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September 15, 2020
An Eerily Familiar Incident
In our April 2, 2007 Patient Safety Tip of the Week “More Alarm Issues” we described a catastrophic case with numerous lessons learned. A patient with asthma arrived mid-morning at an emergency room with status asthmaticus. Treatment was begun but the patient required intubation and mechanical ventilation. He was stabilized and the ICU was called to admit the patient. The ICU had no empty beds but told the ER that they expected a bed to open up shortly. The ER said the patient could stay on a ventilator in an ER room until that bed was ready. Respiratory Therapy evaluated the patient and hooked the patient up to a dual power-source portable ventilator. That was felt to be ideal for this patient because it could be used either with typical AC current in the ER or use its built-in battery during transport.
A call to the ICU after an hour still found no available ICU bed. The ER now started getting busier, but the patient remained stable on the portable ventilator. Unbeknownst to all, the circuit breaker on the AC wall source had tripped, so the portable ventilator was running on battery power. After 5 hours in the ER, the portable ventilator exhausted its battery power and ceased functioning. The patient had a respiratory and then cardiac arrest.
Investigation revealed that no staff had heard any alarms on the EKG monitor even though it was likely the patient would have developed tachycardia and/or bradycardia after the ventilator had ceased functioning. The alarm volume, in fact, had been turned down to a level barely audible even by those in the immediate room. The room was immediately adjacent to the nursing and secretarial work area and staff had turned down the alarm volume because it distracted them from work.
When the hospital team conducting the RCA investigation came to the ER to re-enact the events, they found that the volume on the same alarms had been turned down again. A similar visit done with the health department a week later again found the alarm volume turned down.
Avoiding the snap reaction to take punitive action against the staff member who had initially turned down the alarm volume, it became very clear that the root cause was a flawed design to the ER plus a serious problem with the “culture” in the ER. That design of the ER led to the practice of turning down the alarm volume. One wonders how many ER’s, ICU’s, etc. suffer from this same type of design flaw that promotes such an unsafe practice. I’m always amazed when a hospital administrator proudly states “we designed this unit to have full visual contact of all patients”, only to find that the very proximity led to this practice of lowering alarm volumes. A second root cause was the development of a “culture” in the ER that tolerated manipulation of the alarms as an unsafe workaround.
Another root cause was in the design of the portable ventilator. How was one to know that it was functioning on battery power rather than AC power from the wall outlet? In fact, it did have an indicator light to flag which power source was being utilized. However, that indicator light was located on the back of the unit and not readily visible to staff in the room.
The case is also a good example of how technological “safety” advances may not actually reduce accidents, much like maritime radar simply encouraged ships to go faster. In this case, the “ideal” dual power-source ventilator fostered a false sense of security.
Lastly, the bottleneck caused by bed unavailability in the ICU was yet another root cause that led to implementation of a better system for triage of ICU beds.
A very unfortunate case but it illustrates multiple points that one often sees in cases with adverse outcomes (cascade of errors, latent errors, violations, unsafe workarounds, communication breakdowns, misuse of alarm systems, multiple design flaws, safety “culture” issues, bottlenecks and patient flow issues, and technological advances with unintended consequences).
Fast forward to 2020. A recent Anesthesia Patient Safety Foundation (APSF) case report (Levin 2020) sounds eerily similar to that incident. During the COVID-19 crisis, a patient with respiratory failure was housed in a windowless negative pressure room in a telemetry unit that had been converted to a temporary COVID-19 ICU. Because of the concomitant ventilator shortage, an anesthesia machine ventilator was used to ventilate the patient. On the tenth hospital day an audible alarm sounded at the central station and the patient’s SpO2 was noted to be 45%. Staff responding to the alarm found that multiple things controlled by electricity in the room were not working. The anesthesia ventilator itself was not working and its workstation control screen was dark. The AC power indicator light was off. However, the physiologic monitor, which had a separate battery backup system, was on and functioning. The patient was removed from that ventilator and manually bagged, with prompt return to baseline oxygen saturation levels.
The anesthesia machine ventilator was then connected into a different electrical outlet. The AC power indicator light came on and the machine rebooted. Staff performed the usual pre-use checks and reconnected the patient to the ventilator.
Investigation confirmed that the power supply to the anesthesia machine had been lost due to a tripped circuit breaker, just as in our earlier case. Review of the service log revealed an AC power loss and appropriate cutover to the backup battery. Several alarm messages had been displayed on the workstation screen beginning 28 minutes after the AC power loss progressing from “Battery Low”, “Battery V Low” to “Battery V VERY LOW” and, after 1 hour 43 minutes, to “Battery Empty.” The system shut down after 1 hour 52 minutes. Thus, the anesthesia machine had functioned fully as it was designed to work. It was also likely that use of several electrical appliances in the room may have led to the circuit breaker tripping.
During normal use of an anesthesia workstation, “a qualified anesthesia provider is in constant attendance, able to view the screens, hear audible alarms, and make adjustments as necessary”. The APSF/ASA Guidance on use of such workstations as ventilators elsewhere includes the recommendation that “An anesthesia professional needs to be immediately available for consultation, and to ‘round’ on these anesthesia machines at least every hour.”
Fortunately, the patient in the Levin case did not suffer the dire consequences seen in our earlier case. But the similarities between the two cases are striking. In each case, the tripping of the circuit breaker went unnoticed and staff were unaware that the ventilator was running on battery backup power. While each device did have an indicator that it was on battery backup power, that indicator was either in a position not readily visible or the screen with the warning was not observed because no one was in the room. Multiple root causes were involved in both cases. Unforeseen circumstances led to the use of the surrogate ventilator in both cases (the COVID-19 pandemic in the Levin case, and the ICU backup on our first case). Staff unfamiliarity with the devices may have played a role in each case. Poor design of the working area contributed in both.
The Levin study notes that many conventional ventilators used in ICU’s today also have battery backup systems, some of which only last an hour and that the same problem could have occurred with a conventional ventilator. They also note that some of those ventilators lack the remote monitoring capability that was critical in alerting staff in the current case.
Our recommendations from lessons learned in these 2 cases:
Our bet is that these are not the only cases out there where failure to recognize equipment is running on battery backup led to disasters or near misses. The potential contributing factors are likely present in many hospitals.
References:
Levin MA, Burnett G, Villar J, et al. Anesthesia Machine as an ICU Ventilator-A Near Miss. APSF (Anesthesia Patient Safety Foundation) 2020; September 4, 2020
https://www.apsf.org/article/anesthesia-machine-as-an-icu-ventilator-a-near-miss/
Print “An Eerily Familiar Incident”
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September 2020
AORN has issued a position statement on “Managing Distractions and Noise During Perioperative Patient Care” (AORN 2020). It begins with 4 beliefs:
A major focus is on the use of personal electronic devices (eg, mobile phones, tablets, laptop computers). Ring tones and alarms from personal electronic devices contribute to distraction. And “undisciplined use of cellular devices in the OR by any member of the perioperative team may be distracting and may affect patient care”, and that includes activities such as texting on smartphones.
Excessive noise may also interfere with the ability to communicate effectively, make it difficult to understand content, and contribute to miscommunication and lead to errors.
They note that the Environmental Protection Agency (EPA) recommends that the level of continuous background noise in hospitals not exceed 45 decibels (dB) during the day, and WHO (World Health Organization) recommends that environmental noise levels not exceed 30 dB. Moreover, OSHA (Occupational Safety and Health Administration) permissible exposure limit (PEL) for noise is 90 dBA for all workers for an 8‐hour day. Noise levels in hospitals often exceed such recommendations. Specialties in which powered surgical tools and impact‐producing equipment are used demonstrated higher noise levels than other specialties.
A noisy environment may both be associated with physical and psychological symptoms in healthcare workers and serve as a distraction that interrupts patient care and potentially increases the risk for error. They cite other studies showing causes of distractions and interruptions such as team members entering and leaving the room, equipment alarms, parallel conversations, and telephones or pagers. They also note other studies that showed increases in noise (eg, talking during the closing phase of a surgical procedure) may be associated with increases in surgical site infections.
The AORN position statement then goes on to describe a litany of activities that commonly cause distractions and interruptions in healthcare settings, including patient care activities, behavioral activities, electronic activities, technology, and mechanical/environmental factors,
It then goes on to discuss importance of the sterile cockpit concept, in which nonessential conversation and activities do not occur during critical phases of a surgical procedures, such as time‐out periods, critical dissections, surgical counts, medication preparation and administration, confirming and opening of implants, induction and emergence from anesthesia, and care and handling of specimens. Surgical team members should give their full attention to performing their responsibilities during critical phases. It does acknowledge that critical phases may occur at different times for different team members.
The position statement comes with over 60 references and also has links to useful resources from other organizations.
Prior Patient Safety Tips of the Week dealing with interruptions and distractions:
References:
AORN. (Association of periOperative Registered Nurses). AORN Position Statement on Managing Distractions and Noise During Perioperative Patient Care. AORN Journal 2020; 111(6): 675-680
https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.13064
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We’ve done multiple columns on “the weekend effect” and “the after-hours effect”, in which patient outcomes tend to be worse than for those during “normal” daytime hours (see list of columns below).
But there has been surprisingly little actual documentation of which specific care processes are deficient on those weekends. Liu and colleagues (Liu 2020) recently analyzed data from the American College of Surgeons’ NSQIP database on over 27,000 patients in 362 hospitals with ERAS (Enhanced Recovery After Surgery) programs for elective colorectal surgery (see our February 11, 2020 Patient Safety Tip of the Week “ERAS Rocks!”), The researchers assessed adherence to 9 postoperative process measures, comparing between patients undergoing surgery on Monday through Wednesday compared with Friday while risk-adjusting for procedure type and surgical complexity.
Those who underwent surgery on Friday, compared with Monday through Wednesday, had decreased adherence to mobilization on postoperative day one (POD#1), mobilization on POD#2, and Foley catheter removal by POD#1.
Several hospital-level factors were associated with lower weekend adherence rates: having more hospital beds, fewer nurses per bed, and fewer part-time unit staff per bed. Nonteaching hospitals were associated with lower weekend adherence rates but had better adherence rates overall compared with teaching hospitals. Hospitals with fewer nurses per bed led to a decreased probability of Foley catheter removal and mobilization on POD#1 on the weekend. (Note that having fewer nurses was also associated with decreased adherence to mobilization on POD#1 even during the weekday when compared with better-staffed hospitals).
The authors conclude that to achieve optimal outcomes, protocol adherence is important and requires appropriately resourced patient care teams. They note that the reduced adherence to mobilization and Foley catheter removal noted during the weekend was associated with certain organizational and unit-based factors including nurse and unit staffing ratios. These are potential targets to improve surgical quality to achieve desirable patient care.
We summarized many of our own thoughts on the “weekend effect” in our June 2016 What's New in the Patient Safety World column “Weekend Effect Challenged”. Our own opinion is that the “weekend effect” and “after-hours effect” are real phenomena and that the causes are multifactorial, including both patient-based and system-based contributing factors. Yes, patients admitted at these times are likely sicker and have a higher severity of illness and therefore are likely to have a higher mortality rate. However, as we’ve pointed out over and over, hospitals do not provide the same levels of service 24 hours a day, seven days a week. Staffing patterns, in terms of volume and even more so in terms of experience, are the most obvious difference but there are many others as well. Many diagnostic tests are not as readily available during these times. On-site physician availability may be different and cross-coverage by physicians who lack detailed knowledge about individual patients is common. You also see more verbal orders, which of course are error-prone, at night and on weekends. But the most significant difference is nurse workload on weekends. We’ve described the tremendous increase in nurse responsibilities on weekends due to lack of other staff (no clerical staff, delayed imaging, physicians not on site) that add additional responsibilities to their jobs. Our December 15, 2009 Patient Safety Tip of the Week “The Weekend Effect” discussed how adding non-clinical administrative tasks to already overburdened nursing staff on weekends may be detrimental to patient care. Just do rounds on one of your med/surg floors or ICU’s on a weekend. You’ll see nurses answering phones all day long, causing interruptions in some attention-critical nursing activities. Calls from radiology and the lab that might go directly to physicians now often go first to the nurse on the floor, who then has to try to track down the physician. They end up filing lab and radiology reports or faxing medication orders down to pharmacy, activities often done by clerical staff during daytime hours. Even in those facilities that have CPOE, nurses off-hours often end up entering those orders into the computer because the physicians are off-site and are phoning in verbal orders. You’ll also see nurses giving directions to the increased numbers of visitors typically seen on weekends. They may even end up doing some housekeeping chores and delivering food trays. All of these interruptions and distractions obviously interfere with nurses’ ability to attend to their clinically important tasks (see our Patient Safety Tips of the Week for August 25, 2009 “Interruptions, Distractions, Inattention…Oops!” and May 4, 2010 “More on the Impact of Interruptions”). That is why we think that simply addressing nurse:patient staffing ratios without addressing nurse workload issues may be short-sighted.
All you have to do is spend some time in your hospital on weekends and you’ll readily see that things are different on weekends.
Some of our previous columns on the “weekend effect”:
References:
Liu JY, Merkow RP, Cohen ME, et al. Association of Weekend Effect With Recovery After Surgery. JAMA Surg 2020; Published online August 26, 2020
https://jamanetwork.com/journals/jamasurgery/fullarticle/2769899
Print “September 2020 Care Processes and the Weekend Effect”
Workarounds, or similar intentional violations of a rule or procedure, are very common in healthcare (see our Septemeber 4, 2007 Patient Safety Tip of the Week “Workarounds as a Safety Issue”). They are usually performed with the best of intentions and are usually an indication of a flawed or poorly designed underlying process or system. In fact, any time you see a workaround being performed, you need to look for the root causes that led to the need for a workaround.
In our June 17, 2008 Patient Safety Tip of the Week “Technology Workarounds Defeat Safety Intent” we described an incident we witnessed as we were doing our first electronic medical record implementation. A nurse was using a just-implemented barcoding system to perform medication administration. The bar code on one unit-dose medication would not scan properly because of a crinkle in the barcode. The nurse was to then manually input the barcode from the package onto the system computer. However, the print on the barcode was too small for her to read. She then prepared to cut and paste the medication number from the computer screen into the manual entry input box. That, of course, would have bypassed the whole patient safety concept of a barcoding system, which is to verify that the medication being given is the same as the one on the computer screen. Simply typing in those same numbers seen on the computer screen would have also bypassed the safety mechanism involved in barcoding. While we intercepted this instance to prevent a potential error, there are undoubtedly many similar workarounds being used with barcoding systems.
We wondered how often this type of barcoding system workaround occurred and whether there were other similar workarounds we needed to watch out for. Fortunately, Ross Koppel (Koppel 2008) and his colleagues had just published an article identifying the multiple types of workarounds in barcode systems and their underlying causes. They identified 15 types of workarounds and 31 types of causes for the workarounds in barcoding medication administration systems.
It’s been over 4 years since we did our last column on workarounds. But in the last few weeks there have been two good studies on workarounds.
Researchers in the Netherlands performed a prospective observational study of nurses using barcode techniques to administer medication to inpatients (van der Veen 2020). Of almost 6000 medication administrations they observed, 62.7% involved one or more workarounds. They classified workarounds as:
Procedural (such as not scanning at all)
| 36% |
Patient scanning-related (such as no barcode wristband on the patient)
| 28% |
Medication scanning-related (such as scanning before actual administration of medication, scanning medication for more than one patient at a time, and ignoring computer or scanner alerts)
| 11% |
Potential risk factors associated with workarounds were the day of the week, the timing of the medication administration, the route of administration, the administration of medication from irregularly used classes and the patient–nurse ratio. Though they had no formal measure of nurse workload, the strongest association with workarounds was having the patient:nurse ratio equal to or greater than 6:1 compared to 5:1 or less (adjusted OR 5.61). Other factors, such as the percentage of barcoded medication and work experience, were not associated with workarounds.
We found interesting the association of the nonoral route of administration with workarounds. They provided several examples. Certain routes of administration, such as dermal or inhalation, are often left to the patient for self-administration, and nurses may forget to scan such medication. Another example is certain parenteral medications that need special handling to make it ready to administer (eg. an original vial with infusion powder may contain a barcode, but the infusion bag with the added drug may not be barcoded).
Workarounds were also associated with the time of the medication round and particular days. They were more likely on busy weekdays versus the relatively quiet Sunday (Wow, so much for our “weekend effect)!). Workarounds were also more likely on the rounds scheduled during the afternoon and evening compared to the morning. The authors attributed this to likely saving time during busier parts of the day.
The authors state “In particular, nurse workload and the patient:nurse ratio could be the focus for improvement measures as these are the most clearly modifiable factors identified in this study.” They note their findings emphasize the need to review the patient:nurse ratio, work schedules and medication-related workload per day of the week and per shift to ensure the safe use of the system. They stress the importance of a positive work environment and adequate balance between patients and available nursing care. Good timing, given our September 1, 2020 Patient Safety Tip of the Week “NY State and Nurse Staffing Issues”.
The second study was a review of the published literature on nurses’ use of workarounds related to the electronic health record (Fraczkowski 2020). A total of 33 articles met their inclusion criteria. The authors acknowledge that researchers often classify workarounds differently, but that they generally fit 1 of 3 broad categories: omission of process steps, steps performed out of sequence, and unauthorized process steps. Probable causes included technology, task, organizational, patient, environmental, and usability factors. They note that, compared to research done in acute care settings, there is a dearth of research on workarounds in the ambulatory setting. They conclude that, despite decades of electronic health record development, poor usability remains a key concern for nurses and other members of care team.
Workarounds can be unique, simple or complex, and often extremely innovative. But remember: when you see a workaround, there is always an underlying root cause or causes that led someone to use that workaround. When we do Patient Safety Walk Rounds, one question we often ask nurses or other healthcare workers is “Are there any workarounds you sometimes do?”. It’s important you let them know ahead of time that this question is asked in a nonpunitive manner and is being asked in order to identify barriers or impediments to care and workflow. Importantly, you need to be prepared to address whatever root cause they reveal in their answers!
Some of our prior columns related to workarounds:
September 4, 2007 “Workarounds as a Safety Issue”
May 2008 “UK NPSA Alert on Heparin Flushes”
June 17, 2008 “Technology Workarounds Defeat Safety Intent”
September 15, 2009 “ETTO’s: Efficiency-Thoroughness Trade-Offs”
August 24, 2010 “The BP Oil Spill - Analogies in Healthcare”
March 6, 2012 “Lab Error”
July 2, 2013 “Issues in Alarm Management”
April 8, 2014 “FMEA to Avoid Breastmilk Mixups”
October 7, 2014 “Our Take on Patient Safety Walk Rounds”
April 5, 2016 “Workarounds Overriding Safety”
June 2016 “ISMP Article on Workarounds”
References:
Koppel R, Tosha Wetterneck T, Telles JL, Karsh B-T. Workarounds To Barcode Medication Administration Systems: Their Occurrences, Causes, And Threats To Patient Safety. Journal of the American Medical Informatics Association 2008; 15(4): 408-423
https://academic.oup.com/jamia/article/15/4/408/731255?searchresult=1
van der Veen, W, Taxis, K, Wouters, H, Vermeulen, H, Bates, DW, van den Bemt, PMLA; the BCMA Study Group. Factors associated with workarounds in barcode‐assisted medication administration in hospitals. J Clin Nurs. 2020; 29: 2239– 2250
https://onlinelibrary.wiley.com/doi/full/10.1111/jocn.15217
Fraczkowski D, Matson J, Lopez KD, Nurse workarounds in the electronic health record: An integrative review, Journal of the American Medical Informatics Association 2020; 27(7): 1149-1165
https://academic.oup.com/jamia/article-abstract/27/7/1149/5870050?redirectedFrom=fulltext
Print “September 2020 More on Workarounds”
We’ve done multiple columns on how patient safety is impacted by time of day, day of the week, and month of the year. But Daylight Savings Time?
A study, just presented in abstract form at the SLEEP 2020 meeting, found that adverse events resulting from human errors increased by 18.7% in the week after the Spring time change (Kolla 2020).
The Mayo Clinic researchers began with the premise that the “Spring forward” change at the start of Daylight Savings Time (DST) which reduces sleep opportunity by an hour, could result in sleep deprivation in healthcare workers and lead to an increase the potential for medical errors. The researchers looked at 8 years of data of self-reported adverse events (AE’s) in inpatient, outpatient, and ambulatory settings that occurred 7 days prior to and following the Spring and Fall time changes in a large healthcare organization and identified AE’s likely resulting from human error.
They found that adverse events resulting from human errors increased by a statistically significant 18.7% in the week after the Spring time change. A 5% increase in adverse events in the week following the Autumn return to Standard Time from DST was not statistically significant.
The authors conclude there is a significant increase in human error related AE’s following the “Spring forward” clock change which can jeopardize patient safety. They suggest that DST might best be eliminated. Alternatively, they recommend policy makers and healthcare organizations should evaluate measures to mitigate the increased risk during this period.
The study used self-reported AE’s in a single healthcare organization and there was no formal measure of actual sleep deprivation. But the findings are fascinating. The authors note their findings need to be replicated in other healthcare organizations.
However, the American Academy of Sleep Medicine on August 26, 2020 issued a position statement that these seasonal time changes should be abolished in favor of a fixed, national, year-round standard time (Rishi 2020). It cites “an abundance of accumulated evidence indicates that the acute transition from standard time to daylight saving time incurs significant public health and safety risks, including increased risk of adverse cardiovascular events, mood disorders, and motor vehicle crashes.” It also states that daylight saving time is less aligned with human circadian biology and that circadian misalignment may be associated in the longer term with increased cardiovascular disease risk, metabolic syndrome and other health risks.
Some of our other columns on the role of fatigue in Patient Safety:
November 9, 2010 “12-Hour Nursing Shifts and Patient Safety”
April 26, 2011 “Sleeping Air Traffic Controllers: What About Healthcare?”
February 2011 “Update on 12-hour Nursing Shifts”
September 2011 “Shiftwork and Patient Safety
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
January 2012 “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety
January 3, 2012 “Unintended Consequences of Restricted Housestaff Hours”
June 2012 “June 2012 Surgeon Fatigue”
November 2012 “The Mid-Day Nap”
November 13, 2012 “The 12-Hour Nursing Shift: More Downsides”
July 29, 2014 “The 12-Hour Nursing Shift: Debate Continues”
October 2014 “Another Rap on the 12-Hour Nursing Shift”
December 2, 2014 “ANA Position Statement on Nurse Fatigue”
August 2015 “Surgical Resident Duty Reform and Postoperative Outcomes”
September 2015 “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”
September 29, 2015 “More on the 12-Hour Nursing Shift”
September 6, 2016 “Napping Debate Rekindled”
April 18, 2017 “Alarm Response and Nurse Shift Duration”
July 11, 2017 “The 12-Hour Shift Takes More Hits”
February 13, 2018 “Interruptions in the ED”
April 2018 “Radiologists Get Fatigued, Too”
August 2018 “Burnout and Medical Errors”
September 4, 2018 “The 12-Hour Nursing Shift: Another Nail in the Coffin”
August 2020 “New Twist on Resident Work Hours and Patient Safety”
August 25, 2020 “The Off-Hours Effect in Radiology”
References:
Kolla B, Coombes BJ, Morgenthaler TI, Mansukhani MP. 0173 Spring Forward, Fall Back: Increased Patient Safety-Related Adverse Events Following the Spring Time Change. Sleep 2020; 43(Supplement_1): A69
https://academic.oup.com/sleep/article-abstract/43/Supplement_1/A69/5847223?redirectedFrom=fulltext
Rishi MA, Ahmed O, Perez JHB, et al. Daylight saving time: an American Academy of Sleep Medicine position statement. Journal of Clinical Sleep Medicine 2020; Published online August 26, 2020
https://jcsm.aasm.org/doi/10.5664/jcsm.8780
Print “September 2020 Daylight Savings Time Impacts Patient Safety?”
Print “September 2020 What's New in the Patient Safety World (full column)”
Print “September 2020 AORN on Distractions and Interruptions”
Print “September 2020 Care Processes and the Weekend Effect”
Print “September 2020 More on Workarounds”
Print “September 2020 Daylight Savings Time Impacts Patient Safety?”
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