State of the Art in Clinical and Anatomic Pathology
Error Management
Theory and Application in Transfusion Medicine at a Tertiary-Care Institution
S. Breanndan Moore, MD; Mary L. Foss, BA
Q uality, like pornography, is somewhat difficult to de-
fine, but is usually recognizable when it is seen.
Quality in health care has become a major focus of atten-
tion in recent years for several reasons, including the (1)
burgeoning costs of health care, (2) emergence of data on
the frequency of errors in this field, and (3) the need to
reconcile the first 2 issues with increasing public clamor
for the elimination of errors. As is often the case, the public
and the media express outrage at the revelations of data
on errors, but are quite unwilling to invest public funds
into precautionary systems to minimize the opportunities
for errors. Unfortunately, the avaricious medicolegal cli-
mate in the United States has almost certainly been further
stimulated by the open and frank publication of data on
medical errors. Against this background of media, legal,
and medical pressures to reduce errors, federal and state
governmental regulatory agencies have ratcheted up the
volume and complexity of their regulations, which in turn
have further increased the cost of providing health care.
It would be both misleading and overly simplistic to
equate quality with freedom from errors, but there is
broad consensus that effective systems to make significant
reductions in errors must be an integral part of any part
of health care that is recognized as having a high level of
quality.
Perhaps because of the data management issues intrin-
sic to laboratory medicine, clinical laboratorians have been
innovators and trend setters in the establishment of pa-
rameters for the measurement of quality, especially in lab-
oratory services. In some respects, it has taken several de-
cades for the rest of medicine to catch up. While clinical
pathology in general has been very active in setting up
systems to evaluate the frequency and nature of laboratory
errors, transfusion medicine has been in the forefront be-
cause of the well-established potential for immediate and
clinically catastrophic consequences of errors in the trans-
fusion of blood. For probably 60 years, medical students
have been taught about ABO hemolytic reactions, and for
many decades, most hospitals have established sample
identification criteria that are often more strict for trans-
fusion medicine blood samples than for those destined to
be tested in other clinical laboratories. This strategy was
Accepted for publication June 11, 2003.
From the Division of Transfusion Medicine, Mayo Clinic, Rochester,
Minn.
Reprints: S. Breanndan Moore, MD, Division of Transfusion Medi-
cine, Mayo Clinic, 200 First St, SW, Rochester, MN 55905 (e-mail:
moore.breanndan@mayo.edu).
Arch Pathol Lab Med—Vol 127, November 2003
perhaps one of the earliest forms of laboratory error pre-
vention based on unfortunate clinical experience and very
simple root-cause analysis. This early analysis obviously
indicated that blood sample identification errors were
causative in a significant number of transfusion errors
leading to severe adverse outcomes.
This article outlines the philosophical underpinnings
and experience with a program that evolved over many
years at our institution. We readily admit that this is not
a prescription for how a program can best be developed
at any other institution, because the mission, size, and re-
sources (including the experience level and attitudes of
personnel) are all unique to each institution and are con-
stantly changing and evolving. We merely describe what
has worked at our institution so that others may glean
ideas that can be modified and applied in their own set-
tings. How each institution goes about setting up their
quality programs will depend on their existing programs,
the resources that are available to them, and those issues
that internal or external audits or inspections indicate are
deficiencies in their existing programs. There is no ‘‘one
size fits all’’ approach that can be simplistically applied.
We believe that developing a supportive attitude among
top management and implementation of an adequate qual-
ity and educational infrastructure are more important
than the choice of a particular error management system,
of which there are several available.
ERRORS
Errors can be defined in a number of ways, but most
would agree that an error involves a failure (deviation) in
the performance of a standard operating procedure (SOP).
Looked at from a patient’s perspective, an error in the
transfusion of blood can occur in a variety of situations;
some of which are listed here.
1. An error is made in identifying the patient, who then
receives the wrong product.
2. A patient receives the wrong blood product and has
an adverse reaction, for example, hemolytic reaction. In-
vestigation of the reaction uncovers the transfusion of the
wrong blood product.
3. A patient almost receives the wrong product, but the
error is caught at the bedside (so-called near miss).
4. An error in crossmatching is caught before the blood
is released from the laboratory (another near miss).
5. An error is made with an intralaboratory sample
mix-up and is caught prior to release of the blood.
Error Management—Moore & Foss 1517
 6. An error is made by the venipuncture technicians
when identifying a blood sample.
7. An error is made by the venipuncture technicians
when identifying the patient.
8. An error is made by the ordering physician who or-
ders blood for a patient whom he/she did not intend to
transfuse.
This list is by no means complete and only refers to one
aspect of the lengthy, circuitous process involved in col-
lection, processing, labeling, storage, testing, ordering,
and administration of blood products. This process is in-
tended to function so that safe, appropriately tested,
stored, and matched blood products are delivered to the
correct patient at the time and place intended by the or-
dering physician. When one considers the hundreds of
different SOPs and the dozens of individual technologists,
physicians, and nurses involved in carrying out the mul-
titude of steps in the process, it is astonishing that even
more errors are not made.
DETECTION OF ERRORS
It has been long established that there are limitations to
the ability of humans to perform defined, simple tasks
(however well trained and knowledgeable they are) re-
peatedly without committing a human error.1,2 Data from
the Division of Transfusion Medicine at Mayo Clinic (Do-
nor Center and Transfusion Service, Rochester, Minn) in-
dicate that this limit is about 1 in 10 000 performances at
best and may be considerably more frequent in situations
in which personnel are tired, overworked, stressed, dis-
tracted, or harassed; are poorly or incompletely trained;
or are incompetent for any other reason. Because of the
certainty of human errors, it is critical that there be sys-
tems in place to identify all errors occurring at any stage
of each process involving 1 or many SOPs. If all errors
cannot be analyzed, cataloged, and characterized in a con-
sistent fashion, logic-based solutions cannot be imple-
mented and instead, a reactive, episodic, and unplanned
series of temporary approaches will be hurriedly put in
place whenever a particular error or group of errors hap-
pens to attract attention, either because they get all the
way to a patient who is harmed or are feared likely to do
so. There are several published and well-tried systems de-
signed to help institutions proactively collect data on er-
rors in ways that facilitate the regular, consistent analysis
and characterization of these errors so that trends may be
followed in a methodical fashion.2–4 In our experience, the
American Association of Blood Banks’ Quality Systems
Essentials have been of great value. This well-organized
system provides an excellent starting point upon which to
add locally applicable modifications. Another excellent
event-reporting system is the Medical Event Reporting
System for Transfusion Medicine developed by Kaplan et
al.5 This system is particularly good for ensuring complete
reporting of errors and consistent application of rules of
analysis of those data. It is self-evident that implementa-
tion of such systems and strict application of their tenets
greatly facilitates accreditation and inspection processes,
which are often designed to determine the degree of com-
pliance with these very same error management systems.
Even more helpful has been the insistence of the Food and
Drug Administration (FDA) that blood collection centers
(freestanding or hospital based) operate in an environ-
1518 Arch Pathol Lab Med—Vol 127, November 2003
ment that applies current Good Manufacturing Practices
(cGMPs).
While the extensive rules and regulations applied by
FDA are at times onerous, cGMPs, if consistently adhered
to, force institutions to thoroughly plan, document, and
validate each and every SOP and process. Errors can then
be much more closely visualized against a background of
comprehensively and clearly written SOPs so one can de-
termine just what went wrong. That is the first essential
step in the analytical process. For the collection and doc-
umentation of errors to be dependable, there must be clear
delineation of responsibilities for performance of tasks. For
obvious reasons, there should be a degree of separation of
quality-specific responsibilities so that the individual who
is the supervisor of a particular laboratory is not the sole
person who counts, characterizes, and analyzes the errors
occurring in that laboratory. No one should oversee the
quality indicators and direct appropriate responses based
on errors in their own personal work. Objectivity requires
that the analysis of the data be directed by someone who
has less vested interest in the operational performance of
that area. However, this separation cannot be so great that
the operations supervisor is totally excluded from the pro-
cess of analysis of the errors in his or her area or in the
development of plans for corrective action. Supervisors
and technologists in a particular work area are usually the
most highly knowledgeable about SOPs and systems in
that area and are essential to the planning and validation
of corrective actions. By getting these individuals deeply
involved in root-cause analysis, corrective options, and
planning for such, one makes them part of the solution
rather than part of the problem. However, they should not
be in a position to minimize or deflect appropriate atten-
tion from a problem in their area. By including supervi-
sors and technologists as members of a team evaluating
the problem, one can ensure objectivity and accountability
in the process while also painlessly furthering their edu-
cation concerning the real value of good data, thorough
objective analysis, and the need for understanding of the
big picture rather than just their own more parochial con-
cerns. This approach also helps to inculcate the concept
that quality management is the responsibility of each and
every individual, rather than just the realm of an elite few
quality management personnel. In other words, balance
between the operations and the quality assurance units is
critical to a successful error detection and management
system (Figure 1).
ANALYSIS OF ERRORS
Again, there are multiple schemata described for data
analysis. A particularly effective one is included in the
Medical Event Reporting System for Transfusion Medicine
developed by Kaplan et al.4 This system uses the concept
of analysis of near-miss events as a particularly rich vein
of information. Like other successful schemata, it stresses
the importance of a nonpunitive reporting system. For col-
lection of complete information on errors, individuals
must not only understand why they should be alert to
even minor errors and report them, but also that such re-
porting of their own and others’ mistakes will not lead to
retribution. Nothing will dry up the fund of information
on errors as quickly as the fear of retribution. This non-
punitive philosophical approach must be very clearly and
widely understood throughout the workforce and must be
emphasized and reemphasized (preferably publicly) by
Error Management—Moore & Foss
Figure 1. When operations and the quality assurance (QA) unit are in balance, a healthy tension for error management is created (shaded boxes).
When operations is responsible for all aspects of error management, the objectivity and regulatory review provided by the quality assurance unit
is lost (vertically hatched box). When the quality assurance unit is responsible for all aspects of error management, the concept of quality
management as the responsibility of each and every individual is lost (horizontally hatched box).

the top officers of the organization, such as the medical
director and administrator. The goal should be to create a
culture that rewards the behaviors desired, that is, re-
porting near misses and real errors as potential opportu-
nities for improvements. The system should not be de-
signed to identify ‘‘culprits’’ for punishment when an ad-
verse event occurs.
A great variety of different sortings of the error data
can be performed, from simple to very detailed, depend-
ing on what computer system support one has available.
Data might be stratified according to type of error (clini-
cal, performance, interpretive, etc) by work unit, by time
of day or night, by experience level of personnel, etc. The
particular approach used will depend on the circumstanc-
es of the errors and the leads provided by initial analyses.
Naturally, comprehensive data entry is necessary if the
stratifications are to be meaningful. Similarly important is
the consistent application of the predetermined rules for
characterization of each error. In our setting, a team of
quality technologists collectively and simultaneously per-
form the error data characterization and cataloging so that
they maintain consistency of interpretation. We have also
established a Quality Council, which consists of the med-
ical director as chair, the administrator, all transfusion
medicine staff physicians, and the Quality Team members.
In addition, members of our Education Resource Team are
included. This council acts as an oversight body to estab-
lish policies, review error data and other quality indica-
tors, and review inspections and competency testing re-
sults. These same data are also discussed at a monthly
quality meeting for all supervisors, who then disseminate
the information to all technologists at their regular work
Arch Pathol Lab Med—Vol 127, November 2003
area meetings. In our experience, this regular open dis-
cussion of errors and system failures is a vital part of the
continuous education process within the Division of
Transfusion Medicine. This multiteam approach, with
overlapping membership for wide dissemination of data,
discussion points, and ideas for change, creates an atmo-
sphere in which all personnel feel free to comment and in
which all members are encouraged to participate in plan-
ning for corrective action (Figure 2).
MANAGEMENT OF ERRORS
We reiterate the need for a nonpunitive approach only
because of its critical role in establishing an atmosphere
of open and frank discussion of errors. As mentioned, our
management of quality has involved the establishment of
clearly delineated sets of responsibilities for quality-spe-
cific activities and the foundation of an administrative in-
frastructure to achieve the following goals: (a) involve per-
sonnel at all levels; (b) establish clear lines of communi-
cation regarding quality issues; (c) provide oversight and
accountability; and (d) provide guidance, policies, direc-
tion, and documentation.
The cornerstone of our program is that all errors are to
be reported, documented, and characterized. These steps
are followed by data analysis by the Quality Assurance
Team, including the medical director and administrator.
This analysis includes examination of trends and root-
cause evaluation. These deliberations often result in 1 or
more of the following: (a) collection of more data; (b) per-
formance of focused audits; (c) restratification of data; (d)
corrective action planning; (e) validation of corrective ac-
tion; (f) implementation of corrective action; (g) reevalua-
Error Management—Moore & Foss 1519
Figure 2. A multiteam approach for analysis
of errors. QA indicates quality assurance;
FDA, Food and Drug Administration.
tion of results of corrective action; and (h) application of
lessons learned to other aspects of operations.
Corrective action planning is often quite laborious, be-
cause one has to restrain one’s natural inclination to apply
the quick fix in order to get the satisfaction of seeing the
problem drop from the radar screen. However, for correc-
tive action to be most effective, the root-cause analysis has
to be performed very thoroughly. Since most errors are
the result of system failures, these systems must be care-
fully evaluated not only under the high-power microscope
of the local work area review, but also under the low-pow-
er objective looking at all systems functioning both
throughout the division of transfusion medicine and, in
some cases, as they apply to the institution as a whole. For
example, a transfusion to the wrong patient may result
from an error in blood sample identification simply due
to inadequate institutional policies and practices regard-
ing patient wristband information and application. This is
not to say that one should always be looking for a scape-
goat outside one’s own sphere of responsibilities, but rath-
er that the big picture must always be kept in mind when
dealing with errors, however local the problem may ini-
tially seem.
An example of this type of situation in our institution
was that of the introduction in the mid-1980s of the same-
day surgery concept. This practice change has often re-
sulted in the patient arriving in the operating room at
about the same time as their blood sample for antibody
screening and crossmatching arrives in the laboratory. Ap-
propriate institutional planning should have included dis-
cussions with all downstream service areas, such as the
1520 Arch Pathol Lab Med—Vol 127, November 2003
laboratories, radiology, etc, about the possible consequenc-
es of having patients admitted on the day of surgery. Cor-
rective action for this particular problem in our division
originally involved practice agreements with relevant sur-
gical specialties to ensure that samples were obtained in
a timely fashion or else surgery was scheduled for later in
the day. This approach was initially successful.6,7 However,
recent reappearance of the problem required a different
approach. We recently implemented a presurgical sample
program for surgery. This program, along with computer-
assisted crossmatching, allows eligible patients to have
their compatibility sample collected well in advance of
their scheduled surgery. Implementation of these process
changes has the potential to eliminate a large portion of
the same-day surgery problems related to late arrival of
testing samples in the laboratories. It is too early to judge
whether this new practice will adequately address the
problem. Yet another example of a problem that originated
upstream from Transfusion Medicine was the increasing
rate of blood orders for the wrong patient, which our error
program detected a few years ago. By using control charts,
we monitored this problem and timed its occurrence to
coincide with a change in institutional practice, which had
previously required both handwritten and stamped pa-
tient identifiers (name, unique number) on all blood re-
quests. Removal of the requirement for handwritten infor-
mation was associated with the increase in errors and its
reinstatement with the return from 6/10 000 administra-
tions to previous levels of 1/10 000 administrations (S. B.
Moore, M. L. Foss, unpublished data, June 2003).
Error Management—Moore & Foss
 CREATING A QUALITY CULTURE FOR ERROR
PREVENTION AND MANAGEMENT
For any management system to be effective, it must have
a strategic framework and an administrative infrastruc-
ture. These are integral parts of the quality plan required
under cGMP regulations. We believe that the most critical
element in this strategic framework is the establishment of
a quality culture. Accomplishing this goal is a lot more
difficult than merely articulating a mission statement and
declaring that the organization is strongly supportive of
quality. It requires that, starting with top management,
there be high levels of understanding of quality concepts
and cGMPs, a demonstrated commitment to those con-
cepts, a planning process to ensure their implementation,
top-level realistic understanding of the resources neces-
sary, and the determination to acquire such resources. We
believe that this process of establishing a quality culture
must be clearly seen to be driven by top management per-
sonnel who ‘‘walk the talk,’’ and it must provide for an
extensive and ongoing educational effort to inculcate both
knowledge and commitment throughout the workforce.
In essence, for the establishment of a quality culture
throughout any health care institution there has to be a
firmly held conviction that each individual employee is
privileged to participate in the care of sick people, how-
ever far removed from direct patient contact the employee
may be (eg, laboratories). To help ensure the long-term,
consistent motivation necessary to maintain this culture,
each employee must be trained to consider the importance
of the care of every patient to be equivalent to that they
would ardently wish for if that patient were their own
child, parent, or spouse. The collective, committed, and
cohesive willpower and inventiveness of virtually the en-
tire work force at all levels of an organization will provide
an enormous resource for accomplishing change and im-
provement. If they each consider what would be needed
institutionally to ensure that their child or mother got the
best care, then the direction of the entire entity will be-
come more patient-oriented.
To instill this dedication to excellence, we have initiated
a Quality School, whereby modules are developed for a
wide variety of workforce categories. When individuals
successfully complete their appropriate modules, they are
then, and only then, authorized to perform the appropriate
functions. Other measures that help inculcate the quality
culture include the authors’ meeting with each new em-
ployee within a few weeks of commencing work to discuss
the fundamentals of our philosophy on quality, errors, and
reporting as they relate to the overriding importance of
providing only the best service to all patients. In addition,
each morning there is a working/teaching conference for
transfusion medicine technologists and residents, at which
a transfusion medicine staff physician reviews challenging
clinical cases of the prior 24 hours, options for providing
service for ongoing cases, and any errors or practical prob-
lems already detected in their management. All serologic
red blood cell workups seen in the reference/crossmatch
laboratory (other than negative screens) and complicated
crossmatches are also discussed and signed out at this dai-
ly conference. This work/education conference fosters
real-time discussion of relevant current transfusion prob-
lems and recently detected errors in service, and encour-
ages discussion of their management. Because of the enor-
mous educational value of this conference, we frequently
Arch Pathol Lab Med—Vol 127, November 2003
Examples of Educational Initiatives for
Error Management
● Quality school
● Medical director/administrator meetings with each new em-
ployee
● Daily conferences to review complicated cases, near misses,
and errors
● Annual division-wide current Good Manufacturing Practices
training
● Work unit–specific event-reporting training
● Monthly staff and supervisors’ quality meeting to discuss error
reports
have medical students and medical residents from anes-
thesiology, hematology, and pediatrics in attendance. Their
attendance and involvement in discussions not only helps
foster good working relationships between our transfusion
medicine physicians/technologists and the clinical servic-
es, but also educates the clinicians regarding issues such
as patient and sample identification, informed consent,
and transfusion medicine–based treatment options, for ex-
ample, therapeutic apheresis and intraoperative salvage. It
also provides an excellent opportunity to discuss and em-
phasize the need for greater clarity in communications be-
tween clinicians and the laboratories. Greater understand-
ing of all of these issues helps promote attitudes that fa-
cilitate our overall efforts toward error prevention, detec-
tion, and management. The Table lists examples of this
and other educational initiatives that foster the develop-
ment and maintenance of a quality culture.
SUMMARY
For errors to be prevented, there must be an effective
system for consistently sorting, characterizing, and cata-
loging errors in a timely fashion. There must be separation
of responsibilities for some aspects of error data collec-
tion/processing and operations, but key operations per-
sonnel must be involved in the root-cause analysis and
corrective-action planning, validation, and implementa-
tion. To facilitate these activities, a quality plan must be
in effect to provide not only an essential administrative
infrastructure, but also a mechanism for setting policies
and strategic planning.
For the management of errors, there has to exist a qual-
ity culture that makes it plain that quality is not the pre-
rogative of a few designated quality technologists or a
quality team, but is the responsibility of each employee.
Logically, there must be a nonpunitive approach to errors
to foster reporting and open, frank discussions necessary
for root-cause analysis and planning of corrective action.
There must be a widespread enthusiasm for grasping the
opportunities for improvement provided by the detection
and appropriate analysis of error data. Finally, and per-
haps most importantly, there must be strong leadership
from top management with concomitant determination on
its part to provide the resources necessary to establish the
desired quality within all segments of the operations; that
is, we need to put our money where our mouth is. The
leaders must be so convinced of the financial value to the
institution of quality that they can entice the ultimate fi-
nancial decision makers to provide resources to do what
is ethically and morally appropriate in terms of quality
care for patients.
Error Management—Moore & Foss 1521
 References
1. Taswell HF, Sonnenberg CL. Error analysis: types of error in the blood bank.
In: Smit Sibinga CTh, Taswell HF, eds. Quality Assurance in Blood Banking and
Its Clinical Impact. Hingham, Mass: Martinus Nijhoff Publishers; 1984:227–237.
2. Motschman TL, Santrach PJ, Moore SB. Error/incident management and its
practical applications. In: Duckett JB, Woods LL, Santrach PJ, eds. Quality in
Action. Bethesda, Md: American Association of Blood Banks; 1996.
3. Motschman TL, Moore SB. Error detection and reduction in blood banking.
Clin Lab Med. 1996;16:961–973.
4. Kaplan HS, Battles JB, Van der Schaaf TW, Shea CE, Mercer SQ. Identifi-
1522 Arch Pathol Lab Med—Vol 127, November 2003
cation and classification of the causes of events in transfusion medicine. Trans-
fusion. 1998;38:1071–1081.
5. Kaplan HS, Callum JL, Rabin Fastman B, Merkley LL. The Medical Event
Reporting System for Transfusion Medicine: will it help to get the right blood to
the right patient? Transfus Med Rev. 2002;16:86–102.
6. Moore SB, Reisner RK, Losasso TJ, Brockman SK. Morning admission to the
hospital for surgery the same day: a practical problem for the blood bank. Trans-
fusion. 1987;27:359–361.
7. Moore SB, Reisner RK, Offord KP. Morning admission for a same-day sur-
gical procedure: resolution of a blood bank problem. Mayo Clin Proc. 1989;64:
406–408.
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