Appendix-G-BV-Protocol

NHSN Biovigilance Component
Protocol v1.3.1
www.cdc.gov/nhsn

Appendix G. Incident Definitions (Based on MERS-TM & TESS)
Incident Result
No Recovery, harm
A product related to this incident was transfused; the patient experienced an adverse reaction.
No Recovery, no harm
A product related to this incident was transfused; the patient did not experience an adverse reaction.
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.
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:
o Technical failures beyond the control and responsibility of the facility.
o Poor design of equipment, software, labels or forms.
o Designed correctly but not constructed properly or set up in accessible areas.
o Other material defects.
Organizational:
o Failure at an organizational level beyond the control and responsibility of the facility or department
where the incident occurred.
o Inadequate measures taken to ensure that situational or domain-specific knowledge or information
is transferred to new or inexperienced staff.
o Inadequate quality and/or availability of protocols or procedures within the department (e.g.,
outdated, too complicated, inaccurate, unrealistic, absent or poorly presented).
o 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:
o Human failures originating beyond the control and responsibility of the investigating organization.
This could include individuals in other departments.
o Inability of an individual to apply their existing knowledge to a novel situation.
o An incorrect fit between an individual’s training or education and a particular task.
o A lack of task coordination within a health care team.
o 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.
o Failure in monitoring a process or patient status.
o Failure in performing highly developed skills.
o Failure in whole body movements, e.g. slips, trips and falls.
Patient-related:
o Failures related to patient characteristics or conditions which are beyond the control of staff and
influence treatment.
Other:
o Cannot be classified under any of the other categories.

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