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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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
Page 1 of 56
August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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

2.1

August 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 TAGVHD 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 of organization and presentation of information
Major change in incident reporting requirements. With this release, only incidents
that relate to an adverse patient reaction are required for participation.
Major change in adverse reaction reporting requirements. With this release, minor
allergic reactions are no longer required for participation.
Combined the signs/symptoms with laboratory/radiology columns in case definition
tables for clarity. Listed criteria in alphabetical order where possible for consistency
and clarity. Moved general severity requirements from the appendix to the criteria
tables where they were previously missing.
Re-ordered adverse reaction tables to put respiratory reactions first.
Added Imputability criteria of Doubtful, Ruled Out, and Not Determined to the case
definition tables as OPTIONAL reporting categories. The reporting is not a change,
but including them in the table is new. They were added for clarity.
Added specific AHTR criteria to allow for reporting of non-immune mediated
reactions.
Added a separate case definition table for Other and Unknown reactions. These
categories are available for OPTONAL use.
Removed redundant and unnecessary appendices.
Minor revisions to verbiage throughout for clarity.
Added definitions and illustration of surveillance key terms in Section 1.
Added clarification of surveillance vs. clinical definitions in Section 1.

Page 2 of 56
August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Version

Release Date

Summary of Revisions

2.1.1
2.1.2

September 2013
January 2014

2.1.3

August 2014

Added less-specific case definition categories for OPTIONAL reporting of cases
that do not fully meet CDC case criteria for the following reactions: hypotension,
febrile non-hemolytic, acute hemolytic and delayed hemolytic.
Added a possible case definition category for TTI for OPTIONAL reporting of
syndromic cases that are not laboratory confirmed.
Updated diagram in Section 1 and added version history for v2.0 and v2.1.
Updated the incident codes in Section 4 and included required reporting of discards
and total crossmatch procedures on the Monthly Reporting Denominators form in
Section 5.
Added a suggested citation for the surveillance protocol in Section 1. Updated the
acute hemolytic case definition in Section 3 for clarity. Updated the reporting
requirements in Section 5 for clarity.

Page 3 of 56
August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Table of Contents
Section 1. Hemovigilance Module Surveillance Overview ........................................ 5
Section 2. Hemovigilance Module Annual Facility Survey ....................................... 6
Section 3: Hemovigilance Module Adverse Reactions ............................................. 8
Adverse Reaction Case Classification Criteria Tables .................................................... 10
Transfusion-associated circulatory overload (TACO) ......................................................................... 10
Transfusion-related acute lung injury (TRALI) .................................................................................... 11
Transfusion-associated dyspnea (TAD) ............................................................................................. 12
Allergic reaction .................................................................................................................................. 13
Hypotensive transfusion reaction ....................................................................................................... 14
Febrile non-hemolytic transfusion reaction (FNHTR) ......................................................................... 15
Acute hemolytic transfusion reaction (AHTR) .................................................................................... 16
Delayed hemolytic transfusion reaction (DHTR) ................................................................................ 17
Delayed serologic transfusion reaction (DSTR) ................................................................................. 19
Transfusion-associated graft vs. host disease (TAGVHD) ................................................................. 20
Post transfusion purpura (PTP) .......................................................................................................... 21
Transfusion-transmitted infection (TTI) .............................................................................................. 22
Other/Unknown ................................................................................................................................... 26

Adverse Reaction Glossary ............................................................................................... 27

Section 4. Hemovigilance Module Incidents ............................................................ 29
Incident Codes ................................................................................................................... 30
Occupation Codes ............................................................................................................. 34
Incident Glossary ............................................................................................................... 36

Section 5. Hemovigilance Module Denominators.................................................... 38

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August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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,
minimizing morbidity and mortality of transfusion recipients, and identifying emerging complications and
pathogens associated with blood transfusion.
Settings
The Hemovigilance Module may be used by any U.S. healthcare facility where blood components and
manufactured blood products are transfused (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
components throughout the transfusion process, from product receipt from supplier to administration to
the patient. Participation in the NHSN Hemovigilance Module requires reporting of all adverse
transfusion reactions and reaction-associated incidents that occur for patients transfused at or by
your facility as well as a monthly summary of components transfused or discarded and patient samples
collected for type and screen or crossmatch.
Data Collection Forms and Instructions
Paper versions of all forms used to collect data in the NHSN Hemovigilance 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.
Suggested Citation for the Hemovigilance Module Surveillance Protocol
U.S. Centers for Disease Control and Prevention. The National Healthcare Safety Network
(NHSN) Manual: Biovigilance Component v2.1.3. Atlanta, GA: Division of Healthcare Quality
Promotion, National Center for Emerging and Zoonotic Infectious Diseases. Available at:
http://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf. Accessed [enter date].

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Key Terms (see Fig. 1)
 Adverse event: An unintended and undesirable occurrence before, during or after transfusion of
blood or blood components. Adverse events include both incidents and adverse reactions.
 Adverse reaction: An undesirable response or effect in a patient temporally associated with the
administration of blood or blood components. It may or may not be the result of an incident.
 Incident: Any error or accident that could affect the quality or efficacy of blood, blood components,
or patient transfusions. It may or may not result in an adverse reaction in a transfusion recipient.
 Near miss: A subset of incidents that are discovered before the start of a transfusion that could
have led to a wrongful transfusion or an adverse reaction in a transfusion recipient.
Data Reporting Requirements (See Fig. 1)
 At least 12 months of continuous surveillance
 An annual facility demographic and practice survey for each calendar year of participation
 ALL adverse reactions that follow transfusion at or by your facility
 ALL incidents (i.e., errors or accidents) associated with an adverse reaction
 The number of blood components transfused or discarded and patient samples collected for type

Transfusion-Related
Activities

Transfusions
Reactions

Incidents

and screen or crossmatch each month
Figure 1. Venn diagram of NHSN Hemovigilance Module surveillance terms.
Transfusion-Related Activities
•
•
•
•

Patient Sample Collection
Sample Handling and Testing
Inventory Management
Patient Monitoring

Transfusion
• Number of Components
• Number of Patients

Adverse Events
Reactions
Incidents
Near Miss Incidents
Incidents Related to Transfusion (No Adverse Reaction)
Incidents Related to Transfusion and Adverse Reaction

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August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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 services. 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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August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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. 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 reports should be entered into NHSN after an
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.
Optional Reporting
Reporting suspected adverse reactions where imputability is determined to be doubtful or ruled out is not
required. A facility may report reactions determined to be doubtful or ruled out in order to use NHSN to
document transfusion reaction investigations each month. Adverse reactions that are not defined in the
surveillance protocol may also be reported using the ‘Other’ and ‘Unknown’ adverse reaction categories;
standard severity and imputability criteria are provided for that purpose. CDC will not aggregate or
analyze these optional reports.
Adverse Reaction Classification
Each CDC-defined transfusion-associated adverse reaction must be classified according to the reactionspecific case definition, severity, and imputability criteria printed in this section of the protocol. It is
imperative that every facility classify adverse reactions according to protocol definitions. Accurate
classification will usually require a detailed review of the patient record.
Surveillance definitions are distinctly different from clinical definitions. Surveillance definitions are
designed to capture data consistently and reliably in order to identify trends and inform quality
improvement practices. By using standardized surveillance definitions, data can be aggregated to create
national benchmarks that will permit facilities to compare their performance to a national baseline as well
as within their facility over time. The surveillance definitions are not intended as clinical diagnostic
criteria or to provide treatment guidance.
Defined Adverse Reactions

Transfusion-associated circulatory overload (TACO)

Transfusion-related acute lung injury (TRALI)

Transfusion-associated dyspnea (TAD)

Allergic reaction (where severity = severe, life threatening, or death)

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)
Note

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Reporting of adverse reactions to CDC through NHSN system does NOT take the place of reporting
requirements for blood transfusion-associated adverse events to the Food and Drug Administration
(FDA).
Form
CDC 57.304 Hemovigilance Module Adverse Reaction
Form Instructions
CDC 57.304 Hemovigilance Module Adverse Reaction Table of Instructions

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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 circulatory
overload are possible.

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.

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 appropriate
given the clinical circumstances related to
the reaction.

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

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August 2014

Probable:
Transfusion is a likely contributor to
circulatory overload
AND EITHER
The patient received other fluids as
well
OR
The patient has a history of cardiac
insufficiency that could explain the
circulatory overload, but
transfusion is just as likely to have
caused the circulatory overload.

Possible:
The patient has a history of preexisting cardiac insufficiency that
most likely explains circulatory
overload.
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.

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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

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
appropriate given the clinical
circumstances related to the reaction.

Possible:
N/A

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

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

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August 2014

Probable:
N/A

Possible:
There is evidence of other causes 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
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.

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Transfusion-associated dyspnea (TAD)
Case Definition

Severity

Imputability

Definitive:
Acute respiratory
distress occurring within
24 hours of cessation of
transfusion
AND
Allergic reaction, TACO,
and TRALI definitions
are not applicable.

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
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 appropriate given the clinical
circumstances related to the reaction.

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

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August 2014

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Allergic reaction
Note: Minor allergic reactions (Non-severe) do not have to be reported to 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)
OPTIONAL
Possible:
N/A

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 appropriate given the clinical
circumstances related to the reaction.

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 severity of the adverse reaction is
unknown or not stated.

OPTIONAL
Non-severe:
There is no immediate risk to the life of
the patient, and the patient responds
quickly to symptomatic treatment.

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.
Not Determined:
The relationship between the
adverse reaction and the

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Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

transfusion is unknown or not
stated.

Hypotensive transfusion reaction
Case Definition

Severity

Imputability

Definitive:
All other adverse reactions
presenting with hypotension are
excluded
AND
Hypotension occurs during or
within 1 hour after cessation of
transfusion.

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
OPTIONAL

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 appropriate given
the clinical circumstances
related to the reaction.

Possible:

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.

OPTIONAL
Doubtful:

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Hypotension occurs, does not
meet the criteria above. Other,
more specific reaction definitions
do not apply.

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

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.

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
signs/symptoms.

Probable:
N/A
OPTIONAL
Possible:
FNHTR is suspected, but
reported symptoms and/or
available information are
not sufficient to meet the
criteria defined above.
Other, more specific
adverse reaction definitions
do not apply.

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
appropriate given the clinical circumstances
related to the reaction.

Not Determined:
The severity of the adverse reaction is
unknown or not stated.
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Probable:
There are other potential causes
present that could explain
signs/symptoms, but transfusion
is the most likely cause.

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
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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 components.
Case Definition
Severity
Imputability
Definitive:
Occurs during, or within 24 hours of cessation of
transfusion with new onset of ANY of the following
signs/symptoms:
 Back/flank pain
 Chills/rigors
 Disseminated intravascular coagulation (DIC)
 Epistaxis
 Fever
 Hematuria (gross visual hemolysis)
 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
 Plasma discoloration c/w hemolysis
 Spherocytes on blood film
AND EITHER
(IMMUNE-MEDIATED)
Positive direct antiglobulin test (DAT) for anti-IgG 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.
Probable:
Meets signs and symptoms criteria for acute hemolysis
AND EITHER
(IMMUNE MEDIATED)
Physical cause is excluded but serologic evidence is not
sufficient to meet definitive criteria

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

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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
appropriate given the clinical
circumstances related to the
reaction.
Not Determined:
The severity of the adverse
reaction is unknown or not
stated.

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:
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.
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.

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

AHTR is suspected within 24 hours of cessation of
transfusion, but symptoms, test results, and/or information
are not sufficient to meet the criteria defined above. Other,
more specific adverse definitions do not apply.
Delayed hemolytic transfusion reaction (DHTR)

Note: Report all hemolytic reactions, including when the recipient is intentionally transfused with
incompatible blood components.
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 post-transfusion
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.

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

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.
OPTIONAL
Possible:
DHTR is suspected, but reported
symptoms, test results, and/or
available information are not sufficient
to meet the criteria defined above.

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 appropriate given the
clinical circumstances related to
the reaction.

Not Determined:
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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.

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Other, more specific adverse reaction
definitions do not apply.

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

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.

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
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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:
New alloantibody is identified between 24 hours and 28
days after cessation of transfusion
AND
The patient has other exposures (e.g. transfusion by
another facility or pregnancy) that could explain
seroconversion, but transfusion by your facility is the
most likely cause.

Probable:
N/A

Possible:
New alloantibody is identified between 24 hours and 28
days after cessation of transfusion
AND
The patient was transfused by your facility, but other
exposures are present that most likely explain
seroconversion.

Possible:
N/A

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.

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

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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.

Possible:
N/A

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 appropriate
given the clinical
circumstances related to the
reaction.

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

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Post transfusion purpura (PTP)
Case Definition

Severity

Imputability

Definitive:
Alloantibodies in the patient
directed against HPA or other
platelet specific antigen detected
at or after development of
thrombocytopenia
AND
Thrombocytopenia (i.e., decrease
in platelets to less than 20% of
pre-transfusion 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 post-transfusion
AND
Patient has no other conditions to
explain thrombocytopenia.

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.

Probable:
Alloantibodies in the patient
directed against HPA or other
platelet specific antigen detected
at or after development of
thrombocytopenia.
AND
Decrease in platelets to levels
between 20% and 80% of pretransfusion count.
OPTIONAL
Possible:
PTP is suspected, but laboratory
findings 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 reaction
definitions do not apply.

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 appropriate given the
clinical circumstances related to the
reaction.
Not Determined:
The severity of the adverse reaction is
unknown or not stated.

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

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Transfusion-transmitted infection (TTI)
Case Definition

Severity

Imputability

Definitive:
Laboratory
evidence of a
pathogen in the
transfusion
recipient.

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 component
 Evidence of the pathogen in the donor at the time of donation
 Evidence of the pathogen in an additional component from the same donation
 Evidence of the pathogen in an additional recipient of a component from the
same donation
AND
No other potential exposures to the pathogen could be identified in the recipient.
AND EITHER
Evidence that the recipient was not infected with the pathogen prior to transfusion
OR
Evidence that the identified pathogen strains are related by molecular or extended
phenotypic comparison testing with statistical confidence (p<0.05).

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.
OPTIONAL
Possible:
Temporally
associated
unexplained
clinical illness
consistent with
infection, but no
pathogen is
detected in the
recipient. Other,
more specific
adverse reactions
are ruled out.
Note: Possible
cases cannot meet
the definite or
probable
imputability criteria.

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

Probable:
ONE or more of the following:
 Evidence of the pathogen in the transfused component
 Evidence of the pathogen in the donor at the time of donation
 Evidence of the pathogen in an additional component from the same donation
 Evidence of the pathogen in an additional recipient of a component 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.
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 component 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 components from the same donation were negative
for this pathogen
OR
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.

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
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unknown or not
stated.

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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,
Klebsiella oxytoca
(Trypanosoma cruzi)
Epstein Barr (EBV)
Variant (vCJD)
Klebsiella pneumoniae
Malaria (Plasmodium spp.)
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 potential transfusion-transmitted infections:
1. Identification by testing (e.g., gram stain, other smear/staining, culture, or other method) of a
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 transfusion 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 testing (e.g., blood smear,
histopathology, serologic testing, or polymerase chain reaction) 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.

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Other or 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), transfusion-associated
immunomodulation (TRIM), iron overload, microchimerism, 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 required by CDC.
REPORTING OPTIONAL

Case Definition

Severity

Imputability

Not Applicable:
CDC does not
specifically define the
‘Other’ or ‘Unknown’
adverse reaction
categories, therefore
the case definition
criteria may only be
reported as 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.

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

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 appropriate given the clinical
circumstances related to the reaction.
Not Determined:
The severity of the adverse reaction is unknown
or not stated.

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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.

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Adverse Reaction Glossary
Antibodies often associated with AHTR, DHTR, DSTR:

Anti-A
Anti-B
Anti-A,B
b
a
Anti-Fy Anti-Jk Anti-Jkb

Anti-C
Anti-K

Anti-c
Anti-k

Anti-D
Anti-M

Anti-E
Anti-S

Anti-e
Other

Anti-Fya

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: For the purposes of hemovigilance, an increase of at least 1°C in temperature over the pretransfusion 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).

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Urticaria (hives): Raised wheals on the skin.

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
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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 section 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

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

Product Check-In
(Transfusion Service)
Events that occur during the shipment and receipt of
products into the transfusion service from the
supplier, another hospital site, satellite storage, or
clinical area.
PC 00 Detail not specified
PC 01 Data entry incomplete/incorrect/not performed
PC 02 Shipment incomplete/incorrect
PC 03 Products and paperwork do not match
PC 04 Shipped/transported under inappropriate
conditions
PC 05 Inappropriate return to inventory
PC 06 Product confirmation incorrect/not performed
PC 07 Administrative check not incorrect/not
performed (record review/audit)
PC 08 Product label incorrect/missing

Product Storage
(Transfusion Service)
Events that occur during product storage by the
transfusion service.
US 00 Detail not specified
US 01 Incorrect storage conditions
US 03 Inappropriate monitoring of storage device
US 04 Unit stored on incorrect shelf (e.g.,
ABO/autologous s/directed)
US 05 Incorrect storage location

Inventory Management
(Transfusion Service)
Events that involve quality management of the blood
product inventory.
IM 00 Detail not specified
IM 01 Inventory audit incorrect/not performed
IM 02 Product status incorrectly/not updated online
(e.g., available/discarded)
IM 03 Supplier recall/traceback not appropriately
addressed/not performed
IM 04 Product order incorrectly/not submitted to
supplier
IM 05 Outdated product in available inventory
IM 06 Recalled/quarantined product in available
inventory

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Product/Test Request
(Clinical Service)
Events that occur when the clinical service orders
patient tests or blood products for transfusion.
PR 00 Detail not specified
PR 01 Order for wrong patient
PR 02 Order incompletely/incorrectly ordered (online
order entry)
PR 03 Special processing needs not indicated (e.g.,
CMV negative, autologous)
PR 04 Order not done
PR 05 Inappropriate/unnecessary (intended) test
ordered
PR 06 Inappropriate/unnecessary (intended) blood
product ordered
PR 07 Incorrect (unintended) test ordered
PR 08 Incorrect (unintended) blood product ordered

Product/Test Order Entry
(Transfusion Service)
Events that occur when the transfusion service
receives a patient order. This process may be
excluded if clinical service uses online ordering.
OE 00 Detail not specified
OE 01 Order entered for wrong patient
OE 02 Order incompletely/incorrectly entered online
OE 03 Special processing needs not entered (e.g.,
CMV-, autologous)
OE 04 Order entry not done
OE 05 Inappropriate/unnecessary (intended) test
order entered
OE 06 Inappropriate/unnecessary (intended) blood
product order entered
OE 07 Incorrect (unintended) test ordered
OE 08 Incorrect (unintended) blood product ordered

Sample Collection
(Service collecting the samples)
Events that occur during patient sample collection.
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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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

Sample Handling
(Service collecting the samples)
Events that occur when a patient sample is sent for
testing.
SH 00 Detail not specified
SH 01 Sample sent without requisition
SH 02 Requisition and sample label don’t match
SH 03 Patient ID incomplete/illegible on requisition
SH 04 No Patient ID on requisition
SH 05 No phlebotomist/witness identification
SH 06 Sample sent with incorrect requisition type
SH 07 Patient information (other than ID)
missing/incorrect on requisition
SH 08 Requisition sent without sample
SH 09 Data entry incorrect/incomplete/not performed
SH 10 Sample transport issue (e.g., sample
broken/inappropriate conditions)
SH 11 Duplicate sample sent in error

Sample Receipt
(Transfusion Service)
Events that occur when a sample is received by the
transfusion service.
SR 00 Detail not specified
SR 01 Sample accepted in error
SR 02 Historical review incorrect/not performed
SR 03 Demographic review/ data entry incorrect/not
performed
SR 04 Sample incorrectly accessioned

Sample Testing
(Transfusion Service)
Events that occur during patient sample testing by
the transfusion service.
ST 00 Detail not specified
ST 01 Data entry incomplete/incorrect/not performed
ST 02 Appropriate sample checks
incomplete/incorrect/not performed
ST 03 Computer warning overridden in error or
outside SOP
ST 05 Sample test tube incorrectly accessioned
ST 07 Sample test tubes mixed up
ST 09 Sample test tube mislabeled (wrong patient
identifiers)
ST 10 Equipment problem/failure/not properly QC’d
ST 12 Sample testing not performed
ST 13 Incorrect sample testing method chosen
Page 31 of 56
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Sample Testing (continued)
ST 16 Reagents used were
incorrect/inappropriate/expired/not properly
QC’d
ST 17 ABO/Rh error caught on final check
ST 18 Current/historical ABO/Rh mismatch
ST 19 Additional testing not performed
ST 20 Confirmatory check incorrect/not performed (at
time work performed)
ST 21 Administrative check incorrect/not performed
(record review/audit)
ST 22 Sample storage incorrect/inappropriate

Product Manipulation/Processing/Testing
(Transfusion Service)
Events that occur while testing, manipulating (e.g.,
pooling, washing, aliquoting, irradiating), processing,
or labeling blood products.
UM 00 Detail not specified
UM 01 Data entry incomplete/incorrect/not performed
UM 02 Record review incomplete/incorrect/not
performed
UM 03 Incorrect product (type) selected
UM 04 Incorrect product (patient) selected
UM 05 Product labeled incorrectly (new/updated)
UM 06 Computer warning overridden in error or
outside SOP
UM 07 Special processing needs not checked
UM 08 Special processing needs misunderstood or
misinterpreted
UM 09 Special processing needs performed
incorrectly
UM 10 Special processing needs not performed
UM 11 Equipment problem/failure/not properly QC’d
UM 12 Reagents used were
incorrect/inappropriate/expired/not properly
QC’d
UM 13 Confirmatory check incorrect/not performed (at
time work performed)
UM 14 Administrative check incorrect/not performed
(record review/audit)

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

ST 14 Sample testing performed incorrectly
ST 15 Sample test result misinterpreted

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August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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

Request for Pick-up
(Clinical Service)
Events that occur when the clinical service requests
pick-up of a blood product from the transfusion
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, but patient not
available
RP 05 Product requested for pick-up, but IV not ready
RP 06 Request for pick-up incomplete (e.g., patient
ID/product type missing)
RP 07 Pick-up slip did not match patient information
on product

Product Issue
(Transfusion Service)
Events that occur when the transfusion service
issues blood product to the clinical service.
UI 00 Detail not specified
UI 01 Data entry incomplete/incorrect/not performed
UI 02 Record review incomplete/incorrect/not
performed
UI 03 Product issued for wrong patient
UI 04 Product issued out of order
UI 05 Product issue delayed
UI 06 LIS warning overridden in error or outside SOP
UI 07 Computer issue not completed
UI 08 Issued visibly defective product (e.g.,
clots/aggregates/particulate matter)
UI 09 Not/incorrect checking of unit and/or patient
information
UI 10 Product transport issues (e.g., delayed) by
transfusion service
UI 11 Unit delivered to incorrect location by
transfusion service
UI 12 Product transport issue (from transfusion
service to clinical area)
UI 18 Wrong product issued for intended patient (e.g.,
incompatible)
UI 19 Inappropriate product issued for patient (e.g.,
not irradiated, CMV+)
UI 20 Confirmatory check incorrect/not performed (at
time work performed)
UI 21 Administrative check incorrect/not performed
(record review/audit)
UI 22 Issue approval not obtained/documented
UI 23 Receipt verification not performed (pneumatic
tube issue)
Page 33 of 56
August 2014

Satellite Storage
(Clinical Service)
Events that occur while product is stored and
handled by the clinical service.
CS 00 Detail not specified
CS 01 Incorrect storage conditions of product in
clinical area
CS 02 Incorrect storage location in the clinical area
CS 03 Labeling issue (by clinical staff)
CS 04 Floor/clinic did not check for existing products
in their area
CS 05 Product transport issues (to or between clinical
areas)
CS 06 Monitoring of satellite storage
incorrect/incomplete/not performed
CS 07 Storage tracking/documentation
incorrect/incomplete/not performed

Product Administration
(Clinical Service)
Events that occur during the administration of blood
products.
UT 00 Detail not specified
UT 01 Administered intended product to wrong patient
UT 02 Administered wrong product to intended patient
UT 03 Transfusion not performed in error
UT 05 Bedside check (patient ID confirmation)
incomplete/not performed
UT 06 Transfused product with incompatible IV fluid
UT 07 Transfusion delayed beyond pre-approved
timeframe
UT 09 Transfused unsuitable product (e.g.,
outdated/inappropriately stored)
UT 10 Administered components in wrong order
UT 11 Appropriate monitoring of patient not
performed
UT 14 Transfusion volume too low (per order or SOP)
UT 15 Transfusion volume too high (per order or
SOP)
UT 16 Transfusion rate too slow (per order or SOP)
UT 17 Transfusion rate too fast (per order or SOP)
UT 18 Inappropriate preparation of product
UT 19 Transfusion protocol not followed (not
otherwise specified)
UT 22 Order/consent check incorrect/not performed
UT 23 Transfusion documentation
incorrect/incomplete/not performed
UT 24 Transfusion documentation not returned to
transfusion service
UT 26 Transfusion reaction protocol not followed

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Other
MS 99 Other

Occupation Codes
Laboratory
IVT
MLT
MTE
PHL
Nursing
LPN
CNA
CNM
NUA
NUP
RNU
Physician
FEL

IVT Team Staff
Medical Laboratory Technician
Medical Technologist
Phlebotomist/IV Team
Licensed Practical Nurse
Nurse Anesthetist
Certified Nurse Midwife
Nursing Assistant
Nurse Practitioner
Registered Nurse
Fellow

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August 2014

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

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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

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August 2014

MNT
MOR
OAS
OFR
OH
OMS
OTH
OTT
PAS
PHA
PHW
PLT
PSY
RCH
RDT
RTT
STU
VOL

Maintenance/Engineering
Morgue Technician
Other Ancillary Staff
Other First Responder
Occupational Health Professional
Other Medical Staff
Other
Other Technician/Therapist
Physician Assistant
Pharmacist
Public Health Worker
Physical Therapist
Psychiatric Technician
Researcher
Radiologic Technologist
Respiratory Therapist/Technician
Other Student
Volunteer

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

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:

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

 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.

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Section 5. Hemovigilance Module Denominators
Required Reporting
Facilities must report the total number of units and aliquots of specified blood components transfused
and total number of discards each month. When reporting aliquots, the units from which they are made
should NOT be counted as a transfused unit. The components transfused count should include
autologous units. The total number of patient samples collected and total crossmatch procedures 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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August 2014

NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

***Relevant Tables of Instructions**
Table 1. Hemovigilance Module Annual Facility Survey (CDC 57.300)

For all questions, use information from previous full calendar year.
Data Field

Instructions for Form Completion

Facility ID#

The NHSN-assigned Facility ID number will be auto
entered by the system.
Required. Enter the most recent full calendar year. For
example, if you are completing this survey in February
2008, the survey year will be 2007.

Survey Year

Facility Characteristics

Ownership

Is your hospital a teaching
hospital for physicians and/or
physicians-in-training?
Type of affiliation

Community setting of facility:

How is your hospital
accredited?
Total beds served by the
transfusion service.

Required. Check the ownership type that most closely
describes your facility.
Required. Check Yes if your hospital is a teaching hospital
for physicians and/or physicians-in-training.
Conditionally required. If Yes, select type of affiliation:
Major affiliation: Facility has a program for medical
students and post-graduate medical training.
Graduate affiliation: Facility has a program for postgraduate medical training (i.e., residency and/or
fellowships).
Undergraduate affiliation: Facility has a program for
medical students only.
Required. Check the setting that most closely describes
the location of your facility.
Urban: Areas classified as a Metropolitan Statistical Area
by the U.S. Census Bureau; each area must have at least
one urbanized area of 50,000 or more inhabitants.
Suburban: Areas classified as a Micropolitan Statistical
Area by the U.S. Census Bureau; each Micropolitan
statistical area must have at least one urban cluster of at
least 10,000 but less than 50,000 inhabitants.
Rural: Areas classified as Balance of County by the U.S.
Census Bureau; there are no urban areas of at least
10,000 inhabitants.
Required. Select the organization that accredits your
facility.
Required. Total beds in the facility served by the
transfusion service. Count inpatient and outpatient
areas.

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
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Instructions for Form Completion

Data Field

Number of surgeries performed Required. Enter the total number of inpatient and
per year:
outpatient surgeries performed at your facility in the past
full calendar year.
At what trauma level is your
Required. Indicate the trauma level (1, 2, 3, 4, NA) of your
facility certified?
facility.

Transfusion Service Characteristics

10.

11.

12.

13.

14.
15.

16.

Primary classification of facility Required. Check all facility areas served by the transfusion
areas served by the transfusion service.
service:
Does your healthcare facility
Required. If transfusion services and laboratory support
provide all of its own transfusion are provided 100% by the facility, check Yes. If No, select
services, including all laboratory the description that most closely represents your facility’s
functions?
transfusion service structure.
Is the transfusion service part of Required. Check Yes if your transfusion service functions
the facility’s core laboratory?
as a part of the core laboratory rather than as an
independent department.
How many dedicated
Required. Consider 2 part-time workers as a single full
transfusion service staff
time equivalent (FTE). Include supervisors. Technical FTEs
members are there? (Count full- include Medical Laboratory Technicians and Medical
time equivalents; including
Technologists.
supervisors.)
Does your hospital have a
Required. Indicate whether your facility employs a person
dedicated position or FTE in a or FTE responsible for overseeing the investigation of all
quality or patient safety function transfusion-related adverse reactions. The medical director,
(e.g., TSO) for investigation of managers, supervisors, or others that may also serve this
transfusion-related adverse
purpose within the transfusion service executive
reactions?
management should not be included.
Does your hospital have a
Required. Indicate whether your facility employs a person
dedicated position or FTE in a or FTE responsible for overseeing the investigation of all
quality or patient safety function transfusion errors. The medical director, managers,
(e.g., TSO) for investigation of supervisors, or others within the transfusion service
errors (i.e. incidents)?
executive management should not be included.
Required. If Yes, check the accrediting organization(s).
Is the transfusion service lab
accredited?
Required. Check Yes if a formal committee has been
Does your facility have a
committee that reviews blood established that meets regularly to review blood utilization.
utilization?
Total number of patient
Required. Enter the total number of patient samples
samples collected for type and collected for type and screen or crossmatch in the past full
calendar year.
screen or crossmatch:

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Instructions for Form Completion

Data Field

17. Total number of units/aliquots
transfused annually:

18.
19.

20.

21.

22.

23.
24.

Required. Provide the total number of units and/or aliquots
transfused in the past calendar year of each product type.
The total number of units and aliquots must be ≥0. Do not
include the units from which the aliquots were made in your
unit count. Note: If WBD platelet concentrates or
cryoprecipitates are transfused, enter the number of
individual concentrates pooled into each therapeutic dose.
For example, if 6 individual units were pooled to create one
cryoprecipitate dose, enter 6 units on the survey.
Are any of the following issued Required. Check all products that are maintained and
through the transfusion service? ordered through the transfusion service, or check None.
Required. Check Yes if it is facility policy to transfuse only
Does your facility attempt to
transfuse only leukocyteleukocyte-reduced or leuko-poor cellular components, even
reduced or leuko-poor cellular if some non leukocyte-reduced or non leuko-poor products
components?
are used on occasion.
Are all units stored in the
Required. If some units are routinely stored in other parts
of your facility, check No.
transfusion service?
Conditionally required. If No, check facility location(s)
Locations of satellite storage
where units are also routinely stored.
To what extent does the
Required. Check only the processes that are performed
transfusion service modify
within the transfusion service.
products?
Required. Check Yes if your facility performs blood
Do you collect blood for
transfusion at your facility?
collection in-house.
Type of blood collection
Conditionally required. If Yes, check all uses that apply.
Does your facility perform viral Required. If viral testing is performed, but not in-house,
testing on blood for transfusion? check No.
Does your facility perform point- Required. Check Yes if your facility performs point-of-issue
of-issue bacterial testing on
bacterial testing on platelets.
platelets prior to transfusion?

Transfusion Service Computerization

25. Is the transfusion service
computerized?
System(s) used
26. Is your system ISBT-128
compliant?
27. Does the transfusion service
system interface with the
patient registration system?

Required. If your department uses an electronic system for
any part of the blood product issuing process, check Yes. If
No, skip to the Handling and Testing section.
Conditionally required. If Yes, Check all systems used in
the transfusion service department.
Conditionally required. Check Yes if your department uses
the ISBT-128 code system for unit labeling.
Conditionally required. Check Yes if the transfusion
service computer system directly accesses the patient

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NHSN Biovigilance Component
Hemovigilance Module Surveillance Protocol v2.1.3
www.cdc.gov/nhsn

Instructions for Form Completion

Data Field

28.

29.

30.

31.

registration system (i.e., electronic interface and exchange
of information).
Conditionally required. Check Yes if adverse events,
Are the transfusion service
adverse events entered into a including adverse reactions and/or medical incidents,
hospital-wide electronic
reported to or occurring within your department are entered
reporting system?
into a system that is used across your facility (as opposed
to a system that is maintained entirely within your
department).
Does your facility use positive Conditionally required. Check Yes if your facility uses
patient ID technology for the
positive patient ID technology for the transfusion service,
transfusion service?
and indicate the extent to which it is used.
For what purpose(s)?
Conditionally required. If Yes, check all uses that apply.
System(s) used
Conditionally required. If Yes, check all systems that apply.
Conditionally required. Check Yes if a physician can order
Does your facility have
physician online order entry for laboratory testing directly through a computer system.
test requesting?
Conditionally required. Check Yes if a physician can order
Does your facility have
physician online order entry for blood products directly through a computer system.
product requesting?

Transfusion Service Specimens Handling and Testing

32. Are transfusion service
specimens drawn by a
dedicated phlebotomy team?
33. What specimen labels are used
at your facility?
34. Are phlebotomy staff members
allowed to correct patient
identification errors on pretransfusion specimen labels?
35. What items can be used to
verify patient identification
during specimen collection and
prior to product administration
at your facility?
36. How is routine type and screen
done?
37. Is the ABO group of a pretransfusion specimen routinely
confirmed?
Under what circumstances?

Required. Indicate the frequency with which samples for
transfusion service are drawn by dedicated phlebotomy
staff as opposed to patient care area staff or other staff.
Required. Indicate the type(s) of labels used for patient
identification on the sample tube.
Required. Check Yes if phlebotomy staff members are
allowed to manually correct name, medical record number,
etc., on the specimen label at the time of sample collection.
Required. Check all pieces of information that can be used
to verify patient identification as specified in your hospital
policy.

Required. Check all that apply and estimate the frequency
for each method checked. The total should equal 100%.
Required. Indicate whether the ABO group of a pretransfusion specimen is routinely confirmed.
Conditionally required. If Yes, indicate the circumstance
that requires routine ABO group confirmation.

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Hemovigilance Module Surveillance Protocol v2.1.3
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Data Field

Instructions for Form Completion

Is the confirmation required on
a separately-collected
specimen before a unit of
Group A, B, or AB red blood
cells is issued for transfusion?
38. How many RBC type and
screen and crossmatch
procedures were performed at
your facility by any method?
Crossmatch method frequency.

Conditionally required. Check Yes if a separately-collected
specimen is required for confirmation prior to transfusion of
Group A, B, or AB red blood cells.

Required. Enter the number of RBC type and screen and
RBC crossmatch procedures that were performed by any
method in the past full calendar year.
Conditionally required. If crossmatch procedures were
done, estimate the frequency of each method by which
crossmatch was performed. Total may be >100%.

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NHSN Biovigilance Component
Tables of Instruction v2.1
www.cdc.gov/nhsn

Table 4. Hemovigilance Module Monthly Reporting Denominators (CDC 57.303)

Data Field

Instructions for Form Completion

Facility ID#
Month

The NHSN-assigned Facility ID number will be auto entered by the
system.
Required. Indicate the month for the form being entered.

Year

Required. Indicate the year for the form being entered.

Product

Whole
Blood

Units Transfused, Aliquots Transfused, and Total Discards

Total

Required. Enter the total number of units transfused, aliquots
transfused, and discards of whole blood during the month. Do not
include the units from which aliquots were made in unit count.
Total
Required. Enter the total number of units transfused, aliquots
transfused, and discards of whole blood derived (WBD) red blood
cells (RBCs) during the month that were not irradiated or leukocyte
reduced, irradiated only, leukocyte reduced only, and irradiated and
leukocyte reduced. Total may be more than the four modification
columns combined. Do not include the units from which aliquots
were made in unit count.
Not irradiated Required. Enter the number of units transfused, aliquots
or leukocyte transfused, and discarded WBD RBCs during the month that were
reduced
not irradiated or leukocyte reduced. Do not include the units from
Whole blood
which aliquots were made in unit count.
derived
Irradiated
Required. Enter the number of units transfused, aliquots
Red blood
transfused, and discarded WBD RBCs during the month that were
cells
irradiated only. Do not include the units from which aliquots were
made in unit count.
Leukocyte
Required. Enter the number of units transfused, aliquots
reduced
transfused, and discarded WBD RBCs during the month that were
leukocyte reduced only. Do not include the units from which aliquots
were made in unit count.
Irradiated and Required. Enter the number of units transfused, aliquots
leukocyte
transfused, and discarded WBD RBCs during the month that were
reduced
both irradiated and leukocyte reduced. Do not include the units from
which aliquots were made in unit count.
Total
Required. Enter the total number of units transfused aliquots
transfused, and discarded apheresis RBCs transfused during the
month that were not irradiated or leukocyte reduced, irradiated only,
leukocyte reduced only, and irradiated and leukocyte reduced. Total
Apheresis
may be more than the four modification columns combined. Do not
Red blood
include the units from which aliquots were made in unit count.
cells
Not irradiated Required. Enter the number of units transfused, aliquots transfused
or leukocyte and discarded apheresis RBCs during the month that were not
reduced
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NHSN Biovigilance Component
Tables of Instruction v2.1
www.cdc.gov/nhsn

Instructions for Form Completion

Data Field

Irradiated

Leukocyte
reduced

Irradiated and
leukocyte
reduced
Total

Whole blood
Not irradiated
derived
or leukocyte
Platelets
reduced
Irradiated
Leukocyte
reduced
Irradiated and
leukocyte
reduced
Total

Apheresis
Platelets
Not irradiated
or leukocyte
reduced

irradiated or leukocyte reduced. Do not include the units from which
aliquots were made in unit count.
Required. Enter the number of units transfused, aliquots
transfused, and discarded apheresis RBCs during the month that
were irradiated only. Do not include the units from which aliquots
were made in unit count.
Required. Enter the number of units transfused, aliquots
transfused, and discarded apheresis RBCs during the month that
were leukocyte reduced only. Do not include the units from which
aliquots were made in unit count.
Required. Enter the number of units transfused, aliquots transfused
and discarded apheresis RBCs during the month that were both
irradiated and leukocyte reduced. Do not include the units from
which aliquots were made in unit count.
Required. Enter the total number of units transfused and discarded
WBD platelets during the month that were not irradiated or
leukocyte reduced, irradiated only, leukocyte reduced only, and
irradiated and leukocyte reduced. Total may be more than the four
modification columns combined. Note: Report the number of pooled
units and NOT the number of individual donor concentrates added
to the pooled unit. For example, if 6 donor concentrates were
pooled to create one WBD platelet unit, count one unit for
denominator reporting.
Required. Enter the number of units transfused and discarded
WBD platelets during the month that were not irradiated or
leukocyte reduced.
Required. Enter the number of units transfused and discarded
WBD platelets during the month that were irradiated only.
Required. Enter the number of units transfused and discarded
WBD platelets during the month that were leukocyte reduced only.
Required. Enter the number of units transfused and discarded
WBD platelets during the month that were both irradiated and
leukocyte reduced.
Required. Enter the total number of units transfused, aliquots
transfused, and discarded apheresis platelets during the month that
were not irradiated or leukocyte reduced, irradiated only, leukocyte
reduced only, and irradiated and leukocyte reduced. Total may be
more than the four modification columns combined. Do not include
the units from which aliquots were made in unit count.
Required. Enter the number of units transfused, aliquots
transfused, and discarded apheresis platelets during the month that

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Data Field

were not irradiated or leukocyte reduced. Do not include the units
from which aliquots were made in unit count.
Irradiated
Required. Enter the number of units transfused, aliquots
transfused, and discarded apheresis platelets during the month that
were irradiated only. Do not include the units from which aliquots
were made in unit count.
Leukocyte
Required. Enter the number of units transfused, aliquots
reduced
transfused, and discarded apheresis platelets during the month that
were leukocyte reduced only. Do not include the units from which
aliquots were made in unit count.
Irradiated and Required. Enter the number of units transfused, aliquots
leukocyte
transfused, and discarded apheresis platelets during the month that
reduced
were both irradiated and leukocyte reduced. Do not include the units
from which aliquots were made in unit count.
Total whole Required. Enter the total number of units transfused, aliquots
blood derived transfused, and discarded WBD plasma (e.g., fresh frozen, thawed,
etc.) during the month. Do not include the units from which aliquots
were made in unit count.
Plasma
(all types) Total
Required. Enter the total number of units transfused, aliquots
apheresis
transfused, and discarded apheresis plasma (e.g., fresh frozen,
thawed, etc.) during the month. Do not include the units from which
aliquots were made in unit count.
Cryoprecipitate
Required. Enter the total number of units transfused and discarded
cryoprecipitate during the month. Note: Report the number of
individual concentrates pooled into each therapeutic dose. For
example, if 6 individual concentrates were pooled to create one
cryoprecipitate dose, count 6 units for denominator reporting.
Does your facility transfuse
Required. Select ‘YES’ if your facility transfused Psoralen-treated
psoralen-treated blood
blood products. Select ‘NO’ if your facility does NOT transfuse
products?
Psoralen-treated blood products.
If yes, complete the following Enter total number of psoralen-treated blood products transfused by
table
product type and collection method in the following table.
Whole blood Conditional. Enter the total number of units transfused and
Platelets
derived
discarded WBD Psoralen-treated platelets during the month.

Plasma
all types)

Psoralentreated
Apheresis
Psoralentreated
Whole blood
derived
Psoralentreated

Conditional. Enter the total number of units transfused, aliquots
transfused, and discarded apheresis platelets during the month.
Conditional. Enter the total number of units transfused, aliquots
transfused, and discarded WBD Psoralen-treated plasma (e.g.,
fresh frozen, thawed, etc.) during the month. Do not include the
units from which aliquots were made in unit count.
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Data Field

Apheresis
Psoralentreated

Conditional. Enter the total number of units transfused, aliquots
transfused, and discarded apheresis plasma (e.g., fresh frozen,
thawed, etc.) during the month. Do not include the units from which
aliquots were made in unit count.
Patient samples collected Required. Enter the total number of patients blood samples
for type and screen or
collected during the month for type and screen and/or crossmatch.
crossmatch
Total crossmatch
Required. Enter the total number of crossmatch procedures that
procedures
were actually performed by your facility.
Total patients transfused Optional. Enter the total number of patients transfused by your
facility.
Custom Fields
Optional. Up to 50 custom fields may be added to this form for local
use. Custom data may be collected in an alphanumeric, numeric, or
date format.

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Table 5. Hemovigilance Module Adverse Reaction (CDC 57.304)

Data Field

Instructions for Form Completion

Facility ID#
Adverse Reaction #

The Facility ID number will be auto entered by NHSN.
An adverse reaction number will be auto entered by NHSN.

Share report with FDA

Optional. Check the box if report is to be shared with FDA via the
NSHN group function. Leave the box unchecked if the report is NOT
to be shared with FDA via the NHSN group function.
NOTE: A facility must be a member of the FDA group before reports
can be shared with FDA.

Patient Information

Patient ID

Gender

Required. Enter the medical record number or other facility
alphanumeric identification code for the patient. Note: Facility patient
information is shared across NHSN Component. When an MRN is
entered for a patient that has been previously entered for another
NHSN event, the patient information will automatically populate.
NHSN is HIPPA compliant; it is not recommended to devise a unique
patient identifier for NHSN.
Required. Select the gender of the transfusion recipient.

Date of birth

Required. Enter the date of birth of the transfusion recipient.

Social Security #

Optional. For local use only.

Secondary ID

Optional. For local use only.

Medicare #

Optional. For local use only.

Last Name

Optional. For local use only.

First Name

Optional. For local use only.

Middle Name

Optional. For local use only.

Ethnicity

Optional. For local use only.

Race

Optional. For local use only.

Blood group

Required. Select the blood group of the transfusion recipient. Note:
If the patient’s blood type does not clearly match a single blood type,
select the most relevant blood type and make a note in the
comments section of the form. For example, if a patient is typing with
mixed field reactions following a bone marrow transplant, select the
predominant blood type and enter a note in the comments section
such as, “Group A recipient of group O bone marrow transplant
currently typing as mixed field.”
Primary underlying reason Required. Select the primary reason this patient received a
for transfusion
transfusion. If none of the options are adequate, select “other” and
specify the reason in detail. Avoid using “anemia” as it does not
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Instructions for Form Completion
describe the underlying medical condition of the transfusion
recipient.

Reaction Details

Date reaction occurred
Time reaction occurred
Facility location where
patient was transfused
Link/Unlink Incidents

Signs and symptoms,
laboratory

Required. Enter the date the reaction was first observed in the
transfusion recipient.
Required. Enter the time the reaction was first observed in the
transfusion recipient using a 24-hour clock.
Required. Select the facility location where the patient was
transfused. Note: Only report reactions for recipients transfused
by your facility.
Conditionally required. Select associated incidents from the list
populated by NHSN and SAVE. Note: The incident record must be
entered into the system first and must include the associated Patient
ID number(s). When linking the adverse reaction record, NHSN
searches for matching Patient ID numbers in the incident records.
Required. Check all signs and symptoms observed in the patient at
the time the reaction occurred as well as any associated laboratory
findings. These may or may not be directly related to the observed
reaction as patients receiving transfusions typically have underlying
medical conditions. See Section 3 in the Hemovigilance Module
surveillance protocol for a glossary of signs and symptoms.

Investigation Results

Adverse reaction










Required. Using the case definition criteria in Section 3 of the
Hemovigilance Module surveillance protocol, select the adverse
reaction being reported. Report only one adverse reaction per form.
Note: Report the reaction after the investigation has been
finalized. Incomplete records cannot be saved. If new information
becomes available at a later time, the record can be edited.
Allergic reaction, including anaphylaxis
Acute hemolytic transfusion reaction (AHTR)
Type of AHTR
Conditionally required. Indicate whether the AHTR was immunemediated (specify Ab) or non-immune mediated (specify cause).
Delayed hemolytic transfusion reaction (DHTR)
Type of DHTR
Conditionally required. Indicate whether the DHTR was immunemediated (specify Ab) or non-immune mediated (specify cause).
Delayed serologic transfusion reaction (DSTR)
DSTR antibody
Conditionally required. Specify Antibody(s).
Febrile non-hemolytic transfusion reaction (FNHTR)
Hypotensive transfusion reaction
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Data Field

 Infection
Was a test to detect a
specific antigen
performed on the
recipient posttransfusion?
Positive/Reactive?








Instructions for Form Completion
Conditionally required. Indicate whether or not a test was performed
on the recipient to detect a specific pathogen after the blood
product(s) was/were administered to the recipient.

Conditionally required. If a post-transfusion test was performed,
indicate whether the test was positive or reactive.
Specify organism
Conditionally required. If a post-transfusion test was performed and
found to be positive or reactive, report the detected organism(s).
Was a test to detect a Conditionally required. Indicate whether or not a test was performed
on the donor to detect a specific pathogen after the blood was
specific antigen
performed on the
donated.
donor post-donation?
Positive/Reactive?
Conditionally required. If a post-donation test was performed,
indicate whether the test was positive or reactive.
Specify organism
Conditionally required. If a post-donation test was performed and
found to be positive or reactive, report the detected organism(s).
Was a test to detect a Conditionally required. Indicate whether or not a test was performed
on the implicated blood product to detect a specific pathogen after
specific antigen
performed on the unit the blood product(s) was/were administered to the recipient.
post-transfusion?
Positive/Reactive?
Conditionally required. If a post-transfusion test was performed,
indicate whether the test was positive or reactive.
Specify organism
Conditionally required. If a post-transfusion test was performed and
found to be positive or reactive, enter the detected organism(s).
Post transfusion purpura (PTP)
Transfusion-associated circulatory overload (TACO)
Transfusion-associated dyspnea (TAD)
Transfusion-associated graft vs. host disease
Did the patient receive Conditionally required. Specify whether the patient received any
non-irradiated blood non-irradiated blood products in the two months prior to the
product(s) in the two TAGVHD reaction.
months preceding the
reaction?
Transfusion-related acute lung injury (TRALI)
Antibody studies
Optional. If antibody studies were performed on the donor and/or
performed
the recipient, enter the results.
Unknown Note: Use this category if the patient experienced transfusion-related symptoms,
but the medical event that caused the symptoms could not be diagnosed.
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Instructions for Form Completion

 Other (specify) Note: Use this option if the recipient was diagnosed with an adverse
reaction that is not defined in the Hemovigilance Module protocol (e.g., transfusionassociated acute gut injury (TRAGI), thrombosis).
Case definition criteria
Required. Using the case definition criteria in Section 3 of the
Hemovigilance Module surveillance protocol, select the case criteria
met for the reported adverse reaction.
Severity
Required. Using the case definition criteria in Section 3 of the
Hemovigilance Module surveillance protocol, select the severity
criteria met for the reported adverse reaction.
Imputability
Required. Using the case definition criteria in Section 3 of the
Hemovigilance Module surveillance protocol, select the imputability
criteria met for the reported adverse reaction. Note: Doubtful and
Ruled Out need not be routinely reported.
Outcome

Outcome

Required. Enter the outcome of the transfusion recipient.

Date of death

Conditionally required. If the recipient died following the adverse
reaction, enter the date of death whether or not the death was
transfusion related.
Conditionally required. If the recipient died following the adverse
transfusion reaction, indicate the relationship of the transfusion to
death using the imputability criteria for “Other/Unknown” adverse
reactions defined in Section 3 of the Hemovigilance Module
surveillance protocol.

Relationship of
transfusion to death

Component Details

Was a particular unit
implicated in (i.e.,
responsible for) the
adverse reaction?

Transfusion End Date
Transfusion End Time
Component code (check
system used)
Component code

Required. Indicate whether or not a specific unit could be identified
as the likely cause of the adverse reaction. Details for the implicated
unit must be entered on the first row of the “Component Details”
table. Determine “implicated” independent of case definition and
imputability criteria. If only one unit was transfused, that unit must be
implicated in the reaction. If TACO is being reported, no specific unit
may be implicated regardless of the number of units transfused.
Required. Enter the date the transfusion ended.
Required. Enter the time the transfusion ended using a 24-hour
clock.
Required. Select the labeling system used for the transfused
component(s). Note: Codabar- and ISBT 128-labeled products
may be entered, but each must be entered on their own row.
Required. Enter the component code for the product transfused
using only the portion that identifies the product type. In the sample
label below, the code that identifies the product type is 04250.
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Data Field

Instructions for Form Completion

Note: Enter all components
administered within 24 hours prior to an acute transfusion reaction.
Enter only the component(s) most likely responsible for delayed
reactions based on temporal relationship and clinical judgment.

# of units
Unit number

Note: If the code entered does not match a product description in
NHSN, “Component code not found” will appear in the product
description field. Verify your data entry before continuing; an
incorrect or unrecognized component code will not prevent you from
saving the adverse reaction record.
Required. Enter the total number of units transfused for each
component type. Multiple units may be entered using up to 20 rows.
Conditionally required. If reporting a TRALI, GVHD, or infection
reaction, enter the individual unit number as it appears on the
product label. Unit number is optional for all other adverse reactions.
The sample ISBT-128 unit number would be entered as seen below.
W0000
07
123456
00
D

Unit expiration date

Note: The check digit is optional. If the check digit is entered, the
system will verify that it is correct using an internal check digit
calculator. If the check digit is not entered, the space will remain
blank.
Required. Enter the expiration date of the unit(s). The expiration
date for the sample label below would be 02/11/2007.

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Data Field

Instructions for Form Completion

Unit expiration time

Required. Enter the expiration time of the unit(s). NHSN will auto fill
this editable field to 23:59(11:59PM). The expiration time for the
sample label below would be 15:20.

Required. Select the blood group of the unit(s) transfused; enter N/A
for products where blood group is not applicable.
Implicated in the adverse Conditionally required. If a particular unit was implicated, the unit
reaction?
details must be entered on the first row and this box will be checked.
If no unit can be implicated, these boxes will be inactive.
Blood group of unit

Custom Fields

Optional. Up to 50 custom fields may be added to this form for local use. Custom data may be
collected in an alphanumeric, numeric, or date format.
Comments

Optional. Enter additional information about the incident.

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Table 6. Hemovigilance Module Incident (CDC 57.305)

Data Field
Facility ID#
NHSN Incident #

Instructions for Form Completion
The Facility ID number will be auto entered by NHSN.
An incident number will be auto entered by NHSN.

Local Incident # or Log #

Optional. Enter your facility’s incident report, log, or other locallyassigned incident number.

Discovery

Date of discovery

Required. Enter the date the incident was discovered. It must be
on or after the date the incident occurred.
Time of discovery
Required. Enter the time the incident was discovered using a 24hour clock. If only an approximate time is known, check the “Time
approximate” box. If the time cannot be determined, select “Time
unknown.”
Where in the facility was the Required. Select the location where the incident was discovered.
incident discovered?
This may or may not be the same as the location where the
incident occurred.
At what point in the process Required. Select the process point at which the incident was first
was the incident first
discovered. This may or may not be the same process point at
discovered? (check one)
which the incident occurred.
How was the incident first Required. Select the description that most closely represents how
discovered? (check one)
the incident was first discovered. If “other” is selected, briefly
describe how the incident was discovered.
Occurrence

Date initial incident occurred Required. Enter the date the incident occurred. It must be on or
before the date the incident was discovered.
Time initial incident
Required. Enter the time the incident occurred using a 24-hour
occurred
clock.
Incident summary
Optional. Provide a description of the incident. Note: Only 500
characters are allowed.
Incident code(s): (max 20) Required. Enter a maximum of 20 incident codes and occurrence
locations. Note: A single incident may result in a cascade of
future incidents related to the same sample or blood product.
Report all incidents known to have occurred in association with a
reaction.
Enter the NHSN-defined incident code(s). Incident codes are
 Incident Code
found in the protocol. Note: For each process code (PC: Product
Check-In, etc.) there is an option for unspecified incidents. If no
process code is defined or the process point is unknown for the
incident you are reporting, use MS 99 and briefly describe the
incident.

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Data Field
Instructions for Form Completion
 Occurrence Location Select the location(s) where the incident occurred. This may or
may not be the same as the location where the incident was
discovered.
Job function of the worker(s) Optional. Enter the job function of the worker(s) involved in the
involved in the Incident: (max incident using the occupation codes found in the protocol. This is
the worker who was involved in and may have been responsible
6)
for the incident, but not necessarily. In cases such as equipment
malfunction, this may be the person who discovered the incident.
Incident result
Required. Select the outcome of the incident.


Product transfused,
reaction
 Product transfused, no
reaction
 No product transfused,
unplanned recovery
 No product transfused,
planned recovery
Product action

A product related to this incident was transfused; the patient
experienced an adverse reaction.
A product related to this incident was transfused; the patient did
not experience an adverse reaction.
No product was transfused; the incident was discovered ad hoc,
by accident, by a human lucky catch, etc.
No product was transfused; the incident was discovered through a
standardized process or barrier designed to prevent errors.
Required. Check all that apply.

 Not applicable






The incident was not related to a product, or the incident was
discovered before a product was selected for transfusion.
A blood product related to the incident was intercepted or
Product retrieved and
withdrawn and was not transfused to the patient.
returned to inventory
A blood product was retrieved and destroyed as a result of the
Product retrieved and
incident.
destroyed
Single or multiple units Conditionally required. If any blood product was destroyed,
destroyed?
indicate whether single or multiple units were destroyed.
Single unit
Conditionally required: If a single unit was destroyed, select the
labeling system used and enter the individual unit number OR the
component code of the product.
Multiple units
Conditionally required. If multiple units were destroyed, select the
labeling system used and enter the component code(s) and the
total number of units of each product type destroyed. Note:
Codabar- and ISBT 128-labeled products may be entered.
Product issued but not A blood product related to the incident was issued to the patient
care area but was NOT transfused.
transfused.
A blood product related to the incident was transfused.
Product transfused
Was a patient reaction Conditionally required. If a blood product related to the incident
associated with this
was transfused, indicate whether the patient(s) experienced an
incident?
adverse transfusion reaction.

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Data Field
Patient ID#(s)

Record/other action

Instructions for Form Completion
Conditionally required. If an adverse transfusion reaction
occurred, enter the Patient ID number(s) of the affected patient(s).
Multiple patients can be listed. Note: To link an adverse reaction
to an incident in NHSN, the incident record must be entered into
the system first and must include the Patient ID number(s). When
attempting to link an adverse reaction record, NHSN will search
for matching Patient ID number(s) in the incident records.
Required. Select all follow-up actions that were performed in
response to this incident. If “other” is selected, briefly describe.

Investigation Results

Did this incident receive root Required. Indicate whether a formal, documented root cause
cause analysis?
analysis of the incident was performed.
Custom Fields

Optional. Up to 50 custom fields may be added to this form for local use. Custom data may be
collected in an alphanumeric, numeric, or date format.
Comments

Optional. Enter additional information about the incident.

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File Type	application/pdf
File Title	NHSN Biovigilance Component
Author	rfp9
File Modified	2015-06-03
File Created	2015-06-03