NHSN Biovigilance Component

Hemovigilance Module Surveillance Protocol v2.6

National Healthcare Safety Network

Biovigilance Component
Hemovigilance Module
Surveillance Protocol

Division of Healthcare Quality Promotion

National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
Atlanta, GA, USA

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Version History
Version Release Date Summary of Revisions
1.0 March 2009 First version publicly released.
1.1 June 2010 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.
1.2 July 2010 Corrected definition of hypoxemia in glossary of terms.
1.3 June 2011 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.
2.0 January 2013 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.
2.1 August 2013 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.
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.

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Version Release Date Summary of Revisions

Added a possible case definition category for TTI for OPTIONAL reporting of
syndromic cases that are not laboratory confirmed.
2.1.1 September 2013 Updated diagram in Section 1 and added version history for v2.0 and v2.1.
2.1.2 January 2014 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.
2.1.3 August 2014 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.
2.2 January 2016 Updated contact instructions for consistency in Section 1: User support
Updated version number in Section 1: Suggested Citation
Remove Root Cause Analysis Result from Section 4: Incident Glossary
Updated denominator report description to include Pathogen-reduced products in
Section 5: Required Reporting
2.3 June 2016 Updated denominator report description to include Table 3 description.
2.4 January 2017 Section 1: Setting – Added additional Annual Facility form for Non-Acute Care
Facilities to report.
Section 2: Annual Facility Survey – Added information about Non-Acute Care
Facility Annual Facility Survey, Added links to the Annual Facility Survey – Non-
Acute Care Facility form and table of instructions for clarity.
2.5 January 2018 Section 1: Training, User Support, Data Reporting – Minor language changes for
clarification
Section 3: Adverse Reaction Classification – Added information about module-
generated classification designations.
Adverse Reaction Glossary: Updated the definition of fever to be consistent with
FNHTR criteria.
2.5.2. April 2018 Section 4: Incident codes - UT 06 – “incompatible” replaced with “unapproved”
2.6 March 2021 Section 3: Adverse Reaction Classification - Updated case definition criteria for
TACO reactions

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Table of Contents

Section 1. Hemovigilance Module Surveillance Overview ........................................ 5

Section 2. Hemovigilance Module Annual Facility Survey ....................................... 7
Section 3: Hemovigilance Module Adverse Reactions ............................................. 8
Adverse Reaction Case Classification Criteria Tables ...................................................... 9
Transfusion-associated circulatory overload (TACO) ........................................................................... 9
Transfusion-related acute lung injury (TRALI) .................................................................................... 10
Transfusion-associated dyspnea (TAD) ............................................................................................. 11
Allergic reaction .................................................................................................................................. 12
Hypotensive transfusion reaction ....................................................................................................... 13
Febrile non-hemolytic transfusion reaction (FNHTR) ......................................................................... 14
Acute hemolytic transfusion reaction (AHTR) .................................................................................... 15
Delayed hemolytic transfusion reaction (DHTR) ................................................................................ 16
Delayed serologic transfusion reaction (DSTR) ................................................................................. 17
Transfusion-associated graft vs. host disease (TAGVHD) ................................................................. 18
Post transfusion purpura (PTP) .......................................................................................................... 19
Transfusion-transmitted infection (TTI)............................................................................................... 20
Other or Unknown............................................................................................................................... 22
Adverse Reaction Glossary ............................................................................................... 23
Section 4. Hemovigilance Module Incidents ............................................................ 24
Incident Codes ................................................................................................................... 25
Occupation Codes ............................................................................................................. 28
Incident Glossary ............................................................................................................... 30
Section 5. Hemovigilance Module Denominators.................................................... 31

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Section 1. Hemovigilance Module Surveillance Overview

Purpose
The National Healthcare Safety Network (NHSN) Hemovigilance (HV) Module was created to implement
national surveillance of transfusion-associated adverse events aimed at improving patient safety,
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 non-acute 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 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
NHSN is a web-based application used by healthcare facilities to report surveillance data. Paper
versions of all forms are used to collect data prior to data entry in the NHSN Hemovigilance Module. The
paper forms are available on the NHSN Blood Safety Surveillance 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 Blood Safety Surveillance 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 quarterly newsletter and emails from the Hemovigilance Team.

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 in the subject line
for quickest routing to the 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 v2.5. 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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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 (See Fig. 1)

• An annual facility demographic and practice survey for each calendar year of participation
• ALL adverse reactions defined in this protocol 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
and screen or crossmatch each month

Figure 1. Venn diagram of NHSN Hemovigilance Module surveillance terms.

Transfusion-Related
Transfusions
Activities
Reactions

Incidents

Transfusion-Related Activities Adverse Events

• Patient Sample Collection Reactions
• Sample Handling and Testing
• Inventory Management Incidents
• Patient Monitoring Near Miss Incidents
Transfusion
• Number of Components Incidents Related to Transfusion (No Adverse Reaction)
• Number of Patients Incidents Related to Transfusion and Adverse Reaction

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Section 2. Hemovigilance Module Annual Facility Survey

Required Reporting
Participating facilities must enter the Hemovigilance Module Annual Facility Survey at the time that they
enroll or activate the Biovigilance Component and at the beginning of each calendar year thereafter. The
survey is used by CDC to classify facilities for appropriate comparisons in aggregate data analyses and
to learn more about common practices among transfusion 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.

As of January 2017, non-acute care facilities are able to report hemovigilance data to NHSN. Non-acute
care facilities should complete Annual Facility Survey for Non-acute care facility 57.306. This form
contains questions tailored to non-acute care facilities. Users may refer to the Non-Acute Care Facility
Table of Instructions form 57.306 for detailed instruction about data collection.

Form
CDC 57.300 Hemovigilance Module Annual Facility Survey - Acute Care Facility

CDC 57.306 Hemovigilance Module Annual Facility Survey - Non-Acute Care Facility

Form Instructions
CDC 57.300 Hemovigilance Module Annual Facility Survey - Acute Care Facility Table of Instructions

CDC 57.306 Hemovigilance Module Annual Facility Survey - Non-Acute Care Facility Table of
Instructions

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Section 3: Hemovigilance Module Adverse Reactions

Required Reporting
All CDC-defined transfusion-associated adverse reactions that are possibly, probably, or definitely
related to a transfusion performed by the participating facility must be reported to NHSN. 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. Reports should be entered within 30 days of the month that the reaction occurred or when the
investigation is completed.

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.

Adverse Reaction Classification

Each CDC-defined transfusion-associated adverse reaction must be classified according to the reaction-
specific case definition, severity, and imputability criteria printed in 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.

To assist in classification, the Module will generate and assign designations for case definition, severity,
and imputability based on signs, symptoms, and lab results entered in the investigation results section of
the adverse reaction form.

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. 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 is 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)

Form
Adverse reaction forms are available at the NHSN Blood Safety Surveillance website.

Form Instructions
Adverse Reaction forms’ Table of Instructions are available at the NHSN Blood Safety Surveillance
website.

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Adverse Reaction Case Classification Criteria Tables

Transfusion-associated circulatory overload (TACO)

Case Definition Severity Imputability

Definitive: Non-severe: Definite:
New onset or exacerbation Medical intervention (e.g. symptomatic No other explanations for circulatory
of 3 or more of the treatment) is required but lack of such would overload are possible.
following within 12 hours not result in permanent damage or
of cessation of transfusion: impairment of a bodily function.
(At least 1 of the Probable:
following:) Transfusion is a likely contributor to
Severe: circulatory overload
•Evidence of acute or Inpatient hospitalization or prolongation of AND EITHER
worsening respiratory hospitalization is directly attributable to the The patient received other fluids as
distress (dyspnea, adverse reaction, persistent or significant well
tachypnoea, cyanosis and disability or incapacity of the patient occurs OR
decreased oxygen as a result of the reaction, or a medical or The patient has a history of cardiac
saturation values in the surgical intervention is necessary to insufficiency that could explain the
absence of other specific preclude permanent damage or impairment circulatory overload, but
causes) and/or of a body function. transfusion is just as likely to have
caused the circulatory overload.
•Radiographic or clinical
evidence of acute or Life-threatening:
worsening pulmonary Major intervention required following the Possible:
edema (crackles on lung transfusion (e.g. vasopressors, intubation, The patient has a history of pre-
auscultation, orthopnea, transfer to intensive care) to prevent death. existing cardiac insufficiency that
cough, a third heart sound most likely explains circulatory
and pinkish frothy sputum overload.
in severe cases); or both Death:
AND The recipient died as a result of the OPTIONAL
adverse transfusion reaction. Death Doubtful:
•Elevated brain natriuretic should be used if death is possibly, Evidence is clearly in favor of a
peptide (BNP) or NT-pro probably or definitely related to cause other than the transfusion, but
BNP relevant biomarker transfusion. If the patient died of a cause transfusion cannot be excluded.
other than the transfusion, the severity of the
•Evidence of reaction should be graded as appropriate
cardiovascular system given the clinical circumstances related to Ruled Out:
changes not explained by the reaction. There is conclusive evidence beyond
underlying medical reasonable doubt of a cause other
condition (Elevated central than the transfusion.
venous pressure, evidence Not Determined:
of left heart failure The severity of the adverse reaction is
including development of unknown or not stated. Not Determined:
tachycardia, hypertension, The relationship between the
widened pulse pressure, adverse reaction and the transfusion
jugular venous distension, is unknown or not stated.
enlarged cardiac silhouette
and/or peripheral edema)

•Evidence of fluid overload

Probable:
N/A
Possible:
N/A

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Transfusion-related acute lung injury (TRALI)

Case Definition Severity Imputability

Definitive: Non-severe: Definite:
NO evidence of acute lung Medical intervention (e.g. There are no alternative risk factors for ALI
injury (ALI) prior to symptomatic treatment) is required present.
transfusion but lack of such would not result in
AND permanent damage or impairment of
ALI onset during or within a bodily function. Probable:
6 hours of cessation of N/A
transfusion
AND Severe:
Hypoxemia defined by any Inpatient hospitalization or Possible:
of these methods: prolongation of hospitalization is There is evidence of other causes for acute
• PaO2/FiO2 less than directly attributable to the adverse lung injury such as:
or equal to 300 mm reaction, persistent or significant
Hg disability or incapacity of the patient Direct Lung Injury
• Oxygen saturation occurs as a result of the reaction, or a • Aspiration
less than 90% on medical or surgical intervention is • Pneumonia
room air necessary to preclude permanent • Toxic inhalation
• Other clinical damage or impairment of a body • Lung contusion
evidence function. • Near drowning
AND
Radiographic evidence of Indirect Lung Injury
bilateral infiltrates Life-threatening: • Severe sepsis
AND Major intervention required following • Shock
No evidence of left atrial the transfusion (e.g. vasopressors,
• Multiple trauma
hypertension (i.e., intubation, transfer to intensive care)
• Burn injury
circulatory overload) to prevent death.
• Acute pancreatitis
• Cardiopulmonary bypass
Death: • Drug overdose
Probable:
N/A The recipient died as a result of the
adverse transfusion reaction. OPTIONAL
Death should be used if death is Doubtful:
Possible: possibly, probably or definitely Evidence is clearly in favor of a cause other
N/A related to transfusion. If the patient than the transfusion, but transfusion cannot
died of a cause other than the be excluded.
transfusion, the severity of the
reaction should be graded as
appropriate given the clinical Ruled Out:
circumstances related to the reaction. There is conclusive evidence beyond
reasonable doubt of a cause other than the
transfusion.
Not Determined:
The severity of the adverse reaction
is unknown or not stated. Not Determined:
The relationship between the adverse
reaction and the transfusion is unknown or
not stated.

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Transfusion-associated dyspnea (TAD)

Case Definition Severity Imputability

Definitive: Non-severe: Definite:
Acute respiratory Medical intervention (e.g. symptomatic treatment) Patient has no other conditions
distress occurring within is required but lack of such would not result in that could explain symptoms.
24 hours of cessation of permanent damage or impairment of a bodily
transfusion function.
AND Probable:
Allergic reaction, TACO, There are other potential causes
and TRALI definitions Severe: that could explain symptoms, but
are not applicable. Inpatient hospitalization or prolongation of transfusion is the most likely
hospitalization is directly attributable to the cause.
adverse reaction, persistent or significant disability
Probable: or incapacity of the patient occurs as a result of
N/A the reaction, or a medical or surgical intervention Possible:
is necessary to preclude permanent damage or Other present causes are most
impairment of a body function. likely, but transfusion cannot be
Possible: ruled out.
N/A
Life-threatening: OPTIONAL
Major intervention required following the Doubtful:
transfusion (e.g. vasopressors, intubation, transfer Evidence is clearly in favor of a
to intensive care) to prevent death. cause other than the transfusion,
but transfusion cannot be
excluded.
Death:
The recipient died as a result of the adverse
transfusion reaction. Death should be used if Ruled Out:
death is possibly, probably or definitely related There is conclusive evidence
to transfusion. If the patient died of a cause other beyond reasonable doubt of a
than the transfusion, the severity of the reaction cause other than the transfusion.
should be graded as appropriate given the clinical
circumstances related to the reaction.
Not Determined:
The relationship between the
Not Determined: adverse reaction and the
The severity of the adverse reaction is unknown transfusion is unknown or not
or not stated. stated.

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Allergic reaction
Note: Minor allergic reactions (Non-severe) do not have to be reported to NHSN.

Case Definition Severity Imputability

Definitive: Severe, Life-threatening, Death: Definite:
2 or more of the following Involves respiratory and/or cardiovascular Occurs during or within 2 hours of
occurring during or within 4 systems and presents like an anaphylactic cessation of transfusion
hours of cessation of reaction. There is anaphylaxis when, in AND
transfusion: addition to mucocutaneous symptoms, No other evidence of
• Conjunctival edema there are airway symptoms, hypotension, environmental, drug or dietary
• Edema of lips, tongue and or associated symptoms like hypotonia risks.
uvula and syncope. The respiratory signs and
• Erythema and edema of symptoms may be laryngeal (tightness in
the periorbital area the throat, dysphagia, dysphonia, Probable:
• Generalized flushing hoarseness, stridor) or pulmonary Occurs during or within 2 hours of
• Hypotension (dyspnea, cough, wheezing, cessation of transfusion
• Localized angioedema bronchospasm, hypoxemia). Such a AND
• Maculopapular rash reaction usually occurs during or shortly There are other potential causes
after cessation of transfusion. present that could explain
• Pruritus (itching)
symptoms, but transfusion is the
• Respiratory distress;
most likely cause.
bronchospasm
Death should be used if death is
• Urticaria (hives) possibly, probably or definitely related
to transfusion. If the patient died of a Possible:
cause other than the transfusion, the Occurs 2 - 4 hours after cessation
Probable: severity of the reaction should be graded of transfusion
ANY 1 of the following occurring as appropriate given the clinical OR
during or within 4 hours of circumstances related to the reaction. Other present causes are most
cessation of transfusion: likely, but transfusion cannot be
• Conjunctival edema ruled out.
• Edema of lips, tongue and Not Determined:
uvula The severity of the adverse reaction is
• Erythema and edema of unknown or not stated.
the periorbital area
• Localized angioedema
• Maculopapular rash
• Pruritus (itching)
• Urticaria (hives)

OPTIONAL OPTIONAL OPTIONAL

Possible: Non-severe: Doubtful:
N/A There is no immediate risk to the life of Evidence is clearly in favor of a
the patient, and the patient responds cause other than the transfusion,
quickly to symptomatic treatment. 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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Hypotensive transfusion reaction

Case Definition Severity Imputability

Definitive: Non-severe: Definite:
All other adverse reactions The recipient required no Occurs less than 15 minutes after the start of
presenting with hypotension are more than discontinuation of the transfusion
excluded transfusion and symptom AND
AND management and no long- Responds rapidly (i.e., within 10 minutes) to
Hypotension occurs during or term morbidity resulted from cessation of transfusion and supportive
within 1 hour after cessation of the reaction. treatment
transfusion. AND
The patient has no other conditions that could
• Adults (18 years and Severe: explain hypotension.
older): Inpatient hospitalization or
Drop in systolic BP of prolongation of
greater than or equal to 30 hospitalization is directly Probable:
mmHg and systolic BP attributable to hypotension, Onset is between 15 minutes after start and 1
less than or equal to 80 or hypotension led directly to hour after cessation of transfusion
mmHg. long-term morbidity (e.g., OR
brain damage) The patient does not respond rapidly to
• Infants, children and AND cessation of transfusion and supportive
adolescents (1 year to Vasopressors were not treatment
less than 18 years old): required. OR
Greater than 25% drop in There are other potential causes present that
systolic BP from baseline could explain hypotension, but transfusion is
(e.g., drop in systolic BP of Life-threatening: the most likely cause.
120mmHg to below The recipient required
90mmHg). vasopressors.
Possible:
• Neonates and small Other conditions that could readily explain
infants (less than 1 year Death: hypotension are present.
old OR any age and less The recipient died as a
than 12 kg body weight): result of the adverse
Greater than 25% drop in transfusion reaction.
baseline value using Death should be used if
whichever measurement is death is possibly, probably
being recorded (e.g., mean or definitely related to
BP). transfusion. If the patient
died of a cause other than
the transfusion, the severity
Probable: of the reaction should be
N/A graded as appropriate given
the clinical circumstances
OPTIONAL related to the reaction. OPTIONAL
Possible: Doubtful:
Hypotension occurs, does not Evidence is clearly in favor of a cause other
Not Determined:
meet the criteria above. Other, than the transfusion, but transfusion cannot be
The severity of the adverse
more specific reaction definitions excluded.
do not apply. reaction is unknown or not
stated. 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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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: Non-severe: Definite:
Occurs during or within 4 Medical intervention (e.g. symptomatic Patient has no other conditions
hours of cessation of treatment) is required but lack of such would that could explain
transfusion not result in permanent damage or impairment signs/symptoms.
AND EITHER of a bodily function.
Fever (greater than or
equal to 38°C/100.4°F Probable:
oral and a change of at Severe: There are other potential causes
least 1°C/1.8°F) from pre- Inpatient hospitalization or prolongation of present that could explain
transfusion value hospitalization is directly attributable to the signs/symptoms, but transfusion
OR adverse reaction, persistent or significant is the most likely cause.
Chills/rigors are present. disability or incapacity of the patient occurs as
a result of the reaction, or a medical or surgical
intervention is necessary to preclude Possible:
Probable: permanent damage or impairment of a body Other present causes are most
N/A function. likely, but transfusion cannot be
ruled out.
OPTIONAL OPTIONAL
Possible: Life-threatening: Doubtful:
FNHTR is suspected, but Major intervention required following the Evidence is clearly in favor of a
reported symptoms and/or transfusion (e.g. vasopressors, intubation, cause other than the transfusion,
available information are transfer to intensive care) to prevent death. but transfusion cannot be
not sufficient to meet the excluded.
criteria defined above.
Other, more specific Death:
adverse reaction definitions The recipient died as a result of the adverse Ruled Out:
do not apply. transfusion reaction. Death should be used if There is conclusive evidence
death is possibly, probably or definitely beyond reasonable doubt of a
related to transfusion. If the patient died of a cause other than the transfusion.
cause other than the transfusion, the severity
of the reaction should be graded as
appropriate given the clinical circumstances Not Determined:
related to the reaction. The relationship between the
adverse reaction and the
transfusion is unknown or not
Not Determined: stated.
The severity of the adverse reaction is
unknown or not stated.

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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: Non-severe: Definite:
Occurs during, or within 24 hours of cessation of Medical intervention (e.g. ABO or other allotypic
transfusion with new onset of ANY of the following symptomatic treatment) is RBC antigen
signs/symptoms: required but lack of such would incompatibility is known
• Back/flank pain not result in permanent OR
• Chills/rigors damage or impairment of a Only transfusion-related
• Disseminated intravascular coagulation (DIC) bodily function. (i.e., immune or non-
• Epistaxis immune) cause of acute
• Fever hemolysis is present.
• Hematuria (gross visual hemolysis) Severe:
• Hypotension Inpatient hospitalization or
prolongation of hospitalization Probable:
• Oliguria/anuria
is directly attributable to the There are other
• Pain and/or oozing at IV site
adverse reaction, persistent or potential causes
• Renal failure
significant disability or present that could
AND
incapacity of the patient occurs explain acute
2 or more of the following: as a result of the reaction, or a hemolysis, but
• Decreased fibrinogen medical or surgical intervention transfusion is the most
• Decreased haptoglobin is necessary to preclude likely cause.
• Elevated bilirubin permanent damage or
• Elevated LDH impairment of a body function.
• Hemoglobinemia Possible:
• Hemoglobinuria Other causes of acute
• Plasma discoloration c/w hemolysis Life-threatening: hemolysis are more
• Spherocytes on blood film Major intervention required likely, but transfusion
AND EITHER following the transfusion (e.g. cannot be ruled out.
(IMMUNE-MEDIATED) vasopressors, intubation,
Positive direct antiglobulin test (DAT) for anti-IgG or transfer to intensive care) to OPTIONAL
anti-C3 prevent death. Doubtful:
AND Evidence is clearly in
Positive elution test with alloantibody present on the favor of a cause other
transfused red blood cells Death: than the transfusion, but
OR The recipient died as a result transfusion cannot be
(NON-IMMUNE MEDIATED) of the adverse transfusion excluded.
Serologic testing is negative, and physical cause (e.g., reaction. Death should be
thermal, osmotic, mechanical, chemical) is confirmed. used if death is possibly,
probably or definitely related Ruled Out:
Probable: to transfusion. If the patient There is conclusive
Meets signs and symptoms criteria for acute hemolysis died of a cause other than the evidence beyond
AND EITHER transfusion, the severity of the reasonable doubt of a
(IMMUNE MEDIATED) reaction should be graded as cause other than the
Physical cause is excluded but serologic evidence is not appropriate given the clinical transfusion.
sufficient to meet definitive criteria circumstances related to the
OR reaction.
(NON-IMMUNE MEDIATED) Not Determined:
Physical cause is suspected and serologic testing is The relationship
negative. Not Determined: between the adverse
OPTIONAL The severity of the adverse reaction and the
reaction is unknown or not transfusion is unknown
Possible:
stated. or not stated.
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.

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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: Non-severe: Definite:
Positive direct antiglobulin test (DAT) Medical intervention (e.g. No other explanation for symptoms
for antibodies developed between 24 symptomatic treatment) is or newly-identified antibody is
hours and 28 days after cessation of required but lack of such would present.
transfusion not result in permanent damage
AND EITHER or impairment of a bodily
Positive elution test with function. Probable:
alloantibody present on the An alternate explanation for
transfused red blood cells symptoms or newly-identified
OR Severe: antibody is present, but transfusion is
Newly-identified red blood cell Inpatient hospitalization or the most likely cause.
alloantibody in recipient serum prolongation of hospitalization is
AND EITHER directly attributable to the
Inadequate rise of post-transfusion adverse reaction, persistent or Possible:
hemoglobin level or rapid fall in significant disability or incapacity Other explanations for symptoms or
hemoglobin back to pre-transfusion of the patient occurs as a result newly-identified antibody are more
levels of the reaction, or a medical or likely, but transfusion cannot be ruled
OR surgical intervention is necessary out.
Otherwise unexplained appearance to preclude permanent damage
of spherocytes. or impairment of a body function.

Probable: Life-threatening:
Newly-identified red blood cell Major intervention required
alloantibody demonstrated between following the transfusion (e.g.
24 hours and 28 days after cessation vasopressors, intubation, transfer
of transfusion to intensive care) to prevent
BUT death.
Incomplete laboratory evidence to
meet definitive case definition criteria.
Death:
The recipient died as a result of
NOTE: Patient may be asymptomatic the adverse transfusion
or have symptoms that are similar to reaction. Death should be used
but milder than AHTR; symptoms are if death is possibly, probably or
not required to meet case definition definitely related to transfusion.
criteria. If the patient died of a cause
OPTIONAL other than the transfusion, the OPTIONAL
Possible: severity of the reaction should be Doubtful:
DHTR is suspected, but reported graded as appropriate given the Evidence is clearly in favor of a
symptoms, test results, and/or clinical circumstances related to cause other than the transfusion, but
available information are not sufficient the reaction. transfusion cannot be excluded.
to meet the criteria defined above.
Other, more specific adverse reaction Ruled Out:
definitions do not apply. Not Determined: There is conclusive evidence beyond
The severity of the adverse reasonable doubt of a cause other
reaction is unknown or not than the transfusion.
stated.
Not Determined:
The relationship between the
adverse reaction and the transfusion
is unknown or not stated.

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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: Not Determined: Definite:
Absence of clinical signs Since this is by definition a New alloantibody is identified between 24 hours and 28
of hemolysis reaction with no clinical days after cessation of transfusion
AND symptoms, severity of the AND
Demonstration of new, reaction cannot be Transfusion performed by your facility is the only
clinically-significant graded. possible cause for seroconversion.
antibodies against red
blood cells
BY EITHER Probable:
Positive direct New alloantibody is identified between 24 hours and 28
antiglobulin test (DAT) days after cessation of transfusion
OR AND
Positive antibody The patient has other exposures (e.g. transfusion by
screen with newly another facility or pregnancy) that could explain
identified RBC seroconversion, but transfusion by your facility is the
alloantibody. most likely cause.

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

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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Transfusion-associated graft vs. host disease (TAGVHD)

Case Definition Severity Imputability

Definitive: Non-severe: Definite:
A clinical syndrome occurring from N/A WBC chimerism present in the absence of
2 days to 6 weeks after cessation of alternative diagnoses.
transfusion characterized by:
• Characteristic rash: Severe:
erythematous, maculopapular Patient had marked Probable:
eruption centrally that spreads symptoms and responded to WBC chimerism present
to extremities and may, in treatment. BUT
severe cases, progress to Other potential causes are present (e.g.,
generalized erythroderma and stem cell transplantation).
hemorrhagic bullous Life-threatening:
formation. Patient had severe symptoms
• Diarrhea and required life-saving Possible:
• Fever treatment (e.g., WBC chimerism not present or not done
• Hepatomegaly immunosuppression). OR
• Liver dysfunction (i.e., Alternative explanations are more likely
elevated ALT, AST, Alkaline (e.g., solid organ transplantation).
phosphatase, and bilirubin) Death:
• Marrow aplasia The recipient died as a result OPTIONAL
• Pancytopenia of the adverse transfusion Doubtful:
AND reaction. Death should be Evidence is clearly in favor of a cause
Characteristic histological used if death is possibly, other than the transfusion, but transfusion
appearance of skin or liver biopsy. probably or definitely cannot be excluded.
related to transfusion. If the
patient died of a cause other
Probable: than the transfusion, the Ruled Out:
Meets definitive criteria severity of the reaction should There is conclusive evidence beyond
EXCEPT be graded as appropriate reasonable doubt of a cause other than
Biopsy negative or not done. given the clinical the transfusion.
circumstances related to the
reaction.
Possible: Not Determined:
N/A The relationship between the adverse
Not Determined: reaction and the transfusion is unknown or
The severity of the adverse not stated.
reaction is unknown or not
stated.

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Post transfusion purpura (PTP)

Case Definition Severity Imputability

Definitive: Non-severe: Definite:
Alloantibodies in the patient Medical intervention (e.g. symptomatic Occurs 5-12 days post-transfusion
directed against HPA or other treatment) is required but lack of such AND
platelet specific antigen detected would not result in permanent damage Patient has no other conditions to
at or after development of or impairment of a bodily function. explain thrombocytopenia.
thrombocytopenia
AND
Thrombocytopenia (i.e., decrease Severe: Probable:
in platelets to less than 20% of Inpatient hospitalization or Occurs less than 5 or more than
pre-transfusion count). prolongation of hospitalization is 12 days post-transfusion
directly attributable to the adverse OR
reaction, persistent or significant There are other potential causes
Probable: disability or incapacity of the patient present that could explain
Alloantibodies in the patient occurs as a result of the reaction, or a thrombocytopenia, but transfusion
directed against HPA or other medical or surgical intervention is is the most likely cause.
platelet specific antigen detected necessary to preclude permanent
at or after development of damage or impairment of a body
thrombocytopenia. function. Possible:
AND Alternate explanations for
Decrease in platelets to levels thrombocytopenia are more likely,
between 20% and 80% of pre- Life-threatening: but transfusion cannot be ruled
transfusion count. Major intervention required following out.
the transfusion (e.g. vasopressors,
OPTIONAL intubation, transfer to intensive care) to OPTIONAL
Possible: prevent death. Doubtful:
PTP is suspected, but laboratory Evidence is clearly in favor of a
findings and/or information are not cause other than the transfusion,
sufficient to meet defined criteria Death: but transfusion cannot be
above. For example, the patient The recipient died as a result of the excluded.
has a drop in platelet count to less adverse transfusion reaction. Death
than 80% of pre-transfusion count should be used if death is possibly,
but HPA antibodies were not probably or definitely related to Ruled Out:
tested or were negative. Other, transfusion. If the patient died of a There is conclusive evidence
more specific adverse reaction cause other than the transfusion, the beyond reasonable doubt of a
definitions do not apply. severity of the reaction should be cause other than the transfusion.
graded as appropriate given the
clinical circumstances related to the
reaction. Not Determined:
The relationship between the
adverse reaction and the
Not Determined: transfusion is unknown or not
The severity of the adverse reaction is stated.
unknown or not stated.

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Transfusion-transmitted infection (TTI)

Case Definition Severity Imputability
Definitive: Non-severe: Definite:
Laboratory Medical intervention ONE or more of the following:
evidence of a (e.g. symptomatic • Evidence of the pathogen in the transfused component
pathogen in the treatment) is required • Evidence of the pathogen in the donor at the time of donation
transfusion but lack of such • Evidence of the pathogen in an additional component from the same donation
recipient. would not result in • Evidence of the pathogen in an additional recipient of a component from the
permanent damage same donation
or impairment of a AND
Probable: bodily function. No other potential exposures to the pathogen could be identified in the recipient.
N/A AND EITHER
Evidence that the recipient was not infected with the pathogen prior to transfusion
Severe: OR
Inpatient Evidence that the identified pathogen strains are related by molecular or extended
hospitalization or phenotypic comparison testing with statistical confidence (p<0.05).
prolongation of
hospitalization is Probable:
directly attributable to ONE or more of the following:
the adverse reaction, • Evidence of the pathogen in the transfused component
persistent or • Evidence of the pathogen in the donor at the time of donation
significant disability or • Evidence of the pathogen in an additional component from the same donation
incapacity of the
• Evidence of the pathogen in an additional recipient of a component from the
patient occurs as a
same donation.
result of the reaction,
AND EITHER:
or a medical or
Evidence that the recipient was not infected with this pathogen prior to transfusion
surgical intervention
OR
is necessary to
No other potential exposures to the pathogen could be identified in the recipient.
preclude permanent
damage or
Possible:
impairment of a body
Case fails to meet definite, probable, doubtful, or ruled out imputability criteria.
function.
OPTIONAL OPTIONAL
Possible: Life-threatening: Doubtful:
Temporally Major intervention Laboratory evidence that the recipient was infected with this pathogen prior to
associated required following the transfusion
unexplained transfusion (e.g. OR
clinical illness vasopressors, Evidence is clearly in favor of a cause other than transfusion, but transfusion cannot
consistent with intubation, transfer to be excluded.
infection, but no intensive care) to
pathogen is prevent death. Ruled Out:
detected in the ALL of the following (where applicable):
recipient. Other, • Evidence that the transfused component was negative for this pathogen at the
more specific Death: time of transfusion
adverse reactions The recipient died as • Evidence that the donor was negative for this pathogen at the time of donation
are ruled out. a result of the • Evidence that additional components from the same donation were negative
adverse transfusion for this pathogen
Note: Possible reaction. OR
cases cannot meet There is conclusive evidence beyond reasonable doubt of a cause other than the
the definite or transfusion.
probable Not Determined:
imputability criteria. The severity of the Not Determined:
adverse reaction is The relationship between the adverse reaction and the transfusion is unknown or
unknown or not not stated.
stated.

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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 Cytomegalovirus (CMV) Babesiosis (Babesia spp.) Creutzfeldt-
Escherichia coli Enterovirus spp. Chagas disease Jakob Disease,
Klebsiella oxytoca Epstein Barr (EBV) (Trypanosoma cruzi) Variant (vCJD)
Klebsiella pneumoniae Hepatitis A Malaria (Plasmodium spp.)
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)
Zika Virus (ZIKAVI)

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 transfusion-
transmitted 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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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: Non-severe: Definite:
CDC does not Medical intervention (e.g. symptomatic treatment) Conclusive evidence exists that the
specifically define the is required but lack of such would not result in adverse reaction can be attributed to
‘Other’ or ‘Unknown’ permanent damage or impairment of a bodily the transfusion.
adverse reaction function.
categories, therefore
the case definition Probable:
criteria may only be Severe: Evidence is clearly in favor of
reported as N/A. Inpatient hospitalization or prolongation of attributing the adverse reaction to
hospitalization is directly attributable to the the transfusion.
adverse reaction, persistent or significant disability
or incapacity of the patient occurs as a result of
the reaction, or a medical or surgical intervention Possible:
is necessary to preclude permanent damage or Evidence is indeterminate for
impairment of a body function. attributing the adverse reaction to
the transfusion or an alternate
cause.
Life-threatening:
Major intervention required following the
transfusion (e.g. vasopressors, intubation, transfer Doubtful:
to intensive care) to prevent death. Evidence is clearly in favor of a
cause other than the transfusion, but
transfusion cannot be excluded.
Death:
The recipient died as a result of the adverse
transfusion reaction. Death should be used if Ruled Out:
death is possibly, probably or definitely related There is conclusive evidence
to transfusion. If the patient died of a cause other beyond reasonable doubt of a cause
than the transfusion, the severity of the reaction other than the transfusion.
should be graded as appropriate given the clinical
circumstances related to the reaction.
Not Determined:
The relationship between the
Not Determined: adverse reaction and the transfusion
The severity of the adverse reaction is unknown is unknown or not stated.
or not stated.

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Adverse Reaction Glossary

Antibodies often associated with AHTR, DHTR, DSTR:

Anti-A Anti-B Anti-A,B Anti-C Anti-c Anti-D Anti-E Anti-e Anti-Fya
Anti-Fy Anti-Jk Anti-Jkb
b a Anti-K Anti-k Anti-M Anti-S Other

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, greater than or equal to 38°C/100.4°F oral and a change of
at least 1°C/1.8°F from pre-transfusion value.

Hematuria: Presence of blood or red blood cells in the urine.

Hemoglobinemia: The presence of free hemoglobin in the blood plasma.

Hemoglobinuria: Presence of free hemoglobin in the urine.

Hypoxemia: Abnormal deficiency in the concentration of oxygen in arterial blood. PaO2 / FiO2 less
than or equal to 300 mm Hg OR oxygen saturation is less than 90% on room air.

Jaundice: New onset or worsening of yellow discoloration (icterus) of the skin or sclera (scleral icterus)
secondary to an increased level of bilirubin.

Oliguria: New onset of decreased urinary output (less than 500cc output per 24 hours).

Other rash: Non-urticarial skin rash.

Pruritus: Itching.

Shock: A drop in blood pressure accompanied by a drop in cardiac output including rapid heart rate
(increase to 100 beats per minute or more), rapid breathing, cutaneous vasoconstriction, pallor,
sweating, decreased or scanty urine production, agitation and/or loss of consciousness that required
fluid resuscitation, with or without inotropic support.

Shortness of breath (dyspnea): New onset or significant worsening of shortness of breath; or a

significant increase in respiratory rate (with or without hypoxemia).

Urticaria (hives): Raised wheals on the skin.

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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 57.305). If multiple incidents occur in association
with an adverse reaction then report 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’ to enter the associated patient identifier 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. If there is uncertainty then
please contact NHSN User Support.

Optional Reporting
Any incident may be optionally reported to NHSN using the detailed Incident form (57.305) or the
Monthly Incident Summary form (57.302). Approved deviations from standard operating procedure are
not considered incidents because they did not occur by accident or in error. However, approved
deviations 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 Product/Test Request
(Transfusion Service) (Clinical Service)
Events that occur during the shipment and receipt of Events that occur when the clinical service orders
products into the transfusion service from the patient tests or blood products for transfusion.
supplier, another hospital site, satellite storage, or PR 00 Detail not specified
clinical area. PR 01 Order for wrong patient
PC 00 Detail not specified PR 02 Order incompletely/incorrectly ordered (online
PC 01 Data entry incomplete/incorrect/not performed order entry)
PC 02 Shipment incomplete/incorrect PR 03 Special processing needs not indicated (e.g.,
PC 03 Products and paperwork do not match CMV negative, autologous)
PC 04 Shipped/transported under inappropriate PR 04 Order not done
conditions PR 05 Inappropriate/unnecessary (intended) test
PC 05 Inappropriate return to inventory ordered
PC 06 Product confirmation incorrect/not performed PR 06 Inappropriate/unnecessary (intended) blood
PC 07 Administrative check not incorrect/not product ordered
performed (record review/audit) PR 07 Incorrect (unintended) test ordered
PC 08 Product label incorrect/missing PR 08 Incorrect (unintended) blood product ordered

Product Storage Product/Test Order Entry

(Transfusion Service) (Transfusion Service)
Events that occur during product storage by the Events that occur when the transfusion service
transfusion service. receives a patient order. This process may be
US 00 Detail not specified excluded if clinical service uses online ordering.
US 01 Incorrect storage conditions OE 00 Detail not specified
US 03 Inappropriate monitoring of storage device OE 01 Order entered for wrong patient
US 04 Unit stored on incorrect shelf (e.g., OE 02 Order incompletely/incorrectly entered
ABO/autologous s/directed) online OE 03 Special processing needs not entered
US 05 Incorrect storage location (e.g.,
CMV-, autologous)
Inventory Management OE 04 Order entry not done
(Transfusion Service) OE 05 Inappropriate/unnecessary (intended) test
Events that involve quality management of the blood order entered
product inventory. OE 06 Inappropriate/unnecessary (intended) blood
IM 00 Detail not specified product order entered
IM 01 Inventory audit incorrect/not performed OE 07 Incorrect (unintended) test ordered
IM 02 Product status incorrectly/not updated online OE 08 Incorrect (unintended) blood product ordered
(e.g., available/discarded)
IM 03 Supplier recall/traceback not appropriately Sample Collection
addressed/not performed (Service collecting the samples)
IM 04 Product order incorrectly/not submitted to Events that occur during patient sample collection.
supplier SC 00 Detail not specified
IM 05 Outdated product in available inventory SC 01 Sample labeled with incorrect patient name
IM 06 Recalled/quarantined product in available SC 02 Not labeled
inventory 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

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

Sample Handling Sample Testing (continued)

(Service collecting the samples) ST 16 Reagents used were
Events that occur when a patient sample is sent for incorrect/inappropriate/expired/not properly
testing. QC’d
SH 00 Detail not specified ST 17 ABO/Rh error caught on final check
SH 01 Sample sent without requisition ST 18 Current/historical ABO/Rh mismatch
SH 02 Requisition and sample label don’t match ST 19 Additional testing not performed
SH 03 Patient ID incomplete/illegible on requisition ST 20 Confirmatory check incorrect/not performed (at
SH 04 No Patient ID on requisition time work performed)
SH 05 No phlebotomist/witness identification ST 21 Administrative check incorrect/not performed
SH 06 Sample sent with incorrect requisition type (record review/audit)
SH 07 Patient information (other than ID) ST 22 Sample storage incorrect/inappropriate
missing/incorrect on requisition
SH 08 Requisition sent without sample Product Manipulation/Processing/Testing
SH 09 Data entry incorrect/incomplete/not performed (Transfusion Service)
SH 10 Sample transport issue (e.g., sample Events that occur while testing, manipulating (e.g.,
broken/inappropriate conditions) pooling, washing, aliquoting, irradiating), processing,
SH 11 Duplicate sample sent in error or labeling blood products.
UM 00 Detail not specified
Sample Receipt UM 01 Data entry incomplete/incorrect/not performed
(Transfusion Service) UM 02 Record review incomplete/incorrect/not
Events that occur when a sample is received by the performed
transfusion service. UM 03 Incorrect product (type) selected
SR 00 Detail not specified UM 04 Incorrect product (patient) selected
SR 01 Sample accepted in error UM 05 Product labeled incorrectly (new/updated)
SR 02 Historical review incorrect/not performed UM 06 Computer warning overridden in error or
SR 03 Demographic review/ data entry incorrect/not outside SOP
performed UM 07 Special processing needs not checked
SR 04 Sample incorrectly accessioned UM 08 Special processing needs misunderstood or
misinterpreted
Sample Testing UM 09 Special processing needs performed
(Transfusion Service) incorrectly
Events that occur during patient sample testing by UM 10 Special processing needs not performed
the transfusion service. UM 11 Equipment problem/failure/not properly QC’d
ST 00 Detail not specified UM 12 Reagents used were
ST 01 Data entry incomplete/incorrect/not performed incorrect/inappropriate/expired/not properly
ST 02 Appropriate sample checks QC’d
incomplete/incorrect/not performed UM 13 Confirmatory check incorrect/not performed (at
ST 03 Computer warning overridden in error or time work performed)
outside SOP UM 14 Administrative check incorrect/not performed
ST 05 Sample test tube incorrectly accessioned (record review/audit)
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
ST 14 Sample testing performed incorrectly
ST 15 Sample test result misinterpreted

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

Request for Pick-up Satellite Storage

(Clinical Service) (Clinical Service)
Events that occur when the clinical service requests Events that occur while product is stored and
pick-up of a blood product from the transfusion handled by the clinical service.
service. CS 00 Detail not specified
RP 00 Detail not specified CS 01 Incorrect storage conditions of product in
RP 01 Request for pick-up on wrong patient clinical area
RP 02 Incorrect product requested for pick-up CS 02 Incorrect storage location in the clinical area
RP 03 Product requested prior to obtaining consent CS 03 Labeling issue (by clinical staff)
RP 04 Product requested for pick-up, but patient not CS 04 Floor/clinic did not check for existing products
available in their area
RP 05 Product requested for pick-up, but IV not ready CS 05 Product transport issues (to or between clinical
RP 06 Request for pick-up incomplete (e.g., patient areas)
ID/product type missing) CS 06 Monitoring of satellite storage
RP 07 Pick-up slip did not match patient information incorrect/incomplete/not performed
on product CS 07 Storage tracking/documentation
incorrect/incomplete/not performed
Product Issue
(Transfusion Service) Product Administration
Events that occur when the transfusion service (Clinical Service)
issues blood product to the clinical service. Events that occur during the administration of blood
UI 00 Detail not specified products.
UI 01 Data entry incomplete/incorrect/not performed UT 00 Detail not specified
UI 02 Record review incomplete/incorrect/not UT 01 Administered intended product to wrong patient
performed UT 02 Administered wrong product to intended patient
UI 03 Product issued for wrong patient UT 03 Transfusion not performed in error
UI 04 Product issued out of order UT 05 Bedside check (patient ID confirmation)
UI 05 Product issue delayed incomplete/not performed
UI 06 LIS warning overridden in error or outside SOP UT 06 Transfused product with unapproved IV fluid
UI 07 Computer issue not completed UT 07 Transfusion delayed beyond pre-approved
UI 08 Issued visibly defective product (e.g., timeframe
clots/aggregates/particulate matter) UT 09 Transfused unsuitable product (e.g.,
UI 09 Not/incorrect checking of unit and/or patient outdated/inappropriately stored)
information UT 10 Administered components in wrong order
UI 10 Product transport issues (e.g., delayed) by UT 11 Appropriate monitoring of patient not
transfusion service performed
UI 11 Unit delivered to incorrect location by UT 14 Transfusion volume too low (per order or SOP)
transfusion service UT 15 Transfusion volume too high (per order or
UI 12 Product transport issue (from transfusion SOP)
service to clinical area) UT 16 Transfusion rate too slow (per order or SOP)
UI 18 Wrong product issued for intended patient (e.g., UT 17 Transfusion rate too fast (per order or SOP)
incompatible) UT 18 Inappropriate preparation of product
UI 19 Inappropriate product issued for patient (e.g., UT 19 Transfusion protocol not followed (not
not irradiated, CMV+) otherwise specified)
UI 20 Confirmatory check incorrect/not performed (at UT 22 Order/consent check incorrect/not performed
time work performed) UT 23 Transfusion documentation
UI 21 Administrative check incorrect/not performed incorrect/incomplete/not performed
(record review/audit) UT 24 Transfusion documentation not returned to
UI 22 Issue approval not obtained/documented transfusion service
UI 23 Receipt verification not performed (pneumatic UT 26 Transfusion reaction protocol not followed
tube issue)
Other
MS 99 Other

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Hemovigilance Module Surveillance Protocol v2.6

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

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Occupation Codes
(continued)

Additional Occupation Types

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

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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.

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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. This form must be completed each month that surveillance is conducted and data can
only be entered once the calendar month is over. For instance, February data must be entered after
March 1st. Additionally, data cannot be entered for upcoming months.

Pathogen Reduced Blood Products

The total number of transfused units of blood components which are produced with pathogen-reduction
technology (PRT) should be reported each month, if applicable. These PRT units are reported in Table 2
and are a subset of total number of units and aliquots transfused that are reported in Table 1. Table 3
relates to pathogen reduced apheresis platelets, if reported in table 2. For more guidance please refer to
the Denominator QuickLearn on the NHSN Blood Safety Surveillance website.

Electronic Reporting
In January 2017, the NHSN Hemovigilance Module can accept electronically reported denominator data
via clinical documentation architecture (CDA). Compared to manual reporting, electronic reporting will
decrease the time required for data collection and reporting, reduce data entry errors, and increase data
granularity. In order to electronically report data, facilities’ software system must have CDA functionality.
For more information about electronic reporting and CDA, review CDA Frequently Asked Questions on
the NHSN Blood Safety Surveillance website.

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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