Sentinel Event Alert: Medical Device Alarm Safety
Medical devices used to monitor patients are built with alarms to alert health care personnel when the patient’s readings are outside of a desired range. Other devices alarm when a medication is complete or if there is some interruption in delivery, such as an IV pump. In our complex health care environment, there may be several devices connected to each patient, resulting in hundreds of alarms every day.
According to the Sentinel Event Alert issued by The Joint Commission on April 8, 2013, an estimated 85-99% of these alarms do not require any clinical intervention. As a result, clinicians become desensitized to the sounds as a defense against the onslaught of auditory information. This phenomenon has been labeled “alarm fatigue”. Clinicians then may turn down the volume of the alarm, turn it off or adjust the alarm settings outside the limits that are safe and appropriate for the patient. Common injuries or deaths related to alarms included those from falls, delays in treatment, ventilator malfunction and medication errors. The Boston Globe reported such a case when a 60-year-old man died in the intensive care unit of a hospital because the staff did not respond to alarms that indicated deterioration in his condition.
Recommendations and potential strategies for improvement
The Joint Commission has issued recommendations to reduce patient harm related to alarm fatigue. Many of these recommendations were also made by both the Association for the Advancement of Medical Instrumentation (AAMI) and ECRI Institute and include the involvement of leadership in ensuring that there is a process for safe alarm management and response in high risk areas, establishing guidelines for alarm setting that is tailored for individual patients, determining situations when alarm signals are not clinically necessary and verifying that alarms are audible. The recommendations also emphasize a cross-disciplinary team approach to address alarm safety that involves training of the organization’s processes.
A full report of the Sentinel Event Alert Issue 50: Medical device alarm safety in hospitals can be located on The Joint Commission website at http://www.jointcommission.org.
Webinar for Members and Non-Members: Are You Ready for the ACA PSO Mandate?
Are You Ready?
Demystifying the Affordable Care Act’s PSO Mandate
Members and non-members are invited to join Rory Jaffe, MD, MBA, Executive Director of CHPSO, as he helps demystify one of the Affordable Care Act’s (ACA’s) least-understood mandates during a free webinar May 21, 10–11 a.m.
Health insurance exchanges, a key component of the ACA, will require participating hospitals to:
Report to a PSO;
Utilize a patient safety evaluation system (PSES); and
Implement a comprehensive discharge program.
Dr. Jaffe’s April 9 lunch presentation at the CHPSO Annual Meeting opened up many eyes. This webinar will review and expand on the information provided at the Annual Meeting, including:
Understanding the ACA mandate for reporting to PSOs;
Comprehending the urgency of implementing a Patient Safety Evaluation System, and how to form one; and
Learning what the AHRQ Common Formats really are and see their advantages.
Join CHPSO on May 21, from 10–11 a.m. to review ACA information imperative to your hospital, whether you have established a PSES and are already reporting to a PSO or not. Bring your questions, comments and concerns so that you will soon be able to say, “We are ready!”
An email will be distributed on Thursday, May 16 with webinar participation information to all members of the CHPSO mailing list. If you received this newsletter directly from firstname.lastname@example.org, then you will automatically receive the information. If this newsletter was forwarded to you, please be sure to sign up for our mailing list
in order to receive the most up-to-date information.
CalHEN Seeking Success Stories
Hospitals are active in patient care measurement and improvement activities. The California Hospital Engagement Network (CalHEN) have featured hospitals who are proud to share their success stories in making hospital care better and safer, leading to improvements in patient outcomes. The goal of sharing success stories is to educate and increase awareness of safety activities throughout the hospitals and health systems. CalHEN plans to feature success stories focused on 11 areas of hospital-acquired conditions—such as CAUTI and CLABSI reduction, elective pre-term delivery reduction, preventable readmissions reduction, adverse drug events, surgical site infections prevention and ventilator-associated pneumonia. Our main goal is to work to strive to reduce harm by 40 percent and readmissions by 20 percent by the end of 2013.
We encourage you to tell your own story:
Compile your success stories. You can download the suggested format template by clicking here. Please submit your hospital success story to the California Hospital Engagement Network.
Use the success stories as the foundation of your communication efforts—with your staff, community, patients, etc.
Several of CalHEN's current success stories were presented in the HEN breakout session at the CHPSO Annual Meeting and are available to review on the CalHEN website.
A Follow-Up: Un-retrieved Device Fragments
In the March edition of CHPSO Patient Safety News
, we discussed the multistate collaboration headed by CHPSO with a particular interest in small miscellaneous items (SMI) and un-retrieved device fragments (UDF). As reported then, in-OR orthopedic procedures and out-of-OR vascular procedures (e.g., central line placement) were associated with the most frequent events in our sample.
It is very difficult to estimate overall risk of serious harm from UDFs and SMIs. However, the FDA reported that it receives about 1000 adverse event reports per year. While the FDA encourages reports of lesser (or no harm), most reports fit into the mandatory reporting categories: death or serious injury.
In response to these reports, the FDA issued the following recommendations
Use medical devices in accordance with their labeled indications and the manufacturer’s instructions for use, especially during insertion and removal.
Inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.
Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.
If the device is damaged, retain it to assist with the manufacturer’s analysis of the event.
Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs. leaving the fragment in the patient.
Advise the patient of the nature and safety of unretrieved device fragments including the following information:
a. The material composition of the fragment (if known);
b. The size of the fragment (if known);
c. The location of the fragment;
d. The potential mechanisms for injury, e.g., migration, infection;
e. Procedures or treatments that should be avoided such as MRI exams in the case of metallic fragments. This may help to reduce the possibility of a serious injury from the fragment.
CHPSO also recommends that hospitals evaluate more specific risk mitigation strategies. For example, since incident reports received by CHPSO indicate that guidewires are a recurring non-OR retained item, we recommend that organizations pay particular attention to applying the above FDA recommendations to vascular catheterization—e.g., identifying ways to assure accounting for guidewires during and after placement. As hospitals gain more experience in reducing these risks and share their experiences with CHPSO, we expect to share more specific recommendations.
Reminder: CHPSO / ECRI Deep Dive Call to Action
Report at least 10 laboratory-related events by May 24
CHPSO, ECRI Institute, and partner PSOs have performed two previous PSO Deep Dives. The first was on medication errors and the second on health IT. This year, we will be focusing on laboratory-related events.
As a member of CHPSO, you have the opportunity to participate in this collaborative which will help you and your colleagues learn from your laboratory-related adverse events and, more importantly, help prevent similar errors from reaching others. Thanks to the federal Patient Safety and Quality Improvement Act (PSQIA), CHPSO members may report near misses and incidents through a voluntary and confidential mechanism.
A laboratory-related event is a defect occurring at any part of the laboratory cycle, from ordering tests to reporting results and appropriately interpreting and reacting on these. These errors may lead to repeat testing and/or wrong or delayed care to a patient. Your participation in this deep dive will assist in the exploration of patient safety risks associated with laboratory events.
To that end we are asking members to submit at least ten laboratory events from April 15 through May 24. The laboratory fields are available in the event type Laboratory/Radiology.
Your data will be used in combination with all other facilities in the collaborative to do a deep dive analysis of all laboratory events and related events submitted and provide the results. We will post all materials on your PSO website for access to copies of reports, PowerPoint, research, tools, etc. We will also present the results at a webinar to all PSO members.
To get started, log in to the CHPSO / ECRI Portal to enter events or, if an automated conduit has been established, transfer them electronically from your event reporting system.
Member RCA Series: It Starts with Your Culture
Monday, May 11, 2013, 10–11 a.m., PDT
Even though many institutions are working hard to improve safety, the lack of attention to “systems thinking” and too much focus on individual blame prevents hospitals from identifying where systems break down. Resources are committed to addressing the basics of regulatory compliance but often do not extend to prevention and development of a proactive approach to patient safety and quality improvement. We will explore approaches to developing a culture that is committed to successfully improving patient safety, eliminating preventable harm and improving outcomes.
For more information on the RCA Series, visit http://www.chpso.org/root-cause-analysis.
This call is for members only. Members will receive an email with call in information Thursday before the call. If you are a CHPSO member and want to ensure you are on our Member mailing list, please email email@example.com.
CHPSO / ECRI Webinar: Challenges of Agitated/Violent Patients in the Medical Setting
Proactive Responses to Avoid Reactive Risks
May 20, 2013, 11:30 a.m.–12:30 p.m. PDT
Health care workers on the front line of care are at risk of being injured by patients who become violent because of their emotional or clinically agitated condition. Although the emergency department is a particularly high-risk setting for aggressive behavior, these incidents can occur in care settings throughout the hospital and involve acute as well as behavioral health patients. We have received reports of patient aggression and violence that will form the basis of our discussion of the emergency care and psychiatric literature toward a comprehensive organizational response to a significant source of trauma, stress, injury, claims, and lost work time in healthcare.
This webinar enables members to discuss events in a safe and protected environment to improve patient care. During the call, we will review case studies based on events reported by PSO members. No identifying information will be included and the cases will be relevant for any acute care facility. We encourage you to participate in the dialogue so that we can learn from each other.
This call is for members only. Members will receive an email with call-in information Thursday before the call.
CAHQ Webinar: CHPSO's Mission and the Bigger Picture
Thursday, May 16, 2013, 10–11a.m., PDT
Rhonda Filipp, RN, MPA, Director of Quality and Patient Safety will be conducting a webinar titled “CHPSO’s Mission and the Bigger Picture,” sponsored by the California Association for Healthcare Quality (CAHQ).
Understand the purpose & function of PSOs
Understand how to define Patient Safety Work Product (PSWP) and Patient Safety Evaluation Systems (PSES)
Be able to describe the mission and patient safety initiatives of the California Hospital Patient Safety Organization
Registration and additional information is at http://cahq.org/docs/CHPSO_registration_05-16-13.pdf
Did You Miss One of Our Webinars?
We now have a webinar archive section
on our website for those members who were not able to attend the live webinar. These webinars will generally be posted within a few days after the live presentation. Unfortunately, not all webinars will be available for posting and sometimes we will only have the slide presentation to offer. Please note that this is a “member’s only” section. If you are not yet a member of CHPSO, please contact us to learn how to become a member at firstname.lastname@example.org
Upcoming Patient Safety Events