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We addressed some aspects of falls in our April 16, 2007 and July 17, 2007 Patient Safety Tip of the Week columns and also in our December 18, 2007 discussion about bed rails. Several additional publications shed additional light on the topic of falls with injury.
The UK National Patient Safety Agency in February 2007 published Slips, trips and falls in hospital: the third report from the Patient Safety Observatory. It provides some significant data on incidence, impact and cost of falls, circumstances of falls, risk factors and interventions. Though they report separately for acute hospitals, community hospitals, and mental health facilities, the overall rate of falls for hospitalized patients is 4.8 falls per 1000 bed days. The cost per fall obviously varies by the severity of any associated injury but they estimate the average annual cost related to falls for an average 800-bed acute care facility to be about 92,000.
Over 400 risk factors predisposing to falls have been identified and most falls result from a combination of factors. Older patients, particularly those over 80, are most vulnerable to both falls and to injury from falls. Only a minority of reported falls (about 5%) were actually witnessed by staff. What patients were doing when they fell: 24% were mobilizing, 23% were falls from bed, 14% were falls from a commode or toilet, 11% falls from trolleys, 5% falls from chairs, and 3% falls in bathrooms. Given the time spent in each activity, falls while using the commode or toilet seem to be disproportionately high.
They point out some very interesting findings. First and foremost is the use of fall risk scores. Very few have been validated in populations other than those in which they originated and most either over- or under-predict the risk of falls. Importantly, they were all designed to predict falls, which is not the same as preventing falls. So if a fall risk scoring tool is used, one must still look to see which risk factors are modifiable. Strikingly, the study quotes Dr. David Oliver, author of one of the most widely used tools (STRATIFY), as having become skeptical of the use of such tools.
They do note that multifactorial interventions have reduced falls by 18%. There are, of course, some potential benefits of reducing fall rates (such as improving patient confidence and independence) but the most important outcome indicator to monitor is falls with injury. Also, since many of the fall-related injuries are relatively minor scrapes, cuts and bruises, a good argument can be made the the the most important outcome indicator should be moderate or serious fall-related injury. But, in fact, there is almost no evidence in the literature supporting any intervention having a significant effect on the occurrence of fall-related injury.
There have been several articles in the past two months on fall prevention in the peer-reviewed literature. Von Rentein-Kruse and Krause(1) published a prospective cohort study on geriatrics wards that used a historical control and compared fall and injury rates before and after a multifactorial intervention. They found that the relative risk of falling was significantly reduced (RRR = 0.77) after implementation of the intervention but that the risk of injury was not reduced. Note that this degree of risk reduction is similar to that noted in the NHS study.
Coussement et al.(2) just published a meta-analysis on fall-prevention interventions in acute and chronic hospital settings and found no conclusive evidence that hospital fall prevention programs can reduce the number of falls or fallers. They noted more studies are needed to confirm the tendency observed in the analysis of individual studies that targeting a patient's most important risk factors for falls actively helps in reducing the number of falls. They also noted that these interventions seem to be useful only on long-stay care units.
Another recent meta-analysis, by Gates et al.(3), focused on older people in community and emergency settings rather than hospitalized patients. However, it focused on studies with multifactorial interventions similar to many of those used on inpatients. It also concluded that the evidence of improvement fall-related outcomes after such interventions is lacking. Again, most importantly, there is no convincing evidence that injuries are reduced by such interventions.
Thus, it is very clear that our evidence base is severely lacking when it comes to proven interventions that reduce the risk of injury from falls. Fortunately, there are ongoing programs actively seeking answers to the relevant questions.
IHIs Reducing Harm from Falls initiative is already revealing some interesting findings. Some have found that the association between aging and falls is less strong than the literature would have us believe. Beverly Nelson, MS, RN, CNAA, Director of Nursing Practice Programs at MD Anderson Cancer Center instituted a fall prevention noted Sometimes younger patients think they have more energy or strength than they do. Thats why we need to be vigilant about preventing falls for all patients. She also noted We discovered that many people who had had a particular kind of GI surgery were falling. Because these patients can develop diarrhea after surgery, we found that putting a bedside commode nearby reduced falls. They also instituted hourly safety checks on that unit, in which a nurse checks on the patients and offers assistance with toileting or any other activity that requires patients to be mobile.
The WHO Collaborating Centre for Patient Safety and the WHO World Alliance for Patient Safety have proposed 5 new topics for Patient Safety Solutions that have been selected as priorities by the Collaborating Centre's International Steering Committee. Prevention of patient falls is one of those priority topics.
The Prevention of Falls Network Europe (ProFaNE) website has links to many useful fall prevention resources and has ongoing research into prevention of injuries from falls.
References:
Our May 8, 2007 Tip of the Week Doctor, when do I get this red rubber hose removed? talked about the problem of urinary tract infections related to unnecessary urinary catheters. We had noted a large number of patients had Foley catheters in place for inadequate medical reasons. So 16 years ago, we established catheter rounds and began putting a brightly-colored sticker on the order sheets of all patients with a Foley catheter, requiring the physician to indicate the reason for the Foley catheter and the expected duration of its use. Catheter use dropped about 50%!
Over the years, weve recommended the systems hospitals put in place can be low-tech or hi-tech. The simple colored sticker alert mentioned above was very effective. Adding lines for indication and duration to pre-printed order sheets can also be effective. For those facilities fortunate enough to have computerized physician order entry, add a new pop-up screen with these questions any time someone orders a Foley catheter.
But weve always been amazed at how often we get to go into a hospital and still make this remarkably simple recommendation! Very few hospitals pay attention to this simple intervention that reduces both patient morbidity and hospital cost.
Now, for the first time, the scope of this problem has been studied on a national basis. Sanjay Saint, M.D. and colleagues at the University of Michigan just published Preventing Hospital-Acquired Urinary Tract Infection in the United States: A National Study (1) in the January issue of Clinical Infectious Diseases. They mailed written surveys to over 700 US hospitals and had an excellent response rate of over 70%. They found that 56% of hospitals did not have a system for monitoring which patients had urinary catheters placed, and 74% did not monitor catheter duration. Thirty percent of hospitals reported regularly using antimicrobial urinary catheters and portable bladder scanners; 14% used condom catheters, and only 9% used catheter reminders. VA hospitals were more likely than non-VA hospitals to use portable bladder scanners, condom catheters, and suprapubic catheters but non-VA hospitals were more likely to use antimicrobial urinary catheters.
Our August 21, 2007 Tip of the Week Costly Complications About to Become Costlier alerted facilities to the fact that, as of October 2008, CMS/Medicare will no longer pay hospitals for catheter-associated UTIs. So having a good system in place to prevent this complication is essential. Nosocomial UTIs, still the most common nosocomial infection, are not only a safety issue for patients but they are also very costly to hospitals. The average additional cost for patients who develop nosocomial UTIs is about $2000-3000 due to increased length of stay and increased antibiotic and supply needs. So establishing systems to prevent unnecessary Foley use is not only good for your patient safety program, it is also very cost-effective.
The system you put in place should have both a pre-emptive component and a surveillance component. As above, the pre-emptive component can be either low-tech or hi-tech. The simple colored sticker alert mentioned above was very effective. Adding lines for indication and duration to pre-printed order sheets can also be effective. If you have computerized physician order entry (CPOE), add a new pop-up screen with these questions any time someone orders a Foley catheter.
Beware of unintended consequences, though. Your policy should not be so restrictive that patients who truly do need a Foley catheter are made uncomfortable. Alternatives to Foley catheters may include condom catheters or intermittent catheterization. And, as Saint et al. point out, use of portable bladder scanners may reduce the need for any kind of catheter in the first place. And, if the patient does require a urinary catheter, consider using an antimicrobial one.
The second component of your system is the surveillance component. That means assessing all patients with urinary catheters to see if they still need them. We routinely look for unnecessary catheters during patient safety walk rounds and so should you. However, you need a system in place so they are looked for on a daily basis. Make this activity a checklist item on nursing rounds or teaching rounds. Also, if your hospital uses a barcode system to track inventory, adapt that system to alert you to every patient to whom a catheter was attached.
Be sure to include monitoring and measuring in your QI activities because the initial Hawthorne effect of implementing such a system often fades with time.
And, as pointed out by Dr. Saint and his colleagues, educating your patients to question why they need or still need a catheter should be part of your patient-oriented patient safety program.
References:
Saint S, Kowalski CP, Kaufman SR, et al. Preventing Hospital-Acquired Urinary Tract Infection in the United States: A National Study. Clinical Infectious Diseases 2008; 46:243250
http://www.journals.uchicago.edu/doi/abs/10.1086/524662
Adverse events related to medication are especially likely in the elderly. In 1991, Dr. Mark Beers and others developed explicit criteria for inappropriate medication use in the elderly. The original intended patient population was nursing home based but subsequent updates of the now-famous Beers list have been expanded to cover the elderly in general. However, a paper in the Annals of Internal Medicine(2) by Dudnitz, et al in December concluded that medications on the Beers List accounted for few visits to emergency departments for adverse events. Rather, 3 drugs not on the list (warfarin, insulin, and digoxin) accounted for far more emergency department visits for adverse events. In fact, they calculated that the risk for emergency department visits for adverse events due to these 3 medications was 35 times greater than for those medications on the Beers list considered to be almost always inappropriate. Also, nine of the 10 most medications most frequently implicated in emergency department visits for adverse events came from 3 drug categories (oral anticoagulant or antiplatelet agents, antidiabetic agents, and narrow therapeutic index drugs) accounted for 47.5% of the visits.
That paper should not diminish the importance of identifying prescription of potentially inappropriate Beers List drugs in the elderly. Rather, it emphasizes the need to also monitor hi-alert drugs better in the elderly. Hospitals, which should already be assessing use of hi-alert medications as part of their quality improvement and patient safety initiatives, probably already focus on insulin and warfarin which are two of the medications most often implicated in serious medication-related adverse patient outcomes in hospitalized patients.
A good paper Minimizing Adverse Drug Events in Older Pateients(3) by Pham and Dickman appears in the December 15, 2007 issue of American Family Physician. At least a third of older persons taking five or more medications will suffer an adverse event each year and many are both predictable and preventable.
Weve seen an interesting phenomenon in several different settings now. When a computerized system of alerts and reminders is set up to notify physicians when one of their patients is on a drug that is on the Beers List, the physician seldom discontinues the flagged drug in that individual patient. However, the number of new prescriptions for that drug diminishes in the patient population cared for by that physician. When we ask the physicians why they did not discontinue the drug, we usually get a response like this: This patient has already been on this drug now for some time. It is producing the desired response and the patient is tolerating it very well. Why would I switch them over to another drug that might not work and might have undesirable side effects? Pretty hard to argue against that argument. In many such cases, the patient indeed has been on the drug for many years before they turned 65 (the typical target age at which the computerized alerts are set to trigger). It may not be necessary to discontinue the drug in such circumstances. However, it should alert the clinician to use the lowest effective dosage in the patient and at least consider whether better alternatives might be present. As people get older, the effects of some drugs may affected by diminishing renal clearance. Fortunately, since we now in most places have ready access to the patients GFR (glomerular filtration rate), we can see when we might need to reduce the dosage of a drug excreted predominantly renally. But there are many drugs that otherwise become poorly tolerated in the elderly. In particular, drugs that have anticholinergic side effects or those that cause orthostatic hypotension are more likely to cause symptomatic adverse effects in the elderly. Temperature regulation also becomes impaired with age and the use of certain drugs may predispose the elderly to heat stroke. So it always makes sense to regularly review the patients medication regimen and consider which drugs might be switched to an alternate drug or discontinued all together.
The Pham and Dickman article nicely describes the brown bag method of medication review that is useful in managing the older patient. That, of course, consists of having the patient bring all their medication with them on the initial visit and again every 6-12 months for review. This can lead to discontinuation of a medication in about 20% of cases and change in medication in another 29%. We have seen similar outcomes in medication review done in several other settings. CMS, when it rolled out the Medicare Part D drug benefit program, mandated use of Medication Therapy Management (MTM) for certain Medicare recipients. That consists of a review of all a patients medications and counseling, usually done with a pharmacist either face-to-face or by telephone. That results frequently in either discontinuation or change in some of the drugs a patient may have been taking. Unfortunately, the CMS mandate is only for those Medicare recipients spending more than $4200 per year on covered medications or some with a certain number of chronic diseases or on a certain number of medications. Some of the smarter Medicare managed care plans have realized that the MTM program is good for both patient safety and the bottom line so they have developed similar programs for even those patients not meeting the mandate criteria. Other organizations may also provide similar services. The Western New York Chapter of the Alzheimer Association has an In-Home Memory Loss and Dementia Care Consultation Service that includes a comprehensive medication review. Quite commonly in this population that medical review will reveal that a patient is on one or more medications that may be causing unwanted consequences. And implementation of the medication reconciliation requirements for hospitals and other healthcare facilities has greatly facilitated such medication reviews in those patients unfortunate enough to have required hospitalization. During medication reconciliation, be it on admission or discharge or transfer, we frequently encounter a drug a patient no longer needs or a duplication of pharmacologic therapy or a problem with dosage of a medication.
The Pham and Dickman article also lists several useful questions to ask during a medication review that are adapted from an article by Hamdy et al(4):
Lastly, the Pham and Dickman article discusses two other medication issues significant in the elderly: underprescribing and nonadherence. Underprescribing is failure to use a medication for which there is a good evidence-based indication. That, of course, is a problem not exclusive to the elderly, though we may have a tendency to mistakenly think that the elderly may not benefit as much from certain interventions. The nonadherence (noncompliance) issue is especially important in the elderly for a variety of reasons, including cost, communication issues, visual or cognitive impairment, etc. Specifically questioning patients or their caregivers about such issues is a very important part of the medication review.
In our October 23, 2007 Patient Safety Tip of the Week on Medication Reconciliation Tools we noted that many of the available medication reconciliation forms that are currently in use lack a field to clarify the indication for which the medication was prescribed. Many medications (eg. beta-blockers, digoxin) may have several indications and you need to know which one applies to your patient. And the dosage of the medication may vary depending upon the indication for use. Similarly, most medication forms and lists fail to include reason for discontinuation. It is important to know if a medication was discontinued because of lack of efficacy, side effect, allergy, or formulary or economic reasons.
So if you are setting up a CPOE (computerized physician order entry) system into your clinic or practice setting, make sure that you include a field for medication indication. Good rules-based alerts and reminders that you might set up as clinical decision support tools take into account not only the drug, but the indication, possible drug-drug interactions, possible drug-disease interactions, possible drug-food interactions, allergies, past adverse reactions, age, size, weight, gender, GFR and other laboratory or physiologic variables, and other items. Managing medications is getting more and more complex in all patients and even more so in the elderly.
References:
Our August 21, 2007 Tip of the Week Costly Complications About to Become Costlier provided estimates of the costs to hospitals of some common potentially preventable complications. And in our November 2007 Whats New in the Patient Safety World column we pointed out an excellent paper by ECRI Institute on how to get ready for the CMS final rule on Hospital-Acquired conditions.
Two recent published studies shed some new light on determining the costs of such complications.
The Costs of Nosocomial Infections by Kilgore et al. in the journal Medical Care is the largest study of its kind. Most previous studies on the costs of nosocomial infections have had small sample sizes and used matched controls taken from similar patient populations that did not have nosocomial infections. That is not an ideal methodology because there are a number of potential biases. One of the biggest issues is the confounding variable of length of stay (LOS). In many cases, excess LOS is due to the nosocomial infection. However, in others excess LOS may simply reflect severity of illness and indicate a patient who is also at risk for nosocomial infections. So they attempted to correct for confounding variables, particularly for LOS. They collected data from over a million admissions at 55 hospitals which utilized a common cost-accounting system. So their cost estimates are true cost estimates, not based on charges or reimbursements or other surrogates.
They found that nosocomial infections, on average, led to $12,197 in incremental costs ($7007 in added variable costs) and 5.4 extra days in LOS. When they performed sensitivity analyses using modified regression models to take into effect the confounding of LOS, the increased cost associated with the average nosocomial infection was $4644. They feel that these two numbers represent the likely true upper and lower limits for estimated cost of nosocomial infections. Obviously, the incremental cost depends on the type of nosocomial infection, with infections of the cerebrospinal fluid or respiratory tract being the most expensive ($31,573 and $24,408 respectively) and urinary tract infections the least at $3936. (UTIs, however are the most frequent nosocomial infection. See our January 8, 2008 Tip of the Week Urinary Catheter-Associated Infections for recommendations on how to avoid them.)
The Kilgore study is the best weve come across in terms of both size and methodology to better get at the real costs of these serious complications or care.
The second paper deals with the cost of some complications in ICUs. In our November 2007 Whats New in the Patient Safety World column we had noted a paper by Kaushal et al showing the average cost per adverse event for patients in the MICU was $3961 and the attributable increase in LOS was 0.77 days. Corresponding numbers for patients in the CCU were $3857 and 1.08 days. That study included adverse events of all types.
Now, a very interesting paper Costs of Intravenous Adverse Drug Events in Academic and Nonacademic Intensive Care Units by Nuckols et al. found that IV ADEs resulted in $6647 higher costs and 4.8 day longer stays compared to control patients in academic ICUs but no significant difference in cost or LOS in nonacademic ICUs. There was no significant difference in the preventability or severity of the ADEs between the two settings and patient characteristic differences did not seem to explain this unexpected disparity. Additional length of stay was largely responsible for the excess costs in the academic setting. Though the authors could not exclude factors such as regional or case mix variations, they ascribed most of the difference to the post-event care in the academic setting. They hypothesize that some of the problems with continuity of care and other inefficiencies found in academic settings may have led to the longer lengths of stay. They suspect that some of the post-event care in the nonacademic settings was simply rendered in the outpatient setting but that in the academic setting there were delays in transfer to floors or discharges.
The findings, if replicated in other studies, would have some significant implications, depending upon whether your facility is primarily an academic setting or a nonacademic one.
For an academic setting, the message is two-fold. 26% of the IV ADEs were considered preventable and the total post-event costs for preventable IV ADEs was $8413 higher compared to $5856 higher for nonpreventable IV ADEs. Therefore, a foucs on prevention of IV ADEs is clearly important. And the medications involved most often were opiods, propofol, benzodiazepines, anticoagulants, and insulin all medications that should be part of a facilitys quality improvement and patient safety focus on hi-alert medications. Many of the interventions in the literature to prevent ADEs (CPOE, bar coding, use of a pharmacist as part of the ICU team, standardized order sets, checklists, etc.) may well have a good return on investment in both human and financial terms. Secondly, it highlights the need for academic centers to improve the coordination and continuity of care with those who will be primarily responsible for care after discharge.
For nonacademic facilities, the implications are less clear. They may mean that it will take longer to recover the costs of some of the hi-tech interventions designed to prevent medication errors. However, programs to prevent the avoidable IV ADEs are still obviously important to reduce patient morbidity and mortality.
It would be interesting to see how the results of the Nuckols et al study might be altered by applying a statistical methodology similar to the one used by Kilgore et al in the nosocomial infection cost analysis. Particularly since LOS accounted for the majority of the excess cost in the Nuckols et al patient population, one might expect to see less of a true difference between the academic and nonacademic ICU experiences.
By the way, the Kaushal study mentioned earlier was done in an academic setting.
References:
Kilgore ML, Ghosh K, Beavers,C M, Wong DY, Hymel PA, Brossette SE. The Costs of Nosocomial Infections. Medical Care 2008; 46(1):101-104
Kaushal R, Bates DW, Franz C, Soukup JR, Rothschild JM. Cost of adverse events in intensive care units. Critical Care Med 2007; 35: 24792483 http://www.ccmjournal.com/pt/re/ccm/abstract.00003246-200711000-00001.htm;jsessionid=HTGGGQPGTkTZpWzDpr4TTTHhTRhtVkQnVknJQtLKTYGdyySFJkp2!607026366!181195629!8091!-1?index=1&database=ppvovft&results=1&count=10&searchid=1&nav=search
Nuckols TK. MD, Paddock S, Bower AG, Rothschild JM, Fairbanks RJ. Carlson B, Panzer RJ, Hilborne LH. Costs of Intravenous Adverse Drug Events in Academic and Nonacademic Intensive Care Units. Medical Care 2008; 46(1):17-24
Print More on the Cost of Complications
When we were putting together our December 7, 2007 Patient Safety Tip of the Week on Surgical Fires, we found the prospect of surgical fires to be, frankly, quite frightening! And one question we found ourselves asking was Why arent there more fires in hospitals outside the OR?. Given that there are so many areas in a hospital where oxygen is utilized, one would certainly expect to see some reports of accidental fires. There certainly have been episodic reports of fires due to patients or staff smoking near oxygen but few other reports of oxygen-related fires outside the OR.
This month there was a report from Mercy Hospital in Coon Rapids, Minnesota of an unfortunate incident in which a neonate suffered burns in a flash fire while in an open-topped bassinette under a warmer while using an oxygen hood. Though nurses promptly extinguished the flames, the infant suffered burns over about 18% of his head and body.
Allina Hospitals and Clinics, the parent organization of the hospital, has assembled a team to assist with the root cause analysis of the incident. Much to their credit, they have asked the ECRI Institute, which is the foremost authority on surgical fires, to participate in that RCA investigation. They are also coordinating the investigation with the Minnesota Department of Health, CMS, the Minnesota State Fire Marshalls Office, and the local Police and Fire Departments. They expect the investigation to take 3-6 months. While some useful lessons learned may well emerge early in the RCA investigation, thoroughness and diligence in this case are critical. The circumstances in this unique case are likely to be replicated in multiple hospitals throughout the world every day. So it is extremely important that this investigation uncover key lessons to disseminate widely.
Fires have been reported in some other oxygen-rich environments in hospitals. There have been over 50 deaths in a 20-year period of patients in hyperbaric oxygen chambers(1). Because of that known risk of fires, chamber operators typically perform a safety check to ensure a patient is not entering the chamber with any objects that might cause combustion or anything that might scratch the interior of the tank (2). Particularly with the recent proliferation of traditional and topical hyperbaric oxygen uses, whether evidence-based or otherwise, careful attention to the potential risk of fires is extremely important.
The Minnesota investigation undoubtedly will focus on some of the equipment typically used in the neonatal nursery, including the warming device, monitoring devices (including sensors), and any other electronic equipment in proximity to the oxygen. But keep in mind that in an oxygen-enriched environment any spark theoretically could lead to ignition. That could include a spark due to static electricity or a spark related to two pieces of metal coming in contact and likely many other commonplace occurrences. They will also undoubtedly take a close look at the configuration of the oxygen hood used to provide the therapeutic oxygen-enriched environment. They will also look for potential fire fuels (remember the fire triad: an oxydizer, a heat source, and a fuel). Combustible materials and substances are in common use in many areas of a hospital. Alcohol-based skin prep agents have been particularly hazardous in ORs because they may saturate the covers/drapes and the vapors may become trapped(3). Of course, many hospitals now have made much more widespread use of alcohol-based disinfectants in their fight to avoid hospital-acquired infections. Conceivably, one of the unintended consequences of that battle might be an increase in the likelihood of inadvertently providing fuel for a rare fire. And there may be other lotions or creams being used therapeutically that are flammable.
Just as we need to ensure that everyone who enters an operating room has had appropriate training in surgical fire risk and procedures, we now need to consider similar training of everyone for any area in which oxygen is being used. This obviously would include not only staff, but everyone who might enter that area. That would include housestaff, agency personnel, and even parents and other visitors.
The patient safety community anxiously awaits the root cause analysis on the Minnesota case because its findings undoubtedly will impact on neonatal units everywhere
And, lastly, hospitals need to take a careful look to ensure that the clinical indications for use of concentrated oxygen are carefully adhered to. Just as in our discussions about the unnecessary use of urinary catheters, undoubtedly there are circumstances where neonates or other patients are reflexly begun on oxygen. Hospitals should have evidence-based criteria not only for starting oxygen therapy but also for its continuation and discontinuation.
Updates: See also our Whats New in the Patient Safety World columns for April 2008 More Neonatal Incubator Fires and March 2009 Followup on the Minnesota Bassinet Fire.
References:
Print Thoughts on the Recent Neonatal Nursery Fire
Edmund Funai, M.D. from Yale-New Haven Hospital presented at the annual meeting of the Society for Maternal-Fetal Medicine results of implementation of a multifactorial strategy to reduce obstetrical errors (1). The program he and his colleagues implemented successfully reduced errors by 50% over a two and one-half year period and helped to significantly lower the hospitals malpractice premiums.
The intervention used several well-established patient safety tools and techniques, such as communication training and standardization (in this case standardization of interpretation of fetal monitoring) and introduced a new patient safety nursing position. They also developed a multidisciplinary committee to oversee the patient safety activities.
Its well-known that communication breakdowns have been consistently seen as root causes in 60-70% of all sentinel events reported to Joint Commission. The communication training they utilized involved mandatory crew resource management (CRM) training.
The Yale press release includes a link to a 13-minute discussion with Dr. Funai in iTunes format. He discusses the fact that communications breakdowns underlie the vast majority of adverse events. In particular, he points out the increase in handoffs resulting from new residency workhour restrictions and their potential role in communication breakdowns. He stresses the importance of empowering any and all members of the team to speak up when they see something is possibly wrong. The added patient safety nurse improved continuity of care considerably, served as a patient safety resource, and helped review adverse events. Their implementation also included standardization of some interventions, such as administration of oxytocin.
Well echo the value of addition of a nurse clinician to the team. In the mid-1990s we developed a nurse case manager program at the Erie County Medical Center at a time when residency workhour restrictions were first being instituted in New York state. We utilized experienced, respected nurse clinicians who understood systems of care. We found that the nurse case manager improved continuity of care tremendously, not only on a day-to-day basis, but also when teaching services would rotate on a monthly basis. This program was largely responsible for a substantial improvement in mortality rates, reduction in length of stay, and improvement in patient and family satisfaction. Sometimes adding a valuable resource can result in an overall net savings of human and financial resources. This is especially so in teaching hospitals.
A second presentation by staff from Lehigh Valley Hospital (2) at the same annual meeting of the Society for Maternal-Fetal Medicine also demonstrated a drop in errors after implementation of crew resource management.
These articles are of interest since a previous randomized controlled trial of teamwork training by Nielsen et al (3) failed to demonstrate measurable improvements in labor and delivery outcomes. It may be that the time period for translation of the improved team communication to hard outcome results is longer than in this study. However, the Nielsen study is a good reminder that we should not simply accept concepts and ideas that sound rational but we need to validate their effects on hard outcomes.
Our May 15, 2007 and May 22, 2007 Patient Safety Tips of the Week discussed crew resource management (CRM) and other communication training tools, such as TeamSTEPPS and SBAR techniques.
Simulation is another tool that has been gaining more widespread acceptance in the patient safety community. Maslovitz et al (4) developed a simulation-based curriculum for ob/gyn residents and midwives and were able to identify multiple recurrent mistakes in the management of several emergency scenarios. For example, in one scenario they found that late transfer to the operating room and delayed administration of blood products seemed to occur because almost all trainees inaccurately estimated the blood loss by a mean factor of 50%. The authors have used this information to begin testing solutions to the problems identified. They also demonstrated improvement in management when some of the trainees later repeated the simulation scenarios.
An excellent paper by Foster et al (5) used a trigger tool to study adverse events on an obstetric service. (See our October 30, 2007 Patient Safety Tip of the Week Using IHI's Global Trigger Tool for a description of the use of trigger tools.) They confirmed that severe adverse events are rare in obstetrics and their overall incidence of adverse events was only 2%. However, they identified important quality problems in 5% of the cases. Importantly, most of these were preventable systems problems that subsequently led to search for possible solutions. Based on the types of problems they identified, they concluded that interventions most likely to have a positive impact on patient safety would be those that focus on team work, communication, and work flow.
These are all good examples of how the ob/gyn community is beginning to incorporate patient safety into both their training programs and actual practice.
References:
(1) Press release Yale University. New Strategy Helps Reduce Errors in Obstetrical Care. February 2, 2008 http://www.yale.edu/opa/newsr/08-02-02-01.all.html
(2) Beil L. Medscape Medical News. Two Studies Describe Approaches Shown to Reduce Obstetrical Errors. February 4, 2008 http://www.medscape.com/viewarticle/569668
(3) Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, Greenberg P, McNamee P, Salisbury M, Birnbach DJ, Gluck PA, Pearlman MD, King H, Tornberg DN, Sachs BP.Effects of Teamwork Training on Adverse Outcomes and Process of Care in Labor and Delivery: A Randomized Controlled Trial. Obstetrics & Gynecology 2007; 109(1): 48-55
(4) Maslovitz S, Barkai G, Lessing, JB, Ziv A, Many A. Recurrent Obstetric Management Mistakes Identified by Simulation. Obstetrics & Gynecology 2007; 109(6): 1295-1300
(5) Forster AJ, Fung I, Caughey S, Oppenheimer L, Beach C, Shojania KG; van Walraven C. Adverse Events Detected by Clinical Surveillance on an Obstetric Service. Obstetrics & Gynecology 2006; 108(5): 1073-1083
Print Reducing Errors in Obstetrical Care
In our May 1, 2007 Patient Safety Tip of the Week The Missed Cancer we talked about the need for all physicians to have a system for tracking patient test results to help avoid such disasters as the missed cancer. Offices that have incorporated audits of tracking tests results into their QI activities have shown gaps that could lead to significant adverse patient outcomes. Eastwood (1) in a 6-month audit of a practice in the UK noted a 0.48% rate of missing test results. That may sound like a small number but given the thousands of tests ordered each year in a typical practice, that translates into a substantial quality and patient safety issue.
Tracking test results is obviously important for the well-being of your patients. But it is also important for the well-being of your practice. Failure to diagnose and delay in diagnosis are two of the most common reasons for medical malpractice awards and test results falling through the cracks are a big reason for both. In addition, CMS is now working on development of physician office quality measures and one in the making is Tracking of Lab Test Results and Referrals (2).
Last week, while putting together our Tip of the Week on reducing errors in obstetrical care, we happened to come across an excellent ACOG Committee Opinion on Tracking and Reminder Systems (3). Such systems can be simple (such as a log book or index card files or paper-based tickler system) or complex (such as a computerized system) but need to be reliable, standardized, understood by appropriate office staff, and regularly reviewed. They stress the number of people with responsibility should be limited but responsibility should never reside solely with one person. Educating the patient on the reason for and importance of the test or referral is the first step. Also, let the patient know that your office will get back to them with the results of the test whether it is normal or otherwise and tell them to contact your office if the have not heard from your office within a specified period of time. When a patient fails to keep a followup appointment, that should be recorded in the medical record and attempts should be made to reschedule that appointment.
The tracking system should have an office policy and procedure and input from the staff during planning of that system is important. This should include how the patient should be contacted and documentation of followup in the chart. Specific time frames for followup of the various types of tests should be established. A central location for the system is critical so that it is accessible by appropriate office staff and it is not appropriate to keep the reminders in individual patient charts. Staff members should be cross-trained on the use of the system so that the system does not fail in the absence of key individuals. And, of course, that system for conveying results to patients must be in compliance with HIPAA regulations.
The article provides samples of some of the elements to keep in the tracking system. When results come back, the appropriate clinician should review, date, initial or sign, and document in the chart and in the system what is to be done next. When the patient is contacted, there should be a note to that effect in the chart along with the date and documentation of the discussion that took place. If more testing or referrals or other follow-ups result, those should be put back into the tracking system as well.
The practice needs to prioritize what it wants to put in the tracking system. But that usually includes all laboratory and radiological tests, other diagnostic tests, and referrals to specialists. We recommend also including special attention to items related to recent ER visits or hospitaliziations.
It is also not enough just to have a policy, procedure and system in place. Your quality improvement activities must also periodically and regularly audit, measure and review the outcomes of such system.
In our November 2007 Whats New in the Patient Safety World column we mentioned The Kentucky Medical Association published a nice tool for Tracking Test Results Within a Physican Practice (4). It notes that as many as a third of physicians surveyed had no reliable way to track test results. It provides solid advice on setting up a system in your office, whether electronic or paper-based. This paper, and the ACOG paper above, both stress that keeping the system simple, with as few steps as possible, is very important. The KMA paper addresses creating a log of the tests ordered and creating a pending file, regardless of whether your system is electronic or paper-based. They suggest keeping a pending tray for patient charts awaiting test results. They discuss some of the electronic/computer solutions available but also note, as we did in our May 1, 2007 Patient Safety Tip of the Week The Missed Cancer, that simple off-the-shelf computer programs such as Microsoft Excel, Access, Word or Outlook may be utilized for many of the necessary functions. They go on to discuss the physician review of results and designation of who and how the patient will be contacted. They stress that results of all tests, whether abnormal or normal, should be communicated to the patient. They note HIPAA issues, such as the fact you should never send results on a postcard or leave results on a personal answering maching. They do discuss potential use of automated test result voice mail systems that have built in confidentiality security. They do point out, however, that abnormal results should be addressed differently than normal results. The physician, after reviewing the abnormal results, should contact the patient by phone. If they cannot be contacted by phone, a certified letter should be sent asking them to contact the physician. And the system should have a provision for handling emergent or life-threatening results. And they discuss documentation in the chart both of the results and the patient notification. Lastly, they discuss the importance of explaining the results tracking system to the patient, perhaps even providing them with a flow chart and instructions or FAQs on the system.
Overall, the ACOG and KMA documents are very worthwhile reads for every office practice (or hospital-based practice).
Other good sources of information about results tracking systems include medical malpractice carriers. CRICO/RMF, the patient safety and medical malpractice company owned by and serving the Harvard medical community, provides online samples of effective and exemplary practices for tracking test results (6). They also provide a larger downloadable document What Works: Effective Practices for Office-based Care. The Amercian Physicians Assurance Corporation also has an online document for REDUCING PHYSICIAN LIABILITY WITH TRACKING AND FOLLOW-UPSYSTEMS (7) by: R. Stephen Trosty, JD, MHA, CPHRM, that has good suggestions.
However, even computerized alert and reminder systems arent 100% successful. Singh et al (8) reported followup on 1017 imaging report alerts transmitted electronically. They found that over a third of the alerts went unacknowledged, including 4% of abnormal results. Overall, 0.2% of outpatient imaging was lost to followup. Clearly, we still have a long way to go in fixing the barriers and system issues in ensuring test results get appropriately acknowledged and acted upon. Another study (9) looked for followup after abnormal imaging reports were telephoned to referring physicians and found that 9.3% had no evidence of imaging followup even after multiple communications (though there might be legitimate reasons for lack of imaging followup in some cases).
References:
(1) Eastwood B. Tracking the fate of laboratory test results. British Journal of General Practice 2003; 53: 493
http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1314634&blobtype=pdf
(2) CMS Special Project: Development of Physician Office Quality Measures
(3) ACOG Committee on Quality Improvement and Patient Safety. Committee Opinion. Tracking and Reminder Systems. Obstetrics & Gynecology 2006; 107: 745-747
(4) Kentucky Medical Association. Tracking Test Results Within a Physician Practice. http://www.kyma.org/Patient_Safety/Member_Resources/documents/Tracking Test Results.pdf
(5) CRICO RMG. Tracking Test Results. 2006
http://www.rmf.harvard.edu/high-risk-areas/diagnosis/tracking-test-results/index.aspx
(6) CRICO RMF. What Works: Effective Practices for Office-based Care. 2006 http://www.rmf.harvard.edu/patient-safety-strategies/office-practices/main/menu.aspx
(7) Trosty RS. Amercian Physicians Assurance Corporation. REDUCING PHYSICIAN LIABILITY WITH TRACKING AND FOLLOW-UP SYSTEMS. 2005 http://www.apassurance.com/RiskMgt/Articles_RM/Tracking_FollowUp_Systems_42005.pdf
(8) Singh H, Arora HS, Vij MS, MDc, Rao R, Khan MM, Petersen LA. Communication Outcomes of Critical Imaging Results in a Computerized Notification System .J Am Med Inform Assoc. 2007; 14:459-466
(9) Ridley EL. Using informatics to meet communication challenges.
http://www.auntminnie.com/index.asp?Sec=sup&Sub=pac&Pag=dis&ItemId=79929
Accessed February 7, 2008.
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Joint Commission has just issued a new Sentinel Event Alert Preventing accidents and injuries in the MRI suite, with numerous excellent recommendations about MRI safety. Perhaps most surprising, however, is that Joint Commission has only five MRI-related cases in its Sentinel Event database. Also this February, the FDA updated a previous alert about avoiding burns from electrodes and cables during MRI exams. There are clearly many more MRI-related adverse events and near-misses from which valuable lessons can be learned. Now that HHS has announced its proposal to establish PSOs (Patient Safety Organizations), we would hope that the confidential reporting to those organizations will result in dissemination of multiple other lessons learned from MRI-related events.
Given the astounding growth of MR imaging facilities over the past decade and the increasing indications for MR imaging, it is no surprise that more vulnerable patients are also having MR imaging studies. Critically-ill patients needing intensive monitoring and intensive care now often undergo MR imaging studies and are at risk for adverse events that may be directly related to the MR procedure or indirectly related. Our October 16, 2007 Patient Safety Tip of the Week Radiology as a Site at High-Risk for Medication Errors
The American College of Radiology issued its updated guidance document for safe MR practices in the June 2007 issue of the American Journal of Radiology (Kanal et al 2007).
The Joint Commission Sentinel Event Alert and the ACR Guidance outline multiple safety issues related to MR imaging and provide recommendations.
Not even a month after the first published paper on projectile cylinder accidents in MRI units (Chaljub et al 2001), there was a fatality related to an MR-related projectile accident. A 6 y.o. boy developed respiratory distress while undergoing an MRI. There was a problem with the oxygen source in the MRI suite. Both MR technologists briefly left the MR suite to try to resolve the issue but in the interim a nurse responding to anesthesiologists calls for help found an oxygen cylinder in the control room and brought it into the MR room. Unfortunately, it was steel cylinder and the MR pulled the cylinder free, thrusting it into the bore of the MR machine and causing a fatal head injury to the boy. Root cause analysis of the latter event showed the typical cascade of events and errors that collectively led to the unfortunate outcome. Many of the same conditions and events occurred in the cases assembled by Chaljub et al. had reported on 5 projectile cylinder accidents at 2 academic medical centers. Cases involved ferromagnetic cylinders of oxygen or nitrous oxide inadvertently being introduced into the MR rooms and turned into projectiles by the magnetic forces of the MR machine, resulting in patient injury or damage to the MR unit or both. They also sent out questionnaires to multiple academic MR units and found slightly more than 50% of those who responded had experienced similar projectile incidents. Objects involved included vacuum cleaners, mop buckets, tools boxes, ventilators, defibrillators, wheelchairs, IV poles, etc. Failure to adhere to MR safety policies and human error were cited as the most common reasons for the accidents.
These and other events have been taken into account in the ACR Guidance, initially published in 2002 and updated in 2004 and 2007. They stress that each MRI facility needs to have safety policies and procedures, a medical director with overall responsibility for safety, adequate training of all individuals, and strict access restrictions. The MR suite needs to be divided into 4 zones, each with progressive access restriction based upon level of training. Zone 1 is really any area outside the MR suite where staff and the general public may be. Zone 2 is the area where patients begin to be accompanied by MR-trained personnel and screening begins. Zones 3 and 4 are where the magnetic fields come into play. It is important to understand that in most cases the magnetic forces are always on (many people erroneously think they are only present during actual scanning). Zone 3 is just outside the actual MR room and access here is strictly controlled. All individuals here must be escorted by designated MR personnel who ensure that safety policies and procedures are being followed. These areas should be physically restricted so that non-designated staff or the public cannot enter. Use of key locks or passkey locking systems or other reliable method should be used to prevent unauthorized access. (Even combination locks are discouraged because the combinations may be given out too easily). Zone 4 is the actual room where the magnet is housed. It should be clearly demarcated and marked as hazardous, with a red light and sign that the magnet is in operation (with appropriate power supply backup for these alerts). Individuals may enter Zone 4 only under supervision of level 2 MR-trained personnel (usually the MR technologist) and there should be visual control of all access paths to this zone by those personnel (direct line of sight or video camera).
Rescusciation of patients should not be carried out in Zone 4. In those patients in need of rescuscitation, appropriately trained and certified level-2 MR-personnel should perform CPR or other rescuscitative measures as the patient is immediately removed from Zone 4 to a predetermined safe area where full rescuscitative efforts may be continued.
Training is critical for MR personnel. The ACR guidance outlines training needs for level 1 and level 2 MR personnel. Strong consideration should also be given to providing some level of education/training to other individuals who might be called to the MR suite during emergencies (medical or nursing staff, respiratory therapy, outside firemen or police, etc.).
The MR screening process is critical. All non-MR personnel must pass the screening process before entering Zone 3. All individuals must be screened not only for ferromagnetic objects but also for other devices or conditions which may be adversely affected by magnetic forces. The screening must be performed by MR-trained personnel who are authorized to conduct the screening. The screening procedure is beyond the scope of this column and the reader is referred to the ACR Guidance for details. Note that use of conventional metal detectors is discouraged because of false positives and false negatives and other issues. The guidance talks about questions to be asked during screening, physical findings, screening techniques and procedures, who needs x-ray screening for potential ferromagnetic clips, implants, etc. It also discusses issues related to special circumstances such as pregnancy, patients needing sedation, patients needing accompaniment and other issues.
Think about all the reports you hear about things missed during airport security screening. No one could possibly remember everything that must be considered during the MR screening process. Ferromagnetic materials may be present in things like tattoos, makeup, drug patches, unretrieved device fragments, and other places youd never suspect. Hence, good use of checklists is a must.
Projectile accidents are not the only kind of adverse event that may be encountered in the MR suite. Burns and thermal injury are other potentially significant consequences. The magnetic forces may induce voltage and currents in electrically conductive materials, resulting in significant heat generation. All unnecessary electrically conductive materials should be removed during the screening process. When they cannot be removed, care should be taken during positioning to avoid large diameter conducting loops, which are particularly vulnerable to heat generation (see the ACR Guidance for details). The FDA updated alert on burns from MRI discusses patients wearing ECG electrodes and cables suffering burns during MRI. It, and the nursing journal article that served as a source (Lange 2006), discuss proper techniques for managing patients with such electrodes or cables who must undergo MRI. Note that thermal injury may also occur internally, related to implants or wires.
Fires have been reported during MRI as well. Frankly, were surprised they havent occurred more often given that MRI may result in heat generation and many patients have an oxygen source during the MRI (see our December 4, 2007 Patient Safety Tip of the Week on Surgical Fires). Fire extinguishers need to be MR-safe or MR-compatible.
Maintenance issues become important (see our August 7, 2007 Patient Safety Tip of the Week on the Role of Maintenance in Incidents). Many hospitals and facilities use outside vendors for maintenance of equipment and supplies such as oxygen cylinders and fire extinguishers. It is crucial that such vendors understand the issues related to MR and use appropriate labeling to minimize the chance of inadvertently storing ferromagnetic versions in or near the MR area.
Stronger magnets, such as 3-tesla units, are being used more and more often. One would expect projectile accidents to be more serious with stronger magnets. While there is some evidence that thermal injury may be more likely with stronger magents, the ACR guidance cautions that one cant assume safety when a patient has safely undergone a previous MRI. There have been cases where thermal injury occurred during exam with a weaker magnet after prior exam with a stronger magnet, and vice versa.
Issues related to use of gadolinium and contrast agents are discussed in the ACR Guidance, as are issues related to acoustic trauma, pacemaker or other device malfunction, cryogen injury, and other special considerations.
Your quality improvement program obviously needs to review all incidents and near misses related to MR imaging (directly or indirectly). But you should also perform some sort of audits of adherence to the screening and other safety procedures. Results need to be incorporated into feedback to staff and lessons learned need to be readily shared.
Looking for a topic for FMEA (Failure Mode and Effects Analysis) to meet your Joint Commission requirements (or better yet just because you are proactive in your patient safety culture!)? What better place to look than your MR unit? You can ask what youd do if there was a problem with oxygen source or a problem related to a hi-alert drug like a sedating agent or neuromuscular blocking agent used in the MR unit. You could simulate a cardiac or respiratory arrest or a fire in the MR unit. In any event, you should have periodic drills for some of the potential disasters, such as fires. The appendix in the ACR Guidance has a good section on Emergency Preparedness.
An MRI suite safety calculator is available online and is a good place to start when you are looking at your MR safety program.
References:
Kanal E et al. ACR Guidance Document for Safe MR Practices: 2007. AJR 2007; 188: 1-27 http://www.acr.org/SecondaryMainMenuCategories/quality_safety/MRSafety/safe_mr07.aspx
Chaljub G, Kramer LA, Johnson RF, Johnson RF, Singh H, Crow WN. Projectile Cylinder Accidents Resulting from the Presence of Ferromagnetic Nitrous Oxide or Oxygen Tanks in the MR Suite. Am. J. Roentgenol., Jul 2001; 177: 27 30
Lange S, Nguyen QN. Cables and electrodes can burn patients during MRI. Nursing 2006; 36: 18
http://www.fda.gov/cdrh/psn/show-60-electrodes.html
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A new study (Peberdy et al 2008) using data on CPR voluntarily submitted by 507 participating hospitals demonstrated that patients were less likely to survive in-hospital cardiac arrest that occurred at night or on weekends. The only areas of the hospital not having this time-of-day disparity were the emergency room and the trauma service. The disparity persisted even after adjustment for numerous patient and hospital variables. The disparities were more pronounced for arrest in non-monitored patients, unwitnessed arrests, and arrests with asystole as the original rhythm documented. All these suggest delays in recognizing patients in trouble may play role.
Another recent study (Chan et al. 2008) had shown almost a third of in-hospital cardiac arrests had delays in defibrillation. That study had shown after-hours occurrence as one of several variables associated with delayed defibrillation.
Two new studies (Jeffrey 2008) have also confirmed the observation of previous studies that the mortality rates for patients with stroke are higher if they are admitted at night or on weekends. Even after adjustment for demographic and socioeconomic factors, patient characteristics and hospital characteristics, the relationship between off-hour admission and mortality remained significant. The relationship was more pronounced for hemorrhagic stroke.
Other studies have shown medical errors to be more frequent at night and studies on accidents in other industries reveal that some of the most famous disasters have occurred off-hours (eg. Bhopal, Piper Alpha, Chernobyl, Three Mile Island). Car crashes are more likely to occur between midnight and 6AM. Our August 28, 2007 Tip of the Week Lessons Learned from Transportation Accidents talked about some of the contributory factors in the ValuJet accident, which included many issues related to maintenance work done at night.
Our November 27, 2007 Patient Safety Tip of the Week More on Rapid Response Teams mentioned the NICE Guideline Acutely ill patients in hospital. Recognition of and response to acute illness in adults in hospital recommendation that patients should not be transferred back to wards between 22:00 and 07:00 unless absolutely necessary. This was an evidence-based recommendation, though most of the studies were done in the UK, Canada, Australia, or countries other than the United States.
One of the presentations at IHIs Annual National Forum on Quality Improvement this past December was The Hospital at Night Program: Reducing Risks at Our Most Vulnerable Time of the Day by David Gozzard and Carol Haraden. This described a redesign of hospital structure and processes in anticipation of a significant limitation of work hours imposed by the European Union (the European Working Time Directive). As part of the redesign they collected data on the tasks performed off-hours and found that many tasks performed by doctors at night could be redistributed to nonmedical staff and that many tasks could be performed during daytime hours. For instance, leaving space in the OR schedule for emergencies reduced delays in regularly scheduled cases and reduced the likelihood of doing overflow cases at night. They also focused on communication and handoffs and made greater use of SBAR and written reports that were discussed verbally. And they made better use of the MEWS (Modified Early Warning System) to identify patients at risk of deterioration. Preliminary, largely anecdotal, experiences with the program have been positive. It will be most interesting to see the effect of this program on hard outcome measures.
Some of the principles in The Hospital at Night Project sound much like some of the principles from the Toyota Production System/Lean Thinking approach (removal of unnecessary tasks, reducing duplication, etc.).
Of course, physiological changes that have circadian rhythms may result in patient deterioration after-hours. However, the more easily modifiable factors have to do with the systems we practice in within hospitals.
It is more likely that physiological changes and circadian rhythms in care providers, such as fatigue and inattention, may play a role. There are plenty of studies now demonstrating deterioration in cognitive and physical skills with sleep deprivation. These, and some well publicized incidents such as the Libby Zion case, have led to the restriction of work hours for physicians in training. The Bell Commission, which developed the original residency workhour restrictions in New York in the 1980s, cited the more frequent occurrence of hospital incidents at night and on weekends as a sign of work-related fatigue. Of course, those are also times when there is more cross-coverage of patients and the covering physicians generally have less knowledge about the patients they cover. So the debate has ensued as to which is worse: errors related to fatigue or errors related to handoffs. It is fairly clear we must avoid fatigue as much as possible by adherence to workhour restriction rules. So focusing on improvement of handoffs and other communication issues becomes an important patient safety activity.
Handoffs are one of the critical processes subject to errors that may result in incidents with adverse outcomes. Considerable research done in other industries (Lardner 1996) has some lessons for healthcare. Information at handoffs should be repeated by more than one method. For example, the communication may be written but then should be conveyed by a second method, such as a face-to-face verbal communication. Cues such as speech inflection and body language may convey important messages during such face-to-face communications, enhancing memory of the salient points. The verbal face-to-face contact also provides the opportunity for 2-way communication and feedback, both of which are essential in ensuring that both parties understand the information conveyed. Adding structure to written documents and defining what should be included in handoffs are very helpful. Hence, the popularity of techniques like SBAR (Situation-Background-Assessment-Recommendation). And eliminating unnecessary information may be very important. Lastly, training and education in handoffs should be a priority for organizations, as should providing adequate time for such handoffs.
Of interest is that some industries have found that 12-hour shifts appear to be associated with better handoffs. Presumably this is because the same two individuals are participating together in most of the handoffs here. We are unaware of any studies done in healthcare settings where 12-hour shifts have been compared to 8-hour shifts (eg. in emergency rooms) with hard outcome measurements.
Staffing patterns for a variety of healthcare workers (nurses, pharmacists, physicians, lab technicians, radiology staff, etc.) tend to be lower at night. Environmental factors such as poor lighting may contribute to medication errors and other errors. Ironically, our empathetic response to let the patient get some sleep may even be a contributory factor in some adverse events.
So one can see that there are multiple factors that make off-hours in a hospital times when patients are especially vulnerable. A lot more research is needed to continually focus attention on those factors which are modifiable.
References:
Peberdy M, Ornato JP, Larkin GL, et al. Survival from in-hospital cardiac arrest during nights and weekends. JAMA. 2008;299:785-792
http://jama.ama-assn.org/cgi/content/abstract/299/7/785
Chan PS, Krumholz HM, Nichol G, et al. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med 2008; 358:9-17
http://content.nejm.org/cgi/content/abstract/358/1/9
Jeffrey S, Barclay L. Deaths Higher for Strokes Treated at Night, on Weekends. Medscape New Article. February 22, 2008
http://www.medscape.com/viewarticle/570545
Gozzard D, Haraden C.The Hospital at Night Program: Reducing Risks at Our Most Vulnerable Time of the Day. Report from IHIs 19th Annual National Forum on Quality Improvement in Health Care, December 9-12, 2007, Orlando, Florida
Lardner R. Offshore Technology Report OTO 96 003. Effective Shift Handover A Literature Review. Health & Safety Executive, 1996
http://www.hse.gov.uk/research/otopdf/1996/oto96003.pdf
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March 4, 2008
Housestaff Awareness of Risks for Hazards of Hospitalization
A recent article (Fernandez et al 2008) found that housestaff often had poor awareness of a number of risk factors their elderly inpatients had for the hazards of hospitalization. They developed a 24-question Hazards of Hospitalization Questionnaire and had housestaff answer these questions on a sample of their elderly hospitalized patients. Answers were compared to those of a study investigator on the same patients. Most of the patients had multiple risk factors. While there was good agreement on some of the questions, there was poor agreement or frank disagreement on multiple other risks such as patient orientation to place and duration of hospitalization, patient quality of sleep, presence of pain, history of falls, mood, quantity of food intake, use of assist devices (eg. glasses, hearing aids, canes) at home, and name of the primary care physician.
The authors point out that the areas of agreement tended to be related to things for which physicians had to write orders. They speculate as to why they tended to be unaware of the other risks and provide good discussion about both the medical education system and the need for good communication among the interdisciplinary care team.
We look at their results from a slightly different perspective. They likely would find the same level of unawareness for any physician at any level of training in any hospital in which they administered the questionnaire. For years, those of us who are neurologists have jokingly said that the Neuro WNL that appears in so many H&Ps stands for we never looked so it comes as no surprise that some of these risk factors were not recognized. But rather than focusing so much on why they might be unaware, the key finding here is that they identified things that physicians are not good at (i.e. they are not good at identifying certain types of risk factors). The focus then should be to develop systems that can capture these risk factors and then make the physician aware of their presence.
There are obviously several ways to accomplish this. Nursing staff already perform many risk assessments on admission (eg. fall risk assessment, decubitus risk assessment, etc.). DVT risk assessments are also being done more frequently, either by the physicians or nursing staff. Weve pointed out in several of our Tips of the Week that such assessments need to be updated when changes take place during the hospital stay. We have also found that other members of the care team are much more likely to identify many of the risk factors noted in this paper. The use of nurse case managers on several of our academic teaching services provided much improved continuity of care, particularly after the implementation of restricted workhour rules for housestaff. Multiple other nonphysician providers that interact with patients (physical or occupational therapists, respiratory therapists, pharmacists, etc.) could also identify some of these risk factors.
Trigger tools have received attention recently (see our October 30, 2007 Patient Safety Tip of the Week Using IHI's Global Trigger Tool) and many of the questions in the Hazards of Hospitalization Questionnaire could be incorporated into a trigger tool. Trigger tools can be manual or computerized. Unfortunately, most of the risk factors here that were not identified are also not readily identified independently via computerized systems.
If the Hazards of Hospitalization Questionnaire tool developed by the authors can be validated in several settings or populations, it has tremendous potential to help us prevent complications commonly seen during and after hospitalization.
Issues such as risk for delirium, that could be identified early by the Hazards of Hospitalization Questionnaire tool, are extremely important. Not only is delirium associated with increased morbidity and mortality, but it is also associated with prolonged lengths of stay and excess costs (Leslie et al. 2008). At least 2 studies have demonstrated that multifactorial interventions targeted at elderly inpatients at risk for delirium may shorten hospital length of stay, reduce duration of delirium, and reduce mortality (Lundstrom et al. 2005; Naughton et al 2005).
We really like this tool and feel it has lots of potential. It should be tested and validated in other settings and organizations should look for ways to best identify the risk factors and integrate them into a system of alerts and reminders that help focus attention early on preventable events.
References:
Fernandez HM, Callahan KE, Likourezos A, Leipzig RM. House Staff Member Awareness of Older Inpatients' Risks for Hazards of Hospitalization. Arch Intern Med.2008;168(4):390-396 http://archinte.ama-assn.org/cgi/content/abstract/168/4/390
Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-Year Health Care Costs Associated With Delirium in the Elderly Population. Arch Intern Med 2008; 168(1): 27-32. http://archinte.ama-assn.org/cgi/content/abstract/168/1/27
Naughton BJ, Saltzman S, Ramadan F, Chadha N, Priore R, Mylotte JM. A multifactorial intervention to reduce prevalence of delirium and shorten hospital length of stay. J Am Geriatr Soc. 2005; 53(1):1823
Lundstrm M, Edlund A, Karlsson S, Brnnstrm B, Bucht G, Gustafson Y. A multifactorial intervention program reduces the duration of delirium, length of hospitalization, and mortality in delirious patients. J Am Geriatr Soc. 2005; 53(4): 622628
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March 11, 2008
Lessons from Ophthalmology
John Simon and his colleagues at Albany Medical College have presented their retrospective review of 106 cases of surgical confusions in several venues (Simon 2007a, Simon 2007b, Simon 2007c). These include 42 cases from the Ophthalmic Mutual Insurance Co. and 64 cases from the New York Patient Occurrence and Reporting Tracking System (NYPORTS). 67 cases involved wrong lens implants, 15 cases wrong-eye operations, 14 cases wrong-eye block, 8 wrong patient or procedure, and 2 wrong corneal transplant. Based on these findings, they estimate an incidence of 6.9 such errors per 100,000 ophthalmologic surgeries.
Implantation of the wrong intraocular lens was the most common occurrence in both databases. Errors in both the preoperative period and operative period were found to lead to the incorrect implantation. In the preoperative period, contributory causes identified included faulty calibration of the A-scan equipment, transposition of records from the ophthalmologists office, transcription errors, switched patient identification stickers, and transposition of IOL power calculations while faxing records on two patients at the same time.
Intraoperative errors in almost all cases involved failure to identify the lens specifications properly before implantation. Multiple contributory factors were indentified, including changes in the OR schedule, changed staff assignments, staff changes during the procedure, poor lighting, multitasking and other distractions, and misreading the label on the implant box. In one case the surgeon had dropped multiple patient charts and they were out of order when reassembled. (Note in our June 5, 2007 Patient Safety Tip of the Week Patient Safety in Ambulatoy Surgery we discourage the practice of allowing the medical records of multiple patients to be in the operating room since it is too easy to mistakenly pick up the chart of the wrong patient during a procedure.) In 77% of the cases with adequate information the authors felt that adherence to Universal Protocol would have prevented the adverse event but most of the preoperative errors would not have been identified using Universal Protocol.
On the other hand, most of the 14 cases of anesthetic block to the wrong eye and 8 cases of wrong patient/procedure did result from inadequate verification procedures and could have been prevented by following Universal Protocol. While some of the contributory factors are those we have seen in other wrong site surgeries (eg. patients with similar names, site markings being obscured by skin pigmentation or covered by the OR cap or drapes, etc.), there were some factors somewhat unique to this patient population. Many (probably most) patients having cataract surgery have cataracts in both eyes. And in the elderly population the incidence of problems with cognition is more likely to result in patients misidentifying surgical site themselves.
For each type of event, the authors also examined the responsibilities, what as done for the patient, patient outcomes and severity, and liability payments. They give a good discussion of important steps to take, beginning in the office right on through the final verification process, to help prevent incidents of these types. They also have a good discussion about the importance of disclosure and apology to the patient.
Our June 5, 2007 Patient Safety Tip of the Week Patient Safety in Ambulatoy Surgery noted some other issues that may impact on cases done in the ambulatory setting. One factor is that a surgeon will often be performing many cases of the same or similar procedures. Interestingly, very experienced surgeons may be more likely to be involved in wrong-site cases, perhaps because their experience allows them to schedule so many cases in one day. The quality of the medical records is often not as good in ambulatory settings. The facility medical record is often scant and the physician often brings in his/her office notes that are unofficial as far as the facility is concerned. Often critical information is in the physician office record and never appears in the facility medical record. It is therefore incumbent upon the facility and entire team to ensure the adequacy of the medical record and all documentation prior to the procedure. And there are certain production pressures unique to the ambulatory setting. When a surgeon is booked for many cases in one day, there is a higher likelihood of last-minute changes in the schedule. Also, weve seen cases in the ambulatory setting where one patient may demand a procedure earlier in the day, leading to last-minute alterations in the order on the schedule. And lastly, the pressure to get cases done promptly and stay on schedule are everpresent.
The American Academy of Ophthalmology has issued good guidance statements onavoiding wrong-site surgery and avoiding incorrect intraocular lens placement , with good examples of how checklists might be utilized.
References:
Simon JW. Preventing Surgical Confusions In Ophthalmology (presentation at NYSDOH Patient Safety Conference, Albany, NY, May 2007)
Simon JW. Preventing Surgical Confusions In Ophthalmology (An American Ophthalmolgical Society Thesis). Trans Am Ophthalmol Soc 2007;105:513-529
http://www.aosonline.org/xactions/2007/1545-6110_v105_p513.pdf
Simon JW, Ng Y, Khan S, Strogatz D. Surgical Confusions in Ophthalmology. Archives of Ophthalmology. 2007; 125(11):1515-1522
http://archopht.ama-assn.org/cgi/content/abstract/125/11/1515
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March 18, 2008
Is Desmopressin on Your List of Hi-Alert Medications?
Well bet you dont have desmopressin (DDAVP) on your list of hi-alert medications, but maybe you should. DDAVP is the synthetic form of the natural antidiuretic hormone arginine vasopressin. It has shown up in the literature muliple times in the past 3 months because of adverse outcomes related to it.
The FDA issued an alert in December 2007 about the dangers of severe hyponatremia and seizures related to desmopressin. This alert was based on their review of 61 post-marketing cases of hyponatremic seizures associated with desmopressin use, including two fatal cases. Children with primary nocturnal eneuresis (PNE) taking intranasal formulations of desmopressin are particularly susceptible to these complications so the FDA alert cautions that the intranasal formulation is no longer indicated for treatment of PNE. It also cautions that treatment of PNE with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid/electrolyte disturbances. And it cautions that all desmopressin formulations should be used with caution in patients at risk for water intoxication with hyponatremia or in patients taking medications that may cause them to drink more fluids, such as tricyclic antidepressants or SSRIs.
ISMP Canada issued an alert earlier this month about the need for monitoring protocols in patients taking desmopressin. This followed a report of a patient who developed diabetes insipidus following neurosurgical removal of a nonmalignant brain tumor. The patient was treated with desmopressin and had numerous problems with fluid/electrolyte management and had a positive fluid balance of several liters, resulting in death presumably from water intoxication and cerebral edema. Even minor increases in electrolyte-free water have been associated with disproportionately high increases in intracranial pressure. Contributing factors in this case were continued administration of hypotonic fluids and DDAVP after the serum sodium had normalized and the rapidity of the shift from a hypernatremic state to a hyponatremic state.
And a case study from this months AHRQ WebM&M dealt with an adverse outcome related to desmopressin. Though the WebM&M focused on the issue of hold orders, the case again pointed out the dangers associated with desmopressin.
These cases point out two important reasons to identify desmopressin as a hi-alert medication. First, it is a drug that may be associated with serious, even fatal, complications. Second, its a drug that many physicians, nurses, and pharmacists have limited experience with. Yet it is being used clinically in many different circumstances. Whereas its use was originally primarily in patients with central diabetes insipidus, DDAVP is now often used in cardiac surgery, for uremic bleeding, for treatment of hemophilia A or Type 1 von Willebrands disease, and more recently being used frequently for treating nocturnal eneuresis in children or nocturia in elderly patients and patients with hyperactive bladder. Many patients now end up being admitted for an unrelated illness and staff unfamiliar with DDAVP are saddled with managing it during a hospitalization. That is exactly the circumstance where having available strict protocols and monitoring programs is a smart addition to your medication safety program.
The young and the elderly are two populations that are more prone to develop hypontremia during DDAVP treatment. Therefore, the recent upsurge in use for bladder-related conditions is playing a role in the probable increase in adverse events related to DDAVP. DDAVP also has a relatively long and variable duration of action. Issues of unusually long half-life or bioactivity have been implicated in some cases of adverse events related to DDAVP (Dehoorne et al. 2006). In some cases, hyponatremia due to DDAVP may have been made more likely by a second drug, such as ibuprofen (Garcia et al. 2003).
The ISMP Canada alert recommends development and use of standardized order sets (preprinted orders or electronic order sets), including monitoring parameters, for postoperative management of postoperative neurosurgical patients to facilitate early diagnosis and management of central diabetes insipidus. They also discuss the need for discussion of such potential complications to be a part of all hand-offs. They stress the importance of standardized order sets for monitoring patients treated with DDAVP, including the frequency with which the parameters should be monitored. Urine output, by itselt, should not be used to determine whether subsequent doses of DDAVP are given. The trend in the monitored parameters may be as important as the actual numbers. The choice and rate of IV fluids and the need for DDAVP should be determined by the results of those parameters. The patients should be carefully monitored for signs or symptoms of hyponatremia or water intoxication. Besides seizures, headache, nausea, vomiting and obtundation are common symptoms of water intoxication. In addition to the standardized order sets, everyone caring for the patient should have ready access to information and protocols about the drug and the monitoring. Families, too, should be engaged in monitoring because they may pick up subtle changes in the patient before professional staff would. And it is critical that the laboratory test results be available on a prompt basis.
Though the ISMP Canada alert is aimed at neurosurgical patients, the advice is wise and most of it is also applicable to other types of patients being treated with DDAVP. Perhaps the most important initial question to ask is whether continued use of DDAVP is even indicated during the acute hospitalization. For many of it uses, particularly the bladder-related ones, there may be no reason to use DDAVP at all during the hospital stay. If it is determined that DDAVP should be continued, then the type of standardized order sets and monitoring protocols similar to those in the ISMP Canada alert should be used.
Most hospitals have included in their hi-alert medication safety programs categories of drugs that have a narrow therapeutic index or possible severe adverse side effects and then looked at drugs within those categories that may be particularly likely to be unfamiliar to clinical staff. For example, most hospitals include anticoagulants in their hi-alert medication safety program and typically focus on coumadin, heparin, LMWHs, and antiplatelet agents. However, some have recognized that drugs like argotroban may need to be used under rare circumstances and that few practitioners have extensive experience with that drug. Therefore, they have made special attempts to make appropriate information on the less familiar drug available to practitioners and have developed standardized order sets for dealing with such drugs. The same sort of logic should apply to DDAVP and it should be addressed in your hi-alert medication safety program.
References:
FDA Alert 12/4/2007. Information for Healthcare Professionals: Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) http://www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm
ISMP Canada Alert March 3, 2008. Desmopressin Incidents Identify a Need to Evaluate Monitoring Protocols. http://www.ismp-canada.org/download/ISMPCSB2008-01DDAVP.pdf
AHRQ WebM&M. Hold That Order. March 2008 http://www.webmm.ahrq.gov/case.aspx?caseID=171
Dehoorne JL, Raes AM, van Laecke, E, Hoebeke EP, Vande Walle JG. Desmopressin Toxicity Due to Prolonged Half-Life in 18 Patients With Nocturnal Enuresis.
The Journal of Urology,2006; 176: 754-758 http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B7XMT-4K8Y775-3J&_user=10&_coverDate=08/31/2006&_alid=707110399&_rdoc=17&_fmt=summary&_orig=search&_cdi=29679&_sort=d&_docanchor=&view=c&_ct=73&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=50356436a760b8c893564231548ead5e
Garca EBG, Ruitenberg A, Madretsma GS, Hintzen RQ. Hyponatraemic coma induced by desmopressin and ibuprofen in a woman with von Willebrand's disease. Haemophilia 2003; 9: 232-234 http://www.blackwell-synergy.com/doi/abs/10.1046/j.1365-2516.2003.00719.x?prevSearch=allfield:(garcia)
Print Is Desmopressin on Your List of Hi-Alert Medications?
March 25, 2008 More on MRSA
The waters got muddied in the last month on what to do to prevent some hospital-associated infections (HAIs). Our January 2008 Whats New in the Patient Safety World column on Two Timely Articles on MRSA Interventions noted that a universal screening program at Evanston Northwestern had been successful in reducing both MRSA transmission and MRSA blood stream infections. Now two new studies on universal screening seem to come to contradictory conclusions about the value of universal screening for MRSA.
A Swiss study published in JAMA (Harbarth et al. 2008) found that universal screening for MRSA in surgical patients resulted in no reduction in surgical MRSA infections even though it did identify many previously unknown MRSA carriers.
But a US study published in the Annals of Internal Medicine concluded that universal MRSA screening on admission resulted in a 70% reduction in MRSA infections. This study was actually an extension of the previously published Evanston Northwestern work. It was a study done in 3 hospitals and consisted of a preliminary phase in which MRSA screening was done just in ICUs, then a second phase in which MRSA screening was performed on all patients at admission. They found no statistically significant improvement when screening was performed on just ICU patients but the 70% reduction in MRSA infections found after implementation of the universal screening was statistically significant.
So why the different results and conclusions? Both studies utilized rapid turnaround molecular testing techniques for MRSA and did not rely on culture results for screening. The average time from admission screening to test reporting was 22.5 hours in the Swiss study and slightly less (0.67 days) in the US study. The Swiss study only included patients admitted for surgery, whereas the US study included all admitted patients. A relatively low background MRSA infection rate in the Swiss study may have made demonstration of statistically significant improvement after the intervention more difficult.
Note that both studies actually used multiple interventions. Both used conventional contact isolation, with private rooms or cohorting of MRSA patients, mandatory gown/gloves/mask for all visits, and dedicated equipment (eg. stethoscopes) in the rooms. In addition to the rapid screening, both used topical treatments for decolonization of carriers to varying degrees. One also suspects that adherence to infection control techniques such as hand hygiene were probably more closely adhered to in the setting of a formal study than they are in a typical hospital setting.
Though both studies should be lauded for their practical designs, they reflect the great difficulty in developing an effective strategy for dealing with MRSA and related issues in the absence of true randomized controlled trials. So the jury is still out on what is the most effective way to deal with prevention of MRSA infections.
One consideration not noted in either study is that of unintended consequences of contact isolation. Kirkland and Weinstein (Kirkland 1999) found that healthcare workers who treated patients in contact isolation entered their rooms less frequently and had significantly less direct contact with them. Saint et al. (2003) found that attending physicians in two teaching hospitals were about half as likely to examine patients in contact isolation. Another study (Stelfox et al. 2003) showed that isolated patients are twice as the likely as control patients to suffer an adverse event during hospitalization. The difference was primarily due to preventable adverse events and included event such as falls, decubiti, and fluid/electrolyte disorders. In fact, the latter events were 8 times more likely in isolated patients. They also had a cohort of congestive heart failure patients in isolation and these patients were much less likely to have certain interventions and evidence-based care than a control group of congestive heart failure patients. And we have all seen that patients in contact isolation often do not get services such as active rehabilitation that they might get were they not in isolation.
These potential unintended consequences of contact isolation need to be closely monitored and every attempt should be made to ensure they do not happen. It would be a tragedy to allow an asymptomatic carrier of MRSA to get a decubitus because he/she was seen less frequently while in isolation.
References:
Harbarth S, Fankhauser C, Schrenzel J, Christenson J, Gervaz P, Bandiera-Clerc C, Renzi G, Vernaz N, Sax H, Pittet D. Universal Screening for Methicillin-Resistant Staphylococcus aureus at Hospital Admission and Nosocomial Infection in Surgical Patients. JAMA.2008;299(10):1149-1157
http://jama.ama-assn.org/cgi/content/abstract/299/10/1149
Robicsek A, Beaumont JL, Paule SM, Hacek DM, Thomson RB, Kaul KL, King P, Peterson LR. Universal Surveillance for Methicillin-Resistant Staphylococcus aureus in 3 Affiliated Hospitals. Ann Intern Med 2008; 148: 409-418 http://www.annals.org/cgi/content/abstract/148/6/409#FN
Kirkland KB, Weinstein JM. Adverse effects of contact isolation. The Lancet 1999; 354: 1177-1178 http://www.thelancet.com/journals/lancet/article/PIIS0140673699041963/abstract
Saint S, Higgins LA, Nallamothu BK, Chenoweth C. Do physicians examine patients in contact isolation less frequently? A brief report. Am J Infect Control 2003; 31: 354-356 http://www.ajicjournal.org/article/S0196-6553(02)48250-8/abstract
Stelfox HT, Bates DW, Redelmeier DA. Safety of Patients Isolated for Infection Control. JAMA.2003;290:1899-1905
http://jama.ama-assn.org/cgi/content/abstract/290/14/1899 (abstract)
http://jama.ama-assn.org/cgi/reprint/290/14/1899 (pdf)
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