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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

 

 

 

 

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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/

 

 

 

 

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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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