Welcome to the National Healthcare Safety Network, or NHSN, Quick Learn series.
This presentation will provide information on the Hemovigilance Module’s Medical Adverse
Reaction Form.
We will review the Hemovigilance Module program goals and the purpose of the Adverse Reaction
report.
We will show you where to find the adverse reaction form and demonstrate data entry.
NHSN is an internet-based surveillance system operated by CDC for the purpose of tracking
healthcare-associated infections.
The mission of NHSN has expanded to include tracking of multidrug-resistant organisms,
healthcare personnel safety and vaccination compliance, and transfusion-related adverse
events.
The Biovigilance Component, which includes the Hemovigilance Module, is one of the five
components of the NHSN.
There are no fees for healthcare facilities to participate in NHSN or NHSN related activities,
including facility enrollment.
In addition, there is no cost to participating facilities for ongoing user support by CDC
staff, including assistance with facility enrollment, training, and analysis.
The goals of the NHSN Hemovigilance Module are to provide a systematic method for monitoring
transfusion-related adverse reactions and incidents, estimate the burden of transfusion
reactions, and identify emerging threats to blood safety with the ultimate goal of improving
patient safety and minimizing morbidity and mortality among transfusion recipients.
The NHSN Hemovigilance Module collects data through five forms, including the Adverse
Reaction form.
An adverse reaction is an undesirable response or effect in a patient that is associated
with the administration of blood or blood components.
It may or may not be the result of an incident.
Each transfusion-associated adverse reaction must be classified according to the reaction-specific
case definition, severity, and imputability criteria.
Every facility must classify adverse reactions according to protocol definitions.
Whether or not the transfused product is “Implicated” should be determined independently from their
case definition and imputability criteria.
There are twelve different reportable adverse reactions that might be associated with a
transfusion.
The Adverse Reaction Form is shown on the left.
The form’s corresponding Table of Instructions is shown on the right.
You can find a detailed description of the form in the Table of Instructions.
You can access these forms with the URLS at the top of the slide.
The Adverse Reaction form is used by CDC for national analyses to calculate rates of transfusion
reactions.
The Adverse Reaction Report form is entered within 30 days of the reaction and must be
completed for each adverse reaction that meets protocol criteria to be included in aggregated
national analysis.
The Adverse Reaction form captures data on patient information, reaction details, medical
history, signs and symptoms, investigation results, patient treatment and outcome, and
component details.
The Internal Adverse Reaction Investigation Report serves as a source to complete this
form.
An asterisk indicates a required field.
If a patient experiences more than one adverse reaction during or following the same transfusion
episode, complete a separate form for each reaction.
Adverse reactions with an imputability of “doubtful” or “ruled out” do not need
to be reported.
The Adverse Reaction Form has seven sections: Patient Information, Patient Medical History,
Reaction Details, Investigation Results, Patient Treatment, Outcome, and Component Details.
Let’s walk through each section.
The Patient Information section includes the patient’s demographic characteristics as
well as the primary reason for transfusion.
Dropdown menus with the ICD-10-CM codes are used to enter the information into the Medical
History.
This section collects pertinent information about a patient’s admitting diagnosis, underlying
indication for transfusion, relevant comorbid conditions at the time of the transfusion
related to the adverse reaction, and relevant past medical procedures.
For more information about entering medical history and using ICD-10-CM codes, review
the Medical History QuickLearn.
The Transfusion History section captures information regarding previous transfusions.
The Reaction Details section captures timing and location of the adverse reaction that
occurred.
Users should link the adverse reaction with a previously reported incident.
The Investigation Results section includes manifested clinical symptoms, type of adverse
reaction, and classification criteria for the reaction – the specific case definition,
severity and imputability.
The Patient Treatment section includes information regarding treatment the patient received for
the transfusion reaction.
The Outcome section provides information about the patient’s death, if death occurred,
and the possible association between the outcome and the transfusion.
The Component Details section captures the information that identifies the compatibility
of the transfusion unit that caused the reaction.
After all the data has been entered, click Save.
Custom fields are variables that a facility can create and use for event or procedure-specific
data to get additional information.
Custom fields are for internal use.
Only facility users with Administrative rights can add custom fields.
The system allows up to 50 custom fields, including date, numeric, or alphanumeric fields.
Entering data in custom fields is optional.
Data entered in custom fields will not be analyzed by the CDC.
To access the Adverse Reaction form go to c-d-c dot-gov-slash-n-h-s-n and click on Reporting
and Surveillance for Enrolled Facilities near the bottom of the page.
Click on Acute Care Hospitals and Facilities, scroll down, and select Blood Safety Surveillance.
Then click the Data Collection Forms drop down menu and choose Adverse Reaction form.
Each form has a corresponding customizable version and
table of instructions.
For more information, visit CDC-dot-gov-slash-NHSN.
For questions, e-mail NHSN at CDC-dot-gov
and include Hemovigilancein the subject line