Healthcare Consulting Services
April 5, 2011
More Aviation Principles
We had planned this week to move away from our recent theme of culture of patient safety. However, we came upon a great new paper discussing aviation safety concepts and their current or potential applications in healthcare (Lewis 2011). This follows a recent debate in the British Medical Journal as to whether we have gone too far in applying aviation analogies to healthcare (Rogers 2011; Gaba 2011). With the added weight of the new Lewis paper, well declare Gaba the winner of the debate: we still have a lot we can learn from the aviation industry that can be applied to healthcare.
And the senior author on the new paper is none other than James Bagian, the former astronaut and NASA engineer turned VA patient safety guru. The title Counterheroism, Common Knowledge, and Ergonomics: Concepts from Aviation That Could Improve Patient Safety reveals the three themes that emerge from a group of 15 aviation safety concepts that we can better apply to healthcare.
The first theme, counterheroism, is one that only evolved in aviation over a long time. Anyone who has seen the movies The Right Stuff or Top Gun remembers the daring, swashbuckling style of early aviators that fostered the culture of can do or change in mid-air that fostered workarounds and novel fixes to problems. But that gradually gave way in commercial aviation to a culture in which such ad lib solutions were no longer considered to be heroic and following structured standardized procedures became the norm. Basically, the new culture of safety emphasizes the role of teams and the system as a whole. In healthcare, where the medical profession has always glorified innovation and problem solving as highly desirable traits, its no surprise that resistance from physicians has been a barrier to change. Of course, if the focus is really on problem solving one should readily appreciate that teamwork is more likely to achieve success than individual or solo efforts.
Some of the aviation safety concepts under the counterheroism theme are use of checklists, alternating roles, the first-names-only rule, and crew resource management (CRM). Alternation of roles (eg. the pilot and first officer typically take turns flying the aircraft at various times) and the first-names-only rule are concepts that tend to flatten the hierarchy and make it much more likely that any individual on the team will feel free to speak up when a potential safety hazard is identified.
The second major theme is common knowledge. Examples in aviation are the joint safety briefings for pilots and crew before flights, publicizing detailed minimum safety requirements, and rules such as the sterile cockpit rule or the bottle to throttle rule. Weve emphasized the equivalent of the sterile cockpit rule in healthcare in multiple columns (see prior aviation-related patient safety columns listed at the end of this column). Once a rule becomes common knowledge and someone is seen to violate that rule, all other team members are authorized to bring this to the attention of the violating party.
The third theme is ergonomics or human factors engineering, including design to mistake-proof or use forcing functions. Use of standardized layouts is important so that pilots moving from plane to plane are not confused by location of various controls and dials. Weve previously noted the problems that arise when different ventilators or monitoring equipment are used in different ICUs and staff have to float between these ICUs. Their example of mistake proofing is the automatic locking of the landing gear lever in the down position whenever the plane is on the ground. In healthcare, we mistake proof, for example, by preventing connection of catheters to wrong sites or gas lines to the wrong gas outlet. Their aviation example of forcing functions is the Traffic Alert and Collision Avoidance System, which identifies a potential collision and orders the pilots to take appropriate actions. The healthcare equivalent might be the requirement for manual overrides for dangerous medication administration. Another example is flight envelope protection, which we might liken to a form of constraint. This is where the system prevents the pilot from doing something with the plane that is beyond safe limits. The example given in the paper is a computer system that negates a command from the pilot that would pitch the aircraft beyond the stalling angle. The example they provide from healthcare would be a system that prevents too high a concentration of oxygen being delivered to a patient with type 2 respiratory failure (i.e. those prone to hypercarbia).
The paper goes on to describe the cost:benefit analysis of implementing the various safety measures and many of the barriers likely to be encountered amongst physicians when attempting to implement such changes.
One of the most interesting concepts is the black box. That, of course, is the device that records all the flight data, conversations in the cockpit, and information related to crashes. They describe the resistance encountered from pilots when the systems were introduced because crew knew that everything was being recorded. They note this may lead to more civility between pilots and between pilots and air traffic controllers. But the main utility of such recording systems is to be able to identify anomalies and go back to discuss why those occurred so as to prevent similar future occurrences. They suggest a theoretical potential for a healthcare black box recording telephone conversations. We have also been advocates for recording the surgical time-out (or other events) in the OR with the intent of using the playback in a constructive manner to improve teamwork. Similarly, we have mentioned in several prior columns the LOSA (Line Operations Safety Audits) audits done in aviation. In these, someone sits alongside the crew on a flight and records actions and interactions and later provides feedback to the crew in attempt to improve operations.
By the way, the interview with James Bagian (Schulz 2010) mentioned above is worth reading. Most of his comments are in keeping with the theme that the biggest difference between aviation and healthcare is related to the difference in culture. Bagian also points out that a much higher percentage of the budget is spent on safety and training in the aviation industry compared to healthcare.
And what about the debate in the British Medical Journal? How could you possibly think we have gone too far with the analogies to aviation? We dont really think that James Rogers, who takes the yes we have gone too far side of the debate, is discounting the valuable lessons that can be learned from aviation. Rather he points out areas in which differences between healthcare and aviation call for different types of safety interventions. But one of the biggest differences, he concedes, is that there are more authority gradients in healthcare, the very theme we have been emphasizing in our recent columns.
Our prior Patient Safety Tips of the Week on aviation safety lessons and healthcare:
May 18, 2010 Real-Time Random Safety Audits
June 2, 2009 Why Hospitals Should FlyJohn Nance Nails It!
May 26, 2009 Learning from Tragedies. Part II
May 19, 2009 Learning from Tragedies
October 2, 2007 Taking Off From the Wrong Runway
August 28, 2007 Lessons Learned from Transportation Accidents
Lewis GH, Vaithianathan R, Hockey PM, Hirst G, Bagian JP. Counterheroism, Common Knowledge, and Ergonomics: Concepts from Aviation That Could Improve Patient Safety. The Milbank Quarterly 2011; 89(1): 438
Schulz K. The Wrong Stuff: What it Means to Make Mistakes. Risky Business: James BagianNASA astronaut turned patient safety experton Being Wrong. Slate 2010; Posted Monday, June 28, 2010 5:01 PM
Rogers J. Head to Head. Have we gone too far in translating ideas from aviation to patient safety? Yes. BMJ 2011; 342:c7309 published online 14 January 2011
Gaba DM. Head to Head. Have we gone too far in translating ideas from aviation to patient safety? No. BMJ 2011; 342:c7310 published online 14 January 2011
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April 12, 2011
Medication Issues in the
Acute care settings have dominated the literature on patient safety. But there are significant patient safety issues on the ambulatory care side as well. Probably the four most common safety issues in ambulatory care are (1) diagnostic errors (2) medication errors (3) failure to follow up on test results and (4) missed opportunities to prepare patients for hospitalizations.
But medication errors are both frequent occurrences in the ambulatory setting and perhaps most amenable to improvement. One of the earliest studies on the frequency and impact of drug complications in outpatients (Gandhi 2000) found that 18% of outpatients responding to surveys reported a drug complication but that chart review found documentation of the event in only 3%. Number of medical problems, failure to explain side effects, and language other than English or Spanish were factors associated with drug complications. Almost half those with complications sought medical attention and 5% required hospitalization. 13% had a documented previous reaction to the offending drug. The occurrence of a drug complication also impacted negatively on patient satisfaction.
The same group later did a prospective cohort study (Gandhi 2003) in ambulatory practices and found 25% of outpatients had adverse drug events, 13% of which were serious. They found 28% of the events were ameliorable and 11% preventable. Number of medications was significantly associated with adverse events. Drug classes most often involved were SSRIs, beta blockers, ACE inhibitors, and NSAIDs. Significantly, physician failure to respond to medication-related symptoms was notetd in 63% of the ameliorable adverse events and in 37% the patient failed to inform the physician of the symptoms. Most of the errors occurred in the prescribing or monitoring phases. They also noted that many of the events could be potentially preventable using computerized medication prescribing using clinical decision support tools.
An even later study by the same group (Gandhi 2005) showed that basic computerized prescribing systems may not be adequate to prevent serious medication adverse events and that more advanced systems using clinical decision support tools (like dose and frequency checking) are likely necessary to improve patient safety. The theoretical potential impact of medication safety alerts on medication safety and healthcare utilization is substantial (Weingart 2009a) but in practice most physicians override such safety alerts in currently implemented systems (Isaac 2009). Hence, avoid alert fatigue by using alerts for just the most important safety issues and consider making those hard alerts that cannot be easily overridden.
A study done on ambulatory patients aged 65 and older (Gurwitz 2003) found a rate of 5% per year of adverse drug events. This study used a variety of methods to detect the adverse events but did not directly contact the patients. The higher rates in the Gandhi studies suggests that chart-based methods are likely to significantly underestimate the frequency of adverse drug events. Almost 28% of the events were considered potentially preventable. Problems in the prescribing and monitoring phases were most common and problems with patient adherence were also significant.
Compared to the offending drugs in inpatient adverse drug events (which involve more often insulin, anticoagulants, narcotics, sedative/hypnotics, and chemotherapy), those in the ambulatory setting more often involve antidepressants, antihypertensive medications, cardiovascular medications, hypoglycemic agents, and non-opioid analgesics. However, keep in mind that the above studies were done prior to the recent surge in use of narcotic analgesics, particularly the longer-acting ones, that may be associated with adverse events (Bohnert 2011, Cohen 2010). And dont forget that many of the hospitalizations result from adverse events related to anticoagulants.
Just as importantly though, many of the inpatient adverse drug events are related to confusion regarding medications originally presecribed on outpatients. Insulin is the classic drug in the regard. In fact, in the UK there has been a recent emphasis on using insulin passports to help avoid such problems when patients get admitted (NPSA 2011). The actual passport is a foldable medication list that the patient can carry in a wallet or purse. There is also a separate information booklet for patients describing what questions they should be asking when admitted to the hospital. You can also use patient medication tools like the Massachusetts Coalition for the Prevention of Medical Errors Patient Med List or the AHRQ411 How to Create a Pill Card.
The mechanics of the drug prescription are also important. Even when we are doing what we think may be the safest practices, we must be wary of unintended consequences. For example, as neurologists we often prescribe anticonvulsants daw (dispense as written) so that the patient always gets a brand name rather than a generic equivalent. That is not because we think the brand name is any better than the generic. It is simply that the bioavailability may differ from one generic manufacturer to another. Patients always given the anticonvulsant from the same generic manufacturer do usually achieve stable blood levels. However, if the pharmacy switches manufacturers, the blood levels may change and a patient may end up below or above the desired therapeutic range. So many of us use the daw to ensure that a drug from the same manufacturer is dispensed each time. However, recently a paper looked at the consequences of daw prescribing and found that a much higher percentage of patients are not adherent when their medications are dispensed daw another unintended consequence of what we thought was the safest procedure!
And how you tell patients to take their meds (the sig: on your prescriptions) is also critical. A recent study (Wolf 2011) gave well-educated volunteers prescriptions for seven drugs and watched them try to figure out how and when to take them all. They could theoretically be consolidated to be taken in 4 dosing sets per day. Yet only 15% were able to consolidate the regimen to 4 times daily or less. Most ended up with regimens taking medications 6 or 7 times daily. Even the instructions twice daily and every 12 hours resulted in medications being taken at different times.
There is also often a disparity between what the physician thinks the patient is taking and what the patient is actually taking. In one study (Schillinger 2005) 50% of patients reported taking warfarin doses that were discordant with what the physician reported, often resulting in either over- or under-anticoagulation.
And dont forget to avoid dangerous abbreviations. Use ISMPs expanded list of Do Not Use abbreviations rather than the shorter Joint Commission minimal list used by most hospitals (see our July 14, 2009 Patient Safety Tip of the Week Is Your Do Not Use Abbreviations List Adequate?). Remember that any abbreviation you use in your prescriptions, lists or medical records has a chance of being copied into an order or medical record in a hospital or other setting. Interestingly, in some settings computerized alerts have helped reduce use of dangerous abbreviations (Myers 2011).
Weve also done several columns on medication errors in other ambulatory settings (see our Patient Safety Tips of the Week for June 12, 2007 Medication-Related Issues in Ambulatory Surgery, August 14, 2007 More Medication-Related Issues in Ambulatory Surgery, March 24, 2009 Medication Errors in the OR, October 16, 2007Radiology as a Site at High-Risk for Medication Errors). And, of course, weve done numerous columns on Beers List of potentially inappropriate medications in the elderly (see our January 15, 2008 Patient Safety Tip of the Week Managing Dangerous Medications in the Elderly and our Whats New in the Patient Safety World columns for June 2008 Potentially Inappropriate Medication Use in Elderly Hospitalized Patients and September 2010 Beers List and CPOE and October 19, 2010Optimizing Medications in the Elderly).
So what should you be doing?
Gandhi TK, Burstin HR, Cook EF, et al. Drug complications in outpatients.
J Gen Intern Med. 2000; 15(3): 149-154
Gandhi TK, Weingart SN, Borus J, et al. Adverse Drug Events in Ambulatory Care.
N Engl J Med 2003; 348: 1556-1564
Gandhi TK, Weingart SN, Seger AC, et al. Outpatient prescribing errors and the impact of computerized prescribing. J Gen Intern Med. 2005; 20(9): 837-841
Weingart SN, Simchowitz B, Padolsky H, et al. An Empirical Model to Estimate the Potential Impact of Medication Safety Alerts on Patient Safety, Health Care Utilization, and Cost in Ambulatory Care. Arch Intern Med.2009;169(16):1465-1473
Isaac T, Weissman JS, Davis RB, et al. Overrides of Medication Alerts in Ambulatory Care. Archives of Internal Medicine 2009; 169(3): 305-311
Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug
events among older persons in the ambulatory setting. JAMA 2003;289:1107-16
Bohnert ASB, Valenstein M, Bair MJ, et al. Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths
JAMA. 2011; 305(13): 1315-1321
Cohen M. Doctors risk patient safety by prescribing fentanyl painkiller for short-term pain. Philly.com November 8, 2010
National Patient Safety Agency (UK). Patient Safety Alert: The adult patients passport to safer use of insulin. March 30, 2011
Insulin passport (foldable list)
Patient information booklet for insulin passport
Massachusetts Coalition for the Prevention of Medical Errors. Patient Med List.
AHRQ411 How to Create a Pill Card.
Wolf MS; Curtis LM, Waite K, et al. Helping Patients Simplify and Safely Use Complex Prescription Regimens. Arch Intern Med. 2011; 171(4): 300-305
Schillinger D, Machtinger E, Wang F, Rodriguez M, Bindman A. Preventing medication errors in ambulatory care: the importance of establishing regimen concordance. In: Henriksen K, Battles J, Lewin DI, Marks E, eds. AHRQ Peer-Reviewed Publication: Advances in Patient Safety: From Research to Implementation, Vol. 2. Rockville, MD; 2005.
April 19, 2011
DVT Prophylaxis in Acute
Stroke: Controversy Reappears
The controversy over DVT prophylaxis in stroke patients resurfaced last week in a series of letters in the Annals of Internal Medicine (Sprigg 2011; Kearon 2011). Though the debating letters were titled Should Patients With Stroke Wear Compression Stockings?, the controversy was really about pharmacological, not mechanical, VTE prophylaxis.
Patient with acute stroke, particularly those with significant lower extremity weakness, are at significant risk for DVT and pulmonary embolism. This applies to both acute ischemic infarcts and intracerebral hemorrhages. And in both types there is either significant risk of hemorrhagic transformation or worsening of hemorrhage when pharmacological prophylaxis is used.
So, for years, graduated compression stockings have been used as a strategy to prevent DVT in patients with stroke. Though in the US we have felt that the evidence for use of these (as opposed to pneumatic compression stockings) in stroke patients was scant, they have been used extensively in other countries. And, while we were skeptical about their effectiveness, most of us took an attitude that it cant hurt.
Then the CLOTS trial 1 (see our Whats New in the Patient Safety World column for July 2009 Unintended Consequences of a DVT Prevention Strategy) showed that not only do thigh-high graduated stockings not prevent DVT in stroke patients, they actually cause harm. Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to graduated compression stockings than in those allocated to avoid their use.
Then the CLOTS Trial 2 (see our October 2010 Whats New in the Patient Safety World column Graduated Compression Stockings: CLOTS Confuses Clinicians) published its results and they absolutely confused the issue. Clots Trial 2 compared thigh-length graduated compression stockings to below-knee stockings and found fewer cases of VTE with the thigh-length stockings. The study populations and protocols for the two trials were the same, though the sites differed. The CLOTS Trial 2 was discontinued early because of the results of CLOTS Trial 1 but had already reached its predetermined enrollment goal. Proximal DVT, the primary study outcome, had an absolute risk reduction in the thigh-length group of 2.5% and the relative risk reduction was 31%. There were no differences in distal DVT, pulmonary emboli or deaths between the 2 groups. There were more cases with skin problems in the thigh-length group but these were relatively mild.
The authors consider several possible explanations for the seemingly contradictory results of the 2 trials. One is that below-knee stockings might actually increase the risk for DVT in stroke patients. The other is that the first CLOTS trial may have underestimated a positive effect of the thigh-length stockings.
In the accompanying editorial (Kearon 2010) it was noted there remain significant uncertainties as to how to best prevent DVT in stroke patients. Moreover, these studies highlight the need for randomized controlled trials of graduated compression stockings in other patient populations since they are so widely used in other patient populations. Even in surgical patients, where graduated compression stockings have been shown in multiple studies to reduce the occurrence of VTE, there has been no comparison of thigh-length vs. below-knee stockings. And while guidelines generally recommend use of thigh-length stockings, below-knee stockings are probably used more frequently in actual practice.
The new controversy is not about the mechanical DVT prophylaxis but about whether pharmacological prophylaxis is indicated in any patients with acute stroke. It was raised by Sprigg et al. who point out that data from 2 previous large trials (Bath 2001, IST 1997) suggest such pharmacoprophylaxis is as likely to cause symptomatic intracerebral hemorrhage as it is to prevent pulmonary embolism. Kearon et al., in their response (Kearon 2011), are quick to point out they did not advocate routine use of pharmacoprophylaxis.
Note that the most recently published consensus guidelines on DVT prophylaxis in acute stroke (Albers 2008) recommend: For acute ischemic stroke patients with restricted mobility, we recommend prophylactic low-dose subcutaneous heparin or low-molecular-weight heparins (Grade 1A). They did review multiple studies, including the above mentioned ones, to arrive at that conclusion. A systematic review (Andr 2007) also suggested that prophylactic low-dose subcutaneous heparin or low-molecular-weight heparins are partially effective but that the findings are stronger for their preventing DVT than pulmonary emboli or death.
Suffice it to say that we still have much to learn about the best VTE prophylaxis in patients with acute stroke and significant weakness or immobility. Graduated compression stockings probably should not be used and, if they are used, careful attention to the underlying skin is a must. We will have to await the results of the CLOTS Trial-3, which is looking at both the efficacy and safety of pneumatic compression stockings in stroke patients. And the issue of pharmacoprophylaxis remains controversial. It may well turn out that use of low-dose unfractionated heparin or low-molecular-weight heparins may someday prove to have a desirable risk:benefit ratio, particularly after the period of maximum risk of hemorrhagic transformation, but that remains controversial. Its clear that further study is necessary on both mechanical and pharmacological methods of VTE prophylaxis in acute stroke patients and it is the net benefit (risk of reducing the VTE risk vs. risk of intracerebral hemorrhage) that is most important.
In the interim, wed probably advocate for use of pneumatic compression stockings. But dont be surprised there if unintended consequences pop up! They also have a potential for skin complications, tend to further immobilize some patients, and are more expensive. Hopefully CLOTS-3 will provide us answers soon.
Sprigg N, Geeganage CM, Bath PMW. Should Patients With Stroke Wear Compression Stockings? Annals of Internal Medicine 2011; 154(7): 506
Kearon C, O'Donnell M. Should Patients With Stroke Wear Compression Stockings? Annals of Internal Medicine 2011; 154(7): 506-507
The CLOTS Trials Collaboration. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. The Lancet 2009; 373:1958 - 1965, 6 June 2009
The CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration. Thigh-Length Versus Below-Knee Stockings for Deep Venous Thrombosis Prophylaxis After Stroke
A Randomized Trial. Annals of Internal Medicine 2010. Published early on line September 21, 2010
Kearon C, O'Donnell M. Should Patients With Stroke Wear Compression Stockings to Prevent Venous Thromboembolism? (Editorial). Annals of Internal Medicine 2010; 153(9): 610-611
The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. International Stroke Trial Collaborative Group. Lancet 1997; 349: 1569-81
Bath PM, Lindenstrom E, Boysen G, De Deyn P, Friis P, Leys D, et al. Tinzaparin in acute ischaemic stroke (TAIST): a randomised aspirin-controlled trial. Lancet. 2001; 358: 702-10
Albers GW, Amarenco P, Easton JD, Sacco RL, Teal P; American College of Chest Physicians. Antithrombotic and thrombolytic therapy for ischemic stroke: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008; 133: 630S-669S
Andr C, de Freitas GR, Fukujima MM. Prevention of deep venous thrombosis and pulmonary embolism following stroke: a systematic review of published articles. Eur J Neurol. 2007; 14:21-32
April 26, 2011
Sleeping Air Traffic
Controllers: What About
Weve read with great interest all the recent news articles about air traffic controllers falling asleep on the job and have been appalled that the response of the authroities has been to fire them all. When you see the same problem pop up at multiple sites you have a system problem. This is not much different than the concentrated KCl issue in healthcare. The initial response years ago when nurses inadvertently administered fatal doses of concentrated KCl was to fire them. That response, of course, removed the one person likely never to make that mistake again and ignored the presence of a widespread system problem, i.e. that we were putting the patients (and nurses) in jeopardy by making concentrated KCl so readily available in the hospital.
So while the air traffic control system struggles to save face rather than address the root causes, we need to ask ourselves whether similar issues exist in healthcare. Of course they do. In both industries, 24x7 coverage is required and workers are often called upon to deal with emergent situations at all times of day or night. Moreover, the general background on night shifts in most industries (usually less noise, less light, less activity, etc.) probably has a soporific effect. Hence, the ability to remain vigilant and capable of quick decision making is both critical and problematic.
In our November 9, 2010 Patient Safety Tip of the Week 12-Hour Nursing Shifts and Patient Safety we did discuss some of the issues related to working long shifts, varying shifts, consecutive shifts, and night shifts. In that Tip we referred to an excellent 3-part series this year Is It Time to Pull the Plug on 12-Hour Shifts? by Geiger-Brown and colleagues. Part 3 of that series contained some great suggestions for protecting nurses working the night shifts (use of buddy systems, planned power naps, avoiding certain types of tasks during the bodys circadian nadir around 2-4 AM, and encouraging nurses to speak up when they are tired).
Now a new study (Fallis 2011) provides a very timely discussion about napping on the night shift. Fallis and colleagues provide a detailed discussion about the literature on fatigue and threats to both patient and personal safety in nurses (and other healthcare workers) on the night shift and the literature on the effects of napping on night shifts in multiple industries. They then did focused interviews with 13 experienced nurses working the night shift in the emergency room or ICU setting in a community hospital in Canada. Ten of the 13 described themselves are regular nappers on the night shift (meaning that they often took brief naps on scheduled breaks if circumstances permitted). Three major themes evolved: the environmental scan, the impact of napping, and the consequences of not napping. The environmental scan was an analysis of all the variables taken into consideration in making a decision as to whether a nap was feasible. Those included things like how busy the unit was, what the mix of experienced vs. inexperienced nurses was, who was available for relieving them, and whether anyone was working a double shift.
The impact of napping could be positive or negative. Most of the regular nappers noted a positive impact, such as awakening refreshed and able to think more clearly. But naps are not for everyone. One of the downsides of naps is occasionally awakening and temporarily feeling disoriented and slow to respond or the phenomenon of sleep inertia. Almost a quarter of the interviewees in the Fallis study mentioned this and it was the primary reason that several of them had become non-nappers.
The consequences of not napping included slowed mental processes and foggy thinking. Nurses found themselves having to check things multiple times. They gave examples of missing arrhythmias on telemonitoring screens because of decreased vigilance. Many found the period between 4AM and 6AM to be most vulnerable. (Note that almost all studies on fatigue and sleepiness on the night shift do identify a roughly two-hour period where concentration abilities are at their worst but the exact time of that nadir differs from study to study).
Prior studies in nursing have revealed a strong correlation between lack of sleep and errors that have the potential to adversely affect patient care (Dorrian 2006). That Australian study concluded that less sleep may lead to the increased likelihood of making an error, and importantly, the decreased likelihood of catching someone else's error.
Drowsiness, fatigue, and sleep deprivation also have an impact on personal health of nurses. The issue of nurses having accidents while driving home from work drowsy is fairly well known (Scott 2007, Dorrian 2006). While that applies to drowsiness after any shift, it is more prevalent after night shifts. Working while tired also predisposes to more needle sticks, stress levels, and other health issues.
Putting systems in place to allow napping on the night shift is not easy. First, you have to provide adequate relief staffing to ensure full coverage of your units at all times. You already must do this for other breaks (meal breaks, bathroom breaks, etc.) that nurses need on any shift. Most nurses will tell you they often work shifts with no breaks at all because of staffing shortages or mismatches between staffing and patient acuity. Second, you need to provide an appropriate physical environment conducive to taking a brief nap (quiet and comfortable, free from interruptions, yet close enough for the nurse to be aroused to respond to patient care emergencies). Third, you need to have in place a system of prioritization in which naps would be allowed only if all preset criteria are met. And lastly you need to have in place a management culture that recognizes the problem as real and is supportive of efforts to address the problem rather than approach it in a punitive manner.
Many (or most) nurses may have difficulty napping if they have one or more patients who are unstable. One other barrier mentioned by several nurses in the Fallis study was fear of what the public would think about nurses napping on the job. Given the news media responses in the recent air traffic controller cases, it is clear that raising public awareness about the dangers of fatigue and the benefits of napping under appropriate circumstances is very important.
So is there an objective evidence base to suggest that naps become a feature embedded into nursing (or other healthcare worker) shifts? Actually there was a randomized controlled trial of naps on the night shift for both physicians and nurses working in the ER (Smith-Coggins 2006). In that study, physicians (residents) and nurses who worked at least 3 consecutive night shifts in the ER were randomized to a nap group or a control no-nap group. The intervention was a scheduled 40-minute nap around 3AM (the actual monitored time napping was about 25 minutes). A battery of cognitive and performance tests were administered at 4AM and 7:30AM and then a driving simulation was done at 8AM. Those in the nap group had fewer performance lapses at 7:30AM and took less time to insert an IV. They also reported less fatigue and sleepiness and more vigor. On the driving simulation they did not perform better overall than the non-nap group, though they showed less dangerous driving tendencies and fewer behavioral signs of tiredness during the simulation. Interestingly, in view of the comments about sleep inertia in the Fallis study mentioned above, those in the nap group performed more poorly on a memory test administered at 4AM (immediately after the nap). So this study strongly supports the concept of the restorative nap during the night shift even though actual impact on patient outcomes was not measured or assessed.
Naps may be pertinent outside the night shift as well. Those of us who treat patients with migraine have long recognized the benefit of allowing someone in the midst of a migraine to take a brief nap. We often see migraineurs who would have been unproductive on the job for an entire workday able to waken from a short nap refreshed and able to return to productive work.
Sleeping air traffic controllers may be fodder for Jay Lenos late night television jokes but lets not let those jokes deter us from taking a hard look at a real problem in not just air traffic control but in healthcare as well. If we fail to openly address this real issue, it will continue to be a problem that continues in a manner not in the best interest of patient or personal safety.
Further studies should be encouraged to measure the actual impact of such naps on patient care and to answer other key questions (what is the best time for the nap? optimal duration of the nap? optimal wake up period after the nap? etc.). Remember, any positive impact of such a napping program would have to be balanced against any potential negative impact youd introduce by requiring coverage of patients for an hour or so by physicians and nurses unfamiliar with those patients. But rather than snicker at people napping on the job we need to get serious about a problem potentially detrimental to the care of our patients and the well-being of our staffs.
Geiger-Brown J. Trinkoff AM. Is It Time to Pull the Plug on 12-Hour Shifts? Part 3. harm reduction strategies if keeping 12-Hour Shifts. Journal of Nursing Administration 2010; 40(9): 357-9, 2010 Sep
Fallis, WM, McMillan DE, Edwards MP. Napping During Night Shift: Practices, Preferences, and Perceptions of Critical Care and Emergency Department Nurses
Crit Care Nurse March 31, 2011 vol. 31 no. 2 e1-e11
Dorrian J, Lamond N, van den Heuvel C, et al. A Pilot Study of the Safety Implications of Australian Nurses' Sleep and Work Hours. Chronobiology International 2006; 23(6): 11491163
Scott LD, Hwang W-T, Rogers AE, et al. The Relationship between Nurse Work Schedules, Sleep Duration, and Drowsy Driving. Sleep 2007; 30(12): 1801-1807
Smith-Coggins R, Howard SK, Mac DT, et al. Improving Alertness and Performance in Emergency Department Physicians and Nurses: The Use of Planned Naps. Ann Emerg Med 2006; 48: 596-604
May 3, 2011
It's All in the Timing
In our April 26, 2011 Patient Safety Tip of the Week Sleeping Air Traffic Controllers: What About Healthcare? we discussed the issue of fatigue on the night shift and the potential role it may play in patient care errors. That may apply to both nurses and physicians. And in this months Whats New in the Patient Safety World column More on Nursing Workload and Patient Outcomes we noted that patient ER visits and hospital readmissions are increased when nurses are working overtime.
Are there other examples where duration worked may have a detrimental effect on patient safety? It turns out there are several good examples. For a number of years now it has been pointed out that endoscopists tend to detect fewer colonic polyps or adenomas later in the day. Also, completeness of colonoscopy may fall off later in the day. In both examples patient characteristics and patient preparation probably do not explain the phenomenon and quite likely a factor related to operator fatigue is in play.
It was noted that the number of incomplete colonoscopies was about 60% higher when done in the afternoon than the morning, even after adjustment for patient characteristics and inadequate bowel preps (Sanaka 2007). The implication was that operator fatigue may play a role in this poorer performance in the afternoon.
Similarly, adenoma detection on colonoscopy also declined about 20% in the afternoon compared to the morning (Sanaka 2009). There was actually a trend to declining adenoma detection by each hour elapsed. A more recent study (Lee 2011) confirmed this and demonstrated that there was a 4.6% reduction in polyp detection for each elapsed hour of the day. And, if you look at it from the patients perspective, each position you are in the queue successively is associated with a 5.4% reduction in polyp detection.
Note that the above studies do not necessarily imply fatigue. Alternate explanations might be due to the monotony of the procedures causing inattentiveness or even time pressures to finish the day leading to less thorough evaluations. Whether it is operator fatigue, monotony, or time pressure the net effect seems to be the same and interventions to improve successful exams should be considered. Another recent study (Gurudu 2011) looked at the difference between colonoscopies scheduled in half-day blocks vs. full-day blocks and concluded that adenoma detection rate was not different in the afternoon compared to morning if endoscopists were each working just a half-day but the rate of adenoma detection was significantly lower in the afternoon if the same endoscopist did both morning and afternoon blocks. Another study done at the Mayo Clinic (Munson 2011) showed that the reduction in adenoma detection rates did not fall off when colonoscopists worked 3-hour shifts. And another new study (Freedman 2011) showed stable polyp detection rates throughout the day when moderated colonoscopist procedure loads were used in conjunction with split-dose bowel preparations.
An editorial by Spiegel (Spiegel 2011) summarizes the literature on this variation of detection of polyps or adenomas by time of day and notes it has occurred in almost all settings where colonoscopies are done. He even points out the in the Munson study noted above, though there was no hourly dropoff in detection rates for the first two shifts, there was a dropoff in detection rates between the start and end of the third shift. He notes, however, that setting caps on endoscopic work shifts such as done at the Mayo Clinic may be helpful in reducing the dropoff in detection rates.
What about other specialties? A similar phenomenon has been reported in radiology. One study (Krupinski 2010) showed a significant reduction in diagnostic accuracy of radiologists after a day of clinical reading (average 8 hours), as measured by reduced ability to detect fractures. This correlated with subjective ratings of fatigue and eyestrain and objective errors in (ocular) accommodation. Even though radiologists recognized the eyestrain and/or fatigue they did not take any longer to interpret films at the end of the day.
But fatigue, per se, may not be the sole cause of errors in such cases. Monotony certainly also may play a role. Its well known that fewer abnormalities are found by pathologists or cytology techs looking at slides for long periods (hence the interest in automated procedures to screen specimens for abnormalities). Nurses or technicians monitoring telemetry screens are also less likely to detect abnormalities when watching monitors for long periods. Errors related to monotony have been seen in other industries such as trucking, banking, inspecting goods, measuring parts, lifeguard surveillance, railway transportation, etc.
A study looking at the effects of sleep debt and monotonous work in process operators working 12-hour shifts (Sallinen 2004) showed that the effects of monotonous work are at least as harmful as moderate sleep debt. They called for more attention to the activity-provoking nature of work as a means to maintain alertness at work. They also note that our ever-increasing automation and introduction of computer technology may contribute to monotony and diminished pace of work, perhaps increasing the risk of sleepiness.
So what are the take-home lessons from all this (other than that well be sure to have our next colonoscopies early in the day!)? First, there is obvious utility in looking at various outcome measures not just in the aggregate but also by time of day (and maybe day of the week as well). Second, limiting the workload in some circumstances may make sense. The cap of 3-hours per session for individual colononoscopists, as done at the Mayo Clinic, may make sense. Thirdly, we need to take a closer look at the issue of monotony in a whole variety of processes and look for ways to better break up the day and vary the pace of many of our healthcare workers to minimize the potentially fatiguing effect of monotony.
Sanaka MR, Shah N, Mullen KD, et al. Afternoon Colonoscopies Have Higher Failure Rates than Morning Colonoscopies. The American Journal of Gastroenterology 2006; 101: 2726-2730
Sanaka MR, Deepinder F, Thota PN, et al. Adenomas Are Detected More Often in Morning Than in Afternoon Colonoscopy. The American Journal of Gastroenterology 2009; 104: 1659-1664
Lee A, Iskander JM, Gupta N, et al. Queue Position in the Endoscopic Schedule Impacts Effectiveness of Colonoscopy. The American Journal of Gastroenterology 2011 (published online March 29, 2011)
Gurudu SR, Ratuapli SK, Leighton JA, et al. Adenoma Detection Rate Is Not Influenced by the Timing of Colonoscopy When Performed in Half-Day Blocks. The American Journal of Gastroenterology (published online April 19, 2011)
Munson GW, Harewood GC, Francis DL, et al. Time of day variation in polyp detection rate for colonoscopies performed on a 3-hour shift schedule.Gastrointestinal Endoscopy 2011; 73(3): 467-475
Freedman JS, Harari DY, Bamji ND, et al. The detection of premalignant colon polyps during colonoscopy is stable throughout the workday.
Gastrointestinal Endoscopy 2011; (published online March 14, 2011. )
Spiegel BMR. Does time of day affect polyp detection rates from colonoscopy?
Gastrointestinal Endoscopy 2011; 73(3): 476-479
Krupinski EA, Berbaum KS, Caldwell RT, et al. Long Radiology Workdays Reduce Detection and Accommodation Accuracy. Journal of the American College of Radiology 2010; 7(9): 698-704
Print Its All in the Timing
May 10, 2011
Readmissions: Not As Easy As
Preventing hospital readmission has been a hot topic since CMS announced there will be financial penalties for hospitals having poor track records on readmissions for certain conditions. The first batch of targeted conditions are congestive heart failure, MI and pneumonia and the clock starts ticking this October. The potential penalties apply not just to those three conditions but to all Medicare discharges. And the list of targeted diagnoses will expand in the future. In addition, those organizations forming Accountable Care Organizations (ACOs) will also want to reduce avoidable readmissions as a major means of improving both cost and quality.
Its been a while since we did a column focusing on readmissions. Our February 24, 2009 Patient Safety Tip of the Week Discharge Planning: Finally Something That Works! began to address the rehospitalization problem and focus on the hospital discharge process and we followed that up with Patient Safety Tips of the Week for April 7, 2009 Project RED and April 14, 2009 More on Rehospitalization After Discharge. In those columns, we discussed the New England Journal of Medicine (Jencks et al 2009) study on Medicare data that showed 19.6% of all patients discharged from an acute care hospital are rehospitalized within 30 days and the randomized study (Jack et al. 2009) from Project RED that documented considerable improvement in rehospitalization rates using a structured hospital discharge program. Recall that that study showed about a 30% reduction in rehospitalizations or ER visits after hospital discharge and saved about $412 per patient. We encourage you to go click the links to those columns to see the numerous strategies that are being employed to prevent readmissions.
Interventions utilized include the following:
But its a lot easier said than done. A few recent papers have highlighted the difficulties.
Though there are some predictors of rehospitalizations (certain DRGs, presence of ESRD, long LOS, many prior hospitalizations), some have noted that the data strongly support the need to re-engineer the process for all patients, not just targeted ones. And in this age of limited resources it would be useful to be able to risk stratify patients by their likelihood of readmission. A much smaller fraction of the patients accounts for the bulk of the readmissions. Unfortunately, identifying them is not so easy.
One group (Allaudeen 2010) performed multivariate analysis on both clinical and nonclinical data on over 10,000 consecutive admissions to the medicine services at UCSF and identified a handful of risk factors that appeared to predict readmission. These included nonclinical factors like race and Medicaid as payor plus clinical factors like inpatient use of narcotics or steroids, cancer (with or without metastases), renal failure, congestive heart failure, iron deficiency anemia and weight loss. They note that they were not trying to put together a risk prediction rule and note that several prior attempts by multiple groups to do so have not been successful.
However, that same group (Allaudeen 2011) just published another paper noting the inability of providers to predict unplanned readmissions. They did a study over a 5-week period where they asked providers (physicians, nurses, case managers) to predict which patients were likely to be readmitted within 30 days. They also calculated the P(ra) score for the same patients. The latter is a tool the Probability for Readmission score which is widely used in managed care to predict subsequent utilization of resources. It turns out that none of the groups nor the P(ra) score performed very well in predicting readmissions. Physicians were the closest to the actual readmission rates but all the others significantly overestimated the risk. The other major finding was that the actual readmission rate was over 32%, far higher than one would expect from the literature (perhaps because their followup methodology was more thorough).
So are there any tools that are good at predicting readmission? Many are using the Risk Assessment Tool: the 8Ps from Project BOOST. We previously mentioned the P(ra) and in the UK they utilize the PARR++ and Combined Predictive Model. All are reasonable at predicting future use of healthcare resources but may not be specific for predicting readmission. Other groups (eg. EQHealth Solutions, the Medicare QIO in Louisiana) are working with tools to assess readmission risk but there are no published results yet. And yet others (Amarasingham) have developed condition-specific readmission risk prediction tools. The latter for CHF has been followed by a 40% reduction in Medicare readmissions at Parkland Health & Hospital System (Betbeze 2011). It may also turn out that simpler tools such as the Frailty Index (Fried 2001) or the more extensive frailty index (Rockwood 2005) are good predictors of readmission, though they have not specifically been studied for that. A different form of Elder Risk Assessment (Takahashi 2011) was not able to predict readmissions from SNFs to hospitals.
Another recent paper (Hansen 2011) has some equally disturbing findings about the discharge process. They did a study of over 1000 patients who were readmitted and compared them to about 1000 patients who were otherwise closely matched but not readmitted. Surprisingly, they found no association between readmission and documentation of most of the elements we consider to be key to the discharge process (eg. medication reconciliation, timely transmission of discharge summaries, specific discharge instructions, etc.). Its not clear whether the problems lie with the documentation or whether those components are not as effective as we think.
Another study (Showalter 2011) looked at another in vogue intervention provision of standardized electronic discharge instructions. They found that these failed to reduce readmissions or post-discharge ED visits within 30 days. A recent systematic review of the efficacy of computer-enabled discharge communication interventions (Motamedi 2011) found improvements in timeliness and physician/patient satisfaction and a perceived reduction in adverse events but noted that reporting on more important outcomes like readmission and mortality were inconsistent.
Links to some of our prior columns on readmissions:
February 24, 2009 Discharge Planning: Finally Something That Works!
April 7, 2009 Project RED
April 14, 2009 More on Rehospitalization After Discharge.
Jencks SF, Williams MV, Coleman EA.. Rehospitalizations among Patients in the Medicare Fee-for-Service Program. NEJM 2009; 360: 1418-1428
Jack BW, Chetty VK, Anthony D et al. A Reengineered Hospital Discharge Program to Decrease Rehospitalization: A Randomized Trial. Annals of Internal Medicine 2009; 150(3): 178-187
Allaudeen N, Vidyarthi A, Maselli J, Auerbach A. Redefining readmission risk factors for general medicine patients. J Hosp Med 2010; 6(2): 54-60
Allaudeen N, Schnipper JL, Orav EJ, et al. Inability of Providers to Predict Unplanned Readmissions. J Gen Intern Med 2011; Online First March 11, 2011
Hansen LO, Strater A, Smith L, et al. Hospital discharge documentation and risk of rehospitalisation. BMJ Qual Saf 2011; Published Online First: 22 April 2011
Showalter JW, Rafferty CM, Swallow NA, et al. Effect of Standardized Electronic Discharge Instructions on Post-Discharge Hospital Utilization. J Gen Intern Med 2011; Online First April 16, 2011
Motamedi SM, Posadas-Calleja J, Straus S, et al. The efficacy of computer-enabled discharge communication interventions: a systematic review. BMJ Qual Saf 2011; 20: 403-415
Project BOOST. Tool for Addressing Risk: A Geriatric Evaluation for Transitions.
The Kings Fund. Predicting and Reducing Re-admission to Hospital. Updated 1/04/10
PARR++ and Combined Predictive Model
Medicare QIO for Louisiana (EQHealth Solutions). Discharge Risk Assessment.
Betbeze P. Know Your Readmission Risk Score. HealthLeaders Media, March 16, 2011
Amarasingham R. National Association of Public Hospitals and Health Systems. Parkland Health and Hospital System. Using an Automated Model to Identify Heart Failure Patients at Risk for 30-Day Readmission or Death Using EMR Data.
Fried LP, Tangen CM, Walston J; et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001; 56(3): M146-M156
Rockwood K, Song X, MacKnight C, et al. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 August 30; 173(5): 489495
Takahashi PY, Chandra A, Cha S, Borrud A. The Relationship Between Elder Risk Assessment Index Score and 30-Day Readmission From the Nursing Home. Hospital Practice 2011; 39(1): DOI: 10.3810/hp.2011.02.379 March 21, 2011
van Walraven C, Bennett C, Jennings A, et al. Proportion of hospital readmissions deemed avoidable: a systematic review. CMAJ 2011 183: E391-E402
Goldfield N. How important is it to identify avoidable hospital readmissions with certainty? CMAJ 2011 183: E368-E369
May 17, 2011
Depression - Again!
A year ago we discussed the issue of respiratory depression due to opioids in our Patient Safety Tips of the Week for July 13, 2010 Postoperative Opioid-Induced Respiratory Depression and September 21, 2010 Dilaudid Dangers.
And in our January 4, 2011 Patient Safety Tip of the Week Safer Use of PCA we noted that in 2006, in response to growing concerns about respiratory depression in patients due to opioid-induced respiratory depression, the APSF (Anesthesia Patient Safety Foundation) convened a workshop to address related issues (Weinger 2006). And in 2009 and 2010 the APSF again called for greater scrutiny of PCA (patient-controlled analgesia) in the postoperative period (Weinger 2009, Overdyk 2010). And ECRI Institute in its Top 10 Health Technology Hazards for 2011 included oversedation during use of PCA infusion pumps as Number 7 on its list (see our January 2011 Whats New in the Patient Safety World column ECRIs Top 10 Health Technology Hazards for 2011).
This month two more papers highlight the risks of death due to opioid-induced respiratory depression. A root cause analysis (Diamond 2011) on the sudden unexpected death of a young patient admitted with renal colic is particularly insightful. The patient likely died from respiratory depression related to opioid analgesics. Multiple communication issues occurred (faulty medication reconciliation, failure to buck the authority gradient, etc.) and there were issues concerning the understanding of the dosage of Dilaudid (akin to those raised in our September 21, 2010 Patient Safety Tip of the Week Dilaudid Dangers). The patient was also receiving other drugs that depress respiration. And, most important of all, the monitoring protocol was inadequate. The issues raised in this case are seen at hospitals across the country over and over.
In the second paper (Ramachandran 2011) the authors found 32 patients over a 6-year period who suffered life-threatening critical respiratory events in a population of postoperative patients receiving analgesic therapy at an academic medical center. These were adult patients who required rescue treatment with naloxone or endotracheal intubation or cardiopulmonary resuscitation. Four of the patients died. They found significant associations between the events and the following comorbidities: CHF, postoperative acute renal failure, obstructive sleep apnea, cardiac dysrhythmia, diabetes, CAD and hypertension. Interestingly, obesity and COPD were not more frequent in the group with complications. Over 40% received more than one type of opioid and Dilaudid was the primary opioid in three of the deaths. Deep sedation and nocturnal presentation were also notable in some cases, particularly those who died.
They found some very interesting findings regarding the timing of the events. Three of the four deaths occurred within the first 24 hours postoperatively (2 within 6 hours) and three of the four deaths occurred between midnight and 6 AM. Five of the 32 events occurred in the PACU and the rest occurred on general surgical floors. They note that some of the very early events may also reflect cumulative effects of the opioids plus residual effects of the anesthesia.
They also noted that many of the events occurred at relatively modest opioid dosages and when pain levels were still significant. That suggested that some might have an increased opioid sensitivity. Given the nocturnal occurrences and events at relatively modest opioid dosages, the authors speculated about the potential role of obstructive sleep apnea (OSA) in many patients. Two of the deaths occurred in patients with known OSA. The association with acute renal failure also suggested reduced opioid clearance or global organ dysfunction as contributing factors.
The study did not include details of the monitoring protocols used. Youll recall in our February 22, 2011 Patient Safety Tip of the Week Rethinking Alarms we discussed a provocative article (Lynn 2011) on alarms and their failure to identify deteriorating patients early. The authors describe 3 patterns of unexpected in-hospital deaths and demonstrate the problems with threshold-based alarms (almost all currently used alarm systems use threshold-based principles) in detecting early deterioration. Indeed, they posit that threshold-based alarms themselves often cause us to miss signs of early deterioration.
One of the three patterns of deterioration they noted was the classic CO2 narcosis but they noted many of these cases are complicated by the third pattern, that typically seen in sleep apnea. The important point they made is that there may be a huge difference when the patient is awake and when he/she is asleep. In those with sleep apnea one sees repetitive reductions in airflow and oxygen saturation during sleep followed by arousals. The arousals rescue the patient but eventually the capacity or reserve of the patient to recover with arousals becomes impaired (often in response to narcotics or sedatives) and the patient may experience sudden death during sleep. The authors discuss the inability of currently used oximeters to recognize this pattern. They even imply that this pattern may give rise to oximeters alarming and being interpreted as false alarms attributed to motion artifact, etc. because when staff respond to the alarm the patient is now awake, breathing normally and has a normal oxygen saturation.
Warnings about this latter pattern become even more concerning given the significant percentage of patients being admitted who are at risk for sleep apnea (see our Whats New in the Patient Safety World columns for November 2010 More on Preoperative Screening for Obstructive Sleep Apnea and July 2010 Obstructive Sleep Apnea in the General Inpatient Population).
Lynn et al went on to discuss the flaws in current threshold-based alarm systems and the need for true smart alarms that integrate multiple physiological parameters and respond to patterns of changes in these. This article provides tremendous insight into why the concept of rapid response teams has proven disappointing to date. As we have mentioned in several of our own columns on rapid response teams, the problem is not with the response teams. Rather it is with our poor recognition of early clinical deterioration.
No one knows the actual incidence and prevalence of opioid-induced respiratory depression but it is likely much higher than one thinks. The ECRI paper notes that the true prevalence of respiratory depression in patients on PCA may be as high as 41%.
The ECRI recommendations are for monitoring not just vital signs but also mental status, pulse oximetry and capnography. The summary of a 2006 workshop on postoperative respiratory depression sponsored by APSF (Weinger 2006) noted most participants felt that the same monitoring should be applied to all patients, noting that even low-risk patients occasionally develop respiratory failure while receiving opioids by PCA or neuraxial techniques. They also note that avoiding even one case of patient harm from respiratory depression could justify the cost of monitoring all patients. Thus a policy of zero tolerance for harm due to postoperative opioid-induced respiratory depression should be the goal. They all noted inadequacies of current monitoring systems but recommend at least pulse oximetry and continuous respiratory monitoring on all patients on PCA. They stressed that oxygen should not be used unless there is a specific indication since oxygen therapy may significantly delay recognition of respiratory depression.
The problem of oxygen therapy complicating issues was also raised recently in another paper (Wijesinghe 2011). They looked at the effect of supplemental oxygen on hypercapnia in patients with the obesity-associated hypoventilation syndrome and found a significant and prompt increase in pCO2, similar to what is seen in COPD patients. They note that up to a third of morbidly obese patients may have this syndrome. They do note that the worsening of hypercapnia by oxygen was not universal in this population, speculating that their may be subgroups more vulnerable than others, a point stressed in the informative editorial accompanying that paper (Mokhlesi 2011).
We think it is particularly important in your use of opioids that you screen for those conditions which will increase the likelihood of respiratory depression. You may find helpful two tools we use when doing FMEAs of the PCA pump process: the PCA Pump Audit Tool and the PCA Pump Criteria.
Prior Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression:
Weinger MB. Dangers of Postoperative Opioids. APSF Workshop and White Paper Address Prevention of Postoperative Respiratory Complications. APSF Newsletter 2006; 21: 61-67 Winter 2006-2007
Weinger MB, Stoelting RK. Special Editorial. Dangers of Postoperative OpioidsIs There A Cure? APSF Newsletter 2009; 24(2): 25-26 Summer 2009
Overdyk FJ. Postoperative Opioids Need System-Wide Overhaul (Letter to the Editor). APSF Newsletter 2010; 24(4): 61, Winter 2009-2010
ECRI. ECRI Institutes 2011 Top 10 Health Technology Hazards. Health Devices 2010; 39(11): 386-398
Diamond R. When pain management proves fatal. In-house errors lead to a patient's overdose. Today's Hospitalist May 2011
Ramachandran SK, Haider N, Saran KA, et al. Life-threatening critical respiratory events: a retrospective study of postoperative patients found unresponsive during analgesic therapy. J Clin Anesth 2011; 23(3): 207-213
Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11February2011)
Wijesinghe M, Williams M, Perrin K, Weatherall M, Beasley R. The Effect of Supplemental Oxygen on Hypercapnia in Subjects With Obesity-Associated Hypoventilation: A Randomized, Crossover, Clinical Study. Chest May 2011; 139(5) 1018-1024
Mokhlesi B, Tulaimat A, Parthasarathy S. Oxygen for Obesity Hypoventilation Syndrome: A Double-edged Sword? Chest May 2011; 139(5): 975-977
May 24, 2011
Hand Hygiene Resources
Its been a while since we did our last column on hand hygiene (see our January 5, 2010 Patient Safety Tip of the Week Hows Your Hand Hygiene?). The New England Journal of Medicine recently put out a hand hygiene video. Its actually quite good, being thorough, accurate, and professionally done. But remember our mantra Stories Not Statistics. There are certain types of presentation that are much more memorable than others. We came across two other videos on hand hygiene that are more likely to have a lasting impact on your staff (and patients).
One that sends a very powerful message was just put out by the US Department of Health and Human services. Healthcare-Associated Infections are Serious is a video that is part of the HHS Partnering to Heal toolkit. This is a particularly good video to play for your staff because it shows a staged root cause analysis on a young patient who dies from a hospital-acquired infection after admission for a usually benign condition. It tells a compelling story that every healthcare worker can empathize with and realize it could happen in their facilities.
But our favorite video on HAIs and hand washing is the one done by the Penn State Hershey Medical Center Infection Control Team. This also sends a powerful message that is likely to be remembered. Its semi-animated format also introduces a bit of levity that makes this one an ideal video to be shown to patients and families as well. We have found that the majority of patients remain very reluctant to challenge their physicians or other staff on hand washing. But if you give them an opportunity to do so in a less contentious manner they are more likely to ask staff about hand hygiene. If they can laugh a bit and say Doctor, that funny video said you are supposed to wash your hands first! they are more likely to speak up and really get the physician to wash his/her hands. So we recommend you consider integrating this video into your patient education program on admission (you can run it on an iPad or similar device) or, if you integrate messaging with your TV system, run it periodically on the TV.
In our January 5, 2010 Patient Safety Tip of the Week Hows Your Hand Hygiene? you may remember we put on the table the concept of the Wanted poster. That might be an old-West style poster of their attending physician dressed in cowboy attire with the caption BEWARE!...Armed and DangerousIf you see this doctor, make sure he washes his hands!. Then the patient could simply point to the poster and hopefully he and his physician will chuckle as the physician washes his/her hands. We havent yet found any takers on this idea. So if you try it, let us know how it worked!
In that prior column we also mentioned the ongoing Joint Commission Center for Transforming Healthcare Hand Hygiene Project. They have since published the best practices emerging from that project. That project also served as the basis for their free web-based tool, the Targeted Solutions Tool, for hand hygiene projects in which many of you are participating.
The 8 hospitals participating in the original project used a Six Sigma methodology to address improving compliance with hand hygiene. Their list of root causes for failure to clean hands included the following:
For each of the causes listed above the organizations developed potential solutions, piloted them, and measured impact. Sometimes the solutions were simple, like standardizing where the dispensers were located and making sure they were always filled. Most located them near the doorways to the patient rooms but others included putting them in high-traffic hallways or near high-touch objects. We liked the suggestion of painting the background so they stood out against the background.
But looking at workflows and re-engineering them was very important. One hospital calculated that nurses would have to wash their hands over 200 times a shift. So redesign of workflow to minimize the number of times a nurse would have to go in and out of a patients room was critical. Ensuring needed supplies were in the room reduced the amount of movements. (Note that such workflow redesign may have the added benefit of reducing interruptions.) One hospital double teamed the respiratory therapists drawing blood gases. Another reengineered the way food service workers delivered and picked up trays.
Gloves remain a big issue. The perception that you dont have to wash your hands if you are wearing gloves remains pervasive.
While most started with secret shoppers to monitor compliance with hand hygiene and some used soap/sanitizer gel utilization rates as a proxy for hand washing, half used new technologies such as infrared badges to monitor hand washing by staff. You may have seen some of those technologies highlighted recently in the New York Times (Rosenberg 2011). Displaying compliance charts and providing feedback was critical. Many hospitals also provided immediate coaching when they saw problems with hand compliance (the coaching was delivered by someone other than the secret shopper).
But there is another constituency frequently ignored visitors. A healthcare worker recently told us about her own experience as a patient. She said her physicians and nurses were pretty good about washing their handsbut her friends and relatives came and went without any understanding about hand hygiene. A couple hospitals in the project did engage families in their initiatives. They did it primarily to have families also be vigilant about staff washing their hands but they noticed that the families also mimicked that behavior.
But perhaps most important of all is that basic premise we keep returning to a culture of safety. Culture trumps policy every time. Bob Wachter points out in many of his talks that we will suspend doctors from our medical staffs for delinquent medical records but yet we let them get away with not washing their hands all the time. Compliance with hand hygiene has to be something that everyone buys into starting with your clinical and administrative leaders and makes a priority in your organization.
Overall, the 8 hospitals in the Hand Hygiene Project improved their hand hygiene compliance rates to over 80% and most improved their rate of healthcare-associated infections (though the report did not detail the latter).
Note: There also are a variety of good video resources on hand hygiene available at the APIC website, some very serious and others a bit lighter and humorous.
Longtin Y, Sax H, Allegranzi B. et al. Hand Hygiene. N Engl J Med 2011; 364 :e24 March 31, 2011
US Department of Health and Human Services. Healthcare-Associated Infections are Serious video
Penn State Hershey Medical Center Infection Control Team/McGuckinMethodsIntl.
Healthcare Worker Hand Hygiene Educational Training Video.
Joint Commission Center for Transforming Healthcare, American Hospital Association, Health Research and Educationsl Trust. Hand Hygiene Project: Best Practices from Hospitals Participating in the Joint Commission Center for Transforming Healthcare Project. November 2010
Joint Commission Center for Transforming Healthcare. Targeted Solutions Tool.
Rosenberg T. Better Hand-Washing Through Technology. The New York Times. April 25, 2011
APIC. Videos and other resources on hand hygiene.
Print Hand Hygiene Resources
May 31, 2011
Book Review: Human Factors
and Team Psychology in a
High Stakes Environment
Per our tradition, we have usually reviewed a patient safety book over the holiday. We had hoped to review Sidney Dekkers new book but Amazon had not yet released it. So youll have to wait for the July 4 holiday for that review. Instead we read Human Factors and Team Psychology in a High Stakes Environment (St. Pierre et al 2008). We werent disappointed. This is a good book to read regardless of how far along you are into human factors and patient safety. Quite frankly, for those of you who are new to the concepts of human factors engineering in healthcare this is actually a great book to start with! It covers the key human factors concepts and does so in a readable and understandable fashion (those of you who have struggled through some of the original human factors literature will appreciate the simplicity of language in this book!).
Each chapter begins with a brief clinical vignette that serves as a trigger for several discussion points in that chapter. You know we like that technique because everything is much easier to remember when it can be tied to a story of some sort.
The first chapter begins with a discussion about how we use mental models to help us plan and implement actions. But it also notes many of the things we do that can lead to errors. For example, we frequently adjust our preferred mental model instead of challenging our current point of view (i.e. we often look for confirming information and ignore disconfirming information). And we have a tendency to defend our feeling of competence. They also have a brief discussion here about the value of teams (eg. increasing cognitive resources, having more to shoulder the load, etc.) but also note that teams can, for a variety of reasons, sometimes degrade the performance of individual team members. (They delve into teamwork in detail in later chapters). They note that technical proficiency is not enough and that non-technical skills, such as interpersonal skills (communication, leadership, teamwork) and cognitive skills (situational awareness, planning, decision making, task management, etc.) are equally important.
The second chapter stresses the dynamics of critical situations and the need to keep your mental model up-to-date and stress flexibility as being key to dealing with such. They note we often miss subtle situational clues but can also be overwhelmed by too much information. Here they do also get into the cognitive psychology concepts of skills, rules, and knowledge. The third chapter discusses examples of errors related to execution failure and planning failure and the concepts of slips, lapses, mistakes, bad rules, misinterpretation of good rules, and nonapplication of good rules. They also discuss violations vs. errors and how latent errors combine with active errors to produce critical sitiuations. They also begin to talk about teamwork errors.
The fourth chapter begins with a physician responding to an incident in which both a police officer and a perpetrator are shot. The physician tends first to the officer, who has the less severe injuries, leaving the more seriously injured patient unattended for a long time period. That leads to a discussion of how emotions and feelings and attitudes may drive some of our actions. Chapter 5 focuses on how our perception affects our mental models and discusses how we need to take second looks and consider how our emotions may be affecting our perception. Chapter 6 discusses many cognitive psychology concepts like schemata and scripts and how our brain tends to use the most cognitively economic resources, which may not be the most appropriate in many situations. Concepts such as blindness to the obvious, fixation errors, ambiguity aversion, and other biases are discussed. This chapter has some useful tips on wiping the slate clean, critically evaluating your first hypothesis and generating alternative hypotheses.
Chapter 7 is an excellent discussion on goals, which serve as beacons for actions. They note that goals should be positive (not negative or ambiguous), specific, structured and prioritized but also flexible. They should be checked for conflicts and contradictions. Importantly, they stress we need to be aware of non-factual goals. The latter are goals such as control, status, power, demonstration of competence, etc. that often unconsciously interfere with the tasks at hand. It also has a good discussion of planning.
Chapter 8 gets into the concepts of attention, vigilance, concentration, and situational awareness and discusses how fatigue impairs multiple functions. Chapter 9 is all about how stress (both acute and chronic) can impair judgement, lead to cognitive tunnel vision and other maladaptive behaviors. It also develops the concept of team stress.
Chapter 10 discusses the steps taken in good strategies and the potential use of decision aids (such as the DECIDE aid used in firefighting or the FOR-DEC used in aviation). They highlight the importance of reviewing effects of a strategy to detect errors early and asking for feedback from all team members to assess both effectiveness and potential for errors.
Chapter 11 begins to focus on the role of teams in detail. It talks about the positive attributes of good team players (eg. good listeners, be self-critical, solve conflicts constructively, etc.) and has a good discussion on how teamwork grows. They stress how good team members cross monitor each other, both for errors and to ensure that workload is not unbalanced. It notes the importance of team training, feedback, and open communication but also goes into why some teams fail. It notes some character traits of bad team members and why communication sometimes fails. It gets into shared misconceptions and the problems sometimes encountered with group think, majority vote, and the illusion of unanimity. This chapter has some excellent practical tips for teams (rehearsing skills daily, clarifying roles, stating opinions clearly, speaking rather than implying, cross monitoring teammates, etc.
Chapter 12 is all about communication. It is very good about aspects of communication aside from words. It has an excellent discussion about how tone, pitch and pacing of speech can significantly impact communication and how nonverbal communication (gestures, posture, facial expression, eye contact, etc.) are critical parts of communication. They provide some great examples of how the same message can be helpful or detrimental, depending on how that message is delivered. It highlights features of good and bad listening and how some interpersonal conflicts may lead to behaviors that impair good communication..
The remaining chapters discuss leadership, organizational issues, and many patient safety and quality improvement concepts.
Overall, this is a good book for you to get an understanding of many of the basic elements of human factors and it has excellent discussions about teams, communication, and leadership. This is a very worthwhile read!
Note: There is a new hardcover version of this work that is to be released soon (due out on July 29, 2011). You may wish to wait for its release, though if you like reading the e-reader version (Kindle in this case) you can read the original version now.
St. Pierre M, Hofinger G, Buerschaper C. Human Factors and Team Psychology in a High Stakes Environment. 2008 Springer Verlag, Berlin Heidelberg (Kindle edition)
June 6, 2011
Timeouts Outside the OR
Wrong-site surgery was in the news again last month following an incident in Oregon in which the wrong eye of a patient was operated on (Rojas-Burke 2011). In that case the incident occurred despite the performance of the surgical timeout and marking of the correct eye. Apparently the surgeon was at the head of the table and lost orientation and the surgical mark was covered up.
But the OR is not the only place that wrong site events occur. Weve long known that wrong-site procedures outside the OR are frequent (in our Patient Safety Tip of the Week November 25, 2008 Wrong-Site Neurosurgery we noted that chest tubes inserted on the wrong side was the most frequent wrong-site occurrence in New York State in the past). In our December 6, 2010 Patient Safety Tip of the Week More Tips to Prevent Wrong-Site Surgery we noted a study (Stahel 2010) highlighting the continued occurrence of wrong-patient and wrong-site occurrences that had some interesting revelations. The Stahel paper notes how often events such as mislabeling pathology specimens, mixups in medical records or imaging studies or lab reports contributed to the adverse events even inside the OR. That study highlights the importance of the time-out in multiple venues of patient care where correct identification of patients and clinical information is critical.
Another new study (Kelly 2011) surveyed emergency departments to determine use of timeout protocols. They found that 13% of the emergency physicians responding were unaware of the existence of formal timeout policies in their emergency departments and only 35% felt they were warranted. Those that did feel timeouts were necessary identified certain procedures (eg. chest tube insertion, lumbar puncture, paracentesis, or procedures using sedation) that should utilize timeouts.
The authors point out that the ED environment might be especially at risk for wrong-patient, wrong-site procedures because of multiple factors (time pressures, multiple providers, multiple handoffs, etc.). But they also note some of the reasons that ED physicians may feel they dont need timeouts. They note the fact that most ED patients are alert and have injuries that are physically evident (eg lacerations) as major reasons some providers do not feel their patients are at risk. They also note that, compared to procedures done in the OR where several weeks may go by between scheduling and the actual procedure, those done in the ER are usually done promptly, theoretically reducing the time interval for confusion to occur. And the same physician who evaluates the patient is likely to perform the procedure. Some also felt that the presence of family members might help reduce the likelihood of such incidents. Though that reasoning may be prevalent in EDs, it obviously does not make the ED a safe environment from the perspective of wrong-patient, wrong-site procedures. You still have many of the same factors that contribute to wrong-site surgery in the OR. For example, imaging studies may have mislabeled laterality or the provider may simply put up the image backwards (or have the image on the wrong patient). And not all ED patients are alert and cooperative enough or mentally competent enough to assist with correct identification of sites for procedures. And not all injuries have external markers of injury (eg. not all fractures may be externally apparent). Similarly, even family members may provide erroneous information regarding laterality. And there may have been a change of shift where a new team may now be performing the procedure on the patient. And to that list wed add the ever present risk of interruptions and distractions in the ED (see our March 8, 2011 Patient Safety Tip of the Week Yes, Physicians Get Interrupted Too!). So clearly there are lots of reasons for providers in the ED setting to be using timeouts before performing procedures.
Speaking of imaging procedures, the Pennsylvania Patient Safety Authority (PPSA) has an article on Universal Protocol in radiology services in their most recent issue of the Pennsylvania Patient Safety Advisory. They note the many errors that may take place on the ordering and scheduling side. These include things like transcription errors (where the physician is not directly entering the order into a computer him/herself), choosing the wrong patient or wrong study from a dropdown list, or ordering the wrong study. They note that mammograms often get confused (screening vs. diagnostic). And failure to note a disparity between reason for the study and the study ordered is common.
But failure to identify the patient correctly is also common. One common mistake is using passively obtained information during patient identification. For example, if you ask Are you Mr. Brown?, you might get a yes or no response when the patient did not understand or correctly hear the question. Therefore, you always need to ask the patient to state his/her name and then use a second indentifier as well. That second identifier should never be a location or room number. For example, a patient may have been moved from one room to another in a busy ER to accommodate another patient with higher severity of illness. And inpatients commonly are transferred from room to room. Even many offices have multiple rooms and a patient might get moved from an exam room to a procedure room.
And if you want to see some scary examples of other ways in which patient identification errors may occur, see ISMPs March 10, 2011 article Oops, Sorry, Wrong Patient!.
For invasive radiological procedures, use of timeouts and the Universal Protocol are clearly indicated. In our June 2010 Whats New in the Patient Safety World column WHO Checklist for Radiological Interventions we noted that WHO has come out with a modification of its Surgical Safety Checklist just for radiological procedures. The WHO Surgical Safety Checklist for Radiological Interventions ONLY, like its predecessor, has three parts: a sign in, a timeout, and a sign out phase.
The PPSA also has a great toolkit available to help organizations minimize the risk of wrong-patient or wrong-site procedures in radiology.
The PPSA radiology article also has some good recommendations that can be applied to any site where the potential for wrong patient, wrong-site events could happen. They note that in addition to having policies and procedures and training in place, you need to enforce compliance with those. So you need to audit and solicit feedback. You need to empower all your staff to challenge when there is any doubt about the patient, the procedure, the site, etc.and all staff need to communicate well and include hearback or readback under appropriate circumstances. The PPSA toolkit mentioned above also includes a Did You ID Me poster and button that are great tools to get your patients involved in the identification safety process.
And, obviously, share stories about events or near-misses that may have occurred in similar settings. Especially in outpatient settings where wrong-patient, wrong-site incidents are less common, staff may need to hear about such an event that could take place in their setting before they change their culture to beware that it could happen here, too.
Recently, researchers and quality improvement personnel at Northwestern University (Barsuk 2011) reported on a project to re-engineer their processes for compliance with Universal Protocol for bedside procedures. They looked at lumbar punctures, thoracenteses and paracenteses done on the medicine services at their facilities. Analyzing their processes, they found that staff were often unaware of Universal Protocol (or perhaps unaware that it was required not just for OR procedures, but for bedside procedures as well) and that nurses were frequently never notified by physicians when their patients were undergoing such procedures. In their redesigned process the physician initiates the process by entering an order via CPOE with an anticipated time. This order would automatically populate the nurses alert list and provide the nurse with a timeout form and notice of a procedure-specific supply kit to procure. Only the nurse has a key to those procedure kits. This is a forcing function that forces the physician-nurse communication to take place. The nurse brings the timeout checklist and the kit to the bedside at the specified time and the nurse and physician go through the timeout procedure, which gets documented in the EMR. Compliance with Universal Protocol went from 16% before to 94% after implementation of this redesigned process. Elegant!
In our December 6, 2010 Patient Safety Tip of the Week More Tips to Prevent Wrong-Site Surgery we stressed that the verification procedure should be an active one rather than a passive one and all potentially distracting noncritical activities be suspended during the timeout and verification procedure. It is critical that all questions during the timeout verification procedure be phrased in a manner that requires and active answer. Never should you assume that no answer means concurrence. And all involved should be verifying that they are verifying information from relevant documents, not just second-hand information. Any site marking needs to be clearly visible in the prepped, draped field during the timeout. And all this must take place in an environment where all staff are encouraged to speak up and voice any concerns. If there are any concerns, the person performing the procedure must resolve those concerns based on primary sources of information to the satisfaction of all team members.
What about your office(s)? Ask yourself the following questions:
Dont make the mistake of thinking thatll never happen to us. Any setting in which procedures occur is at risk for wrong-patient, wrong-site events. Be proactive. Look at all your sites, assess your potential vulnerabilities, and institute the protections you need to keep your patients safe!
Some of our prior columns related to wrong-site surgery:
Patient Safety Tip of the Week columns:
September 23, 2008 Checklists and Wrong Site Surgery
June 5, 2007 Patient Safety in Ambulatoy Surgery
March 11, 2008 Lessons from Ophthalmology
September 14, 2010 Wrong-Site Craniotomy: Lessons Learned
November 25, 2008 Wrong-Site Neurosurgery
January 19, 2010 Timeouts and Safe Surgery
June 8, 2010 Surgical Safety Checklist for Cataract Surgery
December 6, 2010 More Tips to Prevent Wrong-Site Surgery
Whats New in the Patient Safety World columns:
Rojas-Burke J. Wrong body part, wrong patient surgeries continue despite new procedures.OregonLive.com May 25, 2011
Stahel PF, Sabel AL, Victoroff MS, et al. Wrong-Site and Wrong-Patient Procedures in the Universal Protocol Era. Analysis of a Prospective Database of Physician Self-reported Occurrences. Arch Surg.2010; 145(10): 978-984
Kelly JJ, Farley H, O'Cain C, et al. A Survey of the Use of Time-Out Protocols in Emergency Medicine. The Joint Commission Journal on Quality and Patient Safety 2011; 37(6): 285-288
Pennsylvania Patient Safety Authority. Applying the Universal Protocol to Improve Patient Safety in Radiology Services. Pennsylvania Patient Safety Advisory 2011; 8(2): 63-69
Did You ID Me
Institute for Safe Medication Practices (ISMP). Oops, sorry, wrong patient! A patient verification process is needed everywhere, not just at the bedside. ISMP Medication Safety Alert.. Acute Care Edition. March 10, 2011
NPSA (UK). WHO Surgical Safety Checklist: for radiological interventions only. April 2010
Barsuk JH Brake H, Caprio T, et al. Process Changes to Increase Compliance With the Universal Protocol for Bedside Procedures. Arch Intern Med. 2011; 171(10): 947-949
Print Timeouts Outside the OR
June 14, 2011
Failure to Follow Up
Weve written numerous columns about important test results slipping through the cracks. Maybe some day, when Accountable Care Organizations (ACOs) and truly integrated health systems exist and interoperability across a wide variety of electronic medical record platforms is functional, tracking and following up on test results may be easier. But in the meantime most systems have areas of significant vulnerability where patients may have tests done and no one follows up on them. Tests pending after hospitalization are one such area (see our Patient Safety Tip of the Week March 1, 2011 Tests Pending at Discharge). Often studies done during an inpatient hospitalization may not have results reported at the time a patient is discharged and the fact that those results are pending may never be properly communicated to the physician who will be following the patient after discharge.
But the emergency department is an even greater area of vulnerability to this problem. Think about it. Emergency physicians (and nurse practitioners and physicians assistants) work shifts in the ED. They may hand off patients to incoming physicians and not be involved in the discharge of that patient. Additionally, some tests are not run immediately (they may only be run certain days of the week or even be sent out to other labs) so results are not available prior to discharging the patient. Also the ED physician often sees only a wet read on radiology or imaging studies and the official report (which may differ or contain additional findings not contained in the wet read) may come back the next day. And sometimes that emergency physician may never again work a shift at that particular ED. So there is plenty of opportunity for such studies to fall through the cracks and potentially endanger patients.
A new article by a physician/attorney (Moore 2011) puts the issue in perspective and discusses many of the legal and liability issues involved. Moore notes that the failure of duty to follow up is often the reason for large liability rewards. He provides actual case examples to demonstrate why it is imperative the ED physician (or group) ensure that the patient or the physician who will be following the patient, or preferably both, are notified of any abnormal test results and the need to follow up.
In one case, the ED physician initialed a radiology report showing a lung mass and ordered it faxed to the PCPs office. However, the PCP never received the report and eventually the emergency physician group (but not the ED physician herself) was held liable when a delayed diagnosis of cancer led to a malpractice suit. In another, a PSA test was ordered in the ED and the abnormal results never followed up. That led to the emergency physician being held liable when the patient found out he had prostate cancer at a later date.
The author goes on to discuss the legal concepts of contributory negligence and comparative fault, which may vary from state to state. The bottom line is that (at least in most states) even when a patient is partially at fault for failure to follow up, a physician may be held at least partially liable if all appropriate steps were not taken to foster appropriate follow-up.
Moores recommendations are important. First, hospitals (and emergency and radiology departments and laboratories) need to have protocols in place for communicating abnormal test results or report discrepancies for patients seen in the ED, and ensure that those protocols are adhered to.
He discusses the critical importance of verbally conveying to the patient the findings and why follow-up is important, including the potential consequences if he/she does not follow up. Documentation of that discussion in the medical record is critical. And, if the patient has not yet left the ED, this should be included in the discharge instructions. Moore also stresses that in some areas where access to follow-up medical care may be limited the ED physician may need to specify whom to contact if he/she is unsuccessful at getting that follow-up.
In addition, every attempt should be made to ensure that there is appropriate notification of the physician who will ultimately follow up on the abnormal test result. And you need to close the loop and ensure that such physicians have, indeed, been made aware of the result and their need to follow up with the patient. Simply faxing the report to the physician without ensuring they actually saw the report is not enough. So if you call or otherwise contact that physician, document it in the chart.
When the patient has already left the ED, every attempt should be made to contact the patient (by phone, written or electronic means maintaining HIPAA privacy of course) and that contact should also be documented in the medical record. Sometimes certified mail must be used. He also notes that you cant give up if the patient is not at the address or phone number given to the ED. In such cases, you need to at least check the phone book or other resources to try to locate the patient.
And one very good recommendation: avoid ordering unnecessary tests! And, if you do order them, make sure you document who is going to follow up on that result (the examples given are ordering a cholesterol or PSA for convenience of the patient).
But the ED and emergency physicians are not the only ones with potential liability. The radiologists and radiology departments also have duties to ensure that appropriate notification of patients and recommendations for follow-up have taken place. Weve previously discussed some of the systems radiology departments have put into place (see articles listed at the end of todays column).
Our March 9, 2010 Patient Safety Tip of the Week Communication of Urgent or Unexpected Radiology Findings noted a Pennsylvania Patient Safety Advisory on communication of radiograph discrepancies between radiology and emergency departments. The Pennsylvania Patient Safety Authority had received over 3000 reports of ER radiology discrepancies over a 4 year period and has some good risk reduction strategies. They recommend a system be in place to review discrepancies between the ER physician interpretation and the radiologist interpretation for all shifts. The system can be either paper-based or use notations on the PACS system. But the key thing is that it is a two-way system. The radiologist needs to see how the ER physician interpreted the study and vice versa. Discrepancies must be communicated to the ER in a timely fashion. The method of communication is most often verbal between practitioners and such communication should be documented in the patients medical record. And then a system must be in place for timely communication of the discrepancies and findings to the referring physician or physician who will be assuming care of the patient or the patient himself. There has been an increasing trend for radiologists to communicate directly with patients regarding the findings.
A new study (Anthony 2011) describes the policy and protocol for action on critical results put in place at the Brigham and Womens Hospital in Boston and how compliance with the follow-up improved from 28% to over 90% with their quality improvement program. They used the Joint Commission requirement for reporting critical test results and recommendations from the American College of Radiology, the Massachusetts Hospital Association, and Massachusetts Coalition for the Prevention of Medical Errors to develop and implement their policy.
First they had to define what critical results were. They then stratified them into priority categories corresponding to the urgency with which notification was needed. Red alerts (eg. for ischemic bowel or intracerebral hemorrhage) required notification within 60 minutes. Orange alerts were for conditions which could lead to significant morbidity if not addressed within 2-3 days (eg. impending fracture or intraabdominal abscess). Yellow alerts were for conditions not immediately life-threatening but could lead to significant morbidity if not addressed (eg. solitary pulmonary nodule or renal mass). Notification for these was required within 3 days.
They then set up an escalation process for assuring timely communication of test results. This included the referring/ordering physician, covering physician, housestaff, other member of the care team, attending physician, chief of service, department chair and chief medical officer in that order. For outpatients cared for by patients outside the medical center, if the patients physician could not be contacted, the patient should be contacted for red or orange alerts and told to go to the medical centers emergency department (or nearest ED) or to follow up with their physician for yellow alerts. Red and orange alerts required face-to-face or telephone contact. Yellow alerts could be via face-to-face or telephone contact or other verifiable method of communication. And the policy required documentation of the communication in the medical record.
About 10% of their studies had results falling into one of the 3 alert categories, though the percentage varied substantially by type of study and origin of the patient. For instance about 25% of studies done on emergency patients or patients referred for nuclear medicine tests required communication of abnormal results, whereas less than 5% of those having musculoskeletal imaging needed such alerts.
The authors point out that there is no current national standard of what results are considered critical or alertable. They note that almost 10% of their tests resulted in findings in one of the 3 alertable categories so that the communication process could be time-consuming and interruptive for both radiologists and recipients of the alerts. Thus potentially automating the process may be a desired future enhancement.
So you need to set up a system in your organization for identification of pending tests and one for notification when results are abnormal. In the ED, identification of pending tests could be as simple as using paper-based checklists to determine whether ordered tests have been resulted or not. Or you can develop more complicated rules-based algorithms to identify those tests with pending results in your electronic medical records. If your ED physicians do not return for several days (or never return) you need to have another person designated to identify test results as they come back and close the loop with both the patients and the physicians who will be rendering subsequent care. Then follow the advice given in the above articles to make the appropriate contacts and document your efforts in the medical records.
Note also one of the problems we have noted in several hospital systems is that the database of referring physician addresses and phone numbers is often not up-to-date. So faxing a report to the fax number you have on hand is not adequate. You need some way to ensure that the physician received the full report and will take action on it.
See also our other columns on communicating significant results:
Moore GP. Liability of Emergency Physicians for Studies Ordered in the Emergency Department: Court Cases and Legal Defenses. J Emerg Med 2011; 40(2): 225-228
Anthony SG, Prevedello LM, Damiano MM, et al. Impact of a 4-year Quality Improvement Initiative to Improve Communication of Critical Imaging Test Results. Radiology 2011; 259(3): 802-807
PPSA Communication of Radiograph Discrepancies between Radiology and Emergency Departments
Pa Patient Saf Advis 2010; 7(1): 18-22
Print Failure to Follow Up
June 21, 2011
STOPP Using Beers' List?
Okay, we admit it. We may have been backing a loser! For years we have been advocates of use of Beers List of potentially inappropriate medications in the elderly (see our Whats New in the Patient Safety World column for September 2010 Beers List and CPOE). But at least we have always mentioned that the Beers List concept is not truly evidence-based. The list was originally conceived by an expert consensus panel and there are no randomized controlled trials regarding the safety in the elderly for each of the drugs on the list or predictive utility of the list as a whole. But because there is ample evidence in the literature that each of those drugs may be associated with untoward effects in the elderly, we remained strong advocates of using clinical decision support tools to alert healthcare providers of such potentially inappropriate drugs in the elderly.
In reality, the literature has been mixed on the ability of Beers List to predict adverse drug events (ADEs). But now Irish researchers (Hamilton 2011) have developed a new list and compared its usefulness to Beers List. First they developed and validated the STOPP (Screening Tool of Older Persons potentially inappropriate Prescriptions) tool (Gallagher 2008). Then they looked at 600 consecutive adults age 65 and older who were admitted to a university medical center. They found 329 ADEs in these 600 patients, two-thirds of which were considered causal or contributory to admission to the hospital. And of those ADEs, 69% were considered to be avoidable or potentially avoidable. There was a significant association between these ADEs and prescription of potentially avoidable medications on the STOPP list but no significant association with medications from Beers List.
Take-home points from the study are that the STOPP criteria identified potentially avoidable ADEs impacting on hospitalization over twice as often as did Beers criteria and that such ADEs are extremely common. Future studies are needed to determine whether use of the STOPP criteria (and its related tool, the START criteria) may prove useful in actually reducing ADEs in the elderly and potentially lead to reductions in medication costs and healthcare utilization costs. But this is a great start!
The editorial accompanying the Hamilton paper (Schnipper 2011) talks about using tools like STOPP to improve design and implementation of clinical decision support tools to minimize alert fatigue that we see so commonly with CPOE systems. In our Whats New in the Patient Safety World column for September 2010 Beers List and CPOE we noted a study (Mattison 2010) in which researchers carefully chose a subset of potentially inappropriate drug (PIMs) from Beers list drugs to which to attach computerized warnings. They were able to demostrate approximately a 20% reduction in prescribing of flagged drugs. That decrease was noted immediately after implementation and was sustained over time. As a control they noted no reduction in those other Beers list drugs that were not flagged. The study is important in that it confirms that alerts during CPOE can reduce prescription of potentially inappropriate drugs in the elderly. But it also contains other very useful lessons:
There is considerable overlap of drugs on Beers List and the STOPP tool. A nice PowerPoint presentation on the STOPP and START tools is available at this site: OMahony 2010. The STOPP tool tends to focus more on the common avoidable instances of inappropriate prescribing. It puts more emphasis on drug-drug interactions and duplicate drug class prescribing. It adds some drugs not included on Beers List and omits other drugs that are included on Beers List.
The above, of course, does not mean that Beers List is useless. We owe a great deal to the clinicians who developed and revised Beers List over the years because it has raised awareness of inappropriate prescribing in the elderly. What the study done by Hamilton et al. does is demonstrate that what sound like good ideas really do need to be validated in more scientifically rigorous fashions for whatever intent they are designed for. We really look at their work as a refinement of the Beers List concept.
A second study in that same issue of the Archives of Internal Medicine looked at inappropriate medications in elderly ICU survivors (Morandi 2011). That study did use Beers criteria for potentially avoidable medications (PIMs) and actually inappropriate medications (AIMs) and looked prospectively at 600 patients aged 60 and older who were discharged from the hospital after a stay in an ICU for either respiratory failure or shock. Though a significant number of patients were already on a PIM or AIM prior to admission, the numbers in both categories increased at the time of discharge. And of the 103 patients on at least one PIM at discharge, 59% also had at least one AIM and 59% of the AIMs at discharge had been started while the patient was in the ICU. This study really highlights the importance of medication reconciliation not only at admission and discharge but also at all transitions of care, particularly transfers to and from ICUs. Many medications may be temporarily needed in critically-ill patients in an ICU but are no longer indicated after transfer out of the ICU. We actually previously discussed the work of this group and others in our March 2011 Whats New in the Patient Safety World column Inappropriate Medications Often Start in the ICU.
Lastly, the STOPP tool and Beers list are not the only things to keep in mind in managing your older patients. There are many valuable lessons and recommendations in a recent article Principles of Conservative Prescribing (Schiff 2011) that we can all apply to all our patients.
Some of our past columns on Beers List and Inappropriate Prescribing in the Elderly:
Patient Safety Tips of the Week:
Whats New in the Patient Safety World columns:
Hamilton H, Gallagher P, Ryan C, et al. Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients. Arch Intern Med2011; 171(11): 1013-1019
Gallagher P, Ryan C, Byrne S, Kennedy J, OMahony D. STOPP (Screening Tool of Older Persons Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation. Int J Clin Pharmacol Ther 2008; 46(2): 72-83
Schnipper JL. Medication Safety: Are We There Yet?: Comment on "Potentially Inappropriate Medications...
Arch Intern Med 2011; 171(11): 1019-1020
Mattison MLP, Afonso KA, Ngo LH, Mukamal KJ. Preventing Potentially Inappropriate Medication Use in Hospitalized Older Patients With a Computerized Provider Order Entry Warning System. Arch Intern Med. 2010; 170(15): 1331-1336
OMahony D. Inappropriate Prescribing in Older People (Powerpoint presentation). BGS Autumn 2010
Morandi A, Vasilevskis EE, Pandharipande PP, et al. Inappropriate Medications in Elderly ICU Survivors: Where to Intervene? Arch Intern Med 2011; 171: 1032-1034
Schiff GD, Galanter WL, Duhig J, et al. Principles of Conservative Prescribing. Arch Intern Med.Published online June 13, 2011
Print STOPP Using Beers List?
June 28, 2011
Long-Acting and Extended-
Release Opioid Dangers
Your probably tired of our frequent columns on the dangers of IV opiates (see our May 17, 2011 Patient Safety Tip of the Week Opioid-Induced Respiratory Depression Again! which has links to all the other columns as well). But the opiate category (which should rank near the top on your high alert medication list) should also include opiates that are delivered in ways other than by the IV route. And, in fact, the newer opiate formulations are either more potent or designed to produce a longer peak action, two characteristics that lead to some of the greatest dangers that have been popping up. We are referring to the long-acting and extended-release forms of opiates. These have been designed to be used in patients who are opioid-tolerant and have pain of a chronic nature that has not been controlled with more conventional opiates. They were not intended to be used for treatment of acute pain nor to be used as first line agents in patients with pain. But in practice they are often being (mis)used in that way.
The rate of prescription opioidrelated overdose deaths increased substantially in the United States over the past decade (Bohnert 2011) and the higher death rate correlates with higher opioid doses. The problem has become so severe that the FDA has recently announced a risk evaluation and mitigation strategies (REMS) campaign to reduce risks associated with prescribing these agents.
ISMPs Michael Cohen has warned of the dangers and the risks taken by providers who prescribe transdermal fentanyl patches for acute pain (Cohen 2010). Though reports of deaths related to transdermal fentanyl patches have been accumulating for years, he became very concerned when 3 deaths in young adults related to these patches were reported in 2010, each in relation to acute pain (eg. dental pain, post-tonsillectomy pain, etc.). ISMP has had a series of alerts in the newsletters regarding the dangers (ISMP 2007). Though they noted the importance of educating physicians, nurses and pharmacists about the dangers, they stressed that additional measures are necessary to prevent such disastrous outcomes (see below).
And Cohen also warned that children commonly mistake such transdermal patches for Band-Aids, tattoos or stickers and may put them on their skin with devastating, even fatal, outcomes (Cohen 2011). Discarded used fentanyl patches may contain substantial amounts of active drug and there have been deaths reported after children applied these to their skin (and pets that have died after retrieving them from the trash).
ISMP Canada also reviewed multiple incidents related to fentanyl patches reported through the International Medication Safety Network (ISMP Canada 2009). They analyzed over 3000 incidents, including 271 resulting in harm and 8 resulting in death. They found 3 basic themes: (1) dose was higher than required or patch was replaced too soon (2) patient should not have received the medication (3) dose was lower than required or patch was replaced too late or omitted. They found that lack of knowledge or awareness of the potency applied to both providers and patients/caregivers. Complex dosing was especially error-prone and lack of communication at handoffs and transitions of care led to many incidents. They also identified issues with product design. They recommended development of real-time aids, such as manual checklists or electronic decision support tools, that could assist providers and patients/caregivers. Verifying appropriate indications for use and confirming opiate tolerance are two of the most important elements of a safe prescribing program for fentanyl patches.
ISMP (US) provides a very good brochure for patients on fentanyl patches with not just warnings but advice on use, storage, and disposal of the patches.
And dont forget that many transdermal drug patches contain metal or ferromagnetic elements that may lead to burns during MRI scanning (see our March 2009 Whats New in the Patient Safety World column Risk of Burns during MRI Scans from Transdermal Drug Patches). Fentanyl patches do appear on the FDA list of transdermal drug patches with metal backings (FDA 2009).
And then there are the transmucosal formulations of opiates. A 2007 FDA warning on Fentora, a potent opioid pain medication, is used only for treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it. Breakthrough pain is an intense increase in pain that occurs with rapid onset, even when opioid pain-control medication is being used. Patients who take narcotic pain medications daily and around-the-clock develop tolerance and are more resistant to the dangerous side effects of these medications than patients who take narcotic pain medication on a less frequent basis. The FDA alert noted serious adverse effects and deaths occurring in patients treated with Fentora, often patients who had acute pain and were not opioid-tolerant.
In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another transmucosal fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose.
Off-label use of these drugs to treat acute pain has been increasing. The California Workers Compensation Institute reports more than 14 percent of claims with minor back injury had at least one prescription for Actiq or Fentora. The newest transmucosal opiate on the market is Onsolis. These drugs are big business. Its estimated that the overall U.S. market for transmucosal fentanyl products for breakthrough pain, including generics, totaled $375 million in 2009 (Vinluan 2011).
Sustained-release or extended-release tablets are also problematic and switching from one opiate to another is often problematic (AHRQ Web M&M 2006). In the AHRQ case a young man with low back pain was switched from Vicodin to MS Contin and after one dose of the latter became obtunded with respiratory depression necessitating intubation and a long, complicated ICU stay. The dose of MS Contin far exceeded the dose of Vicodin that he had been receiving. It is very common to see misunderstandings of the relative potencies of the various opiate preparations. Therefore, equianalgesic conversion tables should be used when making such switches, keeping in mind that even those provide only approximations. As in the AHRQ article, reducing the calculated dose of the new drug 25-50% is often a good strategy when making such conversions. Weve also seen a case where a patient who took an intentional overdose of MS Contin developed respiratory failure almost 24 hours after ingestion. So understanding the potential delayed effects of ingested longer-acting opiates is critical.
Concentrated liquid preparations also give rise to problems. Another ISMP Alert (ISMP 2008) described two cases in which patients were mistakenly given 20 mg/ml solutions of oxycodone oral solutions rather than the intended 1 mg/ml, both with devastating results. Most such errors occur when the prescriber orders the medicine in ml rather than mg. That ISMP Alert has good recommendations about ways to help avert such errors. In addition to prescribing in mg rather than ml, they stress restricting use of these agents to patients who require higher than usual doses because of severe chronic pain or who are unable to swallow larger volumes of liquids. They describe using CPOE systems to alert prescribers (eg. adding the word concentrated to the drug name, showing warnings about the potential adverse effects) and barcoding systems to help verify the correct solution (eg. creating a hard stop that requires the nurse check with a pharmacist before dispensing). They also have advice for dispensing community pharmacists, such as printing warnings on the patients receipts or linking mandatory pharmacist counseling of patients to these preparations. They also warn against covering the concentration on the manufacturers label with a pharmacy label. And creating awareness of the risks among patients and caregivers plus healthcare staff is very important.
And remember that all the patients at high risk for respiratory depression from IV opiates are also at risk with these alternative opiate preparations. That includes patients with conditions such as COPD and sleep apnea. One of the deaths referred to in the 2007 ISMP alert on fentanyl patches occurred in a patient with sleep apnea (ISMP 2007).
Hospitals and health systems need to standardize on a short list of conventional opiates. Only the more conventional ones should appear in standardized order sets. Yes, they do need to provide access to the alternate formulations for individual cases (such as patients with intractable pain from cancer) but should restrict prescribing access for the latter to those providers who have established special competencies in using such drugs for managing complex pain (eg. pain specialists, palliative care specialists, or physicians specifically credentialed by your organization based on their training and/or competencies). And they need to put in place constraining functions that prevent use of these drugs for inappropriate purposes. For example, CPOE alerts can require a valid indication and clarification as to whether a patient is opiate-tolerant or opiate-naive (with hard stops in some cases). And access to equianalgesic dose conversion tables must be readily available, whether linked to CPOE or provided elsewhere. At all times be aware of all the opiates a patient may be receiving and any other drugs that may produce drowsiness or depress respiration. Tying warnings to bardcoding verification prior to administration is also advisable, as are independent double checks. Be especially wary at transitions of care. Medication reconciliation at those vulnerable times is critical. And make sure that the patient and family or caregivers understand the potent nature of these agents and risks involved and know what signs of potential toxicity to watch for. Lastly, be aware that, at least theoretically, patients on such potent agents may be at risk for withdrawal symptoms when there is a substantial reduction in dosage. Weve also seen a patient on chronic opiate therapy develop acute withdrawal when naloxone was administered to treat a likely overdose.
See also our prior Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression:
Bohnert ASB, Valenstein M, Bair MJ, et al. Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths. JAMA. 2011; 305(13): 1315-1321
FDA. Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS).
Cohen M. Doctors risk patient safety by prescribing fentanyl painkiller for short-term pain. Philly.com November 8, 2010
ISMP. Ongoing, Preventable Fatal Events With Fentanyl Transdermal Patches Are Alarming! ISMP Medication Safety Alert! Acute Care Edition. June 28, 2007
Cohen M. Warning! Kids may mistake drug patches as Band-Aids, tattoos or stickers. Philly.com January 3, 2011
ISMP Canada. Analysis of International Findings from Incidents Involving Fentanyl Transdermal Patches. ISMP Canada Safety Bulletin 2009; 10: 1-2 (December 30, 2009)
ISMP. Fentanyl patches brochure. 2011
FDA. Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings. 3/5/2009; updated 3/9/2009
FDA MedWatch Safety Alert. Fentora (fentanyl buccal tablet). September 26, 2007
New report shows growing off-label narcotic use in California. RiskandInsurance.com May 26, 2011
Vinluan F. FDAs REMS program puts BDSI at a disadvantage in cancer drug market. MEDCITY News June 8, 2011
AHRQ (Strassels SA discussant). AHRQ Web M&M. Miscalculated Risk. August 2006.
ISMP. Tragic events with concentrated opiate oral solutions. ISMP Medication Safety Alert! Community/Ambulatory Care Edition. July 2008
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