Patient Safety Tip of the Week Archive

What’s New in the Patient Safety World

October 2016

· Hospital Quality? Ask a Nurse

· Are Overnight Extubations Safe?

· Another Codeine Warning for Children

· AACN Alert on Feeding Tube Placement

· MRI Safety: There’s an App for That!

Hospital Quality? Ask a Nurse

In a couple past columns we briefly mentioned a study by McHugh and Stimpfel (McHugh 2012) which showed nurses’ ratings of hospital quality and safety correlate well with more formal measures. Now a new study done in Swedish hospitals extends upon that work (Smeds-Alenius 2016). The study used a survey of nurses in 67 Swedish hospitals and covered over 200,000 general, vascular, and orthopedic surgical procedures. The researchers found that hospitals in the highest tertile of nurses reporting excellent quality of care had a 23% lower odds of 30-day inpatient mortality. Similarly, hospitals in the highest tertile of nurses reporting excellent patient safety had a 26% lower odds of 30-day inpatient mortality. The study validates the previous work of McHugh and Stimpfel and suggests that nurses’ assessments could be used as legitimate measures of quality and patient safety. The authors do recognize that inpatient mortality is a crude measure of both safety and quality (Lilford 2010, Girling 2012). Mortality rates may be appropriate indicators for some conditions but not others. Moreover, patient-related factors and patient socioeconomic factors, advance directive issues, plus other factors impact inpatient mortality rates. Even after risk adjustment for patient-related variables, mortality rates may be less than ideal measures of quality or patient safety. The current study was done in Sweden supposedly to minimize some of the confounding factors seen in the US such as variation in insurance status and correlated health status.

So could nurse assessment be used as a formal measure of quality and patient safety? We would have no qualms about using nurse assessments as an informal measure and we do often ask nurses their opinion on quality and patient safety in their hospitals. It might help inform us in our decisions about whether to have a procedure at their hospital. However, what is unknown is what would happen to the observed correlation between nurse assessment and mortality rates if this were to become a formal measure of quality and patient safety. Would nurses continue to provide honest assessments if they knew that the very viability of their hospital might be jeopardized by public disclosure of such assessments? We may never know the answer to that question.

But when we are asked by someone what is the best way to tell whether a hospital has good quality and safety we have no problem telling them “ask a nurse”!

References:

McHugh MD, Stimpfel AW. Nurse reported quality of care: A measure of hospital quality. Research in Nursing & Health 2012; Article first published online: 21 AUG 2012

http://onlinelibrary.wiley.com/doi/10.1002/nur.21503/abstract

Smeds-Alenius L, Tishelman C, Lindqvist R, Runesdotter S, McHugh MD. RN assessments of excellent quality of care and patient safety are associated with significantly lower odds of 30-day inpatient mortality: A national cross-sectional study of acute-care hospitals. International Journal of Nursing Studies 2016; 61: 117–124

http://www.journalofnursingstudies.com/article/S0020-7489%2816%2930075-X/fulltext

Lilford R, Pronovost P. Using hospital mortality rates to judge hospital performance: a bad idea that just won't go away. BMJ 2010; 340: c2016

http://www.bmj.com/content/340/bmj.c2016.full?ijkey=3a399ca15c89df179d16ad75aaf9f9f3257aaf0a&keytype2=tf_ipsecsha

Girling AJ, Hofer TP, Wu J, et al. Case-mix adjusted hospital mortality is a poor proxy for preventable mortality: a modelling study. BMJ Qual Saf 2012; 21(12): 1052-1056 Published Online First: 15 October 2012

http://qualitysafety.bmj.com/content/21/12/1052.full?sid=53664ed3-dc01-47d1-8be8-d33be15c7132

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Are Overnight Extubations Safe?

Since the 1990’s one of the key components of “clinical pathways” for cardiac surgery has been early extubation of patients, often protocol-based. That was a key to reducing ICU lengths of stay for such patients.

Indeed, one study heavily weighted toward cardiothoracic surgery patients (Tischenkel 2016) found that intensive care unit extubations at night did not have higher likelihood of reintubation, LOS, or mortality compared to those during the day. In fact, trends in that study favored nighttime extubation for both reintubation rates and mortality and those extubated at night had significantly lower lengths of stay.

Given the complications associated with mechanical ventilation and extended intubation, it might seem wise that patients should be extubated as soon as possible. Those complications include ventilator-associated pneumonias, delirium, neuromuscular syndromes, etc. Hence, there might be theoretical reasons to favor early extubation. But what are the empirical data favoring overnight extubation? A new study looks at patient outcomes in patients who were extubated overnight and has some surprising results (Gershengorn 2016). In a retrospective analysis of a cohort of almost 100,000 mechanically ventilated patients they found 20.1% were extubated overnight and that rate has decreased over time. For those patients who had been mechanically ventilated for less than 12 hours reintubation rates were similar between those extubated overnight vs. during the daytime but mortality was increased for those extubated overnight (5.6% vs. 4.6%). For those mechanically ventilated more than 12 hours, those extubated overnight had higher reintubation rates and higher ICU and hospital mortality with no difference in length of stay.

One intriguing finding was that the odds ratios for increased mortality in those extubated overnight were higher than the odds ratios for reintubations. While several possible reasons were discussed by the authors, they favored a hypothesis that “palliative” extubations may have accounted for this (with the theory that palliative extubations are more likely to take place when family is present at night).

They also attributed the disparity between their study and that by Tischenkel and colleagues (Tischenkel 2016) to a significant difference in the number of patients undergoing cardiothoracic surgery.

Keep in mind that the Gershengorn study was a retrospective cohort study. As pointed out in the accompanying editorial (Moore 2016), though the study had excellent data collection as part of a large collaborative study there was lack of information on the circumstances and reasons for extubation (and reasons why some were not reintubated).

In our September 20, 2016 Patient Safety Tip of the Week “Downloadable ABCDEF Bundle Toolkits for Delirium” we discussed a study (Balas 2013a , Balas 2014) that was a prospective, cohort, before-after study of the ABCDE bundle at a large, tertiary medical center, involving patients from multiple ICU’s. They found patients treated with the ABCDE bundle, which leads to earlier extubation, experience more days breathing without assistance and a shorter duration of ICU delirium. The odds of delirium were cut almost in half. Patients on the bundle were also more likely to be mobilized out of bed during their ICU stay. No significant differences were noted in self-extubation or reintubation rates. But it should be noted that one of the barriers encountered in implementation was that nurses and respiratory therapists were often concerned about spontaneous breathing trials being done at night (Balas 2013b).

Though the findings of the Gershengorn study are associations and do not prove causality, they certainly put to question the practice of overnight extubations. We suspect that there may well be differences in outcomes both by type of ICU and nature of the underlying problem. But it is certainly worth all hospitals taking a look at their current practices and outcomes.

References:

Tischenkel BR, Gong MN, Shiloh AL, et al. Daytime vs nighttime extubations: a comparison of reintubation, length of stay, and mortality. J Intensive Care Med 2016; 31(2): 118-126

http://jic.sagepub.com/content/31/2/118

Gershengorn HB, Scales DC, Kramer A, Wunsch H. Association between Overnight Extubations and Outcomes in the Intensive Care Unit. JAMA Intern Med 2016; Published Online First September 06, 2016

http://archinte.jamanetwork.com/article.aspx?articleid=2547203

Moore PK, Matthay MA. Overnight Extubation in Patients with Mechanical Ventilation. Is It Harmful? JAMA Intern Med 2016; Published online September 06, 2016

http://archinte.jamanetwork.com/article.aspx?articleid=2547200

Balas M, Olsen K, Gannon D, et al. Safety And Efficacy Of The ABCDE Bundle In Critically-Ill Patients Receiving Mechanical Ventilation. Abstract at Society of Critical Care Medicine 42^nd Critical Care Congress. Presented January 20, 2013. Crit Care Med 2012; 40(12) (Suppl.): 1

http://journals.lww.com/ccmjournal/Abstract/2012/12001/1___SAFETY_AND_EFFICACY_OF_THE_ABCDE_BUNDLE_IN.4.aspx

Balas MC, Vasilevskis EE, Olsen KM, et al: Effectiveness and safety of the awakening and breathing coordination, delirium monitoring/management, and early exercise/mobility bundle. Crit Care Med 2014; 42: 1024-1036

http://journals.lww.com/ccmjournal/Abstract/2014/05000/Effectiveness_and_Safety_of_the_Awakening_and.2.aspx

Balas MC, Burke WJ, Gannon D, et al. Implementing the awakening and breathing coordination, delirium monitoring/management, and early exercise/mobility bundle into everyday care: opportunities, challenges, and lessons learned for implementing the ICU Pain, Agitation, and Delirium Guidelines. Crit Care Med 2013; 41(9 Suppl 1): S116-127

http://journals.lww.com/ccmjournal/Fulltext/2013/09001/Implementing_the_Awakening_and_Breathing.10.aspx

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Another Codeine Warning for Children

It’s been over 4 years since the first warnings appeared about the dangers of using codeine in children. Our previous 5 columns on the dangers of codeine in children discussed the multiple safety alerts from the FDA (FDA 2012, FDA 2013, FDA 2015). These columns described cases of death and serious adverse effects in children treated with codeine following adenotonsillectomy for obstructive sleep apnea. The problem originally noted for codeine was that there are genetic variations that cause some people to be “ultra-rapid metabolizers” of codeine, which leads to higher concentrations of morphine in the blood earlier.

In our January 2016 What's New in the Patient Safety World column “FDA Gets Even Tougher on Codeine in Kids” we noted that an advisory committee to the FDA recommended that codeine be contraindicated for pain and cough management in children and adolescents (Firth 2015). They also recommended restricting codeine's over-the-counter availability for this group. Of 29 voting members, 20 voted to contraindicate use of the drug for pain and cough in children younger than 18 years old. Most of the others voted to restrict its use only in younger children. However, the FDA has not yet taken formal action on those recommendations.

While the initial warnings focused on avoiding codeine in children who were undergoing adenotonsillectomy for obstructive sleep apnea (OSA), the dangers apply more globally to children. Now an even tougher stance is being taken by the American Academy of Pediatrics in a statement “Codeine: Time to Say ‘No’ ” (Tobias 2016). That paper reiterates the evidence of adverse effects of codeine in children and their mechanisms. It notes that codeine is still available in over-the-counter cough formulas in 28 states and the District of Columbia without a prescription.

The Tobias paper does discuss the pros and cons of alternatives to codeine in the pediatric population, noting that almost all of them also have some potential downsides. Those alternatives include oxycodone, hydrocodone, oral morphine, and tramadol. It also mentions tapentadol, which is not yet FDA-approved for use in children. It notes that use of acetaminophen and nonsteroidal antiinflammatory drugs (NSAIDs) are legitimate alternatives in many or most children. Regarding the continued presence of codeine in many antitussive formulations, it notes that neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown.

Our May 2014 What's New in the Patient Safety World column “Pediatric Codeine Prescriptions in the ER” noted the continued frequent prescription of codeine-containing products in children despite the previous warnings about adverse reactions. In our November 2015 What's New in the Patient Safety World column “FDA Safety Communication on Tramadol in Children” we noted that education does not seem to have reduced prescription of codeine-containing products. We therefore advocated incorporating “hard stops” (alerts requiring acknowledgement of the warnings about codeine or other opioid in children) into CPOE and e-prescribing systems. We would hope that the FDA takes more forceful action, as recommended by the previous advisory committee and the current American Academy of Pediatrics, to reduce the risk of codeine-associated respiratory depression and other adverse events.

Regardless of whether the FDA takes action or not, you should be monitoring your organization’s prescription of codeine-containing products and taking active steps (like the hard stops noted above) to force your prescribers to think twice when contemplating use of codeine in children.

Some of our previous columns on opioid safety issues in children:

September 2012 “FDA Warning on Codeine Use in Children Following Tonsillectomy”
March 2013 “Further Warning on Codeine in Children Following Tonsillectomy”
May 2014 “Pediatric Codeine Prescriptions in the ER”
November 2015 “FDA Safety Communication on Tramadol in Children”
January 2016 “FDA Gets Even Tougher on Codeine in Kids”

References:

FDA. FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. 8/15/12

http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm

FDA. FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy. Update February 20, 2013

http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm

FDA (Food and Drug Administration) Briefing Document: The safety of codeine in children 18 years of age and younger. Joint Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting . December 10, 2015

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM475975.pdf

Firth S. FDA Panel Urges Stronger Regulation of Codeine. An FDA advisory committee voted 28-0 to remove the drug from its OTC monograph for cough and cold. MedPage Today 2015; December 11, 2015

http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/55159

Tobias JD, Green TP, Coté CJ, Section on Anesthesiology and Pain Medicine, Committee on Drugs. Codeine: Time to Say “No”. Pediatrics 2016; Originally published online September 19, 2016

http://pediatrics.aappublications.org/content/early/2016/09/15/peds.2016-2396

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AACN Alert on Feeding Tube Placement

One of our columns that surprisingly is near the top of our “hit” list was our November 1, 2011 Patient Safety Tip of the Week “So What’s the Big Deal About Inserting an NG Tube?”. In that column we noted that nasogastric tube (NG tube) insertion is so common that we tend to forget its risks. But if you’ve ever seen a patient die because their enteral feeds were inadvertently given into their lungs or develop meningitis because the NG tube went through a basal skull fracture, you won’t take this cavalier attitude toward NG tubes. We noted 3 Patient Safety Alerts from the UK’s NPSA (NPSA 2005a, NPSA 2005b, NPSA 2011) that reported numerous incidents, including deaths and other bad outcomes related to misplaced NG tubes.

Feeding tube misplacement is an issue not just in the UK. The American Association of Critical-Care Nurses issued a press release (AACN 2016) on September 15, 2016 calling attention to their practice alert “Initial and Ongoing Verification of Feeding Tube Placement in Adults” issued earlier this year. According to that new guideline, the expected practice during the insertion procedure is to use a combination of two or more of the following bedside methods to predict tube location:

Observe for signs of respiratory distress
Use capnography if available
Measure pH of aspirate from tube if pH strips are available
Observe visual characteristics of aspirate from the tube

Confirmation by radiography is still the most important element but results of the above elements can be used to determine when it is time to use radiography to confirm tube location and they may also be able to reduce the number of confirming radiographs to one.

Just as important, the alert discusses methods of tube location that should not be used. It stresses that nurses should not use the auscultatory (air bolus) or water bubbling method (holding tube under water) to determine tube location.

It also has important considerations for the radiologic confirmation of tube location. Correct placement of a blindly inserted small-bore or large-bore tube should be confirmed with a radiograph that visualizes the entire course of the tube prior to its initial use for feedings or medication administration. Once correct tube placement is confirmed, the exit site from the patient’s nose or mouth should be immediately marked and documented to assist in subsequent determinations of tube location. After feedings are started, tube location should be checked at four-hour intervals.

The practice alert is well-referenced, both in terms of citing the literature on adverse effects of tube misplacement and the supporting evidence for the recommended best practices.

We refer you back to our November 1, 2011 Patient Safety Tip of the Week “So What’s the Big Deal About Inserting an NG Tube?” for other lessons learned and other issues regarding NG and other feeding tubes. Pay particular attention to the section on radiologic confirmation. First, the x-ray requisition should clearly state the x-ray is for determination of tube placement. All too often we still see x-ray requisitions filled out with something like the admission diagnosis rather than the real reason for the x-ray. And you need to make sure that the person doing the interpretation is appropriately credentialed to do so (for example, if someone other than the radiologist is doing the interpretation). And feeding should not be commenced via that tube until the radiologist (or appropriately credentialed person) has documented the tube is in the correct location.

References:

AACN (American Association of Critical-Care Nurses). Feeding Tubes Require Initial and Ongoing Verification to Minimize Complications. American Association of Critical-Care Nurses updates Practice Alert on feeding tube placement. Press Release 15-Sep-2016

http://www.newswise.com/articles/feeding-tubes-require-initial-and-ongoing-verification-to-minimize-complications

AACN (American Association of Critical-Care Nurses). AACN Practice Alert: Initial and Ongoing Verification of Feeding Tube Placement in Adults. CriticalCareNurse 2016; 36(2): e8-e13 April 2016

http://www.aacn.org/wd/practice/content/feeding-tube-practice-alert.pcms?menu=practice

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MRI Safety: There’s an App for That!

One of the questions addressed before anyone gets an MRI scan is whether the patient has any sort of implant or device or foreign body that may be adversely affected by the magnetic fields. Sounds simple, doesn’t it? Don’t we just look at a list of those items that would contraindicate an MRI scan?

Well, it is not so simple. Dr. Emanuel Kanal, director of MR services at University of Pittsburgh Medical Center and a well-known expert on MRI safety issues, has developed the MR Safety Implant Risk Assessment app on the IOS (iPhone) platform to address the multiple factors involved. A recent interview with him on AuntMinnie.com, the popular radiology website, discussed the details and intricacies of the app (Ridley 2016).

Factors affecting the safety during MRI include not only the type of implant but also its location, the type of MRI scan being done, the part of the body being imaged, the strength of the magnet and other issues of configuration of the MRI machine, and other considerations such as the location of the various energy sources relative to the patient’s location in the MRI suite. Kamal notes that what is safe in one system may not be safe in another. Moreover, a patient might safely have one part of the body imaged by MRI but not another. Importantly, some patients may be being denied potentially helpful MRI scanning that could be safely performed given the correct type of study and equipment.

The intended audience for the app is MR technologists, radiologists, or MR physicists and it requires technical knowledge about MRI. Kamal describes the app as a teaching tool in addition to its practical utility in determining whether a patient can be safely imaged by MR. Kamal, who is also a licensed pilot, describes the checklist format that forces the user to consider all the potential safety concerns before concluding that the patient may have the MR study safely performed.

The interview is worth your reading and you should make sure that those involved in your MRI unit know about the nature and availability of the app. But the interview was enlightening even for those of us lacking the technical MR expertise. As a neurologist, I highly suspect after reading it that there have been instances where I referred patients for alternative imaging modalities when an MRI actually could have been performed safely.

Speaking of safety in the MRI suite, we should also note that a coalition of societies and organizations dealing with MRI has proposed a delineation of responsibilities for the management of MRI facilities (Calamante 2016).

Some of our prior columns on patient safety issues related to MRI:

February 19, 2008 “MRI Safety”

March 17, 2009 “More on MRI Safety”
October 2008 “Preventing Infection in MRI”
March 2009 “Risk of Burns during MRI Scans from Transdermal Drug Patches”
January 25, 2011 “Procedural Sedation in Children”
February 1, 2011 “MRI Safety Audit”
October 25, 2011 “Renewed Focus on MRI Safety”
August 2012 “Newest MRI Hazard: Ingested Magnets”
October 22, 2013 “How Safe Is Your Radiology Suite?”
October 21, 2014 “The Fire Department and Your Hospital”
August 25, 2015 “Checklist for Intrahospital Transport”
August 2016 “Guideline Update for Pediatric Sedation”

References:

Ridley EL. Mobile App Spotlight: Kanal's MR safety implant risk tool. AuntMinnie.com 2016; August 24, 2016

http://www.auntminnie.com/index.aspx?sec=sup&sub=mri&pag=dis&ItemID=114953

Apple iTunes store. Kanal's MR Safety Implant Risk Assessment (app).

https://itunes.apple.com/us/app/kanals-mr-safety-implant-risk/id1114168862

Calamante F, Ittermann B, Kanal E, The Inter-Society Working Group on MR Safety and Norris D. Recommended responsibilities for management of MR safety. JMRI 2016; Early View 3 Jun 2016

http://onlinelibrary.wiley.com/doi/10.1002/jmri.25282/epdf

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