FAILURE MODES AND EFFECTS ANALYSIS

FMEA

REDUCING FALLS AND INJURY

SUNY DOWNSTATE MEDICAL CENTER

UNIVERSITY HOSPITAL OF BROOKLYN

MAY 2012 – MARCH 2013

 Objectives of this document

• Describe SUNYDMC, University Hospital of Brooklyn

• Defined FMEA process in this institution
• Describe the FMEA project selection process
• Explain the application of the FMEA process to “Reducing Falls and Preventing
Injury from Falls” at UHB
• Report on the results achieved by the project team

Background of SUNYDMC

SUNYDMC is the only academic medical center in Brooklyn, serving a large

population–over 2.3 million people–and one that is among the most diverse in the world.
Today, SUNY Downstate is one of the nation’s leading urban medical centers. SUNY
Downstate comprises a College of Medicine, College of Health Related Professions,
College of Nursing, School of Graduate Studies, and University Hospital of Brooklyn.

What is an FMEA?

FMEA (failure Modes and Effects Analysis) as it’s applied in healthcare is a proactive
team-oriented approach to risk reduction that seeks to improve patient safety by
minimizing risk potential in high risk processes.
Rather than focus on a problem-after the occurrence, FMEA looks at what could go
strong at each step, the so-called “Failure Modes”, assigns a risk score to each of these
possibilities and provides for a team-oriented approach to focus resources on priority
issues.

Why use FMEAs in healthcare?

Since the 1960’s FMEA’s have been used in nuclear, military, aviation, food and
automotive industries to improve safety with significantly positive results. The same
process can be used in healthcare to improve safety and reduce medical errors. The Joint
Commission standards require facilities to select at least one high-risk process for
proactive risk assessment each year.

Choosing Reduction of Falls and Injury as an FMEA project at UHB

Preventing patient falls is a top priority for every caregiver/ administrator in healthcare.
Despite heightened national attention to this issue, patient fall rates across the US
continue to escalate, putting patients and caregivers at increasing risk. Up to 50% of

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hospitalized patients are at risk for falls, and almost half of those who fall suffer an
injury.

In today’s evolving pay-for-performance environment, healthcare facilities have a huge

financial stake in reducing the number of patient falls. As of 2008, hospitals no longer
receive payments for treating injuries caused by in-hospital falls, based on a 2007 final
rule by the Centers for Medicare & Medicaid Services (CMS). The average hospital stay
for patients who fall is 12.3 days longer, and injuries from falls lead to a 61% increase in
patient-care costs.

In 2005, the Joint Commission introduced a national patient safety goal requiring
hospitals to reduce the risk of patient harm resulting from falls and to implement a falls-
reduction program. In 2010, this requirement was upgraded to a standard.

While the falls rates at UHB compare favorably to national benchmarks, the Nursing
Department has identified areas where the quality of care is not optimal. As with many
clinical challenges, there’s no single easy answer to the challenges posed by patient falls.
An interdisciplinary collaboration analyzing the data, searching for best evidenced-based
practices, learning from colleagues’ successes, disseminating enhanced outcomes, and
eliminating ineffective practices will help us as we work to reduce patient falls on our
units and across our organization.

Conducting the FMEA – Project Methodology

Step 1 – Define the FMEA topic – reduce falls and injury associated with falling

Step 2 – Assemble the team

Cheryl Okundaye RN – Associate Nursing Director, PI and Patient Safety

Cheryl Rolston RN – Nursing director
Corey Straker – Director, Environmental Services
Debra Dickstein – Director, Physical Medicine and Rehabilitation
Dianne Woods RN – Deputy Nursing Director, Team Leader
Erica Gumbs RN – Staff Nurse Rehab
Jack Vanasco – Director, Transportation
Jaycinth Blackman RN– Director Performance Improvement
Judy Drummer RN Senior Nursing Administrator, ED
Lilyann Jeu – Clinical Pharmacist
Muhammad Islam – Director Patient Safety
Oliver Jardine – director Radiology
Redetha Abrahams-Nichols RN – Assistant director of Nursing, ED
Sherly Bristol-Gabin RN – Staff Nurse Medicine
Stanley Augustin RN Staff Nurse, Rehab
Susan Vaughan – Staff Assistant
Won Lee – Assistant Director of Nursing, Medicine

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Step 3 - Review the process – using a comprehensive gap analysis (see attached)
we analyzed our falls program against 7 metrics (coordination of falls program, reporting,
accountability, education, screening, assessment, best practices)

Step 4 – Brainstorm potential failure modes. Causes and effects – the

team assessed each indicator for whether we met it fully, partially or not at all. We
brainstormed the potential failure mode (what might happen), the potential causes,
probability of harm, and severity of harm.

Step 5 - Evaluate the risk of failure (criticality index) – the team then
matched the probability of harm against the type of harm that could occur and determined
a risk score of 1 -3; 1 – high risk, 2 – medium risk, 3 – low risk (see attached).

Step 6 – Create an Action Plan – the following items were chosen to be addressed
first:

• Have a process in place to engage frontline staff in the falls prevention process
o Implement post fall huddle process on NS 61, 62, 72, 74 ; determine
timeline to roll out to all nursing units
o Nurse managers on NS 61,62,72,74 conduct audits of hourly rounds
o Nursing units receive report card monthly with unit falls rate
o Associate Nursing Director PI makes monthly unit rounds to discuss data
o Annual Nursing Education Workshop (ANEW) for 2013 includes
simulation case study of falls
o NS 74 implemented care plans based on specific risk factors; determine
timeline to roll out to all nursing units
o
• Have department specific procedures in place to address their role in falls
prevention
o Radiology
§ Revised unit log to have column for “Strapped In” – safety
measure to prevent falls from x-Ray table
o ED
§ reviewed their falls for 2012, the literature for ED falls and the
documentation currently in the T system
§ The T system supports a falls risk assessment so there is no need to have
a different assessment.
§ For Feb – March2013, every patient who comes through the main ED
has been assessed for risk to fall using the T system. Criteria will be
refined to our patient population and then move the risk assessment to
triage

o Rehab
§ Evaluated Rehab specific assessment tool but based on
characteristics of our patients decided to continue use of current
Morse scale

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 §
Reinforcement of hourly rounding with staff
§
Nursing Director conducts weekly rounds for patient interviews
§
Post fall huddle process implemented
§
Care plans that link interventions to specific risk factors laminated
and posted for staff reference
• Have a process in place for communication of patient fall risk during hand-off
between departments
o SBAR for procedures revised and implemented ; now includes
transporters formally in patient identification process
• Have a process in place to focus interventions on specific risk factors
o Evaluate usefulness of care plans that link interventions to specific risk
factors; if useful determine timeline to roll out to all units
o “Review of medications/ conditions they treat which are commonly associated
with falls” presented by Clinical Pharmacist to team– included a literature review
as well as specific UHB information.
o Recommendations to delete/ reduce dosages of hi risk meds in Healthbridge will
be presented to Pharmacy and Therapeutics Committee in March 2013.
o Develop and distribute a visual alert to staff – target date April, 2013.

Step 7 - Determine FMEA project success – Falls will continue to be a

significant concern to all hospitals. Through the use of this FMEA risk factors have been
addressed and reduced. Based on internal, state-wide and national benchmark data our
falls rate continues to be lower than comparative data. The team believes there is still
much work to do to provide an optimum safe patient environment and thus we will
continue as a team to address and reduce falls and injury risk.

References

Special Report: Best Practices in Falls Reduction: A Practical Guide. Accessed from
www. AmericanNurseToday. March 2011
Meeting the Challenge of Falls Reduction
Reducing falls: a call to action
How to build a successful business case for a falls-reduction program
Components of a comprehensive fall-risk assessment
Focusing on staff awareness and accountability in reducing falls
Creating a culture of safety: Building a sustainable fall-reduction program
Current and emerging innovations to keep patients safe

UHC Patient Safety Net – Fall Prevention Web Conference. April 19. 2012

Achieving Sustained Improvement in Nursing Quality. New York State Partnership for
Patients Presentation. September 24, 2012

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UHC Patient Safety Net Fall Prevention Web Conference – Implementing successful
Strategies. August 12, 2012

Weinberg, Jeffrey et al. An Inpatient Fall Prevention Initiative in a Tertiary Care

Hospital. The Joint Commission Journal on Quality and Patient Safety. Vol 37, Number
7, July 2011.

Brown, Diane et al. The Kaiser Permanente FMEA Model – Simplified for Healthcare
Personnel. Journal for Healthcare Quality. Vol 27, No 1, pp 45-55. 2005.

Road Map to a Comprehensive Falls Prevention Program. Minnesota Hospital

Association. 2011.

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 Falls Prevention FMEA – 2012-13
Step/ link in process Potential failure Potential Probability Severity Risk Code/ Recommended actions
mode – what causes of harm of harm number***
*** based on Kaiser Permanente FMEA model – simplified for might happen level
Healthcare
1. COORDINATION FALLS PROGRAM-
1a. The facility promotes a team approach to falls prevention within the A A C C 3
interdisciplinary falls team comprised of clinical and non-clinical staff.
2a. The team has at least one team member that is a healthcare provider A A C C 3
with a background/additional education in falls prevention.
3a. There is a designated coordinator(s) for the facility’s falls prevention A A C C 3
program.
4a. The coordinator(s) has dedicated time to serve in this coordination role. A B,C C C 3
5a. A process is in place to engage front-line staff in the falls prevention A,B A,B,C E B or C 1-2
planning process.
6a. An interdisciplinary group oversees the strategic plan for the falls A A,B C C 3
prevention program.
7a. The falls prevention program plan is reviewed by the group and A A,B C C 3
updated periodically throughout the year.
8a. An interdisciplinary team is involved in implementing the falls A A,B C C 3
prevention program, including representation from across the facility (e.g.
nursing, medical staff, radiology, transport services, PT/OT/RT speech
therapy, social services, environmental services, pharmacy).
9a. Department specific procedures are in place to address their unique A,B A E B 1
role in falls prevention.
10a. The facility utilizes a Unit-Based champion” approach to falls A A,B,C D C 3
prevention (or a hospital-wide champion approach for smaller facilities).
11a. The Fall prevention program includes: A,B A D or E C 3
Fall prevention practices for special populations such as mental health,
stroke, TBI, cardiovascular.
12a. Additional screening, beyond the fall risk screening tool, to determine A,B A D B or C 2-3
individual patient’s risk for fall-related injury (e.g. A = Age; B = Bone
density; C=Coagulation;
S= Post-Surgical.
13a. Interventions to reduce serious injuries for patients at risk for fall- B A E B 2-3
related injury. e.g. high/low bed, floor mats, hip protectors, helmets for
patients with missing bone flap.
2. REPORTING- Data Collection: A A,D D C,D 3
2a. The facility has a concurrent reporting process (such as occurrence
reporting) in place to collect information on all falls within the facility.
2b. The fall event documentation system (electronic or paper) is designed A A D C,D 3
to capture sufficient detail about the event to allow for adequate event
analysis.

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 Potential failure Potential Probability Severity Risk Code/ Recommended actions
mode – what causes of harm of harm number***
might happen level
Data Analysis: A D D C,D 3
2c. A process is in place to review and analyze reported fall event
information on a regular basis for learnings and improvement
opportunities.
2d. Falls data are shared within the unit and across units on a regular A B,D D C,D 3
basis.
2e. Data reports shared with staff provide information beyond falls rates to A B,D D C,D 3
help staff understand the types of falls occurring and the causes of the
falls.
2f. Fall cases are routinely shared through patient stories as well as A B,D D C,D 3
through data.
3. ACCOUNTABILITY-
3a. Clinical staff is informed of expectations regarding falls risk screening, A,B A,D E B 1
assessment and interventions to prevent falls.
3b. Non-clinical staff is informed of expectations regarding their role in the A,B A,D E B 1
prevention of falls.

3c. Expectations and supporting education have been incorporated into new A,B A,D E C 2
employee orientation for clinical (e.g. nursing, therapy, pharmacy) and non-
clinical (e.g. environmental services, dietary, transportation) staff.
3d. Expectations and supporting education have been incorporated info new A,B A,D D C 2
physician and resident orientation.
3e. Fall prevention is incorporated into continuing educational opportunities A,B A,D D C 2
for physicians and residents (e.g. including falls prevention as a component
of residence program, interdisciplinary rounds, grand rounds, speakers,
physician newsletter).
3f. On-going falls prevention education for all staff is provided at least A,B A,D D C 2
annually.
3g. Members of the falls prevention team(s) have additional training on falls A,B D C 3
prevention so that they can serve as resources to their units (this may be
provided through the falls champions or outside opportunities).
3h. The facility has a process in place to update administration on the status A A,D D B-C 2-3
of falls prevention efforts and any factors that may enhance or limit success.
3i. Administration includes falls prevention and the on-going evaluation at A A,D E C 2
the program in strategic planning and resource allocation.
4. EDUCATION-
4a. Patient/family education tools are disseminated for falls safety as A,B A,C,D D C-D 3
appropriate.
4b. A process is in place for at-risk patients, and their families, to A,B A,C,D D C-D 3
demonstrate understanding of their level of risk and role in falls prevention
and injury risk reduction.

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 Potential Potential causes Probabilit Severi Risk Recommended actions
failure mode – y of harm ty of Code/
what might harm number**
happen level *
4c. The facility requires, AND has a designated place to document, falls A B C C-D 3
prevention patient/family education.
4d. A process is in place to provide al-risk patients, and their families A,B A,C,D D C-D 3
discharge instructions about fall prevention strategies at home.
4e. The facility expects, AND has as designated place to document, that
staff provide additional prevention education when:
1. The patient’s condition improves making them more vulnerable to A,B A,C,E,F D C-D 3
attempting unassisted transfers.
2. The patient has a change in status that would make them more A,B A,C,E,F D C-D 3
vulnerable to a fall (e.g. change in medication, undergoing a
procedure). A,B A,C,E,F D C-D 3
3. The patient has experienced a fall in the facility.
5. SCREENING-.
5a. The facility uses validated, reliable fall risk screening tools A A F B-C 1-2 Priority
5b. The facility requires, AND has a designated place to document, formal A A D B-C 1-2
screening of all patients within 8 hours of admission for in-patients.
The facility requires, AND has a designated place to document, re-screening
of patient risk:
1. at least every 24 hours; A A,G E B-C 1-2
2. with transfer between units A A,G E B-C 1-2
3. with change in status/condition (e.g. post procedure, high-fall risk A A,G E B-C 1-2
medication change post fall.
5c. A structured process is in place to screen outpatients for fall risk:
1. In the Emergency Department
2. In Radiology A A,I E B-C 1-2
3. In other outpatient areas identified by the facility as higher risk A A,I E B-C 1-2
areas for falls through review of the facility’s falls data. A A,I E B-C 1-2
4. A structured process is in place to put fall prevention interventions A A,I E B-C 1-2
in place for outpatients identified at-risk for falls
6. ASSESSMENT-.
6a. If screen is positive for fall risk, the facility requires, AND has a A,B A,E,F E B-C 1-2
designated place to document, further comprehensive clinical assessment
of patient’s risk factors to link risk factors to appropriate interventions
6b. A structured process is in place to identify patients at high-risk for injury A,B A E B-C 1-2
from falls.
6c. A structured process is in place to identity each patient’s mobility status. A,B A E B-C 1-2
6d. A process is in place to generate referrals to interdisciplinary team A,B A D B-C 1-2
members to contribute to the comprehensive clinical assessment.

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 Potential Potential causes Probabilit Severi Risk Recommended actions
failure mode – y of harm ty of Code/
what might harm number**
happen level *
6e. There is a designated place to document evidence of involvement of A,B A,E D B-C 2-3
team members in the clinical assessment of fall risk factors.
6f. A system is in place to alert all staff to the patient’s fall-risk status. A,B A, E B-C 2
6g. A system is in place to alert all staff to the patient’s mobility status. A,B A E B-C 2
6h. There is a process in place for communication of patient fall risk during A,B A, E B-C 1
hand-offs between departments (e.g., transport form, verbal communication
process).
6i. There is a process in place for receiving departments to review fall risk A,B A,G,I E B-C 1
information and implement appropriate prevention strategies.
7. BEST PRACTICE-

7a. The facility has a process in place to focus interventions on specific risk A,B A,G,H,I D B-C 1
factors rather than on general risk score.
7b. The facility has decision-support tools accessible (electronic or paper) A,B A,I D B-C 1
that provide staff with the intervention options that should be considered for
each fall risk factor.
7c.The clinical staff has a process in place to care for all patients using A,B A,G E B-C
universal fall precautions - at a minimum.
7d. The facility has implemented a plan to utilize appropriate staff and A,B A,B,I D B-C 2-3
equipment for transfers and/or repositioning tasks as indicated by patient
mobility status.
7e. For patients assessed as high-risk for falls, the facility has the following
intervention options in place: A,B I D B-C 1-2
1. Review by physician and/or pharmacist of high-fall risk
medications and timing of medication administration.

2. A plan to reduce the use of sedative hypnotics for sleep (e.g. A,B A,I D B-C 2-3
Ambien, Ativan and Benadryl).

3. A structured criteria for identifying patients that should have staff A,B A,H E B-C 1-2
remain within arms reach of patient when toileting.

4. A structured ‘staying within arms reach” program (1:1, 1::2) A,B A,H E B-C 1-2

5. Scheduled toileting plan (e.g. toileting prior to administration of A,B G,H,I E B-C 1-2
high-fall risk medications. - such as sleep aids and narcotics, prior
to end of shift or during hourly rounding).

6. Use of tall injury prevention equipment such as low-beds and A,B A,B,I E B-C 2-3
bedside floor mat.

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 7. The facility utilizes a hand-off process during nursing shift reports A,B G,I E B-C 1-2
to communicate CHANGES in fall risk and injury risk, and to
observe it interventions are in place.
A,B G,I E B-C 1-2
8. The facility has a process in place to communicate a patients risk
and prevention interventions to other staff caring for the patient
(e.g. physician, dietitian, PT, OT).

7f. The facility has instituted purposeful bedside rounding for all patients
which includes:
1. Structured process for conducting rounding including clear A,B G E B-C 1
expectations of components covered during rounds.

2. Expectations include anticipating the care needs of the patient, A,B G D B-C 1-2
e.g. medications due in the next hour, transportation to test or
therapy.

3. Effective methods for engaging the patient during bedside rounds. A,B G E B-C 1-2

4. A roll-out plan for rounding which includes small tests of changes A,B G E B-C 1-2
to develop an effective process and tong-term plan for hard-wiring
rounding into work flow.
A,B G E B-C 1-2
5. Involvement of front-tine staff in development of rounding process.

6. Involvement of nurse managers/leaders in regularly scheduled A,B G E B-C 1-2

rounding auditing and coaching.

7. A standardized auditing tool/process for conducting rounding A,B G D B-C 1-2

audits.

8. The facility has a process in place to reduce fall-risk for patents A,B A, D B-C 2-3
post-surgery (i.e. while in PACU and 6 hours after transfer to
nursing unit).
A,B A D B-C 2-3
9. Fall risk is re-assessed following the post-surgical period.
A,B G,I D B-C 2-3
10. The facility has a process in place to evaluate patient fall risk plan
of care with the interdisciplinary team.
7g. A process is in place to conduct a post-fall safety huddle after any fall A,B A,G,H,I D B-C 2-3
occurs.
7h. A process is in place to follow-up on any recommendations/corrective A,B G,I D B-C 2-3
actions from safely huddles.
7i. The fall prevention program post fall assessment guideline includes A,B A D B-C 2-3
Neuro checks for fallers with positive signs of head trauma or complaints of
headache post fall.

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 Potential Potential causes Probabilit Severi Risk Recommended actions
failure mode – y of harm ty of Code/
what might harm number**
happen level *
7j. The facility requires a revised plan of care based on post-fall analysis as A,B G D B-C 1-2
needed.
7k. Patients are automatically considered high-risk following a fall during A,B H E B-C 1-2
that stay and appropriate interventions are put in place.
7l. The facility has a structured process in place for fall team member(s) or A,B D C D 2
designees to participate in environmental safety rounds, at least quarterly, to
assess environmental safety across the hospital related to falls.
7m. The facility has a process in place to implement recommendations A,B D,G,I D D 2
resulting from environmental safety rounds.
7n. The facility has a process in place for front-line staff to integrate fall A,B H E B-C 1-2
prevention checks in their rounding process for every patient.
7o. Fall prevention checks include:
1. Check that bed alarms are in place and activated as appropriate. A,B G D B-C 2-3

2. Patient beds are in the correct position. B G E B 1

3. Ensuring sates pathways, e.g. reduced clutter, clear and well-lit B G E B-C 1-2
pathway to bathroom, IV poles are in a safe position.

4. Appropriate equipment and assistive devices, e.g. raised toilets A,B A,G,H,I E B-C 1-2
with safety rails, commodes, shower chairs, floor mats are in use
.
5. Managers incorporate fall prevention checks during their
observation audits and provide feedback to front-line stall on a A G,I D B-C 1
least a quarterly basis.

6. The facility has an algorithm in place to assign low-beds and floor

mats to patients identified at high-risk for injury related to falls. B A,B,I D B-C 3

7. Equipment to reduce risk for injury (e.g. low beds, hip protectors, B A,B D B-C 3
floor mats) is accessible to staff.

8. The facility has guidelines in place for appropriate bed alarm use, B B D B-C 2-3
or alternatives to alarms (e.g. sitters), individualized to the
patient’s risk factors.
9. Forcing functions (e.g. alarm reset reminders on beds) or B A,B D B-C 2-3
reminders (e.g. signage) are in place for resetting alarms prior to
leaving patients room.
10. Front-line staff from across the facility (e.g. therapy staff, nursing A,B B D B-C 1
assistants) is trained on falls prevention equipment (e.g. bed
alarms, chair alarms, low-bed use, and floor mat placement).

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 POTENTIAL FAILURE MODE – WHAT MIGHT HAPPEN
A. Increased falls
B. Increased injury

POTENTIAL CAUSES
A. Lack of knowledge
B. Lack of administrative support
C. Perceived/ actual Heavy workload
D. Unclear roles and responsibilities
I. Low prioritization of falls p/p
E. IT issues
F. Duplicate, redundant documentation
G. Inadequate staff accountability to follow p/p
H. Lack of critical thinking when applying falls p/p

PROBABILITY/LIKELIHOOD OF HARM
A. Impossible - (physically impossible to occur)
B. Improbable - (so unlikely it can be assumed occurrence may not be experienced)
C. Remote - (not likely to occur but possible)
D. Occasional - (may occur)
E. Probable - (quite likely to occur)
F. Frequent – (Almost certain to occur)

SEVERITY OF HARM
A. Category 1 – Catastrophic (death)
B. Category 2 – Critical (severe or severely exacerbated injury or illness)
C. Category 3 – Marginal (minor of mildly exacerbated injury or illness)
D. Category 4 – Negligible (trivial or trivially exacerbated injury or illness)

RISK CODE
1 - High risk 2 - Medium risk 3. - Low risk
LIKELIHOOD/PROBABILITY OF HARM
DESCRIPTION OF CATEGORY/ Impossible Improbable Remote Occasional Probable Frequent
INJURY
physically so unlikely not likely may occur quite almost
impossible it can be to occur likely to certain
to occur assumed but occur to occur
occurrence possible
may not be
experienced
A B C D E F
Category Illness/Injury
Catastrophic Death A 3 3 2 1 1 1
Critical Severe injury B 3 3 3 2 1 1
Marginal Minor injury C 3 3 3 3 2 2
Negligible No injury D 3 3 3 3 3 3

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