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Patient Safety Tip of the Week   

April 23, 2019

In and Out the Door and Other OR Flow Disruptions

We’ve often discussed the role of unnecessary foot traffic in the OR and opening of OR doors and the potential to increase the risk for surgical site infections. Such traffic likely also has the effect of increasing distractions and interruptions in the OR, which are factors contributing to many adverse events.

In our March 10, 2009 Patient Safety Tip of the Week “Prolonged Surgical Duration and Time Awareness” we noted a study (Lynch 2009) that suggested increased foot traffic may be factor related to prolonged procedures that increases the likelihood of surgical site infections.

In our November 24, 2015 Patient Safety Tip of the Week “Door Opening and Foot Traffic in the OR” we discussed a study from Johns Hopkins that formally studied how often OR doors are opened during joint arthroplasty surgeries and the impact on OR air flow (Mears 2015). The researchers measured how often and for how long OR doors were opened during 191 hip and knee arthroplasty procedures. They also measured air pressures in the OR and adjacent corridors. They found that, on average, OR doors were open 9.5 minutes per case and the average time between door openings was 2.5 minutes. As you’d expect the number and duration of door openings correlated with the length of surgery. In 77 of the 191 cases positive pressure within the OR was defeated. The implications are obvious. While they found only one surgical infection in the 191 cases, the effects of the door opening on OR pressure and air flow theoretically would predispose to surgical infections. OR’s have positive pressure to avoid flow of air and airborne pathogens from nonsterile adjacent areas.

Andersson and colleagues (Andersson 2012) investigated air quality, expressed as colony-forming units (CFU)/m3, in OR’s during orthopedic trauma surgery. They found a strongly positive correlation between the total CFU/m3 per operation and total traffic flow per operation, after controlling for duration of surgery. There was also a correlation with the number of persons present in the OR and surgery case duration. The authors concluded results of this study support interventions aimed at preventing surgical site infections by reducing traffic flow in the OR.

Discussion with Dr. Andersson, the lead author of that study, revealed that door openings related to social visits and for no detectable reasons together accounted for 27% of the traffic flow (Rosenthal 2019). The leading reasons doors were opened were for supplies (26%) and for staff breaks (20%). Only 7% of door openings during surgery were for expert consultation. 14% of the door openings occurred while the wound was open.

Weiser et al. (Weiser 2018), measuring pressure and air flow, found that opening single doors did not allow contaminated air into the OR but simultaneous opening of two doors does allow contaminated air to flow into the OR. In a commentary on the Weiser study (Hofheinz 2018) it was noted that over half of door opening events take place during room and sterile tray set up and it is possible that there are simultaneous double door opening events during this time, allowing contaminated air into the operating room with possible contamination of the trays. Many interventions have focused on restricted door opening only once the initial incision is made but this study suggests the OR should be restricted to a single door during both room set up and the actual surgical procedure. It also suggests that sterile instrument trays should be covered with sterile towels after opening until they are ready for use.

But there is even another scenario that would not require both doors to open. As reported by Rosenthal (Rosenthal 2019) in an interview with lead author Edmiston (Edmiston 2005) they identified a sink in an anteroom adjacent to an OR as the source of potential contamination. They discovered that whenever the faucet was turned on and water hit the sink, it created an aerosol. Anyone walking through the anteroom when the aerosol was present could carry the bacteria into the OR, which could then contaminate a surgical wound.

Okay, so door openings and closings in the OR may be bad. What do we do about it? First, we need to understand the reasons for OR door opening/closing. Rovaldi and King (Rovaldi 2015) found the top five reasons for unnecessary traffic in an OR were

• supply procurement
• vendor foot traffic
• warm solution and blanket acquisition
• staff breaks
• communication

But they found different reasons for door openings during the pre-incision and post-incision time frames. During the pre-incision period, causes of door openings included supply procurement, sterility of trays, equipment requirements, and patient comfort items. Although many of the reasons overlap both periods, the main causes of door openings during the post-incision period were communication, vendor foot traffic, and personnel reliefs.

Loisona et al. (Loisona 2017) found the following reasons for entries to/exits from the OR:

• 44.5% for equipment
• 13.8% for communication
• 13.1% linked to staffing
• 8,8%  switching of team members
• 2.6%  lunch or coffee breaks

You should begin your quality improvement program for limiting unnecessary OR door opening by measuring the frequency of such opening and determining the reasons for such openings. There are inexpensive magnetic or infrared devices you can install to count the number of times the doors are opened and closed. There are several ways to identify the reasons. One would be to have a student or someone simply observe and ask the reason every time someone enters or leaves the OR or opens/closes the doors. In our December 2017 What's New in the Patient Safety World column “A Fix for OR Foot Traffic?” we suggested is keeping a log where staff are required to log in every time they leave and enter the OR for each case, similar to what was done in the Canadian study (Camus 2016).  Of course, there will be blowback from many of your staff that this might be time consuming. It need not be. How many of you have an electronic device like an Amazon Echo or a Google Home Assistant and say something like “Alexa, add paper towels to my grocery list.”? Alexa creates a grocery list and adds paper towels to it. You could do the same with such a device in your substerile OR area and, when the OR door alarm sounds, require the person entering the OR to say something like “Alexa, this is surgical tech Yvonne Jones entering the OR with new equipment” and Alexa could add the name of the staff member and the reason to the log created when the case began. Voila! It took years before we learned about barcoding from our supermarkets and applied it to healthcare. It’s time we take a lesson from our hi-tech kitchens! We’ll bet that simply requiring such a log will probably result in some reduction in unnecessary door openings.

Understanding those reasons logically leads to interventions that might be expected to reduce unnecessary foot traffic and door opening/closing.

Hamilton and colleagues (Hamilton 2018) found that simply monitoring door opeinings during joint arthroplasty was not effective in reducing the occurrences. However, after a novel educational seminar given to all personnel, there was a significant reduction in the incidence of operating room door openings, reducing a potential risk factor for surgical site infections.

A few studies that relied primarily on educational and behavioral interventions have had moderate success in reducing OR traffic. Pulido et al. (Pulido 2017) compared traffic rates in hip and knee arthroplasty cases against traffic rates during non-arthroplasty cases to examine the effects of verbal interventions implemented by the surgeon to reduce intraoperative traffic. The surgeon in the interventional group implemented verbal protocols to OR staff to limit excessive intraoperative traffic. Comparing the 2 groups, the interventional group averaged 33 movements per hour while the noninterventional group averaged 46 movements per hour. The authors conclude that their results suggest that operative room traffic can be reduced through simple verbal protocols established by the surgical team. DiBartola et al. (DiBartola 2019) implemented a multidisciplinary intervention that included education, OR signage, and team-based accountability and behavioral interventions. Average door openings per minute decreased by 22% after intervention. They concluded that behavioral interventions that focus on education, awareness, and efficiency strategies can decrease overall OR traffic for orthopedic cases.

Others have not noted significant improvements with educational programs alone. We all know that education and training are necessary for most quality and patient safety interventions, but we also know that they are not particularly effective in producing desired results, particularly on a sustained level. “Nudges” are a bit more useful. But the best interventions are constraints and forcing functions. Another key to successful interventions is providing alternative actions when we use any sort of alert or warning, something we’ve clearly learned in CPOE implementations. One example of the latter is providing a means of communication between those outside the OR and those inside the OR. That could be an intercom, though some have used phone systems. These allow questions to be asked and answered without opening the OR doors.

In our December 2017 What's New in the Patient Safety World column “A Fix for OR Foot Traffic?” we noted a study which looked at the impact of an audible alarm on reducing OR foot traffic during total joint arthroplasties (Eskildsen 2017). Researchers placed an audible alarm on the substerile operating room door that sounded continuously when the door was ajar. This resulted in a significant difference in the overall mean door openings per minute between the period with no alarm and with an alarm. Prior to the door alarm, the substerile door was opened a mean of 88.12 times per case, or 0.53 times per minute. After the door alarm was installed, door openings decreased to a mean of 69.46 times per surgery, or 0.42 times per minute. However, this effect slowly decreased over the time of the intervention.

The percentage of time the door was left ajar per case also decreased significantly with the alarm. Prior to the intervention the door remained open for a mean of 14.45 minutes per case, or 8.65% of overall surgical time. After the door alarm was installed the mean duration of time that the door remained open decreased to 10.81 minutes per surgery, or 6.63% of the overall surgical time.

Unfortunately, the study was not large enough to determine whether the reduced door opening had an impact on surgical infection rates. But the findings certainly suggest that this may be one way to reduce such infections. However, we have 2 cautions about such an alarm. First, you need to be extremely careful that the alarm does not produce distractions or interruptions that might lead to other errors in the OR. Second, as with any alarm system, alarm fatigue is likely to occur.

Rovaldi and King (Rovaldi 2015) implemented a 3-phase multidisciplinary educational and operational quality improvement initiative to assess the effect of process interventions on reducing OR door openings. They analyzed the effectiveness of door opening deterrents (eg, a pull shade, magnetic yellow caution tape across the door frame) and changes in traffic processes (eg, clear‐covered implant carts). The interventions and process changes showed a 50% reduction in door openings compared to the baseline. See our comments below on this study.

In our July 26, 2016 Patient Safety Tip of the Week “Confirmed: Keep Your OR Doors Closed” we highlighted a study that demonstrated a program to reduce unnecessary door openings may reduce surgery-related infections (Camus 2016). A Canadian hospital did a manual count of door openings during total joint replacement operations and revision procedures. They counted between 42 and 70 door openings per operation from incision time to joint capsule closure time. Operations averaged 75 minutes. Reasons for entering and exiting the OR during operations included retrieving charts, instruments, or equipment, and taking a break. Next their CUSP (Comprehensive Unit-Based Program) team brainstormed and came up with key changes, including stopping all traffic in and out of the OR between total joint capsule opening and closure, communicating by phone, and increasing the use of templates to identify implant size prior to each operation. They also put a sign on the OR door reminding staff to minimize traffic and asking them to record why they are entering the OR during an operation. Subsequent traffic audits taken every six months indicated an amazing reduction in OR traffic from between 42 and 70 door openings to 3.2 door openings per case. They felt this intervention may have contributed to a decrease in orthopedic SSIs from 2.8 percent to 2.1 percent. The Canadian team is expanding its program to multiple other services and other hospitals in their multi-hospital system.

Saver (Saver 2014) recommended the following strategies:

• take breaks between cases or after skin closure
• place specimens by the door
• call staff outside the OR to bring supplies and equipment once the patient has entered the room
• have OR charge nurses and managers call into the OR for time estimates and other information
• before scrubbing in for lunch or shift relief, call into the OR to verify a break is appropriate
• place signs at key points as reminders to limit OR traffic
• schedule cases likely to draw a high number of observers in a room with an observation deck, if possible
• give Wi-Fi phones to float staff to facilitate communication without entering OR rooms.

Thomas (Thomas 2018) has the following suggestions:

1. “Let your fingers do the walking.” (Use a phone located right outside the OR so that the person on it is visible to the OR team through a window to communicate with key personnel within the OR).
2. If there are implants, give them a sign. (They post a sign outside the room for orthopedic or breast implant procedures: "Do not come in! Implants being implanted.") That the equivalent of the “On the Air” sign we’ve talked about before.
3. Clear the room of unneeded equipment. (And put that equipment in a temporary spot in a hallway outside the OR so that no one needs to come into the OR looking for it.)
4. Have all supplies in the room. up to 20% of door openings are for supplies or equipment so it’s key to know what equipment, supplies, and implants you will need before the case begins. We recommend you don’t just rely on “preference cards”. Rather, you should have checklists that you discuss during the pre-op “huddle” (briefing) you should be conducting before every case.
5. If they don't remember, remind them. Though we all know the consequences of opening and closing the door too much, you'll have to remind each other to use the OR door as little as possible.

AORN’s 2019 Guidelines will also include a list of 14 interventions for reducing door opening (AORN 2019).

The nature and timing of any signage is important. Rovaldi et al. (Rovaldi 2015) had an interesting observation. At one point prior to their quality improvement project, magnetic signs stating “Do Not Enter” or “Implants in Use. Do Not Enter” had been placed on the OR doors. But these were never removed from the doors. Hence, they had minimal impact. The most important signage they used was on a pull-down shade that was pulled down at the time of incision to warn outsiders not to enter the OR. This was a shade that, when pulled down, covered half the window on the door and stated “Incision” and would be seen from the sterile inner core area. Worried you might forget to pull down the shade? Add this to your timeout/safe surgery checklist! That sign is basically a version of one of the interventions we’ve recommended in several of our columns – a sign akin to the “On the Air” sign in TV, radio, or recording studios that lights up when the case is in progress.

The Rovaldi study (Rovaldi 2015) is worth your reading because it has a good discussion of problems encountered in any change endeavor. They found that a substantial reduction in door opening following their phase 1 was not sustained. So, the QI team went back to various stakeholder meetings, identified champions, and offered rewards for useful suggestions. That led to one key suggestion about the signage: the pull-down shade. This was a shade that, when pulled down, covered half the window on the door and stated “Incision” and would be seen from the sterile inner core area. The other key suggestions that came out of those meetings were: use of magnetic yellow caution tape across the door frame, and clear-covered implant carts. And providing feedback to all about both the frequency of door opening and SSI rates was another important step in sustaining the improvement.

They also noted a vendor issue (Please don’t get us started on the issue of vendors in the OR!) where vendors needed additional implant sizes or having to go into or out of the room for communication reason. That led to the suggestion of the clear-covered implant carts. Note that the Camus study noted above (Camus 2016) promoted use of templates to identify implant size prior to each operation to minimize the need for going in and out of the OR for implants.

Though the Rovaldi team liked the idea of the yellow magnetic tape across the OR door, it had limited usefulness in practice because draping the tape was often forgotten.

We mentioned earlier that unnecessary OR traffic likely also has the effect of increasing distractions and interruptions in the OR, which are factors contributing to many adverse events. A recent study (Joseph 2018) went beyond unnecessary foot traffic and looked also at other “minor” flow disruptions in the OR that may increase the risk for patient safety issues. The researchers looked at equipment malfunction, door openings, case irrelevant conversations, loud noises and alarms, communication breakdowns, environmental clutter and constrained spaces. They also took into account that the physical layout of the OR and the OR environment have important roles in promoting or preventing such flow disruptions. It is an excellent review of activities that occur in various “zones” of the OR that lead to minor or major flow disruptions.

Also we’ve discussed in numerous columns how use of presurgical “huddles” or briefings and postsurgical debriefings may help identify issues that can lead to reduction in surgical duration and unnecessary OR traffic (see our December 30, 2014 Patient Safety Tip of the Week “Data Accumulates on Impact of Long Surgical Duration”). The pre-op huddle can help ensure you have all necessary equipment and supplies so you don’t have to open and close doors to find them after a case has begun. And the post-op debriefing can identify things that should have been in the OR so that your next cases don’t have the same problems. If you use the type of log we described earlier, we’d suggest you make review of the log part of your post-op debriefing. You are doing debriefings after every case, aren’t you?

Our prior columns focusing on surgical OR foot traffic and door opening:

• March 10, 2009           “Prolonged Surgical Duration and Time Awareness”
• January 2010               “Operative Duration and Infection”
• August 26, 2014         “Surgeons’ Perception of Intraoperative Time”
• December 30, 2014     “Data Accumulates on Impact of Long Surgical Duration”
• November 24, 2015     “Door Opening and Foot Traffic in the OR”
• July 26, 2016              “Confirmed: Keep Your OR Doors Closed”
• December 2017           “A Fix for OR Foot Traffic?”

References:

Lynch RJ, Englesbe MJ, Sturm L, et al. Measurement of Foot Traffic in the Operating Room: Implications for Infection Control. American Journal of Medical Quality 2009; 24: 45-52

http://ajm.sagepub.com/content/24/1/45.abstract

Mears SC, Blanding R, Belkoff SM. Door Opening Affects Operating Room Pressure During Joint Arthroplasty. Orthopedics 2015; 38(11): e991-e994

http://www.healio.com/orthopedics/journals/ortho/2015-11-38-11/%7B78670b1e-21b9-41dc-89fa-528c0ab00a85%7D/door-opening-affects-operating-room-pressure-during-joint-arthroplasty

Andersson AE, Bergh I, Karlsson J, et al. Traffic flow in the operating room: An explorative and descriptive study on air quality during orthopedic trauma implant surgery. American Journal of Infection Control 2012; 40(8): 750-755

https://www.ajicjournal.org/article/S0196-6553(11)01248-X/fulltext

Rosenthal T. OR Air Contamination Standards Needed to Control SSI Risk. Anesthesiology News 2019; April 5, 2019

https://www.anesthesiologynews.com/Online-First/Article/03-19/OR-Air-Contamination-Standards-Needed-to-Control-SSI-Risk/54537?sub=52153C6B7C3BB349A4FFAFB1611190E8862F46281279B07E9A816426066&enl=true&dgid=U080421119&utm_source=enl&utm_content=1&utm_campaign=20190408&utm_medium=button

Weiser MC, Shemesh S, Chen DD, et al. The Effect of Door Opening on Positive Pressure and Airflow in Operating Rooms. Journal of the American Academy of Orthopaedic Surgeons 2018; 26(5): e105–e113

https://journals.lww.com/jaaos/Abstract/2018/03010/The_Effect_of_Door_Opening_on_Positive_Pressure.9.aspx

Hofheinz E. Double OR Doors = Infection Risk! Orthopedics This Week 2018; March 6, 2018

https://ryortho.com/breaking/double-or-doors-infection-risk/

Edmiston CE, Seabrook GR, Cambria RA, et al. Molecular epidemiology of microbial contamination in the operating room environment: Is there a risk for infection? Surgery 2005; 138(4): 573-579; discussion 579-582

https://www.surgjournal.com/article/S0039-6060(05)00421-6/abstract

Rovaldi CJ, King PJ. The Effect of an Interdisciplinary QI Project to Reduce OR Foot Traffic. AORN Journal 2015; 101(6): 666-681

https://aornjournal.onlinelibrary.wiley.com/doi/pdf/10.1016/j.aorn.2015.03.011

Loisona G, Troughtonb R, Raymond F, et al. Compliance with clothing regulations and traffic flow in the operating room: a multi-centre study of staff discipline during surgical procedures. Journal of Hospital Infection 2017; 96(3): 281-285

https://www.sciencedirect.com/science/article/pii/S0195670117301792

Camus S. Operating Room Traffic Monitoring Improves Patient Safety. Abstract session presentation at the 2016 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) Conference. July 18, 2016 as reported in ACS (American College of Surgeons). Minimizing Operating Room Traffic May Improve Patient Safety by Lowering Rates of Surgical Site Infections. ACS Press Release July 18, 2016

https://www.facs.org/media/press-releases/2016/nsqip-ssi-071816

Hamilton WG, Balkam CB, Purcell RL, et al. Operating room traffic in total joint arthroplasty: Identifying patterns and training the team to keep the door shut. Am J Infect Control 2018; 46(6): 633-636

https://www.ajicjournal.org/article/S0196-6553(18)30007-5/fulltext

Pulido RW, Kester B, Schwarzkopf R. Effects of Intervention and Team Culture on Operating Room Traffic. Quality Management in Health Care 2017; 26(2): 103-107

https://www.ingentaconnect.com/content/wk/qmh/2017/00000026/00000002/art00007

DiBartola AC, Barron C, Smith S, et al. Decreasing Room Traffic in Orthopedic Surgery: A Quality Improvement Initiative. American Journal of Medical Quality 2019; First Published January 17, 2019

https://journals.sagepub.com/doi/abs/10.1177/1062860618821180

Eskildsen SM, Moskal PT, Laux J, Del Gaizo DJ. The Effect of a Door Alarm on Operating Room Traffic During Total Joint Arthroplasty. Helio Orthopedics 2017; 40(6): e1081-e1085

https://www.healio.com/orthopedics/journals/ortho/2017-11-40-6/%7B56fe95c3-d5d8-4907-b954-aa596cfe8b09%7D/the-effect-of-a-door-alarm-on-operating-room-traffic-during-total-joint-arthroplasty

Saver C. OR traffic data demonstrate need to reduce door openings. OR Manager 2014; 30(7) 1-3

https://www.ormanager.com/wp-content/uploads/2014/07/0714_ORM_10_OR_traffic.pdf

Thomas M. Infection Prevention: Are You Opening the Door to SSIs? Simple steps to reduce OR foot traffic - a preventable infection risk. Outpatient Surgery Magazine 2018; 19(8): 26-29 August 2018

http://www.outpatientsurgery.net/_media/pop/print-article?id=15517

AORN (Association of periOperative Registered Nurses). 2019 Guidelines: Be Ready For 3 Big Changes. AORN Blog 2019; January 6, 2019

https://www.aorn.org/blog/2019-guidelines

Joseph A, Khoshkenar A, Taaffe KM, et al. Minor flow disruptions, traffic-related factors and their effect on major flow disruptions in the operating room. BMJ Qual Saf 2018; Published Online First: 29 August 2018

https://qualitysafety.bmj.com/content/early/2018/08/29/bmjqs-2018-007957

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What's New in the Patient Safety World?

April 2019

·iCOMPARE Study on Resident Work Hour Rules

·New Simple OSA Screening Tool: BOSTN

·ISMP on Designing Effective Warnings

·FDA Warning on Surgical Staplers Opens a Can of Worms

iCOMPARE Study on Resident Work Hour Rules

There is no question that fatigue has a detrimental impact on healthcare workers (see our many columns listed below on that topic). Way back in the 1990’s the Bell Commission in New York State led to restriction on resident work hours. At the time we asked Dr. Bell what empirical evidence was there that such restrictions would improve patient care. His response was that the NYSDOH received more incident reports about care on nights or weekends. We pointed out that those are also times when care is often rendered by physicians who are less familiar with patients. We’ve often framed the question as “Do I want to be cared for by a sleepy resident who knows me or by an alert resident who knows very little about me?”. So, the question has always been whether patient outcomes are more impacted by fatigue or by discontinuity of care and inadequate handoffs.

New York State’s restriction on resident work hours was subsequently adopted (with some minor adjustments) by the ACGME (Accreditation Council for Graduate Medical Education) in 2003. Since the ACGME policies were put in place, there have been multiple attempts to measure the impact on patient care, but results have been mixed. In our many columns (listed below) on the conflicting studies on the impact of housestaff workhour restrictions on patient safety we’ve laid our hopes for better answers on two ongoing randomized trials, one in surgery (the FIRST trial) and one in internal medicine (the iCOMPARE trial).

We discussed the results of the FIRST (surgical residency) trial (Bilimoria 2016) in our March 2016 What's New in the Patient Safety World column “Does the Surgical Resident Hours Study Answer Anything?”.

Now, results of the iCOMPARE trial have been published (Silber 2019, Basner 2019). iCOMPARE involved 63 internal-medicine residency programs that were randomized to a group with standard ACGME duty hours or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts (but still complied with the 80 hour per week restriction).

The primary outcome measure, change in 30-day mortality, was not significantly different between the two groups (Silber 2019). Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also not significantly different.

The authors conclude that allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety

The second paper from the iCOMPARE trial looked at the effects of flexible scheduling vs. strict scheduling on sleep, sleepiness, and alertness of medical trainees (Basner 2019). The researchers found no significant difference between the groups in total sleep duration (as measured by actigraphy) or sleepiness (as measured by the Karolinska Sleepiness Scale). But noninferiority of the flexible group for alertness (as measured by the brief computerized Psychomotor Vigilance Test) was not established.

The conclusion is that there was no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. But both those measures were averages over time. Those in flexible-hour programs averaged 2.23 hours less sleep during night calls and the average was increased by sleeping more hours on days off. Also, those in flexible programs reported less alertness and more sleepiness after extended night shifts than during day shifts.

Last year the iCOMPARE trial published results of its impact on educational aspects and resident satisfaction with the flexible policies vs. standard duty-hour policies (Desai 2018). There were no significant between-group differences in the mean percentages of time that interns spent in direct patient care and education nor in trainees’ perceptions of an appropriate balance between clinical demands and education. Scores on in-training examinations also did not differ significantly between groups. But a survey of interns revealed that those in flexible programs were more likely to report dissatisfaction with multiple aspects of training, including educational quality (odds ratio 1.67), overall well-being (OR 2.47), and how the program affects their personal lives with friends and family (OR, 6.11).

Perhaps not surprisingly, directors of flexible programs were less likely to report dissatisfaction with multiple educational processes, including time for bedside teaching.

The bottom line of that paper is that interns in flexible programs were less satisfied with their educational experience than were their peers in standard programs, but program directors were more satisfied.

In the editorial accompanying the FIRST trial results, John Birkmeyer had pointed out that much of the work formerly done primarily by residents is now done primarily by others (Birkmeyer 2016). For example, there are often board-certified intensivists in the ICU’s and many associate providers working with multidisciplinary teams. We’ll add that many hospitals also have hospitalists covering larger portions of the patient population. And many hospitals have more in-house attending availability at night.

Interestingly, there has been little publication on the impact of resident work-hour restrictions on attending physicians. One study looked at whether more attending involvement in morning work rounds might improve patient safety (Finn 2018). They found that there was no significant difference in medical error rate with this increased supervision. But interns were less likely to speak up in the presence of an attending on work rounds and interns felt less efficient and less autonomous (residents also felt less autonomous). But attending physicians rated the quality of care higher when they participated on work rounds.

The editorial accompanying the current iCOMPARE papers (Rosenbaum 2019) also points out that the patient perspective has been left out. It would not have been possible to correlate HCAHPS survey data from Medicare with the small randomized groups. We might also note that patient families, who may only be able to visit the patient in the evening, may find it difficult to speak to a physician sufficiently knowledgeable about the patient.

So, have we answered our fundamental question? We now have results of both the FIRST and iCOMPARE trials that show flexible resident work-hour policies have similar patient outcomes and resident educational values compared to the strict ACGME policies. That’s reassuring. It pretty much answers the question that we raised from the beginning: the issue of fatigue vs. increased handoffs/discontinuity is a wash. The authors of the safety article on iCOMPARE conclude that allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety. But both studies have shown that residents have more negative perceptions of the impact of the flexible policies on their personal lives and overall well-being. Given that, we actually see little reason for the ACGME to alter its recommendations regarding resident work hours.

Some of our other columns on housestaff workhour restrictions:

December 2008           “IOM Report on Resident Work Hours”

February 26, 2008       “Nightmares: The Hospital at Night”

January 2010               “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 2011               “No Improvement in Patient Safety: Why Not?”

November 2011          “Restricted Housestaff Work Hours and Patient Handoffs”

January 3, 2012           “Unintended Consequences of Restricted Housestaff Hours”

June 2012                    “Surgeon Fatigue”

November 2012          “The Mid-Day Nap”

December 10, 2013     “Better Handoffs, Better Results”

April 22, 2014             “Impact of Resident Workhour Restrictions”

January 2015               “More Data on Effect of Resident Workhour Restrictions”

August 2015               “Surgical Resident Duty Reform and Postoperative Outcomes”

September 2015          “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”

March 2016                 “Does the Surgical Resident Hours Study Answer Anything?”

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”

References:

Bilimoria KY, Chung JW, Hedges LV, et al. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 2016; published online first February 2, 2016

http://www.nejm.org/doi/full/10.1056/NEJMoa1515724?query=TOC

Silber JH, Bellini LM, Shea JA, et al. Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med 2019; 380: 905-914

https://www.nejm.org/doi/full/10.1056/NEJMoa1810642

Basner M, Asch DA, Shea JA, et al. Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med 2019; 380: 915-923

https://www.nejm.org/doi/full/10.1056/NEJMoa1810641

Desai SV, Asch DA, Bellini LM, et al. Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med 2018; 378: 1494-1508

https://www.nejm.org/doi/full/10.1056/NEJMoa1800965

Finn KM, Metlay JP, Chang Y, et al. Effect of Increased Inpatient Attending Physician Supervision on Medical Errors, Patient Safety, and Resident Education. A Randomized Clinical Trial. JAMA Intern Med 2018; Published online June 4, 2018

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2682517

Birkmeyer JD. Surgical Resident Duty-Hour Rules - Weighing the New Evidence (editorial). N Engl J Med 2016; published online first February 2, 2016

http://www.nejm.org/doi/full/10.1056/NEJMe1516572?query=TOC

Rosenbaum L, Lamas D. Eyes Wide Open — Examining the Data on Duty-Hour Reform. N Engl J Med 2019; 380: 969-970

https://www.nejm.org/doi/full/10.1056/NEJMe1817497

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New Simple OSA Screening Tool: BOSTN

We’ve done numerous columns on obstructive sleep apnea (OSA) and particularly the risks OSA brings in the perioperative period. Therefore, we always advocate screening patients for OSA preoperatively. Though there are several tools that can be used for screening, the STOP-Bang tool is the one used most often and has been well validated.

But now a new simpler tool, the BOSTN score, has generated considerable interest (Raub 2018). The BOSTN score assigns one point for each of the following:

• Body mass index of 30 kg/m2 or greater
• Observed apnea
• Snoring that is loud
• Tiredness in the daytime
• Neck circumference of 16.5 inches or greater in females and 17.5 inches or greater in males

 A score of 2 or more points indicates a high risk for OSA.

Raub and colleagues reported on their experience with use of BOSTN at Beth Israel Deaconess Medical Center (BIDMC).  BOSTN is preoperatively applied by nurses at BIDMC. Patients with high OSA risk are then flagged in the medical record, and electronic decision support options are provided to clinicians.

Over 200,000 adult patients undergoing non-cardiac surgery between 2008-2017 were evaluated. Patients with an ASA classification of 6 or undergoing multiple surgical procedures in one day were excluded. 9.6% of these were classified as high risk for OSA by BOSTN score and 1.5% of these required postoperative mechanical ventilation within 7 days after surgery.

Patients with BOSTN ≥ 2 and STOP-BANG ≥ 5 showed lower odds for postoperative mechanical ventilation (aOR 0.58). Patients with BOSTN ≥ 2 were discharged earlier (aIRR 0.65) and were less frequently readmitted within 30 days (aOR 0.91).

C-statistics revealed an excellent diagnostic ability of both BOSTN and STOP-BANG for postoperative mechanical ventilation requirement and the predictive performance of the two tools was comparable.

The authors conclude that clinical implementation of the BOSTN screening, paired with a decision support system in the electronic medical record, a flag of BOSTN ≥ 2 is associated with improved respiratory complication rates and decreased hospital utilization rates.

We consider preoperative screening for OSA one the most important pieces of a good pre-op evaluation (see our August 17, 2010 Patient Safety Tip of the Week “Preoperative Consultation – Time to Change”). The STOP-Bang score is still the gold standard but we expect to see a lot more using the BOSTN score.

Our prior columns on obstructive sleep apnea in the perioperative period and other acute settings:

June 10, 2008              “Monitoring the Postoperative COPD Patient”

August 18, 2009         “Obstructive Sleep Apnea in the Perioperative Period”

August 17, 2010         “Preoperative Consultation – Time to Change”

July 2010                    “Obstructive Sleep Apnea in the General Inpatient Population”

July 13, 2010              “Postoperative Opioid-Induced Respiratory Depression”

November 2010          “More on Preoperative Screening for Obstructive Sleep Apnea”

February 22, 2011       “Rethinking Alarms”

November 22, 2011    “Perioperative Management of Sleep Apnea Disappointing”

March 2012                 “Postoperative Complications with Obstructive Sleep Apnea”

May 22, 2012              “Update on Preoperative Screening for Sleep Apnea”

February 12, 2013       “CDPH: Lessons Learned from PCA Incident”

February 19, 2013       “Practical Postoperative Pain Management”

March 26, 2013           “Failure to Recognize Sleep Apnea Before Surgery”

June 2013                    “Anesthesia Choice for TJR in Sleep Apnea Patients”

September 24, 2013    “Perioperative Use of CPAP in OSA”

May 13, 2014              “Perioperative Sleep Apnea: Human and Financial Impact”

March 3, 2015             “Factors Related to Postoperative Respiratory Depression”

August 18, 2015         “Missing Obstructive Sleep Apnea”

June 7, 2016                “CPAP for Hospitalized Patients at High Risk for OSA”

October 11, 2016        “New Guideline on Preop Screening and Assessment for OSA”

November 21, 2017    “OSA, Oxygen, and Alarm Fatigue”

July 17, 2018              “OSA Screening in Stroke Patients”

References:

Raub D, Nabel S, Rostin P, et al. Validation of the Boston Score, A Clinically Established Preoperative Prediction Instrument to Quantify Obstructive Sleep Apnea. 2018 Annual Meeting of the American Society of Anesthesiologists (abstract A2266).

http://www.asaabstracts.com/strands/asaabstracts/printAbstract.htm?index=0&year=2018&absnum=4459&type=search&year=2018

Print “April 2019 New Simple OSA Screening Tool: BOSTN”

ISMP on Designing Effective Warnings

In several of our recent columns on the recent fatal accident with the neuromuscular blocking agent vecuronium, we discussed the role of inadequate warnings (see our Patient Safety Tips of the Week for December 11, 2018 “Another NMBA Accident”, January 1, 2019 “More on Automated Dispensing Cabinet (ADC) Safety” and February 12, 2019 “From Tragedy to Travesty of Justice”). We’ve recommended that the warning on the ADC screen should be one that requires verification that the patient is intubated/ventilated or that the drug is being used to facilitate intubation. A high alert medication like an NMBA should also require an independent double check. And the warning on the vial of vecuronium obviously was not salient enough to attract the attention of the nurse who prepared and administered the vecuronium to a patient who was not being ventilated. And a barcoding system was not operational in the radiology area where the drug was administered. There were multiple other factors contributing to the cascade of events that led to the fatal outcome but the above are examples of where effective warnings could have averted this tragic outcome.

Inadequate warnings have also been contributing factors to many other serious medication-related incidents. So it is very timely that ISMP has highlighted the problem in one of their recent Medication Safety Alerts (ISMP 2019). This is an outstanding article that uses multiple human factors concepts and empirical evidence to make recommendations that should help all organizations that deal with medications.

ISMP notes that a warning system may include several components that complement each other and various forms of technology. ISMP notes that the ability of warnings to be effective depends on their ability to:

1. reach their target audience
2. capture the attention of recipients at the right time
3. cause recipients to understand the risk, believe that the warning relates to them, and understand the actions they need to take
4. lead the recipients to respond appropriately

ISMP notes that practitioners will not typically search for or seek out warnings. So, warnings must be sufficiently conspicuous to capture attention. The article discusses in detail the following important features of warnings:

• Target audience
• Source credibility
• Clinical importance
• Font size and text format
• Font style
• Letter case
• Signal words
• Color
• Affirmative wording
• Pictorials
• Placement
• Physical interactivity
• Specifics for electronic alerts
• Usability testing
• Perception of risk

We encourage you to go to the ISMP article for details on each of those. For example, under “signal words” they note that “Danger” is more likely to attract attention than “Caution” or “Warning”. They also note that signal words may be used in either auditory or visual warnings.

The section on “Specifics for electronic alerts” is very important. It describes location of text in the visual field and the importance that no scrolling be required in the main message (noting a difference between primary and secondary text). The most critical warnings should be interactive (modal) and should shade the rest of the screen while being presented. It discusses how options that require a response should be presented and that the safest choice should be presented first and should be the default option.

This ISMP article is a “must read” for anyone dealing the patient safety and all healthcare workers who deal with medications. Many of the concepts also apply to warnings that may apply to things other than medications (for example, oxygen, other medical gases, various medical devices, etc.).

And, just because you can design an effective warning, don’t forget the best preventive action in many cases is not give the healthcare worker the opportunity to select the dangerous medication in the first place. For example, do not put neuromuscular blocking agents in places they don’t belong. NMBA’s should only be kept in areas where they are truly needed (OR, ICU, ER, or as part of Rapid Sequence Intubation kits). They should not be stored in floor stock or ADC’s on other units.

References:

ISMP (Institute for Safe Medication Practices). Your attention please… Designing effective warnings. ISMP Medication Safety Alert! Acute Care Edition 2019. February 28, 2019

https://www.ismp.org/resources/your-attention-please-designing-effective-warnings-0

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FDA Warning on Surgical Staplers Opens a Can of Worms

Another under-the-radar problem has just popped up. The FDA (FDA 2019), between January 1, 2011 to March 31, 2018, received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:

• 366 deaths
• over 9,000 serious injuries
• over 32,000 malfunctions

Common problems noted in those incident reports include:

• opening of the staple line or malformation of staples,
• misfiring
• difficulty in firing
• failure of the stapler to fire the staple
• misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)

Such incidents may result in bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence, and death. Such malfunctions or misuse also may result in prolonged surgical procedures or unplanned, additional surgical interventions.

The FDA makes a number of recommendations for hospitals and healthcare professionals. It notes that a range of staple sizes should be available to facilitate selection of the appropriate size cartridge for the tissue type and thickness (but keep in mind that different companies may use different color schemes on the cartridges to indicate different staple sizes). Difficulty squeezing the handle of the stapler may indicate the need to select a different size staple. The FDA recommends avoiding use of the stapler on tissue that is too thick or too thin for the selected staple size.

It is especially important to consider other options if the patient’s tissue is edematous, friable, or necrotic, because the staples may be less likely to securely approximate tissue. Clamping the stapler on delicate tissue can still cause injury even if no staples are fired.

Operators obviously need to be sure that unintended structures, such as urinary bladder, or foreign objects, such as clips, are not in the staple line.

The warning specifically cautions about the use of surgical staplers near large blood vessels, such as the aorta. It states that, if a malfunction of the stapler occurs while applying staples across a blood vessel, clamp or ligate the vessel before releasing the stapler, while the stapler is still closed on the tissue.

The FDA also plans to develop a draft guidance for public comment, discuss this as a topic at an upcoming advisory committee meeting, and is considering reclassification of surgical staplers as Class II medical devices.

The FDA also notes that there are likely many more reported incidents involving surgical staplers submitted as Alternative Summary Reports so it will be analyzing those reports as well as any new ones submitted after the above dates.

Stapler malfunction may be particularly problematic in laparoscopic or other minimally invasive procedures. Kwazneski et al. (Kwazneski 2013) found that most minimally invasive surgeons have experienced laparoscopic linear stapler malfunction and 25% have had to significantly alter the planned operative procedure due to the malfunction. They noted difficulty getting helpful feedback from the manufacturers despite contacting them. They noted the lack of clarity for how to report such malfunctions. Note that the current FDA letter to health care providers does spell out how to report such malfunctions.

The experience of Kwazneski et al. was also recently highlighted in a Kaiser Health News article discussing that reports of incidents related to many medical devices are hidden from the public because they have been exempted from such reporting (KHN 2019). The article notes that, “since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.” While deaths must still be reported in MAUDE, the “hidden” database has included serious injury and malfunction reports for about 100 medical devices,

So, the stapler issue may be just the tip of the iceberg. It’s likely that problems related to multiple other medical devices have evaded scrutiny because they have been “exempted” from reporting to MAUDE or other publicly accessible databases.

References:

FDA (US Food and Drug Administration). Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers. March 8, 2019

https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm632938.htm?utm_campaign=Surgical%20Staplers&utm_medium=email&utm_source=Eloqua

Kwazneski DR, Six CK, Stahlfeld KR. The Unacknowledged Incidence of Laparoscopic Stapler Malfunction. Surg Endosc 2013; 27(1): 86-89

https://link.springer.com/article/10.1007%2Fs00464-012-2417-y

KHN (Kaiser Health News). Hidden FDA reports detail harm caused by scores of medical devices. Tampa Bay Times 2019; March 7, 2019

https://www.tampabay.com/investigations/2019/03/07/hidden-fda-reports-detail-harm-caused-by-scores-of-medical-devices/

Print “April 2019 FDA Warning on Surgical Staplers Opens a Can of Worms”

Print “April 2019 What's New in the Patient Safety World (full column)”

Print “April 2019 iCOMPARE Study on Resident Work Hour Rules”

Print “April 2019 New Simple OSA Screening Tool: BOSTN”

Print “April 2019 ISMP on Designing Effective Warnings”

Print “April 2019 FDA Warning on Surgical Staplers Opens a Can of Worms”



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