Monthly Archives: December 2011

Root Cause Analysis

Alarm-Related Ventilator Deaths

By ThinkReliability Staff

Although The Joint Commission dropped alarm safety as a patient safety goal in 2005 (a year after setting it as a goal), recent reviews by the US Food and Drug Administration and the ECRI Institute have noted concerns with alarm-associated ventilator deaths.  We can look at the issue of alarm-related ventilator deaths in a Cause Map, or visual root cause analysis, to see some of the causes related to these deaths, and some plans to reduce them.

Ventilator-related deaths occur when a patient who can not intake sufficient oxygen on their own (due to illness or injury) no longer receives sufficient oxygen from a ventilator.  Only a few minutes of insufficient oxygen intake can  result in brain damage or even death.  The patients do not receive sufficient oxygen from the ventilator because it stops working due to malfunction, becomes blocked with mucus, or becomes dislodged or disconnected, potentially due to patient movement.  In addition to an issue with the ventilator providing sufficient air to the patient, a death can occur when the ventilator issue is not fixed immediately.

Normally the ventilator issue is not fixed immediately because the caregiver is unaware of the issue. (Caregiver in this instance includes not only healthcare professionals but families caring for loved ones at home who are dependent on ventilators.)  In these cases, the caregiver is unaware of an issue with the ventilator because they are dependent on listening for an alarm to indicate a problem, and they don’t notice the alarm.  Caregivers not noticing an alarm were determined to cause 65% of ventilator deaths, according to The Joint Commission.

How do caregivers miss an alarm?  There are many possible reasons.  The ventilator alarm may not sound due to a malfunction.  Although this issue is commonly cited, the ECRI study determined that this was the case in only 2 of 119 cases it examined.  The alarm may not be sufficiently obvious to a busy caregiver.  Namely, the alarm may be set inappropriately by personnel who have insufficient training on ventilator systems.  Relatively few patients are on ventilators, and insufficient funding and time for training may mean that staff (or families) do not adequately understand how the ventilator works.   Another cause may be that some ventilators sound only once.  If you miss it, it’s done.  (As a solution, ventilator manufacturers are considering alarms that continue until reset.)

Another issue related to lack of responding to alarms is an issue known as “alarm fatigue”.  Caregivers can become desensitized to alarms, hearing so many every day, many of which are false alarms.  Ventilators, too, can produce false alarms when a patient coughs, or rolls over.

What can be done to reduce these deaths?  The first line of attack is frequent vacuuming and careful placement of the ventilator to reduce the risk of it becoming clogged or dislodged.  Next, an attempt to make caregivers less dependent on alarms, and more able to see problems using other indications, and more ventilator training may increase the ability of caregivers spotting issues without waiting for alarms.  As far as dealing with alarm fatigue, consideration should be taken into how alarms are presented to nurses.  Too many audible alarms may lead to ignoring even the life-threatening ones.  It may be better to have non-urgent issues presented as “alerts” rather than a one-time beeping.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Hospital Acquired Condition

Facial Burns from Surgical Fires

By ThinkReliability Staff

At least two patients received burns to the face from surgical fires in early December 2011.  Surgical fires are becoming an increasing risk to patients (and staff) in the operating room.  Although the 550-650 surgical fires a year that are estimated to occur by the ECRI Institute is a small percentage of patients undergoing surgery, this doesn’t make surgical fires seem “rare” to those who are affected.

A surgical fire, like any fire, requires the presence of three elements: a heat (or ignition) source, fuel, and an oxidizing agent.  Oxygen is necessarily present for breathing; however, additional oxygen supplied to the patient increases the risk of a fire.  Additionally, nitrous oxide produces oxygen from thermal decomposition.  An increased level of oxygen increases the risk of a surgical fire.  Like oxygen, fuel will always be present in a surgical room.  Prep agents, drapes, and even a patient’s hair are fuel sources.  Vapors from insufficiently dry prep agents are extremely flammable.  Although some drapes are advertised as flame-resistant, the ECRI has determined that all types of drapes burn in oxygen.

Surgical equipment, such as electro-cautery devices and lasers, are believed to provide the ignition source for many surgical fires.  The increased use of such devices is believed to contribute to the increase in surgical fires.  Although these devices can provide benefits during surgery, a non-ignition source tool should be considered for surgery performed near the oxygen supply of a patient requiring oxygen.

The best way to protect patients from surgical fires is to prevent them by reducing the use of oxygen, decreasing the flammability of potential fuel sources in the operating room (by allowing prep agents to dry and coating hair or other flammable objects with water-based lubricant) and ensuring that heat sources are monitored carefully to reduce the risk of ignition.  In addition, operating teams should be prepared in the case of fire to minimize effects on patient and staff safety by taking steps to extinguish the fire and evacuate if necessary.

The effects and causes of surgical fires, as well as some recommended solutions, can be diagrammed in a Cause Map, a visual form of root cause analysis.  To view the Cause Map for surgical fires, please click “Download PDF” above.  Or click here to read a more detailed write-up about patient burns.

Additional resources on surgical fires:

ECRI Institute

FDA

The Joint Commission

Anesthesia Patient Safety Foundation (APSF)

Root Cause Analysis

Surgical Tools Cleaned with Hydraulic Fluid

By Kim Smiley

In late 2004, a healthcare system in North Carolina realized that it had been using elevator hydraulic fluid instead of cleaning detergent when cleaning its surgical tools.  Before the problem was realized, the improperly cleaned tools were used on 3,650 patients.  An analysis by infection control, material and toxicology experts determined that the sterilization process of the tools was not affected and that trace metals left on the tools from the hydraulic fluid were in too small of amounts to cause risk to patients.  Nonetheless, the potential for these safety risks is an impact to the patient safety goal.  Additionally, the fact that improperly cleaned tools were used on patients is an impact to the patient services goal.  Lastly, the re-cleaning and sterilization required for the tools is an impact to the labor goal.

This incident can be examined in a Cause Map or visual root cause analysis. The first step is to define the problem with respect to the impacts to the organization’s goals, as described above.  The second step is to begin with the impacted goals and ask “why” questions to diagram the cause-and-effect relationships that led to the incident.  In this case, improperly cleaned tools were used on patients because the tools were cleaned with hydraulic fluid and the tools were used on patients.  The tools were used on patients because it was not immediately obvious that they had been improperly cleaned.  The tools did retain an oily feel; however, the tools are lubricated as part of the cleaning and sterilization process to avoid rust and ensure proper operation and so may retain an oily feel.

The tools were cleaned with hydraulic cleaning fluid because the hydraulic fluid was stored in the cleaning detergent containers and delivered to system hospitals.  The containers were filled with elevator hydraulic fluid by an elevator maintenance company and left where they were picked up by the cleaning detergent provider.  The provider did not realize that the containers had been tampered with (as they were not relabeled and either had no indication of tampering or were not inspected for tampering) and so delivered them to the hospitals for use.

Once the problem was realized, the affected tools were re-cleaned and sterilized and the detergent replaced.  Follow-up monitoring was performed and appointments offered to the affected patients, despite determination that the sterilization process was not affected and that the trace metals were not in sufficient amounts to affect patient safety.  Employees were trained in container management and a process was added to verify the status of containers delivered to and used in the hospital.  Additionally, a process to determine when product integrity has been compromised.  An external review by the Centers for Medicaid and Medicare Services has certified that the impacted hospitals are in compliance with standards based on these implemented corrective actions.

To view the Outline, Cause Map and implemented solutions, please click “Download PDF” above.  Or click here to read information provided by the affected healthcare system.