies and resources on patient safety issues in ambulatory care.
The report obviously calls for greater research into the prevalence and nature of errors and patient safety issues in the ambulatory setting and focused research on interventions to mitigate those problems. Note that the NQFs recently updated list of serious reportable events has begun to include events occurring in the ambulatory setting.
One area not really discussed in the AMA monograph is infection control in the office setting. Fortunately, the CDC recently published a helpful guide to infection prevention for outpatient settings (CDC 2011).
There are a few validated tools out there for assessing patient safety in primary care offices. The best known are the MGMA Physician Practice Patient Safety Assessment and the European Practice Assessment tool. The latter was shown in a recent article to lead to improvements in complaint management, analysis of critical incidents, and quality development/quality policy in primary care practices (Szecsenyi 2011).
We reviewed our site and were actually pleasantly surprised at how many columns weve done focusing on topics pertinent to patient safety in the ambulatory setting.
Some of our prior Patient Safety Tips of the Week on diagnostic error:
Some of our prior Patient Safety Tips of the Week on medication safety in ambulatory care:
Some of our prior columns on communicating significant results:
Some of our prior columns on wrong site procedures in the ambulatory setting:
Lorincz CY, Drazen E, Sokol PE, Neerukonda KV, Metzger J, Toepp MC, Maul L, Classen DC, Wynia MK. Research in Ambulatory Patient Safety 20002010: A 10-Year Review. American Medical Association, Chicago IL 2011
Singh H, Graber ML, Kissam SM, et al. System-related interventions to reduce diagnostic errors: a narrative review. BMJ Qual Saf 2012; 21: 160-170
Starling J, Thosani MK, Coldiron BM. Determining the safety of office-based surgery: what 10 years of Florida data and 6 years of Alabama data reveal. Dermatol Surg. 2011; Oct 19; [Epub ahead of print].
NQF (National Quality Forum). Serious Reportable Events In Healthcare2011 Update: A CONSENSUS REPORT. 2011
CDC (Centers for Disease Control and Prevention). Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care. May 2011
MGMA. Physician Practice Patient Safety Assessment (PPPSA), a self-assessment tool.
European Practice Assessment Program.
Szecsenyi J, Campbell S, Broge B, et al. Effectiveness of a quality-improvement program in improving management of primary care practices. CMAJ 2011; 183: E1326-E1333
January 31, 2012
Medication Safety in the OR
The OR is a setting at risk for medication errors for a variety of reasons (and note that when we use the term OR here we also include all the other areas collectively making up the perioperative setting). These reasons include the complexity of the cases, the increasing number of comorbidities, the pace of activity, the distractions and interruptions, the changing of personnel at various times, hand-printed labels that can get smudged, multiple patient IV lines and catheters of various types, and fact that many high-alert drugs and look-alike/sound-alike (LASA) drugs are used in the OR. In addition, many of the safety checks and balances we use in other parts of the hospital are often absent in the OR. We often have one person (the anesthesiologist) obtaining, mixing or preparing, administering, documenting in the record, and monitoring the effects of the medications. So the double checks we use elsewhere (eg. by pharmacists or nurses or the patient himself) are often not used in the OR. Similarly, many ORs do not yet have IT integration with the hospitals other IT systems so safety measures such as bedside medication verification (BMV aka barcoding) may not be usable in the OR. In addition, the physical constraints of the OR often result in syringes, medication vials, basins with fluids, etc. being in a position that someone could inadvertently use the wrong item in the midst of a rapidly progressing situation. Clutter (ever looked at an anesthesiologists work station!) is often a contributing factor to errors. Add to that the multi-tasking that the anesthesiologist must do and you can see how our systems make this setting so potentially prone to errors.
In fact, medication errors do occur frequently in the OR. In malpractice claims against anesthesiologists, medication errors are considered the most preventable and tend to lead to higher payouts than other types of claims.
This month two new valuable resources on medication errors in the OR became available: a medication safety video from the Anesthesia Patient Safety Foundation (APSF 2012) and the 2012 edition of the Perioperative Standards and Recommended Practice from the Association of periOperative Registered Nurses (AORN 2012).
The new AORN standards address medication safety at each of the phases of medication use (procuring, prescribing, transcribing, dispensing, administering, monitoring, and disposal). They really focus on a multidisciplinary approach and note that monitoring compliance with medication safety practices is critical, yet seldom done in a rigorous fashion in most ORs,
One of their key new recommendations is not to use multidose vials. While most facilities use multidose vials, primarily as a cost-saving measure, they give rise to two problems. First, they introduce the risk of cross-contamination. Second, they increase the risk that a patient may be given too much of a medication. Another recommendation that has caused some controversy is to puncture intravenous solution containers as close to time of use as possible. In some ORs, to improve efficiency, multiple medications and solutions that are expected to be used are prepared in advance. While that may improve efficiency the tradeoff is on the safety side (see our September 15, 2009 Patient Safety Tip of the Week ETTOs: Efficiency-Thoroughness Trade-Offs). They also stress the importance of maintaining sterility. That is important not only when transferring newly prepared medications to the sterile field but also when one syringe might be used for incremental injections. Another key recommendation is to include a pharmacist in perioperative medication management, if not physically during actual cases at least being involved in the planning and oversight of OR medication safety programs.
The APSF medication safety video (APSF 2012) is about 15 minutes long and includes some clips you may have previously seen in ISMP videos highlighting testimonials from some providers at the sharp end of unfortunate medication incidents in the OR. It is largely based on STPC paradigm published in their Spring 2010 Newsletter (APSF 2010). STPC stands for:
The video begins with the oft-quoted statistic that a significant medication error will occur in one of every 133 cases where anesthesia is administered and that 4% of closed malpractice claims for anesthesiologists involve medication errors. It points out many of the high-risk drugs used in the OR. That includes not only the usual suspects we see in other parts of the hospital (eg. opiates, anticoagulants, insulin, benzodiazepines) but also drugs more unique to the OR such as neuromuscular blocking agents (NMBAs) and epinephrine or vasopressors. They point out a variety of the common errors in the OR, including syringe swaps, labeling errors, substitution errors, and injection into wrong ports. A full quarter of the errors involved in the claims involve substituting the wrong drug for an intended drug (eg. giving a NMBA instead of epinephrine or vice versa) and almost a third are due to giving incorrect doses.
Recurrent themes in OR cases with medication errors are lack of standardization and lack of protocols in the setting of production pressures and other distractions. Drug labeling errors and syringe swaps are often implicated as causes of OR medication errors.
The video highlights the importance of labeling all medications and syringes and reading those labels before administering the drugs. They also talk about making drug labels distinctive. They mention color-coding of labels to help recognition of high-alert drugs (though this remains somewhat controversial where statewide or national standards for color-coding have not been established). But they note that APSF says this is not enough and has failed to prevent medication errors so more is needed.
Standardization is a fundamental patient safety concept. This applies not only to things like drug dosages and drug concentrations but also to drug preparation, workplace design, equipment models, and clinical protocols. They describe all the Joint Commisssion requirements for appropriate labeling for all drugs and syringes (and dont forget you need to also label any liquids you put in sterile containers or basins on the sterile field). Having drugs in standardized concentrations prevents someone from inadvertently giving a patient a dose that is 100- or 1000-times higher than the intended dose. That is especially important with high-alert drugs like epinephrine, phenylephrine, heparin, etc. Lots of anesthesiologists like to have their room in the OR and not have to switch from room to room. If you standardize the workspace in each room that becomes less a barrier at the same time it helps prevent errors. Admittedly, the medication needs are quite different for cardiac and intracranial cases than, say, for orthopedic cases. So sometimes the standardized items need to be standardized by case type. If you dont have some of the technology safeguards mentioned below, consider requiring verification of high-risk medications by a second person prior to administration. And use read-back and hear-back to facilitate understanding in all your OR communications.
Pharmacy/Premixed/Prefilled refers not only to having pharmacists involved in your program but also to using premixed solutions and prefilled syringes so that your anesthesiologist is not trying to prepare those things while attending to multiple other things. Let someone else do that preparation, whether it is a pharmacist in an OR satellite pharmacy or pre-packaged drugs and solutions purchased from commercial vendors. As in the AORN resource, they strongly recommend a pharmacist being physically part of the OR but, if that is not feasible, at least being involved in the planning and oversight of OR medication safety programs.
Technology is a key component of patient safety systems in preventing medication errors in most other parts of the hospital and should also be used in the OR. Barcoding (BMV) is a critical component of that but feedback and clinical decision support tools are also important. Ideally, your OR computer systems should be integrated with your hospital electronic health record so that information exchange is facilitated in both directions. Documentation of drug administration on EHRs theoretically should improve efficiency, though the clunkiness of some current user interfaces may actually detract from OR efficiencies. Undoubtedly these will improve in the future. The video optimistically looks to voice recognition technology to help with that efficiency. And use of standardized infusion pumps with standardized drug libraries (smart pumps) are used in other parts of the hospital and should be used in the OR and perioperative area as well. Make sure that the pumps and the concentrations of the drugs used are standardized so that these pumps can go with the patient when they go from the PACU to the ICU, etc.
Culture, of course, refers to developing the culture characteristics that are hallmarks of the culture of patient safety. This includes adoption of a Just Culture approach, recognition that most bad outcomes typically involve multiple system errors rather just human error, having a non-punitive system for reporting errors and near-misses, and learning from adverse events or near-misses and sharing those lessons learned. In the APSF video, Michael Cohen from ISMP stresses that good people make errors and points out that there is usually a cascade of multiple errors or contributing factors in every case where there is a bad outcome. Focusing on fixing systems rather than people leads to more success in safety in any industry (not to mention that systems are easier to fix than people!).
Changing some aspects of culture can be difficult, particularly since so many anesthesiologists have prided themselves in their autonomy and independence and abilities to think fast and improvise. So getting them to buy into standardization, use of protocols, checklists, etc. may be met with some resistance. Using the technique of stories, not statistics (see our December 2009 Whats New in the Patient Safety World column Stories, Not Statistics) may be helpful. The APSF video does include reference to the well-known unfortunate case in which a young boy died after inadvertent injection of concentrated epinephrine. In the consensus conference that led to development of the STPC paradigm, multiple speakers provided such real-life examples of errors that led to deaths or other serious outcomes. Those included cases of injection of wrong drugs or injection of drugs into the wrong (eg. epidural) catheters or other injection ports. Using such stories or real-life examples, particularly if you can also tell the story from the point of the second victim (the provider involved) is a very useful way to get buy-in from not just your anesthesiologists, but every one involved in perioperative care (including administrators and especially CFOs!).
The APSF video should be part of mandatory training for all your personnel involved in perioperative care. Its short but to the point and makes a compelling case for the need to change our ways and our culture in the OR. That video and the Spring 2010 APSF Newsletter plus the new AORN standards are very valuable resources to help you ensure medication safety in your OR and perioperative environment. For those of you who happen to be in Canada, ISMP Canada has a collaborative that uses their Operating Room Medication Safety Checklist (ISMP Canada 2009), another very valuable tool. At least the last time we checked its use is still restricted to the Canadian hospitals participating in the collaborative but we expect it will be further refined and eventually made available to everyone.
If you havent yet adopted the recommendations from these resources, we expect that you will soon. But dont forget the other critical piece: you need to audit and monitor compliance with any of these safety interventions you put in place. Make it part of your Patient Safety Walk Rounds, part of your regular OR Committee agenda and part of your Medication Safety Committee or Patient Safety Committee agenda.
APSF (Anesthesia Patient Safety Foundation). Medication Safety In The Operating Room: Time For A New Paradigm (video). 2012
AORN (Association of periOperative Registered Nurses). Perioperative Standards and Recommended Practice. 2012
APSF (Anesthesia Patient Safety Foundation). APSF Newsletter. Spring 2010
ISMP Canada. Operating Room Medication Safety Checklist. Version 2. 2009
February 7, 2012
Another Neuromuscular Blocking Agent Incident
In our January 31, 2012 Patient Safety Tip of the Week Medication Safety in the OR we mentioned neuromuscular blocking agents (NMBAs) as being high-alert medications in the OR. Most hospitals keep NMBAs on their list of high-alert medications for the entire hospital but many took action steps years ago after an ISMP Safety Alert (ISMP 2005) to limit access to these drugs outside the OR and have not paid as much attention to them since. Its been almost 5 years since we first did a column on NMBA risks (see our July 31, 2007 Patient Safety Tip of the Week Dangers of Neuromuscular Blocking Agents and our November 2007 Whats New in the Patient Safety World column FMEA Related to Neuromuscular Blocking Agents). Other than an excellent review by the Pennsylvania Patient Safety Authority in 2009 (PPSA 2009) the news and literature have been relatively quiet on NMBAs.
But a recent incident in a hospital in Florida (ABC News 2011) has rekindled concern about NMBAs. In the Florida case an order was written for 20 mg famotidine IV but a nurse gave by mistake 20 mg IV pancuronium. The patient subsequently became paralyzed and had a respiratory arrest. Though resuscitated, he suffered severe brain damage and eventually died. We dont know the details of the case but apparently some safety steps such as barcoding verification, independent double checks, and monitoring were not done. In addition, the drug was available on the unit on which it was administered and perhaps should not have been (see below for recommendations about restricting access for these drugs to only certain units). The hospital apparently has subsequently removed the drugs from all areas other than the OR.
The PPSA review (PPSA 2009) noted that they had received 154 reports dealing with NMBAs over a 5-year period. Most importantly, the percentage of cases where patient harm occurred was nearly 13 times higher than the percentage of harm seen in their overall drug-related incident database. Harm came to the patient in over 9% of cases, a figure similar to that found in a 2006 report from the MedMarx database. The vast majority of the PPSA reports involved either the wrong medication being given, i.e. an NMBA was given rather than a different intended drug, or an incorrect dose of an NMBA. Of course, the former is the most serious category because this usually involved patients who were not being mechanically ventilated and were at the greatest risk for respiratory arrest from NMBA administration.
But again stories, not statistics! All the above statistics wont help you remember the importance of safety regarding NMBAs. But a few stories will!
A patient is in need of an emergency CT scan one night. There is no nurse available in the radiology suite so the ER resident accompanies the patient for the CT scan. The patient is in need of sedation for the scan and the resident inadvertently administers vecuronium IV to the patient, resulting in respiratory arrest necessitating rescuscitation.
A patient is undergoing a surgical procedure in the OR and the physician asks the CRNA to give IV antibiotic. The CRNA reaches into the anesthesia medicine drawer, where all the medications are kept, and pulls out a vial of vecuronium thinking it was the antibiotic and adds it to the IV bag. Shortly thereafter its noted that the patient is not breathing well and she requires intubation (PPSA 2009).
A syringe filled with an NMBA is not properly disposed of. It is later mistaken for a syringe full of normal saline and used as a saline flush on an infant who suffered a respiratory arrest as a result (ISMP 2005).
Seven infants receive subcutaneous doses of atracurium instead of hepatitis B vaccine. All developed respiratory distress. Five recovered but one suffered permanent injury and one died. An anesthesiologist had placed a vial of atracurium in the refrigerator of the nursery that had a similar appearance to vaccine vials (Koczmara 2007).
Obviously, the biggest risk of NMBAs is in patients who are not being mechanically ventilated. There are a couple circumstances where NMBAs may be inadvertently ordered and given in non-ventilated patients. We previously mentioned a case (see our June 19, 2007 Patient Safety Tip of the Week Unintended Consequences of Technological Solutions) where an unintended consequence of CPOE led to inadvertent administration of a neuromuscular blocking agent to a patient who was not being mechanically ventilated (ISMP 2007). In that case the physician was ordering from a remote site and inadvertently entered orders on the wrong patient. The other circumstance is when a patient in an ICU is extubated and weaned from a respirator and transferred to a regular floor and someone writes continue all previous orders not recognizing that such might include orders for NMBAs in a now unventilated patient.
Look-alike/sound-alike (LASA) issues are root causes in many NMBA incidents. Very often the vials closely resemble vials of other more common medications and solutions. How and where drugs are stored is an important contributing factor in many of the adverse NMBA incidents. Many of the reported incidents involving NMBAs being confused with another intended drug have involved NMBAs that were stored in refrigerators, especially in refrigerators where such are not usually stored. The vials have been confused with vials of other substances like normal saline, heparin, and vaccines. The 2005 ISMP alert (ISMP 2005) had several examples. In one instance an anesthesiologist put a vial of an NMBA in a refrigerator on a different unit that does not usually stock NMBAs and the vial was mistaken for hepatitis B vaccine and was inadvertently given to seven infants. In others, vials of NMBAs looked similar to vials of either vaccines or the diluents used with those vaccines, resulting in multiple patients being exposed to the NMBAs.
The sound-alike issues are also problematic. Norcuron (vecuronium) has been mistaken for Narcan, vecuronium for vancomycin, atracurium for Ativan, etc. In other cases, look-alike packaging has been a major contributing factor.
Limiting access to NMBAs is arguably the most import intervention to prevent incidents. Many hospitals restrict them to the OR and pharmacy. In those areas where they might be needed emergently (eg. in the ER or ICU where they may be needed for emergent intubations) the drugs can be sequestered or sealed in the intubation kits so that they are available only at the time of intubation.
But while restricting access is important, keep in mind those incidents above where NMBAs popped up in areas where they were not supposed to be. So there clearly must be other safety measures taken and you need to be ever vigilant to items showing up where they are not supposed to be.
Storage of NMBAs in automated dispensing machines can be especially problematic. Probably most important is only storing them in areas where they are clearly needed. Where needed, they should be kept in single access drawers. But there needs to be a special warning that the NMBA should not be used in patients who are not intubated/mechanically ventilated. Such a message could be delivered in those automated systems having the capability of messaging when an NMBA is selected for removal from a drawer. Similarly, the type of CPOE error noted earlier might be avoided by programming in an alert ensuring the patient is intubated/ventilated when the physician enters an order for an NMBA.
Most important are warning labels for vials, syringes, bags, or storage boxes containing NMBAs. Both ISMP and the PPSA recommend using fluorescent red labels that state Warning: Paralyzing Agent Causes Respiratory Arrest.
The ISMP Canada review (Koczmara 2007) notes that a form of confirmation bias often is a contributing factor. Specifically, because the vials and labels may look similar to those of the expected medication, we tend to see what we expect to see rather than what we actually see. The phenomenon is also sometimes known as inattentional blindness (ISMP 2009).
Part of your medication safety program should include education and communication about NMBAs. They should never be referred to as muscle relaxants and should never be allowed to be ordered on a prn basis (PPSA 2009). Similarly, the phrase renew all previous orders should never be allowed. Rather, when patients are transferred from one unit to another, the physician should write out each of the orders as if they were brand new orders. The same applies when the physician is using CPOE. While some CPOE systems have functions (or workarounds) that facilitate renewal of a large number of orders, beware that such can give rise to unintended consequences.
Prompt disposal of unused NMBAs is also essential. Several of the previously mentioned incidents involved use of NMBA preparations that had been poorly labeled and left behind from use with one patient, then were inadvertently administered to other patients. ISMP recommends that unused NMBAs (whether in vials, bags, or syringes) be placed in a sequestered bin for immediate pickup by pharmacy
Obviously, use of traditional medication safety measures, such as barcoding, are important and NMBAs, being high-alert drugs, should require independent double checks before being dispensed and before being administered.
Lastly, you may find 2 other resources on NMBAs helpful. In our July 31, 2007 Patient Safety Tip of the Week Dangers of Neuromuscular Blocking Agents we recommended this is a good issue to address in FMEA (Failure Mode and Effects Analysis) in your organization. Susan Paparella (Paparella 2007), from ISMP, did exactly that in the Journal of Emergency Nursing (see our November 2007 Whats New in the Patient Safety World column FMEA Related to Neuromuscular Blocking Agents). The ED staff had recognized NMBAs as high-alert drugs and were contemplating their removal from ED stores, to be replaced in kits prepared for rapid-sequence intubation. FMEA is especially useful in such situations where change is to take place, because it helps identify potential unintended consequences. The article nicely describes how you do a FMEA exercise and provides examples for scoring probability and severity and use of a hazard scoring matrix. Lastly, one of the AHRQ M&M Conference cases (Weinger 2003) on an NMBA incident had 2 terrific downloadable videos addressing some of the communications issues in that case. It is well worth reading and watching the videos.
Again, consider adding NMBA Safety to your list of things you look for in your Patient Safety Walk Rounds and consider doing a FMEA on NMBA use in your organization.
ISMP (Institute for Safe Medication Practices). Paralyzed by mistakes. Preventing errors with neuromuscular blocking agents. ISMP Medication Safety Alert Acute Care Edition 2005; September 22, 2005 issue
PPSA (Pennsylvania Patient Safety Authority). Patient Safety Advisory.
Neuromuscular Blocking Agents: Reducing Associated Wrong-Drug Errors
Pa Patient Saf Advis 2009; 6(4): 109-14.
ABC News (Caron C.) Nurse Gives Patient Paralytic Instead of Antacid. November 21, 2011
Koczmara C, Jelincic V. Neuromuscular blocking agents: Enhancing safety by reducing the risk of accidental administration. ISMP Canada 2007 in the Spring 2007 publication of the Canadian Association of Critical Care Nurses (CACCN).
ISMP (Institute for Safe Medication Practices). Remote CPOE error-a situation that's more than remotely possible. ISMP Medication Safety Alert Acute Care Edition 2007; May 31, 2007
ISMP (Institute for Safe Medication Practices). Inattentional blindness: What captures your attention? ISMP Medication Safety Alert Acute Care Edition 2009; February 26, 2009
Paparella, Susan RN, MSN Failure Mode and Effects Analysis: A Useful Tool for Risk Identification and Injury Prevention. Journal of Emergency Nursing. 33(4):367-371, August 2007
Weinger MB, Blike GT. Intubation Mishap. AHRQ Web M&M. September 2003
February 14, 2012
Handoffs - More Than Battle of the Mnemonics
Weve probably done more columns on the problems associated with handoffs in healthcare than any other topic (see the listing and links at the end of todays column). Handoffs are among the most common transactions in transitions at all levels of the healthcare system and are also among the processes most prone to error. We know that breakdowns in communication are contributing factors in roughly 70% of all Sentinel Events in Joint Commissions Sentinel Event database and many of those breakdowns occur during handoffs. We had been intending for some time now to do a column on an excellent Australian initiative on improving handoffs. But in just the last couple months several more initiatives on improving handoffs have also been published. Importantly, each points out that the tools and formats used are really situation-dependent. That is, a tool or format used in one setting may not work well in another.
There are a number of key features of to successful handoffs in any situation (adequate time, minimal distraction, adequate allowance for interactive discussion where the recipient is able to review all relevant material and has ample opportunity to ask questions, using language that is clearly understood by all parties, use of read-back, repeat-back and hear-back to ensure that communication is understood by all parties, etc.) The most successful handoffs utilize both a written/computerized component and a verbal component and need to meet confidentiality standards. And dont forget that during a handoff you are not only passing on information but also passing on responsibility for care of the patient.
But another key feature of handoffs is use of some sort of a tool with a standardized format to remind staff of all the important elements to cover during a handoff. Mnemonics may be very helpful in that regard. Over the course of all those previous columns weve covered handoff tools and formats that go by a variety of acronyms and mnemonics: SBAR, ISBAR, iSoBAR, I PASS the BATON, PACE, the 5 Ps, SHARED and others.
An ongoing project by several pediatric organizations, the I-PASS Study, perhaps best puts the issue in perspective (Starmer 2012). This collaborative project is looking at improving the handoff process and reducing errors and improving patient outcomes. But they are going about it in the right way. First, they recognized that the format of some handoff tools may not be optimal for other handoffs. An example they use is SBAR. Dont get us wrong SBAR is a great format for many handoffs. We use it frequently in demonstrating how communication across professions may be facilitated. For instance, after an RCA showed that a nurse was reluctant (probably for a variety of reasons) to ask a physician to physically come see a patient, we noted that SBAR could have been very helpful:
Situation Patient X is becoming increasingly diaphoretic and nauseous.
Background She was admitted with a non-ST elevation MI.
Assessment I think she is extending her MI.
Recommendation: I think you should come to see her immediately.
But the leaders of the pediatric collaborative recognized that the SBAR format does not work very well for resident-to-resident handoffs, etc. because the situations are much more complex. They note that SBAR is ideal for situations where a brief summary suffices and less than 5 key points need to be communicated, and is especially suited for communications across hierarchical boundries.
So, even though adoption of SBAR has been shown to reduce adverse events in hospitals, they looked at other formats. They first piloted a tool/format and analyzed both the benefits and the downsides of the tool. The tool/format they started with was the SIGNOUT tool but when they analyzed the handoffs during the pilot they recognized that most did not adhere well to that format. Moreover, the residents involved in that pilot said that a tool/format needed to be short, easy to remember, and not have elements that overlapped each other. They also recognized that it would have to integrate with the increasing use of computerized tools for handoffs and other communication.
So after considering other tools (such as I PASS the BATON from the TeamSTEPPS program) and brainstorming, they came up with the I-PASS format (and note that even though it sounds like the I PASS the BATON format it is a totally different format):
I: Illness Severity
P: Patient Summary
A: Action List
S: Situation Awareness and Contingency Planning
S: Synthesis by Receiver
The final S emphasizes a key feature of all successful communication: it ensures that the message is fully understood by the person receiving the handoff, including asking questions then summarizing the key steps and restating the key actions/to-do steps.
The Starmer article includes a nice example of use of the I-PASS format in a clinical handoff.
The article also summarizes some of the key elements that make a mnemonic successful. It needs to be catchy, symbolic, parsimonious, utilitarian, and somehow link a visual image to a process or subject. The I-PASS mnemonic certainly accomplishes that.
The I-PASS Study collaborative is now ongoing at 10 pediatric institutions, utilizing a resident handoff bundle that includes not only the I-PASS format but also team training and a template for the written or computerized portion of handoffs. We look forward to seeing the impact this collaborative has on reducing errors and improving patient safety.
The Australian Commission on Safety and Quality in Health Care (ACSQHC) recently updated its Clinical Handover program that was launched in 2007 to improve handover communication across a range of healthcare settings (ACSQHC 2011).
The ACSQHC Clinical Handover pilot program had numerous lessons learned. Perhaps most surprising was the need to convince clinicians that the current way of doing business was simply not adequate and that change was necessary. So developing a compelling case for change was essential. Potential benefits they considered for clinicians include decreased duplication of effort, concise communication with other staff, clear allocation of staff roles, higher staff morale and more confidence in giving and receiving patient handovers, and a reduction in errors and adverse events caused by miscommunication at handovers.
Their toolkit includes a suggested project plan that includes conventional advice about a change management project (support from top leadership, involvement of strong clinical champions, stakeholder engagement, input from staff at all levels and from patients, adequate allocation of resources, identification of barriers and facilitators of change, etc.). They then describe piloting the project, flowcharting current practices, doing a PDSA style rapid improvement project, and sustaining a project. Establishing clear cut goals and measures is critical in demonstrating that any performance improvement project actually leads to improvement. The tools provided are excellent, not only for a clinical handover project but for almost any improvement project. Links to reference materials are excellent and they even provide a host of presentations for various clinical settings.
They point out that, through use of handover mnemonics such as SBAR, ISBAR, ISOBAR, iSoBAR, SHARED, handovers may be facilitated but that there is no evidence that any mnemonic is better than another in terms of improving patient safety and that the choice of handover mnemonic must be considered in the local context.
An external evaluation found that overall the Pilot Program has:
Perhaps the most important lesson from the ACSQHC project is that there is no one handoff mnemonic that is ideal for all handoff situations. There are advantages and disadvantages of each mnemonic in different settings.
The emergency department presents yet another unique situation for handoffs. A UK project came up with the ABC of handover tool for ED handoffs (Farhan 2012). They noted that some mnemonics commonly used in the UK, such as JUMP (Jobs outstanding, Unseen patients, Medical contacts, Patients to be aware of) and ANTICipate (Administrative data, New information, Tasks, Illness, Contingency planning), were better suited for ward handovers than for ED handovers. Rather than focusing on just the transfer of information and responsibility for single patients, they focused on the transfer of responsibility of a whole department, the ED, at change of shift. That includes knowledge of all the patients in the ED, prioritization of risks, pending tests and other issues, patient flow and waiting time issues, staffing patterns, equipment issues, planned patient dispositions (admissions, transfers, discharges), and even events taking place in the community that might impact the ED. And, since the project was done at an academic medical center, teaching responsibilities were considered as well. They recognized that poor handovers were not only associated with potentially bad patient outcomes but also added a considerable amount of unnecessary work for ED providers (some estimated they lost 1-3 hours per shift catching up after a poor handover). Using direct observation of handoffs, a series of semi-structured interviews with ED participants of all levels, and consensus building they were able to develop a tool called the ABC of handover though it really has the elements ABCDE:
A Areas and Allocation
B Beds, Bugs, Breaches
C Colleagues, Consultant on Call
D Deaths, Disasters, Deserters
E Equipment, External Events
Note that the ED practices in the UK allow for a one hour overlap at change of shift that is dedicated for handovers. In addition, they recommend that another brief review of progress take place halfway through a shift.
They have formalized a template for this tool and developed laminated cards and posters to facilitate its use. They also recommend keeping a written record of the handovers. Though the tool might seem to violate the parsimonious characteristic desired in the I-PASS collaborative, it does have an easy to use format that clearly reminds all participants to discuss a host of important ED issues at each handover and still takes less than 5 minutes to complete. The article provides some good examples of issues that might be discussed during handovers using the tool.
A follow up study on the impact of the ABC of handover tool (Farhan 2011) showed that discussion of the items considered to be essential increased from a mean of 34% at each handover to 86% and staff felt that the tool improved their situational awareness and made them more proactive on operational issues such as staffing and equipment shortages.
Also in February ACOG released its updated committee opinion on Communication Strategies for Patient Handoffs (ACOG 2012). Note that they advocate the I PASS the BATON format from the TeamSTEPPS program as their structured communication tool and also discuss SBAR. But their document also discusses things like barriers to effective handoffs and ways to facilitate good handoffs.
Note that ACOG does consider e-mail to be an appropriate form of handoff as long as receipt of the e-mail can be acknowledged. But they stress that voice mail or other messages for which receipt cannot be acknowledged are not acceptable formats. We personally would discourage use of e-mail as the sole component of handoffs since it limits at least to some degree the ability of the recipient to ask questions, which is a core component of good interactive handoffs, and lacks the body language that is such an important part of any communication. The document does, however, have good discussion about the physical environment for handoffs and is quite good in pointing out the language and cultural aspects of communication and styles of communication.
We think the information youll find in the pediatric I-PASS project, ACSQHC project, the ABC of handover, the ACOG opinion, and the AORN toolkit we noted in our December 2011 Whats New in the Patient Safety World column AORN Perioperative Handoff Toolkit will be valuable to help you improve your handoff processes in multiple venues.
Mnemonics and the tools or format that they denote may be very helpful in your handoffs. The key message is that you need to implement tools that address the needs of each particular type of handoff that occurs in your organization.
Read about many other handoff issues (in both healthcare and other industries) in some of our previous columns:
May 22, 2007 More on TeamSTEPPS
August 28, 2007 Lessons Learned from Transportation Accidents
December 11, 2007 CommunicationCommunicationCommunication
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, InattentionOops!
April 13, 2010 Update on Handoffs
July 12, 2011 Psst! Pass it onHow a kids 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
Starmer AJ, Spector ND, Srivastava R, et al. and the I-PASS Study Group. I-PASS, a Mnemonic to Standardize Verbal Handoffs.
Pediatrics 2012; 129(2): 201 -204
ACSQHC (Austrailian Commission on Safety and Quality in Health Care) Clinical Handover. October 25, 2011
Farhan M, Brown R, Woloshynowych M, Vincent C. The ABC of handover: a qualitative study to develop a new tool for handover in the emergency department. Emerg Med J 2012; Published Online First: 3 January 2012 http://emj.bmj.com/content/early/2012/01/03/emermed-2011-200199.full.pdf+html?sid=4b3509fa-c354-42cb-a27c-b80721ddeec5
Farhan M, Brown R, Vincent C, Woloshynowych M. The ABC of Handover: impact on shift handover in the emergency department. Emerg Med J 2011; published online 28 December 2011
ACOG. Committee on Patient Safety and Quality Improvement. Committee Opnion Number 517. Communication Strategies for Patient Handoffs. February 2012
AORN. Perioperative Patient 'Hand-Off' Tool Kit.
February 21, 2012
Improving PCA Safety with Capnography
Weve stressed on numerous occasions the difficulties monitoring patients on PCA pumps or receiving postoperative opioids by other routes. The primary danger is development of respiratory failure. Some patients may be at greater risk because of concomitant conditions (eg. obstructive sleep apnea, massive obesity, COPD, various neuromuscular disorders) or because of concomitant medications (benzodiazepines or other sedating agents).
Use of pulse oximetry to monitor such patients can give rise to a false sense of security (see our December 6, 2011 Patient Safety Tip of the Week Why You Need to Beware of Oxygen Therapy). Patients with respiratory depression secondary to opioids or sedatives typically develop CO2 retention well before they develop oxygen desaturation. So a good monitoring strategy would utilize capnography.
One organization recently shared its experience with adoption of capnography for all patients on PCA pumps (Maddox 2012). They use the capnography apparatus to monitor both the respiratory rate and the end-tidal CO2.
Their initial experience led to adjustment of their monitoring parameters. They started with alerts programmed for respiratory rates of 10 or less or no breath for 30 seconds and an end-tidal CO2 level of 50. However, they found too many nuisance alarms at those levels so reprogrammed their alert targets to respiratory rates of 6 and end-tidal CO2 to 60.
The article nicely describes all the steps they went through to plan and implement the system and the daily mechanics involved. Since 2004 they have used the system for virtually all patients on PCA and have also begun using it on patients receiving epidural PCA or opioids via other routes. In over 5000 patients they have had no serious respiratory complications of PCA. They also calculated an estimated ROI (based on potentially avoided intubations, transfers to ICU, etc.) and felt that the 5-year ROI was about $2.5 million for their organization. Plus all the ROI in human terms! Pretty impressive!
They do note that patient mobility is limited when hooked up to the pumps and capnography equipment. However, they also note that most patients who are mobile no longer have the need for the PCA pumps.
Continuous capnography may not be the complete answer to patient safety in patients on PCA. Note that several times we have quoted the excellent article by Lynn and Curry (Lynn 2011) that discussed several mechanisms for unexpected deaths in hospitalized patients (see our February 22, 2011 Patient Safety Tip of the Week Rethinking Alarms). That article nicely outlines the multiple problems involved in developing the ideal monitoring system. Our September 6, 2011 Patient Safety Tip of the Week More Tips on PCA Safety also noted a unique apnea prevention device (Zornow 2011) that uses inputs from multiple modalities to create a system for alerting providers to impending respiratory disasters.
We also came across some excellent informal discussions on PCA safety through the Beckers ASC Review website (www.beckerasc.com). One was an interview with Bryanne Patail of the VAs National Center for Patient Safety (Wong 2012) who noted that more than 50 percent of these events events related to infusion pumps, suggesting that incidents with PCA pumps are about 10 times more frequent than with general-purpose pumps. That, of course, reflects that occurrence of respiratory depression related to the opioid infusions. The VA has also reduced its PCA events by integrating capnography into its PCA systems. The second was about the Physician-Patient Alliance for Health & Safety (PPAHS) putting together a working group to create a checklist targeted towards PCA (Kurtz 2011). It has interviews with multiple healthcare providers who have excellent suggestions for items to be included on such a checklist. On the Physician-Patient Alliance for Health & Safety website are some heart-wrenching stories about patients who died during PCA, likely as a result of inadequate monitoring. We look forward to seeing that checklist when it is ready.
In our May 17, 2011 Patient Safety Tip of the Week Opioid-Induced Respiratory Depression Again! we encouraged hospitals to perform their own FMEA (Failure Mode and Effects Analysis) on the PCA process and provided links to two tools we use when doing FMEAs of the PCA pump process: the PCA Pump Audit Tool and the PCA Pump Criteria. And we hope that youll go back and look at the string of recommendations we made in our September 6, 2011 Patient Safety Tip of the Week More Tips on PCA Safety. We think you will find them extremely helpful.
Understanding the complexities of respiration as it relates not only to various medications but also to underlying patient conditions is extremely important in managing the postoperative patient. Implementing a PCA safety program is one of the most important things your organization can do to improve the perioperative care of patients and avoid unnecessary morbidity and mortality.
Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
Prior columns pertaining to oxygen safety:
Maddox RR, Williams CK. Clinical Experience with Capnography Monitoring for PCA Patients. APSF Newsletter 2012; 26(3: 47-50 Winter 2012
Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)
Zornow MH. Clinical Testing of the Apnea Prevention Device: Proof of Concept Data. Anesth Analg 2011; 112:;582-586
Wong M. Reducing Errors With Patient-Controlled Analgesia Pumps: Q&A With Bryanne Patail of the National Center for Patient Safety. Physician-Patient Alliance for Health & Safety. February 09, 2012
Kurtz R. How to Prevent 'Dead-in-Bed' Syndrome With Patients After Surgery: Q&A With Physician Experts & PPAHS. November 09, 2011
Physician-Patient Alliance for Health & Safety
February 28, 2012
AACN Practice Alert on Delirium in Critical Care
In our June 23, 2009 Patient Safety Tip of the Week More on Delirium in the ICU we noted that delirium, if appropriately looked for, occurs in over 60% of ICU patients at some time during their ICU stay. Some studies say the incidence may be as high as 80%. And the occurrence of delirium increases morbidity and mortality, time on ventilator, ICU and total hospital length of stay, and costs. We provided multiple lessons learned in that column, particularly regarding the relationship between delirium and sedation practices in the ICU.
The American Association of Critical-Care Nurses (AACN) has recently published an evidence-based Practice Alert on Delirium Assessment and Management (AACN 2011). Its recommendations include:
While weve discussed most of these in our previous columns on delirium, there are some relatively new emphases here that are valuable. First is the emphasis on early exercise, starting with passive ROM exercises within the first 3 days in the ICU and having a progressive mobility program. This recommendation is based on several studies showing that progressive mobility in critically ill patients improves not only physical function but also improves cognitive function as well (reducing delirium duration by 2 days).
They also recommend use of the THINK mnemonic to identify potential causes of the delirium:
T Toxic situations
H - Hypoxemia
I Infection/sepsis (nosocomial), Immobilization
N Nonpharmacologic interventions (Are these being neglected?)
K K+ or electrolyte problems
They provide a good discussion on avoiding benzodiazepines and a good discussion on the paucity of data supporting use of any of the antipsychotic drugs.
Lastly, they suggest putting these recommendations all together through use of the ABCDE bundle (Awakening and Breathing, Careful sedation choice, Delirium monitoring, and Early progressive mobility and exercise). See our December 2010 Whats New in the Patient Safety World column The ABCDE Bundle for details.
We like these recommendations, particularly their use of THINK and ABCDE mnemonics to help with the assessment and management of delirium.
Note also that a new tool to predict delirium in ICU patients has been developed and validated (van den Boogaard 2012) in several Dutch hospitals. The PRE-DELIRIC tool uses 10 risk factors that can readily be obtained within 24 hours of admission to the ICU (age, APACHE-II score, admission group, coma, infection, metabolic acidosis, use of sedatives and morphine, urea concentration, and urgent admission). The tool was considerably better at predicting delirium than were the individual predictions of nurses and physicians. Note, however, that the tool does not include presence of dementia or alcohol misuse (mainly because the incidence in their population was too low to include for statistical reasons). The authors point out that any patient having either of those two risk factors should be considered at high risk for delirium regardless of the PRE-DELIRIC score. The authors suggest that the value of the predictive tool is to allow staff to implement preventive measures in the highest risk patients but spare lower risk patients from those interventions. Wed argue those preventive measures make sense in all ICU patients. The biggest difference between our thinking and that of the Dutch authors is that they appear to consider drug prophylaxis (haloperidol) to prevent delirium, a concept we dont buy into at this time because of a scant evidence base. The non-pharmacologic preventive measures are pretty risk-free and probably good for most ICU patients anyway.
Nevertheless, we like the idea of using a simple risk prediction tool that does not take a lot of time and effort. We would hope that future studies would look at whether implementation of preventive measures based upon risk stratification actually reduces the incidence or duration of ICU delirium. The PRE-DELIRIC tool is downloadable from the authors in both English and Dutch versions in multiple formats (pdf, html, Excel).
Some of our prior columns on delirium assessment and management:
AACN (American Association of Critical-Care Nurses). Practice Alert. Delirium Assessment and Management. November 2011
van den Boogaard M, Piockkers P, Slooter AJC, et al. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ 2012; 344: e420 Published 9 February 2012
downloadable versions of the PRE-DELIRIC model/tool
March 6, 2012
Laboratories are one of the few areas in medicine that can claim to approach six sigma standards regarding error rates. Regulatory standards from CMS, the Joint Commission, CLIA, CAP, and various state health departments set the bar high and most labs have very robust quality assurance, proficiency testing, and performance improvement programs in place. However, most of those standards and statistics apply to the analytical phase of laboratory work. The pre-analytical and post-analytical phases are the areas today where the majority of lab errors occur (Hammerling 2012).
Much of the best formal literature on laboratory errors comes from Croatia and Italy. Two of the most prolific writers on errors pertaining to laboratory medicine, Mario Plebani and Guiseppe Lippi discuss the brain to brain loop in lab testing (Plebani 2011). This emphasizes the need to consider the entire loop from the time a test is ordered (eg. is it the correct test?) to the time the results are interpreted and used to apply to a plan of care for a patient. They note that currently that loop is never closed. That is, we dont have metrics that measure how the lab is part of patient outcomes. In fact, patient care involving non-laboratory personnel accounts for 95% of the extra-analytical mistakes involved in lab errors (Lippi 2010). To use a sports analogy, statisticians in baseball assign an error to an individual even though some errors are truly team errors. Plus many of the errors that we will uncover are really symptomatic of flawed systems rather than individual errors. The National Quality Forum (NQF 2009) also recognizes the importance of the pre-analytical and post-analytical phases in its 6 preferred practices for measuring and reporting patient safety, including items like accuracy of ordering for lab tests and communicating the results.
But, lacking good loop metrics, how do we get our arms around this problem? One potential method would be to use the tracer methodology, akin to the way Joint Commission uses tracers during their surveys. You can trace a test through its full loop in hospitalized inpatients. If you employ physicians on the outpatient side you can also trace a test through the full loop for outpatients or emergency department patients.
Below are the steps wed recommend in doing a tracer on laboratory testing:
Where would you start? Which tests should you look at? One option would be to take a look at your highest volume tests, since statistically most errors in the loop would occur for these tests. However, you might also consider looking at tests you already know may be abused or of controversial value. Or you might look at tests for which errors would be likely to have the most serious patient consequences.
After you choose a test on which to run a tracer, lets start at the beginning: the ordering of the test by a clinician. Is the rationale for ordering the test clear from the medical record? Is it for diagnosis related to current patient symptoms? Is it for screening or risk factor management? Is it a necessary follow up to a prior abnormal test result? Is it for monitoring treatment (eg. serum drug levels) or assessing for treatment efficacy or side effects?
But there are other questions you should ask. Was there a prior result of that test that might have sufficed? Was that result known? Could it have been known? Was that result available on the hospital IT system or the regional RHIO? Did the provider attempt to see if a prior result was available?
If the rationale for the test is not obvious, also look to see if there were circumstances that nudged the provider to order the test. Was the test part of a panel or was ordering the test influenced by its appearance on a standardized order set or clinical protocol or the way the lab requisition was formatted (some commercial labs use the requisition form in a manner that tends to market certain tests).
Was the timing of the ordered test appropriate? For example, if the test was for a serum anticonvulsant level was the test likely ordered before a steady state level would have been achieved? Or if it is an HbA1C level has enough time elapsed since the change in management that the HbA1C level would reflect the overall glycemic status resulting from that change?
The patient interaction must be considered as well. Was the reason for the test discussed with the patient? Was special preparation for the test (eg. fasting) discussed with the patient? Most importantly, did the provider discuss with the patient how long it would be before the test results come back and how the result will be communicated with him/her (more on that on the post-analytic phase)?
Lastly, an most importantly, before ordering a test the clinician should ask him/herself, and discuss with the patient (1) what will we do if the test result is normal? (2) what will we do if it is abnormal as we expect it to be? (3) what will we do if it shows us something unexpected? For example, do you really need to order that C-reactive protein (CRP) in your patient who has multiple CAD risk factors and a high LDL who you are going to treat with statins regardless of the CRP result?
Keep in mind that some lab results may be abnormal by chance. If you have a 5% chance that a test result will fall outside the normal range statistically and you order a comprehensive metabolic profile of 18-20 tests you are very likely to have one test result that is abnormal. Interestingly, when we talk to lab directors we often get responses like it is less expensive and more efficient for me to run the panel than the individual test. That, however, fails to take into account the expense and inconveniences that will be generated following up on such an abnormal result.
Was it written out on a prescription form? Was a lab requisition used? Was CPOE used? Regardless of the method used, was the intent of the order clear? Were there handwriting issues? Inappropriate abbreviations used? Was it clear who was ordering the test? (Ever get a test report for a patient who was not your patient because the lab could not read the name of the actual ordering physician?)
Where, when and how was the specimen obtained? Were the appropriate patient identification procedures used prior to obtaining the specimen? Were the correct tubes or other containers used for collecting the specimen? Were they correctly labeled? Are all specimens labeled immediately and individually? How did they get to the lab (collected at the lab, sent by courier to the lab, transported from a hospital unit to the lab, etc.)? Do you have a system that actually tracks the specimen on its way to the lab? How do you know if a specimen never reached the lab? If the specimen and test were time-sensitive, did the specimen get to the lab within the appropriate time frame?
We recommend particular attention be paid to sites doing point of care (POC) testing, whether in the office or at the bedside in the hospital. Our experience is that procedures for identification and labeling of specimens in those settings are more prone to workarounds and thus more errors.
Actually, we dont know how many steps are in this phase and it is not the focus of todays column. But see our Patient Safety Tips of the Week for October 9, 2007 Errors in the Laboratory, November 16, 2010 Lost Lab Specimens and October 11, 2011 LEAN in the Lab for details on this phase.
Was the report accurate? Was the report done promptly? Was the report made available promptly? Did you send the report back to the ordering provider? Should it have been sent to anyone else (eg. was it requested that a copy go to the patients PCP?), keeping in mind that studies show sending a result to 2 clinicians actually doubles the likelihood that no one will follow up on the result? If the result was a critical value (or a finding requiring urgent response), how and to whom and in what timeframe was that result communicated?
When did the physician (or other ordering provider) receive the report? Did he/she acknowledge reading the report? If the ordering physician is no longer in the loop (eg. the ED physician who only worked one shift) did the report get to another physician who acknowledged the report and followed up appropriately? Do the lab, the ordering physician, and the patient each have systems in place to ensure that any test ordered actually completes the entire loop (i.e. that no test falls through the cracks)?
Perhaps the most important part of the loop is the responsible physician acknowledging the test result and using that result in clinical management of the patient. A couple striking statistics (Plebani 2007) are that clinicians ignore or overlook 25-60% of abnormal laboratory results and 45% of results to urgent laboratory tests requested by the emergency department were never accessed!
Weve talked on numerous occasions about pending tests falling through the cracks. The result that comes back after an inpatient is discharged is one example and weve suggested that you always include in discharge summaries a tests pending section so the next provider for that patient is at least alerted to a result he/she needs to check. Weve also suggested that you use your EHRs to send a results returned after discharge to the alert list for your inpatient providers.
But the Emergency Department is a particularly vulnerable area. Thats for two reasons: (1) the patients stay for short periods and (2) the providers work in shifts and may not return to that hospital for long periods (or not at all). So you need to have in place some system in which test results returning after the patient has left are reviewed by a clinician and important results get conveyed to the patient and the provider who will next care for that patient.
The February 2012 issue of AHRQ Web M&M has a case (Mohta 2012) that illustrates an error in a situation that likely occurs frequently and may be underappreciated: the amended lab report. In that case a young pregnant woman was admitted to a hospital with hypertension and protein on urinary dipstick testing. A 24-hour urine for protein was initially (erroneously) reported as negative for significant proteinuria. A resident was preparing the patient for discharge when the attending physician fortunately double-checked the result. In fact, the initial erroneous report had been amended and did, in fact, show significant proteinuria. That confirmed a diagnosis of pre-eclampsia and significantly altered the clinical management of the patient.
Weve discussed on multiple occasions the issue of test results reaching the chart after a patient is discharged. However, this one is even more concerning because the initial report was negative and one would not have left himself reminders to follow up on pending tests (because this test was no longer considered pending).
Proteinuria may not be on the critical results list in all hospital labs. Many labs we have seen do include it as a critical result for pregnant patients. However, most IT systems lack foolproof ways of identifying pregnant women. So they tend to use as a workaround the service of the attending physician. That works fine if the patient is on the obstetrics service and has an attending clearly identifiable as an obstetrician. But what if the patient is instead on the service of a family medicine physician (who may have obstetric privileges but is listed on the computer system under family medicine rather than obstetrics)? Or on another service all together? Or in the emergency room?
The case, though, also has important implications from the perspective of our prior discussions on diagnostic error.
Did the physician appropriately interpret the result of the test?
Did the physician document the result in the patient record? Did the physician indicate his/her interpretation of the test results as it pertains to the patient? Did the physician develop an action plan to deal with the test result? Note that an action plan may be required both on tests with abnormal results and tests with normal results.
Was the patient notified of the result? Was the patient made aware of the implications of the test result and the next steps? Was notification timely? Who did the notification and how was the notification done and was that appropriate? Could that notification have taken place via other means that might have still been appropriate but more timely or more convenient?
Did the test address the reason for which it was originally ordered? Did the test have to be repeated? Did the test lead to further tests? Would those tests have been done anyway if the abnormal test had not been done in the first place? Did the test result (normal or abnormal) have meaningful impact on the patients care?
We dont have time in todays column to address all the cognitive factors to be considered in assessing the impact of lab tests on diagnosis. In our prior discussions of diagnostic error we have talked about many of the processes that can promote diagnostic error (anchoring, premature closure, confirmation bias, etc.). But looking at how a test result influenced (or did not influence) the diagnostic reasoning may be illuminating for both the physician and others.
If an error did occur, was the patient be informed of the error? What if no patient harm occurred? Who was involved in disclosure and apology to the patient? Weve done numerous columns on disclosure and apology. A good discussion on communicating pathology and laboratory errors from the perspective of the pathologist and laboratory was published recently (Dintzis 2011).
You can see that using the tracer methodology can reveal a lot about your vulnerabilities in the lab error loop. It is, however, a very labor-intensive and time-consuming methodology. Ultimately we would hope to be able to computerize or otherwise automate parts of this process so that it could be utilized more efficiently.
The vast majority of occurrences called lab errors are obviously errors in our overall systems of care. Many of the same considerations apply equally well to radiology and diagnostic imaging. We need to do a better job of assessing where those potential vulnerabilities in our systems are and take steps to close those gaps.
Some of our other columns on errors related to laboratory studies:
See also our other columns on communicating significant results:
Hammerling JA. A Review of Medical Errors in Laboratory Diagnostics and Where We Are Today. Lab Medicine 2012; 43: 41-44
Plebani M, Lippi G. Closing the brain-to-brain loop in laboratory testing. Opinion Paper. Clinical Chemistry & Laboratory Medicine 2011; 49(7): 1131-1133, July 2011.
Lippi G, Simundic A-M, Mattiuzzi C. Overview on patient safety in healthcare and laboratory diagnostics. Biochemia Medica 2010; 20(2): 131-143
National Quality Forum. Preferred Practices for Measuring and Reporting Patient Safety and Communication in Laboratory Medicine: A Consensus Report. April 2009 last updated May 6, 2011
Plebani M. Laboratory errors: How to improve pre- and post-analytical phases? (Editorial). Biochemia Medica 2007; 17(1): 5-9.
Mohta VJ. Amended Lab Results: Communication Slip. AHRQ Web M&M February 2012
Dintzis SM, Stetsenko GY, Sitlani CM, et al. Communicating Pathology and Laboratory Errors. AJCP 2011 135:760-765
Print Lab Error
March 13, 2012
Medical Emergency Team Calls to Radiology
Weve done multiple columns (see list at end of this column) on the patient safety issues that occur in the radiology suite, most of which have little to do with radiology per se. In our October 16, 2007 Patient Safety Tip of the Week Radiology as a Site at High-Risk for Medication Errors we noted at least 14 factors that make adverse events more likely in the radiology suite. Undoubtedly there are many more contributing factors and conditions.
Recently, a series of articles by Lora K. Ott and colleagues (Ott 2012, Ott 2011a, Ott 2011b) has looked at medical emergency team/rapid response team calls to the radiology suite and analyzed patient factors related to those calls. The percentages in the papers differ, presumably because the time frames for each were different, but the most recent paper appears to account for all the cases over a two-year time period so well use those statistics. The majority of the calls (60%) were for patients not from the ICUs and for almost half they occurred on the patients first day in the hospital. The authors speculate that this could be due to several reasons: (1) ICU patients are recognized to be more at risk and are more likely to be accompanied to radiology by nursing staff (2) the subtler evolving signs of clinical deterioration may not have been appreciated in the patients from the general units who are not as closely monitored.
The majority had a Charlson comorbidity index equal to or greater than 4 and about a third each had nasal cannula oxygen, dyspnea, or tachycardia.
The nature of the events in the radiology suite were primarily cardiac in 41%, respiratory in 29%, and neurological in 25% and most required a higher level of care after the event.
44% of the calls involved patients undergoing CT scan and 22% MRI scanning. That should not be surprising, given our many prior articles on safety issues in the radiology suite. During either procedure the patient is relatively isolated from monitoring staff for periods of time. In addition, sedation may be used to facilitate completion of some of those studies. Dislodging of catheters, tubes and lines during transfer to the CT/MRI platforms could also play a role. Also, the nature of the underlying condition necessitating the CT or MRI scan may also predispose these patients to the types of deterioration seen. In one of the earlier papers (Ott 2011b) neurological causes of deterioration were more frequent so its not surprising that many of these would have occurred during CT or MRI.
In one of the articles (Ott 2011b) peak time for such events was between 10 AM and noon. The authors ascribe this interesting temporal trend as most likely reflecting detection on morning rounds of symptoms and signs necessitating the diagnostic studies.
Although few of the patients died in the radiology suite, the overall prognosis in patients needing medical emergency team interventions in radiology was not good. A quarter of the patients died during the hospitalization and two-thirds had poor outcomes.
Transport of ICU patients to the radiology suite has for a long time been known to be hazardous. In our September 16, 2008 Patient Safety Tip of the Week More on Radiology as a High Risk Area we noted a paper by Smith et al (Smith 1990) which reported adverse events during 34% of all ICU transports. Specifically, transport of ICU patients to the CT suite was associated with a 71% incidence of adverse events. Adverse events included disconnection of monitoring equipment, interruption of vasoactive medication drips, unintentional extubations, etc. A program at the University of Missouri (Stearley 1998) showed that use of a specifically trained ICU transport team had an overall complication rate of only 15.5%, most of the complications being minor.
But we were somewhat surprised by the frequency of events in non-ICU patients in the studies by Ott and colleagues. We suspect that may reflect that ICU patients are most often accompanied by ICU staff on transports to radiology whereas those from the non-ICU areas are more likely to be transported by nonclinical personnel.
So that brings us back to another of our favorite topics the handoff. In our February 14, 2012 Patient Safety Tip of the Week Handoffs More Than Battle of the Mnemonics we discussed how the structure and format of handoffs needs to be tailored to the specific situation. The Ticket to Ride concept (see our Patient Safety Tips of the Week for April 8, 2008 Oxygen as a Medication and November 18, 2008 Ticket to Ride: Checklist, Form, or Decision Scorecard?) is a tool ideally suited for the radiology suite. It was originally developed for patients on oxygen therapy needing transport to radiology since studies had shown over 50% of such transports resulted in patients running out of oxygen. However, this concept addressing handoffs has been expanded to include attention to medication management, suicide risk, wandering risk, etc. in patients transported to radiology or other sites within the hospital.
The Pennsylvania Patient Safety Authority Patient Safety Advisory discussed development of a standardized handoff communication tool for intrahospital transports (PPSA 2009). It has an excellent discussion on the development of questions youll want to use in your own transport communication tool.
The Maryland Patient Safety Organizations Handoffs & Transitions Learning Network, in their version of the Ticket to Ride, recommends inclusion of the following information on the form:
The Ticket to Ride format we recommend also includes details about the oxygen (flow rate, estimated time of oxygen remaining in tank, etc.). We also recommend including timing of other key medications, such as insulin, and time of last meal. Some patients remain in the radiology suite for long periods so you dont want a diabetic to get hypoglycemic because he got insulin but not food. And dont forget to include things like code status. Having a checkbox regarding the patients mental status and level of arousal is important. Weve seen patients become obtunded or confused in transit to radiology and its often incorrectly assumed that was their baseline status. The tool should also include checkboxes to indicate if the patient is at risk for suicide or wandering. Its also valuable to include on the Ticket to Ride a reminder to make sure you bring the patients reading glasses or hearing aid since these may be needed if informed consent for a procedure is to be obtained in the radiology suite.
But dont forget that research indicates that the best handoffs include both a written and a verbal component. So if nursing staff are not accompanying the patient from a floor to the radiology suite, there is no substitute for the floor nurse speaking directly to the radiology nurse.
Physicians and nurses often have an underappreciation of the risks that are present when they send their patients to the radiology suite. Increased awareness of the dangers and vulnerabilities is helpful and tools such as the Ticket to Ride help increase that awareness.
Some of our prior columns on patient safety issues in the radiology suite:
Some of our prior columns on the Ticket to Ride concept:
Ott LK, Pinsky MR, Hoffman LA, et al. Medical emergency team calls in the radiology department: patient characteristics and outcomes. BMJ Qual Saf 2012; published online ahead of print March 2, 2012
Ott LK, Hoffman LA, Hravnak M. Intrahospital Transport to the Radiology Department: Risk for Adverse Events, Nursing Surveillance, Utilization of a MET, and Practice Implications. Journal of Radiology Nursing 2011; 30(2): 49-54
Ott LK, Hravnak M, Clark S, Amesur NB. Patients Instability, Emergency Response, and Outcomes in the Radiology Department.
Am J Crit Care November 2011; 20(6): 461-469
Smith I, Fleming S, Cernaianu A. Mishaps during transport from the intensive care unit. Critical Care Medicine. 1990; 18(3): 278-281
Stearley HE. Patients' outcomes: intrahospital transportation and monitoring of critically ill patients by a specially trained ICU nursing staff. American Journal of Critical Care. 1998; 7(4): 282-7
PPSA (Pennsylvania Patient Safety Authority). Patient Safety Advisory. Safe Intrahospital Transport of the non-ICU Patient Using Standardized Handoff Communication.
Pa Patient Saf Advis 2009; Mar;6(1): 16-9.
Maryland Patient Safety Organization. Handoffs & Transitions Learning Network. 2008
March 20, 2012
Adverse Events Related to Psychotropic Medications
Weve seen an explosive growth in the prescription of psychotropic medications in the past decade so it should come as no surprise that we are also seeing more frequent adverse events related to them.
Studies on inpatient psychiatry units have revealed overall rates of adverse drug events and medication errors to be similar to those seen on general hospital patients (Rothschild 2007). Most medication errors were associated with physician orders (68%) but there was also a high rate of nursing transcription errors (20%). Of the psychotropic drugs the class of atypical antipsychotic drugs accounted for the most adverse drug events.
A couple articles recently have highlighted some of the issues related to psychotropic drugs. The first was one regarding the relative risk of death in older residents of nursing homes prescribed antipsychotic medications (Huybrechts 2012). It has been known for some time now that the atypical antipsychotic drugs were associated with an increased risk of cerebrovascular incidents and death. In 2005 the FDA added black box warnings about the risk for death for these drugs when used in the elderly with dementia and then added similar warnings in 2008 for the more traditional antipsychotic drugs. Yet they continue to be widely prescribed in the nursing home setting. The Huybrechts paper quantifies the risks of the individual drugs in the nursing home setting. They used a large Medicare and Medicaid dataset and were able to determine the relative mortality risks for a variety of the antipsychotic drugs relative to their reference drug resperidone. They found that haloperidol had over double the risk of death compared to resperidone and that the effects were strongest shortly after starting the drug. Quetiapine had a slightly reduced risk compared to resperidone and most of the other antipsychotics had risks similar to resperidone. In general, the risks increased as the dosage was increased for all the drugs except quetiapine. Its hard to justify use of these drugs in this population, given their limited efficacy and these significant risks. The authors caution that, when they must be used (when non-pharmacologic interventions have failed), they should be used in the lowest doses possible and the patients should be carefully monitored.
The second article was an analysis by ISMP Canada of incidents involving psychotropic medications (ISMP Canada 2012). They found that of almost 80,000 medication incidents reported over an 11-year period 7.4% involved psychotropic medications. And of the latter 2.3% were associated with patient harm. They found incidents spanning nearly all healthcare settings and several themes were seen in three main settings: the community, the hospital, and the long-term care settings.
In the community setting they found 3 main themes: (1) multiple medication theme (2) incorrect medication theme and (3) incorrect patient theme. They point out that in patients taking multiple psychotropic medications it is often difficult to sort out what side effects are due to which medication and which might be due to the underlying condition. They also saw cases where the patient was given the wrong medication and it was incorrectly assumed by the patient they had been switched to a different brand of the intended medication. And they note that medications for spouses (or other family members sharing the same last name) may be mixed up in pharmacies or at home.
In the long-term care setting they note that patients are particularly susceptible to the effects of multiple medications and that the elderly are more susceptible to the harmful effects of medications for a variety of physiologic reasons. Here also the means by which medications are administered may lead to the wrong patient getting a medication. An example they give is one in which a medication for one patient was put in the patients cereal. However, the patient was not given the cereal immediately and another patient inadvertently ate the cereal. They note that if this route is taken the medication should be mixed in with a minimal amount of food and immediately given to the patient.
In the hospital setting, one variation of the multiple medications theme was patients taking medications they brought in from home. All hospitals must have strict policies for sequestering medications brought in from home or sending those medications back home with family or other caregivers. In those rare cases where a medication from home must be administered, it should be stored and dispensed by the hospital pharmacy and subject to all usual safety measures used by the hospital (barcoding, etc.). Another common problem they encountered in medication reconciliation is when only the labels from the medication bottles from home are read. Patients may be taking only half the dose that was printed on the label or taking one every other day or some other regimen. Another theme they see in hospitals is the incorrect dose theme, in particular related to verbal orders in which hear-back and read-back are not properly used. Lastly, the dose omission theme appears when a medication is intentionally or unintentionally left off a medication list. When the patient then transitions to another level of care the medication never gets restarted. They provide an example of a patient going through a withdrawal syndrome from such inadvertent discontinuation of a psychotropic drug. Such withdrawal symptoms may lead to misdiagnoses if the possibility of drug withdrawal is never considered. (See our August 30, 2011 Patient Safety Tip of the Week Unintentional Discontinuation of Medications After Hospitalization for an estimate of how often such inadvertent discontinuations occur).
In regard to the multiple medication theme it is important to note the tremendous increase in psychotropic polypharmacy in the past decade or so. One study (Mojtabai 2010) looking at office-based psychiatry practices showed that the median number of psychotropic medications prescribed at each visit increased from one in 1996 to two in 2006. These included many instances of patients receiving 2 or more antidepressants, 2 or more antipsychotics, or 2 or more sedative/hypnotics. The authors note that the evidence base for such combination therapy is often lacking. Moreover, off-label use of antipsychotics has also become very common (Leslie 2012).
There are also some unique problems with medication reconciliation and psychotropic drugs. For a variety of reasons patients may not reveal that they are taking such drugs. And even when you populate your medication reconciliation forms by downloads from your RHIO or from third party vendors like PBMs psychotropic drugs are typically excluded because of specific legal confidentiality provisions.
While research into psychotropic medication errors and adverse events has been scant on the inpatient side, there has been almost no literature on the outpatient side. One paper (Maidment 2009) discusses some of the issues involved on the outpatient side. Some are service operational issues, such as delivery of behavioral health care across multiple transitions, with the associated problems in communication across providers, fragmented roles and responsibilities. As above, medication reconciliation is a process particularly vulnerable to error. The Maidment paper notes a study (Morcos 2002) in a mental health facility that demonstrated discrepancies in medication reconciliation in 43% of admissions and 69% of discharges. A second issue identified by Maidment et al. is the fact that many patients with mental health illnesses have multiple physical comorbidities and complex medication regimens. A third issue is the lack of training and familiarity with certain classes of medication. Many adverse drug events on behavioral health units are due to non-psychotropic drugs (eg. insulin) that the behavioral health staff is less familiar with. In the Rothschild study (Rothschild 2007) non-psychiatric drugs accounted for only 4% of the errors but they accounted for a third of the potentially preventable events on psychiatric units. Likewise, many of the psychotropic drug adverse events seen on general med/surg units likely reflects a similar unfamiliaritiy with those drugs. And that problem of unfamiliarity with psychotropic drugs is now extending to the primary care. And a fourth issue is the cognitive impairment and communications problems that may prevent a patient with mental health problems from helping avoid medication errors. More than that, levels of distrust between patients and professionals may further compromise the situation.
More and more, because of the shortage of psychiatrists nationwide, primary care physicians are managing more behavioral health conditions like depression. But in many cases they may be relatively uncomfortable managing some of the psychotropic agents needed. Many communities are adopting the DIAMOND model (ICSI 2007) for management of depression in the primary care setting. That model is based on the great work from the IMPACT study led by the University of Washington. That approach utilizes the PHQ-9 for both screening and monitoring outcomes, a stepped care approach for treatment modification and intensification, and use of care coordinators embedded in the primary care practices. However, one of the key elements is a regular interaction with a psychiatrist or other behavioral health provider. At those regular sessions specific questions about psychotropic drugs are often discussed.
We all know about the parkinsonian side effects, tardive dyskinesias and other movement disorders plus sexual dysfunction and orthostatic hypotension that may result from many psychotropic medications. Obesity, insulin resistance, and the metabolic syndrome are some of the serious complications of atypical antipsychotics. But there are multiple other potentially serious complications of some psychotropic drugs that are, fortunately, relatively infrequent. The best known are the neuroleptic malignant syndrome and the serotonin syrndrome. In our June 29, 2010 Patient Safety Tip of the Week Torsade de Pointes: Are Your Patients At Risk? we discussed how some drugs may prolong the Q-T interval and lead to ventricular tachycardia. Our October 2010 Whats New in the Patient Safety World column Antipsychotic Drugs and Venous Thrombembolism noted that there is an increased risk of venous thromboembolism with antipsychotic drugs, though the overall risk is relatively low. And a recent study (Jambet 2012) described a fatal abdominal compartment syndrome in 2 patients taking multiple psychotropic drugs.
So are there interventions known to help minimize adverse drug events related to psychotropic drugs? A study (Jayaram 2011) in a hospital setting found that an error reporting system in conjunction with CPOE (computerized physician order entry), education, and continuous feedback on errors resulted in a significant reduction in such medication adverse events. Case ascertainment in that study was limited and it is not known whether the results can be applied to other settings, such as the outpatient setting, but the results are promising. Grasso and colleagues (Grasso 2003) also look to the promise of CPOE in preventing such errors but also point out the utility of the iPhone or other PDA you probably have with you now in providing useful information about these drugs. They recommend use of protocols or order sets, particularly for those drugs with narrow therapeutic windows, and use of decision support tools to identify other conditions (diagnoses or lab results) that might lead to changing orders for psychotropic drugs. And education of physician and nursing staffs and patients themselves are important.
To that wed add the need to establish formal auditing when prescribing psychotropic drugs. For each you should have a formal protocol specifying which common side effects to look for and when to look.
We think that ultimately well need more sophisticated monitoring programs, perhaps similar to how we use trigger tools, to monitor for both adverse drug events and medication errors. However, what is clear is that there is currently a paucity of high quality systematic studies on ADEs and errors related to psychotropic drugs and how to prevent them.
Rothschild JM, Mann K, Keohane CA, et al. Medication safety in a psychiatric hospital. General Hospital Psychiatry 2007; 29(2): 156-162
Huybrechts KF, Gerhard T, Crystal S, et al. Differential risk of death in older residents in nursing homes prescribed specific antipsychotic drugs: population based cohort study. BMJ 2012; 344:e977 (Published 23 February 2012)
ISMP Canada. Analysis of Harmful Medication Incidents Involving Psychotropic Medications. ISMP Canada Safety Bulletin 2012; 12(2): 1-5 March 6, 2012
Mojtabai R, Olfson M. National Trends in Psychotropic Medication Polypharmacy in Office-Based Psychiatry. Arch Gen Psychiatry 2010; 67(1): 26-36
Leslie DL, Rosenheck R. Off-Label Use of Antipsychotic Medications in Medicaid. Am J Manag Care 2012; 18(3): e109-e117
Maidment ID, Parmentier H. Medication error in mental health: implications for primary care. Ment Health Fam Med. 2009; 6(4): 203207
Morcos S, Francis S-A, Duggan C. Where are the weakest links?: A descriptive study of discrepancies in prescribing between primary and secondary sectors of mental health service provision. Psychiatric Bulletin 2002; 26: 371-374
ICSI. DIAMOND Initiative. Depression Improvement Across Minnesota. 2007
IMPACT. Evidence-Based Depression Care.
Jambet S, Guiu B, Olive-Abergel P, Grandvuillemin A, et al. Psychiatric druginduced fatal abdominal compartment syndrome. American Journal of Emergency Medicine 2012; 30(3): 513.e5-513.e7
Jayaram G, Doyle D, Steinwachs D, Samuels J. Identifying and Reducing Medication Errors in Psychiatry: Creating a Culture of Safety Through the Use of an Adverse Event Reporting Mechanism. Journal of Psychiatric Practice. 17(2):81-88, March 2011
Grasso BC, Rothschild JM, Genest R, Bates DW. What Do We Know About Medication Errors in Inpatient Psychiatry? Joint Commission Journal on Quality and Safety 2003; 29(8): 391-400
March 27, 2012
Action Plan Strength in RCA's
We still have a strong conviction that the RCA (root cause analysis) is probably the most important learning tool that an organization with a good culture of safety has at its disposal. We encourage organizations to do RCAs not just on events with bad patient outcomes but on any event that had the potential to induce harm (near-misses).
But when you do your RCAs you need to track the action items you identified for each RCA and determine:
1) were they actually implemented?
2) were they effective?
3) were there any unintended consequences?
We recommend you keep a list or table of such identified action items from all your RCAs to discuss at your monthly patient safety committee or performance improvement committee meetings. Only that sort of rigorous discipline will ensure that you did what you said you were going to do, i.e. that you closed the loop. It is amazing at how often you do an RCA on a new event and realize you had a previous similar event and that the action items you recommended to prevent recurrence were never carried out. Our March 30, 2010 Patient Safety Tip of the Week Publicly Released RCAs: Everyone Learns from Them discussed an RCA done on a case where enteral feedings were inadvertently given intravenously. At that hospital there had been a similar incident several years earlier. After that incident an extensive root cause analysis was done and multiple recommendations were made, including key recommendations that should have prevented the current incident. But all those recommendations had not yet been fully implemented. More importantly, the recommendations were communicated back to those individuals deemed to be in the need to know but not widely disseminated to middle or front line management nor to front line staff.
Auditing for compliance with the recommendations is a good way to identify whether your risky situations continue. Think about this issue at your organization: how many times have you done an RCA and found that your frontline staff were completely unaware of an intervention you thought you had implemented after a previous incident? We will answer that for you: it happens all the time!
A new study (Morse & Pollack 2012) looks at another issue you should be monitoring in your RCAs strength of action items. We classify actions in RCAs as weak, intermediate, and strong based upon the likelihood that they will result in the desired effect and prevent similar occurrences in the future. Obviously, wed like to make sure that our RCA action items dont just fall in the weak category and that each RCA would contain at least one strong action item. So Morse and Pollack looked at 20 RCAs that had been done in their Childrens hospital and categorized all the action items. They used the VA National Center for Patient Safety recommended hierarchy of actions to categorize their action items. They had 78 action plans in their 20 RCAs. They categorized their action plans as weaker 46.2%, intermediate 43.6%, and stronger 10.3%. Overall 90% of their RCAs had at least some intermediate or stronger action items but 10% had only weaker ones.
One day when we were driving on the Pennsylvania Turnpike to a patient safety conference we passed through numerous road construction zones. We were struck by the myriad of signs and tools used to try to get drivers to slow down in these zones. Some resulted in virtually no drivers slowing down, others got them to slow down a little, and some really got them under the speed limit. The analogy to the strength of RCA action items was striking! So we put them together in pictures with RCA action items and now incorporate them in our webinar presentations on doing good RCAs. Click here to see them. Remember: images are more likely to be remembered than words!
Morse and Pollack did note that 4 of their 78 recommended action plans (5%) never got implemented. Wed say that is in keeping with our experience at multiple healthcare organizations. There were a variety of reasons for that failure of implementation but most involved lack of leadership support, usually because the resources needed did not seem commensurate with the proposed value of the action item (see our September 15, 2009 Patient Safety Tip of the Week ETTOs: Efficiency-Thoroughness Trade-Offs).
Prior studies in the VA system (Hughes 2006) analyzed action items from RCAs and found that 30% were not implemented and another 25% were only partially implemented. Stronger action items were more likely to be implemented. Actions that were assigned to specific departments or people were more likely to be implemented than those assigned to general areas. And they found that the patient safety manager plays a critical role in RCA action implementation.
Hopefully your patient safety or performance improvement committees have broad multidisciplinary representation and dont just consist of department managers. Discussion of the strength of action items from RCAs and ensuring that action items actually got implemented in such multidisciplinary meetings helps raise the bar for patient safety. Moreover, it gets people to think outside their departmental silos and bring lessons learned to the broader audience. It is amazing how some events get reviewed just at a departmental or unit level and lessons learned never get shared with others. We once did an RCA in a case where lack of timely response to the temperature sensor alarm in a refrigerator led to loss of some stored products. In doing that RCA we tried to identify other systems using temperature (or other) sensors/alarms that might be similarly vulnerable. In fact, there had been at least 3 prior events in other areas that had been similar. Yet those events had been dealt with strictly at the departmental level and lessons learned not shared with other departments. No lesson learned is so small that it shouldnt be shared with others. A high performing health system has a culture of disseminating lessons learned no matter how small those lessons learned may seem. Moreover, knowing which types of action plans actually work is invaluable.
Morse RB, Pollack MM. Root Cause Analyses Performed in a Children's Hospital: Events, Action Plan Strength, and Implementation Rates. Journal of Healthcare Quality 2012; 34(1): 5561)
Hughes D. Root Cause Analysis: Bridging the Gap Between Ideas and Execution. VA NCPS Topics in Patient Safety TIPS 2006; 6(5): 1,4 Nov/Dec 2006
VA National Center for Patient Safety. RCA Tools. Actions & Outcomes. Recommended hierarchy of actions.
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