Six Steps to Managing an Infection Control Breach

Six Steps to Managing
an Infection Control Breach

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Managing an Infection Control Breach
In 1999, the Institute of Medicine published the
now famous report “To Err Is Human,” which
dropped a bombshell on the medical community
by reporting that up to 98,000 people a year die
because of hospital mistakes.
The number was initially disputed but is now
widely accepted. Medical error is a leading
cause of death in the U.S. and the rate of
harm is even higher.

According to the World Health Organization,
the chance of being harmed while traveling by
plane is one in a million, while the chance of
being harmed in healthcare is only one in 300.
Infection control breaches–when there is a
failure to follow established infection control
procedures that prevent the transmission of
infectious organisms–remain a major threat
to patient safety.

In 2004, a health system in
North Carolina notified
more than 3,500 patients
of its failure to properly
clean surgical instruments.
In 2008 and 2009, three
Veterans Affairs medical
centers notified more than
10,000 patients about a
failure to appropriately
clean reusable medical
equipment.
In 2018, a hospital in
Denver cancelled all
surgeries discovery that
the hospital had engaged
in inadequate surgical
instrument sterilization
practices for 18 months.

To prevent infections and improve patient safety,
healthcare organizations need to implement
infection control procedures, regularly assess
infection prevention protocols, and establish an
infection surveillance program that helps ensure
adherence to established protocols.
Taking these steps will help prevent an
infection control breach from occurring.
When facing a breach, organizations
need to respond efficiently and effectively.

Evaluating an Infection Control Breach
The CDC outlines the following six steps to evaluate infection control breaches:
Identify the infection control breach1
2
3
4
5
6
Gather additional data
Notify and involve key stakeholders
Perform a qualitative assessment
Make decisions about patient notification and testing
Handle communications and logistical issues
Perform direct observation of practices that may have led to the breach.
Determine the time frame of the breach and determine which patients may have been exposed.
Stakeholders should be identified and engaged as early as possible.
Categories A and B are levels of identifiable risk, such as using contaminated syringes.
Patient notification recommended for all Cat-A breaches. Cat-B breaches, notification based on risk.
The goal is to achieve consensus on whether patient notification is appropriate.

One healthcare organization had an operational response to an infection
control breach by notifying 260 patients that they may have been
exposed to blood-borne pathogens.
The breach involved surgical instruments that had been
soaked in antimicrobial agents and went through
steam sterilization, but additional cleaning steps
were not performed as expected.
Upon identification of the breach, the
issue was escalated to the leadership
team and investigated in accordance
with the CDC recommendations.

The breach was classified as a Category B Breach (likelihood of blood
exposure is uncertain), and after much thoughtful discussion, public
health leaders and health system leadership made the decision
to notify the affected patients.
Patient notification and management of the
recommended Hepatitis B, Hepatitis C,
and HIV testing was complicated and
stressful for both the patients and staff.

Managing the event required the following steps:
Activate the incident command system.
Set up and staff call center with well-trained staff to manage patient notification processes
Select and staff a testing center location.
Develop workflows for timely processing of samples and results validation.
Create and send notification letters to affected patients. Establish patient notification procedures.
Train call center staff to the workflows.
Develop communication materials for patients, the public, and health system employees.
Establish mechanisms for securely tracking and managing patient communication.
Monitor performance of the call center and testing completion rates, adjusting call center
operations accordingly
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To manage the infection risk, the organization had to
complete these actions as quickly and effectively as
possible, carrying out many of them concurrently.
It was challenging to balance these tasks–while
seeking to restore trust with the patients and
public by transparently disclosing the event
in a competent, caring manner.
The organization had to ensure there was
adequate time to develop the detailed
workplans that would result in the most
positive experience possible for patients.

Because the organization wanted to ensure the
breach was not disclosed publicly prior to the
impacted patients receiving notification, they
deployed as few people in the planning
activities as possible, which delayed the
timeliness of patient notification.
The team developed an analytics application
that was used to track all patient activity.
The application minimized the need to access
the electronic medical record, ensuring staff
accessed the minimum amount of protected
health information necessary to effectively
manage the event.

The application supported staff in escalating issues to
the responsible party (risk management, legal, public
information officer, lab, physician on call, etc.).
The application was used to monitor performance,
track call work volume, and visualize the number of
patients that had completed testing and the number
still outstanding.
They were able to use the application to monitor
turn-around time from date of testing to results
notification and inform the decision about when to
close the call center.

As for protocol changes, the sterilization of
supplies was returned to the centralized sterile
processing department.
The ordering process changed to ensure
infection preventionists were included in any/all
purchasing of devices used for sterilization–
preventing the root cause that contributed to the
breach in the first place.
The patient notification process was
effective, with 92% of the patients
completing the recommended testing.

While more needs to be done to
prevent infection control breaches from
occurring and improve patient safety,
the organization responded as quickly
as possible in a way that would rebuild
trust with both patients and the public.

For more information:
“This book is a fantastic piece of work”
– Robert Lindeman MD, FAAP, Chief Physician Quality Officer

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Click to read additional information at www.healthcatalyst.com
Has more than 20 years’ experience in nursing and healthcare. Prior to joining Health Catalyst,
she was a director of professional practice at PeaceHealth and was responsible for improving
patient safety and outcomes, organizational outcomes, leader and staff competency, and the
nurse practice environment. Heather developed and implemented best practice and evidence-
based nursing care standards, facilitated practice changes throughout the organization, and ensured
appropriate integration of nursing standards and workflow into the EHR. Heather has served as adjunct
faculty teaching entry level nursing students, and has held pro tem appointments with the Washington
State Nursing Care Quality Assurance Commission (the state regulatory board for nursing) as a member
of the advanced practice sub-committee, and as a reviewing commission member, reviewing cases of
alleged misconduct and participating in disciplinary hearings. Heather has a Master of Nursing degree
from Washington State University, and is board certified by the American Nurses Credentialing Center as
a clinical nurse specialist in public and community health. Heather has been the recipient of leadership
awards from both Sigma Theta Tau, the International Honor Society for Nursing, and the Northwest
Organization of Nurse Executives.
Heather Schoonover

Six Steps to Managing an Infection Control Breach

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