RCA Framework
Revised 2/27/2013
ROOT CAUSE ANALYSIS AND ACTION PLAN:
Critical Care Infection Spike in Transplant Patients Q1 2014
Stenotrophomonas maltophilia, aspergillus, mycobacterium
#
1
2
3
4
Analysis Question
What was the intended
process flow?
Prompts
Root Cause Analysis Findings
List the relevant process steps as defined by the policy,
procedure, protocol, or guidelines in effect at the time of the
event. You may need to include multiple processes.
Note: The process steps as they occurred in the event will be
entered in the next question.
Examples of defined process steps may include, but are not
limited to:

Site verification protocol

Instrument, sponge, sharps count procedures

Patient identification protocol

Assessment (pain, suicide risk, physical, and
psychological) procedures

Fall risk/fall prevention guidelines
See basic infection prevention strategies in flow sheet:
SCIP measures, HH, bundles of care, culturing, heightened
awareness by interdisciplinary rounding team for immunospressed
patients, frequent vitals, labs. No breaks in technique or process
were identified.
Were there any steps in the
process that did not occur as
intended?
Explain in detail any deviation from the intended processes
listed in Analysis Item #1 above.
What human factors were
relevant to the outcome?
Discuss staff-related human performance factors that
contributed to the event.
Examples may include, but are not limited to:

Boredom

Failure to follow established policies/procedures

Fatigue

Inability to focus on task

Inattentional blindness/ confirmation bias

Personal problems

Lack of complex critical thinking skills

Rushing to complete task

Substance abuse

Trust
Consider all medical equipment and devices used in the course
of patient care, including AED devices, crash carts, suction,
oxygen, instruments, monitors, infusion equipment, etc. In your
discussion, provide information on the following, as applicable:
No interruption of process was identified, except for the patients
that were discharged and readmitted prior to diagnosis or
infections—preventing the identification of timing or source of
infection.
Respiratory cleaning of ventilators review revealed the use of cidex
actually exceeded manufacturer’s recommendations.
How did the equipment
performance affect the
outcome?
High census and high ventilator volumes during this time period
were noted. No specific factors related to this were identified, no
incomplete staffing, no same staff, no excessive overtime, no
personal problems, inattention, fatigue or competency issues
identified.
Ventilators—all respiratory parts are a closed system with
disposable parts that come into contract with patient respirations.
All ventilators were in constant use on other patients without similar
infectious organisms noted.
Root Cause
Yes/No
Plan of
Action/ risk
reduction
strategy?
no
yes
no
no
no
yes
no
yes
Page 1
#
Analysis Question
Prompts






5
6
7
8
9
What controllable
environmental factors directly
affected this outcome?
What uncontrollable external
factors influenced this
outcome?
Were there any other factors
that directly influenced this
outcome?
What are the other areas in
the organization where this
could happen?
Was the staff properly
qualified and currently
competent for their
responsibilities at the time of
the event?
Descriptions of biomedical checks
Availability and condition of equipment
Descriptions of equipment with multiple or removable
pieces
Location of equipment and its accessibility to staff
and patients
Staff knowledge of or education on equipment,
including applicable competencies
Correct calibration, setting, operation of alarms,
displays, and controls
What environmental factors within the organization’s control
affected the outcome?
Examples may include, but are not limited to:

Overhead paging that cannot be heard

Safety or security risks

Risks involving activities of visitors

Lighting or space issues
The response to this question may be addressed more globally
in Question #17. This response should be specific to this event.
Identify any factors the organization cannot change that
contributed to a breakdown in the internal process, for example
natural disasters.
List any other factors not yet discussed.
List all other areas in which the potential exists for similar
circumstances. For example:

Inpatient surgery/outpatient surgery

Inpatient psychiatric care/outpatient psychiatric care
Identification of other areas within the organization that have the
potential to impact patient safety in a similar manner. This
information will help drive the scope of your action plan.
Include information on the following for all staff and providers
involved in the event. Comment on the processes in place to
ensure staff is competent and qualified. Examples may include
but are not limited to:

Orientation/training

Competency assessment (What competencies do the
staff have and how do you evaluate them?)
Root Cause Analysis Findings
Recent construction adjacent areas for OR (ICRA was followed)
Wows
Curtain cleaning
Linens-delivery and exchange, use
Dietary, delivery
HH
HVAC
Water in rooms
Windows
Lead cleaning
Monitoring cleaning
Bedrail cleaning
No plants or flowers were allowed (family was allowed to bring
fruits, vegetables and foods)
Open air from windows was permitted during the time period
Change of linens—one observation of linen touching the floor—
post-infections and not related to the type of organism diagnosed in
patients.
Computer sharing, inconsistent process for cleaning the WOWs
and keyboards.
Anti- rejection medications for post-transplant patients cause
immunosupressed and vulnerable states. Patients went home and
were subjected to other organisms prior to readmissions in some of
these cases. Unable to determine exact source or timing.
RCA Framework
Revised 2/27/2013
Plan of
Root Cause
Action/ risk
Yes/No
reduction
strategy?
no
Yes
yes
Action items
1-18
attached
no
no
no
no
no
yes
None identified
Med-surg, telemetry also house post-transplant patients—no
similar infections of related concern noted.
All of the following were reviewed for competency, credentialing,
privileging with no issues identified. :
Transplant team
Pharmacy
Nursing
Respiratory
Critical care providers
Page 2
#
Analysis Question
Prompts




10
11
12
13
14
15
How did actual staffing
compare with ideal levels?
What is the plan for dealing
with staffing contingencies?
Were such contingencies a
factor in this event?
Did staff performance during
the event meet expectations?
To what degree was all the
necessary information
available when needed?
Accurate? Complete?
Unambiguous?
To what degree was the
communication among
participants adequate for this
situation?
Provider and/or staff scope of practice concerns
Whether the provider was credentialed and privileged
for the care and services he or she rendered
The credentialing and privileging policy and
procedures
Provider and/or staff performance issues
Include ideal staffing ratios and actual staffing ratios along with
unit census at the time of the event. Note any unusual
circumstance that occurred at this time. What process is used to
determine the care area’s staffing ratio, experience level and
skill mix?
Include information on what the organization does during a
staffing crisis, such as call-ins, bad weather or increased patient
acuity.
Describe the organization’s use of alternative staffing.
Examples may include, but are not limited to:

Agency nurses

Cross training

Float pool

Mandatory overtime

PRN pool
If alternative staff were used, describe their orientation to the
area, verification of competency and environmental familiarity.
Describe whether staff performed as expected within or outside
of the processes. To what extent was leadership aware of any
performance deviations at the time? What proactive
surveillance processes are in place for leadership to identify
deviations from expected processes? Include omissions in
critical thinking and/or performance variance(s) from defined
policy, procedure, protocol and guidelines in effect at the time.
Discuss whether patient assessments were completed, shared
and accessed by members of the treatment team, to include
providers, according to the organizational processes.
Identify the information systems used during patient care.
Discuss to what extent the available patient information (e.g.
radiology studies, lab results or medical record) was clear and
sufficient to provide an adequate summary of the patient’s
condition, treatment and response to treatment.
Describe staff utilization and adequacy of policy, procedure,
protocol and guidelines specific to the patient care provided.
Analysis of factors related to communication should include
evaluation of verbal, written, electronic communication or the
lack thereof. Consider the following in your response, as
appropriate:
Root Cause Analysis Findings
RCA Framework
Revised 2/27/2013
Plan of
Root Cause
Action/ risk
Yes/No
reduction
strategy?
Dietary/RD
Infection prevention/ID
Consulting providers
Preoperative staff
Residents
Social work/ case mgt
No issues were identified with staffing ratios, competency or
excessive overtime. No unusual circumstances occurred during
this time.
no
no
There are staffing plans in place to deal with unanticipated events.
Agency nurses were not used during this time in ICU, the critical
care unit does utilize agency for supplementing staffing. The same
competencies are used to make assignments. Respiratory and
nursing have several open positions. Both areas use overtime as
necessary. This was not identified as an issue in these cases.
no
no
no
no
no
yes
no
no
no
no
Not applicable
No issues were identified with any performance deviations specific
to these patients. Performance issues were identified following
diagnosis on one occasion with dietary and one occasion with linen
handling and both non-contributory.
There were no substantially related delays in lab work, obtaining
cultures or starting treatment in any of these patients. Some of
these organisms, such as mycobacterium are a long, slow growth
period and treatment was started prior to receiving the final
cultures which always take extended time due to their inherent
nature. Assessments were documented regularly, with concurrent
vital signs and multiple layers of team assessments with regular,
consistent and reliable involvement from the highest level of
specialized providers.
Handoffs, communication and multidisciplinary rounding were
completed in a timely fashion and communicated and documented
regularly with these patients. No issues were identified.
Page 3
#
Analysis Question
Prompts
Root Cause Analysis Findings
RCA Framework
Revised 2/27/2013
Plan of
Root Cause
Action/ risk
Yes/No
reduction
strategy?


16
17
Was this the appropriate
physical environment for the
processes being carried out
for this situation?
What systems are in place to
identify environmental risks?
The timing of communication of key information
Misunderstandings related to language/cultural barriers,
abbreviations, terminology, etc.

Proper completion of internal and external hand-off
communication

Involvement of patient, family and/or significant other
Consider processes that proactively manage the patient care
environment. This response may correlate to the response in
question 6 on a more global scale.
What evaluation tool or method is in place to evaluate process
needs and mitigate physical and patient care environmental
risks?
How are these process needs addressed organization-wide?
Examples may include, but are not limited to:

alarm audibility testing

evaluation of egress points

patient acuity level and setting of care managed
across the continuum,

preparation of medication outside of pharmacy
Identify environmental risk assessments.

Does the current environment meet codes,
specifications, regulations?

Does staff know how to report environmental risks?

Was there an environmental risk involved in the event
that was not previously identified?
Construction was occurring outside the ICU during the time period
for the NI building and windows were opened by family and staff
possibly allowing contaminants to enter. Some of the patients went
home into uncontrolled environments and returned and were
possibly exposed. Rooms were cross-verified and 2 rooms held
the same patient. Terminal cleaning was performed postconstruction on all rooms re-purposed during adjacent OR
construction. HVAC tested negative for the organisms in question.
no
yes
no
yes
no
yes
Risk assessments include ICRA for construction, annual IC risk
assessment, regular EOC rounding, leadership rounds,
multidisciplinary rounds were performed. Staff, residents and
providers receive annual training on SERS reporting in addition to
annual safety fairs and initial orientation.
Window opening capability and proximity to ongoing construction
was not addressed prior to the infections. The organisms were not
specific to potential contaminants in the soil-but this was identified
as a potential risk.
18
What emergency and failuremode responses have been
planned and tested?
Describe variances in expected process due to an actual
emergency or failure mode response in connection to the event.
Related to this event, what safety evaluations and drills have
been conducted and at what frequency (e.g. mock code blue,
rapid response, behavioral emergencies, patient abduction or
patient elopement)?
Emergency responses may include, but are not limited to:

Fire

External disaster

Mass casualty

Medical emergency
Failure mode responses may include, but are not limited to:

Computer down time

Diversion planning
Organization regularly conducts a broad spectrum of emergency
management code drills, fire drills and has plans for facility
construction, downtime, power loss, utility issues. Facility
construction on the adjacent OR area had appropriate ICRA fully
executed. The windows were not initially considered in NI building
construction. The organisms do not directly relate to open air.
HVAC was negative and water sampling was negative for
applicable organisms.
Page 4
#
19
20
21
22
23
24
Analysis Question
How does the organization’s
culture support risk reduction?
What are the barriers to
communication of potential
risk factors?
How is the prevention of
adverse outcomes
communicated as a high
priority?
Prompts

Facility construction

Power loss

Utility issues
How does the overall culture encourage change, suggestions
and warnings from staff regarding risky situations or problematic
areas?

How does leadership demonstrate the organization’s
culture and safety values?

How does the organization measure culture and
safety?

How does leadership establish methods to identify
areas of risk or access employee suggestions for
change?

How are changes implemented?
Describe specific barriers to effective communication among
caregivers that have been identified by the organization. For
example, residual intimidation or reluctance to report co-worker
activity.
Identify the measures being taken to break down barriers (e.g.
use of SBAR). If there are no barriers to communication
discuss how this is known.
Describe the organization’s adverse outcome procedures and
how leadership plays a role within those procedures.
How can orientation and inservice training be revised to
reduce the risk of such events
in the future?
Describe how orientation and ongoing education needs of the
staff are evaluated and discuss its relevance to event. (e.g.
competencies, critical thinking skills, use of simulation labs,
evidence based practice, etc.)
Was available technology
used as intended?
Examples may include, but are not limited to:

CT scanning equipment

Electronic charting

Medication delivery system

Tele-radiology services
Describe any future plans for implementation or redesign.
Describe the ideal technology system that can help mitigate
potential adverse events in the future.
How might technology be
introduced or redesigned to
reduce risk in the future?
Root Cause Analysis Findings
A safe culture has been a particular focus for the past year in
biannual Safety fairs, the safety survey results from the ARHQ
survey (conducted apx Q 18-24 months) and action plans.
Leadership training in the past 18 months has included sessions on
safe culture and emotional intelligence. Revised orientation was
completed for residents and staff on SERS reporting and safety
culture.
Communication regarding infections, risk for infections and
identification of infections in the transplant patient are
communicated through interdisciplinary rounds in the ICU several
days per week. This supplements direct caregiver interaction
between transplant providers and the critical care staff. Rounds
and surveillance increased as a result of the findings.
Infection Prevention of hospital acquired conditions is an
organizational priority for 2014 and included in the Infection
Control Plan, the Performance Improvement Plan and goals, with
monitoring results reported to MEC, IC, PIC, Quality Committee,
EOC and Transplant Committees as well as up to the Board.
Tracking of infections specific to the transplant population was
improved and added to additional surveillance by the ICP and
reported to the IC Committee.
The following departments received re-education on infection
prevention standards: respiratory, dietary, linen handlers, and
nursing, residents and the transplant team on importance of hand
hygiene, cleaning standards, contamination and had ATP testing
results shared. Respiratory had re-education on use of cidex and
timing of soaks and glove changes. Competencies were reviewed
and not changed.
No issues with technology were identified.
ATP testing was increased with concurrent feedback and actions
as needed. Surveillance in the electronic infection tracking system
of culture results was expanded.
RCA Framework
Revised 2/27/2013
Plan of
Root Cause
Action/ risk
Yes/No
reduction
strategy?
no
no
no
yes
no
yes
no
yes
no
no
no
yes
Page 5
RCA Framework
Revised 2/27/2013
Page 6
Plan of Action
Risk Reduction Strategies
Responsible
Party
Date
Started
2/1/14
Action Item #1:
Date
Complete
d
RCA Framework
Revised 2/27/2013
Method: Policy, Education, Audit, Observation &
Implementation
2/28/14
Windows in critical care units were bolted shut.
Staff education in small groups and 1:1 with follow-up memo from IC issued.
Action Item #2: Computers:
Two WOWs (workstations on wheels) were provided as dedicated for
transplant team care and mobile use.
Norm Epps
Carolyn Carter
2/18/14
2/18/14
ICU leadership rounds to monitor weekly,
exceptions reported to PIC
Quality team random audit
Action Item # 3:
John
Santangelo
2/18/14
2/28/14
EOC and ICU leadership rounds
Action Item #:
Carolyn Carter
2/1/14
Daily huddles, ICU leadership rounds
Current process was an ICU caregiver cleans their own at beginning of shift
with wipes and prn (hand hygiene surveillance auditors have been
empowered to stop the line if gloves used or inappropriate contamination
observed)
Action Item # 4:
Hand hygiene surveillance in ICUs by IP showed <50% compliance,
concurrent education completed with ICU caregivers, staff and therapists,
this is ongoing, with additional quality person assigned for hand hygiene
monitoring. Additional personnel dedicated to 1 hour weekly ICU HH
surveillance, this will be reported to IC and PIC committees going forward.
Ongoing
each
shift
Priscilla
DawkinsLevinsky
2/18/14
ongoing
Quarterly to IC and PIC
Action Item #5:
Verified the 3 organisms under discussion as part of the scope of this group
will be included IC surveillance, IP will set-up as standardized inpatient
alert process, and will track in Theradoc electronic surveillance system
going forward with reporting to IC Committee.
Priscilla
DawkinsLevinsky
February
2014
ongoing
Report quarterly to IC Committee
Action Item # 6:
Reggie
Severe
February
2014
ongoing
Variations reported to ICP and critical care
committee
Critical care screen/keyboard/mouse cleaning by team & change-out of
equipment as indicated occurred over the past week, special keyboard
covers replaced and installed by IT going forward prn.
Respiratory therapy & IC reviewed the ventilator and respiratory cleaning
process per manufacturer’s recommendations, logs are kept up-to-date and
in office, manager reinforced the cleaning process with RT staff, clarification
Page 7
RCA Framework
Revised 2/27/2013
of process is: set a timer for exact soak minutes (opportunity was identified
to not greatly exceed soak times), reminders were provided to team overall
use of PPE, there are baseline staffing levels—some surge situations can
occur and are handled individually.
Action Item #7:
Dianne King
February
2014
February
26, 2014
Analysis by ID and by task force completed
on 2/26/14
Action Item #8:
Visitors may not bring flowers into ICU currently. This will be expanded to
include fresh fruit and vegetables not be permitted to reduce the possibility
of contamination.
Carolyn Carter
February
27, 2014
February
27. 2014
Daily huddles and new process in ICU.
Action Item #9:
The 2013 Infection Prevention Plan evaluation will reflect inclusion of review
of organisms/ risk-identified concerns from the past year’s data. The 2014
IC Plan and risk assessment will include expansion of special population for
transplant and be submitted to IC Committee for review and approval.
Priscilla
DawkinsLevinsky
February
27, 2014
March
26, 2014
Passed IC Committee, P & P and MEC
Action Item # 10:
Infection Control ICU rounds will be expanded to include nights and
weekends with increased frequency in critical care to quarterly. Respiratory
therapy will be included in critical care IC rounds. Results and action plans
as needed continue to be reported to IC Committee.
Action Item # 11:
Hand hygiene surveillance in ICUs by IP showed <50% compliance,
concurrent education completed with ICU caregivers, staff and therapists,
this is ongoing, with additional quality person assigned for hand hygiene
monitoring. Have identified personnel dedicated to 1 hour additional weekly
ICU HH surveillance, this will be reported to IC and PIC committees going
forward. Use of TJC HH tool for tracking.
Priscilla
DawkinsLevinsky
March
2014
ongoing
Reports to IC Committee quarterly
Priscilla
DawkinsLevinsky
March
1,2014
ongoing
Report to IC and PIC committees quarterly
February
March 7,
ORGANISM TRENDING (3 for time period of 1/1/12—2/1/14 was
completed. Patients were cross-referenced by organism, timing, ICU care
during their visits, as well as cross referenced for the use of a ventilator
during their care. Microbiology provided organism culture and patient
specific information to cultures such as dates of service, culture location and
organism specifics. Cross referencing was completed by Quality. Ventilator
identification was obtained from direct medical record review by Quality.
Ventilator serial numbers were provided by RT.
Action Item # 12: ICU curtains have been exchanged out over the week as
Page 8
RCA Framework
Revised 2/27/2013
access, supply and manpower permitted, now return to regular cycle
exchange with process in place for a notification to EVS every time they are
identified as soiled or isolation, curtains in large volume changes need preordering.
Action Item #13:
12, 2014
2014
EOC and ICU leadership rounds
Dianne King
3/15/14
April 10,
2014
Task force and IC Committee, HVAC
cleaning reports to EOC and IC Committees
Lon BenAsher
2/1/14
2/18/14
IC rounding for monitoring
Michael
Jackson
2/1/14
2/18/14
IC rounding for monitoring
Michael
Jackson
2/1/14
2/18/14
IC rounding for monitoring
Jan Shear and
Dianne King
2/1/14
Target
4/24/14
IC rounding for monitoring
Reggie
Severe
2/1/14
2/18/14
IC rounding for monitoring
Michael
Jackson
Three ICU rooms were identified as having housed patients identified with
organisms and/or were in close proximity to previous construction timing—
these were selected for environmental culturing of HVAC and water.
Timeline contracts, materials, scheduled, anticipate results, apx by 3/15/14.
Action Item # 14:
Dietary single time observed contamination (container item drop to floor not
discarded) follow-up group education and individual counseling.
Action Item # 15:
EVS daily room clean now has a heavy focus on bedrails, education
reinforcement is ongoing, competency was demonstrated, observation
increased by supervisor day/evening and supplemented with ATP
surveillance. ICU cleaning process reviewed by Priscilla and Michael
Jackson.
Action Item # 16:
Linen single time observed contamination (touching floor) follow-up group
education and individual counseling.
Action Item # 17:
Re-education of Residents: Additional education need was identified and
completed for ICU & transplant rotation residents and fellows on HH. Was
completed concurrently in small groups and 1:1 sessions by Quality. Will
additionally be covered in mandatory meeting 4/24/14.
Action Item # 18:
Re-education of Respiratory-Additional HH and exchange of gloves
education need was completed for RT in small groups and 1:2 by manager.
Page 9