Blood Safety Surveillance

Training

• Facility Enrollment or Component Activation [PDF - 1.49 MB] Audience: Facilities interested in participating in the Hemovigilance Module.
• Surveillance Requirements and Data Reporting [PDF - 987 KB] Audience: Facilities participating in the Hemovigilance Module.
• Incident Reporting [PDF - 1.61 MB] Audience: Hemovigilance Module users that will be collecting and entering data on incidents related to blood transfusion.
• Adverse Reaction and Denominator Reporting [PDF - 1.18 MB] Audience: Hemovigilance Module users that will be collecting and entering data on blood transfusion recipient adverse reactions.
• Hemovigilance Module: Introduction to Analysis [PDF - 1.04 MB] Audience: Blood transfusion services personnel collecting and/or entering information on blood transfusion recipient adverse reactions. If you will be classifying or identifying adverse reactions you must view Adverse Reaction Case Definition Exercises first.
• Hemovigilance Module: Adverse Reaction Case Definition Exercises [PDF - 16.2MB]. Audience: Blood transfusion services personnel collecting and/or entering information on blood transfusion recipient adverse reactions. If you will be classifying or identifying adverse reactions you must view Adverse Reaction Case Definition Exercises first.

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Protocols

• NHSN Manual: Biovigilance Component Protocol [PDF - 326 KB] January 2013
  Guidelines and procedures for monitoring hemovigilance.
  
  Table of Contents:
  • Section 1. Hemovigilance Module Surveillance Overview [PDF - 326 KB]
  • Section 2. Hemovigilance Module Annual Facility Survey [PDF - 326 KB]
  • Section 3: Hemovigilance Module Adverse Reactions [PDF - 326 KB]
    • Adverse Reaction Case Classification Criteria Tables [PDF - 326 KB]
      • Transfusion-associated circulatory overload (TACO) [PDF - 326 KB]
      • Transfusion-related acute lung injury (TRALI) [PDF - 326 KB]
      • Transfusion-associated dyspnea (TAD) [PDF - 326 KB]
      • Allergic reaction [PDF - 326 KB]
      • Hypotensive transfusion reaction [PDF - 326 KB]
      • Febrile non-hemolytic transfusion reaction (FNHTR) [PDF - 326 KB]
      • Acute hemolytic transfusion reaction (AHTR) [PDF - 326 KB]
      • Delayed hemolytic transfusion reaction (DHTR) [PDF - 326 KB]
      • Delayed serologic transfusion reaction (DSTR) [PDF - 326 KB]
      • Transfusion-associated graft vs. host disease (TAGVHD) [PDF - 326 KB]
      • Post transfusion purpura (PTP) [PDF - 326 KB]
      • Transfusion-transmitted infection (TTI) [PDF - 326 KB]
      • Other/Unknown [PDF - 326 KB]
    • Adverse Reaction Glossary [PDF - 326 KB]
  • Section 4. Hemovigilance Module Incidents [PDF - 326 KB]
    • Incident Codes [PDF - 326 KB]
    • Occupation Codes [PDF - 326 KB]
    • Incident Glossary [PDF - 326 KB]
  • Section 5. Hemovigilance Module Denominators [PDF - 326 KB]

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Data Collection Forms

• 57.300 Hemovigilance Module Annual Facility Survey [PDF - 76 KB] January 2013
  • 57.300 Form Instructions [PDF - 88 KB]
• 57.301 Hemovigilance Module Monthly Reporting Plan [PDF - 30 KB] January 2013
  • 57.301 Form Instructions [PDF - 48 KB]
• 57.302 Hemovigilance Module Monthly Incident Summary [PDF - 73 KB] January 2013
  • 57.302 Form Instructions [PDF - 146 KB]
• 57.303 Hemovigilance Module Monthly Reporting Denominators [PDF - 36 KB] January 2013
  • 57.303 Form Instructions [PDF - 62 KB]
• 57.304 Hemovigilance Module Adverse Reaction [PDF - 86 KB] January 2013
  • 57.304 Form Instructions [PDF - 96 KB]
• 57.305 Hemovigilance Module Incident [PDF - 53 KB] January 2013
  • 57.305 Form Instructions [PDF - 76 KB]

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Supporting Materials

• CDC Location Labels and Location Descriptions [PDF - 250 KB] January 2013
• NHSN Key Terms [PDF - 418 KB] January 2013
• Biovigilance Component Alerts [PDF - 255 KB] Audience: To guide users on how to navigate the Incomplete/Missing List on the Action items tab (alerts).
• Activating the Biovigilance Component [PDF - 311 KB] Audience: To guide facilities that are already enrolled in NHSN in activating the Biovigilance Component and adding their first users.
• Hemovigilance Module: Customizing Forms [PDF - 248 KB] Audience: To guide users that wish to add custom fields (i.e. variables) to data collection forms in the Hemovigilance Module.
• Location Mapping in NHSN  [PDF - 244 KB] Audience: To guide users in adding and mapping facility locations.
• Linking Incident Records to Adverse Reaction Records in the Hemovigilance Module [PDF - 248 KB] Audience: To guide users on how to link Incident records to Adverse Reaction records in the Hemovigilance Module.
• Reporting No Events in a Month [PDF -168 KB] Audience: To guide users on how to report no adverse reaction or no incidents during a reporting month.
• Biovigilance Component - Variable Reference List [PDF - 326 KB]

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FAQs

• About the Hemovigilance Module
• CMS Hospital Inpatient Quality Reporting Program
• New NHSN agreement [PDF - 33 KB]

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