In our May 20, 2014 Patient Safety Tip of the Week “Ophthalmology: Blue Dye Mixup” we discussed an unfortunate case where methylene blue was used during cataract surgery rather than trypan blue and noted we suspected this risk could be present at many hospitals or ambulatory surgery centers.
Well, in fact, it
has happened before. An almost identical case in North Carolina just resulted in
a $1.5 million malpractice award (Upchurch
2014). The patient was undergoing
cataract surgery and the ophthalmologist ordered VisionBlue
(trypan blue) to stain the cataract so it could be safely removed. But a nurse instead
brought methylene blue and handed it to a surgical technician, who gave it to the
ophthalmologist. Both the nurse and the technician testified they announced
that the drug was methylene blue but the ophthalmologist apparently never heard
that. The patient became permanently blind in that eye and developed glaucoma
in it as well.
Though we don’t want to minimize the importance of communication and personal accountability in such cases, it is very clear there is a huge system issue here. The system actually put those healthcare workers and the patient in a vulnerable position that allowed the mistake to happen. It is very much akin to the concentrated potassium chloride issue of the past in which nurses accidentally administered fatal doses of concentrated KCl to patients. There was little reason for nurses to have access to vials of concentrated KCl yet we placed them on nursing units and it was simply a matter of time until someone unwittingly drew up a syringeful and administered a fatal dose. Our eventual system fix was to remove vials of concentrated KCl from floor stock on nursing units.
We need to do the same thing in this scenario. We need to eliminate the opportunity for nurses or technicians and ophthalmologists to inadvertently allow methylene blue in a patient’s eye. As we noted in our May 20, 2014 Patient Safety Tip of the Week “Ophthalmology: Blue Dye Mixup” this is really an example of confusion about LASA (look-alike, sound-alike) drug pairs. So if you are an OR or ASC that does eye surgeries, you should add this drug pair (methylene blue and trypan blue) to your LASA list and take appropriate precautions to minimize the chance they might be mixed up. If you are a facility that only does eye cases, you probably have no need for methylene blue and therefore should not stock it at all. In other facilities where you may have a legitimate need for methylene blue (for example, it is used to help identify leaks in some surgeries or to help identify tissue in need of debridement in others) you clearly need to store the two blue dyes separately. If you have a dedicated “eye” room and can store all the medications and materials for eye surgery there (or in an automated dispensing cabinet dedicated to ophthalmology) make sure that methylene blue is not in those areas. It might even be worth considering putting warning labels on methylene blue stating “not for eye cases” or something to that effect. We are unaware of any “tallman” lettering conventions for this drug pair. A logical one might be “METHYLENE blue” and “TRYPAN blue” but you’d have to make sure that these choices are not confused with any other drugs or substances you stock.
This is a serious situation that could put your patients, your staff, and your reputation at risk. It deserves your immediate attention to ensure it doesn’t happen in your facilities.
This is also a great example of our failure to disseminate valuable lessons learned promptly. The North Carolina case occurred in 2008, the California case (CDPH 2014) in 2013. We don’t know if the North Carolina case had been discussed in the ophthalmology literature before. We’re also willing to bet that these two cases were not the only ones. With the concentrated KCl issue it took many years for people to recognize that these cases were happening at multiple different hospitals and ultimately implement a system change. Let’s hope it does not take many years for hospitals and ASC’s to implement system changes here.
Some of our previous patient safety columns involving ophthalmology issues:
June 5, 2007 “”
March 11, 2008 “Lessons from Ophthalmology”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
June 2012 “Tailored Timeouts for Ophthalmologists”
May 20, 2014 “Ophthalmology: Blue Dye Mixup”
Upchurch K. Jury awards cataract patient $1.5M in malpractice suit. The Herald-Sun Aug. 20, 2014
CDPH (California Department of Public Health). 2014. Intake Number CA00368387.
Though we’ve been big advocates of “hourly rounding”, also known as “purposeful rounding” and other names, we’ve only done a couple columns about it. Our July 26, 2011 Patient Safety Tip of the Week “Hourly Rounding” discussed how hourly rounding, when done well, not only improves patient satisfaction but also reduces nurse interruptions and may improve patient safety outcomes.
We think implementing hourly rounding programs is a no-brainer. Yet many hospitals have not implemented such programs. One of the reasons is that it involves a major change in nurse workflow and mindset and usually requires a significant investment of time and money in training and education.
So researchers at St. Luke’s Episcopal Hospital in Houston, Texas, already proponents for hourly rounding, sought to see if a “train the trainer” program could lead to successful implementation of an hourly rounding program without the more time- and cost- intensive structured programs typically utilized in such implementations (Krepper 2014). They compared the two approaches on two comparable 32-bed cardiovascular surgery nursing units. One unit received the structured approach, which consisted of a 4-hour workshop for staff, posters in patient rooms informing patients and families what to expect, charting of the rounding activities both in the electronic medical record and a separate paper log kept in the patient rooms, use of rounding “scripts”, and coaching/mentoring. The other unit received its training via a “train the trainer” approach that had been successfully used in the organization for several other improvement initiatives. One staff member (the “trainer”) received in-depth training but the rest of the staff just learned from that trainer. The rest of the staff on that unit learned from the trainer. There were no in-room logs and no posters or ongoing coaching/mentoring for this unit. The nurses on this unit did chart their rounds in the electronic medical record and the nurse manager of the unit did follow up with staff.
The researchers collected data over a 6-month implementation period and another 6 months to determine whether the results were sustainable. There was less call light use and fewer steps taken by the day-shift staff during the study period on the intervention unit but no significant difference between the two units in staff perception of “having enough time”. There were no statistically significant differences in the number of patient falls, 30-day readmission rates, and patients’ perception of care between the two untis.
The authors concluded that adding additional structure did not provide any significant advantage over use of the “train the trainer” program. The hospital did make several changes after the study was completed. They did away with the in-room paper logs and posters but installed white boards in patient rooms to inform the patients and families when to expect regular “comfort care rounds”. Staff are not coached to use a specific “script”. Each nursing unit is now allowed to decide the best time for rounding and who will do the rounding (i.e. nurse vs. patient care assistant).
The latter issue is of interest. In our August 28, 2012 Patient Safety Tip of the Week “New Care Model Copes with Interruptions Better” we described an innovative program at University of Pittsburgh Medical Center (UPMC) that was successful in improving care while handling interruptions (Kowinsky 2012). They basically categorized two types of work: “predictable” and “unpredictable”. The predictable work occurs repetitively and reliably and can be scheduled. This includes things like rounding, feeding, repositioning, vital signs, etc. The unpredictable work consists of tasks that tend to occur randomly over the course of the day and includes things like answering call bells, blood draws, transporting patients, handling admissions and discharges, etc. Because of the two types of work they created two types of roles to deal with them. The “reliable rounder” addressed the predictable work and the “variable rounder” addressed the unpredictable work. During the simulation exercise carried out on an unoccupied available nursing unit, they developed scenarios and scripts and had observers watch and critique those doing role-playing. Frontline nurses participated with leaders and quality improvement staff and provided feedback to improve the model. They then piloted the new model on a telemetry unit. It was budget neutral since the same number of personnel was required as in the old model. The model was well received by hospital staff and at both 90 days and one year there were significant improvements in call bell response times, blood collection times, and other quality/service metrics.
So we remain advocates of the hourly rounding concept. It appears that hospitals now have a choice as to the specific staff members who do the rounds and the amount of resources needed to implement an hourly rounding program.
For those of you who wish to know more about hourly rounding we suggest that you read our July 26, 2011 Patient Safety Tip of the Week “Hourly Rounding” which describes the concepts and elements of such programs, the evidence for improvement in patient care and patient satisfaction, and has good references.
Krepper R, Vallejo B, Smith C, et al. Evaluation of a Standardized Hourly Rounding Process (SHaRP). Journal for Healthcare Quality 2014; 36(2): 62–69, March/April 2014
Kowinsky AM, Shovel J, McLaughlin M, et al. Separating Predictable and Unpredictable Work to Manage Interruptions and Promote Safe and Effective Work Flow. Journal of Nursing Care Quality 2012. 27(2): 109-115, April/June 2012
About a year ago we began reporting some statistics from SAMHSA (Substance Abuse and Mental Health Services Administration) and the Drug Abuse Warning Network (DAWN), a public health surveillance network that monitors drug-related ED visits in the US. In our June 2013 What’s New in the Patient Safety World column “Zolpidem and Emergency Room Visits” we noted the DAWN report showed emergency department visits for adverse reactions involving zolpidem increased 220% from 2006 to 2010 (SAMHSA 2013).
SAMSHA has just issued another DAWN report showing that the number of emergency department visits for overmedication involving zolpidem almost doubled from 2005-2006 to 2009-2010 (SAMSHA 2014). Other drugs were combined with the zolpidem were noted in over half (57%) of the cases. Note that the 2013 SAMSHA report included cases of ER visits related to any adverse reaction to zolpidem whereas all the cases in the current SAMSHA report involve overmedication with zolpidem, with or without use of concomitant drugs. In 2005-2006 there were over 21,000 ER visits in the US related to zolpidem overmedication. This increased to over 42,000 ER visits in 2009-2010. Almost a third of the visits were in patients in the 45-54 year old age range and females accounted for two-thirds of the cases. Compared to the age distribution of adverse events involving zolpidem, which were more common in older patients, cases involving overmedication were more evenly distributed by age group. The concomitant drugs most often included narcotic pain relievers, anti-anxiety medications or other sleep medications, including benzodiazepines, and alchohol.
Almost half (47%) of the ER visits resulted in hospital admission or transfer and 26% resulted in admission to an ICU.
And last year the FDA issued warnings about the dosing of zolpidem and recommendations to avoid driving the day after using some zolpidem products (see our June 2013 What’s New in the Patient Safety World column “Zolpidem and Emergency Room Visits” for details). While women seem to be more susceptible to effects of zolpidem, leading the FDA to require manufacturers to lower the initial recommended dose for females, a lower initial dose in males may be wise, too.
Another recent study (Hampton 2014) estimated the numbers and rates of adverse drug event (ADE) emergency department (ED) visits involving psychiatric medications among US adults between 2009 and 2011. The researchers used the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance system and for drug prescribing during outpatient visits used the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. Although zolpidem caused significantly fewer ED visits per outpatient prescription visit than lithium, quetiapine, haloperidol, or risperidone, it was implicated in 11.5% of adult psychiatric medication ADE ED visits, significantly more than any other drug. The elderly were particularly vulnerable to adverse reactions from zolpidem, similar to the 2013 SAMSHA DAWN report.
Overall, those researchers found an estimated 89,094 psychiatric medication ADE ED visits annually, with 19.3% resulting in hospitalization. Sedatives and anxiolytics, antidepressants, antipsychotics, lithium salts, and stimulants were implicated in an estimated 30,707, 25,377, 21,578, 3,620, and 2,779 respective ADE ED visits annually. They concluded that psychiatric medications are implicated in many ADEs treated in US ED’s and that fforts to reduce ADEs should include adults of all ages but might prioritize medications causing high numbers and rates of ED visits.
It’s clear that sleep medications and psychiatric medications are responsible for many emergency department visits. The potential benefits of such drugs must be carefully weighed against the potential risks and particular attention needs to be paid to dosing and use of concomitant drugs, particularly when zolpidem is prescribed. Particularly regarding sleep medications, attention should be directed at improving sleep hygiene and use of non-pharmacologic means to improve sleep as noted in several our our columns listed below.
Some of our previous columns on safety issues associated with sleep meds:
August 2009 “Bold Experiment: Hospitals Saying No to Sleep Meds”
March 23, 2010 “ISMP Guidelines for Standard Order Sets”
May 2012 “Safety of Hypnotic Drugs”
November 2012 “More on Safety of Sleep Meds”
March 2013 “Sedative/Hypnotics and Falls”
June 2013 “Zolpidem and Emergency Room Visits”
SAMHSA (Substance Abuse and Mental Health Services Administration), Center for Behavioral Health Statistics and Quality. (May 1, 2013). Emergency Department Visits for Adverse Reactions Involving the Insomnia Medication Zolpidem. Rockville, MD
SAMSHA. Emergency Department Visits Attributed to Overmedication That Involved the Insomnia Medication Zolpidem. The DAWN Report August 7, 2014
Hampton LM, Daubresse M, Chang H-Y, et al. Emergency Department Visits by Adults for Psychiatric Medication Adverse Events. JAMA Psychiatry 2014; Published online July 09, 2014
Various tubing misconnections have occurred for decades, often resulting in patient deaths. Reported cases have involved almost any catheter you can think of (substances intended for feeding tubes being given intravenously or via dialysis catheter, intravenous medications being given intrathecally, hypertonic intravenous contrast agents being given intrathecally for myelography, bladder irrigation solutions being given intravenously, intramuscular medications like Bicillin being given intravascularly, IV fluid being injected into a tracheostomy cuff, blood pressure cuffs being hooked up to IV lines, and many more examples).
A variety of contributing factors and root causes for such incidents have been identified. Obviously, the sheer number of tubes and catheters in patients is a big problem. Such are often arranged close together and often look very similar, prompting some to refer to “the spaghetti syndrome”. Failure to trace the tubing back from the patient to the origin is another issue. Particurly vulnerable times are at handoffs or when a patient goes from one unit to another (not just unit-to-unit transfers but especially trips to places like the radiology suite). And the usual environmental and personnel-related factors (poor lighting, staff fatigue, supply shortages, etc.) that are involved in many incidents also contribute here.
But the most salient feature, of course, is that the design of the systems allows 2 things to be connected that were never intended to be connected. The most successful safety interventions in any industry are constraints and forcing functions, i.e. designs that force someone to do something or not to do something. This particular issue is one that should be amenable to use of such forcing function solutions.
Given both the magnitude of the problem and the devastating consequences, several groups began collaborating several years ago to come up with new design solutions to prevent such inadvertent misconnections. The groups included ISO (the International Organization for Standardization), AAMI (the Association for the Advancement of Medical Instrumentations), the FDA, manufacturers and clinicians. Important contributions in the past have also come from ISMP, National Patient Safety Agency (UK), and the Pennsylvania Patient Safety Authority among many others.
The result of the collaboration is that several new sets of connector standards are forthcoming. The first ISO connector standard should be ready in the fall of 2014, with more to follow in 2014 and 2015. Timely is a new Joint Commission Sentinel Event Alert on managing risk during transition to the new ISO tubing connector standards (TJC 2014). While it contains many of the recommendations from its earlier sentinel event alert on tubing misconnections (TJC 2006) it focuses on the risks that might occur during the transition to the new tubing connector standards. It cautions that, though the new standards will ultimately improve patient safety, there could be new risks during this transition period.
The new Joint Commission sentinel event alert has many excellent recommended actions your organization should take. We won’t repeat them here. Go to the actual sentinel event alert and read them. Also see our previous columns on catheter and tubing misconnections listed below. There are links to some excellent resources in them, particularly our April 2012 What’s New in the Patient Safety World column“Tubing Misconnections” and August 23, 2011 Patient Safety Tip of the Week “Catheter Misconnections Back in the News”.
In addition to their recommendations, you should make monitoring of these systems a priority. It would be a good process to add to your “patient safety walk rounds” and doing periodic audits of your organizations practices is another. As before, this topic is an excellent process to conduct FMEA (failure mode and effects analysis) around.
Catheter/tubing misconnections are among the most devastating patient events we have seen, since many result in patient death. See our previous columns on this topic:
July 10, 2007 “Catheter Connection Errors/Wrong Route Errors”
November 2007 “More Patient Deaths from Luer Misconnections”
August 2009 “Catheter Misconnections Continue to Occur”
March 30, 2010 “Publicly Released RCA’s: Everyone Learns from Them”
April 2010 “RCA: Epidural Solution Infused Intravenously”
August 2010 “ISMP Advice on Catheter Misconnections”
August 23, 2011 “Catheter Misconnections Back in the News”
April 2012 “Tubing Misconnections”
TJC (The Joint Commission). Sentinel Event Alert 53: Managing risk during transition to new ISO tubing connector standards. Sentinel Event Alert 2014: 53: 1-6, August 20, 2014
The Joint Commission. Tubing misconnections—a persistent and potentially deadly occurrence. Sentinel Event Alert 2006; Issue 36 April 3, 2006