2

National Healthcare Safety Network
Biovigilance Component
Hemovigilance Module
Surveillance Protocol

Division of Healthcare Quality Promotion
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
Atlanta, GA, USA
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Version History
Version

Release Date

Summary of Revisions

1.0
1.1

March 2009
June 2010

1.2
1.3

July 2010
June 2011

2.0

January 2013

First version publicly released.
Revised background and text in main body of document.
Revised case definition criterion based on WG recommendations, pilot responses,
and CDC recommendations.
Updated FNHTR definition to allow reaction without documented fever.
Defined hypotension for infants and small children
Clarified TAGVD probable and possible criteria.
Corrected definition of hypoxemia in glossary of terms.
Added version number and version history summary.
Summarized introduction and background sections for brevity.
Reorganized surveillance methods section for ease of use.
Clarified reporting of “approved deviation” incidents.
Clarified use of “other” in adverse reaction reporting.
Clarified use of “doubtful” or “ruled out” in adverse reaction reporting.
Added denominator summary options to list of available analysis reports.
Replaced < and > signs with appropriate text for.
Added “cessation of” to time frame requirements in case definitions.
NEW probable case definition category for allergic reaction reporting.
Updated adult hypotensive reaction case definition to align with updated ISBT
definition.
NEW possible imputability category for DHTR.
DELETED possible case definition category for hypotensive reaction.
NEW probable imputability category for PTP reaction.
Updated and clarified imputability categories for TAGVHD reaction.
DELETED possible case definition category for TRALI.
Simplified imputability criteria for TTI.
Clarified case definition and imputability criteria for all adverse reactions.
Complete revision.

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Table of Contents
Section 1. Hemovigilance Module Surveillance Overview ........................................ 4
Section 2. Hemovigilance Module Annual Facility Survey ....................................... 5
Section 3: Hemovigilance Module Adverse Reactions ............................................. 6
Adverse Reaction Case Classification Criteria Tables ...................................................... 7
Transfusion-associated circulatory overload (TACO)........................................................................... 7
Transfusion-related acute lung injury (TRALI) ...................................................................................... 8
Transfusion-associated dyspnea (TAD) ............................................................................................... 9
Allergic reaction .................................................................................................................................. 10
Hypotensive transfusion reaction ....................................................................................................... 11
Febrile non-hemolytic transfusion reaction (FNHTR) ......................................................................... 12
Acute hemolytic transfusion reaction (AHTR) .................................................................................... 13
Delayed hemolytic transfusion reaction (DHTR) ................................................................................ 14
Delayed serologic transfusion reaction (DSTR) ................................................................................. 15
Transfusion-associated graft vs. host disease (TAGVHD) ................................................................. 16
Post transfusion purpura (PTP) .......................................................................................................... 17
Transfusion-transmitted infection (TTI) .............................................................................................. 18
Other/Unknown ................................................................................................................................... 20

Adverse Reaction Glossary ............................................................................................... 21

Section 4. Hemovigilance Module Incidents ............................................................ 22
Incident Codes ................................................................................................................... 23
Occupation Codes ............................................................................................................. 25
Incident Glossary ............................................................................................................... 26

Section 5. Hemovigilance Module Denominators.................................................... 27

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Section 1. Hemovigilance Module Surveillance Overview
Purpose
The National Healthcare Safety Network (NHSN) Hemovigilance (HV) Module was created to implement
national surveillance of transfusion-associated adverse events aimed at improving patient safety and
minimizing unnecessary costs associated with transfusion-related adverse events.
Settings
The Hemovigilance Module may be used by any U.S. healthcare facility where transfusion occurs (e.g.,
adult or pediatric facilities, acute or chronic care facilities). Surveillance must be performed facility-wide,
including patient care areas for emergency, general medical, and surgical patients; obstetrics and
gynecology; orthopedics, oncology, and other chronic diseases; and any other facility location where
transfusions are administered.
Methods
The NHSN Hemovigilance Module requires comprehensive surveillance of patients and blood products
throughout the transfusion process, from product receipt from supplier to administration to the patient.
Participation in the NHSN Hemovigilance Module requires reporting of all CDC-defined adverse
transfusion reactions and associated process incidents that occur for patients transfused at or by
your facility.
Data Reporting Requirements
• At least 12 months of continuous surveillance
• An annual facility demographic and practice survey for each calendar year of participation
• ALL adverse reactions, classified according to CDC-defined case definition criteria
• ALL incidents (i.e., errors or accidents) associated with a reported adverse reaction
• Blood products transfused and samples collected for type and screen or crossmatch each month
Data Collection Forms and Instructions
Paper versions of all forms used to collect data in the NHSN HV Module are available on the NHSN
website. A link to the appropriate form(s) and their instructions is provided in the following sections for
your convenience.
Training
Training presentations are available on the NHSN Biovigilance Component website for self-paced
training and must be reviewed prior to participating in the Hemovigilance Module. CDC also provides
webinar and in-person training opportunities for current NHSN participants. These opportunities are
communicated through the NHSN blast email system.
User Support
CDC is available to answer your questions about the surveillance protocol and to help navigate the
NHSN web application. Please contact us at [email protected]. Type HEMOVIGILANCE MODULE in the
subject line for quickest routing to the Biovigilance/Hemovigilance Team.

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Section 2. Hemovigilance Module Annual Facility Survey
Required Reporting
Participating facilities must enter the Hemovigilance Module Annual Facility Survey at the time that they
enroll or activate the Biovigilance Component and at the beginning of each calendar year thereafter. The
survey is used by CDC to classify facilities for appropriate comparisons in aggregate data analyses and
to learn more about common practices among transfusion departments. The data collected in the survey
covers the previous calendar year. For example, if the facility is enrolling in NHSN for the first time in
October of 2013, report information for January 2012-December 2012 on the first Hemovigilance Module
Annual Facility Survey. In January 2014, complete a new survey with data from January 2013-December
2013. CDC recommends collecting all survey information on a paper form before attempting to enter
data into the web application.
Form
CDC 57.300 Hemovigilance Module Annual Facility Survey
Form Instructions
CDC 57.300 Hemovigilance Module Annual Facility Survey Table of Instructions

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Section 3: Hemovigilance Module Adverse Reactions
Required Reporting
All CDC-defined transfusion-associated adverse reactions that are possibly, probably, or definitely
related to a transfusion performed by the participating facility must be reported to NHSN. Adverse
reaction reports should be entered into NHSN after the investigation of the reaction has been completed
and imputability has been determined to the extent possible. Ideally, reports will be entered within 30
days of the month that the reaction occurred. However, new information can be entered at any time. If a
patient experiences more than one adverse reaction during or following the same transfusion episode,
complete a separate form for each reaction.
Adverse Reaction Classification
Each CDC-defined transfusion-associated adverse reaction must be classified according to specific
case definition, severity, and imputability criteria found in the criteria tables in this section.
Defined Adverse Reactions
• Transfusion-associated circulatory overload (TACO)
• Transfusion-related acute lung injury (TRALI)
• Transfusion-associated dyspnea (TAD)
• Allergic reaction (severe)
• Hypotensive transfusion reaction
• Febrile non-hemolytic transfusion reaction (FNHTR)
• Acute hemolytic transfusion reaction (AHTR)
• Delayed hemolytic transfusion reaction (DHTR)
• Delayed serologic transfusion reaction (DSTR)
• Transfusion-associated graft vs. host disease (TAGVHD)
• Post-transfusion purpura (PTP)
• Transfusion-transmitted infection (TTI)
Optional Reporting
Suspected adverse reactions where imputability is determined to be doubtful or ruled out are not
required for reporting. A facility may report reactions considered doubtful or ruled out in order to use
NHSN to document transfusion reaction investigations each month. CDC will not aggregate or analyze
these adverse reaction reports. Adverse reactions that are not defined in the suveillance protocol may be
reported using the ‘Other’ and ‘Unknown’ adverse reaction categories using standard severity and
imputability criteria.
Note
Reporting of adverse reactions to CDC through NHSN system does NOT take the place of reporting
requirements for blood transfusion-associated adverse events to Food and Drug Administration (FDA).
Hospitals and transfusion services should immediately report complications that may be related to the
blood donor or to the manufacture of the blood components to the collection facility (Code of Federal
Regulations. Title 21 CFR 606.170(a), 2006) and are required to report suspected transfusion-related
fatalities directly to FDA (Code of Federal Regulations Title 21 CFR 606.170(b), 2006).
Form
CDC 57.304 Hemovigilance Module Adverse Reaction
Form Instructions
CDC 57.304 Hemovigilance Module Adverse Reaction Table of Instructions

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Adverse Reaction Case Classification Criteria Tables
Transfusion-associated circulatory overload (TACO)
Case Definition

Severity

Imputability

Definitive:
New onset or exacerbation of
3 or more of the following
within 6 hours of cessation of
transfusion:
• Acute respiratory
distress (dyspnea,
orthopnea, cough)
• Elevated brain natriuretic
peptide (BNP)
• Elevated central venous
pressure (CVP)
• Evidence of left heart
failure
• Evidence of positive fluid
balance
• Radiographic evidence
of pulmonary edema

Non-severe:
Medical intervention (e.g. symptomatic
treatment) is required but lack of such would
not result in permanent damage or impairment
of a bodily function.

Definite:
No other explanations for
volume overload are possible.

Probable:
N/A

Possible:
N/A

N/A

Severe:
Inpatient hospitalization or prolongation of
hospitalization is directly attributable to the
adverse reaction, persistent or significant
disability or incapacity of the patient occurs as
a result of the reaction, or a medical or
surgical intervention is necessary to preclude
permanent damage or impairment of a body
function.
Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation,
transfer to intensive care) to prevent death.

Death:
The recipient died as a result of the adverse
transfusion reaction. Death should be used
if death is possibly, probably or definitely
related to transfusion. If the patient died of a
cause other than the transfusion, the severity
of the reaction should be graded as 1, 2 or 3
as appropriate given the clinical
circumstances related to the reaction.
Not Determined:
The severity of the adverse reaction is
unknown or not stated.
REPORTING OPTIONAL
N/A

Probable:
Transfusion is a likely
contributor to volume overload
AND EITHER
The patient received other
fluids as well
OR
The patient has a history of
cardiac insufficiency that
could explain the volume
overload.
Possible:
The patient has a history of preexisting cardiac insufficiency
that most likely explains volume
overload.

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Doubtful:
Evidence is clearly in favor of a
cause other than the
transfusion, but transfusion
cannot be excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the
transfusion.

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Transfusion-related acute lung injury (TRALI)
Case Definition

Severity

Imputability

Definitive:
NO evidence of acute lung
injury (ALI) prior to
transfusion
AND
ALI onset during or within 6
hours of cessation of
transfusion
AND
Hypoxemia defined by any of
these methods:
• PaO2/FiO2 less than or
equal to 300 mm Hg
• Oxygen saturation less
than 90% on room air
• Other clinical evidence
AND
Radiographic evidence of
bilateral infiltrates
AND
No evidence of left atrial
hypertension (i.e. circulatory
overload).

Non-severe:
Medical intervention (e.g. symptomatic
treatment) is required but lack of such
would not result in permanent damage or
impairment of a bodily function.

Definite:
There are no alternative risk factors
for ALI present.

Probable:
N/A

Possible:
N/A

N/A

Probable:
N/A
Severe:
Inpatient hospitalization or prolongation of
hospitalization is directly attributable to the
adverse reaction, persistent or significant
disability or incapacity of the patient occurs
as a result of the reaction, or a medical or
surgical intervention is necessary to
preclude permanent damage or impairment
of a body function.

Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation,
transfer to intensive care) to prevent death.
Death:
The recipient died as a result of the
adverse transfusion reaction. Death
should be used if death is possibly,
probably or definitely related to
transfusion. If the patient died of a cause
other than the transfusion, the severity of
the reaction should be graded as 1, 2 or 3
as appropriate given the clinical
circumstances related to the reaction.
Not Determined:
The severity of the adverse reaction is
unknown or not stated.
REPORTING OPTIONAL
N/A

Possible:
There is evidence of other risk
factors for acute lung injury such
as:
Direct Lung Injury
• Aspiration
• Pneumonia
• Toxic inhalation
• Lung contusion
• Near drowning
Indirect Lung Injury
• Severe sepsis
• Shock
• Multiple trauma
• Burn injury
• Acute pancreatitis
• Cardiopulmonary bypass
• Drug overdose
Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion,
but transfusion cannot be excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the transfusion.

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Transfusion-associated dyspnea (TAD)
Case Definition

Severity

Imputability

Definitive:
Acute respiratory distress
that occurring within 24
hours of cessation of
transfusion
AND
Allergic reaction, TACO,
and TRALI are ruled out.

Non-severe:
Medical intervention (e.g. symptomatic
treatment) is required but lack of such would
not result in permanent damage or impairment
of a bodily function.

Definite:
Patient has no other conditions
that could explain symptoms.

Probable:
N/A

Possible:
N/A

Severe:
Inpatient hospitalization or prolongation of
hospitalization is directly attributable to the
adverse reaction, persistent or significant
disability or incapacity of the patient occurs as
a result of the reaction, or a medical or surgical
intervention is necessary to preclude
permanent damage or impairment of a body
function.

Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation,
transfer to intensive care) to prevent death.

Probable:
There are other potential causes
that could explain symptoms, but
transfusion is the most likely
cause.

Possible:
Other present causes are most
likely, but transfusion cannot be
ruled out.

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Death:
The recipient died as a result of the adverse
transfusion reaction. Death should be used if
death is possibly, probably or definitely
related to transfusion. If the patient died of a
cause other than the transfusion, the severity
of the reaction should be graded as 1, 2 or 3
as appropriate given the clinical circumstances
related to the reaction.

N/A

Not Determined:
The severity of the adverse reaction is
unknown or not stated.
REPORTING OPTIONAL
N/A

Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion,
but transfusion cannot be
excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the transfusion.

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Allergic reaction
Note: Minor allergic reactions (Severity Grade 1) presenting with only mucocutaneous signs and
symptoms that respond quickly to treatment do not have to be reported in NHSN.
Case Definition

Severity

Imputability

Definitive:
2 or more of the following
occurring during or within 4 hours
of cessation of transfusion:
• Conjunctival edema
• Edema of lips, tongue and
uvula
• Erythema and edema of the
periorbital area
• Generalized flushing
• Hypotension
• Localized angioedema
• Maculopapular rash
• Pruritus (itching)
• Respiratory distress;
bronchospasm
• Urticaria (hives)

Severe, Life-threatening, Death:
Involves respiratory and/or
cardiovascular systems and presents
like an anaphylactic reaction. There is
anaphylaxis when, in addition to
mucocutaneous symptoms, there are
airway symptoms, hypotension, or
associated symptoms like hypotonia
and syncope. The respiratory signs
and symptoms may be laryngeal
(tightness in the throat, dysphagia,
dysphonia, hoarseness, stridor) or
pulmonary (dyspnea, cough,
wheezing, bronchospasm,
hypoxemia). Such a reaction usually
occurs during or shortly after
cessation of transfusion.

Definite:
Occurs during or within 2 hours of
cessation of transfusion
AND
No other evidence of
environmental, drug or dietary
risks.

Probable:
ANY 1 of the following occurring
during or within 4 hours of
cessation of transfusion:
• Conjunctival edema
• Edema of lips, tongue and
uvula
• Erythema and edema of the
periorbital area
• Localized angioedema
• Maculopapular rash
• Pruritus (itching)
• Urticaria (hives)

Possible:
N/A

For the purpose of classification, this
type of allergic reaction would be
graded as:
Severe
Life-threatening
Death
Death should be used if death is
possibly, probably or definitely
related to transfusion. If the patient
died of a cause other than the
transfusion, the severity of the
reaction should be graded as 1, 2 or
3 as appropriate given the clinical
circumstances related to the reaction.

Not Determined:
The severity of the adverse reaction
is unknown or not stated.
REPORTING OPTIONAL
Non-severe:
There is no immediate risk to the life
of the patient, and the patient
responds quickly to symptomatic
treatment.

Probable:
Occurs during or within 2 hours of
cessation of transfusion
AND
There are other potential causes
present that could explain
symptoms, but transfusion is the
most likely cause.

Possible:
Occurs 2 - 4 hours after cessation
of transfusion
OR
Other present causes are most
likely, but transfusion cannot be
ruled out.

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion,
but transfusion cannot be excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the transfusion.

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Hypotensive transfusion reaction
Case Definition

Severity

Imputability

Definitive:
All other adverse reactions
presenting with hypotension are
excluded
AND
Hypotension

Non-severe:
The recipient required no more than
discontinuation of transfusion and
symptom management and no longterm morbidity resulted from the
reaction.

Definite:
Occurs less than 15 minutes after
the start of the transfusion
AND
Responds rapidly (i.e., within 10
minutes) to cessation of transfusion
and supportive treatment
AND
The patient has no other conditions
that could explain hypotension.

•

•

•

Adults (18 years and
older):
Drop in systolic BP of greater
than or equal to 30 mmHg
and systolic BP less than or
equal to 80 mmHg.
Infants, children and
adolescents (1 year to less
than 18 years old):
Greater than 25% drop in
systolic BP from baseline
(e.g., drop in systolic BP of
120mmHg to below
90mmHg).
Neonates and small
infants (less than 1 year
old OR any age and less
than 12 kg body weight):
Greater than 25% drop in
baseline value using
whichever measurement is
being recorded (e.g., mean
BP).

Probable:
N/A

Possible:
N/A

Severe:
Inpatient hospitalization or
prolongation of hospitalization is
directly attributable to hypotension, or
hypotension led directly to long-term
morbidity (e.g., brain damage)
AND
Vasopressors were not required.

Life-threatening:
The recipient required vasopressors.

Death:
The recipient died as a result of the
adverse transfusion reaction. Death
should be used if death is possibly,
probably or definitely related to
transfusion. If the patient died of a
cause other than the transfusion, the
severity of the reaction should be
graded as 1, 2 or 3 as appropriate
given the clinical circumstances
related to the reaction.
Not Determined:
The severity of the adverse reaction is
unknown or not stated.
REPORTING OPTIONAL
N/A

Probable:
Onset is between 15 minutes after
start and 1 hour after cessation of
transfusion
OR
The patient does not respond
rapidly to cessation of transfusion
and supportive treatment
OR
There are other potential causes
present that could explain
hypotension, but transfusion is the
most likely cause.

Possible:
Other conditions that could readily
explain hypotension are present.
Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.
Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion,
but transfusion cannot be excluded.
Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the transfusion.

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Febrile non-hemolytic transfusion reaction (FNHTR)
Note: Reactions may be classified as FNHTRs in the absence of fever if chills or rigors occur.
Case Definition

Severity

Imputability

Definitive:
Occurs during or within 4
hours of cessation of
transfusion
AND EITHER
Fever (greater than or
equal to 38°C/100.4°F oral
and a change of at least
1°C/1.8°F) from pretransfusion value)
OR
Chills/rigors are present.

Non-severe:
Medical intervention (e.g. symptomatic
treatment) is required but lack of such would
not result in permanent damage or
impairment of a bodily function.

Definite:
Patient has no other conditions
that could explain symptoms.

Probable:
N/A

Severe:
Inpatient hospitalization or prolongation of
hospitalization is directly attributable to the
adverse reaction, persistent or significant
disability or incapacity of the patient occurs
as a result of the reaction, or a medical or
surgical intervention is necessary to preclude
permanent damage or impairment of a body
function.

Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation,
transfer to intensive care) to prevent death.

Probable:
There are other potential causes
present that could explain
symptoms, but transfusion is the
most likely cause.
Possible:
Other present causes are most
likely, but transfusion cannot be
ruled out.

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Death:
The recipient died as a result of the adverse
transfusion reaction. Death should be used
if death is possibly, probably or definitely
related to transfusion. If the patient died of a
cause other than the transfusion, the severity
of the reaction should be graded as 1, 2 or 3
as appropriate given the clinical
circumstances related to the reaction.

Possible:
N/A

Not Determined:
The severity of the adverse reaction is
unknown or not stated.
REPORTING OPTIONAL
N/A

Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion,
but transfusion cannot be
excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the transfusion.

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January 2013

Acute hemolytic transfusion reaction (AHTR)
Note: Report hemolytic reactions resulting from immune or non-immune causes, including when the
recipient is intentionally transfused with incompatible blood products.
Case Definition

Severity

Imputability

Definitive:
Occurs during, immediately after, or within 24
hours of cessation of transfusion with ANY of the
following signs/symptoms:
• Back/flank pain
• Chills/rigors
• Discolored urine (gross visual hemolysis)
• Disseminated intravascular coagulation (DIC)
• Epistaxis
• Fever
• Hypotension
• Oliguria/anuria
• Pain and/or oozing at IV site
• Renal failure
AND
2 or more of the following:
• Decreased fibrinogen
• Decreased haptoglobin
• Elevated bilirubin
• Elevated LDH
• Hemoglobinemia
• Hemoglobinuria
AND EITHER
(IMMUNE-MEDIATED)
Positive direct antiglobulin test (DAT) for antiIgG or anti-C3
AND
Positive elution test with alloantibody present on
the transfused red blood cells
OR
(NON-IMMUNE MEDIATED)
Serologic testing is negative, and physical
cause (e.g., thermal, osmotic, mechanical,
chemical) is confirmed.

Non-severe:
Medical intervention (e.g.
symptomatic treatment) is required
but lack of such would not result in
permanent damage or impairment
of a bodily function.

Definite:
ABO or other allotypic
RBC antigen
incompatibility is known
OR
Only transfusion-related
(i.e., immune or nonimmune) cause of acute
hemolysis is present.

Probable:
Meets clinical and laboratory criteria for acute
hemolysis
AND EITHER
(IMMUNE MEDIATED)
Physical cause is excluded but serologic testing
is incomplete

OR
(NON-IMMUNE MEDIATED)
Physical cause is suspected and serologic
testing is negative.

Severe:
Inpatient hospitalization or
prolongation of hospitalization is
directly attributable to the adverse
reaction, persistent or significant
disability or incapacity of the patient
occurs as a result of the reaction,
or a medical or surgical intervention
is necessary to preclude
permanent damage or impairment
of a body function.

Life-threatening:
Major intervention required
following the transfusion (e.g.
vasopressors, intubation, transfer
to intensive care) to prevent death.

Death:
The recipient died as a result of
the adverse transfusion reaction.
Death should be used if death is
possibly, probably or definitely
related to transfusion. If the patient
died of a cause other than the
transfusion, the severity of the
reaction should be graded as 1, 2
or 3 as appropriate given the
clinical circumstances related to the
reaction.
Not Determined:
The severity of the adverse
reaction is unknown or not stated.
OPTIONAL
N/A

OPTIONAL
Possible:
N/A

Page 13 of 27
January 2013

Probable:
There are other
potential causes present
that could explain acute
hemolysis, but
transfusion is the most
likely cause.

Possible:
Other causes of acute
hemolysis are more
likely, but transfusion
cannot be ruled out.

Not Determined:
The relationship
between the adverse
reaction and the
transfusion is unknown
or not stated.
OPTIONAL
Doubtful:
Evidence is clearly in
favor of a cause other
than the transfusion, but
transfusion cannot be
excluded.
Ruled Out:
There is conclusive
evidence beyond
reasonable doubt of a
cause other than the
transfusion.

Delayed hemolytic transfusion reaction (DHTR)
Note: Report hemolytic reactions resulting from intentionally-transfused incompatible blood products.
Case Definition

Severity

Imputability

Definitive:
Positive direct antiglobulin test
(DAT) for antibodies developed
between 24 hours and 28 days after
cessation of transfusion
AND EITHER
Positive elution test with
alloantibody present on the
transfused red blood cells
OR
Newly-identified red blood cell
alloantibody in recipient serum
AND EITHER
Inadequate rise of posttransfusion hemoglobin level or
rapid fall in hemoglobin back to
pre-transfusion levels
OR
Otherwise unexplained
appearance of spherocytes.

Non-severe:
Medical intervention (e.g. symptomatic
treatment) is required but lack of such
would not result in permanent damage or
impairment of a bodily function.

Definite:
No other explanation for
symptoms or newly-identified
antibody is present.

Probable:
Newly-identified red blood cell
alloantibody demonstrated between
24 hours and 28 days after
cessation of transfusion
BUT
Incomplete laboratory evidence to
meet definitive case definition
criteria.
NOTE: Patient may be
asymptomatic or have symptoms
that are similar to but milder than
AHTR; symptoms are not required
to meet case definition criteria.

Possible:
N/A

Severe:
Inpatient hospitalization or prolongation of
hospitalization is directly attributable to the
adverse reaction, persistent or significant
disability or incapacity of the patient occurs
as a result of the reaction, or a medical or
surgical intervention is necessary to
preclude permanent damage or impairment
of a body function.

Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation,
transfer to intensive care) to prevent death.
Death:
The recipient died as a result of the
adverse transfusion reaction. Death
should be used if death is possibly,
probably or definitely related to
transfusion. If the patient died of a cause
other than the transfusion, the severity of
the reaction should be graded as 1, 2 or 3
as appropriate given the clinical
circumstances related to the reaction.

Not Determined:
The severity of the adverse reaction is
unknown or not stated.
REPORTING OPTIONAL
N/A

Probable:
An alternate explanation for
symptoms or newly-identified
antibody is present, but
transfusion is the most likely
cause.

Possible:
Other explanations for
symptoms or newly-identified
antibody are more likely, but
transfusion cannot be ruled
out.

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Doubtful:
Evidence is clearly in favor of
a cause other than the
transfusion, but transfusion
cannot be excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of
a cause other than the
transfusion.

Page 14 of 27
January 2013

Delayed serologic transfusion reaction (DSTR)
Note: Delayed serologic reactions should only be reported for patients transfused by your facility.
Case Definition

Severity

Imputability

Definitive:
Absence of clinical signs of
hemolysis
AND
Demonstration of new,
clinically-significant
antibodies against red blood
cells
BY EITHER
Positive direct antiglobulin
test (DAT)
OR
Positive antibody screen
with newly identified RBC
alloantibody.

Not Determined:
Since this is by definition a reaction with no
clinical symptoms, severity of the reaction
cannot be graded.

Definite:
New alloantibody is identified
between 24 hours and 28 days
after cessation of transfusion
AND
Transfusion performed by your
facility is the only possible cause
for seroconversion.

Probable:
N/A

Possible:
N/A

Probable:
N/A

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Possible:
N/A
REPORTING OPTIONAL
N/A

N/A

Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion,
but transfusion cannot be excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the transfusion.

Page 15 of 27
January 2013

Transfusion-associated graft vs. host disease (TAGVHD)
Case Definition

Severity

Imputability

Definitive:
A clinical syndrome occurring from 2
days to 6 weeks after cessation of
transfusion characterized by:
• Characteristic rash:
erythematous, maculopapular
eruption centrally that spreads to
extremities and may, in severe
cases, progress to generalized
erythroderma and hemorrhagic
bullous formation.
• Diarrhea
• Fever
• Hepatomegaly
• Liver dysfunction (i.e., elevated
ALT, AST, Alkaline phosphatase,
and bilirubin)
• Marrow aplasia
• Pancytopenia
AND
Characteristic histological appearance
of skin or liver biopsy.

Non-severe:
N/A

Definite:
WBC chimerism present in the
absence of alternative diagnoses.

Probable:
Meets definitive criteria
EXCEPT
Biopsy negative or not done.

Severe:
Patient had marked symptoms
and responded to treatment.

Life-threatening:
Patient had severe symptoms and
required life-saving treatment
(e.g., immunosuppression).
Death:
The recipient died as a result of
the adverse transfusion
reaction. Death should be used if
death is possibly, probably or
definitely related to transfusion. If
the patient died of a cause other
than the transfusion, the severity
of the reaction should be graded
as 1, 2 or 3 as appropriate given
the clinical circumstances related
to the reaction.

Possible:
N/A

Not Determined:
The severity of the adverse
reaction is unknown or not stated.

N/A

REPORTING OPTIONAL
N/A

Probable:
WBC chimerism present
BUT
Other potential causes are present
(e.g., stem cell transplantation).

Possible:
WBC chimerism not present or not
done
OR
Alternative explanations are more
likely (e.g., solid organ
transplantation).

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion,
but transfusion cannot be excluded.
Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the transfusion.

Page 16 of 27
January 2013

Post transfusion purpura (PTP)
Case Definition

Severity

Imputability

Definitive:
Alloantibodies in the patient
directed against HPA-1a or other
platelet specific antigen detected at
or after development of reaction
AND
Thrombocytopenia (i.e., decrease
in platelets to less than 20% of pretransfusion count).

Non-severe:
Medical intervention (e.g. symptomatic
treatment) is required but lack of such
would not result in permanent damage or
impairment of a bodily function.

Definite:
Occurs 5-12 days posttransfusion
AND
Patient has no other
conditions to explain
thrombocytopenia.

Probable:
Alloantibodies in the patient
directed against HPA-1a or other
platelet specific antigen detected at
or after development of reaction.
AND
Decrease in platelets to levels
between 20% and 80% of pretransfusion count.

Severe:
Inpatient hospitalization or prolongation of
hospitalization is directly attributable to the
adverse reaction, persistent or significant
disability or incapacity of the patient occurs
as a result of the reaction, or a medical or
surgical intervention is necessary to
preclude permanent damage or impairment
of a body function.

Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation,
transfer to intensive care) to prevent death.
Death:
The recipient died as a result of the
adverse transfusion reaction. Death
should be used if death is possibly,
probably or definitely related to
transfusion. If the patient died of a cause
other than the transfusion, the severity of
the reaction should be graded as 1, 2 or 3
as appropriate given the clinical
circumstances related to the reaction.

Possible:
PTP is suspected, but symptoms
and/or information are not sufficient
to meet defined criteria above. For
example, the patient has a drop in
platelet count to less than 80% of
pre-transfusion count but HPA
antibodies were not tested or were
negative. Other, more specific
adverse reactions are ruled out.

Not Determined:
The severity of the adverse reaction is
unknown or not stated.
REPORTING OPTIONAL
N/A

Probable:
Occurs less than 5 or more
than 12 days post-transfusion
OR
There are other potential
causes present that could
explain thrombocytopenia,
but transfusion is the most
likely cause.

Possible:
Alternate explanations for
thrombocytopenia are more
likely, but transfusion cannot
be ruled out.

Not Determined:
The relationship between the
adverse reaction and the
transfusion is unknown or not
stated.

Doubtful:
Evidence is clearly in favor of
a cause other than the
transfusion, but transfusion
cannot be excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a
cause other than the
transfusion.

Page 17 of 27
January 2013

Transfusion-transmitted infection (TTI)
Case
Definition
Definitive:
Laboratory
evidence of a
pathogen in the
transfusion
recipient.

Probable:
N/A

OPTIONAL
NA

Severity

Imputability

Non-severe:
Medical intervention
(e.g. symptomatic
treatment) is required
but lack of such would
not result in permanent
damage or impairment
of a bodily function.

Definite:
ONE or more of the following:
• Evidence of the pathogen in the transfused product
• Evidence of the pathogen in the donor at the time of donation
• Evidence of the pathogen in an additional product from the same donation
• Evidence of the pathogen in an additional recipient of a product from the
same donation
AND
Evidence that the recipient was not infected with the pathogen prior to transfusion
AND
No other potential exposures to the pathogen could be identified in the recipient.

Severe:
Inpatient
hospitalization or
prolongation of
hospitalization is
directly attributable to
the adverse reaction,
persistent or significant
disability or incapacity
of the patient occurs
as a result of the
reaction, or a medical
or surgical intervention
is necessary to
preclude permanent
damage or impairment
of a body function.
Life-threatening:
Major intervention
required following the
transfusion (e.g.
vasopressors,
intubation, transfer to
intensive care) to
prevent death.
Death:
The recipient died as a
result of the adverse
transfusion reaction.

Not Determined:
The severity of the
adverse reaction is
unknown or not stated.

Probable:
ONE or more of the following:
• Evidence of the pathogen in the transfused product
• Evidence of the pathogen in the donor at the time of donation
• Evidence of the pathogen in an additional product from the same donation
• Evidence of the pathogen in an additional recipient of a product from the
same donation.
AND EITHER:
Evidence that the recipient was not infected with this pathogen prior to
transfusion
OR
No other potential exposures to the pathogen could be identified in the recipient.
Possible:
Case fails to meet definite, probable, doubtful, or ruled out imputability criteria.
Not Determined:
The relationship between the adverse reaction and the transfusion is unknown or
not stated.
OPTIONAL
Doubtful:
Laboratory evidence that the recipient was infected with this pathogen prior to
transfusion
OR
Evidence is clearly in favor of a cause other than transfusion, but transfusion
cannot be excluded.
Ruled Out:
ALL of the following (where applicable):
• Evidence that the transfused product was negative for this pathogen at the
time of transfusion
• Evidence that the donor was negative for this pathogen at the time of
donation
• Evidence that additional products from the same donation were negative for
this pathogen
• Evidence that additional recipient(s) transfused with product(s) from the
same donation were negative for this pathogen.
OR
There is conclusive evidence beyond reasonable doubt of a cause other than the
transfusion.

Page 18 of 27
January 2013

Transfusion-transmitted infection (TTI)
(continued)
Pathogens of well-documented importance in blood safety.
These pathogens have public health significance for hemovigilance, are well-documented blood stream
pathogens, and/or are routinely screened for in blood donors. A full list of potentially infectious organisms is
available in the drop-down pathogen list in NHSN.
Bacterial
Viral
Parasitic
Other
Enterobacter cloacae
Babesiosis (Babesia spp.)
Cytomegalovirus (CMV)
CreutzfeldtEscherichia coli
Enterovirus spp.
Chagas disease
Jakob Disease,
(Trypanosoma cruzi)
Klebsiella oxytoca
Epstein Barr (EBV)
Variant (vCJD)
Malaria (Plasmodium spp.)
Klebsiella pneumoniae
Hepatitis A
Pseudomonas aeruginosa
Hepatitis B
Serratia marcescens
Hepatitis C
Staphylococcus aureus
Human Immunodeficiency Virus 1
Staphylococcus
(HIV-1)
epidermidis
Human Immunodeficiency Virus 2
Staphylococcus
(HIV-2)
lugdunensis
Human Parvovirus B-19
Syphilis (Treponema
Human T-Cell Lymphotropic
pallidum)
Virus-1 (HTLV-1)
Yersinia enterocolitica
Human T-Cell Lymphotropic
Virus-2 (HTLV-2)
West Nile Virus (WNV)

Investigation triggers for infections potentially transfusion-transmitted:
1. Identification by testing (e.g., gram stain, other smear/staining, culture, or other method) of an
unexpected bacterial, mycobacterial, or fungal pathogen in a recipient within the time period from
exposure (i.e., transfusion) to onset of infection appropriate for the suspected pathogen.
2. Identification of an unexpected virus in the recipient by testing (e.g., culture, direct fluorescent
antibody or polymerase chain reaction) within the time period from exposure (i.e., transfusion) to
onset of infection appropriate for the suspected virus.
3. Identification of an unexpected parasite in the recipient by blood smear, histopathology or stool
testing for ova/parasites within the time period from exposure (i.e., transfusion) to onset of infection
appropriate for the suspected parasite.
4. Any of the above laboratory findings in the recipient unit upon residual testing.
5. Unexplained clinical events occurring after transfusion that are consistent with transfusiontransmitted infection, such as:
a. Encephalitis, meningitis, or other unexplained central nervous system abnormalities.
b. Sepsis with or without multi-organ system dysfunction.
c. Hemolytic anemia and/or fever (e.g., in cases of transfusion-associated babesiosis or malaria).
d. Recipient death.
6. For pathogens routinely screened in the blood donor, any infection in the recipient occurring within
6 months after transfusion if:
a. The index donation testing was negative but
b. The donor was subsequently found to be infected, and
c. The recipient had no pre-transfusion history of the same infection.

Page 19 of 27
January 2013

Other/Unknown
Other: Use this option if the recipient experienced an adverse reaction that is not defined in the Hemovigilance
Module surveillance protocol (e.g., transfusion-associated acute gut injury (TRAGI), hyperkalemia, thrombosis).
Unknown: Use this category if the patient experienced transfusion-related symptoms, but the medical event that
caused those symptoms could not be classified.
Note: Reporting ‘Other’ and ‘Unknown’ reactions is not a required by CDC. CDC does not specifically define the
‘Other’ or ‘Unknown’ adverse reaction categories, therefore the case definition criteria may only be reported as N/A.
Standard criteria for severity and imputability are provided for your use.

Case Definition

Severity

Imputability
REPORTING OPTIONAL

N/A

Non-severe:
Medical intervention (e.g. symptomatic treatment)
is required but lack of such would not result in
permanent damage or impairment of a bodily
function.

Severe:
Inpatient hospitalization or prolongation of
hospitalization is directly attributable to the
adverse reaction, persistent or significant disability
or incapacity of the patient occurs as a result of
the reaction, or a medical or surgical intervention
is necessary to preclude permanent damage or
impairment of a body function.
Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation, transfer
to intensive care) to prevent death.

Death:
The recipient died as a result of the adverse
transfusion reaction. Death should be used if
death is possibly, probably or definitely related
to transfusion. If the patient died of a cause other
than the transfusion, the severity of the reaction
should be graded as 1, 2 or 3 as appropriate
given the clinical circumstances related to the
reaction.
Not Determined:
The severity of the adverse reaction is unknown
or not stated.

Page 20 of 27
January 2013

Definite:
Conclusive evidence exists that the
adverse reaction can be attributed to
the transfusion.

Probable:
Evidence is clearly in favor of
attributing the adverse reaction to
the transfusion.

Possible:
Evidence is indeterminate for
attributing the adverse reaction to
the transfusion or an alternate
cause.

Doubtful:
Evidence is clearly in favor of a
cause other than the transfusion, but
transfusion cannot be excluded.

Ruled Out:
There is conclusive evidence
beyond reasonable doubt of a cause
other than the transfusion.

Not Determined:
The relationship between the
adverse reaction and the transfusion
is unknown or not stated.

Adverse Reaction Glossary
Antibodies often associated with AHTR, DHTR, DSTR:
Anti-A
Anti-B
Anti-A,B
Anti-C
Anti-D
Anti-k
Anti-Jka
Anti-Jkb
Anti-S
Anti-Fya

Anti-E
Anti-Fyb

Anti-c
Anti-M

Anti-e
Other

Anti-K

Bronchospasm (wheezing): A contraction of smooth muscle in the walls of the bronchi and
bronchioles, causing acute narrowing and obstruction of the respiratory airway. This constriction can
result in a rasp or whistling sound while breathing.
Chills/rigors: A feeling of cold with shivering or shaking and pallor.
Disseminated intravascular coagulation (DIC): Bleeding disorder characterized by reduction in the
factors involved in blood clotting due to their use in widespread clotting within the vessels. The
intravascular clotting ultimately produces hemorrhage because of rapid consumption of clotting factors.
Edema: Swelling of soft tissues as a result of excessive fluid accumulation.
Epistaxis: Bleeding from the nose.
Fever: An increase of at least 1°C in temperature over the pre-transfusion value.
Hematuria: Presence of blood or red blood cells in the urine.
Hemoglobinemia: The presence of free hemoglobin in the blood plasma.
Hemoglobinuria: Presence of free hemoglobin in the urine.
Hypoxemia: Abnormal deficiency in the concentration of oxygen in arterial blood. PaO2 / FiO2 less
than or equal to 300 mm Hg OR oxygen saturation is less than 90% on room air.
Jaundice: New onset or worsening of yellow discoloration (icterus) of the skin or sclera (scleral icterus)
secondary to an increased level of bilirubin.
Oliguria: New onset of decreased urinary output (less than 500cc output per 24 hours).
Other rash: Non-urticarial skin rash.
Pruritus: Itching.
Shock: A drop in blood pressure accompanied by a drop in cardiac output including rapid heart rate
(increase to 100 beats per minute or more), rapid breathing, cutaneous vasoconstriction, pallor,
sweating, decreased or scanty urine production, agitation and/or loss of consciousness that required
fluid resuscitation, with or without inotropic support.
Shortness of breath (dyspnea): New onset or significant worsening of shortness of breath; or a
significant increase in respiratory rate (with or without hypoxemia).
Urticaria (hives): Raised red spots (with or without itching).

Page 21 of 27
January 2013

Section 4. Hemovigilance Module Incidents
Required Reporting
All incidents (i.e., accidents or errors) that are associated with a reported adverse reaction must be
reported to NHSN using a detailed Incident form (CDC 57.302). If multiple incidents occur in association
with an adverse reaction, report them all. Incidents may occur before (e.g., wrong product released) or
after (e.g., failure to report adverse reaction to blood bank) an adverse reaction. Each reaction must be
reported using the detailed incident form; the incident result must be coded as ‘Product transfused,
reaction’ so that the associated patient identifier can be entered on the form. After the incident record is
entered, the adverse reaction record must be linked to the incident record in the NHSN web application.

Incident Classification
Use the incident codes provided at the end of this chapter to classify incidents. Please contact NHSN
User Support for help coding incidents if there is uncertainty.

Optional Reporting
Any incident may be optionally reported to NHSN using the detailed Incident form (57.302) or the
Monthly Incident Summary form (57.305). Approved deviations from protocol are not considered
incidents because they did not occur by accident or in error. However, these may be optionally reported
for a facility’s use. Incidents that are optionally reported will not be aggregated or analyzed by CDC.

Form
CDC 57.305 Hemovigilance Module Incident
Form Instructions
CDC 57.305 Hemovigilance Module Incident Table of Instructions
Summary Form (Optional)
CDC 57.302 Hemovigilance Module Monthly Incident Summary
Summary Form Instructions (Optional)
CDC 57.302 Hemovigilance Module Monthly Incident Summary Table of Instructions

Page 22 of 27
January 2013

Incident Codes
Note: Incident codes are based on MERS TM (US) and TESS (Canada) incident classification schemes.

Product Check-In
(Products Received from Outside Source)
PC 00 Detail not specified
PC 01 Data entry incomplete/not
performed/incorrect
PC 02 Shipment incomplete/incorrect
PC 03 Product and paperwork do not match
PC 04 Shipped under inappropriate conditions
PC 05 Inappropriate return to inventory
PC 06 Product confirmation
PC 07 Administrative check (2nd check)

Sample Receipt
(Transfusion Service)
SR 00 Detail not specified
SR 01 Sample processed in error
SR 02 Historical review incorrect/not done
SR 03 Demographic review/data entry incorrect/not
done
SR 04 Sample incorrectly accessioned
(test/product)
SR 05 Duplicate sample sent

Product/Test Request
(Clinical Service)
PR 00 Detail not specified
PR 01 Order for wrong patient
PR 02 Order incorrectly entered online
PR 03 Special needs not indicated on order (e.g.,
CMV negative, auto)
PR 04 Order not done/incomplete/incorrect
PR 05 Inappropriate/incorrect test ordered
PR 06 Inappropriate/incorrect blood product
ordered
Sample Collection
(Clinical/Transfusion Service)
SC 00 Detail not specified
SC 01 Sample labeled with incorrect patient name
SC 02 Not labeled
SC 03 Wrong patient collected
SC 04 Collected in wrong tube type
SC 05 Sample QNS
SC 06 Sample hemolyzed
SC 07 Label incomplete/illegible/incorrect (other
than patient name)
SC 08 Sample collected in error
SC 09 Requisition arrived without samples
SC 10 Wristband incorrect/not available
SC 11 Sample contaminated
Sample Handling
(Clinical/Transfusion Service)
SH 00 Detail not specified
SH 01 Sample arrived without requisition
SH 02 Requisition and sample label don’t match
SH 03 Patient ID incorrect/illegible on requisition
SH 05 No phlebotomist/witness identification
SH 06 Sample arrived with incorrect requisition
SH 07 Patient information (other than ID)
missing/incorrect on requisition
SH 10 Sample transport issue

Sample Testing
(Transfusion Service)
ST 00 Detail not specified
ST 01 Data entry incorrect/not performed
ST 02 Appropriate sample checks not done
ST 03 Computer warning overridden
ST 05 Sample tube w/incorrect accession label
ST 07 Sample tubes mixed up
ST 09 Test tubes mislabeled (wrong patient
name/number)
ST 10 Equipment problem
ST 12 Patient testing not performed
ST 13 Incorrect testing method chosen
ST 14 Testing performed incorrectly
ST 15 Test result misinterpreted
ST 16 Inappropriate/expired reagents used
ST 17 ABO/Rh error caught on final check
ST 18 Current and historical ABO/Rh don’t match
ST 19 Additional testing not performed
ST 20 Administrative check at time work performed
ST 22 Sample storage incorrect/inappropriate
Product Storage
(Transfusion Service)
US 00 Detail not specified
US 01 Incorrect storage of unit in transfusion
service
US 02 Expired product in stock
US 03 Inappropriate monitoring of storage device
US 04 Unit stored on incorrect ABO shelf
Available for Issue
(Transfusion Service)
AV 00 Detail not specified
AV 01 Inventory audit
AV 02 Product status not/incorrectly updated in
computer
AV 03 Supplier recall
AV 04 Product ordered incorrectly/not submitted

Page 23 of 27
January 2013

Incident Codes
(continued)
Note: Incident codes are based on MERS TM (US) and TESS (Canada) incident classification schemes.

Product Selection
(Transfusion Service)
SE 00 Detail not specified
SE 01 Incorrect product/component selected
SE 02 Data entry incomplete/incorrect
SE 03 Not/incorrect checking of product and/or
patient information
SE 05 Historical file misinterpreted/not checked
SE 07 Special processing needs not checked
SE 09 Special processing needs not understood or
misinterpreted
SE 11 Special processing not done
Product Manipulation
(Transfusion Service)
UM 00 Detail not specified
UM 01 Data entry incomplete/incorrect
UM 02 Record review incomplete/incorrect
UM 03 Wrong component selected
UM 04 Administrative check at time of manipulation
UM 05 Labeling incorrect
UM 07 Special processing needs not checked
UM 08 Special processing needs misunderstood or
misinterpreted
UM 09 Special processing not/incorrectly done
Request for Pick-up
(Clinical Service)
RP 00 Detail not specified
RP 01 Request for pick-up on wrong patient
RP 02 Incorrect product requested for pick-up
RP 03 Product requested prior to obtaining consent
RP 04 Product requested for pick-up patient not
available
RP 05 Product requested for pick-up IV not ready
RP 06 Request for pick-up incomplete
RP 10 Product transport issue

Product Issue
(Transfusion Service)
UI 00 Detail not specified
UI 01 Data entry incomplete/incorrect
UI 02 Record review incomplete/incorrect
UI 03 Pick-up slip did not match patient information
UI 04 Incorrect unit selected (wrong person or right
person, wrong order)
UI 05 Product issue delayed
UI 06 LIS warning overridden
UI 07 Computer issue not completed
UI 09 Not/incorrect checking of unit and/or patient
information
UI 11 Unit delivered to incorrect location
UI 19 Wrong product issued
UI 20 Administrative review (self, 2nd check at
issue)
UI 22 Issue approval not obtained/documented
Product Administration
(Clinical Service)
UT 00 Detail not specified
UT 01 Administered product to wrong patient
UT 02 Administered wrong product to patient
UT 03 Product not administered
UT 04 Incorrect storage of product on floor
UT 05 Administrative review (unit/patient at
bedside)
UT 06 Administered product w/incompatible IV fluid
UT 07 Administration delayed
UT 08 Wrong unit chosen from satellite refrigerator
UT 10 Administered components in inappropriate
order
UT 11 Appropriate monitoring of patient not done
UT 12 Floor/clinic did not check for existing
products in their area
UT 13 Labeling problem on unit
UT 19 Transfusion protocol not followed
Other
MS 99

Page 24 of 27
January 2013

Occupation Codes
Laboratory
IVT
IVT Team Staff
MLT
Medical Laboratory Technician
MTE
Medical Technologist
PHL
Phlebotomist/IV Team
Nursing
LPN
Licensed Practical Nurse
CNA
Nurse Anesthetist
CNM
Certified Nurse Midwife
NUA
Nursing Assistant
NUP
Nurse Practitioner
RNU
Registered Nurse
Physician
FEL
Fellow
MST
Medical Student
PHY
Attending/Staff Physician
RES
Intern/Resident
Technicians
EMT
EMT/Paramedic
HEM
Hemodialysis Technician
ORS
OR/Surgery Technician
PCT
Patient Care Technician
Other Personnel
CLA
Clerical/Administrative
TRA
Transport/Messenger/Porter

Additional Occupation Types
ATT
Attendant/Orderly
CSS
Central Supply
CSW
Counselor/Social Worker
DIT
Dietician
DNA
Dental Assistant/Technician
DNH
Dental Hygienist
DNO
Other Dental Worker
DNT
Dentist
DST
Dental Student
FOS
Food Service
HSK
Housekeeper
ICP
Infection Control Professional
LAU
Laundry Staff
MNT
Maintenance/Engineering
MOR
Morgue Technician
OAS
Other Ancillary Staff
OFR
Other First Responder
OH
Occupational Health Professional
OMS
Other Medical Staff
OTH
Other
OTT
Other Technician/Therapist
PAS
Physician Assistant
PHA
Pharmacist
PHW
Public Health Worker
PLT
Physical Therapist
PSY
Psychiatric Technician
RCH
Researcher
RDT
Radiologic Technologist
RTT
Respiratory Therapist/Technician
STU
Other Student
VOL
Volunteer

Page 25 of 27
January 2013

Incident Glossary
Incident Result
Product transfused, reaction (No recovery, harm):
A product related to this incident was transfused; the patient experienced an adverse reaction.
Product transfused, no reaction (No recovery, no harm):
A product related to this incident was transfused; the patient did not experience an adverse reaction.
No product transfused, unplanned recovery (Near miss, unplanned recovery):
No product related to this incident was transfused; the incident was discovered ad hoc, by accident, by
human lucky catch, etc.
No product transfused, planned recovery (Near miss, planned recovery):
No product related to this incident was transfused; the incident was discovered through a standardized
process or barrier designed to prevent errors.

Root Cause Analysis Result(s)
Technical:
• Technical failures beyond the control and responsibility of the facility.
• Poor design of equipment, software, labels or forms.
• Designed correctly but not constructed properly or set up in accessible areas.
• Other material defects.
Organizational:
• Failure at an organizational level beyond the control and responsibility of the facility or department where
the incident occurred.
• Inadequate measures taken to ensure that situational or domain-specific knowledge or information is
transferred to new or inexperienced staff.
• Inadequate quality and/or availability of protocols or procedures within the department (e.g., outdated, too
complicated, inaccurate, unrealistic, absent or poorly presented).
• Organizational/cultural attitudes and behaviors. For example, internal management decisions when faced
with conflicting demands or objectives; an inadequate collective approach and its attendant modes of
behavior to risks in the investigating organization.
Human:
• Human failures originating beyond the control and responsibility of the investigating organization. This
could include individuals in other departments.
• Inability of an individual to apply their existing knowledge to a novel situation.
• An incorrect fit between an individual’s training or education and a particular task.
• A lack of task coordination within a health care team.
• Incorrect or incomplete assessment of a situation including related conditions of the patient and materials
to be used before starting the transfusion. Faulty task planning and execution. Example: washing red
blood cells using the same protocol as that used for platelets.
• Failure in monitoring a process or patient status.
• Failure in performing highly developed skills.
• Failure in whole body movements, e.g. slips, trips and falls.
Patient-related:
• Failures related to patient characteristics or conditions which are beyond the control of staff and influence
treatment.
Other:
• Cannot be classified under any of the other categories.
Page 26 of 27
January 2013

Section 5. Hemovigilance Module Denominators
Required Reporting
Facilities must report the total number of units and/or aliquots of specified blood products transfused
each month. When reporting aliquots, the units from which they are made should NOT be counted as a
transfused unit. The products transfused count should include autologous units. The total number of
patient samples collected must also be reported on this form. Denominators should be entered within 30
days of the end of each month.
Form
CDC 57.303 Hemovigilance Module Monthly Reporting Denominators
Form Instructions
CDC 57.303 Hemovigilance Module Monthly Reporting Denominators Tables of Instructions

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