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October 15, 2019
Lots More on MRI Safety
Our April 2, 2019 Patient Safety Tip of the Week “Unexpected Events During MRI” had a fairly comprehensive discussion of some recent developments in MRI safety. But, since MRI safety made ECRI Institute’s annual Top 10 list for Health Technology Hazards for 2020 (ECRI 2019), we thought this is an opportune time for an another update on MRI safety. Item #8 on the ECRI list, “Missing Implant Data Can Delay or Add Danger to MRI Scans”, is also one we’ve discussed in multiple columns (see the list of our prior columns below). Because some implants can heat, move, or malfunction when exposed to an MRI system’s magnetic field, they must be screened for prior to the procedure. ECRI suggests that, akin to an allergy list, organizations develop an implant list that collects all relevant information in one easy-to-access location in the electronic medical record. We like that idea!
In fact, a recent artificial intelligence (AI) study (Valtchinov 2019) used natural language processing (NLP) to identify such implantable devices from radiology reports, emergency department (ED) notes, and other clinical reports (eg, cardiology, operating room, physician notes, radiology reports, pathology reports, patient letters). The proportion of radiology reports, ED notes, and other clinical reports retrieved containing implantable devices with high safety risks for MRI ranged from 1.47% to 1.88%. This is a very promising approach to developing comprehensive lists of implantable devices posing high safety risks for MRI.
The most recent update of ACR guidelines on MR safety (Greenberg 2019) has a section on screening for both patients and non-MR personnel. Particularly illuminating is the section on ferromagnetic materials in unexpected places that may pose a risk for thermal injury during MRI. In our September 2019 What's New in the Patient Safety World column “New MRI Hazard: Magnetic Eyelashes” we discussed the risks associated with a new phenomenon: magnetic eyelashes. But the ACR guideline update notes that clothing and other related products may have incorporated ferromagnetic and/or conductive materials (eg, antimicrobial silver and copper) that are not reliably disclosed in labeling. Examples given include sportswear (including underwear), brassieres, orthotic‐related items (eg, stump covers or stump shrinkers), and blankets, but there are likely others as well. As a result, the guideline recommends patients wear only MR‐Safe gowns or scrubs supplied by the imaging facility for areas in or around the volume of transmitted RF power. The 2013 updated guidelines also discuss issues related to tattoos and dermal adornments. It also discusses orbital X-rays for screening patients having a history of orbital trauma with possible metallic elements. And see below for recommendations on prisoners with metallic restraints or tracking devices.
A recent review of over 1500 reports over a decade of adverse events related to MR reported to FDA (Delfino 2019) categorized adverse events as thermal (59%), mechanical (11%,), projectile (9%), and acoustic (6%). Mechanical events included things like slips, falls, crush injuries, broken bones, and cuts; musculoskeletal injuries from lifting or movement of the device. The authors thought the majority of these were potentially preventable. There were 3 deaths, two involving MRI technicians and the third due to a pain pump malfunction caused by the magnetic field.
One factor contributing to many of the thermal injuries was the MRI coils used in the examination. They noted inadvertent contact with another coil, electrocardiogram electrodes or leads, patient clothing, or stereotaxic head frames in 28% of such cases and skin-to-skin contact in 16%. The most recent update of ACR guidelines on MR safety (Greenberg 2019) advises that to help safeguard against thermal injuries or burns, “insulating pads should be placed between the patient's skin and any transmit RF coil located behind the walls and ceiling of the bore of the magnet system, especially the area of the transmit RF body coil, to ensure spacing between the bore wall and the patient's skin”. It notes that a single‐layer bed sheet is insufficient insulation or spacing. Interestingly, it acknowledges that large conducting loops may be created within the patient's own tissues by points of skin‐to‐skin contact, such as thigh‐to‐thigh contact. So, providing insulation in such areas may also be required to prevent burns.
Another paper (Cross 2018) stresses the importance of training in prevention of adverse MRI events. The authors suggest tailoring the training in accord with how or how likely the staff person is to come in contact with the MRI unit. Comprehensive training would be given to those who routinely work in and around the MRI scanner. That would include radiologists (or others who may be involved in MRI, such as neurologists), technicians, physicists and engineers, radiology nurses, and anyone who routinely may be in the MRI suite. A lesser level of training might be given to those working near the MRI unit who might occasionally be in the unit (eg. other radiologists, nurses, etc.). Any other individuals would be screened before access to the MRI suite.
And, you have to plan for the unexpected. You want to make sure your MRI unit is secured after hours to prevent housecleaning or building maintenance staff from inadvertently stumbling into any zone of the MRI suite or the scanner room itself. The most recent update of ACR guidelines on MR safety (Greenberg 2019) states that the “entry door to Zone IV (MR system room) should be closed except when it must be open for patient care or room/MR system maintenance. During the times that the door to the MR system room must remain open, a "caution" barrier is recommended at the entry to Zone IV to inhibit unintended passage of personnel and/or materials from Zone III to IV. Examples of caution barriers include easily adjusted straps or plastic chains secured across the scanner room doorway.”
In several previous columns, we’ve noted another group that needs training: first responders. Specifically, your local fire and police departments need training (see, for example, our October 21, 2014 Patient Safety Tip of the Week “The Fire Department and Your Hospital”). You don’t want a fireman with an axe and an oxygen tank racing into a room with an active magnet. Nor do you want a policeman with a ferromagnetic weapon in that room. We recommend you conduct training with the fire and police departments at least annually. The problem is more complex in rural or other communities that rely on volunteer firemen. You need to make sure new volunteers get such training before the annual session.
The most recent update of ACR guidelines on MR safety (Greenberg 2019) has a section on management of prisoners and on prison or security personnel weapons (ie, firearms). “Ferromagnetic firearm weapons should not be permitted into Zone III unless deemed absolutely essential for maintenance of security due to the design of the facility. Furthermore, ferromagnetic firearms that are loaded pose a serious threat in Zone IV (the MR system room) due to the possibility of inadvertent discharge”. The 2013 update of ACR guidelines on MR safety (Kanal 2013) recommended that, “in cases where requested to scan a patient, prisoner, or parolee wearing RF bracelets or metallic handcuffs or anklecuffs, request that the patient be accompanied by the appropriate authorities who can and will remove the restraining device before the MR study and be charged with its replacement following the examination.”
The Cross article also describes the important roles played by the MRI medical director, safety officer, and safety expert.
The American College of Radiology (ACR) has published guidelines on MR safety, beginning in 2002 (Kanal 2002) with periodic updates, including major updates in 2013 (Kanal 2013) and most recently in 2019 (Greenberg 2019).
That most recent update (Greenberg 2019) also emphasizes the "full‐stop and final check" concept. “In instances where the patient is sedated or anesthetized, an inpatient, or an emergent case, a ‘full‐stop and final check’ performed by the MRI technologist along with support staff is recommended to confirm the completion of MR safety screening for the patient, support equipment, and personnel MR screening immediately prior to crossing from Zone III to Zone IV. ‘Full‐stop and final check’ may also be useful for nonsedated outpatients and inpatients prior to movement from Zone III to Zone IV. The purpose of this final check is to confirm patient name, ensure that all screening has been appropriately performed, and that there has been no change in patient and/or equipment status while in Zone III.” This is the equivalent of the surgical timeout. For years we have stressed the importance of timeouts outside the OR (see our June 6, 2011 Patient Safety Tip of the Week “Timeouts Outside the OR”).
The update also discusses some emerging issues in MR safety. Particularly of concern is that MR systems are increasingly being installed in environments outside of conventional diagnostic MR facilities (intraoperative/interventional MR, positron emission tomography (PET) MR, and MR‐guided radiation therapy). We refer you to that update for details of the many considerations in such “unconventional” sites.
Lastly, the update alerts us to the need for safety guidelines that will be related to 7T MR. The FDA has now cleared 7T MR for clinical use. It notes that many implants, devices, and foreign bodies, that don’t significantly overheat at lower strength MR, might heat excessively at 7T strength. And certain devices that may retain functionality at lower MR strengths might lose functionality at 7T. A very recent paper (Hoff 2019) outlines the safety risks and associated risk-avoidance strategies of clinical 7-T MRI. Of particular concern are metallic implants and the risk for thermal injury. They note that over 6,000 metallic devices that have undergone evaluation at 1.5- and 3-tesla imaging, but that only 300 or so metallic implants and RF transmit coils have been tested for safety at 7-tesla MRI. Hoff et al. are also concerned about patient bioeffects such as vertigo, dizziness, false feelings of motion, nausea, nystagmus, magnetophosphenes, and electrogustatory effects that are more common and potentially more pronounced at 7 T than at lower field strengths. They suggest that earplugs and headphones could help reduce acoustic noise and related inner-ear and vision abnormalities and that increasing the amount of time patients spend in the 7-tesla static magnetic field as they enter and exit the scanner might help alleviate any physical issues
7T MR will undoubtedly have some diagnostic advantages over lower strength MR units. But, as with any new technology, we need to be vigilant for unintended consequences.
Lastly, one unanswered MR patient safety issue has to do with use of gadolinium contrast agents. Studies have shown cumulative exposure to gadolinium leads to deposition in brain tissue. This is especially a concern in patient with known or suspected multiple sclerosis (MS), in whom multiple MRI’s are commonly part of management. The FDA issued an alert in 2017 (FDA 2017) about tissue retention of gadolinium-based contrast agents that called for MRI units to provide a Medication Guide to patients undergoing MRI with gadolinium-based contrast agents. It notes that, on the whole, benefits of use of gadolinium-based contrast agents probably outweigh the risks but that further investigation is needed. A recent study (Zivadinov 2019) confirmed cumulative retention of gadolinium in brain tissue in MS patients but found no clinical or radiologic correlates of more aggressive disease. The accompanying editorial (Haider 2019) notes that, although no evidence currently exists linking brain gadolinium deposits with clinical consequences, regulatory agencies both in the United States and Europe clearly caution that GBCA should only be administered when informative for patient care.
Some of our prior columns on patient safety issues related to MRI:
References:
ECRI Institute. 2020 Top 10 Health Technology Hazards Executive Brief. October 2019
https://www.ecri.org/landing-2020-top-ten-health-technology-hazards
Valtchinov VI, Lacson R, Wang A, et al. Comparing Artificial Intelligence Approaches to Retrieve Clinical Reports Documenting Implantable Devices Posing MRI Safety Risks. Journal of the American College of Radiology 2019; Published online first August 16, 2019
https://www.jacr.org/article/S1546-1440(19)30862-2/fulltext
Greenberg TD., Hoff MN, Gilk TB, et al. for the ACR Committee on MR Safety. ACR guidance document on MR safe practices: Updates and critical information 2019. J Magn Reson Imaging 2019; published online July 29, 2019
Delfino JG, Krainak DM, Flesher SA, et al. MRI‐Related FDA Adverse Event Reports: A 10‐Year Review. Medical Physics 2019; First published: 16 August 2019
https://aapm.onlinelibrary.wiley.com/doi/10.1002/mp.13768
Cross NM, Hoff MN, Kanal KM. Avoiding MRI-Related Accidents: A Practical Approach to Implementing MR Safety. Journal of the American College of Radiology 2018; 15(12): 1738-1744
https://www.jacr.org/article/S1546-1440(18)30762-2/fulltext
Kanal E, Barkovich AJ, Bell C, et al for the Expert Panel on MR Safety. ACR guidance document on MR safe practices: 2013. J Magn Reson Imaging 2013; 37: 501-530
https://onlinelibrary.wiley.com/doi/10.1002/jmri.24011
Kanal E, Borgstede JP, Barkovich AJ, et al. American College of Radiology White Paper on MR safety. AJR AM J Roentgenol 2002; 178: 1335-1347
https://www.ajronline.org/doi/full/10.2214/ajr.178.6.1781335
Hoff MN, McKinney A, Shellock FG, et al. Safety Considerations of 7-T MRI in Clinical Practice. Radiology 2019 292: 3: 509-551
https://pubs.rsna.org/doi/10.1148/radiol.2019182742
FDA (US Food and Drug Administration). FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. FDA 12/19/2017 and 5/16/2018 Update
Zivadinov R, Bergsland N, Hagemeier J, et al. Cumulative gadodiamide administration leads to brain gadolinium deposition in early MS. Neurology 2019; 93(6): e611-e623
https://n.neurology.org/content/93/6/e611
Haider L, Naismith RT, Rovira A. Use of gadolinium for MRI diagnostic or surveillance studies in patients with MS. Neurology 2019, 93(6): 239-240
https://n.neurology.org/content/93/6/239
Print “Lots More on MRI Safety”
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October 2019
Adverse events, whether in healthcare or other industries, typically result from a combination of human errors and system issues. In developing interventions to prevent adverse events, we most often focus on the system issues. The reason? System issues are easier to address than the human issues.
But we cannot afford to ignore the human errors. A recent study provided an important contribution to better understanding the role of human errors in surgical adverse events. Suliburk and colleagues (Suliburk 2019) developed a new taxonomy to classify human performance deficiencies (HPD’s) and used this tool in analyzing adverse surgical events that occurred in a level I municipal trauma center, a quaternary care university hospital, and a US Veterans Administration hospital. They found that, of the 188 adverse events reviewed, 106 (56.4%) were associated with HPD’s.
Their new taxonomy classified the HPD’s in 5 categories:
Planning or problem solving (Class I)
| Guideline or protocol misapplication Knowledge deficit Diagnostic cognitive bias Treatment cognitive bias Latent mistakes |
Execution (Class II)
| Lack of recognition Lack of attention Memory lapse Technical error |
Rules violation (Class III)
| Ignoring routine or cutting corners Optimizing or personal gain Situational or time pressure |
Communication (Class IV)
| Absent Assumed Misinterpreted |
Teamwork (Class V)
| Ill-defined roles or lack of leadership Lack of group expertise Failure to evaluate progress |
Of the 192 human performance deficiencies identified, they were categorized as:
- execution (51.0%)
- planning or problem solving (8.6%)
- communication (12.5%)
- teamwork (4.7%)
- rules violation (3.1%)
Cognitive errors in execution of care or in case planning or problem solving (51.6%) were the most common HPD’s.
Lack of recognition was the most prevalent cognitive error. The authors gave 2 specific examples of how cognitive errors contributed to the adverse outcomes. In one case, a significant technical error in a surgeon’s performance of an operation was likely precipitated by the initially unappreciated influence of the surgeon’s distraction by an outside telephone call in the operating room. In a second case, a stylus that was inadvertently retained postoperatively was clearly visible but repeatedly unrecognized by radiologists in their reports.
Sound familiar? Just look back at our August 20, 2019 Patient Safety Tip of the Week “Yet Another (Not So) Unusual RSI”. That column featured a case where telephone calls distracted OR staff, contributing to a retained surgical instrument, and a case where a retained surgical instrument was not initially recognized as such on radiographic images.
Suliburk and colleagues note that in their second example, the cognitive bias of lack of attention (by the radiologists) was not the only cognitive error. There was also likely confirmation bias, in that the clinicians likely dismissed their own concerns because they were not validated in official radiology reports.
So, what can we do about these human performance deficiencies (HPD’s)? The authors suggest a role for simulation-based cognitive training for health care practitioners and
teams to reinforce systems-based safety constructs. Playbacks of real-life scenarios could be used, akin to training performed in the aviation and aerospace industries. For example, replay of their first example case could provide an opportunity for behavioral training to reset following intraoperative distractions. Replay of the second example might be used to teach clinicians to avoid losing their situational awareness to the convenience of alternative data (avoiding confirmation bias).
Interventions to avoid human error are difficult to implement and sustain. Our mantra “stories, not statistics” is especially valid here. If we just make all aware of the statistics in the Suliburk study, we’d likely not prevent any adverse events. But tying the stories to simulation training is a good way of getting healthcare professionals to develop better situational awareness and recognize the factors and situations that make cognitive errors more likely.
The Suliburk study is a timely reminder that we cannot rely purely on system improvements to avoid adverse events. Just as we have a renewed focus on diagnostic error, we need to have a broader focus on cognitive errors that influence performance in multiple facets of healthcare.
And, while Suliburk et al. identified only 4.7% of their HPS’s under the “Teamwork” category, it’s very important the simulation exercises involve all members of the team. For example, while you want surgeons to recognize the need to reset after an interruption or distraction, it’s conceivable that other members of the OR team might recognize the need for such resets and speak up when such distractions have occurred. Team training is also important for surgical teams. We remain steadfast supporters of the TeamSTEPPS™ program and its focus on communication and interactions such as the preop huddle and post-op debriefing.
That said, another recent study challenges the assertion that communication problems are the leading cause of medical errors. Clapper and Ching (Clapper 2019) did a systematic review of articles using the terms “medical errors, research, and communication”. In the 42 studies that met their inclusion criteria, three categories of errors were dominant: errors of commission (47.6%), errors of omission (14.2%) and errors through communication (9.5%), though there was some overlap. There were 28.5% of studies in which all three categories together significantly contributed to error. It’s just another reminder that, while we always focus on system issues and communication because those are the contributing factors most amenable to solutions, human errors still are important factors contributing to adverse events.
And, while human error is a major factor in most serious adverse events in healthcare, don’t forget that our systems and poor communication often put healthcare workers in a position where human errors will have devastating consequences. Recall that, in our analysis of a recent neuromuscular blocking agent tragedy in which human error was a proximate cause (see our Patient Safety Tips of the Week for December 11, 2018 “Another NMBA Accident” and February 12, 2019 “From Tragedy to Travesty of Justice”), we identified at least 15 other factors that contributed and, had they been fixed, might have averted the tragedy.
So, while the work of Suliburk et al. reminds us not to underestimate the role of human error in healthcare accidents, lessons learned in well-done root cause analyses (RCA’s) teach us about the complex interaction between humans and the systems we create.
Some of our prior columns on RCA’s, FMEA’s, response to serious incidents, etc:
July 24, 2007 “Serious Incident Response Checklist”
March 30, 2010 “Publicly Released RCA’s: Everyone Learns from Them”
April 2010 “RCA: Epidural Solution Infused Intravenously”
March 27, 2012 “Action Plan Strength in RCA’s”
March 2014 “FMEA to Avoid Breastmilk Mixups”
July 14, 2015 “NPSF’s RCA2 Guidelines”
July 12, 2016 “Forget Brexit – Brits Bash the RCA!”
May 23, 2017 “Trolling the RCA”
See our prior columns on team training, huddles, briefings, and debriefings:
References:
Suliburk JW, Buck QM, Pirko CJ, et al. Analysis of Human Performance Deficiencies Associated With Surgical Adverse Events. JAMA Netw Open 2019; 2(7): e198067 Published online July 31, 2019
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2740065
Clapper, TC, Ching, K. Debunking the myth that the majority of medical errors are attributed to communication. Med Educ 2019; 00: 1-8
https://onlinelibrary.wiley.com/doi/abs/10.1111/medu.13821
Print “October 2019 Human Error in Surgical Adverse Events”
We’ve done several columns on the impact of hearing loss on healthcare costs. But, what about visual loss? We have noted how issues related to vision loss may impact risk for falls and delirium.
Morse et al. (Morse 2019) used 2 large databases of healthcare claims to compare costs incurred following an initial hospitalization for common illnesses by patients with partial visual loss (PVL) or severe visual loss (SVL) vs. those who had no visual loss (NVL).
Medicare enrollees with SVL, compared with those with NVL, had longer mean lengths of stay (6.48 vs 5.26 days), higher readmission rates (23.1% vs 18.7%), and higher hospitalization and 90-day postdischarge costs ($64,711 vs $61,060). That translates to a 4% longer LOS, 22% higher odds of readmission, and 12% higher costs. Similar findings were obtained for those with commercial health insurance.
Extrapolating, they estimated more than $500 million in additional costs annually were spent caring for these patients.
Health Leaders recently highlighted programs at Johns Hopkins and Miami’s Bascom Palmer Eye Institute to engage visually impaired patients and their families during hospitalizations (Cheney 2019). The three areas of focus are patient safety, special accommodations, and discharge and medication management.
Patient safety considerations include braille on the call button, and special guardrails in the stairwells that extend beyond the end of the staircase. In addition, at Hopkins a staff member with them when they are getting up for the first time after surgery and when they are walking the hallways. Physical therapists and techs also ask the patient “How would you like me to best lead you?”
Special accommodations include special signage with high-contrast colors, consistent lighting, and door signage in braille. Johns Hopkins is implementing a Bluetooth way-finding app that can be used from home or while using public transportation. It has voice capability and helps navigate the patient through the hospital, including such things as telling them when to enter an elevator, what button to push, and what floor they are on. At both Hopkins and Bascom Palmer, staff get special training to deal with vision-impaired patients.
Discharge and medication instructions are critically important. Use of audio-recorded instructions is helpful and any written materials use large font sizes or formats that can be used with a screen reader. Medication packaging may have braille or larger print.
It has become increasingly important that we recognize sensory impairments in all patients, not just the elderly, in all healthcare venues. We need to take special precautions to ensure we communicate appropriately with those patients and make their ability to navigate the system as error-free as possible.
A recent study (Reed 2019) followed 4,728 people, half of whom had untreated hearing loss, for a decade starting when they were 61 years old, on average. Untreated hearing loss was associated with $22 434 or 46% higher total health care costs over a 10-year period compared with costs for those without hearing loss. Persons with untreated hearing loss had more inpatient stays (incidence rate ratio, 1.47) and were at greater risk for 30-day hospital readmission (relative risk, 1.44) at 10 years. Similar trends were observed at 2- and 5-year time points across measures.
Another study (Deal 2019) compared patients aged 50 and older who had claims for hearing loss to a propensity matched cohort. Those with hearing loss had a 50% higher risk of dementia and 41% increased risk of depression at 5 years of follow up. The 10-year risk attributable to hearing loss was 3.20 per 100 persons for dementia, 3.57 per 100 persons for falls, and 6.88 per 100 persons for depression.
In several of our columns listed below, we have made a case that hearing loss is a patient safety issue and that use of hearing aids is underutilized. Now a new study (Mahmoudi 2019) found that use of hearing aids in patients aged 66 and older with hearing impairment is associated with a longer time to diagnosis of Alzheimer disease, dementia, depression, anxiety, and injurious falls. Just having an association does not prove causality and it’s probably unlikely that a randomized controlled trial will be done, but it makes sense that improved hearing via hearing aids could lead to the improvements noted.
And, for years, those of us who are neurologists have recognized the “multiple sensory deficit” syndrome as a major cause of impaired ambulation and falls. Many older patients have impairments of sensory function (such as vision, hearing, vestibular function, and proprioception) that individually are not severe enough to produce disability but collectively have an additive or synergistic effect that does result in disability. In our February 2018 What's New in the Patient Safety World column “Global Sensory Impairment and Patient Safety” we noted that geriatricians have now begun to take a broader look at a related concept, “global sensory impairment” (GSI), and its impact on overall health. Patients with worse GSI scores were more likely to have poorer overall health and lose weight, and have died in a 5-year follow up study (Pinto 2017).
It's quite likely that interventions which improve at least vision and hearing may be effective patient safety interventions that reduce overall costs in the health system. Currently, Medicare (other than Medicare Advantage plans) does not cover either glasses or hearing aids. Studies like those above are important in suggesting a likely net benefit from such programs. However, we also need to keep in mind that sometimes there are unintended consequences. For example, several of our prior columns have noted paradoxical increases in falls after certain types of vision correction.
Some of our previous columns on falls after correction of vision:
June 2010 “Seeing Clearly a Common Sense Intervention”
June 2014 “New Glasses and Fall Risk”
August 2014 “Cataract Surgery and Falls”
Some of our columns on the impact of hearing loss:
September 12, 2017 “Can You Hear Me Now?”
February 2018 “Global Sensory Impairment and Patient Safety”
July 2018 “Hearing Loss and Patient Safety”
November 2018 “More on Hearing Loss”
References:
Morse AR, Seiple W, Talwar N, Lee PP, Stein JD. Association of Vision Loss With Hospital Use and Costs Among Older Adults. JAMA Ophthalmol 2019; 137(6): 634-640 Published online April 04, 2019
https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2729901
Cheney C. Focus on 3 Areas When Caring for Vision-Impaired Hospital Patients. Health Leaders 2019; August 21, 2019
Reed NS, Altan A, Deal JA, et al. Trends in Health Care Costs and Utilization Associated With Untreated Hearing Loss Over 10 Years. JAMA Otolaryngol Head Neck Surg 2019; 145(1): 27-34
https://jamanetwork.com/journals/jamaotolaryngology/article-abstract/2714049
Deal JA, Reed NS, Kravetz AD, et al. Incident Hearing Loss and Comorbidity: A Longitudinal Administrative Claims Study. JAMA Otolaryngol Head Neck Surg 2019; 145(1): 36-43
https://jamanetwork.com/journals/jamaotolaryngology/article-abstract/2714050
Mahmoudi, E. , Basu, T. , Langa, K. , McKee, M. M., Zazove, P. , Alexander, N. and Kamdar, N. (2019), Can Hearing Aids Delay Time to Diagnosis of Dementia, Depression, or Falls in Older Adults?. J Am Geriatr Soc. 2019; First published September 4, 2019
https://onlinelibrary.wiley.com/doi/10.1111/jgs.16109
Pinto JM, Wroblewski KE, Huisingh-Scheetz M, et al. Global Sensory Impairment Predicts Morbidity and Mortality in Older U.S. Adults. J Am Geriatr Soc 2017; 65: 2587-2595
http://onlinelibrary.wiley.com/doi/10.1111/jgs.15031/full
Print “October 2019 Visual and Hearing Loss and Medical Costs”
Many of you have read Helen Haskell’s recent essay in the BMJ “Unleash the power of patients to make care safer around the world” (Haskell 2019). It is a compelling argument that we need to bring patients and their families into more of our patient safety activities.
We’ve long recommended incorporation of patients or their families in several of your patient safety initiatives. These include reporting of safety events, and participating in Patient Safety Walk Rounds, FMEA’s, and RCA’s.
In our February 2012 What’s New in the Patient Safety World column “OIG: Hospitals Fail to Recognize Most Cases of Harm” we discussed an article in the Canadian Medical Association Journal (Daniels 2012) which looked at the impact of surveying families of children admitted to a Children’s hospital to see if they saw events they considered to be adverse events. A total of 321 events were identified in 201 of the 544 family reports received. Of these 48% were determined to represent legitimate patient safety concerns. Types of events most often included medication problems, miscommunications (between staff or between staff and families), and equipment problems. Only 8 of the adverse events reported were also reported by health care providers. There was also little change in reporting by health care providers after implementation of the family reporting system.
The Daniels article demonstrates that the perspectives of families and health care workers may differ regarding adverse events or near misses. Importantly, it shows that some of the barriers that prevent health care workers from reporting adverse events or near misses may not apply to families. Such family reporting systems therefore provide an opportunity (another set of eyes and ears) to identify potential patient safety issues in need of improvement.
Incidentally, in the Daniels study families noted that apologies were given only in a minority of cases but, when they were given, they were usually considered adequate. See our prior columns on disclosure and apology (June 22, 2010 Patient Safety Tip of the Week “Disclosure and Apology: How to Do It” and our November 2010 What’s New in the Patient Safety World column “IHI: Respectful Management of Serious Clinical Adverse Events”).
Families responding to the surveys also readily volunteered to participate in future safety improvement initiatives by the hospital.
So, in addition to removing barriers to adverse event reporting for staff, consider using other tools (such as the family adverse event reporting tool discussed above) to better identify patient safety concerns in your facilities. Such a tool may not only help you identify more opportunities to improve but likely also has a positive impact on patient and family satisfaction.
We’ve found that patients and families tend to be even more reluctant than staff to report errors, mistakes, or conditions that may contribute to adverse outcomes. That is why it is extremely important to provide them with a way of reporting in a confidential manner. Note we don’t say “anonymous” since we need in most cases to actuall speak to the patient or family. What you want to convey is that they can speak with someone (eg. a patient advocate or your patient safety coordinator) without fear that their care will be compromised.
Having a patient or patient’s family participate in a FMEA (Failure Mode and Effects Analysis) can be very valuable. When we’ve worked with hospitals on FMEA’s for either breastmilk mixups or switched babies, the perspectives of patients/families have been very important. They often tell you about events or conditions your own staff would not have noticed or been aware of.
In our columns on Patient Safety Walk Rounds (see our Patient Safety Tips of the Week for October 7, 2014 “Our Take on Patient Safety Walk Rounds” and February 27, 2018 “Update on Patient Safety Walk Rounds”) we discussed inclusion of a patient or patient family member. We noted that a Board member might fulfill that role, but Board members may have an “insider” bias. Having an “outsider” pair of eyes and ears may be important. You may be surprised at the things they point out which you had not perceived yourself.
In our July 12, 2016 Patient Safety Tip of the Week “Forget Brexit – Brits Bash the RCA!” we noted we all have problems figuring out how to fit patients and families into the RCA process. Our many columns on critical incident response and disclosure and apology (see list of prior columns below) have emphasized how after disclosure and apology we need to keep patients and families in the loop as we complete our RCA’s and implement actions to prevent similar events in the future. But few of us have figured out how to include patients or their families in the actual RCA process. Often patients and families have unique perspectives and observations that healthcare workers have not seen (or have been unwilling to admit!). More and more research is demonstrating that patients and families impacted by adverse events are highly motivated to help ensure similar events don’t occur to other patients. While we don’t have the perfect solution to inclusion of patients and families on the RCA team, we do recommend that as part of the disclosure and apology process we also appeal to them “we need your help in determining exactly what happened and how we can prevent similar events”. We’ve also stressed the need to avoid intimidation when such interactions with patients and families occur (see our June 22, 2010 Patient Safety Tip of the Week “Disclosure and Apology: How to Do It”). Don’t hold such meetings in a formal Board Room or have 1-2 family members sitting across a table full of individuals dressed in suits or white coats. You must keep the meeting as cordial as possible, expressing your sincere apology and sincere desire to get their perspectives on the events and give them plenty of time to ask questions and present their observations and concerns.
See our July 14, 2015 Patient Safety Tip of the Week “NPSF’s RCA2 Guidelines” for many other recommendations to include in your RCA process.
Patient/family engagement in patient safety activities needs to be an important goal for all organizations. Undoubtedly, local cultures may be facilitators or barriers to such engagement. We think you will be surprised at the positive perspectives patients and their families bring to your organizations.
Some of our prior columns on RCA’s, FMEA’s, response to serious incidents, etc:
July 24, 2007 “Serious Incident Response Checklist”
March 30, 2010 “Publicly Released RCA’s: Everyone Learns from Them”
April 2010 “RCA: Epidural Solution Infused Intravenously”
March 27, 2012 “Action Plan Strength in RCA’s”
March 2014 “FMEA to Avoid Breastmilk Mixups”
July 14, 2015 “NPSF’s RCA2 Guidelines”
July 12, 2016 “Forget Brexit – Brits Bash the RCA!”
May 23, 2017 “Trolling the RCA”
Some of our previous columns on Patient Safety Walk Rounds:
October 7, 2014 “Our Take on Patient Safety Walk Rounds”
February 27, 2018 “Update on Patient Safety Walk Rounds”
Some of our prior columns on Disclosure & Apology:
July 24, 2007 “Serious Incident Response Checklist”
June 16, 2009 “Disclosing Errors That Affect Multiple Patients”
June 22, 2010 “Disclosure and Apology: How to Do It”
September 2010 “Followup to Our Disclosure and Apology Tip of the Week”
November 2010 “IHI: Respectful Management of Serious Clinical Adverse Events”
April 2012 “Error Disclosure by Surgeons”
June 2012 “Oregon Adverse Event Disclosure Guide”
December 17, 2013 “The Second Victim”
July 14, 2015 “NPSF’s RCA2 Guidelines”
June 2016 “Disclosure and Apology: The CANDOR Toolkit”
August 9, 2016 “More on the Second Victim”
January 3, 2017 “What’s Happening to “I’m Sorry”?”
October 2017 “More Support for Disclosure and Apology”
April 2018 “More Support for Communication and Resolution Programs”
August 13, 2019 “Betsy Lehman Center Report on Medical Error”
September 2019 “Leapfrog’s Never Events Policy”
Other very valuable resources on disclosure and apology:
References:
Haskell H. Unleash the power of patients to make care safer around the world: an essay by Helen Haskell. BMJ 2019; 366: l5565
https://www.bmj.com/content/366/bmj.l5565
Daniels JP, Hunc K, Cochrane DD, et al. Identification by families of pediatric adverse events and near misses overlooked by health care providers. CMAJ 2012; 184: 29-34
http://www.cmaj.ca/content/184/1/29
Print “October 2019 Helen Haskell: Putting the Patient in Patient Safety”
Primarily because of the increased use of DOAC’s (direct oral anticoagulants), the Joint Commission established a new National Patient Safety Goal (NPSG.03.05.01) that became effective July 1, 2019 (TJC 2018). The elements of performance (EP’s) are:
Well, it didn’t take long for The Joint Commission to issue a Sentinel Event Alert on managing the risks of direct oral anticoagulants (TJC 2019), It points out that, while DOACs offer ease of use to patients, stopping bleeding events in patients on DOACs is more complicated. Different strategies are required than those for patients on warfarin and heparin.
The alert focuses on the different reversal mechanisms for DOAC’s compared to those for heparin or warfarin. It also notes that a DOAC-specific reversal agent may not be effective in treating another kind of DOAC.
It also emphasizes that perioperative assessment and communication are critical. Before surgery and outpatient procedures such as cardiac catheterization, interventional radiology and colonoscopies —perioperative assessment is critical to assess bleeding risk. Communication about the specifics of a DOAC also is critical at transitions of care for many reasons. Especially important is avoiding therapeutic duplication.
It has the following 6 recommended actions for hospitals/organizations to take:
See the actual Sentinel Event Alert for details on each of those actions.
The alert also provides links to other Joint Commission resources, as well as resources from ISMP (Institute for Safe Medication Practices), the American College of Cardiology, and others. Some other useful studies on DOAC’s we’d like to point out are from the Pennsylvania Patient Safety Authority (Valentine 2018), the British Medical Journal (Vinogradova 2018),
References:
TJC (The Joint Commission). R3 Report. National Patient Safety Goal for anticoagulant therapy. Issue 19, Dec. 7, 2018
https://www.jointcommission.org/assets/1/18/R3_19_Anticoagulant_therapy_Rev_FINAL1.PDF
(TJC 2018)
TJC (The Joint Commission). Sentinel Event Alert 61: Managing the risks of direct oral anticoagulants, July 30, 2019
(TJC 2019)
Valentine D, Gaunt MJ, Grissinger M. Identifying Patient Harm from Direct Oral Anticoagulants. Pa Patient Saf Advis 2018; 15(2).
http://patientsafety.pa.gov/ADVISORIES/Pages/201806_DOACs.aspx
Vinogradova Y, Coupland C, Hill T, Hippisley-Cox J. Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting: cohort study in primary care. BMJ 2018; 362: Published 04 July 2018
https://www.bmj.com/content/362/bmj.k2505
Print “October 2019 Sentinel Event Alert on DOAC’s”
Print “October 2019 What's New in the Patient Safety World (full column)”
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Print “October 2019 Helen Haskell: Putting the Patient in Patient Safety”
Print “October 2019 Sentinel Event Alert on DOAC’s”
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