Use of failure mode and effects analysis for

proactive identification of communication and

handoff failures from organ procurement to
transplantation
A multidisciplinary team from the University of Wisconsin Hospital and Clinics Dina. M. Steinberger, PA-C,
transplant program used failure mode and effects analysis to proactively examine Stephen V. Douglas, RN-C,
opportunities for communication and handoff failures across the continuum of
MS, Mark S. Kirschbaum,
care from organ procurement to transplantation. The team performed a modified
failure mode and effects analysis that isolated the multiple linked, serial, and com- RN, PhD
plex information exchanges occurring during the transplantation of one solid organ. University of Wisconsin, Madison
Failure mode and effects analysis proved effective for engaging a diverse group
Corresponding author: Dina Steinberger,
of persons who had an investment in the outcome in analysis and discussion of PA-C, UW Organ Procurement Organi-
opportunities to improve the system’s resilience for avoiding errors during a time- zation, 450 Science Drive, Suite 220,
pressured and complex process. (Progress in Transplantation. 2009;19:208-215) Madison, WI 53711-9135
(e-mail: dsteinberger@uwhealth.org)

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errors do occur and the associated costs are significant.

Notice to CE enrollees: At a minimum, delays ensue and expensive resources
A closed-book, multiple-choice examination after this (personnel time, operating room services) are wasted.
article tests your ability to accomplish the following More serious outcomes include donor organs compro-
objectives: mised as a result of prolonged cold ischemia time or
1. Discuss the complexity of system errors and the role life-threatening donor-recipient mismatches. Commu-
of hidden or “latent” conditions that produce errors nication and handoff problems are not uncommon in
2. Articulate the purpose of proactive risk assessment health care. The Joint Commission reports, “Inadequate
3. Describe the process of performing a structured communication between care providers or between
analysis using the Failure Mode and Effects Analysis care providers and patients/families is consistently the
(FMEA) method main root cause of sentinel events.” Furthermore, they
4. Determine 3 ways that FMEA can be an effective report that 75% of these communication-based events
and flexible tool for analyzing and improving transplant lead to death.1
processes across the continuum of care The prevalence of communication failures in health
care results not only from the sheer volume of infor-
mation exchanged but also from the many ways that

A conservative estimate is that at least 48 handoffs

of significant information involving a minimum
of 20 clinicians, staff, and family members occur in the
communication channels can be disrupted and infor-
mation mishandled. Although a lack of information
may result in errors from uninformed actions, the prob-
continuum from organ procurement to transplantation lem in today’s data-rich, technological environments
care during the placement of 1 solid organ. Despite a mul- becomes one of having too much information. The
titude of safety checks and verification mechanisms, burden then becomes sifting through the less-critical,

208 Progress in Transplantation, Vol 19, No. 3, September 2009

 Analysis of communication and handoff failures

irrelevant, or bloated information to find—and then their impact on mission success and person-
interpret—relevant information, generally while nel/equipment safety.7
within a time-pressured context. The resulting “cogni-
tive overload” adversely affects decision making and Clinicians, however, have voiced concern over
distorts situational awareness.2 the use of FMEA in clinical situations. “Our patients
One study of decision support and information are not machines!” is the mantra. Although it is true
systems cites examples of adverse outcomes associ- that the complexity of health care is unlike that of any
ated with information mismanagement.3 In one case, it other industry, FMEA has been successfully applied
was shown that adverse events increase significantly to clinical situations before the introduction of new
during periods of physician cross-coverage. Another clinical devices.8
example cites critical laboratory values that, although FMEA methods were imported to health care from
promptly reported in an information system, are over- other industries by leaders in patient safety, including
looked because of the large volume of normal and less the National Center for Patient Safety of the Veterans’
critical values. Affairs.9 Their modification of the tool for health care
Leonard et al4 suggest that the training and com- accommodated scoring to better differentiate risk of
munication styles of nurses and physicians are funda- patient injury when a health care process fails. By
mentally different, and the differences contribute to incorporating a requirement in the leadership stan-
miscommunication. It is common for nurses, for exam- dards of the 2002 edition of the Comprehensive Accred-
ple, to provide broad, narrative descriptions when con- itation Manual for Hospitals, the Joint Commission
sulting physicians. Conversely, physicians, looking provided a catalyst for the spread of this tool, challeng-
for diagnostic cues, want them to “get to the point”; ing health care providers to identify vulnerabilities in
that is, provide only factual highlights concerning their core processes for health care delivery. The Joint
what they view to be the situation at hand. By defini- Commission requires that health care organizations
tion, communication involves multiple participants, apply this method to at least 1 process annually.10
and it is rare for 1 person or factor to lead to a com- The organ procurement and transplant programs
munication breakdown. Typically a series of hidden, had many reasons to engage in this self-analysis. As
or “latent,” flaws in the system interact to produce a previously mentioned, the process from organ procure-
failure.5 Unfortunately, the recipient of the failure may ment to transplantation was known to be a complex,
be a well-intentioned clinician or patient. time-pressured activity; however, the full process had
After experiencing 2 unrelated adverse events not previously been mapped in detail. Furthermore, the
within a year, the Quality Resources Department at the program had experienced various occurrences and
University of Wisconsin Hospital and Clinics deter- breakdowns in process in recent years. The most seri-
mined that the logistical complexities and time pres- ous event resulted in a donor not being properly iden-
sures associated with organ transplantation created a tified as an extended-criteria donor (ECD) and
high-risk work flow and was worthy of additional subsequently an ECD kidney was transplanted into a
analysis. Consequently, we launched a prospective risk non-ECD consenting recipient. Communication fail-
analysis that used the Failure Mode and Effects ures were a key component of this incident. Analysis of
Analysis (FMEA) method. Root cause analyses were this process was endorsed by leaders at the University
conducted after each patient event to identify the con- of Wisconsin Hospital and Clinics, which had recently
tributing factors, to isolate primary causes, and to act redesigned its quality and safety structure in an effort to
to reduce future risk.6 improve accountability, foster a culture of safety, and
Both root cause analysis and FMEA are useful use more data-driven improvement methods to become
tools in efforts to better understand complex systems a more transparent and adaptive learning organization.
and to cultivate high reliability within organizations.
FMEA is a process historically used in manufacturing Objective
settings and is often employed in high-risk industries The FMEA process is a prospective risk analysis
such as aerospace and the military. The FMEA frame- method that capitalizes on the knowledge and experi-
work was developed by the military in 1949 and is ence of front-line clinicians to identify ways in which
described as follows: processes may potentially fail and enact plans to make
processes more resilient. The traditional FMEA
Military Procedure MIL-P-1629, titled Pro- method can be very time-consuming and resource
cedures for Performing a Failure Mode, intensive. The scope is usually limited and focused on
Effects and Criticality Analysis, was used as a narrow part of a complex process.
a reliability evaluation technique to deter- Because this initiative focused on the entire contin-
mine the effect of system and equipment fail- uum of the organ donation and transplant process, the
ures. Failures were classified according to scope was narrowed by examining a common feature

Progress in Transplantation, Vol 19, No. 3, September 2009 209

Steinberger et al

across the entire process, specifically, communica- What steps are already in place to mitigate and prevent
tions and handoffs among clinicians. The success of the failure from occurring? Through iterative discus-
the organ donation process is dependent upon these sion, severity, occurrence, and detection scores were
interactions, which occur under severe time constraints. assigned to each failure mode and a risk priority num-
This analysis identified the processes that were at ber was then calculated by multiplying these scores
highest risk for miscommunication or misidentifica- for each item. All risk priority numbers were ranked at
tion of critical information. the completion of the exercise.
In the second in-person meeting, the team contin-
Methods/Participants ued the scoring, validated the issues identified by the
Professionals representing the key groups of the analysis, prioritized the issues, developed a work plan,
organ procurement organization and transplant center and identified accountabilities for follow-up. In the
who had a stake in the process participated in this proj- final phase of this project, communication occurred
ect. The team included the director of the transplant via e-mail to ensure that results were being generated
service line, the senior vice president of quality and on the work plan.
information, managers of the abdominal and cardio- Ultimately, the FMEA process was applied to 48
thoracic transplant programs, operating room staff, the elements of handoff communication (Table 1). Upon
organ procurement clinical manager, the recovery spe- completion, the highest scoring items allowed the
cialist, quality improvement analysts, and staff from team to prioritize the failure modes into a work plan
risk management. Both managers of the abdominal and (Figure 2).
cardiothoracic programs were practicing transplant Before launching the work plan, team members
coordinators who regularly took clinical call and were presented their findings to hospital leaders, who
very familiar with the organ placement process. Trans- endorsed the plan within the structure of the hospital’s
plant physicians were invited to participate but were newly formed Safety, Satisfaction, and Performance
unable to attend because of scheduling conflicts. Improvement Committee. The multidisciplinary nature
The FMEA was completed in 4 meetings over the of that committee offers a forum for discussion across
course of 4 months. Before the first meeting, individ- departments and clinical service areas and serves to
uals from each key area constructed a high-level critically evaluate the investment of hospital resources
process map representing the core steps in the organ necessary for improvement work.
procurement and transplantation process. This map
begins at the time a designated requestor identifies a Outcomes
potential organ donor and initiates a call to the donor Of the 48 points of handoff communication ana-
referral answering service. A mapping tool known as lyzed, the risk priority numbers ranged from 2 to 300.
a swim-lane diagram allowed the team to visually rep- Five items had the highest risk priority numbers
resent not only the sequence when key constituents (range, 270-300) and 2 additional areas had scores of
became engaged in the process (organ procurement 150 and 180. These 7 items represented the initial
coordinator, procurement team, transplant surgeon, work plan for the team. The group discussed the high-
transplant coordinator, tissue typing laboratory, poten- est scoring items and validated them against known
tial recipient, etc) but also illustrates which informa- practice issues. The work plan (Table 2) lists some of
tion was critical to completion of that step in the the types of issues prioritized by the team.
process (ABO, donor characteristics, recipient status, To ensure that important and long lasting changes
etc). Subsequent iterations of this mapping process were instituted, the group determined that it was impor-
yielded more detail and provided a valuable opportu- tant to document and communicate the specific char-
nity for team members to learn more about each other’s acteristics of this unique work process. Consequently,
roles and responsibilities during the entire process. the team identified several important human factors
The final process map offered enough detail to facili- and workload considerations: cognitive load, fatigue,
tate discussion yet did not devolve into such fine gran- and time demands/production pressure.
ularity as to become unwieldy (Figure 1).
In the first face-to-face meeting, the team applied Cognitive Load
the FMEA framework to key points of handoff com- Up to 8 organs per donor may be in the allocation
munication. This process took 4 hours to complete and process at any one time. This process may involve
was facilitated by the senior vice president of quality multiple coordinators working with different recipi-
and information and members of the Quality Resources ents and their families. The coordinators may also be
Department. The group facilitator led the team through working on multiple donors at the same time, which
a process to answer the questions: What could go leads to exponentially demanding coordination duties.
wrong with each step? What would be the conse- On-call coordinators typically used their own systems
quence? What are the potential causes of this failure? for tracking the status of organ placement. This included a

210 Progress in Transplantation, Vol 19, No. 3, September 2009

 Analysis of communication and handoff failures

Figure 1 Excerpt of process map: organ procurement to transplantation.

variety of notes and flow sheets and a reliance on mem- fewer personnel and resources available. The work of
ory. One strategy to ease the mental burden and make organ placement does not stop until the organs are
the process more reliable involved instituting a struc- transplanted, which often leads to physical and men-
tured “organ map” to serve as a standardized checklist tal fatigue. To address this problem, the organ pro-
for transplant coordinators to track the status of specific curement coordinators reevaluated their second-call
donor-recipient matches. A group of transplant coordi- policy and found that the team needed reeducation
nators evaluated the existing ad hoc tracking systems about the policy.
and designed a standard format and procedure.
Time Demands/Production Pressure
Fatigue Implicit and explicit time demands are involved
Organ procurement and transplant coordinators in the entire process from procurement to transplanta-
commonly work during “off hours” when there are tion. The unspoken rule of thumb is as follows: the

Progress in Transplantation, Vol 19, No. 3, September 2009 211

Steinberger et al

Discussion
Table 1 Handoff communication elements identified in
failure mode and effects analysis This FMEA tool offered a number of beneficial
results that reinforced its utility and enhanced our
No. of items organization’s willingness to use it for other processes.
Area analyzed The FMEA allowed the organization to critically eval-
Communication between organ procure- uate procurement and transplant-related processes,
ment organization and referral agency eliminate redundancies in documentation, and stream-
about a potential donor 3 line and enhance handoffs across settings and serv-
Obtaining donor blood sample for infectious ices. The outcome of the FMEA resulted in numerous
disease testing and tissue typing 6 changes to work processes and procedures, which we
Registering the donor information 6 believe enhanced the reliability, efficiency, and safety
Obtaining the anatomical gift consent form 4 of our services.
During the team debriefing, we asked participants
Establishing donor management orders and
case coordination 5 to describe their perception of the FMEA activity. Par-
ticipants commented that although they all work in
Preparation of donor chart 2
segments of the transplant process together, the
Double verification of donor blood type 1 FMEA activity had been a rare event in which all “the
Verification of donor information by players” were in one room at the same time, thought-
transplant coordinator 4 fully evaluating how they interact.
Recipient selection and preparation for Some structural considerations contributed to the
transplant 8 effectiveness of our collective work. For example, dur-
Verification of recipient blood type 3 ing the meetings we used a paper checklist that served
Verification of donor information by organ both to guide work steps and to document completion.
recovery team 1 By visually flowing out the process, we more easily
Organ and specimen labeling 4 uncovered issues and branches of the work flow that
Organ and recipient verifications before
were problematic or inefficient. The use of a multidis-
transplant surgery (ie, operating room ciplinary group was an effective way to identify the
time-out procedure) 1 vulnerable points in the work flow and gain reason-
Total 48 able confidence that we had made the scope of the
project broad enough to fully identify the inherent
risks. The group members shared the assignment of
quicker the turnaround time, the better the outcome of hazard, prevention, and detection scores and were
transplanted organs. An inherent risk of a high-veloc- involved in developing the action plan. The process
ity environment is that important details will be facilitators worked very hard outside of the group
missed or shortcuts will be taken. Several documenta- meetings to ensure that documents and agenda were
tion activities along the transplantation continuum well organized in order to make the best use of the col-
were deemed to be vulnerable and were addressed in lective group time. The hazard analysis, when fol-
the action plan. These included an evaluation of the lowed meticulously step by step, is necessarily tedious
preoperative documentation by our surgical team and and time-consuming. An interested and invested
the donor-recipient form, which serves as a handoff group membership ultimately makes the process more
tool between the procurement and transplant coordi- thoughtful and effective. Previous teams that com-
nators and the inpatient unit nurses. prised only some of the process owners have been met
In addition to generating the list of specific, action- with skepticism and resistance.
able items for process improvement, the team recog- Subsequent to and in no small part because of the
nized additional benefits as a result of participating in perceived benefit, University of Wisconsin Hospital
the FMEA process. First, this process analysis was one and Clinics has used the FMEA in other important
of the most comprehensive ones that the transplant processes, including most recently the implementation
team had undertaken in many years. It was also the of new electronic health record modules for medication
first time that clinicians from all phases of the trans- management, integrated emergency department docu-
plant continuum were sitting face to face in the same mentation, clinical documentation of patient care, and
room. This process also served as a team-building func- computerized entry of physicians’ orders. The organi-
tion and enabled the staff to clarify others’ roles and zation continues to find value in the deployment of the
responsibilities, thus leading to a new shared under- FMEA tool for improving important patient care and
standing. The “busy-ness” and criticality of transplant operational processes and enhancing patient safety.
work does not afford staff many opportunities to address Because the organ procurement organization at
cross-disciplinary issues and to build common ground. University of Wisconsin Hospital and Clinics is

212 Progress in Transplantation, Vol 19, No. 3, September 2009

 Analysis of communication and handoff failures

Figure 2 Excerpt of scoring grid used in failure mode and effects analysis.

Table 2 FMEA action items

Process
step Item Issue Action
12b Organ donor form in chart Accuracy of data entry Identify key elements and frequency of quality audits and
devise a plan for random audits of charts as well as how
the plan will be implemented.
17 Donor/recipient form (s) Concern about confusion Develop a CHECKLIST and ORGAN MAP to be used by
when coordinators are abdominal transplant coordinators. Previously, a similar
working on multiple method was used that allowed the coordinators to track
donors, assigning organs which recipient was assigned each organ.
to multiple recipients
The program manager will bring these documents to the
larger coordinator group for input and validation.
Ongoing evaluation of the design and utility of these tools.
Report after 1 year of use.
23 Kidney/pancreas pre- Time gap between when Tissue typing department has reported the match-run list
selection of recipients transplant coordinator is is available for coordinators to use approximately 2
before match run com- asked by transplant sur- hours in advance of the full cross-match list.
pleted—clarify what data geon to identify a poten-
is available for transplant tial recipient and when Manager to educate on-call transplant coordinators about
coordinators the match run is ready the availability of the list to facilitate recipient selection.
for review
23 Kidney/pancreas pre- Use of computer queries Currently a “hot list” is pulled for liver and pancreas recipi-
selection of recipients in transplant database ents, which makes it easier for coordinators to address sur-
before match run com- may make preselection geon’s questions (previous surgeries, body mass index, etc)
pleted—create decision of organ recipients more
support tools reliable Preselecting kidney recipients is more difficult because
the list is much longer. A database query tool can help
coordinators start selecting recipients. Program man-
ager will design an in-service training session for on-call
coordinators to learn about using this tool.
39a Specimen labeling—organ Known, ongoing issue Plan-Do-Study-Act in progress with organ procurement
procurement organization organization and University of Wisconsin Laboratory,
with 2 changes being tested: (1) at hospitals in donor
service area—improved guidance (verbal and written)
given to staff about elements of obtaining and labeling
specimens; (2) Information technology programming
change to require double-verification of key identifiers by
staff from organ procurement organization.
36 Operating room check of 3 Missing signatures or Per group discussion, to be handled on a case-by-case
signatures on organ documentation of organ basis. Operating room staff should promptly report these
verification form verification occurrences to the administrative program director.
Consider use of Patient Safety Net to report these. Relates
to surgeons’ requirement to lead a preoperative time-out.

Progress in Transplantation, Vol 19, No. 3, September 2009 213

Steinberger et al

hospital-based and part of the university, its staff Safety 2007. http://www.jointcommissionreport.org/pdf/JC
_2007_Annual_Report.pdfperformanceresults/sentinel.aspx.
members have access to the expertise of staff mem- Accessed February 24, 2009.
bers in the Quality Resources Department who are 2. Ash JS, Sittig DF, Dykstra R, Campbell E, Guappone K. The
trained in conducting FMEAs and root-cause analy- unintended consequences of computerized provider order
entry: findings from a mixed methods exploration. Int J Med
ses. As the vast majority of organ procurement organ- Inform. 2008;78(suppl 1):S69-S76.
izations are independent organizations, they would 3. Bates DW, Gawande AA. Improving safety with information
benefit from training a quality manager or other staff technology. N Engl J Med. 2003;348(25):2526-2534.
4. Leonard M, Graham S, Bonacum D. The human factor: the
members in FMEA methods. By identifying and miti- critical importance of effective teamwork and communication
gating potential risks, the hospital supports the deliv- in providing safe care. Qual Saf Health Care. 2004;13(suppl
ery of safe, quality care to donors and recipients and 1):i85-i90.
5. Sutcliffe KM, Lewton E, Rosenthal MM. Communication
increases the efficiency and effectiveness of the team failures: an insidious contributor to medical mishaps. Acad
members involved in the complex cycle from pro- Med. 2004;79(2):186-194.
curement to transplant. 6. Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight SD,
Mannos DM. The veterans affairs root cause analysis system
in action. Jt Comm J Qual Improv. 2002;28(10):531-545.
Acknowledgments 7. FMEA and FMECA information. What is a FMEA?
Additional members of the FMEA team were Dave http://www.fmea-fmeca.com/what-is-fmea-fmeca.html.
Accessed February 23, 2009.
Lorentzen, Sara O’Loughlin, Linda Coughlin, Matt Bock, 8. Wetterneck TB, Skibinski KA, Roberts TL, et al. Using fail-
Jan Haedt, Jeff Fenne, Tracey Kaltenberg, Mike Armbrust, ure mode and effects analysis to plan implementation of
Mary Francois, and Linda Sauer. smart i.v. pump technology. Am J Health Syst Pharm. 2006;
63(16):1528-1538.
9. DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using
Financial Disclosures health care failure mode and effect analysis: the VA national
None reported. center for patient safety’s prospective risk analysis system. Jt
Comm J Qual Improv. 2002;27(5):248-267.
10. The Joint Commission. Elements of performance for PI.3.20.
References In: Comprehensive Accreditation Manual for Hospitals: The
1. The Joint Commission. Sentinel Event Root Cause and Trend Official Handbook. Oakbrook Terrace, IL: The Joint Com-
Data. The Joint Commission’s Annual Report on Quality and mission; 2008:306.

214 Progress in Transplantation, Vol 19, No. 3, September 2009

 CE Test Test ID 4000.125: Use of failure mode and effects analysis for proactive identification of communication and handoff failures
from organ procurement to transplantation. Learning objectives: 1. Discuss the complexity of system errors and the role of hidden or “latent”
conditions that produce errors 2. Articulate the purpose of proactive risk assessment 3. Describe the process of performing a structured analysis using
the Failure Mode and Effects Analysis (FMEA) method 4. Determine 3 ways that FMEA can be an effective and flexible tool for analyzing and improving
transplant processes across the continuum of care

1. Which of the following is the method used during Failure 6. Which of the following human factors was identified as a possi-
Mode and Effects Analysis (FMEA) to analyze and rank threats ble risk factor in the analysis presented in this article?
associated with potential problems? a. Team communication and stress levels
a. Ranking priority numeral b.Fatigue and time demands
b.Risk assessment tool c. Experience of coordinators and surgeons
c. Risk priority number d.The number of organs being offered and communication with
d.Ranking assessment tool transplant centers receiving the organs

2. Which of the following statements reflects the correct definition 7. Which of the following has been identified by The Joint Com-
of FMEA? mission as a consistent root cause of sentinel events occurring in
a. A technique that focuses on retrospective analysis of historical events hospitals?
b.A technique that prospectively attempts to predict areas of a. Lack of documentation of ABO on admission
vulnerability and risk within a process b.Poor hand washing techniques in the operating room
c. A technique that assesses data outcomes to determine quality of a c. Inadequate communication between health care providers
program d.Inexperienced clinicians caring for complex patient populations
d.A system for evaluating a causal relationship between an identified
problem and all possible causes of the problem 8. During the organ procurement to transplant process how
many communication handoffs were identified and analyzed
3. Which organization requires hospitals to proactively analyze at during the placement of one organ?
least one process every year? a. 8
a. Centers for Medicare and Medicaid b.22
b.National Center for Patient Safety c. 270
c. United Network for Organ Sharing d.48
d.The Joint Commission
9. The FMEA process identified which of the following beneficial
4. This article describes one organization’s application of FMEA to outcomes?
what process? a. Roles and responsibilities were clarified.
a. Communication across the transplant continuum of care b.Redundancies were eliminated in the processes from procurement
b.ABO verification and documentation to transplant.
c. Recipient selection for kidney transplant c. Handoffs were streamlined across the clinical settings.
d.Coordination of the procurement team d.All the above

5. Which statement best describes the selection of the FMEA team 10. A process map of the core steps in the handoffs during organ
members? procurement to transplantation helped to identify which of the
a. The FMEA team should be limited to no more than 4 people to following?
minimize disruption of processes. a. Sequence of handoffs
b.The FMEA team should include “front-line” representatives of each b.Roles of various members of the multidisciplinary team
part of the processes under analysis. c. Critical information required to complete each step
c. The process will last 1 year and consist of bi-weekly meetings. d.All the above
d.The FMEA team is more efficient when managers can attend and
speak about their employees’ processes.
Test answers: Mark only one box for your answer to each question. You may photocopy this form.
1. K a 2. K a 3. K a 4. K a 5. K a 6. K a 7. K a 8. K a 9. K a 10. K a
Kb Kb Kb Kb Kb Kb Kb Kb Kb Kb
Kc Kc Kc Kc Kc Kc Kc Kc Kc Kc
Kd Kd Kd Kd Kd Kd Kd Kd Kd Kd
Test ID: 4000.125 Form expires: September 1, 2011 Contact hours: 1.0 ABTC CEPTC Fee: NATCO members, $0; nonmembers, $35 Passing score: 7 correct (70%)

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Content was relevant to my
Transplant Professionals License number(s)
nursing practice K K
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