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What’s New in the Patient Safety World

March 2020


·       Airway Emergencies in the MRI Suite

·       ISMP Smart Infusion Pump Guidelines

·       Ditch the Bouffant?

·       Risk Factor for Preventable Harm: Psychiatric Diagnosis




Airway Emergencies in the MRI Suite



We’ve done many columns on things that can go wrong while patients are in the radiology suite or the MRI suite. The MRI suite, in particular, presents special challenges for those responding to unanticipated events. That is the reason that training and simulation exercises are so important in preparing all staff for such events.


One such event is the airway emergency occurring in a patient in the MRI suite. Patients undergoing MRI often have multiple acute medical conditions plus comorbidities that may place them at risk for events during MRI. Many of the inpatients are receiving opiates or other drugs that may depress respiration. Add to that the fact that many patients are given sedation before undergoing MRI because of claustrophobia and it should be no surprise that airway emergencies happen in the MRI suite.


Anesthesiologists McClung and Subramanyam (McClung 2020) addressed airway emergencies in the MRI suite in a recent issue of the APSF (Anesthesia Patient Safety Foundation) Newsletter. They begin with a discussion about the importance of understanding the MRI environment is divided into four Zones designated I through IV, with Zone IV being the MRI scanner magnet room. They stress that the MRI magnetic field is “invisible, always on, and can affect ferromagnetic equipment of any size in Zone IV, potentially converting it to a projectile that is drawn into the scanner with a strength and speed that can be deadly”. They also note that, in addition to risks to humans, damage to equipment can occur from such events. (You may recall in our January 7, 2010 Patient Safety Tip of the Week “Even More Concerns About MRI Safety” we noted a Swedish study showing that material injuries were more common than actual human injuries in MRI projectile incidents but the potential for serious human harm was very high).


They then discuss equipment issues, noting that very few airway devices have been specifically designed for safe use in MRI. Medical devices and equipment that might be used in the MR environments should be labelled as MR unsafe, MR conditional, or MR safe. Some laryngeal mask airways and endotracheal tubes contain small amounts of ferromagnetic material but may be designated “MR conditional” because, while they might affect image quality, they are not likely to cause patient harm. Those airway devices have been used safely along with plastic oropharyngeal airways and bag mask ventilation units. But they stress that classic metal laryngoscopes are considered unsafe as malfunction with sudden failure to operate can occur in Zone IV and nickel in the laryngoscope battery is ferromagnetic. Instead, single-use or reusable “MRI-conditional” devices should be used. (Some such devices are expensive but cost considerations would pale compared to costs of a malpractice settlement related to using MR-unsafe devices.)


Next, they stress process and procedures, relying heavily on the most recent update of the ASA practice advisory on anesthetic care for magnetic resonance imaging (ASA 2015). That stresses that, during an airway emergency, anesthesia professionals and other health care providers must be prepared to enter Zone IV quickly. The advisory states that “Alternative MRI safe/conditional airway devices should be immediately available in the MRI suite.” Personnel must recheck themselves for presence of ferromagnetic objects and equipment prior to entering the scanner. That is where we think it’s important for the MRI staff to serve as “traffic cops” during that emergency to enforce checking for ferromagnetic objects. The practice advisory states that airway equipment immediately available to the team in Zone III should be MR-conditional for all scanners in the location. “If it is safe, the airway should be supported with bag mask ventilation while the patient is removed from Zone IV to a nearby location in Zone III or Zone II where a full complement of airway and resuscitation equipment can be used and emergency personnel summoned for help.”


We think it is critical that every facility performing MRI imaging conduct drills and simulations so that all staff responding to an event in the MRI suite are aware of the hazards and know how to properly respond in a manner safe to all. That can be especially problematic in academic medical centers where hew housestaff are continually rotating in and out or in small community or rural facilities where locum tenens or temporary staff are being used. In such circumstances, it is crucial that their initial orientation to the facility include education about the hazards of the MRI suite.


This is actually a good topic for a FMEA (failure mode and effects analysis). You need to ask questions about availability of MR-safe equipment in the MRI suite, what training responding staff are likely to have had, how MRI staff are deployed to help those responders avoid safety issues as they arrive, and others.



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







McClung H, Subramanyam R. Airway Emergencies and Safety in Magnetic Resonance Imaging (MRI) Suite. APSF Newsletter 2020; 35(1): 10-11 February 2020



ASA (American Society of Anesthesiologists). Practice advisory on anesthetic care for magnetic resonance imaging: an updated report by the American Society of Anesthesiologists task force on anesthetic care for magnetic resonance imaging. Anesthesiology 2015; 122: 495-520





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ISMP Smart Infusion Pump Guidelines



A year ago (see our March 5, 2019 Patient Safety Tip of the Week “Infusion Pump Problems”) we did an extensive column on safety issues related to infusion pumps. We hope you’ll go back to that column to review our many recommendations.


But ISMP (Institute for Safe Medication Practices) has now published its long awaited “Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps” (ISMP 2020). We have no intention of replicating here the details of that thorough, practical, up-to-date guideline. You’ll have to read it yourselves.


It describes the various types of errors associated with infusion pumps, including dose-rate and infusion-rate mix up errors, concentration errors, multiple line errors, and others. It summarizes results of several surveys that ISMP undertook in recent years on infusion pump issues and then discusses infrastructure issues, drug library issues, clinical workflow issues, continuous quality improvement (CQI) data, and interoperability with the electronic health record. There is also a section on clinical alerts, soft limits, hard limits, and alarm management.


The guideline also discusses dose error-reduction systems (DERS), a feature of some smart pumps. Facility-customized DERS warn healthcare providers about potential prescribing, calculation, and programming errors by generating alerts intended to prevent infusions from being programmed outside facility-established limits.


The section on building a drug library is especially important. ISMP stresses independent double checking for the entry or modification of each drug-specific element such as the

standardized drug name, applicable tall man lettering, dosing units, concentration, dose limits, and associated clinical alerts.


ISMP recommends you establish care areas/profiles that are tailored to specific patient populations, acuity, and/or patient weight. But you must remember when transferring patients to a different clinical unit to ensure the drug library care area/profile is appropriate for the receiving unit.


Standardization is critical. That includes standardizing the nomenclature of the drug name (including any TALL MAN LETTERING), dose/dosing units (e.g., weight-based versus non-weight-based dosing; mcg/kg versus mg/kg), and dose-rate (e.g., mg/kg/min versus mg/kg/hr) in the drug library. It is also important to make sure this nomenclature is consistent with the EHR, pharmacy infusion labels, and pharmacy IV workflow systems. Standardizing and limiting the number of drug concentrations for continuous and intermittent infusions in the drug library is also important.


Performance of double checks at certain points in the clinical workflow is emphasized. When starting selected facility-defined high-alert medication infusions and at additional facility-defined steps (e.g., change of shift/handoffs, change in the rate/dose of infusion, change in bag/bottle/syringe) require that a double check be performed and documented to verify the following before starting the infusion:


ISMP notes that technology (eg. barcoding) is the preferred method for double checking most of these items but use of a second practitioner is necessary to perform and document an independent double check for line attachment.


It outlines considerations for differentiating infusion pumps used to administer medications and fluids via different routes of administration (e.g., IV, enteral, epidural).


One often overlooked point: “Immediately discard all continuous IV medications and epidural infusions (e.g., continuous infusions of magnesium, neuromuscular blocking agents, and opioids) after discontinuation (i.e., do not leave hanging on an IV pole or at the bedside).”


The ISMP guideline is aimed primarily at use of smart infusion pumps in facilities. It does not delve into issues related to use of infusion pumps in the home setting. We covered some of the latter issues in our March 5, 2019 Patient Safety Tip of the Week “Infusion Pump Problems”. Especially important in the home setting is one of our own critical warnings that applies to any sort of infusion pump, smart or otherwise: never put a potentially lethal amount of a medication in a bag/bottle/syringe, lest some sort of error leads to infusion of the entire amount over too short a period. We have done several columns in which fatal or near-fatal overdoses of chemotherapy agents have been infused inadvertently over several hours when they had been intended to infuse over several days (see our Patient Safety Tips of the Week for September 11, 2007 “Root Cause Analysis of Chemotherapy Overdose” and April 6, 2010 “Cancer Chemotherapy Accidents” and September 15, 2015 “Another Possible Good Use of a Checklist”).


The ISMP guideline also includes multiple metrics that should be monitored as part of your quality improvement program.


This ISMP guideline is a must-read for anyone who encounters infusion pumps in their practice. It has a strong evidence base, is well-referenced, and has many practical recommendations.


As above, we hope you’ll also go back to our March 5, 2019 Patient Safety Tip of the Week “Infusion Pump Problems” for our extensive review of safety issues related to infusion pumps. The current ISMP guidelines also don’t go into detail about some of the special issues involved with PCA (patient-controlled analgesia) pumps. We’ve also included below a list of our prior columns dealing with PCA issues.



Our prior columns related to infusion pump issues:



Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:








ISMP (Institute for Safe Medication Practices). Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps. ISMP 2020; February 10, 2020

(ISMP 2020)





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Ditch the Bouffant?



In 2014 AORN (Association of periOperative Registered Nurses) issued its revised guidelines for surgical attire. There were several recommendations that met with considerable controversy. Two of those were the requirement to wear a bouffant rather than other head covering in the OR and to wear a garment that covered the arms in the OR. A third recommendation was that personal clothing should not be worn beneath scrubs. The Joint Commission and other regulatory agencies began enforcing those recommendations. Surgeons and anesthesiologists pushed back considerably, particularly about the head covering issue which effectively banned the traditional surgical skull cap, citing the lack of a strong evidence base for these practices. We discussed the disparities between the AORN guidelines and those issued by the American College of Surgeons (ACS 2016) in our September 2016 What's New in the Patient Safety World column “American College of Surgeons Statement on Operating Room Attire”.


Taking all arguments into consideration, AORN published updated guideline for surgical attire in July 2019 (AORN 2019), That new guidelines say no recommendation can be made for the type of head covers worn in the semi-restricted and restricted areas. It also says that no recommendation could be made regarding long sleeves, with the exception that long sleeves should be used when performing skin antisepsis. And it left the issue of personal clothing underneath scrubs up to individual hospital policy.


Timely is a study done at the University of Alabama at Birmingham (Wills 2020). Researchers there were able to track SSI’s (surgical site infections) during 3 separate time periods, one in which neither bouffants nor surgical jackets were required, one during which long-sleeved surgical jackets were mandated, and another during which both surgical jackets and bouffants were required. They looked at over 34,00 inpatient surgical cases over a 22-month study period. They found no significant difference in the risk of SSI (1.01% vs 0.99% vs 0.83%), mortality (1.83% vs 2.05% vs 1.92%), postoperative sepsis (6.60% vs 6.24% vs 6.54%), or wound dehiscence (1.07% vs 0.84% vs 1.06%) between the 3 groups.


They estimated expenditure of more than $300,000 annually on surgical jackets. Bouffants were found to be less expensive than surgical skull caps. They conclude that surgical jackets and bouffants are neither beneficial nor cost-effective in preventing SSI’s and that institutions should evaluate their own data to determine whether recommendations by outside governing organizations are beneficial and cost-effective.


A thoughtful editorial (Dipp Ramos 2020) accompanying the Wills paper reminds us that there are other common-sense recommendations regarding attire:


The issue of transmitting pathogenic bacteria is serious and such transmission can take place in both directions (i.e. from hospital to home, or from home to hospital). Mitchell and colleagues (Mitchell 2015) summarized the literature on the role of apparel worn in healthcare settings in the acquisition and transmission of healthcare-associated pathogens. In some countries all laundering of healthcare workers’ uniforms is carried out in-house under regulated conditions. Laird et al. (Laird 2018) discussed in detail the issue of domestic laundering of nurses’ uniforms vs. hospital or commercial laundering and noted the following rules that should be followed if healthcare attire is laundered at home:


In our February 2014 What's New in the Patient Safety World column “SHEA’s New Recommendations for Hospital Attire” we discussed the guidance statement from the Society Healthcare Epidemiology of America (SHEA) for hospital attire outside the OR (Bearman 2014). The guidance attempts to balance professional considerations against the potential risk of transmission of pathogens to patients. It reviewed the laboratory evidence of contamination of various pieces of healthcare workers’ attire with pathogens, including multi-drug resistant pathogens. Though the authors made it clear that the actual role of hospital attire in causing infections in patients was unclear at the time, the guidance has recommendations that are based on practical, theoretical and biologically plausible considerations to reduce the likelihood of transmission of pathogens to patients.


One recommendation was “bare below the elbows (BBE)”, a recommendation used widely in Europe. This means healthcare workers should wear short sleeves during patient contact and have no wristwatch, rings or other jewelry below the elbows.


They also had recommendations regarding the traditional white coats worn by healthcare workers. Workers should have at least 2 white coats available and a convenient and economical way of laundering them. The institution should provide onsite laundering at no cost or low cost when possible. The institution should also provide coat hooks for healthcare workers to remove their white coat (or other long-sleeved outerwear) prior to patient contact. While they note that attire worn in patient contact should be laundered after daily use, they recommend that white coats worn during patient care should be laundered at a minimum once a week or when visibly soiled. While they did not take a firm stance on whether attire should be laundered at home or professionally, they did recommend that if attire is laundered at home a hot-water wash cycle with bleach be used, followed by a cycle in the dryer.


The SHEA paper noted a huge gap between hospital attire policies and their enforcement, with enforcement rates as low as 11%. Given the number of healthcare workers we still see in scrubs in hospital cafeterias, other parts of the hospital, and even shopping alongside us in our local grocery stores, we know it will take much more than a policy to foster true change.


Now is a good time to review your organization’s policies on attire in various areas. Yes, you may find that you can save some costs as pointed out in the Willis paper. But we also suspect that, if you do an audit of compliance with attire guidelines, you’ll find that your staff regularly breaks the rules.




See our prior columns regarding hospital or surgical attire:








ACS (American College of Surgeons). Statement on Operating Room Attire. Online August 4, 2016



AORN (Association of periOperative Registered Nurses). Guidelines for perioperative practice: surgical attire. AORN Facility Reference Center. July 2019



Wills BW, Smith WR, Arguello AM, McGwin G, Ghanem ES, Ponce BA. Association of Surgical Jacket and Bouffant Use With Surgical Site Infection Risk. JAMA Surg 2020; Published online February 12, 2020



Dipp Ramos R, Itani KMF. Emotions, Common Sense, and Evidence in Operating Room Attire. JAMA Surg 2020;  Published online February 12, 2020



Mitchell A, Spencer M, Edmiston C. Role of healthcare apparel and other healthcare textiles in the transmission of pathogens: a review of the literature. Journal of Hospital Infection 2015; 90(4): 285-292



Laird K, et al (2018) Domestic laundering of nurses’ uniforms: what are the risks? Nursing Times 2018; 114: 2, 18-21



Bearman G, Bryant K, Leekha S, et al. SHEA Expert Guidance. Healthcare Personnel Attire in Non-Operating-Room Settings. Infect Control Hosp Epidemiol 2014; 35(2): 107-121  February 2014 electronically published January 16, 2014







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Risk Factor for Preventable Harm: Psychiatric Diagnosis



We’ve done many columns on patient safety issues related to behavioral health (see list at the end of today’s column). But virtually all our columns have focused on patients in the hospital setting. We have largely neglected patient safety risks for this population in the outpatient setting.


A case-control study in Sweden recently reported on patient-related factors associated with risk of preventable harm in first-line health care in 2 settings – primary care and the emergency department (Fernholm 2020).  The researchers found that all psychiatric diagnoses, regardless of severity, nearly doubled the risk of being a reported case of preventable harm (odds ratio 1.96). Excess risk in this group persisted even after adjustment for income and education.


The preventable harm was mostly somatic harm as oppose to psychiatric harm/suicide, and primarily involved diagnostic errors of somatic disease (46% of all preventable harm in this category was due to diagnostic errors). Smaller categories were harm from falls, surgical complications, medication-related and cross infections.


The most common psychiatric diagnoses were depression and anxiety and alcohol- or drug-related psychiatric disorders, with less frequent diagnoses being dementia, bipolar

disease, and psychotic disorders.


Differences in income and education did have some impact on the risk of preventable harm. But even after adjustment for these, the risk of preventable harm for those with psychiatric diagnoses remained significant (odds ratio 1.69).


The authors cite several prior large studies which showed that people with mental illness die prematurely and have higher rates of comorbidities than the general population. They speculate some of this may be due to “diagnostic overshadowing”, where physical symptoms are misattributed to mental illness. They note that patients with mental illness can present physical symptoms as behavioral changes, but they can also present mental discomfort as physical symptoms.


They also note that earlier studies found patients with a history of psychiatric disease have a significantly higher rate of early death after ED discharge than do patients in the

ED without such a history and that most such patients die of non-psychiatric causes


They note contributory factors identified in the hospital setting include difficulties of communication, different expressions of symptoms, problems in knowledge and information gathering, and substance misuse. But they note that reasons for increased risk in primary care have not explored.


Another recent study (Isbell 2020) looked at emotional responses of ED physicians and nurses to 3 types of encounters: one that elicited anger/frustration/irritation (angry encounter), one that elicited happiness/satisfaction/appreciation (positive encounter), and one with a patient with a mental health condition (mental health encounter). Emotions reported in angry and mental health encounters were remarkably similar, highly negative, and associated with reports of low provider engagement compared with positive encounters. The healthcare workers reported their emotions influenced their clinical decision-making and behavior most frequently in angry encounters, followed by mental health and then positive encounters. Emotions in angry and mental health encounters were associated with increased perceptions of patient safety risks; emotions in positive encounters were associated with perceptions of higher quality care.


We’ll speculate that the time factor may well play a role. In our experience, patients with those psychiatric diagnoses generally take more time during visits. So, in settings where busy schedules limit the amount of time spent with each patient (such as primary care and the emergency department), we might expect more errors to occur.


While the exact reasons for this excess risk in this population are unclear, this study should serve as a warning for first line healthcare professionals to use caution in addressing medical issues with such patients and be careful to avoid biases, particular with regard to diagnostic issues.



Some of our past columns on issues related to behavioral health:







Fernholm R, Holzmann MJ, Wachtler C, et al. Patient-related factors associated with an increased risk of being a reported case of preventable harm in first-line health care: a case-control study. BMC Family Practice 2020; 21: 20



Isbell LM, Tager J, Beals K, et al Emotionally evocative patients in the emergency department: a mixed methods investigation of providers’ reported emotions and implications for patient safety. BMJ Quality & Safety 2020; Published Online First: 27 January 2020





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