Healthcare Consulting Services
April 7, 2015
Missing Patients and Death
Though our first column on missing patients was 6 years ago (see our July 28, 2009 Patient Safety Tip of the Week “Wandering, Elopements, and Missing Patients”) there was considerable renewed interest in the topic after a patient was found dead 17 days after going missing at a San Francisco hospital in 2013 (see our October 15, 2013 Patient Safety Tip of the Week “Missing Patients” and our December 2013 What’s New in the Patient Safety World column “Lessons from the SFGH Missing Patient Incident”).
Despite considerable discussion regarding lessons learned from that unfortunate incident, similar cases continue to occur. Several are described below:
An elderly patient suffering from dementia who wandered out of a scandal-hit hospital was found dead in a ditch a quarter of a mile from the grounds the next day (Duffin 2015). She was said to be a ‘known wanderer’, was able to walk out of the hospital, wearing only a cardigan and trousers. She was reportedly seen by a member of staff but not stopped. This was especially problematic since a report, following an inspection in June 2014, stated: ‘The support for patients living with dementia or who may have a learning disability was inconsistent.’ It also raised concerns about staff levels, saying there was a ‘heavy reliance’ on agency staff which, in some instances, ‘affected the delivery and continuity of patient care’.
A 69-year-old man with diminished mental capacity died from complications of hypothermia three days after he walked away from an assisted living facility (Bear 2015).
A 58-year-old man, hospitalized at a San Diego hospital because of head and neck trauma, went missing from the hospital and was found dead at the bottom of a nearby canyon 5 days later (CDPH 2014). This case has the most to learn from because the CDPH publishes the statement of deficiencies (SOD) and hospital plan of correction (POC). Because he was considered at risk for falling, he had both a bed alarm and a video monitor. The patient had confusion that would wax and wane. One morning the Video Monitor Technician notified a Clinical Care Partner (CCP) that the patient was getting out of bed. That CCP went to the patient’s room and found the patient to be missing. The CCP notified the RN, who notified the Charge Nurse. The Charge Nurse called the Security pager number twice and pressed a panic button twice while the CCP and RN went looking for the patient. The CCP, after searching the nursing unit, went down the elevator to the first floor and basement looking for the patient. When the CCP returned to the nursing unit, security was still not there so she contacted them by phone. The panic button was not working. Response by Security was delayed. Five days later the patient was found deceased at the bottom of a canyon adjacent to the facility’s parking structure.
The Director of Security said the pagers should not be used to contact Security in the case of an emergency. Instead, staff should press the panic button and dial 6111. There was actually no written process telling staff how Security should be contacted. In addition, the security technician had been aware that the panic button on that nursing unit had been non-operable for 8 days before it was fixed.
On later review of video tapes the patient was seen exiting the hospital via the front doors, wearing hospital gown, non-skid socks and a cervical traction device. Staff noted it was not uncommon to see patients leaving the building in gowns to smoke outside. So when staff ignore such occurrences it is really a form of “normalization of deviance” where a deviation of behavior is so common we consider it “normal”. That desire to smoke is a risk factor for patient elopement. In our December 2012 What’s New in the Patient Safety World column “Just went to have a smoke…” we joked about a scene in the Denzel Washington movie “Flight” in which 3 hospital inpatients all came to the same hospital stairwell to have a smoke. We wondered how often that might happen and that was soon answered: 18.4% of patients who smoke will smoke at some time during their inpatient hospitalization (Regan 2012).
The hospital’s Plan of Correction (POC) focused heavily on the non-operable panic button. They actually found that many panic buttons in other areas were also non-operable. The hospital ultimately upgraded to a version of the panic button that allows real-time notification of failure of communication/connectivity. Security immediately follows up. If a reboot of the computer fails to correct the problem a technician responds to fix it within 24 hours. Importantly, while the button is non-operable a sticker is placed over it indicating it is “non-operable” and having instructions on how to contact Security. Note that we’ve seen similar problems with panic buttons elsewhere, such as behavioral health units (see our February 4, 2014 Patient Safety Tip of the Week “But What If the Battery Runs Low?”). It is clear that any time you have a critical alert system you must ensure it is functioning at all times so programs like daily testing are a must.
But we might make a case that the heavy focus on the panic buttons was, in fact, too heavy. Panic buttons are a sort of “silent” alarm and they alert only a very few people and don’t really tell them what is wrong or what to look for. Some features of this case are eerily similar to the one at San Francisco General in 2013 (see our October 15, 2013 Patient Safety Tip of the Week “Missing Patients” and our December 2013 What’s New in the Patient Safety World column “Lessons from the SFGH Missing Patient Incident”) though it should be noted this case actually occurred prior to the SFGH case. Valuable time was lost while a single person was searching for the patient. And in both cases it appears that too many people considered it the responsibility of “Security” to search for missing patients and no true system-wide response ever occurred. That should never be the case. While “Security” may command and coordinate a search, there must be a coordinated effort that involves staff from all parts of the hospital. There is no mention of the search protocol in the SOD or POC in the San Diego case.
When a patient is discovered to be missing a brief search of the local unit should be done. If the patient is not found immediately, the “code” for a missing patient should be issued. That is called to the hospital operator and announced over PA system. While most hospitals still use arcane codes for various emergencies, many are moving to “plain language” codes for these alerts. In the case of a missing patient a “plain language” code with the description of the missing patient has the additional advantage that visitors and other patients in the hospital might identify the missing patient. Once the “code” is announced the facility should have a predetermined search grid where every area of the hospital and surrounding grounds has a designated person to search it. A central command post is set up and staff call in to that post once they have searched their sector.
Yes, such procedures are disruptive. All the workers who participate in such searches have other duties and care for all the other patients cannot be abandoned. It’s just like responding to a cardiac arrest. But sector searches can be done in an expedited manner as long as the search sectors are not too large, staff know their responsibilities, and communication to the command post is simple.
Some facilities use an alternative system to alert staff to missing patients. They may use text messages sent out in a “blast” fashion to computer terminals and staff smartphones, the equivalent of the well-known “Amber alert” when a child in the community goes missing. This sort of system can have the advantage of including a description of the patient and perhaps a photograph. But the disadvantages are that it may take longer to implement and you lose the chance that a visitor or other patient might identify the missing patient.
In these incidents and other cases of missing patients we’ve discussed in the past, several themes recur:
All types of facilities need to develop policies and procedures for:
1) doing an assessment for risk of wandering or elopement
2) implementing risk reduction strategies for those patients at risk
3) performing a prompt and thorough search when a patient is missing
Assessment for Wandering Risk
We refer you to our Patient Safety Tips of the Week for July 28, 2009 “Wandering, Elopements, and Missing Patients” for a discussion on the assessment of patients for risk of wandering. Also remember our comments above on the urge to smoke tobacco as a potential risk factor for wandering and elopement.
Reducing the Risk of Wandering
So what do you do when you identify a patient as being at-risk for wandering or elopement? It makes sense to put them in a room where staff would be more likely to see them exit the room (usually closer to the nurse’s station). Many floors have one or two rooms that are video monitored, a logical choice for such patients. Consider having the patient wear a gown that is a different color than the usual gowns so that all staff would recognize such patient as being “lost” if encountered in other parts of the hospital. One hospital we worked with used an off-purple color to flag such patients. The San Diego hospital in today’s index case began using orange colored arm bands to identify patients at high risk of wandering. But make sure your staff all know what those colors mean so they can take action if they see such a patient somewhere they don’t belong.
Potential exit doors on the unit should be fitted with appropriate alarms (that are functioning correctly) and with appropriate signage to keep the door closed. But also consider the downside of locked doors. Many units have doors that are locked automatically and prevent access to the unit. So you need to consider what would happen if a patient wandered out such a door and could not get back in. Such may have been the case in the SFGH incident previously described. We even recall once getting a cellphone call from a physician who responded to a cardiac arrest and got locked in a stairwell and could not get back in to any unit! Also consider that there are times when your locked doors will be automatically unlocked (eg. fire alarms) creating an opportunity for a wandering patient to leave the unit.
Consider keeping the patient in a room with a roommate or have family members stay in the room. Attention to the patient’s physical needs (food, water, warmth, pain management, toileting) are important. Letting the patient walk or exercise under supervision may be useful. Our Patient Safety Tips of the Week for July 28, 2009 “Wandering, Elopements, and Missing Patients” had links to several websites having resources related to management of the patient at risk for wandering.
Construction sites are particularly vulnerable for a few reasons. First, you often have outside workers there who are not thinking about patient safety. So they may leave doors unlocked. Second, construction sites have lots of opportunities for someone to injure themselves. So make sure you pay close attention to any sites at your facility with ongoing construction.
Be especially careful during patient transports. One of the items we recommend including in your “Ticket to Ride” checklist/communication tool for transports (eg to Radiology) is information about wandering risk.
Ultimately, we will look to technology solutions to help in cases of lost or missing patients. Technology already allows us to find our car keys, track our dogs, and locate hospital assets like wheelchairs so technology solutions to track patients are a logical direction. However, we’ll emphasize that technology will always be only part of the response to missing patients. It should never be the sole modality relied upon. The three most obvious technology tools are GPS, RFID, and Bluetooth. A VA analysis suggests GPS beats RFID in most scenarios (VA 2013). But the specific technology chosen will likely differ from facility to facility and may depend upon the need to integrate with other technology needs. For example, though GPS probably would be best for locating patients who have left the facility or hospital grounds, some hospitals may prefer RFID because they are using an RFID system for inventory tracking. Bluetooth would have limited applicability. Many of you probably already use low-power Bluetooth for tracking items like your keys (or maybe your TV remote!). But in the context of missing patients Bluetooth applications would most likely only be of use in alerting staff when a patient leaves the Bluetooth receiving area (about the size of a typical inpatient floor). Similarly, the bracelets used in newborns to prevent abduction can alert staff when a patient leaves the unit but are of little help in locating a patient once they have already left the unit.
Bed alarms are another technology that can alert staff when a patient gets out of bed. Their biggest applicability is in prevention of patient falls, though their success at even that has been less than stellar (see our January 2013 What’s New in the Patient Safety World column “Bed Alarms Fail the Test”). Our own experience with bed alarms has not been particularly good. We often see them malfunction or be improperly installed (see our Patient Safety Tip of the Week “Unintended Consequences of Technological Solutions”) or be disconnected intentionally because they are alarming too frequently. In addition, as in the current CDPH case, patients may still end up leaving the unit despite using bed alarms.
How about low-tech tools? Multiple facilities, particularly long-term care facilities that care for many patients with dementia, often use tricks to disguise doors or otherwise encourage wandering patients to avoid doors. One Canadian hospital uses a door wrap in its continuing care facility that makes the door look like a cabinet full of things (Whitnall 2015). That helps prevent patient with dementia and wandering from going to the doors. Others have used the image of a “black hole” near doors to discourage wandering patients from going to the doors.
Performing a Prompt and Thorough Search if a Patient Goes Missing
Despite our best efforts to identify patients at high risk of wandering and absconding and implementing risk reduction strategies, patients will still wander and get lost. If a patient does go missing, doing a thorough search promptly is crucial. For those missing more than 24 hours, the death rate can be as high as 50% (VA 2013).
When a patient is discovered to be missing a brief search of the local unit should be done. Staff on the unit need to be notified as soon as a patient is missing. A very brief head count of patients and look in rooms on a unit and any adjacent closets, stairwells or elevators is typically done but this should last no more than a couple minutes.
If the patient is not found immediately, the “code” for a missing patient should be issued. That is usually called to the hospital operator and announced over PA system. While most hospitals still use arcane codes for various emergencies, many are moving to “plain language” codes for these alerts. In the case of a missing patient a “plain language” code with the description of the missing patient has the additional advantage that visitors and other patients in the hospital might identify the missing patient. Once the “code” is announced the facility should have a predetermined search grid where every area of the hospital and surrounding grounds has a designated person to search it. A central command post is set up and staff call in to that post once they have searched their sector.
Yes, such procedures are disruptive. All the workers who participate in such searches have other duties and care for all the other patients cannot be abandoned. It’s just like responding to a cardiac arrest. But sector searches can be done in an expedited manner as long as the search sectors are not too large, staff know their responsibilities, and communication to the command post is simple.
Some facilities use an alternative system to alert staff to missing patients. They may use text messages sent out in a “blast” fashion to computer terminals and staff smartphones, the equivalent of the well-known “Amber alert” when a child in the community goes missing. This sort of system can have the advantage of including a description of the patient and perhaps a photograph. But the disadvantages are that it may take longer to implement and you lose the chance that a visitor or other patient might identify the missing patient.
Key assigned staff should immediately go to a designated “command center” from which they will direct the response. Each unit (clinical and nonclinical) will have a specific predetermined area they must search in a systematic fashion. The command center must have an overlay grid of the buildings and surrounding areas and be able to mark off areas on the grid that have been searched. The search teams must have keys to their search areas since sometimes patients lock themselves into rooms inadvertently.
We also recommend early outdoor search since a patient can easily stray far from the building (or into automobile traffic) in a very short period of time. The search grid should include outdoor areas like parking areas, open spaces, bushes and shrubs, and any other adjacent areas where a patient might wander to. A typical grid sector might be 500 x 500 feet. Typically, the search teams comb a sector in a standardized direction (eg. south to north).
We also recommend that the local police department be notified immediately by the operator when the “missing patient code” is called (don’t forget to include them in your planning process and drills). Many facilities also use many security video cameras that are monitored centrally. Security staff may be able to scan those quickly to look for a patient exiting the building.
What do you do when you find the patient? First, be aware they are likely confused and be careful not to frighten them. Do a brief assessment as to whether they may have been injured. Notify the command center you have found the patient and either return them to their unit or to the emergency department. They should be evaluated by a physician at that time to determine whether any injuries have occurred. In the unfortunate circumstance where the patient is found dead, the scene should be left undisturbed because the authorities will treat it as a crime scene.
Staff Education and Drills
All your staff need to be aware of how to respond when a patient goes missing. That means not only describing their roles on their initial orientation but doing an inservice at least annually. Drills are critical for any event that is likely to be rare but critical when it occurs. Especially with relatively rare events, it is important that all staff know what to do during such emergencies and the best way to prepare for those is with drills. Yes, you can and should include education and training on missing patient alerts during orientation and annual reorientation but you have to periodically run a drill to see whether the responses are adequate and timely. During drills one may also see various nooks and crannies and other areas (eg. ventilation ducts) that a patient could get into, perhaps leading to some physical improvements to prevent such dangerous access.
From a few incidents we’ve seen or read about we had the suspicion that missing patient events were more likely on weekends and holidays. A VA study actually showed that was not the case, at least statistically (DeRosier 2005). But keep in mind your drills need to also be done on shifts other than a regular day shift and you also need to inservice staff, such as agency staff, that might be temporarily working at your facility. And that applies to administrators as well! Your administrators likely have a role all missing patient responses (eg. communicating with families, police, etc.) so they must know what their role is on weekends and nights, too.
Despite our best efforts to identify patients at risk for wandering and elopement and interventions to prevent such, it is impossible to prevent all such cases. In the San Diego incident, the patient had been flagged as being at risk for wandering, was put on a video monitor and was even seen getting out of bed on the video monitor, yet still managed to wander out of the hospital anyway. Therefore, it is imperative that every healthcare facility and organization have in place plans and procedures, known by all and rehearsed periodically, in the event a patient goes missing. Plans that consider missing patients the sole responsibility of “Security” are doomed to failure.
It’s always a good time for facilities to say “could that happen here?” and do a thorough review of your policies and procedures for missing patient incidents, including making sure you do appropriate drills for such incidents. You probably will be unable to prevent every potential elopement. When one does occur, do a debriefing session as soon as possible to identify potential missed clues and other useful lessons. Then do a formal RCA (root cause analysis) within a short timeframe. There are always valuable lessons learned that hopefully can prevent other elopements in the future. But even if you’ve not already had a patient go missing it’s good to do a FMEA (failure mode and effects analysis) to determine your potential vulnerabilities. And make sure you do drills, with thorough critiques and debriefings following the drills. When you do your FMEA, consider also what happens to locking doors when a fire alarm goes off. You might even consider doing your missing patient drill immediately following a fire drill.
Our prior columns on wandering, elopements, and missing patients (many with links to other good resources):
Duffin C. Dementia sufferer found dead in a ditch yards away from scandal-hit Stoke Mandeville Hospital after being allowed to wander off her ward. The Daily Mail (UK) 2015; 26 March 2015
Bear J. Man dies of hypothermia complications after wandering away from Longmont assisted living facility. Times-Call (Longmont, CO) 3/31/2015
CDPH (California Department of Public Health). Complaint Intake Number CA00357013. 2014
Regan S, Viana JC, Reyen M, Rigotti NA. Prevalence and Predictors of Smoking by Inpatients during a Hospital Stay. Arch Intern Med 2012; 172(21): 1670-1674
VA. VISN 8 Patient Safety Center of Inquiry, Tampa. Wandering and Missing Incidents in Persons with Dementia. Updated: October 24, 2013
Whitnall C. Ross Memorial hopeful door wrap will discourage wandering patients
Image reflection of hallway cabinet installed on doors exiting the Continuing Care Program. MyKawartha.com March 15, 2015.
DeRosier JM, Taylor L. Analyzing Missing Patient Events at the VA. TIPS (VA Topics in Patient Safety) 2005; 5(6): 1-5
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April 14, 2015
Using Insulin Safely in the Hospital
It’s been almost 5 years since we last did a comprehensive column on insulin-related issues (see our November 2, 2010 Patient Safety Tip of the Week “Insulin: Truly a High-Risk Medication”). More recently we’ve focused more on issues related to insulin pumps and insulin pens and related devices. But 3 recent articles again remind us of the myriad of problems that may occur with insulin.
The first, published by ISMP Canada, is a very instructive case in which insulin administered via an incorrect route for treatment of hyperkalemia resulted in profound hypoglycemia and consequent brain injury (ISMP Canada 2015). The patient was a nondiabetic patient receiving hemodialysis who was admitted to a surgical unit with a bowel obstruction. The patient was found to have significant hyperkalemia and a physician handwrote orders for salbutamol by inhalation, 1 ampule of D50W (route not specified), and regular insulin 10 units (route not specified). The D50W was given intravenously but the regular insulin was given by subcutaneous injection. When later found unresponsive, the patient’s blood glucose level was undetectable. Subsequently it was also determined that the initial potassium level was falsely elevated due to specimen hemolysis.
ISMP Canada does an excellent job describing multiple aspects of the case. But perhaps the most salient lesson is has to do with the difference in duration of action for the D50W and regular insulin administered via the subcutaneous route. For management of hyperkalemia insulin is supposed to be delivered via the IV route, where its action is immediate. But when administered via the subcutaneous route the action of the insulin is delayed and its duration is prolonged. Hence, in this case the action of insulin extended beyond the period of protection by D50W and profound hypoglycemia resulted.
The original orders were handwritten and routes were not specified by, nor subsequently clarified with, the ordering physician. The insulin order was not reviewed by a pharmacist (ward stock availability of both the D50W and insulin bypassed pharmacist review). The nurse’s familiarity with the subcutaneous route for insulin administration may have introduced confirmation bias. A second nurse reviewing the order verified the route of administration that had been on the transcription of the handwritten order (rather than seeing the original handwritten order?). And no order had been given for monitoring blood glucose levels after administration of the insulin. They also noted that different treatment approaches would likely have resulted if the hemodialysis service had been consulted and if the falsely elevated potassium level had been recognized. A significant problem was the lack of a standardized order set for management of hyperkalemia.
They provide a number of recommendations for hospitals, prescribers, healthcare IT systems, nurses and pharmacies to help avoid similar occurrences. But a key recommendation is development and use of order sets for off-label use of commonly used medications, particularly those that are high-alert medications.
This is an excellent article with multiple lessons learned. We hope you will read the article in full.
The second recent article reminds us of the continuing dangers related to U-500 insulin (Leuck 2015). The article is written from the perspective of a pharmacist and contends that any order for U-500 insulin should be considered a red flag and require review by a pharmacist. We couldn’t agree more! The article points out the two biggest reasons for errors related to U-500 insulin: (1) the syringes used and (2) the different units/mL. Unfortunately, there still are currently no syringes calibrated for the higher concentrations so healthcare workers often use this dosage form with insulin syringes that are calibrated for 100 unit per mL insulin preparations. That’s a setup for errors. The author also notes that it may be unclear when a physician writes a prescription for, say, 25 units of U-500 insulin whether they really mean 25 units or 25 mL (the latter representing 125 units of insulin). So the author recommends electronic prescribing systems and EHR’s be programmed to present an alert that would result in a pharmacist reviewing the order with the prescriber and then making sure that nursing staff understand how it is to be administered.
We discussed the syringe issue in our November 2, 2010 Patient Safety Tip of the Week “Insulin: Truly a High-Risk Medication”. In that column we also recommended that the 500 unit per mL preparations be stored completely separate from the other insulin preparations and only be used by specially designated healthcare workers who have received specific training in use of the higher concentration product. Certainly, they should never be stored as part of “floor stock” where they might be easily mixed up with the more common 100 unit per mL preparations. We even raised the question as to whether U-500 insulin should be stocked at all in a hospital. Unfortunately, the need for that higher concentration has been increasing in recent years as more obese patients with insulin resistance have been requiring much higher insulin doses and the higher concentrations may also be needed for patients having implanted insulin pumps. We recommended that if you need to stock the higher concentration, make sure you have some mechanism (like a “hard stop”) to ensure that a pharmacist is involved in validating and preparing the dose and always have an independent double check before such preparations are administered.
The third recent article by the ECRI Institute highlights the vulnerabilities that occur at each step of the entire medication process continuum for insulin (ECRI 2015). They start at the prescribing stage where the classic problem is use of the abbreviation “U” for units. The problem arises when the “U” looks like a zero so the patient inadvertently is given 10 times too high a dose. (Note that similar problems can arise when the abbreviation “IU” for international units is used.). In our November 2, 2010 Patient Safety Tip of the Week “Insulin: Truly a High-Risk Medication” we also noted that we have occasionally found these dangerous abbreviations in old order sets on computer systems or in order sets “customized” by physicians and not properly vetted. Under the prescribing stage the ECRI article also includes the risk of confusion among the many look-alike sound-alike (LASA) insulin formulations. In our previous article we gave some examples of the LASA errors and noted the importance of using tall-man lettering to help avoid some of these errors. We also highlighted the problem that occurs when computerized screens truncate choices on drop-down menus.
At the transcribing stage the ECRI article highlights the problems related to illegible writing and use of acronyms. They also highlight the problem of using outdated medication lists during medication reconciliation when the patient arrives at the hospital. Obviously, insulin doses can be changed frequently and careful reconciliation on admission (and discharge or transfer) is very important. Equally important when medication reconciliation is done on admission is determining accurately when the patient took their last dose of insulin (and their last meal). That is one of the most common errors we find with medication reconciliation. One other problem we have encountered is that many notes, even in the electronic medical record, are still dictated and transcribed. If a physician does not carefully review those transcriptions, errors in insulin dose or preparation may be propagated to other settings.
At the dispensing stage the ECRI article emphasizes failure to double check. That double check should include the insulin product, the concentration, and the dosage. Care needs to be taken here to avoid look-alike sound-alike (LASA) errors. Our November 2, 2010 Patient Safety Tip of the Week “Insulin: Truly a High-Risk Medication” discussed the many reported errors in which heparin and insulin vials are confused.
At the administration stage the ECRI article discusses incorrect doses, formulations, and concentrations plus LASA errors. It also includes here issues with misuse of insulin pens (see our many columns on insulin pen issues listed at the end of today’s column) and problems with erroneous recording of patient’s glucose. Problems with patient identification appear here. They also note here the issue of timing of meals (or lack thereof) in relation to insulin administration.
Here we again would add failure to double check as a hazard. In our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?” we did recommend that double checks be done before administering high-risk medications such as insulin. It is important here also not to over-rely on technology. One problem encountered several times is when the physician prescribes the wrong insulin dose. The nurse may recognize it might be too high a dose but the bar coding system tells the nurse that this is the correct patient and this is the correct insulin preparation and dose that is in the computer. So use of a barcoding system does not obviate the need for double checks.
At the monitoring stage the ECRI article notes problems such as failure to monitor a patient’s response to insulin so that appropriate changes in insulin dose are not made.
We refer you to our November 2, 2010 Patient Safety Tip of the Week “Insulin: Truly a High-Risk Medication” for numerous other important details and links to some excellent resources. It also deals with issues such as problems that can arise during hospital transports and handoffs, problems with co-management of patients, use of insulin drips, and avoiding “sliding scale” insulin coverage. But we think most of the recommendations listed in that column are still worth repeating here:
ISMP reminds us that not all healthcare providers have a good understanding of insulin dosing. A 2011 report by ISMP noted instances where residents or other physicians were administering insulin and made significant errors (ISMP 2011). It is a reminder that many physicians have never received formal training on insulin administration. We should never assume providers know how to administer insulin.
In 2013 the American Society of Health-System Pharmacists (ASHP) Research and Education Foundation convened a multidisciplinary panel of experts to address safe insulin practices. The panel made 10 recommendations (Cobaugh 2013) that address the areas of prescribing, dispensing and storage, administering, monitoring, evaluating and planning:
And while most of our discussion has focused on insulin errors in hospitals, we should be reminded that they also occur in the ambulatory setting. A review of data from poison control centers showed a substantial trend of increasing reports of unintentional therapeutic errors involving insulin from 2000 to 2009 (Spiller 2011). These were primarily in adults age 40 and older but females were disproportionately involved and events occurred more often in late evening. It is not clear whether this reflects the types of error or simply who uses the poison control centers. Unfortunately, the study did not include data on the nature of the therapeutic errors.
When hospitals ask us what are good topics for FMEA’s (failure mode and effects analyses) we often suggest insulin management as an excellent one. Problems can occur at so many stages of the whole insulin management system that doing a FMEA on this can be very rewarding.
Some of our prior columns highlighting the safety issues of insulin, insulin pumps, insulin pens and similar devices:
November 2, 2010 “Insulin: Truly a High-Risk Medication”
September 18, 2012 “Insulin Pump Safety”
February 26, 2013 “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?”
April 2013 “More Tips on Insulin Pen Safety”
April 2014 “Insulin Pens - Again”
March 10, 2015 “FDA Warning Label on Insulin Pens: Is It Enough?”
ISMP Canada. Wrong-Route Incident Involving Insulin and Dextrose Prescribed for Hyperkalemia. ISMP Canada Safety Bulletin 2015; 15(2): 1-4 March 5, 2015
Leuck S. Dosing Dangers of U-500 Insulin. Pharmacy Times 2015; April 7, 2015
ECRI Institute. Insulin Errors Occur Across the Medication Use Process. ECRI Institute’s PSO Monthly Brief. February 2015
FDA. FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients. FDA Safety Announcement 2015; February 25, 2015
ASHP (American Society of Health-System Pharmacists) and Hospital and Health-System Association of Pennsylvania. Professional practice recommendations for safe use of insulin in hospitals. Rockville (MD): American Society of Health-System Pharmacists
Cobaugh DJ, Maynard G, Cooper L, et al. Enhancing insulin-use safety in hospitals: Practical recommendations from an ASHP Foundation expert consensus panel. Am J Health-Syst Pharm 2013; 70(16): 1404-1413
ISMP (Institute for Safe Medication Practices). Misadministration of IV insulin associated with dose measurement and hyperkalemia treatment. ISMP Medication Safety Alert! Acute Care Edition. August 11, 2011
Spiller HA, Borys DJ, Ryan ML, et al. Unintentional Therapeutic Errors Involving Insulin in the Ambulatory Setting Reported to Poison Centers. The Annals of Pharmacotherapy 2011; 45(1): 1-6
April 21, 2015
Slip and Capture Errors
A human factors concept we often see during incident investigations and root cause analyses (RCA’s) in healthcare has been in the media spotlight recently. But many of you heard the term “slip and capture error” for the first time recently after a volunteer police deputy fatally shot a man, thinking he was firing his taser, not his gun (Yan 2015).
Sounds appalling but this is not the first time this has happened. In 2009 a very similar shooting occurred on the Oakland BART system when the officer fired his gun rather than the intended taser (Force Science Institute 2010). In fact, there were at least 6 similar incidents prior to that 2009 shooting (Meyer 2010). So we now have at least 8 such incidents in total.
This sounds vaguely reminiscent of concentrated potassium chloride issues in healthcare in the past. Multiple incidents occurred disseminated both in time and location so it took years for us to see a pattern and look for root causes.
As to the current incident, investigators with a background in human factors analysis were quick to suggest “slip and capture error” as a major contributing factor.
Those of us working in patient safety understand what slips are but what about “capture errors”? Actually we often talk about them but may not recognize that specific nomenclature. Basically, a capture error occurs when two potential actions share the same or similar initial sequences but one action is relatively unfamiliar and the other is a well-known and well-practiced action (the latter often carried out almost automatically or subconsciously). In effect, under certain circumstances the well-practiced action sequence will “capture” the action.
But the capture error is not a new concept. In fact, for years when we are teaching patient safety to medical students, residents, or other healthcare workers and tell them mistakes are inevitable we give them a classic example: “It’s Sunday morning. You intend to go to the grocery store. But you find yourself in your car halfway to your usual workplace/school, far past the grocery store.” (Usually about two thirds of the audience raises their hands when we ask if that has happened to any of them!) That happens to be a classic capture error. The more practiced activity “captured” the intended but less familiar activity.
Usually there are “enabling” factors that contribute to the occurrence of “capture” errors. These include stressful situations, emergencies, distractions or interruptions and others.
Capture errors have long been described by human factors pioneers like James Reason and Don Norman. How about some everyday examples of “capture” errors?
James Reason, widely known as the father of human factors research, provides numerous examples (Reason 1990):
Don Norman (see our November 6, 2007 Patient Safety Tip of the Week “Don Norman Does It Again!”) in his two great books on human factors and design of things (Norman 1988, Norman 2009) has some great examples:
Did you ever rent a car on a trip and turn on the windshield wipers instead of the lights because the control knobs were reversed from the car you usually drive?
In fact, the classic predictable error of using the previous year when you write a check in January of a new year is probably also really a “capture” error.
So what are some healthcare examples of “capture” errors? A nurse or physician, confronted with a new version of a device (eg. ventilator, infusion pump, dialysis machine, etc.), programs in the sequence of keystrokes or dial manipulations he/she used on the old device even though he/she has been inserviced on the new device.
Another example might occur during CPOE. You almost always choose the first option from a drop-down list listing regimens for a certain anticonvulsant. Your software vendor updates the software and the drop-down list is now reordered. Still you choose the first option and this time your patient gets the wrong dose.
A nurse, distracted by a problem with a diabetic patient, delivers a dinner tray to another patient who is supposed to be NPO (Carayon 2012).
We can imagine other scenarios in which “capture” errors might occur. Last week (in our April 14, 2015 Patient Safety Tip of the Week “Using Insulin Safely in the Hospital”) we recommended that hospitals should develop protocol-driven and evidence-based order sets for specific uses of insulin. So let’s assume I just admitted an elderly patient with obtundation and a nonketotic hyperosmolar state. But her past medical history is also relevant for heparin-induced thrombocytopenia (HIT). I log onto the EHR and find this patient’s record. I then go to the order entry section. From a drop down list of those order sets I accidentally choose the order set for DKA or diabetic ketoacidosis (which I use very often) rather than the order set for nonketotic hyperosmotic state (which I only occasionally use). I enter information where prompted but then hurry down to the last section, which deals with DVT prophylaxis, because I’m concerned about her history of HIT or heparin-induced thrombocytopenia (note that this is now a salient distracting feature as we discussed in our January 14, 2014 Patient Safety Tip of the Week “Diagnostic Error: Salient Distracting Features”). To avoid any heparin-based DVT prophylaxis I choose the “other” box and I’m shunted to another menu that has an argatroban order set, which I choose. So now a contributory factor (the history of HIT) helped me perform a well-practiced action (choosing the DKA order set) over a more unfamiliar action (the nonketotic hyperosmolar state order set) that shares many features of the DKA order set. That actually meets the definition of a “capture” error.
There is probably also some relationship or at least overlap of “capture” errors with another human factors concept: inattentional blindness (ISMP 2009). In the latter, which is really a sort of confirmation bias, we tend to see what we expect to see rather than what we actually see. This is often a contributing factor in incidents where medications are drawn up from the wrong vials.
Another interesting thought: technology may cause some “capture” errors. Autotext or automatic completion of phrases by a word processor or smart phone may lead to such errors. We’ve noted several times that every time we type “EHR” (for electronic health record) our word processor converts it to “HER” and we might miss that on proof-reading. Or our smart phone automatically inserts one email address when we really intended a different one. These examples really meet the definition of a “capture” error in that two actions start with the same sequence of steps and one that is far more familiar than the other (at least far more familiar to the computer!) takes over for the intended action. You can bet that there will be analogies with healthcare technologies.
In the taser/gun incidents, use of the taser is the relatively unfamiliar action and use of the gun is the more familiar and well-practiced action. Even if the officer has never fired his/her gun on duty, they all spend considerable time on the shooting range so have practiced use of the gun frequently. But we suspect most have practiced using the taser much less frequently and probably never practiced under stressful conditions.
As Don Norman would tell us, design of systems significantly impacts on how humans use those systems. Design of the taser and its holster likely contributed to each of the incidents. In all of the seven previous taser/gun mistakes the taser had apparently been drawn by the “strong” (dominant) hand, though the location of the taser holster was variable (Meyer 2010). One of the recommendations made by the Forensic Science Institute after the BART case was use “weak-side, weak-hand-draw” taser holsters to minimize the chance of unintentionally drawing one’s gun rather than the taser.
So how do we avoid “capture” errors? The ISMP article on intentional blindness suggests that classic interventions like education and training or rules are unlikely to prevent such errors, at least if those are the only interventions. The same likely applies to “capture” errors. But frequent practice is an obvious intervention that would be expected to help. Checklists might be a good intervention for the new device scenario but certainly are not applicable to situations like the taser/gun scenario that plays out in emergent time frames. Thoughtful design is likely the best intervention. But you can’t design things without actually seeing all the settings and factors that might influence the response.
With everything in the media over the past year about potential excessive use of force by police we often found ourselves saying “why didn’t they just use a taser rather than shoot the suspect?”. Sometimes police did not carry tasers because they were bulky and didn’t always work correctly. Ironically, making police carry poorly designed tasers could have unintended consequences like the most recent incident. After the BART shooting, BART changed its policy to require Taser placement and holster design that accommodates only a “weak-side, weak-hand” draw (Meyer 2010). We’ll leave those design issues up to those who are experts in the field but good design requires feedback from those who will actually use the equipment.
And it’s clear it is not enough to just receive some education/training on use of the taser. Taser use must be practiced just as often (perhaps even more often) than practicing gun use and done under conditions closely simulating those in which a taser is likely to be needed.
While there are clearly many other issues and factors contributing to the most recent taser/gun incident, the fact that 8 such incidents have occurred tells us that there is a strong underlying system vulnerability that is a primary root cause of such incidents.
Yan H. How easy is it to confuse a gun for a Taser? CNN 2015; April 14, 2015
Force Science Institute. Force Science explains "slips-and-capture errors" and other psychological phenomena that drove the fateful BART shooting. PoliceOne.com July 22, 2010
Meyer G. The BART shooting tragedy: Lessons to be learned. PoliceOne.com July 12, 2010
Reason J. Human Error. Cambridge: Cambridge University Press. 1990. p. 68
Norman D. The Psychology of Everyday Things. New York: Doubleday. 1988. P. 107
Norman D. The Design of Future Things. New York: Basic Books. 2009. P. 107
Carayon P (ed.). Handbook of Human Factors and Ergonomics in Health Care and Patient Safety. Boca Raton: CRC Press. 2012; p. 349
ISMP (Institute for Safe Medication Practices). Inattentional blindness: What captures your attention? ISMP Medication Safety Alert Acute Care Edition 2009; February 26, 2009
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April 28, 2015
Failure to Escalate
Our October 2009 What’s New in the Patient Safety World column “Complications – Prevent Them or Manage Them Better?” highlighted a study with striking implications for patient safety in surgery (Ghaferi et al 2009). Using data from the National Surgical Care Improvement Project (SCIP), the researchers showed that a two-fold variation in surgical mortality rates amongst hospitals is not explained by the characteristics of the patients or by the occurrence of complications. Complication rates, in fact, were quite similar at high-mortality hospitals and low-mortality hospitals. What differed, however, were the mortality rates in those cases where major complications occurred. The study thus lends credence to the concept raised by Silber et al (Silber 1992) of “failure to rescue” as the major explanation for differences in mortality across hospitals. Essentially what it implies is that the variation in mortality rates is due to differences in the way hospitals react to and manage complications.
So you’ve probably all heard the term “failure to rescue” and we’ve done numerous columns on “failure to recognize early clinical deterioration” (see list at end of today’s column). But somewhere in between those two phenomena is “failure to escalate”. The latter was coined a year ago by researchers in the UK (Johnston 2014). Now that same group has published results and recommendations from a FMEA (failure mode and effects analysis) on the escalation of care process (Johnston 2015).
The first study (Johnston 2014) was a qualitative one in which participants from multiple disciplines and multiple hospitals underwent semi-structured interviews. It found that a decision to escalate was based upon five key themes: patient, individual, team, environmental, and organizational factors. Two key findings were that escalation protocols were nonexistent or unclear and that poor availability of senior surgical staff was a concern. It was also felt that the hospital pager system was archaic and should be replaced by mobile phones and direct communication. Hierarchical issues were identified as a barrier, with junior physicians often reluctant to contact senior physicians for fear of humiliation or criticism or because they were overconfident in their own skills and judgment. They also noted that fragmentation of the surgical care team as a result of the European Working Time Directive (which restricts resident work hours similarly to ACGME work hour restrictions in the US) made it difficult sometimes to determine who was in charge or whom to call. Transparent escalation protocols, increased senior clinician supervision, and communication skills training were highlighted as strategies to improve escalation of care.
One other key factor raised by nurses was lack of a “worried” criterion. We’ve noted in several columns that early warning systems work best when there is a component that reflects the nurse’s clinical impression, which is sometimes difficult to put in concrete terms (see our prior columns for March 2012 “Value of an Expanded Early Warning System Score” and July 15, 2014 “Barriers to Success of Early Warning Systems”).
In the FMEA Johnston and colleagues identified 33 steps in the escalation process (Johnston 2015). Those steps were identified through 42 hours of observation on surgical wards at 3 London hospitals. A risk-assessment survey and expert consensus group identified then 18 hazardous failures associated with these steps and assigned risk scores to them.
They broke them down into various categories. Concerns during process steps involving nurses included insufficient staffing, failures in taking and transcribing vital signs, failure to identify early deterioration, difficulty communicating with patients (eg. dementia), fear of criticism by junior physicians, and limitations of the pager system. Their recommendations included better nurse:patient ratios, electronic vital sign recording and documentation, a formal escalation protocol that would remove the hierarchical barriers, and increased use of smartphones.
Concerns during process steps involving junior physicians included failure to take an adequate history or perform a thorough examination, failure to review medication or I&O charts or case notes, incorrect initial treatment, and failure to inform the senior physician. Recommendations included improved staffing (especially availability of senior physicians), better integration of electronic health records, and emphasizing the importance of the escalation protocol to junior physicians.
Concerns during process steps involving senior physicians included communication and availability issues plus lack of ICU beds or sufficient OR’s at night. Recommendations included development of a clear escalation protocol, developing guidelines for appropriate levels of care based upon diagnoses, physiologic parameters, early warning scores, etc., and improved bed/OR availability.
Flattening of the hierarchy was stressed as a critical factor in improving the culture of safety.
Two other points are worthy of mention. First, the studies were largely done in academic and/or teaching environments so a key sequence of communication was from nurse to resident to attending in most cases. That might differ in a community hospital but there is still often another physician (eg. hospitalist, “house” physician, etc.) involved even there. So we don’t know how many of their steps can be generalized to other settings. But the concepts are still the same. The second point is that early warning systems (the MEWS) are already widely used in the UK compared to their infrequent use in the US.
The editorial accompanying the 2015 Johnston study (Ghaferi 2015) discusses the comparative pros and cons of FMEA and RCA and the importance of a culture of safety. It highlights the need for further research into the phenomena of failure to escalate and failure to rescue.
Our regular readers know we are fond of the FMEA (failure mode and effects analysis) in healthcare. Both the FMEA and RCA (root cause analysis) have advantages. The obvious advantage of the FMEA is that you don’t have to wait for an adverse event to have occurred. More importantly we find that, in addition to identifying potential vulnerabilities in your systems and processes, doing a FMEA is an excellent tool in helping to build a culture of safety and teamwork. Doing a FMEA requires you gather together a multidisciplinary team representing all the healthcare workers involved in a process and you map out all the steps involved in that process or processes. You’d be surprised at all the steps you never even thought about. It really gives you a good perspective of what your co-workers are doing. Moreover, it is done in a setting where everyone should feel free to speak up and there are no fears of blame, retribution, etc. Hierarchical barriers are (usually) not present.
Just as their predecessors raised awareness of “failure to rescue”, Johnston and colleagues have done an excellent job of both putting “failure to escalate” on the map and showing us how to use FMEA as a learning tool.
Some of our other columns on MEWS or recognition of clinical deterioration:
Our other columns on rapid response teams:
Ghaferi AA, Birkmeyer JD, DimickJB. Variation in Hospital Mortality Associated with Inpatient Surgery. N Engl J Med 2009; 361: 1368-1375
Silber JH, Williams SV, Krakauer H, Schwartz JS. Hospital and patient characteristics associated with death after surgery: a study of adverse occurrence and failure to rescue. Med Care 1992; 30: 615-29
Johnston M, Arora S, Anderson O, et al. Escalation of Care in Surgery: A Systematic Risk Assessment to Prevent Avoidable Harm in Hospitalized Patients; Ann Surg 2015; 261(5): 831-838
Johnston M, Arora S, King D, et al. Escalation of care and failure to rescue: a
multicenter, multiprofessional qualitative study. Surgery 2014; 155: 989-994
Ghaferi AA, Dimick J. Understanding Failure to Rescue and Improving Safety Culture.
Ann Surg 2015; 261(5): 839-840
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May 5, 2015
Errors with Oral Oncology Drugs
Most reports on chemotherapy errors have focused on IV or intrathecal chemotherapy agents. But oral chemotherapy agents have been increasing in number and reports of errors relating to them are beginning to appear. Several recent articles provide important lessons to avoid such incidents.
ISMP Canada last month published an analysis of incidents involving oral chemotherapy agents that were reported to their incident database or to a national Canadian incident reporting database (ISMP Canada 2015). They analyzed 516 incidents over a 12 year period and while patient harm or death occurred in only a small minority of cases there were multiple lessons learned. They were able to identify 3 major themes: (1) lack of specialized knowledge by care providers (2) medication name mix-ups and (3) lack of safe medication handling processes. They provide case examples to illustrate each of these themes.
Chemotherapy regimens can be very complex and ISMP Canada notes that community pharmacists may not have a good understanding of chemotherapy cycles, side-effect profiles, etc. The same applies to many other non-oncologist healthcare professionals. As a result, patient education on these complex issues may be insufficient. The example they provide is a patient who was on a protocol-defined capecitabine cyclical dosing regimen who was mistakenly given capecitabine daily when admitted as an inpatient and then the prescription given the patient at discharge also erroneously called for daily capecitabine. You may recognize this problem of prescribing a drug daily rather than on a different regimen because we’ve written about very similar problems with methotrexate in the past (see our What’s New in the Patient Safety World columns for July 2010 “Methotrexate Overdose Due to Prescribing Error” and July 2011 “More Problems with Methotrexate”).
As a subtheme of the “lack of specialized knowledge” they mention that failure to include some critical information on the prescriptions may contribute. Such information might include diagnosis, patient height and weight, duration of the chemotherapy cycle, etc.
The second theme, medication name mix-ups, of course is not unique to chemotherapy agents. The ISMP Canada study notes a partial list of some of these easily mistaken drug name pairs, which may include confusion between brand names, between generic names or between brand and generic names. (Note that ISMP Canada is putting together a list of easily confused medications with TALLman lettering recommendations and ISMP in the US has recently updated its list of confused medication names.) It discusses the importance of using TALLman lettering to help avoid such errors, as well as including the indication and both brand and generic drug names on prescriptions and use of barcoding. Note that another recent article (O’Rourke 2015) identifies several factors make this particularly problematic in oncology. For example, the names of many chemotherapy agents end in “nib”.
The third theme in the ISMP Canada report is lack of safe handling procedures. Remember - many chemotherapy agents are hazardous substances and precautions must be taken to prevent exposure of healthcare workers, caretakers, etc. to these substances. Prominent warning labels should be used and standardized procedures for handling these medications are needed. The latter would include things like designating who can prepare, dispense, or administer such agents and appropriate precautions such as use of personal protective equipment and use of designated devices. An example given was failure to properly clean a tray that had been used for filling a hydroxyurea prescription before using the tray to fill another prescription. They also note use of automated packaging technologies, particularly in the long-term care setting, may inadvertently contaminate multiple medications if the packing device is exposed to hazardous chemotherapy agents.
ISMP Canada also cautions hospitals to be wary of allowing patients to use their own supply of medications when hospitalized because this may bypass many of the safety interventions put in place to prevent such incidents.
Many of these issues were identified in a classic article on medication errors related to oral chemotherapy (Weingart 2010). Weingart and colleagues identified issues with oral chemotherapy from a variety of sources. They identified over 500 such errors, including 99 actual adverse drug events. While many of the remaining events were near-misses they did provide the opportunity for patient harm and thus were helpful in identifying potential vulnerabilities. The most common complications with harm involved bone marrow suppression or compromise of treatment efficacy. The errors identified occurred in every stage of the medication use process and involved oncologists, pharmacists, nurses, patients, and patients’ families or friends. Wrong dose errors were most frequent but wrong drug errors also occurred. One particularly salient problem was supplying the wrong number of days. As noted above, chemotherapy regimens may be very complex and involve cycles and different dosing at different times so this can result in confusion for patients, pharmacists, and other healthcare workers. Actually, last year ISMP provided an example of this in an unfortunate incident where a woman being treated for a brain tumor received an overdose of lomustine (ISMP 2014). A mail order pharmacy dispensed a 3-dose supply of lomustine rather than a single dose. The patient, who had been used to taking her previous chemotherapy as a single dose, took the whole supply of lomustine as a single dose before she realized the mistake. This led to a protracted painful death with bone marrow suppression. Ironically, this was not the first such case. ISMP noted multiple prior similar errors. ISMP recommended that prescribers always specify a single dose when prescribing lomustine and specifically provide both verbal counselling and written instructions for the patient. Pharmacies and pharmacists should program alerts into their computer systems to specify “single dose only” (ISMP also suggests avoiding mail order pharmacies for such drugs since they often provide multi-month supplies and payors should only pay for single doses of such drugs) and do appropriate counselling of patients. They also note the FDA and manufacturers need to ensure that warnings appear in a much more obvious way for such drugs.
Weingart et al. also noted several cases where health literacy issues and language barriers probably played a role. The wrong drug errors were often due to look-alike sound-alike (LASA) confusion and were likely to involve chemotherapy agents being given to patients who did not have cancer. They also identified missed dose errors, errors related to confusing or ambiguous instructions, incomplete prescriptions, and others.
Importantly, the Weingart study demonstrated that the types of errors identified varied significantly by the source of the reports, i.e. reports from hospital sources differed from those from pharmacy sources, and so on.
One recent article described the team approach at Memorial Sloan-Kettering to preventing oral chemotherapy agent errors (O’Rourke 2015). Among common causes of chemotherapy errors they noted ones that may affect any medication, such as miscommunicated verbal orders, interruptions, LASA issues, use of abbreviations, packaging/labeling issues, legibility/fax issues, and drug shortages. They again highlighted the issue of taking daily doses when a different regimen was intended and provide examples, including the ones regarding methotrexate and lomustine that we discussed earlier. But they also point out that many chemotherapy agents have interactions with medications patients are taking for other medical conditions and provide a list of selected interactions. They stress a team approach and use of standardized protocols and processes. They also stress one of our frequent recommendations (“stories not statistics”), noting that the presentation of actual events is a powerful tool in educating staff about possible errors.
One particular concern with chemotherapy agents is dose calculation. Doses for some drugs are based upon the patient’s weight or body surface area (BSA), the latter requiring knowledge of the patient’s height. Any time we are dealing with dose calculations the issue of decimal points arises. In our September 9, 2008 Patient Safety Tip of the Week “Less is More…and Do You Really Need that Decimal?” we discussed whether numbers should ever follow a decimal point. They may be important in certain circumstances (eg. for a dose of 0.3 mg or 2.7 mg of a drug you would avoid rounding). However, at higher doses they become much less relevant and rounding of the dose is appropriate. For example, let’s say you performed a calculation and the result was a recommended dose of a drug is 72.2 mg. Is there really a difference if the patient gets 72 mg or 72.2 mg of most drugs? Yet ordering the latter dosage increases the risk that the decimal point may not be seen or not input into a computer or missed in a faxed order and the patient gets a 10x overdose. So we strongly recommend that in writing medication orders one specifically decides whether such fractional doses are important or merely place the patient at increased risk of an error.
Speaking of weight-based and BSA-based dose calculations, making the ECRI Institute Top 10 list for patient safety concerns for 2015 were medication errors related to pounds and kilograms (ECRI 2015). Calculations done mixing up pounds and kilograms can result in roughly a two-fold error in calculated dose. Especially for oncology drugs that have a very narrow therapeutic index and safety margin, such errors could easily result in toxicity or in lack of efficacy, depending on which direction the error is made in.
ECRI recommends doing away with scales that measure in pounds in healthcare settings and requiring all weights be input into EHR’s using only kilograms. Note that one could still erroneously enter a value in pounds in an EHR field but clinical decision support tools can at least compare a value to an expected weight and flag those falling outside that range. But it’s not failsafe. A PPSA advisory (PPSA 2009) on the importance of accurate weights in avoiding medication errors did not list chemotherapy agents among their most frequently reported medication errors but nevertheless had important recommendations. PPSA also recommends including the date of the weight. That might be particularly relevant to oncology patients who may have had significant weight change since the last recorded weight.
Both the ISMP and Memorial Sloan-Kettering experiences look to use of computerized tools to help prevent such errors. Using CPOE (computerized physician order entry) or e-prescribing systems has the advantage of automating dose calculations, thereby reducing some potential errors. They also provide easy access to standardized order sets. They also have the advantage of being able to use clinical decision support tools for generating alerts for excessive doses, etc.
Partners Healthcare and the Dana Farber Cancer Institute built a system for electronically prescribing oral chemotherapy agents (Weingart 2012). That system provided support for calculating doses based upon patient weight or body surface area and even calculations for toxicity-related dose adjustments. It also included a field for the primary cancer diagnosis, which could either be imported from other fields in the EHR or input by the ordering clinician, and another field for indicating reason for the chemotherapy agent (eg. curative, adjuvant, palliative). Clinicians could also input items such as the cycle number or a clinical trial number. The system also had the other capabilities we expect in e-prescribing systems like allergy alerts, drug-drug interaction alerts, renal dose warnings, etc. The system was well-accepted by clinicians. The reason for the chemotherapy agent was seldom entered. The primary cancer diagnosis was entered in about half the cases, perhaps because that diagnosis was often imported from other fields. There was also a free-text field where prescribers could enter things like clarifying the number of tablets of different strengths that should be taken together. Alerts were triggered in 5.9% of prescriptions but most were actually not helpful (the dose-limit for some drugs had been set below the currently used standard). Overall, 6 drugs accounted for 83% of the prescriptions, likely reflecting the patient population served by the study hospitals and practices. They learned some valuable lessons for building such systems. One was that use of the diagnosis and reason/intent field was suboptimal. Clinicians also need easier ways to indicate things like cycle number, days per cycle, nontreatment days, and instructions for combining tablets of different strength. They also learned that dose-limit alerts need to be updated regularly to keep up with current practice standards.
Another study compared non-intercepted dose errors for chemotherapy agents in paper-based vs. computer-based systems (Mattsson 2015). They found an overall risk of a prescription dose error of 1.73 per 100 prescriptions (1.60 for CPOE and 1.84 errors per 100 prescriptions, a nonsignificant difference). Fifteen different types of errors and four potential risk factors were identified. They found the computer system reduced the risk of calculation errors but introduced other errors. The Mattsson and Weingart studies highlight the potential of computerized systems to reduce errors but both show we have a long way to go in reaching that goal.
A handy monograph on preventing chemotherapy errors (Kloth 2010) has a great list of the “Do’s” and Do Not’s” of prescribing. Many of the “Do Not’s” apply to all prescribing, not just chemotherapy agents (eg. abbreviations, trailing zeros, lack of zero preceding decimals, etc.). But a few are especially important when chemotherapy drugs are used. Kloth recommends never using verbal orders for chemotherapy. Also describing “vials” should not be done since vials of chemotherapy agents come in so many sizes and concentrations. He also cautions against using outdated laboratory results for those agents that may be affected by things like renal or hepatic function. Among the “Do’s” is always writing the full name (preferably the generic name) of the drug. For doses greater than 5 mg use rounding so no digits appear after a decimal point (see above). He also emphasizes the importance of double checks. In our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?” we concluded that double checks remain a relatively weak safety intervention and they are prone to errors but, done correctly, the independent double check probably does provide an additional element to our defenses against errors. Particularly for high-alert medications, such as chemotherapy agents, doing independent double checks at multiple stages makes a lot of sense.
Our prior columns related to chemotherapy safety:
ISMP Canada. Analysis of Incidents Involving Oral Chemotherapy Agents. ISMP Canada Safety Bulletin 2015; 15(4): 1-4, April 22, 2015
ISMP (Institute for Safe Medication Practices). ISMP’s List of Confused Drug Names. Updated February 2015
O’Rourke K. Preventing Oral Chemo Errors: A Team Approach. Pharmacy Practice News 2015; 42: 1-4 March 2015
Weingart SN, Toro J, Spencer J, et al. Medication errors involving oral chemotherapy. Cancer 2010; 116(10): 2455-2464
ISMP (Institute for Safe Medication Practices). With oral chemotherapy, we simply must do better! ISMP Medication Safety Alert! Acute Care Edition. July 17, 2014
ECRI Institute. Top 10 Patient Safety Concerns for 2015
PPSA (Pennsylvania Patient Safety Authority). Medication Errors: Significance of Accurate Patient Weights. Pa Patient Saf Advis 2009; 6(1): 10-15
Weingart SN; Mattsson T; Zhu J; Shulman LN; Hassett M. Improving electronic oral chemotherapy prescription: can we build a safer system? Journal of oncology practice/American Society of Clinical Oncology 2012; 8(6): e168-73, 2012 Nov
Mattsson TO, Holm B, Michelsen H, et al. Non-intercepted dose errors in prescribing antineoplastic treatment: a prospective, comparative cohort study. Ann Oncol 2015; 26(5): 981-986 First published online: January 28, 2015
Kloth DD. Guide to the Prevention of Chemotherapy Medication Errors. Second Edition. New York: McMahon Publishing 2010
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May 12, 2015
More on Delays for In-Hospital Stroke
Though the “window” for thrombolytic therapy for acute ischemic stroke may be as long as 4.5 hours, those stroke patients who do best are those who receive thrombolytic therapy within the first 60 minutes from onset of symptoms, termed the “golden hour”. Yet only a small minority of acute stroke patients arrive at the hospital within the golden hour. There is one group of patients who theoretically should be ideal for thrombolytic therapy within the golden hour: those patients having a stroke while already an inpatient in the hospital. But we’ve lamented in several of our columns that times to diagnosis and treatment may be paradoxically prolonged in patients having in-hospital strokes. In our March 18, 2014 Patient Safety Tip of the Week “Systems Approach Improving Stroke Care” we noted a study that mentioned times to treatment are often paradoxically increased in patients having in-hospital strokes (Meretoja 2012). And in our September 23, 2014 Patient Safety Tip of the Week “Stroke Thrombolysis: Need to Focus on Imaging-to-Needle Time” we noted a study (Sauser 2014) that had the interesting observation that decisions take longer when the physician has more time available. Those authors also noted prior studies have demonstrated patients with shorter onset-to-arrival (OTA) times often have longer door-to-needle (DTN) times.
Then in our January 27, 2015 Patient Safety Tip of the Week “The Golden Hour for Stroke Thrombolysis” we reiterated the seeming paradox that patients having an in-hospital stroke tend to get delays in evaluation and management compared to those having community-onset strokes. One of the studies we highlighted had only been reported in an abstract presented at the Canadian Stroke Congress 2014 (Saltman 2014). Results of that study have now been published in their entirety and provide considerable insight into the complex nature of the problems associated with in-hospital stroke and demonstrate that the issue is not so clear-cut (Saltman 2015).
The study was a prospective cohort study conducted in Ontario, Canada and included almost 1000 patients with in-hospital stroke compared to almost 29,000 patients with community-onset stroke. Patients with in-hospital stroke had significantly longer times from symptom recognition to neuroimaging (median, 4.5 vs 1.2 hours) and both lower use of thrombolysis (12% vs 19%) and longer time from stroke recognition to administration of thrombolysis (median 2.0 vs 1.2 hours). Those with in-hospital stroke had a longer median length of stay following stroke onset (17 vs 8 days), were more likely to be dead or disabled at discharge (77% vs 65% with modified Rankin Scale score of 3-6), and were less likely to be discharged home from the hospital (35% vs 44%). However, after adjustment for age, stroke severity, and other factors, mortality rates at 30 days and 1 year after stroke were similar in those with in-hospital stroke and community-onset stroke.
So the results confirm previous observations that patients with in-hospital strokes seem to get less timely and less appropriate interventions. But a real highlight of the study is that patients having in-hospital stroke may be a significantly different patient population than those having community-onset stroke. Though the two groups had similar rates of independent functional status prior to admission, those with in-hospital strokes were generally older, had more comorbidities and vascular risk factors, and greater stroke severity. In those cases where no thrombolytic therapy was given the stated reason was contraindication to thrombolytic therapy in 46% of in-hospital stroke patients compared to 9% in community-onset patients. This may reflect a high percentage of patients that had just recently had surgery during their hospital admission.
But very few of the in-hospital stroke patients were cared for on a specialized stroke unit or even had their stroke care being primarily overseen by a neurologist. They also tended to have lower rates of evaluations usually done in stroke patients (eg. swallowing evaluations, carotid imaging, etc.).
There were also differences with regard to the location where the patient had their in-hospital stroke. As you might expect, those having a stroke in the angiography suite had shorter median times to neuroimaging and were more likely to receive thrombolytic therapy whereas those on cardiac surgical services had the longest median time to neuroimaging and were least likely to receive thrombolytic therapy.
So Saltman and colleagues really come to two conclusions: (1) there is considerable room for improvement of diagnosis and care of patients having in-hospital stroke and (2) there are unique characteristics of the patients having in-hospital stroke. They suggest that there probably should be special protocols and algorithms for management of patients with in-hospital stroke, with appropriate education and training of all parties involved, and activation of stroke teams to deal with such patients expediently.
Recognition of stroke signs and symptoms in patients already hospitalized may be difficult in some cases due to things like sedation, mechanical ventilation, dressings and casts and arm boards impairing limb movement, etc. Also, staff on some services (eg. surgical services) may not be as aware of what to do when signs or symptoms of stroke appear. Compared to the emergency department, staff on such units may not know how to activate the “stroke team” or even be aware that a “stroke team” exists.
And, upon further review, it should not really be surprising that time to neuroimaging might be prolonged. In our numerous columns on application of LEAN techniques to stroke care (see list below) we’ve emphasized that hospitals performing well actually have the patient with community-onset stroke arrive directly at the imaging suite. But think about how long it takes to mobilize some of our most critically-ill inpatients for transport to radiology. They have multiple lines in place and may be on supplemental oxygen or mechanical ventilation and staffing arrangements need to be made for someone to attend to the patient in the neuroimaging suite. There are clearly patient safety issues that must be addressed for such in-hospital transports (see our October 22, 2013 Patient Safety Tip of the Week “How Safe Is Your Radiology Suite?”). While the editorial accompanying the Saltman article (Dulli 2015) notes that neuroimaging facilities are only “an elevator ride” away in most hospitals, the actual situation for most in-hospital stroke patients is much more complicated than an “elevator ride”.
Informed consent may also be an issue since many stroke patients may be unable to communicate. Typically, community-onset stroke patients arrive at the hospital with some family who might be able to participate in informed consent. But for patients with in-hospital stroke it may take longer to contact family or health care proxies to participate in the informed consent process.
And the issue of contraindications for thrombolytic agents in patients with recent surgery is a difficult one. Quite frankly, the evidence base for when such could be used after surgery (and how it applies to specific surgeries) is not well developed. There probably are a number of circumstances where thrombolytic therapy could be given to patients with recent surgery but those need to be better defined. Those of you who have struggled just to get your surgeons to use low-dose heparin DVT prophylaxis post-op know what we are talking about! Most surgeons are very concerned about bleeding in such patients if they were to receive thrombolytic therapy.
And we understand that many patients with in-hospital stroke may not (or should not) be transferred to the stroke unit. They likely have need for the care expertise on the unit where they were (eg. surgical unit, ICU, etc.). But that does not mean they should not have access to the expertise of the stroke team. A hospital stroke team should be available not only for responding to stroke alerts from the emergency department but also to respond to alerts from anywhere in the hospital and provide continuing consulting. Importantly, the stroke team that would follow stroke patients on units other than the stroke unit should also have a stroke nurse as a critical team member. A stroke nurse may be more attuned to certain aspects of care (eg. swallowing dysfunction, avoiding contractures, etc.) than staff on a non-stroke unit.
So what should your hospital be doing? While we all need to wait for the stroke research community to help us develop protocols and algorithms for approach to in-hospital strokes occurring in various inpatient populations, at a minimum you should:
Since at least 4% of strokes and probably more (Saltman 2015 , Kimura 2006) occur in patients already hospitalized for other reason, hospitals need to be cognizant that they are likely to have such strokes occur in their facility and be prepared to deal with them promptly.
Some of our previous columns on improving stroke care:
November 6, 2012 “Using LEAN to Improve Stroke Care”
March 18, 2014 “Systems Approach Improving Stroke Care”
September 23, 2014 “Stroke Thrombolysis: Need to Focus on Imaging-to-Needle Time”
January 27, 2015 “The Golden Hour for Stroke Thrombolysis”
Meretoja A, Strbian D, Mustanoja S, et al. Reducing in-hospital delay to 20 minutes in stroke thrombolysis. Neurology 2012; 79: 306–313
Sauser K, Levine DA, Nickles AV, Reeve MJ. Hospital Variation in Thrombolysis Times Among Patients With Acute Ischemic StrokeThe Contributions of Door-to-Imaging Time and Imaging-to-Needle Time. JAMA Neurol. 2014; 71(9): 1155-1161
Saltman A, et al. Canadian Stroke Congress. Presented October 6, 2014. Abstract 8094
In-Hospital Stroke Patients Wait Longer for Care. as reported in Medscape Oct 09, 2014.
Also reported in Canadian Stroke Congress. Code Stroke on the Ward. Press Release October 6, 2014
Saltman AP, Silver FL, Fang J, et al. Care and Outcomes of Patients With In-Hospital Stroke. JAMA Neurol 2015; Published online May 04, 2015
Dulli DA. In-Hospital Stroke. Hidden in Plain Sight. JAMA Neurol 2015; Published online May 04, 2015
Kimura K, Minematsu K, Yamaguchi T. Characteristics of In-Hospital Onset Ischemic Stroke. Eur Neurol 2006; 55(3): 155-159
May 19, 2015
Dueling Chlorhexidine Studies
Chlorhexidine in the past decade became the most widely used antiseptic agent in a variety of settings. Its use is part of the CDC Guidelines for the Prevention of
Intravascular Catheter-Related Infections (O'Grady 2011). It is the most widely used antiseptic agent used for skin preparation prior to surgical procedures. Many patients also use chlorhexidine bathing on the day prior to elective surgical procedures. And many ICU’s have adopted daily chlorhexidine bathing in an effort to reduce healthcare-associated infections (HAI’s).
But chlorhexidine has come under fire recently. We’ve previously noted that chlorhexidine preparations with alcohol are typically flammable and have been implicated in some surgical fires (see our Patient Safety Tips of the Week for December 13, 2011 “Surgical Fires Again”, August 12, 2014 “Surgical Fires Back in the News”, and December 16, 2014 “More on Each Element of the Surgical Fire Triad”). After a case described in the latter column a hospital implemented a policy prohibiting alcohol-based skin preps in any emergency surgery that does not allow sufficient drying time (usually 3 minutes or longer). Instead they have gone back to non-alcohol-based preps like Betadine for such emergency cases. We’ve also noted problems with “the fine print” on package inserts and labels in some cases. In several of our prior articles we noted another surgical fire in which a hospital had switched from the 10.5 ml Chloraprep applicator, which did not have the warning to avoid use in head and neck surgery, to the 26 ml applicator which did have the warning. It was actually quite predictable that staff would assume the new supplies were the same as the old and not “read the fine print”.
Then came patient safety’s infamous “first scandal” (Wachter 2014) in which several NQF Safe Practices included the recommendation to “use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin antiseptic preparation…” after lobbying by Dr. Charles Denham. It was later revealed that Denham had an undisclosed financial relationship with CareFusion, the manufacturer of ChloraPrep which was the only one on the market containing that formulation. Both CareFusion and Denham faced heavy fines for their involvement and Denham was removed from NQF committees and his post as editor of the Journal of Patient Safety. The latter journal also uncovered several articles in which Denham failed to disclose conflicts of interest.
Wachter also notes that a key New England Journal of Medicine article (Climo 2013), that concluded daily bathing with chlorhexidine-impregnated washcloths significantly reduced the risks of acquisition of MDROs and development of hospital-acquired bloodstream infections, has also been questioned because of conflict of interest issues.
Now a new study has challenged the reported efficacy of daily chlorhexidine bathing in ICU’s (Noto 2015). The study by Noto and colleagues was a cluster randomized, crossover study of 9340 patients admitted to 5 adult intensive care units of a tertiary medical center. It compared once-daily bathing of all patients with disposable cloths impregnated with 2% chlorhexidine or nonantimicrobial cloths as a control. Those researchers found that daily bathing with chlorhexidine did not reduce the incidence of health care–associated infections including CLABSIs, CAUTIs, VAP, or C difficile. They conclude their findings do not support daily bathing of critically ill patients with chlorhexidine.
Several commentaries have noted some limitations of the Noto study. Pittet and Angus (Pittet 2015) noted that the study was a single-center study and was not blinded (both staff and patients could have known which type of cloth was being used). They also questioned the validity of the composite endpoint since the strongest data supporting use of chlorhexidine is in preventing CLABSI’s, not the other component HAI’s. Soto-Hernandez (Soto-Hernandez 2015) points out considerable differences in the patient populations reported in the Climo and Noto studies. The Noto population had low rates of HAI’s in both arms and patients had very short ICU lengths of stay, whereas the Climo population had considerably longer ICU lengths of stay and included a unit with bone marrow transplantation patients.
But whether or not the findings by Noto et al. can be generalized to other ICU’s they certainly send the message that ICU’s should question the practice of daily chlorhexidine bathing and perhaps look at their own experience.
To make things even more complicated, another new study reported in the American Journal of Infection Control (Cassir 2015) found that daily chlorhexidine cleansing did reduce the incidence rate of HAI caused by gram-negative bacteria, highlighting the role of the transient gram-negative bacteria skin colonization in the pathogenesis of HAI. The study, which was relatively small, enrolled patients who had at least one previous episode of sepsis. Similarly, another recent small randomized controlled trial in a SICU demonstrated a 44% reduction in CLABSI, CAUTI, VAP, and incisional SSI’s with every other day chlorhexidine bathing compared to soap and water bathing (Swan 2014). That study was presented in abstract only.
Hence, our column title “dueling chlorhexidine studies”.
Good old betadine
The antiseptic that chlorhexidine largely replaced in many settings was povidone-iodine. As above, in several of our columns on surgical fires we have noted hospitals changing back to povidone-iodine for cases at high risk for surgical fire (see our December 16, 2014 Patient Safety Tip of the Week “More on Each Element of the Surgical Fire Triad”). Now another new study has demonstrated that application of povidone-iodine to the nostrils at least an hour prior to spinal surgery significantly reduced surgical infections (Flynn 2015).
Can resistance develop to antiseptics?
In addition to the conflicting studies on efficacy of chlorhexidine, there has been some additional research suggesting that bacteria might develop resistance to chlorhexidine (Suwantarat 2014). Those authors found that in units that bathe patients daily with chlorhexidine, organisms causing central line-associated bloodstream infections (CLABSIs) were more likely to have reduced chlorhexidine susceptibility than organisms causing CLABSIs in units that do not bathe patients daily with chlorhexidine (86% vs 64%). The investigators suggest that surveillance is needed to detect reduced chlorhexidine susceptibility with widespread chlorhexidine use.
The Bottom Line
You can bet that hospitals will begin to take a close look at their practice of daily chlorhexidine bathing in ICU’s. The Noto study suggests that the considerable expense of this practice is not likely paying off in terms of fewer HAI’s. You can expect also attempts to replicate the Noto study in other hospitals. And, while povidone-iodine is not practical for daily bathing, expect to see some more head-to-head trials of to povidone-iodine vs. chlorhexidine for some of the other indications.
O'Grady NP, Alexander M, Burns LA, et al. Guidelines for the Prevention of
Intravascular Catheter-Related Infections, 2011. CDC (Centers for Disease Control and Prevention) 2011
CDC (Centers for Disease Control and Prevention). Checklist for Prevention of Central Line Associated Blood Stream Infections. CDC 2011
Wachter R. Patient Safety’s First Scandal: The Sad Case of Chuck Denham, CareFusion, and the NQF. Wachter’s World blog. The-Hospitalist.org January 30, 2014
Climo MW, Yokoe DS, Warren DK, et al. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med 2013; 368: 533-542
Noto MJ, Domenico HJ, Byrne DW, et al. Chlorhexidine Bathing and Health Care–Associated Infections. A Randomized Clinical Trial. JAMA 2015; Published online January 20, 2015
Pittet D, Angus DC. Daily Chlorhexidine Bathing for Critically Ill Patients: A Note of Caution. JAMA 2015; Published online January 20, 2015
Soto-Hernandez JL. Comment and Response. Chlorhexidine Bathing and Infections in Critically Ill Patients. N Engl J Med 2015; 313(18): 1863
Cassir N, Thomas G, Hraiech S, et al. Chlorhexidine daily bathing: Impact on health care–associated infections caused by gram-negative bacteria. American Journal of Infection Control 2015; Available online 19 March 2015
Swan J, Bui L, Pham V et al. RCT of Chlorhexidine vs. Soap & Water Bathing for Prevention of Hospital-Acquired Infections in SICU. Critical Care Medicine 2014; 42(12): A1369-A1370, December 2014
Suwantarat N, Carroll KC, Tekle TMT, et al. High Prevalence of Reduced Chlorhexidine Susceptibility in Organisms Causing Central Line-Associated Bloodstream Infections. Infection Control & Hospital Epidemiology 2014; 35(9): 1183-1186, September 2014
Flynn NA, Carr M. Society for Healthcare Epidemiology of America (SHEA) Spring 2015 Conference: Abstract 1809. Presented May 14, 2015.
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May 26, 2015
How Safe is the Lab You Use?
The Milwaukee Journal Sentinel has done an excellent series on patient safety issues related to laboratories (Gabler 2015). Gabler does a great job using real people stories to illustrate the devastating impact a lab error can have on the lives of patients and their families. But she goes much further and delves into the lack of transparency about laboratory errors and the inability of the general public or even you, the healthcare professional, to know how well the laboratory to which you refer patients is actually performing.
Our regular readers know we are fond of “stories, not statistics” to foster patient safety. Gabler shows how inaccurate HIV diagnoses and false paternity tests destroyed families and incorrect pregnancy testing and blood compatibility testing put neonates in jeopardy. And how failure to heed a lab technician’s warnings about a faulty analyzer resulted in that lab tech being exposed to HIV and HCV and more than 400 patients possibly receiving inaccurate HIV and HCV results.
But, while the stories in this series are indeed compelling, the statistics are even more bothersome. Gabler uncovered not only numerous specific errors and deviations occurring in various labs but also found significant flaws in the regulatory oversight of the labs. Labs appear to have the ability to choose some quality parameters as they see fit and they can choose their oversight organization in some cases. One example given was a lab in which staff failed proficiency testing in pregnancy testing one quarter. Yet rather than do repeat proficiency testing for pregnancy testing that lab “simply didn’t participate in an outside check of its pregnancy testing the following quarter”. Gabler also discusses labs cutting corners to save money (eg. using expired reagents, putting off fixing faulty equipment, etc.).
There are 35,000+ labs in the US. While they must meet the federal standards of the Centers for Medicare and Medicaid Services (CMS), the surveys are usually outsourced to other organizations. State inspectors handle about 50% of labs, with accrediting organizations like The Joint Commission (TJC) or the College of American Pathologists (CAP) reviewing 46%, including most hospitals and large clinics. New York and Washington run their own programs, accounting for the remaining 4%. CMS sends teams to survey a small percentage of labs (about 2%) and to audit the surveys being done by those other organizations.
When CMS does those audits they allow up to a very generous 20% disparity rate (between the CMS findings and the other organization’s findings) before CMS reviews the work being done by those organizations. In 2013 The Joint Commission exceeded that 20% threshold, with 9 of 43 audited inspections not meeting the CMS expectations.
But the public might become aware of faulty laboratory practices only if a regulatory body sanctions that lab. And such sanctions are relatively rare. Findings of surveys are not made public if the lab submits a plan of corrective action that is accepted by the oversight agency.
We all appreciate it when organizations like The Joint Commission take on an “educational” role and an approach to facilitate improvement. But at the same time we don’t want to be sending our patients to a lab that has substandard processes.
So how do you know if your favorite lab is safe or not? You won’t find the answer on any website. Your best bet is to be tied into your hospital’s quality improvement system and make sure that your medical staff representation on all the quality committees is actively participating. But that will only help you get a feel for how safe the hospital lab is. For those using proprietary and/or commercial labs, good luck!
So why aren’t there publicly available measures of lab quality and safety? There is certainly considerable public reporting of hospital quality and safety measures (albeit some good and some bad measures). But a patient is actually much more likely to use a lab than a hospital. The vast majority of quality indicators monitored in laboratories are either too technical or of little interest to the general public. But some potential candidates for publicly reported measures might be:
Of course, you’d have to have standardized ways of determining these measures so the system cannot be “gamed”.
We’ve done multiple columns on errors related to laboratory studies (see list below), many or most of which actually occur before the specimen arrives at the lab (as in our Patient Safety Tips of the Week for October 9, 2007 “Errors in the Laboratory“ and March 6, 2012 ““Lab” Error”). Lost lab specimens can leave patients without a diagnosis (see our November 16, 2010 Patient Safety Tip of the Week “Lost Lab Specimens”). One particularly serious error highlighted in several of our columns is mislabeling of specimens. A CAP study in 2011 had shown a specimen labeling error rate of 1.1 per 1000 cases (Nakhleh 2011). Because that has such potentially devastating consequences for patients, the College of American Pathologists (CAP) has just issued guidelines for uniform labeling of blocks and slides in surgical pathology (Brown 2015). CAP put together a panel of experts to develop that guideline. A systematic literature review found the overall evidence inadequate to inform the guideline so the panel had to rely on expert consensus opinion for 10 of their 12 recommendations.
In several of our columns on specimen mislabeling errors we’ve mentioned that you, as a clinician, should be suspicious when a “surprise” diagnosis (or lack of an expected diagnosis) comes back from the lab. There are DNA-based tools that labs can use to look for switched or cross-contaminated lab specimens.
There are other checks that can be done for some highly sensitive tests. For example, in the Gabler article one lab has two samples of each person's DNA tested by two different lab technicians. Another safeguard requires that whenever a man is excluded as father of a child, the company double-checks to make sure the child's swab wasn't accidentally switched with the mother's swab, since the two often have their cheeks swabbed at the same time.
So, how safe is the lab you use? What quality indicators would you like to see for those labs?
Some of our other columns on errors related to laboratory studies:
Gabler E. Hidden Errors. A Watchdog Report. Weak oversight allows lab failures to put patients at risk. Milwaukee Journal Sentinel 2015; May 16, 2015
Nakhleh RE, Idowu MO, Souers RJ, et al. Mislabeling of cases, specimens, blocks, and slides: a College of American Pathologists study of 136 institutions. Arch Pathol Lab Med 2011; 135(8): 969-974
Brown RW, Speranza VD, Alvarez JO, et al. Uniform Labeling of Blocks and Slides in Surgical Pathology. Guideline From the College of American Pathologists Pathology and Laboratory Quality Center and the National Society for Histotechnology. Arch Pathol Lab Med 2015; Early Online Release April 21, 2015
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June 2, 2015
Reminders of Dilaudid Dangers
It’s been almost 5 years since we did our first column on the dangers of Dilaudid/HYDROmorphone (see our September 21, 2010 Patient Safety Tip of the Week “Dilaudid Dangers”) but it remains one of our most frequently accessed columns. Unfortunately, many of the systemic problems we’ve noted in association with Dilaudid treatment persist and preventable deaths continue to occur. Two new cases serve as a reminder of some of those key problems.
The first appears in a statement of deficiencies and plan of correction from the California Department of Public Health (CDPH 2014). A patient was admitted with abdominal pain, nausea, vomiting and diarrhea and began receiving IV Dilaudid for pain. Two 1 mg doses were given in the emergency department separated by 3 hours. On admission to the floor Dilaudid doses were increased to 2 mg, then 4 mg so that the patient received a total of 20 mg of Dilaudid over a 24-hour period (CDPH calculated that dose as being equivalent of 133 mg morphine). Unfortunately, the patient was found unresponsive at 2:56 AM on the day after admission and emergency resuscitation efforts were unsuccessful.
The rest of that story is typical from our many columns on failure to appropriately monitor patients who are on opioid therapy (see list at the end of today’s column). The period between finding the patient unresponsive and the last prior assessment was 3 hours and 26 minutes. There was no documentation of the patient’s pain level or sedation level before or after each Dilaudid dose. And there is no mention of how respiratory status was to be monitored. We assume pulse oximetry was not used in this case because the plan of correction adds pulse oximetry to their revised policy for intravenous dosing of HYDROmorphone. Of course, you already know that visual assessment of respiration and pulse oximetry by themselves are not adequate for monitoring for opioid-related respiratory depression. Rather, monitoring with capnography and looking for apnea are recommended in addition to pulse oximetry.
Details about comorbidities are not specified in the CDPH report other than that the Coroner’s Autopsy Report notes under “other significant conditions” morbid obesity and obstructive sleep apnea. At the very least those conditions should have placed the patient in a very high risk category for any opioid therapy. Patients with obstructive sleep apnea usually have normal appearance of breathing and normal oxygen saturation while they are awake, providing a false sense of security. It is only when they are not aroused and fall back to sleep that the obstructive apnea supervenes.
There is also no mention about whether the patient was opioid-naïve or opioid-tolerant, an important consideration in dosing of any opioid.
The second case was an 85-year-old patient admitted to a Canadian hospital with a suspected bowel obstruction and prescribed 1-2 milligrams of Dilaudid every three hours, to be given by “subcutaneous” injection (Blackwell 2015). The patient suffered respiratory depression, developed pneumonia and died the next day. This case appeared in the news media because the physician apparently conveyed to the family that the medication had nothing to do with the patient’s demise, a position apparently supported by the coroner’s initial report. However, family prompted further review of the case and the coroner later issued a new statement, saying death probably resulted from “narcotic overdose.” The family, meanwhile, complained to the College of Physicians and Surgeons, which issued to the physician a “verbal caution” saying he should have been open about the significance of the “very large” dose of dilaudid given to an elderly, dehydrated patient unaccustomed to powerful opioids. Instead, he was “evasive and vague,” the committee concluded.
No further details about that case are available but it again raises two key issues related to such cases: (1) physicians (and other healthcare workers) often don’t have an appreciation of the relative potency of HYDROmorphone compared to morphine and (2) the issue of opioid-naïve vs. opioid-tolerant patients is important. And though HYDROmorphone can apparently be used by the subcutaneous route, we’ve not seen that route used in hospitalized patients. We suspect that may have been a route unfamiliar to the pharmacist(s) and nurse(s) at that hospital as well.
The major problem is misperception of the relative potency of HYDROmorphone. All too many healthcare professionals mistake HYDROmorphone as being equivalent to morphine when, in fact, HYDROmorphone is much more potent on a mg basis. While estimates of equipotency vary considerably in the literature, most now agree that 1 mg. of Dilaudid is probably the equivalent of at least 7 mg. of morphine. Chang and colleagues (Chang 2006) had noted several years ago that emergency room physicians and nurses who were hesitant to administer 7 to 10 mg. of morphine were not reluctant to administer 1 to 1.5 mg. of Dilaudid. They point out this is an illusion that less narcotic is being used with that Dilaudid dose.
We’ve highlighted a series of articles addressing the patient safety issues associated with HYDROmorphone from ISMP Canada in our Patient Safety Tips of the Week for September 21, 2010 “Dilaudid Dangers”and July 3, 2012 “Recycling an Old Column: Dilaudid Dangers”. Then in our November 19, 2013 Patient Safety Tip of the Week “Can We Improve Dilaudid/HYDROmorphone Safety?” we highlighted a safety bulletin from ISMP Canada (ISMP Canada 2013) reporting results of a targeted pilot intervention to improve HYDROmorphone safety. They looked at prior recommendations on HYDROmorphone safety and prioritized them according to a hierarchy of effectiveness and came up with 5 actions designed to improve system safety:
They found that workload issues and alert fatigue were barriers that limited full implementation at some participating hospitals. They note that because of concerns about alert fatigue it may be more practical to limit the dose of HYDROmorphone by using standardized order sets. We concur with that. Order sets, whether computerized or paper-based, can help steer away from using HYDROmorphone as well as helping avoid prescription of inappropriately high doses when it is prescribed. But in your order sets be very careful about having checkbox items that would allow a physician to check two boxes for drugs you don’t want to be used together. For example, in ISMP’s Guideline for Standard Order Sets (see our March 23, 2010 Patient Safety Tip of the Week “ISMP Guidelines for Standard Order Sets”) they note that contraindicated combinations such as IV morphine and epidural HYDROmorphone/bupivacaine should not appear on the same order set (ISMP 2010).
We strongly recommend that you limit the number of opioids to be used in your PCA pumps. You can standardize PCA on morphine and restrict prescription of other opioids to members of your pain management service or providers who have been specifically credentialed and privileged to order other opioids. Keep in mind that there may be legitimate indications for using HYDROmorphone in preference to morphine in some cases. For example, you may have a patient who gets pruritis with morphine, in which case HYDROmorphone may be an acceptable alternative.
In our November 19, 2013 Patient Safety Tip of the Week “Can We Improve Dilaudid/HYDROmorphone Safety?” we noted that look-alike/sound-alike (LASA) issues also continue to occur, in which hydromorphone and morphine are mixed up both in sounding alike and in that vials may be similar. Use of tall man lettering (HYDROmorphone) is advised but, frankly, many healthcare workers still mistakenly assume that HYDROmorphone is an equipotent form of morphine.
To reiterate from our multiple columns on Dilaudid dangers, here are some strategies you should consider to reduce the risk of Dilaudid (and other opioid) adverse events:
“Dilaudid Dangers” is not just a catchy title. It’s a real risk lurking in most hospitals and other healthcare settings today despite warnings from multiple patient safety organizations.
Our prior columns on patient safety issues related to Dilaudid/HYDROmorphone:
Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
CDPH (California Department of Public Health). Complaint Intake Number CA00394996. 2014
Blackwell T. Ontario doctor rebuked for denying role of ‘gross medication error’ in patient’s death. National Post 2015; May 24, 2015
Chang AK, Bijur PE, Meyer RH, et al. Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute Pain: A Randomized Clinical Trial.
Ann Emerg Med 2006; 48: 164-172
ISMP Canada. Safeguards for HYDROmorphone–Results of a Targeted
Demonstration Project. ISMP Canada Safety Bulletin 2013; 13 (10): 1-5 November 4, 2013
ISMP (Institute for Safe Medication Practices). ISMP’s Guideline for Standard Order Sets. 2010
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June 9, 2015
Add This to Your Fall Risk Assessment
A new study of Medicare patients shows that having a diagnosis of overactive bladder is a risk factor for falls (Jayadevappa 2015). The investigators analyzed over 30,000 Medicare patients, using claims data from a random sample of 5% of the Medicare population between 2006 and 2009 and ICD diagnosis codes for overactive bladder (OAB), functional urinary incontinence, urinary incontinence, urinary frequency, urgency urination, nocturia, or stress urinary incontinence. After adjustment for several variables, the risk for falls in those with a diagnosis of overactive bladder was 1.30. The only other variable that was a stronger predictor of falls was a history of previous falls (odds ratio 1.7).
Those who received treatment for overactive bladder had a lower risk of falls compared to those not treated (OR 0.92). However, we recommend caution in jumping to a conclusion that treatment reduces fall risk. Only 10% of patients with a diagnosis of overactive bladder received treatment. The decision whether to use medications for overactive bladder likely takes into account multiple clinical factors that are unlikely to be accounted for in claims data.
We would add a few further words of caution about treatment. Not only are anticholinergic drugs a risk factor for delirium and cognitive impairment in the elderly, but anticholinergic drugs themselves are also a risk factor for falls (Rudolph 2008). And in our February 10, 2015 Patient Safety Tip of the Week “The Anticholinergic Burden and Dementia” we noted a study showing an association between anticholinergic burden and development of dementia (Gray 2015). In that study bladder antimuscarinic drugs were one of the top three categories of anticholinergic drugs prescribed. And even more recently a study has noted an association between anticholinergic drugs and pneumonia in community-dwelling patients age 65 and older (Paul 2015).
Actually, it should not really come as a surprise that an overactive bladder is a risk factor for falls. Is it biologically plausible that overactive bladder would be a risk factor for falls in the elderly? Certainly. Patients with overactive bladder might hurry when they get the urge to void, increasing their risk of tripping and falling. And if they have episodes of incontinence they risk falling from slippery surfaces. They also may get the urge to void at night, with increased risk of falling in poor lighting. A previous study (Vaughan 2010) had shown an association between nocturia and falls and patients with OAB symptoms are likely to have nocturia. And, while most patients have an “idiopathic” OAB, the symptoms of frequency, urgency and precipitate micturition are also seen with neurogenic bladder accompanying a host of neurological conditions, many of which are associated with motor or balance dysfunction that may also be fall risk factors.
In our December 22, 2009 Patient Safety Tip of the Week “Falls on Toileting Activities” we noted that almost half of falls in hospitals occur during activities related to toileting, most occurring when attempting to go from bed or chair to the bathroom or returning from the bathroom rather than when getting on or off the toilet. And, not surprisingly, most of those falls occur at night.
While poor lighting at night is a major contributor to falls, staffing levels during evenings and nights may also contribute. In our December 22, 2009 Patient Safety Tip of the Week “Falls on Toileting Activities” we noted a study showing that most falls related to toileting activities occurred in patients already labeled as being at high risk for falls (Tzeng 2010) and another study (Krauss et al 2008) showing poor staff compliance with toileting schedules, even during a period of a targeted intervention.
We suggested that perhaps the toileting needs of our patients might be better met by aides or staff other than nursing. Perhaps a specially-trained aide or team could work from 10 PM to midnight or 9 PM to 11 PM and just focus on ensuring all patients at high risk for falls get appropriate assistance toileting before they go to sleep. Keep in mind that such attention to toileting is also important in the patient at risk for delirium. Note that we have also mentioned the gender issue on several occasions. Many studies have identified male sex as a risk factor for falls. We don’t know if that is due to macho vs. modesty. If it is the latter, then male patients may be hesitant to ask a female nurse to help them to the bathroom. So consider having some male aides on your “team” to assist male patients with toileting as well.
Patients with OAB symptoms, once they get the urge to void, often need to void right away. So it should be no surprise that an inpatient with OAB won’t wait for a response to the nurse call button and will try to get to the bathroom by him/herself. So at least for male inpatients with OAB one should keep a hand-held urinal within reach at the bedside as long as they have the cognitive capacity to use it. Some females might also be able to utilize a bedpan by themselves before a nurse arrives for assistance.
So here are some of the things you should be doing to reduce the risk of falls in your patients who have symptoms of overactive bladder:
Some of our prior columns related to falls:
Jayadevappa R, Chhatre S, Newman D, Wein A. Association between overactive bladder and risk of falls among Medicare elderly fee-for-service patients. American Urological Association 2015; Abstract PD24-09
Rudolph JL, Salow MJ, Angelini MC, McGlinchey RE. The Anticholinergic Risk Scale and Anticholinergic Adverse Effects in Older Persons. Arch Intern Med 2008; 168(5): 508-513
Gray SL, Anderson ML, Dublin S, et al. Cumulative Use of Strong Anticholinergics and Incident Dementia. A Prospective Cohort Study. JAMA Intern Med 2015; Published online January 26, 2015
Paul KJ, Walker RL, Dublin S. Anticholinergic Medications and Risk of Community-acquired Pneumonia in Elderly Adults: A Population-based Case–control Study. J Am Geriatr Soc 2015; 63(3): 476-485
Vaughan CP, Brown CJ, Goode PS, et al. The Association of Nocturia with Incident Falls in an Elderly Community-Dwelling Cohort. International Journal of Clinical Practice 2010; 64(5): 577-583
Tzeng H-M. Understanding the Prevalence of Inpatient Falls Associated With Toileting in Adult Acute Care Settings. Journal of Nursing Care Quality 2010; 25(1):22-30
Krauss MJ, Tutlam M, Costantinou E, et al. Intervention to Prevent Falls on the Medical Service in a Teaching Hospital. Infection Control and Hospital Epidemiology. Volume 29, Issue 6, Page 539–545, Jun 2008
June 16, 2015
Updates on Delirium
A recent systematic review and meta-analysis of 42 studies on delirium in ICU patients (Salluh 2015) reinforces much of which we have already discussed about delirium. The authors found that about a third (31.8%) of ICU patients develop delirium, most studies using the CAM-ICU tool for diagnosis of delirium. The overall risk of death in patients with delirium was about double that of patients without delirium, and remained high even after adjustment for age and severity of illness (as measured by APACHE II scores). Patients with delirium had longer mean length of stay in the ICU (1.38 days longer), mean hospital length of stay (0.97 days longer), and mean duration of mechanical ventilation (1.79 days longer). Studies on longer term mortality (6 months to 1 year) were conflicting, with some showing considerable relationship between delirium and mortality but at least one sizable study showing no relationship after adjustment for multiple variables. Delirium was associated with worse function on a variety of cognitive outcome measures in multiple studies.
The incidence of postoperative delirium in the elderly tends to be even higher, particularly in certain types of surgery. A new study (Zywiel 2015) looked at hip fracture patients aged 65 and older in Canada over a 2 year period. They found that 48% developed delirium before, during or after surgery. Those with delirium were older and had higher ASA scores but even after adjustment for these factors they had an average 7.4 day longer hospital stay and costs that were 50% higher than those without delirium.
A recent systematic review of risk factors for delirium in the ICU found somewhat surprising results (Zaal 2015). The authors looked only for those risk factors having high or moderate strength of evidence. They identified 33 studies of acceptable quality to review. They found that only 11 putative risk factors for delirium are supported by either strong or moderate level of evidence. There was strong evidence that age, dementia, hypertension, pre-ICU emergency surgery or trauma, APACHE II score, mechanical ventilation, metabolic acidosis, delirium on the prior day, and coma are risk factors for delirium and moderate evidence that multiple organ failure is a risk factor for delirium. Evidence was strong that gender is not associated with delirium. They found strong evidence that use of dexmedetomidine is associated with a lower delirium prevalence.
Most striking in the Zaal review is that they found the evidence inconclusive for benzodiazepines, analgosedatives, and opiates as risk factors for delirium. That is disturbing, since those are among the few truly modifiable risk factors traditionally noted for preventing delirium. Multiple previous studies have demonstrated benzodiazepines, sedatives and opioids as factors contributing to the development of delirium. Another recent study found a strong association between infusion of benzodiazepines and/or opioids and transition to delirium in mechanically ventilated ICU patients (Kamdar 2015).
However, we concur with the view of the editorial accompanying the Zaal study that the considerable heterogeneity of the studies makes it very difficult to truly assess risk factors. Brown and Dowdy (Brown 2015) point out that even those studies in the Zaal review using the same tool (the CAM-ICU) found the incidence of delirium in the ICU ranged from 22% to 78%. So the original intent of Zaal and colleagues to use pooled data to assess delirium risk factors was largely precluded by the heterogeneity. Brown and Dowdy conclude that the Zaal results likely reflect preferential collection of certain data as much as any underlying causal link.
The systematic review by Zaal and colleagues (Zaal 2015) found strong evidence that use of dexmedetomidine is associated with a lower delirium prevalence. We don’t concur with that conclusion. Two of the studies they note as showing strong evidence of this beneficial association we discussed in our February 10, 2009 Patient Safety Tip of the Week “Sedation in the ICU: The Dexmedetomidine Study”. We pointed out several methodological and other problems with those studies. We think that the jury is still out on whether use of dexmedetomidine is associated with a lower delirium prevalence.
There are no proven pharmacologic agents for preventing or treating delirium. One that has had some mixed results in past studies is haloperidol. Now a new study even questions whether haloperidol may actually increase the risk of delirium (Pisani 2015). Among nonintubated patients, and after adjustment for time-dependent confounding and important covariates, each additional cumulative milligram of haloperidol was associated with 5% higher odds of next-day delirium.
Another recent systematic review and meta-analysis looked at pharmacologic agents for the prevention and treatment of delirium in patients undergoing cardiac surgery (Mu 2015). It somewhat surprisingly concluded that moderate to high-quality evidence supports the use of pharmacologic agents for the prevention of delirium but those results are based largely on one randomized controlled trial. That trial showed a beneficial effect of intraoperative dexamethasone (Dieleman 2012). They also note their funnel plot indicated that there is likely publication bias. They go on to state that the evidence for treating post-cardiac surgery delirium is inconclusive. The accompanying editorial concurs that there is “no magic bullet” at this time (Bruder 2015). We’ll also note that a substudy of the above mentioned large study showing less delirium with dexamethasone showed no beneficial effect of dexamethasone on postoperative cognitive dysfunction at one or twelve months after cardiac surgery (Ottens 2014).
Of the nonpharmacologic means of preventing and treating delirium, promoting more normal sleep-waking and day-night cycles has been a focus. One study done in a medical ICU employed multifaceted sleep-promoting interventions implemented with the aid of daily reminder checklists for ICU staff (Kamdar 2013). Though improvements in overall sleep quality ratings did not reach statistical significance, there were significant improvements in the incidence of delirium/coma (odds ratio: 0.46) and daily delirium/coma-free status (odds ratio: 1.64). In a subsequent secondary analysis from that study Kamdar and colleagues (Kamdar 2015) found that there was no association between daily perceived sleep quality ratings (by patients or their nurses) and transition to delirium. However, as mentioned above, that study showed a strong association between infusion of benzodiazepines and/or opioids and transition to delirium in mechanically ventilated patients. Interestingly, it also showed that patients reporting use of sleep aids at home were less likely to transition to delirium.
Speaking of the relationship between sleep and delirium we had previously noted it was only a matter of time until someone looked at manipulation of melatonin in patients with delirium (see our March 25, 2014 Patient Safety Tip of the Week “Melatonin and Delirium”). In that column we noted 3 studies that had shown a beneficial effect of melatonin or the melatonin agonist ramelteon in preventing or treating delirium. But we expressed our skepticism about these studies because of small numbers, methodological concerns, and “too good to be true” results. A more recent randomized controlled study of almost 400 patients age 65 and older who were scheduled for acute hip surgery found that melatonin treatment did not reduce the risk of delirium (de Jonghe 2014).
The mainstay of delirium prevention has been multicomponent nonpharmacological interventions such as HELP, the Hospital Elder Life Program (see our October 21, 2008 Patient Safety Tip of the Week “Preventing Delirium”). Inouye et al (Inouye 1999) showed in a landmark study of 852 medical patients aged 70 and older that management of 6 risk factors was able to reduce the incidence of delirium from 15% to 9.9%. The number of days with delirium and the number of episodes of delirium was also reduced by the intervention. The intervention targeted cognitive impairment, sleep deprivation, immobility, visual impairment, hearing impairment, and dehydration. This was strong evidence that a multicomponent intervention could be of benefit in reducing delirium.
A meta-analysis of multicomponent nonpharmacological interventions for delirium prevention was recently published (Hshieh 2015). It confirmed that multicomponent nonpharmacological interventions are effective in decreasing delirium incidence and preventing falls. It estimates that potential savings in the US from such programs might be more than $16 billion annually. The meta-analysis included over 4000 patients from 14 studies. Most used HELP or a modified HELP program. Some used volunteers, family, or nurses in their interventions. Overall, the odds of delirium were 53% lower in patients receiving these interventions and the NNT (number needed to treat) was 14.3. In addition, the odds of falling were 62% lower among patients with such interventions (delirium is a risk factor for falls). While there were trends favoring those in the intervention group for length of stay, rate of institutionalization, and changes in functional or cognitive status, these trends did not reach statistical significance.
Multicomponent nonpharmacological interventions may also be used for management of patients who already have delirium. A good example of team-delivered multicomponent nonpharmacological interventions for delirium was recently presented at the American Association of Critical-Care Nurses (AACN) 2015 National Teaching Institute and Critical Care Exposition (Haseeb 2015). A nurse-led team consisted of a critical care nurse, physician, pharmacist, and an exercise physiologist. Patients in a med/surg ICU were randomized in a 2:1 fashion after screening positive for delirium with the CAM-ICU tool. Patients managed by the team had a statistically significant reduction in mean duration of delirium (4.96 vs 9.00 days). There were also statistically significant reductions in duration of therapy for benzodiazepines and opiates.
With the evidence now accumulating for the effectiveness and cost-effectiveness of multicomponent nonpharmacological interventions for delirium prevention and treatment it makes sense for any hospital with a sizable ICU population or significant surgical volume to consider putting together a team to deliver such interventions.
We also refer you back to our December 2014 What’s New in the Patient Safety World column “American Geriatrics Society Guideline on Postoperative Delirium in Older Adults”. The American Geriatrics Society has just published a best practice statement for Postoperative Delirium in Older Adults (AGS Expert Panel 2014). It’s a guideline that really only recommends evidence-based best practices. Though it is for patients with postoperative delirium most of the principle recommendations also apply to delirium in general. And we also refer you back to our many previous columns on delirium prevention and management noted below.
Some of our prior columns on delirium assessment and management:
Salluh JIF, Wang H, Schneider EB, et al. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ 2015; 350: h2538 (published online June 3, 2015)
Zywiel MG, Hurley R, Perruccio A, et al. The Health Economic Implications of Perioperative Delirium in Older Patients with Low-energy Hip Fractures.
American Academy of Orthopaedic Surgeons 2015 Annual Meeting. Paper 038 (abstract).
Zaal IJ, Devlin JW, Peelen LM, Slooter AJC. A Systematic Review of Risk Factors for Delirium in the ICU. Critical Care Medicine 2015; 43(1): 40-47
Kamdar BB, Niessen T, Colantuoni E, et al. Delirium Transitions in the Medical ICU: Exploring the Role of Sleep Quality and Other Factors. Critical Care Medicine 2015; 43(1): 135-141
Brown CH, Dowdy D. Risk Factors for Delirium: Are Systematic Reviews Enough? Critical Care Medicine 2015; 43(1): 232-233
Pisani MA, Araujo KLB, Murphy TE. Association of Cumulative Dose of Haloperidol with Next-Day Delirium in Older Medical ICU Patients. Crit Care Med 2015; 43(5): 996-1002
Mu JL, Lee A, Joynt G. Pharmacologic Agents for the Prevention and Treatment of Delirium in Patients Undergoing Cardiac Surgery: Systematic Review and Metaanalysis. Critical Care Medicine 2015; 43(1): 194-204
Dieleman JM, Nierich AP, Rosseel PM, et al. for the Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative High-Dose Dexamethasone for Cardiac SurgeryA Randomized Controlled Trial. JAMA 2012; 308(17): 1761-1767
Bruder NJ, Velly L. Pharmacologic Approach for Delirium after Cardiac Surgery: There Is No Magic Bullet. Critical Care Medicine 2015; 43(1): 256-257
Ottens TH, Dieleman JM, Sauër AC, et al. Effects of Dexamethasone on Cognitive Decline after Cardiac Surgery: A Randomized Clinical Trial. Anesthesiology 2014; 121: 492-500
Kamdar BB, King LM, Collop NA, et al. The Effect of a Quality Improvement Intervention on Perceived Sleep Quality and Cognition in a Medical ICU. Critical Care Medicine 2013; 41(3): 800-809
de Jonghe A, van Munster BC, Goslings JC, et al.on behalf of the Amsterdam Delirium Study Group. Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial. CMAJ 2014; published ahead of print September 2, 2014
Inouye SK, Bogardus ST, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM. A Multicomponent Intervention to Prevent Delirium in Hospitalized Older Patients. N Engl J Med 1999; 340: 669-676
Hshieh TT, Yue J, Oh E, et al. Effectiveness of Multicomponent Nonpharmacological Delirium Interventions: A Meta-analysis. JAMA Intern Med 2015; 175(4): 512-520
Haseeb C, Prado I, Moscoso-Stafford G, Grami P. Delirium Causing Havoc in Health Care: A Multidisciplinary Approach to Delirium Assessment and Management in the Intensive Care Unit. American Association of Critical-Care Nurses (AACN) 2015 National Teaching Institute and Critical Care Exposition. Abstract RS2. Presented May 19, 2015
The American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative Delirium in Older Adults: Best Practice Statement from the American Geriatrics Society. Journal of the American College of Surgeons 2014; Published Online: November 14, 2014
Print “Updates on Delirium”
June 23, 2015
Again! Mistaking Antiseptic Solutions for Radiographic Contrast
Most of us remember an unfortunate case a few years ago where a patient was inadvertently given intraarterially the antiseptic skin prep solution, chlorhexidine, instead of contrast media (ISMP 2004). That resulted in a leg amputation, followed by a stroke and multiple organ failure and, ultimately, death.
In that case there were two unlabeled basins containing clear solutions that looked alike. So it was not surprising that such accidents might occur. The Joint Commission now requires that all basins, syringes, and other containers in the sterile field be appropriately labeled. Moreover, when any such liquid is to be injected into a patient there should be a verification that the agent is the one intended for injection.
It has been several years since we’ve heard about such accidents. But now the National Health Service in England has just issued an alert following three incidents involving inadvertent injection of skin antiseptic solutions since 2012, and one additional near miss (NHS 2015). Two incidents involved severe harm from confusion between 2% chlorhexidine and x-ray contrast media in circumstances where both substances were in unlabeled basins. The near miss also involved confusion between chlorhexidine and x-ray contrast material despite the fact the two solutions were on different tables. The other incident involved flushing a renal dialysis line with chlorhexidine rather than saline. These cases occurred despite two previous alerts from the National Patient Safety Agency in the UK (NPSA 2007, NPSA 2010).
Incidents involving injection of the wrong substance when two look-alike substances are in proximity and are unlabeled have occurred in multiple venues (angiography suites, cath labs, dialysis units, hospital OR’s, ambulatory surgery centers, and others). Most hospitals have really focused on enforcing the “no unlabeled syringes” and “no unlabeled solutions in basins” in the OR. But it may be that those other areas (radiology suites, cath labs, dialysis units, etc.) may be even more vulnerable to such incidents. And don’t forget bedside procedures. They are probably even more prone to such mistakes. Clear, colorless skin antiseptics might be easily confused with substances intended for spinal injection or injection into other body cavity.
There’s always that tendency to think “I know what’s in that basin” and “there will only be one basin”. Then another basin shows up with a substance similar in appearance, often unbeknownst to the person who will actually be injecting.
There’s also a tendency to keep the skin antiseptics around “just in case we might need them”. Once you’ve prepped the skin, the antiseptic agent should be removed from the sterile field (and even adjacent stands). There is usually easy access to these in most venues if you really do need them again so there is little reason to “keep them around just in case you might need them again”. And remember that the alcohol-based antiseptics are also flammable so you especially don’t want them sitting around where they might get ignited by a heat source during a procedure.
Note that the switch in antiseptics from a brown povidone-iodine solution to a clear chlorhexidine solution likely played a role in some of these incidents, such as the one described in the 2004 ISMP alert.
The steps recommended by ISMP in that 2004 Alert (ISMP 2004) still bear repeating:
To these we’d add:
Such tragic mixups involving accidental injection of skin antiseptic agents are, fortunately, rare. But you don’t want one happening at your facility or to your patients.
ISMP (Institute for Safe Medication Practices). Loud wake-up call: Unlabeled containers lead to patient's death. ISMP Medication Safety Alert! Acute Care Edition. December 2, 2004
NHS (National Health Service) England. Patient Safety Alert NHS/PSA/W/2015/005. Stage One: Warning. Risk of death or severe harm due to inadvertent injection of skin preparation solution. May 26, 2015
National Patient Safety Agency. Promoting safer use of injectable medicines. Patient Safety Alert 20, 2007
National Patient Safety Agency. Injectable medicines in theatres. Signal 1162, 2010;
June 30, 2015
What Are Appropriate Indications for Urinary Catheters?
We’ve had a little hiatus in our ongoing discussions about CAUTI prevention but recently there has been renewed activity in the literature that has been quite interesting. Though we’ve done numerous columns on prevention of CAUTI’s, one of the questions we’re still often asked is “What are the appropriate indications for a urinary catheter?” and how were they determined.
Most of us have been using the indication criteria published by the CDC in 2009 (Gould 2009) as discussed in our June 9, 2009 Patient Safety Tip of the Week “CDC Update to the Guideline for Prevention of CAUTI”. That guideline provided a table listing appropriate indications for indwelling urethral catheters. Appropriate indications in the CDC guideline include:
Most importantly, that guideline stressed that indwelling urethral catheters should not be used for management of incontinence except under very unique circumstances. Nor should they be used just to obtain specimens for culture or diagnostic testing.
But even that guideline left lots of gray areas. For example, to some “critically ill patients” meant all ICU patients could have an indwelling catheter.
To address some of the many unanswered questions regarding appropriate use of urinary catheters, clinicians from the University of Michigan convened an expert panel and utilized the RAND/UCLA Appropriateness Method to come up with recommendations (Meddings 2015). And they went further than just indwelling urinary catheters, also making recommendations regarding external urinary catheters and intermittent straight catheters. The “Ann Arbor Criteria” recommendations apply to medical inpatients, not patients in the perioperative setting.
Appropriate indications for Foley catheters in the Ann Arbor Criteria are:
Inappropriate indications for Foley catheters in the Ann Arbor Criteria are:
The Ann Arbor Criteria paper includes examples that help clarify many of the above criteria.
Perhaps the biggest contribution of the Ann Arbor group work is recognition of the important discussion points that came up during the process. Competing patient safety goals is one recurrent theme we see in the battle to prevent CAUTI’s. The classic such conundrum is the incontinent patient who is at risk for skin breakdown or pressure ulcers. One important situation discussed in the Ann Arbor exercise was managing incontinence in patients with morbid obesity or severe edema in whom concerns about skin issues was important. Panelists recognized that not all hospitals have resources such as mechanical lifts that may be needed for turning and lifting such patients. Unexpected discussion took place regarding what to do in the patient with incontinence-related dermatitis. The panel ultimately decided that Foley catheters or intermittent sterile catheterization were inappropriate for any level of dermatitits but that external catheters might be appropriate for patients with moderate or severe incontinence-associated dermatitis.
One of the indications in the previous CDC guideline was “need for accurate measurements of urinary output in critically ill patients”. Unfortunately, that often meant that almost all patients in ICU’s got urinary catheters. The panelists in the Ann Arbor group uniformly agreed that should not be the case. They may be required in cases where monitoring urine volume hourly is critical for management. But there are usually other ways to assess urine output when it is needed on a daily rather than hourly basis. (Note also that in those who do need monitoring of hourly urine output an external catheter may be inappropriate because it only measures urine the bladder has spontaneously voided.)
The discussion also had some good advice about the need for a urology consultation before decisions regarding Foley catheter insertion or removal in certain circumstances. Specifically, consultation with a urologist should be considered before catheter use in the patient with prostatitis or those with recent urological procedures or urethral trauma.
Another really valuable contribution are the recommendations by the Ann Arbor group regarding indications for external urinary catheters and intermittent straight catheters.
Appropriate indications for external catheters in the Ann Arbor Criteria are:
Inappropriate indications for external catheters in the Ann Arbor Criteria are:
Appropriate indications for Intermittent Straight Catheterization in the Ann Arbor Criteria are:
Inappropriate indications for Intermittent Straight Catheterization in the Ann Arbor Criteria are:
One of the most valuable items in the Ann Arbor document is an example of an “ICU checklist for appropriateness of Foley catheter” (see Figure 4 in the Meddings article).
The Meddings paper notes how often the expert panel kept coming up with scenarios that needed further clarification. Another recent study interviewed nurses and physicians in the emergency department and acute medical wards of a large hospital to examine the thinking that went into decisions about indwelling urinary catheter placement (Murphy 2015). They also found that opinions varied considerably, most notably showing differing beliefs on when such catheters were appropriate for each clinical indication. They found that both patient and non-patient factors influenced decisions. These included clinical setting, resources, patient age and gender, and staff workload. Often decisions were difficult because of conflicting goals, as also noted in the Ann Arbor paper.
In an editorial accompanying the Murphy study, Krein and Saint (Krein 2015) separate CAUTI prevention interventions into the “socio-adaptive” and “technical” components. Socio-adaptive components include behavior change and unit culture whereas technical components include things like catheter reminders and stop orders. Of course, changing behavior and culture are much more difficult. Krein and Saint also take aim at one “indication” that has historically appeared on most catheter appropriateness criteria lists “for patient comfort and dignity in end-of-life situations”. They note that indwelling catheters are neither comfortable nor dignified. We couldn’t agree more. Our experience has been that use of this pseudo-indication is usually camouflage for the convenience of someone else.
As noted above, the “Ann Arbor Criteria” apply to medical inpatients, not patients in the perioperative setting. Of interest related to that is a study which showed the place of catheter insertion was an important risk factor for CAUTI and that the operating room was actually the safest place for catheter insertion (Barbadoro 2015). The authors felt that reflected the importance of hand hygiene and proper aseptic insertion techniques as crucial determinants in CAUTI prevention.
While there are no hard and fast criteria for which patients should have a Foley catheter inserted perioperatively, one needs to use common sense. Not all patients undergoing surgery need a catheter. At one hospital we looked at patients undergoing surgeries expected to be relatively short in duration (eg. laparoscopic cholecystectomy). One surgeon routinely used a Foley, three surgeons did not. Once the “outlier” surgeon realized the others did not use a Foley, he also ceased using Foleys for such cases. Factors to consider in deciding which patients in the OR need Foleys are expected case duration (and likelihood it might be extended by complications), expected volumes of fluid in and fluid out, and location of the surgical procedure on the body (eg urologic surgery or other surgery on contiguous structures of the genitourinary tract).
A few recent studies also addressed efforts to prevent CAUTI’s. One addressed CAUTI prevention in pediatric patients (Davis 2014). The researchers implemented a bundle of interventions including the following:
They found that their CAUTI prevention bundle was associated with a 50% reduction in the mean monthly CAUTI rate.
Another study looked at the impact of a computerized clinical decision support (CDS) intervention reducing the duration of urinary tract catheterizations (Baillie 2014). On the basis of the indication chosen, providers were alerted to reassess the need for the urinary catheter if it was not removed within the recommended time. They first used a stock reminder in their commercial electronic health record but found only 2% of reminders resulted in removal of Foley catheters. They then refined the reminder to have a more palatable user interface and found this resulted in a 15% catheter removal rate. Catheter utilization ratios and CAUTI rates also improved significantly over the duration of the project. We’ve always been big fans of using alerts to both avoid initial use of Foley catheters and prompt early removal of Foley catheters that were inserted. This study, however, points out the importance of the manner in which the alert is delivered.
And for those patients who do have indications for an indwelling urinary catheter, there are important considerations regarding catheter selection and drainage devices. A good summary of catheter types, balloon sizes, catheter lengths and other practical issues also has good suggestions about preparing patients for catheter removal (Yarde 2015).
Nursing home patients have a high prevalence of indwelling urinary catheters. Once again, faculty from the University of Michigan Medical School have led the charge in improving CAUTI rates in this population (Mody 2015). Actually the intervention was a multimodal targeted infection prevention program aimed at nursing home residents with indwelling urinary catheters and/or feeding tubes. The intervention consisted of preemptive barrier precautions (but not patient isolation), active surveillance for multi-drug resistant organisms and infections (with data feedback), and comprehensive staff education regarding infection prevention practices and hand hygiene. Nursing homes randomized to the intervention group were compared with those doing their own infection control programs. While much of the study was focused on reducing MDRO’s, at which it was successful, the impact on CAUTI prevention was striking. The reduction of almost 50% in rates of first CAUTI’s was attributed to reduced antibiotic usage, emphasis on hand hygiene, and education on appropriate catheter care and use.
Our other columns on urinary catheter-associated UTI’s:
Gould CV, Umscheid CA, Agarwal RK, et al. Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2009. CDC HICPAC 2009
Meddings J, Saint S, Fowler KE, et al. The Ann Arbor Criteria for Appropriate Urinary Catheter Use in Hospitalized Medical Patients: Results Obtained by Using the RAND/UCLA Appropriateness Method. Ann Intern Med 2015; 162(9_Supplement): S1-S34
Murphy C, Prieto J, Fader M. “It's easier to stick a tube in”: a qualitative study to understand clinicians’ individual decisions to place urinary catheters in acute medical care. BMJ Qual Saf 2015; Published online 11 June 2015
Krein SL, Saint S. What’s your excuse for Foley use? BMJ Quality & Safety Online First 2015; published on 1 June 2015
Barbadoro P, Labricciosa FM, Recanatini C, et al. Catheter-associated urinary tract infection: Role of the setting of catheter insertion. American Journal of Infection Control 2015; Published online: March 31, 2015
Davis KF, Colebaugh AM, Eithun BL, et al. Reducing Catheter-Associated Urinary Tract Infections: A Quality-Improvement Initiative. Pediatrics 2014; 134:3 e857-e864; published ahead of print August 11, 2014
Baillie CA, Epps M, Hanish A, et al. Usability and Impact of a Computerized Clinical Decision Support Intervention Designed to Reduce Urinary Catheter Utilization and Catheter-Associated Urinary Tract Infections. Infection Control & Hospital Epidemiology 2014; 35(9): 1147-1155
Yarde D. Managing indwelling urinary catheters in adult. Nursing Times 2015; 111(22): 12-13 May 27, 2015
Mody L, Krein SL, Saint S, et al. A Targeted Infection Prevention Intervention in Nursing Home Residents with Indwelling Devices: A Randomized Clinical Trial. JAMA Intern Med 2015; 175(5): 714-723
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March 5, 2013
February 26, 2013
February 19, 2013
February 12, 2013
February 5, 2013
January 29, 2013
January 22, 2013
January 15, 2013
January 8, 2013
January 1, 2013
December 25, 2012
Tip of the Week on Vacation
December 18, 2012
December 11, 2012
December 4, 2012
November 27, 2012
November 20, 2012
November 13, 2012
November 6, 2012
October 30, 2012
October 23, 2012
October 16, 2012
October 9, 2012
October 2, 2012
September 25, 2012
September 18, 2012
September 11, 2012
September 4, 2012
August 28, 2012
August 21, 2012
August 14, 2012
August 7, 2012
July 31, 2012
July 24, 2012
July 17, 2012
July 10, 2012
Tip of the Week on Vacation
July 3, 2012
June 26, 2012
June 19, 2012
June 12, 2012
June 5, 2012
May 29, 2012
May 22, 2012
May 15, 2012
May 8, 2012
May 1, 2012
April 24, 2012
April 17, 2012
April 10, 2012
April 3, 2012
March 27, 2012
March 20, 2012
March 13, 2012
March 6, 2012
February 28, 2012
February 21, 2012
February 14, 2012
February 7, 2012
January 31, 2012
January 24, 2012
January 17, 2012
January 10, 2012
January 3, 2012
December 20, 2011
December 13, 2011
December 6, 2011
November 29, 2011
November 22, 2011
November 15, 2011
November 8, 2011
November 1, 2011
October 25, 2011
October 18, 2011
October 11, 2011
October 4, 2011
September 27, 2011
September 20, 2011
September 13, 2011
September 6, 2011
August 30, 2011
August 23, 2011
August 16, 2011
August 9, 2011
August 2, 2011
July 26, 2011
July 19, 2011
July 12, 2011
July 5, 2011
June 28, 2011
June 21, 2011
June 14, 2011
June 6, 2011
May 31, 2011
May 24, 2011
May 17, 2011
May 10, 2011
May 3, 2011
April 26, 2011
April 19, 2011
April 12, 2011
April 5, 2011
March 29, 2011
The Silent Treatment:A Dose of Reality
March 22, 2011
March 15, 2011
March 8, 2011
March 1, 2011
February 22, 2011
February 15, 2011
February 8, 2011
February 1, 2011
January 25, 2011
January 18, 2011
January 11, 2011
January 4, 2011
December 28, 2010
December 21, 2010
December 14, 2010
December 6, 2010
November 30, 2010
November 23, 2010
November 16, 2010
November 9, 2010
November 2, 2010
October 26, 2010
October 19, 2010
October 12, 2010
October 5, 2010
September 28, 2010
September 21, 2010
September 14, 2010
September 7, 2010
August 31, 2010
August 24, 2010
August 17, 2010
August 10, 2010
August 3, 2010
Tip of the Week on Vacation
July 27, 2010
July 20, 2010
July 13, 2010
July 6, 2010
June 29, 2010
June 22, 2010
June 15, 2010
June 8, 2010
June 1, 2010
May 25, 2010
May 18, 2010
May 11, 2010
May 4, 2010
April 27, 2010
April 20, 2010
April 13, 2010
April 6, 2010
March 30, 2010
March 23, 2010
March 16, 2010
March 9, 2010
March 2, 2010
February 23, 2010
February 16, 2010
February 9, 2010
February 2, 2010
January 26, 2010
January 19, 2010
January 12, 2010
January 5, 2010
December 29, 2009
December 22, 2009
December 15, 2009
December 8, 2009
December 1, 2009
November 24, 2009
November 17, 2009
November 10, 2009
November 3, 2009
October 27, 2009
October 20, 2009
October 13, 2009
October 6, 2009
September 29, 2009
September 22, 2009
September 15, 2009
September 8, 2009
September 1, 2009
August 25, 2009
August 18, 2009
August 11, 2009
August 4, 2009
July 28, 2009
July 21, 2009
July 14, 2009
July 7, 2009
June 30, 2009
June 23, 2009
June 16, 2009
June 9, 2009
June 2, 2009
May 26, 2009
May 19, 2009
May 12, 2009
May 5, 2009
April 28, 2009
April 21, 2009
April 14, 2009
April 7, 2009
March 31, 2009
March 24, 2009
March 17, 2009
March 10, 2009
March 3, 2009
February 24, 2009
February 17, 2009
February 10, 2009
February 3, 2009
January 27, 2009
January 20, 2009
January 13, 2009
January 6, 2009
December 30, 2008
December 23, 2008
December 16, 2008
December 9, 2008
December 2, 2008
November 25, 2008
November 18, 2008
November 11, 2008
November 4, 2008
October 28, 2008
October 21, 2008
October 14, 2008
October 7, 2008
September 30, 2008
September 23, 2008
September 16, 2008
September 9, 2008
September 2, 2008
August 26, 2008
August 19, 2008
August 12, 2008
August 5, 2008
July 29, 2008
July 22, 2008
July 15, 2008
July 8, 2008
July 1, 2008
June 24, 2008
June 17, 2008
June 10, 2008
June 3, 2008
May 6, 2008
April 29, 2008
April 22, 2008
April 15, 2008
April 8, 2008
April 1, 2008
March 25, 2008
March 18, 2008
March 11, 2008
March 4, 2008
February 26, 2008
February 19, 2008
February 12, 2008
February 5, 2008
January 29, 2008
January 22, 2008
January 15, 2008
January 8, 2008
January 1, 2008
December 25, 2007
December 18, 2007
December 11, 2007
December 4, 2007
November 20, 2007
November 13, 2007
November 6, 2007
October 30, 2007
October 23, 2007
October 16, 2007
October 9, 2007
October 2, 2007
September 25, 2007
September 18, 2007
September 11, 2007
September 4, 2007
August 28, 2007
August 21, 2007
August 14, 2007
August 7, 2007
July 31, 2007
July 24, 2007
July 17, 2007
July 10, 2007
July 3, 2007
June 26, 2007
June 19, 2007
June 12, 2007
June 5, 2007
May 29, 2007
May 22, 2007
May 15, 2007
May 8, 2007
May 1, 2007
April 23, 2007
April 16, 2007
April 9, 2007
April 2, 2007
March 26, 2007
March 19, 2007
March 12, 2007
March 5, 2007
February 26, 2007