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Seven Things To Know When You Receive A Notice Of Investigation From The Department Of Health

Alarm Safety

Joint Commission – National Patient Safety Goal NPSG-06.01.01

By Michael L. Smith, R.R.T., J.D.
Healthcare providers including RTs are constantly bombarded by hundreds of alarms each day in the clinical setting. Unfortunately, those healthcare providers may become desensitized to those alarms over time resulting in alarm fatigue and severe consequences for their patients.
The Joint Commission Sentinel Event database includes 98 reported alarm events between 2009 and 2012 with 80 of those events resulting in a patient death. Also, according to the Joint Commission, 566 patient deaths attributed to alarm events are included in a database maintained by the Food and Drug Administration. Clinical alarms have consistently been at the top or near the top of the list of the top 10 technical hazzards as reported by James Keller of the ECRI Institute. In order to better address the problems associated with alarm safety, the Joint Commission recently approved new National Patient Safety Goal NPSG.06.01.01 dealing with alarm safety.
The National Patient Safety Goal will be implemented in two phases. In Phase 1, hospitals are required to identify the most important alarms and potential risks associated with those alarms. The Phase 1 elements of performance are:

EP 1: As of July 1, 2014, leaders establish alarm system safety as a hospital priority.

EP 2: During 2014, identify the most important alarm signals to manage based on the following:
Input from the medical staff and clinical departments
Risk to patients if the alarm signal is not attended to or if it malfunctions
Whether specific alarm signals are needed or unnecessarily contribute to alarm noise and alarm fatigue
Potential for patient harm based on internal incident history
Published best practices and guidelines

In Phase 2, hospitals will be required reduce or eliminate the risks associated with those alarms. The Phase 2 elements of performance are:

EP 3: As of January 1, 2016, establish policies and procedures for managing the alarms identified in EP 2 above that, at a minimum, address the following:
Clinically appropriate settings for alarm signals
When alarm signals can be disabled 
When alarm parameters can be changed 
Who in the organization has the authority to set alarm parameters
Who in the organization has the authority to change alarm parameters
Who in the organization has the authority to set alarm parameters to “off”
Monitoring and responding to alarm signals
Checking individual alarm signals for accurate settings, proper operation, and detectability

EP 4: As of January 1, 2016, educate staff and licensed independent practitioners about the purpose and proper operation of alarm systems for which they are responsible.

NPSG.06.01.01. is not the first Joint Commission safety goal addressing alarms in clinical settings. In 2003 and 2004, the Joint Commission had a safety goal concerning the maintenance and testing of alarms. That previous alarm safety goal was retired by the Joint Commission in 2005.

RTs will need to play an integral role in assisting their hospitals in compliance with the standards of NPSG.06.01.01. Ventilators along with other critical care equipment were specifically listed as equipment with alarms that can pose significant risks to patients if the alarms are not properly managed. Obviously, ventilator alarms can indicate a significant event affecting a patient. If not managed properly, a ventilator malfunction may cause serious injury or death to a patient.

Michael L. Smith, JD, RRT is board certified in health law by The Florida Bar and practices at The Health Law Firm in Altamonte Springs, Fla. This article is for general information only and is not a substitute for formal legal advice.
This article was originally published in Advance for Respiratory Care and Sleep Medicine.