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What’s New in the Patient Safety World

October 2020


·       IHI’s National Action Plan to Advance Patient Safety

·       Pre-op Testing Before Cataract Surgery Leads to What?

·       Common Cause Analysis

·       New Warnings on Implants and MRI




IHI’s National Action Plan to Advance Patient Safety



In September, IHI (Institute for Healthcare Improvement) released “Safer Together: A National Action Plan to Advance Patient Safety”. This report was the culmination of collaboration among 27 national organizations committed to advancing patient safety, with input from all relevant stakeholder groups, including patient and family advocates.


The National Action Plan has 17 recommendations to advance patient safety in 4 categories:


Culture, Leadership, and Governance


1.     Ensure safety is a demonstrated core value.

2.     Assess capabilities and commit resources to advance safety.

3.     Widely share information about safety to promote transparency.

4.     Implement competency-based governance and leadership.

Patient and Family Engagement

5.     Establish competencies for all health care professionals for the engagement of patients, families, and care partners.

6.     Engage patients, families, and care partners in the co-production of care.

7.     Include patients, families, and care partners in leadership, governance, and safety and improvement efforts.

8.     Ensure equitable engagement for all patients, families, and care partners.

9.     Promote a culture of trust and respect for patients, families, and care partners.

Workforce Safety


10.  Implement a systems approach to workforce safety.

11.  Assume accountability for physical and psychological safety and a healthy work environment that fosters the joy of the health care workforce.

12.  Develop, resource, and execute on priority programs that equitably foster workforce safety.

Learning System


13.  Facilitate both intra- and inter-organizational learning.

14.  Accelerate the development of the best possible safety learning networks.

15.  Initiate and develop systems to facilitate interprofessional education and training on safety.

16.  Develop shared goals for safety across the continuum of care.

17.  Expedite industry-wide coordination, collaboration, and cooperation on safety.


From the IHI site you can download the plan plus an implementation resource guide and a self-assessment tool.


The focus on workforce safety is timely, in view of the COVID-19 pandemic, and addresses not only the physical well-being of our healthcare workers but also the psychological and emotional health issues, including burnout.


And, of course, it also emphasizes a need we have long advocated: the need to share lessons learned on a much wider scale.






IHI (Institute for Healthcare Improvement). National Action Plan to Advance Patient Safety. IHI 2020






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Pre-op Testing Before Cataract Surgery Leads to What?



We often do talks on the adverse effects of low-value care and how such can lead to the diagnostic cascade and injuries to patients. One of our favorite examples is pre-op testing prior to cataract surgery. Most patients undergoing cataract surgery do not need any pre-op testing because it neither decreases the incidence of perioperative adverse events nor improves cataract surgery outcomes. Yet pre-op testing continues to be surprisingly frequent.


We often cite an article by Ganguli et al. (Ganguli 2019) that care cascades after preoperative EKG for cataract surgery can be costly. Of those who had a pre-op EKG, 15.9% had at least 1 potential cascade event. Those included more tests, cardiology visits, and treatment. Spending for the additional services was up to $565 per Medicare beneficiary, or an estimated $35,025,923 annually across all Medicare beneficiaries in addition to the $3,275,712 paid for the preoperative EKG’s. That study focused on cost and did not assess whether those who had a care cascade suffered any adverse events.


But a new study (Chen 2020) shows yet another unexpected adverse effect of pre-op testing in older patients prior to cataract surgery – falls!


Chen and colleagues looked at data on almost 250,000 Medicare patients. They measured the mean and median number of days between ocular biometry and cataract surgery, calculated the proportion of patients waiting >30 days or >90 days for surgery, and determined the odds of having a fall within 90 days of biometry among patients of high-testing physicians (testing performed in ≥75% of their patients) compared to patients of low-testing physicians.


Falls before cataract surgery in patients of high-testing physicians increased by 43% within the 90 days following ocular biometry (1.0% vs 0.7%). The adjusted odds ratio of falling within 90 days of biometry in patients of high-testing physicians versus low-testing physicians was 1.10 (1.07 after adjusting for surgical wait time). Fall-related hip fractures, other fractures and joint dislocations were also significantly more frequent during the period between biometry and surgery for those patients treated by high-testing physicians.


The delay associated with having a high-testing physician was approximately 8 days (estimate 7.97 days).


Confounding factors cannot be excluded as contributing to the disparity. Patients treated by higher-testing physicians were, on average, slightly older and in poorer health status but Charlson comorbidity index was comparable for the 2 groups. However, the authors found a lack of association between physician testing behavior and falls in the 360 days preceding biometry and felt that supports their hypothesis that falls that occur after a patient begins preparing for surgery are associated with the routine use of preoperative testing, rather than from other underlying differences in patients of high-testing physicians compared to patients of low-testing physicians.


Though the absolute numbers of patient having falls or fall-related injuries during the delay before surgery were low, any such events are unwarranted since the testing is unnecessary. This is probably the first study to document actual detrimental patient outcomes that occur as a result of unnecessary testing in this population. So not only does such unnecessary testing lead to unnecessary cost to the healthcare system, it probably does also result in some degree of patient harm. We also suspect that procedures related to diagnostic cascades following such testing may well also be associated with some degree of patient harm.


This is likely yet another example of “less is more”.


We’ve done several columns (listed below) on the relationship, at times complex and sometimes counterintuitive, between vision problems and falls.



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”

October 2019 “Visual and Hearing Loss and Medical Costs”



Some of our prior columns related to falls:






Ganguli I, Lupo C, Mainor AJ, et al. Prevalence and Cost of Care Cascades After Low-Value Preoperative Electrocardiogram for Cataract Surgery in Fee-for-Service Medicare Beneficiaries. JAMA Intern Med 2019; 179(9): 1211-1219



Chen CL, McLeod SD, Lietman TM, et al. Preoperative medical testing and falls in Medicare beneficiaries awaiting cataract surgery. Ophthalmology 2020; Published online September 10, 2020





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Common Cause Analysis



We learn a great deal from performing root cause analyses (RCA’s) after various incidents. But one thing many organizations fail to do is to learn to identify themes that are common to multiple incidents. One process to identify such themes is called common cause analysis.


Basically, a common cause analysis involves aggregation of RCA’s and identification of themes common to events found in RCA’s done after the individual events. It often better brings into focus system vulnerabilities that might be downplayed in individual RCA’s. For example, you might identify one or more factors in multiple RCA’s on seemingly unrelated events.


A recent paper showed how one pediatric hospital used common cause analysis of hospital safety events that involve radiology to identify opportunities to improve quality of care and patient safety (Khalatbari 2020). The authors reviewed all RCA’s of incidents involving diagnostic or interventional radiology over a 5+ year period.


From 19 safety events, they identified 64 sequential interactions that were attributed to the radiology department. Of these 19 events, 9 were classified as a serious safety event, 9 as a precursor safety event, and 1 as a known complication. The 9 serious safety events included a delay in diagnosis or treatment (6) or other procedural errors (3). The 9 precursor safety events included a wrong or unnecessary procedure (3), procedural errors (3), delay in diagnosis or treatment (2) and loss of patient data (1). Overall, five diagnostic errors occurred. The two most common system failure modes identified for all 64 sequential interactions were culture (32.8%) and process (21.9%).


Common cause analysis uses Pareto charts to prioritize those factors that occur most often in untoward incidents. It also uses identification of “key processes” (specific sequences of distinct tasks that are essential to the delivery of care and service in the hospital) and “key activities” (distinct tasks that are part of a key process and which may be components of multiple key processes). Some of you may recognize those concepts as being similar to some of the important elements of LEAN.


The authors conclude that common cause analyses of safety events allow for a more robust understanding of system failures and have the potential to generate more specific process improvement strategies to prevent the reoccurrence of similar errors.


We cite this study not so much to highlight their specific findings, especially since the paper is somewhat difficult to read and uses a lot of technical jargon and taxonomies not often used by most of us. Rather, we wish to draw your attention to the potential utility of common cause analysis.


In another paper that may be a bit more clinically relevant to most, Clapper and Crea (Clapper 2010) used common cause analysis to investigate medication errors throughout the system in a large health organization, identify solutions, and reduce adverse events in high-risk medications by 50%.


And, in our September 10, 2013 Patient Safety Tip of the Week “Informed Consent and Wrong Site Surgery” we discussed a paper that performed a common cause analysis after a series of wrong-site surgical events in a US hospital (Mallett 2012). One of the themes they identified was related to documents used in verification. They found that the consents were not always placed in the correct location in the medical record, were not available to be reconciled, did not specify laterality, and were not obtained by the practitioner performing or involved in the procedure. One of their solutions was revision of the consent form to include a legend (right, left, and bilateral) next to where the practitioner writes the name of the procedure to be performed. That provides a visual cue to the practitioner to ensure laterality during the informed consent procedure. Secondly, they implemented a policy that informed consent must be only obtained by the physician/practitioner performing the procedure or by the resident/fellow who will be performing or assisting with the procedure.


Common Cause Analysis (CCA) is another tool to add to your armamentarium for identifying system factors contributing to adverse events. It’s particularly good for identifying factors whose importance you might otherwise underattribute as significant vulnerabilities in your organization.



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”

October 2019               “Human Error in Surgical Adverse Events”

January 2020               “ISMP Canada: Change Management to Prevent Recurrences”







Khalatbari H, Menashe SJ, Otto RK, et al. Clarifying radiology’s role in safety events: a 5-year retrospective common cause analysis of safety events at a pediatric hospital. Pediatr Radiol 2020; 50, 1409-1420



Clapper C, Crea K. Common Cause Analysis. Patient Safety & Quality Healthcare 2010; May/June 2010



Mallett R, Conroy M, Saslaw LZ, Moffatt-Bruce S. Preventing Wrong Site, Procedure, and Patient Events Using a Common Cause Analysis. American Journal of Medical Quality 2012; 27: 21-29





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New Warnings on Implants and MRI



In our many columns on patient safety issues in the MRI suite, issues related to implants have often been stressed. Certain implants can become heated during MRI scans, they may become dislodged, or they might malfunction.


Analysis of an FDA database revealed over 600 adverse events related to implantable hearing devices during MRI scanning over a 10-year period (Ward 2020a). Most were cochlear implants, but a few were middle ear implants or bone conduction implants and 2 were brainstem implants. The most common cause of the adverse events was dislocation of the magnet in the implantable device, often causing pain. This often leads to premature cessation of the MRI study. In some cases, manufacturer protocols may allow removal of the magnet prior to the MRI but some events occurred even when following manufacturer guidelines. Headbands or splints are recommended by manufacturers in some cases but, even then, adverse events sometimes occurred. Rarely, there was malfunction of the implanted device. Also, implantable devices may lead to artifacts that make interpretation of certain areas difficult.


Thermal burns are the most common adverse MRI event in an FDA database (Forrest 2020a) but most of these are related to superficial devices like coils and EKG leads. Yet even deep implants that have ferromagnetic properties can heat and cause internal thermal injuries. But reassuring was a recent study showing that clinicians can safely perform clinical 3-tesla MRI scans with metal artifact reduction sequence (MARS) protocols on patients with hip arthroplasty implants without excessive thermal heating of the devices (Forrest 2020b). On the other hand, the thermal effects due to the switching of gradient coil (GC) fields on metallic hip implants has been less well studied (Ward 2020b) For the echo-planar imaging (EPI) sequence, which is needed to perform functional MRI and diffusion-tensor imaging, heating is strongly dependent on the position of the body within the scanner  The researchers found almost no heating when the implant is at z ≈ 0 from the scanner center, whereas the worst cases occur with z ≈ 300 mm


All the more important that we always ascertain the presence of any implant in a patient prior to undergoing an MRI scan.



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






Ward P. Implantable hearing devices cause MRI safety concerns. 2020; August 10, 2020



Forrest W, Thermal burns top FDA list of MRI adverse event reports. 2020; August 13, 2020



Forrest W. ARRS: MRI protocols don't affect hip implant temperature. 2020; May 10, 2019



Ward P. Caution needed with MRI of patients with metallic implants. 2020; August 13, 2020






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Print “October 2020 What's New in the Patient Safety World (full column)”

Print “October 2020 IHI’s National Action Plan to Advance Patient Safety”

Print “October 2020 Pre-op Testing Before Cataract Surgery Leads to What?”

Print “October 2020 Common Cause Analysis”

Print “October 2020 New Warnings on Implants and MRI”



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