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ECRI Institute’s annual Top 10 list for Health Technology Hazards has just been published for 2020 (ECRI 2019).
Topping the list is “Misuse of Surgical Staplers”, which we discussed in our April 2019 What's New in the Patient Safety World column “FDA Warning on Surgical Staplers Opens a Can of Worms”. ECRI points out that, rather than the device itself malfunctioning, adverse consequences are most often related to how the surgical stapler is used. Errors in use include selecting an incorrect staple size, clamping on tissue that is too thick or too thin, and clamping on, or firing over, another instrument or clip. ECRI notes that effective training and familiarity should specifically include hands-on practice with the specific model of stapler to be used.
Some items on this year’s list, like $5 “Alarm, Alert, and Notification Overload” are no surprise and have been the topic of many of our columns.
But, somewhat of a surprise to us is #2 “Adoption of Point-of-Care Ultrasound Is Outpacing Safeguards”. But perhaps it shouldn’t be such a surprise. Thoughout the years, we’ve had to referee turf battles between our ED physicians and our radiologists over who can do ultrasound testing. While we’ve generally sided with the radiologists on the issue, there are clearly some circumstances where the ability to perform ultrasound on an emergent basis is desirable. One example might be confirmation of suspected cardiac tamponade. But we’ve always required strict credentialing and privileging before allowing anyone to perform bedside or point-of-care ultrasound. One of our former colleagues, Dietrich Jehle, M.D., has authored books on ultrasound in the ED (Heller 2002) and in the trauma patient (Jehle 2003).
ECRI, however, cautions that sometimes point-of-care ultrasound is used inappropriately and, at other times, is not used when it should be. It also notes that there may be overreliance on point-of-care ultrasound when a more comprehensive exam by an imaging specialist is indicated. ECRI points out that, in addition to addressing specialty-specific issues, “policies and procedures should address institution-wide concerns, including user training and credentialing, exam documentation, and data archiving”.
Number 3 on this year’s list is “Infection Risks from Sterile Processing Errors in Medical and Dental Offices”. We all know about problems related to inadequately sterilized instruments in hospitals and ASC’s (eg. contaminated endoscopes and bronchoscopes, etc.). And those have occurred in facilities that have expertise in sterilization procedures. What about those venues that lack such sophisticated expertise? ECRI notes that settings that may lack such sterilization program include medical offices (e.g., OB/GYN, dermatology), dental offices, and similar locations that are not serviced by a central sterile processing department. ECRI suggests that safety programs in such facilities should include designating a qualified staff member or contractor to support office infection prevention and control practices and providing appropriate training for, and conducting periodic competency testing of, benchtop sterilizer operators.
When we do talks on the excessive cost of healthcare in the US, we often discuss “medical arms races” and highlight the widespread adoption of surgical robots that has outpaced the evidence-based use of such devices. Hospital after hospital purchased surgical robots when their competitor down the street bought one (often with the threat their surgical or Ob/Gyn specialists would take their business to the other hospital). ECRI’s #5 on this year’s list is “Unproven Surgical Robotic Procedures May Put Patients at Risk”.
While acknowledging the utility of surgical robots in some circumstances, ECRI notes the robots may not provide tactile feedback on forces exerted on tissue and that, in some cases, complications from a robotic procedure may not appear for years. Therefore, ECRI stats that healthcare facilities “need robust processes for approving the application of surgical robots in new procedures, as well as comprehensive programs for training, credentialing, and privileging surgeons and OR staff for those procedures”. Further, ECRI cautions patients to recognize that robotic procedures are not inherently better or worse than traditional minimally invasive procedures.
Another item on the list, #8 “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!
ECRI’s #9 “Medication Errors from Dose Timing Discrepancies in EHRs” has also been the topic of many of our columns on the unintended consequences of health information technology. In our January 2013 What's New in the Patient Safety World column “More IT Unintended Consequences” we discussed the problem of default values leading to unanticipated problems. We used as an example start times for an order. We might write an order for a medication we want started now but the computer may default that order to the next “standard” time of medication administration resulting in a delay or omission of an important dose.
ECRI provides a similar example: “Late in the morning, a physician enters an order for a once-daily medication and assumes that the patient will be given the first dose that morning. At that facility, however, the default administration time programmed into the EHR for once-daily medications is 8:00 a.m. Because the order was placed later in the morning, the medication for that patient would not appear on the nurse’s worklist until the following morning, unless the prescriber was aware of the default administration time and had specifically changed the time within the order.” ECRI suggests that dose timing errors can be made less likely “if an EHR order-entry system prominently displays the scheduled medication administration time, allows prescribers to easily modify that time, and includes a “now” option for medications that need to be administered as soon as possible.” Good suggestion!
And 2 of the items on ECRI’s 2020 list, #4 “Hemodialysis Risks with Central Venous Catheters—Will the Home Dialysis Push Increase the Dangers?” and #7 “Cybersecurity Risks in the Connected Home Healthcare Environment” bring into consideration issues beyond the hospital, namely safety hazards related to care in the home.
The full ECRI 2020 list:
1. Misuse of Surgical Staplers
2. Adoption of Point-of-Care Ultrasound Is Outpacing Safeguards
3. Infection Risks from Sterile Processing Errors in Medical and Dental Offices
4. Hemodialysis Risks with Central Venous Catheters—Will the Home Dialysis Push Increase the Dangers?
5. Unproven Surgical Robotic Procedures May Put Patients at Risk
6. Alarm, Alert, and Notification Overload
7. Cybersecurity Risks in the Connected Home Healthcare Environment
8. Missing Implant Data Can Delay or Add Danger to MRI Scans
9. Medication Errors from Dose Timing Discrepancies in EHRs
10. Loose Nuts and Bolts Can Lead to Catastrophic Device Failures and Severe Injury
As usual, ECRI’s list is timely and valuable, with good recommendations. We recommend you download the free executive brief (ECRI 2019) or, if you are a member, the full document.
Some of our prior columns on patient safety issues related to MRI:
ECRI Institute. 2020 Top 10 Health Technology Hazards Executive Brief. October 2019
Heller MB, Jehle D. Ultrasound in Emergency Medicine. Center Page, Inc.; 2nd edition (2002)
Jehle D, Heller MB. Ultrasonography in Trauma: The FAST Exam. American College of Emergency (2003)
We’ve done several columns highlighting the problems that patients with Parkinson’s Disease run into when they get hospitalized for any reason (see our What’s New in the Patient Safety World columns for August 2011 “Problems Managing Medications in Parkinson’s Disease”, December 2012 “More on Hospitalized Parkinson’s Disease Patients” and June 2015 “More Risks for Parkinson Inpatients”). Patients with Parkinson’s typically require specific timing of their medications in order to minimize the “on-off” phenomenon and to avoid hyperkinesias. This results in their requiring multiple dosing throughout the day and often at unusual times. Meeting this very precise timing of doses is problematic for most hospitals and hospital units because they are used to their own standardized times for medication dispensing and administration. And most anti-Parkinsonian medications are available only in oral form so it is especially problematic when the patient is NPO or is otherwise unable to swallow. Some anti-Parkinson’s formulations are also of the extended-release variety and should not be crushed. Moreover, drugs that worsen extrapyramidal function are often used in the hospital and these may significantly worsen Parkinsonian features. Patients with Parkinson’s also seem to get temporary declines in function when they get a systemic problem, like an infection.
Recognizing these vulnerabilities when patients with Parkinson’s are admitted to hospitals is a first step in preventing complications, minimizing hospital lengths of stay, and avoiding functional deterioration.
HealthLeaders recently highlighted a program that has been successful in addressing these problems in inpatients witih Parkinson’s Disease (Cheney 2019). In 2017, Hackensack University Medical Center in Hackensack, New Jersey, formally launched a strict medication adherence protocol for inpatients with Parkinson's Disease. This resulted in significant improvements in several metrics. Length of stay for all Parkinson's patients at the hospital decreased from 7.125 days in 2017 to 6.750 days in 2018. The readmissions rate for Parkinson's patients decreased from 13.9% in 2017 to 12.8% in 2018.
There were four primary components of the medication adherence protocol:
1. Patient identification
2. Metrics to assess medication management
3. Metrics evaluation and implementation of action plans
Patient identification is a key to the process. They established a flag that appears any time someone opens the record of a patient with Parkinson’s Disease. That leads to care plans in the electronic record including the timing of medication and contraindicated medications.
Their metrics include patient identification, making sure all of the medicines are in the formulary, and making sure that patients get medication in the customized fashion that they get at home. It’s important in patients with Parkinson’s Disease that they don’t get put on the hsopital’s default medication administration times. They also track contraindication medications and attempt to intervene in real time if one is ordered.
They have a disease-specific committee that develops action plans. That committee looks at the data, assesses it, and comes up with plans to improve the compliance.
Education and training for the strict medication adherence protocol involves almost anyone that will come in contact with Parkinson’s patients (physicians, advanced practice practitioners, nurses, physical therapists, radiation technologists, and pharmacists).
In our December 2012 What’s New in the Patient Safety World column “More on Hospitalized Parkinson’s Disease Patients”) we noted a study from The Netherlands (Gerlach 2012) found that 21% of Parkinson patients admitted to a hospital experienced deterioration of motor function and 33% had one or more complications. Moreover, 26% received incorrect anti-Parkinson medications, which was the most significant reason associated with clinical deterioration.
In our June 2015 What's New in the Patient Safety World column “More Risks for Parkinson Inpatients” we highlighted an ISMP column (ISMP 2015) that began with two case examples that illustrate some of these critical problems. ISMP then provided a list of important actions that should be undertaken for inpatients with Parkinson’s Disease:
We encourage you to read the ISMP article for details under each of the above bullet points. Also, one of the interviewees in the HealthLeaders article on the Hackensack program has co-authored an excellent book for hospitalists managing Parkinson’s inpatients (Azmi 2018).
Our prior columns on problems related to Parkinson’s Disease patients as inpatients:
Cheney C. 4-Part Protocol Improves Care, Lowers Costs for Hospitalized Parkinson's Patients. HealthLeaders 2019; October 09, 2019
Gerlach OHH, Broen MPG, van Domburg PHMF, et al. Deterioration of Parkinson's disease during hospitalization: survey of 684 patients. BMC Neurology 2012, 12: 13 (8 March 2012)
ISMP (Institute for Safe Medication Practices). Delayed administration and contraindicated drugs place hospitalized Parkinson’s disease patients at risk. ISMP Medication Safety Alert! Acute Care Edition. March 12, 2015
Azmi H, Gupta F. Parkinson's Disease for the Hospitalist: Managing the Complex Care of a Vulnerable Population. Lioncrest Publishing (November 19, 2018)
Handoffs have been the topic of many of our previous patient safety columns, but we haven’t written about them much in the past couple years. Handoffs, of course, occur at transitions of care that are periods of vulnerability from a patient safety perspective. Handoffs involve not only transfer of information but also transfer of responsibility.
Of the numerous handoff protocols out there, I-PASS is probably the one we’ve written about most often.
We first described I-PASS in our February 14, 2012 Patient Safety Tip of the Week “Handoffs – More Than Battle of the Mnemonics”, a column that highlighted the need to tailor handoff formats to the specific tasks at hand. I-PASS came about because existing formats were not optimal for resident-to-resident handoffs. But I-PASS is much more than a mnemonic and format for handoffs. It also involves extensive team training (based on TeamSTEPPS™) and resident training modules, simulation and role playing, faculty development resources and tools, direct observation of handoffs with feedback, and generation of a printed handoff document that can be integrated with the electronic medical record.
In our December 2014 What's New in the Patient Safety World column “I-PASS Passes the Test” we discussed the publication of the final results of the I-PASS project (Starmer 2014). After implementation of I-PASS the rate of medical errors decreased by 23% and the rate of preventable medical errors decreased by 30%. Significantly, there was no increase in the amount of time spent on handoffs and there was no significant change in resident workflow or the amount of resident contact with patients and families.
Specific medical error types reduced in the I-PASS collaborative included diagnostic errors, errors related to medical history or physical examination, multifactorial errors, and errors related to therapies other than medications or procedures. (Errors related to medications, procedures, falls, and nosocomial infections did not change.)
The reduction in medical errors was significant at six of the nine sites participating. Study authors had no explanation for the lack of improvement at three sites, since they also demonstrated improved inclusion of key elements in the handoff process.
Now another study has demonstrated that implementation of a handoff bundle, modeled on the intervention in the original I-PASS study, was associated with decreased medical errors and preventable adverse events on an academic family medicine inpatient unit (Dewar 2019). The handoff tool was designed and implemented in the electronic medical record (EMR). This tool was updated by the team, which was about to sign out, to allow incoming team members to view the chart and discuss the case while performing the sign-out process. They adhered to a strict no-interruption rule during handoffs (a poster campaign was used to remind facility nursing staff to not interrupt the resident team during this critical time in which sign-out was occurring). The authors conducted a retrospective review of admissions in the 6 months before and after implementation of the program.
Medical error rate dropped from 6.0 to 2.2 per 100 admissions and preventable medical errors dropped from 0.65 to 0.15 per 100 admissions. Non-intercepted potential adverse events dropped from 1.30 to 0.44 per 100 admissions. And intercepted potential adverse events dropped from 0.98 to 0.74 per 100 admissions. Errors with little potential for harm dropped from 2.77 to 0.74 per 100 admissions.
The authors acknowledge that the most significant reduction was in errors with little potential for harm. They also note that the relatively few cases with harm were most often related to medications administered to patients. They suggest future research might focus on medication errors and that the handoff process might benefit from inclusion of a clinical pharmacist.
Similar to the original I-PASS study, the investigators are not able to separate out which component of the I-PASS “bundle” is most important in reducing errors. But it is reassuring that the I-PASS program is successful in reducing errors in yet another venue.
Read about many other handoff issues (in both healthcare and other industries) in some of our previous columns:
May 15, 2007 “Communication, Hearback and Other Lessons from Aviation”
May 22, 2007 “More on TeamSTEPPS™”
August 28, 2007 “Lessons Learned from Transportation Accidents”
December 11, 2007 “Communication…Communication…Communication”
February 26, 2008 “Nightmares….The Hospital at Night”
September 30, 2008 “Hot Topic: Handoffs”
November 18, 2008 “Ticket to Ride: Checklist, Form, or Decision Scorecard?”
December 2008 “Another Good Paper on Handoffs”.
June 30, 2009 “iSoBAR: Australian Clinical Handoffs/Handovers”
April 25, 2009 “Interruptions, Distractions, Inattention…Oops!”
April 13, 2010 “Update on Handoffs”
July 12, 2011 “Psst! Pass it on…How a kid’s game can mold good handoffs”
July 19, 2011 “Communication Across Professions”
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
December 2011 “AORN Perioperative Handoff Toolkit”
February 14, 2012 “Handoffs – More Than Battle of the Mnemonics”
March 2012 “More on Perioperative Handoffs”
June 2012 “I-PASS Results and Resources Now Available”
August 2012 “New Joint Commission Tools for Improving Handoffs”
August 2012 “Review of Postoperative Handoffs”
January 29, 2013 “A Flurry of Activity on Handoffs”
December 10, 2013 “Better Handoffs, Better Results”
February 11, 2014 “Another Perioperative Handoff Tool: SWITCH”
March 2014 “The “Reverse” Perioperative Handoff: ICU to OR”
September 9, 2014 “The Handback”
December 2014 “I-PASS Passes the Test”
January 6, 2015 “Yet Another Handoff: The Intraoperative Handoff”
March 2017 “Adding Structure to Multidisciplinary Rounds”
August 22, 2017 “OR to ICU Handoff Success”
October 2017 “Joint Commission Sentinel Event Alert on Handoffs”
October 30, 2018 “Interhospital Transfers”
April 9, 2019 “Handoffs for Every Occasion”
I-PASS Study website.
Starmer AJ, Spector ND, Srivastava R, et al. Changes in Medical Errors after Implementation of a Handoff Program. N Engl J Med 2014; 371: 1803-1812
Dewar Z, Yurkonis T, Attia M. Hand-off bundle implementation associated with decreased medical errors and preventable adverse events on an academic family medicine in-patient unit: A pre-post study. Medicine 2019; 98(40): e17459, October 2019
Trigger tools improve our ability to identify adverse events. The beauty of trigger tool methodology (see our Patient Safety Tips of the Week for October 30, 2007 “Using IHI's Global Trigger Tool” and April 15, 2008 “Computerizing Trigger Tools”) is that it allows you to screen a large number of records that potentially have the item you are really looking for. Then in the subset of records that contain the “trigger” you can then do manual chart review to verify details. It basically streamlines what would otherwise be a very labor- and time-intensive process that would not otherwise be practical.
Historically, identification of adverse events in emergency departments (ED’s) has relied primarily on reporting systems. That leads to an underestimation of adverse events. Recently there have been an interest in the use of trigger tools to identify adverse events in emergency departments.
Griffey et al. (Griffey 2019) looked at the impact of 97 individual “triggers” that could identify cases for review from the electronic medical record. That identified over 76,000 ED visits with at least one trigger. They then performed manual review on a subset of 1726 records to determined whether adverse events had occurred. The reviews found 21.6 adverse events per 100 records. There was good correlation between the automated qurery and the manual review (sensitivity >70% for 80 triggers; specificity >92% for all). They then looked at whether the number of triggers or use of “weighted” triggers could improve the yield. An estimated 10.3% of records with greater than 1 of these triggers would include an adverse event in the ED, but selecting only records with greater than or equal to 4 or greater than or equal to 9 triggers improves yield to 17% and 34.8%, respectively. Further enhancements, such as trigger weighting, enhanced the yield to as high as 52%. Use of trigger tools like these would obviously make the burden of manual record review much less onerous.
A study from Taiwan (Lee 2019) prospectively evaluated a monitoring system that combined 2 reporting methods and 5 trigger tool methods to capture adverse events in the ED of an academic medical center. Of adverse events identified, 77.2% were identified using reporting methods, 26% using trigger tool methods, and 3.2% using both methods. Most patients (81.7%) incurred temporary, minor physical impacts. Compared with reporting methods, trigger tool methods had a lower positive predictive rate to identify adverse events overall but a greater proportion of adverse events occurring during the preinterventation and postintervention phases, and more cases of severe physical impact or death. The authors conclude that combined use of the different methods had synergistic benefits for monitoring adverse events in the ED.
Obviously, use of multiple methods to identify adverse events in the ED (as well as other settings) improves the yield. But use of trigger tools has great promise in improving our ability to identify such events.
Some of our prior columns on trigger tool methodology:
Griffey RT, Schneider RM, Todorov AA. The Emergency Department Trigger Tool: A Novel Ap.roach to Screening for Quality and Safety Events. Annals of Emergency Medicine 2019; Volume 0, Issue 0 Published October 14, 2019
Griffey RT, Schneider RM, Adler LM, et al. Development of an Emergency Department Trigger Tool Using a Systematic Search and Modified Delphi Process. Journal of Patient Safety 2016; Publish Ahead of Print June 16, 2016 https://journals.lww.com/journalpatientsafety/Abstract/publishahead/Development_of_an_Emergency_Department_Trigger.99596.aspx
Griffey RT, Schneider RM, Sharp BR, et al. Multicenter Test of an Emergency Department Trigger Tool for Detecting Adverse Events. Journal of Patient Safety 2018; Publish Ahead of Print July 18, 2018
Lee W-H, Zhang E, Chiang C-Y, et al. Comparing the Outcomes of Reporting and Trigger Tool Methods to Capture Adverse Events in the Emergency Department
Journal of Patient Safety 2019; 15(1): 61-68
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