In our presentations on alarm safety we always point out that not all alarms are connected directly to patients. But other alarms may have a significant impact on patients and need to be incorporated into you alarm management program.
One example of such alarm that we usually raise is that which responds to the temperature in a refrigerator falling out of the desired range. That has been in the news lately because incidents at two separate fertility clinics involved loss of tissue when the temperatures in the refrigerating units rose above levels necessary to preserve the specimens. But you may have refrigerators that store blood products or tissue implants or vaccines that require specific temperature ranges for storage. You may also have temperature alarms that require a specific temperature range in your IT server farm.
On the same day in early March of this year, rare refrigerator malfunctions were experienced at two fertility clinics, one in Cleveland and one in San Francisco, potentially affecting thousands of patients' eggs and embryos (Nestel 2018). At the clinic in San Francisco a senior embryologist noticed, toward the end of the day while doing routine checks of the tanks, that the nitrogen level in one tank was very low. The tank with the depleted levels of liquid nitrogen was refilled. Another filled tank stored downstairs in the building replaced it and the tissue specimens were transferred. That facility brought in independent experts and are conducting a full investigation (Brookbank 2018) but details of that investigation are not known at this time.
The situation in Cleveland apparently was a little different. A letter of disclosure and apology sent to 950 patients potentially impacted by loss of eggs and embryos (Buduson 2018) said a remote alarm system on the storage tank containing the eggs and embryos, which was designed to alert an employee to temperature fluctuations, was turned off. It was unclear when the remote alarm was turned off, but an alert to an employee as the temperature inside the tank began to rise was not sent or received. It was unclear who turned off the alarm and how long the alarm had been turned off. The lab was not staffed on the night of the malfunction. There was also a history of malfunctions involving the storage tank. For weeks prior to the malfunction there apparently had been difficulty with what is called the “liquid nitrogen automatic fill” and the facility was working with the manufacturer to correct the problem.
While the Cleveland letter apparently discussed the role of human error, there obviously were also system problems and other factors that contributed to the unfortunate incident. Periods around maintenance of equipment are vulnerable times. We discussed this in our August 7, 2007 Patient Safety Tip of the Week “Role of Maintenance in Incidents”, in which we discussed the excellent work of James Reason and Alan Hobbs plus that of Don Norman. Also, in our March 5, 2007 Patient Safety Tip of the Week “Disabled Alarms” and several other columns on alarms, we noted instances where the oxygen blender alarms on ventilators had been disabled during maintenance and were not corrected prior to use in patients. When maintenance is done on any equipment we recommend to staff doing maintenance have a checklist they use to remind them of things they must do. And one of those items would be to restore any alarms they might have disabled during the maintenance.
There was also apparently a workaround being used in the Cleveland case. Liquid nitrogen was being added to the tank manually because they were having issues with the mechanism is that is supposed to automatically refill the liquid nitrogen to keep the specimens cold (Wamsley 2018). The liquid nitrogen was brought in a container from a nearby lab and poured into the tank. A letter sent to patients by the clinic said. "The liquid nitrogen levels in the tank were monitored and appeared to be appropriate on Friday and Saturday, but we now suspect that may not have been the case."
And we are not told of any potential design issues. For example, how do you know the alarm is powered and active? The smoke detector or carbon monoxide detector in your home has a button you press that indicates the alarm is functional. Is there a similar capability on these refrigerator alarms?
When dealing with valued resources, such as the specimens in a fertility clinic, redundancy and backup systems are a must. We don’t know details about their systems but, obviously, the technology is available to indicate an alarm malfunction or disconnection. We get a “your motion camera has been disconnected” message by email and text message every time our motion detection camera gets disconnected from our WiFi system. We would assume similar capabilities should exist to alert someone when a freezer alarm system has been disconnected (though, even then, you might anticipate an event that disables both your refrigerator alarm and your WiFi system).
In our February 4, 2014 Patient Safety Tip of the Week “But What If the Battery Runs Low?” we gave the following anecdote: You have an alarm that responds to the temperature in a refrigerator dropping below a set value to protect against loss of the medical products inside. You took great care to make sure the thermometer was not on the same electrical supply as the refrigerator. However, the battery on the thermometer had not been checked recently and had no charge when the refrigerator actually lost power. All the medical products in the refrigerator are lost.
And, of course, the other issue was that the event took place on a night when the lab was not staffed. Even when the alarm is working properly, you need to make sure your system of response is also working. We once did a root cause analysis (RCA) on an incident where the temperature in a refrigerator storing implants rose above the desired range. An alarm was triggered. Of course, these incidents never happen during the daytime when all sorts of staff are around to respond! They tend to happen at night or on weekends. The alarm went to the ER (that was one area staffed 24 x 7, so someone would be alerted), who then notified the nursing supervisor. The nursing supervisor attempted to contact the on-call biomedical engineer. That call went initially to someone who was not actually on-call. By the time the biomedical engineer actually on-call was reached, several hours had gone by and the tissue implants were no longer usable. Fortunately, no patient was harmed or inconvenienced by the episode, but the facility did incur some financial loss due to the loss of the implants.
There should be a checklist and set of instructions informing the person responding to the alarm what to do. Probably the best place to put this is right on the refrigerating unit. You don’t want to bury it in a thick policy manual where the respondent may not even find it in a timely fashion.
You also want to make sure that you have an appropriate “escalation” practice (i.e. who to call next if the first person called fails to respond in a timely fashion). While we have such escalation procedures in place for clinical staff, many facilities are less deliberate with regard to non-clinical staff escalation procedures.
Given the low statistical probability of such events occurring at two remote fertility clinics on the same day. we’d question whether this was truly coincidental or whether such systems could be vulnerable to hacking. We would assume the two facilities have communicated with each other about the coincidence and have assessed for potential hacking.
The Cleveland facility certainly did the right thing in being forthright and honest in letting affected patients know about the error(s) and expressing heartfelt apology. It also let them know that a proper investigation was being undertaken to address problems so a similar incident does not recur in the future. The hospital system says it is refunding storage fees to those patients who had stored eggs and embryos, as well as offering tailored emotional and medical support, including a free round of IVF for those who want it (Wamsley 2018). The hospital system isn't asking patients to sign a release in order to access the services. Our numerous columns on disclosure and apology (listed below) illustrate that, not only is disclosure and apology the right thing to do, it likely reduces legal costs in the long run as well. Similarly, the Cleveland facility response is in keeping with the trend to communication and resolution programs (columns also listed below).
Most healthcare incidents involve a single patient (aside from those misidentification incidents that involve pairs of patients). But sometimes incidents, like the ones above, impact multiple patients and the issues there become much more complex. We refer you to our June 16, 2009 Patient Safety Tip of the Week “Disclosing Errors That Affect Multiple Patients” for recommendations in such cases.
Lastly, the fertility clinic incidents led to a blog on responding to bad press (Laub 2018) that is worth your review. In the highlighted video Ron Harman King, of Vanguard Communications, offers the following four “commandments” when dealing with bad press:
Read that blog and watch the video. We agree with King’s sage advice. But there is, perhaps, one additional recommendation we’d make. Though we fully endorse the concept of “don’t run and hide”, we also caution organizations to avoid unnecessarily rekindling the bad press after it has disappeared from attention. We’ve seen too many organizations try to offer excuses, often lame ones, for bad incidents long after the media cycle had bypassed them, only to get the issues back on the front page.
We’ll bet your facility likely has some refrigerators or freezer units that store important blood or tissue specimens or vaccines. And we know your IT server farm relies on optimal temperature ranges. But how many of you have ever questioned what would happen if there was an alarm malfunction in one of these units? Have you done a FMEA (failure mode and effects analysis) of such alarm systems? Do you look at these alarms when you are doing Patient Safety Walk Rounds? Are the appropriate people alerted when these alarms are triggered? Do those people know how to respond when such alarms trigger? Is there a checklist that helps responders take all necessary steps when such an alarm triggers? Do you know how such alarms are powered and what the impact of a power failure or battery failure might be? Do you have backup systems in place?
And when you do your FMEA, don’t forget to ask if the necessity for storing things in the refrigerator was appropriate in the first place. In the example RCA we discussed above, there was actually little reason for storage of the implants. They could have just as easily been obtained on a just-in-time basis. They were just creating unused excess inventory.
So what should you be doing?
Lastly, we need to learn from other incidents and near misses. Several years prior to the incident discussed above where the implants were lost due to the freezer failure, there had been a similar episode in the blood bank and another one in the IT server farm. Some of the same system problems in those incidents were in play in the current incident. Yet those events had been dealt with strictly at the departmental level and lessons learned not shared with other departments. No lesson learned is so small that it shouldn’t be shared with others. A high performing health system has a culture of disseminating lessons learned no matter how “small” those lessons learned may seem. Moreover, knowing which types of action plans actually work is invaluable.
Despite our caution about rekindling the incident in the media, we would also hope that the lessons learned when each of these fertility organizations does their root cause analysis (RCA) would somehow be disseminated because virtually all other healthcare organizations may be vulnerable to similar incidents with the refrigerator or freezer systems they use for a variety of purposes.
Prior Patient Safety Tips of the Week pertaining to alarm-related issues:
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”
Other very valuable resources on disclosure and apology:
Nestel ML. Fertility clinic cryostorage fridge malfunction on same day as Cleveland hospital. ABC News (abc7.com) 2018; March 12, 2018
Brookbank M. Second fertility clinic suffers malfunction on same day as University Hospitals. News5cleveland.com 2018; Mar 11, 2018 Updated: Mar 12, 2018
Buduson S. Human error blamed for Ohio fertility center malfunction, says 4,000 eggs and embryos lost. TheIndyChannel 2018; Mar 27, 2018
Wamsley L. Ohio Fertility Clinic Says 4,000 Eggs And Embryos Destroyed When Freezer Failed. NPR Vermont Public Radio 2018; March 28, 2018
Laub G. The Four Commandments of Confronting Bad Press - Ron Harman King offers insights from the university of hard knocks. MedPage Today 2018; March 28, 2018
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